ZOLEDRONIC ACID - Z SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

M05BA08

INN (Nama Antarabangsa):

ZOLEDRONIC ACID

Dos:

4MG

Borang farmaseutikal:

SOLUTION

Komposisi:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

5ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

BONE RESORPTION INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-02-15

Ciri produk

_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
..................................................