Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
PEGINTERFERON BETA 1A
MEDISON PHARMA LTD
L03AB13
SOLUTION FOR INJECTION
PEGINTERFERON BETA 1A 63 MCG / 0.5 ML
S.C
Required
BIOGEN IDEC LTD, UK
PEGINTERFERON BETA-1A
Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis
2020-11-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied by physician’s prescription only PLEGRIDY 63 MCG PLEGRIDY 94 MCG PLEGRIDY 125 MCG SOLUTION IN A PRE-FILLED PEN COMPOSITION: Each pen of PLEGRIDY 63 contains peginterferon beta-1a 63 µg Each pen of PLEGRIDY 94 contains peginterferon beta-1a 94 µg Each pen of PLEGRIDY 125 contains peginterferon beta-1a 125 µg Inactive ingredients and allergens in this medicine: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information’ . READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. This medicine is intended for the treatment of adults aged 18 or over. 1. WHAT IS THIS MEDICINE INTENDED FOR? PLEGRIDY is intended for the treatment of symptoms of relapsing-remitting multiple sclerosis. THERAPEUTIC GROUP: Interferons. Multiple sclerosis (MS) is a chronic illness that affects the central nervous system (CNS), including the brain and spinal cord. In this illness the body ’ s immune system 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. In relapsing-remitting MS there are periods when the disease is not active (remission) in between flare-ups of symptoms (relapses). The disease can be manifested in various forms in different patients. The symptoms of multiple sclerosis include: • Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs • Acute or chronic pain, bladder and bowel problems, sexual prob Leggi il documento completo
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Plegridy 63 micrograms solution for injection in pre -filled pen or syringe. Plegridy 94 micrograms solution for injection in pre -filled pen or syringe. Plegridy 125 micrograms solution for injection in pre filled pen or syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 63 microgram pre -filled pen or syringe contains 63 micrograms of peginterferon beta -1a* in 0.5 mL solution for injection. Each 94 microgram pre -filled pen or syringe contains 94 micrograms of peginterferon beta -1a* in 0.5 mL solution for injection. Each 125 microgram pre filled pen or syringe 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 substance, peginterferon beta-1a, is a covalent conjugate of interferon beta-1a, produced in Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) using an O-2-methylpropionaldehyde linker. The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. For more information see section 5.1. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless solution with pH 4.5-5.1. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1)._ _ 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Efficacy of Plegridy has been demonstrated over placebo. Direct comparative data for Plegridy versus non-pegylated interferon beta or data on efficacy of Plegridy after switching from a non- pegylated interferon beta are not available. This should be considered w Leggi il documento completo