APO-LAMIVUDINE-ZIDOVUDINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LAMIVUDINE; ZIDOVUDINE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

J05AR01

INN (International Name):

ZIDOVUDINE AND LAMIVUDINE

Dosering :

150MG; 300MG

Legemiddelform:

TABLET

Sammensetning:

LAMIVUDINE 150MG; ZIDOVUDINE 300MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0235460001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-01-14

Preparatomtale

_APO-LAMIVUDINE-ZIODOVUDINE (Lamivudine and Zidovudine Tablets) _
_ Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-LAMIVUDINE-ZIDOVUDINE
Lamivudine and Zidovudine Tablets
Tablets, 150 mg Lamivudine and 300 mg Zidovudine, Oral
Apotex Standard
Antiretroviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
APR 27, 2012
Date of Revision:
JUNE 19, 2023
Submission Control Number: 271249
_APO-LAMIVUDINE-ZIODOVUDINE (Lamivudine and Zidovudine Tablets) _
_ Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
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
4.1
Dosing Considerations
..............................................................