País: Canadà
Idioma: anglès
Font: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
FRESENIUS KABI CANADA LTD
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
2014-11-13
_ _ PRODUCT MONOGRAPH PR ZOLEDRONIC ACID FOR INJECTION 4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION Bone Metabolism Regulator FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Revision: May 26, 2017 Submission Control No: 205586 _ _ _Zoledronic Acid for Injection-PM-ENG-v6.0 _ _ _ _Page 2 of 56_ 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 ................................................................................................. 22 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 ............................................................................................. Llegiu el document complet