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Unione Europea - slovacco - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika na systémové použitie - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 a 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 a 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 je definovaný ako priebeh infekcie alebo neschopnosť zlepšiť po minimálne 7 dní pred terapeutické dávky účinných protiplesňové terapia. 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 a 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 a 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 a 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 je definovaný ako priebeh infekcie alebo neschopnosť zlepšiť po minimálne 7 dní pred terapeutické dávky účinných protiplesňové terapia. 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 a 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 a 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 je definovaný ako priebeh infekcie alebo neschopnosť zlepšiť po minimálne 7 dní pred terapeutické dávky účinných protiplesňové terapia. 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):- invázne aspergillosis u pacientov s ochorením, ktoré je žiaruvzdorných na amphotericin b alebo itraconazole alebo u pacientov, ktorí netolerujú týchto liekov;- fusariosis u pacientov s ochorením, ktoré je žiaruvzdorných na amphotericin b alebo u pacientov, ktorí netolerujú z amphotericin b;- chromoblastomycosis a mycetoma u pacientov s ochorením, ktoré je žiaruvzdorných na itraconazole alebo u pacientov, ktorí netolerujú z itraconazole;- kokcidiomykóza u pacientov s ochorením, ktoré je žiaruvzdorných na amphotericin b, itraconazole alebo fluconazol alebo u pacientov, ktorí netolerujú týchto liekov;- oropharyngeal kandidóza: ako v prvej línii liečby u pacientov, ktorí majú závažné ochorenie alebo sú imunokompromitovaných, v ktorých reakcie na aktuálne terapia sa očakáva, že byť chudobným. refractoriness je definovaný ako priebeh infekcie alebo neschopnosť zlepšiť po minimálne 7 dní pred terapeutické dávky účinných protiplesňové terapia. 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.

Unione Europea - slovacco - EMA (European Medicines Agency)

rotateq

merck sharp & dohme b.v. - rotavírusový sérotyp g1, sérotyp g2, sérotyp g3, sérotyp g4, sérotyp p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq je indikovaný na aktívnu imunizáciu dojčiat od veku šiestich týždňov do 32 týždňov na prevenciu gastroenteritídy spôsobenej rotavírusovou infekciou. rotateq je možné použiť na základe oficiálnych odporúčaní.

Unione Europea - slovacco - EMA (European Medicines Agency)

ristaben

merck sharp & dohme b.v. - sitagliptín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pre dospelých pacientov s typu 2 diabetes mellitus, ristaben je uvedené na zlepšenie glykemický ovládanie:ako monotherapy:u pacientov nedostatočne kontrolovaná diétou a cvičením samostatne, a pre ktorých je metformín je nevhodné z dôvodu kontraindikácie alebo neznášanlivosti;ako duálnej perorálnej terapie v kombinácii s:metformín, keď diéta a cvičenie plus metformín sám neposkytujú dostatočnú glykemický kontrolu;sulfonylmocoviny, keď diéta a cvičenie plus maximálna tolerovaná dávka sulfonylmocoviny sám neposkytujú dostatočnú glykemický kontrolu a keď metformín je nevhodné z dôvodu kontraindikácie alebo neznášanlivosti;a peroxisome proliferator-aktivovaný-receptor-gama (ppary) agonist i. a thiazolidinedione) pri použití ppary agonist je vhodné a keď diéta a cvičenie plus ppary agonist sám neposkytujú dostatočnú glykemický kontrolu;ako triple ústne terapia v kombinácii s:sulfonylmocoviny a metformín, keď diéta a cvičenie plus dual terapia pomocou týchto liekov neposkytujú dostatočnú glykemický kontrolu;ppary agonist a metformín, keď použitie ppary agonist je vhodné a keď diéta a cvičenie plus dual terapia pomocou týchto liekov neposkytujú dostatočnú glykemický ovládanie. ristaben je tiež označené ako doplnok k inzulínom (s metformínom alebo bez), ak diéta a cvičenie plus stabilnej dávke inzulínu neposkytujú dostatočnú glykemický ovládanie.

Unione Europea - slovacco - EMA (European Medicines Agency)

victrelis

merck sharp dohme ltd - boceprevir - hepatitída c, chronická - antivirotiká na systémové použitie - victrelis je indikovaný na liečbu chronickej hepatitídy c (chc) genotypu 1 infekcie, v kombinácii s peginterferónom alfa a ribavirínom u dospelých pacientov s kompenzovaným ochorením pečene, ktorí neboli predtým liečení alebo ktorí zlyhala predchádzajúca liečba.

Unione Europea - slovacco - EMA (European Medicines Agency)

temodal

merck sharp & dohme b.v. - temozolomid - glioma; glioblastoma - antineoplastické činidlá - temodal tvrdé kapsuly je indikovaný na liečbu:u dospelých pacientov s novo diagnostikovanou glioblastoma multiforme súčasne s rádioterapiou a následne ako monotherapy liečby u detí vo veku od troch rokov, dospievajúcich a dospelých pacientov s malígny gliomy, ako glioblastoma multiforme alebo anaplastický astrocytom, ukazuje opakovania alebo postupu po štandardnej terapie.