Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID
SANOFI ISRAEL LTD
J07CA02
SUSPENSION FOR INJECTION
TETANUS TOXOID 5 LF / 1 DOSES; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE; FILAMENTOUS HAEMAGGLUTININ (FHA) 5 MCG/DOSE; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE; PERTACTIN (PRN) 3 MCG/DOSE; DIPHTHERIA TOXOID 2 LF / 1 DOSES
I.M
Required
SANOFI PASTEUR LTD, CANADA
DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
Active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. Adacel is not indicated for treating diseases caused by B.pertussis, C.diphtheriae or C. tetani infections.
2014-11-30
1 1 NAME OF THE MEDICINAL PRODUCT ADACEL® suspension for injection. Diphtheria, Tetanus, Pertussis (acellular component) Vaccine (adsorbed, reduced antigen(s) content) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 mL) contains: Diphtheria Toxoid Not less than 2 IU* (2 Lf) Tetanus Toxoid Not less than 20 IU* (5 Lf) Pertussis Antigens Pertussis Toxoid 2.5 micrograms Filamentous Haemagglutinin 5 micrograms Pertactin 3 micrograms Fimbriae Types 2 and 3 5 micrograms Adsorbed on aluminium phosphate 1.5 mg (0.33 mg Al 3+ ) * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia. This vaccine may contain traces of formaldehyde and glutaraldehyde which are used during the manufacturing process (see sections 4.3 and 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection ADACEL® appears as a cloudy white suspension. 4 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis in children, adolescents and adults aged 4 to 64 years. ADACEL® is not to be used for the treatment of disease caused by _B.ordetella pertussis, C.-_ _orynebacterium diphtheriae _ or _Clostridium tetani _ infections. POSOLOGY AND METHOD OF ADMINISTRATION Posology RECOMMENDED DOSE 2 The immunization schedule with ADACEL® should follow local recommendations. ADACEL® (0.5mL) should be administered as a booster dose by the intramuscular route. Re-dosing with ADACEL® can be used to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 year intervals. The preferred site is into the deltoid muscle. Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined. The use of ADACEL® in management of tetanus-prone wounds should follow local recommendations. Canada's National Advisory Committee on Immunization ( NACI ) and US Advisory Committee on Immunization Διαβάστε το πλήρες έγγραφο