Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
INFLUENZA VIRUS (NH) A/CALIFORNIA/7/2009 (H1N1)pdm09 - LIKE STRAIN
GLAXOSMITHKLINE PTE LTD
J07BB02
15 mcg haemagglutinin/0.5 ml
INJECTION
SUBCUTANEOUS, INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG
1999-04-08
1 FLUARIX™ INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) QUALITATIVE AND QUANTITATIVE COMPOSITION Fluarix™ is an inactivated influenza vaccine (split virion), containing antigens (propagated in embryonated eggs) equivalent to the following types and subtypes: A/California/7/2009 (H1N1)pdm09-like strain [variant A/Christchurch/16/2010 (NIB-74xp)] A/Texas/50/2012 (H3N2)-like strain [variant A/Texas/50/2012 (NYMC X-223A)] B/Massachusetts/02/2012-like strain [variant B/Massachusetts/02/2012 (NYMC BX-51B)] This vaccine complies with the WHO recommended strains (Northern Hemisphere) for the season 2014/2015. Each 0.5 ml vaccine dose (Fluarix™) contains 15 µg haemagglutinin of each of the recommended strains. Fluarix™ meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS INDICATIONS Fluarix™ is recommended for prophylaxis against influenza in adults and children older than 6 months of age. Fluarix™ is especially recommended for subjects who: - are over 60 years of age, - suffer from diseases of the cardiovascular system, metabolic diseases (diabetes), cystic fibrosis, chronic respiratory diseases and chronic renal insufficiency, - suffer from congenital or acquired immune deficiency. Vaccination can be recommended for individuals exposed to increased risk of infection because of their occupation, such as medical personnel. In addition, prevention of disease in the workforce could lead to substantial economic benefits. 2 DOSAGE AND ADMINISTRATION Adults and children over 3 years of age: one dose of 0.5 ml. Children from 6 to 36 months of age: one dose of 0.25 ml. For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. Baca dokumen lengkapnya