Prospecto: information for the user

Prolasplan 1000 mg powder and solvent for solution for infusion

alpha1-antitrypsin

Read this prospectus carefully before starting to use this medication, as it contains important information for you

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

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

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

-If you experience adverse effects,consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

1. What is Prolasplan and what is it used for

2. What you need to know before starting to useProlasplan

3. How to use Prolasplan

4. Possible adverse effects

5. Storage of Prolasplan

6. Contents of the pack and additional information

Prolasplan contains alpha1-antitrypsin and belongs to a group of medications known as “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 deficiencyof 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.

Prolasplan is indicated to restore the balance between alpha1-antitrypsin and elastases in the lung, and consequently, prevent further deterioration in pulmonary emphysema.

This medication is used as chronic treatment in certain types of patients with alpha1-antitrypsin deficiency as determined by their doctor.

No use Prolasplan

-If you are allergic (hypersensitive) to alpha1-antitrypsin or to any of the other components of this medication (including those listed in section 6).

-If you have a deficiency of certain immunoglobulins known as IgA, as severe allergic reactions may develop, which can even lead to anaphylactic shock.

Warnings and precautions

-Consult your doctor, pharmacist, or nurse before starting to use Prolasplan.

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

Allergic reactions (hypersensitivity)

Allergic reactions to Prolasplan may rarely 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 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 human plasma medications, standard measures are taken, including:

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

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

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

Despite this, when administering blood-derived or human plasma medications, the possibility of transmission of infectious agents cannot be completely ruled out. This also applies to emerging or unknown viruses and other pathogens.

These procedures are considered effective against enveloped viruses, such as the 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 severe 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 human plasma-derived medications (such as protease inhibitors) be vaccinated against hepatitis A and B.

It is strongly recommended that each time Prolasplan 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 use

Since the effectiveness of Prolasplan 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 Prolasplan in children or adolescents under 18 years of age.

Use of Prolasplan with other medications

No interactions between Prolasplan 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 believe you may be pregnant.

The passage of Prolasplan 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.

Prolasplan contains sodium

Prolasplan contains approximately 110.4 mg of sodium (main component of table salt) per vial. For a patient weighing 75 kg, this 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.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The treatment with alpha1-antitrypsin should be performed or supervised by specialist doctors in chronic obstructive pulmonary disease.

Afterdissolving the powder with the solvent included in the package, the reconstituted solution must be administered by intravenous infusion. A specialist doctor in chronic obstructive pulmonary disease will supervise the first infusions with this medication.

Dose

The amount of Prolasplan 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 (human) per ml).

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

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

Home treatment

After the first infusions, a specialist doctor may decide that you are eligible for home treatment. The medication can also be administered by a healthcare professional, but only after receiving adequate training. Your doctor will ensure that the healthcare professional receives adequate training on:

• 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 allergic reaction symptoms and the measures to be taken in case they occur (see also section 4).

If you use more Prolasplan than you should

Until date, the effects of an overdose are unknown.

Inform your doctor or healthcare professional if you believe you have used more Prolasplan than you should so that they can take the necessary measures.You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forgot to use Prolasplan

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

If you interrupt the treatment with Prolasplan

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

If you have any other doubts 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 occur during Prolasplan infusion, you should suspend or interrupt the infusion, depending on the nature and severity of the side effect.

Severe side effects

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

Inform your doctor or nurse immediately if 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 infusion and initiate the necessary treatment as needed.

In case ofhome treatmentinterrupt the infusion immediately and contact your doctor or healthcare professional.

During treatment with Prolasplan the following side effects have been observed:

Infrequent (affecting up to 1 in 100 people):

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

-Hives (urticaria).

-Dizziness, drowsiness, headache.

-Difficulty breathing (dyspnea).

-Cutaneous eruptions.

-Nausea.

-Joint pain (arthralgia).

Rare (affecting 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 (affecting up to 1 in 10,000 people):

-Anaphylactic shock.

Reporting 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 leaflet. You can also report them directly through theSpanish System for 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.

Keepthis medicationout of the sight and reach of children.

Store at a temperature below25°C. Do not freeze.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used always within 3 hours of preparation. Unused product must be discarded.

Do not usethis medicationafter the expiration date that appears on the vial label and on the packagingafter CAD.The expiration date is the last day of the month indicated.

Do not use the reconstituted solution of this medication if you observe that it is cloudy or presents sediment.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Prolasplan

• The active principle is human alpha1-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 alpha1-antitrypsin is a white to beige powder.

The reconstituted solution is transparent.

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

The Prolasplan box contains:

• 1 vial with powder containing 1000 mg of human alpha1-antitrypsin.
• 1 vial with 40 ml of solvent (water for injection).
• 1 Mix2Vial transfer device for reconstitution.

Holder of the marketing authorization and responsible manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Last review date of this leaflet: May 2021

The detailed and updated information on this medication 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 medication on a flat work surface during the preparation of the solution.

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

3.Remove the protective cap from the powder vial and clean the top of the stopper with an alcohol wipe. Let the rubber stopper dry.

4.Repeat this step with the sterile water vial.

5.Open the sterile packaging of the Mix2Vial by removing the cap (Figure 1). Do not remove the device from its packaging.

6.Place the solvent vial in a vertical position on a flat surface. Holding the solvent vial firmly, press the blue terminal of the Mix2Vial down until the tip pierces the stopper (Figure 2).

7.Remove the transparent packaging of the Mix2Vial and discard it (Figure 3).

8.Place the powder vial in a vertical position on a flat surface and invert the solvent vial with the Mix2Vial still attached.

9.Holding the powder vial firmly on a flat surface, press the transparent terminal of the Mix2Vial down until the tip pierces the stopper (Figure 4). The solvent will automatically transfer to the powder vial through the vacuum contained in the Mix2Vial.

Note:If the Mix2Vial is connected at an angle, the vacuum in the product vial may be lost and the solvent will not transfer to the product vial. If the vacuum is lost, use a sterile syringe and needle to withdraw the sterile water from the solvent vial and inject it into the powder vial, directing the flow against the wall of the vial.

10.With the solvent and powder vials still attached to the Mix2Vial, gently rotate (Figure 5) until the powder is completely dissolved. Do not shake to avoid foam formation. The reconstituted solution must be transparent. Do not use it if you observe particles or abnormal coloration.

11.Since more than one vial of product will be needed to achieve the required dose, repeat the previous instructions using an additional package with a new Mix2Vial. Do not reuse the Mix2Vial.

12.Remove the Mix2Vial (Figure 6) and administer the product with aseptic technique.

Thetotaldisolution must be obtained in 5 minutes.

Only transparent solutions should be used. Prolasplan should not be mixed with other infusion solutions. The reconstituted solution must be used within 3 hours of preparation.

The reconstituted solution must be administered by slow intravenous infusion using an appropriate infusion device (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).