CRIXIVAN CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

INDINAVIR (INDINAVIR SULFATE)

Sẵn có từ:

MERCK CANADA INC

Mã ATC:

J05AE02

INN (Tên quốc tế):

INDINAVIR

Liều dùng:

300MG

Dạng dược phẩm:

CAPSULE

Thành phần:

INDINAVIR (INDINAVIR SULFATE) 300MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HIV PROTEASE INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2016-11-01

Đặc tính sản phẩm

_ _
_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
...