Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 50 mg/mL
Grifols Australia Pty Ltd
normal immunoglobulin
Injection, intravenous infusion
Excipient Ingredients: human immunoglobulin A; water for injections; sorbitol
Intravenous
1 X 10mL vial
(S4) Prescription Only Medicine
Replacement Therapy in: Primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, Wiskott Aldrich Syndrome; Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital AIDS and recurrent infections. Immunomodulation: Idiopathic thrombocytopenia purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, Guillian Barre syndrome. Allogenic bone marrow transplantation.
Visual Identification: Clear or slightly opalescent, colourless or pale yellow solution; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2008-12-23
1 CONSUMER MEDICINE INFORMATION LEAFLET 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 Flebogamma 5% DIF is and what it is used for 2. Before you use Flebogamma 5% DIF 3. How to use Flebogamma 5% DIF 4. Possible side effects 5. How to store Flebogamma 5% DIF 6. Further information 1. WHAT FLEBOGAMMA 5% DIF IS AND WHAT IT IS USED FOR Flebogamma 5% DIF is a solution for intravenous infusion containing 50 g/l human normal immunoglobulin. This medicine belongs to the pharmacotherapeutic group called immune sera and immunoglobulins. Flebogamma 5% DIF is used for: Treatment of patients who do not have sufficient antibodies (replacement therapy): • Primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - Wiskott Aldrich syndrome • Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. • Children with congenital AIDS and recurrent infections. Treatment of patients with certain inflammatory disorders (immunomodulation): • Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome. Treatment or prevention of infections after a bone marrow transplantation (allogeneic bone marrow transplantation). 2 If you have any question about use of Flebogamma 5% DIF please ask your doctor. 2. BEFORE YOU USE FLEBOGAMMA 5% DIF DO NOT USE FLEBOGAMMA 5% DIF - if you are allergic (hypersensitive) to human n Lue koko asiakirja
1 AUSTRALIAN PRODUCT INFORMATION FLEBOGAMMA 5% DIF (HUMAN NORMAL IMMUNOGLOBULIN (IVIG) 50 MG/ML) SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Human normal immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flebogamma 5% DIF (dual _ _ inactivation plus nanofiltration) (IVIg) is a sterile, liquid ready to use, preparation of highly purified immunoglobulin (IgG) obtained from human plasma pools. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, ion exchange chromatography, low pH treatment, pasteurisation, solvent detergent treatment and two sequential nanofiltrations through 35 nm and 20 nm pore size nanofilters connected in series. Flebogamma 5% DIF is a highly purified (≥ 97% IgG), unmodified, human IgG that contains the antibody specificities found in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 66.6%, IgG 2 , 28.5%, IgG 3 , 2.7%, and IgG 4 , 2.2%. Flebogamma 5% DIF contains only trace amounts of IgA (lower than 0.05 mg/ml). In the final formulation, Flebogamma 5% DIF contains 5 g human normal immunoglobulin and 5 g sorbitol (as stabiliser) in 100 ml of water for injections. There is no preservative in the formulation. The Fc and Fab functions are maintained in Flebogamma 5% DIF. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. The pH of the solution ranges from 5 to 6 and the osmolality from 250 to 350 mOsm/kg, which is within the normal physiologic range. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Flebogamma 5% DIF is indicated for: Replacement therapy in: Primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - Wiskott Aldrich syndrome 2 Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital AIDS and r Lue koko asiakirja