Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
CALCITONIN SALMON (UNII: 7SFC6U2VI5) (CALCITONIN SALMON - UNII:7SFC6U2VI5)
Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)
INTRAMUSCULAR
PRESCRIPTION DRUG
Calcitonin salmon 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. Calcitonin salmon 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). Calcitonin salmon 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 furose
How Supplied Calcitonin Salmon Injection, USP, Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 USP Units per mL. NDC 24201-400-02 carton containing 1 x 2 mL multi-dose vial Storage and Handling Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.
Abbreviated New Drug Application
CALCITONIN SALMON- CALCITONIN SALMON INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC.(DBA LEUCADIA PHARMACEUTICALS) ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCITONIN SALMON INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCITONIN SALMON INJECTION. CALCITONIN SALMON INJECTION, SYNTHETIC, FOR SUBCUTANEOUS OR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 1975 INDICATIONS AND USAGE Calcitonin salmon 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) DOSAGE AND ADMINISTRATION Symptomatic Paget’s disease of bone: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.1, 2.5) Hypercalcemia: start with 4 USP Units/kg body weight every 12 hours. Increase to 8 USP Units/kg every 12 hours if no improvement in 1-2 days. Increase further to 8 USP Units/kg every 6 hours if no improvement after 2 more days ( 2.2) Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.3, 2.5) DOSAGE FORMS AND STRENGTHS Injection: 200 USP Units per mL sterile solution in 2 mL multi-dose vials ( 3) CONTRAINDICATIONS Hypersensitivity to calcitonin salmon or any of the excipients ( 4) WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin salmon ( 5.1) Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D ( 5.2) Malignanc Citiți documentul complet