GELOPLASMA

Main information

  • Trade name:
  • GELOPLASMA 3 Grams Solution for Infusion
  • Dosage:
  • 3 Grams
  • Pharmaceutical form:
  • Solution for Infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GELOPLASMA 3 Grams Solution for Infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Blood substitutes and plasma protein fractions

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0566/038/001
  • Authorization date:
  • 20-04-2007
  • Last update:
  • 20-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

What is in this leaflet

1. What GELOPLASMA, solution for infusion, is and what it is used for

2. What you need to know before you use GELOPLASMA, solution for infusion

3. How to use GELOPLASMA, solution for infusion

4. Possible side effects

5. How to store GELOPLASMA, solution for infusion

6. Contents of the pack and other 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. What you need to know before you use GELOPLASMA,solution for infusion

Do not use GELOPLASMA, solution for infusion:

if you are allergic to gelatin or any of the other ingredients of this medicine (listed in sec-

tion 6);

if you are allergic to an allergen called “galactose-α-1,3-galactose (alpha-Gal)” or to red

meat (mammal meat) and offal;

if you have an excess of fluid in the body;

if you have hyperkalaemia (excess of potassium in the blood);

if you have an high accumulation of alkaline substance (e.g. bicarbonate, lactate) in your

blood and body fluid;

if you are at the end of pregnancy (during labour/delivery): see "Pregnancy, breast-

feeding and fertility" section.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using GELOPLASMA, solution for infusion:

This solution must not be given by intramuscular injection.

This solution may cause accumulation of alkaline substance in your blood due to the

presence of lactate ions.

This solution may not have its alkalinising action in case 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 this solution.

Read all of this leaflet carefully before you start using this medicine because it

contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have further questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may

harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

Package leaflet: Information for the user

GELOPLASMA

solution for infusion

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 and other handling

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.

Any unused medicinal product or waste material should be disposed of in

accordance with local requirements.

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6. Contents of the pack and other information

What GELOPLASMA, solution for infusion, contains

The active substances are:

Modified liquid gelatin*

amount expressed as anhydrous gelatin

. . . . . . . . . . .3.0000 g

Sodium chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.5382 g

Magnesium chloride hexahydrated

. . . . . . . . . . . . . . . .0.0305 g

Potassium chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.0373 g

Sodium (S)-lactate solution

amount expressed as sodium lactate . . . . . . . . . . . . . .0.3360 g

per 100 ml of solution for infusion

* partially hydrolysed and succinylated

The other ingredients are: sodium hydroxide; succinic anhydride as succinic acid;

hydrochloric acid, concentrated; water for injections.

Ionic formula:

Sodium = 150 mmol/l

Potassium = 5 mmol/l

Magnesium = 1.5 mmol/l

Chloride = 100 mmol/l

Lactate = 30 mmol/l

Total osmolality: 295 mOsm/kg

pH: 5.8 to 7.0

What GELOPLASMA, solution for infusion, looks like and contents of the pack

GELOPLASMA, solution for infusion is presented in 500 ml PVC bag with overwrap (box

of 1 and 15) or Freeflex (polyolefine) bag with overwrap (box of 20).

Not all pack sizes may be marketed

Marketing Authorisation holder and Manufacturer

Marketing Authorisation Holder Manufacturer

Fresenius Kabi Limited Fresenius Kabi France

Cestrian Court, 6 rue du Rempart

Eastgate Way, Manor Park, 27400 Louviers

Runcorn, Cheshire, France

This medicinal product is authorised in the Member States of the EEA under the

following names:

Austria:

GELOPLASMA Infusionslösung

Czech Republic:

Geloplasma, infuzní roztok

Estonia:

Geloplasma, infusioonilahus

Finland:

GELOPLASMA infuusioneste, liuos

France:

PLASMION, solution pour perfusion

Germany:

Geloplasma Infusionslösung

Hungary:

Geloplasma oldatos infúzió

Ireland:

GELOPLASMA, solution for infusion

Italy:

Infuplas soluzione per infusione

Latvia:

Geloplasma šķīdums infūzijām

Lithuania:

GELOPLASMA infuzinis tirpalas

Norway:

Geloplasma infusjonsvæske, oppløsning

Poland:

GELOPLASMA

Portugal:

Geloplasma, Solução para perfusão

Romania:

Geloplasma 3 g/100 ml soluţie perfuzabilă

Slovakia;

GELOPLASMA, infúzny roztok

Slovenia:

Geloplasma raztopina za infundiranje

Spain:

Geloplasma, solución para perfusión

GELOPLASMA solution for infusion

This leaflet was last revised in December 2017.

4253-4.qxp_PLASMION 20/12/2017 09:06 Page1

Because of the possibility of allergic reactions appropriate monitoring is necessary. In

case of an allergic reaction, the infusion must be stopped immediately and appropriate

treatment given.

In these cases GELOPLASMA should not be given to you due to possible cross-

reactions:

- if you know you have an allergy to red meat (mammal meat) or offal;

- if you have been tested positive to antibodies (IgE) against the allergen alpha-Gal;

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:

- 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.

Other medicines and GELOPLASMA, solution for infusion

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

GELOPLASMA, solution for infusion, with food and drink

Not applicable.

Pregnancy, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no or limited amount of data from the use of GELOPLASMA, solution for

infusion, in pregnant women. GELOPLASMA, solution for infusion, must only be given if

clinically necessary. Your physician has assessed the benefits versus the potential risk to

the baby.

Breast-feeding

It is unknown whether GELOPLASMA, solution for infusion, is excreted in human breast

milk. A risk to the baby cannot be excluded.

Fertility

There are no data on the effects of GELOPLASMA, solution for infusion, on human or

animal fertility.

Driving and using machines

Not relevant.

GELOPLASMA, solution for infusion, contains:

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 use GELOPLASMA

Always use this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

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, solution for infusion.

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, solution for infusion, than you should:

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 of 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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist

or nurse.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people):

- Anaphylactic shock (severe allergic reaction);

- Allergic skin reaction.

If you notice these effects, please inform your doctor or nurse immediately, your infusion will

be stopped immediately and you will be given any necessary treatment (see also section 2

“What you need to know before you use GELOPLASMA, solution for infusion”, notably for

allergies involving the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat and

offal).

Very rare (may affect up to 1 in 10,000 people):

- Decrease of blood pressure;

- Slowing of heart rate;

- Breathing difficulties;

- Fever, chills.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly:

For UK - via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - HPRA Pharmacovigilance

Earlsfort Terrace - IRL - Dublin 2

Tel: +353 1 6764971 - Fax: +353 1 6762517 - Website: www.hpra.ie

e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this

medicine.

5. How to store GELOPLASMA, solution for infusion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container. The expiry

date refers to the last day of that month. Do not store above 25°C.

Do not freeze.

Do not store in a refrigerator.

Once opened: use immediately, discard any unused portion.

Do not use this medicine if you notice:

- that the container is damaged,

- that the solution is not clear,

- that fluid has been removed from the bag

Do

not

throw

away

any

medicines

via

wastewater

or

household

waste.

Ask

your

pharmacist how to throw away medicines you no longer use. These measures will help

protect the environment.

The following information is intended for healthcare professionals only:

Posology and method of administration

Posology

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, solution for infusion. The haemodynamic, haematological and

coagulation system should be monitored.

Paediatric population

See above.

Method of administration

The solution is administered intravenously.

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 dilution of coagulation

factors should be avoided.

If more than 2000 to 3000 ml of GELOPLASMA, solution for infusion, are infused

pre-and intra-operatively, it is recommended that the serum protein concentration

be checked post-operatively, especially if there are signs if tissue oedema

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