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SOLTRAN - summary of medicine characteristics

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Summary of medicine characteristics - SOLTRAN

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

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

7 MARKETING AUTHORISATION HOLDER

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk, IP24 3SE

8. MARKETING AUTHORISATION NUMBER(S)

8. MARKETING AUTHORISATION NUMBER(S)

PL 0116/0218

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

9 September 1991