Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
Immunoglobulin - normal; Normal Immunoglobulin (Human); normal immunoglobulin (human)
Grifols Australia Pty Ltd
Medicine Registered
GAMUNEX ® 1 CONSUMER MEDICINE INFORMATION GAMUNEX ® Normal Immunoglobulin (Human), 10% for Intravenous or Subcutaneous Administration WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GAMUNEX ® . It does not contain all the available information. 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 you receiving GAMUNEX ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT GAMUNEX ® IS USED FOR GAMUNEX ® is used to replace antibodies (used to fight infections) in people with conditions that impair the body’s ability to make antibodies. These conditions include: • Primary Immunodeficiency Diseases. • Symptomatic Hypogammaglobulinaemia secondary to underlying disease or treatment. _ _ GAMUNEX ® is also used to modulate the immune system in people whose immune systems are not working well. These conditions include • Idiopathic Thrombocytepenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. People with ITP have antibodies that do not work properly and may need treatment with GAMUNEX ® to raise blood platelet counts to prevent bleeding or prior to undergoing surgery. • Guillain Barré Syndrome (GBS). • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). • Kawasaki disease. This medicine belongs to a group of medicines called immunoglobulins. ASK YOUR DOCTOR Прочитайте повний документ
Page 1 of 20 PRODUCT INFORMATION NAME OF THE MEDICINE GAMUNEX ® , NORMAL IMMUNOGLOBULIN (HUMAN), 10%, FOR INTRAVENOUS OR SUBCUTANEOUS ADMINISTRATION DESCRIPTION GAMUNEX ® , normal immunoglobulin (human), 10%, is a ready-to-use sterile solution of human immune globulin protein for intravenous or subcutaneous administration. GAMUNEX ® supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacteria or their toxins. GAMUNEX ® consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. GAMUNEX ® contains trace levels of fragments and IgA (≤ 0.084 mg/mL) and IgM. The distribution of IgG subclasses is similar to that found in normal serum. The measured buffer capacity is 35 mEq/L and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285 - 295 mOsmol/kg). The pH of GAMUNEX ® is 4.0 – 4.5. GAMUNEX ® contains no preservative. GAMUNEX ® is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. The plasma is sourced from paid donors in the USA. Two of the four ethanol fractionation steps of the Cohn-Oncley process have been replaced by tandem anion-exchange chromatography. The IgG proteins are not subjected to heating or chemical or enzymatic modification steps. Fc and Fab functions of the IgG molecule are retained, but do not activate complement or pre-Kallikrein activity in an unspecific manner. The protein is stabilized during the process by Прочитайте повний документ