מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
TARO PHARMACEUTICALS INC
M05BA08
ZOLEDRONIC ACID
4MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
INTRAVENOUS
6* 5ML(VIAL)
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761002; AHFS:
APPROVED
2014-02-26
PRODUCT MONOGRAPH PR TARO-ZOLEDRONIC ACID CONCENTRATE (ZOLEDRONIC ACID FOR INJECTION) 4 MG ZOLEDRONIC ACID/5 ML INCORPORATED AS THE MONOHYDRATE Sterile concentrate for injection MUST BE DILUTED BEFORE USE Bone Metabolism Regulator TARO PHARMACEUTICALS INC. 130 East Drive, Brampton, Ontario, Canada L6T 1C1 CONTROL NUMBER: 222810 DATE OF PREPARATION: January 2, 2019 _TARO-ZOLENDRONIC ACID CONCENTRATE _ _ _ Page 2 of 55 _ _ 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 ....................................................................................................................... 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 ....... קרא את המסמך השלם