FLUAD INFLUENZA VACCINE

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

INFLUENZA VIRUS (NH) A/CALIFORNIA/07/2009 (H1N1) - LIKE STRAIN

Dostupné z:

NOVARTIS (SINGAPORE) PTE LTD

ATC kód:

J07BB02

Dávkovanie:

>=15 mcg haemagglutinin/0.5 ml

Forma lieku:

INJECTION

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

Prescription Only

Výrobca:

Novartis Vaccines and Diagnostics S.r.l.

Dátum Autorizácia:

2001-11-09

Príbalový leták

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