TARO-ZOLEDRONIC ACID CONCENTRATE SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Tillgänglig från:

TARO PHARMACEUTICALS INC

ATC-kod:

M05BA08

INN (International namn):

ZOLEDRONIC ACID

Dos:

4MG

Läkemedelsform:

SOLUTION

Sammansättning:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

6* 5ML(VIAL)

Receptbelagda typ:

Prescription

Terapiområde:

BONE RESORPTION INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2014-02-26

Produktens egenskaper

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
.......