INFLUVAC SUB-UNIT, SUSPENSION FOR INJECT 15,15,15 Microgram Suspension for Injection

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A) B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B)

Commercializzato da:

Abbott Healthcare Products Ltd

INN (Nome Internazionale):

A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X

Dosaggio:

15,15,15 Microgram

Forma farmaceutica:

Suspension for Injection

Tipo di ricetta:

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

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

0000-00-00

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Influvac Sub-unit, suspension for injection (influenza vaccine, surface antigen, inactivated).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
- A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, X-181) 15 micrograms HA **
- A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012, X-223A) 15 micrograms HA **
- B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, BX-51B) 15 micrograms HA **
per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU
recommendation for the 2014/2015 season.
For a full list of excipients see section 6.1.
Influvac may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium
bromide, polysorbate 80, or gentamicin, which are used during the manufacturing process (see section 4.3).
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 those who run an increased risk of associated complications.
Influvac is indicated in adults and children from 6 months of age.
The use of Influvac should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults: 0.5 ml.
_Paediatric population_
Children from 36 months onwards: 0.5 ml.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/07/2014_
_CRN 2148606_
_page number: 1_
C