BONEFOS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE)

Available from:

BAYER INC

ATC code:

M05BA02

INN (International Name):

CLODRONIC ACID

Dosage:

60MG

Pharmaceutical form:

SOLUTION

Composition:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE) 60MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-12-27

Summary of Product characteristics

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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