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, colourless or slightly yellowish.

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 a colloidal plasma volume substitute for:
Treatment of relative or absolute hypovolaemia and shock.
Prophylaxis of hypotension caused by relative hypovolaemia during induction of epidural or spinal anaesthesia, due to imminent significant blood loss in a surgical setting.
Procedures involving extracorporeal circulation as a component of priming fluid in combination with crystalloid solutions (e.g. heart-lung machine).

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

Hypersensitivity to gelatin or to any of the excipients.
Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat.
Hypervolaemia.
Hyperhydration.
Acute congestive cardiac failure.

4.4 Special Warnings and Precautions for Use

Anaphylactoid/anaphylactic reactions.

Gelofusine should be administered with caution to patients with a history of allergic diseases (e.g. asthma).
Modified fluid gelatin solutions rarely cause allergic (anaphylactic/anaphylactoid) reactions of varying degrees of severity. In order to detect the occurrence of an allergic reaction as early as possible, up to the first 20 mL should be infused slowly and the patient should be under careful observation especially at the beginning of the infusion.
Due to possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (alphaGal), the risk of sensitisation and consequent anaphylactic reaction to gelatin-containing solutions could be highly increased in patients with a history of allergy to red meat (mammalian meat) and offal and/or tested positive for anti-alpha-Gal IgE antibodies. Gelatin-containing colloidal solutions should not be used in these patients (see Section 4.3 Contraindications).
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.

Risks related to fluid and electrolyte administration.

Gelofusine should be administered with caution to patients:
at risk of circulatory overload e.g. patients with right or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oligo- or anuria.
with severely impaired renal function.
with severe hypernatraemia.
with severe hyperchloraemia.
with oedema with water/salt retention.
with major blood coagulation disorders.
of advanced age as these are more prone to develop disorders such as cardiac or renal insufficiency.
As with all colloids, Gelofusine should only be used if hypovolaemia cannot be sufficiently treated with crystalloids alone. In severe hypovolaemia colloids are usually applied in combination with crystalloids.
Volume overload due to overdose or too rapid infusion must always be avoided. The dosage must be adjusted carefully, particularly in patients with pulmonary or cardiocirculatory problems.
Checks of serum electrolyte concentrations, acid-base balance and water balance are necessary, in particular in patients with hypernatraemia, hyperchloraemia or impairment of renal function.
Electrolytes and fluids should be substituted according to individual requirements if necessary.
As Gelofusine contains no calcium, special attention should be paid to the appearance of symptoms of hypocalcaemia such as tetanie and paraesthesia.
The haemodynamic, haematological and coagulation system should be monitored.
During compensation of severe blood losses by infusions of large amounts of Gelofusine, the haematocrit and electrolytes must be monitored under all circumstances.
Likewise in those situations the dilution effect on coagulation factors should be observed, especially in patients with existing disorders of haemostasis.
Because the product does not substitute lost plasma protein, it is advisable to check the plasma protein concentrations (also see Section 4.2 Dose and Method of Administration, Maximum daily dosage).
In cases of pressure infusion which might be necessary in vital emergencies, all air must be removed from the container and the infusion set before the solution is administered. This is to avoid the risk of air embolism that might otherwise be associated with the infusion.

Use in hepatic impairment.

Special care and adaptation of the dosage is recommended for patients with impaired hepatic function.

Use in renal impairment.

Special care and adaptation of the dosage is recommended for patients with impaired renal function.

Use in the elderly.

Caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that are frequently associated with advanced age.

Paediatric use.

There is insufficient experience with the use of Gelofusine in children. Therefore, Gelofusine should only be administered to these patients if the expected benefits clearly outweigh potential risks.

Effects on laboratory tests.

Laboratory blood tests (blood group or irregular antibodies) are possible after Gelofusine infusions. Nevertheless, it is recommended to draw blood samples before the infusion of Gelofusine in order to avoid hampered interpretation of results.
Gelofusine may have an influence on the following clinical-chemical tests, leading to falsely high values:
erythrocyte sedimentation rate,
specific gravity of the urine and
non-specific protein determinations, e.g. the biuret method.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution should be exercised in patients concurrently taking or receiving medicinal products that can cause sodium retention (e.g. corticosteroids, non-steroidal anti-inflammatory agents) as concomitant administration may lead to oedema.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effect of Gelofusine on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that Gelofusine will affect fertility.
(Category B2)
There are no or limited amount of data on the use of Gelofusine in pregnant women. Animal studies are insufficient with respect to developmental toxicity. Due to the limited data available and the possibility of severe anaphylactic/anaphylactoid reactions, with consequent fetal and neonatal distress, the use of Gelofusine solution should be restricted to emergency situations.
 There are no or limited data regarding the excretion of succinylated gelatin in mother's milk but because of its high molecular weight it is not expected that the milk will contain relevant amounts. Sodium and chloride are normal constituents of the human body and of food. No significant increase in the content of these electrolytes in mother's milk is expected following the use of Gelofusine.

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)

Adverse drug reactions can occur during and after the use of Gelofusine. These will usually involve anaphylactic/anaphylactoid reactions of varying severity (also see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, notably for hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) and allergy to red meat and offal). There are no data relating to a special pattern or incidence of adverse reactions in paediatric patients.
Undesirable effects are listed according to their frequencies as follows: 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); not known: (cannot be estimated from the available data).

Tabulated list of adverse reactions.

Immune system disorders.

Rare.

Anaphylactic/anaphylactoid reactions up to shock.
Cardiac disorders.

Very rare.

Tachycardia.
Vascular disorders.

Very rare.

Hypotension.
General disorders and administration site conditions.

Very rare.

Fever, chills.
Gastrointestinal disorders.

Not known.

Nausea, vomiting, abdominal pain.
Investigations.

Not known.

Oxygen saturation decreased.
Blood and lymphatic system disorders.

Very common.

Decreased haematocrit and reduced concentration of plasma proteins.

Common (depending on the administered dose).

Relatively large doses of Gelofusine result in dilution of coagulation factors and can therefore affect blood coagulation. Prothrombin time can be increased and activated partial thromboplastin time (aPTT) can be prolonged after administration of large doses of Gelofusine (see Section 4.4 Special Warnings and Precautions for Use).

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

Symptoms.

Overdose of Gelofusine may cause hypervolaemia and circulatory overload, with a significant fall in haematocrit and plasma proteins, accompanied by an electrolyte and acid base imbalance. This may be associated with consecutive impairment of heart and lung function (pulmonary oedema). Symptoms of circulatory overload are, for example, headache, dyspnoea and jugular vein congestion.

Treatment.

In case circulatory overload appears, the infusion must be stopped and a rapid-acting diuretic should be given. If an overdose occurs, the patient should be treated symptomatically with monitoring of electrolytes.
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.

The negative charges introduced into the gelatin molecule by succinylation causes an expansion of the molecule. The molecular volume is therefore higher than that of unsuccinylated gelatin of the same molecular weight.
Gelofusine has a measured initial volume effect of 79% - 100% of the infused volume, with a volume effect half-life of 4 - 5 hours.
The colloid-osmotic pressure of the solution determines the extent of initial volume effect. The duration of the effect depends on the clearance of the colloid mainly by renal excretion. Since the volume effect of Gelofusine is equivalent to the administered amount of solution. Gelofusine is a plasma substitute, not a plasma expander.
The solution also restores the extravascular compartment and does not disturb the electrolyte balance of the extracellular space.
Gelofusine substitutes intra- and extravascular volume deficits caused by losses of blood, plasma and interstitial fluid. Thus, the mean arterial pressure, the left ventricular end-diastolic pressure, the cardiac stroke volume, the cardiac index, the oxygen supply, the microcirculation and the diuresis are increased without dehydrating the extravascular space.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Distribution.

After infusion Gelofusine is rapidly distributed in the intravascular compartment.

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

Genotoxicity.

No genotoxicity studies have been conducted with Gelofusine.

Carcinogenicity.

No carcinogenicity studies have been conducted with 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 freeze.
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