Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
PHARMASCIENCE INC
M05BA08
ZOLEDRONIC ACID
4MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
INTRAVENOUS
5ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761002; AHFS:
APPROVED
2014-02-26
PRODUCT MONOGRAPH PR PMS-ZOLEDRONIC ACID (Zoledronic Acid for Injection) 4 mg zoledronic acid / 5 mL incorporated as the monohydrate for intravenous infusion Bone Metabolism Regulator PHARMASCIENCE INC. 6111 Royalmount Avenue, Suite 100 June 02, 2009 Montréal, Canada H4P 2T4 www.pharmascience.com Date of Revision: June 3, 2016 Submission Control No: 195313 _pms-ZOLEDRONIC ACID Product Monograph _ _Page 2 of 55_ 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................................................................................................................ 22 DOSAGE AND ADMINISTRATION ........................................................................................... 23 OVERDOSAGE .............................................................................................................................. 26 ACTION AND CLINICAL PHARMACOLOGY .......................................................................... 27 STORAGE AND STABILITY ....................................................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................... 31 PART II: SCIENTIFIC INFORMATION .................................................................................. 33 PHARMACEUTICAL INFORMA Olvassa el a teljes dokumentumot