PLANGAMMA 50 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Plangamma50mg/mlsolution for infusion

Human normal immunoglobulin (IgIV)

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 signs of illness are the same as yours.
• If you get 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 package leaflet:

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

1. What is Plangamma and what is it used for

What is Plangamma

Plangamma contains human normal immunoglobulin. This medicine belongs to a group of medicines called intravenous immunoglobulins. These are used to treat conditions where the immune system does not work properly against diseases.

What Plangamma is used for

Treatment in adults, children, and adolescents (2-18 years) who lack sufficient antibodies (replacement therapy). There are two groups:

• Patients with Primary Immunodeficiency Syndrome (PIS), a congenital antibody deficiency (group 1).
• Patients with Secondary Immunodeficiency Syndrome (SIS) in patients who suffer from severe or recurrent infections, who do not respond to antimicrobial treatment and who have demonstrated a deficiency of specific antibodies (PSAF)* or a serum level of <4 g l (group 2).< li>

*PSAF = inability to double the antibody titre against the pneumococcal polysaccharide and polypeptide vaccine antigens.

Treatment of adults, children, and adolescents (2-18 years) who are susceptible and in whom active vaccination against measles is contraindicated or not recommended.

Treatment in adults, children, and adolescents (2-18 years) with certain autoimmune conditions (immunomodulation). These are classified into five groups:

• Primary immune thrombocytopenia, when the number of platelets in the bloodstream is drastically reduced. Platelets are an important part of the blood clotting process, and a reduced number of platelets can cause bleeding and bruising. This product is also used in patients with a high risk of bleeding or before surgery, to increase the number of platelets.

• Guillain-Barré syndrome, in which the immune system attacks the nerves and prevents them from functioning properly.

• Kawasaki disease (in this case, together with acetylsalicylic acid), a childhood disease in which the blood vessels (arteries) in the body become inflamed.

• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease that causes weakness in the limbs, numbness, pain, and fatigue.

• Multifocal motor neuropathy (MMN), a rare disease that causes slow, asymmetric weakness in the limbs without sensory loss.

2. What you need to know before you use Plangamma

Do not use Plangamma

• If you are allergic to human immunoglobulins or to any other component of this medicine (listed in section 6).

• If you have IgA deficiency in blood or have developed antibodies to IgA.

• If you have fructose intolerance, a rare genetic disorder that means you do not produce the enzyme that breaks down fructose. In infants and young children (0-2 years), hereditary fructose intolerance (HFI) may not have been diagnosed and could be fatal, so they should not receive this medicine. (See special precautions regarding excipients at the end of this section).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Plangamma.

Some adverse reactions may occur more frequently:

• if administered at a high infusion rate.
• if you have hypogammaglobulinemia or agammaglobulinemia (a condition that involves low levels of immunoglobulin in the blood) with or without IgA deficiency.
• if you receive Plangamma for the first time, or have changed from another human normal immunoglobulin (IgIV) product, or have not received an infusion for a long period (e.g., several weeks). You will be closely monitored for up to one hour after the infusion to detect possible adverse reactions.

Allergic reactions are rare. These may occur in isolated cases if you do not have sufficient IgA immunoglobulins in your blood or if you have developed anti-IgA antibodies.

Patients with pre-existing risk factors

Please inform your doctor if you have any other medical condition and/or disease, as greater caution is required in patients with pre-existing risk factors for thrombotic events. In particular, inform your doctor if you have:

• diabetes
• high blood pressure
• a history of vascular disease or thrombotic events
• overweight
• reduced blood volume
• diseases that increase blood viscosity
• are over 65 years of age

Patients with kidney problems

If you have kidney problems, your doctor should consider whether to discontinue treatment, as cases of acute renal failure have been reported in patients who received IgIV treatment, usually in patients with risk factors.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Effects on blood tests

After receiving Plangamma, the results of certain blood tests (serological tests) may be altered for some time. If you have a blood test after receiving Plangamma, please inform the analyst or your doctor that you have received this medication.

Special safety precautions

When medicines are prepared from human blood or plasma, a series of measures must be taken to prevent the possible transmission of infections to patients. These measures include:

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

• testing of each donation and plasma pool for possible viruses or infections,

• inclusion of a series of stages in the processing of blood or plasma that can inactivate or eliminate viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be totally excluded. This also applies to unknown or emerging viruses and other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and for non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections, such as those contained in the medicine, are protective.

It is highly recommended that each time Plangamma is administered to a patient, a record is kept of the name of the medicine and the batch number administered, in order to maintain a link between the patient and the product batch.

Children and adolescents

Vital signs (body temperature, blood pressure, heart rate, and respiratory rate) should be monitored during the infusion of Plangamma.

Using Plangamma with other medicines

? Inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

? Effects on vaccines: Plangamma may reduce the effectiveness of certain types of vaccines (live attenuated vaccines). In the case of rubella, mumps, and varicella, a period of up to 3 months should elapse after receiving this medicine and before receiving these vaccines. In the case of measles, the period is up to 1 year.

• The concomitant use of medicines that increase water excretion from the body (loop diuretics) should be avoided during treatment with Plangamma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Patients may experience reactions (such as dizziness or nausea) during treatment that could affect their ability to drive and use machines.

Plangamma contains sorbitol

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medicine. Patients with HFI cannot break down fructose, which can cause serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or if your child cannot take sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

Plangamma contains sodium

This medicine contains less than 7.35 mg of sodium (the main component of table salt/cooking salt) per 100 ml. This is equivalent to 0.37% of the maximum daily intake of 2 g of sodium recommended for an adult.

3. How to use Plangamma

Plangamma is for intravenous administration (injection into a vein). You can administer it yourself if you have previously received complete training from hospital staff or a healthcare professional. You must perform the infusion exactly as you have been taught to avoid the presence of germs. You should never administer an injection if you are alone; a healthcare professional with experience in preparing medicines, cannulation, administration, and monitoring of adverse reactions should always be present.

The dose you receive will depend on your disease and weight and will be calculated by your doctor (see section "Instructions for healthcare professionals" at the end of the package leaflet).

At the start of the infusion, you will receive Plangamma at a low rate (0.01-0.02 ml/kg/min). If you tolerate it well, your doctor may gradually increase the infusion rate (up to 0.1 ml/kg/min).

Use in children

The dose in children is not considered to be different from that in adults, as it depends on the disease and the child's weight.

If you receive more Plangamma than you should

If you receive more Plangamma than you should, your body may suffer from fluid overload. This can occur especially if you are a patient at risk, for example, if you are elderly or have heart or kidney problems. Consult your doctor immediately.

If you forget to use Plangamma

Consult your doctor or pharmacist immediately and follow their instructions.

You should not take a double dose to make up for a forgotten dose.

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, Plangamma can cause side effects, although not everybody gets them.

In some isolated cases, the following adverse reactions have been described with immunoglobulin preparations. Tell your doctor if you experience any of the following side effects during or after the infusion:

• A sudden drop in blood pressure and, in isolated cases, anaphylactic shock (whose symptoms are skin rash, hypotension, palpitations, wheezing, coughing, sneezing, and difficulty breathing, among others), even in patients who have not shown hypersensitivity to previous administrations.
• Cases of temporary non-infectious meningitis (whose symptoms are headache, fear or sensitivity to light, neck stiffness).
• Cases of temporary reduction in the number of red blood cells in the blood (reversible hemolytic anemia/hemolysis).
• Cases of transient skin reactions (adverse effects on the skin).
• Increased serum creatinine levels (a test that measures kidney function) and/or acute renal failure (whose symptoms are pain in the lumbar region, fatigue, decreased urine output).
• Thromboembolic reactions such as myocardial infarction (pressure in the chest area with a feeling of a rapid heartbeat), stroke (weakness in the muscles of the face, arms, or legs, difficulty speaking or understanding others when they speak), pulmonary embolism (shortness of breath, chest pain, and fatigue), and deep vein thrombosis (pain and swelling in a limb).
• Cases of transfusion-related acute lung injury (TRALI) that cause hypoxia (lack of oxygen), dyspnea (difficulty breathing), tachypnea (agitated breathing), cyanosis (lack of oxygen in the blood), fever, and hypotension.

Other side effects:

Common (may affect up to 1 in 10 people):

• headache
• reaction at the injection site
• fever (increase in body temperature)

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

• positive Coombs test
• dizziness
• increase or decrease in blood pressure
• bronchitis
• cough
• wheezing
• abdominal pain (including upper abdominal pain)
• diarrhea
• vomiting
• nausea
• urticaria
• pruritus (itching)
• skin rash
• contact dermatitis
• back pain
• myalgia
• arthralgia (joint pain)
• muscle cramps
• tremors (feeling of chills)
• weakness
• pain
• inflammation at the injection site
• reaction at the injection site (including edema, pruritus, swelling, and pain)
• implant migration
• increase in body temperature

Frequency not known (cannot be estimated from the available data):

• chest pain
• flushing (redness of the skin)
• malaise
• dyspnea (difficulty breathing)

Other side effects in children and adolescents

It was observed that the proportion of headache, fever, increased heart rate, and decreased blood pressure was higher in children than in adults.

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 Surveillance 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 Plangamma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

Do not store above 30°C. Do not freeze.

The solution should be clear or slightly opalescent. Do not use this medicine if the solution is cloudy or has deposits.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition ofPlangamma

• The active principle is normal human immunoglobulin (IgIV). One ml contains 50 mg of normal human immunoglobulin, of which at least 97% is IgG.

Each 10 ml vial contains: 0.5 g of normal human immunoglobulin

Each 50 ml vial contains: 2.5 g of normal human immunoglobulin

Each 100 ml vial contains: 5 g of normal human immunoglobulin

Each 200 ml vial contains: 10 g of normal human immunoglobulin

Each 400 ml vial contains: 20 g of normal human immunoglobulin

The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3, and 2.2% IgG4. The IgA content is less than 50 micrograms/ml.

• The remaining components are sorbitol and water for injectable preparations (see section 2 for more information on components).

Product Appearance and Container Content

Plangamma is a solution for infusion. The solution is transparent or slightly opalescent, colorless or pale yellow.

Plangamma is presented in vials of 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml, and 20 g/400 ml.

Container size: 1 vial

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona - Spain

Date of the Last Revision of this Prospectus 06/2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended only for healthcare professionals (see section 3 for more information):

Posology and Method of Administration

The dose and dosing regimen depend on the indication.

It may be necessary to individualize the dosing regimen for each patient according to the clinical response. The dose based on body weight may require adjustment in patients with low weight or overweight. The following dosing regimen can be used as a guideline.

The recommended posology is described in the following table:

Plangamma should be administered intravenously at an initial rate of 0.01-0.02 ml/kg/min during the first thirty minutes. If well tolerated, the administration rate can be gradually increased up to a maximum of 0.1 ml/kg/min.

In the clinical trial conducted with patients with chronic ITP, a significant increase in mean platelet levels (64,000/µl) was obtained, although not reaching normal levels.

Pediatric Population

Since the posology for each indication is based on body weight and adjusted to the clinical outcome of the conditions indicated above, the posology in children does not differ from that indicated for adults.

Incompatibilities

Plangamma should not be mixed with other medications or intravenous solutions and should be administered using a separate intravenous line.

Special Precautions

Sorbitol

Patients with hereditary fructose intolerance (HFI) should not receive this medication unless it is strictly necessary.

Babies and children (under 2 years) may not be diagnosed with hereditary fructose intolerance (HFI). Medications (containing sorbitol/fructose) administered intravenously can be potentially fatal and should be contraindicated for this population unless there is an absolute clinical need and no alternative is available.

Before receiving this medication, the patient's medical history should be thoroughly reviewed for symptoms of HFI.

It is highly recommended that each time Plangamma is administered to a patient, a record of the medication name and batch number administered be kept to maintain a relationship between the patient and the product batch.

Handling and Disposal Instructions

The product should reach room temperature (not above 30 °C) before use.

The solution should be transparent or slightly opalescent. Do not use Plangamma if the solution is turbid or contains sediment.

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.