Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - ošpice virus enders' edmonston sev (v živo, zmanjšan), mumpsu virus jeryl lynn (raven b) sev (v živo, zmanjšan), virus rdečk wistar ra 27/3 sev (v živo, zmanjšan) - rubella; mumps; immunization; measles - cepiva - m-m-rvaxpro je označen za sočasno cepljenje proti ošpicam, mumpsu in rdečkam pri posameznikov 12 mesecev ali več. za uporabo v ošpice izbruhov, ali za post-izpostavljenost cepljenje, ali za uporabo v prej necepljenih otrocih, starejših od 12 mesecev, ki so v stiku z dovzetni nosečnice in osebe verjetno, da je dovzetna za mumpsu in rdečkam.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - cepivo proti humanim papilomavirusom [tipi 6, 11, 16, 18, 31, 33, 45, 52, 58] (rekombinantni, adsorbirani) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomavirus cepiva - gardasil 9 je označen za aktivno imunizacijo posameznikov v starosti od 9 let proti naslednje hpv bolezni:premalignant poškodbah in raka, ki vplivajo na materničnem vratu, vulva, vagina in anus, ki jih povzročajo cepiva proti hpv typesgenital bradavice (condyloma acuminata), ki jih povzročajo posebne hpv tipov. glej poglavja 4. 4 in 5. 1 za pomembne informacije o podatkih, ki podpirajo te navedbe. uporaba gardasil 9 mora biti v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - fosaprepitant - vomiting; cancer - antiemetics in antinauseants, - preprečevanje slabosti in bruhanja, povezanih z močno in zmerno emetogenic kemoterapijo raka pri odraslih in pediatričnih bolnikih, starih 6 mesecev in več. ivemend 150 mg je podana kot del kombiniranega zdravljenja.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirusni serotip g1, serotip g2, serotip g3, serotip g4, serotip p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq je indiciran za aktivno imunizacijo dojenčkov od šestih tednov do 32 tednov za preprečevanje gastroenteritisa zaradi rotavirusne okužbe. rotateq je treba uporabiti na podlagi uradnih priporočil.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotiki za sistemsko uporabo - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomicin - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibacterials za sistemsko uporabo, - cubicin je indiciran za zdravljenje naslednjih okužb. odraslih in pediatričnih (1 do 17 let) pri bolnikih z zapleteno kože in mehkega tkiva okužb (cssti). odraslih bolnikih z desno-sided (obojestransko), infektivnih endocarditis (rie) zaradi staphylococcus aureus. priporočljivo je, da je odločitev za uporabo daptomycin je treba upoštevati, da protibakterijsko dovzetnost organizma in je treba na podlagi strokovno svetovanje. odraslih in pediatričnih (1 do 17 let) pri bolnikih s staphylococcus aureus bacteraemia (sab). pri odraslih, uporabite v bacteraemia bi morala biti povezana z rie ali z cssti, medtem ko so pri pediatričnih bolnikih, uporabite v bacteraemia bi morala biti povezana z cssti. daptomycin je aktiven proti gram pozitivne bakterije le. v mešanih okužb, kjer je za gram negativne in/ali določene vrste anaerobnih bakterij, ki so osumljene, cubicin je treba co-daje z ustrezno protibakterijsko zastopnik (- i). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine - okužbe z virusom hiv - antivirusi za sistemsko uporabo - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - rekombinantne vezikularni stomatitis virus (sev, indiana) z izbrisom sredstev glikoprotein, nadomesti z zaire ebolavirus (sev kikwit 1995) površine glikoprotein - hemoragične mrzlice, ebola - cepiva - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. uporaba ervebo mora biti v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 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 in 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 opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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 in 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 opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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 opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sugamadeks - neuromuskularna blokada - vsi drugi terapevtski izdelki - zavrnitev nevromuskularne blokade, ki jo inducira rocuronium ali vecuronium. za peadiatric prebivalstva: sugammadex je priporočena le za rutinsko odprave rokuronij zaradi blokade pri otrocih in mladostnikih.