Soltran
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soltran
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Potassium Citrate EP
Sodium Citrate EP
Mannitol BP
Magnesium Sulphate EP
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 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. Contra-Indications
None known.
4.4. Special Warnings and Special 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. Interactions with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
Not Applicable.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
None known.
4.9. Overdose
None known.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Not Appropriate.
5.2. Pharmacokinetic Properties
Not Appropriate.
5.3. Pre-clinical Safety Data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Water for Injection EP to 100% w/v Conc. Hydrochloric Acid QS
6.2. Incompatibilities
None known.
6.3 Shelf life
Unopened: 15 months
6.4. Special Precautions for Storage
Storage temperature should not exceed 25°C.
6.5. Nature and Content of Container
Viaflex® Plastic Container of 1000, 2000 and 3000ml volume sealed in a plastic overpouch.
6.6. Instruction for Use, Handling and Disposal
Not for Intravenous Infusion
Do not use unless solution is clear and the container is undamaged. For use under medical supervision only.
For use on one occasion only.
Do not store partially used containers.
7 MARKETING AUTHORISATION HOLDER
Baxter Healthcare Ltd.,
Caxton Way,
Thetford,
Norfolk,
IP24 3SE
8. MARKETING AUTHORISATION NUMBER(S)
PL 0116/0218
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9 September 1991
10
DATE OF REVISION OF THE TEXT
16/02/2012