Label: information for the user

OCTAGAMOCTA®50 mg/ml solution for infusion

Normal human immunoglobulin for intravenous administration (IGIV)

This medication is a solution of normal human immunoglobulin (IgG), that is a solution of human antibodies, for intravenous administration (infusion into a vein). Immunoglobulins are normal components of the human body and support the body's immune system. Octagamocta 50 mg/ml contains all the activities of IgG present in the normal population. Appropriate doses of this medication can restore abnormally low IgG levels to normal condition.

Octagamocta 50 mg/ml has a broad spectrum of antibodies against various infectious agents.

What Octagamocta 50 mg/ml is used for

This medication is used as replacement therapy in children, adolescents (0-18 years) and adults in different patient groups:

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

Octagamocta 50mg/ml can be used for the treatment of adults and children and adolescents (0‑18years) who have been exposed to measles or who have a risk of exposure to measles and in whom active vaccination against measles is not indicated or not recommended.

Octagamocta 50 mg/ml can also be used inthe treatment of the following autoimmune disorders (immunomodulation):

• in patients with immune thrombocytopenia (ITP), a condition in which platelets are destroyed and, consequently, their number is reduced and who have a high risk of bleeding or need to correct platelet count before surgery.
• in patients with Kawasaki disease, a condition that causes inflammation of several organs.
• in patients with Guillain-Barré syndrome, a condition that causes inflammation of certain parts of the nervous system.
• in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease that results in chronic inflammation of the peripheral parts of the nervous system and causes muscle weakness and/or numbness mainly in legs and arms.
• in patients with multifocal motor neuropathy (NMM), a condition characterized by a slow, progressive, asymmetric weakness of the limbs without sensory loss.

No useOctagamocta50 mg/ml:

• If you are allergic to human immunoglobulin, or to any of the other components of this medication (listed in section 6).

• If you have a deficiency of immunoglobulin A (IgA deficiency) and have developed antibodies against IgA.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Octagamocta 50 mg/ml.

It is strongly recommended that, each time a dose of Octagamocta 50 mg/ml is administered, the name of the medication and batch number administered be recorded in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

• in the case of high infusion rates
• when receiving this medication for the first time 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

In the case of an adverse reaction, the infusion rate should be reduced or the infusion should be interrupted. The treatment of an adverse effect will depend on the nature and severity of the adverse effect.

Circumstances and conditions that increase the risk of adverse effects

• After administration of the medication, very rarely, thromboembolic events such as heart attack, stroke, and deep vein thrombosis, for example in the lower leg, or pulmonary vessel thrombosis 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 immobility, and ingestion of certain hormones (e.g., "the pill"). Ensure adequate fluid intake. In addition, Octagamocta 50 mg/ml should be administered as slowly as possible.
• If you have had kidney problems in the past or if you have certain risk factors such as diabetes, obesity, or more than 65 years of age, this medication 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 (which is known as hemolysis).

When is it necessary to reduce or stop infusions?

• Headaches and neck stiffness may occur, several hours to 2 days after treatment with this medication.
• 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 shock.
• In very rare cases, acute lung injury caused by transfusion (TRALI) may occur after receiving immunoglobulins, including Octagamocta 50 mg/ml. This may cause an accumulation of non-cardiac fluid in the lung spaces.You will recognize TRALI by serious breathing difficulties, normal heart function, and an increase in body temperature (fever). Symptoms typically occur between 1 and 6 hours after receiving the treatment.

Inform your doctor or healthcare professional immediately if you notice any of these reactions during or after administration of this medication. They will decide whether to reduce the infusion rate or stop it completely or if other measures are necessary.

• Sometimes, solutions of immunoglobulin like Octagamocta 50 mg/ml may trigger a reduction in white blood cell count. This condition usually resolves spontaneously within 1-2 weeks.

Viral safety

When administering medications derived from human plasma or blood, certain measures must be taken to prevent infections from passing to patients. These measures include:

• A careful selection of donors to ensure exclusion of those who are at risk of being carriers of infectious diseases.
• Analysis of specific markers of infections in individual donations and plasma mixtures for signs of virus/infection.
• Inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

Despite these measures, when administering medications derived from human blood or plasma, the possibility of transmission of infectious agents cannot be excluded entirely. This also applies to emerging or unknown viruses or other types of infections.

These measures are considered effective for enveloped viruses such as HIV, hepatitis B virus, and hepatitis C virus.

The measures taken may have limited value against non-enveloped viruses, such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with transmission of infections by hepatitis A virus or parvovirus B19, possibly due to the protective effect of the antibodies against these infections present in the medication.

Children and adolescents

No specific or additional warnings or precautions apply to the pediatric population.

Use of Octagamocta 50 mg/ml with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, even those obtained without a prescription, or if you have received a vaccine in the past three months.

The infusion line should be cleaned before and after administration of the medication by circulating a 0.9% saline solution or a 5% dextrose solution through it.

Concomitant use with diuretics should be avoided.

Octagamocta 50 mg/ml may reduce the effect of live virus vaccines, such as those for measles, rubella, mumps, and varicella.

After administration of this medication, a period of 3 months should elapse before vaccination with live viruses. In the case of measles, this reduction may increase to 1 year.

Effects on blood tests

If you are to have a blood test after receiving this medication, inform the person who will be taking the sample or your doctor that you have received a solution of human normal immunoglobulin, as this treatment may affect the results.

Glucose in blood test

Some types of glucose meters (denoted as glucometers) may interpret the maltose contained in this medication as glucose. This may cause false high glucose readings during infusion or within 15 hours after infusion and, as a consequence, inappropriate administration of insulin, leading to hypoglycemia (i.e., a decrease in blood sugar levels) that could be fatal. Similarly, cases of authentic hypoglycemia may not be treated if the hypoglycemic state is masked by false high glucose readings.

As a result, when administering this medication or other products containing maltose, glucose measurement in blood should be performed with a system that uses a specific method for glucose measurement.Systems based on the glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-colorant-oxidorreductase methods should not be used.

Review the product information for the glucose meter, including the reagent strips, to determine if the system is suitable for use with parenteral products containing maltose. If in doubt, consult your doctor to determine if the glucose meter being used is suitable for use with parenteral products containing maltose.

Use of Octagamocta 50 mg/ml with food, beverages, and alcohol

No effects have been observed. Adequate hydration should be ensured before infusion when using this medication.

Pregnancy, lactation, and fertility

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

The safety of this medication during pregnancy has not been determined in controlled clinical trials and should be administered with caution to pregnant women and lactating women.This medication IgIV frequently crosses the placenta, especially during the third trimester.Clinical experience with immunoglobulins indicates that no adverse effects should be expected during pregnancy, or in the fetus, or in the newborn.

Immunoglobulins are excreted in human breast milk.No adverse effects are expected in breastfed infants or in lactating women.

Clinical experience with immunoglobulins suggests that no adverse effects should be expected on fertility.

Driving and operating machines

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

Octagamocta 50 mg/ml contains sodium

100 ml of this medication contains 35 mg of sodium (main component of table salt/cooking salt). This is equivalent to 1.75% of the maximum daily sodium intake recommended for an adult.

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

Your doctor will decide if you need this medication and at what dose.este medicamentoy a qué dosis.Este medicamentose administra como una perfusión intravenosa (perfusión en una vena) por parte de personal sanitario.La dosis y el régimen posológico dependen de la indicacióny pueden necesitar ser individualizados para cada paciente.

Si tiene cualquier otra duda sobre el uso deeste medicamento, pregunte a su médico o farmacéutico.

Use in children and adolescents

The intravenous administration of Octagamocta 50 mg/ml in children and adolescents (0-18 years) does not differ from that of adults.

If you receive more Octagamocta 50mg/ml than you should

It is very unlikely that an overdose will occur becauseeste medicamentonormalmente se administra bajo supervisión médica. If, despite this, you receive more Octagamocta50mg/mldel que debe, 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 your age is advanced or if you have a heart or kidney disease. Make sure you are well hydrated. Inform your doctor if you have any known medical problems.

If you forgot to use Octagamocta 50mg/ml

Consult your doctor to discuss what to do..

Like all medications, this one 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 (they are all very rareand may affect 1 in 10,000 infusions).

In some cases, your doctor will decide to stop treatment, reduce the dose, or suspend treatment:

• Face, tongue, and tracheal inflammationthat may cause severe difficulty breathing
• Acute allergic reactionswith difficulty breathing, hives, wheezing, and decreased blood pressure
• Cerebrovascular accidentsthat may cause weakness and/or numbness in one side of the body
• Heart attackwith chest pain
• Arm and leg pain and inflammation caused by ablood clot
• Anemiathat causes difficulty breathing or paleness
• Chest pain and difficulty breathing caused by ablood clot in the lung
• Severe kidney disordersthat may cause difficulty urinating
• Alung conditioncalled acute transfusion-related lung injury (TRALI, in English), which causes difficulty breathing, blue skin, fever, and decreased blood pressure.

• Intense headachein combination with any of the following symptoms, such asneck stiffness, drowsiness, fever, light sensitivity, nausea, vomiting (these may be signs of meningitis)

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

The following side effects have also been described:

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

• Hypersensitivity (allergic reaction)
• Headache

Less frequent side effects(may affect 1 in 100 infusions):

• Leukopenia (low white blood cell count)
• Changes in heart rhythm
• Changes in blood pressure
• VomitingBack pain
• Chest pain
• Chills
• Nausea

• Fever
• Feeling tired

• Reactions at the injection site
• Anomalies in blood test results or liver function tests

Other side effects that did not occur in clinical trials, but have also been described, are:

• Fluid overload
• Low sodium levels in the blood

• Feeling agitated, anxious, confused, or nervous

• Migraine
• Speech disorders
• Loss of consciousness

• Dizziness

• Itching or tingling sensation in the skin
• Reduced touch or sensitivity
• Light sensitivity

• Involuntary muscle contractions

• Visual disturbances
• Chest pain

• Palpitations

• Temporary blue discoloration of the lips or other skin areas

• Circulatory collapse or shock
• Phlebitis (inflammation of the veins)
• Pale skin
• Cough

• Respiratory disorders

• Pulmonary edema (fluid accumulation in the lungs)
• Bronchospasm (difficulty breathing or wheezing)
• Respiratory failure

• Low oxygen levels in the blood
• Diarrhea, abdominal pain

• Urticaria, skin itching

• Redness of the skin

• Dermatitis
• Peeling of the skin
• Skin inflammation

• Hair loss

• Joint or muscle pain
• Weakness or stiffness of the muscles

• Severe muscle cramps

• Neck pain, leg and arm pain
• Kidney pain

• Swelling of the skin (edema)

• Hot flashes, increased sweating
• Chest pain

• Flu-like symptoms

• General feeling of cold or heat or discomfort and weakness
• Drowsiness

• Burning sensation
• Error in blood glucose measurements

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the label and on the packaging.

Store below 25ºC.Do not freeze.

Storethe vial in the outer packaging to protect it from light.

After the first opening, the medication must be used immediately.

Do not usethe medicationif you observethatthe solution is cloudy, has sediment, or an intense color.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition ofOctagamocta50 mg/ml

• The active principle is 50 mg/ml human normal immunoglobulin (human antibodies) (of which at least 95% is immunoglobulin G).
• The other components are maltose, water for injection.
• The components used in the conditioning of Octagamocta 50 mg/ml do not contain latex.

Aspect of the product and content of the package

Octagamocta 50 mg/mlis a perfusion solution and is available in vials (2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml, 25 g/500 ml).

Presentations:

1 gin20 ml

2.5 gin50 ml

5 gin100 ml

10 gin200 ml

2 x 10 gin 2 x 200 ml

3 x 10 gin3 x 200 ml

25 gin500 ml

Only some sizes of packaging may be commercially available.

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

Marketing Authorization Holder

Octapharma S.A.

Avda. Castilla, 2.(P.E. San Fernando)
Ed. Dublín, 2nd Floor
28830 San Fernando de Henares

Madrid

Responsible for Manufacturing

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235, A-1100 Vienna, Austria

or

OctapharmaS.A.S.

70-72 rue de Marèchal Foch, BP 33, F-67380 Lingolsheim, France

or

Octapharma AB

SE-112 75 Stockholm, Sweden

or

Octapharma GmbH

Elisabeth Selbert Strasse 11, 40764 Langenfeld, Germany

Tel.: +49 (02173) 917 - 0
Fax: +49 (02173) 917 – 111

(only for Germany)

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

This leaflet was last revised on:07/2024

This information is intended exclusively for healthcare professionals:

• The medicine should be taken to room temperature or body temperature before administration.
• The solution should be from transparent to slightly opalescent and colorless to slightly yellow
• Do not use turbid or sediment-containing solutions.
• All unused products or waste material, should be disposed of in accordance with local requirements.
• This medicine should not be mixed with other medicines.
• The perfusion line should be cleaned before and after administration of the medicine, by circulating a 0.9% saline solution or a 5% dextrose solution through it.

The detailed and updated information on this medicine is available on the

website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.es/.