Ask a doctor about a prescription for ALBUPLAN 50 G/L SOLUTION FOR INFUSION
Package Leaflet: Information for the User
Albuplan 50 g/l, Solution for Infusion
Human Albumin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Contents of the Package Leaflet
Albuplan 50 g/l is presented as a solution for intravenous infusion containing proteins obtained from human plasma (plasma proteins), which is the liquid part of the blood. Each vial contains a solution with 50 g of plasma proteins/l, of which at least 95% is human albumin.
This medicine belongs to the group of medicines called plasma substitutes and plasma protein fractions.
Albuplan 50 g/l is used to restore and maintain circulating blood volume when a volume deficit has been demonstrated and the use of a colloid is considered appropriate.
If you have any doubts about the use of Albuplan 50 g/l, consult your doctor.
Do not use Albuplan 50 g/l
Be careful with Albuplan 50 g/l
Information about transmission of infectious agents
When medicines derived from human plasma or blood are administered, certain measures are taken to prevent the transmission of infections to patients. Such measures include:
Despite this, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely excluded. This also applies to emerging or unknown viruses or other types of infections.
No cases of viral infections have been reported with albumin manufactured according to the specifications and processes established in the European Pharmacopoeia.
It is highly recommended that each time healthcare personnel administer a dose of Albuplan 50 g/l, they record the name of the medicine and batch number administered in order to maintain a record of the batches used.
Use of Albuplan 50 g/l with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.
No specific complications of human albumin with other medicines are known.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Tell your doctor if you are pregnant or breastfeeding. Your doctor will decide if Albuplan 50 g/l can be used during pregnancy and breastfeeding.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Important information about some of the components of Albuplan 50 g/l
This medicine contains 333.5 mg of sodium (main component of table/cooking salt) in each 100 ml vial, 833.8 mg of sodium in each 250 ml vial, and 1667.5 mg of sodium in each 500 ml vial. This is equivalent to 16.7%, 41.7%, and 83.4%, respectively, of the maximum daily sodium intake recommended for an adult. However, depending on the required dose, it is possible that the patient may receive more than 1 vial.
This medicine contains less than 39 mg (1 mmol) of potassium per vial, so it is considered essentially "potassium-free".
Albuplan 50 g/l is a hospital medicine, so it will be administered to you in a hospital by the corresponding healthcare personnel.
Your doctor will decide, based on your particular condition, the amount of product to be administered, the speed at which it will be administered, how often, and the duration of your treatment with Albuplan 50 g/l.
If you use more Albuplan 50 g/l than you should
If you have been administered more Albuplan 50 g/l than you should, consult your doctor or pharmacist immediately.
In case of overdose or accidental administration, consult the Toxicology Information Service. Phone: 91 562 04 20.
If you forget to use Albuplan 50 g/l
Consult your doctor immediately and follow their instructions.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
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 after EXP.
Do not store above 25°C. Do not freeze.
Keep the vial in the outer packaging to protect it from light.
The solution should be clear or slightly opalescent. Do not use this medicine if you notice that the solution is cloudy or has formed a deposit.
Once the pack is opened, the contents should be used immediately.
Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations. 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.
Composition of Albuplan 50 g/l
See section 2 "Important information about some of the components of Albuplan 50 g/l" for additional information about the components.
Appearance of the product and pack contents
Albuplan 50 g/l is a solution for infusion. The solution is clear, slightly viscous, almost colorless, yellow, amber, or green.
Albuplan 50 g/l is presented in vials containing 100 ml, 250 ml, or 500 ml of product.
Pack sizes: 1 vial
Marketing authorization holder and manufacturer
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN
Date of last revision of this leaflet:June 2019
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
This information is intended only for healthcare professionals:
Unused solutions should be disposed of properly.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for ALBUPLAN 50 G/L SOLUTION FOR INFUSION – subject to medical assessment and local rules.