Privigen 50ml IV infusion
Marketed by Dexa Medica
Ingredients in every 50 ml
|Human normal immunoglobulin||5000 mg|
Each package contains
|ATC Level 1||J - Antiinfectives for systemic use|
|ATC Level 2||J06 - Immune Sera and Immunoglobulins|
|ATC Level 3||J06B - Immunoglobulins|
The dosage and dosage regimen is dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response. The following dosage regimens are givens as a guideline.
Replacement therapy in primary immunodeficiency syndromes
The dosage regimen should achieve a through IgG level (measured before the next infusion) of at least 5 to 6 g/L. Three to 6 months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) followed by at least 0.2 g/kg bw every 3 to 4 weeks.
The dose required to achieve a through level of 5 to 6 g/L is of the order of 0.2 to 0.8 g/kg bw/month. The dosage interval when steady state has been reached varies from 3 to 4 weeks. Trough levels should be measured in order to adjust the dose and dosage interval.
Replacement therapy in myelomas or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with congenital AIDS and recurrent infections
The recommended dosage is 0.2 to 0.4g/kg bw every 3 to 4 weeks.
Replacement therapy in hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT)
The recommended dose is 0.2-0.4g/kg bw every 3-4 weeks.
Immune thrombocytopenic purpura
0.8 to 1 g/kg bw on day one, which may be repeated once within 3 days, or 0.4g/kg bw daily for 2 to 5 days. The treatment can be repeated if relapse occurs.
0.4g/kg bw/day over 5 days. Experience in children is limited.
1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Chronic inflammatory demyelinating polyneuropathy (CIDP)
The recommended starting dose is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw over 1 to 2 consecutive days every 3 weeks.
The long-term therapy over 24 weeks should be subject to the physician's discretion depends on the patient's response to the maintenance therapy. The dosage regimen are adjusted according to the individual course of the disease.
Replacement therapy in
1. Primary immunodeficiency syndromes (PID) such as:
– congenital agammaglobulinaemia and hypogammaglobulinaemia
– common variable immunodeficiency
– severe combined immunodeficiency
– Wiskott-Aldrich syndrome
2. Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections
3. Children with congenital AIDS and recurrent infections
4. Hypogammaglobulinaemia in patients after allogenic haematopoietic stem cell transplantation (HSCT)
1. Immune trombocytopenia purpura (ITP) in children or Adults at high risk of bleeding or prior to surgical interventions to correct the platelet count
2. Guillain-Barre syndrome
3. Kawasaki disease
4. Chronic inflammatory demyelinating polyneuropathy (CIDP).