natgillin/translations-raw huggingface dataset:
De nedenfor beskrevne data afspejler eksponeringen for Tasigna hos totalt 279 patienter fra et randomiseret fase III studie hos patienter med nydiagnosticeret Ph+CML i kronisk fase behandlet med 300 mg nilotinib 2 gange dagligt.
The data described below reflect exposure to Tasigna in 279 patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated with 300 mg of nilotinib twice daily.
De nedenfor beskrevne data afspejler eksponeringen for Tasigna hos totalt 717 patienter fra et randomiseret fase III studie hos patienter med nydiagnosticeret Ph+CML i kronisk fase behandlet med den anbefalede dosis på 300 mg 2 gange dagligt (n=279) og fra et open-label-, multicenter fase II studie hos imatinib-resistente eller intolerante patienter med CML i kronisk fase (n=321) og accelererede fase (n=137) behandlet med den anbefalede dosis på 400 mg 2 gange dagligt.
The data described below reflect exposure to Tasigna in a total of 717 patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily (n=279) and from an open-label multicentre Phase II study in patients with imatinib-resistant or intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg twice daily.
De nedenfor beskrevne dosisjusteringer anbefales til håndtering af grad 3- eller 4-neutropeni eller - trombocytopeni eller anden toksicitet af grad 3 eller 4, som vurderes at være relateret til lenalidomid.
Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
De nedenfor beskrevne kliniske data tyder på, at risikoen for klinisk betydningsfulde interaktioner med samtidigt administrerede lægemidlerer lav.
Clinical data described below suggest that the risk for clinically meaningful interactions by co- administered medicinal products is low.
De nedenfor beskrevne studier (GOAL, TORCH og SMART) blev udført med den samme fastdosis- kombination, salmeterolxinafoat og fluticasonpropionat (FP), men undersøgte et tidligere godkendt præparat; de beskrevne studier blev ikke udført med Aerivio Spiromax.
The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
De nedenfor beskrevne studier (GOAL, TORCH og SMART) blev udført med den samme fastdosis- kombination, salmeterolxinafoat og fluticasonpropionat (FP), men undersøgte et tidligere godkendt præparat; de beskrevne studier blev ikke udført med Airexar Spiromax.
The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
De nedenfor rapporterede bivirkninger er klassificeret efter den hyppighed, hvormed de optræder:
The adverse reactions reported below are classified according to frequency of occurrence as follows:
De nedenfor resumerede dosisjusteringer anbefales til håndtering af grad 3- eller 4-neutropeni eller trombocytopeni eller anden toksicitet af grad 3 eller 4, som vurderes til at være relateret til lenalidomid.
Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
De negative embryoføtale virkninger af Neparvis er relateret til angiotensin- receptor-antagonistvirkningen (se pkt.
The adverse embryofoetal effects of Neparvis are attributed to the angiotensin receptor antagonist activity (see section 4.6).
De netop har påbegyndt insulinbehandling eller har skiftet til et andet insulinpræparat,
you have just begun insulin treatment or changed to another insulin preparation,
De ni andre pneumokok- serotyper blev ikke påvirket af samtidig administration.
There was no impact of co-administration on the other nine pneumococcal serotypes.
De ni undersøgelser viste, at det første injektionsforløb med Infanrix hexa var ligeså effektivt til at danne beskyttende antistoffer som separate vacciner, der indeholdt de samme aktive stoffer.
The nine studies showed that the first course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as separate vaccines containing the same active substances.
De nne indlægsseddel blev senest godkendt de n
This le afle t was last approve d in
De nne indlægsseddel blev senest godkendt de n
This le afle t was last approved in
De nne indlægsseddel blev senest ændret
This le afle t was last revised in
De nogensinde har haft leverproblemer – De skal måske have en anden dosis af lægemidlet
you have ever had liver problems - you might need a different dose of this medicine
De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes:
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
De normale procedurer for omgang med anti-cancer medicin skal følges:
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted:
De normale procedurer for omgang med lægemidler mod kræft skal følges:
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
De novo resistens over for emtricitabin/lamivudin blev set i 4 tilfælde, og i 2 tilfælde tillige over for rilpivirin med en konsekvent krydsresistens over for efavirenz (2/2), nevirapin (2/2) og etravirin (1/2).
De novo resistance to emtricitabine/lamivudine was seen in 4 cases, and also to rilpivirine in 2 cases, with a consequent cross resistance to efavirenz (2/2), nevirapine (2/2) and etravirine (1/2).
De nuværende tilgængelige data både in vitro og hos patienter tyder på, at HBV, som eksprimerer den adefovirforbundne resistensmutation rtN236T, er følsom over for lamivudin.
The currently available data both in vitro and in patients suggest that HBV expressing the adefovir- associated resistance mutation rtN236T is susceptible to lamivudine.
De nærmere oplysninger fremgår af indlægssedlen.
For further details see the package leaflet.
De nærmere oplysninger fremgår af indlægssedlen.
For more information on how to use Nordimet, see the package leaflet.
De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
For further information see the summary of product characteristics (also part of the EPAR).
De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
See the summary of product characteristics (also part of the EPAR) for more information.
De nærmere oplysninger fremgår af produktresuméet (også er en del af denne EPAR).
For full details, see the summary of product characteristics (also part of the EPAR).
De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
See the Summary of Product Characteristics, also part of the EPAR, for full details.
De nærmere oplysninger om behandling med Zytiga fremgår af indlægssedlen (også en del af EPAR), eller du kan kontakte din læge eller dit apotek.
For more information about treatment with Zytiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De nærmere oplysninger om, hvordan doserne beregnes, fremgår af produktresuméet (også en del af denne EPAR).
Full details on how to calculate the doses are included in the summary of product characteristics (also part of the EPAR).
De nævnte forholdsregler anses for tilstrækkelige til beskyttelse mod vira som HIV-virus, hepatitis B-virus og hepatitis C-virus (kappeklædte vira) og mod hepatitis A-virus (ikke-kappeklædte vira).
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
De nævnte reaktioner kan optræde, inden du forlader lægens klinik.
Such reactions may occur before leaving the doctor’s surgery.
De nævnte reaktioner vil sædvanligvis optræde, inden du forlader lægens klinik.
Such reactions may occur before leaving the doctor’s surgery.
De nødvendige aseptiske forholdsregler skal overholdes således, at kravene i overensstemmelse med Good Manufacturing Practice (GMP) for lægemidler overholdes.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
De nødvendige doseringsremedier til børn med en kropsvægt på op til 20 kg (dvs. medicinbæger med målemarkeringer ved 20, 40, 60 og 80 ml; 10 ml og 20 ml orale doseringssprøjter med målemarkeringer hver 1 ml) følger ikke med Kuvan-pakningen.
The devices required for dosing in children up to 20 kg body weight (i.e. medicine cup with graduations at 20, 40, 60, 80 ml; 10 ml and 20 ml oral dosing syringes with graduation at 1 ml divisions) are not included in the Kuvan pack.
De nødvendige lægemidler bør være lettilgængelige i tilfælde af alvorlige overfølsomhedsreaktioner.
Appropriate supportive therapies should be readily available in case of a severe hypersensitivity reaction.
De objektive responsrater i den randomiserede population (investigators vurdering) var 41,6 % (docetaxel+capecitabin) vs.
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs.
De observerede behandlingsvirkninger hos svært overvægtige og overvægtige patienter med type 2- diabetes mellitus (undersøgelse NB-304) var noget mindre udtalte end dem, der observeres i de andre fase 3-undersøgelser.
The treatment effects observed in obese and overweight subjects with type 2 diabetes mellitus (Study NB-304) were somewhat less pronounced than those observed in the other Phase 3 studies.
De observerede bivirkninger fra et pædiatrisk klinisk forsøg med H5N1-vaccinen er anført herunder.
The observed adverse reactions from a pediatric clinical trial with the H5N1 vaccine are listed below.
De observerede bivirkninger hos patienter i behandling for myelodysplastisk syndrom eller mantelcellesyndrom er opstillet nedenunder efter systemorganklasse og hyppighed.
The adverse reactions observed in patients treated for myelodysplastic syndromes and mantle cell lymphoma are listed below by system organ class and frequency.
De observerede bivirkninger i kliniske studier med RCC og DTC var sammenlignelige.
Similar adverse reactions were observed in clinical trials in RCC and DTC .
De observerede forbedringer i ppFEV1 hos patienter i behandling med lumacaftor/ivacaftor i studie 1 eller studie 2 blev opretholdt i studie 3 (figur 1).
The improvements in ppFEV1 observed in patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 were sustained in Trial 3 (Figure 1).
De observerede MIC-stigninger var for en stor dels vedkommende reversible i de behandlingsfrie perioder.
MIC increases observed were in large part reversible during off- treatment periods.
De observerede typer af nyrebivirkning med Stribild var i overensstemmelse med tidligere erfaring for tenofovirdisoproxilfumarat.
The types of renal adverse reactions seen with Stribild were consistent with previous experience with tenofovir disoproxil fumarate.
De observerede UGE-værdier kan omsættes til et fald på 308 kcal til 476 kcal/dag.
308 kcal/day to 476 kcal/day.
De observerede værdier ved maksimal plasmakoncentration er 9 gange større end IC50 for abacavir, som er 0,08 μg/ml eller 0,26 μM, når der gives 600 mg abacavir to gange daglig.
The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
De off-white, ovale tabletter har påtrykt ”Renagel 400” på den ene side.
The off-white, oval tablets are imprinted with “Renagel 400” on one side.
De off-white, ovale tabletter har påtrykt ”Renagel 800” på den ene side.
The off-white, oval tablets are imprinted with “Renagel 800” on one side.
De off-white, ovale tabletter har påtrykt ”SH800” på den ene side.
The off-white, oval tablets are imprinted with “SH800” on one side.
De offentliggjorte undersøgelser viste, at Crixivan sammen med ritonavir frembragte tilsvarende koncentrationer af indinavir i blodet som Crixivan uden ritonavir.
The published studies showed that Crixivan boosted with ritonavir produced similar blood levels of indinavir to Crixivan taken without ritonavir.
De oftest rapporterede bivikrninger er snue, døsighed, hovedpine, træthed og svimmelhed.
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache ,fatigue and dizziness.
De oftest rapporterede bivikrninger er snue, døsighed, hovedpine, træthed og svimmelhed.
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
De oftest rapporterede bivikrninger er snue, døsighed, hovedpine, træthed og svimmelhed.
The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
De oftest rapporterede bivirkninger er
Most frequently reported were:
De oftest rapporterede bivirkninger er blødninger, der forekommer hos cirka 14 % af patienterne behandlet kortvarigt efter elektiv hofte-eller knæalloplastik, hos 16,6 % af patienterne med atrieflimren behandlet langvarigt for at forebygge apopleksi og systemisk emboli og hos 14,4 % af patienterne behandlet for DVT/LE.
The most commonly reported adverse reactions are bleedings occurring in total in approximately 14 % of patients treated short-term for elective hip or knee replacement surgery, 16,6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and SEE, and in 14,4 % of patients treated for DVT/PE.
De oftest rapporterede bivirkninger er snue, døsighed, hovedpine, træthed og svimmelhed.
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
De og Deres læge kan dog beslutte, at De selv kan indsprøjte Simponi.
However, you and your doctor may decide that you may inject Simponi yourself.
De og Deres læge skal afklare, om det er bedst at ophøre med amning eller afbryde behandlingen med Cinacalcet Mylan.
Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Cinacalcet Mylan.
De omfattede følgende: Nonsteroide antiinflammatoriske midler (inklusive acetyl- salicylsyre), anilider (såsom paracetamol), HR2R-receptorantagonister og syrepumpehæmmere, diuretika, digoxin og hjerteglycosider, organiske nitrater og andre vasodilatatorer til hjertesygdom, calcium- antagonister, betablokkere, ACE-hæmmere, angiotensin II-antagonister, selektive beta-2-adreno- ceptoragonister, peroral antikoagulantia, trombocytfunktionshæmmende midler, statiner, fibrater og benzodiazepinderivater.
These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
De omfattede følgende: Nonsteroide antiinflammatoriske midler (inklusive acetylsalicyl- syre), anilider (såsom paracetamol), H2-receptorantagonister og syrepumpehæmmere, diuretika, digoxin og hjerteglycosider, organiske nitrater og andre vasodilatatorer til hjertesygdom, calcium- antagonister, betablokkere, ACE-hæmmere, angiotensin II-antagonister, selektive beta-2-adreno- ceptoragonister, peroral antikoagulantia, trombocytfunktionshæmmende midler, statiner, fibrater og benzodiazepinderivater.
These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
De omfattede infektion og graft-versus- host-disease (GVHD), som, også selv om der ikke var en direkte årsagssammenhæng, var hovedårsagerne til morbiditet og mortalitet, især ved allogen HPCT.
These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
De omfattede infektion og graft-versushost- disease (GVHD), som, også selv om der ikke var en direkte årsagssammenhæng, var hovedårsagerne til morbiditet og mortalitet, især ved allogen HPCT.
These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
De omfattede sygdomme var akut leukæmi efter første remission, under første eller senere recidiv, under første remission (højrisiko) eller ved induktionssvigt; kronisk myeloid leukæmi i den kroniske eller fremskredne fase; primær refraktær eller resistent recidiverende Hodgkins sygdom eller non- Hodgkin lymfom samt myelodysplastisk syndrom.
Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin’s disease or non-Hodgkin’s lymphoma, and myelodysplastic syndrome.
De omfatter appetitløshed, opkastning, diarré og irritation ved endetarmen.
The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
De omfatter en nedsættelse af antallet af implantationssteder, forstyrrelser af den normale fødsel (dystocia), en øgning af viscerale variationer(nyre pelvis ureter syndrom) og tandabnormaliteter på F1 afkommet hos rotter.
They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
De omfatter Hyppig vandladning, tørst, appetitløshed, kvalme, opkastning, døsighed eller træthed, rød tør hud, mundtørhed og acetonelugtende ånde.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.
De omfatter spytflåd (rotte og hund), pupildilatation (hund) og to tilfælde af kramper hos hunde i det generelle toksicitetsstudieprogram.
These included salivation (rat and dog), pupil dilatation (dog), and two incidences of convulsions in dogs in the general toxicity study programme..
De omfatter:
These include
De omfatter: Hyppig vandladning, tørst, appetitløshed, følelse af at være syg (kvalme og opkastning), døsighed eller træthed, rød, tør hud, mundtørhed og en frugtlugtende (acetonelugtende) ånde.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
De omfatter: Hyppig vandladning, tørst, appetitløshed, kvalme eller opkastning, døsighed eller træthed, rødmen, tør hud, mundtørhed og en frugtagtig (acetonelugtende) ånde.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
De omfatter: Hyppig vandladning, tørst, appetitløshed, kvalme eller opkastning, døsighed eller træthed, rødmen, tør hud, mundtørhed og en frugtlugtende (acetonelugtende) ånde.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
De omfatter: Hyppig vandladning; tørst; appetitløshed; kvalme eller opkastning; døsighed eller træthed; ansigtsrødme; tør hud; mundtørhed og frugtlugtende (acetonelugtende) ånde.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
De omgivende områder skal beskyttes for at sikre, at der kun påføres EVICEL på den overflade, der skal behandles.
Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.
De opblandede vacciner skal administreres ved subkutan injektion.
The mixed vaccines should be administered by subcutaneous injection.
De opblandene vacciner skal administreres ved subkutan injektion.
The mixed vaccines should be administered by subcutaneous injection.
De opdaterede data skal indsendes senest
The updated data should be submitted by 31st December 2015
De opfølgende tests for inhibitor hos denne patient, efter personen var taget ud af studiet, var negative.
Follow-up inhibitor tests in this patient after withdrawal from the study were negative.
De opførte advarsler og forholdsregler gælder for både voksne og børn.
The listed warnings and precautions apply both to adults and children.
De oplever en smertefuld rødme af huden og/eller blister på kroppen eller i munden.
you get painful reddening of the skin and/or blisters on the body or in the mouth;
De oplever en smertefuld rødme af huden på Deres hænder og fødder.
you get reddening painful skin on your hands and feet;
De oplysninger, som understøttede anvendelsen af Wilzin, kom fra i alt 255 patienter med Wilsons’ sygdom.
In total, data to support the use of Wilzin came from 255 patients with Wilson’s disease.
De opløselige tabletter er kun til patienter, der ikke kan indtage filmovertrukne tabletter.
The dispersible tablets are only for use in patients who cannot take the film-coated tablets.
De opløselige tabletter har delekærve, så de kan deles i fire dele, hver indeholdende 8 mg bosentan.
The dispersible tablets have score lines so that they can be broken into quarters, each containing 8 mg bosentan.
De opnåede koncentrationer af ritonavir efter 350 til 400 mg/m² to gange daglig hos pædiatriske patienter var sammenlignelige med de koncentrationer, der blev opnået hos voksne, som fik 600 mg (ca.
Ritonavir concentrations obtained after 350 to 400 mg/m² twice daily in paediatric patients were comparable to those obtained in adults receiving 600 mg (approximately 330 mg/m²) twice daily.
De opstår normalt inden for de første tre dage efter vaccinationen, de er normalt milde og forsvinder af sig selv inden for nogle få dage.
They usually occur within the first three days after vaccination, are usually mild and resolve within a few days.
De opstår, selvom du har taget din normale smertestillende opioidmedicin (såsom morfin, fentanyl, oxycodon eller hydromorphon) for at kontrollere dine konstante baggrundssmerter.
It comes on even though you have taken your usual opioid pain killer (such as morphine, fentanyl, oxycodone or hydromorphone) to control your constant background pain.
De optimale behandelingsduur is nog niet formeel vastgesteld.
The optimal duration of treatment has not been formally established.
De optiske metoder er ikke pålidelige til koagulationsprøver ved tilstedeværelse af Oxyglobin.
Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
De orange til gråligorange filmovertrukne tabletter på 15 mg er ovale-aflange tabletter præget med ”15” på den ene side og ”MEM” på den anden side.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘15’ on one side and imprint ‘MEM’ on the other side.