Geloplasma Solution For Infusion
Out of date information, search anotherdilution of coagulation factors should be avoided.
If more than 2000 to 3000 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.
Overdose
If overdose occurs, stop the infusion and give a fast acting diuretic.
In case of overdose, the patient should be treated symptomatically and electrolytes should be monitored.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
Aseptic handling of the solution must be ensured
Check that the container is intact and the solution clear before use.
Discard any container which is damaged or from which fluid has been
removed.
The residual volume of solution left after infusion must never be used again later
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6. FURTHER INFORMATION What GELOPLASMA contains
The active substances are:
Modified liquid gelatin*
amount expressed as anhydrous gelatin . .3.0000 g
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Sodium chloride .........................0.5382 g
Magnesium chloride hexahydrated .......0.0305 g
Potassium chloride .......................0.0373 g
Sodium (S)-lactate solution
per 100 ml of solution for infusion * partially hydrolysed and succinylated
This product contains 0.06% of succinic acid as a product resulting from the manufacturing process.
The other ingredients are: sodium hydroxide, hydrochloric acid, water for injection.
Ionic formula:
Sodium =
Potassium = Magnesium = Chloride = Lactate =
150 mmol/l 5 mmol/l 1.5 mmol/l 100 mmol/l 30 mmol/l
Total osmolality: 295 mOsm/kg pH: 5.8 to 7.0
What GELOPLASMA looks like and contents of the pack
GELOPLASMA, solution for infusion is presented in 500 ml PVC or Freeflex (polyolefine) bags with overwrap.
Marketing Authorisation holder and Manufacturer
Marketing Authorisation Holder Manufacturer
Fresenius Kabi Limited Cestrian Court,
Eastgate Way, Manor Park, Runcorn, Cheshire,
WA7 1NT, UK
Fresenius Kabi France 6 rue du Rempart 27400 Louviers France
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Czech Republic, Estonia, Finland, Germany, Greece, Ireland, Latvia, Lithuania, Poland, Portugal, Slovakia, Spain, UK: Geloplasma France: Plasmion Italy: Infuplas
This leaflet was last approved in 03/2012.
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Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again.
■ If you have further questions, please ask your doctor or your pharmacist.
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
■ If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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In this leaflet:
1. What GELOPLASMA, solution for infusion is and what it is used for
2. Before you use GELOPLASMA
3. How to use GELOPLASMA
4. Possible side effects of GELOPLASMA
5. How to store GELOPLASMA
6. Further information
1. WHAT GELOPLASMA solution for infusion IS AND WHAT IT IS USED FOR
GELOPLASMA is a solution for intravenous infusion. It contains gelatin, which belongs to a group of medicines known as plasma volume expanders. Plasma volume expanders work by increasing the fluid in your blood stream, which helps keep your blood stream and therefore your blood pressure stable.
This medicine is an emergency treatment in case of low blood volume in the following situations:
■ Haemorrhage (bleeding), dehydration, capillary leak (Increased microvascular permeability), burns;
■ severe vasodilatation (widening of blood vessels) from traumatic, surgical, septic or toxic origin.
It is also used in the treatment of low blood volume associated with hypotension (low blood pressure) in the context of severe vasodilatation related to the effects of hypotensive drugs, notably during anesthesia.
2. BEFORE YOU USE GELOPLASMA
Do not use GELOPLASMA in the following situations:
■ if you are allergic (hypersensitive) to the active substances or to any other ingredients of GELOPLASMA;
■ in case of excess fluid in the body;
■ in case of hyperkalaemia (excess of potassium in the blood);
■ in case of high accumulation of alkaline substance (e.g. bicarbonate, lactate) in your blood and body fluid;
■ at the end of pregnancy (during labour/delivery): see "Pregnancy and Breast-feeding" section.
Take special care with GELOPLASMA:
■ This solution must not be given by intramuscular injection.
■ This solution may cause accumulation of alkaline substances in your blood due to the presence of lactate ions.
■ This solution may not have its alkalinising action in cases of impaired liver function since lactate metabolism may be disturbed.
■ GELOPLASMA must not be administered 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 and any laboratory blood tests are possible if you have received up to 2 litres of liquid gelatin but it may be preferred to draw the sample for these tests before the infusion of GELOPLASMA.
■ Because of the possibility of allergic reaction, appropriate monitoring is necessary. In case of an allergic reaction, the infusion must be stopped immediately and appropriate treatment given.
■ Use of this solution requires clinical and laboratory monitoring of:
- blood pressure, and possibly central venous pressure (measured by a catheter in a vein that leads directly to the heart);
- urine output;
- haematocrit (blood volume) and electrolytes (ions present in the blood).
Especially in the following situations:
- congestive heart failure (a condition in which the heart cannot pump enough blood to the body's other organs);
- respiratory functional impairment;
- severe kidney disease;
- oedema with water/salt retention;
- circulatory overload (excess of intravascular liquid);
- treatment with corticosteroids or their derivatives;
- blood clotting disorders.
Using other medicines:
■ Use of other intravenous medicines at the same time as GELOPLASMA is inadvisable.
■ Since this solution contains potassium, it is preferable to avoid using potassium and medicinal products that may cause excess of potassium in blood.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding:
The safety of the product in pregnant women has not been assessed and GELOPLASMA must only be given if clinically necessary. Your physician has assessed the benefits versus the potential risk to the baby. Administration to breast-feeding mothers is not regarded as harmful. You should tell your doctor if you are pregnant, if you think you might be pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of GELOPLASMA:
This medicine contains 5 mmol of potassium per litre. Patients with reduced kidney function or patients on controlled potassium diet
should take this information into account.
This medicine contains 150 mmol of sodium per litre. Patients on controlled sodium diet should take this information into account.
3. HOW TO TAKE GELOPLASMA
Always use GELOPLASMA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. You will receive your medicine by infusion (intravenous drip). A pump can be used to increase the rate of infusion.
The rate of infusion, along with the volume infused, will depend on your specific requirements.
The quantity 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 kg, 500 ml (1 bag) is administered at appropriate infusion rate.
If there is a blood loss of more than 1.5 litres in an adult, blood is generally administered as well as GELOPLASMA.
Tests may be carried out throughout your treatment to ensure that your blood pressure, blood and coagulation parameters are controlled.
If you have been given more GELOPLASMA than recommended:
Higher doses may cause your blood volume to be excessive.
Increased pressure in the pulmonary circulation leads to leakage of fluid into the extravascular space and may cause fluid on the lungs (symptoms, breathlessness).
If overdose occurs, the infusion will be stopped immediately and a quick active diuretic (drug increasing the flow of urine from your body) will be given.
4. POSSIBLE SIDE EFFECTS OF GELOPLASMA
Like all medicines, GELOPLASMA can have side effects, although not everybody gets them.
There have been rare reports of allergic skin reactions. Possibility of anaphylactic shock (severe allergic reaction). If you notice these effects, please inform immediately your doctor.
The following have been reported more rarely: decrease of blood pressure, slowing of heart rate, breathing difficulties, fever, chills.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE GELOPLASMA
Do not store above 25°C.
Do not freeze.
Do not store in a refrigerator.
Do not use GELOPLASMA if you notice:
- that the container is damaged,
- that the solution is not clear,
- that fluid has been removed from the bag.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the container.
Once opened : use immediately, discard any unused portion.
The following information is intended for healthcare professionals only:
Posology and method of administration
The 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.
If there is blood/fluid loss in excess of 1.5 litres in the adult (i.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.
Special warnings and special precautions for use
Warnings
This solution must not be given by intramuscular injection.
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
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