Pentaglobin (Solution) Instructions for Use

Marketing Authorization Holder

Biotest Pharma, GmbH (Germany)

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur.)

Dosage Form

Pentaglobin

Solution for intravenous administration 50 mg/1 ml: 10 ml or 20 ml amp., 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

10 ml – ampoules (1) – cardboard packs.
20 ml – ampoules (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

Human immunoglobulin, by replenishing the deficiency of antibodies, reduces the risk of developing infections in patients with primary and secondary immunodeficiency.

Indications

Congenital immunodeficiency states (congenital complete or partial immunodeficiency, variable immunodeficiency, severe combined immunodeficiencies, Wiskott-Aldrich syndrome); idiopathic thrombocytopenic purpura (especially acute forms in children).

Acquired immunodeficiency (chronic lymphocytic leukemia, AIDS in children, bone marrow transplantation and other types of transplantation); Kawasaki syndrome (as an addition to acetylsalicylic acid therapy); prevention and therapy of infectious diseases.

ICD codes

Dosage Regimen

Administer Pentaglobin solution by intravenous infusion only.

Determine the dose and infusion rate based on the specific indication, patient’s clinical condition, and body weight.

For replacement therapy in immunodeficiencies, administer a dose of 0.2 to 0.4 ml/kg body weight (equivalent to 10 to 20 mg IgM/kg).

Infuse this dose once daily for three consecutive days.

For severe bacterial infections, administer a dose of 1.0 ml/kg body weight (equivalent to 50 mg IgM/kg) once daily.

Continue this regimen for three consecutive days; in life-threatening situations, administer for up to five days.

For idiopathic thrombocytopenic purpura (ITP), administer a higher dose of 1.6 to 2.0 ml/kg body weight (equivalent to 80 to 100 mg IgM/kg) once daily for two to five consecutive days.

Adjust the total daily dose and duration based on the patient’s platelet count response.

Initiate the infusion at a low rate of 0.3 ml/kg/hour.

If well tolerated after 15 minutes, gradually increase the infusion rate to a maximum of 2.0 ml/kg/hour.

Do not exceed the maximum recommended infusion rate.

Monitor the patient’s vital signs continuously throughout the infusion and for at least 20 minutes after its completion.

Use an infusion pump to ensure accurate control of the administration rate.

Do not mix Pentaglobin with other intravenous medications or solutions.

Use the solution immediately after opening the vial or ampoule; discard any unused portion.

Adverse Reactions

Headache, chills, increased body temperature, nausea, vomiting, joint pain, back pain, allergic reactions.

Rarely – decreased blood pressure, in isolated cases – anaphylactic shock, symptoms of aseptic meningitis (severe headache, nausea, vomiting, increased body temperature, neck stiffness, photosensitivity, impaired consciousness), worsening of renal failure in patients with impaired renal function.

Contraindications

Hypersensitivity, IgA deficiency in the presence of antibodies against IgA in the patient.

With caution pregnancy, lactation period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during lactation (breastfeeding).

Pediatric Use

Use is possible according to indications and in accordance with the dosage regimen.

Special Precautions

A temporary increase in the content of administered antibodies in the patient’s blood after immunoglobulin administration may cause false-positive results in serological tests.

The recommended infusion rate of the drug should not be exceeded (severe adverse reactions may develop). The patient should be under medical supervision throughout the entire infusion period and for 20 minutes after it.

Drug Interactions

Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chickenpox (if administered within the first 2 weeks after vaccination against measles, mumps, and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months later).

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.