CRIXIVAN CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

INDINAVIR (INDINAVIR SULFATE)

Mevcut itibaren:

MERCK CANADA INC

ATC kodu:

J05AE02

INN (International Adı):

INDINAVIR

Doz:

300MG

Farmasötik formu:

CAPSULE

Kompozisyon:

INDINAVIR (INDINAVIR SULFATE) 300MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

HIV PROTEASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2016-11-01

Ürün özellikleri

_ _
_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
...