INFLUVAC inactivated influenza 0.5 mL vaccine needle free syringe 2014

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Influenza virus haemagglutinin

Available from:

Mylan Health Pty Ltd

INN (International Name):

Influenza virus haemagglutinin

Summary of Product characteristics

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PRODUCT INFORMATION
INFLUVAC
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NAME OF THE MEDICINE
Influvac inactivated influenza vaccine (surface antigen)
DESCRIPTION
Influvac is a clear colourless suspension for injection. It is an
egg-grown, inactivated influenza virus
vaccine based on isolated surface antigens of A and B strains of
myxovirus influenza.
The type and amount of viral antigens in Influvac conform to the
requirements of the Australian
Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of
Health for the winter of 2017.
The strains chosen for vaccine manufacture are endorsed by the AIVC as
being antigenically equivalent
to the reference virus.
This is a purified, inactivated influenza vaccine (surface antigen),
each 0.5 mL of which contains
antigens representative of the following type:
A/Michigan/45/2015 (H1N1)pdm09-like strain (A/Singapore/GP1908/2015,
IVR-180) 15 µg
haemagglutinin/dose
A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014,
X-263B)15 µg
haemagglutinin/dose
B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type)15 µg
haemagglutinin/dose
INACTIVE:
Potassium chloride, monobasic potassium phosphate, dibasic sodium
phosphate, sodium chloride,
calcium chloride dihydrate, magnesium chloride hexahydrate and water
for injections.
PHARMACOLOGY
The vaccine stimulates production of antibodies with a specific
capacity against influenza. Protection is
only against those strains of the virus from which the vaccine is
prepared or closely related strains.
Seroprotection is obtained within 2-3 weeks. The duration of
post-vaccination immunity varies between
6-12 months.
INDICATIONS
For the prevention of influenza caused by influenza virus, types A and
B.
For full details regarding recommendations for influenza vaccination,
please refer to the relevant
National Immunisation Guidelines.
CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients
and to residues of eggs, chicken
protein, formaldehyde, cetrimonium bromide, polysorbate 
                                
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