Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium citrate dihydrate; Mannitol; Magnesium sulfate heptahydrate; Potassium citrate monohydrate
Baxter Healthcare Ltd
n/a
Sodium citrate dihydrate; Mannitol; Magnesium sulfate heptahydrate; Potassium citrate monohydrate
8.2gram/1litre ; 33.8gram/1litre ; 10gram/1litre ; 8.6gram/1litre
Liquid
Intraarterial
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 05413760019178
OBJECT 1 SOLTRAN Summary of Product Characteristics Updated 01-Apr-2015 | Baxter Healthcare Ltd 1. Name of the medicinal product Soltran 2. Qualitative and quantitative composition 2.1. ACTIVE INGREDIENTS Potassium Citrate EP Sodium Citrate EP Mannitol BP Magnesium Sulphate EP 2.2. QUANTITATIVE COMPOSITION Potassium Citrate 0.86% w/v Sodium Citrate 0.82% w/v Mannitol 3.38% w/v Magnesium Sulphate 1.0% w/v 3. Pharmaceutical form Sterile, nonpyrogenic aqueous solution 4. Clinical particulars 4.1 Therapeutic indications For use in the preservation of the human kidney prior to transplantation. For use in the preservation of the human liver and pancreas prior to transplantation. For use in _in vivo_ perfusion of the human kidneys prior to surgical repair. 4.2 Posology and method of administration Related living donors: approximately 200-300ml of the solution is delivered to the isolated, ice packed kidney via the renal artery at a pressure of 120 cms of water. The kidney is perfused until the solution coming from the renal vein is clear of macroscopic blood. Cadaveric donors: approximately 2-3 litres of the solution is delivered at 4°C via the isolated aortic segment to the kidney. The rate of flow is approximately 200ml per minute and pressures of 120-140 mm of mercury are used. Liver and pancreas transplantation: precise dosage requirements and administration technique are determined by the medical practitioner. _In vivo_ surgical repair: precise dosage requirements and administration technique are determined by the medical practitioner. 4.3 Contraindications None known. 4.4 Special warnings and precautions for use Soltran has a high potassium content and should not be given intravenously to patients. When used for _in vivo_ surgical repair of kidneys, small volumes of solution should be used, and adequate suction provided on the renal vein to prevent absorption of the solution. Do not use unless solution is clear and container undamaged. 4.5 Interaction with other medicinal products and other forms of interaction N Read the complete document