Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
daclizumab
Biogen Idec Ltd
L04AC01
daclizumab
Immunosuppressants
Multiple Sclerosis
Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Revision: 8
Withdrawn
2016-07-01
36 B. PACKAGE LEAFLET Medicinal product no longer authorised 37 PACKAGE LEAFLET: INFORMATION FOR THE USER ZINBRYTA 150 MG solution for injection in pre-filled syringe ZINBRYTA 150 MG solution for injection in pre-filled pen DACLIZUMAB BETA 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. IN ADDITION TO THIS LEAFLET YOU WILL BE GIVEN A PATIENT CARD BY YOUR DOCTOR. THIS HAS IMPORTANT SAFETY INFORMATION THAT YOU NEED TO KNOW BEFORE AND DURING TREATMENT WITH ZINBRYTA. • Keep this leaflet and the Patient Card. You may need to read them again. Keep the leaflet and Card with you during treatment and for 6 months after the last dose of Zinbryta, since side effects may occur even after you have stopped treatment. • If you have any further questions, ask your doctor. • 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zinbryta is and what it is used for 2. What you need to know before you use Zinbryta 3. How to use Zinbryta 4. Possible side effects 5. How to store Zinbryta 6. Contents of the pack and other information 7. Instructions for injecting Zinbryta 1. WHAT ZINBRYTA IS AND WHAT IT IS USED FOR The active substance in Zinbryta is daclizumab beta. This is a type of medicine called a monoclonal antibody. WHAT ZINBRYTA IS USED FOR Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments. In MS, the body’s immune system Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 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 Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection. Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection. Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by a physician experienced in the management of multiple sclerosis. Posology The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month. In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule. If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule. Only one dose should be administered a Прочетете целия документ