INVIVAC 2005/2006 15 Microgram Suspension for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
A/CALIFORNIA/7/2004 (H3N2) – LIKE STRAIN A/NEW CALEDONIA/20/99 (H1H1)-LIKE STRAIN B/SHANGHAI/361/2002 – LIKE STRAIN
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
A/CALIFORNIA/7/2004 (H3N2) – LIKE STRAIN A/NEW CALEDONIA/20/99 (H1H1)-LIKE STRAIN B/SHANGHAI/361/2002 – LIKE STRAIN
Dosage:
15 Microgram
Pharmaceutical form:
Suspension for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2011-03-31
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Invivac 2005/2006, suspension for injection (influenza vaccine, surface antigen, inactivated, virosome).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
- A/California/7/2004 (H3N2) like strain
(A/New York/55/2004 NYMC X-157 reass.) 15 microgram HA**
- A/New Caledonia/20/99(H1N1)-like
(A/New Caledonia/20/99 IVR-116 reass.) 15 microgram HA**
- B/Shanghai/361/2002- like strain
(B/Jiangsu/10/2003) 15 microgram HA** per 0.5 ml dose.
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2005/2006
season.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in prefilled syringes; a slightly opalescent 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 Invivac 2005/2006 should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 0.5 ml.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
Children: the clinical data available are too limited to vaccinate children with Invivac.
For instructions for preparation, _see section 6.6._
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken protein (Invivac does
not contain more than 0.5 µg ovalbumin per dose) or gentamicin.
Immunisation shall be postponed in patients with febrile illness or acute infection.
IRISH MEDICINES BOARD
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