Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 5 g
Grifols Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: sorbitol; human immunoglobulin A; water for injections
Intravenous
5 g/50 mL - single vial pack
(S4) Prescription Only Medicine
Replacement therapy indications: - Primary Immunodeficiency (PI) Diseases - Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,Immunomodulation indications: - Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barr? syndrome - Kawasaki disease.
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
2013-02-12
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 10% DIF is and what it is used for 2. Before you use Flebogamma 10% DIF 3. How to use Flebogamma 10% DIF 4. Possible side effects 5. How to store Flebogamma 10% DIF 6. Further information 1. WHAT FLEBOGAMMA 10% DIF IS AND WHAT IT IS USED FOR WHAT FLEBOGAMMA 10% DIF IS Flebogamma 10% DIF is a solution for intravenous infusion containing 100 g/l human normal immunoglobulin. Flebogamma 10% DIF is one of the group of medicines called intravenous immunoglobulins. These are used to treat conditions where the body’s defence system against disease is not working properly. WHAT FLEBOGAMMA 10% DIF IS USED FOR Treatment of patients who do not have sufficient antibodies (replacement therapy): • Primary Immunodeficiency (PI) Diseases • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Treatment of patients with certain inflammatory disorders (immunomodulation): • Idiopathic Thrombocytopaenic Purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome. • It is used to treat Kawasaki disease, an illness in children where the blood vessels (arteries) in the body become enlarged. If you have any question about use of Flebogamma 10% DIF please ask your doctor. 2 2. BEFORE YOU USE FLEBOGAMMA 10% DIF DO NOT USE FLEBOGAMMA 10% DIF - If you are allergic (hypersensitive) to human normal immunoglobulin or any of the other ingredients of Flebogamma 10% DIF (see special warnin Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PRODUCT INFORMATION FLEBOGAMMA 10% DIF (HUMAN NORMAL IMMUNOGLOBULIN (IVIG) 100 MG/ML) SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Human normal immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flebogamma 10% 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 10% 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 , 27.9%, IgG 3 , 3.0%, and IgG 4 , 2.5%. Flebogamma 10% DIF contains only trace amounts of IgA (lower than 100 micrograms/ml). In the final formulation, Flebogamma 10% DIF contains 10 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 10% 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 Replacement therapy indications: • Primary Immunodeficiency (PI) Diseases • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. 2 Immunomodulation indications: • Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome. • Kawasaki disease. 4.2 D OSE AND Διαβάστε το πλήρες έγγραφο