Pandemrix

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75ug

Tilgjengelig fra:

GlaxoSmithKline NZ Limited

INN (International Name):

Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75 µg

Dosering :

3.75 mcg

Legemiddelform:

Suspension for injection

Sammensetning:

Active: Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75ug Excipient: Dibasic sodium phosphate dodecahydrate Magnesium chloride Monobasic potassium phosphate Octoxinol Polysorbate 80 Potassium chloride Sodium chloride Thiomersal Water for injection D-alpha Tocoferol Dibasic sodium phosphate dodecahydrate Monobasic potassium phosphate Polysorbate 80 Potassium chloride Sodium chloride Squalene Water for injection

Enheter i pakken:

Vial, glass, Adjuvant, 0.225 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

GlaxoSmithKline Biologicals (Dresden)

Indikasjoner:

indicated for prophylaxis of influenza in an officially declared pandemic situation. The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, Adjuvant - 0.225ml per dose, 10 doses per vial - 250 dose units - 5 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Antigen - 0.25ml per dose, 10 doses per vial - 500 dose units - 5 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light. combined with adjuvant

Autorisasjon dato:

2008-12-24

Preparatomtale

1
NEW ZEALAND DATA SHEET
PANDEMRIX
®
PANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03
ADJUVANTED)
NAME OF THE MEDICINE
_PANDEMRIX_, emulsion and suspension for emulsion for injection.
Pandemic influenza vaccine (split virion, inactivated, AS03
adjuvanted).
DESCRIPTION
The antigen composition will be determined depending on the strain for
the pandemic influenza
that will be recommended by the World Health Organisation (WHO).
Each 0.5mL vaccine dose contains 3.75 micrograms
1
of antigen
2
of the recommended strain and is
adjuvanted with AS03
3
.
1
haemagglutinin
2
propagated in eggs
3
The GlaxoSmithKline proprietary AS03 adjuvant system is composed of
squalene (10.68
milligrams), DL-
α
-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
Each 0.5mL vaccine dose also contains the excipients Polysorbate 80,
Octoxinol 10, Thiomersal,
Sodium Chloride, Disodium hydrogen phosphate, Potassium dihydrogen
phosphate, Potassium
Chloride,
Magnesium
chloride,
Alpha-tocopherol,
Monobasic
potassium
phosphate,
Squalene,
Dibasic
sodium
phosphate
dodecahydrate,
Monobasic
potassium
phosphate,
and
water
for
injections. The vaccine may also contain the following residues: egg
residues including ovalbumin,
gentamicin sulfate, formaldehyde, sucrose and sodium deoxycholate.
This medicine has been granted provisional consent under section 23 of
the Medicines Act 1981.
CLINICAL PHARMACOLOGY
CLINICAL TRIALS
This section describes the clinical experience with the mock-up
vaccines 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 efficacy and safety data obtained with
mock-up vaccines are relevant for
the pandemic vaccines.
2