INFLUVAC SUB-UNIT 2011/2012, SUSPENSION FOR INJECTION (INFLUENZA VACCINE, SURFACE ANTIGEN, INACTIVATED)
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
A/CALIFORNIA/07/2009 (H1N1)V A/BRISBANE/59/2007 (H1N1) - LIKE STRAIN (A/BRISBANE/59/2007, IVR-148) PH.EUR B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)
Available from:
Abbott Healthcare Products Ltd
Dosage:
15,15,15 Microgram
Pharmaceutical form:
Suspension for Injection
Authorization date:
1998-05-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Influvac Sub-unit 2011/2012, suspension for injection (influenza vaccine, surface antigen, inactivated).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*:
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2011/2012
season.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in prefilled syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Influvac Sub-unit 2011/2012 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
weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
For instructions for preparation, see _section 6.6, Special precautions for disposal of a used medicinal product or waste_
_derived from such medicinal product and other handling of the product._
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken proteins (such as
ovalbumin), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
-A/California/7/2009 (H1N1): derived s
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