ACLASTA SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

M05BA08

INN (الاسم الدولي):

ZOLEDRONIC ACID

جرعة:

5MG

الشكل الصيدلاني:

SOLUTION

تركيب:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BONE RESORPTION INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0141761003; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2022-12-13

خصائص المنتج

Page1 of 65
PRODUCT MONOGRAPH
Pr
ACLASTA
®
(zoledronicacid injection)
5mg/100mL solutionforintravenousinfusion
Bone MetabolismRegulator
SandozCanadaInc.
110 Rue deLauzon
Boucherville,Quebec
CanadaJ4B1E6
Control Number:269479
ACLASTAisaregisteredtrademark
DateofPreparation:
DEC 9,2022
Page2 of65
Table of Contents
PARTI:HEALTHPROFESSIONALINFORMATION..........................................................3
SUMMARYPRODUCTINFORMATION
........................................................................3
INDICATIONSAND CLINICALUSE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGSANDPRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................11
DRUGINTERACTIONS
..................................................................................................25
DOSAGEAND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................29
ACTIONANDCLINICAL PHARMACOLOGY
............................................................29
STORAGE ANDSTABILITY
..........................................................................................32
SPECIALHANDLINGINSTRUCTIONS
.......................................................................33
DOSAGEFORMS,COMPOSITIONAND PACKAGING
.............................................33
PARTII:SCIENTIFICINFORMATION
...............................................................................34
PHARMACEUTICAL
INFORMATION..........................................................................34
CLINICALTRIALS
..........................................................................................................34
DETAI