Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sugammadex - neiromuskulārā blokāde - visi pārējie terapeitiskie produkti - rokuronija vai vekuronija izraisītas neiromuskulārās blokādes atsākšana. par peadiatric iedzīvotāju skaits: sugammadex ir tikai ieteicama regulāra maiņa rocuronium izraisītu blokādes bērniem un pusaudžiem.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformīns hidrohlorīds - cukura diabēts, 2. tips - cukura diabēts - pacientiem ar 2. tipa cukura diabētu:efficib ir norādīts kā palīglīdzekli, lai diētu un vingrinājumiem, lai uzlabotu glycaemic kontroles pacientiem nepietiekami kontrolē par to maksimālā pieļaujama devu metformīns atsevišķi vai tām, kas jau tiek ārstēti ar kombināciju sitagliptin un metformīns. efficib ir norādīts kombinācijā ar sulfonilurīnvielas pamata, (es. trīskāršās kombinācijas terapija), kā palīglīdzekli, lai diētu un vingrošanu pacientiem nepietiekami kontrolē par to maksimālā pieļaujama devu metformīns un sulfonilurīnvielas pamata. efficib ir norādīts kā triple kombinēto terapiju ar ppar agonistu (i. a thiazolidinedione) kā palīglīdzekli, lai diētu un vingrošanu pacientiem nepietiekami kontrolē par to maksimālā pieļaujama devu metformīns un ppar agonistu. efficib ir arī norādīts, kā pievienot uz insulīna i. , triple kombinēto terapiju), kā palīglīdzekli, lai diētu un vingrinājumiem, lai uzlabotu glycaemic kontroles pacientiem, ja tās ir stabilas devas insulīna un metformīns vien nenodrošina pietiekamu kontroles glycaemic.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitants - vomiting; postoperative nausea and vomiting; cancer - pretvemšanas un antinauseants, - emend 40 mg cietās kapsulas tiek norādīts novēršanas pēcoperācijas slikta dūša un vemšana (ponv) pieaugušajiem. emend ir pieejama arī kā 80 mg un 125 mg cietās kapsulas, lai novērstu sliktu dūšu un vemšanu, kas saistītas ar augsti un vidēji emetogenic vēža ķīmijterapija pieaugušajiem un pusaudžiem no 12 gadu vecuma (skatīt atsevišķu zāļu apraksts). emend ir pieejama arī kā 165 mg cietās kapsulas, lai novērstu akūta un aizkavēta nelabums un vemšana, kas saistīta ar ļoti emetogenic cisplatin, pamatojoties vēža ķīmijterapija pieaugušajiem un novēršanu, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija pieaugušajiem. emend ir arī pieejama kā pulveris iekšķīgai apturēšanu, lai novērstu sliktu dūšu un vemšanu, kas saistītas ar augsti un vidēji emetogenic vēža ķīmijterapija bērniem, maziem bērniem un zīdaiņiem vecumā no 6 mēnešiem līdz mazāk nekā 12 gadus. emend 80 mg, 125 mg, 165 mg cietās kapsulas un emend pulveris iekšķīgai apturēšanu tiek sniegta kā daļa no terapijas kombinācija.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

leti pharma, s.l.u. - recombinant protein q from leishmania infantum mon-1 - inaktivēta baktēriju vakcīnas (ieskaitot mycoplasma, toxoid un chlamydia) - suņi - lai aktīvi imunizētu suņus no 6 mēnešu vecuma, lai mazinātu risku attīstīt leihmaniozes klīnisko gadījumu.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

eli lilly and company limited - spinosads, milbemycin oksīms - pretparazītu izstrādājumi, insekticīdi un repelenti, endectocides - suņi - par ārstēšanu un profilaksi blusu (ctenocephalides felis) invāzijas suņiem, ja viena vai vairākas šādas pazīmes tiek prasīts vienlaicīgi: profilakses heartworm slimības (l3, l4 dirofilaria immitis) profilakse;angiostrongylosis, samazinot infekcijas līmenim, ar bērnišķīgu pieaugušo (l5) angiostrongylus vasorum;ārstēšana kuņģa-zarnu trakta nematode infekcijām, ko izraisa hookworm (l4, bērnišķīgu pieaugušo, l5) un pieaugušo ancylostoma caninum), apaļtārpi (negatavi pieaugušo l5, un pieaugušo toxocara canis un pieaugušo toxascaris leonina) un whipworm (pieaugušo trichuris vulpis).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin - cukura diabēts, 2. tips - cukura diabēts - pieaugušiem pacientiem ar 2. tipa cukura diabētu, januvia ir norādīts, lai uzlabotu glycaemic kontrole:kā monotherapy:pacientiem nepietiekami kontrolēts ar diētu un vingrošanu, vieni un kuriem metformīns ir nevietā, jo kontrindikācijas vai nepanesamību;kā dual dobuma terapija kombinācijā ar:metformīns, kad diētu un vingrošanu, plus metformīns vien nenodrošina pietiekamu glycaemic kontrole;sulfonilurīnvielas pamata, kad diētu un vingrošanu, plus maksimālā pieļaujama devu sulfonilurīnvielas pamata, vien nenodrošina pietiekamu glycaemic kontroli un, ja metformīns ir nevietā, jo kontrindikācijas vai neiecietība;a peroxisome-proliferator aktivizēts receptoru-gamma (ppary) agonistu (i. a thiazolidinedione), kad izmantot ppary agonistu ir gadījumā un tad, ja diēta un fiziskā plus ppary agonistu vien nenodrošina pietiekamu glycaemic kontrole;ppary agonistu (i. a thiazolidinedione), kad izmantot ppary agonistu ir gadījumā un tad, ja diēta un fiziskā plus ppary agonistu vien nenodrošina pietiekamu glycaemic kontroli;kā triple dobuma terapija kombinācijā ar sulfonilurīnvielas pamata, un metformīns, kad diētu un vingrošanu, plus dual terapija ar šīm zālēm nesniedz pienācīgu glycaemic kontrole;ppary agonists un metformīns, kad izmantot ppary agonistu ir gadījumā un tad, ja diēta un fiziskā plus dual terapija ar šīm zālēm nesniedz pienācīgu glycaemic kontrole. januvia ir arī norādīts, kā add-on, lai insulīnu (ar vai bez metformīns) tad, ja diēta un fiziskā plus stabilu devu insulīna nenodrošina pietiekamu kontroles glycaemic.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumabs - 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 - antineoplastiski līdzekļi - 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. pacientiem ar egfr vai bĀziskĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics sistēmiskai lietošanai - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 un 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 un 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 ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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 un 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 un 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 un 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 ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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 un 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 un 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 ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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):- invazīvās aspergillosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b vai itraconazole, vai pacientiem, kuri nepanes no šīm zālēm;- fusariosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, vai pacientiem, kuri nepanes no amfotericīna b;- chromoblastomycosis un mycetoma pacientiem ar slimību, kas ir ugunsizturīgi, lai itraconazole, vai pacientiem, kuri nepanes no itraconazole;- coccidioidomycosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, itraconazole vai fluconazole, vai pacientiem, kuri nepanes no šīm zālēm;- orofaringālas kandidoze: kā pirmās līnijas terapija pacientiem, kuriem ir smagas slimības vai pat cilvēkiem ar traucētu imūnsistēmu, kuriem atbildes uz aktuāliem terapija ir sagaidāms, ka būs slikti. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - avanafil - erektilā disfunkcija - drugs used in erectile dysfunction - erektilā disfunkcijas ārstēšana pieaugušiem vīriešiem. lai spedra būtu efektīva, seksuālo stimulāciju ir vajadzīgs.