APO-ATAZANAVIR CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ATAZANAVIR (ATAZANAVIR SULFATE)

Verfügbar ab:

APOTEX INC

ATC-Code:

J05AE08

INN (Internationale Bezeichnung):

ATAZANAVIR

Dosierung:

300MG

Darreichungsform:

CAPSULE

Zusammensetzung:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30

Verschreibungstyp:

Prescription

Therapiebereich:

HIV PROTEASE INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0149741004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2018-07-23

Fachinformation

_APO-ATAZANAVIR PRODUCT MONOGRAPH _
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_ PAGE 1 OF 84 _
PRODUCT MONOGRAPH
PR
APO-ATAZANAVIR
Atazanavir capsules
Apotex Standard
150 mg, 200 mg and 300 mg, Oral
(as atazanavir sulfate)
Azapeptide Inhibitor of HIV-1 Protease
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
AUGUST 21, 2020
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 242061
_APO-ATAZANAVIR PRODUCT MONOGRAPH _
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_ PAGE 2 OF 84 _
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
.....................................................................................
43
OVERDOSAGE
........................................................................................................................
46
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
47
STORAGE AND STABILITY
.................................................................................................
51
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 51
PART II: SCIENTIFIC INFORMATION
...............................................................................
53
PHARMACEUTICAL INFORMATION
.................................................................................
53