Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etanercept
Wyeth Pharmaceuticals
L04AB01
etanercept
50mg/ml
solution for s/c injection
(4) pre-filled glass pen-syringes 1ml and (4) alcohol swabs
Prescription
Registered
2017-09-26
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enbrel ® 50 mg solution for injection in pre-filled syringe. Enbrel ® 50 mg solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: etanercept 50.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clear or opalescent from colourless to yellow liquid. Small transparent to white amorphous particles are permissible. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Rheumatoid arthritis _ In combination with methotrexate, Enbrel ® is prescribed to adults for the treatment of moderate and severe active rheumatoid arthritis when response to disease-modifying anti- rheumatic drugs (DMARDs), including methotrexate, has been inadequate. Enbrel ® may be prescribed as monotherapy in case of inefficacy or intolerance of methotrexate. Enbrel ® is indicated for the treatment of severe active and progressive rheumatoid arthritis in adults who have not been previously treated with methotrexate. _Juvenile_ _idiopathic_ _polyarthritis_ Treatment of active juvenile idiopathic polyarthritis (seropositive and seronegative) in children and adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel ® in the pharmaceutical form of a solution for subcutaneous injection), who have had an ineffective response or intolerance to methotrexate. Treatment of extended oligoarthritis in children and adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel ® in the pharmaceutical form of a “solution for subcutaneous injection”), who have had an ineffective response or intolerance to methotrexate. Treatment of psoriatic arthritis in adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel ® in the pharmaceutical form of a “solution for subcutaneous injection”), who have had an ineffective response or intolerance to methotrexate. Treatment of arthritis associated with enthesitis in adolescents aged 12 Lesen Sie das vollständige Dokument