FLUVIRIN (INACTIVATED INFLUENZA VACCINE) %v/v Suspension for Injection

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

A/SINGAPORE686 - LIKE STRAIN (H1N1) A/WUHAN /359/95 (H3N2)-LIKE STRAIN B/BEIJING /184/93-LIKE STRAIN

Dostupno od:

Chiron Vaccines Limited

INN (International ime):

A/SINGAPORE686 - LIKE STRAIN (H1N1) A/WUHAN /359/95 (H3N2)-LIKE STRAIN B/BEIJING /184/93-LIKE STRAIN

Doziranje:

%v/v

Farmaceutski oblik:

Suspension for Injection

Status autorizacije:

Withdrawn

Datum autorizacije:

2008-12-29

Svojstava lijeka

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluvirin, Suspension for injection in pre-filled syringe. [Influenza Vaccine (Surface antigen,
Inactivated) Ph. Eur.]
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase) propagated in embryonated
chicken eggs, inactivated by betapropiolactone, split by nonoxynol 9 and purified, of strains:
This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the
year 2004/2005.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 4 years: 0.5 ml.
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.
A/New Caledonia/20/99 (H1N1) - like strain
(A/New Caledonia/20/99 (IVR-116)) Ph. Eur.
15 micrograms** Haemagglutinin
A/Fujian/411/2002(H3N2) – like strain
(A/Wyoming/3/2003 X-147)
15 micrograms** Haemagglutinin
B/Shanghai/361/2002 - like strain
(B/Jiangsu/10/2003)
15 micrograms** Haemagglutinin
per 0.5 ml dose.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2007_
_CRN 2035477_
_page number: 1_
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken proteins,
betapropiolactone, nonoxynol 9, neomycin, polymyxin, formaldehyde, or thiomersal.
Immunisation shall be postponed in patients with febrile illness or acu