TEVA-ABACAVIR/LAMIVUDINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

J05AR02

INN (Medzinárodný Name):

LAMIVUDINE AND ABACAVIR

Dávkovanie:

600MG; 300MG

Forma lieku:

TABLET

Zloženie:

ABACAVIR (ABACAVIR SULFATE) 600MG; LAMIVUDINE 300MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0251241001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2016-03-14

Súhrn charakteristických

_Teva-Abacavir/Lamivudine (abacavir and lamivudine tablets) Page 1 of
49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ABACAVIR/LAMIVUDINE
Abacavir and Lamivudine Tablets
Tablets, 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine,
Oral
BP
Antiretroviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No.: 278427
Date of Initial Authorization:
March 14, 2016
Date of Revision:
February 9, 2024
_Teva-Abacavir/Lamivudine (abacavir and lamivudine tablets) Page 2 of
49 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
04/2022
3 Serious Warnings and Precautions Box
04/2022
4 Dosage and Administration, 4.1 Dosing Considerations
04/2022
7 Warnings and Precautions, General, Renal Insufficiency
04/2022
7 Warnings and Precautions, Clinical Management of Abacavir HSRs
04/2022
7 Warnings and Precautions , Immune
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................2
TABLE OF
CONTENTS………………………………………………………………………………………………………………2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1 INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics (< 18 years of age)
................................................................................................
4
1.2 Geriatrics (≥ 65 years of age)
................................................................................................
4
2 CONTRAINDICATIONS
...........................................................................................................
4
3 SERIOUS_ _WARNINGS AND PRECAUTIONS
......................................................