FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard dose of 5-HT3 antagonists.
Danish: Standarddosering af 5-HT3-antagonister.
English: This tells you how to prepare a dose of EMEND as an oral suspension.
Danish: Denne fortæller, hvordan du skal tilberede en dosis EMEND pulver til oral suspension.
English: The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Danish: Metabolisme af aprepitant finder hovedsagelig sted via oxidation i morfolinringen og i sidekæderne, og de resulterende metabolitter var kun svagt aktive.
English: A summary of the primary and secondary endpoints is shown in Table 4.
Danish: En opsummering af de primære og sekundære endepunkter fremgår af tabel 4.
English: The benefit of aprepitant combination therapy in the full study population was mainly driven by the results observed in patients with poor control with the standard regimen such as in women, even though the results were numerically better regardless of age, tumour type or gender.
Danish: Fordelen ved aprepitant-kombinationsterapi i den totale studiepopulation var hovedsageligt drevet af de resultater, der sås hos patienter, der blev dårligt kontrolleret med standardregimet, som for eksempel hos kvinder, selvom resultaterne numerisk var bedre, når man så bort fra alder, tumortype eller køn.
English: Aprepitant was given orally with 50 mL of water 1 to 3 hours before anaesthesia.
Danish: Aprepitant blev givet oralt med 50 ml vand 1-3 timer før anæstesi.
English: Caution is advised and additional monitoring may be appropriate in patients receiving medicinal products metabolized primarily or partly by CYP3A4 (see section 4.4).
Danish: Forsigtighed tilrådes og yderligere monitorering kan være nødvendig hos patienter, som får lægemidler, der primært eller delvist metaboliseres af CYP3A4 (se pkt.
English: Dizziness and fatigue may occur following administration of EMEND (see section 4.8).
Danish: Svimmelhed og træthed kan forekomme efter administration af EMEND (se pkt.
English: Take the EMEND capsule on the first day of your chemotherapy cycle, together with other medicines, to prevent nausea and vomiting.
Danish: Tag EMEND kapslen den første dag i kemoterapiperioden sammen med anden medicin for at forebygge kvalme og opkastning.
English: Concomitant intake of a 40 mg dose with a standard breakfast decreased the aprepitant Cmax by 18 % but did not affect AUC.
Danish: Indtagelse af en dosis på 40 mg sammen med et standard morgenmåltid resulterede i et fald i aprepitants Cmax på 18 %, men påvirkede ikke AUC.
English: Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Danish: På grund af aprepitants antiemetiske virkning vil lægemiddelinduceret opkastning sandsynligvis ikke være effektiv.
English: This is because their treatment will need to be changed before starting this medicine.
Danish: Dette skyldes, at behandlingen skal justeres, før barnet begynder at tage dette lægemiddel.
English: Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
Danish: Din læge har ordineret EMEND, et antiemetikum, for at afhjælpe kvalme og opkastning i forbindelse med kemoterapi.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Smid ikke medicin ud med spildevand eller husholdningsaffald.
English: Dexamethasone should also be administered in the evenings on Days 3 and 4.
Danish: Dexamethason skal også indgives om aftenen på dag 3 og 4.
English: Side effects for which the frequency is not known: - Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction).
Danish: Bivirkninger, hvor hyppigheden ikke er kendt: - Stevens-Johnsons syndrom/toksisk epidermal nekrolyse (sjælden, alvorlig hudreaktion).
English: The efficacy of the 125 mg powder for oral suspension has not been established in children 12 years of age and older.
Danish: Virkningen af 125 mg pulver til oral suspension er ikke klarlagt hos børn i alderen 12 år og derover.
English: Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressant is not recommended during the 3 days of co-administration with EMEND.
Danish: På grund af 3-dages regimets korte varighed og de tidsbestemte begrænsede ændringer i eksponeringen frarådes dosisreduktion af immunsuppressiva i de 3 dage, hvor EMEND også administreres.
English: The safety and efficacy of EMEND powder for oral suspension in infants below 6 months of age or weighing less than 6 kg has not been established.
Danish: Sikkerheden og virkningen af EMEND pulver til oral suspension hos spædbørn under 6 måneder eller som vejer under 6 kg er ikke klarlagt.
English: The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Danish: Farmakokinetikken for aprepitant er nonlineær i det kliniske dosisområde.
English: If a corticosteroid, such as dexamethasone, is co-administered with EMEND, the dose of the corticosteroid should be administered at 50 % of the usual dose (see sections 4.5 and 5.1).
Danish: Hvis et kortikosteroid, såsom dexamethason, administreres sammen med EMEND, skal kortikosteroiddosis administreres ved 50 % af den sædvanlige dosis (se pkt.
English: For additional information on the co-administration with corticosteroids, see section 4.5.
Danish: For yderligere oplysninger om administration sammen med kortikosteroider se pkt.
English: Adolescents (aged 12 through 17 years)
Danish: Unge (i alderen 12-17 år)
English: PET/aluminium/LLDPE sachets
Danish: PET/aluminium/LLDPE-folieposer.
English: EMEND powder for oral suspension is given as part of combination therapy (see section 4.2).
Danish: EMEND pulver til oral suspension gives som en del af en kombinationsbehandling (se pkt.
English: If you have taken too many capsules, contact your doctor immediately.
Danish: Hvis du har taget for mange kapsler, skal du straks kontakte lægen.
English: Fosaprepitant regimen (N =1,106) **
Danish: Fosaprepitantregime (N= 1.106)**
English: The half-life of aprepitant is 25 % lower in females as compared with males and its tmax occurs at approximately the same time.
Danish: Halveringstiden for aprepitant er 25 % lavere hos kvinder sammenlignet med mænd, og tmax ses cirka samtidig.
English: To prevent foaming, do not shake the mixing cup.
Danish: For at forhindre skumdannelse må blandebægeret ikke rystes.
English: Figure 2 Time to first vomiting episode from start of chemotherapy administration - paediatric patients in the overall phase-Cycle 1 (Intent to treat population)
Danish: Figur 2 Tid til første opkastningsepisode fra start af administration af kemoterapi - pædiatriske patienter i den totale fase - cyklus 1 (Intent to treat-population)
English: The content of each single-use sachet is to be suspended in 4.6 mL of water giving a final concentration of 25 mg per mL.
Danish: Indholdet af hver foliepose til engangsbrug skal opløses i 4,6 ml vand, hvilket giver en slutkoncentration på 25 mg pr. ml.
English: The doctor may have to check the condition of the child's liver during treatment.
Danish: Det kan derfor være nødvendigt for lægen at kontrollere barnets leverfunktion under behandlingen.
English: EMEND capsules contain sucrose.
Danish: EMEND kapsler indeholder saccharose.
English: Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon
Danish: Blod og lymfesystem Febril neutropeni, anæmi
English: Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.
Danish: Fortæl det til din læge, hvis du tager disse lægemidler, idet din behandling skal justeres, før du begynder at tage EMEND.
English: The daily dose of dexamethasone on Days 1 and 2 should be reduced by approximately 50 % when co-administered with EMEND 165 mg on Day 1 to achieve exposures of dexamethasone similar to those obtained when given without EMEND 165 mg.
Danish: Den daglige dosis dexamethason på dag 1 og 2 bør reduceres med ca. 50%, når det administreres sammen med EMEND 165 mg på dag 1 for at opnå den samme eksponering af dexamethason, som når det gives uden EMEND 165 mg.
English: WHEN: Take one EMEND 80 mg capsule each morning on the next two days.
Danish: HVORNÅR: Tag en EMEND 80 mg kapsel hver morgen de to efterfølgende dage.
English: Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Danish: Data vedrørende virkningsgraden for kombination med andre kortikosteroider og 5-HT3-antagonister er begrænsede.
English: EMEND 165 mg is given on Day 1 only, approximately one hour before the start of chemotherapy, as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.
Danish: EMEND 165 mg gives kun på dag 1, ca. en time før start af kemoterapi som del af et behandlingsregime, som også omfatter et kortikosteroid og en 5-HT3 antagonist.
English: Percentage point difference (%) and 95 % C.I.
Danish: Forskel i procentpoint (%) og 95 % CI
English: For aprepitant no clinical data on exposed pregnancies are available.
Danish: Der er for aprepitant ingen kliniske data vedrørende eksponerede graviditeter.
English: EMEND increased the AUC of midazolam 25 % on Day 4 and decreased the AUC of midazolam 19 % on Day 8 and 4 % on Day 15.
Danish: EMEND øgede AUC for midazolam med 25 % på dag 4 og nedsatte AUC for midazolam med 19 % på dag 8 og 4 % på dag 15.
English: - if the child is using ‘terfenadine' or ‘astemizole' (for hay fever and other allergies).
Danish: - hvis barnet bruger “terfenadin” eller “astemizol” (til behandling af høfeber og andre allergitilstande).
English: It should be taken into account that some people feel dizzy and sleepy after taking EMEND.
Danish: Bemærk, at nogle mennesker bliver svimle eller søvnige efter at have taget EMEND.
English: When dispensing dose(s) to the caregiver, instruct them to refrigerate the oral dispenser(s) until they are ready to administer the dose.
Danish: Når dosis (doser) gives til plejere, skal de instrueres i at opbevare dispenseringssprøjten i køleskabet, indtil de er klar til at indgive dosis.
English: For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Danish: For yderligere information om potentiel interaktion for aprepitant ved højere og multiple doser se Produktresuméet for EMEND 80 mg hårde kapsler og EMEND 125 mg hårde kapsler.
English: As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 2 consecutive days as prescribed by your doctor.
Danish: Da kvalme og opkastning kan forekomme i dagene efter kemoterapi er det vigtigt, at du tager EMEND i 2 fortløbende dage, som foreskrevet af lægen.
English: Aprepitant is also an inducer of CYP2C9.
Danish: Aprepitant er også en inducer af CYP2C9.
English: It is anticipated that EMEND 165 mg would cause similar induction of CYP2C9, CYP3A4, and glucuronidation than that caused by the administration of the 3-day oral aprepitant regimen, for which a transient induction with its maximum effect 6 to 8 days after first aprepitant dose has been observed.
Danish: Det forventes, at EMEND 165 mg vil medføre lignende induktion af CYP2C9, CYP3A4 og glukuronidering i forhold til den, som administration af et 3-dages oral aprepitant-regime medførte, og for hvilket der er set en forbigående induktion med maksimal virkning 6-8 dage efter den første dosis aprepitant.
English: In 2 multicentre, randomised, double-blind, active comparator-controlled, parallel-group phase III clinical studies in adults, aprepitant was compared with ondansetron for the prevention of PONV in 1,658 patients undergoing open abdominal surgery.
Danish: I 2 multicenter, randomiserede, dobbeltblindede, aktive komparator-kontrollerede fase-III kliniske undersøgelser med parallelle grupper hos voksne blev aprepitant sammenlignet med ondansetron til forebyggelse af PONV hos 1.658 patienter, der fik foretaget åben abdominal kirurgi.
English: As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 3 consecutive days as prescribed by your doctor.
Danish: Da kvalme og opkastning kan forekomme i dagene efter kemoterapi er det vigtigt, at du tager EMEND i 3 fortløbende dage, som foreskrevet af lægen.
English: The effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller.
Danish: Virkningen af aprepitant på plasmakoncentrationen af intravenøst administrerede CYP3A4-substrater forventes at være mindre.
English: Fosaprepitant 150 mg was shown to be non-inferior to that of the 3-day regimen of aprepitant.
Danish: Fosaprepitant 150 mg var non-inferiør i forhold til 3-dages behandlingsregimet med aprepitant.
English: The dose of dexamethasone accounts for active substance interactions.
Danish: Dexamethasondosis tager højde for interaktioner med den aktive substans.
English: Take one EMEND 80 mg capsule each morning.
Danish: Tag en EMEND 80 mg kapsel hver morgen.
English: Methylprednisolone: Although the concomitant administration of methylprednisolone with the single 40 mg dose of aprepitant has not been studied, a single 40 mg dose of aprepitant produces a weak inhibition of CYP3A4 and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree.
Danish: Methylprednisolon: Selvom samtidig administration af methylprednisolon med en enkelt 40 mg dosis aprepitant ikke er undersøgt, forårsager en enkelt 40 mg dosis aprepitant en svag hæmning af CYP3A4, og det forventes ikke at ændre methylprednisolons plasmakoncentration i klinisk signifikant grad.
English: The antiemetic activity of EMEND was evaluated over a 5-day (120 hour) period following the initiation of chemotherapy on Day 1.
Danish: EMENDs antiemetiske aktivitet blev vurderet over en 5-dags (120 timer) periode efter initiering af kemoterapi på dag 1.
English: The Cmax was 10 % higher on Day 1 and 24 % higher on Day 5 in elderly relative to younger adults.
Danish: Cmax var 10% højere på dag 1 og 24% højere på dag 5 hos ældre i forhold til yngre voksne.
English: Aprepitant regimen (N =1,134) **
Danish: Aprepitantregime (N= 1.134)**
English: Choose the oral dispenser based on the dose.
Danish: Vælg den orale dispenseringssprøjte på baggrund af dosis.
English: The primary endpoint was complete response in the delayed phase (25 to 120 hours following initiation of chemotherapy) in Cycle 1.
Danish: Det primære endepunkt var komplet respons i den forsinkede fase (25 til 120 timer efter initiering af kemoterapi) i cyklus 1.
English: No clinically important effect resulted on Day 4 (midazolam AUC0-∞ 1.2-fold increase) and a slight change in midazolam AUC0-∞ was observed on Day 8 (35 % decrease).
Danish: Der fremkom ingen klinisk betydningsfuld virkning på dag 4 (midazolams AUC0-∞ steg 1,2 gange), og en mindre ændring i midazolams AUC0-∞ sås på dag 8 (fald på 35%).
English: - This medicine has been prescribed for you or the child only.
Danish: - Lægen har ordineret dette lægemiddel til dig eller barnet personligt.
English: The 3-day oral aprepitant regimen resulted in an about 30-35 % reduction in AUC of CYP2C9 substrates and up to a 64 % decrease in ethinyl estradiol trough concentrations.
Danish: Det 3-dages oral aprepitant-regime medførte en reduktion på omkring 30-35% af CYP2C9substraternes AUC og et fald på op til 64% i ethinylestradiols dalkoncentration.
English: After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant.
Danish: Efter rekonstitution indeholder 1 ml oral suspension 25 mg aprepitant.
English: - if the child is using ‘cisapride' - (for problems with digestion).
Danish: - hvis barnet bruger “cisaprid” - (til behandling af problemer med fordøjelsen).
English: 3 mg/kg orally Maximum dose 125 mg
Danish: 3 mg/kg oralt Maksimal dosis 125 mg
English: Always give this medicine together with other medicines, to prevent nausea and vomiting.
Danish: Giv altid dette lægemiddel sammen med anden medicin for at forebygge kvalme og opkastning.
English: In healthy young adults, the increase in AUC0- was 26 % greater than dose proportional between 80 mg and 125 mg single doses administered in the fed state.
Danish: For raske unge voksne var øgningen i AUC0- 26 % højere end dosisproportionaliteten mellem 80 mg og 125 mg enkeltdoser administreret på fuld mave.
English: • Once mixed, measure the recommended volume (dose) of suspension with the oral dispenser.
Danish: • Afmål den anbefalede volumen (dosis) af suspensionen med dispenseringssprøjten, når alt er blandet.
English: The oral suspension may be taken with or without food.
Danish: Den orale suspension kan tages med eller uden mad.
English: In controlled clinical studies in adults receiving general anaesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron intravenously.
Danish: I kontrollerede kliniske undersøgelser af voksne, der fik generel anæstesi, fik 564 patienter 40 mg aprepitant oralt og 538 patienter fik 4 mg ondansetron i.v.
English: Therefore, no dose adjustment is recommended.
Danish: Man bør derfor ikke justere dosis.
English: Healthcare professionals: See the instructions for preparation of the oral suspension for healthcare professionals at the end of this package leaflet.
Danish: Læger og sundhedspersonale: Se instruktionen til læger og sundhedspersonale vedrørende klargøring af den orale suspension sidst i denne indlægsseddel.
English: There were no margins to clinically relevant exposure.
Danish: Der var ingen margin for klinisk relevant eksponering.
English: Oral administration of the capsule with an approximately 800 Kcal standard breakfast resulted in an up to 40 % increase in AUC of aprepitant.
Danish: Oral administration af kapslerne sammen med et normalt morgenmåltid på ca. 800 kilokalorier resulterede i en øgning på op til 40 % i AUC for aprepitant.
English: The effects of EMEND or other medicines might be influenced if you or the child take EMEND together with other medicines including those listed below.
Danish: Virkningen af EMEND eller anden medicin kan påvirkes, hvis du eller barnet tager EMEND sammen med anden medicin, herunder de lægemidler, der er nævnt nedenfor.
English: For adolescents aged 12-17 years, EMEND is available as capsules containing 80 mg, or 125 mg of aprepitant.
Danish: Til unge i alderen 12-17 år fås EMEND som kapsler indeholdende 80 mg eller 125 mg aprepitant.
English: INDIVIDUAL MEASURES
Danish: INDIVIDUELLE MÅL
English: Table 1 Percent of post-operative adults responding by treatment group Combined results from 2 Phase III trials
Danish: Tabel 1 Procent post-operative voksne, som responderer pr. behandlingsgruppe Kombinerede resultater fra to fase-III-undersøgelser
English: Table 4 Number (%) of paediatric patients with complete response and no vomiting by treatment group and phase - Cycle 1 (Intent to treat population)
Danish: Tabel 4 Antal (%) pædiatriske patienter med komplet respons og ingen opkastning ud fra behandlingsgruppe og fase - cyklus 1 (Intent to treat-population)
English: Given the short duration of increased exposure, dose reduction of the immunosuppressant based on Therapeutic Dose Monitoring is not recommended on the day of and the day after administration of EMEND 165 mg.
Danish: På grund af den korte varighed af den forhøjede eksponering og på basis af TDM (Therapeutic Dose Monitoring) anbefales dosisreduktion af det immunsuppressive lægemiddel ikke på den dag, hvor EMEND 165 mg administreres samt dagen efter.
English: 5-HT3 antagonists
Danish: 5-HT3 antagonister
English: The mixture will be cloudy pink to light pink.
Danish: Blandingen bliver mudret lyserød til svagt lyserød.
English: The doctor may therefore have to monitor the condition of your or the child's liver.
Danish: Det kan derfor være nødvendigt for lægen at kontrollere din eller barnets leverfunktion.
English: In a juvenile toxicity study in dogs treated from post natal day 14 to day 42, a decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and oedema of vaginal tissues were seen in females from 4 mg/kg/day.
Danish: I et toksicitetsstudie med unge hunde, som blev behandlet fra dag 14 til dag 42 postnatalt, blev der set reduceret testikelvægt og størrelse af Leydig-celler hos hanner ved 6 mg/kg/dag, og øget uterusvægt, hypertrofi af livmoderen og livmoderhalsen og ødemer i det vaginale væv blev set hos hunner fra 4 mg/kg/dag.
English: 2 mg/kg orally Maximum dose 80 mg
Danish: 2 mg/kg oralt Maksimal dosis 80 mg
English: It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
Danish: Det er ukendt, om aprepitant udskilles i human mælk; derfor bør man ikke amme under behandling med EMEND.
English: Stop giving this medicine and see a doctor straight away if you notice any of the serious side effects above.
Danish: Stop med at give dette lægemiddel og kontakt straks lægen, hvis du bemærker et eller flere af ovenstående alvorlige bivirkninger.
English: This combination (i.e. EMEND, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16 % on Day 6, 9 % on Day 8, 7 % on Day 15 and 17 % on Day 22.
Danish: Denne kombination (dvs. EMEND, ondansetron og dexamethason) sænkede AUC for oral midazolam 16 % på dag 6, 9 % på dag 8, 7 % på dag 15 og 17 % på dag 22.
English: A PET study in healthy young men administered a single oral dose of 165 mg aprepitant or a single intravenous dose of 150 mg fosaprepitant demonstrated similar brain NK1 receptor occupancy at Tmax, (≥ 99 %), 24 hours (≥ 99 %), 48 hours (≥ 97 %), and 120 hours (37 to 76 %) following dosing.
Danish: Et PET-studie hos raske unge mænd, som fik en enkelt oral dosis 165 mg aprepitant eller en enkelt dosis 150 mg fosaprepitant i.v., viste lignende forhold vedrørende hjernens NK1-receptorer ved tmax (≥99%), 24 timer (≥99%), 48 timer (≥97%) og 120 timer (37 til 76%) efter dosering.
English: Based on interaction studies with tolbutamide and oral contraceptives, total exposure of concomitantly administered active substances metabolised by CYP2C9 or CYP3A4 may be reduced up to 15-30 %.
Danish: Baseret på interaktionsundersøgelser med tolbutamid og kontraceptiva kan den samlede eksponering af samtidigt administrerede aktive substanser, der metaboliseres via CYP2C9 eller CYP3A4, reduceres op til 15
English: Efficacy was based on the evaluation of the following primary and key secondary endpoints: No vomiting in the overall period (0 to 120 hours post-chemotherapy), evaluation of safety and tolerability of the aprepitant regimen for chemotherapy induced nausea and vomiting (CINV), and complete response (defined as no vomiting and no use of rescue therapy) in the overall period (0 to 120 hours post-chemotherapy).
Danish: Virkningen var baseret på vurderingen af følgende primære og vigtige sekundære endepunkter: Ingen opkastning i hele perioden (0-120 timer efter kemoterapi), vurdering af sikkerhed og tolerabilitet af aprepitantregimet mht. kvalme og opkastning i forbindelse med kemoterapi (CINV) samt komplet respons (defineret som ingen opkastning og ingen anvendelse af erstatningsterapi) i hele perioden (0120 timer efter kemoterapi).
English: Adverse reactions were reported in approximately 4 % of adults treated with 40 mg aprepitant compared with approximately 6 % of patients treated with 4 mg ondansetron intravenously.
Danish: Der er rapporteret om bivirkninger hos ca. 4% af voksne i behandling med 40 mg aprepitant sammenlignet med ca. 6% af patienterne i behandling med 4 mg ondansetron i.v.
English: It can also be stored refrigerated (between 2°C and 8°C) for up to 72 hours.
Danish: Den kan også opbevares i køleskab (mellem 2 °C og 8 °C) i op til 72 timer.
English: Capsule shell (80 mg) Gelatin
Danish: Kapselskal (80 mg) Gelatine
English: EMEND is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3.
Danish: EMEND administreres oralt 1 time før kemoterapi på dag 1, 2 og 3.