Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - fosaprepitant - vomiting; cancer - antiemetics a antinauseants, - predchádzanie nevoľnosti a zvracanie spojené s vysoko a stredne emetogenic rakoviny chemoterapiou u dospelých a pediatrických pacientov vo veku od 6 mesiacov a staršie. ivemend 150 mg je uvedená ako súčasť kombinovanej liečbe.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, hydrochlorid metformín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pre pacientov s diabetes mellitus 2. typu:janumet je uvedené ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov s nedostatočne kontrolovanou na ich maximálna tolerovaná dávka metformín sám alebo tí, ktorí už liečená kombinácia sitagliptin a metformínom. janumet je indikovaný v kombinácii s sulfonylmocoviny i. trojlôžkových kombinovaná liečba) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a sulfonylmocoviny. janumet je označené ako triple kombinovaná liečba s ppar agonist i. , thiazolidinedione) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a ppar agonist. janumet je tiež uvedené, ako pridať na inzulín (i. trojlôžkových kombinovaná liečba) ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov pri stabilnej dávke inzulínu, a metformín sám neposkytujú dostatočnú glykemický ovládanie.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastické činidlá - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. u pacientov s egfr alebo alkalickÝm pozitívne nádor mutácie by tiež dostali cielenú liečbu pred prijatím keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Európska únia - slovenčina - EMA (European Medicines Agency)

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterokolitída, pseudomembranózna - imunitný séra a imunoglobulíny, - zinplava je indikovaná na prevenciu recidívy infekcie clostridium difficile (cdi) u dospelých s vysokým rizikom recidívy cdi.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pre dospelých pacientov s typu 2 diabetes mellitus, xelevia 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-aktivuje 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. xelevia je tiež označené ako doplnok k inzulínom (s metformínom alebo bez), ak diéta a cvičenie plus stabilnej dávke inzulínu neposkytujú dostatočnú glykemický ovládanie.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, hydrochlorid metformín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pre pacientov so typu 2 diabetes mellitus:ristfor je uvedené ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov s nedostatočne kontrolovanou na ich maximálna tolerovaná dávka metformín sám alebo tí, ktorí už liečená kombinácia sitagliptin a metformínom. ristfor je indikovaný v kombinácii s sulfonylmocoviny i. triple kombinovaná liečba) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a sulfonylmocoviny. ristfor je označené ako triple kombinovaná liečba s peroxisome proliferator-aktivovaný-receptor-gama (ppary) agonist i. a thiazolidinedione) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a ppary agonist. ristfor je tiež označené ako doplnok na inzulín (i. triple kombinovaná liečba) ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov pri stabilnej dávke inzulínu, a metformínom sám neposkytujú dostatočnú glykemický ovládanie.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, hydrochlorid metformín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pre pacientov so typu 2 diabetes mellitus:velmetia je uvedené ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov s nedostatočne kontrolovanou na ich maximálna tolerovaná dávka metformín sám alebo tí, ktorí už liečená kombinácia sitagliptin a metformínom. velmetia je indikovaný v kombinácii s sulfonylmocoviny i. triple kombinovaná liečba) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a sulfonylmocoviny. velmetia je označené ako triple kombinovaná liečba s ppar agonist i. a thiazolidinedione) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a ppar agonist. velmetia je tiež uvedené, ako pridať na inzulín (i. triple kombinovaná liečba) ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u pacientov pri stabilnej dávke inzulínu, a metformín sám neposkytujú dostatočnú glykemický ovládanie.