Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Immunoglobulin G - human
Sandoglobulin NF Liquid_AU_CMI_3.00 Page 1 of 5 Consumer Medicine Information SANDOGLOBULIN ® NF LIQUID NORMAL IMMUNOGLOBULIN (HUMAN) 12 % (120 G/L) - INTRAVENOUS INJECTION WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about Sandoglobulin ® NF Liquid. It does not contain all the available information about Sandoglobulin ® NF Liquid. 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 taking Sandoglobulin ® NF Liquid 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 need to read it again. WHAT SANDOGLOBULIN ® NF LIQUID IS USED FOR Your medicine is Sandoglobulin ® NF Liquid. Sandoglobulin ® NF Liquid contains human ‘immunoglobulins’ which are also called antibodies, 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 Sandoglobulin ® NF Liquid either for the replacement of antibodies because your antibody levels are low (referred to as immunodeficiency) or for a condition where there is an imbalance in your immune system requiring treatment with antibodies (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. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU ARE GIVEN SANDOGLOBULIN ® NF LIQUID MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY YOU SHOULD NOT BE GIVEN Прочитајте комплетан документ
Sandoglobulin NF Liquid_AU_PI_2.00 Page 1 of 10 Product Information SANDOGLOBULIN ® NF LIQUID AUSTRALIA NAME OF THE MEDICINE Normal immunoglobulin (Human) 12 % (120 g/L) – intravenous injection DESCRIPTION Sandoglobulin ® NF Liquid is a sterile, clear or slightly opalescent, colourless or pale yellow solution of unmodified human immunoglobulin for intravenous injection. Sandoglobulin ® NF Liquid has a nominal osmolality of 360 mOsmol/kg and is approximately isotonic. The pH value of the ready-to-use solution is 5.3 and the solution contains no buffer substances. Sandoglobulin ® NF Liquid is supplied as a 50 mL or 100 mL solution containing 6 g or 12 g of human immunoglobulin respectively. The concentration of the active ingredient (unmodified immunoglobulin G (IgG) of human origin) is 12 % (120 g/L). At least 96 % (typically 99 %) of the total protein is IgG (at least 90 % of it exists as monomers and dimers). The product contains further small amounts of IgG fragments (≤ 10 %), aggregates (≤ 2 % - typically 0.5 %), albumin (≤ 3 %) and traces of Immunoglobulin A (IgA) and Immunoglobulin M (IgM). The level of IgA in the product is normally below 15 mg/L. The distribution of the IgG subclasses present in Sandoglobulin ® NF Liquid closely resembles that in normal human plasma. The distribution of IgG subclasses present in Sandoglobulin ® NF Liquid is, on the average, 64.5 % IgG 1 , 32.4 % IgG 2 , 2.3 % IgG 3 and 0.8 % IgG 4 . Prekallikrein activator (PKA) levels are less than 10 IU/mL. Sandoglobulin ® NF Liquid contains the following stabilisers: proline, isoleucine and nicotinamide. The stabilisers, in particular nicotinamide, minimise the formation of IgG dimers, which is important for the tolerability of the product. The preparation contains traces of sodium chloride (≤ 10 mmol/L). Sandoglobulin ® NF Liquid contains no carbohydrates (for example sucrose or maltose) or antimi Прочитајте комплетан документ