BONEFOS SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE)

MAH:

BAYER INC

ATC_code:

M05BA02

INN:

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

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-12-27

SPC

_ _
_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.
_ _
_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