Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
TRISODIUM EDETATE
Sinclair Pharmaceuticals Limited
200 Mg/Ml
Solution for Infusion
1991-03-15
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Limclair 200 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of concentrate solution contains 1 g of trisodium edetate. Also contains 8.37 mmol (192.5 mg) sodium per 5 ml. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion A clear, colourless, sterile concentrate for solution with a pH of 7.0-8.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Limclair is indicated for hypercalcaemia and, by local application, for calcareous corneal opacities, resulting from lime burns and band keratitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous injection: The injection should be diluted with Sodium Chloride Intravenous Infusion B.P. or Glucose Intravenous Infusion B.P. (5% w/v) i.e. the average dose of 5 g per day diluted in 500 ml of the dilutions. For ophthalmic purposes: A 0.4% solution is obtained by dilution of 1 in 50 using distilled water as the diluent (i.e. 1 ml LIMCLAIR made up to 50 ml). Routes of administration: Either the intravenous route or locally as a corneal bath. Dose: Adults (including the elderly): The average dose is 5 g per day. This is administered by slow intravenous infusion up to 70 mg/kg body weight daily. The intravenous drip is regulated so that 2 to 3 hours are required for total infusion. Children: Up to 60 mg/kg (1 g/35 lb) body weight daily, by slow intravenous infusion. 4.3 CONTRAINDICATIONS Renal disease. With caution in tuberculosis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Too rapid intravenous infusion or too high concentration may lower the serum calcium level precipitously and cause IRISH MEDICINES BOARD ____________________________________________ Izlasiet visu dokumentu