ZOMETA LYOPHILIZED POWDER POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Dostupno od:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC koda:

M05BA08

INN (International ime):

ZOLEDRONIC ACID

Doziranje:

4MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

6ML

Tip recepta:

Prescription

Područje terapije:

BONE RESORPTION INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2008-10-31

Svojstava lijeka

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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.......................................