INFANRIX IN A PREFILLED SYRINGE %v/v Suspension for Injection
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
28-05-2024
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN
Tillgänglig från:
GlaxoSmithKline (Ireland) Limited
INN (International namn):
DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN
Dos:
%v/v
Läkemedelsform:
Suspension for Injection
Receptbelagda typ:
Product subject to prescription which may not be renewed (A)
Bemyndigande status:
Authorised
Tillstånd datum:
0000-00-00
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infanrix Suspension for Injection in a pre-filled syringe.
Dephtheria-tetanus-and-pertussis (acellular component) vaccine (absorbed).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
'Infanrix' contains diphtheria toxoid, tetanus toxoid and three purified pertussis antigens
[pertussis toxoid (TP), filamentous haemagglutinin (FHA) and pertactin (69 kilo Dalton
outer membrane protein)] adsorbed on to an aluminium salt.
Each 0.5 ml dose contains:
Diphtheria toxoid
not less than 30 IU
Tetanus toxoid
not less than 40 IU
Pertussis toxoid
25 micrograms
Filamentous haemagglutinin
25 micrograms
Pertactin
8 micrograms
Aluminium (as Aluminium Hydroxide)
0.5 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Suspension for Injection in a pre-filled syringe.
Turbid suspension for deep intramuscular injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
'Infanrix' is indicated for active primary immunisation against diphtheria, tetanus and pertussis from the age of 2
months onwards and as a booster dose for children who have previously been immunised with 3 doses of either DTPa
or DTPw vaccine according to the national policy in effect at the time.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
Adults and elderly: Not recommended.
Children (up to and including 6 years of age): 0.5 ml of the vaccine by deep intramuscular injection.
The primary immunisation course consists of 3 doses with an interval of at least one month between each dose. The
first dose should normally be given when the child is two months old.
A booster dose should be given after the completion of a primary course of DTP according to the national policy in
effect at the time.
_METHOD OF ADMINISTRATION_
Shake well before use and administer by deep intramuscular
Läs hela dokumentet
