APO-LAMIVUDINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LAMIVUDINE

Предлага се от:

APOTEX INC

АТС код:

J05AF05

INN (Международно Name):

LAMIVUDINE

дозиране:

150MG

Лекарствена форма:

TABLET

Композиция:

LAMIVUDINE 150MG

Начин на приложение:

ORAL

Броя в опаковка:

10/100

Вид предписание :

Prescription

Терапевтична област:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0128157001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2012-04-27

Данни за продукта

_APO-LAMIVUDINE (Lamivudine Tablets) _
_ _
_Page 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LAMIVUDINE
Lamivudine (as lamivudine methanol solvate) Tablets
Tablets, 150 mg and 300 mg, Oral
Apotex Standard
Antiretroviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
APR 27, 2012
Date of Revision:
JUN 2, 2023
Submission Control Number: 271187
_APO-LAMIVUDINE (Lamivudine Tablets) _
_ _
_Page 2 of 46 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
[Removed] 06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS
06/2023
7 WARNINGS AND PRECAUTIONS, General
[Removed] 06/2023
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
...............................................................................................................
4
1.2 Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
..............................