AGRIPPAL inactivated influenza (surface antigen) vaccine injection pre-filled syringe (without needle) 2015

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Influenza virus haemagglutinin

Dostupné z:

Seqirus Pty Ltd

INN (Medzinárodný Name):

Influenza virus haemagglutinin

Stav Autorizácia:

Registered

Súhrn charakteristických

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AGRIPPAL
® 2015
NAME OF MEDICINE
Inactivated Influenza Vaccine (surface antigen)
DESCRIPTION
Agrippal 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 influenza
virus. The antigen composition and strains for the 2015 influenza
season corresponds to the
following types:
A/California/7/2009 (H1N1)– like strain;
A/Switzerland/9715293/2013 (H3N2)-like strain ; and
B/Phuket/3073/2013-like strain
The type and amount of viral antigens in Agrippal conform to the
requirements of the
Australian Influenza Vaccine Committee (AIVC) and the New Zealand
Ministry of Health for
the winter of 2015. The strains chosen for vaccine manufacture are
endorsed by the AIVC as
being antigenically equivalent to the reference virus.
Each 0.5 mL vaccine dose contains 15µg haemagglutinin of each of the
recommended strains.
The vaccine preparation also contains Sodium chloride 4.0 mg,
Potassium chloride 0.1 mg,
Potassium dihydrogen phosphate 0.1 mg, Sodium phosphate-dibasic 0.66
mg, Magnesium
chloride 0.05 mg, Calcium chloride 0.06 mg and Water for Injections to
0.5 mL. The vaccine
may contain residues of the following substances: eggs, chicken
proteins, kanamycin sulfate,
neomycin sulfate, sodium citrate, barium sulfate, formaldehyde,
sucrose, cetrimonium
bromide (CTAB), polysorbate 80 and less than 0.2 µg of ovalbumin per
0.5 mL dose.
PHARMACOLOGY
Agrippal induces humoral antibodies against haemagglutinins, the
surface antigens of the
virus. These antibodies neutralize influenza viruses and are important
in the prevention of
natural infections.
Seroprotection is generally obtained within 2 to 3 weeks. The duration
of postvaccinal
immunity to homologous strains or to strains closely related to the
vaccine strains varies but is
usually 6-12 months.
Influenza viral strains undergo antigenic changes from year to year.
Therefore the antigen
component of Agrippal is revised for every flu season and annual
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