ZOMETA LYOPHILIZED POWDER POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

זמין מ:

NOVARTIS PHARMACEUTICALS CANADA INC

קוד ATC:

M05BA08

INN (שם בינלאומי):

ZOLEDRONIC ACID

כמות:

4MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

6ML

סוג מרשם:

Prescription

איזור תרפויטי:

BONE RESORPTION INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0141761001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2008-10-31

מאפייני מוצר

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_Page 1 of _47
PRODUCT MONOGRAPH
Pr
ZOMETA* Lyophilized Powder
(Zoledronic acid for Injection)
4 mg/vial
Pr
ZOMETA* Concentrate
(Zoledronic acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate
Bone Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
Dorval, Quebec
H9S 1A9
Date of Preparation:
August 16, 2000
Date of Revision:
September 20, 2005
CONTROL # 097402
Pr
ZOMETA* is a registered trademark
_ _
_Page 2 of _47
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....................................................................................................9
DRUG INTERACTIONS
....................................................................................................5
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND
STABILITY..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIALS.......................................