infusion solution
succinylated gelatin (modified gelatin, liquid)

1. What Gelofusine is and what it is used for

Gelofusine is a so-called volume replacement for plasma. This means that it replaces lost fluid in the blood circulation.

Gelofusine is used to

  • replace blood and body fluid lost as a result of e.g. an operation, an accident or a burn. It can be used in combination with blood transfusion if needed .
  • prevent low blood pressure ( hypotension ) which may occur with spinal or epidural anesthesia or due to the risk of extensive blood loss in connection with surgery .
  • in combination with other infusion fluids increase the circulating blood volume using e.g. heart-lung machine.

2. What you need to know before you use Gelofusine

Do not use Gelofusine

  • if you are allergic to gelatin or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to an allergen called galactose-α-1,3-galactose (alpha-gal) or to red meat (meat of mammals) and intestinal food
  • if your circulating blood volume is too large
  • if you have excess fluid in your body
  • if you have a certain type of heart failure ( acute congestive heart failure ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Gelofusine.

Tell your doctor

  • if you have an allergic disease such as asthma . You may then be at greater risk of developing an allergic reaction .

Due to the risk of possible cross-reactions, Gelofusine should not be given to you in the following cases

  • if you know you are allergic to red meat (meat of mammals) or intestinal foods
  • if you have received a positive test result for antibodies ( IgE ) to allergen et alpha-gal.

Your doctor should take special care if you suffer from:

  • heart disease
  • high blood pressure
  • fluid in the lungs
  • severe kidney disease.

These conditions can get worse if you are given large amounts of fluid as a drip into a vein.

The doctor prescribes the preparation with caution:

  • if the concentration of sodium or chloride in your blood is greatly increased
  • of water and salts accumulate in the body which can cause swelling of the tissue are
  • if the blood’s coagulation capacity is significantly reduced
  • if you are older

During treatment with Gelofusine, the composition of the blood is monitored. If necessary, your doctor may also give you other medicines, such as salts and fluids.

Children

There is only limited experience with the use of Gelofusine in children. The doctor will give this medicine to children only if absolutely necessary.

Results for laboratory tests

Your doctor may take blood or urine samples before giving you Gelofusine. This is because some test results may be affected after you have received this medicine and may therefore be unreliable.

Other medicines and Gelofusine

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.

It is especially important that your doctor knows if you are taking or receiving medicines that may cause sodium accumulation (eg spironolactone, triamterene, amiloride, ACE inhibitors such as captopril, or enalapril, corticosteroids such as cortisone, or non-steroidal anti-inflammatory drugs such as diclofenac ). Concomitant use of this medicine may cause swelling of the arms, hands, legs, and feet ( edema ). 

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant. Gelofusine should be avoided during pregnancy due to possible allergic reactions. However, your doctor may give you this medicine in an emergency.

Breast-feeding

Tell your doctor if you are breastfeeding. There is limited information on the excretion of this medicine in breast milk, but based on its chemical properties it is unlikely that it will pass into breast milk.

Your doctor will decide if you should stop breastfeeding or treat with this medicine after weighing the benefits of breastfeeding for your baby and the benefits of the treatment for you.

Fertility

There is no information on the effect of this medicine on the fertility of humans or animals. However, based on the properties of the constituents, fertility is unlikely to be affected.

Driving and using machines

This medicine has no effect on the ability to drive and use machines.

3. How to use Gelofusine

Your doctor will only give you Gelofusine if treatment with preparations called crystalloids alone is not considered sufficient.

Your doctor will carefully adjust the dose of Gelofusine to prevent fluid overload. This is especially true if you have problems with your lungs, heart, or circulation.

Dosage

Gelofusine is given intravenously, ie. by drip.

Adults

How much you get and for how long depends on how much blood or fluid you have lost and on your condition.

Your doctor will perform tests (eg on your blood and blood pressure ) during treatment and dose one of Gelofusine will be adjusted according to your needs. If necessary, you can also be given blood or packed red blood cells.

Use for children

There are only limited data from the use of this medicine in children. The doctor will only give this medicine to children if it is considered necessary for the child’s recovery. In these cases, the child’s clinical condition is taken into account and the treatment is monitored particularly closely.

If you use more Gelofusine than you should 

An overdose of Gelofusine can cause excessive blood volume in the body ( hypervolemia ) and fluid overload that can affect heart or lung function.

You may experience headaches and difficulty breathing.

In case of an overdose, the doctor will take the necessary measures.

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

4. Possible side effects

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

All plasma substitutes involve a small risk of allergic reactions, which are usually mild or moderate, but which in very few cases can also be serious. Such reactions are thought to be more common in patients with known allergic conditions such as asthma. For this reason, healthcare professionals will observe you carefully, especially at the beginning of infusion one.

The following side effects can be serious. If you get any of the following side effects, talk to your doctor straight away:

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

  • allergic (anaphylactic / anaphylactoid) reactions, such as difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, feeling of pressure in the chest or throat, abdominal pain, swelling of the neck and face

Infusion one should be stopped immediately and you should be given the necessary care in case of an allergic reaction (see also section 2 “What you need to know before using Gelofusine”, especially for allergies involving the allergen et galactose-α-1,3-galactose (alpha-gal), red meat and offal).

Other side effects include:

Very common (may affect up to 1 in 10 people):

  • decreased number of red blood cells and protein in the blood.

Common (may affect up to 1 in 100 people):

  • the blood does not coagulate as well as before and you may notice that you are bleeding more than before.

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

  • palpitation
  • low blood pressure
  • fever, chills.

Has been reported (occurs in an unknown number of users):

  • nausea, vomiting, abdominal pain
  • decreased oxygen content in the blood which can cause dizziness.

Additional side effects are in children

There are no data on any differences in side effects in children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gelofusine

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 label and outer carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

Do not use this medicine if you notice

  • turbidity or discoloration of the solution
  • that the packaging has leaked.

Previously opened or partially used packaging of Gelofusine should be discarded. Partially used bags should not be reconnected.

The product should be used immediately after opening.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substances are succinylated gelatin (modified gelatin, liquid) and sodium chloride

succinylated gelatin (modified gelatin, liquid) 40.0 g
sodium chloride 7.0 g
   
Electrolyte content
sodium 154 mmol
chloride 120 mmol
  • The other ingredients are water for injections, hydrochloric acid (for pH adjustment ) and sodium hydroxide (for pH adjustment ).

Physico-chemical properties
pH 7.4 ± 0.3
osmolarity 274 mOsm / l

What the medicine looks like and contents of the pack

Gelofusine is an infusion solution, a solution given by intravenous drip (drip into a vein).

Gelofusine is a clear, colorless, or slightly yellowish sterile solution.

Available in:

  • 500 ml polyethylene bottles (Ecoflac) in packs of 10 bottles
  • polypropylene bags (Ecobag) of 250 ml and 500 ml in packs of 20 bags
  • 1000 ml polypropylene bags (Ecobag) in packs of 10 bags.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany

Postal address
B. Braun Melsungen AG
34209 Melsungen, Germany

Information provided by:

B. Braun Medical AB

Box 110

182 12 Danderyd

Muhammad Nadeem

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