ALBUPLAN 200 G/L SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Albuplan 200 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Albuplan 200 g/l and what is it used for
2. What you need to know before you use Albuplan 200 g/l
3. How to use Albuplan 200 g/l
4. Possible side effects
5. Storage of Albuplan 200 g/l
6. Contents of the pack and further information

1. What is Albuplan 200 g/l and what is it used for

Albuplan 200 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 200 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 200 g/l is used to restore and maintain 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 200 g/l, consult your doctor.

2. What you need to know before you use Albuplan 200 g/l

Do not use Albuplan 200 g/l

• If you are allergic (hypersensitive) to the active substance or any of the other components of this medicine (listed in section 6) (see “Important information about some of the components of Albuplan 200 g/l” at the end of this section).

Be cautious with Albuplan 200 g/l

• If you have a special risk due to an increase in blood volume, for example, in cases of severe heart disease, arterial hypertension, dilated veins in the esophagus, fluid in the lungs, coagulation disorders, severe decrease in red blood cells or absence of urine.
• When there are signs of increased blood volume (headache, respiratory disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately.
• When there are signs of an allergic reaction. The infusion should be stopped immediately.
• When used in patients with severe brain injury due to trauma.

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. These measures include:

• careful selection of donors, to exclude those who are at risk of being carriers of infectious diseases,
• analysis of specific infection markers in individual donations and in plasma pools,
• the inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

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 200 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 200 g/l with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 200 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 200 g/l

This medicine contains 33.4 mg of sodium (main component of table/cooking salt) in each 10 ml vial, 166.8 mg of sodium in each 50 ml vial, and 333.5 mg of sodium in each 100 ml vial. This is equivalent to 1.7%, 8.3%, and 16.7%, 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".

3. How to use Albuplan 200 g/l

Albuplan 200 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 200 g/l.

If you use more Albuplan 200 g/l than you should

If you have been administered more Albuplan 200 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 200 g/l

Consult your doctor immediately and follow their instructions. You should not be given a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Mild reactions such as flushing, skin rash, fever, nausea may occur. Such reactions are rare.

• Very rarely, severe allergic reactions (anaphylactic shock) may occur.

• For information on viral safety, see section 2.

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 Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Albuplan 200 g/l

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 if a deposit has formed.

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.

6. Contents of the pack and further information

Composition of Albuplan 200 g/l

• The active substance is human albumin. One milliliter of Albuplan 200 g/l contains 200 mg of plasma proteins, of which at least 95% is human albumin.

• The other components are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, and water for injections.

See section 2 "Important information about some of the components of Albuplan 200 g/l" for more information about the components.

Appearance of the product and pack contents

Albuplan 200 g/l is a solution for infusion. The solution is clear, slightly viscous, almost colorless, yellow, amber, or green.

Albuplan 200 g/l is presented in vials containing 10 ml, 50 ml, or 100 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 Healthcare Products (AEMPS) http://www.aemps.es/

This information is intended only for healthcare professionals:

• Albuplan 200 g/l should be administered intravenously, by perfusing the contents of the vial directly, or diluted with an isotonic solution (e.g., 5% glucose solution or physiological saline solution). Mixing with electrolyte solutions should be done under aseptic conditions.

• Albumin solutions should not be diluted with water for injection, as this could cause hemolysis in the recipient.

• Human albumin should not be mixed with other medicines, whole blood, or red blood cell concentrates.

• The solutions should be clear or slightly opalescent. Turbid or sediment-containing solutions should not be used, as this may indicate that the protein is unstable or the solution has been contaminated. Once the vial is opened, its contents should be used immediately.

• The infusion is performed intravenously, using a single-use, sterile, and apyrogenic infusion set. Before inserting the infusion set into the stopper, it should be disinfected with a suitable antiseptic. Once the infusion set is connected to the vial, the contents should be perfused immediately.

• The infusion rate should be adjusted to the specific circumstances of each case and the indication. During plasma exchange, the infusion rate should be adjusted to the exchange rate. If the dose and infusion rate are not adjusted to the patient's circulatory situation, hypervolemia may occur. In the event of the first clinical signs of circulatory overload (headache, dyspnea, jugular congestion), increased blood pressure, or increased venous pressure and pulmonary edema, the infusion should be interrupted.

• If large volumes are administered, the product should be brought to room or body temperature before use.

• When concentrated albumin is administered, it should be ensured that the patient has adequate hydration. Patients should be adequately monitored to avoid circulatory overload and hyperhydration.

• When albumin is administered, the patient's electrolyte balance should be monitored, and appropriate measures should be taken to restore or maintain it if necessary.

• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and red blood cells) should be ensured.

Solutions that have not been used should be disposed of properly.