Европейски съюз - български - EMA (European Medicines Agency)

pharmaand gmbh - пегинтерферон алфа-2а - hepatitis c, chronic; hepatitis b, chronic - Иммуностимуляторы, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 и 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. С уважение към решението да се започне лечение на педиатрични пациенти виж раздели 4. 2, 4. 4 и 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 и 5. Вирусът на хепатит С (hcv) генотипа на определен вид дейности, виж раздели 4. 2 и 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. При решение да започне лечение в детска възраст е важно да се разгледат спиране на растежа, предизвикана от комбинирана терапия. Обратимостта на инхибиране на растежа на доверие. Решението трябва да бъде взето на индивидуална основа (виж раздел 4.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v. - днес компанията открива, развива, grazoprevir - Хепатит c, хроничен - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 и 5. Вирусът на хепатит С (hcv) генотип-специфична активност виж раздели 4. 4 и 5.

Европейски съюз - български - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - Артрит, ревматоиден - Имуносупресори - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant може да се използва като монотерапия или в комбинация с метотрексат. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Европейски съюз - български - EMA (European Medicines Agency)

amgen europe b.v. - адалимумаб - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - Имуносупресори - rheumatoid arthritis  amgevita 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. лечение на тежък активен и прогресивното ревматоиден артрит при възрастни, не по-рано лекувани с метотрексат. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita намалява скоростта на прогресия на увреждане на ставите как се измерва с рентгенови и подобрява физическите функции, при назначаването в комбинация с метотрексат. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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). amgevita може да бъде дадено като монотерапии в случай на непоносимост към метотрексат или при продължително лечение с метотрексат е неподходящо (при ефективност в монотерапии виж раздел 5. Адалимумаб не е проучена обстойно при пациенти на възраст по-малко от 2 години. enthesitis-related arthritis amgevita 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 spondyloarthritis ankylosing spondylitis (as) amgevita 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 as amgevita 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. psoriatic arthritis amgevita 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. amgevita намалява 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 подобрява физическите функции. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita 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) amgevita 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 disease amgevita 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 disease amgevita 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 colitis amgevita 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. uveitis amgevita 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 uveitis amgevita 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.

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - Саксаглиптин - Захарен диабет тип 2 - Лекарства, използвани при диабет - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Европейски съюз - български - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - Антибактериални средства за подаване на заявления, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 и 5. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v. - пегинтерферон алфа-2b - Хепатит c, хроничен - Иммуностимуляторы, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Моля, консултирайте се с Рибавирин и боцепревир кратки характеристики на продукта (smpcs), когато пегинтрон трябва да се използва в комбинация с тези лекарства. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. Пегинтрон в комбинация с рибавирином (bitherapy) е показан за лечение на ХГС-инфекция при възрастни пациенти, по-рано не е получавала лечение, включително и на пациенти с клинично стабилна ХИВ-инфекция и при възрастни пациенти, които не предишно лечение интерфероном Алфа (пегилированным или пегилированным) и рибавирином или комбинирана терапия интерфероном-Алфа под формата на монотерапии. Монотерапия интерфероном, включително пегинтрон, показва предимно при непоносимост или противопоказания към рибавирину. Моля, обърнете се към Смпц рибавирином пегинтрон, когато се използва в комбинация с рибавирином. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. При вземане на решение да не се отложи лечението до зряла възраст, е важно да се отчете, че комбинираната терапия предизвиква забавяне на растежа, който може да бъде необратим при някои пациенти. Решението трябва да бъде взето на индивидуална основа. Моля, обърнете се към Смпц Рибавирин капсули или перорален разтвор, когато пегинтрон трябва да се използва в комбинация с рибавирином.

Европейски съюз - български - EMA (European Medicines Agency)

nordic group b.v. - тегафур, gimeracil, oteracil - Стомашни неоплазми - Антинеопластични средства - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Европейски съюз - български - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - sucroferric oxyhydroxide - hyperphosphatemia; renal dialysis - Лекарства за лечение на гиперкалиемии и гиперфосфатемии - velphoro е показан за контрол на нивата на серумния фосфор при пациенти с хронична бъбречна недостатъчност при възрастни (ckd) при хемодиализа (hd) или перитонеална диализа (pd). velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with ckd stages 4-5 (defined by a glomerular filtration rate.

Европейски съюз - български - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - азацитидин - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Антинеопластични средства - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.