Prolasplan 1000 mg powder and solvent for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prolasplan 1000 mg powder and solvent for solution for infusion

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 may 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

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

1. What Prolasplan is and what it is used for

Prolasplan contains alpha1-antitrypsin and belongs to a group of medicines called "proteinase 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. In inherited alpha1-antitrypsin deficiency, there is an imbalance 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.

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

This medicine 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 Prolasplan

Do not use Prolasplan

• If you are allergic (hypersensitive) to alpha1-antitrypsin or to any of the other components of this medicine (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 Prolasplan.
• Inform your doctor if you have severe heart failure (cardiac insufficiency). Extreme caution is required, as Prolasplan may cause a transient increase in blood volume.

Allergic reactions (hypersensitivity)

Allergic reactions to Prolasplan 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 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 other pathogens of unknown origin.

These procedures are considered effective against enveloped viruses, such as the human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. The 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 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 Prolasplan 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 Prolasplan 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 Prolasplan in children or adolescents under 18 years of age.

Other medicines and Prolasplan

No interactions between Prolasplan 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 might be pregnant.

It is unknown whether Prolasplan 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 use machines have been observed.

Prolasplan contains sodium

Prolasplan 1000 mg contains approximately 110.4 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 Prolasplan

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Treatment with alpha1-antitrypsin should be carried out or supervised by physicians specialized in chronic obstructive pulmonary disease.

After dissolving the powder with the solvent provided in the package, the reconstituted solution must be administered by intravenous infusion. A specialist in chronic obstructive pulmonary disease will supervise the first infusions with this medicine.

Dosage

The amount of Prolasplan you are given 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 solution for infusion and contains 25 mg of human alpha1-antitrypsin inhibitor per ml).

Your doctor will determine the duration of your treatment, as the need to limit treatment duration 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 initial infusions, a specialist physician may decide that you are suitable for home treatment. The medicine may also be administered by a healthcare professional, but only after receiving adequate training. Your doctor will ensure that appropriate 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 if such reactions occur (see also section 4).

If you use more Prolasplan than you should

The effects of an overdose are currently unknown.

Inform your doctor or healthcare professional immediately if you think you have used more Prolasplan than you should, so that appropriate measures can be taken. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Prolasplan

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

If you stop using Prolasplan

If treatment with this medicine is stopped, your condition may worsen. Consult your doctor immediately if you wish to discontinue treatment with this medicine.

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 Prolasplan infusion, the infusion must be slowed down or stopped, depending on the nature and severity of the adverse reaction.

Possible serious adverse effects

Hypersensitivity reactions may rarely occur (affecting up to 1 in 1,000 people). In very rare cases, these reactions may present as anaphylactic reactions of any type (affecting 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, skin eruption, 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 necessary.

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 Prolasplan:

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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prolasplan

Store below 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

Keep this medicine 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.

6. Contents of the pack and other information

Composition of Prolasplan

• 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 container

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

Once reconstituted with water for injections, the solution should be clear 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.

The Prolasplan 1000 mg powder and solvent for solution for infusion pack contains:

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

Marketing Authorisation Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Date of the most recent revision of this summary:

Detailed and up-to-date information on this medicine 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:

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 Prolasplan powder and solvent (sterile water for injections) are at room temperature (20–25°C).

3. Remove the protective caps from both the Prolasplan vial and the solvent vial, and clean the neck rims and stoppers with an alcohol wipe. 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.

The total solution must be obtained within approximately 5 minutes.

Only solutions that are clear to slightly opalescent, colorless, pale green, pale yellow, or pale brown, and free from visible particles should be used. Prolasplan 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 kg of body weight per minute (equivalent to 6 ml per minute for a patient weighing 75 kg).