FLUARIX VACCINE

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

INFLUENZA VIRUS (NH) A/CALIFORNIA/7/2009 (H1N1)pdm09 - LIKE STRAIN

Dostupné z:

GLAXOSMITHKLINE PTE LTD

ATC kód:

J07BB02

Dávkovanie:

15 mcg haemagglutinin/0.5 ml

Forma lieku:

INJECTION

Spôsob podávania:

SUBCUTANEOUS, INTRAMUSCULAR

Typ predpisu:

Prescription Only

Výrobca:

GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG

Dátum Autorizácia:

1999-04-08

Príbalový leták

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.