DAKLINZA TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
05-07-2019
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Aktiv ingrediens:
DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)
Tilgjengelig fra:
BRISTOL-MYERS SQUIBB CANADA
ATC-kode:
J05AP07
INN (International Name):
DACLATASVIR
Dosering :
30MG
Legemiddelform:
TABLET
Sammensetning:
DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 30MG
Administreringsrute:
ORAL
Enheter i pakken:
28
Resept typen:
Prescription
Terapeutisk område:
HCV Replication Complex Inhibitors
Produkt oppsummering:
Active ingredient group (AIG) number: 0157290001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2019-08-01
Preparatomtale
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_DAKLINZA (daclatasvir) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
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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
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_DAKLINZA (daclatasvir) _
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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
...................................................................
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