Prolastina 1000 mg, powder and solvent for solution for infusion
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Prolastina 1.000 mg powder and solvent for solution for infusion
Active substance: human alpha1-antitrypsin
Read the entire 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, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Prolastina is and what it is used for
- What you need to know before using Prolastina
- How to use Prolastina
- Possible adverse effects
- How to store Prolastina
- 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, whose function is to inhibit the activity of certain enzymes such as elastases that can damage the lungs. When there is an inherited deficiency of alpha1-antitrypsin, an imbalance occurs between alpha1-antitrypsin and elastases. This 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 types of patients with alpha1-antitrypsin deficiency, as determined by your doctor.
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
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Consult your doctor, pharmacist, or nurse before starting to use Prolastina.
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Inform your doctor if you have severe heart failure (cardiac insufficiency). Extreme caution is required, as Prolastina may cause a transient increase in blood volume.
Allergic reactions (hypersensitivity)
Allergic reactions to Prolastina are rare, 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 an allergic or hypersensitivity reaction during the infusion of the medicine, inform your doctor or nurse immediately.
Information on safety regarding the risk of infections
To prevent 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 having infections,
- testing of each donation and plasma pool for the presence of 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 transmission of infectious agents cannot be completely excluded. 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, inactivation/removal procedures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus or parvovirus B19. Parvovirus B19 infection may have serious consequences in pregnant women (fetal infection) and in patients with immunodeficiency or increased erythropoiesis (e.g., in cases of haemolytic anaemia).
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 for 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 use of machines
No effects on the ability to drive or operate machinery have been observed.
Prolastina contains sodium
Prolastina 1000 mg contains approximately 110.4 mg of sodium (the 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 first infusions of Prolastina.
Home treatment
After the initial infusions, a healthcare professional may also administer Prolastina, but only after receiving adequate training. If your doctor decides you are suitable for home treatment, they will ensure that appropriate training is provided to the healthcare professional regarding:
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how to prepare and administer the reconstituted solution for infusion (see the illustrated instructions at the end of this leaflet),
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how to maintain the sterility of the product (aseptic infusion techniques),
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how to keep a treatment record,
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how to recognize adverse reactions, including symptoms of allergic reactions, and the measures to be taken if such effects 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 the active substance per kg of body weight is recommended (for a patient weighing 75 kg, this dose corresponds to 180 ml of the reconstituted solution for infusion and contains 25 mg of human alpha1-antitrypsin inhibitor per ml). This dose is normally sufficient to maintain protective levels of alpha1-antitrypsin inhibitor to prevent worsening of pulmonary emphysema.
Your doctor 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 doctor or pharmacist.
If you use more Prolastina than you should
The effects of an overdose are currently unknown.
- Inform your doctor or healthcare professional if you think you have used more Prolastina than you should, so they can take appropriate action.
- In case of overdose or accidental administration, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount administered.
If you forget to use Prolastina
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Consult your doctor to determine whether the missed dose should be administered.
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Do not administer a double dose to make up for a missed infusion.
If you stop using Prolastina
If treatment with Prolastina is interrupted, your condition may worsen. Contact your doctor immediately if you wish to discontinue treatment with Prolastina.
If you have any further questions about the use of this medicine, ask your doctor, 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 down or stopped, depending on the nature and severity of the adverse effect.
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.
Immediately inform your doctor or nurse 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 stop the infusion and initiate appropriate treatment as needed.
In 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 rashes.
- 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Prolastin
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 the 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.
After reconstitution with water for injections, the solution should be transparent to slightly opalescent, colourless, pale green, pale yellow, or pale brown, and free from visible particles.
1 ml of reconstituted solution contains 25 mg of human alpha1-antitrypsin.
Single pack
Prolastina 1,000 mg powder and solvent for solution for infusion contains:
- 1 vial with powder containing 1,000 mg of human alpha1-antitrypsin.
- 1 vial with 40 ml of solvent (water for injections).
- 1 transfer device for reconstitution.
The multipack of Prolastina 1,000 mg contains:
- 4 individual boxes of Prolastina 1,000 mg.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grifols Deutschland GmbH
Colmarer Straße 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 authorised in the Member States of the European Economic Area under the following names:
Prolastin 1000 mg Germany, France, Ireland
Prolastin Austria, Greece, Italy, Netherlands, Poland, Portugal
Prolastina Croatia, Cyprus, Czech Republic, Denmark, Finland, Norway, Spain, Slovakia, Sweden
Pulmolast 1000 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 of 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:
- Use aseptic conditions (cleaning and disinfection) to maintain sterility. Reconstitute the medicine on a flat working surface during solution preparation.
- Ensure that the vials of Prolastina powder and solvent (sterile water for injections) are at room temperature (20–25°C).
- Remove the protective caps from both the Prolastina vial and the solvent vial, and clean the neck rims and stoppers with an alcohol wipe. Allow the rubber stoppers to dry.
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Open the sterile container of the transfer device by completely removing the cap. Do not remove the device from its packaging.
Place the solvent vial upright on a flat surface and hold it firmly. Without removing the outer packaging, press the blue end of the transfer adapter downward until the tip pierces the stopper and locks into place. Avoid twisting.
Place the Prolastina powder vial upright. Turn the combined unit of adapter and solvent vial upside down 180°. Push the transparent/white end of the straight adapter downward, without twisting, until the tip pierces the stopper and locks into place.
Due to the vacuum in the powder vial, the solvent transfer will begin automatically. Wait for the transfer of solvent to complete. Remove the adapter with the connected solvent vial at an angle of approximately 45°.
Gently swirl the Prolastina vial until the powder is completely dissolved. Do not shake to avoid foaming. Do not touch the stopper. Administer the product using an aseptic technique.- 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 5 minutes for the 1000 mg Prolastina presentation.
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 an appropriate infusion set (not included). The infusion rate must be less than 0.08 ml per kilogram of body weight per minute (equivalent to 6 ml per minute for a 75 kg patient).