Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Influenza virus haemagglutinin, Quantity: 15 microgram/mL
AU Pharma Pty Ltd
Influenza virus haemagglutinin
Injection, suspension
Excipient Ingredients: trometamol; water for injections; sodium chloride; polysorbate 80
Intramuscular
Packs of 20 (5.0mL in 10 dose vial)
Medicine Registered
(S4) Prescription Only Medicine
Pandemic Influenza Vaccine H5N1 Baxter is indicated for prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official recommendations.
Visual Identification: off-white, opalescent, translucent suspension.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2010-09-03
Pandemic Influenza Vaccine H5N1 BAXTER Product Information (whole virion, Vero cell derived, inactivated) Pandemic Influenza Vaccine H5N1 BAXTER PI 130515 Page 1 of 9 Baxter PANDEMIC INFLUENZA VACCINE H5N1 BAXTER _ _ NAME OF THE MEDICINE Pandemic Influenza Vaccine H5N1 Baxter (whole virion, Vero cell derived, inactivated), suspension for injection. DESCRIPTION Pandemic Influenza Vaccine H5N1 Baxter is a suspension for injection. After shaking, the vaccine is off-white, opalescent, translucent suspension. Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*: 7.5 micrograms** per 0.5 ml dose. * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin It is presented in a multidose container or a single-dose syringe, and contains as excipients Trometamol, Sodium chloride, Polysorbate and Water for injection. PHARMACOLOGY _PHARMACODYNAMIC PROPERTIES _ Pharmacotherapeutic group: Influenza, inactivated, whole virus, ATC Code J07BB01. This section describes the clinical experience with the mock-up vaccine following a two-dose administration. Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses. These antigens can be considered as ‘novel’ antigens and simulate a situation where the target population for vaccination is immunologically naïve. Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines. The immunogenicity of the 7.5 µg non-adjuvanted formulation of Pandemic Influenza Vaccine H5N1 Baxter (strain A/Vietnam/1203/2004) has been evaluated in 2 clinical studies in adults aged 18 – 59 years (N=312) and in subjects aged 60 years and older (N=272) following a 0, 21 day schedule. Pandemic Influenza Vaccine H5N1 BAXTER Product Information (whole virion, Vero cell derived, Přečtěte si celý dokument