PROLASTINA 4.000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

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-antitrypsin

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 experience 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 pack

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

1. What is Prolastina and what is it used for

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

Alpha1-antitrypsin is a normal component of human blood, whose function is to inhibit the activity of certain enzymes such as elastases that can damage the lungs. When there is a hereditary deficiency of alpha1-antitrypsin, there is an imbalance between alpha1-antitrypsin and elastases. This can lead to progressive destruction of lung tissue and the development of pulmonary emphysema. Pulmonary emphysema is an abnormal enlargement of the lung, accompanied by destruction of lung tissue. Prolastina is indicated to restore the balance between alpha1-antitrypsin and elastases in the lung, and consequently, to prevent further deterioration of pulmonary emphysema.

Prolastina is used as chronic treatment in certain patients with alpha1-antitrypsin deficiency as determined by their doctor.

2. What you need to know before you use Prolastina

Do not use Prolastina

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

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before you start using Prolastina.

• Tell your doctor if you have severe heart failure (heart failure). Caution is required, as Prolastina may cause a transient increase in blood volume.

Allergic reactions (hypersensitivity)

Rarely, allergic reactions to Prolastina may occur, even if you have previously been administered human alpha1-antitrypsin inhibitors and have tolerated them well.

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

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

Safety information 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 the exclusion of donors at risk of infection,
• testing of each donation and plasma pool to detect possible viruses or infections
• inclusion of stages in the manufacturing process to inactivate/eliminate 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 and other pathogens.

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

If you receive chronic treatment with plasma-derived medicines (such as protease inhibitors), it is recommended that you be vaccinated against hepatitis A and B.

It is strongly recommended that each time you are administered Prolastina, the name and batch number of the medicine be recorded; this allows for the monitoring 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, it is recommended that patients quit 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.

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

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking 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, so it should not be administered to women during breastfeeding.

Ask your doctor if you are breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Prolastina containssodium

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

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

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

3. How to use Prolastina

After reconstituting the solution with the solvent included in the pack, Prolastina should be administered by intravenous infusion. A specialist doctor in chronic obstructive pulmonary disease will supervise the first infusions with Prolastina.

Home treatment

After the first infusions, a healthcare professional may also administer Prolastina, but only after receiving adequate training. If your doctor decides that you are suitable for home treatment, they will ensure that the healthcare professional receives adequate training 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 product's sterility (aseptic infusion techniques),
• how to keep a record of the treatment,

• how to identify side effects, including symptoms of allergic reactions and the measures to be taken if they occur (see also section 4).

Dose

The amount of Prolastina administered is based on your body weight. A weekly dose of 60 mg of the active substance per kg of body weight is recommended (in the case of a patient weighing 75 kg, this dose is equivalent to 180 ml of the reconstituted solution for infusion and contains 25 mg of alpha1-antitrypsin inhibitor (human) per ml), which is normally sufficient to maintain the protective levels of the alpha1-antitrypsin inhibitor to prevent the worsening of pulmonary emphysema.

Your doctor will tell you how long you should use Prolastina, as the need to limit the duration of treatment has not been established to date.

If you think that the effect of Prolastina is too strong or too weak, talk to your doctor or pharmacist.

If you use more Prolastina than you should

To date, the effects of an overdose are unknown.

• Tell your doctor or healthcare professional if you think you have used more Prolastina than you should, so they can take the necessary measures.
• In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Prolastina

• Ask your doctor if the forgotten dose should be administered.
• Do not administer a double dose to make up for the missed infusion.

If you stop using Prolastina

If you stop using Prolastina, your disease may worsen. Talk to your doctor immediately if you want to stop using Prolastina.

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.

If side effects occur during the infusion of Prolastina, you should stop or interrupt the infusion, depending on the nature and severity of the side effect.

Serious side effects

Rarely, allergic reactions (hypersensitivity) may occur (may affect up to 1 in 1,000 people), in some very rare cases these reactions may occur as anaphylactic reactions of any type (may affect up to 1 in 10,000 people), even if you have not experienced allergy symptoms in previous infusions.

Tell your doctor or nurse immediatelyif you notice any of the following symptoms:

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

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

In case of home treatment, interrupt the infusion immediatelyand contact your doctor or healthcare professional.

During treatment with Prolastina, the following side effects have been observed:

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

• Chills, fever, flu-like symptoms, chest pain.
• Hives (urticaria).
• Dizziness, drowsiness, headache.
• Difficulty breathing (dyspnea).
• Skin rashes.
• Nausea.
• Joint pain (arthralgia).

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

• Allergic reactions.
• Fast heart rate (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 side effects

If you experience 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 through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side 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 be used within 3 hours of preparation. The unused product must be discarded. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away 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 which is stated on the label of the vial and on the carton.

6. Container Contents and Additional Information

Composition of Prolastin

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

Appearance of the Product and Container Contents

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

Once reconstituted with water for injectable preparations, the solution should be between transparent and slightly opalescent, colorless, pale green, pale yellow, or pale brown and free of visible particles.

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

A single container contains:

Prolastin 4000 mg powder and solvent for solution for infusion:

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

Prolastin 5000 mg powder and solvent for solution for infusion:

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

Marketing Authorization Holder and Manufacturer

Holder:

Grifols Deutschland GmbH

Colmarer Straße 22

60528 Frankfurt

Germany

Phone: +49 69/660 593 100

Email: [email protected]

Manufacturer:

Grifols Institute, S.A.

Can Guasch, 2 – Parets del Vallès

08150 Barcelona

Spain

Local Representative:

Grifols Institute, 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]: Denmark, Finland, Norway, Spain, Sweden,

Pulmolast [4000 mg/5000 mg]: Belgium.

Date of the last revision of this leaflet: September 2023.

Detailed and updated 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 conditions (cleaning and disinfection) to maintain sterility. Reconstitute the medication on a flat work surface during the preparation of the solution.
2. Ensure that the Prolastin powder vials and solvent vials (sterile water for injectable preparations) are at room temperature (20-25°C).
3. Remove the protective cap from both the Prolastin vial and the solvent vial, and clean the edges of the neck and the stoppers with an alcohol swab. Let the rubber stoppers dry.

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

The total dissolution should be obtained in approximately 15 minutes for the 4000 mg and 5000 mg presentations of Prolastin.

Only solutions that are between transparent and slightly opalescent, colorless, pale green, pale yellow, or pale brown and free of visible particles should be used. Prolastin should not be mixed with other infusion solutions. The reconstituted solution should be used within 3 hours after preparation.

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