Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
ETANERCEPT
PFIZER PHARMACEUTICALS ISRAEL LTD
L04AB01
SOLUTION FOR INJECTION
ETANERCEPT 50 MG/ML
S.C
Required
PFIZER INC, USA
ETANERCEPT
ETANERCEPT
* Rheumatoid arthritis:- Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. - Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.* Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease. * Plaque psoriasis Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.* Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* Juvenile idiopathic arthritis- Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. - Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less than 2 years.* Axial spondyloarthritis- Ankylosing spondylitis(AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.- Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs)
2015-01-31
Enbrel 25 mg and 50 mg PFS, PIL, CC 291023 1 2022-0078193, 2022-0078596 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only. ENBREL ® 25 MG SOLUTION FOR INJECTION ENBREL ® 50 MG SOLUTION FOR INJECTION Ready-to-use solution for subcutaneous injection ACTIVE INGREDIENT AND ITS QUANTITY: Enbrel 25 mg solution for injection: etanercept 50 mg/ml Enbrel 50 mg solution for injection: etanercept 50 mg/ml Inactive ingredients and allergens: see section 2 under "Important information about some of this medicine’s ingredients " and section 6 “Further Information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, contact your doctor or pharmacist. This medicine has been prescribed for you/your child. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. In addition to the leaflet, the preparations Enbrel 25 mg solution for injection and Enbrel 50 mg solution for injection also have a patient safety information card. This card contains important safety information that you need to know and that you should follow before you start treatment and during treatment with Enbrel 25 mg solution for injection or Enbrel 50 mg solution for injection. Carefully read the patient safety information card and patient information leaflet before you start using this medicine. Keep the card in case you need to read it again. 1. WHAT IS THIS MEDICINE INTENDED FOR? Enbrel is intended for the treatment of adults for the following indications: • Active RHEUMATOID ARTHRITIS in adults for whom treatment with disease modifying anti-rheumatic drugs (DMARDS), including methotrexate, has been inadequate; Enbrel can be used in combination with methotrexate in patients who do not respond adequately to treatment with methotrexate alone. • Active and progressive PSORIATIC ART Διαβάστε το πλήρες έγγραφο
Enbrel PFS and PFP, LPD, CC 170124 2023-0088170 1 1. NAME OF THE MEDICINAL PRODUCT ENBREL 25 MG SOLUTION FOR INJECTION, IN PRE-FILLED SYRINGE ENBREL 50 MG SOLUTION FOR INJECTION, IN PRE-FILLED SYRINGE OR PRE-FILLED PEN. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of Enbrel 25 mg solution for injection - contains 25 mg of etanercept. Each pre-filled syringe of Enbrel 50 mg solution for injection - contains 50 mg of etanercept. Each pre-filled pen of Enbrel 50 mg solution for injection -contains 50 mg of etanercept. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, and colourless to pale yellow or pale brown. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated ) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis . Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. PATIENT Διαβάστε το πλήρες έγγραφο