The active substance is albumin (200 mg/mL).
Each 50 mL vial contains 10 g of human albumin.
The solution contains 200 mg/mL (20%) total protein with a purity of at least 95% human albumin.
Excipients/Inactive Ingredients: sodium chloride, sodium caprylate and water for injections.
VIALEBEX contains human albumin. Albumin is a blood protein produced by the liver.
VIALEBEX is used for restoration and maintenance of circulating blood volume in cases of demonstrated hypovolemia when use of a colloid is appropriate.
The choice to use albumin rather than an artificial colloid should be made based on the patient's clinical condition in accordance with official recommendations.
Posology: The dose required must be determined based on the blood volume to be restored and not on plasma albumin levels.
Mode and route of administration: VIALEBEX infusion must be performed under the supervision of a health professional. He/she will ensure that the treatment is proceeding properly and will take all necessary measures if an allergy arises.
The solution should be infused by intravenous route either directly or after dilution in an isotonic solution (for example 50 mg/mL (5%) glucose or 9 mg/mL (0.9%) sodium chloride).
In the event administration of large volumes, the solution should be brought to room or body temperature before infusion.
Any unused product or waste material should be disposed of in accordance with local requirements.
If the patient used more VIALEBEX 200 mg/mL, solution than he/she should: Hypervolemia (increased circulating blood volume) may occur if the dose and rate of administration are too high. If the patient experiences headache, breathing difficulties, increased volume of the big veins of the neck (jugular vein), increase of arterial blood pressure or of central venous pressure or pulmonary oedema, notify the doctor immediately. This could be due to an overdose. The doctor will immediately stop the treatment and perform frequent monitoring of blood test results.
For further questions on use of this product, ask the doctor or pharmacist.
Do not use VIALEBEX 200 mg/mL, solution for infusion: If the patient is allergic (hypersensitive) to the active substance (albumin) or any of the other ingredients of VIALEBEX (refer to Description).
Allergic or anaphylactic type reactions require immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock should be implemented.
The patient should be monitored carefully to guard against circulatory overload and hyperhydration.
The electrolyte status of the patient should be monitored and the necessary measures taken to restore or maintain electrolyte balance.
Risk of allergic reactions: The doctor will inform about the warning signs of an allergic reaction (see Side Effects). If one of these signs does occur, immediately stop the treatment and alert the doctor to start appropriate treatment depending on the type and severity of the reaction.
Medical tests: The doctor will perform tests on blood samples to ensure that the treatment is proceeding properly. The doctor will monitor the patient's level of hydration and the various components of the blood (coagulation factors, electrolytes, platelets and red blood cells).
Important information about some of the ingredients of VIALEBEX 200 mg/mL, solution for infusion: This medicinal product contains sodium. VIALEBEX contains 2.8 mg/mL sodium, 280 mg of sodium per 100 ml vial and 140 mg per 50 ml vial. The doctor should take this into account if the patient is on a strict low-salt diet.
Information on safety measures due to the origin of VIALEBEX: VIALEBEX is manufactured from human plasma (the liquid part of blood).
When medicines are prepared from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
These measures include: Careful selection through a medical interview of blood and plasma donors to make sure those at risk of carrying infections are excluded; testing of each donation and pools of plasma for the sign of virus infections.
The medicine's manufacturing process also includes steps able to remove or inactivate viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
No cases of viral contamination from albumin manufactured according to European Pharmacopoeia specifications and the defined procedures have been reported.
Driving and using machines: No effects on the ability to drive and use machines have been observed.
Albumin is a normal component of blood. No studies have been performed in women to determine the safety of this medicinal product during pregnancy and breastfeeding. However no clinical experience with albumin indicates that no harmful effects on the course of pregnancy or on the foetus or newborn child are to be expected.
Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicinal products, VIALEBEX 200 mg/mL, solution for infusion can cause side effects, although not everybody gets them.
Generalised or local allergic reactions such as: swelling of the throat and face (Quincke's oedema), localised or generalised swelling.
Feeling of burning and tingling at the injection site.
Redness, itching (pruritus), skin rashes throughout the entire body or localised areas (generalised urticaria, urticant reaction).
Drop in blood pressure (arterial hypotension).
Increased heart rate (tachycardia), tightness of the chest.
Drowsiness, extreme fatigue (asthenia).
Pins and needles (paraesthesia).
If the patient experience allergic reaction the infusion must be stopped.
Also refer to Risk of allergic reactions under Precautions, to find out how to react to this situation.
Other side effects: Mild reactions such as hot flashes, urticaria, fever or nausea may be observed in rare cases. These reactions usually disappear rapidly upon reduction of the infusion rate or interruption of the infusion.
If any of these side effects gets serious, or noticed any side effects not listed, please inform the doctor or pharmacist.
No interactions between VIALEBEX and other medicines have been observed to date.
Tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Preparation of the medicinal product: The albumin should not be diluted with water for injections as this could lead to haemolysis in the patient.
Do not store above 25°C. Do not freeze. Store the vial in the original package, protected from light.
It is recommended that the product be used immediately once the vial has been opened.
The solution should be clear or slightly opalescent, colourless, yellow, amber, or green. Do not use a solution which is cloudy or has deposits. This could be an indication of protein instability or contamination of the solution.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Soln for infusion (vial) 200 mg/mL (clear or slightly opalescent, colourless, yellow, amber or green) x 50 mL.