CRIXIVAN CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
30-10-2015

有効成分:

INDINAVIR (INDINAVIR SULFATE)

から入手可能:

MERCK CANADA INC

ATCコード:

J05AE02

INN(国際名):

INDINAVIR

投薬量:

400MG

医薬品形態:

CAPSULE

構図:

INDINAVIR (INDINAVIR SULFATE) 400MG

投与経路:

ORAL

パッケージ内のユニット:

90/120/180

処方タイプ:

Prescription

治療領域:

HIV PROTEASE INHIBITORS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2016-11-01

製品の特徴

                                _ _
_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
                                
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