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| Drug class description : | Influenza Vaccine |
| Generic Name : | Surface antigen, inactivated, virosome |
| Drug description : | Influenza virus surface antigen, inactivated, virosome, containing antigens*: A/California/7/2004 (H3N2) (A/New York/55/2004 NYMC X-157)…………15 micrograms ** A/New Caledonia/20/99 (H1N1) (A/New Caledonia/20/99 IVR-116)………15 micrograms ** B/Shanghai/361/2002 (B/Jiangsu/10/2003)…………15 micrograms ** per 0,5 ml dose * propagated in hen's eggs ** haemagglutinin Inflexal V is an inactivated influenza vaccine formulated with virosomes as carrier/adjuvant system, composed of highly purified surface antigens of strain A and B of the influenza virus propagated in fertilized hen's eggs. This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2005/2006 season. |
| Presentation : | INFLEXAL V Suspension for injection Influenza vaccine (surface antigen, inactivated, virosome) 2005/2006 season |
| 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. Dosages of 0.25 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. |
| Contra Indications : | Hypersensitivity to the active substances, to any of the excipients, to eggs, to chicken proteins, to polymyxin B or to neomycin. Immunisation should 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. The vaccine (Inflexal V) should under no circumstances be administered intravascularly. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. |
| Interactions : | The vaccine (Inflexal V) may be given at the same time as other vaccines. Immunisations should be administered into separate limbs. It should be noted that the adverse reactions may be intensified. The immunological response may be diminished if the patient is undergoing imunosuppressant treatment. Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to HIV-1, hepatitis C virus and, especially, HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results may be due to IgM production in response to the vaccine. Pregnancy and lactation 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. The vaccine (Inflexal V) may be used during lactation. |
| Adverse Reactions : | Adverse reactions 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 60 years 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 : | Sanofi Pasteur MSD |
| Drug Availability : | (POM) |
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