GELOPLASMA

PosologyThe solution is administered intravenously. Dosage volume and rate of administration depend upon the individual patient status, circumstances and response to vascular replacement. Modified liquid gelatin is given by IV infusion (drip infusion).

The infusion rate can be increased using a pump. The dose and infusion rate depend upon the patient's needs and blood volume to be replaced and haemodynamic status of the patient. The dose administered is 500 to 1000 ml on average (1 to 2 bags), sometimes more.

As a general rule, in adults and children weighing more than 25 kilos, 500 ml (1 bag) is administered at an appropriate rate depending on the status of the patient. The infusion rate can be increased in case of severe haemorrhage. e.

greater than 20% of blood volume) blood should usually be administered as well as Geloplasma. The haemodynamic, haematological and coagulation system should be monitored. Paediatric population See above. Method of administration The solution is administered intravenously.

The undesirable effects are divided into:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data) Undesirable effects observed during the infusion of this product are: Rare ≥1/10,000 to <1/1,000 Very rare < 1/10,000 Immune system disorders Anaphylactic shock Skin and subcutaneous tissue disorders Allergic skin reaction Vascular disorders Hypotension Cardiac disorders Slowing of heart rate Respiratory,thoracic and mediastinal disorders Respiratory difficulties General disorders and administration site conditions Fever, chills 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 national reporting system. uk/yellowcard.

4 Special warnings and special precautions for use Warnings This solution must not be given by intramuscular injection. This solution may cause metabolic alkalosis because of the presence of lactate ions. This solution may not have its alkalinizing action in patients with impaired liver function since lactate metabolism may be impaired.

This liquid gelatin solution must not be infused at the same time as blood or its derivatives (packed cells, plasma and plasma fractions) but using two separate infusion systems. Determination of blood group, irregular antigens and any laboratory blood tests are possible in patients who have received up to 2 litres of liquid gelatin, though interpretation is hampered by haemodilution and it may be preferred to draw the sample for these tests before the infusion of liquid gelatin.

Because of the possibility of allergic (anaphylactic/anaphylactoid) reactions, appropriate monitoring of patient is necessary. In case of an allergic reaction, the infusion must be stopped immediately and appropriate treatment given.

This medicine contains 5 mmol of potassium per litre. Patients with reduced kidney function or patients on controlled potassium diet should take into consideration this information. This medicine contains 150 mmol of sodium per litre.

Patients on controlled sodium diet should take into consideration this information. Precautions Use of this solution requires clinical and laboratory monitoring of the patient's status: - blood pressure, and possibly central venous pressure; - urine output; - haematocrit and electrolytes.

Especially in the following situations: - congestive heart failure; - pulmonary functional impairment; - severely impaired renal function; - oedema with water/salt retention; - circulatory overload; - treatment with corticosteroids and their derivatives.

- major coagulation disturbances The haematocrit should not fall below 25%; in elderly patients it should not fall below 30%. Blood coagulation disorders caused by dilution of coagulation factors should be avoided. If more than 2,000 to 3,000 ml of Geloplasma are infused pre-and intra-operatively, it is recommended that the serum protein concentration be checked post-operatively, especially if there are signs of tissue oedema.

This medicine must not be used in the following situations: - known or suspected hypersensitivity to gelatine solutions; - predominantly extracellular hyperhydration; - hyperkalemia; - metabolic alkalosis; - end of pregnancy (during labor/delivery): see "Fertility, pregnancy and lactation" section.