ZOLEDRONIC ACID FOR INJECTION SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible des:

PFIZER CANADA ULC

Codi ATC:

M05BA08

Designació comuna 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:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2021-04-08

Fitxa tècnica

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA