PLASBUMIN 20% solution for infusion

Introduction

Package Leaflet: Information for the User

Plasbumin20% Solution for Infusion

Human Albumin 20%

Contents of the Package Leaflet

1. What is Plasbumin 20 and what is it used for
2. What you need to know before you use Plasbumin 20
3. How to use Plasbumin 20
4. Possible side effects
5. Storage of Plasbumin 20
6. Contents of the pack and further information

1. What is Plasbumin 20 and what is it used for

This medicine belongs to a group of medicines called plasma substitutes.

It is presented as a solution for intravenous infusion. Each pack of Plasbumin 20 contains 1 vial with human albumin.

The administration of Plasbumin 20 is indicated for the restoration and maintenance of circulating blood volume when a volume deficit has been demonstrated and the use of a colloid is considered appropriate. The choice of albumin rather than an artificial colloid will depend on the patient's clinical situation and will be based on official recommendations.

2. What you need to know before you use Plasbumin 20

Do not use Plasbumin 20:

If you are allergic (hypersensitive) to albumin or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Plasbumin 20.

Tell your doctor if:

• If you have an allergic reaction or anaphylaxis, as the infusion should be discontinued immediately. In case of hypersensitivity to human plasma proteins, administration will be carried out slowly, taking special precautions and under medical control.
• If you have:

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You should be administered this medicine with caution as hypervolemia (abnormal increase in plasma volume) or hemodilution may occur.

When administering medicines derived from human plasma or blood, certain measures must be taken to prevent infections from being transmitted to patients. These measures include:

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

Despite this, when administering medicines derived from human blood or plasma, the possibility of transmitting infectious agents cannot be completely ruled out. 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 Plasbumin 20, they record the name of the medicine and batch number administered in order to maintain a record of the batches used.

Using Plasbumin 20 with other medicines

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

In general, this medicine should not be mixed with other medicines, including whole blood and red blood cell concentrates.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctor will weigh the potential risk to the fetus and inform you if treatment with this medicine is suitable.

Driving and Using Machines

There are no indications that Plasbumin 20 may affect the ability to drive or use machines.

Important Information about Some of the Components of Plasbumin 20

Patients on low-sodium diets should note that this medicine contains 166.8 mg (7.3 mmol) of sodium per 50 ml vial and 333.5 mg (14.5 mmol) of sodium per 100 ml vial.

Patients with renal insufficiency or on low-potassium diets should note that this medicine contains a maximum of 10 mmol of potassium per liter of infusion solution.

3. How to Use Plasbumin 20

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Plasbumin 20 is a hospital medicine, so it will be administered to you in a hospital by the corresponding healthcare personnel.

The concentration and dose of albumin and the rate at which it will be administered will be adjusted to your needs.

Your doctor will indicate how often and at what intervals Plasbumin 20 should be administered.

Your doctor will indicate the duration of your treatment with Plasbumin 20.

If you use more Plasbumin 20 than you should

Consult your doctor or pharmacist immediately.

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

If you forget to use Plasbumin 20

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

• Rare side effects (occurring in 1 to 10 in every 10,000 patients treated): mild reactions such as flushing, skin rash, fever, and nausea may appear.
• Very rare side effects (occurring in less than 1 in every 10,000 patients treated): 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 Plasbumin 20

Keep this medicine out of the sight and reach of children.

Store in the original package and protect from light. Do not store above 30°C.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the pack after EXP:

The expiry date is the last day of the month stated.

Once the pack is opened, the contents should be used immediately.

Do not use this medicine if you notice that the solution is turbid or contains sediment.

6. Contents of the Pack and Further Information

Composition of Plasbumin 20

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Each vial contains a 20% protein solution, of which at least 95% is human albumin.

• The other components are: sodium caprylate, N-acetyl-DL-tryptophan, ions (sodium, potassium), and water for injections.

For more information on the components, see also “Important Information about Some of the Components of Plasbumin 20” at the end of section 2.

Appearance of the Product and Contents of the Pack

Plasbumin 20is presented as an intravenous infusion solution .

Plasbumin 20 is available in vials containing 50 ml and 100 ml of product.

Package size: 1 vial

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Grifols Deutschland GmbH

Colmarer Straße 22

D-60528 Frankfurt

Germany

Manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Local Representative

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Date of Last Revision of this Leaflet: December 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/

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This information is intended only for healthcare professionals:

• Plasbumin 20 should be administered intravenously, by infusing the contents of the pack directly, or diluted with an isotonic solution (e.g., 5% glucose solution or physiological saline solution). Mixing with electrolyte solutions should be carried out under aseptic conditions.

• Plasbumin 20 should not be diluted with water for injections, as it may cause hemolysis in the recipient.

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

• The infusion is carried out 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 infused immediately.

• The infusion rate should be adjusted to the specific circumstances of each case and to 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 cardiovascular overload (headache, dyspnea, jugular engorgement), increased blood pressure, or increased venous pressure and pulmonary edema, the infusion should be discontinued.

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

• When administering concentrated albumin, it should be ensured that the patient has adequate hydration. Patients should be adequately monitored to avoid circulatory overload and hyperhydration.
• When administering albumin, the patient's electrolyte balance should be monitored and, if necessary, appropriate measures should be taken to restore or maintain it.

• It is necessary to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and red blood cells)

Unused solutions should be disposed of properly.