ISENTRESS HD TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RALTEGRAVIR (RALTEGRAVIR POTASSIUM)

Available from:

MERCK CANADA INC

ATC code:

J05AJ01

INN (International Name):

RALTEGRAVIR

Dosage:

600MG

Pharmaceutical form:

TABLET

Composition:

RALTEGRAVIR (RALTEGRAVIR POTASSIUM) 600MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

HIV INTEGRASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152351004; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-06-21

Summary of Product characteristics

ISENTRESS® AND ISENTRESS HD®_ (raltegravir potassium)_
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_Page 1 of 69_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ISENTRESS®
(*as raltegravir potassium)
*Raltegravir tablets, 400 mg
*Raltegravir chewable tablets, 25 mg, 100 mg
ISENTRESS HD®
(as raltegravir potassium)
Raltegravir tablets, 600 mg
Human immunodeficiency virus integrase strand transfer inhibitor
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
November 9, 2007
Date of Revision:
OCT 30, 2023
Submission Control Number: 276444
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ISENTRESS® AND ISENTRESS HD®_ (raltegravir potassium)_
_ _
_Page 2 of 69_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
7.1 SPECIAL POPULATIONS
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
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