Plangamma 50 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plangamma 50 mg/ml solution for infusion

Normal human 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 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. 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 this leaflet:

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

1. What Plangamma is and what it is used for

What Plangamma is

Plangamma contains normal human immunoglobulin. This medicine belongs to a class of medicines called intravenous immunoglobulins. These are used to treat conditions in which the immune system does not function properly in response to disease.

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

*PSAF = inability to double IgG antibody titres in response to pneumococcal polysaccharide and polypeptide vaccines.

Treatment in adults, children and adolescents (2–18 years) at risk when active measles vaccination 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 component in the blood clotting process, and a low platelet count may cause bleeding and bruising. This product is also used in patients with a high risk of bleeding or prior to surgical intervention, to increase platelet count.

• 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 illness in which blood vessels (arteries) of the body become enlarged.

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

• Multifocal motor neuropathy (MMN), a rare disease causing slowly progressive, asymmetric weakness in the limbs without sensory loss.

2. What you need to know before using 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 against IgA.

• If you have fructose intolerance, a rare genetic condition in which the enzyme responsible for breaking down fructose is not produced. In infants and young children (0–2 years), hereditary fructose intolerance (HFI) may not yet have been diagnosed and could be fatal; therefore, this medicine must not be administered. (See special precautions regarding excipients at the end of this section).

Warnings and precautions

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

Adverse reactions may occur more frequently:

• if administered at a high infusion rate,
• if you have hypogammaglobulinemia or agammaglobulinemia (conditions characterized by low or absent levels of immunoglobulins in blood), with or without IgA deficiency,
• if you are receiving Plangamma for the first time, switching from another human normal immunoglobulin (IVIG) product, or if a long interval (e.g., several weeks) has passed since your last infusion. You will be closely monitored for at least one hour after infusion to detect any possible adverse reactions.

Allergic reactions are uncommon. These may occur in isolated cases if you have insufficient IgA immunoglobulins in blood or if anti-IgA antibodies have developed.

Patients with pre-existing risk factors

Please inform your doctor if you have any other medical condition and/or disease, as increased 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
• 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 treatment should be discontinued, as cases of acute renal failure have been reported in patients receiving IVIG therapy, usually in those with risk factors.

Consult your doctor, even if any of the above conditions occurred in the past.

Effects on blood tests

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

Special safety precautions

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

• careful selection of blood and plasma donors to ensure exclusion of donors at risk of carrying infections,
• testing of each donation and plasma pool for the presence of viruses or infections,
• inclusion of several steps in the manufacturing process that can inactivate or eliminate viruses.

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

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against 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 contained in the medicine are protective.

It is highly recommended that each time Plangamma is administered to a patient, the name of the medicine and the batch number used should be recorded, in order to maintain traceability 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 Plangamma infusion.

Use of Plangamma with other medicines

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

? Vaccine effects: Plangamma may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines). For rubella, mumps, and varicella vaccines, a period of up to 3 months should elapse after receiving this medicine before vaccination. For measles vaccine, the interval should be up to 1 year.

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Plangamma contains sorbitol

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disease, this medicine must not be administered. Patients with HFI cannot break down fructose, which may lead to serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or if your child cannot consume 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/cooking salt) per 100 ml. This corresponds to 0.37% of the maximum daily intake of 2 g of sodium recommended for adults.

3. How to use Plangamma

Plangamma is for intravenous administration (injection into a vein). You may self-administer it if you have previously received complete training from hospital staff or a healthcare professional. You must perform the infusion exactly as instructed to avoid contamination with germs. You must never administer the injection alone; an experienced healthcare professional experienced in drug preparation, cannulation, administration, and monitoring of adverse reactions must always be present.

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

At the beginning 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 different from that in adults, as it depends on the child's condition and body weight.

If you receive more Plangamma than you should

If you receive more Plangamma than you should, your body may experience fluid overload. This is especially possible if you are a high-risk patient, for example if you are elderly or have heart or kidney problems. Contact your doctor immediately.

If you forget to use Plangamma

Contact your doctor or pharmacist immediately and follow their instructions.

Do not administer a double dose to make up for a missed dose.

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, Plangamma may produce adverse effects, although not everyone experiences them.

In isolated cases, the following adverse reactions have been reported with immunoglobulin preparations. Inform your doctor if you experience any of the following reactions during or after infusion:

• Sudden drop in blood pressure and, in isolated cases, anaphylactic shock (symptoms include skin rash, hypotension, palpitations, wheezing, cough, sneezing, and difficulty breathing, among others), even in patients who have not previously shown hypersensitivity to prior administrations.
• Cases of transient non-infectious meningitis (symptoms include headache, photophobia or sensitivity to light, and 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).
• Increase in serum creatinine levels (a test measuring kidney function) and/or acute renal failure (symptoms include lower back pain, fatigue, and decreased urine output).
• Thromboembolic reactions such as myocardial infarction (chest pressure with sensation of rapid heartbeat), stroke (weakness in facial, arm, or leg muscles, difficulty speaking or understanding others when speaking), 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) causing hypoxia (lack of oxygen), dyspnea (difficulty breathing), tachypnea (rapid breathing), cyanosis (lack of oxygen in blood), fever, and hypotension.

Other adverse effects:

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

• headache
• fever (elevated body temperature)
• tachycardia (increased heart rate)
• hypotension

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

• bronchitis
• nasopharyngitis
• dizziness
• hypertension
• increase in blood pressure
• wheezing
• productive cough
• abdominal pain (including upper abdominal pain)
• diarrhea
• vomiting
• nausea
• urticaria
• pruritus (itching)
• skin rash
• back pain
• myalgia (muscle pain)
• arthralgia (joint pain)
• rigors (chills)
• pain
• reaction at injection site
• positive Coombs test
• decrease in blood pressure

Rare (may affect 1 in 1,000 infusions):

• hypersensitivity
• abnormal behavior
• migraine
• blood pressure fluctuations
• erythema (skin redness)
• cough
• asthma
• dyspnea (difficulty breathing)
• epistaxis (nosebleed)
• nasal discomfort
• laryngeal pain
• contact dermatitis
• hyperhidrosis (excessive sweating)
• skin rash
• muscle spasms
• neck pain
• limb pain
• urinary retention
• weakness (fatigue)
• chest pain
• reaction at infusion site (skin redness, extravasation, swelling, and pain)
• reaction at injection site (including injection site edema, pain, itching, and swelling)
• peripheral edema
• increased alanine aminotransferase (hepatic transaminase)

Other adverse effects in children and adolescents

The incidence of headache, fever, increased heart rate, and decreased blood pressure was observed to be higher in children than in adults.

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 Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the label and carton following 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 contains sediments.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Plangamma

• The active substance 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 distribution 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 other components are sorbitol and water for injections (see section 2 for more information on components).

Presentation of the product and contents of the container

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

Plangamma is available 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.

Pack size: 1 vial

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - Spain

Date of the most recent review of this leaflet: September 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 only (see section 3 for more information):

Dosage 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 clinical response. Dosing based on body weight may require adjustment in patients with low body weight or overweight. The following dosing regimens may be used as a general guide.

The recommended dosage is described in the following table:

Plangamma must be administered intravenously at an initial rate of 0.01–0.02 ml/kg/min for the first thirty minutes. If well tolerated, the infusion rate may be gradually increased up to a maximum of 0.1 ml/kg/min.

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

Paediatric population

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

Incompatibilities

Plangamma must not be mixed with other medicinal products or intravenous solutions and must be administered using a separate intravenous line.

Special precautions

Sorbitol

Patients with hereditary fructose intolerance (HFI) must not receive this medicinal product unless strictly necessary.

Infants and children (under 2 years of age) may be undiagnosed for hereditary fructose intolerance (HFI). Intravenous medicinal products (containing sorbitol/fructose) may be potentially fatal and are contraindicated in this population unless there is an absolute clinical need and no alternative is available.

Before administration of this medicinal product, the patient's medical history should be carefully reviewed for symptoms of HFI.

It is highly recommended that each time Plangamma is administered, the name of the medicinal product and the batch number used should be recorded, in order to maintain traceability between the patient and the product batch.

Instructions for handling and disposal

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

The solution should be clear or slightly opalescent. Do not use Plangamma if the solution is cloudy or contains precipitates.

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