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

(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.

No interaction studies have been performed.

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.

None known.

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.

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.