ZIAGEN SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ABACAVIR (ABACAVIR SULFATE)

Доступно од:

VIIV HEALTHCARE ULC

АТЦ код:

J05AF06

INN (Међународно име):

ABACAVIR

Дозирање:

20MG

Фармацеутски облик:

SOLUTION

Састав:

ABACAVIR (ABACAVIR SULFATE) 20MG

Пут администрације:

ORAL

Јединице у пакету:

240 ML

Тип рецептора:

Prescription

Терапеутска област:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

1999-06-04

Карактеристике производа

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