Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
DR REDDY'S LABORATORIES LTD
M05BA08
ZOLEDRONIC ACID
4MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
INTRAVENOUS
5ML(1 VIAL)
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761002; AHFS:
APPROVED
2014-03-21
1 PRODUCT MONOGRAPH Pr ZOLEDRONIC ACID FOR INJECTION CONCENTRATE 4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate) Bone Metabolism Regulator DIN Owner: DR. REDDY’S LABORATORIES LIMITED Bachupally 500 090 - INDIA Imported By: DATE OF REVISION: DR. REDDY’S LABORATORIES CANADA INC. Mississauga ON L4W 4Y1 Canada July 19, 2019 Submission Control No: 228529 2 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 .............................................................................................................. 21 DOSAGE AND ADMINISTRATION .......................................................................................... 21 OVERDOSAGE ............................................................................................................................ 25 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 26 STORAGE AND STABILITY ...................................................................................................... 30 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 30 PART II: SCIENTIFIC INFORMATION ................................................................................... 31 PHARMACEUTICAL INFORMATION ........................................................... Belgenin tamamını okuyun