Pays: Canada
Langue: anglais
Source: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
ACTAVIS PHARMA COMPANY
M05BA08
ZOLEDRONIC ACID
5MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG
INTRAVENOUS
100ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761003; AHFS:
CANCELLED PRE MARKET
2020-04-08
_ _ _ACT ZOLEDRONIC ACID Product Monograph _ _Page 1 of 64_ PRODUCT MONOGRAPH PR ACT_ _ZOLEDRONIC ACID (Zoledronic Acid Injection) Sterile Solution for Intravenous Infusion 5 mg /100 mL zoledronic acid (as zoledronic acid monohydrate) Bone Metabolism Regulator Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Date of Revision: June 1, 2017 Control No.: 205792 _ _ _ACT ZOLEDRONIC ACID Product Monograph _ _Page 2 of 64_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................. 11 DRUG INTERACTIONS ................................................................................................. 25 DOSAGE AND ADMINISTRATION ............................................................................. 27 OVERDOSAGE ............................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 29 STORAGE AND STABILITY ......................................................................................... 32 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION .............................................................................. 34 PHARMACEUTICAL INFORMATION .................... Lire le document complet