Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
OMEGA LABORATORIES LIMITED
M05BA08
ZOLEDRONIC ACID
4MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
INTRAVENOUS
1VIAL*5ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761002; AHFS:
APPROVED
2014-02-26
PRODUCT MONOGRAPH PR Z OLEDRONIC A CID F OR I NJECTION C ONCENTRATE 4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate) Bone Metabolism Regulator Omega Laboratories Limited Date of Preparation: February 18, 2014 11 177 Hamon Montreal, Quebec H3M 3E4 Control No. 158614, 171670 _ _ _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 ................................................................................................. 11 DRUG INTERACTIONS ................................................................................................. 22 DOSAGE AND ADMINISTRATION ............................................................................. 22 OVERDOSAGE ................................................................................................................ 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 27 STORAGE AND STABILITY ......................................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 32 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ......................................................................................................... 35 DETAILED PHARMACOLOGY .................................................. Đọc toàn bộ tài liệu