natgillin/translations-raw huggingface dataset:
Derfor, i tillæg til de laboratorietests, der normalt er påkrævet for at følge patienter med multipel sklerose, anbefales det at supplere med kontrol af leverenzymer og komplet tælling af blodceller, differentialtælling og blodpladetælling med regelmæssige intervaller (1, 3 og 6 måneder) efter behandlingsstart med Rebif, og derefter periodevist ved mangel på symptomer.
Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Derfor, kør ikke bil og betjen ikke værktøj eller maskiner, hvis du føler dig træt, søvnig eller desorienteret af denne behandling.
Therefore,. do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Derfor, på trods af det begrænsede antal sager, bør hypertensiv krise inkluderes i punkt 4.8 i produktresuméet.
Therefore, despite of the limited number of cases, hypertensive crisis should be included in section 4.8 of the SmPC.
Derhalve dient gelijktijdige toediening van NSAID's inclusief Cox-2 remmers en clopidogrel met voorzichtigheid plaats te vinden (zie rubriek 4.4).
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Derhalve kan een direct effect (geringe toxiciteit) of een indirect effect (minder aangename smaak) niet uitgesloten worden.
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Derimod blev behandlingen af rotter med eltrombopag ved en maternel, toksisk dosis på 60 mg/kg/dag (6 gange den humane kliniske eksponering hos ITP-patienter ved doser på 75 mg/dag og 3 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC) forbundet med fosterletalitet (øget præ- og post-implantationstab) og reduceret foster- og uterusvægt under graviditet i fertilitetsstudiet med hunner samt en lav forekomst af cervikale ribben og nedsat fostervægt i fosterudviklingsstudiet.
However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased pre- and post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Derimod er frekvensen af en overfølsomhedsreaktion over for abacavir rapporteret med lavere frekvens hos patienter der ikke er bærer af dette allel.
However, abacavir HSRs have been reported at a lower frequency in patients who do not carry this
Derimod er frekvensen af en overfølsomhedsreaktion over for abacavir rapporteret med lavere frekvens hos patienter, der ikke er bærer af dette allel.
However, abacavir HSRs have been reported at a lower frequency in patients who do not carry this
Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, og alle forekom i follow-up- perioden.
In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, og alle forekom i follow-up- perioden.
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Derimod forbedrede det ikke virkningen, når Corlentor blev anvendt sammen med amlodipin.
However, adding Corlentor to amlodipine did not provide an additional benefit.
Derimod forbedrede det ikke virkningen, når Procoralan blev anvendt sammen med amlodipin.
However, adding Procoralan to amlodipine did not provide an additional benefit.
Derimod hæmmede telbivudin-5'-trifosfat i koncentrationer på op til 100 M ikke de cellulære DNA- polymeraser ,  og .
By contrast, telbivudine-5'-triphosphate at concentrations up to 100 M did not inhibit cellular DNA polymerases , , or .
Derimod inducerede det ingen mutagenicitet i Ames’ test eller i en CHO/HGPRT-genmutationsassay.
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erytem øjeblikkelig afbrydelse af docetaxel- infusion og passende terapi.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erytem øjeblikkelig afbrydelse af docetaxel-infusion og passende terapi.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxel- infusion og passende behandling.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Derimod skal der ske en tæt klinisk opfølgning under behandlingskombinationen og hurtigt efter den antibiotiske behandling.
However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
dermatitis (inklusive eksem),
dermatitis (including eczema),
Dermatitis (inklusive kontaktdermatitis, atopisk dermatitis og bleudslæt), varmeknopper, rode hundelignende udslæt‡, urticaria, viralt exanthem, eksem, erythem
Dermatitis (including contact, atopic, and diaper rash), Heat rash, Rubella-like rash‡, Urticaria, Viral exanthema, Eczema, Erythema
Dermatitis Ikke almindelig
Dermatitis Uncommon
dermatitis KoldsvedØget tendens til at få blå mærker
tendency to bruise
Dermatitis på applikationsstedet
Application site dermatitis
Dermatitis på infusionsstedet
Infusion site dermatitis
Dermatitis Urticaria Pruritisk udslæt* Pruritus*
Dermatitis Urticaria Rash pruritic* Pruritus
Dermatitis, eksem, erytem, hyperhidrose, natlige svedeture, perifert ødem, psoriasis, erytematøst udslæt, maculært udslæt, maculo-papuløst udslæt, papuløst udslæt, pruritisk udslæt, hudlæsion
Dermatitis, eczema, erythema, hyperhidrosis, night sweats, oedema peripheral, psoriasis, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, skin lesion
Dermatitis, erytem
dermatitis, erythema
dermatitis, erythem, vitiligo, urticaria, eksemd, alopeci, nattesved, tør hud
dermatitis, erythema, vitiligo, urticaria, eczemad, alopecia, night sweats, dry skin
dermatitis, fotosensibilisering
dermatitis, photosensitivity
dermatitis, natlige svedeture, pruritus, udslæt, generaliseret pruritus, tør hud
Dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin
dermatitis, nældefeber*, eksem, erytem,
Adverse reaction
dermatitis, pruritus, udslæt, urticaria
dermatitis, pruritus, rash urticaria
dermatitis, skæl
eborrhoeic dermatitis,
dermatitis, skæl
Pregnancy, puerperium and perinatal conditions
Dermatitis;
disorders
Dermatitis;
Nail disorders (no severe)
DermatitisC, pruritusC, urticariaC
DermatitisC, pruritusC,
Dermatofytose
Dermatophytosis
Dermatologiske bivirkninger
Dermatological adverse reactions
Dermed befinder patienten sig i en situation med langsom forværring af sygdommen, uanset om han eller hun har relapser eller ej.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Dermed befinder patienten sig i en situation, hvor sygdommen langsomt forværres, uanset om den blusser op eller ej.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Dermed bliver blodpladerne mindre klæbrige, hvilket mindsker risikoen for, at der opstår en blodprop, og det er med til at forebygge slagtilfælde eller endnu et hjerteanfald.
This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.
Dermed bliver maden i tarmen i længere tid, og det
This causes food to remain in the gut for longer, increasing the absorption of
Dermed forbedres immunsystemet, og risikoen for at udvikle sygdomme, som er forbundet med hiv- infektionen, nedsættes.
This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Dermed får man en ny "dag 1" og en ny "skiftedag".
There is now a new “Day 1” and a new “Change Day”.
Dermed kan der hurtigt tilvejebringes nye oplysninger om sikkerhed.
This will allow quick identification of new safety information.
Dermed kan der hurtigt tilvejebringes oplysninger om sikkerheden.
This will allow quick identification of new safety information.
Dermed øges risikoen for sildenafil-associerede bivirkninger (som omfatter hypotension og synkope).
Thereby, increasing the potential for sildenafil- associated adverse events (which include hypotension and syncope).
Dernæst skal Visudyne aktiveres i øjet 15 minutter efter, at infusionen er begyndt.
The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion.
Derskal dog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der vides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter med medfødt langt QT-syndrom, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi.
However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Derskal drog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der forvides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter hvor syndrom med medfødt langt QT-syndrom er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi.
However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Derskal drog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der vides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter med medfødt langt QT-syndrom er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi
However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Dersom AF opstår igen, bør seponering af dronedaron overvejes.
If AF reoccurs discontinuation of dronedarone should be considered.
Dersom lungetoksicitet bekræftes, bør behandlingen seponeres.
If pulmonary toxicity is confirmed treatment should be discontinued.
Dertil er der ikke fundet kryds-resistens med andre antibiotika inklusiv β-lactamer, makrolider, metronidazoler, quinoloner, rifampin og vancomycin.
Also no cross- resistance has been discovered with any other antibiotic class including β-lactams, macrolides, metronidazole, quinolones, rifampin, and vancomycin.
Derudover anbefales det ved allergisk dermatitis og atopisk dermatitis, at undersøge og behandle komplicerende faktorer, så som bakterie-, svampe- eller parasitære infektioner/infestationer (f.eks. lopper og skab).
Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Derudover anbefales det, at kvindelige partnere til mandlige patienter anvender højeffektiv prævention under behandlingen og i 90 dage efter sidste CellCept-dosis.
In addition, female partners of male patients treated with CellCept are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of CellCept.
Derudover anbefales det, at kvindelige partnere til mandlige patienter anvender højeffektiv prævention under behandlingen og i 90 dage efter sidste Myclausen-dosis.
In addition, female partners of male patients treated with mycophenolate mofetil are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of Myclausen.
Derudover anbefales det, at kvindelige partnere til mandlige patienter i behandling med mycophenolat anvender meget sikker kontraception under behandlingen og i 90 dage efter sidste mycophenolat- dosis.
In addition, female partners of male patients treated with mycophenolate are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of mycophenolate.
Derudover anbefales det, at omgivelserne ligeledes behandles med et egnet bekæmpelsesmiddel.
In addition, it is recommended to treat the environment with a suitable insecticide.
Derudover anses studier udført med MedImmunes 2009 H1N1 pandemiske LAIV-vaccine og sæsonbetingede T/LAIV-influenzavaccine også for understøttende, da alle disse vacciner fremstilles under anvendelse af samme proces, administreres ad samme vej og primært er undersøgt hos behandlingsnaive personer.
In addition, studies conducted with MedImmune’s 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Derudover anså 84 % af lægerne og 100 % af forældrene/omsorgspersonerne glycopyrrolat for at have en virkning sammenlignet med henholdsvis 41 % af lægerne og 56 % af forældrene/omsorgspersonerne for placebo (p ≤ 0,014).
In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (p≤0.014).
Derudover blev 39 tilfælde af bradykardi (hvoraf 8 blev vurderet som alvorlige og de resterende som ikke- alvorlige) rapporteret i alemtuzumab-rapporter modtaget efter markedsføring fra den 1. maj 2015.
In addition, thirty-nine cases of bradycardia (eight of which were assessed as serious, the remainder as non-serious) were reported from alemtuzumab post-marketing reports as of 01 May 2015.
Derudover blev bindingen af florbetaben (18F) til β-amyloidplak i Alzheimers post mortem- hjerneobduktion påvist ved autoradiografi og understøttet af hhv. immunhistokemi eller Bielschowsky-farvning.
In addition, binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated by autoradiography and supported by immunohistochemistry or Bielschowsky stain.
Derudover blev der foretaget endomyokardiebiopsier hos 8 patienter med massive tumorer med kumulative antracyklin-doser på 509 mg/m2– 1.680 mg/m2.
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2–1,680 mg/m2.
Derudover blev der fundet tre letale tilfælde af hepatitis B reaktivering i databasen.
Furthermore, three fatal cases of hepatitis B reactivation were additionally retrieved from the database.
Derudover blev der ikke observeret nogen klinisk signifikante effekter på hjerterytmen ved 24-timers Holter- monitorering hos 53 patienter med KOL, der blev behandlet med umeclidinium/vilanterol 55/22 mikrogram én gang daglig i et studie af 6 måneders varighed eller hos yderligere 55 patienter, der fik umeclidinium/vilanterol 113/22 mikrogram én gang daglig i et andet studie af 6 måneders varighed samt 226 patienter, der umeclidinium/vilanterol 113/22 mikrogram én gang daglig i studiet af 12 måneders varighed.
In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Derudover blev der observeret aggressiv adfærd.
In addition, aggressive behaviour was observed.
Derudover blev der observeret et øget antal CD56bright NK- celler og et nedsat antal regulatoriske T-celler (defineret som CD4+CD127lavFoxP3+ T-celler) inden for 2 uger efter den første dosis, svarende til en vedvarende 5-folds stigning i CD56bright NK-celler i forhold til baseline og et fald på cirka 60% i regulatoriske T-celler i behandlingsfasen med tilbagevenden til baseline-niveauerne cirka 20-24 uger efter den sidste dosis.
In addition, an increase in CD56bright NK cells and a decrease in regulatory T-cells (defined as CD4+CD127lowFoxP3+ T-cells) was observed within 2 weeks after the first dose, with a sustained 5-fold increase in CD56bright NK cells above baseline and an approximately 60% decrease in regulatory T-cells in the treatment phase, with a return to baseline levels approximately 20-24 weeks after the last dose.
Derudover blev det registreret, hvor længe Circovac er effektivt hos smågrisene.
The length of time that Circovac is effective in the piglets has also been studied.
Derudover blev en sammenligning af 2-års versus 1-års Herceptin-behandling udført.
In addition, comparison of two years of Herceptin treatment versus one year of Herceptin treatment was performed.
Derudover blev OPA GMT’er sammenlignet mellem forsøgspersoner, der fik Prevenar 13 med eller uden 2-PE.
In addition, OPA GMTs between subjects receiving Prevenar 13 with or without 2-PE were compared.
Derudover blev Resolors virkning, sikkerhed og tolerabilitet hos mandlige patienter med kronisk obstipation vurderet i et randomiseret, dobbeltblindet, placebokontrolleret 12-ugers multicenterstudie (N = 370).
In addition, the efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multi-centre, randomised, double-blind, placebo–controlled study (N=370).
Derudover blev samlet overlevelse (OS) evalueret med 3 års opfølgning efter EFS-analysen som sekundært endepunkt, og der blev observeret en signifikant forbedring blandt de ITT-forsøgspersoner, der tilfældigt havde fået tildelt dinutuximab- immunterapi plus isotretinoin, sammenlignet med isotretinoin alene.
In addition, overall survival (OS) was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone.
Derudover blev symptombedring og overordnet helbredsstatus vurderet ved hjælp af henholdsvis det gennemsnitlige symptombyrde-indeks fra Lung Cancer Symptom Score (LCSS) og EQ-5D Visual Analogue Scale (EQ-VAS).
In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Derudover bør ordlyden om hypersensitivitet i sektion 4.4 anvendes.
Furthermore, the wording on hypersensitivity in section 4.4 should be adapted.
Derudover bør patienten placeres i liggende eller halvt liggende stilling under infusionen og i mindst 30 minutter efter afsluttet infusion.
In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Derudover bør patienter placeres i liggende eller halvt liggende stilling under infusionen og i mindst 30 minutter efter afsluttet infusion.
In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Derudover er de tilgængelige tabletstyrker ikke egnede til indledende behandling af børn, der vejer under 25 kg, af patienter, der ikke er i stand til at sluge tabletter eller til administration af doser under 125 mg.
In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 125 mg.
Derudover er de tilgængelige tabletstyrker ikke egnede til initialbehandling af børn, der vejer under 25 kg, til patienter, der ikke er i stand til at synke tabletter eller til administration af doser under 250 mg.
In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.
Derudover er den tilhørende frekvenskategori for hver bivirkning anført, baseret på CIOMS III-konventionen og defineret som: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
In addition, the corresponding frequency category for each ADR is based on the CIOMS III convention and is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Derudover er der behandlet børn i 2 fase I undersøgelser (med patienter med CML eller Ph+ akut leukæmi) og et fase II studie.
In addition, children have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Derudover er der behandlet børn og unge i 2 fase I undersøgelser (hos patienter med CML eller Ph+ akut leukæmi) og et fase II studie.
In addition, children and adolescents have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Derudover er der behov for at foretage studier, efter markedsføringstilladelsen er givet, med henblik på at undersøge Opgenras langvarige sikkerhed og effekt samt undersøge den faktiske lægemiddelbrug i "virkeligheden" for yderligere at kunne beskrive produktets sikkerheds- og effektprofil.
In addition, results of the post-authorisation studies to investigate the long term safety and efficacy of Opgenra and also investigate the actual drug utilisation in ‘real life’ are needed to further characterise the safety and efficacy profile.
Derudover er der en potentiel mulighed for, at der opstår en farmakodynamisk interaktion ved samtidig administration pga. additiv renal effekt.
In addition, there is a potential for a pharmacodynamic interaction to occur during co- administration due to additive renal effects.