Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bayer ag - telmisartāns - hipertensija - agents, kas iedarbojas uz renīna-angiotenzīna sistēmu - hypertensiontreatment būtiski hipertensija pieaugušajiem. sirds un asinsvadu preventionreduction par sirds un asinsvadu slimību pacientiem ar acīmredzamām atherothrombotic sirds un asinsvadu slimības (anamnēzē ir koronārā sirds slimība, insults vai perifēro artēriju slimību); vai 2. tipa cukura diabētu ar dokumentētu mērķa orgānu bojājumu.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapīds - hiperholesterolēmija - lipīdu modificējoši aģenti - lojuxta ir norādīts, kā papildinājumu low‑fat diētu un citām lipid‑lowering zālēm ar vai bez zemākā density lipoproteīdu (ldl) aferēzes pieaugušiem pacientiem ar ģimenisko homozygous hypercholesterolaemia (hofh). Ģenētisko apstiprinājumu hofh būtu jāiegūst, kad vien iespējams,. citas formas primāro hyperlipoproteinaemia un sekundārie cēloņi hypercholesterolaemia e. nephrotic sindroms, hipotireoze), ir jāizslēdz.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

astrazeneca ab - olaparibs - olnīcu jaunveidojumi - antineoplastiski līdzekļi - olnīcu cancerlynparza ir norādīts kā monotherapy par:apkope ārstēšanai pieaugušiem pacientiem ar progresējošu (figo posmos, iii un iv) brca1/2-mutācijas (dzimumšūnas līnijas un/vai somatisko) augstas kvalitātes epitēlija olnīcu, olvados, vai primāro peritoneālās vēzi, kas ir atbildes reakcija (pilnīgu vai daļēju) pēc pirmās līnijas platīna ķīmijterapiju. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 un 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacientiem ir jābūt iepriekš apstrādāts ar anthracycline un taxane gadā (neo)palīgvielu vai metastātiska iestatījumu, ja vien pacientiem nebija piemēroti šiem apstrādes veidiem (skatīt 5. iedaļu. pacientiem ar hormonu receptoru (ap)-pozitīvs krūts vēzis ir arī ir bijuši par to, vai pēc iepriekšējas endokrīnās terapijas, vai būt nepiemērota par endokrīnās terapijas. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartāns - hipertensija - angiotensin ii antagonists, plain - hypertensiontreatment būtiski hipertensija pieaugušajiem. sirds un asinsvadu preventionreduction par sirds un asinsvadu slimību pacientiem ar acīmredzamām atherothrombotic sirds un asinsvadu slimības (anamnēzē ir koronārā sirds slimība, insults vai perifēro artēriju slimību); vai 2. tipa cukura diabētu ar dokumentētu mērķa orgānu bojājumu.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - antianēmiski līdzekļi - simptomātiskas anēmijas, kas saistītas ar hronisku nieru mazspēju (crf), ārstēšana pieaugušajiem un bērniem. Ārstēšana simptomātiska anēmija pieaugušo vēža pacientiem ar ne-mieloīdu ļaundabīgu audzēju, kas saņem ķīmijterapiju,.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

glaxosmithkline dungarvan limited - esomeprazole - gastroezofagālā attece - protonu sūkņa inhibitori - nexium control ir indicēts īslaicīgai atviļņa simptomu ārstēšanai (e. grēmas un skābes atkārtotība) pieaugušajiem.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics sistēmiskai lietošanai - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 un 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 un 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 un 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 un 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 un 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 un 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 un 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazīvās aspergillosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b vai itraconazole, vai pacientiem, kuri nepanes no šīm zālēm;- fusariosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, vai pacientiem, kuri nepanes no amfotericīna b;- chromoblastomycosis un mycetoma pacientiem ar slimību, kas ir ugunsizturīgi, lai itraconazole, vai pacientiem, kuri nepanes no itraconazole;- coccidioidomycosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, itraconazole vai fluconazole, vai pacientiem, kuri nepanes no šīm zālēm;- orofaringālas kandidoze: kā pirmās līnijas terapija pacientiem, kuriem ir smagas slimības vai pat cilvēkiem ar traucētu imūnsistēmu, kuriem atbildes uz aktuāliem terapija ir sagaidāms, ka būs slikti. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

viatris healthcare limited - tobramicīns - cystic fibrosis; respiratory tract infections - antibakteriālas līdzekļi sistēmiskai lietošanai, - tobi podhaler ir indicēts hroniskas plaušu infekcijas nomācošai terapijai pseudomonas aeruginosa dēļ pieaugušajiem un bērniem vecumā no 6 gadiem ar cistisko fibrozi. skatīt nodaļas 4. 4 un 5. 1 par datiem dažādās vecuma grupās. jāņem vērā oficiālās vadlīnijas par piemērotu izmantot antibakteriālas vielas.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

sanofi b.v. - sevelamēra karbonāts - hyperphosphatemia; renal dialysis - visi pārējie terapeitiskie produkti - renvela ir indicēts hiperfosfatēmijas kontrolei pieaugušiem pacientiem, kas saņem hemodialīzi vai peritoneālo dialīzi. renvela ir arī norādīts par kontroli hyperphosphataemia pieaugušiem pacientiem ar hronisku nieru slimību nav dialīzi ar seruma fosfora ≥ 1. 78 mmol/l. renvela būtu jāizmanto saistībā ar vairākiem terapijas metodi, kas varētu ietvert kalcija papildināt, 1,25-dihidroksi vitamīns d3 vai vienā no tās analogiem, lai kontrolētu attīstību, nieru mazspēja, kaulu slimība.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

sanofi b.v. - sevelamēra karbonāts - hyperphosphatemia; renal dialysis - visi pārējie terapeitiskie produkti - sevelamer karbonāts winthrop ir norādīts kontroles hyperphosphataemia pieaugušo pacientiem, kas saņem hemodialīzes vai peritoneālās dialīzes. sevelamer karbonāts winthrop ir arī norādīts par kontroli hyperphosphataemia pieaugušiem pacientiem ar hronisku nieru slimību nav dialīzi ar seruma fosfora > 1. 78 mmol/l. sevelamer karbonāts winthrop būtu jāizmanto saistībā ar vairākiem terapijas metodi, kas varētu ietvert kalcija papildināt, 1,25-dihidroksi vitamīns d3 vai vienā no tās analogiem, lai kontrolētu attīstību, nieru mazspēja, kaulu slimība.