Lusduna Evropska unija - slovenščina - EMA (European Medicines Agency)

lusduna

merck sharp & dohme b.v. - insulin glargin - sladkorna bolezen - zdravila, ki se uporabljajo pri diabetesu - zdravljenje diabetesa mellitusa pri odraslih, mladostnikih in otrocih, starih 2 leti in več.

Noxafil Evropska unija - slovenščina - EMA (European Medicines Agency)

noxafil

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.

RotaTeq Evropska unija - slovenščina - EMA (European Medicines Agency)

rotateq

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.

Victrelis Evropska unija - slovenščina - EMA (European Medicines Agency)

victrelis

merck sharp dohme ltd - boceprevir - hepatitis c, kronični - antivirusi za sistemsko uporabo - victrelis je indicirano za zdravljenje kroničnega hepatitisa c (chc) genotip 1 okužbe, v kombinaciji z peginterferon alfa in ribavirin pri odraslih bolnikih z nadomestiti bolezen jeter, ki so predhodno nezdravljenih ali ki niso prejšnje zdravljenje.

Zostavax Evropska unija - slovenščina - EMA (European Medicines Agency)

zostavax

merck sharp & dohme b.v. - virus varicella-zoster (v živo, oslabljen) - herpes zoster; immunization - virusna cepiva - zdravilo zostavax je indicirano za preprečevanje herpes zoster ("zoster" ali pasovec) in posterpetične nevralgije povezane s herpes-zosterom. zostavax je označen za imunizacijo posameznikov 50 let ali starejši.

Pelzont Evropska unija - slovenščina - EMA (European Medicines Agency)

pelzont

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.

Procomvax Evropska unija - slovenščina - EMA (European Medicines Agency)

procomvax

sanofi pasteur msd, snc - polyribosylribitol fosfat iz haemophilus influenzae tipa b, kot prp-ompc, zunanja membrana, beljakovine kompleks neisseria meningitidis (zunanje membrane protein complex v b11 sev neisseria meningitidis podskupini b), adsorbira hepatitis b surface antigen, proizvedene v rekombinantne kvasovke celic (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - cepiva - procomvax je indicirano za cepljenje proti invazivni bolezni, ki povzroča haemophilus influenzae tipa b in proti okužbi, zaradi vseh znanih podtipov virusa hepatitisa b pri dojenčkih 6 tednov do 15 mesecev starosti.

Tredaptive Evropska unija - slovenščina - EMA (European Medicines Agency)

tredaptive

merck sharp dohme ltd. - laropiprant, nicotinic kisline - dislipidemije - sredstva za spreminjanje lipidov - tredaptive je indiciran 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). tredaptive 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 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 tredaptive.

Trevaclyn Evropska unija - slovenščina - EMA (European Medicines Agency)

trevaclyn

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.

Zontivity Evropska unija - slovenščina - EMA (European Medicines Agency)

zontivity

merck sharp dohme limited - vorapaxar sulfat - miokardni infarkt - antitrombotična sredstva - zontivityis so navedeni za zmanjšanje atherothrombotic dogodkov pri odraslih bolnikih z - zgodovina miokardni infarkt (mi)co-daje z acetilsalicilne kisline (asa) in, kjer je primerno, clopidogrel; ali - simptomatsko periferne arterijske bolezni(pad), co-daje z acetilsalicilne kisline (asa) ali, kjer je primerno, clopidogrel.