Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
peginterferon beta-1a
Biogen Netherlands B.V.
L03AB13
peginterferon beta-1a
Immunostimulants,
Multiple Sclerosis
Treatment of relapsing remitting multiple sclerosis in adult patients.
Revision: 24
Authorised
2014-07-18
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE USER PLEGRIDY 63 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE PLEGRIDY 94 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE PLEGRIDY 125 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE peginterferon beta-1a 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 PLEGRIDY IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PLEGRIDY 3. HOW TO USE PLEGRIDY 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PLEGRIDY 6. CONTENTS OF THE PACK AND OTHER INFORMATION 7. INSTRUCTIONS FOR INJECTING PLEGRIDY PRE-FILLED SYRINGE 1. WHAT PLEGRIDY IS AND WHAT IT IS USED FOR WHAT PLEGRIDY IS The active substance in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a modified long-acting form of interferon. Interferons are natural substances made in the body to help protect from infections and diseases. WHAT PLEGRIDY IS USED FOR THIS MEDICINE IS USED TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS) IN ADULTS AGED 18 OR OVER. MS is a long term illness that affects the central nervous system (CNS), including the brain and spinal cord, in which the body’s immune system (its natural defences) damages the protective layer (myelin) that surrounds the nerves in the brain and spinal cord. This disrupts the messages between the brain and other parts of the body, causing the symptoms of MS. Patients with relapsing-remitting MS have periods when the disease is not active (remission) in between flare-ups of symptom Прочетете целия документ
1_ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Plegridy 63 micrograms solution for injection in pre-filled syringe (for subcutaneous use) Each pre-filled syringe contains 63 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 94 micrograms solution for injection in pre-filled syringe (for subcutaneous use) Each pre-filled syringe contains 94 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 125 micrograms solution for injection in pre-filled syringe (for subcutaneous use) Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 125 micrograms solution for injection in pre-filled syringe (for intramuscular use) Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 63 micrograms solution for injection in pre-filled pen (for subcutaneous use) Each pre-filled pen contains 63 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 94 micrograms solution for injection in pre-filled pen (for subcutaneous use) Each pre-filled pen contains 94 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. Plegridy 125 micrograms solution for injection in pre-filled pen (for subcutaneous use)Each pre-filled pen contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. The dose indicates the quantity of the interferon beta-1a moiety of peginterferon beta-1a without consideration of the PEG moiety attached. *The active sub Прочетете целия документ