País: Israel
Idioma: inglés
Fuente: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID
SANOFI ISRAEL LTD
J07CA02
SUSPENSION FOR INJECTION
FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE; FILAMENTOUS HAEMAGGLUTININ (FHA) 5 MCG/DOSE; PERTACTIN (PRN) 3 MCG/DOSE; DIPHTHERIA TOXOID 2 LF / 1 DOSES; TETANUS TOXOID 5 LF / 1 DOSES; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40 DU/DOSE; INACTIVATED POLIO VIRUS (IPV) TYPE 2 8 DU/DOSE; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32 DU/DOSE
I.M
Required
SANOFI PASTEUR, FRANCE
DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 4 years and over as a booster following primary immunisation.Adacel polio is not indicated for primary immunisation. Adacel polio is not indicated for treating diseases caused by B.pertussis, C.Diphtheriae or C.tetani or by poliomyelitis infections
2015-01-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה _____ ךיראת 27.03.2014 __________________ ______תילגנאב רישכת םש ADACEL POLIO _______םושיר רפסמ 142603193800 _____________ מ"עב לקידמ י'צידמ___םושירה לעב םש םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח SPECIAL WARNING AND PRECAUTIONS FOR USE קט תפסות טס Syncope (fainting) has been reported following vaccination with ADACEL ® -POLIO. Procedures shouls be in place to prevent falling injury and manage syncopal reactions POST MARKET ADVERSE DRUG REACTIONS קט תפסות טס _GASTROINTESTINAL DISORDERS_: Abdominal pain ובש ,ןולעה םינמוסמ םייונישה םישקובמה בוהצב רבעוה ראודב ינורטקלא .......ךיראתב 27.03.2014 ........... Leer el documento completo
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 4.1 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. 4.1 POSOLOGY AND METHOD OF ADMINISTRATION Posology RECOMMENDED DOSE 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 Immuniz Leer el documento completo