ROTARIX SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN)

Available from:

GLAXOSMITHKLINE INC

ATC code:

J07BH01

INN (International Name):

ROTA VIRUS, LIVE ATTENUATED

Dosage:

1000000CCID50

Pharmaceutical form:

SUSPENSION

Composition:

ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN) 1000000CCID50

Administration route:

ORAL

Units in package:

1ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0152324003; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-10-09

Summary of Product characteristics

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_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROTARIX
Human rotavirus, live, attenuated, oral vaccine
Oral suspension
Active immunizing agent against infection caused by rotavirus
ATC Code: J07BC01
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Initial Authorization:
Oct 09, 2007
Date of Revision:
April 28, 2021
Submission Control Number: 239437
_©_
_ 2021 GSK group of companies or its licensor_
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_Trademarks are owned by or licensed to the GSK group of companies_
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_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING,
8 ADVERSE REACTION, 10 CLINICAL PHARMACOLOGY
XXX 2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE N OT LISTED
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RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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1.1
Pediatrics
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2
CONTRAINDICATIONS
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4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
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4.2
Recommended Dose and Dosage
Adjustment.......................................................4
4.4
Administration.....................................................................................................5
5
OVERDOSAGE
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