GELASPAN 4 % Roztwór do infuzji
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Gelaspan 4% solution for infusion
Read this leaflet carefully before using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.
Contents of this leaflet:
- 1. What Gelaspan is and what it is used for
- 2. What you need to know before using Gelaspan
- 3. How to use Gelaspan
- 4. Possible side effects
- 5. How to store Gelaspan
- 6. Further information
1. What is Gelaspan and what is it used for
Gelaspan is a so-called plasma volume substitute. This means that it serves to replenish the liquid component that has leaked out of the blood vessels.
Gelaspan is used for:
- Replacing blood and body fluids lost, for example, following surgery, an accident or a burn. If necessary, it can be used in conjunction with blood transfusions
- Preventing low blood pressure (hypotension) that may occur during spinal or epidural anesthesia, or due to impending and significant blood loss in a surgical setting
- Restoring circulating blood volume during the use, for example, of a heart-lung machine, in combination with other infusion fluids
2. What you need to know before using Gelaspan
Do not use Gelaspan
- 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 (mammalian meat) and offal;
- if you have too much blood volume;
- if there is too much water in your body;
- if you suffer from a particular type of heart failure (acute congestive heart failure);
- if you have a level of potassium in your blood that is higher than normal.
Warnings and precautions
Consult your doctor, pharmacist or nurse before using Gelaspan
Tell your doctor:
- if you suffer from an allergic condition such as asthma. In this case, the risk of an allergic reaction may be greater
- in these cases, Gelaspan should not be administered to you due to possible cross-reactions:
- if you know you are allergic to red meat (mammalian meat) or offal
- if you have tested positive for antibodies (IgE) directed against the alpha-Gal allergen. The doctor will pay particular attention to your condition if you suffer from:
- heart problems;
- high blood pressure;
- water in the lungs;
- severe kidney problems. The administration of large amounts of fluids through an intravenous drip may worsen your condition.
In addition, the doctor will proceed with caution
- if you have a severe increase in sodium or chlorine in the blood;
- if you have fluid and salt retention, which may be associated with tissue swelling;
- if you have high levels of potassium in the blood, or if you are taking or undergoing treatment with medicines that cause potassium retention;
- if your blood coagulation is severely impaired;
- if you are elderly.
During the administration of Gelaspan, your blood composition will be monitored.
If necessary, the doctor may administer other medicines to you, such as salts and fluids.
Children
Experience with the use of Gelaspan in children is limited. For this reason, the doctor will administer this
medicine to children only if they consider it absolutely necessary.
Laboratory test results
The doctor may take blood or urine samples before administering Gelaspan, as the results of
some laboratory tests may be altered and prove unreliable after administration of the
medicine.
Other medicines and Gelaspan
Tell your doctor or pharmacist if you are taking or using, or have recently taken or used any other
medicines, including those available without a prescription.
In particular, the doctor needs to know if you are taking or undergoing treatment with medicines that cause sodium retention (e.g. spironolactone, triamterene, amiloride, ACE inhibitors such as captopril or enalapril, corticosteroids such as cortisone or non-steroidal anti-inflammatory drugs such as diclofenac). Concomitant administration with this medicine may cause swelling of the arms, hands, legs and
feet (edema). Also, tell your doctor if you are taking medicines that cause potassium loss, for
example medicines that increase water loss.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Tell your doctor if you are pregnant. Due to possible allergic reactions, the use of this medi-
cine should be avoided during pregnancy. However, the doctor may give you this medicine in emer-
gency situations.
Breastfeeding
Tell your doctor if you are breastfeeding. There is limited information on the excretion of this
medicine into breast milk. The doctor will decide whether to stop breastfeeding or stop the medicine
taking into account the benefit of breastfeeding for the baby and the benefit of therapy for you.
Fertility
There are no data on the effect of this medicine on human or animal fertility. However, due to the nature of its constituents, it is unlikely to affect fertility.
Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.
3. How to use Gelaspan
The doctor will give you Gelaspan only if they believe that other products, called crystalloids, are not sufficient on their own.
The doctor will carefully adjust the dose of Gelaspan to prevent fluid overload. In particular
if you suffer from problems with the lungs, heart or circulation.
Dosage
Gelaspan is administered intravenously, i.e. through a drip.
Adults
The amount that will be administered to you and the duration of the administration will depend on how much blood or
fluid you have lost and your condition.
During treatment, the doctor will perform checks (for example, blood tests and blood pressure)
and the dose of Gelaspan will be adjusted according to the patient's needs. If necessary, you may also receive
blood or cellular concentrates.
Use in children
Experience with the use of this medicine in children is limited. The doctor will administer this medicine
to you only if they consider it necessary for the child's recovery. In these cases, the clinical conditions will be taken into account
and particularly careful monitoring of the therapy will be carried out.
If you use more Gelaspan than you should
An overdose of Gelaspan can cause an excessive increase in blood volume (hypervolemia) and a
fluid overload that can compromise the function of the heart and lungs.
You may notice headache and difficulty breathing.
In case of overdose, the doctor will administer the necessary treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Gelaspan can cause side effects, although not everybody gets them.
All plasma substitutes carry a slight risk of allergic reactions, mostly mild to moderate, but which in rare cases can also become severe. These reactions are thought to be more frequent
in patients with known allergic disorders, such as asthma. For this reason, a healthcare professional will keep you under
close observation, especially at the beginning of the infusion.
The following side effects could be serious. If you experience any of the following side effects,
seek immediate medical attention:
Rare (may affect up to 1 in 1,000 people):
allergic reactions (anaphylactic/anaphylactoid), which include, for example, difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, a feeling of tightness in the chest or throat, stomach pain, swelling of the neck and face.
If an allergic reaction occurs, the infusion will be stopped immediately and you will be
given the necessary treatment (see also section 2 “What you need to know before using Gela-
span”, particularly for allergies involving the allergen called galactose-α-1,3-galactose (alpha-
Gal), red meat and offal).
Other side effects include:
Very common (may affect more than 1 in 10 people):
- reduction in red blood cells and proteins in the blood
Common (may affect up to 1 in 100 people):
- your blood may not clot as well as before, and you may notice increased bruising
Very rare (may affect up to 1 in 10,000 people):
- increased heart rate
- low blood pressure
- fever, chills
Not known (frequency cannot be estimated from available data):
- feeling unwell, nausea, stomach upset
- reduction in oxygen levels in the blood, which can cause dizziness
Additional side effects in children
There is no data relating to a difference in terms of side effects in children.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gelaspan
Keep this medicine out of the sight and reach of children.
Do not use Gelaspan after the expiry date which is stated on the label and the outer packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze.
Do not use Gelaspan if you notice:
- turbidity or a change in the colour of the solution;
- a leakage from the container.
Opened or partially used Gelaspan must be discarded. Bottles or bags that have been partially used must not be reconnected.
6. Package Contents and Other Information
What Gelaspan contains
Active ingredients:
- 1,000 mL of solution contains:
Succinyl gelatin (modified fluid) 40.0 g
Sodium chloride 5.55 g
Sodium acetate trihydrate 3.27 g
Potassium chloride 0.30 g
Calcium chloride dihydrate 0.15 g
Magnesium chloride hexahydrate 0.20 g
Electrolyte concentrations
Sodium 151 mmol/L
Chloride 103 mmol/L
Potassium 4 mmol/L
Calcium 1 mmol/L
Magnesium 1 mmol/L
Acetate 24 mmol/L
Other ingredients are:
water for injections, hydrochloric acid, diluted (for pH correction) and sodium hydroxide (for
pH correction).
Description of Gelaspan’s appearance and package contents
Gelaspan is a solution for infusion that is administered via an intravenous drip (into a vein).
It is a sterile, clear, colorless or slightly yellowish solution.
Gelaspan is supplied in:
- 500 mL low-density polyethylene bottles “Ecoflac plus” available in packs of 10 × 500 mL.
- “Ecobag” (non-PVC) plastic bags sealed with rubber stoppers of 500 mL. available in packs of 20 × 500 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
- B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany
Postal address
34209 Melsungen
Telephone: +49-5661-71-0
Fax: +49-5661-4567
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
| Austria | Gelofusin Iso 40mg/ml Infusionslösung |
| a Belgio | Isogelo oplossing voor infusie, solution pour per- fusion, Infusionslösung |
| n Bulgaria | Gelofusine Balance 4% solution for Infusion |
| d Repubblica Ceca | Gelaspan 4% |
| A Germania | Gelafundin ISO 40mg/ml Infusionslösung |
| Danimarca | Gelaspan |
| Estonia | Gelaspan infusioonilahus 4% |
| Grecia | Gelaspan solution for Infusion 4% |
| Spagna | Gelaspan 40mg/ml solución para perfusión |
| Francia | Gelaspan, solution pour perfusion |
| Ungheria | o Gelaspan 4% oldatos infúzió |
| Irlanda | Gelaspan Solution for Infusion |
| Italia | c Gelaspan |
| Lituania | Gelaspan 4% infuzinis tirpalas |
| Lussemburgo | a Gelafundin ISO 40mg/ml Infusionslösung |
| Lettonia | Gelaspan 4% Solution for Infusion |
| Malta | m Gelaspan 4% Solution for Infusion |
| Norvegia | Gelaspan |
| Paesi Bassi | r Gelaspan, oplossing voor infusie |
| Portogallo | Gelaspan |
| Polonia | a Gelaspan |
| Romania | Gelaspan 40 mg/ml solutie perfuzabila |
| Svezia | F Gelaspan |
| Slovenia | Gelaspan 40 mg/ml raztopina za infundiranje |
| Slovacchia | Gelaspan 4% |
| Regno Unito | l Gelaspan solution for infusion |
The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Gelaspan must not be infused in the same infusion line with blood or blood products (cellular concentrates,
plasma and plasma fractions).
During the compensation of severe blood loss through the infusion of large quantities of Gelaspan, monitoring
of hematocrit and electrolytes must be performed. Hematocrit must not fall below
25%, or 30% in elderly or seriously ill patients.
In such situations, the effect of dilution on coagulation factors must also be monitored, especially in patients with existing hemostasis disorders.
Since the product does not replace lost plasma proteins, it is advisable to monitor their concentrations.
In severe and acute cases, Gelaspan can be infused rapidly via pressure infusion; up to 500 mL of product can be administered in 5-10 minutes, until signs of hypovolemia are no longer detected.
For rapid infusions, Gelaspan can be brought to a temperature not exceeding 37 °C.
In the case of pressure infusion, which may be necessary in life-threatening emergencies, all air must be removed from the container and the infusion set before the solution is administered, to avoid the risk of gas embolism otherwise potentially associated with the infusion.
Influence on laboratory tests
After the infusion of Gelaspan, hematological type laboratory tests (blood group or irregular antibodies) can be performed. Nevertheless, it is recommended to take blood samples before the infusion of
Gelaspan to avoid errors in the interpretation of the results.
Gelaspan can affect the following clinical chemistry analyses, inducing falsely elevated values:
- erythrocyte sedimentation rate,
- specific gravity of urine,
- non-specific tests for protein determination, e.g. biuret method.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 4 %
- Kod ATCB05AA06
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki JELASPANPostać farmaceutyczna: Infusion solution, 35 G/LSubstancja czynna: gelatin agentsProducent: PIRAMAL CRITICAL CARE B.V.Wymaga receptyPostać farmaceutyczna: Infusion solution, 4%Substancja czynna: gelatin agentsProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Infusion solution, 5% (50G/L)Substancja czynna: albuminProducent: BIOTEST PHARMA GMBHWymaga recepty
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JELASPAN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w JELASPAN jest gelatin agents. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
JELASPAN jest produkowany przez B. BRAUN MELSUNGEN AG. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie JELASPAN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić JELASPAN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (gelatin agents) to m.in. EMAJEL, JELOFUSINE, ALBIOMIN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
