البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 5 g
CSL Behring Australia Pty Ltd
Injection, solution
Excipient Ingredients: proline; water for injections
Intravenous
5 g: 50 mL solution in a 50 mL bottle
(S4) Prescription Only Medicine
Replacement therapy for Primary immunodeficiency diseases (PID), Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Immunomodulatory therapy for Idiopathic thrombocytopenic purpura (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count, Guillain-Barr Syndrome (GBS), Kawasaki disease, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Multifocal Motor Neuropathy (MMN), Myasthenia Gravis (MG) exacerbations, Lambert-Eaton Myasthenic Syndrome (LEMS), Stiff Person Syndrome (SPS).
Visual Identification: Clear or slightly opalescent and colourless or pale yellow solution; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-07-07
Privigen AU CMI 3.00 Page 1 of 5 PRIVIGEN ® AU Normal immunoglobulin (Human) 10% (100 g/L), intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about Privigen ® AU. It does not contain all the available information about Privigen ® AU. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of giving you Privigen ® AU against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE,_ _ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may want to read it again. WHAT PRIVIGEN ® AU IS USED FOR Your medicine is Privigen ® AU. Privigen ® AU is a ready-to-use solution for intravenous infusion. Privigen ® AU 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 Privigen ® AU 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 immunoglobulins (referred to as immunomodulation). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. This medicine is not addictive. BEFORE YOU ARE GIVEN PRIVIGEN ® AU MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY YOU SHOULD NOT BE GIVEN THIS MEDICINE. INFORM YOUR DOCTOR OF YOUR BLOOD GROUP, IF KNOWN. YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE: • a history of allergy to human immunoglobulin products (allerg اقرأ الوثيقة كاملة
Privigen AU PI 3.00 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION PRIVIGEN ® AU (HUMAN NORMAL IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human Normal Immunoglobulin 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Privigen ® AU is a sterile, clear or slightly opalescent, colourless or pale yellow solution of human normal immunoglobulin for intravenous infusion. Privigen ® AU is a 10% solution containing 100 mg/mL of total human plasma protein with a purity of at least 98% immunoglobulin G (IgG). More than 90% of the IgG consists of monomers and dimers, aggregates (≤2%–typically below 0.1%) and albumin (≤3%). The distribution of the IgG subclasses is similar to that of normal human plasma (approximate values: 69% IgG 1 , 26% IgG 2 , 3% IgG 3 , 2% IgG 4 ). Privigen ® AU has a nominal osmolality of 320 mOsm/kg and is approximately isotonic. The pH value of the ready-to-use solution is 4.6–5.0. The product contains 250 mmol/L of L-proline as a stabiliser which is a physiological non-essential amino acid. Privigen ® AU contains no carbohydrate stabiliser (e.g. sucrose, maltose) and no preservative, and it has a low sodium content of ≤1 mmol/L. The maximum IgA content is 0.025 mg/mL. Prekallikrein activator (PKA) levels are less than 10 IU/mL. Privigen ® AU is manufactured from human plasma collected in Australia by Australian Red Cross Lifeblood. Privigen ® is manufactured from human plasma collected outside Australia by CSL Plasma. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS REPLACEMENT THERAPY • Primary Immunodeficiency Diseases (PID). • Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Privigen AU PI 3.00 Page 2 of 20 IMMUNOMODULATORY THERAPY • Idiopathic Thrombocytopenic Purpura (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain- اقرأ الوثيقة كاملة