AlbuPlan 200 g/l solution for infusion

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Albuplan 200 g/l is presented as a solution for intravenous infusion containing proteins derived from human plasma (plasma proteins), which is the liquid part of 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 known as plasma substitutes and plasma protein fractions.

Albuplan 200 g/l is used to restore and maintain circulating 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 using Albuplan 200 g/l

Do not use Albuplan 200 g/l

• If you are allergic (hypersensitive) to the active substance or to 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).

Take special care with Albuplan 200 g/l

• If you are at special risk due to an increased blood volume, for example, in cases of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe reduction in red blood cells, or absence of urine output.
• If signs of increased blood volume occur (headache, breathing difficulties, jugular vein distension), or increased blood pressure. The infusion must be stopped immediately.
• If signs of an allergic reaction occur. The infusion must be stopped immediately.
• When used in patients with severe brain injury due to trauma.

Information regarding transmission of infectious agents

When medicines derived from human plasma or blood are administered, certain measures are taken to prevent transmission of infections to patients. These measures include:

• careful selection of donors to exclude those at risk of carrying infectious diseases,
• testing for specific markers of infection in individual donations and plasma pools,
• inclusion of manufacturing steps designed to inactivate and/or remove viruses.

Despite these measures, the possibility of transmitting infectious agents when administering human plasma- or blood-derived medicines cannot be completely ruled out. This also applies to emerging or unknown viruses and other types of infections.

No cases of virus transmission have been reported with albumin manufactured according to the specifications and processes defined 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 the batch number administered, in order to maintain a record of batches used.

Using Albuplan 200 g/l with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No specific complications associated with human albumin in combination with other medicines are known.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide whether Albuplan 200 g/l can be used during pregnancy and breastfeeding.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed.

Important information about some of the components of Albuplan 200 g/l

This medicine contains 33.4 mg of sodium (the 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 corresponds to 1.7%, 8.3%, and 16.7%, respectively, of the maximum recommended daily sodium intake for an adult. However, depending on the required dose, the patient may receive more than one vial.

This medicine contains less than 39 mg (1 mmol) of potassium per vial and is therefore considered essentially “potassium-free”.

3. How to use Albuplan 200 g/l

Albuplan 200 g/l is a hospital-use medicine, therefore it will be administered to you in a hospital by qualified healthcare personnel.

Your doctor will decide, based on your individual condition, the amount of product to be administered, the rate at which it will be given, how often, and the duration of your treatment with Albuplan 200 g/l.

If you have been given more Albuplan 200 g/l than you should have

If you have been administered more Albuplan 200 g/l than intended, consult your doctor or pharmacist immediately.

In case of overdose or accidental administration, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to use Albuplan 200 g/l

Contact your doctor immediately and follow their instructions. Do not administer a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

• Mild reactions such as redness, skin rashes, 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging 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 the solution appears cloudy or if any precipitate has formed.

After opening the container, the contents should be administered immediately.

Any unused medicine and materials that have come into contact with it must be disposed of in accordance with local regulations. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other 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 additional information on the components.

Appearance of the product and contents of the container

Albuplan 200 g/l is an infusion solution. The solution is transparent, slightly viscous, almost colorless, yellow, amber, or green.

Albuplan 200 g/l is supplied in vials containing 10 ml, 50 ml, or 100 ml of solution.

Pack sizes: 1 vial

Marketing Authorization Holder and Manufacturer

Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN

Date of the most recent revision of this package leaflet: June 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

• Albuplan 200 g/l must be administered intravenously, either by direct infusion of the container contents or after dilution with an isotonic solution (e.g., 5% glucose solution or physiological saline). Mixing with electrolyte solutions should be performed under aseptic conditions.

• Albumin solutions must not be diluted with water for injection, as this may cause haemolysis in the recipient.

• Human albumin must not be mixed with other medicinal products, whole blood, or red blood cell concentrates.

• Solutions should be transparent or slightly opalescent. Turbid solutions or those containing sediment must not be used, as this may indicate protein instability or contamination of the solution. Once the container has been opened, its contents must be used immediately.

• Infusion is performed intravenously using a single-use, sterile, pyrogen-free infusion set. Before inserting the infusion set into the stopper, the stopper must be disinfected with an appropriate antiseptic. Once the infusion set is connected to the vial, the contents must be infused immediately.

• The infusion rate must be adjusted according to the individual patient's condition and indication. During plasmapheresis, the infusion rate should be adjusted to match the exchange rate. If the dose and infusion rate are not adapted to the patient's circulatory status, hypervolaemia may occur. In the presence of early clinical signs of circulatory overload (headache, dyspnoea, jugular venous distension), increased blood pressure, elevated venous pressure, or pulmonary oedema, the infusion must be stopped.

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

• When administering concentrated albumin, adequate hydration of the patient must be ensured. Patients must be adequately monitored to avoid circulatory overload and hyperhydration.

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

• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes) must be ensured.

Any unused solution must be properly discarded.