TRIPACEL SUSPENSION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
30-05-2013
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Aktiv bestanddel:
PERTACTIN; FIMBRIAE; FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; TETANUS TOXOID; DIPHTHERIA TOXOID
Tilgængelig fra:
SANOFI PASTEUR LIMITED
ATC-kode:
J07AJ52
INN (International Name):
PERTUSSIS, PURIFIED ANTIGEN, COMB. WITH TOXOIDS
Dosering:
3MCG; 5MCG; 5MCG; 10MCG; 5LF; 15LF
Lægemiddelform:
SUSPENSION
Sammensætning:
PERTACTIN 3MCG; FIMBRIAE 5MCG; FILAMENTOUS HAEMAGGLUTININ 5MCG; PERTUSSIS TOXOID 10MCG; TETANUS TOXOID 5LF; DIPHTHERIA TOXOID 15LF
Indgivelsesvej:
INTRAMUSCULAR
Enheder i pakken:
100
Recept type:
Schedule D
Terapeutisk område:
TOXOIDS
Produkt oversigt:
Active ingredient group (AIG) number: 0628682002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2005-11-08
Produktets egenskaber
SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
253 – TRIPACEL
®
Page 1 of 32
PRODUCT MONOGRAPH
TRIPACEL
®
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE
ADSORBED
Suspension for injection
(For active immunization against Diphtheria, Tetanus and Pertussis)
ATC Code: J07AJ52
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
DATE OF REVISION: April 2013
Control# 164493,
Date of Approval: May 29, 2013
SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
253 – TRIPACEL
®
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 5
SUMMARY PRODUCT INFORMATION
.............................................................................
5
DESCRIPTION
...........................................................................................................................
5
INDICATIONS AND CLINICAL USE
....................................................................................
5
Pediatrics
.................................................................................................................................
6
Geriatrics
.................................................................................................................................
6
CONTRAINDICATIONS
..........................................................................................................
6
Hypersensitivity
.......................................................................................................................
6
Neurological Disorders
............................................................................................................
6
WARNINGS AND PRECAUTIONS
........................................................................................
6
General
.................................................................................................................................
6
Hematologic
.............................................................................................................................
7
Immune
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