Download PLR Article Directory Trinidad and Tobago: April 2012

Thursday 26 April 2012

Trac Tabs

Generic Name: atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid (Oral route)

AT-roe-peen SUL-fate, hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, ben-ZOE-ik AS-id

Commonly used brand name(s)

In the U.S.

Prosed EC

Trac Tabs

Urised

Available Dosage Forms:

Tablet

Tablet, Enteric Coated

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Atropine

Chemical Class: Salicylate, Non-Aspirin

Uses For Trac Tabs

Atropine , hyoscyamine , methenamine , methylene blue, phenyl salicylate , and benzoic acid combination medicine is an anticholinergic, anti-infective, and analgesic. It is given by mouth to help relieve the discomfort caused by urinary tract infections; however, it will not cure the infection itself. This combination medicine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Trac Tabs

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Unusual excitement, nervousness, restlessness or irritability, and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of atropine and hyoscyamine (contained in this combination medicine). Also, when atropine and hyoscyamine are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects.

Geriatric

Confusion or memory loss, constipation, difficult urination, excitement, agitation, drowsiness, or dryness of mouth may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of atropine and hyoscyamine. Also, this combination medicine may cause eye pain in patients who have untreated glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Benzoic Acid

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Methylene BlueBenzyl BenzoateMethenamineAtropineHyoscyamine

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ambenonium

Amitriptyline

Amoxapine

Bupropion

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Isocarboxazid

Linezolid

Maprotiline

Mirtazapine

Nortriptyline

Paroxetine

Phenelzine

Potassium

Protriptyline

Selegiline

Sertraline

Tranylcypromine

Trimipramine

Venlafaxine

Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Buspirone

Nefazodone

Trazodone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Arbutamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

This section provides information on the proper use of a number of products that contain atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid. It may not be specific to Trac Tabs. Please read with care.

While you are taking this combination medicine, it is important for your urine to be acidic. To do this, your doctor may recommend that you eat more protein and such foods as cranberries (especially cranberry juice with vitamin C added), plums, or prunes. You should avoid foods that make the urine more alkaline, such as most fruits (especially citrus fruits and juices), milk, and other dairy products.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Each dose should be taken with a full glass (8 ounces) of water or other liquid (except citrus juices and milk). Drink plenty of water or other liquids every day, unless otherwise directed by your doctor. Drinking enough liquids will help your kidneys work better and lessen your discomfort.

To help clear up your infection completely, keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

In order for this medicine to work well, your urine must be acid (pH 5.5 or below). To make sure that your urine is acid:

Before you start taking this medicine, check your urine with phenaphthazine paper or another test to see if it is acid. If you have any questions about this, check with your health care professional.

You may need to change your diet; however, check with your doctor first if you are on a special diet (for example, for diabetes). To help make your urine more acid you should avoid most fruits (especially citrus fruits and juices), milk and other dairy products, and other foods which make the urine more alkaline. Eating more protein and foods such as cranberries (especially cranberry juice with vitamin C added), plums, or prunes may also help. If your urine is still not acid enough, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For relief of urinary tract symptoms:
  - Adults and children 12 years of age and older—1 to 2 tablets four times a day.
  - Children 6 to 12 years of age—Dose must be determined by the doctor.
  - Children up to 6 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Trac Tabs

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

This medicine may cause some people to have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If your vision continues to be blurred, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take this medicine within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and this medicine too close together may prevent this medicine from working properly.

Trac Tabs Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Blurred vision

eye pain

skin rash or hives

Symptoms of overdose

Blood in urine and/or stools

diarrhea

dizziness

drowsiness (severe)

fast heartbeat

flushing or redness of face

headache (severe or continuing)

lower back pain

pain or burning while urinating

ringing or buzzing in the ears

shortness of breath or troubled breathing

sweating

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Difficult urination (more common with large doses taken over a prolonged period of time)

dryness of mouth, nose, or throat

nausea or vomiting

stomach upset or pain (more common with large doses taken over a prolonged period of time)

This medicine may cause your urine and/or stools to turn blue or blue-green. This is to be expected while you are taking this medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Trac Tabs resources

Trac Tabs Use in Pregnancy & Breastfeeding
Trac Tabs Drug Interactions
Trac Tabs Support Group
16 Reviews for Trac Tabs - Add your own review/rating

Compare Trac Tabs with other medications

Urinary Tract Infection

Wednesday 25 April 2012

Haemonine 500 / Haemonine 1000

1. Name Of The Medicinal Product

Haemonine^® 500

Haemonine^® 1000

Powder and solvent for solution for injection

2. Qualitative And Quantitative Composition

Human plasma derived coagulation factor IX;

Haemonine^® 500 / Haemonine^® 1000 is presented as a powder and solvent for solution for injection containing either 500 or 1000 IU human coagulation factor IX per vial.

When reconstituted with either 5 ml or 10 ml water for injections, Haemonine^® 500 / Haemonine^® 1000 contains approximately 100 IU/ml human coagulation factor IX.

The potency (IU) is determined using the European Pharmacopoeia one stage clotting test. The specific activity of Haemonine^® 500 / Haemonine^® 1000 is

Excipients: The reconstituted product contains 0.19 mmol (4.37 mg) sodium per ml. For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

4.2 Posology And Method Of Administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.

Posology

The dosage and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient´s clinical condition. The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products. Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma). One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.

The calculation of the required dosage of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1-2 % of normal activity. The required dosage is determined using the following formula:

Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.8

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case. Factor IX products rarely require to be administered more than once daily.

In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or in IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Degree of haemorrhage/ Type of surgical procedure	Factor IX level required (%) (IU/dl)	Frequency of doses (hours)/Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleeding or oral bleeding	20 - 40	Repeat every 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma	30 - 60	Repeat infusion every 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages	60 - 100	Repeat infusion every 8 to 24 hours until threat is resolved.
Surgery
Minor including tooth extraction	30 - 60	Every 24 hours, at least 1 day, until healing is achieved.
Major	80 - 100 (pre- and post-operative)	Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30 to 60% (IU/dl).

During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable. Individual patients may vary in their response to factor IX, achieving different levels of in vivo recovery and demonstrating different half-lives.

For long term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 30 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

There are insufficient data to recommend the use of Haemonine^® 500 / Haemonine^® 1000 in children less then 6 years of age. Patients should be monitored for the development of factor IX inhibitors. If the expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor IX inhibitor is present. In patients with high levels of inhibitor, F IX therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of patients with haemophilia. See also 4.4.

Method of administration

Dissolve the preparation as described in Section 6.6. The product should be administered via the intravenous route. It is recommended to not exceed a maximal infusion rate of 5 ml/min.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients or to heparin.

4.4 Special Warnings And Precautions For Use

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor IX. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. In case of shock, the current medical standards for shock-treatment should be observed.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor IX products.

After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.

There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.

Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.

Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the risk being higher in low purity preparations, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC). Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC. In each of these situations, the benefit of treatment with Haemonine^® 500 / Haemonine^® 1000 should be weighed against the risk of these complications.

This medicinal product contains a maximum of 4.9 mmol (113 mg) sodium per standard dose of 2000 IU. To be taken into consideration by patients on a controlled sodium diet.

It is strongly recommended that every time that Haemonine^® 500 / Haemonine^® 1000 is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions of human coagulation factor IX products with other medicinal products are known.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with factor IX. Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available. Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

• Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, fever, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently in patients treated with factor IX containing products. In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).

• Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.

• On rare occasions fever has been observed.

• Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

There is no experience with previously untreated patients (PUPs) so far.

During clinical development no factor IX inhibitor induction was observed in previously treated patients (PTPs, n=36) during 1,493 exposure days.

• There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with such side effects.

• Haemonine^® 500 / Haemonine^® 1000 may contain traces of heparin below the limit of quantitation (0.1 IU/ml) which may cause allergic reactions and reduced blood cell counts which may affect the blood clotting system. Patients with a history of heparin-induced allergic reactions should avoid the use of heparin-containing medicines.

For the evaluation of undesirable reactions of Haemonine^®, the following frequencies were used:

Very common:
Common:
Uncommon:
Rare:
Very rare:	<1/10,000

The following adverse reactions have been reported from patients in clinical studies (1,493 exposure days):

MedDRA Standard System Organ Class	Adverse reactions	Frequency
General disorders and administration site conditions	Feeling cold	rare
Respiratory, thoracic and mediastinal disorders	Dyspnoe	rare

For safety with respect to transmissible agents see 4.4.

4.9 Overdose

No symptoms of overdose with human coagulation factor IX have been reported.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: antihemorrhagics: blood coagulation factor IX.

ATC code: B02BD04.

Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed. Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

There are insufficient data to recommend the use of Haemonine^® 500 / Haemonine^® 1000 in children less than 6 years of age.

5.2 Pharmacokinetic Properties

A pharmacokinetic study with 13 patients yielded the following results:

Using a biphasic model the mean initial half-life was 2.2 ± 1.9 h at initial visit and 3.1 ± 2.9 h at month 3, respectively. The mean terminal half-life was calculated as 28.5 ± 12.1 h at initial visit and 30.1 ± 14.7 h at month 3. The incremental recovery of Haemonine^® was 69.8 ± 21.6 % and 72.2 ± 22.2 % at initial visit and at month 3, respectively. This corresponded to an incremental recovery of 0.015 ± 0.005 IU/ml/IU/kg body weight at initial visit and of 0.016 ± 0.005 IU/ml/IU/kg body weight at month 3. Other pharmacokinetic parameters of Haemonine^® are: Area under the curve (AUC): about 25 IU · h/ml; Mean residence time (MRT): about 33 h; Clearance: about 200 ml/h.

5.3 Preclinical Safety Data

The preparation contains exclusively human plasma derived proteins, namely high purity coagulation factor IX, which is identical with the endogenous factor IX.

Preclinical studies in an Ames test showed no mutagenic potential of the preparation.

Haemonine^® was tested for abnormal toxicity and thrombogenic potential in different rabbit models. The results revealed no signs for toxicological or thrombogenic potential.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Powder:

arginine

lysine

sodium chloride

sodium citrate

Solvent:

water for injections.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some injection equipment.

6.3 Shelf Life

2 years

The product should be used immediately after reconstitution.

6.4 Special Precautions For Storage

Do not store above 25°C.

Do not freeze.

Keep the vials in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

1 package Haemonine ^® 500 contains:

1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)

1 vial with solvent (5 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains:

1 disposable syringe (5 ml), 1 double-filter transfer system, 1 butterfly cannula.

1 package Haemonine ^® 1000 contains:

1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)

1 vial with solvent (10 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains:

1 disposable syringe (10 ml), 1 double-filter transfer system, 1 butterfly cannula.

Further package sizes:

1 package Haemonine ^® 250 contains:

1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)

1 vial with solvent (5 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains:

1 disposable syringe (5 ml), 1 double-filter transfer system, 1 butterfly cannula.

6.6 Special Precautions For Disposal And Other Handling

Absolute sterility is to be ensured in all steps of the procedure !

Dissolution of the concentrate:

• Warm the solvent (water for injections) and powder to room temperature in the unopened vials; this temperature (max. 35°C) is to be maintained during the dissolution process (about 10 minutes). If a water bath is used for warming, it must be strictly ensured that the water does not come into contact with the caps or stoppers of the vials. Otherwise the medicinal product could be contaminated. Remove the caps from both vials in order to expose the central portions of the rubber stoppers.

• Clean the stoppers with a disinfectant.

• Pull off the closure of the packaging of the transfer system pack.

With the water bottle standing upright, place the open side of the pack (blue part of the transfer system) onto the water bottle.

• Remove the packaging. This exposes the transparent part of the transfer system.

• Turn the combination of transfer system and water vial upside down and, with the vial of dry substance standing upright, push the transparent part of the transfer system into the dry substance vial.

The vacuum present in the dry substance vial causes the water to run into this vial.

Unscrew the blue part of the transfer system together with the water vial.

Gently rocking the vial with product helps to dissolve the dry substance. Do not shake vigorously, all foaming is to be avoided ! The solution should be clear or slightly opalescent.

• The solution ready for use should be used immediately after dissolving. Do not use solutions that are cloudy or have deposits.

Injection:

• Once you have dissolved the dry substance as described above, screw the enclosed syringe with its Luer-Lock connector onto the substrate vial with the transparent part of the transfer system.

This will allow you to draw the dissolved preparation easily into the syringe. A separate filter is unnecessary because the transfer system has its own integral filter.

• Carefully unscrew the bottle with the transparent part of the transfer system and inject the injection preparation slowly intravenously using the enclosed butterfly needle.

Injection rate: 2 – 3 ml/minute.

After the butterfly needle has been used, it can be made safe with the protective cap.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Biotest Pharma GmbH

Landsteinerstrasse 5

63303 Dreieich

Germany

Phone: +49 6103 801-0

Fax: +49 6103 801-150

8. Marketing Authorisation Number(S)

PL 04500/0008

9. Date Of First Authorisation/Renewal Of The Authorisation

19/12/2008

10. Date Of Revision Of The Text

19/12/2008

Tuesday 24 April 2012

Cortomycin Suspension

Generic Name: neomycin, polymyxin B, and hydrocortisone ophthalmic (NEE oh MYE sin, POL ee MIX in, HYE droe KOR ti sone off THAL mik)

Brand Names:

What is neomycin, polymyxin B and hydrocortisone ophthalmic?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Hydrocortisone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin, polymyxin B and hydrocortisone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B and hydrocortisone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about neomycin, polymyxin B and hydrocortisone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not use neomycin, polymyxin B and hydrocortisone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin, polymyxin B and hydrocortisone ophthalmic?

Use neomycin, polymyxin B and hydrocortisone eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops.

To apply the eyedrops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store neomycin, polymyxin B and hydrocortisone ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin, polymyxin B and hydrocortisone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Neomycin, polymyxin B and hydrocortisone ophthalmic side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect neomycin, polymyxin B and hydrocortisone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin, polymyxin B and hydrocortisone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Cortomycin Suspension resources

Cortomycin Suspension Side Effects (in more detail)
Cortomycin Suspension Use in Pregnancy & Breastfeeding
Cortomycin Suspension Drug Interactions
Cortomycin Suspension Support Group
0 Reviews for Cortomycin - Add your own review/rating

Cortisporin Ophthalmic Suspension Prescribing Information (FDA)

Cortisporin Ophthalmic Suspension Drops Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cortomycin Suspension with other medications

Blepharitis
Conjunctivitis, Bacterial
Keratitis
Keratoconjunctivitis
Uveitis

Where can I get more information?

Your pharmacist has additional information about neomycin, polymyxin B and hydrocortisone written for health professionals that you may read.

See also: Cortomycin side effects (in more detail)

Saturday 21 April 2012

Tylenol with Codeine No. 3

Generic Name: acetaminophen and codeine (Oral route)

a-seet-a-MIN-oh-fen, KOE-deen FOS-fate

Oral route(Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product .

Commonly used brand name(s)

In the U.S.

APAP w/Codeine

Capital w/Codeine

Pyregesic-C

Tylenol w/Codeine

Tylenol w/Codeine #3

Tylenol w/Codeine #4

Tylenol with Codeine No. 3

Vopac

Available Dosage Forms:

Tablet

Capsule

Elixir

Suspension

Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Tylenol with Codeine No. 3

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Tylenol with Codeine No. 3

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acetaminophen and codeine oral suspension in children younger than 3 years of age. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Dezocine

Diazepam

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pentazocine

Pentobarbital

Phenobarbital

Prazepam

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiopental

Triazolam

Acenocoumarol

Carbamazepine

Isoniazid

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Ethanol

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Tylenol with Codeine No. 3. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

For oral dosage form (suspension):
- For mild to moderate pain:
  - Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.
  - Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.
  - Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.
  - Children younger than 3 years of age—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For mild to moderately severe pain:
  - Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tylenol with Codeine No. 3

It is very important that your doctor check the progress of you or your child while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, especially those containing acetaminophen (Tylenol (R)), and herbal or vitamin supplements.

Tylenol with Codeine No. 3 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficult or troubled breathing

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

shortness of breath

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

cough or hoarseness

difficulty with swallowing

dizziness

fast heartbeat

fever with or without chills

general feeling of tiredness or weakness

hives

itching

lower back or side pain

painful or difficult urination

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

tightness in the chest

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain

bloody or cloudy urine

chills

constricted, pinpoint, or small pupils (black part of the eye)

convulsion

dark urine

headache

increased sweating

light-colored stools

loss of appetite

loss of consciousness

nausea

sudden decrease in the amount of urine

unpleasant breath odor

vomiting

vomiting of blood

yellow eyes or skin

More common

Drowsiness

lightheadedness

relaxed and calm

sleepiness

Incidence not known

Difficulty having a bowel movement (stool)

false or unusual sense of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tylenol with Codeine No. 3 side effects (in more detail)

More Tylenol with Codeine No. 3 resources

Tylenol with Codeine No. 3 Side Effects (in more detail)
Tylenol with Codeine No. 3 Use in Pregnancy & Breastfeeding
Drug Images
Tylenol with Codeine No. 3 Drug Interactions
Tylenol with Codeine No. 3 Support Group
28 Reviews for Tylenol with Codeine No. 3 - Add your own review/rating

Compare Tylenol with Codeine No. 3 with other medications

Cough
Osteoarthritis
Pain

Wednesday 18 April 2012

Lac-Hydrin Cream

Pronunciation: LACK-tick ASS-id
Generic Name: Lactic Acid
Brand Name: Examples include AmLactin and Lac-Hydrin

Lac-Hydrin Cream is used for:

Treating mild to severe forms of dry, scaly skin.

Lac-Hydrin Cream is a humectant. Exactly how it works is unknown but it increases the amount of water in the skin, making it softer and more pliable.

Do NOT use Lac-Hydrin Cream if:

you are allergic to any ingredient in Lac-Hydrin Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lac-Hydrin Cream:

Some medical conditions may interact with Lac-Hydrin Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Lac-Hydrin Cream. Because little, if any, of Lac-Hydrin Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lac-Hydrin Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lac-Hydrin Cream:

Use Lac-Hydrin Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Apply Lac-Hydrin Cream to the affected area and rub in thoroughly twice daily or as directed by your health care provider.

Wash your hands immediately after using Lac-Hydrin Cream, unless your hands are part of the treated area.

If you miss a dose of Lac-Hydrin Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Lac-Hydrin Cream.

Important safety information:

Lac-Hydrin Cream may cause stinging or burning when applied to cracked or scraped skin (eg, after shaving).

Lac-Hydrin Cream is for external use only. Avoid contact with the eyes, lips, or mucous membranes.

Lac-Hydrin Cream may be harmful if swallowed. If you or someone you know may have taken Lac-Hydrin Cream by mouth, contact your local poison control center or emergency room immediately.

Overuse of topical products may worsen your condition.

Lac-Hydrin Cream may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Lac-Hydrin Cream. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Lac-Hydrin Cream during pregnancy. It is unknown if Lac-Hydrin Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Lac-Hydrin Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Lac-Hydrin Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; dry skin; flushing; irritation; itching; rash; stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); worsening of condition.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lac-Hydrin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Lac-Hydrin Cream may be harmful if swallowed.

Proper storage of Lac-Hydrin Cream:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep Lac-Hydrin Cream out of the reach of children and away from pets.

General information:

If you have any questions about Lac-Hydrin Cream, please talk with your doctor, pharmacist, or other health care provider.

Lac-Hydrin Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lac-Hydrin Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Lac-Hydrin resources

Lac-Hydrin Side Effects (in more detail)
Lac-Hydrin Use in Pregnancy & Breastfeeding
Lac-Hydrin Support Group
0 Reviews for Lac-Hydrin - Add your own review/rating

Compare Lac-Hydrin with other medications

Dry Skin
Pityriasis rubra pilaris

Idroxocobalamina

Idroxocobalamina may be available in the countries listed below.

Ingredient matches for Idroxocobalamina

Hydroxocobalamin

Idroxocobalamina (DCIT) is known as Hydroxocobalamin in the US.

International Drug Name Search

Glossary

DCIT

Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Saturday 14 April 2012

Isorythm LP

Isorythm LP may be available in the countries listed below.

Ingredient matches for Isorythm LP

Disopyramide

Disopyramide phosphate (a derivative of Disopyramide) is reported as an ingredient of Isorythm LP in the following countries:

France

International Drug Name Search

Hespan

hetastarch in sodium chloride

Dosage Form: injection, solution
Hespan®

(6% hetastarch in 0.9% sodium chloride injection)

Hespan Description

Hespan® (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains:

Hetastarch.............................................................................................................6 g

Sodium Chloride, USP..........................................................................................0.9 g

Water for Injection, USP...........................................................................................qs

pH adjusted with Sodium Hydroxide, NF if necessary

Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154

pH: approximately 5.9 with negligible buffering capacity

Calc. Osmolarity: approximately 309 mOsM

Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. Hetastarch is characterized by its molar substitution and also by its molecular weight. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is an average of approximately one α-1,6 branching point for every 20 glucose monomer units.

The chemical name for hetastarch is hydroxyethyl starch.

The structural formula is as follows:

Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units.

Hespan® is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident.

The Excel® Container is Latex-free; PVC-free; and DEHP-free.

The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector.

Hespan - Clinical Pharmacology

The plasma volume expansion produced by Hespan® approximates that of 5% Albumin (Human). Intravenous infusion of Hespan® results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular status.

Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of Hespan® (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours. This is a variable process but generally results in an intravascular hetastarch concentration of less than 10% of the total dose injected by two weeks. A study of the biliary excretion of Hespan® in 10 healthy males accounted for less than 1% of the dose over a 14 day period. The hydroxyethyl group is not cleaved by the body but remains intact and attached to glucose units when excreted. Significant quantities of glucose are not produced as hydroxyethylation prevents complete metabolism of the smaller polymers.

The addition of hetastarch to whole blood increases the erythrocyte sedimentation rate. Therefore, Hespan® is used to improve the efficiency of granulocyte collection by centrifugal means.

In randomized, controlled, comparative studies of Hespan® (6% hetastarch in 0.9% sodium chloride injection) (n=92) and Albumin (n=85) in surgical patients, no patient in either treatment group had a bleeding complication and no significant difference was found in the amount of blood loss between the treatment groups.1–4

Indications and Usage for Hespan

Hespan® is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma.

The adjunctive use of Hespan® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

Contraindications

Hespan® is contraindicated in patients with known hypersensitivity to hydroxyethyl starch. It is also contraindicated in clinical conditions where volume overload is a potential problem, such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia.

Patients with pre-existing coagulation or bleeding disorders should not be given Hespan®.

Warnings

Life threatening anaphylactic/anaphylactoid reactions have been rarely reported with Hespan®; death has occurred, but a causal relationship has not been established. Patients who develop severe anaphylactic/anaphylactoid reactions may need continued supportive care until symptoms have resolved.

Hypersensitivity reactions can occur even after Hespan® has been discontinued.

Usage in Plasma Volume Expansion

Hespan® has not been adequately evaluated to establish its safety in situations other than treatment of hypovolemia in elective surgery.

Large volumes of Hespan® may transiently alter the coagulation mechanism due to hemodilution and a direct inhibitory action on Factor VIII. Administration of volumes of Hespan® that are greater than 25% of the blood volume in less than 24 hours may cause significant hemodilution reflected by lower hematocrit and plasma protein values. Administration of packed red cells, platelets, or fresh frozen plasma should be considered if clinically indicated.

Hespan® is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. However, this risk of bleeding diminished within hours.5–6

Hematocrit may be decreased and plasma proteins diluted excessively by administration of large volumes of Hespan®. Administration of packed red cells, platelets, and fresh frozen plasma should be considered if excessive dilution occurs.

Use over extended periods: Hespan® has not been adequately evaluated to establish its safety in situations other than leukapheresis that require frequent use of colloidal solutions over extended periods. In some cases, hetastarch has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand's-like syndrome and/or Factor VIII deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve. Certain conditions may affect the safe use of Hespan® on a chronic basis. For example, in patients with subarachnoid hemorrhage where Hespan® is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur. Intracranial bleeding resulting in death has been reported.7

Usage in Leukapheresis

Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using Hespan® due to the volume expanding effects of hetastarch and to the collection of platelets and erythrocytes. Hemoglobin levels usually return to normal within 24 hours. Hemodilution by Hespan® may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels. None of these decreases are to a degree recognized to be clinically significant risks to healthy donors.

Precautions

General

If administration is by pressure infusion, all air should be withdrawn or expelled from the bag through the medication port prior to infusion.

Caution should be used when administering Hespan® to patients allergic to corn because such patients can also be allergic to hetastarch.

If a hypersensitivity effect occurs, administration of the drug should be discontinued and appropriate treatment and supportive measures should be undertaken (see WARNINGS).

When using Hespan® for plasma volume expansion, caution should be taken to avoid excessive hemodilution and circulatory overload especially in those patients at risk for developing congestive heart failure and pulmonary edema. Hespan® is primarily excreted via the kidneys so caution should be exercised in patients who have impaired renal function. Although the risk of circulatory overload is largely dependent on the clinical circumstances, use of doses higher than 20 mL/kg/24h will increase the risk significantly. Increased risk of coagulation abnormalities and bleeding is also associated with higher doses. Patients vital signs and hemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time should be monitored closely.

Hespan® should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system.

Regular and frequent clinical evaluation and complete blood counts (CBC) are necessary for proper monitoring of Hespan® use during leukapheresis. If the frequency of leukapheresis is to exceed the guidelines for whole blood donation, you may wish to consider the following additional tests: total leukocyte and platelet counts, leukocyte differential count, hemoglobin and hematocrit, prothrombin time (PT), and partial thromboplastin time (PTT).

Indirect bilirubin levels of 8.3 mg/L (normal 0.0–7.0 mg/L) have been reported in 2 out of 20 normal subjects who received multiple infusions of Hespan® (6% hetastarch in 0.9% sodium chloride injection). Total bilirubin was within normal limits at all times; indirect bilirubin returned to normal by 96 hours following the final infusion. The significance, if any, of these elevations is not known; however, caution should be observed before administering Hespan® to patients with a history of liver disease.

Elevated serum amylase levels may be observed temporarily following administration of Hespan® although no association with pancreatitis has been demonstrated. Serum amylase levels cannot be used to assess or to evaluate for pancreatitis for 3–5 days after administration of Hespan®. Elevated serum amylase levels persist for longer periods of time in patients with renal impairment. Hetastarch has not been shown to increase serum lipase.

One report suggests that in the presence of renal glomerular damage, larger molecules of Hespan® can leak into the urine and elevate the specific gravity. The elevation of specific gravity can obscure the diagnosis of renal failure.

Hespan® is not eliminated by hemodialysis. The utility of other extracorporeal elimination techniques has not been evaluated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies of animals have not been performed to evaluate the carcinogenic potential of hetastarch.

Teratogenic Effects

Pregnancy Category C

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. There are no adequate and well-controlled studies in pregnant women. Hespan® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hespan® is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of Hespan® in pediatric patients have not been conducted. However, in one small double-blind study, 47 infants, children, and adolescents (ages 1 year to 15.5 years) scheduled for repair of congenital heart disease with moderate hypothermia were randomized to receive either Hespan® or Albumin as a postoperative volume expander during the first 24 hours after surgery. Thirty-eight children required colloid replacement therapy, of which 20 children received Hespan®. No differences were found in the coagulation parameters or in the amount of replacement fluids required in the children receiving 20 mL/kg or less of either colloid replacement therapy. In children who received greater than 20 mL/kg of Hespan®, an increase in prothrombin time was demonstrated (p=0.006).8 There were no neonates included in this study.

Adverse Reactions

Reported adverse reactions with hetastarch include:

General

Hypersensitivity (see WARNINGS).

Death, life-threatening anaphylactic/anaphylactoid reactions, cardiac arrest, ventricular fibrillation, severe hypotension, non-cardiac pulmonary edema, laryngeal edema, bronchospasm, angioedema, wheezing, restlessness, tachypnea, stridor, fever, chest pain, bradycardia, tachycardia, shortness of breath, chills, urticaria, pruritus, facial and periorbital edema, coughing, sneezing, flushing, erythema multiforme, and rash.

Cardiovascular

Circulatory overload, congestive heart failure, and pulmonary edema (see PRECAUTIONS).

Hematologic

Intracranial bleeding, bleeding and/or anemia due to hemodilution (see WARNINGS) and/or Factor VIII deficiency, acquired von Willebrand's-like syndrome, and coagulopathy including rare cases of disseminated intravascular coagulopathy and hemolysis.

Metabolic

Metabolic acidosis.

Other

Vomiting, peripheral edema of the lower extremities, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, and muscle pains.

Hydroxyethyl starch-associated pruritus has been reported in some patients with deposits of hydroxyethyl starch in peripheral nerves.

Hespan Dosage and Administration

Dosage for Acute Use in Plasma Volume Expansion

Hespan® is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration.

Adults

The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required although higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred (see WARNINGS and PRECAUTIONS).

Pediatric Patients

Adequate, well-controlled clinical trials to establish the safety and effectiveness of Hespan® in pediatric patients have not been conducted (see PRECAUTIONS, Pediatric Use).

Dosage in Leukapheresis

250 to 700 mL of Hespan® (6% hetastarch in 0.9% sodium chloride injection) to which citrate anticoagulant has been added is typically administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The Hespan® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

When stored at room temperature, Hespan® admixtures of 500–560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.

General Recommendations

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

If administration is by pressure infusion, all air should be withdrawn or expelled from the bag through the medication port prior to infusion.

The safety and compatibility of other additives have not been established.

Directions for Use of EXCEL® Container

Caution: Before administering to the patient, review these directions:

Visual Checking

Do not remove the plastic infusion container from its overwrap until immediately before use.

While the overwrap is intact, identify the solution as Hespan®, the lot number, and the expiration date.

Check that the solution is clear.

Inspect the intact unit for signs of obvious damage. If present, the unit should not be used.

Removal of Overwrap

To open overwrap, tear at any notch located at either end of unit. After removing the overwrap, check for any leakage by squeezing container firmly. If any leaks are found, discard unit as sterility may be impaired.

Preparation for Administration (Use aseptic technique.)

Close flow control clamp of administration set.

Twist off plug from port designated "Infusion Set Port".

Insert spike of infusion set into port with a twisting motion until the set is firmly seated.

Suspend container from hanger.

Follow manufacturer's recommended procedures for the administration set.

Discontinue administration and notify physician immediately if patient exhibits signs of adverse reactions.

How is Hespan Supplied

Hespan® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.

NDC	Cat. No.	Size
Hespan® (6% hetastarch in 0.9% sodium chloride injection)
0264-1965-10	L6511	500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Revised: September 2010

References

Diehl J., et al., Clinical Comparison of Hetastarch and Albumin in Postoperative Cardiac Patients. The Annals of Thoracic Surgery, 1982;34(6):674–679.

Gold M., et al., Comparison of Hetastarch to Albumin for Perioperative Bleeding in Patients Undergoing Abdominal Aortic Aneurysm Surgery. Annals of Surgery, 1990;211(4):482–485.

Kirklin J., et al., Hydroxyethyl Starch versus Albumin for Colloid Infusion Following Cardiopulmonary Bypass in Patients Undergoing Myocardial Revascularization. The Annals of Thoracic Surgery, 1984;37(1):40–46.

Moggio RA., et al., Hemodynamic Comparison of Albumin and Hydroxyethyl Starch in Postoperative Cardiac Surgery Patients. Critical Care Medicine, 1983;11(12):943–945.

Knutson JE., et al., Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery? Anesthesia Analg., 2000;90:801–7.

Cope JT., et al., Intraoperative Hetastarch Infusion Impairs Hemostasis After Cardiac Operations. The Annals of Thoracic Surgery, 1997;63:78–83.

Damon L., Intracranial Bleeding During Treatment with Hydroxyethyl Starch. New England Journal of Medicine, 1987;317(15):964–965.

Brutocao D., et al., Comparison of Hetastarch with Albumin for Postoperative Volume Expansion in Children After Cardiopulmonary Bypass. Journal of Cardiothoracic and Vascular Anesthesia, 1996;10(3):348–351.

EXCEL and Hespan are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y36-002-755 LD-233-1

PRINCIPAL DISPLAY PANEL - 500 mL

Hespan®

(6% hetastarch in 0.9%

sodium chloride injection)

Y94-003-110

LD-262-1

REF L6511

NDC 0264-1965-10

500 mL

EXCEL® CONTAINER

For intravenous use only.

Each 100 mL contains: Hetastarch 6 g

Sodium Chloride USP 0.9 g in Water for Injection, USP

pH adjusted with Sodium Hydroxide, NF

pH: approximately 5.9 with negligible buffering capacity

Calc. Osmolarity: approximately 309 mOsM

Electrolytes (mEq/L): Sodium 154 Chloride 154

If administration is by pressure infusion, all air

should be withdrawn or expelled from the bag

through the medication port prior to infusion.

Sterile, nonpyrogenic. Use only if solution is clear and container

and seals are intact. Single dose container. Discard unused solution.

Recommended Storage: Store at room temperature,

25ºC (77ºF). Avoid excessive heat. Protect from freezing.

Usual Dosage: See package insert for complete information.

Rx only

EXCEL and Hespan are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y94-003-141

LD-152-3

Do not remove overwrap until ready for use. After removing the

overwrap, check for minute leaks by squeezing container firmly.

If leaks are found, discard solution as sterility may be impaired.

DO NOT INTRODUCE ADDITIVES OTHER THAN CITRATE INTO BAG.

EXP

LOT

Hespan
hetastarch in sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0264-1965
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HETASTARCH (HETASTARCH)	HETASTARCH	6 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION)	SODIUM CHLORIDE	0.9 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0264-1965-10	12 CONTAINER In 1 CASE	contains a CONTAINER
1		500 mL In 1 CONTAINER	This package is contained within the CASE (0264-1965-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA890105	04/04/1991

Labeler - B. Braun Medical Inc. (002397347)

Revised: 07/2011B. Braun Medical Inc.

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