BIVALIRUDIN FOR INJECTION POWDER FOR SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BIVALIRUDIN

متاح من:

JUNO PHARMACEUTICALS CORP.

ATC رمز:

B01AE06

INN (الاسم الدولي):

BIVALIRUDIN

جرعة:

250MG

الشكل الصيدلاني:

POWDER FOR SOLUTION

تركيب:

BIVALIRUDIN 250MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

DIRECT THROMBIN INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0148342001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-01-22

خصائص المنتج

Page 1 of 44
PRODUCT
MONOGRAPH PR
BIVALIRUDIN FOR INJECTION
Lyophilized
Powder
250 mg/vial
Direct Thrombin Inhibitor
Intravenous Injection
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, Ontario L5N 2X7
Date of Preparation:
April 12, 2021
Control No: 249905
Page 2 of 44
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................
15
DOSAGE AND ADMINISTRATION
.................................................................................
15
OVERDOSAGE
..............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 22
STORAGE AND STABILITY
...........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
....................................................................................
25
PHARMACEUTICAL INFORMATION
.............................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
....................