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Composition |
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Each ml of SIGMACALVIT Vitamin D3 (Cholecalciferol) ... 5000 IU |
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Injection contains: |
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Calcium gluconolactobionate … Benzyl alcohol (as preservative) … 85% v/v |
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137.5 mg |
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Cyanocobalamin … 50 mcg |
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Therapeutic Indications & Usage |
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SIGMACALVIT Injection is indicated for the treatment of hypocalcemia for those conditions requiring a prompt increase in blood plasma calcium concentrations, vitamin D deficiency and alkalosis. It is also indicated for the prevention of hypocalcemia during exchange transfusions. |
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SIGMACALVIT Injection can also be administered as adjunctive therapy in a number of conditions, including the following: rickets; osteomalacia; insect bites or stings such as Black Widow Spider bites; sensitivity reactions, particularly when characterized by urticaria; as an aid in the treatment of depression due to overdosage of magnesium sulfate; as an aid in management of the acute symptoms in lead colic. |
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Contraindications |
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SIGMACALVIT is contraindicated in those hypersensitive to its ingredients, hypercalcemia and hypercalciuria (e.g., in hyperparathyroidism, vitamin D overdosage, decalcifying tumors such as plasmocytoma, bone metastases), severe renal or cardiac diseases like ventricular fibrillation, andcalcium loss due to immobilization.
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Precautions & Warnings |
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In mild hypercalciuria (exceeding 300 mg/24 hours) as well as in chronic renal failure, or where thereis evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion whilst on SIGMACALVIT Injection. If necessary, the dosage of SIGMACALVIT should be reduced or calcium therapy discontinued. Additional high vitamin D intake should be avoided during SIGMACALVIT Injection therapy unless especially indicated. |
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Tissue irritation and necrosis may occur with intramuscular (IM) SIGMACALVIT Injection especially in infants and small children. High dose calcium therapy (as SIGMACALVIT) by any of the parenteral routes should always be accompanied by very careful monitoring of blood concentration and urinary calcium excretion, particularly in children. Treatment with SIGMACALVIT Injection should be stopped at once if blood calcium exceeds 2.62 to 2.74 mmol/L (105 to 119 mg/L) or if more than 0.12 mmol/kg (5 mg/kg) is excreted in the urine in a period of 24 hours. Heart rhythm should alsobe monitored. |
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When severe hypocalcemia co-exists with hyperphosphatemia (>6 mmol/L), patients should be treated for hyperphosphatemia prior to the administration of SIGMACALVIT Injection; the aim is to achieve a proper calcium/phosphate ratio in order to prevent extraskeletal deposition of calcium. |
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Rapid injection of SIGMACALVIT may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. SIGMACALVIT Injection should be advocated during lactation and pregnancy only if strictly required. |
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SIGMACALVIT Injection is not to be combined with parenteral tetracyclines, and should be advocated with extreme precaution (very slow and in small amounts administration) along with cardiac glycosides. SIGMACALVIT Injection is not intended for intravenous or intracardiac use. |
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Adverse Reactions |
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Parenteral calcium (SIGMACALVIT Injection) may cause flushing, nausea, vomiting, drowsiness, sweating and hypotension. Hypersensitivity reactions could occur due to the ingredients in SIGMACALVIT Injection. |
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Drug interactions |
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The ionotropic and toxic effects of cardiac glycosides and calcium (in SIGMACALVIT Injection) are synergistic and arrhythmias may occur if these drugs are given together. Calcium (in SIGMACALVIT Injection) complexes tetracyclines and renders them inactive. |
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Recommended Dosage & Administration |
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ADULTS: 1-2 ml SIGMACALVIT Injection IM daily or on alternate days or on longer intervals for 10-15 injections, or as prescribed. |
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ELDERLY CHILDREN: Half adult dose, or as prescribed. |
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Presentation |
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SIGMACALVIT Injection: 15 ml vials. |
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