Panziga^® (Solution) Instructions for Use

Marketing Authorization Holder

Octapharma Pharmazeutika Produktionsges m.b.H. (Austria)

Manufactured By

Octapharma S.A.S. (France)

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur.)

Dosage Form

Panziga®

Infusion solution 100 mg/1 ml: fl. 10 ml, 25 ml, 50 ml, 100 ml, 200 ml or 300 ml

Dosage Form, Packaging, and Composition

Infusion solution transparent or slightly opalescent, from colorless to light yellow.

* accompanying plasma protein

Excipients : glycine – 17.3 mg, water for injections – up to 1 ml.

10 ml – glass bottles (1) – cardboard packs.
25 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
300 ml – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immunoglobulin

Pharmacological Action

Human Ig, 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 by intravenous infusion only. Do not administer as a bolus injection.

Determine the dose and frequency based on the specific indication, the patient’s clinical response, and individual tolerability.

For primary immunodeficiency syndromes, administer a starting dose of 0.4-0.8 g/kg body weight. Follow with maintenance doses of 0.2-0.8 g/kg every 3-4 weeks to maintain trough IgG levels above 5 g/L.

For idiopathic thrombocytopenic purpura, administer a total dose of 0.8-1.0 g/kg body weight. This can be given as a single daily infusion or divided over 2-3 consecutive days.

For Kawasaki disease, administer a single dose of 2.0 g/kg body weight as an intravenous infusion, in conjunction with acetylsalicylic acid therapy.

For secondary immunodeficiencies, administer a dose of 0.2-0.4 g/kg body weight every 3-4 weeks.

Adjust the infusion rate according to patient tolerability. Begin the infusion at 0.5 ml/kg/hour for the first 30 minutes. If well tolerated, gradually increase the rate to a maximum of 5.0 ml/kg/hour.

Do not exceed the recommended maximum infusion rate. Monitor the patient’s vital signs continuously during the infusion and for at least 20 minutes after its completion.

For pediatric patients, calculate the dose based on body weight. Adhere to the same infusion rate guidelines as for adults, adjusting for the child’s size and clinical condition.

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 lactation (breastfeeding).

Pediatric Use

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

Special Precautions

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

The recommended infusion rate of the drug should not be exceeded (severe adverse events 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.