TARO-ZOLEDRONIC ACID CONCENTRATE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible depuis:

TARO PHARMACEUTICALS INC

Code ATC:

M05BA08

DCI (Dénomination commune internationale):

ZOLEDRONIC ACID

Dosage:

4MG

forme pharmaceutique:

SOLUTION

Composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

6* 5ML(VIAL)

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BONE RESORPTION INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-02-26

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
TARO-ZOLEDRONIC ACID CONCENTRATE
(ZOLEDRONIC ACID FOR INJECTION)
4 MG ZOLEDRONIC ACID/5 ML INCORPORATED AS THE MONOHYDRATE
Sterile concentrate for injection
MUST BE DILUTED BEFORE USE
Bone Metabolism Regulator
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario, Canada
L6T 1C1
CONTROL NUMBER:
222810
DATE OF PREPARATION:
January 2, 2019
_TARO-ZOLENDRONIC ACID CONCENTRATE _
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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
.......................................................................................................................
23
DOSAGE AND ADMINISTRATION
...................................................................................................
23
OVERDOSAGE
.....................................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
28
STORAGE AND STABILITY
...............................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 32
PART II: SCIENTIFIC INFORMATION
.......