natgillin/translations-raw huggingface dataset:
I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1,0 % for patienter, der blev behandlet med Trevaclyn med eller uden et statin.
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST  3 X ULN, consecutive) was 1.0 % for patients treated with Trevaclyn with or without a statin.
I kontrollerede og åbne studier med voksne og pædiatriske patienter med Humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis , candidiasis, aspergillose og listeriose).
In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, ,blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
I kontrollerede og åbne studier med voksne og pædiatriske patienter med Humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis , candidiasis, aspergillose og listeriose).
In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis candidiasis, aspergillosis and listeriosis).
I kontrollerede og åbne studier med voksne og pædiatriske patienter med Humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis , candidiasis, aspergillose og listeriose).
In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
I kontrollerede og åbne studier med voksne og pædiatriske patienter med Humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks.dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis, candidiasis, aspergillose og listeriose).
In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
I kontrollerede studier af Orgalutran med FSH, hvor der er anvendt en lang protokol med GnRH- agonist som reference, resulterede Orgalutran-behandlingen i en hurtigere follikelvækst i de første dage af stimulationen, mens den sidste kohorte af voksende follikler var lidt mindre og gennemsnitligt producerede mindre østradiol.
In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
I kontrollerede studier blandt trombocytopeniske patienter med HCV (n = 1.439) oplevede 38 ud af 955 personer (4 %), som blev behandlet med eltrombopag, en TEE, og 6 ud af 484 personer (1 %) i placebogruppen oplevede TEE.
In controlled studies in thrombocytopenic patients with HCV (n=1,439), 38 out of 955 subjects (4%) treated with eltrombopag experienced a TEE and 6 out of 484 subjects (1%) in the placebo group experienced TEEs.
I kontrollerede studier blandt trombocytopeniske patienter med HCV (n = 1.439) oplevede 38 ud af 955 personer (4 %), som blev behandlet med eltrombopag, en TEE, og 6 ud af 484 personer (1 %) i placebogruppen oplevede TEE.
In controlled studies in thrombocytopenic patients with HCV (n=1439), 38 out of 955 subjects (4%) treated with eltrombopag experienced a TEE and 6 out of 484 subjects (1%) in the placebo group experienced TEEs.
I kontrollerede studier med Humira (startdosis på 160 mg i uge 0 og 80 mg i uge 2, efterfulgt af 40 mg hver uge med start i uge 4) hos patienter med hidrosadenitis suppurativa med en kontrolperiode af 12 til 16 ugers varighed, forekom ALAT-stigning ≥ 3 x ULN hos 0,3% af patienterne i Humira- behandling og hos 0,6% af patienterne i kontrol-behandling.
In controlled trials of Humira (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of Humira-treated patients and 0.6% of control-treated patients.
I kontrollerede studier med Humira hos patienter med uveitis (startdosis på 80 mg i uge 0 efterfulgt af 40 mg hver anden uge med start i uge 1) i op til 80 uger med en gennemsnitligt behandlingtid på 166,5 dage for patienter behandlet med Humira og 105,0 dage for patienter i kontrol-armen, forekom
In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in patients with uveitis up to 80 weeks with a median exposure of 166.5 days and
I kontrollerede studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs.
The overall incidence of adverse reactions reported with telmisartan (was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
I kontrollerede studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs.
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41,4% vs 43.9 %) in controlled trials in patients treated for hypertension.
I kontrollerede studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs.
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
I kontrollerede studier med trombocytopeniske patienter med HCV, som modtog interferon behandling (n = 1439), oplevede 38 ud af 955 patienter (4 %) som fik eltrombopag, og 6 ud af 484 patienter (1 %) i placebogruppen tromboemboliske hændelser (TEEs).
In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 subjects (4%) treated with eltrombopag and 6 out of 484 subjects (1%) in the placebo group experienced thromboembolic events (TEEs).
I kontrollerede studier var 1158 (34,7 %) af de patienter, der blev behandlet med Praluent ≥65 år, og 241 (7,2 %) af de patienter, der blev behandlet med Praluent var ≥75 år.
In controlled studies, 1158 patients (34.7%) treated with Praluent were ≥65 years of age and 241 patients (7.2%) treated with Praluent were ≥75 years of age.
I kontrollerede studier viste 1 års behandling med lamivudin signifikant suppression af HBV-DNA- replikation (34-57 % af patienterne var under assay detektionsgrænserne (Abbott Genostics solution hybridization assay, LLOD < 1,6 pg/ml)], normaliseret ALAT-niveau (40-72 % af patienterne), induceret HBeAg-serokonversion (bortfald af HBeAg og HBeAb-detektion med HBV-DNA bortfald [ved konventionel assay], 16-18 % af patienterne), forbedret histologi (38-52 % af patienterne havde ≥ 2 points fald i Knodell histologisk aktivitets index [HAI]), og reduceret fibroseudvikling (hos 3-17 % af patienterne) og udvikling til cirrose.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
I kontrollerede studier viste 1 års behandling med lamivudin signifikant suppression af HBV-DNA- replikation [34-57 % af patienterne var under assay detektionsgrænserne, (Abbott Genostics solution hybridization assay, LLOD < 1,6 pg/ml)}, normaliseret ALAT-niveau (40-72 % af patienterne), induceret HBeAg-serokonversion (tab af HBeAg og HBeAb-detektion med HBV-DNA tab [ved konventionel assay], 16-18 % af patienterne), forbedret histologi (38-52 % af patienterne havde ≥ 2 points fald i Knodell histologisk aktivitets index [HAI]), og reduceret fibroseudviklinger (hos 3-17 % af patienterne) og udvikling til cirrose.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
I kontrollerede, kliniske forsøg var incidensen af diarré hos Riprazo HCT-behandlede patienter 1,3 %, sammenlignet med 1,4 % for aliskiren- eller 1,9 % for hydrochlorthiazidbehandlede patienter.
In controlled clinical trials, the incidence of diarrhoea in Riprazo HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
I kontrollerede, kliniske forsøg var incidensen af diarré hos Sprimeo HCT-behandlede patienter 1,3 %, sammenlignet med 1,4 % for aliskiren- eller 1,9 % for hydrochlorthiazidbehandlede patienter.
In controlled clinical trials, the incidence of diarrhoea in Sprimeo HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
I kontrollerede, kliniske studier var incidensen af diarré hos Rasilez HCT-behandlede patienter 1,3 %, sammenlignet med 1,4 % for aliskiren- eller 1,9 % for hydrochlorthiazidbehandlede patienter.
In controlled clinical trials, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
I kortidsstudier med rotter har memantin ligesom andre NMDA-antagonister kun induceret neuronal vakuolisering og nekrose (Olney-læsioner) efter doser, der medfører meget høje maksimale serumkoncentrationer.
In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
I kortidsstudier på rotter har memantin ligesom andre NMDA-antagonister kun induceret neuronal vakuolisering og nekrose (Olney-læsioner) efter doser, der medfører meget høje maksimale serumkoncentrationer.
In short term studies in rats,memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
i kortpakning
EU/1/06/360/007
I korttidsstudier sås et fald i retikulocyttal og regenerativ hyperplasi af de røde blodlegemer (kun hos rotter) ved doser, der blev dårligt tålt af rotter og hunde (> 10 eller 7 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og > 4 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
At poorly tolerated doses in rats and dogs (> 10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and> 4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short term studies.
I korttidsstudier sås et fald i retikulocyttal og regenerativ hyperplasi af de røde blodlegemer (kun hos rotter) ved doser, der blev dårligt tålt af rotter og hunde (> 10 eller 7 gange den humane kliniske eksponering hos voksne eller pædriatriske ITP-patienter ved doser på 75 mg/dag og > 4 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
At poorly tolerated doses in rats and dogs (> 10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and> 4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short term studies.
I kroppen
Examples include:
I kroppen behandles radium ligesom det naturlige calcium i knoglerne.
In the body, radium is handled like the calcium naturally found in the bones.
I kroppen binder sirolimus sig til et protein, der findes inden i cellen, og danner derved et »kompleks«.
In the body, sirolimus attaches to a protein that is found inside cells to make a ‘complex’.
I kroppen går denne analog ind på guaninets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af nyt dna (dna-polymeraser).
In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
I kroppen indtager 5-FU pyrimidinets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af ny dna.
In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
I kroppen omdannes mycophenolatmofetil til mycophenolsyre, som virker ved at blokere et enzym ved navn "inosinmonofosfatdehydrogenase".
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase’.
I kroppen omdannes pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i DNA og RNA, cellernes genetiske materiale).
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells).
I kroppen omdannes pemetrexed til en aktiv form, som blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i dna og rna, cellernes genetiske materiale).
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells).
I kroppen omdannes trifluridin til en aktiv form, der trænger direkte ind i dna'et, cellernes genetiske materiale.
In the body, trifluridine is converted into an active form that is incorporated directly into DNA, the genetic material of cells.
I kroppen stimulerer et hormon kaldet "trombopoietin" produktionen af blodplader i knoglemarven.
In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets in the bone marrow.
I kroppen stimulerer et hormon kaldet "trombopoietin" produktionen af blodplader ved at binde sig til visse receptorer i knoglemarven.
In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets by attaching to certain receptors in the bone marrow.
I kroppen.
In your body
I Krystexxa er uricase bun- det til det kemiske stof polyethylenglycol (PEG), der nedsætter den hastighed, hvormed uricase udskil- les fra kroppen, så det virker i længere tid.
In Krystexxa, uricase has been attached to a chemical, polyethylene glycol (PEG), which decreases the rate at which uricase is removed from the body, allowing its action to last longer.
I laboratorieundersøgelser hos rotter er der set dosisrelateret teratogen, føtotoksisk og maternotoksisk effekt ved høje doser (40 og 160 milligram pr. kg administreret dagligt i 10 dage i drægtighedsperioden).
Laboratory studies in rats have shown evidence of dose-related teratogenic, foetotoxic and maternotoxic effects at high dosages (40 and 160 mg/kg administered daily for 10 days during their gestational period).
I laboratorieundersøgelserne blev det påvist, at Purevax RC beskytter mod de sygdomme, der er angivet ovenfor.
In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above.
I laboratorieundersøgelserne blev det påvist, at Purevax RCP beskytter mod de sygdomme, der er angivet ovenfor.
In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above.
I laboratorieundersøgelserne blev det påvist, at Purevax RCPCh beskytter mod de sygdomme, der er angivet ovenfor.
In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
I langsigtede dyreundersøgelser inhiberer zoledronsyre knogleresorptionen uden negativ påvirkning af knogledannelse, knoglemineralisation eller knoglernes mekaniske egenskaber.
long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
I langsigtede forlængelser af kliniske studier blev beskyttelse observeret efter dosis 3 hos PPE- populationen.
In long-term extensions of clinical studies, protection has been observed postdose 3 in the PPE population.
I langtids-opfølgningsstudiet af protokol 015 blev 1984 kvinder i alderen 16-23 år fulgt gennem Gardasil-vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 015, 1984 women 16-23 years old during vaccination with Gardasil in the base study were followed.
I langtids-opfølgningsstudiet af protokol 015 blev 1984 kvinder i alderen 16-23 år fulgt gennem Silgard-vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 015, 1984 women 16-23 years old during vaccination with Silgard in the base study, were followed.
I langtids-opfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Gardasil- vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed.
I langtids-opfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Silgard- vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Silgard in the base study, were followed.
I langtids-opfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Gardasil- vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed.
I langtids-opfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Silgard- vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Silgard in the base study, were followed.
I langtids-opfølgningsstudiet af protokol 019 blev 684 kvinder i alderen 24-45 år fulgt gennem Gardasil-vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 019, 684 women 24-45 years old during vaccination with Gardasil in the base study were followed.
I langtids-opfølgningsstudiet af protokol 019 blev 684 kvinder i alderen 24-45 år fulgt gennem Silgard- vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 019, 684 women 24-45 years old during vaccination with Silgard in the base study, were followed.
I langtidsforsøg blev der observeret nyretumorer (adenomer og karcinomer) ved alle de afprøvede doser, hvilket mest sandsynligt er en konsekvens af denne kroniske beskadigelse af nyrerne.
In long-term studies, renal tumours (adenomas and carcinomas) were observed at all doses tested, most likely as a consequence of this chronic renal damage.
I langtidsundersøgelserne var Abilify efter indtil et års behandling mere effektivt end placebo og lige så effektivt som haloperidol.
In the long-term studies, Abilify was more effective than placebo, and as effective as haloperidol, after up to a year of treatment.
I langvarige kliniske undersøgelser var den gennemsnitlige doseringshyppighed ca. hver 12. uge, dette kan dog variere fra person til person, og en del af patienterne opretholdt en betydelig forbedring i forhold til basislinjen i 16 uger eller længere.
In long term clinical studies, the average dosing frequency was approximately every 12 weeks, however this may vary between subjects and a proportion of patients maintained a significant improvement relative to baseline for 16 weeks or longer.
I lasergruppen fik 67 patienter erstatningsbehandling med Eylea begyndende i uge 24 (aktiv kontrol/ Eylea 2 mg-gruppe), hvilket resulterede i en bedring af visus med omkring 5 bogstaver fra uge 24 til 52.
In the laser group 67 patients received rescue treatment with Eylea beginning at week 24 (Active Control/ Eylea 2mg group) which resulted in improvement of visual acuity by about 5 letters from week 24 to 52.
i lavere effekt og manglende hiv- kontrol.
may be associated with lower efficacy and loss of HIV control.
I lenalidomidarmen seponerede 11/81 (14 %) patienter med stor tumorbyrde behandlingen i løbet af behandlingscyklus 1 vs.
During treatment cycle 1, 11/81 (14%) patients with high tumour burden were withdrawn from therapy in the lenalidomide arm vs.
I leveren, nyrerne og tarmkanalen nåede indholdet af 64Cu maksimum efter få timer og faldt derefter jævnt.
Liver, kidney and the intestinal tract reached their maximal content of 64Cu within the first few hours, and then radioactivity steadily diminished.
I levermikrosomer hæmmer pitolisant ikke signifikant CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 eller CYP3A4 eller uridindiphosphat-glukuronosyltransferaseisoformerne UGT1A1, UGT1A4, UGT1A6, UGT1A9 og UGT2B7 i en koncentration på op til 13,3 µM, et betydeligt højere niveau end de niveauer, der opnå s med terapeutisk dosis.
On liver microsomes, pitolisant does not significantly inhibit the activities of the cytochromes CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 or CYP3A4 and of uridine diphosphate glucuronosyl transferases isoforms UGT1A1, UGT1A4, UGT1A6, UGT1A9 and UGT2B7 up to the concentration of 13.3 µM, a level considerably higher than the levels achieved with therapeutic dose.
I lighed med alle andre terapeutiske proteiner er der mulighed for immunogenicitet.
As with all therapeutic proteins, there is the potential for immunogenicity.