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

Product name and form

Volplex 4% w/v Solution for Infusion.

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

Qualitative and quantitative composition

Succinylated gelatin (Modified Fluid Gelatin) 4% w/v in Water for Injections, also containing sodium chloride.

Electrolytes:

Sodium ion (Na+): 154 mmol/litre
Chloride ion (Cl¯): 125 mmol/litre

Active Ingredient Description
Gelatin

Gelatin is a colloidal plasma substitute. When used in the treatment of hypovolaemia gelatin produces significant increases in blood volume, cardiac output, stroke volume, blood pressure, urinary output and oxygen delivery. Gelatin promotes osmotic diuresis, thereby helping to protect the kidneys from the adverse effects of hypovolaemia.

List of Excipients

Sodium chloride
Sodium hydroxide/hydrochloric acid
Water for injection
Volplex contains no preservatives

Pack sizes and marketing

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.

Marketing authorization holder

Beacon Pharmaceutical Limited, The Bower 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF

Marketing authorization dates and numbers

PL 18157/0243

09/06/2010

Drugs

Drug Countries
VOLPLEX United Kingdom

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