Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
HUMAN NORMAL, IMMUNOGLOBULIN
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Withdrawn
2005-10-04
Intraglobin F / Package insert 1/7 PACKAGE INSERT INTRAGLOBIN ® F 50 mg/ml; solution for infusion ACTIVE SUBSTANCE Human normal immunoglobulin for intravenous administration COMPOSITION 1 ml solution contains − active substance(s): human plasma protein 50 mg thereof immunoglobulin ≥ 95 % − excipient(s): glucose monohydrate (corresponding to 25 mg glucose), sodium ions (78 µmol), chloride ions (78 µmol), water for injections. The distribution of IgG subclasses is defined around 62 % IgG1, 34 % IgG2, 0.5 % IgG3 and 3.5 % IgG4. The IgA content is limited to ≤ 2.5 mg/ml. PHARMACEUTICAL FORM Solution for infusion. The solution is clear to slightly opalescent and colourless to pale yellow. PRESENTATIONS Ampoule with 10 ml and 20 ml Vial with 50 ml, 100 ml and 200 ml PHARMACOTHERAPEUTIC GROUP Human normal immunoglobulin for intravenous administration NAME AND ADDRESS OF AUTHORIZATION HOLDER AND MANUFACTURER Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany Intraglobin F / Package insert 2/7 INDICATIONS Replacement therapy in: Primary immunodeficiency syndromes: − congenital agammaglobulinaemia and hypogammaglobulinaemia − common variable immunodeficiency − severe combined immunodeficiencies Secondary hypogammaglobulinaemia in patients with chronic lymphocytic leukaemia and multiple myeloma with recurrent bacterial infections. Children with congenital AIDS who have repeated bacterial infections. Immunomodulation Idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count. Kawasaki disease. Allogeneic bone marrow transplantation CONTRA-INDICATIONS Hypersensitivity to any of the components. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficie Aqra d-dokument sħiħ
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Intraglobin ® F 50 mg/ml; solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin for intravenous use (IVIg) Human plasma protein 50 g/l of which at least 95 % is IgG. The distribution of IgG subclasses is defined around 62 % IgG1, 34 % IgG2, 0.5 % IgG3 and 3.5 % IgG4. The IgA content in finished product is limited to ≤ 2.5 mg/ml. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is clear to slightly opalescent and colourless to pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in: Primary immunodeficiency syndromes: − congenital agammaglobulinaemia and hypogammaglobulinaemia − common variable immunodeficiency − severe combined immunodeficiencies Multiple myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Immunomodulation Idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count. Kawasaki disease. Allogeneic bone marrow transplantation Page 2 of 8 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dose and dosage regimen is dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline: Replacement therapy in primary immunodeficiency syndromes The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 - 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occu Aqra d-dokument sħiħ