|
1 Indications And Usage Miacalcin Synthetic Injection Is A Calcitonin, Indicated For The Following Conditions: • Treatment Of Symptomatic Paget’s Disease Of Bone When Alternative Treatments Are Not Suitable ( 1.1 ) • Treatment Of Hypercalcemia ( 1.2 ) • Treatment Of Postmenopausal Osteoporosis When Alternative Treatments Are Not Suitable. Fracture Reduction Efficacy Has Not Been Demonstrated ( 1.3 ) Limitations Of Use: • Due To The Possible Association Between Malignancy And Calcitonin Salmon Use, The Need For Continued Therapy Should Be Re-Evaluated On A Periodic Basis ( 1.4 , 5.3 ) 1.1 Treatment Of Paget’s Disease Of Bone Miacalcin Injection Is Indicated For The Treatment Of Symptomatic Paget’s Disease Of Bone In Patients With Moderate To Severe Disease Characterized By Polyostotic Involvement With Elevated Serum Alkaline Phosphatase And Urinary Hydroxyproline Excretion. There Is No Evidence That The Prophylactic Use Of Calcitonin Salmon Is Beneficial In Asymptomatic Patients. Miacalcin Injection Should Be Used Only In Patients Who Do Not Respond To Alternative Treatments Or For Whom Such Treatments Are Not Suitable (E.g., Patients For Whom Other Therapies Are Contraindicated Or For Patients Who Are Intolerant Or Unwilling To Use Other Therapies). 1.2 Treatment Of Hypercalcemia Miacalcin Injection Is Indicated For The Early Treatment Of Hypercalcemic Emergencies, Along With Other Appropriate Agents, When A Rapid Decrease In Serum Calcium Is Required, Until More Specific Treatment Of The Underlying Disease Can Be Accomplished. It May Also Be Added To Existing Therapeutic Regimens For Hypercalcemia Such As Intravenous Fluids And Furosemide, Oral Phosphate Or Corticosteroids, Or Other Agents. 1.3 Treatment Of Postmenopausal Osteoporosis Miacalcin Injection Is Indicated For The Treatment Of Postmenopausal Osteoporosis In Women Greater Than 5 Years Postmenopause. The Evidence Of Efficacy For Calcitonin Salmon Injection Is Based On Increases In Total Body Calcium Observed In Clinical Trials. Fracture Reduction Efficacy Has Not Been Demonstrated. Miacalcin Injection Should Be Reserved For Patients For Whom Alternative Treatments Are Not Suitable (E.g., Patients For Whom Other Therapies Are Contraindicated Or For Patients Who Are Intolerant Or Unwilling To Use Other Therapies). 1.4 Important Limitations Of Use Due To The Possible Association Between Malignancy And Calcitonin Salmon Use, The Need For Continued Therapy Should Be Re-Evaluated On A Periodic Basis [See Warnings And Precautions (5.3) ] .
|