ZOLEDRONIC ACID - Z SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

M05BA08

INN (nume internaţional):

ZOLEDRONIC ACID

Dozare:

4MG

Forma farmaceutică:

SOLUTION

Compoziție:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BONE RESORPTION INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-02-15

Caracteristicilor produsului

_Zoledronic Acid – Z _
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_Page 1 of 51 _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID - Z
(Zoledronic acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Bone Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
July 21, 2017
Control No. : 206684
_Zoledronic Acid – Z _
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_Page 2 of 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION....................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
...............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
.............................................................................................................
12
DRUG INTERACTIONS
.............................................................................................................
20
DOSAGE AND ADMINISTRATION
.........................................................................................
20
OVERDOSAGE
............................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
25
STORAGE AND STABILITY
.....................................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
..................................................