Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Normal immunoglobulin human
Octapharma Ltd
J06BA01
Normal immunoglobulin human
165mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 14050100; GTIN: 5060237670433
PACKAGE LEAFLET: INFORMATION FOR THE USER GAMMANORM, 165 MG/ML, SOLUTION FOR INJECTION Human normal immunoglobulin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. − 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 symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Gammanorm is and what it is used for 2. Before you use Gammanorm 3. How to use Gammanorm 4. Possible side effects 5. How to store Gammanorm 6. Further information 1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infections. The purpose of this treatment is to attain normal antibody levels. Gammanorm is used as replacement therapy in adults and children to treat primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency (CVID) - severe combined immunodeficiency - IgG subclass deficiencies with recurrent infections - myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. 2. BEFORE YOU USE GAMMANORM DO NOT USE GAMMANORM - if you are hypersensitive to human normal immunoglobulin or any of the other ingredients of Gammanorm. - intravenously (Gammanorm must not be administered into a vein). Page 1 of 7 Gammanorm, 165 mg/ml, solution for injection - Human normal immunoglobulin - intramuscularly (into a muscle) by yourself. Gammanorm must not be given into a muscle if you have any bleeding disorders. TAKE SPECIAL CARE WITH GAMMANORM - Tell your doctor if you have any other illnesses. - If Gammanorm is accidentally administered into a blood Read the complete document
OBJECT 1 GAMMANORM Summary of Product Characteristics Updated 22-Jun-2017 | Octapharma Limited 1. Name of the medicinal product GAMMANORM, 165 mg/ml, solution for injection 2. Qualitative and quantitative composition Human normal immunoglobulin (SC/IMIg) Human normal immunoglobulin 165 mg/ml* *corresponding to human protein content of which at least 95 % is IgG. One vial of 6 ml contains: 1 g* of human normal immunoglobulin. One vial of 10 ml contains: 1.65 g * of human normal immunoglobulin. One vial of 12 ml contains: 2 g* of human normal immunoglobulin. One vial of 20 ml contains: 3.3 g * of human normal immunoglobulin. One vial of 24 ml contains: 4 g* of human normal immunoglobulin. One vial of 48 ml contains: 8 g* of human normal immunoglobulin. Distribution of IgG subclasses: IgG 1 59% IgG 2 36% IgG 3 4.9% IgG 4 0.5% IgA max. 82.5 microgram/ml For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection The liquid preparation is clear or slightly opalescent and colourless or pale-yellow or light-brown. 4. Clinical particulars 4.1 Therapeutic indications Replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency (CVID) - severe combined immunodeficiency - IgG subclass deficiencies with recurrent infections Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. 4.2 Posology and method of administration POSOLOGY REPLACEMENT THERAPY The treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. The dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guidance. The dosage regimen using the subcutaneous route should achieve a sustained level of IgG. A loading dose of at least 0.2-0.5 g/kg may be required. Afte Read the complete document