EMAGEL 35 G/L Infusion solution
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Інструкція із застосування EMAJEL
Зміст інструкції
EMAGEL 35 g/l solution for infusion
Poligelina
Read this leaflet carefully before you start to use 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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What EMAGEL is and what it is used for
- 2. What you need to know before you use EMAGEL
- 3. How to use EMAGEL
- 4. Possible side effects
- 5. How to store EMAGEL
- 6. Contents of the pack and other information
1. What is EMAGEL and what is it used for
Emagel contains the active ingredient poligeline which is a medicine belonging to the category of
plasma substitutes (liquid part of the blood), they work by increasing the fluid in the circulating blood.
Emagel is used in the treatment of conditions of severe hypovolemia (reduction of blood volume)
in situations where the use of dextran 80-85 is contraindicated.
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before using EMAGEL
Do not use EMAGEL
- If you are allergic to polygelin or any of the other ingredients of this medicine (listed in section 6), as anaphylactic/anaphylactoid reactions have been observed.
- If you experience hypercalcemia (increased calcium concentration in the blood).
- If you are undergoing digitalis therapy (used in some heart diseases).
The use of Emagel is subject to certain restrictions in that the doctor, considering the need for infusion, must adopt special precautions:
- in all cases where an increase in volume within the blood vessels and its related consequences (e.g. increased amount of blood pumped with each heartbeat, increased blood pressure), an increase in the volume of interstitial fluids (present between cells) or dilution of the blood may constitute a specific risk to you. Examples of such circumstances are: decompensated heart failure (a condition in which the heart fails to pump blood in adequate quantities to meet the body's needs), high blood pressure, esophageal varices (dilations of the veins of the esophagus), pulmonary edema (presence of water in the lung), predisposition to bleeding, failure to produce urine due to a kidney problem or structures following the kidney;
- in all patients in whom the risk of histamine release is greater (e.g. subjects with allergic reactions or similar reactions and patients with a history of response to histamine).
In the latter case, Emagel may only be administered after initiating adequate preventive measures (see “Warnings and precautions”).
Warnings and precautions
Talk to your doctor or nurse before you are given EMAGEL.
The infusion must be stopped immediately if intolerance reactions occur.
Mild forms of these reactions can be kept under control by administering antihistamine medications. In the presence of severe reactions, follow the directives of modern shock therapy.
If you belong to the category of patients in whom the risk of histamine release is greater [e.g. if you have experienced allergic reactions or similar reactions, if you have a medical history of allergic diseases such as asthma, or if you are at risk of histamine-induced reactions as a result of a cumulative effect due to the concurrent use of medications that release histamine such as anesthetics, muscle relaxants, pain relievers, ganglioplegics (which block the propagation of nerve impulses) and anticholinergics (which block a hormone called acetylcholine)] this medicine may only be administered after initiating adequate preventive measures such as the administration of anti-H1 and anti-H2 antihistamine medications.
In general, the administration of red blood cells (blood cells) or coagulation factors should be considered - at the latest - when the hematocrit value (percentage of cells in the blood) falls below 25% by volume.
In general, the use of hydro-saline solutions should be evaluated and controlled with data relating to blood levels of potassium, calcium and pH (blood acidity) in order to avoid undesirable accumulation of salts or dangerous interference with cardiac, renal, pulmonary or central nervous system function.
The infusion of Emagel may determine a transient increase in erythrocyte sedimentation rate (ESR), a laboratory test.
Only clear solutions from intact vials should be used. Since Emagel does not contain preservatives, there is a possibility of secondary contamination of opened vials treated with non-sterile means (needles and cannulas). This obviously prevents its use.
The Emagel solution remains clear even at low temperatures, up to near the freezing point. However, for physiological reasons, the solution should be infused at a temperature corresponding to that of the body.
For technical reasons, there is a residual volume of air in the containers. Therefore, when using plastic infusion bottles, the infusion pressure must be monitored, as the risk of gas embolism (presence of gas bubbles in the circulating blood) cannot be excluded.
Other medicines and EMAGEL
Tell your doctor if you are taking, have recently taken or might take any other medicine.
- Emagel can be mixed with common infusion solutions [saline solutions, glucose solution (containing sugars), Ringer's solution (solution used to increase blood volume), etc.] as well as with muscle relaxants, barbiturates (sedatives), circulatory agents, corticosteroids, vitamins, antitetanus serum, antibiotics of the penicillin and tetracycline groups.
- Histamine-induced reactions may occur as a result of a cumulative effect due to the concurrent use of medications that release histamine [such as anesthetics, muscle relaxants, pain relievers, ganglioplegics (which block the propagation of nerve impulses) and anticholinergics (which block a hormone called acetylcholine)]. However, due to its calcium ion content, it should not be mixed with citrated preserved blood (to prevent coagulation). There are no reservations, however, regarding the association of Emagel with sufficiently heparinized blood (with the addition of heparin, an anticoagulant).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk, ask your doctor for advice before using this medicine.
Emagel has been widely used in pregnancy. Regarding the course of pregnancy, the health of the fetus and the newborn, no adverse effects have been observed (Category A).
Nevertheless, in general, particular attention should be paid in cases where body fluid or volume substitutes are administered during or immediately after pregnancy.
Driving and operating machinery
No interference with the ability to drive vehicles and operate machinery has been reported.
EMAGEL contains:
- Sodium chloride:This medicine contains 1671 mg (72.71 mmol) of sodium per 500 ml, equivalent to 83.5% of the maximum recommended daily intake of sodium by the WHO.
- EMAGEL is considered to have a high sodium content. To be taken into consideration in people with impaired renal function or who are following a low-sodium diet.
- Potassium chloride:This medicine contains 2.69 mmol of potassium per 500 ml. To be taken into consideration in patients with impaired renal function or in patients following a low-potassium diet.
3. How to use EMAGEL
Use this medicine following the doctor's instructions exactly. If you have any doubts
consult your doctor.
The solution is ready for infusion and is administered intravenously.
The quantity and duration of the infusion depend on the needs of each individual case.
Generally, adults are given 500 ml in 1-2 hours (approximately 40-60 drops per minute).
In case of severe shock, rapid infusion of 500 ml under pressure within
5-10 minutes may be necessary.
Repeated infusions of Emagel, even up to a total quantity of several liters in a few days, are also perfectly tolerated.
Use in children
Children are generally given 10 ml/kg.
If you use more EMAGEL than you should
The need to administer considerable doses of Emagel requires careful
monitoring of circulatory parameters. A possible dilution effect of the blood may
affect the coagulation potential and blood cells, although normalization occurs rapidly, at the latest within 24 hours.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During or after infusion of plasma substitutes (liquid part of the blood), transient skin reactions (urticaria, wheals), low blood pressure, increase or decrease in heart rate, nausea/vomiting, difficulty breathing, increased body temperature and/or chills may occasionally occur.
Rare hypersensitivity reactions have been observed that are severe enough to reach a state of shock.
In these cases, the countermeasures to be taken depend on the nature and severity of the side effect.
The onset of a side effect should determine the immediate suspension of the infusion, with the simultaneous initiation of therapeutic measures commensurate with the nature and severity of the effect itself.
It has been shown that the release of histamine represents the determining cause for the onset of side effects related to the infusion of Emagel.
The speed of the infusion may promote the onset of histamine-induced reactions.
See also the sections “Warnings and precautions” and “Other medicines and EMAGEL”.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, 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 EMAGEL
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 packaging. The expiry date refers to the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
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. Contents of the pack and other information
What EMAGEL contains
- The active ingredient is poligelina. 1000 ml of Emagel contains 35 g of poligelina (corr. to a nitrogen content of 6.3 g)
- The other ingredients are: sodium chloride; potassium chloride; calcium chloride and water for injectable preparations.
The corresponding electrolytic concentration is: sodium ion 145 (mmol/l); potassium ion 5.1
(mmol/l); calcium ion 6.25 (mmol/l); chloride ion 145 (mmol/l).
Description of the appearance of EMAGEL and contents of the pack
Solution for infusion.
Bottle of 500 ml.
Marketing Authorisation Holder
Piramal Critical Care B.V.
Rouboslaan 32 (ground
floor) 2252 TR,
Voorschoten
Netherlands
Manufacturers
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor)
2252 TR, Voorschoten
Netherlands
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- Країна реєстрації
- Лікарська формаInfusion solution, 35 G/L
- Код АТХB05AA06
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до EMAJELЛікарська форма: Infusion solution, 4 %Діюча речовина: gelatin agentsВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Infusion solution, 4%Діюча речовина: gelatin agentsВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Infusion solution, 5% (50G/L)Діюча речовина: АльбуминВиробник: BIOTEST PHARMA GMBHПотрібен рецепт
Аналоги EMAJEL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог EMAJEL у Польща
Аналог EMAJEL у Україна
Аналог EMAJEL у Іспанія
Лікарі онлайн щодо EMAJEL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на EMAJEL онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
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Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
EMAJEL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у EMAJEL — gelatin agents. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
EMAJEL виробляється компанією PIRAMAL CRITICAL CARE B.V.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування EMAJEL з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати EMAJEL у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (gelatin agents) включають JELASPAN, JELOFUSINE, ALBIOMIN. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
