Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN DIPHTHERIA TOXOID TETANUS TOXOID HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE TETANUS TOXOID
GlaxoSmithKline (Ireland) Limited
PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN DIPHTHERIA TOXOID TETANUS TOXOID HAEMOPHILUS INFLUENZAE TYPE B
%v/v
Powder for 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-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 Прочитајте комплетан документ