VOLPLEX Solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Volplex 4% w/v Solution for Infusion.
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
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): ...
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 ...
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 ...
Contraindications
Volplex is contra-indicated in patients with a known hypersensitivity to succinylated gelatin. Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal ...
Special warnings and precautions for use
(i) Severe anaphylactic or anaphylactoid reactions have been reported following the intravenous administration of succinylated gelatin. These are rare, having an incidence of between 1 in 6,000 and 1 in ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
There is very little information available on the use of plasma substitutes in pregnant or lactating women. As with all drugs, the benefits and risks must be assessed. Volplex may be used in the initial ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The major undesirable effect risk associated with succinylated gelatin is that of a severe anaphylactic or anaphylactoid reaction, the occurrence and treatment of which is discussed in 4.4 Special warnings ...
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).
Pharmacodynamic properties
Pharmacotherapeutic group: Gelatin agents ATC code: B05AA06 Volplex is a colloidal plasma substitute. When used in the treatment of hypovolaemia Volplex produces significant increases in blood volume, ...
Pharmacokinetic properties
The half-life of Volplex is about 4 hours, with the majority of the dose administered being eliminated by renal excretion within 24 hours.
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
List of excipients
Sodium chloride Sodium hydroxide/hydrochloric acid Water for injection Volplex contains no preservatives
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Volplex does not interfere with blood grouping or cross-matching.
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 ...
Marketing authorization holder
Beacon Pharmaceutical Limited, The Bower 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF
Marketing authorization number(s)
PL 18157/0243
Date of first authorization / renewal of the authorization
09/06/2010
Date of revision of the text
18<sup>th</sup> March 2020
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