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

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Influenza virus haemagglutinin, Quantity: 15 microgram/mL

Disponible des:

AU Pharma Pty Ltd

Designació comuna internacional (DCI):

Influenza virus haemagglutinin

formulario farmacéutico:

Injection, suspension

Composición:

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

Vía de administración:

Intramuscular

Unidades en paquete:

Packs of 20 (5.0mL in 10 dose vial)

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

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

Estat d'Autorització:

Registered

Data d'autorització:

2010-09-03

Fitxa tècnica

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,