INACTIVATED INFLUENZA VACCINE 15/15/15mc %v/v Suspension for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)

Fáanlegur frá:

Sanofi Pasteur MSD Ltd

ATC númer:

J07BB02

INN (Alþjóðlegt nafn):

A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KONG/4801/

Skammtar:

15/15/15mc %v/v

Lyfjaform:

Suspension for Injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Influenza vaccines

Leyfisstaða:

Transfer Pending

Leyfisdagur:

1998-05-01

Upplýsingar fylgiseðill

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DOCUMENT OUTLINE * 974980 Influenza (Rovi) Pack 10 - PIL
[/2146490.PA0544_034_001.31a2450d-0198-4210-81d2-7f520bc6d21d.000001Product_Leaflet_Approved.140813.html#1] * 975000 Influenza 10 pck Leaflet
[/2146490.PA0544_034_001.31a2450d-0198-4210-81d2-7f520bc6d21d.000001Product_Leaflet_Approved.140813.html#2]

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for injection in prefilled syringe.
Influenza vaccine (split virion, inactivated).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
•
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
............................................................................................................................ 15 micrograms HA**
•
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
............................................................................................................................ 15 micrograms HA**
•
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
............................................................................................................................ 15 micrograms HA**
Per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2016/2017 season.
For the full list of excipients, see Section 6.1.
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP may contain traces of eggs, such as ovalbumin, and of
neomycin, formaldehyde and octoxinol- 9, which are used during the manufacturing process (see Section 4.3).
3 PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and opalescent liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza.
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is indicated in adults and children from 6 months of
age.
The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be based