INFANRIX-IPV/HIB SUSPENSION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

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)

Tilgængelig fra:

GLAXOSMITHKLINE INC

ATC-kode:

J07CA06

INN (International Name):

DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS

Dosering:

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

Lægemiddelform:

SUSPENSION

Sammensætning:

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

Indgivelsesvej:

INTRAMUSCULAR

Enheder i pakken:

250ML

Recept type:

Schedule D

Terapeutisk område:

VACCINES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2004-08-09

Produktets egenskaber

_ _
_ _
_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
.........