Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
human normal immunoglobulin (SCIg)
CSL Behring GmbH
J06BA01
human normal immunoglobulin (SCIg)
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 (see section 4.4).- Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of
Revision: 21
Authorised
2011-04-14
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER HIZENTRA 200 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION Human normal immunoglobulin (SCIg = S ub C utaneous I mmuno G lobulin) 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 or healthcare professional. − 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 healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hizentra is and what it is used for 2. What you need to know before you use Hizentra 3. How to use Hizentra 4. Possible side effects 5. How to store Hizentra 6. Contents of the pack and other information 1. WHAT HIZENTRA IS AND WHAT IT IS USED FOR WHAT HIZENTRA IS Hizentra belongs to the class of medicines called human normal immunoglobulins. Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections. HOW HIZENTRA WORKS Hizentra contains immunoglobulins that have been prepared from the blood of healthy people. Immunoglobulins are produced by human body’s immune system. They help your body to fight infections caused by bacteria and viruses or maintain the balance in your immune system (referred to as immunomodulation). The medicine works in exactly the same way as the immunoglobulins naturally present in your blood. WHAT HIZENTRA IS USED FOR _Replacement therapy _ Hizentra is used to raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy). The medicine is used in adults and children (0-18 years) in the following situations: 1. Treatment of patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficienci Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Hizentra 200 mg/ml solution for subcutaneous injection Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (SCIg) One ml contains: Human normal immunoglobulin ................................................................................................... 200 mg (purity: at least 98% is immunoglobulin type G (IgG)) Vials Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin Pre-filled syringes Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin Each pre-filled syringe of 20 ml solution contains: 4 g human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG1 ............ 69% IgG2 ............ 26% IgG3 ............ 3% IgG4 ............ 2% The maximum IgA content is 50 micrograms/ml. Produced from the plasma of human donors. Excipients with known effects Hizentra contains approximately 250 mmol/L (range: 210 to 290) of L-proline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for subcutaneous injection. The solution is clear and pale-yellow or light-brown. Hizentra has an approximate osmolality of 380 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, children and adolescents (0-18 years) in: − Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). 3 − Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of Прочетете целия документ