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Iso-oncotic gelatine solution for intravenous volume substitution. Modified Gelatine Composition 1000 ml of solution for infusion contain: Active substances Succinylated Gelatine 40.0 g (modified fluid gelatine) average molecular weight 30 000 daltons Mw (weight average) Mn (number average) 23 200 daltons Sodium chloride 7.01 g Sodium hydroxide 1.36 g Excipients Water for injections to Electrolyte concentrations Sodium Chloride 1000 ml

154 mmol/l 120 mmol/l

pH 7.4±0.3 Theoretical osmolarity 274 mosm/l Gelation point ≤ 3 °C The gelatine is prepared from the bones of cattle. Characteristics/Effects Pharmacological Properties Gelofusine is a 4 % w/v solution of succinylated gelatine (also known as modified fluid gelatine) with an average molecular weight of 30 000 daltons (weight average). It has a relative viscosity of 1.9 at 37 °C and a colloid-osmotic pressure of 34 mmHg. The isoelectric point is at pH 4.5. The negative charges introduced into the molecule by succinylation lead to an expansion of the molecule, thus rendering it markedly more voluminous than unsuccinylated protein chains of the same molecular weight. The characteristics of Gelofusine result in a sufficient volume effect over about 3 – 4 hours. Toxicological Properties The toxicological studies on Gelofusine showed that the product is well tolerated. So, the maximum dose of the product is limited by its volume and dilution effects.

the oxygen supply and the diuresis are increased. Only a minor amount is excreted in faeces and not more than about 1 % is metabolised. Lost plasma protein is not substituted by Gelofusine. – extra-corporal circulation (heart-lung machine. . Mechanism of Action The colloid-osmotic pressure of the solution determines the extent of its initial volume effect. haemodialysis). the left-ventricular end-diastolic pressure. Metabolism/elimination: Most of the infused Gelofusine is excreted in urine. Indications Colloidal plasma volume substitute for – prophylaxis and treatment of relative or absolute hypovolaemia. The proteolytic metabolism is so adaptable that even under the condition of renal insufficiency no accumulation of gelatine is observed. There is no evidence that Gelofusine is stored in the reticulo-endothelial system or elsewhere in the organism.g. The duration of the effect depends on the clearance of the colloid by redistribution and excretion. – haemodilution. Gelofusine may be used as plasma volume substitute for – prophylaxis of hypotension (e. The smaller molecules are excreted directly by glomerular filtration while the larger molecules first are degraded proteolytically in the liver and then are also excreted in urine. Pharmacokinetics in special clinical situations: The plasma half-life time of Gelofusine may be prolonged in patients on haemodialysis (GFR < 0.2 Therapeutic Effect Gelofusine substitutes intravascular volume deficits caused by losses of blood or plasma. it does not have a plasma expanding effect. the cardiac index. Pharmacokinetics Absorption/Distribution After infusion. Dosage/Clinical Use Dosage and infusion rate are adjusted according to individual needs and are controlled by monitoring the usual circulatory parameters (e. After infusion for plasma volume substitution the half-life time of the intravascular effect of Gelofusine is 4 – 5 hours.g. the cardiac stroke volume. during induction of epidural or spinal anaesthesia).5 ml/min). So Gelofusine is a plasma substitute. Gelofusine is rapidly distributed in the intravascular but in part – regarding the low molecular weight fraction – also in the interstitial compartment. Thus the mean arterial pressure. The volume effect of Gelofusine is equivalent to the administered amount of solution. Further. blood pressure).

a dose of 20 ml/kg BW should not be exceeded. For compensation of major losses of blood or plasma the average dose is between 1000 and 2000 ml. volumes between 500 and 1000 ml are required. If the solution is given under pressure. Maximum infusion rate: The maximum infusion rate depends on the actual cardio-circulatory situation. Maximum daily dose: The therapeutic limit is dependent on the dilution effect. the amount of infused solution corresponds to the withdrawn plasma volume. the first 20 – 30 ml should be infused slowly and under careful observation of the patient. 37 °C. Method of administration Gelofusine is administered intravenously. Special caution should be taken so that the air in the container and in the giving set are expelled before administration.3 In order to avoid the occurrence of anaphylactoid/anaphylactic reactions described under Undesirable Effects. as a rule 500 – 1000 ml of Gelofusine will be required. In isovolaemic haemodilution. The amount of Gelofusine required during extracorporal circulation depends on the system used. using a pressure cuff or an infusion pump. the solution should be warmed to max. In emergency situations or shock conditions an initial dose of 500 ml may be administered by forced infusion over 5 – 10 min. in case of emergency please refer to the paragraph “Restrictions for use. Normally. In this case the amount of solution infused may be as much as 10 – 15 l/24 h (monitor haematocrit!). Only solutions that are clear and free of precipitate should be infused. After stabilisation of the cardiovascular situation.and intraoperative routine prophylaxis. warnings”. being infused over 1 – 3 hours. substitution of erythrocytes or full blood should be considered. Recommended doses For compensation of minor losses of blood or plasma as well as for pre. Unused portions of the solution must not be stored for later use. below 30 %). The infusion must be used immediately after preparation. If the haematocrit falls below 25 % (in patients at cardiovascular or pulmonary risk. the infusion can be continued with doses corresponding to the actual losses of blood or plasma. Restrictions of Use Contraindications Gelofusine must not be administered in the case of: – hypersensitivity towards gelatine – hypervolaemia – hyperhydration – severe cardiac insufficiency – recent event of cardiac infarction . Before starting the infusion. As a rule.

When giving the infusion under pressure in case of emergency. then corrective measures should be taken. e. Because Gelofusine has no buffering capacity. children. – chronic liver diseases. deficiencies should be corrected to a target level of 5 g/100 ml by infusion of human albumin. – hypernatraemia. Because the product does not substitute lost plasma protein. – states of dehydration. paraesthesia). afibrinogenaemia). it is advisable to check the plasma protein concentrations 6 – 12 hours after an operation. signs of tetany. This applies in particular to patients on medication with digitalis. expel air from container and fill half of drip chamber Turn container and expel air from infusion device Close clamp Place container in pressure cuff .) Attention should be paid to the insufficiency of plasma protein stocks in infants.g.g. special caution should be taken so that the air in the container and in the giving set are expelled before administration. checks of the serum electrolyte concentrations are required. The following precautions should be observed: Electrolytes are to be substituted according to specific requirements Necessary monitoring During compensation of severe blood losses by massive infusions of Gelofusine.g. and the elderly. Especially in patients with existing disorders of haemostasis (e. If required. asthma. the haematocrit must be monitored under any circumstances. Special caution should be exercised and doses should be adjusted carefully in patients with – blood coagulation disorders. Quick’s test and aPTT below 35 % of normal). (It is necessary to wait 6 hours after an intervention as the biuret protein assay does not distinguish between gelatine and plasma proteins. – renal insufficiency. Likewise in those situations the dilution effect on coagulation factors should be observed (critical values: platelet count below 50 000/µl. – left or right ventricular insufficiency.4 – – severe disturbances of blood coagulation severe renal insufficiency Warnings Gelofusine should only be administered with caution in the cases of: – known allergic diseases. Instruction for Ecoflac® Infusion (under pressure) Insert infusion set Hold container upright Leave clamp open. Special attention should be paid to the appearance of symptoms of hypocalcaemia (e. – haemorrhagic diathesis. it has no effect on acidosis.

if its expected benefits definitely outweigh possible risks. Anaphylactic or anaphylactoid reactions caused by gelatine solutions may either be histamine-mediated or histamine independant. It is not known whether Gelofusine passes into breast milk. Adverse reactions may occur in conscious and anaesthetized patients. Severe anaphylactoid reactions (grade III or IV) are rare with an incidence of about 1 : 13 000. nor is it possible to foresee the course and severity of any such reaction. Histamine release can be prevented by the use of a combination of H1. Patients receiving Gelofusine must be continuously observed for the occurrence of anaphylactoid or anaphylactic reactions. . Sufficient experience with application during the breast-feeding period and in children under 1 year is not available. Prophylactic administration of corticosteroids has not proved effective. just as of any colloidal volume substitutes. In the acute phase of volume deficiency shocks so far no anaphylactic or anaphylactoid reaction has ever been reported. Because of possible anaphylactoid or anaphylactic reactions.and H2 receptor blockers. Interactions Incompatibilities may occur when the solution is mixed with other medicaments. the preparation should only be administered during pregnancy. Undesirable effects After the administration of Gelofusine infusions. shock. Close observation of the patient during infusion. especially while the first 20 – 30 ml of the solution are being infused. anaphylactoid or anaphylactic reactions of varying degrees of severity may occur. Results of compatibility tests will be provided on request. These reactions manifest as fever or cutaneous eruptions (urticaria) or sudden flushing of the face and neck. Stop of infusion immediately.5 - Build up pressure Open clamp and start infusion Pregnancy/Lactation Pregnancy category C: Controlled studies have been carried out neither in animals nor in pregnant women. In rare cases they may proceed over sudden flushing of the face and neck to drop in blood pressure. cardiac and respiratory arrest. It cannot be predicted by any test procedure which patients are likely to experience anaphylactic or anaphylactoid reactions. General guidelines for the prophylaxis of adverse reactions: Adequate information of physicians and nursing staff about the type and severity of possible adverse reactions that may be encountered after the administration of a colloidal volume substitute. as soon as there are any indications of adverse reactions. Availability of all apparatus and medication required for resuscitation.

unspecific plasma protein assays (e. Please refer also to the paragraph “Restrictions for use.6 Admixture of fat emulsions must be avoided. specific gravity of urine.” Available Packages Ecoflac® : Date of last revision July 2002. Overdose Overdose of Gelofusine may lead to unintended hypervolaemia associated with consecutive impairment of heart and lung function. the infusion must be stopped immediately. warnings”. It must only be used until the date stated on the container after “Exp. dyspnoea. by the biuret method).g. jugular vein congestion) appear. it should be warmed to body temperature before starting the infusion. Other information Incompatibilities Incompatibilities may occur when the solution is mixed with other medicaments. using a pressure cuff or an infusion pump. Influence on diagnostic methods: Gelofusine may have an influence on the following clinical-chemical tests. leading to falsely high values: erythrocyte sedimentation rate. Storage Gelofusine should not be stored above 25 °C. As soon as symptoms of circulatory overload (headache. Instructions for use If the solution is administered by forced infusion. 10 × 500 ml .