Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Human plasma protein
Biotest Pharma GmbH
J06BA; J06BA02
Human plasma protein
100 gram(s)/litre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.
Marketed
2013-02-15
Intratect 100 g/L, solution for infusion Package leaflet 1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ INTRATECT 100 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 100 g/L is and what it is used for 2. What you need to know before you use Intratect 100 g/L 3. How to use Intratect 100 g/L 4. Possible side effects 5. How to store Intratect 100 g/L 6. Contents of the pack and other information 1. WHAT INTRATECT 100 G/L IS AND WHAT IT IS USED FOR Intratect 100 g/L 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 100 g/L 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 100 g/L can restore normal values when blood levels of Immunoglobulin G (IgG) are low. INTRATECT 100 G/L IS USED IN ADULTS, CHILDREN, AND ADOLESCENTS (0–18 YEARS) WHO DO NOT HAVE SUFFICIENT ANTIBODIES (REPLACEMENT THERAPY) IN CASES OF: • Patients who are born with a lack of antibodies (primary immunodeficiency syndromes, PID) • Acquired lack of antibodies (secondary immunodeficiency syndrome, SID) in patients who suffer from severe or recurrent infections and ineffective antimicrobial treatment with either proven specific antibody failure or low IgG level (< 4 g/L) INTRATECT 100 G/L IS ALSO USED IN ADULTS, CHILDREN, AND ADOLESCENTS (0–18 YEARS) TO T Read the complete document
Health Products Regulatory Authority 10 July 2023 CRN00DNZZ Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Intratect 100 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 100 mg (purity of at least 96% IgG) Each vial of 10 mL contains: 1 g of human normal immunoglobulin Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin Each vial of 50 mL contains: 5 g of human normal immunoglobulin Each vial of 100 mL contains: 10 g of human normal immunoglobulin Each vial of 200 mL contains: 20 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 1800 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 100 g/L has a pH of 5.0–5.6 and an osmolality of 280–380 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 * 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 inflammator Read the complete document