DAKLINZA TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)

から入手可能:

BRISTOL-MYERS SQUIBB CANADA

ATCコード:

J05AP07

INN（国際名）:

DACLATASVIR

投薬量:

30MG

医薬品形態:

TABLET

構図:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 30MG

投与経路:

ORAL

パッケージ内のユニット:

28

処方タイプ:

Prescription

治療領域:

HCV Replication Complex Inhibitors

製品概要:

Active ingredient group (AIG) number: 0157290001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2019-08-01

製品の特徴

_Pr_
_DAKLINZA (daclatasvir) _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DAKLINZA
®
daclatasvir tablets, 30 and 60 mg
(as daclatasvir dihydrochloride)
Antiviral Agent
Bristol-Myers Squibb Canada
Montréal, Canada
Date of Preparation:
12 August 2015
Date of Revision
July 5, 2019
DAKLINZA is a registered trademark of Bristol-Myers Squibb Holdings
Ireland used under
licence by Bristol-Myers Squibb Canada.
Submission Control No: 226078
_Pr_
_DAKLINZA (daclatasvir) _
_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...................................................................