Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE POTASSIUM CHLORIDE SODIUM LACTATE SOLUTION 60%
Maco Pharma (UK) Ltd
Solution for Infusion
2007-05-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hartmann's Solution Compound Sodium Lactate Intravenous Infusion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1000 ml contains : ionic formula For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear colourless solution. Osmolarity : 278 mOsm/l (approx.) pH : 5.0 – 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ringer Lactate solution is indicated for : _-_ Restoration of extracellular fluid and electrolyte balances or replacement of extracellular fluid loss where isotonic concentrations of electrolytes are sufficient - Short term volume replacement (alone or in association with colloid) in case of hypovolemia or hypotension. - Regulation or maintenance of metabolic acidosis balance and/or treatment of mild to moderate metabolic acidosis (except lactic acidosis) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the Elderly and Children: The dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, and concomitant therapy. Recommended dosage: The amount of Compound Sodium Lactate solution (Ringer Lactate solution) needed to restore normal blood volume is 3 to 5 times the volume of lost blood. The recommended dosage is: - for adults : 500 ml to 3 Litres / 24h - for babies and children: 20 ml to 100 ml / kg / 24 h Sodium Chloride 6.00g Sodium (Na + ) 131 mmol/l Potassium Chloride 0.40g Potassium (K + ) 5 mmol/l Calcium Chloride dihydrate 0.27g Calcium (Ca ++ ) 2 mmol/l Sodium lactate 60% 5.16g Chloride (Cl - ) 111 mmol/l Bicarbonate (as Lactate) 29 mmol/l IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/02/2011_ _CRN 2081070_ _page number: Leggi il documento completo