Country: Malta
Language: English
Source: Medicines Authority
HUMAN NORMAL, IMMUNOGLOBULIN
Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2016-02-23
Page 1 of 7 _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER PANZYGA, 100 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 only. 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 Panzyga is and what it is used for 2. What you need to know before you use Panzyga 3. How to use Panzyga 4. Possible side effects 5. How to store Panzyga 6. Contents of the pack and other information 1. WHAT PANZYGA IS AND WHAT IT IS USED FOR WHAT PANZYGA IS Panzyga 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 blood and support the immune defense of your body. Panzyga contains all IgG which are present in the human blood of healthy people. Adequate doses of Panzyga may restore abnormally low IgG levels to the normal range. Panzyga has a broad spectrum of antibodies against various infectious agents. WHAT PANZYGA IS USED FOR Panzyga is used as replacement therapy in children and 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 specific diseases and/or treatments and experiencing severe or recurrent infections Panzyga can be further Read the complete document
_Page 1 of 15 _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Panzyga, 100 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains: Human normal immunoglobulin………………….100 mg (Purity of at least 95 % 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 bottle of 50 ml contains: 5 g of human normal immunoglobulin. Each bottle of 60 ml contains: 6 g of human normal immunoglobulin. Each bottle of 100 ml contains: 10 g of human normal immunoglobulin. Each bottle of 200 ml contains: 20 g of human normal immunoglobulin. Each bottle of 300 ml contains: 30 g of human normal immunoglobulin. Distribution of the IgG subclasses (approx. values): IgG 1 65 % IgG 2 28 % IgG 3 3 % IgG 4 4 % The maximum IgA content is 300 micrograms/ml Produced from the plasma of human donors. Excipient(s) with known effect This medicinal product contains 69 mg sodium per vial of 100 ml equivalent to 3.45% 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 solution is clear or slightly opalescent and colourless or pale yellow. The pH of the solution is 4.5 to 5.0, the osmolality is ≥ 240 mosmol/kg. _Page 2 of 15 _ _ _ 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: • Read the complete document