Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)
BRISTOL-MYERS SQUIBB CANADA
J05AP07
DACLATASVIR
60MG
TABLET
DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 60MG
ORAL
28
Prescription
HCV Replication Complex Inhibitors
Active ingredient group (AIG) number: 0157290002; AHFS:
CANCELLED POST MARKET
2019-12-03
_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 ................................................................... Perskaitykite visą dokumentą