SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Balgela 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

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

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)

Number average molecular weight(Mn) pH

Osmolarity

4 CLINICAL PARTICULARS

4.1    Therapeutic indications

Balgela 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.

Balgela 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

Balgela 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 Balgela should be warmed to no more than 37°C if possible. In severe acute blood loss, Balgela 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, Balgela 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 Balgela, it can be given through the same giving set since Balgela has negligible calcium content and therefore does not clot blood. Balgela can also be used to reconstitute packed red cells.

4.3 Contraindications

Balgela is contra-indicated in patients with a known hypersensitivity to succinylated gelatin

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 Balgela is given rapidly to normovolaemic patients, and may be assumed to be more hazardous in patients with known allergic conditions such as asthma.

Treatment: The infusion of Balgela should be stopped. Further treatment will depend on the severity of the 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 Balgela in any patient liable to develop circulatory overload (for example, congestive cardiac failure or renal failure with oliguria or anuria).

Treatment: The infusion of Balgela 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 Balgela.

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.

Balgela 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”.

A list of rare undesirable effects that have been associated with the administration of Balgela 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

4.9 Overdose

As an overdose of Balgela 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

Balgela is a colloidal plasma substitute. When used in the treatment of hypovolaemia Balgela produces significant increases in blood volume, cardiac output, stroke volume, blood pressure, urinary output and oxygen delivery.

Balgela promotes osmotic diuresis, thereby helping to protect the kidneys from the adverse effects of hypovolaemia.

5.2 Pharmacokinetic properties

The half-life of Balgela is about 4 hours, with the majority of the dose administered being eliminated by renal 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 (for pH adjustment)

Water for injection

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

10 DATE OF REVISION OF THE TEXT

18/10/2016