Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Baxalta UK Ltd
J06BA02
Not applicable
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5413760415659
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR SUBCUTANEOUS USE HUMAN NORMAL IMMUNOGLOBULIN This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What HyQvia is and what it is used for 2. What you need to know before you use HyQvia 3. How to use HyQvia 4. Possible side effects 5. How to store HyQvia 6. Contents of the pack and other information 1. WHAT HYQVIA IS AND WHAT IT IS USED FOR WHAT HYQVIA IS HyQvia contains two solutions for infusion (drip) under the skin (subcutaneous or SC infusion). It is supplied as a package containing one vial of human normal immunoglobulin 10% (the active substance) and one vial of recombinant human hyaluronidase (a substance which helps the human normal immunoglobulin 10% reach your blood). Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”. Immunoglobulins are also known as antibodies and are found in healthy people’s blood. Antibodies are part of the immune system (the body’s natural defences) and help your body to fight infections. HOW HYQVIA WORKS The vial of immunoglobulins has been prepared from the blood of healthy people. The medicine works in exactly the same way as the immunoglobulins naturally present in the Citiți documentul complet
OBJECT 1 HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR SUBCUTANEOUS USE Summary of Product Characteristics Updated 24-May-2017 | Shire Pharmaceuticals Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product HyQvia 100 mg/ml solution for infusion for subcutaneous use 2. Qualitative and quantitative composition HyQvia is a dual vial unit consisting of one vial of human normal immunoglobulin (Immune Globulin 10% or IG 10%) and one vial of recombinant human hyaluronidase (rHuPH20). Human normal immunoglobulin (SCIg) One ml contains: Human normal immunoglobulin...................100 mg (purity of at least 98% IgG) Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG 1 ≥ 56.9% IgG 2 ≥ 26.6% IgG 3 ≥ 3.4% IgG 4 ≥ 1.7% The maximum IgA content is 140 micrograms/ml. Produced from the plasma of human donors. Excipients with known effects: • Recombinant human hyaluronidase (rHuPH20) Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. • Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion (infusion). IG 10% is a clear or slightly opalescent and colourless or pale yellow solution. Recombinant human hyaluronidase is a clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Replaceme Citiți documentul complet