Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonasool - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimükoosid süsteemseks kasutamiseks - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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 ja 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 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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):- invasiivsed aspergillosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b või itraconazole, või patsientidel, kes ei talu neid ravimeid;- fusariosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, või patsientidel, kes ei talu, amphotericin b;- chromoblastomycosis ja mycetoma patsientidel, kellel on haigus, mis on tulekindlad, et itraconazole, või patsientidel, kes ei talu, itraconazole;- coccidioidomycosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, itraconazole või fluconazole, või patsientidel, kes ei talu neid ravimeid;- farüngeaalne kandidoos: kui esimese rea ravi patsientidel, kellel on raske haigus, või on immunocompromised, kelle vastus aktuaalne ravi on oodata halb. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformiin vesinikkloriid - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - patsientidel tüüp-2 diabeet:efficib on näidustatud lisandina toitumise ja treeningu parandamiseks glycaemic kontrolli patsientidel, ebapiisavalt kontrollitud nende maksimaalne talutav annus metformiin üksi või need, kes on juba ravitakse kombinatsioon sitagliptin ja metformiin. efficib on näidustatud kombinatsioonis sulphonylurea i. kolmekordne kombineeritud ravi) lisandina toitumise ja treeningu patsientidel, ebapiisavalt kontrollitud nende maksimaalne talutav annus metformiin ja sulphonylurea. efficib on näidustatud triple kombineeritud ravi ppar agonist i. a thiazolidinedione) lisandina toitumise ja treeningu patsientidel, ebapiisavalt kontrollitud nende maksimaalne talutav annus metformiin ja ppar agonist. efficib on ka märgitud, et lisada kohta, et insuliini i. , kolmekordne kombineeritud ravi) lisandina toitumise ja treeningu parandamiseks glycaemic kontrolli patsientidel, kui see on stabiilne annus insuliin ja metformiin üksi ei taga piisavat kontrolli glycaemic.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptiin - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - täiskasvanud patsientidel, kellel on tüüp-2 diabeet, januvia on näidustatud parandada glycaemic kontroll:kui monotherapy:patsientidel, ebapiisavalt kontrollitud dieet ja füüsiline koormus üksi ning kellele metformiin ei sobi tõttu vastunäidustusi või talumatust;dual suukaudne ravi koos:metformiin, kui dieedi ja füüsilise koormuse pluss metformiin üksi ei taga piisavat glycaemic kontrolli;sulphonylurea, kui dieedi ja füüsilise koormuse pluss maksimaalne talutav annus sulphonylurea üksi ei taga piisavat glycaemic kontrolli ja kui metformiin ei sobi tõttu vastunäidustusi või talumatust;a peroxisome-proliferator-activated-retseptor gamma (ppary) agonist i. a thiazolidinedione), kui kasutada ppary agonist on sobiv ja kui dieedi ja füüsilise koormuse pluss ppary agonist üksi ei taga piisavat glycaemic kontrolli;ppary agonist i. a thiazolidinedione), kui kasutada ppary agonist on sobiv ja kui dieedi ja füüsilise koormuse pluss ppary agonist üksi ei taga piisavat glycaemic kontrolli;kui kolmekordse suukaudse ravi koos:sulphonylurea ja metformiin, kui dieedi ja füüsilise koormuse pluss dual ravi nende ravimitega ei ole tagatud piisav glycaemic kontrolli;ppary agonist ja metformiin, kui kasutada ppary agonist on sobiv ja kui dieedi ja füüsilise koormuse pluss dual ravi nende ravimitega ei taga piisavat kontrolli glycaemic. januvia on ka märgitud, et add-on, et insuliini (koos või ilma metformiin), kui dieedi ja füüsilise koormuse pluss stabiilse annuse insuliini ei taga piisavat kontrolli glycaemic.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp and dohme b.v - ribavirin - c-hepatiit, krooniline - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol on näidustatud koos teiste kroonilise hepatiit c (chc) ravimitega täiskasvanutel. rebetol on näidustatud kombinatsioonis teiste ravimitega ravi kroonilise c-hepatiidi (chc) pediaatrilisi patsiente (laste 3-aastased ja vanemad) ja noorukid), mida ei ole varem ravitud ja ilma maksa dekompensatsiooni.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - viirus, elus nõrgestatud, leetrid, viirus, elus nõrgestatud, mumps, viirus, elus nõrgestatud, punetised, viirus, elus nõrgestatud, tuulerõuged - chickenpox; rubella; measles; mumps; immunization - vaktsiinid - proquad on näidustatud samaaegne vaktsineerimine leetrite, mumpsi, punetiste ja tuulerõugete isikutel alates 12 kuu vanusest. proquad võib manustada isikutele alates 9 kuu vanusest eritingimustel (e. , et need on vastavuses riiklike vaktsineerimiste ajakava, puhangu olukorrad või reisi piirkonna kõrge levimus leetrite.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatiit b, rekombinantse pinnaantigeen - hepatitis b; immunization - vaktsiinid - 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. spetsiifilise riski-kategooriate tuleb immunised tuleb põhjal määrata kindlaks ametlike soovituste. võib eeldada, et hepatiit d ka tuleb vältida vaktsineerimist koos hbvaxpro, sest hepatiit d (põhjustatud delta agent) ei esine puudumisel hepatiit-b nakatumise. 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. spetsiifilise riski-kategooriate tuleb immunised tuleb põhjal määrata kindlaks ametlike soovituste. võib eeldada, et hepatiit d ka tuleb vältida vaktsineerimist koos hbvaxpro, sest hepatiit d (põhjustatud delta agent) ei esine puudumisel hepatiit-b nakatumise. 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. võib eeldada, et hepatiit d ka tuleb vältida vaktsineerimist koos hbvaxpro, sest hepatiit d (põhjustatud delta agent) ei esine puudub b-hepatiidi nakkus.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp dohme ltd - inimese papilloomiviiruse tüübi 6 l1-proteiini, inimese papilloomiviiruse tüübi 11 l1-proteiini, inimese papilloomiviiruse tüübi 16 l1-proteiini, inimese papilloomiviiruse tüübi 18 l1-proteiini - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaktsiinid - silgard on vaktsiin kasutamiseks vanuses 9 aastat ennetamise:premalignant suguelundite kahjustused (emakakaela, vulvar ja tupe), premalignant anal kahjustused, emakakaela vähk ja päraku vähk põhjuslikult seotud teatavate oncogenic inimese papilloomiviiruse (hpv) tüübid;suguelundite tüükad (condyloma acuminata) põhjuslikult seotud kindlate hpv tüübid. vt lõigud 4. 4 ja 5. 1, et saada olulist teavet selle näidustust toetavate andmete kohta. kasutada silgard peab olema kooskõlas ametlike soovitustega.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir kaaliumi - hiv-nakkused - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebise on näidustatud kombinatsioonis teiste anti‑retroviral ravimitega inimese immuunpuudulikkuse viiruse (hiv‑1) infektsiooniga täiskasvanutel, noorukitel ja lastel alates 6 aastat ja kehakaaluga vähemalt 30 kg ilma praegu või varem anamneesis viirusevastaste ravimite insti (integraasi ülekande inhibiitorite) ja nrti (nukleosiidi pöördtranskriptaasi inhibiitorite) suhtes (vt lõigud 4 klassid. 2, 4. 4 ja 5.

Euroopa Liit - eesti - 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 - antineoplastilised ained - 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. patsiendid, kellel on egfr-või kristallimise positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nikotiinhape - düslipideemiad - lipiidi modifitseerivad ained - pelzont on näidustatud ravi dyslipidaemia, eriti patsientidel, kellel on kombineeritud segatud dyslipidaemia (mida iseloomustab kõrgenenud low-density-lipoproteiin (ldl) kolesterooli ja triglütseriidide ja madala high-density-lipoproteiin (hdl)kolesterooli) ja patsientidel, kellel on esmane hypercholesterolaemia (heterozygous perekondliku ja mitte-perekondlik). pelzont tuleks kasutada patsientidel kombineerituna 3-hüdroksü-3-methylglutaryl-koensüüm-a (hmg-coa)-reduktaasi inhibiitorid (statins), kui kolesterooli alandav mõju ja hmg-coa-reduktaasi inhibiitor monotherapy on ebapiisav. seda saab kasutada nii monotherapy ainult patsientidel, kellele hmg-coa-reduktaasi inhibiitorid, loetakse sobimatuks või ei ole talutav. dieedi ja muude mittefarmakoloogiliste raviviiside e. treening, kehakaalu vähendamine) tuleks jätkata ravi ajal koos pelzont.