PAMIDRONATE DISODIUM OMEGA 6 MG/ML SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PAMIDRONATE DISODIUM

Verfügbar ab:

OMEGA LABORATORIES LIMITED

ATC-Code:

M05BA03

INN (Internationale Bezeichnung):

PAMIDRONIC ACID

Dosierung:

6MG

Darreichungsform:

SOLUTION

Zusammensetzung:

PAMIDRONATE DISODIUM 6MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10ML

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0123608005; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2004-03-09

Fachinformation

PRODUCT MONOGRAPH
PR
PAMIDRONATE DISODIUM OMEGA
(PAMIDRONATE DISODIUM FOR INJECTION)
3 MG / ML, 6 MG / ML AND 9 MG / ML
Sterile Solution for Injection
For intravenous infusion only
THERAPEUTIC CLASSIFICATION
Bone Metabolism Regulator
Omega Laboratories Limited
Date of Revision:
11 177 Hamon Street
February 17, 2022
Montreal, Quebec
H3M 3E4
Submission
Control No: 254663
_Product Monograph - _
_Pr_
_Pamidronate Disodium Omega 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
..............................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
...........................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 21
STORAGE AND STABILITY
......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
.............................................................................26
PHARMACEUTICAL INFORMATION
.......................................................................
26
CLINICAL TRIALS
.............................................................................