देश: साइप्रस
भाषा: यूनानी
स्रोत: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
IMMUNOGLOBULIN HUMAN NORMAL
BIO PRODUCTS LABORATORY LIMITED (0000009242) DAGGER LANE, ELSTREE, HERTFORDSHIRE, WD6 3BX
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
5G/100ML
SOLUTION FOR INTRAVENOUS INFUSION
IMMUNOGLOBULIN HUMAN NORMAL (8000012671) 5% W/V
INTRAVENOUS USE
Εθνική Διαδικασία
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 50ML (200016001) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 200 ml (200016002) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 100ML (200016003) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 _Vigam Liquid_ _PL 08801/0040_ 1. NAME OF THE MEDICINAL PRODUCT Vigam Liquid is a 5 % w/v normal immunoglobulin sterile liquid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) (IVIg) One ml contains: Human normal immunoglobulin 50 mg (Purity of at least 95% IgG) Each 2.5 g vial of 50 mL contains: 2.5 g of Human normal immunoglobulin. Each 5 g vial of 100 mL contains: 5 g of Human normal immunoglobulin. Each 10 g vial of 200 mL contains: 10 g of Human normal immunoglobulin. Distribution of the IgG subclasses is similar to plasma (approximate values): IgG1: 64 % IgG2: 29 % IgG3: 6 % IgG4: 1 % The maximum IgA content is 14 micrograms/ml. Produced from the plasma of human donors. Excipient(s): For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Vigam Liquid is a sterile liquid for intravenous administration which varies from colourless to pale amber or pale green. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, and children and adolescents (0-18 years) in: 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 and recurrent bacterial infections Immunomodulation in adults, and children and adolescents (0-18 years) in: 2 _Vigam Liquid_ _PL 08801/0040_ 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Replacement therapy should be initiated and monitore पूरा दस्तावेज़ पढ़ें