BONEFOS SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE)

Disponibil de la:

BAYER INC

Codul ATC:

M05BA02

INN (nume internaţional):

CLODRONIC ACID

Dozare:

60MG

Forma farmaceutică:

SOLUTION

Compoziție:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE) 60MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BONE RESORPTION INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0122982003; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-12-27

Caracteristicilor produsului

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_BONEFOS Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
PR BONEFOS
®
Clodronate disodium for injection
60 mg/mL
for slow intravenous infusion only
and
Clodronate disodium capsules
400 mg/capsule
Bone metabolism regulator
(Antihypercalcemic agent)
Bayer Inc.
2920 Matheson Boulevard East,
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Submission Control No. 200438
Date of Revision:
March 30, 2017
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc.
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_BONEFOS Product Monograph _
_Page 2 of 29_
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
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
................................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................1