Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Methotrexate
Therakind (Europe) Limited
L04AX03
methotrexate
Antineoplastic agents
Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis
In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
Revision: 12
Authorised
2017-03-29
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER JYLAMVO 2 MG/ML ORAL SOLUTION methotrexate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist. - 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Jylamvo is and what it is used for 2. What you need to know before you take Jylamvo 3. How to take Jylamvo 4. Possible side effects 5. How to store Jylamvo 6. Contents of the pack and other information 1. WHAT JYLAMVO IS AND WHAT IT IS USED FOR Jylamvo is a medicine that: - suppresses the growth of certain cells in the body that multiply rapidly (an anticancer medicine) - reduces unwanted reactions by the body's own defense mechanisms (an immunosuppressive agent) - has an anti-inflammatory effect Jylamvo is used in patients with: - the following rheumatic and skin diseases: o active rheumatoid arthritis (RA) in adults o polyarthritic forms (when five or more joints are affected) of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate o severe, treatment-resistant, disabling psoriasis that does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, as well as in severe psoriasis that also affects the joints (psoriatic arthritis) in adult patients - acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over You must talk to a doctor if you do not feel better or if you feel worse 2. WHAT YO Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jylamvo 2 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 2 mg methotrexate. Excipients with known effect One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jylamvo is for use in the following indications: In rheumatological and dermatological diseases • Active rheumatoid arthritis in adult patients. • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. • Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology • Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Posology _Rheumatological and dermatological diseases _ 3 _ _ IMPORTANT WARNING ABOUT THE DOSAGE OF JYLAMVO (METHOTREXATE) In the treatment of rheumatological or dermatological diseases, Jylamvo (methotrexate) MUST ONLY BE TAKEN ONCE A WEEK . Dosage errors in the use of Jylamvo (methotrexate) can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen. The prescriber should specify the day of Прочетете целия документ