FrancophonIA/ELRC3.0 huggingface dataset:
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes straks.
English: The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Danish: De første 2 tal angiver måneden; de næste 4 tal angiver årstallet.
English: NR = Not Reported
Danish: NR = Ikke indberettet
English: Elderly (≥65 years)
Danish: Ældre (≥65 år)
English: Difference (95 % CI)
Danish: % (95 % CI)
English: Complete response Overall
Danish: Komplet respons Totalt
English: Relationship between concentration and effect
Danish: Forholdet mellem koncentration og effekt
English: Acute phase§§
Danish: Akut fase§§
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2-8 °C).
English: Complete response† Delayed phase‡ Complete response† Overall§
Danish: Komplet respons† Forsinket fase‡ Komplet respons† Totalt§
English: A summary of the primary and secondary endpoints is shown in Table 7.
Danish: En opsummering af de primære og sekundære endepunkter fremgår af Tabel 7.
English: Other side effects that have been reported are listed below.
Danish: Andre bivirkninger, som er rapporteret, er anført nedenfor.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold før anvendelse, brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2-8 °C.
English: CYP3A4 interactions
Danish: CYP3A4-interaktioner
English: Do not give IVEMEND to children under 6 months of age or who weigh less than 6 kg, because it has not been studied in this population.
Danish: Giv ikke IVEMEND til børn under 6 måneder eller som vejer under 6 kg, da det ikke er undersøgt i denne population.
English: Safety data following the administration of the 3-day IV/oral/oral regimen were also included.
Danish: Sikkerhedsdata efter administrationen af det 3-dages intravenøse/orale/orale regime blev også inkluderet.
English: The potential effects on reproduction of alterations in neurokinin regulation are unknown.
Danish: De mulige indvirkninger af forandringer i neurokininregulering på reproduktion er ikke kendt.
English: Twelve metabolites of aprepitant have been identified in human plasma.
Danish: Der er identificeret tolv aprepitantmetabolitter i human plasma.
English: See the package leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: Although a 32 mg intravenous dose of ondansetron was used in clinical trials, this is no longer the recommended dose.
Danish: Selvom en intravenøs ondansetrondosis på 32 mg blev anvendt i kliniske studier, er dette ikke længere den anbefalede dosis.
English: Pack sizes: 1 or 10 vials.
Danish: Pakningsstørrelser: 1 eller 10 hætteglas.
English: This effect was not considered clinically important.
Danish: Denne virkning ansås ikke for at være klinisk betydningsfuld.
English: *Reported in patients taking a higher dose of aprepitant.
Danish: *Rapporteret hos patienter, der har fået højere aprepitantdosis.
English: Your doctor may therefore have to monitor the condition of your liver.
Danish: Det kan derfor være nødvendigt for lægen at kontrollere din leverfunktion.
English: The estimated time to first emesis is depicted by the Kaplan-Meier plot in Figure 1.
Danish: Den anslåede tid indtil første episode med emesis fremgår af Kaplan-Meier plottet i figur 1.
English: This medicine should not be used during pregnancy unless clearly necessary.
Danish: Dette lægemiddel må ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: IVEMEND works by blocking signals to that area, thereby reducing nausea and vomiting.
Danish: IVEMEND virker ved at blokere signalerne til dette område, hvorved kvalme og opkastning mindskes.
English: In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided.
Danish: I tilfælde af overdosering bør fosaprepitant seponeres og generel understøttende behandling og monitorering iværksættes.
English: Swirl the vial gently.
Danish: Vend hætteglasset forsigtigt rundt.
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.
Danish: Aprepitants sikkerhedsprofil er vurderet hos ca. 6.500 voksne og 184 børn og unge.
English: If you are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.
Danish: Disse overfølsomhedsreaktioner har generelt reageret på afbrydelse af infusionen og administration af hensigtsmæssig behandling.
English: Adults The entire volume of the prepared infusion bag (150 ml) should be administered.
Danish: Voksne Hele indholdet af den tilberedte infusionspose (150 ml) skal administreres.
English: The following information is intended for medical or healthcare professionals only:
Danish: Nedentående oplysninger er til læger og sundhedspersonale:
English: Efficacy was based on evaluation of the following composite measures: complete response in both the overall and delayed phases and no vomiting in the overall phase.
Danish: Effekten var baseret på vurdering af følgende sammensatte målinger: Komplet respons både totalt og i de forsinkede faser og ingen opkastning i hele perioden.
English: Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Danish: Endvidere bør der udvises særlig forsigtighed ved samtidig behandling med irinotecan, idet denne kombination kan medføre øget toksicitet.
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: If necessary, for volumes less than 150 ml, the calculated volume can be transferred to an appropriate size bag or syringe prior to administration by infusion.
Danish: Om nødvendigt ved et volumen på under 150 ml kan det beregnede volumen overføres til en pose eller sprøjte af en passende størrelse før administration via infusion.
English: The brain has a specific area that controls nausea and vomiting.
Danish: I hjernen er der et særligt område, som kontrollerer kvalme og opkastning.
English: It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists".
Danish: Det tilhører en gruppe af lægemidler, der kaldes "neurokinin 1 (NK1) receptorantagonister".
English: Aprepitant is highly protein bound, with a mean of 97 %.
Danish: Aprepitant er stærkt proteinbundet, i gennemsnit 97%.
English: Administration and infusion site reactions
Danish: Reaktioner på administrations- og infusionsstedet
English: The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below.
Danish: Virkningen af IVEMEND eller anden medicin kan påvirkes, hvis du tager IVEMEND sammen med anden medicin, herunder de lægemidler, der er nævnt nedenfor.
English: Before treatment with this medicine, tell your doctor if you have liver disease because the liver is important in breaking down the medicine in the body.
Danish: Før behandling med dette lægemiddel skal du fortælle lægen, hvis du har en leversygdom, da leveren er vigtig ved nedbrydning af medicinen i kroppen.
English: **N: Number of adult patients included in the primary analysis of complete response.
Danish: *Primært endepunkt står med fed. **N: Antal voksne patienter inkluderet i den primære analyse af det totale respons.
English: Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple tissues.
Danish: Det ser således ud til, at omdannelsen af fosaprepitant til aprepitant kan foregå i flere væv.
English: IVEMEND may have minor influence on the ability to drive and use machines.
Danish: IVEMEND kan have en mindre indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: It should be taken into account that some people get dizzy and get sleepy after using IVEMEND.
Danish: Bemærk, at nogle mennesker bliver svimle eller søvnige efter at have fået IVEMEND.
English: The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out.
Danish: Fosaprepitants bidrag til den overordnede antiemetiske effekt er ikke tilstrækkeligt belyst, men et forbigående bidrag i den initiale fase kan ikke udelukkes.
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 emesis induceret af et lægemiddel sandsynligvis ikke være effektiv.
English: Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine.
Danish: Vævsdød (nekrose) er forekommet hos nogle personer, der får denne type kemoterapibehandling.
English: White to off-white amorphous powder.
Danish: Hvidt til off-white pulver i amorf form.
English: C]- fosaprepitant to healthy subjects, 57 % of the radioactivity was recovered in urine and 45 % in faeces.
Danish: C]-fosaprepitant til raske forsøgspersoner blev 57% af radioaktiviteten genfundet i urinen og 45% i fæces.
English: Occupancy of brain NK1 receptors, in this study, correlate well with aprepitant plasma concentrations.
Danish: Okkuperingen af hjernens NK1-receptorer i dette studie korrelerer med aprepitants plasmakoncentration.
English: Following a single intravenously administered 100 mg dose of [
Danish: Efter en enkelt intravenøst administreret 100 mg dosis af [
English: ENDPOINTS*
Danish: ENDEPUNKTER*
English: If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.
Danish: Udvikles tegn eller symptomer på lokal irritation, skal injektionen eller infusionen afbrydes og startes på ny i en anden vene.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke IVEMEND efter den udløbsdato, der står på pakningen og hætteglasset efter EXP.
English: Hormonal contraceptives
Danish: Hormonelle kontraceptiva
English: Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Danish: Aprepitant er en selektiv højaffinitets-antagonist på humane substans-P neurokinin-1 (NK1)-receptorer.
English: The efficacy of fosaprepitant was evaluated based on the primary and secondary endpoints listed in Table 8 and was shown to be superior to the control regimen with regard to complete response in the delayed and overall phases.
Danish: Fosaprepitants virkning blev vurderet på baggrund af de primære og sekundære endepunkter anført i tabel 8 og viste sig at være bedre (superior) i forhold til kontrolregimet med hensyn til komplet respons i de forsinkede og totale faser.
English: In children and adolescents (6 months to 17 years of age), the recommended dose of IVEMEND is based on the patient's age and weight.
Danish: Hos børn og unge (i alderen 6 måneder til 17 år) er den anbefalede dosis af IVEMEND baseret på patientens alder og vægt.
English: There were no margins to clinically relevant exposure of aprepitant.
Danish: Der var ingen margin for klinisk relevant eksponering for aprepitant.
English: IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
Danish: IVEMEND bør gives sammen med et kortikosteroid og en 5HT3-antagonist som specificeret i tabellerne nedenfor.
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: Aprepitants metabolisme sker hovedsageligt ved oxidation i morfolinringen og i sidekæderne, og de resulterende metabolitter var kun svagt aktive.
English: 1-Day Regimen of Fosaprepitant in Adults
Danish: 1-dages regime med fosaprepitant hos voksne
English: *Nausea and vomiting were efficacy parameters in the first 5-days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Danish: *Kvalme og opkastning var effektparametre i de første 5 dage efter kemoterapibehandling og blev først derefter betragtet som bivirkninger.
English: Aprepitant undergoes extensive metabolism.
Danish: Aprepitant metaboliseres ekstensivt.
English: The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Danish: Lægemidlet må ikke rekonstitueres eller blandes med opløsninger, for hvilke der ikke er fastslået fysisk og kemisk kompatibilitet (se pkt.
English: For information regarding birth control, see ‘Other medicines and IVEMEND'.
Danish: For information angående prævention, se "Brug af anden medicin sammen med IVEMEND".
English: Intravenous administration in adults occurs preferably through a running intravenous infusion over 20-30 minutes.
Danish: Intravenøs administration hos voksne skal helst foregå ved løbende intravenøs infusion over 2030 minutter.
English: If you get dizzy or get sleepy, avoid driving or using machines after using this medicine (see ‘Possible side effects').
Danish: Hvis du bliver svimmel eller søvnig, skal du undgå at køre bil eller betjene maskiner, efter du har fået dette lægemiddel (se punkt 4 Bivirkninger).
English: fosaprepitant dose were also observed following an oral dose of [
Danish: fosaprepitant, sås også efter en oral dosis af [
English: Moderately Emetogenic Chemotherapy (MEC)
Danish: Moderat emetogen kemoterapi (MEC)
English: There were no treatment-related effects on mating, fertility or embryonic/foetal survival, and no pathological changes in the reproductive organs.
Danish: Der var ingen behandlingsrelateret indvirkning på parring, fertilitet eller embryonal- og fosteroverlevelse og ingen patologiske ændringer i de reproduktive organer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF MARKEDSFØRINGSTILLADELSEN
English: The safety and efficacy of IVEMEND in infants below 6 months of age have not been established.
Danish: IVEMENDs sikkerhed og virkning hos spædbørn under 6 måneder er ikke klarlagt.
English: Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2 % of the dose was recovered in the dialysate.
Danish: Hæmodialyse udført 4 eller 48 timer efter dosering havde ingen signifikant virkning på farmakokinetikken for aprepitant; mindre end 0,2% af dosis blev genfundet i dialysatet.
English: IVEMEND should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see section 4.2).
Danish: IVEMEND må ikke gives som bolusinjektion, men skal altid fortyndes og gives som langsom intravenøs infusion (se pkt.
English: Aprepitant after fosaprepitant administration
Danish: Aprepitant efter administration af fosaprepitant
English: Therefore, the recommendations for use of IVEMEND with other medicinal products in paediatric patients are based upon adult data from fosaprepitant and aprepitant studies.
Danish: Derfor er anbefalingerne for brug af IVEMEND sammen med andre lægemidler hos pædiatriske patienter baseret på data fra voksne i studier med fosaprepitant og aprepitant.
English: EMEND capsules or EMEND for oral suspension may be used on Days 2 and 3 instead of IVEMEND, as shown in
Danish: EMEND kapsler eller EMEND pulver til oral suspension kan anvendes på dag 2 og 3 i stedet for IVEMEND, som vist i tabel 3.
English: 80 mg intravenously OR 80 mg orally (EMEND capsules)
Danish: 80 mg intravenøst ELLER 80 mg oralt (EMEND kapsler)
English: Disodium edetate (E386)
Danish: Dinatriumedetat (E386)
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Danish: Der mangler data vedrørende effekten på CYP2C8 og CYP2C19.
English: Fosaprepitant does not seem to interact with the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin.
Danish: Fosaprepitant ser ikke ud til at interagere med transportstoffet P-glykoprotein, som den udeblevne interaktion mellem oral aprepitant og digoxin viser.
English: 12 mg orally
Danish: 12 mg oralt
English: Do not administer IVEMEND as a bolus injection or undiluted solution.
Danish: Giv ikke IVEMEND som bolusinjektion eller som ufortyndet opløsning.
English: IVEMEND contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige "natriumfri".
English: Please talk to your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl altid lægen eller på apoteket, hvis du tager et eller flere af følgende lægemidler:
English: Preparation of IVEMEND 150 mg for intravenous administration:
Danish: Tilberedning af IVEMEND 150 mg til intravenøs administration:
English: IVEMEND should not be used during pregnancy unless clearly necessary.
Danish: IVEMEND bør ikke anvendes under graviditet, med mindre det er absolut nødvendigt.
English: • Volume to administer (ml) equals the recommended dose (mg)
Danish: • Volumen, der skal administreres (ml) er lig med den anbefalede dosis (mg)
English: Rifampicin decreased the mean terminal half-life of oral aprepitant by 68 %.
Danish: Rifampicin nedsatte oral aprepitants gennemsnitlige terminale halveringstid med 68%.
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 IVEMEND.
Danish: På grund af den korte varighed af den øgede eksponering frarådes dosisreduktion af immunsuppressiva på basis af terapeutisk dosismonitorering på den dag, hvor IVEMEND administreres samt dagen efter.
English: Your doctor may ask you to take other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Danish: Lægen kan bede dig om at tage anden medicin, herunder et kortikosteroid (fx dexamethason) og en "5HT3-antagonist" (fx ondansetron) til at forebygge kvalme og opkastning.
English: Tell your doctor if you are taking these medicines since the treatment must be modified before you start using IVEMEND.
Danish: Fortæl det til din læge, hvis du anvender disse lægemidler, da behandlingen i så fald skal justeres, før du begynder behandling med IVEMEND.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvenserne defineres som: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is not known whether aprepitant is excreted in human milk.
Danish: Det vides ikke, om aprepitant udskilles i human modermælk.
English: IVEMEND contains the active substance fosaprepitant which is converted to aprepitant in your body.
Danish: IVEMEND indeholder det aktive stof fosaprepitant, der omdannes til aprepitant i kroppen.
English: An alternative dose regimen that may be used with single-day chemotherapy regimens is shown in Table 4.
Danish: Et alternativt dosisregime, som kan anvendes med et 1-dages kemoterapiregime, er vist i tabel 4.
English: C]- fosaprepitant, a prodrug for aprepitant, indicating a substantial presence of metabolites in the plasma.
Danish: C]fosaprepitant, et prodrug til aprepitant, hvilket indikerer en betydende tilstedeværelse af metabolitter.
English: However, it should be noted that the value of the toxicity studies carried out with rodents, rabbits and monkeys, including the reproduction toxicity studies, are limited since systemic exposures to fosaprepitant and aprepitant were only similar or even lower than therapeutic exposure in adult humans.
Danish: Det skal imidlertid anføres, at værdien af de toksicitetsstudier, der blev udført med gnavere, kaniner og aber, inklusive reproduktions-toksicitetsstudierne, er begrænset, da systemisk eksponering for fosaprepitant og aprepitant kun var den samme eller lavere end eksponering hos voksne mennesker efter terapeutiske doser.
English: Therefore, there is no evidence of interaction with the use of IVEMEND 150 mg and 5-HT3 antagonists.
Danish: Derfor er der ikke tegn på interaktion ved anvendelse af IVEMEND 150 mg sammen med 5-HT3antagonister.
English: Carcinogenic potential in rodents was only investigated with orally administered aprepitant.
Danish: Karcinogenicitet hos gnavere blev kun undersøgt med oralt administreret aprepitant.
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 ingen klinisk betydningsfuld indvirkning har på aprepitants farmakokinetik.
English: What you need to know before you use IVEMEND
Danish: Det skal du vide, før du begynder at bruge IVEMEND
English: Aprepitant is excreted in the milk of lactating rats after intravenous administration of fosaprepitant as well as after oral administration of aprepitant.
Danish: Aprepitant udskilles i mælken hos diegivende rotter både efter intravenøs administration af fosaprepitant og efter oral administration af aprepitant.
English: Hepatic impairment: Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic impairment is not expected to alter the conversion of fosaprepitant to aprepitant.
Danish: Nedsat leverfunktion: Fosaprepitant metaboliseres i forskellige ekstrahepatiske væv; nedsat leverfunktion forventes derfor ikke at ændre omdannelsen af fosaprepitant til aprepitant.
English: Pre-clinical data obtained with intravenous administration of fosaprepitant and oral administration of aprepitant reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity (including in vitro tests), and toxicity to reproduction and development.
Danish: Prækliniske data, der er opnået med intravenøs administration af fosaprepitant og oral administration af aprepitant, viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter enkelt dosis og gentagne doser, genotoksicitet (herunder in vitro tests) og reproduktions- og udviklingstoksicitet.
English: In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Danish: In vitro-studier med humane levermikrosomer indikerer, at aprepitant primært metaboliseres af CYP3A4, muligvis med mindre deltagelse af CYP1A2 og CYP2C19.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh class C).
Danish: Der er ingen kliniske eller farmakokinetiske data for patienter med svært nedsat leverfunktion (Child-Pugh klasse C).