natgillin/translations-raw huggingface dataset:
Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i farmakokinetikken efter multiple doser.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i farmakoninetikken efter multiple doser.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Der sås sammenlignelig eksponering og fordeling af Voncento hos <6-årige og hos 6-12-årige forsøgspersoner.
Voncento exposure and disposition were comparable between <6-year-old and 6-12-year-old subjects.
Der sås sammenlignelige remissions-rater ved uge 8for 160/80 mg og 80/40 mg induktionsregimerne, men bivirkninger var hyppigere i gruppen med 160/80 mg.
Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by Week 8 and adverse events were more frequently noted in the 160/80 mg group.
Der sås sammenlignelige responsrater (konfirmeret udetekterbar viral load < 50 hiv 1-RNA- kopier/ml) i uge 96 i rilpivirin-gruppen og efavirenz-gruppen.
The response rate (confirmed undetectable viral load < 50 HIV-1 RNA copies/ml) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
Der sås signifikant større forbedring i generel livskvalitet (QoL) i crizitonib-armen sammenlignet med kemoterapi-armen (samlet forskel i ændring fra baseline var 13,8; p <0,0001).
Significantly greater improvement in global QOL was observed in the crizotinib arm compared to the chemotherapy arm (overall difference in change from baseline scores 13.8; p-value <0.0001).
Der sås signifikante forbedringer af den lægelige kliniske vurdering af autoinflammatorisk sygdomsaktivitet: samlet vurdering af autoinflammatorisk sygdomsaktivitet, vurdering af hudsygdom (urtikarielt hududslæt), artralgi, myalgi, hovedpine/migræne, konjunktivitis, træthed/utilpashed, vurdering af andre relaterede symptomer og af patientens vurdering af symptomer.
Significant improvements were seen in physician’s clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient’s assessment of symptoms.
Der sås statistisk signifikante (p<0,0001) fald i HbA1c og kropsvægt sammenlignet med placebo (tabel 3), når empagliflozin blev givet som supplement til metformin, metformin og et sulfonylurinstof eller til pioglitazon med eller uden metformin.
Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Der sås svær levertoksicitet hos hunde behandlet i 2 uger, inkluderende forhøjede leverenzymer, hepatocellulær nekrose, galdevejsnekrose samt galdevejshyperplasia.
Severe liver toxicity was observed in dogs treated for 2weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Der sås svære hæmoragiske bivirkninger (grad ≥3) hos 2,2% af alle trastuzumabemtansinbehandlede patienter og hos 1,8% af patienter af asiatisk etnicitet behandlet med trastuzumabemtansin.
The incidence of severe haemorrhagic events (Grade ≥3) occurred in 2.2% of the overall trastuzumab emtansine treated patients and 1.8% of Asian trastuzumab emtansine treated patients.
Der sås synergistisk antiretroviral aktivitet, når humane T-lymfeceller inficerede med LAI varianten af hiv-1 blev inkuberet med indinavir og enten zidovudin, didanosin eller en non-nukleosid revers transcriptasehæmmer.
Synergistic antiretroviral activity was observed when human T–lymphoid cells infected with the LAI variant of HIV–1 were incubated with indinavir and either zidovudine, didanosine, or NNRTIs.
Der sås tegn på embryo- og modertoksicitet, men ikke teratogenicitet, ved doser af ranolazin på op til 400 mg/kg/dag (2.400 mg/m2/dag) hos rotter og 150 mg/kg/dag (1.800 mg/m2/dag) hos kaniner.
Signs of embryonal and maternal toxicity, but not teratogenicity, were seen at doses of ranolazine up to 400 mg/kg/day (2400 mg/m2/day) in rats and 150 mg/kg/day (1800 mg/m2/day) in rabbits.
Der sås tilfredstillende globalt respons (fuldstændig eller delvis resolution af alle tilhørende symptomer, radiografiske/bronkoskopiske abnormaliteter ved baseline) hos 53% af de voriconazolbehandlede patienter sammenlignet med 31% af patienterne behandlet med komparatoren.
A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31 % of patients treated with comparator.
Der sås tilfredstillende globalt respons (fuldstændig eller delvis resolution af alle tilhørende symptomer, radiografiske/bronkoskopiske abnormaliteter ved baseline) hos 53% af de voriconazolbehandlede patienter sammenlignet med 31% af patienterne behandlet med komparatoren.
A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Der sås øget hyppighed af ikke fatalt MI og slagtilfælde hos kvinder i det irbesartan- baserede regime versus det amlodipin-baserede regime, mens frekvensen af hospitalindlægge lse på grund af hjertefejl blev reduceret i den samlede population.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Der sås øget hyppighed af ikke fatalt MI og slagtilfælde hos kvinder i det irbesartan- baserede regime versus det amlodipin-baserede regime, mens frekvensen af hospitalindlæggelse på grund af hjertefejl blev reduceret i den samlede population.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Der sås øget incidens af opportunistiske infektioner ved kronisk imatinib-behandling.-
An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Der tager visse andre lægemidler, der er nævnt i produktinformationen
Taking certain other drugs mentioned in the product information
Der tilrådes
administration.
Der tilrådes forsigtighed i tilfælde af kombination med CYP3A4-substrater, der har en snæver terapeutisk margen, dvs. immunosuppressive midler (cyclosporin, tacrolimus, sirolimus) samt CYP3A4-metaboliserede cytotoksika, dvs. cyclophosphamid, etoposid, finasterid, ifosfamid, tamoxifen og vincaalkaloider.
Caution is advised in case of combination with CYP3A4 substrates having a narrow therapeutic margin i.e. immunosuppressive agents (cyclosporine, tacrolimus, sirolimus) as well as CYP3A4- metabolised cytotoxics, i.e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca- alcaloids.
Der tilrådes forsigtighed ved ordinering af lurasidon sammen med lægemidler, som vides at forlænge QT-intervallet, f.eks. antiarytmika af klasse IA (f. eks. kinidin, disopyramid) og antiarytmika af klasse III (f.eks. amiodaron, sotalol), visse antihistaminer, visse andre antipsykotika, og visse malariamidler (f.eks. mefloquin).
Caution is advised when prescribing lurasidone with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g. quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Der tilrådes forsigtighed ved samtidig administration af Senshio og fluconazol (se pkt.
Caution is recommended when co-administering Senshio with fluconazole (see section 4.5).
Der tilrådes forsigtighed, hvis mirabegron administreres samtidig med lægemidler, som har et snævert terapeutisk indeks og metaboliseres i væsentlig grad af CYP2D6, som f.eks. thioridazin, klasse 1C- antiarytmika (f.eks. flecainid, propafenon) og tricykliske antidepressiva (f.eks. imipramin, desipramin).
Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6, such as thioridazine, Type 1C antiarrhythmics (e.g., flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine).
Der tilrådes forsigtighed, når bisfosfonater administreres sammen med aminoglykosider, da begge stoffer kan have en additiv virkning og give et lavere serum-calcium-niveau i længere perioder end påkrævet.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required.
Der tilrådes forsigtighed, når bisfosfonater indgives sammen med aminoglykosider, calcitonin eller loop-diuretika, da disse stoffer kan have en additiv effekt og give et lavere serumcalciumniveau i længere perioder end påkrævet (se pkt.4.4).
Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4)..
Der tilrådes forsigtighed, når Zoledronsyre Hospira indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Der tilrådes forsigtighed, når zoledronsyre indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Der tilrådes forsigtighed, når Zoledronsyre Teva indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
Caution is advised when Zoledronic acid Teva is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Der tilrådes forsigtighed, når Zometa indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler
Caution is advised when Zometa is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Der tilrådes forsigtighed, når Zometa indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
Caution is advised when Zometa is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Der tilstræbes en hæmoglobinkoncentration på mellem 10 og 12 g/dl (6,2-7,5 mmol/l) undtaget hos pædiatriske patienter, hvis hæmoglobinkoncentration bør ligge mellem 9,5 og 11 g/dl (5,9-
The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Der trækkes 1 ml KRYSTEXXA op af hætteglasset i en steril sprøjte.
1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Der trækkes 1 ml KRYSTEXXA op af hætteglasset med en steril sprøjte.
1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Der udføres i øjeblikket kliniske forsøg med ReFacto AF hos tidligere ubehandlede patienter (PUP’er).
Clinical trials are ongoing in previously untreated patients (PUPs) with ReFacto AF.
Der udførtes rutinemæssigt immunohistokemi med Kit antistof (A-4502, polyklonalt kaninserum, 1:100; DAKO Corporation, Carpinteria, CA) i overensstemmelse med analyse ved avidin-biotin- peroxidasekompleksmetode efter antigengenfinding.
Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Der var 1 tilfælde (0,1 %) af endometriecancer, 1 tilfælde af sarkom (0,1 %) og 1 tilfælde (0,1 %) af endometriehyperplasi blandt de forsøgsdeltagere, der blev behandlet med raloxifen 60 mg.
There was 1 case (0.1%) of endometrial cancer, 1 case of sarcoma (0.1%), and 1 case (0.1%) of endometrial hyperplasia in the raloxifene 60 mg-treated subjects.
Der var 1 tilfælde af ovariecancer i 40 mg- behandlingsgruppen efter op til 5 år.
There was one case of ovarian cancer in the 40 mg treatment group up to 5 years.
Der var 10 nye virologiske svigt mellem den primære analyse i uge 48 og uge 96 (3 patienter med en virusbelastning ved baseline ≤ 100.000 kopier/ml og 7 patienter med en virusbelastning ved baseline > 100.000 kopier/ml).
There were 10 new virologic failures between the Week 48 primary analysis and Week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Der var 10 nye virologiske svigt mellem den primære analyse ved uge 48 og uge 96 (3 patienter med baseline viral belastning ≤ 100.000 kopier/ml og 7 patienter med baseline viral belastning > 100.000 kopier/ml).
There were 10 new virologic failures between the week 48 primary analysis and week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Der var 17 nye virologiske svigt mellem den primære analyse i uge 48 og uge 96 (6 patienter med en virusbelastning ved baseline ≤ 100.000 kopier/ml og 11 patienter med en virusbelastning ved baseline > 100.000 kopier/ml).
There were 17 new virologic failures between the Week 48 primary analysis and Week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Der var 17 nye virologiske svigt mellem den primære analyse ved uge 48 og uge 96 (6 patienter med baseline viral belastning ≤ 100.000 kopier/ml og 11 patienter med baseline viral belastning > 100.000 kopier/ml).
There were 17 new virologic failures between the week 48 primary analysis and week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Der var 23 patienter (4,4 %) med en QTc-forøgelse fra baseline >60 msek.
There were 23 patients (4.4%) with a QTc increase from baseline >60 msec.
Der var 3 tilfælde (0,2 %) af endometriecancer og 1 tilfælde (0,1 %) af endometriehyperplasi i placebogruppen.
There were 3 cases (0.2%) of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the placebo group.
Der var 5 med komplet respons og 32 med delvist respons ved en ORR på 70% (95% CI: 56%; 82%).
There were 5 complete responses and 32 partial responses for an ORR of 70% (95% CI: 56%, 82%).
Der var 7/317 patienter (2%) i Eviplera-armen og 6/152 patienter (4%) i armen med sent skift, som seponerede studielægemidlet permanent pga. bivirkninger opstået under behandlingen (treatment- emergent adverse events (TEAE)).
There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse events (TEAE).
Der var 703 patienter, som oplevede en hændelse inden for det sekundære sammensatte MACE- endepunkt (første hændelse af kardiovaskulær død, ikke-dødeligt myokardieinfarkt, ikke-dødeligt apopleksi og akut revaskularisering på grund af ustabil angina).
There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Der var 703 patienter, som oplevede en hændelse inden for det sekundære, sammensatte MACE- endepunkt (første hændelse af kardiovaskulær død, ikke-dødeligt myokardieinfarkt, ikke-dødelig apopleksi og akut revaskularisering på grund af ustabil angina).
There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Der var 703 patienter, som oplevede en hændelse inden for det sekundære, sammensatte MACE- endepunkt (første hændelse af kardiovaskulær død, ikke-dødeligt myokardieinfarkt, ikke-dødeligt apopleksi og akut revaskularisering på grund af ustabil angina).
There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Der var bevis på direkte hæmning af CYP2E1 forårsaget af fampridin ved 30 μM (cirka 12% hæmning), hvilket er cirka 100 gange så meget som den gennemsnitlige plasma- fampridinkoncentration målt for 10 mg tabletten.
There was evidence of direct inhibition of CYP2E1 by fampridine at 30 μM (approximately 12% inhibition) which is approximately 100 times the average plasma fampridine concentration measured for the 10 mg tablet.
Der var designet et klinisk studie med patienter med moderat til svæ r psoriasis for at undersøge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregimen med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregime med Remicade (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Der var desuden bedring i patienternes symptomer såsom smerter og inflammation, og deres syn var blevet bedre.
There were also reductions in patients’ symptoms, such as pain and inflammation, and improvements in vision.
Der var dog ikke nogen forsinket neonatal udvikling efter eksponering in utero eller gennem mælken.
However, there was no delay in neonatal development following exposure in utero or via milk.
Der var dog ikke tilstrækkeligt bevis til at underbygge anvendelsen af Zykadia hos disse patienter.
However, the evidence was insufficient to support the use of Zykadia in these patients.
Der var dog ingen evidens af klinisk signifikante bivirkninger i PLATO-studiet efter samtidig administration af et eller flere lægemidler, der er kendt for at inducere bradykardi (f.eks.
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g.
Der var dog ingen signifikant forskel på mortalitet af alle årsager mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling, RR 0,96 95 % KI [0,89-1,02] p=0,20.
However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone- based therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Der var dog nogen usikkerhed om virkningerne af Zinforo hos patienter med visse meget svære infektioner.
However there were uncertainties about the effects of Zinforo in patients with certain very severe infections.
Der var dødelige tilfælde i det kliniske cabozantinib- program.
Fatal haemorrhages have occurred in the cabozantinib clinical program.
Der var dødelige tilfælde i det kliniske cabozantinib-program.
Fatal perforations have occurred in the cabozantinib clinical program.
Der var en forbedring i NYHA-klasse hos 37,7 % af patienterne i ivabradin- gruppen mod 25,0 % i placebogruppen.
There was an improvement in NYHA class in 37.7% of ivabradine patients versus 25.0% in the placebo group.
Der var en forskel på 4,7 procentpoint til fordel for armen med Herceptin subkutan formulering.
45.4 % (95 % CI: 39.2 %, 51.7 %) in the Herceptin subcutaneous arm, a difference of 4.7 percentage points in favour of the Herceptin subcutaneous arm.
Der var en gennemsnitlig forøgelse af trombocyttallet på 22,2  109/l og en gennemsnitlig forøgelse af hæmoglobinkoncentrationen på 0,95 g/dl.
There was a mean increase of 22.2  109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Der var en højere frekvens af alvorlige bivirkninger herunder pneumoni, akut afstødning, transplantattab og død i gruppen behandlet med sirolimus (n=60, median- tid efter transplantation 36 måneder).
There was a higher rate of serious adverse events, including pneumonia, acute rejection, graft loss and death, in this sirolimus treatment arm (n=60, median time post-transplant 36 months).
Der var en højere incidens af alvorlige infektioner, inklusive opportunistiske infektioner og TB hos patienter som fik golimumab 100 mg, sammenlignet med patienter, som fik golimumab 50 mg, i de kontrollerede og ikke-kontrollerede dele af de pivotale studier med en median follow-up på op til 3 år.
In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of approximately 2 years, there was a greater incidence of serious infections, including opportunistic infections and TB in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
Der var en initial stigning i hyppigheden af bivirkninger hos cirka én ud af fem patienter, observeret i op til otte uger efter de først havde skiftet fra konventionelle hydrocortison- tabletter givet tre gange daglig til tabletter med modificeret udløsning givet én gang daglig.
There was an initial increase in the frequency of adverse reactions in about one in five patients, observed up to eight weeks after first changing from conventional hydrocortisone tablets given three times daily to once daily modified-release tablets.
Der var en lav forekomst af gentamicinresistente bakterier, isolerede i otitis hos hunde før behandling mellem 2008 og 2010 (fastsat ifølge CLSI guideline, breakpoint ≥ 8 for alle isoleringer undtagen for stafylokokker ≥ 16 μg/ml): 4,6%, 2,9% og 12,5% for henholdsvis Staphylococcus spp., Pseudomonas and Proteus spp.
Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment (determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp. respectively.