ALBUMIN HUMAN CSL BEHRING 200 g/L SOLUTION FOR INFUSION
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Introduction
Package Leaflet: Information for the User
Human Albumin CSL Behring 200 g/l Solution for Infusion
Active Substance: Human Albumin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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Contents of the Package Leaflet
- What is Human Albumin CSL Behring and what is it used for
- What you need to know before you use Human Albumin CSL Behring
- How to use Human Albumin CSL Behring
- Possible side effects
- Storage of Human Albumin CSL Behring
- Contents of the pack and other information
1. What is Human Albumin CSL Behring and what is it used for
What is Human Albumin CSL Behring
Human Albumin CSL Behring is a plasma substitute.
How Human Albumin CSL Behring works
Albumin stabilizes the volume of circulating blood. It transports hormones, enzymes, medicines, and toxins. The albumin present in Human Albumin CSL Behring comes from human plasma. Therefore, the albumin works exactly as if it were your own protein.
What Human Albumin CSL Behring is used for
Human Albumin CSL Behring is indicated for the restoration and maintenance of circulating blood volume. It is usually used in intensive care situations when your blood volume has decreased dangerously. This can occur, for example:
- due to severe blood loss after an injury or
- due to an extensive superficial burn
The decision to use Human Albumin CSL Behring should be made by your doctor. This will depend on your clinical situation.
2. What you need to know before you use Human Albumin CSL Behring
Read this section carefully. The following information should be considered by you and your doctor before Human Albumin CSL Behring is administered to you.
Do not use Human Albumin CSL Behring
- If you are allergic to human albumin (hypersensitive) or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Human Albumin CSL Behring.
What circumstances increase the risk of suffering from side effects
Your doctor or healthcare professional will be particularly careful if an abnormal increase in blood volume (hypervolemia) or blood dilution (hemodilution) could be dangerous for you. Examples of these situations are:
- heart failure that needs to be treated with medicines (decompensated heart failure),
- high blood pressure (hypertension),
- enlargement of the esophageal vein (esophageal varices),
- abnormal accumulation of fluid in the lung (pulmonary edema),
- predisposition to bleeding (hemorrhagic diathesis),
- severe reduction of red blood cells or hematites in the blood (severe anemia),
- severe reduction of urine excretion due to urination deficiency or kidney deficiency (renal and post-renal anuria).
Consult your doctor or pharmacist before treatment if you experience any of the above.
When perfusion may need to be interrupted
- Allergic reactions (hypersensitivity reactions) may occur, which can be severe and cause shock (see section 4).
Consult your doctor or pharmacist immediately if you notice such reactions during the perfusion of Human Albumin CSL Behring. Your doctor will interrupt its administration and start the appropriate treatment.
- If the dose and perfusion rate have not been adjusted, an abnormal increase in blood volume (hypervolemia) may occur, which can lead to an overload of the heart and circulatory system (cardiovascular overload).
The first signs of such an overload are headache and difficulty breathing or swelling of the neck veins (jugular congestion).
Consult your doctor or pharmacist immediately if you experience these symptoms. Your doctor will interrupt the treatment and control your circulation if necessary.
Viral safety
When medicines are manufactured from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include:
- careful selection of blood and plasma donors to ensure that donors with a risk of being carriers of infections are excluded,
- analysis of each individual donation and plasma pools for signs of viruses and infections,
- inclusion of steps in the processing of blood or plasma that can inactivate or eliminate viruses.
Despite these measures, when medicines obtained from human blood or plasma are administered, it cannot be completely excluded that the possibility of transmitting infections. This applies to emerging or unknown viruses and other types of infections.
There are no reports of viral infections with albumin manufactured according to the requirements of the European Pharmacopoeia and according to established processes.
It is strongly recommended that each time you are administered a dose of Human Albumin CSL Behring, the name and batch number of the product be recorded to maintain a record of the batches used.
Use of Human Albumin CSL Behring with other medicines
No specific interactions of Human Albumin CSL Behring with other medicines are known. No harmful effects or interactions are expected.
However, always inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.
Human Albumin CSL Behring should not be mixed with other medicines or blood products.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Human Albumin CSL Behring has not been studied individually in pregnant or breastfeeding women. However, medicines containing human albumin have been used in pregnant or breastfeeding women. Experience shows that no harmful effects are expected on gestation or on the fetus or newborn.
Driving and using machines
No effects of Human Albumin CSL Behring on the ability to drive or use machines have been observed.
Human Albumin CSL Behring contains sodium
50 ml vial
This medicine contains 144 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 7.2% of the maximum daily intake of sodium recommended for an adult.
100 ml vial
This medicine contains 287.5 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 14.4% of the maximum daily intake of sodium recommended for an adult.
3. How to use Human Albumin CSL Behring
Human Albumin CSL Behring should be administered by your doctor. Human Albumin CSL Behring is intended for intravenous infusion only.
Your doctor will decide how much Human Albumin CSL Behring you should be given. The amount and rate of infusion depend on your individual needs.
Your doctor will regularly check important blood flow values such as:
- your blood pressure,
- your pulse, or
- your urine production (diuresis),
These values are checked to determine the correct dose and infusion rate.
If you use more Human Albumin CSL Behring than you should
In case of overdose, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.
Human Albumin CSL Behring is only administered under medical supervision. Therefore, it is very unlikely that you will be given an overdose. You may experience an abnormal increase in blood volume (hypervolemia) if the dose and infusion rate are too high, which can lead to an overload of the heart and circulatory system (cardiovascular overload).
The first symptoms of such an overload are:
- headache,
- difficulty breathing, or
- swelling of the neck veins (jugular congestion).
If you notice these symptoms, please inform your doctor immediately.
Additionally, your doctor may detect symptoms such as
- higher blood pressure,
- increased central venous pressure, or
- abnormal accumulation of fluid in the lung (pulmonary edema).
In all these cases, your doctor will stop the infusion and control your circulation if necessary.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects may occur even if you have already received Human Albumin CSL Behring and tolerated it well.
General experiencewith human albumin solutions shows that the following effects can be observed.
Allergic reactions (hypersensitivity reactions) may occur, which can very rarely be severe and cause shock.
Symptoms of an allergic reaction can include one, some, or several of the following:
- Skin reactions, for example, redness, itching, swelling, blisters, skin rashes, or hives (urticaria).
- Difficulty breathing, for example, wheezing, chest tightness, difficulty breathing, or coughing.
- Swelling of the face, eyelids, lips, tongue, or throat.
- Symptoms similar to a cold, for example, stuffy nose or nasal discharge, sneezing, red eyes, itching, swelling, or watery eyes.
- Headache, stomach pain, nausea, vomiting, or diarrhea.
If you notice these reactions during the infusion of Human Albumin CSL Behring, inform your doctor or pharmacist. In this case, your doctor will stop the infusion and start the appropriate treatment.
The following mild side effects may occur rarely(may affect up to 1 in 1,000 people):
- flushing
- itchy rash (urticaria)
- fever
- nausea
They usually disappear quickly when the infusion rate is reduced or the infusion is stopped.
The following serious side effect may occur very rarely(affects up to 1 in 10,000 people):
- shock
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Human Albumin CSL Behring
- 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 carton and on the label after EXP. The expiry date is the last day of the month shown.
- Do not store above 25°C.
- Do not freeze.
- Keep the vial in the outer packaging to protect it from light.
- Once the pack is opened, the contents should be used immediately.
- Do not use this medicine if you notice that the solution is cloudy or contains particles.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of Human Albumin CSL Behring
- The active substance is human albumin.
Human Albumin CSL Behring is a solution that contains 200 g/l of total protein, of which at least 96% is human albumin.
A 100 ml vial contains at least 19.2 g of human albumin.
A 50 ml vial contains at least 9.6 g of human albumin.
- The other ingredients are sodium caprylate, N-acetyl-DL-tryptophan, sodium chloride, sodium hydroxide, and hydrochloric acid (in small quantities to adjust the pH) and water for injections.
Appearance and packaging
Human Albumin CSL Behring is a solution for infusion. The solution is clear and slightly viscous. It can be almost colorless or yellow, amber, or green.
Package sizes:
- One vial per pack (50 ml/100ml)
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
CSL Behring GmbH
Emil-von-Behring Strasse 76
D-35041 Marburg
Germany
You can obtain further information on this medicine from the representative of the marketing authorization holder:
CSL Behring S.A.
c/ Tarragona 157, planta 18
08014 Barcelona
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Austria Human Albumin "CSL Behring" 20% Infusionslösung
Belgium Human Albumin CSL Behring 200 g/l oplossing voor infusie
Human Albumin CSL Behring 200 g/l solution pour perfusion
Human Albumin CSL Behring 200 g/l Infusionslösung
Bulgaria Human Albumin CSL Behring 200 g/L solution for infusion
Croatia Albumeon 200 g/l otopina za infuziju
Cyprus Albumeon
Czech Republic Human Albumin CSL Behring 200 g/l
Denmark Albumin "Behring"
Estonia Human albumin CSL Behring / 200 g/l / infusioonilahus
Finland Albumin Behring
France Albumine Humaine CSL Behring 200 g/L, solution pour perfusion
Germany Albumeon
Greece Albumeon
Hungary Human Albumin CSL Behring 200 g/l oldatos infuzio
Iceland Albumin Behring / 200 g/l / solution for infusion
Ireland Human Albumin CSL Behring / 200 g/l / solution for infusion
Italy Albumeon, 200 g/l, soluzione per infusione
Latvia Human Albumin CSL Behring 200 g/l solution for infusion
Lithuania Human albumin CSL Behring 200 g/l infuzinis tirpalas
Luxembourg Human Albumin CSL Behring 200 g/l solution pour perfusion
Malta Albumeon 20, 200 g/l, solution for infusion
Netherlands Human Albumin CSL Behring 200 g/l oplossing voor infusie
Norway Albumin Behring
Poland Human Albumin CSL Behring 200 g/l
Portugal Albumina Humana CSL Behring 200 g/l solução para perfusão
Romania ALBUMEON 200 g/l soluție perfuzabilă
Slovakia Human Albumin CSL Behring 200 g/l
Slovenia Humani Albumin CSL Behring 200 g/l raztopina za infundiranje
Spain Albúmina Humana CSL Behring 200 g/l solución para perfusión
United Kingdom Albumeon 20, 200 g/l solution for infusion
Date of last revision of this leaflet:November 2020
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
- Country of registration
- Availability in pharmaciesSupply issue reported
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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