Country: Կանադա
language: անգլերեն
source: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
GENERIC MEDICAL PARTNERS INC
M05BA08
ZOLEDRONIC ACID
4MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
INTRAVENOUS
100
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761002; AHFS:
APPROVED
2014-05-08
_Page 1 of 54_ PRODUCT MONOGRAPH PR ZOLEDRONIC ACID CONCENTRATE FOR INJECTION (Zoledronic Acid for Injection) 4 mg zoledronic acid/5 mL incorporated as the monohydrate for intravenous infusion Concentrate – must be diluted before use Bone Metabolism Regulator Generic Medical Partners Inc. 251 Consumers Road, Suite 1200, Toronto, Ontario, Canada M2J 4R3 DATE OF REVISION: August 14, 2017 Control No.: 207383 _Page 2 of 54_ 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 .................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 20 DOSAGE AND ADMINISTRATION ............................................................................. 21 OVERDOSAGE ................................................................................................................ 25 ACTION AND CLINICAL PHARMACOLOGY............................................................ 25 STORAGE AND STABILITY ......................................................................................... 29 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 30 PART II: SCIENTIFIC INFORMATION .............................................................................. 31 PHARMACEUTICAL INFORMATION ......................................................................... 31 CLINICAL TRIALS .............................................................. read_full_document