PMS-PAMIDRONATE POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PAMIDRONATE DISODIUM

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

M05BA03

INN (Internationale Bezeichnung):

PAMIDRONIC ACID

Dosierung:

60MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

PAMIDRONATE DISODIUM 60MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0123608003; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2003-12-09

Fachinformation

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
....................