ZOLEDRONIC ACID INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible depuis:

MARCAN PHARMACEUTICALS INC

Code ATC:

M05BA08

DCI (Dénomination commune internationale):

ZOLEDRONIC ACID

Dosage:

5MG

forme pharmaceutique:

SOLUTION

Composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BONE RESORPTION INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-07-25

Résumé des caractéristiques du produit

_Page 1 of 68_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Marcan Pharmaceuticals Inc.,
Date of Preparation:
2 Gurdwara Road, Suite #112,
July 24, 2018
Ottawa, ON, K2E 1A2
CONTROL NUMBER: 203800
_Page 2 of 68_
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..................................................................................................10
DRUG INTERACTIONS
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STAB
IL
I
T
Y
..........................................................................................33
SPECIAL HANDLING INSTRUCTIONS
.......................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II: SCIENTIFIC
INFORMATION
...............................................................................35
PHARMACEUTICAL
INFORMATION..........................................................................35
CLINICAL
TR
IA
L
S
..............................................................................................