ZOLEDRONIC ACID CONCENTRATE SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible desde:

APOTEX INC

Código ATC:

M05BA08

Designación común internacional (DCI):

ZOLEDRONIC ACID

Dosis:

4MG

formulario farmacéutico:

SOLUTION

Composición:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

5ML

tipo de receta:

Prescription

Área terapéutica:

BONE RESORPTION INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2015-07-20

Ficha técnica

Page 1 of 51
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile concentrate solution for intravenous infusion
BONE METABOLISM REGULATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
March 12, 2021
SUBMISSION CONTROL NUMBER: 246127
Page 2 of 51
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
...................................................................................................
20
DOSAGE AND ADMINISTRATION
..................................................................................
20
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
24
STORAGE AND STABILITY
............................................................................................
28
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 29
PART II: SCIENTIFIC INFORMATION
.................................................................................
30
PHARMACEUTICAL INFORMATION
...............................................................................
30
CLINICAL TRIALS
...............................................................