ZOLEDRONIC ACID CONCENTRATE FOR INJECTION SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Pieejams no:

GENERIC MEDICAL PARTNERS INC

ATĶ kods:

M05BA08

SNN (starptautisko nepatentēto nosaukumu):

ZOLEDRONIC ACID

Deva:

4MG

Zāļu forma:

SOLUTION

Kompozīcija:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

BONE RESORPTION INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2014-05-08

Produkta apraksts

_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE FOR INJECTION
(Zoledronic Acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Concentrate – must be diluted before use
Bone Metabolism Regulator
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200,
Toronto, Ontario, Canada
M2J 4R3
DATE OF REVISION:
August 14, 2017
Control No.: 207383
_Page 2 of 54_
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
.............................................................................
21
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY............................................................
25
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
..............................................................