CRIXIVAN CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

INDINAVIR (INDINAVIR SULFATE)

Verfügbar ab:

MERCK CANADA INC

ATC-Code:

J05AE02

INN (Internationale Bezeichnung):

INDINAVIR

Dosierung:

200MG

Darreichungsform:

CAPSULE

Zusammensetzung:

INDINAVIR (INDINAVIR SULFATE) 200MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

360

Verschreibungstyp:

Prescription

Therapiebereich:

HIV PROTEASE INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0133330001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2014-09-19

Fachinformation

_ _
_CRIXIVAN_
®
_ (indinavir sulfate) _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
CRIXIVAN
®
indinavir capsules
200 and 400 mg
(as indinavir sulfate)
HIV Protease Inhibitor
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
http://www.merck.ca
Date of Revision:
June 9, 2014
SUBMISSION CONTROL NO: 173211
_ _
_CRIXIVAN_
®
_ (indinavir sulfate) _
_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
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.........................................................................
26
CLINICAL TRIALS
....................................................................................................