Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - za bolnike z tipa 2 sladkorna bolezen:efficib je indicirano kot dodatek k dieti in telesni za izboljšanje glycaemic nadzor pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom sam ali tistih, ki se že zdravijo z kombinacijo sitagliptin in metformin. efficib je navedeno v kombinaciji z sulfonil sečnine (i. trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. efficib je označen kot trojna kombinacija terapije z ppar agonist (i. a thiazolidinedione) kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in ppar agonist. efficib je prikazano tudi kot dodajte na insulin (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor pri bolnikih, pri stabilen odmerek insulina in metforminom sam ne zagotavljajo ustrezne glycaemic nadzor.

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 and dohme b.v - ribavirin - hepatitis c, kronični - antivirals for systemic use, antivirals for treatment of hcv infections - zdravilo rebetol je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa c (chc) pri odraslih. rebetol je navedeno v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa c (chc) pri pediatričnih bolnikih (otroci od 3 let in več in mladostniki), ki še niso bila obdelana in brez jeter decompensation.

Evropska unija - slovenščina - 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 - antineoplastična sredstva - 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. pri bolnikih z egfr ali alk pozitivnih tumorjev mutacije, ki naj bi prav tako prejel usmerjena terapija pred prejemom 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.

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 - 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.

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)

merck sharp & dohme b.v. - virus, živi oslabljeni, ošpice, virus, živi oslabljeni, mumps, virus, živi oslabljeni, rdečkam, virus, živi oslabljen, noric - chickenpox; rubella; measles; mumps; immunization - cepiva - zdravilo proquad je indicirano za sočasno cepljenje proti ošpicam, mumpsu, rdečkam in noricam pri osebah, starih od 12 mesecev. proquad se lahko upravljajo posamezniki iz 9 mesecev starosti v posebnih okoliščinah (e. tako , da so skladni z nacionalnimi cepljenje urnike, izbruh situacijah, ali potovanje v regiji z visoko razširjenost ošpicam.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, rekombinantni površinski antigen - hepatitis b; immunization - cepiva - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. posebno ogroženih kategorij, da se immunised določi na podlagi uradnih priporočil. pričakovati je, da se hepatitis d bo prav tako mogoče preprečiti z imunizacijo z hbvaxpro, kot je hepatitis d (zaradi delta agent) ne pride v odsotnosti hepatitis-b, okužbe. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. posebno ogroženih kategorij, da se immunised določi na podlagi uradnih priporočil. pričakovati je, da se hepatitis d bo prav tako mogoče preprečiti z imunizacijo z hbvaxpro, kot je hepatitis d (zaradi delta agent) ne pride v odsotnosti hepatitis-b, okužbe. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. pričakovati je, da se hepatitis d bo prav tako mogoče preprečiti z imunizacijo z hbvaxpro, kot je hepatitis d (zaradi delta agent) ne pride v odsotnosti hepatitis b okužbe.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitant - vomiting; postoperative nausea and vomiting; cancer - antiemetics in antinauseants, - emend 40 mg trde kapsule je indicirano za preprečevanje pooperativne navzee in bruhanja (ponv) pri odraslih. emend je na voljo tudi kot 80 mg in 125 mg trde kapsule za preprečevanje slabosti in bruhanja, povezanih z močno in zmerno emetogenic kemoterapijo raka pri odraslih in mladostnikih v starosti od 12 (glej ločen povzetek glavnih značilnosti zdravila). emend je na voljo tudi kot 165 mg trde kapsule za preprečevanje akutne in zapoznele slabost in bruhanja, povezanih z močno emetogenic cisplatin, ki temelji kemoterapijo raka pri odraslih in preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenic kemoterapijo raka pri odraslih. emend je na voljo tudi v obliki praška za ustno suspenzije za preprečevanje slabosti in bruhanja, povezanih z močno in zmerno emetogenic kemoterapijo raka pri otrocih, malčke in dojenčke, starejše od 6 mesecev do manj kot 12 let. emend 80 mg, 125 mg, 165 mg trde kapsule in emend v prahu za ustno vzmetenje so podana kot del kombiniranega zdravljenja.