natgillin/translations-raw huggingface dataset:
Data fra patienter, som har været i behandling med Plegridy i 2 år, tyder på, at under 1 % (5/715) udviklede persisterende neutraliserende antistoffer mod interferon beta-1a-delen af peginterferon beta-1a.
Data from patients treated up to 2 years with Plegridy suggests that less than 1% (5/715) developed persistent-neutralising antibodies to the interferon beta-1a portion of peginterferon beta-1a.
Data fra produkter, der forlænger QT intervallet indikerer dog, at en blokering af hERG- kaliumkanaler med mere end 20 % kan være klinisk relevant.
However, based on data from products known to prolong the QT-interval, a block of hERG potassium channels of > 20 % may be clinically relevant.
Data fra randomiserede, kontrollerede, kliniske studier viser, at Myocets effekt og kardielle sikkerhed i denne population var sammenlignelig med det, der er observeret hos patienter, som var under 65 år gamle.
Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Data fra raske frivillige, der fik enkeltdosis dasatinib 100 mg 30 minutter efter et fedtrigt måltid, viste en 14% stigning i gennemsnitligt AUC for dasatinib.
Data from healthy subjects administered a single, 100 mg dose of dasatinib 30 minutes following a high-fat meal indicated a 14% increase in the mean AUC of dasatinib.
Data fra samtidig anvendelse af parenteral midazolam med andre protease-hæmmere tyder på en mulig stigning på 3 – 4 gange i plasmaniveauerne for midazolam.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3 – 4 fold increase in midazolam plasma levels.
Data fra sorte individer var meget begrænsede, men i samme størrelsesorden som hos kaukasiere.
Data from Black individuals was very limited but in the same range as for Caucasians.
Data fra stabilitetsstudier påviser, at vaccinens komponenter er stabile i 72 timer, når de opbevares ved temperaturer på mellem 8 °C og 42 °C. Derefter skal Gardasil bruges eller bortskaffes.
Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C. At the end of this period Gardasil should be used or discarded.
Data fra stabilitetsstudier påviser, at vaccinens komponenter er stabile i 72 timer, når de opbevares ved temperaturer på mellem 8 °C og 42 °C. Derefter skal Gardasil bruges eller bortskaffes.
Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to ° 42 C. At the end of this period Gardasil should be used or discarded.
Data fra stabilitetsstudier påviser, at vaccinens komponenter er stabile i 72 timer, når de opbevares ved temperaturer på mellem 8 °C og 42 °C. Derefter skal Silgard bruges eller bortskaffes.
Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C. At the end of this period Silgard should be used or discarded.
Data fra studie JP16003, et enkelt-arm-studie med Herceptin (4 mg/kg i.v.-støddosis og 2 mg/kg i.v. ugentligt) og docetaxel (60 mg/m2 i.v.) hos japanske kvinder med HER2-positiv metastisk brystkræft, tydede på, at samtidig administration af Herceptin ikke påvirkede docetaxels enkeltdosis- farmakokinetik.
Data from study JP16003, a single-arm study of Herceptin (4 mg/kg IV loading dose and 2 mg/kg IV weekly) and docetaxel (60 mg/m2 IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of Herceptin had no effect on the single dose pharmacokinetics of docetaxel.
Data fra studier med alogliptin, metformin, pioglitazon (thiazolidindion), voglibose (alfaglukosidasehæmmer) og glyburid (sulfonylurinstof) har ikke påvist klinisk relevante farmakokinetiske interaktioner.
Results from alogliptin studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha- glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Data fra studiet indikerede, at uanset alder og sværhedsgrad af den underliggende sygdom var børn, unge og voksne med astma samt patienter med KOL i stand til at opnå inspiratoriske flowhastigheder med Spiromax- inhalationsdevicet, der svarede til hastighederne ved det markedsførte multidosis pulver-inhalationsdevice.
The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Data fra to identisk designede, randomiserede, kontrollerede, kliniske multicenterstudier i fase III (SO14695; SO14796) støtter anvendelsen af capecitabin til 1. linjebehandling af metastatisk kolorektalkræft.
Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Data fra to kliniske multicenterstudier i fase II støtter anvendelsen af capecitabin-monoterapi hos patienter, hos hvem taxoider og et anthracyklinindeholdende kemoterapiregime har svigtet, eller hos hvem yderligere anthracyklinbehandling ikke er indiceret.
Data from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Data fra to studier (MONT BLANC, BPD952A2308 og DENALI, BPD952A2309), udført efter godkendelse, bekræftede Lucentis’ virkning, men viste ikke yderligere effekt ved kombinationsbehandling med verteporfin (Visudyne fotodynamisk terapi) og Lucentis, sammenlignet med Lucentis som monoterapi.
Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.
Data fra udviklingsprogrammet for den sukutane formulering af MabThera indikerer, at dannelsen af anti-rituximab-antistoffer (HACA) efter subkutan administration er sammenlignelig med dannelsen efter intravenøs administration.
Data from the development programme of MabThera subcutaneous formulation indicate that the formation of anti-rituximab antibodies (HACAs) after subcutaneous administration is comparable with that observed after intravenous administration.
Data fra undersøgelserne DPM-CF-301 og 302 tyder på, at dosisjustering ikke er nødvendig for disse patientpopulationer.
Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Data hos pædiatriske populationer
Data in paediatric populations
Data i den kliniske hovedundersøgelse blev analyseret for indvirkningen af mulige kovariater på eksponeringen for lomitapid.
Data in the pivotal clinical trial were analyzed with respect to the impact of potential covariates on lomitapide exposure.
Data i tabel 1 er baseret på de kontrollerede forsøg (I-IX, CLASSIC I, GAIN og CHARM) (beskrevet i punkt 5.1), som omfatter 3271 patienter, der fik Trudexa, og 1809 patienter, der fik enten placebo eller aktiv kontrol i den kontrollerede behandlingsperiode.
The data in Table 1 is based on the controlled Studies (I−IX,CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
Data i Tabel 1 er primært baseret på placebo-kontrollerede studier med
The data in Table 1 are based primarily on the placebo controlled Studies involving
Data i tabellerne nedenfor beskriver bivirkninger rapporteret fra kliniske studier og spontan rapportering.
The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Data indhentet med en mock-up-vaccine vil understøtte en vaccinationsstrategi, der sandsynligvis vil blive anvendt med den pandemiske vaccine: data vedrørende klinisk effekt og sikkerhed af mock-up-vacciner er relevante for pandemi-vacciner.
Data obtained with a mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Data indikerer derfor, at AFLUNOV kan administreres samtidig med ikke-adjuverede sæsoninfluenzavacciner (ved injektion i modsatte ekstremiteter).
Therefore the data indicate that AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Data indikerer derfor, at Pandemrix kan gives tre uger efter administration af ikke- adjuverede sæsoninfluenza-vacciner.
Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Data indikerer dog, at beskyttelsen mod pertussis muligvis er faldende hos børn i alderen 7-8 år efter administration af 3-5-12-månedersprogrammet.
However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month’s schedule.
Data indikerer således, at Arepanrix kan administreres samtidig med ikke-adjuverede sæsoninfluenza- vacciner (injiceret i modsatte ekstremiteter).
Therefore the data indicate that Arepanrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Data indikerer således, at Pandemrix kan administreres samtidig med ikke-adjuverede sæsoninfluenza- vacciner (injiceret i modsatte ekstremiteter).
Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Data indikerer således, at raltegravirs væsentligste clearance-mekanisme hos mennesker er UGT1A1-medieret glucuronidering.
Thus the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 17).
The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 17).
Data indsamlet fra 51 ILP-patienter viste, at maks. koncentrationer af tasonermin i perfusionskredsløbet opnås inden for 30 min. efter påbegyndelse af ILP og rangerer mellem 3000 og 4000 nanogram/ml.
Data obtained from 51 ILP patients demonstrated maximum concentrations of tasonermin in the perfusion circuit are reached 30 min after the onset of ILP and range between 3000 and 4000 ng/ml.
Data kommer fra rutinemæssig lægemiddelovervågning, hyppighederne er baseret på statistisk modellering af data fra placebokontrollerede kliniske studier.
Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebo- controlled clinical trial data.
Data med den samlede overlevelse fra en anden post hoc-analyse, hvor skæringen for dataindsamling var 18. december 2012, er vist i figur 3.
Overall survival data from a further post-hoc analysis based on a 18 December 2012 data cut are shown in Figure 3.
Data om baktericid antistofpersistens otte måneder efter Bexsero-vaccination i 2-, 3- og 4-måneders-alderen og seks måneder efter Bexsero-vaccination i 2-, 4- og 6-måneders-alderen (præ-booster) og boosterdata efter en fjerde dosis Bexsero givet i 12-måneders-alderen er opsummeret i tabel 3.
Data on bactericidal antibody persistence at 8 months after Bexsero vaccination at 2, 3 and 4 months of age, and at 6 months after Bexsero vaccination at 2, 4 and 6 months of age (pre booster time point) and booster data after a fourth dose of Bexsero administered at 12 months of age are summarised in Table 3.
Data om behandlingsskift: Efter administration af 75 mg clopidogrel én gang daglig i 10 dage, blev 40 raske forsøgspersoner skiftet til prasugrel 10 mg én gang daglig med eller uden en loading-dosis på 60 mg.
Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Data om brug af Signifor til patienter over 65 år er begrænsede, men intet tyder på, at dosisjustering er nødvendig hos disse patienter (se pkt.
Data on the use of Signifor in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).
Data om et begrænset antal eksponerede graviditeter hos kvinder med Wilson´s sygdom, giver ikke nogen indikation om fosterskader eller skader på den gravide.
Data on a limited number of exposed pregnancies in patients with Wilson’s disease give no indication of harmful effects of zinc on embryo/foetus and mother.
Data om et begrænset antal eksponerede graviditeter viser, at betain, vandfri, ikke medfører uventede hændelser ved graviditet eller fostrets/det nyfødte barns sundhed.
Data on a limited number of exposed pregnancies indicate no adverse event of betaine anhydrous on pregnancy or on the health of the foetus/newborn child.
Data om levertransplanterede patienter er baseret på i.v. behandling med CellCept i op til 14 dage efterfulgt af oral behandling.
Data in hepatic transplant patients are based on i.v. dosing of CellCept for up to 14 days followed by oral dosing.
Data om Nanostring RNA-gensignatur
Data on the Nanostring RNA gene signature
Data om profilering af immunceller (perifert blod) (kun melanomstudier)
Data on Immune cell profiling (peripheral blood) (melanoma studies only)
Data om RNA og proteomisk profilering af serum
Data on RNA and proteomic serum profiling
Data om sikkerheden af Spectrila hos spædbørn < 1 år er begrænset.
Data on safety of Spectrila in infants < 1 year of age is limited.
Data om trinvis bedring er begrænset, men lader til at ligne den, der ses hos patientpopulationen på 12 år eller ældre.
Data on incremental recovery is limited but appears similar to that seen in the patient population of 12 years of age or older.
Data om virkningsgraden for kombinationen med andre kortikosteroider og 5-HT3 antagonister er begrænsede.
Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Data opnået fra voksne viste, at samtidig administration af adjuveret H5N1-vaccine og sæsonantigener (inaktiveret overflade, ikke adjuverede) ikke medførte nogen interferens for hverken sæsonstammer eller H5N1-stamme.
Data obtained in adults showed that co-administration of adjuvanted H5N1 vaccine and seasonal (inactivated surface, non-adjuvanted) antigens did not lead to any interference neither for seasonal strains nor for H5N1 strain.
Data opnået i forbindelse med administration af en ikke-adjuveret sæsoninfluenza-vaccine (Fluarix, som beskrevet ovenfor) tre uger før administration af en dosis Pandemrix (H1N1)v til raske voksne over 60 år, indikerede ikke nogen signifikant interferens i immunresponset over for Pandemrix (H1N1)v.
Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v.
Data pr. studie
Data by study
Data præsenteres separat for cancerpatienter, PBPC mobilisering hos raske donorer, SCN-patienter og patienter med HIV, så de afspejler de forskellige bivirkningsprofiler for disse populationer.
Data are presented separately for cancer patients, PBPC mobilisation in normal donors, SCN patients and patients with HIV, reflecting the different adverse reaction profiles in these populations.
Data præsenteres separat for cancerpatienter, PBPC-mobilisering hos normale donorer, patienter med svær kronisk neutropeni og patienter med hiv, og afspejler de forskellige bivirkningsprofiler hos disse populationer
Data are presented separately for cancer patients, PBPC mobilisation in normal donors, SCN patients and patients with HIV, reflecting the different adverse reaction profiles in these populations.
Data præsenteret fra kontrollerede studier inkluderede 1.357 patienter, hvoraf 766 fik Aranesp og 591 patienter fik r-HuEPO.
Data presented from controlled studies included 1357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Data tydede imidlertid på en 20 % højere levetiracetamclearance hos børn, som fik enzyminducerende antiepileptika.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.
Data tydede imidlertid på en 20 % højere levetiracetamclearance hos børn, som fik enzyminducerende antiepileptika.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Data tydede imidlertid på en 20 % højere levetiracetamclearance hos børn, som tog enzyminducerende antiepileptiske lægemidler.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.
Data tydede på, at insulin glulisin givet 2 minutter før måltidet giver samme postprandiale glykæmiske kontrol som regular human insulin givet 30 minutter før måltidet.
Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycemic control compared to regular human insulin given 30 minutes before the meal.
Data tyder på, at selvom ritonavir er en P-gp-hæmmer, er nettopåvirkningen af Aptivus plus lavdosis ritonavir ved det foreslåede dosisregime ved steady state P-gp-induktion.
Data suggest that, although ritonavir is a P-gp inhibitor, the net effect of Aptivus, co- administered with low dose ritonavir, at the proposed dose regimen at steady-state, is P-gp induction.
Data tyder på, at østrogen-receptoren kan regulere ekspression af gener via mindst to forskellige mekanismer, som er ligand-, vævs- og/eller genspecifikke.
Data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/or gene- specific.
Data vedr. skift
Switching data
Data vedr. utilsigtede reaktioner hos CAPS-patienter baserer sig på en open-label undersøgelse af 43 patienter med NOMID/CINCA behandlet med Kineret i op til 5 år, med en samlet Kineret- eksponering på 159,8 patientår.
Adverse reactions data in CAPS patients are based on an open-label study of 43 patients with NOMID/CINCA treated with Kineret for up to 5 years, with a total Kineret exposure of 159.8 patient years.
Data vedrørende anvendelse af stiripentol til børn under 12 måneder er begrænsede.
Data are limited about the use of Diacomit under 12 months of age.
Data vedrørende bio- / tumormarkører fra samtlige kliniske studier i det
Data on bio-/tumour markers from all clinical studies in the clinical program
Data vedrørende Fexerics primære og sekundære farmakodynamik, sikkerhedsfarmakologi og farmakokinetik blev udledt fra toksikologistudier med gentagne doser og afslørede ingen sikkerhedsproblemer for mennesker.
Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans.
Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet fra OMC- BUS-4 studiet (under allogeneic) (n=61).
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet fra OMC-BUS- 4 studiet (under allogeneic) (n=61).
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) .
Data vedrørende hæmning tyder på, at der ikke er nogen risiko for interaktion med BCRP-substrater på systemisk niveau.
Data of inhibition indicate that there is no risk of interaction with BCRP substrates at the systemic level.
Data vedrørende KOL-eksacerbationer blev indsamlet i de 6-måneders og 12-måneders pivotale studier.
COPD exacerbation data was collected in the 6- and 12–month pivotal studies.
Data vedrørende langtidsvirkning – pædiatrisk population
Long-term efficacy data - paediatric population
Data vedrørende mobilisering og engraftment fra supplerende fase II-studier (plerixafor 0,24 mg/kg doseret om aftenen eller morgenen inden aferese) på patienter med non-Hodgkins lymfom, Hodgkins sygdom eller multipelt myelom svarede til dataene fra fase III-studierne.
Mobilisation and engraftment data from supportive Phase II studies (plerixafor 0.24 mg/kg dosed on the evening or morning prior to apheresis) in patients with non-Hodgkin’s lymphoma, Hodgkin’s disease, or multiple myeloma were similar to those data for the Phase III studies.
Data vedrørende muligheden for hæmning af CYP1A2 er begrænsede, og interaktioner med theophyllin og caffein kan derfor ikke udelukkes på grund af øgede plasmaniveauer af theophyllin og caffein, som kan opstå via hæmning af deres levermetabolisme, hvilket potentielt kan føre til toksicitet.
Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of the increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity.
Data vedrørende sikkerheden og effekten efter 2 års behandling med natalizumab er genereret fra kontrollerede, dobbeltblindede studier.
Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, double– blind studies.
Data, der er beskrevet nedenfor, afspejler eksponeringen af en Benlysta-dosis på 10 mg/kg hos 674 patienter med SLE, herunder 472 patienter, som blev eksponeret i mindst 52 uger.
The data described below reflect exposure to Benlysta 10 mg/kg in 674 patients with SLE, including 472 exposed for at least 52 weeks.
Data, som skal indsamles i løbet af studiet:
Data to be collected on study:
Data, som underbygger dosistitrering ved reumatoid arthritis, stammer fra ATTRACT, ASIPRE og START studierne.
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study.
Data-resuméer for gennemsnitlig ændring i kropsvægt afspejler Intent-to-Treat (ITT) population, defineret som forsøgspersoner, der blev randomiseret, havde en baseline kropsvægtsmåling og havde mindst én kropsvægtsmåling efter baseline i den definerede behandlingsfase, ved hjælp af en 'last observation carried forward' (LOCF) analyse, samt en completers analyse.
Data summaries for mean change in body weight reflect the Intent-to-Treat (ITT) population, defined as subjects who were randomized, had a baseline body weight measurement, and had at least one post-baseline body weight measurement during the defined treatment phase, using a last observation carried forward (LOCF) analysis, as well as a completers analysis.
data.
was reported.
Dataafskæring: 7. september 2012
cutoff: 07 Sep 2012
Database cut off-dato: 6. januar 2014.
Database cutoff date 06 January 2014
Database cut-off-dato: 6. januar 2014.
Database cutoff date 06 January 2014
Databehandling med filtreret tilbageprojektion og rekonstruktion i tre planer (transaksial, koronal og sagittal) anbefales.
Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal) is recommended.
Dataene antyder, at Cosentyx ikke undertrykker humoral immunrespons over for meningokok- og influenzavacciner.
The data suggest that Cosentyx does not suppress the humoral immune response to the meningococcal or influenza vaccines.