PMS-ZOLEDRONIC ACID SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponibil de la:

PHARMASCIENCE INC

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:

2014-02-26

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
PMS-ZOLEDRONIC ACID
(Zoledronic Acid for Injection)
4 mg zoledronic acid / 5 mL incorporated as the monohydrate for
intravenous infusion
Bone Metabolism Regulator
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite

100
June 02, 2009
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Revision:
June 3, 2016
Submission Control No: 195313
_pms-ZOLEDRONIC ACID Product Monograph _
_Page 2 of 55_
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................................................................................................................
22
DOSAGE AND ADMINISTRATION
...........................................................................................
23
OVERDOSAGE
..............................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
27
STORAGE AND STABILITY
.......................................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 31
PART II: SCIENTIFIC INFORMATION
..................................................................................
33
PHARMACEUTICAL INFORMA