ISENTRESS TABLET (CHEWABLE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RALTEGRAVIR (RALTEGRAVIR POTASSIUM)

Pieejams no:

MERCK CANADA INC

ATĶ kods:

J05AJ01

SNN (starptautisko nepatentēto nosaukumu):

RALTEGRAVIR

Deva:

100MG

Zāļu forma:

TABLET (CHEWABLE)

Kompozīcija:

RALTEGRAVIR (RALTEGRAVIR POTASSIUM) 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

60

Receptes veids:

Prescription

Ārstniecības joma:

HIV INTEGRASE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0152351003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2012-12-07

Produkta apraksts

ISENTRESS® AND ISENTRESS HD®_ (raltegravir potassium)_
_ _
_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
_ _
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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