Aranesp Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

aranesp

amgen europe b.v. - darbepoetínu alfa - anemia; cancer; kidney failure, chronic - iné prípravky protianemický - liečba symptomatickej anémie spojenej s chronickým zlyhaním obličiek (crf) u dospelých a detských pacientov. liečbu symptomatických anémia u dospelých pacientov s rakovinou s non-myeloidná malignancies dostávajú chemoterapiu.

Busilvex Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

busilvex

pierre fabre medicament - busulfán - transplantácia hematopoetických kmeňových buniek - antineoplastické činidlá - busilvex nasleduje cyklofosfamid (bucy2) je indikovaný ako kondicionačnej liečby pred transplantáciou konvenčné hematopoetických prekurzorových buniek (hpct) u dospelých pacientov, keď kombinácia je považovaná za najlepšie dostupné možnosti. busilvex nasledujúce fludarabine (fb) je označené ako klimatizácia liečba pred hematopoetickú predok buniek transplantácia (hpct) u dospelých pacientov, ktorí sú kandidátmi pre zníženie intenzity klimatizáciou (ric) režim. busilvex nasleduje cyklofosfamidom (bucy4) alebo melphalan (bumel) je označené ako klimatizácia liečba pred konvenčné hematopoetickú predok bunky transplantáciu v pediatrických pacientov.

Tepadina Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

tepadina

adienne s.r.l. s.u. - thiotepa - transplantácia hematopoetických kmeňových buniek - antineoplastické činidlá - v kombinácii s inými chemoterapia liekov:s alebo bez celkovej telesnej ožiareniu (tbi), ako je klimatizácia liečba pred allogeneic alebo autológne hematopoetickú predok buniek transplantácia (hpct) v hematologické ochorenia u dospelých a pediatrických pacientov, keď vysoké dávky chemoterapie s hpct podpory je vhodné pre liečbu solídne nádory u dospelých a pediatrických pacientov. navrhuje sa, aby tepadina musí byť predpísané lekármi zažil v klimatizácia liečba pred hematopoetickú predok bunky transplantáciu.

Busulfan Fresenius Kabi Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

busulfan fresenius kabi

fresenius kabi deutschland gmbh - busulfán - transplantácia hematopoetických kmeňových buniek - alkylsulfonáty - busulfán fresenius kabi nasleduje cyklofosfamid (bucy2) je indikovaný ako kondicionačnej liečby pred transplantáciou konvenčné hematopoetických prekurzorových buniek (hpct) u dospelých pacientov, keď kombinácia je považovaná za najlepšie dostupné možnosti. busulfan fresenius kabi nasleduje cyklofosfamidom (bucy4) alebo melphalan (bumel) je označené ako klimatizácia liečba pred konvenčné hematopoetickú predok bunky transplantáciu v pediatrických pacientov.

Noxafil Liên Minh Châu Âu - Tiếng Slovak - 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.

Trecondi Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

trecondi

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - transplantácia hematopoetických kmeňových buniek - antineoplastické činidlá - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Comirnaty Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

comirnaty

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vakcíny - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. použitie tejto vakcíny by mali byť v súlade s oficiálne odporúčania.