Immunoglobulin Sigardis (Solution) Instructions for Use

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur.)

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 conditions (congenital complete or partial immunodeficiency, common 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 as an intravenous infusion only. Do not administer by bolus injection.

For primary immunodeficiency, administer a dose of 0.4-0.8 g/kg body weight every 3-4 weeks. Adjust the dose and interval to achieve a trough IgG level of at least 5-6 g/L.

For idiopathic thrombocytopenic purpura (ITP), administer a dose of 0.8-1.0 g/kg body weight. A second dose may be administered if required.

For chronic lymphocytic leukemia, administer a dose of 0.3-0.4 g/kg body weight every 3-4 weeks.

For Kawasaki syndrome, administer a single dose of 2.0 g/kg body weight in conjunction with acetylsalicylic acid.

For bone marrow transplantation, administer a dose of 0.5 g/kg body weight. Repeat doses weekly from one week before to three months after transplantation.

Initiate the first infusion at a rate of 0.5 mL/kg/hour. If well tolerated, gradually increase the rate every 30 minutes to a maximum of 4 mL/kg/hour.

For subsequent infusions, if the previous infusion was well tolerated, initiate at a rate of 1 mL/kg/hour and increase to a maximum of 4 mL/kg/hour.

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

Discontinue the infusion immediately if adverse reactions occur. Resume at a slower rate only after symptoms have completely resolved.

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, photophobia, 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 of serological tests.

The recommended infusion rate of the drug should not be exceeded (severe adverse reactions may develop). The patient must 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, and varicella (if administered within the first 2 weeks after vaccination against measles, mumps, and rubella, vaccinations with these vaccines should be repeated no earlier than after 3 months).

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.