VOLPLEX Solution for infusion Ref.[9421] Active ingredients: Gelatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Beacon Pharmaceutical Limited, The Bower 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF

Therapeutic indications

Volplex 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.

Volplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.

Posology and method of administration

Volplex 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 Volplex should be warmed to no more than 37°C if possible. In severe acute blood loss, Volplex 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, Volplex 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.

If blood is to be given at the same time as Volplex, it can be given through the same giving set since Volplex has negligible calcium content and therefore does not clot blood. Volplex can also be used to reconstitute packed red cells.

NB No distinction between the recommended doses and dosage schedule for adults, children and the elderly is necessary as the rate of administration depends on the condition of the individual patient.

Overdose

As an overdose of Volplex may give rise to circulatory overload and electrolyte imbalance (see Section 4.4 Special warnings and precautions for use).

Shelf life

The shelf life for Volplex 500 ml and 1,000 ml is 2 years.

Special precautions for storage

Do not store above 25°C. Do not freeze or refrigerate.

Nature and contents of container

Volplex is supplied in sterile flexible infusion bags (500 or 1,000 ml), which are overwrapped.

For 500 ml bags, each pack contains 10 units.

For 1,000 ml bags, each pack contains 6 units.

Special precautions for disposal and other handling

Do not use unless container is free of particles. Do not use if moisture is present between the container and the overwrap, or if the overwrap is damaged. Do not use if the container is not intact before breaking the seal. Check for leaks by squeezing the container before use. For single dose use only. Discard any unused solution immediately after initial use. Do not reconnect any partially used containers.

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