This information is intended for use by health professionals

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

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 Preclinical 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 contents of container

Viaflex® Plastic Container of 1000, 2000 and 3000ml volume sealed in a plastic overpouch.

6.6 Special precautions for disposal and other handling

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 / 17 December 2006

10. Date of revision of the text

16 February 2012