ZOLEDRONIC ACID INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Boleh didapati daripada:

MARCAN PHARMACEUTICALS INC

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

Jenis preskripsi:

Prescription

Kawasan terapeutik:

BONE RESORPTION INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-07-25

Ciri produk

_Page 1 of 68_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Marcan Pharmaceuticals Inc.,
Date of Preparation:
2 Gurdwara Road, Suite #112,
July 24, 2018
Ottawa, ON, K2E 1A2
CONTROL NUMBER: 203800
_Page 2 of 68_
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..................................................................................................10
DRUG INTERACTIONS
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STAB
IL
I
T
Y
..........................................................................................33
SPECIAL HANDLING INSTRUCTIONS
.......................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II: SCIENTIFIC
INFORMATION
...............................................................................35
PHARMACEUTICAL
INFORMATION..........................................................................35
CLINICAL
TR
IA
L
S
..............................................................................................