natgillin/translations-raw huggingface dataset:
De ordinerende læger bør være opmærksomme på risikoen for falske negative resultater af tuberkulintesten, særligt hos patienter der er alvorligt syge eller immunforsvarskompromitterede.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
De ordinerende læger skal også have tilsendt et informationskort, som gives til de patienter, der får Xarelto, hvorpå der er anført sikkerhedspåmindelser til patienterne.
Prescribers will also receive a patient alert card to give to patients receiving Xarelto containing key safety reminders for patients.
De oritavancinkoncentrationer, der findes i blodet efter administration af en dosis på 1.200 mg, kan give falsk forhøjede værdier i visse laboratorietest (se tabel 1).
Oritavancin concentrations achieved in the blood after 1200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
De ovenfor anførte kurver illustrerer den relative mængde glucose, som over tid er nødvendig for at opretholde blodglucose koncentrationer nær fasteniveau og viser samtidig den tidsrelaterede effekt af disse insuliner på glucosemetabolismen.
The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
De ovenfor anførte kurver illustrerer den relative mængde glucose, som over tid er nødvendig for at opretholde blodglucose-koncentrationer nær fasteniveau og viser samtidig den tidsrelaterede effekt af disse insuliner på glucosemetabolismen.
The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
De ovenfor beskrevne tests og metoder til monitorering af hjertefunktionen under antracyklin- behandling skal anvendes i følgende rækkefølge: EKG-monitorering, måling af venstre ventrikels ejektionsfraktion og endomyokardiel biopsi.
The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
De ovenstående instruktioner 1 til 12 gentages derfor ved brug af yderligere en pakning, der indeholder en overførselsanordning, for at rekonstituere det andet hætteglas med solvens.
Therefore, repeat instructions 1 to 12 above using an additional package containing a transfer device to reconstitute the second of two powder vials.
De patienter i 2NN studiet, som ved studiets afslutning i uge 48 stadig blev behandlet i klinikken og var i aktiv behandling, blev tilbudt at deltage i dette studie.
Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
De patienter i induktionsstudierne UNITI-1 og UNITI-2 (476 patienter), som ikke havde klinisk respons på induktionsbehandling med ustekinumab i uge 8, overgik til den ikke-randomiserede del af vedligeholdelsesstudiet (IM-UNITI) og fik på det tidspunkt en subkutan injektion med ustekinumab på 90 mg.
Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time.
De patienter ≥ 75 år, hos hvem fordelen ved prasugrel var mest tydelig omfattede dem med diabetes, STEMI, højere risiko for stenttromboser eller tilbagevendende hændelser.
Patients ≥ 75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events.
De patienter, der blev behandlet med methylnaltrexonbromid, havde også signifikant højere afføringsfrekvens inden for
Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within
De patienter, der blev behandlet med Perjeta, levede gennemsnitligt i 18,5 måneder uden forværring af sygdommen, sammenholdt med 12,4 måneder for dem, der fik placebo.
On average, patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
De patienter, der blev behandlet med Stivarga, levede i gennemsnit 147 dage uden forværring af deres sygdom, sammenlignet med 28 dage for de patienter, der fik placebo og støttebehandling.
Patients treated with Stivarga lived on average for 147 days without their disease getting worse compared with 28 days for patients taking placebo and supportive care.
De patienter, der blev behandlet med tasimelteon, opnåede en samlet bedring i global klinisk funktion (CGI- C = 2,6), mens de placebobehandlede patienters status var ingen bedring (CGI-C = 3,4) fra baseline-sværhed af Non-24 (forskel i mindste kvadraters gennemsnit = -0,8; p=0,0093) (tabel 4 ).
Patients treated with tasimelteon experienced an overall improvement in clinical global functioning (CGI- C = 2.6) as compared to patients treated with placebo who showed no improvement status (CGI-C = 3.4) compared to the severity of Non-24 at baseline (LS mean difference = -0.8; p=0.0093) (Table 4).
De patienter, der blev valgt til den anden undersøgelse, var dem, der havde hyppige anfald, nemlig mindst to anfald om måneden i gennemsnit.
The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
De patienter, der deltog i dette studie, havde aktiv sygdom (defineret som BASDAI ≥ 4 og VAS for total rygsmerte ≥ 4, hver på en skala på cm) på trods af aktuel eller tidligere NSAID-behandling og havde ikke tidligere fået behandling med biologiske lægemidler herunder anti-TNF-behandling.
Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
De patienter, der desuden fik interferon gamma, var for få til, at det kunne fastslås, om udfaldet for patienterne derved blev endnu bedre.
There were too few patients also receiving interferon-gamma to determine whether this improved the patients’ outcome further.
De patienter, der fik behandling med TPF, fik signifikant mindre forværring af deres globale helbredsscore i forhold til patienter i behandling med PF (p = 0,01, med anvendelse af EORTC QLQ- C30-skalaen).
Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelsese sammenlignet med dem, der fik mitoxantron.
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
De patienter, der fik mindst én dosis af studiemedicin, og som havde en positiv dyrkning for Candida- arter fra et normalt sterilt sted, før de indgik i studiet, blev inkluderet i den modificerede intent-to-treat (MITT)-population.
Patients who received at least one dose of study medication and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intent- to-treat (MITT) population.
De patienter, der fik minimum en ACR Pedi 30-respons i slutningen af periode A, blev randomiseret til en dobbeltblind seponeringsfase (periode B) og fik enten abatacept eller placebo i 6 måneder eller indtil opblussen af sygdommen, som defineret i studiet.
Patients achieving at least a ACR Pedi 30 response at the end of Period A were randomized into a double-blind, withdrawal phase (Period B), and received either abatacept or placebo for 6 months or until JIA disease flare as defined in the study.
De patienter, der fik Myocet, havde en lavere risiko for at få hjerteproblemer end de patienter, der fik standard-doxorubicin.
Patients receiving Myocet were less likely to experience heart problems than those receiving standard doxorubicin.
De patienter, der fik Opdivo, overlevede i omkring 25,0 måneder sammenlignet med 19,6 måneder for de patienter, der fik everolimus.
Patients given Opdivo survived for around 25.0 months, compared with 19.6 months in patients given everolimus.
De patienter, der fik placebo i år 2, havde en gennemsnitlig stigning på 4 % sammenlignet med baseline, men der var sket et lille fald i forhold til status efter 12 måneders Preotactbehandling.
For the patients who received placebo during the second year, the mean percent increase was 4.1 compared to baseline, but had decreased slightly compared to the end of 12 months of Preotact treatment.
De patienter, der fik tildelt sædvanlig behandling, fulgte et laksansbehandlingsregimen for opioidinduceret obstipation, der blev fastlagt af investigatoren på baggrund af dennes bedste kliniske vurdering, eksklusive perifere my-opioid- receptorantagonister.
Patients assigned to usual care followed a laxative treatment regimen for OIC determined by the investigator according to best clinical judgment, excluding peripheral mu-opioid receptor antagonists.
De patienter, der fik titreret selexipag til en individuelt tolereret dosis (trin af 200 mikrogram to gange dagligt op til 800 mikrogram to gange dagligt; N = 33), opnåede en statistisk signifikant gennemsnitlig reduktion i den pulmonale vaskulære modstand på 30,3 % (95 % konfidensinterval [CI]: -44,7 %, -12,2 %; p = 0,0045) og en stigning i indekseret minutvolumen (median behandlingsvirkning) på 0,41 l/min/m2 (95 % CI: 0,10; 0,71) sammenlignet med placebo (N = 10).
Patients titrating selexipag to an individually tolerated dose (200 micrograms twice daily increments up to 800 micrograms twice daily; N = 33) achieved a statistically significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI]: 44.7%, 12.2%; p = 0.0045) and an increase in cardiac index (median treatment effect) of 0.41 L/min/m2 (95% CI: 0.10, 0.71) compared to placebo (N = 10).
De patienter, der fik Xofigo, var også længere om at udvikle tegn og symptomer på fremadskridende sygdom såsom knoglebrud og smerter i knoglerne.
Patients given Xofigo also took longer for signs and symptoms of progressive disease such as fractures and bone pain to develop.
De patienter, der får behandling med immunsuppressiva herunder Advagraf, har en øget risiko for opportunistiske infektioner (bakteriel, fungal, viral og protozoal).
Patients treated with immunosuppressants, including Advagraf are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal).
De patienter, der får behandling med immunsuppressiva herunder Modigraf, har en øget risiko for opportunistiske infektioner (bakteriel, fungal, viral og protozoal).
Patients treated with immunosuppressants, including Modigraf, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal).
De patienter, der får den høje dosis Torisel til behandling af mantlecellelymfom, kan på grund af indholdet af alkohol i lægemidlet opleve en påvirkning af deres evne til at køre eller til at betjene maskiner (se afsnittet Advarsler og forsigtighedsregler og Trafik- og arbejdssikkerhed).
For patients receiving the higher dose of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicine may impair your ability to drive or use machines [see section “Torisel contains ethanol” (alcohol)].
De patienter, der gennemførte undersøgelser, fik forbedret deres FEV1, korrigeret for alder og højde, med 0,39 % med Colobreathe, sammenholdt med 0,78 % for tobramy- cin.
Among patients that completed the study, the improvement in FEV1 adjusted for age and height was 0.39% with Colobreathe compared with 0.78% with tobramycin.
De patienter, der ikke tidligere havde fået BRAF-hæmmer (n< 63), opnåede en objektiv responsrate på 87%, inklusive komplet respons hos 16% af patienterne.
The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
De patienter, der indrulleres i kliniske studier (CT-AMT-010-01, CT-AMT 011-01, CT-AMT 011-02), skal følges op i LPLD-registreret.
The patients enrolled in clinical studies (CT-AMT-010-01, CT-AMT 011-01, CT- AMT 011-02) should be followed up in the LPLD registry.
De patienter, der kunne indgå i studiet, skulle være behandlet med mindst 3 antiretrovirale lægemiddelklasser [≥ 1 nukleosid reverse transkriptase-hæmmer (NRTI), ≥ 1 non-nukleosid reverse transkriptase-hæmmer (NNRTI), ≥ 2 proteasehæmmere, og/eller enfurvirtid] eller dokumenteret resistens over for mindst én i hver klasse.
Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥1 nucleoside reverse transcriptase inhibitors (NRTI), ≥1 non-nucleoside reverse transcriptase inhibitors (NNRTI), ≥2 protease inhibitors (PI), and/or enfurvirtide] or documented resistance to at least one member of each class.
De patienter, der supplerede med Inovelon, oplevede også et fald på 42,5 % i antallet af 'tonisk- atoniske' anfald (en almindelig type epileptisk anfald hos patienter med Lennox-Gastaut syndrom, som ofte medfører, at patienten falder om) sammenlignet med en stigning på 1,9 % hos de patienter, der supplerede med placebo.
Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic’ seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo.
De patienter, der var i behandling med Nevanac, havde mindre sandsynlighed for øjensmerter og målbare tegn på inflammation (celler og flare i kammervæske) i den tidlige postoperative periode til endt behandling end de patienter, der blev behandlet med dets vehikel.
Patients treated with NEVANAC were less likely to have ocular pain and measurable signs of inflammation (aqueous cells and flare) in the early postoperative period through to the end of treatment than those treated with its vehicle.
De patienter, der var randomiseret til kemoterapi, kunne overgå til crizotinib- behandling efter sygdomsprogression som defineret i RECIST og bekræftet ved IRR.
Patients randomised to chemotherapy could crossover to receive crizotinib upon RECIST-defined disease progression confirmed by IRR.
De patienter, som blev behandlet med tocilizumab, berettede om forbedring i alle patientrapporterede resultater (Health Assessment Questionnaire Disability Index – HAQ-DI, den korte version af SF-36 og Functional Assessment of Chronic Illness Therapy Questionnaires).
Tocilizumab-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
De patienter, som blev randomiseret til vedligeholdelsesbehandling, skulle have en ECOG performancestatus på 0 eller 1.
All patients included in this study had an ECOG performance status 0 or 1.
De patienter, som fik kemoterapi og oplevede uafhængigt verificeret sygdomsprogression efter den første planlagte sygdomsvurdering, kunne overkrydses til at få 2 mg/kg eller 10 mg/kg pembrolizumab hver 3. uge i et dobbeltblindet design.
Patients on chemotherapy who experienced independently verified progression of disease after the first scheduled disease assessment were able to crossover and receive 2 mg/kg or 10 mg/kg of pembrolizumab every 3 weeks in a double blind fashion.
De patienter, som fuldførte den indledende studieperiode på 24 uger, kunne deltage i et kontrolleret langvarigt forlængelsesstudie af 28 ugers varighed (i alt 52 uger).
Patients who completed the initial 24-week study period were eligible to enter a controlled 28 week long-term study extension (52 weeks).
De patienter, som får biologisk behandling for moderat til svær reumatoid artrit, skal overvåges for at opdage alvorlige infektioner i tide, da symptomer på akut inflammation kan mindskes i forbindelse med suppression af akutfasereaktionen.
Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reactants.
De patienter, som ikke responderer på glukagon, skal gives intravenøs glucose.
Patients who fail to respond to glucagon must be given glucose solution intravenously.
De patienter, som levede op til diagnosen svær sepsis havde a) kendt eller mistænkt infektion, b) kliniske tegn på en systemisk reaktion på infektion inklusiv feber eller hypotermi, leukopeni eller leukocytose, takykardi og takypnø og c) akut organ- dysfunktion.
Patients meeting the clinical diagnosis of severe sepsis had a) known or suspected infection, b) clinical evidence of systemic response to infection including fever or hypothermia, leucopenia or leucocytosis, tachycardia and tachypnoea, and c) acute organ dysfunction.
De patiënten moesten ofwel ECG veranderingen vertonen die overeenkwamen met een recente ischemie of gestegen hartenzymen of troponine I- of T-spiegels die minstens tweemaal hoger lagen dan de bovengrens van de normale waarden.
Patients were required to have either ECG changes compatible with new ischaemia or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.
De patiënten werden aselect behandeld met clopidogrel 75 mg/dag of ASA 325 mg/dag en werden gedurende 1 tot 3 jaar gevolgd.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
De patiënten werden behandeld gedurende een periode tot 5 jaar.
Patients were treated for up to 5 years.
De patiënten werden behandeld gedurende een periode tot één jaar.
Patients were treated for up to one year.
De patiënten werden gedurende 30 dagen gevolgd.
The patients were followed for 30 days.
De patiënten werden gerandomiseerd om clopidogrel (300 mg ladingsdosis gevolgd door 75 mg/dag N = 6259) of placebo (N = 6303) te krijgen, beide in combinatie met ASA (75-325 mg eenmaal per dag) en andere standaardbehandelingen.
Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
De patiëntenpopulatie bestond voor 19,7% uit vrouwen en voor 29,2% uit patiënten ≥ 65 jaar.
The patient population included 19.7% women and 29.2% patients ≥ 65 years.
De patiëntenpopulatie omvatte 27,8% vrouwen, 58,4% patiënten ≥ 60 jaar (26% ≥ 70 jaar) en 54,5% patiënten die werden behandeld met fibrinolytica.
The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
De patiëntenpopulatie omvatte 41,8 % vrouwen.
The patient population included 41.8 % women.
De perforerede blistere indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet.
Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
De perforerede blistere, hvor folien kan trækkes af, indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet.
Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
De placebo-justerede gennemsnitlige maksimale stigninger i QTc i forhold til baseline efter 800 mg, 1200 mg og 1600 mg voriconazol var henholdsvis 5,1 msek., 4,8 msek. og 8,2 msek. og 7,0 msek. for ketoconazol 800 mg.
The placebo- adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
De placebo-justerede gennemsnitlige maksimale stigninger i QTc i forhold til baseline efter 800 mg, 1200 mg og 1600 mg voriconazol var henholdsvis 5,1; 4,8 og 8,2 msek. og 7,0 msek. for ketoconazol 800 mg.
The placebo- adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
de placebokontrollerede fase 2- og fase 3-studier (poolede data) omfattede 1.346 HCV-inficerede patienter incidensen er baseret på hyppigheden af indberetttede bivirkninger (se også Abnorme laboratorieundersøgelser nedenfor)
the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below)
De plasmaconcentraties van de actieve metaboliet waren met 20% (oplaaddosis) en 14% (onderhoudsdosis) verminderd bij de gelijktijdige behandeling met pantoprazol 80 mg eenmaal per dag.
The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
de pointes er rapporteret i
Pointes have been reported with voriconazole
De poolede studier bestod af studierne 046 (Europa/Australien), 047 (Nordamerika [NA]) og 074 (Europa/NA).
Pooled studies consisted of 046 (Europe / Australia), 047 (North America [NA]) and 074 (Europe / NA).
De poolede studier bestod af studierne 046 (Europa/Australien), 047 (Nordamerika [NA]) og 074 (Europa/NA).
Pooled studies consisted of studies 046 (Europe / Australia), 047 (North America [NA]) and 074 (Europe / NA).
De populations-forudsagte farmakokinetiske eksponeringsværdier (median med 5-95 percentiler) for Herceptins subkutane doseringsregimer hos patienter med tidlig brystkræft er vist i tabel 12 nedenfor.
The population predicted PK exposure parameter values (median with 5th - 95th Percentiles) for Herceptin SC dosing regimens in EBC patients are shown in Table 13 below.
De populations-forudsagte farmakokinetiske eksponeringsværdier (median med 5-95 percentiler) og farmakokinetiske parameter-værdier ved klinisk relevante koncentrationer (Cmax og Cmin) hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft behandlet med de godkendte ugentlige og 3-ugers doseringsregimer er vist nedenfor i tabel 14 (serie 1), tabel 15 (steady- state) og tabel 16 (farmakokinetiske parametre)
The population predicted PK exposure values (median with 5th - 95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady- state), and Table 16 (PK parameters).
De potente CYP3A-induktorer rifampicin og naturlægemidler, som indeholder perikon (Hypericum perforatum).
The strong CYP3A inducers rifampicin and herbal preparations containing St John’s wort (Hypericum perforatum).
De potentielle effekter af inhibitorer og en inducer af flere af disse enzymveje på asenapins farmakokinetik blev undersøgt specifikt fluvoxamin (CYP1A2-inhibitor), paroxetin (CYP2D6-inhibitor), imipramin (CYP1A2/2C19/3A4-inhibitor), cimetidin (CYP3A4/2D6/1A2-inhibitor), carbamazepin (CYP3A4/1A2-inducer) og valproat (UGT inhibitor).
The potential effects of inhibitors and an inducer of several of these enzyme pathways on asenapine pharmacokinetics were studied, specifically fluvoxamine (CYP1A2 inhibitor), paroxetine (CYP2D6 inhibitor), imipramine (CYP1A2/2C19/3A4 inhibitor), cimetidine (CYP3A4/2D6/1A2 inhibitor), carbamazepine (CYP3A4/1A2 inducer) and valproate (UGT inhibitor).
De potentielle interaktioner mellem romiplostim og samtidig anvendte lægemidler som følge af bindingen til plasmaproteiner kendes endnu ikke.
The potential interactions of romiplostim with co- administered medicinal products due to binding to plasma proteins remain unknown.
De potentielle komplikationer kan ofte undgås ved at sikre, at patienter:
Potential complications can often be avoided by ensuring that patients: