INFANRIX-HIB %v/v Powder for suspension for injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN DIPHTHERIA TOXOID TETANUS TOXOID HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE TETANUS TOXOID

Dostopno od:

GlaxoSmithKline (Ireland) Limited

INN (mednarodno ime):

PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN DIPHTHERIA TOXOID TETANUS TOXOID HAEMOPHILUS INFLUENZAE TYPE B

Odmerek:

%v/v

Farmacevtska oblika:

Powder for suspension for injection

Tip zastaranja:

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

Status dovoljenje:

Authorised

Datum dovoljenje:

0000-00-00

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infanrix-Hib Powder and suspension for suspension for injection
Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type B conjugate vaccine (adsorbed)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) of vaccine contains:
3 PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infanrix-Hib’ is indicated for active primary immunisation against diphtheria, tetanus and pertussis and Hib from the
age of two months onwards and as a booster dose for children who have previously been immunised with three doses of
DTPa or DTPw or ‘Infanrix-Hib’ vaccine according to the national policy in effect at the time.
‘Infanrix-Hib is not suitable for use in children over 36 months.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly: Not recommended.
Children (up to 36 months): 0.5ml of the vaccine by deep intramuscular injection.
The primary immunisation course consists of three doses at two, four and six months.
Booster dose
Diphtheria toxoid
1
not less than 30.00
IU
Tetanus toxoid
1
not less than 40.00
IU
_Bordetella pertussis _antigens
Pertussis toxoid
1
25.00
micrograms
Filamentous
haemagglutinin
1
25.00
micrograms
Pertactin
1
25.00
micrograms
Haemophilus tybe b polysaccharide
(polyribosylribitol phosphate)
10.00
micrograms
conjugated to tetanus toxoid as
carrier protein
approximately 30.00
micrograms
1
Adsorbed on aluminium hydroxide, hydrated 0.5 milligrams A1
3+
For excipients, _see section 6.1_
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 02/07/2014_
_CRN 2144401_
_page number: 1_
Following completion of the primary immunisation series, an