FrancophonIA/ELRC3.0 huggingface dataset:
English: Most adverse reactions reported in these clinical studies were described as mild to moderate in intensity.
Danish: De fleste af de rapporterede bivirkninger i disse kliniske undersøgelser blev beskrevet som milde til moderate i intensitet.
English: HOW:
Danish: HVORDAN:
English: WHEN:
Danish: HVORNÅR:
English: The terminal half-life ranged from approximately 9 to 13 hours.
Danish: Den terminale halveringstid varierede fra ca. 9 til 13 timer.
English: EMEND is taken just once a day for 3 consecutive days.
Danish: EMEND skal tages en gang om dagen i 3 fortløbende dage.
English: The efficacy of the aprepitant regimen was evaluated in a single cycle (Cycle 1).
Danish: Virkningen af aprepitantregimet blev evalueret i en enkelt cyklus (cyklus 1).
English: The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 L in humans.
Danish: Den geometriske gennemsnitsværdi af distributionsvolumen ved steady state (Vdss) er ca. 66 liter hos mennesker.
English: * - Acute phase
Danish: * - akut fase
English: 1-day regimen of fosaprepitant 150 mg in adults
Danish: 1-dags regime med fosaprepitant 150 mg hos voksne
English: 0-24 hours
Danish: 0-24 timer
English: Aprepitant 40 mg orally (N=541)
Danish: Aprepitant 40 mg oralt (N=541)
English: *Reported in patients taking a higher dose of aprepitant.
Danish: *Rapporteret hos patienter, der tog en højere dosis aprepitant.
English: Ondansetron was given intravenously immediately before induction of anaesthesia.
Danish: Ondansetron blev givet intravenøst umiddelbart før påbegyndelse af anæstesi.
English: This effect may be expected to be more pronounced for orally administered methylprednisolone.
Danish: Denne virkning kan forventes at være mere udtalt for oralt administreret methylprednisolon.
English: Patients had the opportunity to receive open-label aprepitant in subsequent cycles (Optional Cycles 2-6); however efficacy was not assessed in these optional cycles.
Danish: Patienterne fik mulighed for at få ikke-blindet aprepitant i efterfølgende cyklusser (valgfrie cyklusser 2-6); virkningen blev dog ikke vurderet i disse valgfrie cyklusser.
English: Different pack sizes including different strengths are available.
Danish: Forskellige pakningsstørrelser med forskellige styrker er tilgængelige.
English: OTHER PRESPECIFIED ENDPOINTS Complete response
Danish: ANDRE FORUDSPECIFICEREDE ENDEPUNKTER Komplet respons
English: • Discard any remaining suspension and waste material.
Danish: • Bortskaf eventuel resterende suspension og affald.
English: Use this medicine within 2 days of getting the medicine from the healthcare provider.
Danish: Brug medicinen inden for 2 dage, efter du har fået den fra sundhedspersonalet.
English: Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Danish: Endvidere bør samtidig administration med irinotecan udvises med særlig forsigtighed, da kombinationen kan resultere i øget toksicitet.
English: This effect may become apparent only after the end of a 3-day treatment with EMEND.
Danish: Denne virkning viser sig eventuelt først efter afslutning af en 3-dages behandling med EMEND.
English: Of the paediatric patients, 29 % in the aprepitant regimen and 28 % in the control regimen used dexamethasone as part of the regimen in Cycle 1.
Danish: 29 % af de pædiatriske patienter i aprepitantregimet og 28 % i kontrolregimet brugte dexamethason som en del af regimet i cyklus 1.
English: Aprepitant is excreted in the milk of lactating rats.
Danish: Aprepitant udskilles i mælken hos diegivende rotter.
English: The recommended dose of EMEND powder for oral suspension is based on weight, as specified in the table below.
Danish: Den anbefalede dosis af EMEND pulver til oral suspension er baseret på vægt, som angivet i tabellen nedenfor.
English: The potential effects on reproduction of alterations in neurokinin regulation are unknown.
Danish: Den mulige virkning på reproduktion af forandringer i neurokininreguleringen er ikke kendt.
English: Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Danish: Opsummering af sikkerhedsprofilen Sikkerhedsprofilen for aprepitant blev undersøgt hos ca. 6.500 voksne.
English: In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided.
Danish: I tilfælde af overdosering bør EMEND seponeres og almindelig understøttende behandling og overvågning iværksættes.
English: Mild induction of glucuronidation is also seen with 80 mg oral aprepitant given for 7 days.
Danish: Mild induktion af glukuronidering ses også med 80 mg oral aprepitant givet i 7 dage.
English: An additional study was completed with intravenous administration of midazolam and EMEND.
Danish: Et supplerende studie blev udført med intravenøs administration af midazolam og EMEND.
English: Do not give the child more of this medicine than the doctor recommends.
Danish: Du må ikke give barnet mere af dette lægemiddel, end lægen anbefaler.
English: Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The terminal half-life is approximately 9 hours after administration of a single 40 mg dose.
Danish: Den terminale halveringstid er ca. 9 timer efter administration af en enkelt 40 mg dosis.
English: This is because the liver is important in breaking down the medicine in the body.
Danish: Dette skyldes, at leveren er vigtig ved nedbrydning af lægemidlet i kroppen.
English: Intravenous dexamethasone was permitted as part of the antiemetic regimen for paediatric patients in both age groups, at the discretion of the physician.
Danish: Brug af intravenøs dexamethason blev tilladt som en del af antiemetika-regimet for pædiatriske patienter i begge aldersgrupper efter lægens vurdering.
English: Complete response (0-24 hours)
Danish: Komplet respons (0-24 timer)
English: Swallow the capsule whole with some liquid.
Danish: Slug kapslen hel sammen med væske.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12
Danish: Farmakoterapeutisk gruppe: Antiemetika og kvalmestillende lægemidler, ATC-kode: A04AD12
English: A dose reduction (50 %) of dexamethasone was required for paediatric patients receiving aprepitant.
Danish: En dosisreduktion (50 %) af dexamethason var påkrævet for pædiatriske patienter, der fik aprepitant.
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults in more than 50 studies and 184 children and adolescents in 2 pivotal paediatric clinical trials.
Danish: Sikkerhedsprofilen for aprepitant blev undersøgt hos ca. 6.500 voksne i flere end 50 studier og 184 børn og unge i 2 betydningsfulde kliniske studier med pædiatriske patienter.
English: EMEND 40 mg is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
Danish: EMEND 40 mg er indiceret til forebyggelse af postoperativ kvalme og opkastning (PONV) hos voksne.
English: If no chemotherapy is given on Days 2 and 3, EMEND should be administered in the morning.
Danish: Hvis der ikke gives kemoterapi på dag 2 og 3, skal EMEND administreres om morgenen.
English: - It is common to have medicine leftover in the cup.
Danish: - Det er normalt, at der er medicin tilbage i bægeret.
English: The results were evaluated for each individual study and for the 2 studies combined.
Danish: Resultaterne evalueredes for hvert enkelt studie og kombineret for begge studier.
English: The percentage of subjects reporting no vomiting over the first 24 hours following surgery was similar for subjects receiving aprepitant versus ondansetron.
Danish: Procentdelen af forsøgspersoner, som rapporterede ingen opkastning i løbet af de første 24 timer efter operation, var tilsvarende for de forsøgspersoner, der fik aprepitant versus ondansetron.
English: BLISTER TEXT
Danish: BLISTERTEKST
English: Twelve metabolites of aprepitant have been identified in human plasma.
Danish: Der er identificeret tolv metabolitter af aprepitant i human plasma.
English: The safety and exploratory efficacy of aprepitant were evaluated in a Phase I clinical study (n=50) using a 40 mg powder for oral suspension.
Danish: Aprepitants sikkerhed og eksplorative virkning blev vurderet i et klinisk fase I-studie (n=50) med et 40 mg pulver til oral suspension.
English: If you forget to give EMEND
Danish: Hvis du har glemt at tage EMEND
English: Start on the day after your chemotherapy.
Danish: Start dagen efter din kemoterapibehandling.
English: No dose reduction was required for paediatric patients receiving the control regimen.
Danish: Ingen dosisreduktion var påkrævet for pædiatriske patienter, der fik kontrolregimet.
English: **N: Number of patients included in the primary analysis of complete response.
Danish: *Primært endepunkt står med fed. **N: Antal patienter inkluderet i den primære analyse af det totale respons.
English: - If there is any foam, wait for the foam to disappear before going on to Step 9.
Danish: - Hvis der er skumdannelse, skal du vente, til skummet forsvinder, før du fortsætter til trin
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender.
Danish: Forskel og konfidensinterval (CI) blev beregnet ved anvendelse af metoden fremsat af Miettinen og Nurminen og korrigeret for køn.
English: An analysis of efficacy in subpopulations in Cycle 1 demonstrated that, regardless of age category, gender, use of dexamethasone for antiemetic prophylaxis, and emetogenicity of chemotherapy, the aprepitant regimen provided better control than the control regimen with respect to the complete response endpoints.
Danish: En analyse af virkningen i subpopulationerne i cyklus 1 viste at, uanset alderskategori, køn, brug af dexamethason til antiemetika-profylakse og kemoterapiens emetogenicitet, aprepitantregimet gav bedre kontrol end kontrolregimet med hensyn til endepunkterne for komplet respons.
English: WHEN and HOW to take EMEND
Danish: HVORNÅR og HVORDAN indtages EMEND?
English: If you are the parent of a child taking EMEND, please read this information carefully.
Danish: Hvis du har et barn, der tager EMEND, skal du læse denne information grundigt.
English: The color of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink).
Danish: Medicinens farve i dispenseringssprøjten kan have forskellige nuancer af lyserød (let til mørk lyserød).
English: A population pharmacokinetic analysis of aprepitant in paediatric patients (aged 6 months through 17 years) suggests that gender and race have no clinically meaningful effect on the pharmacokinetics of aprepitant.
Danish: En farmakokinetisk populationsanalyse af aprepitant hos pædiatriske patienter (i alderen 6 måneder til og med 17 år) tyder på, at køn og race har ingen klinisk betydningsfuld effekt på aprepitants farmakokinetik.
English: Complete response
Danish: Komplet respons
English: Mix the EMEND suspension gently by swirling 20 times; then gently invert the mixing cup 5 times.
Danish: Bland EMEND-suspensionen forsigtigt ved at slynge det rundt 20 gange; vend derefter forsigtigt blandebægeret rundt 5 gange.
English: p < 0.01 when compared to control regimen p < 0.05 when compared to control regimen No vomiting = No vomiting or retching or dry heaves n/m = Number of patients with desired response/number of patients included in time point.
Danish: p < 0,01 ved sammenligning med kontrolregimet p < 0,05 ved sammenligning med kontrolregimet Ingen opkastning = Ingen opkastning eller opkastningsfornemmelser n/m = Antal patienter med ønsket respons/antal inkluderede patienter på dette tidspunkt.
English: Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Danish: Aprepitant ser ikke ud til at interagere med transportstoffet P-glykoprotein, som den udeblevne interaktion mellem aprepitant og digoxin viser.
English: See enclosed leaflet for additional information about how to take EMEND.
Danish: Se vedlagte information for yderligere oplysninger om, hvordan EMEND indtages.
English: The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Danish: Den anslåede tid indtil første opkastning i den kombinerede analyse er vist ved Kaplan-Meier plot i figur 1.
English: Recommended dose of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years
Danish: Anbefalet dosis af EMEND oral suspension hos pædiatriske patienter i alderen 6 måneder til under 12 år
English: OUTER PACKAGING - STANDARD PACK (CARTON)
Danish: YDRE EMBALLAGE - STANDARDPAKNING (KARTON)
English: This effect may become apparent approximately 7 days following the single dose administration of EMEND 165 mg.
Danish: Denne virkning kan vise sig ca. 7 dage efter administration af en enkelt dosis EMEND 165 mg.
English: Hold the EMEND powder for oral suspension sachet upright and shake the contents to the bottom before opening the sachet.
Danish: Hold folieposen med EMEND-pulveret til oral suspension lodret og ryst indholdet ned i bunden, før folieposen åbnes.
English: For each dose of EMEND, you will get a pre-filled oral dispenser that contains the child's prescribed dose.
Danish: For hver dosis EMEND vil du få en fyldt dispenseringssprøjte til oral anvendelse, som indeholder den dosis, der er ordineret til barnet.
English: Complete response to the aprepitant regimen and standard therapy, respectively, was reached in 209/324 (65 %) and 161/320 (50 %) in women and 83/101 (82 %) and 68/87 (78 %) of men.
Danish: Komplet respons på aprepitantregimet og standardbehandlingen opnåedes hos henholdsvis 209/324 (65%) og 161/320 (50%) blandt kvinderne og hos 83/101 (82%) og 68/87 (78%) blandt mændene.
English: Additionally, no significant nausea in the overall period (0 to 120 hours post-chemotherapy) was evaluated as an exploratory endpoint, and in the acute and delayed phases as a post-hoc analysis.
Danish: Desuden vurderedes "no significant nausea" i hele perioden (0-120 timer efter kemoterapi) som et eksplorativt endepunkt, og i de akutte og forsinkede faser som en post-hoc analyse.
English: For information regarding pregnancy, breast-feeding and contraception, ask your doctor for advice.
Danish: For information vedrørende graviditet, amning eller prævention skal du spørge din læge til råds.
English: Do not give EMEND and tell the doctor or pharmacist if the child is using any of the following medicines (see also under ‘Do not give EMEND').
Danish: Giv ikke EMEND og fortæl det til lægen eller apotekspersonalet, hvis barnet bruger et eller flere af følgende lægemidler (se også under ”Giv ikke EMEND”).
English: This leaflet has been written for the parent or carer who will give this medicine to the child- please read this information carefully.
Danish: Denne indlægsseddel er skrevet til den forælder eller plejer, som skal give medicinen til barnet - læs denne information grundigt.
English: The antiemetic activity of aprepitant was evaluated during the 0 to 48 hour period following the end of surgery.
Danish: Den antiemetiske virkning af aprepitant blev vurderet i løbet af perioden på 0-48 timer efter afsluttet kirurgi.
English: Fosaprepitant placebo, aprepitant placebo, and dexamethasone placebo (in the evenings on Days 3 and 4) were used to maintain blinding (see section 4.2).
Danish: Fosaprepitant placebo, aprepitant placebo og dexamethason placebo (om aftenen på dag 3 og 4) blev anvendt for at opretholde blindingen (se pkt.
English: Following a single intravenously administered 100 mg dose of [
Danish: Efter en enkelt intravenøs administreret 100 mg dosis af [
English: The plasma clearance of aprepitant is dose-dependent, decreasing with increased dose and ranged from approximately 60 to 72 mL/min in the therapeutic dose range.
Danish: Plasmaclearance af aprepitant er dosisafhængig, idet clearance faldt ved øget dosis og varierede fra ca. 60 til 72 ml/min i det terapeutiske dosisområde.
English: Do not take more capsules than the doctor recommends.
Danish: Du må ikke tage flere kapsler end lægen har foreskrevet.
English: - if the child is using medicines that contain ‘pimozide' (for mental health problems).
Danish: - hvis barnet bruger lægemidler, der indeholder “pimozid” (til behandling af psykiske lidelser).
English: The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table.
Danish: Frekvenskategorierne, der er angivet i tabellen, er baseret på studier med voksne; de frekvenser, som blev observeret i studierne med pædiatriske patienter, var sammelignelige eller lavere, medmindre det er angivet i tabellen.
English: Patients receiving the aprepitant regimen were receiving chemotherapy for a variety of tumour types including 52 % with breast cancer, 21 % with gastrointestinal cancers including colorectal cancer, 13 % with lung cancer and 6 % with gynaecological cancers.
Danish: De patienter, der fik aprepitantregimet, fik kemoterapi for forskellige tumortyper, herunder 52% med brystcancer, 21% med gastrointestinal cancer, herunder kolorektal cancer, 13% med lungecancer og 6% med gynækologisk cancer.
English: Fill the mixing cup with room temperature drinking water.
Danish: Fyld blandebægeret med stuetempereret drikkevand.
English: Pink to light pink powder.
Danish: Lyserødt til svagt lyserødt pulver.
English: - Slowly push the plunger all the way down to give all the medicine in the oral dispenser.
Danish: - Tryk langsomt stemplet hele vejen ned, til al medicinen i dispenseringssprøjten er givet.
English: Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Danish: Fosaprepitant, et aprepitant-prodrug som ved intravenøs administration hurtigt konverteres til aprepitant.
English: • For more details on preparation and administration of the suspension, see the package leaflet and the instructions for preparation of the oral suspension for healthcare professionals.
Danish: • For yderligere oplysninger om klargøring og administration af suspensionen se indlægssedlen og instruktionen til læger og sundhedspersonale vedrørende klargøring af den orale suspension.
English: EMEND works by blocking signals to that area and is used to prevent nausea and vomiting after surgery in adults.
Danish: EMEND virker ved at blokere signalerne til det område og anvendes til at forebygge kvalme og opkastning efter operation hos voksne.
English: Method of administration The hard capsule should be swallowed whole.
Danish: Den hårde kapsel bør sluges hel.
English: EMEND works by blocking signals to that area, thereby reducing nausea and vomiting.
Danish: EMEND virker ved at blokere signalerne til dette område, hvorved kvalme og opkastning mindskes.
English: Aprepitant is highly protein bound, with a mean of 97 %.
Danish: Aprepitant er stærkt proteinbundet, med et gennemsnit på 97 %.
English: Statistically significant differences in efficacy were also observed in each of the 2 individual studies.
Danish: Statistisk signifikante forskelle i virkning observeredes i hver af de to individuelle studier.
English: Do not give EMEND powder for oral suspension to children under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years, because the powder for oral suspension has not been studied in this population.
Danish: Giv ikke EMEND pulver til oral suspension til børn under 6 måneder eller som vejer under 6 kg, eller til unge mellem 12 og 18 år, da pulver til oral suspension ikke er undersøgt hos denne gruppe.
English: Clinical treatment guidelines should be considered as regards the need for prophylactic treatment against postoperative nausea and vomiting (PONV).
Danish: Retningslinjer for klinisk behandling, der tager hensyn til behovet for profylaktisk behandling mod postoperativ kvalme og opkastning (PONV), bør overvejes.
English: EMEND or placebo and ondansetron were administered 1 hour and 30 minutes prior to initiation of chemotherapy, respectively.
Danish: Henholdsvis EMEND eller placebo og ondansetron blev administreret 1 time og 30 minutter før initiering af kemoterapi.
English: Delayed phase No vomiting Overall
Danish: Forsinket fase Ingen opkastning Totalt
English: Read all of this leaflet carefully before you start using this medicine because it contains important information.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: The estimated time to first vomiting after initiation of chemotherapy treatment was longer with the aprepitant regimen (estimated median time to first vomiting was 94.5 hours) compared with the control regimen group (estimated median time to first vomiting was 26.0 hours) as depicted in the Kaplan-Meier curves in Figure 2.
Danish: Den anslåede tid til første opkastning efter initiering af kemoterapibehandling var længere med aprepitantregimet (anslået mediantid til første opkastning var 94,5 timer) sammenlignet med kontrolregimet (anslået mediantid til første opkastning var 26,0 timer) som vist i Kaplan-Meierkurverne i figur 2.
English: EMEND 80 mg hard capsules are taken just once a day for 2 consecutive days.
Danish: EMEND 80 mg hårde kapsler skal tages en gang om dagen i 2 fortløbende dage.
English: Aprepitant undergoes extensive metabolism.
Danish: Aprepitant metaboliseres i stort omfang.
English: Aprepitant displays non-linear pharmacokinetics.
Danish: Aprepitant udviser nonlineær farmakokinetik.
English: Fill the oral dispenser with the prescribed dose from the mixing cup according to the table below.
Danish: Fyld dispenseringssprøjten med den ordinerede dosis fra blandebægeret i henhold til tabellen nedenfor.
English: If the child feels dizzy or sleepy, they should not ride a bicycle or use any tools or machines.
Danish: Hvis barnet bliver svimmel eller søvnig, skal de undgå at køre på cykel eller betjene værktøj eller maskiner.
English: Make sure the oral dispenser contains the prescribed dose.
Danish: Sørg for, at dispenseringssprøjten indeholder den ordinerede dosis.
English: Patients were randomised to receive 40 mg aprepitant, 125 mg aprepitant, or 4 mg ondansetron.
Danish: Patienterne blev randomiseret til at få 40 mg aprepitant, 125 mg aprepitant eller 4 mg ondansetron.
English: The mean absolute oral bioavailability of aprepitant is 67 % for the 80 mg capsule and 59 % for the 125 mg capsule.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed for aprepitant er 67 % for 80 mg kapslen og 59 % for 125 mg kapslen.
English: The efficacy of the aprepitant regimen was apparently maintained during all cycles.
Danish: Virkningen af aprepitant behandlingsregimet vedligeholdtes tilsyneladende i alle behandlingerne.
English: C]-fosaprepitant, a prodrug for aprepitant, indicating a substantial presence of metabolites in the plasma.
Danish: C]fosaprepitant, et aprepitant-prodrug, hvilket indikerer en væsentlig tilstedeværelse af metabolitter i plasma.
English: Also, some other medicines can affect the way this medicine works.
Danish: Andre lægemidler kan også påvirke virkningen af dette lægemiddel.
English: Relationship between concentration and effect
Danish: Relationen mellem koncentration og effekt
English: Fosaprepitant 150 mg, a lyophilised prodrug of aprepitant for intravenous administration, is also available as a single dose and may be used as an alternative to oral EMEND 165 mg.
Danish: Fosaprepitant 150 mg, et frysetørret aprepitant-prodrug til intravenøs administration, fås også som enkeltdosis og kan anvendes som alternativ til oral EMEND 165 mg.
English: Infants, toddlers and children (aged 6 months to less than 12 years, and not less than 6 kg) EMEND is given for 3 days as part of a regimen that includes a 5-HT3 antagonist.
Danish: Spædbørn, småbørn og børn (i alderen 6 måneder til under 12 år, og ikke under 6 kg) EMEND gives i 3 dage som en del af et behandlingsregime, som inkluderer en 5-HT3-antagonist.