国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN
GlaxoSmithKline (Ireland) Limited
DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN
%v/v
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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 完全なドキュメントを読む