Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE
Baxter Healthcare Limited
SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE
%v/v
Solution for Infusion
Withdrawn
2008-03-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Half Strength Compound Sodium Lactate Intravenous Infusion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION This provides 66mmol/l Na + , 2.7mmol/l K + , 1mmol/l Ca 2+ , 56mmol/l Cl - and 14mmol/l Lactate. For excipients see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Sterile, non-pyrogenic, clear, colourless, aqueous solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Half Strength Compound Sodium Lactate Intravenous Infusion is indicated for prophylactic and replacement therapy requiring the use of Sodium Chloride and Lactate, with minimal amounts of Calcium and Potassium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 DOSAGE The dosage is dependant upon the age, weight and clinical condition of the patient. 4.2.2 ADMINISTRATION The solution is for administration by intravenous infusion. 4.3 CONTRAINDICATIONS Half Strength Compound Sodium Lactate Intravenous Infusion is contraindicated in patients with congestive heart failure, severe impairment of renal function or oedema with Sodium retention. It is also contraindicated in patients with liver disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 4.4.1 Administration should be carried out under regular and careful surveillance; plasma electrolyte levels should be monitored during use. 4.4.2 This fluid should be administered with great care to patients with renal insufficiency. 4.4.3 Do not administer unless solution is clear and container undamaged. Sodium Lactate 1.61 g/l Potassium Chloride 200 mg/l Sodium Chloride 3.0 g/l Calcium Chloride Dihydrate 135 mg/l IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/08/2006_ _CRN 2023805_ _page number: 1_ 4.4.4 Discontinue infusion Baca dokumen lengkap