ACLASTA SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible desde:

SANDOZ CANADA INCORPORATED

Código ATC:

M05BA08

Designación común internacional (DCI):

ZOLEDRONIC ACID

Dosis:

5MG

formulario farmacéutico:

SOLUTION

Composición:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

100ML

tipo de receta:

Prescription

Área terapéutica:

BONE RESORPTION INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-12-13

Ficha técnica

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