Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Malta Medicines Authority
HUMAN NORMAL, IMMUNOGLOBULIN
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2012-04-09
Intratect, 50 g/L, solution for infusion Package leaflet PAGE 1 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ INTRATECT, 50 G/L, 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, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Intratect is and what it is used for 2. What you need to know before you use Intratect 3. How to use Intratect 4. Possible side effects 5. How to store Intratect 6. Contents of the pack and other information 1. WHAT INTRATECT IS AND WHAT IT IS USED FOR Intratect is an extract of human blood which contains antibodies (the body’s own defensive substances) to diseases, available in the form of a solution for infusion. The solution is ready for infusion into a vein (a “drip”). Intratect contains human normal immunoglobulin (antibodies) from blood donated by a broad spectrum of the population and is likely to contain antibodies to most common infectious diseases. Adequate doses of Intratect can restore normal values when blood levels of Immunoglobulin G are low. Intratect is used in adults, and children and adolescents (0-18 years) who do not have sufficient antibodies (replacement therapy) in cases of: • Patients born with lack of antibodies (primary immunodeficiency syndromes) • Patients* suffering from severe or recurrent infections and ineffective antimicrobial treatment with lack of antibodies (secondary immunodeficiencies) *Patients with proven specific antibody failure or IgG level < 4 g/L Intratect is also used in adults, and children and adolescents (0-18 years) to treat inflammatory disorders (immunomodulation) such as: • Primary immune thrombocytopenia (ITP, where a patie Կարդացեք ամբողջական փաստաթուղթը
PAGE 1 OF 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Intratect, 50 g/L, solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Human normal immunoglobulin (IVIg) 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION One mL contains: Human normal immunoglobulin 50 mg (purity of at least 96% 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): IgG1 57% IgG2 37% IgG3 3% IgG4 3% The maximum IgA content is 900 micrograms/mL. Produced from the plasma of human donors. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is clear to slightly opalescent and colourless to pale yellow. Intratect has a pH of 5.0–5.6 and an osmolality of 250–350 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, 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 PAGE 2 OF 13 * PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines Immunomodulation in adults, 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 section 4.2) • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) • Multifocal motor neuropathy (MMN) 4.2 POSOLOGY AND METHOD OF A Կարդացեք ամբողջական փաստաթուղթը