DAKLINZA TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)

Pieejams no:

BRISTOL-MYERS SQUIBB CANADA

ATĶ kods:

J05AP07

SNN (starptautisko nepatentēto nosaukumu):

DACLATASVIR

Deva:

60MG

Zāļu forma:

TABLET

Kompozīcija:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 60MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

28

Receptes veids:

Prescription

Ārstniecības joma:

HCV Replication Complex Inhibitors

Produktu pārskats:

Active ingredient group (AIG) number: 0157290002; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2019-12-03

Produkta apraksts

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