Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 2.5 g
CSL Behring Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: glycine; water for injections
Intravenous
25mL
(S4) Prescription Only Medicine
Intragam? 10 is indicated for replacement IgG therapy in: ?Primary Immunodeficiency Diseases (PID) ?Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam? 10 is indicated for immunomodulatory therapy in: ?Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?Kawasaki disease ?Guillain-Barre Syndrome (GBS) ?Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ?Multifocal Motor Neuropathy (MMN) ?Myasthenia Gravis (MG) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe MG when other treatments have been ineffective or caused intolerable side effects ?Short-term therapy for severely affected nonparaneoplastic Lambert-Eaton Myasthenic Syndrome (LEMS) patients ?Treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.
Visual Identification: Clear or slightly opalescent, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2011-04-01
Intragam 10 AU CMI 12.00 Page 1 of 5 INTRAGAM ® 10 Human Normal Immunoglobulin 10% (10 g/100 mL), solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Intragam ® 10. It does not take the place of talking to your doctor. It does not contain all the available information about Intragam ® 10. All medicines have risks and benefits. Your doctor has weighed the benefits of you receiving Intragam ® 10 against the possible risks. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE,_ _ ASK YOUR DOCTOR. FOLLOW YOUR DOCTOR’S ADVICE EVEN IF IT IS DIFFERENT FROM WHAT THIS LEAFLET SAYS. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT AS YOU MAY NEED TO READ IT AGAIN. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated. WHAT INTRAGAM ® 10 IS USED FOR Your medicine is Intragam ® 10, a solution for intravenous infusion. Intragam ® 10 contains human immunoglobulins and is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Immunoglobulins are also called antibodies and are a type of protein found in the blood. Immunoglobulins are produced by your body’s immune system to fight infections caused by bacteria and viruses. If you do not have enough antibodies you may not be able to fight off diseases. Your doctor may give you Intragam ® 10 either for: • the replacement of antibodies because your antibody levels are low (referred to as immunodeficiency), or • a condition where there is an imbalance in your immune system requiring treatment with antibodies (referred to as immunomodulation). Your doctor may have prescribed Intragam ® 10 for another reason. Ask your doctor if you have any questions about why Intragam ® 10 has been prescribed for you. BEFORE YOU ARE GIVEN INTRAGAM ® 10 MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY Olvassa el a teljes dokumentumot
Intragam 10 AU PI 12.00 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION INTRAGAM ® 10 (HUMAN NORMAL IMMUNOGLOBULIN) 1 NAME OF THE MEDICINE Human Normal Immunoglobulin 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Intragam ® 10 is a sterile, preservative free, clear or slightly opalescent and colourless or pale yellow solution for intravenous infusion. Intragam ® 10 contains 10% (10 g/100 mL) of human plasma protein with a purity of at least 98% immunoglobulin G (IgG). At least 90% of the IgG consists of monomers and dimers (typically >96%). Aggregates are <3%. The distribution of the IgG subclasses closely resembles that found in normal human plasma (approximate mean ranges: 47.6–56.2% IgG 1 , 41.5–49.5% IgG 2 , 1.3–1.6% IgG 3 , 0.9– 1.3% IgG 4 ). Intragam ® 10 has a nominal osmolality of 350 mOsmol/kg and is approximately isotonic. The pH value of the ready-to-use solution is 4.25 (4.05–4.45). Intragam ® 10 contains 2.25 g of glycine in each 100 mL as a stabiliser which is a physiological non-essential amino acid. Intragam ® 10 does not contain a carbohydrate stabiliser (e.g. sucrose, maltose) and contains no preservative. Intragam ® 10 contains only trace amounts of IgA, typically <0.025 mg/mL. The maximum prekallikrein activator (PKA) levels are less than 28.6 IU/mL (typically ≤1.2 IU/mL). Intragam ® 10 is manufactured from human plasma collected by Australian Red Cross Lifeblood. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Intragam ® 10 is indicated for replacement IgG therapy in: • Primary Immunodeficiency Diseases (PID) • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam 10 AU PI 12.00 Page 2 of 17 Intragam ® 10 is indicated for immunomodulatory therapy in: • Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count • Kawasaki disease • Guillain-Barré Syndrome (GBS) • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP Olvassa el a teljes dokumentumot