Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Normal immunoglobulin human
Grifols UK Ltd
Normal immunoglobulin human
100mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 14050100; GTIN: 4250414900151
OBJECT 1 GAMUNEX 10% Summary of Product Characteristics Updated 03-Nov-2014 | Grifols UK Ltd 1. Name of the medicinal product _Gamunex 10%,_ 100 mg/ml, solution for infusion 2. Qualitative and quantitative composition Human normal immunoglobulin (IVIg) One ml contains: human normal immunoglobulin ...............................................................................100 mg (purity of at least 98% IgG) One vial of 10 ml contains: 1 g One vial of 50 ml contains: 5 g One vial of 100 ml contains: 10 g One vial of 200 ml contains: 20 g Distribution of the IgG subclasses (average values): IgG1 .................... 62.8% IgG2 .................... 29.7% IgG3 ...................... 4.8% IgG4 ................ ....2.7% 1 ml _Gamunex 10%_ contains 100 mg protein with an IgG content of at least 98% (IgA content: mean: 59 micrograms/ml; max.: 84 micrograms/ml; results from 5 different batches). Produced from plasma of human donors. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion 4. Clinical particulars 4.1 Therapeutic indications Replacement therapy in adults, and children and adolescents (0-18 years): - Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). - Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed. - Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation. - Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT). - Congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome. - Kawasaki disease. - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 4.2 Posology and Прочитајте комплетан документ