Consumer medicine information

Gelofusine

Gelatin succinylated

BRAND INFORMATION

Brand name

Gelofusine

Active ingredient

Gelatin succinylated

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Gelofusine.

1. What is in this leaflet

This leaflet contains some common questions about Gelofusine.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risk of you taking this medicine against the benefits they expect it will have for you.

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

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

2. What is Gelofusine used for

Gelofusine is a plasma volume substitute. This means, it replaces fluid lost from the circulation.

Gelofusine is used to replace blood and body fluid, which have been lost as a result of, for example, an operation, an accident or a burn. It can be used instead of, or as well as, a blood transfusion.

It may also be used for filling up the circulating blood volume during use of the heart-lung machine or artificial kidney.

3. Before you are given Gelofusine

When you must not be given Gelofusine

DO NOT USE GELOFUSINE:

  • if you are allergic (hypersensitive) to gelatin or any of the other ingredients of Gelofusine
  • if your circulating blood volume is too large
  • if you have excess fluid in your body
  • if you are at markedly increased risk of bleeding because your blood clotting is severely impaired.

TAKE SPECIAL CARE WITH GELOFUSINE

Please inform your doctor:

  • if you have problems with your heart or your kidneys because giving large amounts of liquids through an intravenous drip may affect these organs
  • if you are suffering from allergic diseases such as asthma, because you may be at a greater risk to experience an allergic reaction.
    All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very few cases also become severe. Such reactions are assumed to be more frequent in patients with known allergic conditions such as asthma. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.

TAKING OR USING OTHER MEDICINES

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

PREGNANCY AND BREAST-FEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding, please inform your doctor. Although you may be given Gelofusine during pregnancy and while breast-feeding, the possible risks and benefits should be considered carefully.

DRIVING AND USING MACHINES

Not relevant. Gelofusine is normally given to immobile patients in a controlled setting (e.g. emergency treatment, acute treatment in a hospital or a day therapy unit) and this excludes the likelihood of driving and using machines.

4. How to use Gelofusine

Gelofusine is given intravenously, i.e. by a drip.

How much you are given and for how long will depend on how much blood or fluid you have lost and on your condition.

For children, the doctor will determine the dose especially carefully. A child will receive this medicine only if the doctor considers it essential for his/her recovery.

The doctor will carry out tests (on your blood and blood pressure, for example) during your treatment, and the dose of Gelofusine will be adjusted according to your needs.

IF YOU USE MORE GELOFUSINE THAN YOU SHOULD

An overdose of Gelofusine may give rise to circulatory overload and to alterations of your blood salt (electrolyte) levels.

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

5. Possible Side Effects

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

As mentioned above, in rare cases (i.e. in 1 to 10 treated patients in 10,000) mild skin reactions (hives, nettle rash) may occur.

In very rare cases (i.e. in less than 1 treated patient in 10,000) an allergic shock has been observed.

It must be stressed that allergic reactions are extremely rare, but should they occur there are established methods of treating them, which would be used immediately by the attending doctor.

Uncommon side effects (affecting 1 to 10 treated patients in a 1,000) include:

  • short lasting queasiness or belly pain
  • short lasting mild rise of body temperature.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

6. Storage

Keep out of the reach and sight of children.

Do not use Gelofusine after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.

Store below 25°C.

Do not use Gelofusine if you notice:

  • cloudiness or discoloration of the solution
  • leaking of the container.

Previously opened or partly used Gelofusine should be thrown away. Partially used bags should not be reconnected.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

7. Product Description

What Gelofusine looks like

Gelofusine is a solution for infusion administered through an intravenous drip (a drip into a vein).

It is a clear colourless or slightly yellowish sterile solution.

It comes in:

  • polyethylene bottles (Ecoflac plus) of 500 ml, available in packs of 10
  • polyethylene bottles (Ecoflac plus) of 1000 ml, available in packs of 10
  • non-PVC plastic bags (Ecobag) of 500 ml, available in packs of 10
  • non-PVC plastic bags (Ecobag) of 1000 ml, available in packs of 10

Ingredients

The active substances are succinylated (modified fluid) gelatin and sodium chloride.

1000 ml of the solution contain:

  • Succinylated (modified fluid) gelatin 40.0 g
  • Sodium 154 mmol/L
  • Chloride 120 mmol/L

The other ingredients are water for injections and sodium hydroxide for pH adjustment.

Australian Registration Numbers:
500 mL bottles (Ecoflac plus) ARTG 60644
1000 mL bottles (Ecoflac plus) ARTG 60645
500 mL plastic bags (Ecobag) ARTG 78102
1000 mL plastic bags (Ecobag) ARTG 78103

8. Sponsor Details

B. Braun Australia Pty Ltd
17 Lexington Drive
Bella Vista NSW 2156
Australia
Toll Free Number: 1800 251 705

9. Date of Information

This leaflet was updated in January 2010.

Published by MIMS November 2014

BRAND INFORMATION

Brand name

Gelofusine

Active ingredient

Gelatin succinylated

Schedule

Unscheduled

 

1 Name of Medicine

Succinylated gelatin.

2 Qualitative and Quantitative Composition

See Tables 1 and 2.
Gelofusine is manufactured from gelatin derived from bovine material sourced only from BSE-free cattle. It is a 4% colloidal solution of succinylated gelatin (also known as Modified Fluid Gelatin) in physiological saline. The resultant solution is clear.

List of excipients with known effect.

Contains sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Gelofusine is indicated as a colloidal plasma volume substitute in:
1. Treatment and prevention of hypovolaemia:
absolute hypovolaemia from haemorrhage or other cases of intravascular fluid loss or perioperative intravascular fluid maintenance; and
relative hypovolaemia secondary to induction of epidural or spinal anaesthesia, non-hypovolaemic shock.
2. Haemodilution (perioperative, therapeutic venesection).
3. Extra-corporeal circulation (cardiac surgery, plasma exchange, haemodialysis).

4.2 Dose and Method of Administration

Total dosage, duration and rate of infusion will depend upon the amount of blood or plasma lost and condition of the patient, and will need to be adjusted as necessary by monitoring the usual circulatory parameters e.g. blood pressure.
The risk of circulatory overload by too rapid infusion or inappropriately large doses must be borne in mind. In order to detect the occurrence of anaphylactoid/anaphylactic reactions as early as possible the first 20-30 mL should be infused slowly and under careful observation.

Maximum daily dosage.

The therapeutic limit is dependent on the dilution effect. If the haematocrit falls to below 25% (in patients at cardiovascular or pulmonary risk 30%), erythrocytes or full blood should be considered (Gelofusine may be used concomitantly with blood, the rate and amount depending on the clinical condition of the patient). For significant bleeds Gelofusine should not be the sole replacement factor used.

Maximum infusion rate.

The maximum rate of infusion is dependent on the state of the cardiac circulation. The rate of administration can be increased by the application of pressure to the container or by use of a giving set pump. Before administration, Gelofusine should be warmed to no more than 37°C. See Table 3.

Further information.

Electrolytes should be substituted as required. Fluid balance and coagulation parameters should be monitored.
Mixing with other drugs may produce incompatibilities. Therefore, only mixtures of known compatibility should be prepared.
Gelofusine has a low calcium content (max. 0.4 mmol/L) and therefore will not cause clotting of citrated blood or plasma.
Do not use unless the solution is clear and free from particles. Do not use if the container appears damaged or has been previously opened.

4.3 Contraindications

Known hypersensitivity to gelatin.
Hypervolaemia or hyperhydration.
Severe cardiac insufficiency.
Severe blood clotting disorders.

4.4 Special Warnings and Precautions for Use

Special care and adaptation of the dosage is recommended for patients with impaired renal and hepatic function, hypertension, pulmonary oedema, disorders of blood coagulation and fluid depletion. Gelofusine should be administered with caution to patients with hypernatraemia and states of dehydration.
Gelofusine has been associated with rare but severe reactions similar to anaphylaxis. Patients should be monitored carefully for relevant symptoms and signs so that the product infusion can be stopped and appropriate urgent treatment can be commenced.

Anaphylactoid/anaphylactic reactions.

In common with all colloidal plasma volume substitutes, Gelofusine can cause anaphylactoid/anaphylactic reactions of varying severity, ranging from benign skin symptoms (urticaria) through flushing of the face and neck, to the much less frequent but more severe reactions involving acute decrease in blood pressure, shock, bronchospasm, cardiac or respiratory arrest.
Such reactions can occur both in conscious and anaesthetised patients. Patients receiving Gelofusine have to be carefully observed in case of potential anaphylactoid/anaphylactic reactions.
The use of Gelofusine should be avoided in patients with a known history of drug allergy because of the greater risk of anaphylactoid/anaphylactic reactions with colloidal plasma substitutes.

General guidelines for prophylaxis and treatment of anaphylactoid/ anaphylactic reactions.

There is no known test to identify in advance patients liable to experience anaphylactoid/anaphylactic reactions nor can the course of such reactions be predicted. They can either be histamine-mediated or histamine independent. Histamine release can be prevented by the use of a combination of H1- and H2-receptor blockers. Prophylactic use of a corticosteroid has not been proven to be of value.
Medical and nursing staff must be aware of the potential grade and severity of reactions attributable to colloidal plasma volume substitutes.
Careful observation of patients during administration of the first 20-30 mL of Gelofusine.
Resuscitation apparatus and drugs must be immediately available.
Should an anaphylactoid/anaphylactic reaction occur, the infusion must be stopped immediately.
Medical management of anaphylactoid and anaphylactic reactions consists of three steps, those for the acute management of the reaction, and those which may be regarded as additional and as supportive. These are discussed below. All are important for the management of the patient and should be considered concurrently.
An anaphylactoid reaction is a life-threatening emergency. As in all medical emergencies, initial management should be directed at the ABC of resuscitation i.e. Airway, Breathing and Circulation.
Referring to guidelines established by the Australasian College for Emergency Medicine, the Australasian Society of Clinical Immunology and Allergy, the Australian and New Zealand College for Anaesthesists, The Royal Australasian College of Physicians and the Royal Australian College for General Practitioners, the principles of management include:
1. Cease administration of Gelofusine. In concert with steps (2) and (3), change I.V. giving set and commence rapid fluid resuscitation with crystalloids (Normal saline or Hartmann's solution).
2. Administer oxygen. Intubate the trachea and ventilate if respiratory difficulties or cardiovascular collapse occur.
3. Administer adrenaline (I.M. or I.V. according to severity) on a weight basis (up to 5 microgram/kg). Doses may need to be repeated intravenously at 5 minute intervals, or a continuous infusion of adrenaline to be established.
4. Additional measures may be useful, including nebulised beta-2 adrenergic agonists for bronchospasm, I.V. antihistamines, including H1 and H2 antagonists, and corticosteroids. Nebulised adrenaline may help laryngeal oedema, but tracheal intubation should not be delayed if upper airway obstruction is progressive.
5. Supportive treatment includes frequent observation of vital signs and if possible monitoring of ECG and pulse oximetry.
All patients who have suffered an anaphylactoid reaction must be admitted to hospital. Patients who remain clinically unstable after initial resuscitation should be admitted to an intensive care unit.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Clinical-chemical parameters may be affected. Thus, the results of the following laboratory determinations can be elevated: blood sedimentation rate, specific gravity of the urine and nonspecific protein determinations (e.g. by the biuret method).

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions have been reported.
If blood is 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been carried out to determine the effects of Gelofusine on fertility.
(Category B3)
There are no adequate, well controlled studies in pregnant women. When given to pregnant rats (20 mL IP twice a day), Gelofusine was embryotoxic. Also, the risk of anaphylactoid/anaphylactic reactions cannot be entirely excluded.
 No information is available relating to the use of Gelofusine in lactating women, neonates or children under one year.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with all colloidal volume substitutes, allergic (anaphylactoid/anaphylactic) reactions of varying severity can occur after infusion of Gelofusine. These reactions manifest themselves as skin reactions (urticaria) or can result in flushing of the face and neck. In rare cases, a drop in blood pressure, shock or cardiac and respiratory arrest could occur.
Paradoxical hypotensive reactions have been reported to occur in patients receiving gelatin based plasma volume expanders concurrently with ACE inhibitors. Caution is advised when using Gelofusine in patients receiving ACE inhibitors, particularly in association with albumin.
Overdosage of volume replacement solutions may lead to unintended hypervolaemia with consecutive impairment of heart and lung function. As soon as symptoms of circulatory overload begin to manifest, e.g. dyspnoea, jugular vein congestion, the infusion must be stopped immediately.
Administration of Gelofusine leads to dilution of coagulation factors and should therefore be applied with great caution in patients with disturbances of blood coagulation.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

The potential exists for volume overload and haemodilution to occur as a result of too large a total dose and/or too rapid infusion. This potential is increased in patients with pre-existing cardiac or renal impairment. The use of Gelofusine in such patients should be accompanied by careful attention to dosage and administration.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Succinylation of the gelatin molecule results in a negatively charged molecule with consequent spatial expansion. Due to this property it fills more volume than non-succinylated protein chains of the same molecular weight.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Distribution.

Gelofusine has a volume effect lasting approximately 3-4 hours.

Metabolism.

Only about 1% of the infused drug is metabolised.

Excretion.

The major route of elimination is urinary excretion, with only a very small amount excreted in the faeces.

5.3 Preclinical Safety Data

Limited studies of the toxicity of Gelofusine in animals have been undertaken. The animal studies available indicate that the maximum dosage of Gelofusine is limited by the volume infused and its haemodiluting effects.

Genotoxicity.

There have been no animal or clinical studies to determine the likely carcinogenicity or mutagenic potential of Gelofusine.

Carcinogenicity.

There have been no animal or clinical studies to determine the likely carcinogenicity or mutagenic potential of Gelofusine.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, sodium hydroxide and water for injections.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Mixing with other drugs may produce incompatibilities. Therefore, only mixtures of known compatibility should be prepared.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Do not use after the expiry date printed on the container.

6.5 Nature and Contents of Container

Gelofusine is available in the following containers and pack sizes:
1 x 10 Ecoflac of 500 mL - AUST R 60644.
1 x 10 Ecobag of 500 mL - AUST R 78102.
1 x 10 Ecobag of 1000 mL - AUST R 78103.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

68915-24-2.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes