5 mg/100 mL zoledronic acid (as zoledronic acid monohydrate) Solution for intravenous infusion Bone Metabolism Regulator
DIN Owner: Dr. Reddy’s Laboratories Limited Bachupally 500 090 - INDIA
Date of Preparation: March 11, 2014
Imported By: Innomar Strategies Inc. 3470 Superior Court Oakville, Ontario L6L 0C4 CANADA
Date of Revision: October 30, 2014
Submission Control Number: 178083
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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.....................................................................................................8 DRUG INTERACTIONS ....................................................................................................14 DOSAGE AND ADMINISTRATION ................................................................................14 OVERDOSAGE .................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 STORAGE AND STABILITY...........................................................................................19 SPECIAL HANDLING INSTRUCTIONS .......................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19
PART II: SCIENTIFIC INFORMATION ................................................................................20 PHARMACEUTICAL INFORMATION..........................................................................20 CLINICAL TRIALS ..........................................................................................................21 DETAILED PHARMACOLOGY .....................................................................................28 TOXICOLOGY ..................................................................................................................29 REFERENCES ...................................................................................................................36
PART III: CONSUMER INFORMATION..............................................................................38
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ZOLEDRONIC ACID INJECTION 5 mg/100 mL zoledronic acid (as zoledronic acid monohydrate) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Intravenous infusion
Dosage Form / Strength
Clinically Relevant Non-medicinal Ingredients
5 mg/100 mLª
• mannitol • sodium citrate dihydrate • water for injection ª One vial with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis. INDICATIONS AND CLINICAL USE Zoledronic Acid Injection 5 mg/100 mL is indicated for: • The prevention of postmenopausal osteoporosis in women with osteopenia as a single intravenous infusion. • The treatment of Paget’s disease of the bone in men and women, as a single-dose intravenous infusion. Treatment is indicated in patients with Paget’s disease of the bone with elevations in serum alkaline phosphatase (SAP) of at least two times the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease to induce remission (normalization of serum alkaline phosphatase). The effectiveness of zoledronic acid injection is based on serum alkaline phosphatase (SAP) levels. Geriatrics (> 65 years of age): No overall differences in safety and efficacy were observed according to age (see WARNINGS AND PRECAUTIONS – Special Populations). Pediatrics (
