देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
HUMAN NORMAL, IMMUNOGLOBULIN
Kedrion S.p.A Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga - Lucca, Italy
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN 50 g/l
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 50 g/l
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2005-10-27
_ _ _ _ _IgVena-PIL-50-100-200 ml-MT-K22 _ _Page 1 of 13 _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER IG VENA 50 G/L SOLUTION FOR INFUSION HUMAN NORMAL IMMUNOGLOBULIN (IVIG) FOR INTRAVENOUS USE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What IG Vena is and what it is used for 2. What you need to know before you use IG Vena 3. How to use IG Vena 4. Possible side effects 5. How to store IG Vena 6. Contents of the pack and other information 1. WHAT IG VENA IS AND WHAT IT IS USED FOR IG Vena is a solution of human normal immunoglobulin for intravenous use. Immunoglobulins are human antibodies present also in the blood. IG Vena is used for: TREATMENT OF ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS) WHO DO NOT HAVE SUFFICIENT ANTIBODIES (REPLACEMENT THERAPY) IN THE FOLLOWING CASES: 1. Patients with inborn deficiency of antibodies production (primary immunodeficiency syndromes) 2. Patients with acquired deficiency of antibody production (secondary immunodeficiencies) who suffer from severe or recurrent infections due to different medical conditions (e.g. oncological or autoimmune diseases or due to the consequent treatment of those diseases). Those patients demonstrated ineffective treatment with antibiotics and either did not have sufficiently positive increment of IgG titer of antibody after vaccination (pneumococcal polysaccharide and polypeptide antigen vaccines) or had a level of Ig G in their blood <4 g/l. TREATMENT OF ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS) WITH CERTAIN INFLAMMATORY DISORDERS (IMMUNOMODULATION) IN THE FOLLOWING SITUATIONS: 1. Patients who do not have enough blood platelets (Primary Immune Thrombocytopenia, ITP), and पूरा दस्तावेज़ पढ़ें
_Ig Vena-SPC-MT-K22 _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IG Vena 50 g/l Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg). One ml of solution contains: Human normal immunoglobulin 50 mg (purity of at least 95% IgG) Each vial of 20 ml contains: 1 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains:10 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG 1 62,1 % IgG 2 34,8 % IgG 3 2,5 % IgG 4 0,6 % The maximum IgA content is 50 micrograms/ml. Produced from the plasma of human donors. Excipients with known effect: The product contains 100 mg of maltose per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution should be clear or slightly opalescent, colourless or pale yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, and children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes (PID) with impaired antibody production • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either PROVEN SPECIFIC ANTIBODY FAILURE (PSAF)* or serum IgG level of <4 g/l _Ig Vena-SPC-MT-K22 _ * PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines 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 (in conjunction with acetylsalicylic acid; see 4.2) • Chronic inflammatory demyelinating poliradiculoneuropathy (CIDP) • Multifocal motor neuropathy (MMN) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Replacement th पूरा दस्तावेज़ पढ़ें