Land: Canada
Taal: Engels
Bron: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
STRIDES PHARMA CANADA 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
2014-06-24
Page 1 of 58 PRODUCT MONOGRAPH PR ZOLEDRONIC ACID FOR INJECTION CONCENTRATE 4 mg zoledronic acid/5 mL incorporated as the monohydrate for intravenous infusion BONE METABOLISM REGULATOR Strides Pharma Canada Inc. Date of Revision: 1565, Boul. Lionel-Boulet August 11, 2020 Varennes, Quebec Canada, J3X 1P7 Submission Control No.: 241322 Page 2 of 58 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 ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 23 DOSAGE AND ADMINISTRATION ..................................................................................... 23 OVERDOSAGE ....................................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 28 STORAGE AND STABILITY ................................................................................................. 32 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 32 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ................................................................................. 34 CLINICAL TRIALS ......................................... Lees het volledige document