Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HAEMAGGLUTININ STRAIN A (H1N1); HAEMAGGLUTININ STRAIN A (H3N2); HAEMAGGLUTININ STRAIN B
ABBOTT INDONESIA - Indonesia
HAEMAGGLUTININ STRAIN A (H1N1); HAEMAGGLUTININ STRAIN A (H3N2); HAEMAGGLUTININ STRAIN B
CAIRAN INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML
ABBOTT BIOLOGICALS B.V - NETHERLANDS
2017-05-22
INFLUVAC NH 2023/2024 INFLUENZA VACCINE NAME OF THE MEDICINAL PRODUCT Influvac, suspension for injection (influenza vaccine, surface antigen, inactivated) QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: -A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022, IVR-238) 15 micrograms HA ** - A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/9/2021, SAN-10) 15 micrograms HA ** -B/Austria/1359417/2021-like virus (B/Austria/1359417/2021, BVR-26) 15 micrograms HA ** per 0.5 ml dose. * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and competent authority decision for the 2023/2024 season. For a full list of excipients see section List of excipients. Influvac may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin, which are used during the manufacturing process (see section Contraindications). PHARMACEUTICAL FORM Suspension for injection in prefilled syringes, a colourless clear liquid, filled in single-dose syringes. DISETUJUI OLEH BPOM: 04/10/2023 ID: EREG100346VR12300137 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Prophylaxis of influenza in adults over 18 years of age; especially those who run an increased risk of associated complications. The use of Influvac should be based on official recommendations. POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: 0.5 ml. METHOD OF ADMINISTRATION Method of Administration Immunisation should be carried out by intramuscular or deep subcutaneous injection. Precautions to be taken before handling or administrating the medicinal product: For instructions for preparation of the medicinal product before administration, see section Special precautions for disposal and other handling. It should be administered before the beginning of the influenza season Baca dokumen lengkapnya