INFANRIX-IPV/HIB SUSPENSION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PERTUSSIS TOXOID; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN; DIPHTHERIA TOXOID; TETANUS TOXOID; INACTIVATED POLIOVIRUS TYPE I; INACTIVATED POLIOVIRUS TYPE II; INACTIVATED POLIOVIRUS TYPE III; HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T)

Disponible desde:

GLAXOSMITHKLINE INC

Código ATC:

J07CA06

Designación común internacional (DCI):

DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS

Dosis:

25MCG; 25MCG; 8MCG; 30UNIT; 40UNIT; 40UNIT; 8UNIT; 32UNIT; 10MCG

formulario farmacéutico:

SUSPENSION

Composición:

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; HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10MCG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

250ML

tipo de receta:

Schedule D

Área terapéutica:

VACCINES

Resumen del producto:

Active ingredient group (AIG) number: 0950281002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2004-08-09

Ficha técnica

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_February 17, 2017 _
_Page 1 of 29_
PRODUCT MONOGRAPH
INFANRIX
®
-IPV/HIB
HIBERIX
® RECONSTITUTED WITH INFANRIX
®
-IPV
Combined diphtheria, tetanus, acellular pertussis, inactivated
poliomyelitis,
_Haemophilus influenzae_ type b vaccine
Sterile suspension for injection
Single dose pre-filled syringe or vial INFANRIX
®
-IPV (suspension for injection)
and
Single dose vial HIBERIX
®
(lyophilized powder for injection)
Active immunizing agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
DATE OF APPROVAL:
May 29, 2017
SUBMISSION CONTROL NO: 203029
_©_
_ 2017GSK Inc. All Rights Reserved _
_INFANRIX and HIBERIX are registered trademarks of GSKBiologicals SA,
used under license by GSKInc_.
_ _
_ _
_February 17, 2017 _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 4
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
7
DRUG INTERACTIONS
.....................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................. 11
OVERDOSAGE
...................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................... 13
STORAGE AND STABILITY
.............................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........