Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
INFLUENZA VIRUS (NH) A/CALIFORNIA/07/2009 (H1N1) - LIKE STRAIN
NOVARTIS (SINGAPORE) PTE LTD
J07BB02
>=15 mcg haemagglutinin/0.5 ml
INJECTION
INTRAMUSCULAR
Prescription Only
Novartis Vaccines and Diagnostics S.r.l.
2001-11-09
FLUAD-Novartis Vaccines and Diagnostics S.r.l. pl- SG January 2014 Confidential Page 1 of 4 FLUAD ™ , SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE INFLUENZA VACCINE, SURFACE ANTIGEN, INACTIVATED, ADJUVANTED WITH MF59C.1 2010/2011 Season COMPOSITION. One dose (0.5 ml) contains: _ACTIVE INGREDIENTS:_ Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs and adjuvanted with MF59C.1, of strains: A/California/07/2009 (H1N1) – like strain (A/California/07/2009, NYMC X-181) 15 micrograms HA* A/Perth/16/2009 (H3N2) – like strain (A/Victoria/210/2009, NYMC X-187) 15 micrograms HA* B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008) 15 micrograms HA* *haemagglutinin _ADJUVANT: _MF59C.1 which is an exclusive adjuvant: 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, 0.66 mg sodium citrate, 0.04 mg citric acid, and water for injections. _EXCIPIENTS_: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections. This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2010/2011 season. PHARMACEUTICAL FORM AND CONTENTS. Suspension for injection in pre-filled syringe. 1 pre-filled syringe of one dose (0.5 ml). The vaccine appears as a milky-white suspension. PHARMACOTHERAPEUTIC CATEGORY. Influenza vaccine. ATC code: J07BB02. INDICATIONS. Active immunisation against influenza in the elderly (65 years of age and over), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases). The use of FLUAD should be based on official recommendations. CONTRAINDICATIONS. Hypersensitivi Прочитајте комплетан документ