Panvax H1N1 vaccine

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Influenza virus A/California/7/2009 (H1N1) - like strain 15ug

Доступно од:

Seqirus (NZ) Ltd

INN (Међународно име):

Influenza virus A/California/7/2009 (H1N1) - like strain 15 µg

Дозирање:

15 mcg/0.5mL

Фармацеутски облик:

Suspension for injection

Састав:

Active: Influenza virus A/California/7/2009 (H1N1) - like strain 15ug Excipient: Calcium chloride dihydrate Dibasic sodium phosphate Monobasic potassium phosphate Monobasic sodium phosphate dihydrate Potassium chloride Sodium chloride Thiomersal Water for injection

Јединице у пакету:

Syringe, glass, 0.5 mL, 1 pack, 0.5 mL

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Seqirus Pty Ltd

Терапеутске индикације:

For active immunisation to prevent influenza disease caused by the influenza A(H1N1) virus, in adults, adolescents and children 10 years of age and older.

Резиме производа:

Package - Contents - Shelf Life: Syringe, glass, 0.5 mL, 1 pack - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 0.5 mL, 10 pack - 5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, multi-dose, 5 mL, 10 pack - 50 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Датум одобрења:

2007-06-22

Карактеристике производа

Panvax
®
 H1N1 Vaccine (TT50-7970) 
5 mL and 10mL multi-dose vial and 0.5mL pre-filled single 
dose syringe presentations 
Data Sheet
February 2010

Page 1 of 7 
NAME OF THE MEDICINE 
Panvax
®
 H1N1 Vaccine 
H1N1 Pandemic influenza vaccine (split virion, inactivated). 

DESCRIPTION 
Panvax
®
 H1N1 Vaccine is a purified, inactivated, monovalent, split virion
(split virus) 
vaccine. A single 0.5 mL dose contains antigen of the
following type:  

A/California/7/2009 (H1N1) (NYMC X-179A) (A/California/7/2009
(H1N1)v-like)   
15 µg haemagglutinin (HA) per dose 

Each 0.5 mL dose contains, nominally: sodium chloride 4.1 mg, sodium
phosphate – 
dibasic anhydrous 0.3 mg, sodium phosphate – monobasic 0.08 mg,
potassium 
chloride 0.02 mg, potassium phosphate – monobasic 0.02 mg, calcium
chloride 
1.5 μg and thiomersal 50 μg (for multi-dose
vial presentation only). 

The following are present in each 0.5 mL dose: sodium
taurodeoxycholate 
 5 μg, 
ovalbumin  ≤ 1.0 μg, sucrose < 10 μg, neomycin 
 0.7 ng, polymyxin B sulfate 
 0.11 ng and beta-propiolactone  1.4 ng. 

The virus strain in this vaccine complies with the Australian
Influenza Vaccine 
Committee (AIVC) decision, endorsing the World Health Organisation
recommended 
virus for the influenza A(H1N1) vaccine.  

Panvax
®
 H1N1 Vaccine is prepared from influenza virus propagated in the
allantoic 
fluid of embryonated chicken eggs. The virus is harvested from the
eggs, purified by 
zonal centrifugation, inactivated with beta-propiolactone and
disrupted with sodium 
taurodeoxycholate to produce split virion particles.  

PHARMACOLOGY 
Immunisation with inactivated influenza vaccines has been shown to
induce 
antibodies to the viral surface glycoproteins, haemagglutinin and
neuraminidase. 
These antibodies are important in the prevention of natural
infection. 

CLINICAL TRIALS 
Clinical trials are being conducted to assess the immunogeni