Soltran solution 1litre Viaflex bags

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Sodium citrate dihydrate; Mannitol; Magnesium sulfate heptahydrate; Potassium citrate monohydrate

Предлага се от:

Baxter Healthcare Ltd

АТС код:

n/a

INN (Международно Name):

Sodium citrate dihydrate; Mannitol; Magnesium sulfate heptahydrate; Potassium citrate monohydrate

дозиране:

8.2gram/1litre ; 33.8gram/1litre ; 10gram/1litre ; 8.6gram/1litre

Лекарствена форма:

Solution for organ preservation

Начин на приложение:

Regional perfusion

Клас:

No Controlled Drug Status

Вид предписание :

Never Valid To Prescribe As A VMP

Каталог на резюме:

BNF: ; GTIN: 05413760019178

Данни за продукта

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