PMS-PAMIDRONATE POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PAMIDRONATE DISODIUM

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

M05BA03

INN (International Name):

PAMIDRONIC ACID

Dosering :

90MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

PAMIDRONATE DISODIUM 90MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

10 ML

Resept typen:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0123608002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2002-09-10

Preparatomtale

PRODUCT MONOGRAPH
PR
PMS-PAMIDRONATE
(Pamidronate disodium for injection, House standard)
15mg/vial, 30 mg/vial, 60 mg/vial and 90 mg/vial
For intravenous infusion only
BONE METABOLISM REGULATOR
PHARMASCIENCE INC
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
March 30, 2017
Montreal, Quebec
H4P 2T4
www.pharmascience.com
CONTROL NO. 200445
_pms-PAMIDRONATE Product Monograph _
_Page 2 of 44_
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.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
.....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 20
STORAGE AND
STABILITY...............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 25
PART II: SCIENTIFIC INFORMATION
................................................................................
26
PHARMACEUTICAL
INFORMATION...............................................................................
26
CLINICAL TRIALS
....................