VAL-ZOLEDRONIC ACID SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ZOLEDRONIC ACID (ZOLEDRONIC ACID HEMIPENTAHYDRATE)

متاح من:

BAUSCH HEALTH, CANADA INC.

ATC رمز:

M05BA08

INN (الاسم الدولي):

ZOLEDRONIC ACID

جرعة:

4MG

الشكل الصيدلاني:

SOLUTION

تركيب:

ZOLEDRONIC ACID (ZOLEDRONIC ACID HEMIPENTAHYDRATE) 4MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BONE RESORPTION INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0141761002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-09-16

خصائص المنتج

_ _
PRODUCT MONOGRAPH
PR
VAL-ZOLEDRONIC ACID
Zoledronic Acid for Injection
4 mg zoledronic acid /5 mL (incorporated as the hemipentahydrate)
concentrate solution for intravenous infusion in prefilled syringe
STERILE
CONCENTRATE / MUST BE DILUTED BEFORE USE
BONE METABOLISM REGULATOR
BAUSCH HEALTH, CANADA INC
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 14, 2021
Laval, Quebec
H7L 4A8
Control #: 255538
_Pr_
_VAL-ZOLEDRONIC ACID Product Monograph Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
.......