Celvapan

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Influenza Virus Type A haemagglutinin 7.5ug equivalent to A/California/07/2009 (H1N1);  

Disponibbli minn:

Baxter Healthcare Ltd

INN (Isem Internazzjonali):

Influenza Virus Type A haemagglutinin 7.5 µg (=A/California/07/2009 (H1N1))

Dożaġġ:

7.5 mcg

Għamla farmaċewtika:

Suspension for injection

Kompożizzjoni:

Active: Influenza Virus Type A haemagglutinin 7.5ug equivalent to A/California/07/2009 (H1N1)   Excipient: Polysorbate 80 Sodium chloride Trometamol Water for injection

Unitajiet fil-pakkett:

Vial, glass, multi-dose, 20 x 5ml (each 10 x 5ml doses), 100 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Baxter AG

Indikazzjonijiet terapewtiċi:

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Vial, glass, multi-dose, 20 x 5ml (each 10 x 5ml doses) - 100 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours opened stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

2009-08-10

Karatteristiċi tal-prodott

1 
CELVAPAN 
_PANDEMIC INFLUENZA VACCINE (WHOLE VIRION, VERO CELL DERIVED, _
_INACTIVATED) SUSPENSION FOR INJECTION _
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Whole virion influenza vaccine, inactivated containing antigen of pandemic
strain*: 

A/California/07/2009 (H1N1)  7.5 micrograms** per
0.5 mL dose. 

*   propagated in Vero
cells (continuous cell line of mammalian origin) 
** expressed in micrograms haemagglutinin. 

This
vaccine complies with the WHO recommendation and EU decision for
the 
pandemic. 

This
is a multidose container. See _Nature and Contents of the Container_ for
the 
number of doses per vial. 

For a full list of excipients, see _List of Excipients_. 
PHARMACEUTICAL FORM

Suspension for injection.  
The vaccine is
an off-white, opalescent, translucent suspension.  
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
Prophylaxis of influenza in an officially declared pandemic
situation. Pandemic 
influenza vaccine should be used in accordance with official
guidance. 

_POSOLOGY AND METHOD OF ADMINISTRATION _
This pandemic
influenza vaccine H1N1 has been authorised based on data obtained 
with a version containing H5N1 antigen supplemented with data obtained with the 
vaccine containing H1N1 antigen. The Clinical Particulars
section will be updated in 
accordance with emerging additional data. 

From clinical studies limited safety data are available for Celvapan (H1N1) in healthy 
adult and elderly subjects and in children (see _Special Warnings and Precautions for _
_Use_ and _Undesirable Effects_.). 

The decision to use CELVAPAN
(H1N1) in each age group defined below should 
take into account the extent of the clinical data available with a version of the vaccine 
2 
containing H5N1 antigen and the disease characteristics
of the current influenza 
pandemic.