AGRIPPAL Suspension for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)
Available from:
Novartis Vaccines and Diagnostics S.r.l.
Pharmaceutical form:
Suspension for Injection
Authorization date:
1999-02-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AGRIPPAL
Suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated)
(2011/2012 SEASON)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains*:
A/California/07/2009 (H1N1) - derived strain used NYMC X-181
15 micrograms HA**
A/Perth/16/2009 (H3N2) - like strain used NYMC X-187 derived from A/Victoria/210/2009 15 micrograms HA**
B/Brisbane/60/2008
15 micrograms HA**
Per 0.5 ml dose
* propagated in fertilized hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the
2011/2012season.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine appears as a clear liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated
complications.
The use of AGRIPPAL should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 36 months: 0.5 ml
Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/03/2012_
_CRN 2106327_
_page number: 1_
weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
For instructions for preparation, see section 6.6.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active s
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