Yuflyma Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

yuflyma

celltrion healthcare hungary kft. - адалимумаб - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - Имуносупресори - rheumatoid arthritisyuflyma in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Адалимумаб, както е показано, за да се намали скоростта на прогресия на увреждане на ставите как се измерва с рентгенови и подобряване на физическата функция при назначаването в комбинация с метотрексат. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Адалимумаб не е проучена обстойно при пациенти на възраст по-малко от 2 години. enthesitis-related arthritisyuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asyuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psoriatic arthritisyuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Адалимумаб, както е показано, за да се намали скоростта на прогресия на периферната ставите, измерена с помощта на рентген при пациенти с полиартикулярным вариант симетрични подтипове на заболяване (виж раздел 5. 1) и за подобряване на физическата функция. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 и 5. crohn’s diseaseyuflyma is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaseyuflyma is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitisyuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisyuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisyuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitisyuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Vildagliptin / Metformin hydrochloride Accord Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

vildagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - Захарен диабет тип 2 - Лекарства, използвани при диабет - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 и 5. 1 за наличните данни за различни комбинации).

Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

clopidogrel/acetylsalicylic acid zentiva (previously duocover)

sanofi-aventis groupe - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - Антитромботични агенти - Остър Коронарный Инфаркт syndromemyocardial .

Poulvac E. coli Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

poulvac e. coli

zoetis belgium sa - Живият aroa ген заличава escherichia coli, тип 078, щам ec34195 - Имуномодулатори за птици, живи бактериални ваксини - chicken; turkeys - За активна имунизация на пилета-бройлери и бъдещи слоеве / животновъдите, за да се намали смъртността и поражението (перикарден излив, перигепатиты, airsacculitis), свързани с e. coli серотипа o78.

Versican Plus L4 Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

versican plus l4

zoetis belgium s.a. - interrogans серовара лептоспир серогруппы Аустралис Братислава, прецедете mslb 1088, l. interrogans серогруппы icterohaemorrhagiae серовар icterohaemorrhagiae, прецедете mslb 1089, l. interrogans серогруппы Кашницкого Кашницкого серовара, прецедете mslb 1090, л. kirschneri серогруппы grippotyphosa grippotyphosa серовара, прецедете mslb 1091 (всъщност има) - Инактивированные бактериални ваксини (включително и микоплазма, анатоксин и хламидия), имуномодулатори за кучета - Кучета - Активна имунизация на кучета от шест седмици от възрастта, за да се предотврати клиничните признаци, както и инфекции на пикочните екскреция е причинена от Лептоспир развлечения Братислава, тянитолкая, grippotyphosa и icterohaemorrhagiae. Началото на имунитета: Имунитетът е доказан от 4 седмици след завършване на основния курс. Продължителност на имунитета: Най-малко една година след основния ваксинационен курс.

Lantus Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

lantus

sanofi-aventis deutschland gmbh - инсулин гларжин - Захарен диабет - Лекарства, използвани при диабет - Лечение на захарен диабет при възрастни, юноши и деца на възраст над 2 години.

Toujeo (previously Optisulin) Liên Minh Châu Âu - Tiếng Bulgaria - EMA (European Medicines Agency)

toujeo (previously optisulin)

sanofi-aventis deutschland gmbh - инсулин гларжин - Захарен диабет - Лекарства, използвани при диабет - Лечение на захарен диабет при възрастни, юноши и деца над 6 години.

AMPICLOX L.C 75 mg, 200 mg Bungari - Tiếng Bulgaria - БАБХ (Българска агенция по безопасност на храните)

ampiclox l.c 75 mg, 200 mg

zoetis belgium s.a - Ампицилин, Клоксациллин - интрамамарна суспензия - 75 mg, 200 mg - крави

CLAMOXYL L.A. injection 150 mg/ml Bungari - Tiếng Bulgaria - БАБХ (Българска агенция по безопасност на храните)

clamoxyl l.a. injection 150 mg/ml

zoetis belgium sa - Амоксицилин (като Амоксициллина тригидрат) - инжекционна суспензия - 150 mg/ml - говеда, котки, кучета, овце, прасета

DECCOX 6 % 6, 06 g/ 100 g Bungari - Tiếng Bulgaria - БАБХ (Българска агенция по безопасност на храните)

deccox 6 % 6, 06 g/ 100 g

zoetis belgium s.a. - decoquinate - медикаментозен премикс - 6, 06 g/ 100 g - агнета, дзвиски, овце, телета