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 ingredient: human alpha1-antitrypsin

Read this leaflet carefully before starting to use this medicine,because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects,consult your doctor, pharmacist or nurse, evenifthey are not listed in this leaflet. See section 4.

1.What Prolastina is and what it is used for

2.What you need to knowbefore starting to use Prolastina

3.How to use Prolastina

4.Possible side effects

5.Storage of Prolastina

6.Contents of the pack andadditional information

Prolastina belongs to a group of medications 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, prevent further deterioration in pulmonary emphysema.

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

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 severe allergic reactions may occur, which can even lead to anaphylactic shock.

Warnings and precautions

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

-Inform your doctorif you have severe heart failure (heart failure). Caution will be required, as Prolastina may cause a temporary increase in blood volume.

Allergic reactions (hypersensitivity)

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

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

If you experience any symptoms of an allergic reaction to hypersensitivity during the infusion of the medication, 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 blood-derived or plasma-derived medications, standard measures are taken, including:

•the careful selection of blood and plasma donors to ensure the exclusion of donors at risk of infection,

•the analysis of each donation and plasma mixture to detect possible viruses or infections

•the inclusion of stages in the manufacturing process to inactivate/eliminate viruses.

Despite this, when administering blood-derived or plasma-derived medications, the possibility of transmission of infectious agents cannot be completely ruled out. This also applies to emerging or unknown 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 for pregnant women (fetal infection), and for patients with immunodeficiency or increased erythropoiesis (e.g., in the case of hemolytic anemia).

It is recommended that patients receiving chronic treatment with plasma-derived medications (such as protease inhibitors) be vaccinated against hepatitis A and B.

It is strongly recommended that each time Prolastina is administered, the name and batch number of the medication be noted; this allows for tracking of patients who have received each batch of product.

Tobacco 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

No experience is available on the use of Prolastina in children or adolescents under 18 years of age.

Other medications and Prolastina

No interactions between Prolastina and other medications are known.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medication.

No controlled clinical trials are available on the use of this medication during pregnancy. Inform your doctor if you are pregnant or think you may be pregnant.

The passage of Prolastina into breast milk is unknown, so it should not be administered to breastfeeding women.

Consult your doctor if you are breastfeeding.

Driving and operating machinery

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

Prolastina contains sodiumsodium

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

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

For a patient with a body weight of 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-sodium diet.

After reconstituting the solution with the solvent included in the packaging, Prolastina must be administered by intravenous infusion. A specialist doctor in chronic obstructive pulmonary disease will supervise the first infusions of 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 this 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 sterile (aseptic infusion techniques),
• how to record the treatment,

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

Dose

The amount of Prolastina you are administered is based on your body weight.It is recommended to administer a weekly dose of 60mg of the active ingredient per kg of body weight (in the case of a patient weighing75 kg, this dose is equivalent to 180ml of the reconstituted solution for infusion and contains 25 mg of alpha1-antitrypsin inhibitor (human) per ml), which is normally sufficient to maintain the levels of protection of the alpha1-antitrypsin inhibitor to prevent the worsening of pulmonary emphysema.

Your doctor will indicate the duration of your treatment, as the need to limit the duration of treatment has not yet been established.

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

If you use more Prolastina than you should

Until now, the effects of an overdose are unknown.

• Inform your doctor or healthcare professional if you think you have used more Prolastina than you should so that 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 medication and the amount administered.

If you forget to use Prolastina

• Consult your doctor if the missed dose should be administered.
• Do not administer a double dose to compensate for the missed infusion.

If you interrupt treatment with Prolastina

If treatment with Prolastina is interrupted, your disease may worsen. Consult your doctor immediately if you want to interrupt treatment with Prolastina.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If side effects occurduring the perfusion of Prolastina, you should suspend or interrupt the perfusion, depending on the nature and severity of the side effect.

Severe possible side effects

Rarely, hypersensitivity reactions (which can affect up to 1 in 1,000 people) may occur, in some cases very rarely these reactions may occur as anaphylaxis of any type (which can affect up to 1 in 10,000 people), although no allergy symptoms have been experienced in previous infusions.

Inform your doctor or nurseimmediatelyif you observe any of the following symptoms:

• eruption, hives, itching,
• difficulty swallowing,
• swelling in the face or mouth,
• redness,
• difficulty breathing (dyspnea),
• fall in blood pressure,
• alteration of heart rhythm,
• chills

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

In the case of home treatmentinterrupt the perfusion immediatelyand contact your doctor or healthcare professional.

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

Infrequent (which can affect up to 1 in 100 people):

-Chills, fever, flu-like symptoms, chest pain.

-Hives (urticaria).

-Dizziness, drowsiness, headache.

-Difficulty breathing (dyspnea).

-Skin eruptions.

-Nausea.

-Joint pain (arthralgia).

Rare (which can 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 (which can affect up to 1 in 10,000 people):

-Anaphylactic shock.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above25°C.

Do not freeze.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used always within 3 hours following its preparation.The unused productmust be discarded. Do not throw any medication down the drain or with household waste. Ask your pharmacist how to discard unused medications. These measures will help protect the environment.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and on the box.

Composition of Prolastina

• The active principle is human alpha 1-antitrypsin (derived from human blood or plasma).
• The other components are sodium chloride, sodium dihydrogen phosphate, and water for injection (solvent/diluent).

Appearance of the product and contents of the package

Human alpha 1-antitrypsin is a white or pale yellow or brownish powder or a friable mass.

Once reconstituted with water for injection, the solution should be transparent or 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 alpha 1-antitrypsin.

One individual package contains:

Prolastina 4000 mg powder and solvent for solution for infusion:

• 1 vial containing 4000 mg of human alpha 1-antitrypsin.
• 1 vial containing 160 ml of solvent (sterile water for injection).
• 1 transfer device for reconstitution.

Prolastina 5000 mg powder and solvent for solution for infusion:

• 1 vial containing 5000 mg of human alpha 1-antitrypsin.
• 1 vial containing 200 ml of solvent (sterile water for injection).
• 1 transfer device for reconstitution.

Holder of the marketing authorization and manufacturer

Holder::

Grifols Deutschland GmbH

Colmarer Straße 22

60528 Frankfurt

Germany

Phone: +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 with 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.

Last review date 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 Medical Devices (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 medicinal product on a flat work surface during the preparation of the solution.

2.Ensure that the vials of Prolastina powder and solvent (sterile water for injection) are at room temperature (20-25°C).

3.Remove the protective cap from both the vial of Prolastina and the vial of solvent and clean the neck and stopper with an alcohol wipe. Allow the rubber stopper to dry.

10.If more than one vial of product is needed to achieve the required dose, repeat the above instructions using the additional package containing 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 Prolastina.

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

The reconstituted solution should be administered by slow intravenous infusion using an infusion set (not included). 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).