Summary of Product Characteristics (SmPC) - Volplex
1 NAME OF THE MEDICINAL PRODUCT
Volplex 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 sodium chloride.
Electrolytes
Sodium ion (Na+) 154 mmol/litre
Chloride ion (Cl-) 125 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
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.
4.2 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 37ºC 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.
4.3 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 (see section 4.4)
4.4 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 13,000 units. However, they may be more likely to occur if Volplex is given rapidly to normovolaemic patients, and may be assumed to be more hazardous in patients with known allergic conditions such as asthma.
Due to possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (alpha-Gal), the risk of sensitization and consequent anaphylactic reaction to gelatin-containing solutions could be highly increased in patients with history of allergy to red meat (mammal meat) and offal and/or tested positive for anti-alpha-Gal IgE antibodies. Gelatin-containing colloidal solutions should not be used in these patients (see section 4.3)
Treatment: The infusion of Volplex should be stopped. Further treatment will depend on the severity of the anaphylactic reaction; administration of supplemental oxygen; an alternative infusion fluid; and the parenteral administration of adrenaline (e.g. for adults, 0.5 ml of a 1 in 1,000 solution intramuscularly, repeated every 5 minutes as necessary, or
5 ml of a 1 in 10,000 solution slowly intravenously), and an antihistamine (e.g. chlorpheniramine 10 – 20 mg slowly intravenously) should be considered.
(ii) Caution should be exercised in infusing Volplex in any patient liable to develop circulatory overload (for example, congestive cardiac failure or renal failure with oliguria or anuria) since excessive volumes may give rise to circulatory overload and electrolyte imbalance.
Treatment: The infusion of Volplex should be stopped and the patient treated symptomatically. Electrolytes should be monitored. If necessary, a diuretic can be given to promote fluid loss. Decreased urinary output secondary to shock is not a contraindication unless there is no improvement in urine output after the initial dose of Volplex.
Important information about excipients
This medicinal product contains 1771mg sodium in each dose (500ml), equivalent to 88.5% of the WHO recommended maximum daily dietary intake for sodium. The maximum daily dose of this product is equivalent to 354% of the WHO recommended maximum daily intake for sodium. Volplex is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed
4.6 Fertility, 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 treatment of blood loss during pregnancy where plasma volume replacement is needed.
4.7 Effects on ability to drive and use machines
None known.
4.8 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 and precautions for use” (see also section 4.3 notably for hypersensitivity to galactose- α-1,3-galactose (alpha-Gal) and allergy to red meat and offal).
A list of rare undesirable effects that have been associated with the administration of Volplex is given beneath;
Rare effects (>1 in 10,000 to <1 in 1,000)
Immune system disorders
Anaphylactic reaction
Anaphylactoid reaction
Nervous system disorders
Tremor
Cardiac disorders
Tachycardia
Vascular disorders
Hypotension
Hypertension
Respiratory, thoracic and mediastinal disorders
Wheezing
Dyspnoea
Hypoxia
Skin and subcutaneous disorders
Urticarial reactions
Sweating
General disorders and administration site reactions
Chills
Pyrexia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
An overdose of Volplex may give rise to circulatory overload and electrolyte imbalance (see Section 4.4 Special warnings and precautions for use).
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group : Gelatin agents ; ATC code B05A A 06
Volplex is a colloidal plasma substitute. When used in the treatment of hypovolaemia Volplex produces significant increases in blood volume, cardiac output, stroke volume, blood pressure, urinary output and oxygen delivery.
Volplex promotes osmotic diuresis, thereby helping to protect the kidneys from the adverse effects of hypovolaemia.
5.2 Pharmacokinetic properties
The half-life of Volplex is about 4 hours, with the majority of the dose administered being eliminated by renewal excretion within 24 hours.
5.3 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Sodium hydroxide/hydrochloric acid
Water for injection
Volplex contains no preservatives
6.2 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.
6.3 Shelf life
The shelf life for Volplex 500ml and 1000ml is 2 years.
6.4 Special precautions for storage
Do not store above 25°C. Do not freeze or refrigerate.
6.5 Nature and contents of container
Volplex is supplied in sterile polypropylene flexible infusion bags (500 or 1,000 ml) with a flexible polymeric tube connected to the following differently shaped infusion cones:
Polycarbonate funnel with an infusion stopper (siliconesed clorobutyl rubber stopper) and an external aluminium crimp seal covered by means of a plastic flip-off cover.
or
Polycarbonate funnel with an infusion stopper (butyl rubber stopper) and a polypropylene flip cap (Aluminium bordered cap or Aluminium-plastic bordered cap).
The infusion bags are over-wrapped with a laminated polypropylene film
For 500 ml bags, each pack contains 10 units.
For 1,000 ml bags, each pack contains 6 units.
6.6 Special precautions for disposal
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
7 MARKETING AUTHORISATION HOLDER
Kent Pharma UK Limited,
2nd Floor, Connect 38,
1, Dover Place,
Ashford,
Kent,
England,
TN23 1FB.
8 MARKETING AUTHORISATION NUMBER(S)
PL 51463/0104
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/01/2008
10 DATE OF REVISION OF THE TEXT
03/04/2023