País: Canadá
Língua: inglês
Origem: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
TEVA CANADA LIMITED
M05BA08
ZOLEDRONIC ACID
5MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG
INTRAVENOUS
100ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761003; AHFS:
CANCELLED POST MARKET
2019-08-08
1 PRODUCT MONOGRAPH PR ZOLEDRONIC ACID INJECTION (zoledronic acid injection) 5 mg/100 mL solution for intravenous infusion Bone Metabolism Regulator Teva Canada Limited 30 Novopharm Court, Toronto, Ontario M1B 2K9 DATE OF REVISION: July 10, 2017 CONTROL NUMBER: 205639 2 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 ......................................................................................................... 11 DRUG INTERACTIONS ......................................................................................................... 25 DOSAGE AND ADMINISTRATION ..................................................................................... 27 OVERDOSAGE ....................................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 29 STORAGE AND STABILITY ................................................................................................. 32 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 33 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 33 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ................................................................................. 34 CLINICAL TRIALS ....... Leia o documento completo