VAL-PAMIDRONATE DISODIUM SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PAMIDRONATE DISODIUM

Beszerezhető a:

VALEO PHARMA INC

ATC-kód:

M05BA03

INN (nemzetközi neve):

PAMIDRONIC ACID

Adagolás:

9MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

PAMIDRONATE DISODIUM 9MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

10ML

Recept típusa:

Prescription

Terápiás terület:

BONE RESORPTION INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0123608006; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2015-07-17

Termékjellemzők

_ _
PRODUCT MONOGRAPH
Pr
VAL-PAMIDRONATE DISODIUM
(Pamidronate Disodium for Injection)
9 mg/mL
For I.V. infusion only
Bone Metabolism Regulator
Valeo Pharma Inc.
16667 Hymus Boulevard
Kirkland, Quebec
H9H 4R9
Date of Preparation:
March 20, 2012
Submission Control No: 154009
_ _
V
AL
-P
AMIDRONATE
D
ISODIUM
_ _
_Page 2 of 32_
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............................................................................................6
DRUG INTERACTIONS
..........................................................................................11
DOSAGE AND ADMINISTRATION
......................................................................11
OVERDOSAGE.........................................................................................................15
ACTION AND CLINICAL
PHARMACOLOGY.....................................................15
STORAGE AND
STABILITY..................................................................................18
DOSAGE FORM, COMPOSITION AND
PACKAGING........................................18
PART II:
SCIENTIFIC
INFORMATION..............................................................................20
PHARMACEUTICAL
INFORMATION..................................................................20
CLINICAL TRIALS
..................................................................................................21
DETAILED PHARMACOLOGY
.............................................................................24
TOXICOLOGY....................................................