PREFLUCEL Unknown Suspension for Injection

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

A/CALIFORNIA/07/2009 (H1N1), A/VICTORIA/361/2011 (A/H3N2), B/HUBEI-WUJIAGANG/158/2009 (B)

MAH:

Nanotherapeutics Bohumil S.R.O

ATC_code:

J07BB02

INN:

A/CALIFORNIA/07/2009 (H1N1), A/VICTORIA/361/2011 (A/H3N2), B/HUBEI-WUJIAGANG/158/2009 (B)

dosage:

Unknown

pharmaceutical_form:

Suspension for Injection

prescription_type:

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

therapeutic_area:

Influenza vaccines

authorization_status:

Withdrawn

authorization_date:

2017-03-08

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Preflucel suspension for injection in a pre-filled syringe
Influenza Vaccine (split virion, inactivated, prepared in cell cultures)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
* propagated in Vero cells (continuous cell line of mammalian origin)
** haemagglutinin
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2012/2013
season.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe. PREFLUCEL is a clear to opalescent suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza in adults and elderly.
The use of PREFLUCEL should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (18 years of age and older) and elderly (older than 60 years of age): 0.5 ml
_Paediatric population_
The safety and efficacy in subjects below 18 years of age have not been evaluated (see section 5.1).
Method of administration
Immunization should be carried out by intramuscular injection (into the deltoid muscle).
For instructions of the vaccine before administration, see section 6.6.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.) or residues
(e.g. formaldehyde, benzonase or sucrose).
It is recommended to postpone the immunization in patients with moderate or severe acute illness with or without
fever.
A/California/07/2009 (H1N1)
15 micrograms HA**
A/Victoria/361/2011 (A/H3N2)
15 micrograms HA**
B/Hubei-Wujiagang/158/2009 (B)
15 micrograms HA**
per 0.5 ml dose
HEALTH PRODUCTS REGULATORY AUTHORITY
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