FrancophonIA/ELRC3.0 huggingface dataset:
English: At the end of the follow-up period (post-dose day 8), up to slight local subacute inflammation was noted following paravenous and intramuscular administration and additional up to moderate focal muscle degeneration/necrosis with muscle regeneration following intramuscular administration.
Danish: Ved slutningen af follow-up-perioden (efter dosering på dag 8) sås indtil let lokal subakut inflammation efter paravenøs og intramuskulær administration, og desuden sås indtil moderat fokal muskeldegeneration/nekrose med muskelregeneration efter intramuskulær administration.
English: All paediatric patients
Danish: Alle pædiatriske patienter
English: The reconstituted and diluted medicinal product should be inspected visually for particulate matter and discoloration before administration.
Danish: Det rekonstituerede og fortyndede lægemiddel skal undersøges visuelt for partikler og misfarvning før administration.
English: In patients 12 years and older, the volume to be administered is calculated as follows:
Danish: Hos patienter i alderen 12 år og derover beregnes det volumen, der skal administreres, på følgende måde:
English: • if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or any of the other ingredients (listed in section 6).
Danish: • hvis du er allergisk over for fosaprepitant, aprepitant, eller over for polysorbat-80 eller et eller flere af de øvrige indholdsstoffer (angivet i punkt 6).
English: IVEMEND 150 mg should be administered intravenously and should not be given by the intramuscular or subcutaneous route.
Danish: IVEMEND 150 mg bør indgives intravenøst og bør ikke gives intramuskulært eller subkutant.
English: Ketoconazole increased the terminal half-life of oral aprepitant about 3-fold.
Danish: Ketoconazol øgede oral aprepitants terminale halveringstid ca. 3 gange.
English: Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Danish: Desuden undergik fosaprepitant en hurtig og næsten komplet omdannelse til aprepitant i S9-præparater fra andet humant væv inklusive nyre, lunge og ileum.
English: 150 mg intravenously none none none
Danish: 150 mg intravenøst ingen ingen ingen
English: The appearance of the reconstituted solution is the same as the appearance of the diluent.
Danish: Den rekonstituerede opløsning har samme udseende som diluenten.
English: The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Danish: Aprepitants farmakokinetik er non-lineær i det kliniske doseringsområde.
English: The safety profile of fosaprepitant in adult and paediatric patients was generally similar to that observed with aprepitant.
Danish: Sikkerhedsprofilen for fosaprepitant hos voksne og pædiatriske patienter var generelt sammenlignelig med sikkerhedsprofilen, der blev observeret med aprepitant.
English: Effect of other medicinal products on the pharmacokinetics of aprepitant resulting from administration of fosaprepitant 150 mg
Danish: Andre lægemidlers indvirkning på aprepitants farmakokinetik som følge af administration af fosaprepitant 150 mg
English: In healthy young adults, aprepitant accounts for approximately 19 % of the radioactivity in plasma over 72 hours following a single intravenous administration 100 mg dose of [
Danish: Hos raske, unge voksne tegner aprepitant sig for ca. 19% af radioaktiviteten i plasma over 72 timer efter en enkelt intravenøst administreret 100 mg dosis af [
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 orale behandlingsregime med aprepitant medførte en reduktion på ca. 30-35% i AUC for CYP2C9-substraterne og et fald på op til 64% i dalkoncentrationer for ethinylestradiol.
English: Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Danish: Data vedrørende effekten af kombination med andre kortikosteroider og 5-HT3-antagonister er begrænsede.
English: P-Value
Danish: P-værdi
English: Dexamethasone should also be administered in the evenings on Days 3 and 4.
Danish: Dexamethason bør også gives om aftenen på dag 3 og 4.
English: In rabbits, fosaprepitant caused initial transient local acute inflammation following paravenous, subcutaneous and intramuscular administration.
Danish: Hos kaniner forårsagede fosaprepitant initial forbigående lokal akut inflammation efter paravenøs, subkutan og intramuskulær administration.
English: IVEMEND should be used with caution in these patients (see section 5.2).
Danish: IVEMEND bør anvendes med forsigtighed hos disse patienter (se pkt.
English: • Volume to administer (ml) = recommended dose (mg/kg) x weight (kg) o Note: Do not exceed maximum doses (see section 4.2).
Danish: • Volumen, der skal administreres (ml) = anbefalet dosis (mg/kg) x vægt (kg) o Bemærk: Må ikke overskride de maksimale doser (se pkt.
English: In adults (18 years of age and older), the recommended dose of IVEMEND is 150 mg fosaprepitant on Day 1 (day of chemotherapy).
Danish: Hos voksne (i alderen 18 år og derover) er den anbefalede dosis af IVEMEND 150 mg fosaprepitant på dag 1 (dagen for kemoterapi).
English: It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.
Danish: Infusion bør ikke reinitieres hos patienter, som får overfølsomhedsreaktioner.
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 hensigtsmæssig hos patienter, som får lægemidler, der primært eller delvist metaboliseres af CYP3A4 (se pkt.
English: In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 adults including 371 healthy subjects and 2,084 patients, and 199 children and adolescents with chemotherapy induced nausea and vomiting (CINV).
Danish: I kliniske studier er forskellige formuleringer af fosaprepitant blevet administreret til i alt 2.687 voksne herunder 371 raske forsøgspersoner og 2.084 patienter samt 199 børn og unge med kemoterapiinduceret kvalme og opkastning (CINV).
English: Dexamethasone: The oral dexamethasone dose should be reduced by approximately 50 % when coadministered with fosaprepitant (see section 4.2).
Danish: Dexamethason: Den orale dexamethasondosis bør reduceres med ca. 50%, når det administreres samtidigt med fosaprepitant (se pkt.
English: Figure 1: Percent of adult patients receiving Moderately Emetogenic Chemotherapy who remain emesis free over time
Danish: Figur 1: Procent voksne patienter, der fik moderat emetogen kemoterapi, og som forbliver emesis-frie over tid
English: Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Danish: Fosaprepitant blev hurtigt omdannet til aprepitant i in vitro-inkubationer med leverpræparater fra mennesker.
English: In patients 6 months to less than 12 years, the volume to be administered is calculated as follows:
Danish: Hos patienter i alderen 6 måneder til under 12 år beregnes det volumen, der skal administreres, på følgende måde:
English: Standard dose of 5-HT3 antagonists.
Danish: Standarddosering af 5HT3-antagonister.
English: IVEMEND 150 mg was shown to be non-inferior to that of the 3-day regimen of aprepitant.
Danish: IVEMEND 150 mg viste sig at være noninferiør i forhold til 3-dages behandlingsregimet med aprepitant.
English: What IVEMEND looks like and contents of the pack IVEMEND is a white to off-white powder for solution for infusion.
Danish: Udseende og pakningsstørrelser IVEMEND er et hvidt til off-white pulver til infusionsvæske.
English: IVEMEND must be reconstituted and then diluted prior to administration.
Danish: IVEMEND skal rekonstitueres og fortyndes før administration.
English: Determine the volume to be administered from this prepared infusion bag, based on the recommended dose (see section 4.2).
Danish: Bestem det volumen, der skal administreres fra den tilberedte infusionspose på basis af den anbefalede dosis (se pkt.
English: Gently invert the bag 2-3 times (see ‘How to use IVEMEND').
Danish: Vend forsigtigt posen op og ned 2-3 gange (se Sådan skal De bruge IVEMEND).
English: Delayed phase No vomiting Overall
Danish: Forsinket fase Ingen emesis Totalt
English: Necrosis was also reported in some patients with concomitant vesicant chemotherapy.
Danish: Nekrose blev også rapporteret hos nogle patienter ved samtidig administration af vesicant kemoterapi.
English: 8 mg orally twice daily
Danish: 8 mg oralt to gange dagligt
English: Discard any remaining solution and waste material.
Danish: Bortskaf eventuel resterende rekonstitueret og fortyndet opløsning samt affald.
English: , Mg including Hartman's and lactated Ringer's solutions.
Danish: , Mg inklusive Hartmans opløsning og Ringers væske indeholdende lactat.
English: The total exposure of CYP3A4 substrates may increase up to 2-fold on Days 1 and 2 after coadministration with a single 150 mg fosaprepitant dose.
Danish: Den totale eksponering af CYP3A4-substrater kan stige op til 2 gange på dag 1 og 2 efter administration sammen med en enkelt dosis 150 mg fosaprepitant.
English: See the summary of product characteristics for EMEND capsules and EMEND powder for oral suspension for complete clinical information regarding studies performed with oral aprepitant.
Danish: Se produktresuméerne for EMEND kapsler og EMEND pulver til oral suspension for fuldstændige kliniske oplysninger vedrørende de studier, der er udført med oral aprepitant.
English: Highly Emetogenic Chemotherapy (HEC)
Danish: Højemetogen kemoterapi (HEC)
English: The powder is reconstituted and diluted before use.
Danish: Pulveret opløses og fortyndes før brug.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end de i pkt.
English: In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ml and higher, dependent on the formulation.
Danish: Hos forsøgsdyr har ikke-kommercielle formuleringer af fosaprepitant forårsaget vaskulær toksicitet og hæmolyse ved koncentrationer under 1 mg/ml og højere, afhængigt af formuleringen.
English: Vascular disorders flushing, thrombophlebitis (predominantly, infusion-site thrombophlebitis)
Danish: Flushing, tromboflebit (overvejende tromboflebit på infusionsstedet)
English: Gender No dose adjustment is necessary based on gender (see section 5.2).
Danish: Køn Dosisjustering er ikke nødvendig på basis af køn (se pkt.
English: Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness.
Danish: De fleste alvorlige reaktioner på infusionsstedet er forekommet med en vis type kemoterapibehandling, som kan brænde din hud eller danne blærer på huden (vesicant) med bivirkninger, inklusive smerter, hævelser og rødme.
English: In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were up to 3 times and 40 times, respectively, higher than clinical values.
Danish: I de udførte studier vedrørende sikkerhedsfarmakologi og toksicitet efter gentagne doser hos hunde var fosaprepitants Cmax og aprepitants AUC henholdsvis 3 gange og 40 gange højere end de kliniske værdier.
English: The dose of dexamethasone accounts for active substance interactions.
Danish: Dexamethasondosis blev valgt for at tage højde for interaktioner med den aktive substans.
English: Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4.
Danish: Dexamethason bør gives 30 minutter før kemoterapibehandling på dag 1 og om morgenen på dag 2-4.
English: No data are available following the administration of a 3-day IV fosaprepitant regimen in paediatric patients.
Danish: Der foreligger ingen data efter administrationen af et 3-dages intravenøst fosaprepitantregime hos pædiatriske patienter.
English: IVEMEND 150 mg is given as part of a combination therapy (see section 4.2).
Danish: IVEMEND 150 mg gives som en del af en kombinationsbehandling (se pkt.
English: See the product information for the selected 5-HT3 antagonist for appropriate dosing information Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.
Danish: Se produktinformationen for de valgte 5-HT3antagonister for information om hensigtsmæssig dosering Dexamethason bør gives 30 minutter før kemoterapibehandling på dag 1.
English: Depending on the chemotherapy treatment, there are two ways IVEMEND may be given: IVEMEND is given only on Day 1 (single day of chemotherapy) IVEMEND is given on Day 1, 2, and 3 (single or multiple days of chemotherapy) o Oral formulations of aprepitant may be prescribed on Days 2 and 3 instead of IVEMEND.
Danish: Afhængigt af typen af kemoterapibehandling er der to måder, hvorpå IVEMEND kan gives: IVEMEND gives kun på dag 1 (på en enkelt dag med kemoterapi) IVEMEND gives på dag 1, 2 og 3 (på en enkelt dag eller over flere dage med kemoterapi) o Orale formuleringer af aprepitant kan ordineres på dag 2 og 3 i stedet for IVEMEND.
English: After reconstitution and dilution: 24 hours at 25°C.
Danish: Efter rekonstituering og fortynding: 24 timer ved 25 °C.
English: † Complete response = no vomiting and no use of rescue therapy.
Danish: † Komplet respons = ingen opkastning og ingen brug af erstatningsbehandling.
English: IVEMEND is incompatible with any solutions containing divalent cations (e.g., Ca
Danish: IVEMEND er uforligelig med opløsninger, der indeholder divalente kationer (fx Ca
English: EU/1/07/437/003 1 x 1 vial EU/1/07/437/004 1 x 10 vials
Danish: EU/1/07/437/003 1 x 1 hætteglas EU/1/07/437/004 1 x 10 hætteglas
English: In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ml and higher, although tests in human whole blood were negative.
Danish: I humane vaskede blodlegemer forekom hæmolyse også med ikke-kommercielle formuleringer af fosaprepitant ved koncentrationer på 2,3 mg/ml og højere, selvom test i humant fuldblod var negative.
English: Caution is advised when warfarin, acenocoumarol, tolbutamide, phenytoin or other active substances that are known to be metabolised by CYP2C9 are administered with IVEMEND.
Danish: Der bør udvises forsigtighed når warfarin, acenocoumarol, tolbutamid, phenytoin eller andre aktive substanser, der vides at blive metaboliseret af CYP2C9, administreres sammen med IVEMEND.
English: It is anticipated that fosaprepitant would cause less or no greater induction of CYP2C9, CYP3A4 and glucuronidation than that caused by the administration of oral aprepitant.
Danish: Det forventes, at fosaprepitant vil forårsage mindre eller ingen større induktion af CYP2C9, CYP3A4 og glukuronidering, end administration af oral aprepitant medfører.
English: Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy.
Danish: Let trombose på injektionsstedet er set ved højere doser uden samtidig administration af vesicant kemoterapi.
English: An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded.
Danish: Interaktion med oralt administrerede kemoterapeutika, som primært eller delvist metaboliseres ved hjælp af CYP3A4 (fx etoposid, vinorelbin), kan ikke udelukkes.
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.
Danish: Følgende regimer anbefales til forebyggelse af kvalme og opkastning i forbindelse med emetogen cancerkemoterapi.
English: ** Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.
Danish: ** Dexamethason skal administreres 30 minutter før kemoterapibehandling på dag 1.
English: 2 mg/kg intravenously OR 2 mg/kg orally (EMEND oral suspension)
Danish: 2 mg/kg intravenøst ELLER 2 mg/kg oralt (EMEND oral suspension)
English: Due to modest decreases in protein binding of aprepitant in patients with renal disease, the AUC of pharmacologically active unbound aprepitant was not significantly affected in patients with renal impairment compared with healthy subjects.
Danish: På grund af beskedne fald i proteinbindingen for aprepitant hos patienter med nyresygdom blev AUC for det farmakologisk aktive, ubundne aprepitant ikke signifikant påvirket hos patienter med nedsat nyrefunktion sammenlignet med raske forsøgspersoner.
English: Co-administration with warfarin (a CYP2C9 substrate) In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely for 14 days following the use of fosaprepitant (see section 4.5).
Danish: Samtidig administration af warfarin (et CYP2C9-substrat) Hos patienter i kronisk behandling med warfarin bør International Normaliseret Ratio (INR) monitoreres hyppigt i 14 dage efter anvendelse af fosaprepitant (se pkt.
English: All metabolites observed in urine, faeces and plasma following an intravenous 100 mg [
Danish: Alle metabolitter, der er set i urin, fæces og plasma efter en intravenøs 100 mg dosis af [
English: The following information was derived from studies conducted with oral aprepitant and studies conducted with intravenous single-dose fosaprepitant co-administered with dexamethasone, midazolam, or diltiazem.
Danish: Følgende information stammer fra studier udført med oral aprepitant samt studier, der er udført med intravenøs fosaprepitant som enkeltdosis ved samtidig administration af dexamethason, midazolam eller diltiazem.
English: Fosaprepitant placebo and dexamethasone placebo (on Day 1) were used to maintain blinding.
Danish: Placebo for fosaprepitant og dexamethason (på dag 1) blev anvendt for at opretholde blinding.
English: Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.
Danish: Forebyggelse af kvalme og opkastning i forbindelse med højemetogen og moderat emetogen cancerkemoterapi hos voksne og pædiatriske patienter i alderen 6 måneder og derover.
English: It is anticipated that IVEMEND would cause less or no greater 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 6-8 days after first aprepitant dose has been observed.
Danish: Det er forventeligt, at IVEMEND vil medføre mindre eller ingen større induktion af CYP2C9, CYP3A4 og glukuronidering end administration af det 3-dages behandlingsregime med aprepitant medfører, idet der for dette er set en forbigående induktion med maksimal effekt 6-8 dage efter første aprepitantdosis.
English: After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Danish: Efter rekonstitution og fortynding har den kemiske og fysiske stabilitet ved anvendelse vist sig at være 24 timer ved 25 °C.
English: In an additional active-controlled clinical study in 1,169 adult patients receiving aprepitant and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with aprepitant.
Danish: I et supplerende aktivt kontrolleret klinisk studie med 1.169 voksne, der fik aprepitant og højemetogen kemoterapi, var bivirkningsprofilen generelt den samme som i de øvrige HEC-studier med aprepitant.
English: Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant.
Danish: Da fosaprepitant omdannes til aprepitant, forventes de bivirkninger, der er forbundet med aprepitant, også at forekomme med fosaprepitant.
English: Control regimen (N =498) **
Danish: Kontrolregime (N =498) **
English: • with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems).
Danish: • sammen med medicin, som indeholder pimozid (til behandling af psykiske lidelser), terfenadin og astemizol (til behandling af høfeber og andre allergitilstande), cisaprid (til behandling af problemer med fordøjelsen).
English: Fosaprepitant must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride.
Danish: Fosaprepitant må ikke anvendes samtidigt med pimozid, terfenadin, astemizol eller cisaprid.
English: The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with oral aprepitant than with standard therapy in adults or paediatric patients or in postmarketing use.
Danish: Følgende bivirkninger blev observeret med højere frekvens med oral aprepitant end med standardbehandling i en poolet analyse af HEC- og MEC-studier hos voksne eller pædiatriske patienter eller ved anvendelse efter markedsføring.
English: The safety profile of the 3-day IV fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day fosaprepitant regimen as the low daily trough levels do not significantly increase the exposures on subsequent days.
Danish: Sikkerhedsprofilen for det 3-dages intravenøse fosaprepitantregime hos pædiatriske patienter forventes at være sammenlignelig med sikkerhedsprofilen for det 1-dages fosaprepitantregime, da de lave daglige dalværdier ikke øger eksponeringen på de efterfølgende dage betydningsfuldt.
English: Post-marketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.
Danish: Efter markedsføring er der rapporteret om neurotoksicitet, der er en potentiel bivirkning af ifosfamid, efter samtidig administration af aprepitant og ifosfamid.
English: In the same analysis, safety was evaluated for 199 patients receiving either HEC or MEC and a single dose of IVEMEND at or above the recommended 3-day regimen of IVEMEND.
Danish: I den samme analyse blev sikkerheden vurderet for 199 patienter, der fik enten HEC eller MEC og en enkeltdosis IVEMEND ved eller over den anbefalede dosis for 3-dages regimet med IVEMEND.
English: Effect of fosaprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Danish: Fosaprepitants effekt på andre aktive substansers farmakokinetik CYP3A4-hæmning
English: The potential for interactions with multi-day fosaprepitant regimens are anticipated to be no greater than those for oral aprepitant regimens.
Danish: Potentialet for interaktioner ved flere dages behandling med fosaprepitantregimer forventes ikke at være større end interaktionerne for orale aprepitantregimer.
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with IVEMEND.
Danish: Der bør tages hensyn til den potentielle effekt af midazolams eller andre benzodiazepiners øgede plasmakoncentration, der metaboliseres via CYP3A4 (alprazolam, triazolam), når disse gives samtidigt med IVEMEND.
English: Dizziness and fatigue may occur following administration of IVEMEND (see section 4.8).
Danish: Svimmelhed og træthed kan forekomme efter administration af IVEMEND (se pkt.
English: These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Disse studier viste hverken direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryonal-/føtaludvikling, fødsel eller postnatal udvikling (se pkt.
English: The pharmacological effect of fosaprepitant is attributed to aprepitant.
Danish: Fosaprepitants farmakologiske effekt tilskrives aprepitant.