Azacitidine Accord Unión Europea - letón - EMA (European Medicines Agency)

azacitidine accord

accord healthcare s.l.u. - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiski līdzekļi - azacitidine accord ir norādīts ārstēšanai pieaugušiem pacientiem, kuriem nav tiesību uz hematopoētisko cilmes šūnu transplantācijas (hsct) ar:- intermediate-2 un augsta riska mielodisplastiskais sindromi (mds) saskaņā ar starptautisko zīlēšana vērtēšanas sistēma (ipss),- hroniskas myelomonocytic leikēmija (cmml) ar 10-29 % smadzeņu signālu bez myeloproliferative saslimšanām,- akūta mieloīda leikēmija (aml) ar 20-30 % sprādzieni un multi-raduraksti displāziju, saskaņā ar pasaules veselības organizācijas (pvo) klasifikācija,- aml ar >30% smadzeņu sprādzieni saskaņā ar pvo klasifikāciju.

Tigecycline Accord Unión Europea - letón - EMA (European Medicines Agency)

tigecycline accord

accord healthcare s.l.u. - tigeciklīns - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibakteriālas līdzekļi sistēmiskai lietošanai, - tygecycline accord ir norādīts pieaugušajiem un bērniem, kas vecāki par astoņiem gadiem, par attieksmi pret šādām infekcijām (skatīt 4. 4 un 5. 1):sarežģītu ādas un mīksto audu infekcijas (cssti), izņemot diabēta pēdu infekciju (skatīt 4. iedaļu. 4)sarežģīta iekšējai-vēdera infekcijām (ciai)tygecycline vienojoties, ir jāizmanto tikai situācijās, kad citas alternatīvas antibiotikas nav piemērotas (skatīt 4. 4, 4. 8 un 5. jāņem vērā oficiālās vadlīnijas par piemērotu izmantot antibakteriālas vielas.

Fampridine Accord Unión Europea - letón - EMA (European Medicines Agency)

fampridine accord

accord healthcare s.l.u. - fampridīns - multiplā skleroze - other nervous system drugs - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

Rivaroxaban Accord Unión Europea - letón - EMA (European Medicines Agency)

rivaroxaban accord

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotiskie līdzekļi - venozās trombembolijas (vte) profilakse pieaugušiem pacientiem, kuriem tiek veikta gēnu vai ceļa locītavas locītavas operācija. Ārstēšana ar dziļo vēnu tromboze (dvt) un plaušu embolija (pe), un novērst atkārtotu dvt un pe pieaugušajiem. (see section 4. 4 for haemodynamically unstable pe patients. Ārstēšana ar dziļo vēnu tromboze (dvt) un plaušu embolija (pe), un novērst atkārtotu dvt un pe pieaugušajiem. (see section 4. 4 haemodynamically nestabila pe pacientiem). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Ārstēšana ar dziļo vēnu tromboze (dvt) un plaušu embolija (pe), un novērst atkārtotu dvt un pe pieaugušajiem. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 un 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Ārstēšana ar dziļo vēnu tromboze (dvt) un plaušu embolija (pe), un novērst atkārtotu dvt un pe pieaugušajiem. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Abiraterone Accord Unión Europea - letón - EMA (European Medicines Agency)

abiraterone accord

accord healthcare s.l.u. - abiraterona acetāts - prostatas audzēji - endokrīnā terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Icatibant Accord Unión Europea - letón - EMA (European Medicines Agency)

icatibant accord

accord healthcare s.l.u. - icatibant acetate - angioedēma, iedzimta - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Dasatinib Accord Unión Europea - letón - EMA (European Medicines Agency)

dasatinib accord

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiski līdzekļi - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva Unión Europea - letón - EMA (European Medicines Agency)

covid-19 vaccine (inactivated, adjuvanted) valneva

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vakcīnas - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Sitagliptin Accord Unión Europea - letón - EMA (European Medicines Agency)

sitagliptin accord

accord healthcare s.l.u. - sitagliptin hydrochloride - cukura diabēts, 2. tips - cukura diabēts - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated 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 diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Vildagliptin / Metformin hydrochloride Accord Unión Europea - letón - EMA (European Medicines Agency)

vildagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - cukura diabēts, 2. tips - cukura diabēts - 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 un 5. 1 pieejamo datu par dažādām kombinācijām).