দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
HUMAN NORMAL, IMMUNOGLOBULIN
Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2018-09-18
_PL139600201-5 _ 1/10 _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER OCTAGAM 50 MG/ML, SOLUTION FOR INFUSION Human Normal Immunoglobulin (IVIg) 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 pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT OCTAGAM 50 MG/ML IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAGAM 50 MG/ML 3. HOW TO USE OCTAGAM 50 MG/ML 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE OCTAGAM 50 MG/ML 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 _0B_ WHAT OCTAGAM 50 MG/ML IS AND WHAT IT IS USED FOR WHAT OCTAGAM 50 MG/ML IS Octagam 50 mg/ml is a human normal immunoglobulin (IgG) solution (i.e. solution of human antibodies) for intravenous administration (i.e. infusion into a vein). Immunoglobulins are normal constituents of the human body and support the immune defence of your body. Octagam 50 mg/ml contains all IgG activities which are present in the normal population. Adequate doses of this medicinal product may restore abnormally low IgG levels to the normal range. Octagam 50 mg/ml has a broad spectrum of antibodies against various infectious agents. WHAT OCTAGAM 50 MG/ML IS USED FOR Octagam 50 mg/ml is used as replacement therapy in children, adolescents (0-18 years) and adults in different groups of patients: - Patients with inborn deficiency of antibodies (primary immunodeficiency syndromes, such as congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies) - Patients with an acquired deficiency of antibodies (secondary immunodeficiency) due to spe সম্পূর্ণ নথি পড়ুন
_SPC121900201-5 _ _1/17 _ SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octagam 50 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains : Human normal immunoglobulin 50 mg (purity of at least 95% IgG) Each vial of 20 ml contains 1g of human normal immunoglobulin. Each bottle of 50 ml contains 2.5g of human normal immunoglobulin. Each bottle of 100 ml contains 5g of human normal immunoglobulin. Each bottle of 200 ml contains 10g of human normal immunoglobulin. Each bottle of 500 ml contains 25g of human normal immunoglobulin. Distribution of the IgG subclasses (approx. values): IgG 1 ca. 60% IgG2 ca. 32% IgG3 ca. 7% IgG4 ca. 1% The maximum IgA content is 200 micrograms/ml. Produced from the plasma of human donors. _Excipient(s) with known effect: _ This medicinal product contains 35 mg sodium per 100 ml, equivalent to 1.75% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The liquid preparation is clear to slightly opalescent and colourless to slightly yellow. The pH of the liquid preparation is 5.1 – 6.0, the osmolality is ≥ 240 mosmol/kg. _SPC121900201-5 _ _2/17 _ 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 <4g/l. *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 platele সম্পূর্ণ নথি পড়ুন