Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Normal immunoglobulin human
Bio Products Laboratory Ltd
J06BA02
Normal immunoglobulin human
50mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 14050100; GTIN: 5019943000010
VIGAM ® LIQUID 2.5 G, 5 G AND 10 G 5% W/V SOLUTION FOR INFUSION HUMAN NORMAL IMMUNOGLOBULIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. VLL12 • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT VIGAM LIQUID IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIGAM LIQUID 3. HOW TO USE VIGAM LIQUID 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE VIGAM LIQUID 6. CONTENT OF PACK AND OTHER INFORMATION 1. WHAT VIGAM LIQUID IS AND WHAT IT IS USED FOR Vigam Liquid is a solution containing the active substance called human normal immunoglobulin (a protein in the body used to fight infections) which is obtained from blood plasma from screened donors. These donors are selected from the USA. The product is given by injection into a vein (intravenous infusion). It can be given in a hospital or for use at home and is only available on a doctor’s prescription. This medicine is used to replace antibodies which are missing from your body in primary antibody deficiencies (lack of certain proteins protective against infection that you may either have been born with or may develop during life) such as: • agammaglobulinaemia (deficiency of gamma globulins in the blood), • hypogammaglobulinaemia (low levels of immunoglobulin G (IgG), IgA and/or IgM), • common variable immunodeficiency (failure of the immune system to produce antibodies against infections), • severe combined immunodeficiency (a severe genetic disorder of the immune system making you susceptible to infections), • Wiskott Aldrich syndrome (hereditary disord Pročitajte cijeli dokument
OBJECT 1 VIGAM LIQUID IS A STERILE LIQUID OF 5 G% NORMAL IMMUNOGLOBULIN Summary of Product Characteristics Updated 23-Nov-2015 | Bio Products Laboratory Limited 1. Name of the medicinal product Vigam Liquid is a 5 % w/v normal immunoglobulin sterile liquid. 2. Qualitative and quantitative composition Human normal immunoglobulin (IVIg) One ml contains: Human normal immunoglobulin 50 mg (Purity of at least 95% IgG) Each 2.5 g vial of 50 mL contains: 2.5 g of Human normal immunoglobulin. Each 5 g vial of 100 mL contains: 5 g of Human normal immunoglobulin. Each 10 g vial of 200 mL contains: 10 g of Human normal immunoglobulin. Distribution of the IgG subclasses is similar to plasma (approximate values): IgG1: 64 % IgG2: 29 % IgG3: 6 % IgG4: 1 % The maximum IgA content is 14 micrograms/ml. Produced from the plasma of human donors. Excipient(s): For a full list of excipients see section 6.1. 3. Pharmaceutical form Vigam Liquid is a sterile liquid for intravenous administration which varies from colourless to pale amber or pale green. 4. Clinical particulars 4.1 Therapeutic indications Replacement therapy in adults, and children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed. • Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation. • Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT). • Congenital AIDS and recurrent bacterial infections 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 platelet count • Guillain Barré Syndrome • Kawasaki disease. 4.2 Posology and method of administration Replace Pročitajte cijeli dokument