Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sugammadex - taugakerfi - Öll önnur lækningavörur - afturköllun taugavöðvablokkunar sem valdið er af rócuronium eða vecuronium. fyrir peadiatric íbúafjöldi: sugammadex er einungis fyrir lífi viðsnúningur rocuronium völdum umsátur í börn og unglingar.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - follitrópín beta - infertility; hypogonadism - hormón kynlíf og stillum kynfæri - Í kvenkyns:fertavid er ætlað fyrir meðferð ófrjósemi í eftirfarandi klínískum aðstæður:egglos (þar á meðal einn eggjastokkum, pcod) í konur sem hafa verið daufur til meðferð við clomifene citratecontrolled eggjastokkum oförvun að framkalla þróun mörgum konum í læknisfræðilega aðstoðar æxlun forrit [e. glasafrjóvgun/fóstur flytja (tÆknifrjÓvgun/et), kynfrumuflutning innan eggjaleiðara flytja (gjÖf) og intracytoplasmic sprauta sæði (icsi). Í karl:skortir hefðir rannsakað vegna hypogonadotrophic kynkirtlavanseytingu.

Evrópusambandið - íslenska - 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 - Æxlishemjandi lyf - 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. sjúklingar með egfr eða t jákvæð æxli stökkbreytingar ætti líka að hafa fengið miða meðferð áður en þú færð 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - glargíninsúlín - sykursýki - lyf notuð við sykursýki - meðferð sykursýki hjá fullorðnum, unglingum og börnum 2 ára og eldri.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterocolitis, pseudomembranous - Ónæmiskerfið sera og mótefni, - zinplava er ætlað til að koma í veg fyrir endurtekna clostridium difficile sýkingu (cdi) hjá fullorðnum sem eru í mikilli hættu á að endurtekna cdi.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - lifrarbólga c, langvinn - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 og 5. fyrir lifrarbólgu c veira (hcv) arfgerð-sérstakur starfsemi sjá kafla 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp and dohme b.v - sjúklingum - lifrarbólga c, langvinn - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol er ætlað í samsettri meðferð með öðrum lyfjum til meðferðar við langvarandi lifrarbólgu c (chc) hjá fullorðnum. rebetol er ætlað ásamt öðrum lyf til meðferð langvarandi lifrarbólgu c (chc) fyrir börn sjúklingar (börn 3 ára og eldri og unglingar) ekki áður meðferð og án lifur lifrarbilun.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - temózólómíð - glioma; glioblastoma - Æxlishemjandi lyf - temodal erfitt hylki er ætlað fyrir meðferð:fullorðinn sjúklinga með nýlega greind glioblastoma multiforme samhliða með geislameðferð og síðan eitt og sér meðferð, börn frá þriggja ára aldri, unglingum og fullorðinn sjúklinga með illkynja glioma, eins og glioblastoma multiforme eða anaplastic astrocytoma, að sýna endurkomu eða framvindu eftir standard meðferð.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - letermovir - cytomegalovirus sýkingar - veirueyðandi lyf til almennrar notkunar - prevymis er ætlað til að fyrirbyggja cmv (cmv) endurvakning og sjúkdómurinn í fullorðinn cmv-mótefni viðtakendur [r+] af ósamgena skurðaðgerðir stafa klefi grætt (hsct). Íhuga ætti að opinbera leiðsögn á réttri notkun af veirum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic sýru - sykursýki, tegund 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro er ætlað í fullorðnir 18 ára og eldri með tegund 2 sykursýki sem viðbót til að fæði og æfa til að bæta blóðsykursstjórnun:eitt og sér í sjúklingar sem notkun kvarta er talið óviðeigandi vegna óþol eða frábendingar. auk þess önnur lyf fyrir meðferð sykursýki.