Plangamma 100 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plangamma 100mg/ml solution for infusion

Human normal immunoglobulin (igiv)

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 effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Plangamma is and what it is used for
2. What you need to know before using Plangamma
3. How to use Plangamma
4. Possible adverse 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 human normal 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 work properly against diseases.

What Plangamma is used for

Replacement therapy in adults, children and adolescents (2–18 years) who lack sufficient antibodies. 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 specific antibody deficiency (PSAF)* or a serum level of <4 g/l (group 2).

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

Treatment in adults, children and adolescents (2–18 years) at risk when 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, a condition in which the number of platelets in the bloodstream is drastically reduced. Platelets are an important part of 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 surgery, to increase the platelet count.

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

• Kawasaki disease (in this case together with acetylsalicylic acid), a childhood illness in which blood vessels (arteries) throughout 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 fructoses is not produced. In infants and young children (0–2 years), hereditary fructose intolerance (HFI) may not have been diagnosed and could be fatal; therefore, they must not receive this medicine. (See special precautions regarding excipients at the end of this section).

Warnings and precautions

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

Adverse reactions may occur more frequently:

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

Allergic reactions are uncommon. These may occur in isolated cases if you do not have sufficient IgA-type immunoglobulins in your 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
• age over 65 years

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 treatment, usually in those with risk factors.

Consult your doctor, even if any of the above circumstances have occurred 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 undergo a blood test 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 series of measures must be 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 infections,

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

• inclusion of a series of steps during blood or plasma processing that can inactivate or remove viruses.

Despite these measures, when medicines prepared 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, and against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with infections from hepatitis A or parvovirus B19, 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.

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 (vaccines containing live attenuated viruses). For rubella, mumps, and varicella, a period of up to 3 months should elapse after receiving this medicine before receiving these vaccines. For measles, the period is 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 or 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 disorder, you must not receive this medicine. 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 (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 an adult.

3. How to use Plangamma

Plangamma is for intravenous administration (injection into a vein). You may self-administer it if you have previously received full training from hospital staff or a healthcare professional. You must perform the infusion exactly as you have been taught in order to avoid contamination with germs. You must never administer an injection by yourself; a 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 ml/kg/min). If you tolerate it well, your doctor may gradually increase the infusion rate (up to 0.08 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 may occur especially if you are a high-risk patient, 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.

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 cause 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 aseptic 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 skin reactions).
• Increase in serum creatinine levels (a test measuring kidney function) and/or acute kidney 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 speech), 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 (bluish discoloration of the skin due to low blood oxygen), fever, and decreased blood pressure.

Other adverse effects:

Very common (may affect more than 1 in 10 people):

• Headache

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

• Tachycardia (increased heart rate)
• Hypotension (decreased blood pressure)
• Fever (increased body temperature)
• Chills (sensation of being cold)
• Nausea
• Vomiting
• Back pain
• Myalgia (muscle pain)

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

• Hypersensitivity
• Cold/flu-like symptoms
• Dizziness
• Tremors
• Photophobia (excessive sensitivity to light)
• Vertigo
• Hypertension (increased blood pressure)
• Wheezing
• Abdominal pain (including upper abdominal pain)
• Diarrhea
• Flatulence
• Pruritus (itching)
• Skin rash
• Limb discomfort
• Muscle spasms and stiffness
• Neck pain
• Limb pain
• Chest discomfort/chest pain
• Fatigue
• Feeling cold
• Malaise
• Peripheral edema
• Increased heart rate
• Contusion
• Urinary tract infection
• Aseptic meningitis (non-infectious meningitis)
• Decrease in red and white blood cells
• Anorexia (loss of appetite)
• Insomnia
• Radiculopathy (neck or back pain and other symptoms such as numbness, tingling, and weakness in arms and legs)
• Vasovagal syncope (temporary loss of consciousness)
• Conjunctivitis (inflammation of the eye conjunctiva)
• Maculopathy (disease of the macula in the retina of the eye)
• Blurred vision
• Ear pain
• Cyanosis (bluish discoloration of the skin)
• Increase or decrease in blood pressure
• Flushing
• Hematoma
• Thrombosis
• Lymphedema
• Dyspnea (difficulty breathing)
• Epistaxis (nosebleed)
• Nasal discharge (excess mucus)
• Nasal pain
• Upper respiratory tract syndrome
• Abdominal discomfort and distension
• Dry mouth
• Hematemesis (vomiting blood)
• Acne
• Alopecia
• Hyperhidrosis (excessive sweating)
• Ecchymosis (skin bruising)
• Erythema (redness of the skin)
• Arthralgia (joint pain)
• Musculoskeletal discomfort
• Injection-related reaction and injection site reaction (including erythema and pain at the infusion site)
• Nervousness
• Pseudoflu-like syndrome
• General physical deterioration
• Decreased hemoglobin
• Increased reticulocyte count
• Decreased heart rate

Other adverse effects in children and adolescents

The incidence of headache, chills, fever, nausea, vomiting, decreased blood pressure, increased heart rate, and back pain was observed to be higher in children than in adults. Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.

Adverse effects may decrease if Plangamma 50 mg/ml is administered instead of Plangamma 100 mg/ml. Consult your doctor if adverse effects increase.

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 packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plangamma

• The active substance is normal human immunoglobulin (IgIV). One ml contains 100 mg of normal human immunoglobulin, of which at least 97% is IgG.

Each 50 ml vial contains: 5 g of normal human immunoglobulin
Each 100 ml vial contains: 10 g of normal human immunoglobulin
Each 200 ml vial contains: 20 g of normal human immunoglobulin

The percentage distribution of IgG subclasses is approximately 66.6% IgG1, 27.9% IgG2, 3.0% IgG3, and 2.5% IgG4. The IgA content is less than 100 micrograms/ml.

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

Presentation of the product and pack contents

Plangamma is an infusion solution. The solution is transparent or slightly opalescent, colourless or pale yellow.

Plangamma is available in vials of 5 g/50 ml, 10 g/100 ml, and 20 g/200 ml.

Pack size: 1 vial
Only some pack 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 most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for 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.

The dosing regimen may need to be individualized for each patient based on clinical response. Dosing based on body weight may require adjustment in patients with low body weight or obesity. 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 ml/kg/min for the first 30 minutes. If well tolerated, increase the rate to 0.02 ml/kg/min for the second 30 minutes. If again well tolerated, increase the rate to 0.04 ml/kg/min for the third 30 minutes. If the patient continues to tolerate the infusion well, the rate may be further increased by 0.02 ml/kg/min at 30-minute intervals, up to a maximum of 0.08 ml/kg/min.

It has been demonstrated that the frequency of adverse reactions to intravenous immunoglobulin (IVIG) increases with the infusion rate. The administration rate should be slow during initial infusions. If no adverse reactions occur, the rate may be gradually increased in subsequent infusions until the maximum rate is reached. For patients who have experienced adverse reactions, it is advisable to reduce the infusion rate in subsequent administrations, limiting the maximum rate to 0.04 ml/kg/min or administering IVIG at a 5% concentration.

Paediatric population

Since the dosage for each indication is based on body weight and adjusted according to the clinical response to the conditions listed 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 should 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 suggestive 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.

Handling and disposal instructions

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 particulate matter.

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