Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
alpha1-proteinase inhibitor (human)
CSL Behring GmbH
B02AB02
alpha1-proteinase inhibitor (human)
Antihemorrhagics,
Genetic Diseases, Inborn, Lung Diseases
Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,
Revision: 7
Authorised
2015-08-20
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER RESPREEZA 1,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION RESPREEZA 4,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION RESPREEZA 5,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION Human alpha 1 -proteinase inhibitor 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 doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Respreeza is and what it is used for 2. What you need to know before you use Respreeza 3. How to use Respreeza 4. Possible side effects 5. How to store Respreeza 6. Contents of the pack and other information 1. WHAT RESPREEZA IS AND WHAT IT IS USED FOR WHAT RESPREEZA IS This medicine contains the active substance human alpha 1 -proteinase inhibitor, which is a normal component of the blood and is found in the lung. There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase. Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha 1 -proteinase inhibitor deficiency). WHAT RESPREEZA IS USED FOR This medicine is used in adults with known severe alpha 1 -proteinase inhibitor deficiency (an inherited condition also called alpha 1 antitrypsin deficiency) who have developed a lung condition called emphysema. Emphysema develops when the lack of alpha 1 -proteinase inhibitor results in a condition in which neutrophil elastase is not being properly controlled, damaging the tiny air sacs in the lungs through which oxygen passes Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Respreeza 1,000 mg powder and solvent for solution for infusion. Respreeza 4,000 mg powder and solvent for solution for infusion. Respreeza 5,000 mg powder and solvent for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Respreeza 1,000 mg powder and solvent for solution for infusion One vial contains approximately 1,000 mg of human alpha 1 -proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. After reconstitution with 20 ml solvent, the solution contains approximately 50 mg/ml of human alpha 1 -proteinase inhibitor. The total protein content is approximately 1,100 mg per vial. Respreeza 4,000 mg powder and solvent for solution for infusion One vial contains approximately 4,000 mg of human alpha 1 -proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. After reconstitution with 76 ml solvent, the solution contains approximately 50 mg/ml of human alpha 1 -proteinase inhibitor. The total protein content is approximately 4,400 mg per vial. Respreeza 5,000 mg powder and solvent for solution for infusion One vial contains approximately 5,000 mg of human alpha 1 -proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. After reconstitution with 95 ml solvent, the solution contains approximately 50 mg/ml of human alpha 1 -proteinase inhibitor. The total protein content is approximately 5,500 mg per vial. *Produced from the plasma of human donors. Excipients with known effect Respreeza contains approximately 1.9 mg sodium per ml of reconstituted solution (81 mmol/l). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for infusion. The powder is white to off-white. The solvent is a clear and colourless solution. The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Res Izlasiet visu dokumentu