Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Influenza virus haemagglutinin
Mylan Health Pty Ltd
Influenza virus haemagglutinin
_Influvac PI _ _ _ _ _ _Version 9 _ _Page 1 of 5 _ PRODUCT INFORMATION INFLUVAC _ _ NAME OF THE MEDICINE Influvac inactivated influenza vaccine (surface antigen) DESCRIPTION Influvac is a clear colourless suspension for injection. It is an egg-grown, inactivated influenza virus vaccine based on isolated surface antigens of A and B strains of myxovirus influenza. The type and amount of viral antigens in Influvac conform to the requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the winter of 2017. The strains chosen for vaccine manufacture are endorsed by the AIVC as being antigenically equivalent to the reference virus. This is a purified, inactivated influenza vaccine (surface antigen), each 0.5 mL of which contains antigens representative of the following type: A/Michigan/45/2015 (H1N1)pdm09-like strain (A/Singapore/GP1908/2015, IVR-180) 15 µg haemagglutinin/dose A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, X-263B)15 µg haemagglutinin/dose B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type)15 µg haemagglutinin/dose INACTIVE: Potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections. PHARMACOLOGY The vaccine stimulates production of antibodies with a specific capacity against influenza. Protection is only against those strains of the virus from which the vaccine is prepared or closely related strains. Seroprotection is obtained within 2-3 weeks. The duration of post-vaccination immunity varies between 6-12 months. INDICATIONS For the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines. CONTRAINDICATIONS Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken protein, formaldehyde, cetrimonium bromide, polysorbate Read the complete document