ACLASTA SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
13-12-2022
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Tilgængelig fra:
SANDOZ CANADA INCORPORATED
ATC-kode:
M05BA08
INN (International Name):
ZOLEDRONIC ACID
Dosering:
5MG
Lægemiddelform:
SOLUTION
Sammensætning:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
100ML
Recept type:
Prescription
Terapeutisk område:
BONE RESORPTION INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0141761003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2022-12-13
Produktets egenskaber
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
Læs hele dokumentet
