natgillin/translations-raw huggingface dataset:
Den fortyndede infusionsvæske skal opbevares ved temperaturer mellem 2C – 8C og bruges inden for 24 timer.
Store the diluted infusion solution between 2 C and 8 C and use within 24 hours.
Den fortyndede opløsning af Soliris gives ved intravenøs infusion i løbet af 25-45 minutter hos voksne og 1-4 timer hos pædiatriske patienter enten ved naturligt tilløb, med en pumpe af sprøjtetypen eller med en infusionspumpe.
The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump.
Den fortyndede opløsning af Soliris kan før indgift opbevares ved 2 °C til 8 C i indtil 24 timer.
Diluted solution of Soliris may be stored at 2°C – 8°C for up to 24 hours prior to administration.
Den fortyndede opløsning er klar og farveløs.
The diluted solution is a clear, colourless solution.
Den fortyndede opløsning kan opbevares i op til 24 timer ved 2 C - 8 C
The diluted solution can be held for up to 24 hours at 2C – 8C.
Den fortyndede opløsning kan opbevares i op til 24 timer ved 25 °C. Opløsningen er under disse forhold både kemisk og fysisk stabil.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25oC.
Den fortyndede opløsning kan opbevares i op til 24 timer ved 25 °C. Opløsningen er under disse forhold både kemisk og fysisk stabil.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25C.
Den fortyndede opløsning må ikke nedfryses.
The diluted solution must not be frozen.
Den fortyndede opløsning må ikke opvarmes i mikroovn eller anden varmekilde end den forekommende rumtemperatur.
The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Den fortyndede opløsning skal anvendes omgående, da den ikke indeholder konserveringsmiddel.
The diluted solution should be used immediately.
Den fortyndede opløsning skal anvendes straks.
The diluted solution should be use immediately
Den fortyndede opløsning skal beskyttes mod lys indtil infusion.
The diluted solution should be protected from light until administration (see section 6.3).
Den fortyndede opløsning skal blandes grundigt ved at vende op og ned på posen flere gange.
The diluted solution must be mixed thoroughly by inverting several times.
Den fortyndede opløsning skal bruges inden for 6 timer og anvendes under aseptiske forhold som en 1-times infusion ved temperaturer under 25°C og under normale lysforhold.
The infusion bag solution should be used within 6 hours below 25°C and normal lighting conditions including the one hour infusion to the patient.
Den fortyndede opløsning skal henstå, til den er nået op på rumtemperatur (18 °C - 25 °C), før den administreres.
The diluted solution should be allowed to warm to room temperature [18°C – 25°C] prior to administration by exposure to ambient air.
Den fortyndede opløsning skal inspiceres visuelt for partikler og misfarvning, før administration.
The diluted solution should be inspected visually for particulate matter and discolouration prior to administration.
Den fortyndede opløsning skal yderligere fortyndes (se pkt.
The reconstituted solution must be diluted further (see section 6.6).
Den fortyndede opløsning til intravenøs indgivelse skal bruges indenfor 24 timer efter fremstillingen.
Diluted solution for intravenous administration should be used within 24 hours after preparation.
Den fortyndede Zoledronsyre Accord infusionsvæske bør anvendes straks for at undgå mikrobiologisk kontaminering.
The diluted Zoledronic Acid Accord infusion solution should be used immediately in order to avoid microbial contamination.
Den fortyndede Zoledronsyre Hospira infusionsvæske bør anvendes straks for at undgå mikrobiologisk kontaminering.
The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
Den forudbestemte sammenligning af den primære virkning var mellem ” Viramune to gange daglig”- gruppen og efavirenzgruppen.
The predetermined primary efficacy comparison was between the Viramune twice daily and the efavirenz treatment groups.
Den forudbestemte sammenligning af den primære virkning var mellem ”Viramune to gange daglig”- gruppen og efavirenzgruppen.
The predetermined primary efficacy comparison was between the Viramune twice daily and the efavirenz treatment groups.
Den forudspecificerede kliniske nettofordel (primært effektendepunkt plus større blødning) blev indberettet med en hazard ratio på 0,849 ((95% KI: 0,633- 1,139), nominel p-værdi p=0,275).
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a hazard ratio of 0.849 ((95% CI: 0.633 - 1.139), nominal p value p= 0.275).
Den forudspecificerede kliniske nettofordel (primært virkningsresultat plus større blødninger) for den samlede analyse blev indrapporteret med en hazard ratio på 0,771 ((95% KI: 0,614 – 0,967), nominel p-værdi p=0,0244).
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a hazard ratio of 0.771 ((95% CI: 0.614 – 0.967), nominal p value p= 0.0244).
Den forudspecificerede rPFS-analyse viste en statistisk signifikant forbedring mellem behandlingsgrupperne med en 81,4 % reduktion i risiko for radiografisk progression eller død [HR = 0,186 (95 % KI: 0,149; 0,231), p < 0,0001].
At the pre-specified rPFS analysis, a statistically significant improvement was demonstrated between the treatment groups with an 81.4% reduction in risk of radiographic progression or death [HR = 0.186 (95% CI: 0.149, 0.231), p < 0.0001].
Den forventede in-vivo-peak-stigning i faktor X-niveau udtrykt som IE/dl (eller % af det normale) kan estimeres ved hjælp af følgende formler:
The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Den forventede ivacaftor-eksponering, der er baseret på observerede ivacaftor-koncentrationer i fase 2- og 3-studier, bestemt ved hjælp af den populationsfarmakokinetiske analyse er vist pr. aldersgruppe i tabel 55.
Predicted ivacaftor exposure based on observed ivacaftor concentrations in Phase 2 and 3 studies as determined using population PK analysis is presented by age group in Table 5.
Den forventede kliniske fordel af at kombinere dinotefuran med permethrin blev demonstreret i en laboratorieundersøgelse hos hund og viste en forlængelse af effektivitetsvarigheden mod C. canis- lopper til 4 uger.
The anticipated clinical benefit resulting from a combination of dinotefuran with permethrin was demonstrated in one laboratory study on dogs which showed a prolongation of the duration of efficacy against C. canis fleas to 4 weeks.
Den forventede kliniske fordel af at kombinere dinotefuran med permethrin blev demonstreret i en laboratorieundersøgelse hos hunde og viste en forlængelse af effektivitetsvarigheden mod C. canis- lopper til 4 uger.
The anticipated clinical benefit resulting from a combination of dinotefuran with permethrin was demonstrated in one laboratory study on dogs which showed a prolongation of the duration of efficacy against C. canis fleas to 4 weeks.
Den forventede mængde metabolitakkumulation ved steady state er dog ikke farmakodynamisk væsentlig, da terminalhalveringstiden kun er 1-2 timer hos disse forsøgspersoner.
However, the predicted amount of metabolite accumulation at steady state is not pharmacodynamically important because the terminal elimination half-life is only 1–2 hours in these subjects.
Den forventede totale eksponering hos børn efter intravenøse vedligeholdelsesdoser på 4 mg/kg og 8 mg/kg 2 gange dagligt var sammenlignelig med den for voksne efter intravenøse doser på hhv.
The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and
Den forventede totale eksponering hos børn efter oral vedligeholdelses- behandling på 9 mg/kg (maksimalt 350 mg) 2 gange dagligt var sammenlignelig med den for voksne efter oral behandling med 200 mg 2 gange dagligt.
The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily.
Den forøgede tenofovir-eksponering kan forstærke effekten af bivirkninger ved tenofovir, herunder nyresygdomme.
The increased exposure of tenofovir could potentiate tenofovir- associated adverse events, including renal disorders.
Den forøgede tenofovir-eksponering kan forstærke effekten af bivirkninger ved tenofovir, herunder nyresygdomme.
The increased exposure of tenofovir could potentiate tenofovir-associated adverse events, including renal disorders.
Den forøgede tenofovir-eksponering kan forstærke effekten af bivirkninger ved tenofovirdisoproxilfumarat, herunder nyresygdomme.
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil fumarate, including renal disorders.
Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovirdisoproxilfumarat, herunder nyrerelaterede bivirkninger.
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil fumarate, including renal disorders.
Den fraktion af sitagliptin, som er reversibelt bundet til plasmaproteiner, er lav (38%).
The fraction of sitagliptin reversibly bound to plasma proteins is low (38 %).
Den fremlagde dog oplysninger fra offentliggjorte undersøgelser om anvendelsen af Avonex til patienter i alderen mellem 12 og 18 år.
However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years.
Den fremstillede injektionsvæske skal helst anvendes med det samme.
The reconstituted product should preferably be used immediately.
Den fremstillede injektionsvæske skal være klar eller let opaliserende og farveløs.
The prepared solution will be clear to sligthly opalescent and colourless.
Den fremstillede opløsning indeholder 22 × 106 IE (1.300 μg) aldesleukin per 1,2 ml.
The resulting solution contains 22 x 10 6 IU (1,300 µg) of aldesleukin per 1.2 mL.
Den fremstillede opløsning skal indgives over 60 minutter uanset infusionsvolumen (50 ml, 100 ml eller 250 ml).
The resulting solution should be administered over 60 minutes for all infusion volumes (50 ml, 100 ml or 250 ml).
Den fremstillede, fortyndede opløsning til infusion via en vene kan opbevares i køleskab (2 °C – 8 °C) i op til maksimalt 3 timer efterfulgt af op til 1 time ved stuetemperatur (20 °C – 25 °C) før anvendelse.
This prepared diluted solution for intravenous infusion can be stored refrigerated at 2°C - 8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C - 25°C) before administration.
Den frie koncentration af efavirenz, der er nødvendig for 90 - 95 % hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag-
The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine- resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Den frie koncentration af efavirenz, der er nødvendig for 90 – 95% hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag-
The free concentration of efavirenz required for 90 to 95 % inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Den frie koncentration af efavirenz, der er nødvendig for 90–95% hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag-
The free concentration of efavirenz required for 90 to 95 % inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Den frysetørrede Haemophilus influenzae type b (HIB) komponent er et hvidt pulver.
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.
Den fuld- stændige liste over indberettede bivirkninger med Forxiga fremgår af indlægssedlen.
For the full list of side effects reported with Forxiga, see the package leaflet.
Den fulde produktinformation for ritonavir skal derfor læses før påbegyndelse af kombinationsterapi med Telzir og ritonavir.
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
Den fuldstændige beskrivelse af de indberettede bivirkninger for Exubera fremgår af indlægssedlen.
For the full description of the side effects reported with Exubera, please see the package leaflet.
Den fuldstændige beskrivelse af samtlige indberettede bivirkninger ved Revasc fremgår af indlægssedlen.
For the full description of all side effects reported with Revasc, see the Package Leaflet.
Den fuldstændige EPAR Eklira Genuair findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Eklira Genuair can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Abilify findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Abilify can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Abilify Maintena findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Abilify Maintena can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Abseamed findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Abseamed can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aclasta findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aclasta can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Actelsar HCT findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Actelsar HCT can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Actos findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Actos can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Actraphane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Actraphane can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Actrapid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Actrapid can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Adasuve findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Adasuve can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Adcetris findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Adcetris can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Adcirca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Adcirca can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Adenuric findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Adenuric can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Adjupanrix find s på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Adjupanrix can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Adrovance findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Adrovance can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Advate findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Advate can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Advocate findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for Advocate can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Den fuldstændige EPAR for Aerinaze findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aerinaze can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aerius findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aerius can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aerivio Spiromax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Aerivio Spiromax can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Afinitor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Afinitor can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aflunov findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aflunov can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Airexar Spiromax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Airexar Spiromax can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Aivlosin findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for Aivlosin can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Den fuldstændige EPAR for Aldurazyme findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Aldurazyme can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Alimta findes på agenturets websted under website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Alimta can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Alli findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Alli can be searched for on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aloxi findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aloxi can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Alprolix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Alprolix can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Ambirix findes på agenturets websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Ambirix can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Ameluz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Ameluz can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Amlodipin/Valsartan Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Amlodipine/Valsartan Mylan can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Angiox findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Angiox can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Aprovel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Aprovel can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den fuldstændige EPAR for Aptivus findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aptivus can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den fuldstændige EPAR for Aranesp findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Aranesp can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.