TD POLIO ADSORBED SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TETANUS TOXOID; DIPHTHERIA TOXOID; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY

Pieejams no:

SANOFI PASTEUR LIMITED

ATĶ kods:

J07CA01

SNN (starptautisko nepatentēto nosaukumu):

DIPHTHERIA-POLIOMYELITIS-TETANUS

Deva:

5LF; 2LF; 32UNIT; 8UNIT; 40UNIT

Zāļu forma:

SUSPENSION

Kompozīcija:

TETANUS TOXOID 5LF; DIPHTHERIA TOXOID 2LF; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 8UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY 40UNIT

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

5X0.5ML

Receptes veids:

Schedule D

Ārstniecības joma:

TOXOIDS

Produktu pārskats:

Active ingredient group (AIG) number: 0528062002; AHFS:

Autorizācija statuss:

MARKETED

Autorizācija datums:

2001-04-12

Produkta apraksts

SANOFI PASTEUR
SECTION 1.3.1
245-TD-IPV
NOTIFIABLE CHANGE – CLEAN-PRODUCT MONOGRAPH
CONFIDENTIAL/PROPRIETARY INFORMATION
PAGE 1 OF 24
PRODUCT MONOGRAPH
TD POLIO ADSORBED
TETANUS AND DIPHTHERIA TOXOIDS ADSORBED AND
INACTIVATED POLIOMYELITIS VACCINE
Suspension for Injection
(For Active Immunization Against
Tetanus, Diphtheria and Poliomyelitis)
ATC Code: J07CA01
Manufactured by:
SANOFI PASTEUR LIMITED
Date of Preparation:
Toronto, Ontario, Canada
December 2010
Control #: 143444
Date of Approval: December 23, 2010
SANOFI PASTEUR
SECTION 1.3.1
245-TD-IPV
NOTIFIABLE CHANGE – CLEAN-PRODUCT MONOGRAPH
CONFIDENTIAL/PROPRIETARY INFORMATION
PAGE 2 OF 24
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................5
SUMMARY PRODUCT INFORMATION
..................................................................................5
DESCRIPTION
...............................................................................................................................
5
INDICATIONS AND CLINICAL USE
........................................................................................5
Tetanus
6
Diphtheria..........................................................................................................................................6
Poliomyelitis......................................................................................................................................6
Pediatrics 6
CONTRAINDICATIONS...............................................................................................................
7
WARNINGS AND
PRECAUTIONS.............................................................................................7
General
7
Hematologic
......................................................................................................................................8
Immune
8
Neurologic
.........................................................................................................................................8
Special Popu