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ALBUTEIN 200 G/L SOLUTION FOR INFUSION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ALBUTEIN 200 G/L SOLUTION FOR INFUSION

Albutein® 200 g/l

Solution for infusion


HUMAN ALBUMIN



P-287


GRIFOLS


Background: White


7 1/2”


8 13/16”


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 Albutein® 200 g/l is and what it is used for

  • 2. Before you use Albutein® 200 g/l

  • 3. How to use Albutein® 200 g/l

  • 4. Possible side effects

  • 5. How to store Albutein® 200 g/l

  • 6. Further information

1. WHAT ALBUTEIN® 200 g/l IS AND WHAT IT IS USED FOR

Albutein® 200 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 200 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.

Albutein® 200 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 Albutein® 200 g/l please ask your doctor.


2. before you use albutein® 200 g/l

Do not use Albutein® 200 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 Albutein® 200 g/l at the end of this section).

Take special care with Albutein® 200 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 oesophagus)

  • – 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 Albutein® 200 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 Albutein® 200 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 Albutein® 200 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 Albutein® 200 g/l

Patients on a controlled sodium diet should take into consideration that this medicine contains 166.8 mg (7.3 mmol) sodium per vial of 50 ml, and 333.5 mg (14.5 mmol) sodium per vial of 100 ml.

This medicine contains very low levels of potassium.


8 13/16”


3. how to use albutein® 200 g/l

Albutein® 200 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 Albutein® 200 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 Albutein® 200 g/l than you should

If you have been given more Albutein® 200 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 Albutein® 200 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, Albutein® 200 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: or telephone 0808 100 3352. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store albutein® 200 g/l

Keep out of the reach and sight of children.

Do not use Albutein® 200 g/l after the expiry date which is stated on the bottle label and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °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 Albutein® 200 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 Albutein® 200 g/l contains

  • – The active substance is human albumin. One millilitre of Albutein® 200 g/l contains 200 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.

What Albutein® 200 g/l looks like and contents of the pack

Albutein® 200 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.

Albutein® 200 g/l is supplied in bottles containing 50 ml and 100 ml of product. Pack size of 1 bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and Manufacturer:

Instituto Grifols, S.A.

Can Guasc, 2 – Parets del Valles

08150 Barcelona – SPAIN

Distributed by: Grifols UK Ltd.

Byron House

Cambridge Business Park

Cambridge CB4 0WZ

This leaflet was last revised in 06/2018.

3052343

Instituto Grifols, S.A.

Can Guasc, 2 – Parets del Valles 08150 Barcelona – SPAIN

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is ALBUTEIN 200 G/L solution for infusion used for?

ALBUTEIN 200 G/L solution for infusion is primarily used to treat or prevent low blood protein levels in patients, particularly in cases of liver disease, trauma, burns, or certain surgeries.

How does ALBUTEIN work in the body?

ALBUTEIN works by increasing the amount of protein in your blood, helping to maintain blood volume and improve the body's ability to transport nutrients and oxygen.

Who can receive ALBUTEIN infusions?

ALBUTEIN can be administered to adults and children who have low protein levels due to medical conditions. However, specific eligibility should be determined by your healthcare provider.

What are the common side effects of ALBUTEIN?

Common side effects may include headache, nausea, fever, or allergic reactions. Contact your healthcare provider if you experience any unusual symptoms.

How is ALBUTEIN administered?

ALBUTEIN is given through an intravenous (IV) infusion. A healthcare professional will administer it in a medical setting.

How long does an ALBUTEIN infusion take?

The duration of an ALBUTEIN infusion can vary based on individual needs and the doctor's orders, but it typically takes between 2 to 4 hours.

Can I receive ALBUTEIN while pregnant or breastfeeding?

Pregnant or breastfeeding women should consult their doctor before receiving ALBUTEIN to ensure it’s safe for both mother and child.

Are there any dietary restrictions while receiving ALBUTEIN?

There are no specific dietary restrictions while receiving ALBUTEIN, but it's essential to follow any advice from your healthcare provider regarding diet.

Can I take other medications while receiving ALBUTEIN?

Always inform your healthcare provider about any other medications you are taking to avoid potential interactions when receiving ALBUTEIN.

What should I do if I miss a dose of ALBUTEIN?

If you miss a scheduled infusion of ALBUTEIN, contact your healthcare provider to reschedule as soon as possible.

Is there anyone who should not receive ALBUTEIN?

Patients with severe heart failure or fluid overload conditions should not receive ALBUTEIN without careful medical supervision. Always discuss your health history with your doctor.

What are the storage conditions for ALBUTEIN before use?

Before use, store ALBUTEIN at room temperature away from light. Do not freeze it.

Can children receive ALBUTEIN infusions?

Yes, children can receive ALBUTEIN infusions if prescribed by their healthcare provider based on their medical condition.

Does ALBUTEIN contain any allergens?

ALBUTEIN is generally considered safe but always check with your healthcare provider regarding potential allergens specific to you or consult the product packaging.

What should I monitor during an infusion of ALBUTEIN?

During the infusion, healthcare providers will monitor vital signs and watch for any reaction like rash or difficulty breathing. Alert them immediately if you feel unwell.

Is it safe to drive after receiving an infusion of ALBUTEIN?

Some patients may feel lightheaded after an infusion; it's best to have someone drive you home after treatment until you know how it affects you.

Can I exercise after receiving an infusion of ALBUTEIN?

It is advisable to avoid strenuous exercise immediately after an infusion. Consult with your doctor about when it’s safe for you to resume physical activity.

Will I need additional treatments after my first dose of ALBUTEIN?

Your doctor will decide if additional treatments are necessary based on how well you respond and your overall health condition.

How often can I receive infusions of ALBUTEIN?

The frequency of infusions will depend on individual health needs and should be determined by your healthcare provider.

Where can I find more information about my treatment with ALBUTEIN?

For more information about your treatment with ALBUTEIN, consult your healthcare provider or visit reputable health websites that provide details on plasma protein therapies.