1. Name Of The Medicinal Product
MASTAFLU®, suspension for injection (influenza vaccine, surface antigen, inactivated)
2. Qualitative And Quantitative Composition
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strains:
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per 0.5 ml dose.
* propagated in hens' eggs
** haemagglutinin
This vaccine complies with the WHO recommendation (northern hemisphere), and the decision of the EU for the 2006/2007 season.
For excipients, see 6.1.
3. Pharmaceutical Form
Suspension for injection in pre-filled syringes.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
4.2 Posology And Method Of Administration
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited; doses of 0.25 ml or 0.5 ml have been used.
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.
4.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken protein (MASTAFLU does not contain more than 1 microgram ovalbumin per dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
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.
MASTAFLU should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
MASTAFLU 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 results. The transient false positive reactions could be due to the IgM response by the vaccine.
4.6 Pregnancy And Lactation
Limited data from vaccinations in pregnant women do not indicate that adverse fetal 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.
MASTAFLU may be used during lactation.
4.7 Effects On Ability To Drive And Use Machines
MASTAFLU is unlikely to produce an effect on the ability to drive and use machines.
4.8 Undesirable Effects
Adverse events 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 and at least 50 elderly subjects aged 60 or older. Safety evaluation is performed during the first 3 days following vaccination.
Undesirable effects reported are listed according to the following frequency:
Adverse events from clinical trials:
Common (>1/100, <1/10)
Local reactions: redness, swelling, pain, ecchymosis, induration.
Systemic reactions: fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia. These reactions usually disappear within 1-2 days without treatment.
From post-marketing surveillance additionally, the following adverse events have been reported:
Uncommon (>1/1,000, <1/100)
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Rare (>1/10,000, <1/1,000)
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Allergic reactions, in rare cases leading to shock, have been reported.
Very rare (<1/10,000)
Vasculitis with transient renal involvement. Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
4.9 Overdose
Overdosage is unlikely to have any untoward effect.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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 6-12 months.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.
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
MASTAFLU should be stored at +2°C to +8°C (in a refrigerator). Do not freeze. Protect from light.
6.5 Nature And Contents Of Container
0.5 ml suspension for injection in pre-filled syringe (glass, type 1), pack of 1 or 10.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
MASTAFLU should be allowed to reach room temperature before use. Shake before use.
For administration of a 0.25 ml dose from a syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a reproducible volume of vaccine remains in the syringe, suitable for administration.
7. Marketing Authorisation Holder
Solvay Healthcare Limited
Mansbridge Road
West End
Southampton
SO18 3JD
8. Marketing Authorisation Number(S)
PL 00512/0170
9. Date Of First Authorisation/Renewal Of The Authorisation
14 June 2000/December 2002
10. Date Of Revision Of The Text
September 2006
Legal category
POM
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