APO-ABACAVIR-LAMIVUDINE-ZIDOVUDINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE; ZIDOVUDINE

Commercializzato da:

APOTEX INC

Codice ATC:

J05AR04

INN (Nome Internazionale):

ZIDOVUDINE, LAMIVUDINE AND ABACAVIR

Dosaggio:

300MG; 150MG; 300MG

Forma farmaceutica:

TABLET

Composizione:

ABACAVIR (ABACAVIR SULFATE) 300MG; LAMIVUDINE 150MG; ZIDOVUDINE 300MG

Via di somministrazione:

ORAL

Confezione:

60

Tipo di ricetta:

Prescription

Area terapeutica:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0345541001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-11-08

Scheda tecnica

Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ABACAVIR-LAMIVUDINE
Abacavir and Lamivudine Tablets
600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine
Antiretroviral Agent
Manufacturer’s Standard
Date of Revision:
December 27, 2019
Submission Control No: 233546
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
M