CRIXIVAN CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

INDINAVIR (INDINAVIR SULFATE)

Dostupné s:

MERCK CANADA INC

ATC kód:

J05AE02

INN (Mezinárodní Name):

INDINAVIR

Dávkování:

300MG

Léková forma:

CAPSULE

Složení:

INDINAVIR (INDINAVIR SULFATE) 300MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

HIV PROTEASE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0133330004; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2016-11-01

Charakteristika produktu

_ _
_Product Monograph - CRIXIVAN_
_®_
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
CRIXIVAN
®
indinavir sulfate capsules
100, 200, 300, and 400 mg
(as indinavir)
HIV Protease Inhibitor
MERCK FROSST CANADA LTD.
16711 Trans Canada Highway
KIRKLAND QC H9H 3L1
Canada
www.merckfrosst.com
Date of Revision:
February 13, 2007
SUBMISSION CONTROL NO: 110356
CRIXIVAN is a
®
Registered Trademark of Merck & Co., Inc.
Used under licence.
_ _
_Product Monograph - CRIXIVAN_
_®_
_ _
_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...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE................................................................................................................
22
ACTION AND CLINICAL
PHARMACOLOGY............................................................
22
STORAGE AND STABILITY
.........................................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL
INFORMATION.........................................................................
27
CLINICAL TRIALS
...