INFANRIX-IPV SUSPENSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PERTUSSIS TOXOID; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN; DIPHTHERIA TOXOID; TETANUS TOXOID; INACTIVATED POLIOVIRUS TYPE I; INACTIVATED POLIOVIRUS TYPE II; INACTIVATED POLIOVIRUS TYPE III

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

J07CA02

INN (nume internaţional):

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

Dozare:

25MCG; 25MCG; 8MCG; 30UNIT; 40UNIT; 40UNIT; 8UNIT; 32UNIT

Forma farmaceutică:

SUSPENSION

Compoziție:

PERTUSSIS TOXOID 25MCG; FILAMENTOUS HAEMAGGLUTININ 25MCG; PERTACTIN 8MCG; DIPHTHERIA TOXOID 30UNIT; TETANUS TOXOID 40UNIT; INACTIVATED POLIOVIRUS TYPE I 40UNIT; INACTIVATED POLIOVIRUS TYPE II 8UNIT; INACTIVATED POLIOVIRUS TYPE III 32UNIT

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

100

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

VACCINES

Rezumat produs:

Active ingredient group (AIG) number: 0839081001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2021-10-26

Caracteristicilor produsului

_Webtop\1100\607\131-non-pm-Infanrix-IPV.doc _
_August 20, 2014 _
_Page 1 of 16_
PRODUCT MONOGRAPH
INFANRIX
®
-IPV
Combined diphtheria, tetanus, acellular pertussis and
inactivated poliomyelitis vaccine
Sterile suspension for injection
Single dose pre-filled syringe
Active immunizing agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Approval:
September 11, 2014
Submission Control No: 177364
_©_
_2014 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_INFANRIX is a registered trade-mark, used under license by
GlaxoSmithKline Inc. _
_Webtop\1100\607\131-non-pm-Infanrix-IPV.doc _
_August 20, 2014 _
_Page 2 of 16_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
4
ADVERSE REACTIONS
.......................................................................................
6
DRUG INTERACTIONS
.......................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................... 9
OVERDOSAGE
...................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................... 10
STORAGE AND STABILITY
.............................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 11
PART II: SCIENTIFIC INFORMATION
............................................................