Fluarix Vaccine
Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Notice patient
(PIL)
10-05-2024
Résumé des caractéristiques du produit
(SPC)
10-05-2024
Ingrédients actifs:
Influenza virus haemagglutinin
Disponible depuis:
GlaxoSmithKline Australia Pty Ltd
classe:
Medicine Registered
Notice patient
1
FLUARIX
®
_(Inactivated Split Influenza Vaccine) _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
FLUARIX vaccine. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor
has weighed the possible risks of
you/your child having FLUARIX
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING FLUARIX TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
VACCINE. You may need to read it
again.
WHAT FLUARIX IS USED FOR
FLUARIX is used to prevent
certain types of influenza. The
vaccine works by causing the
body to produce its own
protection (antibodies) against
three different types of influenza
virus. Each year new types of
influenza virus can appear, so
every year FLUARIX is changed
to contain fragments of the new
types of virus. Therefore,
influenza vaccination is
recommended every year.
PLEASE NOTE THAT FLUARIX WILL
ONLY PROTECT YOU AGAINST THE
THREE TYPES OF INFLUENZA VIRUS
USED TO MAKE THE VACCINE. IT
WILL NOT PROTECT YOU FROM
INFLUENZA CAUSED BY OTHER
TYPES OF INFLUENZA VIRUS OR FROM
INFECTIONS WITH OTHER AGENTS
CAUSING FLU-LIKE SYMPTOMS
(SUCH AS THE COMMON COLD).
Influenza is an infectious illness.
Influenza is spread by small
droplets from the nose, throat or
mouth of an infected person.
Symptoms of influenza begin 48
hours after coming into contact
with the virus. These consist of
chills, fever, generalised aches
and pains, headache and
respiratory symptoms (sore
throat, runny nose, cough). The
severity and type of symptoms
can vary.
Lire le document complet
Résumé des caractéristiques du produit
1
FLUARIX® PRODUCT INFORMATION
(INACTIVATED SPLIT INFLUENZA VACCINE)
NAME OF THE MEDICINE
Fluarix inactivated split influenza
vaccine suspension for injection
DESCRIPTION
Fluarix is an inactivated and purified split influenza
vaccine. The antigen composition
and strains for the 2013 influenza season corresponds
to the following types:
A/California/7/2009 (H1N1)pdm09-like strain used (NIB-74xp) derived from
A/Christchurch/16/2010: 15µg haemagglutinin per dose.
A/Victoria/361/2011 (H3N2)-derived strain used (IVR-165): 15µg haemagglutinin per
dose.
B/Wisconsin/1/2010-like strain used (NYMC BX-39) derived from B/Hubei-
Wujiagang/158/2009: 15µg haemagglutinin per dose.
Fluarix is prepared using whole virus cultivated in embryonated hens' eggs. The
virus is concentrated and purified by clarification, adsorption and centrifugation. The
purified whole virus is then treated with
the detergent sodium deoxycholate and again
centrifuged, and the resulting antigen suspension is inactivated with formaldehyde.
Each 0.5 ml vaccine dose contains 15
g haemagglutinin of each of the
recommended strains (total of 45 µg haemagglutinin). The vaccine preparation also
contains alpha tocopheryl acid succinate, sodium deoxycholate, sodium chloride,
magnesium chloride, potassium chloride, potassium phosphate monobasic, sodium
phosphate dibasic dodecahydrate, sucrose, polysorbate 80, octoxinol 10,
formaldehyde and gentamicin sulfate in water for injections.
The manufacture of this product includes exposure to bovine derived materials. No
evidence exists that any case of vCJD (considered to be the human form of bovine
spongiform encephalopathy)
Lire le document complet
