Country: Kanada
Tungumál: enska
Heimild: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
MARCAN PHARMACEUTICALS INC
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
2018-02-05
PRODUCT MONOGRAPH ZOLEDRONIC ACID CONCENTRATE FOR INJECTION (Zoledronic Acid for Injection) 4 mg Zoledronic acid/5 mL incorporated as the monohydrate Sterile liquid concentrate must be diluted before use Bone Metabolism Regulator Marcan Pharmaceuticals Inc. Date of Preparation: February 5, 2018 77 Auriga Drive, Suite#4, Ottawa, ON, K2E 7Z7 Control # 198168 _Page 2 of 52_ 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..................................................................................................11 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................25 STORAGE AND STAB IL I T Y ..........................................................................................29 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................29 PART II: SCIENTIFIC INFORMATION ...............................................................................30 PHARMACEUTICAL INFORMATION..........................................................................30 CLINICAL TR IA L S ..........................................................................................................31 D Lestu allt skjalið