ACLASTA SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-12-2022
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Active ingredient:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
M05BA08
INN (International Name):
ZOLEDRONIC ACID
Dosage:
5MG
Pharmaceutical form:
SOLUTION
Composition:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG
Administration route:
INTRAVENOUS
Units in package:
100ML
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0141761003; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-12-13
Summary of Product characteristics
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
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