Prolastina 5,000 mg powder and solvent for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prolastina 4000 mg powder and solvent for solution for infusion

Prolastina 5000 mg powder and solvent for solution for infusion

Active substance: human alpha1-antitripsin

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. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Prolastina is and what it is used for
2. What you need to know before using Prolastina
3. How to use Prolastina
4. Possible adverse effects
5. How to store Prolastina
6. Contents of the pack and other information

1. What Prolastina is and what it is used for

Prolastina belongs to a group of medicines called "protease inhibitors".

Alpha1-antitrypsin is a normal component of human blood that functions by inhibiting the activity of certain enzymes such as elastases, which can damage the lungs. In cases of hereditary alpha1-antitrypsin deficiency, an imbalance occurs between alpha1-antitrypsin and elastases. This imbalance may lead to progressive destruction of lung tissue and the development of pulmonary emphysema. Pulmonary emphysema is an abnormal enlargement of the lungs accompanied by destruction of lung tissue. Prolastina is indicated to restore the balance between alpha1-antitrypsin and elastases in the lungs, thereby preventing further deterioration in pulmonary emphysema.

Prolastina is used as a long-term treatment in certain patients with alpha1-antitrypsin deficiency, as determined by their physician.

2. What you need to know before using Prolastina

Do not use Prolastina

• If you are allergic (hypersensitive) to alpha1-antitrypsin or to any of the other components of Prolastina (listed in section 6).
• If you have a deficiency of certain immunoglobulins known as IgA, as serious allergic reactions may develop, which could even lead to anaphylactic shock.

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to use Prolastina.

• Inform your doctor if you have severe heart failure (cardiac insufficiency). Extreme caution will be required, as Prolastina may cause a transient increase in blood volume.

Allergic reactions (hypersensitivity)

Hypersensitivity reactions to Prolastina may rarely occur, even if you have previously received human alpha1-antitrypsin inhibitors and tolerated them well.

Your doctor will inform you about the symptoms of allergic reactions and will advise you on what to do if you experience any (see also section 4).

If you experience any symptoms of a hypersensitivity allergic reaction during the infusion of the medicine, inform your doctor or nurse immediately.

Information on safety regarding the risk of infections

To prevent the transmission of infectious diseases due to the use of medicines derived from human blood or plasma, standard measures are taken, including:

• careful selection of blood and plasma donors to ensure exclusion of donors at risk of infections,
• testing of each donation and plasma pool for possible viruses or infections,
• inclusion of steps in the manufacturing process to inactivate/eliminate viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging viruses and pathogens of unknown origin.

These procedures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. However, the inactivation/elimination procedures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus or parvovirus B19. Infection with parvovirus B19 may have serious consequences in pregnant women (fetal infection) and in patients with immunodeficiency or increased erythropoiesis (e.g., in cases of hemolytic anemia).

If you receive chronic treatment with medicines derived from human plasma (such as protease inhibitors), vaccination against hepatitis A and B is recommended.

It is strongly recommended that each time Prolastina is administered, the name and batch number of the medicine be recorded; this allows traceability of patients who have received each batch of product.

Smoking

Since the efficacy of Prolastina is compromised by the presence of tobacco smoke in the lungs, patients are advised to stop smoking.

Children and adolescents

There is no experience with the use of Prolastina in children or adolescents under 18 years of age.

Other medicines and Prolastina

No interactions between Prolastina and other medicines are known.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There are no controlled clinical trials on the use of this medicine during pregnancy. Inform your doctor if you are pregnant or think you may be pregnant.

It is unknown whether Prolastina passes into breast milk; therefore, it should not be administered to women who are breastfeeding.

Consult your doctor if you are breastfeeding.

Driving and using machines

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

Prolastina contains sodium

Prolastina 4000 mg contains approximately 441.6 mg of sodium (main component of table/cooking salt).

Prolastina 5000 mg contains approximately 552.0 mg of sodium (main component of table/cooking salt).

For a patient weighing 75 kg, the recommended dose corresponds to 24.84% of the maximum daily sodium intake recommended for an adult. Consult your doctor or pharmacist if you have been advised to follow a low-salt (sodium) diet.

3. How to use Prolastina

After reconstituting the solution with the solvent provided in the package, Prolastina must be administered by intravenous infusion. A physician specialized in chronic obstructive pulmonary disease will supervise the initial infusions of Prolastina.

Home treatment

After the initial infusions, a healthcare professional may also administer Prolastina, but only after receiving adequate training. If your physician determines that you are suitable for home treatment, they will ensure that proper training is provided to the healthcare professional regarding:

• how to prepare and administer the reconstituted solution for infusion (see the illustrated instructions at the end of this leaflet),

• how to maintain the sterility of the product (aseptic infusion techniques),

• how to keep a treatment record,

• how to recognize adverse reactions, including symptoms of allergic reactions, and the measures to be taken should such reactions occur (see also section 4).

Dosage

The amount of Prolastina you receive is based on your body weight. A weekly dose of 60 mg of active substance per kg of body weight is recommended (for a patient weighing 75 kg, this dose corresponds to 180 ml of the reconstituted infusion solution, containing 25 mg of human alpha1-antitrypsin inhibitor per ml). This dose is normally sufficient to maintain protective levels of alpha1-antitrypsin inhibitor to prevent progression of pulmonary emphysema.

Your physician will determine the duration of your treatment, as it has not yet been established whether treatment duration needs to be limited.

If you feel that the effect of Prolastina is too strong or too weak, consult your physician or pharmacist.

If you use more Prolastina than you should

The effects of an overdose are currently unknown.

• Inform your physician or healthcare professional if you think you have used more Prolastina than you should, so appropriate measures can be taken.
• In case of overdose or accidental administration, contact your physician or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Prolastina

• Consult your physician to determine whether the missed dose should be administered.
• Do not administer a double dose to make up for a missed infusion.

If you stop using Prolastina

If treatment with Prolastina is discontinued, your condition may worsen. Contact your physician immediately if you wish to discontinue treatment with Prolastina.

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

4. Possible adverse effects

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

If adverse effects occur during the infusion of Prolastina, the infusion should be slowed or stopped, depending on the nature and severity of the adverse reaction.

Possible serious adverse effects

Rarely, hypersensitivity reactions may occur (may affect up to 1 in 1,000 people); in very rare cases, these reactions may present as anaphylactic reactions of any type (may affect up to 1 in 10,000 people), even if no allergic symptoms were experienced during previous infusions.

Inform your doctor or nurse immediately if you notice any of the following symptoms:

• rash, hives, itching,
• difficulty swallowing,
• swelling of the face or mouth,
• redness,
• difficulty breathing (dyspnea),
• drop in blood pressure,
• irregular heartbeat,
• chills

Your doctor or healthcare professional will decide whether to reduce or interrupt the infusion and initiate appropriate treatment as needed.

In the case of home treatment, stop the infusion immediately and contact your doctor or healthcare professional.

The following adverse effects have been observed during treatment with Prolastina:

Uncommon (may affect up to 1 in 100 people):

• Chills, fever, flu-like symptoms, chest pain.
• Skin rash (urticaria).
• Dizziness, lightheadedness, headache.
• Difficulty breathing (dyspnea).
• Skin eruptions.
• Nausea.
• Joint pain (arthralgia).

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions.
• Rapid pulse (tachycardia).
• Low blood pressure (hypotension).
• High blood pressure (hypertension).
• Back pain.

Very rare (may affect up to 1 in 10,000 people):

• Anaphylactic shock.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Prolastina

Do not store above 25°C.

Do not freeze.

Do not refrigerate the solution after reconstitution. The reconstituted solution must always be used within 3 hours of preparation. Any unused product should be discarded. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. These measures will help protect the environment.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial label and carton. The expiry date refers to the last day of the month indicated.

6. Contents of the pack and other information

Composition of Prolastina

• The active substance is human alpha1-antitrypsin (derived from human blood or plasma).
• The other components are sodium chloride, sodium dihydrogen phosphate, and water for injections (solvent/diluent).

Appearance of the product and contents of the pack

Human alpha1-antitrypsin is a white, pale yellow, or pale brown powder or friable mass.

Once reconstituted with water for injections, the solution should be transparent to slightly opalescent, colorless, pale green, pale yellow, or pale brown, and free from visible particles.

1 ml of the reconstituted solution contains 25 mg of human alpha1-antitrypsin.

One individual pack contains:

Prolastina 4000 mg powder and solvent for solution for infusion:

• 1 vial containing 4000 mg of human alpha1-antitrypsin as powder.
• 1 vial containing 160 ml of solvent (water for injections).
• 1 transfer device for reconstitution.

Prolastina 5000 mg powder and solvent for solution for infusion:

• 1 vial containing 5000 mg of human alpha1-antitrypsin as powder.
• 1 vial containing 200 ml of solvent (water for injections).
• 1 transfer device for reconstitution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grifols Deutschland GmbH

Colmarer Straβe 22

60528 Frankfurt

Germany

Telephone: +49 69/660 593 100

Email: [email protected]

Manufacturer:

Instituto Grifols, S.A.

Can Guasch, 2 – Parets del Vallès

08150 Barcelona

Spain

Local Representative:

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Prolastin [4000 mg/5000 mg]: Austria, Ireland, Italy, France, Germany, Greece, Netherlands, Poland, Portugal,

Prolastina [4000 mg/5000 mg]: Croatia, Cyprus, Czech Republic, Denmark, Finland, Norway, Slovakia, Spain, Sweden,

Pulmolast [4000 mg/5000 mg]: Belgium.

Date of the most recent review of this summary: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals and patients suitable for home treatment.

Preparation of the reconstituted solution for infusion:

1. Use aseptic techniques (cleaning and disinfection) to maintain sterility. Reconstitute the medicine on a flat working surface during solution preparation.
2. Ensure that the vials of Prolastina powder and solvent (sterile water for injections) are at room temperature (20–25°C).
3. Remove the protective caps from both the Prolastina vial and the solvent vial, and clean the neck rims and stoppers with an alcohol swab. Allow the rubber stoppers to dry.

1. If more than one vial of product is required to achieve the desired dose, repeat the above instructions using the additional container with a new transfer adapter. Do not reuse the adapter.

Complete dissolution should be achieved within approximately 15 minutes for the 4000 mg and 5000 mg Prolastina presentations.

Only solutions that are clear to slightly opalescent, colorless, pale green, pale yellow, or pale brown, and free from visible particles should be used. Prolastina must not be mixed with other infusion solutions. The reconstituted solution must always be used within 3 hours after preparation.

The reconstituted solution must be administered by slow intravenous infusion using a suitable infusion set (not included). The infusion rate must be less than 0.08 ml per kg of body weight per minute (equivalent to 6 ml per minute for a patient weighing 75 kg).