Инструкция по применению JELOFUSINE
Содержание инструкции
- What is Gelofusine and what is it used for
- What you need to know before using Gelofusine
- How to use Gelofusine
- Possible side effects
- How to store Gelofusine
- Package Contents and Other Information
Gelofusine, solution for infusion
succinylgelatin (modified fluid gelatin)
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Gelofusine is and what it is used for
- 2. What you need to know before using Gelofusine
- 3. How to use Gelofusine
- 4. Possible side effects
- 5. How to store Gelofusine
- 6. Contents of the pack and other information
1. What is Gelofusine and what is it used for
Gelofusine is a so-called plasma volume substitute. This means that it replaces fluids
lost from the circulatory system.
Gelofusine is used for:
- replacing blood and body fluids that have been lost as a result of, for example, surgery, an accident or a burn. If necessary, it can be used in combination with a blood transfusion;
- preventing low blood pressure (hypotension), which can occur when undergoing spinal or epidural anesthesia or in the face of an imminent and severe blood loss during surgery;
- the filling of the blood volume in circulation during the use, for example, of a heart-lung machine in combination with other infusion fluids.
2. What you need to know before using Gelofusine
Do not use Gelofusine
- if you are allergic to gelatin or any of the 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 the volume of circulating blood is too high;
- if you have excess fluid in the body;
- if you suffer from certain types of heart failure (acute congestive heart failure).
Warnings and precautions
Consult your doctor, pharmacist or nurse before using Gelofusine
Consult your doctor
- if you suffer from an allergic condition such as asthma. In this case, the risk of developing an allergic reaction may be higher.
- In these cases, Gelofusine 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. Your doctor will pay particular attention to your condition if you suffer from:
- heart problems,
- high blood pressure,
- fluid in the lungs,
- serious kidney problems. The administration of large amounts of fluids through an intravenous infusion may worsen your condition.
Your doctor will also be cautious:
- if you have a severe increase in sodium or chloride in the blood; if you have fluid and salt retention which may be associated with tissue swelling;
- if blood clotting is severely impaired;
- if you are elderly.
During the administration of Gelofusine, the composition of your blood will be monitored. If
necessary, your doctor may also give you other medications such as salts and fluids.
Children
Experience with the use of Gelofusine in children is very limited. Your doctor will only administer this
medicine to a child if they consider it absolutely necessary.
Laboratory test results
Your doctor may ask you for blood or urine samples before administering Gelofusine because
some laboratory test results may be affected by taking this medicine
and thus become unreliable.
Other medicines and Gelofusine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those obtained without a prescription.
In particular, your doctor needs to know if you are taking other medicines that can cause
sodium retention (for example spironolactone, triamterene, amiloride; ACE inhibitors such as captopril or
enalapril; corticosteroids such as cortisone or non-steroidal anti-inflammatory drugs such as diclofenac). The
concomitant administration with this medicine may cause swelling in the arms, hands,
legs and feet (edema).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, inform your doctor. Due to possible allergic reactions, the use of this medicine should
be avoided during pregnancy. In any case, your doctor may administer this medicine
in emergency situations.
Breastfeeding
If you are breastfeeding, inform your doctor. Information on the excretion of this medicine into breast
milk is limited but, based on its chemical characteristics, it is unlikely to pass into breast
milk. The doctor will decide whether to stop breastfeeding or stop therapy taking into
consideration the benefit of breastfeeding for the child and the benefit of therapy for you.
Fertility
There are no data on the effect of this medicine on fertility in animals or humans. However, due to
the nature of its constituents, it is considered unlikely to affect fertility.
Driving and operating machinery
This medicine does not impair your ability to drive vehicles and operate machinery.
3. How to use Gelofusine
The doctor will give you Gelofusine only if they believe that other products called crystalloids are not sufficient
on their own.
The doctor will carefully adjust the dose of Gelofusine to prevent fluid overload,
especially if you have lung, heart or circulation problems.
Dosage
Gelofusine is administered intravenously, i.e. with an infusion.
Adults
The amount and duration of administration depend on how much blood or fluids have been lost and
your general condition.
The doctor will perform tests (on blood and blood pressure, for example) during treatment,
and the dose of Gelofusine will be adjusted according to need. If necessary, blood or concentrated red blood cells may also be
administered.
Use in children
There is insufficient data on the use of this medicine in children. The doctor will administer this
medicine only if they consider it essential for the child's recovery. In these cases, the clinical
conditions will be taken into consideration and the therapy will be monitored with special caution.
If you use more Gelofusine than you should
An overdose of Gelofusine can lead to a blood volume that is too high (hypervolemia) and to
fluid overload, which can affect heart and lung function.
You may notice headache and difficulty breathing.
In case of overdose, your doctor will give you any necessary treatment.
If you have any doubts about the use of this medicine, contact 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 carry a slight risk of allergic reactions which are mostly
mild to moderate, but in very rare cases they can also become severe. These reactions are thought to
be more frequent in patients who suffer from allergic conditions such as asthma. For this reason
you will be closely monitored by a healthcare professional, especially at the beginning
of the infusion.
The following side effects can be serious. If you experience any of the following side effects
consult your doctor immediately.
Rare (may affect up to 1 in 1,000 people):
- allergic reactions (anaphylactic/anaphylactoid), including for example difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, tightness in the chest or throat, stomach pain, swelling of the neck and face. If an allergic reaction occurs, the infusion must be stopped immediately and you will be given any necessary treatment (see also section 2 “What you need to know before using Gelofusine”, particularly regarding allergies involving the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat and offal).
Other side effects:
Very common (may affect up to 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 bleeding.
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):
- nausea, vomiting, stomach pain;
- reduction in oxygen in the blood, which can cause dizziness.
Additional side effects in children
There are no data to support different side effects in children.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse.
You can also report side effects directly through the national reporting system at
https://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 Gelofusine
Keep Gelofusine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the container and on the
outer packaging after the wording “EXP.”. 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 this medicine if you notice:
- turbidity or discoloration of the solution;
- leakage of liquid from the container.
Gelofusine previously opened or partially used must be discarded. Partially used packs
must not be reconnected.
The product must be used immediately after opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Gelofusine contains
The active ingredients are succinyl gelatin (modified fluid) and sodium chloride.
1,000 ml of solution contains:
Succinyl gelatin (modified fluid) 40.0 g
Sodium Chloride 7.0 g
Electrolyte concentrations:
Sodium 154 mmol
Chloride 120 mmol
The other ingredients are water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Physicochemical characteristics
pH 7.4 ± 0.3
Osmolarity 274 mOsm/l
Description of the appearance of Gelofusine and contents of the pack
Gelofusine is a solution for infusion administered via an intravenous drip (a drip into a vein).
It is a sterile, clear, colorless or slightly yellowish solution.
It is marketed in:
- polyethylene bottles (Ecoflac) of 500 ml, available in packs of 10;
- polypropylene bags (Ecobag) of 250 and 500 ml, available in packs of 20;
- polypropylene bags (Ecobag) of 1,000 ml, available in packs of 10.
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
- B. Braun Melsungen 34209 Melsungen Germany
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
| Member State | Medicinal Product Name |
| Austria | Gelofusin - Infusionslösung |
| Belgium | GELOFUSINE, perfusie-oplossing |
| Bulgaria | Gelofusine sol.inf. 4% |
| Cyprus | GELOFUSINE |
| Czech Republic | Gelofusine, inf. |
| Denmark | GELOFUSINE, injektionsvaeske, oplosning |
| Estonia | GELOFUSINE |
| Finland | GELOFUSINE 40 mg/ml |
| France | GELOFUSINE 40 mg/mL, solution pour perfusion |
| Germany | Gelafundin 4% |
| Greece | Gelofusine |
| Hungary | Gelofusine |
| Ireland | Gelofusine Ecobag, Solution for Infusion |
| Italy | GELOFUSINE |
| Latvia | Gelofusine |
| Lithuania | Gelofusine |
| Luxembourg | Gelofusine |
| Malta | Gelofusine |
| Netherlands | Gelofusine, infusievloeistof 40 g/l |
| Poland | Gelofusine |
| Portugal | Gelofusine |
| Romania | Gelofusine 4 g/100 ml soluție perfuzabilă |
| Slovakia | Gelofusine |
| Slovenia | Gelofusine |
| Spain | Gelafundina |
| Sweden | GELOFUSINE |
| United Kingdom | Gelofusine Ecobag |

- Страна регистрации
- Форма выпускаInfusion solution, 4%
- Код АТХB05AA06
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги JELOFUSINEФорма выпуска: Infusion solution, 35 G/LДействующее вещество: gelatin agentsПроизводитель: PIRAMAL CRITICAL CARE B.V.Отпускается по рецептуФорма выпуска: Infusion solution, 4 %Действующее вещество: gelatin agentsПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецептуФорма выпуска: Infusion solution, 5% (50G/L)Действующее вещество: АльбуминПроизводитель: BIOTEST PHARMA GMBHОтпускается по рецепту
Аналоги JELOFUSINE в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог JELOFUSINE в Польша
Аналог JELOFUSINE в Украина
Аналог JELOFUSINE в Испания
Врачи онлайн по JELOFUSINE
Обсудите применение JELOFUSINE и возможные следующие шаги — по оценке врача.
Получите рецепт на JELOFUSINE онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
JELOFUSINE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество JELOFUSINE — gelatin agents. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
JELOFUSINE производится компанией B. BRAUN MELSUNGEN AG. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения JELOFUSINE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить JELOFUSINE в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (gelatin agents) включают EMAJEL, JELASPAN, ALBIOMIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















