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 ltd - laropiprant, nicotinic kisline - dislipidemije - sredstva za spreminjanje lipidov - pelzont je primerna za zdravljenje dyslipidaemia, zlasti pri bolnikih s kombinirano mešano dyslipidaemia (značilno povišane ravni nizko gostoto-hdl (ldl) holesterola in trigliceridov in nizko visoko gostoto-hdl (hdl)holesterol) in pri bolnikih s primarno hypercholesterolaemia (heterozygous družinsko in ne-družinsko). pelzont je treba uporabljati pri bolnikih, ki v kombinaciji z 3-hidroksi-3-methylglutaryl-koencim a (hmg-coa)-reductase inhibitorji (statins), ko je raven holesterola, znižuje učinek hmg-coa-reductase zaviralec monotherapy je neustrezna. lahko se uporablja kot monotherapy le pri bolnikih, pri katerih hmg-coa-reductase inhibitorji so se štejejo za neprimerne ali ne prenaša. prehrana in druge ne-farmakološko zdravljenje (e. vadba, zmanjšanje telesne mase), bi bilo treba še naprej med terapijo z pelzont.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic kisline - dislipidemije - sredstva za spreminjanje lipidov - trevaclyn je indicirano za zdravljenje dyslipidaemia, zlasti pri bolnikih s kombinirano mešani dyslipidaemia (značilno povišane ravni nizko-gostoto-nizke gostote (ldl) holesterola in trigliceridov in nizko visoko-gostoto-lipoprotein (hdl) holesterol) in pri bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in družinsko). trevaclyn je treba uporabljati pri bolnikih, ki v kombinaciji z 3-hidroksi-3-metil-glutaryl-co-encim-a (hmg-coa)-reductase inhibitorji (statins), ko je raven holesterola,-znižuje učinek hmg-coa-reductase-inhibitor monotherapy je neustrezna. lahko se uporablja kot monotherapy le pri bolnikih, pri katerih hmg-coa-reductase inhibitorji so se štejejo za neprimerne ali ne prenaša. prehrana in druge ne-farmakološko zdravljenje (e. vadba, zmanjšanje telesne mase), bi bilo treba še naprej med terapijo z trevaclyn.

Evropska unija - slovenščina - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hiperurikemija - antigout pripravki - zurampic, v kombinaciji z zaviralec ksantinske oksidaze, je indicirano pri odraslih za dodatno zdravljenje pri bolnikih protina (z ali brez tophi), ki niso dosegli cilj serumu sečne kisline z ustrezno odmerek ksantin-oksidaza hiperurikemija zaviralec sam.

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)

glaxo group ltd. - flutikazon furoat - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - nosni pripravki - odrasli, mladostniki (12 let in več) in otroci (od 6 do 11 let). zdravilo alisade je indicirano za zdravljenje simptomov alergijskega rinitisa.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxo group ltd - retapamulin - impetigo; staphylococcal skin infections - antibiotiki in kemoterapevtiki za dermatološko uporabo - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. glej poglavji 4. 4 in 5. 1 za pomembne informacije v zvezi s klinično dejavnost retapamulin proti različne vrste staphylococcus aureus. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split virus influence, inaktivirano, ki vsebujejo antigen*: a/california/7/2009 (h1n1)v, kot sev (x-179a)*razmnožujejo v jajca. - influenza, human; immunization; disease outbreaks - cepiva proti gripi - preprečevanje gripe v uradno prijavljeni pandemični situaciji. pandemije gripe cepiva je treba uporabljati v skladu z uradnimi smernice.

Evropska unija - slovenščina - EMA (European Medicines Agency)

smithkline beecham ltd - rosiglitazone, glimepiride - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - avaglim je navedeno v zdravljenju diabetesa tipa 2 bolezni bolniki, ki ne morejo doseči dovolj glycaemic nadzor na optimalno doziranje sulfonil sečnine monotherapy, in za katere metformin ni primeren, ker contraindication ali nestrpnosti.