PENTACEL LIQUID

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PERTUSSIS TOXOID; FILAMENTOUS HAEMAGGLUTININ; FIMBRIAE; PERTACTIN; DIPHTHERIA TOXOID; TETANUS TOXOID; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT; HAEMOPHILUS INFLUENZAE TYPE B-PRP; TETANUS PROTEIN

Beszerezhető a:

SANOFI PASTEUR LIMITED

ATC-kód:

J07CA06

INN (nemzetközi neve):

DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS

Adagolás:

20MCG; 20MCG; 5MCG; 3MCG; 15LF; 5LF; 40UNIT; 8UNIT; 32UNIT; 10MCG; 30MCG

Gyógyszerészeti forma:

LIQUID

Összetétel:

PERTUSSIS TOXOID 20MCG; FILAMENTOUS HAEMAGGLUTININ 20MCG; FIMBRIAE 5MCG; PERTACTIN 3MCG; DIPHTHERIA TOXOID 15LF; TETANUS TOXOID 5LF; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY 40UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 8UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32UNIT; HAEMOPHILUS INFLUENZAE TYPE B-PRP 10MCG; TETANUS PROTEIN 30MCG

Az alkalmazás módja:

INTRAMUSCULAR

db csomag:

5X0.5ML

Recept típusa:

Schedule D

Terápiás terület:

VACCINES

Termék összefoglaló:

Active ingredient group (AIG) number: 1140261002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2000-03-09

Termékjellemzők

SANOFI PASTEUR
1.3.1 CLEAN PRODUCT MONOGRAPH
242 – PENTACEL
®
NOTIFIABLE CHANGE – REVISED LABELLING
CONFIDENTIAL/PROPRIETARY INFORMATION
Product Monograph Template – Schedule D
Page 1 of 38
PRODUCT MONOGRAPH
PENTACEL
®
ACT-HIB
® RECONSTITUTED WITH QUADRACEL
®
HAEMOPHILUS B CONJUGATE VACCINE (TETANUS PROTEIN - CONJUGATE)
RECONSTITUTED WITH
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE
ADSORBED COMBINED WITH
INACTIVATED POLIOMYELITIS VACCINE
Reconstituted product for injection
(For active immunization against
_Haemophilus influenzae_
type b disease,
Diphtheria, Tetanus, Pertussis and Poliomyelitis)
ATC Code: J07CA06
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
and
SANOFI PASTEUR SA
Lyon, France
DATE OF REVISION:
November 2011
CONTROL NUMBER: 151712
DATE OF APPROVAL: JANUARY 30, 2012
SANOFI PASTEUR
1.3.1 CLEAN PRODUCT MONOGRAPH
242 – PENTACEL
®
NOTIFIABLE CHANGE – REVISED LABELLING
CONFIDENTIAL/PROPRIETARY INFORMATION
Product Monograph Template – Schedule D
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................4
SUMMARY PRODUCT INFORMATION
..................................................................................4
DESCRIPTION
...............................................................................................................................
5
INDICATIONS AND CLINICAL USE
........................................................................................5
Pediatrics
..........................................................................................................................................5
CONTRAINDICATIONS...............................................................................................................
6
Hypersensitivity.................................................................................................................................6
Acute Neurological Disorders
...............................................................................