Prospect: information for the user

Panzyga 100mg/ml infusion solution

Normal human immunoglobulin (IgIV)

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section4.

1.What Panzyga is and for what it is used

2.What you need to know before starting to use Panzyga

3.How to use Panzyga

4.Possible adverse effects

5.Storage of Panzyga

6.Contents of the package and additional information

What is Panzyga

This medication is a solution of normal human immunoglobulin (IgG), that is, a solution of human antibodies, for intravenous administration (that is, infusion into a vein). Immunoglobulins are normal components of human blood and support the body's immune defenses. Panzyga contains all the IgG found in the blood of healthy humans. Appropriate doses of Panzyga can restore abnormally low IgG concentrations to normal levels.

Panzyga has a broad spectrum of antibodies against different infectious agents.

What is Panzyga used for

Panzyga is used as a substitute treatment in children, adolescents (0-18 years) and adults in different patient groups:

• Patients with congenital antibody deficiency (primary immunodeficiency syndromes, such as: congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiencies)
• Patients with antibody deficiency (secondary immunodeficiency) due to specific diseases and/or treatments and who experience severe or recurrent infections.

This medication can be used for the treatment of adults and children and adolescents (0-18 years) who have been exposed to measles or who are at risk of exposure to measles and in whom active vaccination against measles is not indicated or not recommended.

Panzyga can also be used in the treatment of the following autoimmune disorders (immunomodulation):

• In patients with immune thrombocytopenia (PTI), a disease in which platelets are destroyed and, therefore, their number is reduced, and who have a high risk of bleeding or before a surgical procedure to correct the platelet count.
• In patients with Kawasaki disease, a disease that leads to the inflammation of several organs
• In patients with Guillain-Barré syndrome, a disease that leads to the inflammation of certain parts of the nervous system
• In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease that leads to chronic inflammation of the peripheral parts of the nervous system and causes muscle weakness and/or numbness mainly in the legs and arms.

In patients with multifocal motor neuropathy (NMM), a condition characterized by a slow, asymmetric progressive weakness of the limbs without sensory loss.

No use Panzyga:

• if you are allergic to human normal immunoglobulin or to any of the other components of this medication (listed in section 6).
• if you have a deficiency in immunoglobulin A (IgA deficiency) and have developed antibodies against IgA immunoglobulins.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Panzyga.

It is strongly recommended that each time you receive a dose of Panzyga, you record the name and batch number of the product, in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

• at a high infusion rate
• when you first receive Panzyga or, in rare cases, when there has been a prolonged interval since the previous infusion.
• when you have an untreated infection or a chronic underlying inflammation

If an adverse reaction occurs, your doctor will reduce the infusion rate or stop the infusion. The necessary treatment for the adverse event will depend on the nature and severity of the event.

Circumstances and conditions that increase the risk of adverse effects

• After administration of Panzyga, rare events such as thromboembolic events (e.g. heart attack, stroke, and deep vein thrombosis, such as in the lower leg, or pulmonary embolism) may occur. These types of events occur more frequently in patients with risk factors, such as obesity, advanced age, hypertension, diabetes, previous occurrences of these events, prolonged periods of immobilization, and ingestion of certain hormones (e.g. "the pill"). Ensure adequate fluid intake. Additionally, Panzyga should be administered as slowly as possible.

If you have had kidney problems in the past or have certain risk factors such as diabetes, obesity, or are over 65 years of age, Panzyga should be administered as slowly as possible because cases of acute renal failure have been reported in patients with these risk factors. Inform your doctor, even if any of the circumstances mentioned above have occurred in the past.

• Patients with blood groups A, B, or AB, as well as patients with certain inflammatory diseases, have a higher risk of the administered immunoglobulins destroying red blood cells (known as hemolysis).

When may it be necessary to reduce the infusion rate or stop the infusion?

• Severe headaches and neck stiffness may occur in rare cases, several hours to 2 days after treatment with Panzyga.
• Allergic reactions are rare, but may induce anaphylactic shock, even in patients who have tolerated previous treatments.

A sudden drop in blood pressure or shock may be consequences of anaphylactic reaction.

• In very rare cases, acute transfusion-related lung injury (TRALI) may occur after receiving immunoglobulins, including Panzyga. This will result in non-cardiac accumulation of fluid in the lung spaces. You will recognize TRALI by significant difficulty breathing, with normal heart function and increased body temperature (fever). Symptoms usually occur between 1 and 6 hours after receiving the treatment.

Consult your doctor or healthcare professional immediately if you detect any of the symptoms mentioned above during or after the infusion of Panzyga, who will decide whether to reduce the infusion rate or stop it completely, as well as whether further measures are needed.

• In some cases, solutions of immunoglobulins like Panzyga may trigger a decrease in the number of white blood cells. This disorder usually resolves spontaneously within 1 to 2 weeks.

Effects on blood tests

Panzyga contains a wide variety of different antibodies, some of which may affect blood tests. If you have a blood test after receiving Panzyga, inform the person taking the blood sample or your doctor that you have received a solution of human normal immunoglobulin.

Viral safety

When medications are made from blood or plasma, certain measures are taken to prevent infections from being transmitted to patients. These include:

• Careful selection of blood or plasma donors to ensure that those at risk of being carriers of infections are excluded.
• Analysis of specific markers of infections in individual donations and plasma mixtures for signs of virus/infection.
• Steps included by manufacturers in the processing of blood or plasma to inactivate or eliminate viruses.

Despite these measures, when administering medications derived from blood or plasma, the possibility of transmitting an infection cannot be completely ruled out. This also applies to any unknown or emerging viruses or other types of infections.

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

Immunoglobulins have not been associated with infections by hepatitis A virus or parvovirus B19, possibly due to the presence of antibodies against these infections in the product, which have a protective effect.

Children and adolescents

No specific or additional warnings or precautions apply to children and adolescents.

Use of Panzyga with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, or if you have been administered a vaccine in the last three months.

During treatment with Panzyga, concomitant use with medications that increase water excretion from the body (diuretics) should be avoided. Your doctor will decide whether you should use or continue treatment with diuretics.

Panzyga may alter the effect of live attenuated virus vaccinessuch as:

• measles
• rubella
• mumps
• chickenpox

After administration of this product, a 3-month interval should elapse before vaccination with vaccines containing live attenuated viruses. In the case of measles, this alteration may persist for up to 1 year.

Use of Panzyga with food, drinks, and alcohol

No effects have been observed. Adequate hydration should be ensured before administering the medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using or continuing to use this medication.

The safety of this product during pregnancy has not been determined in controlled clinical trials and should be administered with caution to pregnant women and breastfeeding women. Immunoglobulins have been shown to cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins indicates that no adverse effects should be expected during pregnancy, in the fetus, or in the newborn.

Immunoglobulins are excreted in breast milk, so no adverse effects are expected in breastfed infants or in lactating women.

Driving and operating machinery

This medication has no influence, or its influence is insignificant, on the ability to drive or operate machinery. However, patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machinery.

Panzyga contains sodium

This medication contains 69 mg of sodium (main component of table salt/for cooking) in each 100 ml vial. This is equivalent to 3.45% of the maximum daily sodium intake recommended for an adult.

Patients with a low-sodium diet should be aware of this.

Your doctor will decide if you need Panzyga and what dose. The administration of the medication in the form of intravenous infusion (infusion in a vein) is the responsibility of the healthcare staff. The dose and dosing regimen depend on the indication and may need to be adjusted individually for each patient.The medication.

If you have any other questions about the use of thismedicamento,

Use in children and adolescents

The administration(intravenous)of the medication in children and adolescents (0-18 years) does not differ from the administration in adults.

If you receive more Panzyga than you should

It is very unlikely that an overdose will occur becausethis medicamentois normally administered under medical supervision. If, despite this, you receive morePanzygathan you should, the blood may become too thick (hyperviscous), which may increase the risk of blood clots. This may occur especially if you are a high-risk patient, such as if you are advanced in age or have a heart or kidney disease. Make sure you are well hydrated. Inform your doctor if you have any known medical condition.

If you forgot to use Panzyga

Consult your doctor to discuss how to proceed.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor as soon as possible if you experience any of the serious side effects described below (all are very rareand may affect up to1 in 10,000infusions). In some cases, your doctor may need to interrupt treatment and reduce your dose, or stop treatment:

• Swelling of the face, tongue, and tracheathat may cause great difficulty breathing
• Sudden allergic reactionwith difficulty breathing, hives, wheezing, and a drop in blood pressure
• Strokethat may cause weakness and/or loss of sensation in one side of the body
• Heart attackthat causes chest pain
• Blood clotthat causes pain and inflammation in the extremities
• Blood clot in the lungthat causes chest pain and difficulty breathing
• Anemiathat causes difficulty breathing or paleness
• Severe kidney disorderthat may cause inability to urinate
• OnePulmonary conditioncalled transfusion-related acute lung injury (TRALI) that causes difficulty breathing, blue skin, fever, and decreased blood pressure

If you experience any of the above symptoms, contact your doctor as soon as possible.

The following side effects have also been reported:

Frequent side effects(may affect up to 1in 10infusions):

Headache, nausea, fever

Rare side effects(may affect up to 1in 100infusions):

Hives, back pain, chest pain, chills, dizziness, feeling of fatigue, cough, vomiting, abdominal pain, diarrhea, joint pain, muscle pain, itching at the infusion site, rash, neck pain, arm or leg pain, reduced sense of touch or sensation, reduced red blood cells, reduced white blood cells, aseptic meningitis (see also the Adverse reactions and precautions section), eye itching, tachycardia, hypertension, ear pain, stiffness, feeling of cold, feeling of heat, discomfort, chills, numbness, changes in blood tests that report liver function.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possibleside effect that does not appear in this prospectus.You can also report them directly through thenational reporting system..By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Spain

Spanish System for Pharmacovigilance of Medicines for Human Use:

www.notificaRAM.es

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

Do not use this medication after the expiration date that appears on the label and in the box. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Store the container in the outer packaging to protect it from light. Do not freeze.

The medication can be removed from the refrigerator for a period of 12 months (without exceeding the expiration date) and stored above +8°C and below +25°C. During this period, the medication should not be refrigerated again.Discard the medication if it is not used during this period or after the expiration date, whichever occurs first.Record the date the product was removed from the refrigerator on the outer packaging.

Do not use this medication if you observe that the solution is cloudy, has deposits, or has an intense color.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Panzyga

• The active principle is human normal immunoglobulin (human antibodies). Panzyga contains 100mg/ml of human proteins of which at least 95% is immunoglobulin G (IgG).
• The other components are glycine and water for injectable preparations.

Appearance of Panzygaand contents of the container

Solution for infusion available in vials (1g/10ml, 2,5g/25ml) or in bottles (5g/50ml, 6g/60ml, 10g/100ml, 20g/200ml, 30g/300ml).

Container sizes:

1vial (1g/10ml or 2,5g/25ml)

1bottle (5g/50ml; 6g/60ml; 10g/100ml; 20g/200ml or 30g/300ml)

3bottles (3 x 10g/100ml or 3 x 20g/200ml)

The solution is transparent or slightly opalescent, colorless or slightly yellow.

Only some container sizes may be marketed.

Marketing Authorization Holder

Octapharma S.A.

Avda. Castilla, 2. (P.E. San Fernando)
Ed. Dublín, 2nd Floor28830 San Fernando de Henares, Madrid

Manufacturers

Octapharma

72 rue du Maréchal Foch, 67380 Lingolsheim, France

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235, 1100 Vienna, Austria

Octapharma GmbH

Elisabeth-Selbert-Str.11, 40764 Langenfeld, Germany

This medicine is authorized in themember states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet:July 2024

This information is intended solely for healthcare professionals:

• Themedicineshould be taken to room temperature or body temperature before use.
• The solution should be from transparent to slightly opalescent and from colorless to slightly yellow.
• Do not use turbid or sediment-containing solutions.
• Themedicinenot used or waste material, should be disposed of in accordance with local requirements.
• This medicine should not be mixed with other medicines.
• To complete the infusion of themedicinethat may have remained in the tubes at the end of the infusion, it may be circulated through the tube a 0.9% saline solution (9mg/ml) or a 5% dextrose solution (50mg/ml).