1. Name Of The Medicinal Product
FLUVIRIN®, suspension for injection in pre-filled syringe. [Influenza Vaccine (Surface Antigen, Inactivated)]
2. Qualitative And Quantitative Composition
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
A/California/07/2009 (H1N1) – derived strain used NYMC X-181
15 micrograms HA**
A/Perth/16/2009 (H3N2) – like strain used NYMC X-187 derived from A/Victoria/210/2009
15 micrograms HA**
B/Brisbane/60/2008
15 micrograms HA**
per 0.5 ml dose.
* propagated in fertilised hens' eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendation (Northern hemisphere) and EU decision for the 2010/2011 season.
For a full list of excipients see section 6.1.
3. Pharmaceutical Form
Suspension for injection in pre-filled syringe.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of FLUVIRIN® should be based on official recommendations.
4.2 Posology And Method Of Administration
Adults and children from 4 years: 0.5 ml.
For children, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
For instructions for preparation, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. betapropriolactone, nonoxynol 9, neomycin, polymixin and formaldehyde.
Immunisation shall be postponed in patients with febrile illness or acute infection.
4.4 Special Warnings And Precautions For Use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
FLUVIRIN® should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur. The maximum thiomersal content in FLUVIRIN® is 0.002mg (0.0004% w/v).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
FLUVIRIN® may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.
4.6 Pregnancy And Lactation
The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
FLUVIRIN® may be used during lactation.
4.7 Effects On Ability To Drive And Use Machines
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
4.8 Undesirable Effects
Adverse reactions observed from clinical trials
The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.
The following undesirable effects have been observed during clinical trials with the following frequencies:
very common (
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* These reactions usually disappear within 1-2 days without treatment
ADVERSE REACTIONS REPORTED FROM POST-MARKETING SURVEILLANCE
Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:
Blood and lymphatic system disorders:
Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders:
Allergic reactions, in rare cases leading to shock, angioedema
Nervous system disorders:
Neuralgia, paraesthesia, febril convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Vascular disorders:
Vasculitis associated in very rare cases with transient renal involvement
Skin and subcutaneous tissue disorders:
Generalised skin reactions including pruritus, urticaria or non-specific rash
This medicinal product contains thiomersal (an organomercuric compound) as a residue from the manufacturing process and therefore it is possible that sensitisation reactions may occur (see section 4.4.).
4.9 Overdose
Overdosage is unlikely to have any untoward effect.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Influenza vaccine, ATC Code:J07BB02
Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1 List Of Excipients
Buffer solution:
Potassium dihydrogen phosphate
Disodium hydrogen phosphate
Sodium chloride
Water for injection.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
1 year.
6.4 Special Precautions For Storage
Store at +2°C to +8°C (in a refrigerator). Do not freeze. Keep container in the original carton.
6.5 Nature And Contents Of Container
0.5 ml in pre-filled syringe (glass, type I) with stopper (rubber), fitted with a stainless steel needle, pack sizes of 1 and 10 syringes.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
The vaccine should be allowed to reach room temperature before use.
Shake before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Novartis Vaccines and Diagnostics Limited
Gaskill Road
Speke
Liverpool
L24 9GR
UK.
8. Marketing Authorisation Number(S)
PL 18532/0038.
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 7 June 2006
10. Date Of Revision Of The Text
May 2010
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