APO-ABACAVIR-LAMIVUDINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE

Commercializzato da:

APOTEX INC

Codice ATC:

J05AR02

INN (Nome Internazionale):

LAMIVUDINE AND ABACAVIR

Dosaggio:

600MG; 300MG

Forma farmaceutica:

TABLET

Composizione:

ABACAVIR (ABACAVIR SULFATE) 600MG; LAMIVUDINE 300MG

Via di somministrazione:

ORAL

Confezione:

30/90

Tipo di ricetta:

Prescription

Area terapeutica:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-11-02

Scheda tecnica

_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