DAKLINZA TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)

Dostupné z:

BRISTOL-MYERS SQUIBB CANADA

ATC kód:

J05AP07

INN (Medzinárodný Name):

DACLATASVIR

Dávkovanie:

30MG

Forma lieku:

TABLET

Zloženie:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 30MG

Spôsob podávania:

ORAL

Počet v balení:

28

Typ predpisu:

Prescription

Terapeutické oblasti:

HCV Replication Complex Inhibitors

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2019-08-01

Súhrn charakteristických

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_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
...................................................................