Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
immunoglobulin human normal
Octapharma Pharmazeutica Produktionsges. m.b.H. Oberlaaer Strasse 235
immunoglobulin human normal
50mg/ml
solution for infusion
Prescription
_20130415_spc_840_AM_01.00_en.doc _ _1/11 _ SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OCTAGAM 50 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENTS Human normal immunoglobulin (IVIg) 2.2 QUANTITATIVE COMPOSITION 1 ml solution contains: Protein, of which > 95% is human normal immunoglobulin G 50 mg IgA <0.2 mg Distribution of IgG subclasses: IgG 1 ca. 60% IgG2 ca. 32% IgG3 ca. 7% IgG4 ca. 1% For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _4.1.1_ _ _ _REPLACEMENT THERAPY IN: _ • Primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia _20130415_spc_840_AM_01.00_en.doc _ _2/11 _ - common variable immunodeficiency - severe combined immunodeficiencies - Wiskott Aldrich syndrome. • Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. • Children with congenital AIDS who have repeated bacterial infections. _4.1.2_ _ _ _IMMUNOMODULATION _ • Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome • Kawasaki disease. _4.1.3_ _ _ _ALLOGENEIC BONE MARROW TRANSPLANTATION _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _4.2.1_ _ _ _POSOLOGY _ The dose and dosage regimen is dependant on the indication. _ _ In replacement therapy the dosage may need to be individualised for each patient dependant on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline. • The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4.0 - 6.0 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 - 0.8 g/kg followed by at least 0.2 g/kg every three weeks. Replacement therapy in primary immunodefic Lees het volledige document