ZOLEDRONIC ACID INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Boleh didapati daripada:

DR REDDY'S LABORATORIES LTD

Kod ATC:

M05BA08

INN (Nama Antarabangsa):

ZOLEDRONIC ACID

Dos:

5MG

Borang farmaseutikal:

SOLUTION

Komposisi:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100ML(1 VIAL)

Jenis preskripsi:

Prescription

Kawasan terapeutik:

BONE RESORPTION INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0141761003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2014-03-21

Ciri produk

1
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg / 100 mL zoledronic acid (as zoledronic acid monohydrate)
Solution for intravenous infusion
Bone Metabolism Regulator
Manufacturer:
DR. REDDY’S LABORATORIES LIMITED
Bachupally 500 090 – INDIA
Imported/Distributed By:
DATE OF REVISION:
AUGUST 1, 2019
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1 Canada
Submission Control Number: 228238
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
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4
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
.............................................................................................................
10
DRUG
INTERACTIONS..............................................................................................................
24
DOSAGE AND ADMINISTRATION
.........................................................................................
25
OVERDOSAGE
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27
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
27
STORAGE AND STABILITY
.....................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
...................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 31
PART II: SCIENTIFIC INFORMATION
.........