Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
TEVA CANADA LIMITED
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 ZOLEDRONIC ACID FOR INJECTION CONCENTRATE 4 mg /5 mL zoledronic acid (as zoledronic acid monohydrate) Sterile solution, for Intravenous Infusion Bone Metabolism Regulator Teva Canada Limited 30 Novopharm Court, Toronto, Ontario M1B 2K9 Date of Revision: Feb. 15, 2022 Control No. : 254854 _Page 2 of 52 _ 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 ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 21 DOSAGE AND ADMINISTRATION ..................................................................................... 22 OVERDOSAGE ....................................................................................................................... 26 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 26 STORAGE AND STABILITY ................................................................................................. 30 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 31 PART II: SCIENTIFIC INFORMATION ............................................................................... 32 PHARMACEUTICAL INFORMATION ................................................................................. 32 CLINICAL TRIALS ................................................................ Belgenin tamamını okuyun