国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
Human normal immunoglobulin
Baxalta Innovations GmbH
J06BA01
human normal immunoglobulin
Immune sera and immunoglobulins,
Immunologic Deficiency Syndromes
Replacement therapy in adults, children and adolescents (0-18 years) in:Primary immunodeficiency syndromes with impaired antibody production.Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra‑indicated.Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.Hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (HSCT).
Revision: 20
Authorised
2013-05-16
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR SUBCUTANEOUS USE HUMAN NORMAL IMMUNOGLOBULIN 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 2 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) • one vial of recombinant human hyaluronidase (a substance which helps the human normal immunoglobulin 10% reach your blood). Human normal immunoglobulin 10% belong 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 recombinant human hyaluronidase is a protein that makes it easier for the immunoglobulins to be infused (dripped) under the skin and to reach your blood system. The vial of immunoglobulins has been prepared from the blood of healthy people. Immunoglobulins are produced by the human body’s immune system. They help your body to fight infections caused by bacteria and viruses or maintain 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. Recombinant human hyaluronidase (rHuPH20) One mL contains: Recombinant human hyaluronidase. 160 units Each vial of 1.25 mL contains: 200 units of recombinant human hyaluronidase Each vial of 2.5 mL contains: 400 units of recombinant human hyaluronidase Each vial of 5 mL contains: 800 units of recombinant human hyaluronidase Each vial of 10 mL contains: 1600 units of recombinant human hyaluronidase Each vial of 15 mL contains: 2400 units of recombinant human hyaluronidase Excipients with known effects: • Recombinant human hyaluronidase (rHuPH20) The rHuPH20is 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 3. PHARMACEUTICAL FORM Solution for infusion. IG 10% is a clear or slightly opalescent and colourless or pale-yellow solution. The solution has a pH of 4.6 to 5.1 and an osmolality of 240 阅读完整的文件