PMS-ZOLEDRONIC ACID SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Fáanlegur frá:

PHARMASCIENCE INC

ATC númer:

M05BA08

INN (Alþjóðlegt nafn):

ZOLEDRONIC ACID

Skammtar:

4MG

Lyfjaform:

SOLUTION

Samsetning:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

5ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

BONE RESORPTION INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2014-02-26

Vara einkenni

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