Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin, Quantity: 15 microgram/mL

Available from:

AU Pharma Pty Ltd

INN (International Name):

Influenza virus haemagglutinin

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: trometamol; water for injections; sodium chloride; polysorbate 80

Administration route:

Intramuscular

Units in package:

Packs of 20 (5.0mL in 10 dose vial)

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pandemic Influenza Vaccine H5N1 Baxter is indicated for prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official recommendations.

Product summary:

Visual Identification: off-white, opalescent, translucent suspension.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-09-03

Summary of Product characteristics

Pandemic Influenza Vaccine H5N1 BAXTER
Product Information
(whole virion, Vero cell derived, inactivated)
Pandemic Influenza Vaccine H5N1 BAXTER PI 130515
Page 1 of 9
Baxter
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
_ _
NAME OF THE MEDICINE
Pandemic Influenza Vaccine H5N1 Baxter (whole virion, Vero cell
derived, inactivated),
suspension for injection.
DESCRIPTION
Pandemic Influenza Vaccine H5N1 Baxter is a suspension for injection.
After shaking, the vaccine
is off-white, opalescent, translucent suspension. Whole virion
influenza vaccine, inactivated,
containing antigen of pandemic strain*: 7.5 micrograms** per 0.5 ml
dose.
* propagated in Vero cells (continuous cell line of mammalian origin)
** expressed in micrograms haemagglutinin
It is presented in a multidose container or a single-dose syringe, and
contains as excipients
Trometamol, Sodium chloride, Polysorbate and Water for injection.
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Influenza, inactivated, whole virus, ATC
Code J07BB01.
This section describes the clinical experience with the mock-up
vaccine following a
two-dose administration.
Mock-up vaccines contain influenza antigens that are different from
those in the currently
circulating influenza viruses. These antigens can be considered as
‘novel’ antigens and simulate a
situation where the target population for vaccination is
immunologically naïve. Data obtained with
the mock-up vaccine will support a vaccination strategy that is likely
to be used for the pandemic
vaccine: clinical immunogenicity, safety and reactogenicity data
obtained with mock-up vaccines
are relevant for the pandemic vaccines.
The immunogenicity of the 7.5 µg non-adjuvanted formulation of
Pandemic Influenza Vaccine
H5N1 Baxter (strain A/Vietnam/1203/2004) has been evaluated in 2
clinical studies in adults
aged 18 – 59 years (N=312) and in subjects aged 60 years and older
(N=272) following a 0, 21
day schedule.
Pandemic Influenza Vaccine H5N1 BAXTER
Product Information
(whole virion, Vero cell derived,