Human Albumin Grifols 50g/L Solution For Infusion
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Package Leaflet: Information for the User
Human Albumin Grifols® 50 g/l
Solution for infusion
Human albumin
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Human Albumin Grifols® 50 g/l is and what it is used for
2. Before you use Human Albumin Grifols® 50 g/l
3. How to use Human Albumin Grifols® 50 g/l
4. Possible side effects
5. How to store Human Albumin Grifols® 50 g/l
6. Further information
1. WHAT HUMAN ALBUMIN GRIFOLS® 50 g/l IS AND WHAT IT IS USED FOR
Human Albumin Grifols® 50 g/l is a solution for intravenous infusion containing proteins extracted from human plasma, which is the liquid part of the blood. Each bottle contains a solution of 50 g plasma protein/litre of which at least 95% is human albumin protein.
This medicinal product belongs to a group of medicines known as plasma substitutes and plasma protein fractions.
Human Albumin Grifols® 50 g/l is used to restore and maintain the circulating blood volume where volume deficiency has been demonstrated, and use of a plasma substitute is appropriate. The choice of an albumin solution rather than an artificial plasma substitute will depend on the clinical situation of the individual patient, based on official recommendations.
If you have any questions about the use of Human Albumin Grifols® 50 g/l please ask your doctor.
2. BEFORE YOU USE HUMAN ALBUMIN GRIFOLS® 50 g/l Do not use Human Albumin Grifols® 50 g/l
If you are allergic (hypersensitive) to human albumin protein or to any of the other ingredients (see Important information about some of the ingredients of Human Albumin Grifols® 50 g/l at the end of this section).
Take special care with Human Albumin Grifols® 50 g/l
• If you think you are suffering from an allergic reaction with breathing difficulties, feeling weak or any other symptoms, the infusion must be stopped immediately.
• Tell your doctor if you think you are suffering from any of the following conditions:
- A weak heart
- High blood pressure
- Oesophageal varices (enlarged veins in the esophagus)
- Pulmonary oedema (liquid accumulation in the lungs)
- Bleeding or blood clotting disorders
- Severe anaemia (absence of red blood cells)
- Problems with urine production
These conditions may rule out the use of Human Albumin Grifols® 50 g/l in your treatment, or cause the doctor to modify the dosage/infusion rate to avoid complications.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove 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 applies to any unknown or emerging viruses or other types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of Human Albumin Grifols® 50 g/l the name and batch number of the product are recorded in order to maintain a record of all batches that have been used.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No specific interactions of human albumin with other medicines are known.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding you must tell your doctor who will decide if Human Albumin Grifols® 50 g/l can be used.
Driving and using machines
No effects on the ability to drive and use of machines have been observed.
Important information about some of the ingredients of Human Albumin Grifols® 50 g/l
Patients on a controlled sodium diet should take into consideration that this medicine contains 333.5 mg (14.5 mmol) sodium per vial of 100 ml, 833.8 mg (36.3 mmol) sodium per vial of 250 ml, and 1667.5 mg (72.5 mmol) sodium per vial of 500 ml.
This medicine contains very low levels of potassium.
3. HOW TO USE HUMAN ALBUMIN GRIFOLS® 50 g/l
Human Albumin Grifols® 50 g/l is a product intended for hospital administration only. It will be administered as an intravenous infusion by medical staff and must not be self administered. The dosage and the infusion rate of Human Albumin Grifols® 50 g/l you receive, as well as the frequency and duration of your treatment, will be adjusted to your individual requirements. This will be calculated for you by your doctor.
If you use more Human Albumin Grifols® 50 g/l than you should
If you have been given more Human Albumin Grifols® 50 g/l than required, your blood volume may increase. Tell your doctor immediately.
Signs of overdose may include: headache, trouble breathing, jugular vein congestion (enlarged veins in the neck), high blood pressure, and pulmonary oedema (liquid accumulation in the lungs).
If you forget to use Human Albumin Grifols® 50 g/l
Tell your doctor or pharmacist immediately and follow his/her instructions.
You must not be given a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Human Albumin Grifols® 50 g/l can cause side effects, although not everybody gets them.
• Mild reactions such as flush, skin rash, fever and nausea may occur rarely.
• Severe allergic reactions (anaphylactic shock) may occur very rarely.
For information on viral safety, see section 2.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HUMAN ALBUMIN GRIFOLS® 50 g/l
Keep out of the reach and sight of children.
Do not use Human Albumin Grifols® 50 g/l after the expiry date which is stated on the bottle label and carton after EXP.
Do not store above 25 °C. Do not freeze.
Keep the bottle in the outer carton in order to protect from light.
The solution should be clear or slightly opalescent. Do not use Human Albumin Grifols® 50 g/l if you notice that the solution is cloudy or has deposits.
Once the bottle has been opened, the contents should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Human Albumin Grifols® 50 g/l contains
- The active substance is human albumin. One millilitre of Human Albumin Grifols® 50 g/l contains 50 mg of human plasma protein, of which at least 95% is human albumin.
- The other ingredients are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate and water for injections.
For further information about ingredients see also “Important information about some of the ingredients of Human Albumin Grifols® 50 g/l” at the end of section 2.
What Human Albumin Grifols® 50 g/l looks like and contents of the pack
Human Albumin Grifols® 50 g/l is a solution for infusion. The solution is clear and slightly viscous; it can be almost colourless, slightly yellow, slightly amber or slightly green.
Human Albumin Grifols® 50 g/l is supplied in bottles containing 100 ml, 250 ml and 500 ml of product. Pack size of 1 bottle.
Marketing Authorisation Holder and Manufacturer
Distributed by:
Grifols UK Ltd.
Byron House
Cambridge Business Park Cambridge CB4 0WZ
Marketing Authorisation Holder and Manufacturer: Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Valles 08150 Barcelona - SPAIN
This leaflet was last approved in
P - 4
Instituto Grifols, S.A. Can Guasch, 2 - Parets del Valles 08150 Barcelona - SPAIN