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Isoplex 4% w/v Solution for Infusion
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Beacon Pharmaceuticals
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Active ingredient
succinylated gelatin
Legal Category
POM: Prescription only medicine
SmPC
Patient Leaflet
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This information is intended for use by health professionals
1. Name of the medicinal product
Isoplex 4% w/v Solution for Infusion
2. Qualitative and quantitative composition
Succinylated gelatin (Modified Fluid Gelatin) 4% w/v in Water for Injections, also containing electrolytes.
Electrolytes
Sodium ion (Na+)
145 mmol/litre
Chloride ion (Cl¯)
105 mmol/litre
Lactate ion
25 mmol/litre
Potassium ion (K+)
4 mmol/litre
Magnesium ion (Mg2+)
0.9 mmol/litre
3. Pharmaceutical form
Sterile non-pyrogenic solution for infusion.
A clear pale yellow or straw coloured solution contained within a flexible infusion bag.
Key Physico-chemical properties:
Weight average molecular weight (Mw)
30 000 Dalton
Number average molecular weight (Mn)
20 000 Dalton
pH
7.4 + 0.5
Osmolarity
284 mOsm/litre
4. Clinical particulars
4.1 Therapeutic indications
Isoplex is a colloidal plasma substitute indicated for the initial management of hypovolaemic shock caused by, for example, haemorrhage, acute trauma or surgery, burns, sepsis, peritonitis, pancreatitis or crush injury.
Isoplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.
4.2 Posology and method of administration
Isoplex is administered intravenously; the volume and rate of infusion will depend on the condition of the patient. The rate of administration can be increased by the application of pressure to the container or by adjusting the giving set pump. When given rapidly Isoplex should be warmed to no more than 37°C if possible. In severe acute blood loss, Isoplex may be given rapidly (500 ml in 5 – 10 minutes) until signs of hypovolaemia are relieved. When large volumes are given, suitable monitoring should be used to ensure that an adequate haematocrit is maintained (the haematocrit should not be allowed to fall below 25%) and that dilutional effects upon coagulation are avoided. (Expert haematological advice should be sought, especially in cases of massive blood loss).
For massive fluid loss, Isoplex may be used concomitantly with blood, the rate and amount of which depends on the clinical condition of the patient. The haemodynamic status of the patient should be monitored.