Introduction

Dechra

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

Sterile 4 % w/v succinylated Gelatin (modified fluid Gelatin) in Saline.

Gelatin	40.0 g/l
Sodium	154 mmol/l
Chloride	120 mmol/l
Av Mw	30,000
Av Mn	22,600
pH	7.4 ± 0.3
Relative viscosity at 37°C	1.9
Iso-electric point	pH 4.5 ± 0.3
Colloid osmotic pressure	453 mm H2O
Gel point	0°C
Osmolarity	274 mOsm/l

Description: Gelofusine is prepared by hydrolysis and succinylation of bovine collagen.

Uses

Actions: Gelofusine is a colloidal plasma volume substitute. When used in the treatment of hypovolaemia it produces a significant increase in blood volume, cardiac output, stroke volume, blood pressure, urinary output and oxygen delivery. The half-life of Gelofusine is about 4 hours, with the majority of the dose administered being eliminated by renal excretion within 24 hours.

Indications: As a plasma volume substitute in cats, dogs and horses in the initial management of hypovolaemic shock due to, for example, haemorrhage, acute trauma or surgery, burns, sepsis, peritonitis or crush injury.

Dosage and administration

Gelofusine is given intravenously. The volume and the rate of administration will depend upon the condition of the animal, its species and body weight. In general the dose required is approximately equivalent to the calculated volume loss. The rate of administration can be increased by the application of pressure to the container or by use of a giving set pump. When given rapidly it should be warmed to no more than 37°C if possible. In severe acute blood loss a volume equivalent to 1 % of body weight may be given in 5-10 minutes until signs of hypovolaemia are relieved. When large volumes are infused, suitable monitoring should be employed 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, Gelofusine may be used concomitantly with blood, the rate and amount of which would depend upon the clinical condition of the animal. The haemodynamic status of the animal should be monitored.

If blood is to be given at the same time as Gelofusine it can be given through the same giving set since Gelofusine has a negligible Calcium content and therefore does not clot blood. Gelofusine can also be used to reconstitute packed red cells.

Contra-indications, warnings, etc

Known hypersensitivity to Gelofusine.

In common with other colloidal plasma volume expanders, mild urticarial reactions have been reported.

Severe anaphylactoid reactions following use of Gelofusine occur in humans with a reported incidence of between 1 in 6,000 and 1 in 13,000 units administered. Such reactions are related to the release of vasoactive substances and can be assumed to be more frequent and particularly hazardous in animals with known allergic conditions such as asthma. Treatment: The infusion of Gelofusine should be stopped. Further treatment will depend upon the severity of the anaphylactic reaction. Administration of supplemental oxygen; an alternative intravenous fluid; and the parenteral administration of adrenalin and an antihistamine should be considered.

Gelofusine should be given with care to animals who are susceptible to circulatory overloading (e.g. severe 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 should be stopped and the animal treated symptomatically. Electrolytes should be monitored. If necessary a diuretic may 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 Gelofusine.

It should not be used to prevent falls in arterial pressure consequent on spinal or epidural anaesthesia.

Pregnancy and lactation: There is very little information available on the use of plasma substitutes in pregnant or lactating animals. As with all drugs, the benefits and risks of use should be assessed in light of the animal's condition: Gelofusine may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.

General precautions: For animal treatment only.

Withdrawal period: Not to be used in horses intended for human consumption.

Pharmaceutical precautions

Do not store above 25oC. Do not freeze. Keep out of reach of children.

Gelofusine is stable for three years and can be stored at room temperature. Only clear solution should be used: it contains no preservative, and any unused Gelofusine should be discarded once the seal has been opened.

Although water soluble drugs can be given in Gelofusine, experience is limited. If essential, they may be given through the giving set, close to the intravenous cannula. The small Calcium content of Gelofusine does not give rise to clotting in the giving set when citrated blood precedes or follows its administration.

Shelf life: For expiry date, please refer to the label on the container.