Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE)
BAYER INC
M05BA02
CLODRONIC ACID
60MG
SOLUTION
CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE) 60MG
INTRAVENOUS
5ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0122982003; AHFS:
CANCELLED POST MARKET
2018-12-27
_ _ _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 Prečítajte si celý dokument