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| Drug class description : | Influenza Vaccine |
| Generic Name : | Surface antigen, inactivated |
| Drug description : | Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strains: - A/California/7/2004 (H3N2)-like strain (A/New York/55/2004 NYMC X-157 reass.) 15 micrograms** - A/New Caledonia/20/99 (H1N1)-like strain (A/New Caledonia/20/99 IVR-116 reass.) 15 micrograms - B/Shanghai/361/2002-like strain (B/Jiangsu/10/2003) 15 micrograms 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 2005/2006 season. |
| Presentation : | MASTAFLU®, suspension for injection (influenza vaccine, surface antigen, inactivated) |
| Indications : | Prophylaxis of influenza, especially in those who run an increased risk of associated complications. |
| Adult Dosage : | Adults and children from 36 months: 0.5 ml. Immunisation should be carried out by intramuscular or deep subcutaneous injection. |
| Child Dosage : | 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. |
| Contra Indications : | Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken protein, formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin. Immunisation shall be postponed in patients with febrile illness or acute infection. |
| Special Precautions : | 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. |
| Interactions : | 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. 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. |
| Adverse Reactions : | 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. |
| Manufacturer : | MASTA Ltd |
| Drug Availability : | (POM) |
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