ZIAGEN SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ABACAVIR (ABACAVIR SULFATE)

Beschikbaar vanaf:

VIIV HEALTHCARE ULC

ATC-code:

J05AF06

INN (Algemene Internationale Benaming):

ABACAVIR

Dosering:

20MG

farmaceutische vorm:

SOLUTION

Samenstelling:

ABACAVIR (ABACAVIR SULFATE) 20MG

Toedieningsweg:

ORAL

Eenheden in pakket:

240 ML

Prescription-type:

Prescription

Therapeutisch gebied:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0137623002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

1999-06-04

Productkenmerken

_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ZIAGEN, abacavir _
_July 2023 _
_ _
_Page 1 of 34_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZIAGEN
abacavir tablets, 300 mg (as abacavir sulfate)
abacavir oral solution, 20 mg/ml (as abacavir sulfate)
Mfr. Standard
Antiretroviral Agent
ViiV Healthcare ULC
75 Queen Street, Suite 1400
Montreal, Quebec
Canada
H3C 2N6
Date of Initial Approval:
SEPT 10, 2001
Date of Revision:
JUL 05, 2023
Submission Control No: 272514
_©_
_2023 ViiV Healthcare group of companies or its licensor _
_Trademarks are owned by or licensed to the ViiV Healthcare group of
companies _
_ZIAGEN, abacavir _
_July 2023_
_ _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
07/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
TABLE OF CONTENTS
..........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
...............................................................................................................................
4
2
CONTRAINDICATIONS
............................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................................
5
4
DOSAGE AND ADMINISTRATION
............................................................................................
5
4.1
Dosing Considerations
.....................................................................................................