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:

400MG

Dạng dược phẩm:

CAPSULE

Thành phần:

INDINAVIR (INDINAVIR SULFATE) 400MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

90/120/180

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HIV PROTEASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0133330002; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2016-11-01

Đặc tính sản phẩm

_ _
_CRIXIVAN_
®
_ (indinavir sulfate) _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
CRIXIVAN
®
indinavir capsules
400 mg
(as indinavir sulfate)
HIV Protease Inhibitor
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Revision:
October 29, 2015
SUBMISSION CONTROL NO: 185534
_ _
_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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
21
OVERDOSAGE
................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 22
STORAGE AND STABILITY
.........................................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.........................................................................
26
CLINICAL TRIALS
.........................................................................................................
27
DE