Country: Israel
Language: English
Source: Ministry of Health
ETANERCEPT
PFIZER PHARMACEUTICALS ISRAEL LTD
L04AB01
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ETANERCEPT 25 MG/VIAL
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.*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).
2023-08-31
Enbrel powder and solvent, PIL, CC 291023 1 2022-0078193, 2022-0078593, 2022-0078596 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only. ENBREL ® POWDER AND SOLVENT POWDER AND SOLVENT FOR SOLUTION FOR SUBCUTANEOUS INJECTION EACH VIAL WITH POWDER CONTAINS: etanercept 25 mg Inactive ingredients and allergens: see 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 preparation Enbrel powder and solvent also has 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 powder and solvent. Carefully read the patient safety information card and patient 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 ARTHRITIS in adults for whom treatment with disease modifying anti-rheumatic drugs (DMARDS) has been inadequate. • AXIAL SPONDYLOARTHRITIS: o Active and severe NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS in adults who do not respond adequately to treatment with non-steroidal anti-inflammatory drugs. o Severe and active ANKYLOSING Read the complete document
Enbrel powder and solvent, LPD, CC 170124 2023-0088170 1 1. NAME OF THE MEDICINAL PRODUCT ENBREL POWDER AND SOLVENT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 25 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 Powder and solvent for solution for injection (powder for injection). The powder is white. The solvent is a clear, colourless liquid. 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. PATIENT SAFETY INFORMATION CARD The marketing of Enbrel powder and solvent is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. Enbrel powder and solvent, LPD, CC 170124 2023-0088170 2 Treatment of psoriatic Read the complete document