natgillin/translations-raw huggingface dataset:
Yderligere analyser af disse data samt data fra den offentliggjorte litteratur viste, at SIJA og AOSD har fælles kendetegn og virkningerne af Ilaris hos AOSD-patienter forventes at svare til virkninger hos patienter med SIJA.
Further analyses of these data, together with data from the published literature, showed that SIJA and AOSD share common features and that the effects of Ilaris in AOSD patients are expected to be similar to the effects seen in SIJA patients
Yderligere analyser af undergrupper viste en høj risiko for progression til CDMS inden for 2 år hos monofokale patienter med mindst 9 T2-læsioner (55 % risiko for placebo, 26 % for Extavia) eller Gd-forstærkning (63 % mod 33 %).
Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2- lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Yderligere analyser tyder på, at det kirurgiske indgreb ikke påvirkede tendenserne i effektendemålene, og at effekten af IONSYS var ensartet på tværs af de undersøgt BMI’er (< 25 til > 40 kg/m2 body mass index)
Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied (< 25 to > 40 kg/m2 Body Mass Index).
Yderligere antihypertensive præparater (eksklusiv ACE-hæmemer, angiotensin II-receptorantagonister og dihydropyridin- calciumblokkere) blev tilføjet efter behov for at nå blodtryksmålet.
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Yderligere at undersøge de associative analyser mellem PD-L1- og PD-L2-ekspression udført i studierne CA209066, CA209057 og CA209025.
To further investigate the associative analyses between PD-L1 and PD-L2 expression conducted in studies CA209066, CA209057 and CA209025.
Yderligere at undersøge de associative analyser mellem PDL-1- og PDL- 2-ekspression udført i studie CA209-066.
To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Yderligere at undersøge den mulige ændring i tumorens PD-L1-status under behandling og/eller tumorprogression i studierne CA209-009, CA209-038 og CA209-064 efter godkendelse.
To further investigate at post-approval the possible change in PD-L1 status of the tumour during treatment and/or tumour progression in Studies CA209-009, CA209-038 and CA209-064.
Yderligere at undersøge den mulige ændring i tumorens PD-L1-status under behandling og/eller tumorprogression i studierne CA209009, CA209038 og CA209064.
To further investigate the possible change in PD-L1 status of the tumour during treatment and/or tumour progression in studies CA209009, CA209038 and CA209064.
Yderligere at undersøge sammenhængen mellem PDL-1- og PDL- 2-ekspression i fase 1 (CA209009, CA209038 og CA209064) efter godkendelse.
To further investigate at post-approval the relation between PDL-1 and PDL-2 expression in Phase 1 (CA209009, CA209038 and CA209064).
Yderligere behandling med LEMTRADA skal overvejes på individuel basis under hensyntagen til den enkelte patients kliniske tilstand.
Further treatment with LEMTRADA should be considered on an individual basis taking into account the clinical condition of the respective patient.
Yderligere behandling:
Additional treatments:
Yderligere behandlingscykler med Tractocile kan bruges hvis sammentrækningerne af livmoderen opstår igen.
Further treatment with Tractocile can be used if your contractions start again.
Yderligere behandlingscykler med Tractocile kan bruges, hvis sammentrækningerne af livmoderen opstår igen.
Further treatment cycles of Tractocile can be used should contractions recur.
Yderligere behandlingscykler med Tractocile kan bruges, hvis sammentrækningerne af livmoderen opstår igen.
Further treatment with Tractocile can be used if your contractions start again.
Yderligere behandlingsforløb
Re-treatment
Yderligere biomarkører, ud over PD-L1-eksspressionsstatus ved immunhistokemi (IHC) (f.eks.
Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g.
Yderligere bivirkninger
Additional side effects
Yderligere bivirkninger
Additional side effects include:
Yderligere bivirkninger (der ikke er anført i Tabel 2) er rapporteret hos patienter, der fik andre doser (enten < eller > 3 mg/kg) af ipilimumab i kliniske forsøg med melanom.
Additional adverse reactions not listed in Table 2 have been reported in patients who received other doses (either < or > 3 mg/kg) of ipilimumab in clinical trials of melanoma.
Yderligere bivirkninger er blevet rapporteret, efter at medicinen blev markedsført.
Additional side effects have been reported after this medicine was marketed.
Yderligere bivirkninger er set hos patienter, der brugte GANFORT (flerdosisformulering), og kan derfor forekomme med GANFORT enkeltdosis:
Additional side effects have been seen in patients using GANFORT (multi-dose formulation) and so may possibly be seen with GANFORT single-dose:
Yderligere bivirkninger er set hos patienter, der brugte øjendråber med bimatoprost og kan derfor forekomme med GANFORT enkeltdosis:
Additional side effects have been seen in patients using eye drops containing bimatoprost and so may possibly be seen with GANFORT single-dose:
Yderligere bivirkninger er set hos patienter, der brugte øjendråber med bimatoprost og kan derfor forekomme med GANFORT:
Additional side effects have been seen in patients using eye drops containing bimatoprost and so may possibly be seen with GANFORT:
Yderligere bivirkninger er set hos patienter, der brugte øjendråber med timolol, og kan derfor forekomme med GANFORT enkeltdosis.
Additional side effects have been seen in patients using eye drops containing timolol and so may possibly be seen with GANFORT single-dose.
Yderligere bivirkninger er set hos patienter, der brugte øjendråber med timolol, og kan derfor forekomme med GANFORT.
Additional side effects have been seen in patients using eye drops containing timolol and so may possibly be seen with GANFORT.
Yderligere bivirkninger hos børn og unge
Additional side effects in children and adolescents hyperactivity
Yderligere bivirkninger hos patienter med kronisk nyresygdom (renal anæmi)
Additional side effects in people with chronic kidney disease (renal anaemia)
Yderligere bivirkninger hos patienter, som donerer deres eget blod før operation
Additional side effects in people donating their own blood before surgery
Yderligere bivirkninger hos unge
Additional side effects in adolescents
Yderligere bivirkninger hos voksne, som får kemoterapi for cancer
Additional side effects in adults receiving chemotherapy for cancer
Yderligere bivirkninger i forbindelse med brugen af lægemidler indeholdende pravastatin eller fenofibrat, som er observeret i kliniske undersøgelser og fra erfaringen efter markedsføringen, og som potentielt kan forekomme med Pravafenix, er nævnt nedenfor.
Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and post- marketing experience that may potentially occur with Pravafenix are listed below.
Yderligere bivirkninger og laboratorieanomalier rapporteret med en ≥5 % forskel (alle grader) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet versus placebo/FOLFIRI-regimet
Additional adverse reactions and laboratory abnormalities reported with a ≥5% difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen
Yderligere bivirkninger rapporteret efter boostervaccination efterfølgende det primære vaccinationsprogram og/eller catch-up vaccination:
Adverse reactions additionally reported after booster vaccination of primary series and/or catch-up vaccination:
Yderligere bivirkninger, der er observeret, når Ceplene blev brugt til andre typer behandling Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 personer)
Additional side effects observed when Ceplene was used in other types of treatment: Very common side effects (may affect more than 1 in 10 people)
Yderligere bivirkninger, som blev identificeret i forbindelse med brug af kombinationsbehandling (BzmbR-CAP), var hepatitis B- infektion (< 1 %) og myokardieiskæmi (1,3 %).
Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Yderligere bivirkninger, som er blevet rapporteret sammen med andre nicotinsyrepræparater (med eller uden statin) ved brug efter markedsføring eller i kliniske studier, omfatter følgende:
Additional adverse reactions that have been reported with other nicotinic acid medicinal products (with or without a statin) in post-marketing use or in clinical trials include the following:
Yderligere blev der set nedsat fødeindtag hos hunkatte, men ingen signifikant reduktion i deres legemsvægt blev observeret.
Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed.
Yderligere CE-mærkede orale sprøjter kompatible med adapteren kan fås på apoteket.
Additional CE marked oral syringes compatible with the reclosable bottle cap adapter can be obtained from a pharmacy.
Yderligere data er nødvendige for at fastslå, om der er øget risiko for fraktur hos mænd efter en længere opfølgningsperiode.
Additional data are necessary to determine whether there is an increased risk of fracture in males after a longer period of follow-up.
Yderligere data er opnået fra et antal patienter under et compassionate use program.
Some additional data have been obtained from a number of patients in a compassionate use programme.
Yderligere data fra en klinisk undersøgelse, som inkluderede 27 kvinder med gestational diabetes randomiseret til behandling med insulin aspart vs. humaninsulin (insulin aspart: 14; humaninsulin: 13) viste lignende sikkerhedsprofiler mellem behandlingerne.
In addition the data from a clinical trial including 27 women with gestational diabetes randomised to treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar safety profiles between treatments.
Yderligere data understøtter desuden virkningen af Kalydeco hos børn i alderen 2-5 år, som har en G551D- eller S549N-mutation.
Additional data also supports effectiveness of Kalydeco in children aged 2 to 5 years of age with a G551D or S549N mutation.
Yderligere data viste, at patienter, der ikke tidligere var blevet behandlet, og som fik 3g Yervoy per kg kropsvægt overlevede i gennemsnit 13,5 måneder.
The additional data showed that previously untreated patients given Yervoy 3 mg per kg bodyweight survived for an average of 13.5 months.
Yderligere doser skal gives efter lægens anvisning.
Further doses should be administered according to your doctor’s recommendation.
Yderligere dosis på 150 mg eller 2 mg/kg kan overvejes
Maintenance dose: 150 mg or 2 mg/kg
Yderligere dosisjustering kan være nødvendig på basis af individuel tolerabilitet.
Further dose adjustments may be necessary based on individual tolerability.
Yderligere dosisjusteringer kan være nødvendige på basis af individuel tolerabilitet.
Further dose adjustments may be necessary based on individual tolerability.
Yderligere effektdata er tilgængelige fra et randomiseret, åbent fase II-multicenterstudie [JapicCTI- 121850] udført hos japanske patienter med translokationsrelaterede sarkomer (TRS), hvor de mest almindelige var myksoid rundcellet liposarkom (n=24), synovialt sarkom (n=18), mesenkymalt kondrosarkom (n=6) og ekstraskeletalt Ewings sarkom/PNET, alveolært bløddelssarkom, alveolært rabdomyosarkom og klarcellet sarkom (n=5 for hver).
Additional efficacy data are available from a randomized, open-label, multicenter phase II study [JapicCTI-121850] conducted in Japanese patients with translocation-related sarcoma (TRS), most common being myxoid round-cell liposarcoma (n=24), synovial sarcoma (n=18), mesenchymal chondrosarcoma (n=6), and extraskeletal Ewing sarcoma/PNET, alveolar soft part sarcoma, alveolar rhabdomyosarcoma and clear cell sarcoma (n=5 each).
Yderligere effektresultater fremgår af Tabel 7.
Further efficacy results are reported in Table 7.
Yderligere eksplorativ pCR-rate inkluderede lymfeknudestatus (ypT0/isN0 og ypT0N0).
Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
yderligere en injektion i musculus deltoideus (samme dosis) én uge senere (dag 8) genoptagelse af den normale månedlige cyklus af injektioner på 25 mg til 150 mg i enten musculus deltoideus eller gluteus maximus baseret på individuel patienttolerabilitet og/eller virkning.
another deltoid injection (same dose) one week later (day 8) resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy
yderligere en injektion i musculus deltoideus én uge senere (dag 8) ved en dosis på 100 mg genoptagelse af den normale månedlige cyklus af injektioner på 25 mg til 150 mg i enten musculus deltoideus eller gluteus maximus baseret på individuel patienttolerabilitet og/eller virkning.
another deltoid injection one week later (day 8) at the 100 mg dose resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy
Yderligere en til to Suboxone 2 mg/0,5 mg kan administreres på Dag 1, afhængigt af den enkelte patients behov.
An additional one to two Suboxone 2 mg/0.5 mg may be administered on day one depending on the individual patient’s requirement.
Yderligere en til to Suboxone 2 mg/0,5 mg kan administreres på Dag 1, afhængigt af patientens individuelle behov.
An additional one to two Suboxone 2 mg/0.5 mg may be administered on day one depending on the individual patient’s requirement.
Yderligere episoder forekom hos 130 af 4 118 patienter, som fik edoxaban (3,2 %) og hos 146 af 4 122, som fik warfarin (3,5 %).
Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).
Yderligere er der påvist en vedvarende immunologisk hukommelse overfor hepatitis B virus overflade-antigen (HBsAg) fremkaldt af vaccinen ved, at der blev konstateret et anamnestisk antistofsvar på en boosterdosis af en tidligere formulering af Mercks rekombinant hepatitis B vaccine hos raske voksne.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine in healthy adults.
Yderligere er der påvist en vedvarende immunologisk hukommelse overfor hepatitis B virus overflade-antigen (HBsAg) fremkaldt af vaccinen ved, at der blev konstateret et anamnestisk antistofsvar på en boosterdosis af en tidligere formulering af Mercks rekombinant hepatitis B vaccine.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine.
Yderligere er der påvist en vedvarende immunologisk hukommelse overfor hepatitis B virus overflade-antigen (HBsAg) fremkaldt af vaccinen ved, at der blev konstateret et anamnestisk antistofsvar på en boosterdosis af en tidligere formulering af Mercks rekombinant hepatitis B-vaccine.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine.
Yderligere er eksfoliative hudreaktioner kendt for dipeptidyl peptidase-4 (DPP4) hæmmere.
Furthermore, exfoliative skin reactions are known for dipeptidyl peptidase-4 (DPP4) inhibitors.
Yderligere er følgende bivirkning blevet observeret i et studie med patienter med demens associeret med Parkinsons sygdom, som har fået behandling med Exelon depotplaster: agitation (almindelig).
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson’s disease treated with Exelon transdermal patches: agitation (common).
Yderligere er følgende bivirkning blevet observeret i et studie med patienter med demens associeret med Parkinsons sygdom, som har fået behandling med Prometax depotplaster: agitation (almindelig).
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson’s disease treated with Prometax transdermal patches: agitation (common).
Yderligere er følgende bivirkning blevet observeret i et studie med patienter med demens associeret med Parkinsons sygdom, som har fået behandling med rivastigmin depotplaster: agitation (almindelig).
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson’s disease treated with rivastigmine transdermal patches: agitation (common).
Yderligere er følgende bivirkninger rapporteret i kliniske studier med GlaxoSmithKlines andre kombinerede hepatisis A- og hepatitis B-vacciner (givet som 3- eller 4-dosis vaccinationsprogram)
In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline’s other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule)
Yderligere er følgende bivirkninger set i kliniske studier med lignende kombinerede hepatitis A- og hepatitis B-vacciner:
Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include:
Yderligere et klinisk studie blev udført hos 13 PID-patienter (mellem 3-65 år).
In an extension of this study, 13 PID patients (aged 3-65 years) participated in a PK sub-study.
Yderligere evalueringer inkluderede responsvarighed (DOR) og progressionsfri overlevelse (PFS) ifølge investigators vurdering og blinded independent review committee (BIRC) samt samlet overlevelse (OS).
Additional evaluations included duration of response (DOR) and progression-free survival (PFS) by investigator and blinded independent review committee (BIRC) assessment, and overall survival (OS).
Yderligere evalueringer, som viste statistisk signifikans (p<0,05) til fordel for Xolair, omfattede reduktioner i svære astmaeksacerbationer (hvor patienters lungefunktion blev reduceret til under 60 % af personligt bedste, og som krævede systemiske kortikosteroider) og astmarelaterede akutte besøg (bestod af hospitalsindlæggelser, skadestuebesøg og ikke planlagte lægebesøg), og forbedringer i lægens overordnet vurdering af behandlingens effektivitet, Astma-relateret Quality of Life (AQL), astma symptomer og lungefunktion.
Further evaluations which did show statistical significance (p<0.05) in favour of Xolair included reductions in severe exacerbations (where patient’s lung function was reduced to below 60% of personal best and requiring systemic corticosteroids) and asthma-related emergency visits (comprised of hospitalisations, emergency room, and unscheduled doctor visits), and improvements in Physician’s overall assessment of treatment effectiveness, Asthma-related Quality of Life (AQL), asthma symptoms and lung function.
Yderligere fase III-studier
Additional Phase III studies
Yderligere for 10 mg filmovertrukne tabletter:
Additional for 10 mg film-coated tablets:
Yderligere for 10 mg filmovertrukne tabletter: Gul jernoxid
Additional for 10 mg film-coated tablets: Iron oxide yellow
Yderligere for 15 og 20 mg filmovertrukne tabletter:
Additional for 15 mg and 20 mg film-coated tablets:
Yderligere for 15 og 20 mg filmovertrukne tabletter: Gul og rød jernoxid
Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red
Yderligere foranstaltninger til risikominimering
Additional risk minimisation measures
Yderligere forbedringer i neglepsoriasis blev observeret efter uge 32 hos patienter, der kontinuerligt blev behandlet med apremilast.
Further improvements in nail psoriasis were observed at Week 32 in patients continuously treated with apremilast.
Yderligere fortynding af den rekonstituerede opløsning med enten 0,9 % natriumchloridinfusionsvæske eller 5 % glucoseinfusionsvæske er påkrævet for at opnå den endelige koncentration på mellem 25 og 50 mikrogram/ml.
Further dilution of the appropriate volume of the reconstituted solution with either 0.9 % w/v sodium chloride intravenous infusion or 5 % w/v glucose intravenous infusion is required to a final concentration of between 25 and 50 microgram/ml.
Yderligere fortynding af den rekonstituerede opløsning med enten natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller 50 mg/ml (5 %) glucoseopløsning til infusion er påkrævet for at opnå den endelige koncentration på mellem 25 og 50 mikrogram/ml.
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Yderligere fortynding af det passende volumen af koncentratet med enten 0,9 % vægt/volumen natriumchlorid intravenøs infusion eller 5 % vægt/volumen glucose intravenøs infusion er nødvendig for en endelig topotecankoncentration mellem 25 og 50 mikrogram/ml i infusionsopløsningen.
Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Yderligere fortynding af Topotecan Eagle er nødvendig med enten natriumchlorid 9 mg/ml (0,9 % w/v) opløsning til injektion eller glukose 50 mg/ml (5 % w/v) opløsning til injektion for at nå en endelig topotecankoncentration på mellem 25 µg/ml og 50 µg/ml i opløsningen til infusion hos patienten.
Further dilution of Topotecan Eagle is required with either sodium chloride 9 mg/ml (0.9 % w/v) solution for injection or glucose 50 mg/ml (5 % w/v) solution for injection in order to reach a final topotecan concentration of between 25 µg/ml and 50 µg/ml in the solution for infusion to the patient.
Yderligere fortynding er nødvendig.
7.8. Further dilution is required.
Yderligere havde 16% af patienterne en EDSS-score >3,5, 28% havde haft ≥2 attakker i det forudgående år, og 42% havde tidligere fået anden godkendt behandling for MS.
7.0 years, EDSS score 2.0. In addition, 16% of patients had an EDSS score >3.5, 28% had ≥2 relapses in the prior year and 42% had previously received other approved MS treatments.
Yderligere havde 17% af patienterne en EDSS-score >3,5, 32% havde haft ≥2 attakker i det forudgående år, og 30% havde tidligere fået anden godkendt behandling for MS.
≥2 relapses in the prior year and 30% had previously received other approved MS treatments.
Yderligere histologiske studier viste, at behandling med infliximab reducerer infiltreringen af inflammatoriske celler ind i den angrebne del af tarmen og tilstedevæ relsen af betæ ndelsesmarkører på disse steder.
Additional histological studies provided evidence that treatment with infliximab reduces the infiltration of inflammatory cells into affected areas of the intestine and the presence of inflammation markers at these sites.
Yderligere immunogenicitetsanalyser af den enkelte positive prøve viste et lavt titer af anti-siltuximab-antistoffer (1:20) med ikke-neutraliserende egenskaber.
Further immunogenicity analyses of the single positive sample revealed a low titer of anti-siltuximab antibodies (1:20) with non-neutralising capabilities.
Yderligere indgår i sættet et skruelåg (etylenvinylacetat / LDPE) med mulighed for påfyldning af doseringssprøjte.
In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringe-port capability is provided.