APO-ABACAVIR-LAMIVUDINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE

Предлага се от:

APOTEX INC

АТС код:

J05AR02

INN (Международно Name):

LAMIVUDINE AND ABACAVIR

дозиране:

600MG; 300MG

Лекарствена форма:

TABLET

Композиция:

ABACAVIR (ABACAVIR SULFATE) 600MG; LAMIVUDINE 300MG

Начин на приложение:

ORAL

Броя в опаковка:

30/90

Вид предписание :

Prescription

Терапевтична област:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-11-02

Данни за продукта

_APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) _
_Page 1 of 50 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ABACAVIR-LAMIVUDINE
Abacavir and Lamivudine Tablets
Tablets, 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine,
Oral
USP
Antiretroviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 14, 2016
Date of Revision:
OCT 25, 2023
Submission Control Number: 277806
_APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) _
_Page 2 of 50 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2023
7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs
03/2023
7 WARNINGS AND PRECAUTIONS, Immune
03/2023
7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency
03/2023
7 WARNINGS AND PRECAUTIONS, General
10/2023
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 BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dos