FrancophonIA/ELRC3.0 huggingface dataset:
English: Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Danish: Serotonin aktiverer så 5-HT3-receptorer, der befinder sig på afferente vagusnerver, til at påbegynde opkastningsrefleksen.
English: If you do not want to take Akynzeo, discuss this with your doctor.
Danish: Hvis du ikke vil tage Akynzeo, kan du tale med lægen om det.
English: Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%).
Danish: Almindelige bivirkninger rapporteret med netupitant/palonosetron kapsler var hovedpine (3,6 %), forstoppelse (3,0 %) og træthed (1,2 %).
English: Acute phase
Danish: Akut fase
English: There are no data about the use of palonosetron in pregnant women.
Danish: Der er ingen data fra anvendelse af palonosetron til gravide kvinder.
English: moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone
Danish: moxifloxacin, haloperidol, chlorpromazin, quetiapin, thioridazin eller domperidon
English: Very rare cases of anaphylaxis, anaphylactic/anaphylactoid reactions and shock have been reported from the post-marketing use of intravenous palonosetron.
Danish: Meget sjældne tilfælde af anafylaksi, anafylaktiske/anafylaktoide reaktioner og shock er blevet rapporteret fra anvendelsen af intravenøst palonosetron efter markedsføring.
English: Following administration of a single dose of Akynzeo, netupitant is eliminated from the body in a multi-exponential fashion, with an apparent mean elimination half-life of 88 hours in cancer patients.
Danish: Efter administration af en enkelt dosis Akynzeo elimineres netupitant fra kroppen på en multieksponentiel måde med en tilsyneladende gennemsnitlig elimineringshalveringstid på 88 timer hos cancerpatienter.
English: These metabolites each have less than 1% of the 5-HT3 receptor antagonist activity of palonosetron.
Danish: Disse metabolitter har hver under 1 % af palonosetrons 5-HT3-receptorantagonistaktivitet.
English: • conjunctivitis (a type of eye inflammation)
Danish: • konjunktivitis (en form for øjenbetændelse)
English: Studies in animals have shown reproductive toxicity including teratogenic effects in rabbit without safety margin (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, herunder teratogene virkninger, hos kaniner uden sikkerhedsmargin (se pkt.
English: • spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)
Danish: • snurrende fornemmelse (vertigo), svimmelhedsfølelse eller søvnbesvær (insomni)
English: • sleep problems
Danish: • søvnproblemer
English: These effects were not considered clinically important.
Danish: Disse virkninger blev ikke anset for at have klinisk relevans.
English: In a study performed in healthy volunteers, netupitant does not affect the exposure of digoxin, a P-gp substrate, whereas it increases its Cmax by 1.09 fold [90%CI 0.9-1.31].
Danish: I et studie udført hos raske frivillige personer påvirker netupitant ikke eksponeringen over for digoxin, et P-gp-substrat, hvorimod det øger dets Cmaks med 1,09 gange [90 % CI 0,9-1,31].
English: Netupitant is not a substrate for P-gp.
Danish: Netupitant er ikke et substrat for P-gp.
English: Date of first authorisation: 27 May 2015 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 27. maj 2015
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised (see section 4.8).
Danish: Der rådes til passende observation af patienterne for serotonergt syndrom-lignende symptomer (se pkt.
English: The AUC0-24 (Day 1), the AUC24-36 (Day 2) and the AUC84-108 and AUC84-∞ (Day 4) of dexamethasone increased 2.4-fold, with co-administration of 300 mg netupitant.
Danish: AUC0-24 (Dag 1), AUC24-36 (Dag 2) og AUC84-108 og AUC84-∞ (Dag 4) for dexamethason var 2,4 gange forhøjet ved administration sammen med 300 mg netupitant.
English: Women of childbearing potential should not be pregnant or become pregnant while on treatment with netupitant/palonosetron capsules.
Danish: Kvinder i den fertile alder må ikke være gravide eller blive gravide, mens de er i behandling med netupitant/palonosetron kapsler.
English: Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase
Danish: Tabel 3: Andelen af patienter, der fik cisplatin-kemoterapi, respons pr. behandlingsgruppe og fase
English: However, since netupitant/palonosetron capsules contains a 5-HT3 receptor antagonist, caution should be exercised in concomitant use with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval.
Danish: Da netupitant/palonosetron kapsler imidlertid indeholder en 5-HT3-receptorantagonist bør der udvises forsigtighed ved samtidig anvendelse af lægemidler, der forlænger QT-intervallet, eller hos patienter, der har eller har anlæg for at udvikle en forlængelse af QT-intervallet.
English: Interaction with CYP3A4 substrates:
Danish: Interaktion med CYP3A4-substrater:
English: By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.
Danish: Ved at blokere virkningen af substans P og serotonin på denne måde hjælper lægemidlerne med at forhindre stimuleringen af opkastningscentret og den medfølgende kvalme/opkastning.
English: Akynzeo contains sucrose, sorbitol, sodium and may contain traces of soya.
Danish: Akynzeo indeholder saccharose, sorbitol, natrium og kan indeholde spor af soja.
English: The proportion of patients with Overall no impact on daily life was 6.3% higher (p value =0.005) in the Akynzeo group (78.5%) than in the palonosetron group (72.1%).
Danish: Andelen af patienter uden en samlet påvirkning på dagligdagen var 6,3 % højere (p-værdi = 0,005) i Akynzeo-gruppen (78,5 %) end i palonosetrongruppen (72,1 %).
English: • feeling hot, reddening of the face or other areas of the skin (feeling flushed)
Danish: • varmefølelse, rødmen i ansigtet eller andre områder af huden (blussende fornemmelse)
English: Multiple-cycle safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy
Danish: Sikkerhedsstudie med flere cyklusser hos patienter, der enten fik højemetogen kemoterapi eller moderat emetogen kemoterapi
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5-HT3) antagonists; ATC code: A04AA55
Danish: Farmakoterapeutisk klassifikation: Antiemetika og midler mod kvalme, serotonin (5-HT3)antagonister, ATC-kode: A04AA55
English: There are no data about the use of netupitant in pregnant women.
Danish: Der er ingen data fra anvendelse af netupitant til gravide kvinder.
English: Also tell your doctor, pharmacist or nurse if you are taking any of the following medicines as your doctor may need to change the dose of these other medicines:
Danish: Fortæl det også til lægen, apotekspersonalet eller sygeplejersken, hvis du tager nogle af de følgende lægemidler, da det kan være nødvendigt, at din læge ændrer dosis af disse andre lægemidler:
English: No common adverse reactions are attributable to netupitant, the new component of the fixed combination.
Danish: Der kan ikke tilskrives nogen almindelige bivirkninger til netupitant, den nye komponent af den faste kombination.
English: In female subjects (n=18), the mean AUC was 35% higher and the mean Cmax was 26% higher than in male subjects (n=18).
Danish: Hos kvinder (n=18) var den gennemsnitlige AUC 35 % højere, og den gennemsnitlige Cmaks var 26 % højere end hos mænd (n=18).
English: Primary endpoint Complete response
Danish: Primære endepunkt Fuldstændigt respons
English: Neither netupitant nor palonosetron have been evaluated in patients with end-stage renal disease.
Danish: Hverken netupitant eller palonosetron er blevet evalueret hos patienter med nyresygdom i slutstadiet.
English: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment (ChildPugh score 5-8).
Danish: Ingen dosisjustering er nødvendig for patienter med let eller moderat nedsat leverfunktion (ChildPugh-score 5-8).
English: Phospholipidosis (foamy macrophages) has been observed with the administration of netupitant after repeated administration in rats and dogs.
Danish: Fosfolipidose (skummende makrofager) er blevet observeret med administration af netupitant efter gentagen administration hos rotter og hunde.
English: In addition, eye swelling, dyspnoea and myalgia as adverse reactions have been reported with oral palonosetron but not observed during the development of this medicinal product.
Danish: Desuden er der blevet rapporteret øjenhævelse, dyspnø og myalgi som bivirkninger med oral palonosetron, men de blev ikke observeret i løbet af udviklingen af dette lægemiddel.
English: Effect of other medicinal products on the pharmacokinetics of Akynzeo
Danish: Virkningen af andre lægemidler på Akynzeos farmakokinetik
English: • infection and inflammation in the bladder (cystitis)
Danish: • blæreinfektion og -betændelse (cystitis)
English: Upper 95% confidence limit of the point estimates of placebo and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration.
Danish: Den øvre 95 % konfidensgrænse for punktestimaterne af placebo- og baselinekorrigeret QTcI var konstant inden for 10 ms på alle tidspunkter i løbet af de 2 dage efter administration af studiestof.
English: Renal clearance is not a significant elimination route for netupitant-related entities.
Danish: Nyreclearance er ikke en signifikant elimineringsvej for netupitant-relaterede stoffer.
English: Electrocardiogram QT prolonged
Danish: Elektrokardiogram forlænget QT
English: Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant.
Danish: Det blev vist, at netupitant krydsede blod-hjerne-barrieren med en NK1-receptorokkupans på 92,5 %, 86,5 %, 85,0 %, 78,0 % og 76,0 % i striatum hhv. 6, 24, 48, 72 og 96 timer efter administration af 300 mg netupitant.
English: Chemotherapeutic substances produce nausea and vomiting by stimulating the release of serotonin from the enterochromaffin cells of the small intestine.
Danish: Kemoterapeutiske stoffer fremkalder kvalme og opkastning ved at stimulere frigørelsen af serotonin fra enterokromaffinceller i tyndtarmen.
English: Netupitant No effect on fertility has been observed in animal studies.
Danish: Netupitant Der er ikke observeret nogen virkning på fertiliteten i dyreforsøg.
English: Back pain Pain in extremities
Danish: Rygsmerter Smerter i ekstremiteterne
English: Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron.
Danish: Palonosetron elimineres ad flere veje, og ca. 50 % metaboliseres, så der dannes to primære metabolitter: N-oxid-palonosetron og 6-S-hydroxy-palonosetron.
English: Treatment regimens for the Akynzeo and the palonosetron 0.5 mg arms are displayed in Table below.
Danish: Behandlingsprogrammer for armene med Akynzeo og palonosetron 0,5 mg vises i tabellen nedenfor.
English: The primary efficacy endpoint was complete response (CR) rate (defined as no emetic episodes, no rescue medication) within 120 hours (overall phase) after the start of the highly emetogenic chemotherapy administration.
Danish: Det primære endepunkt for virkning var hyppigheden af fuldstændigt respons (complete response, CR) (defineret som ingen emetiske episoder, ingen nødmedicin) inden for 120 timer (samlet fase) efter start på administration af højemetogen kemoterapi.
English: Degeneration of seminiferous epithelium was associated with palonosetron following a one month oral repeat dose toxicity study in rats.
Danish: Degeneration af det seminiferøse epitel blev forbundet med palonosetron efter et 1-måneds toksicitetsstudie med gentagne orale doser hos rotter.
English: Netupitant is not mutagenic.
Danish: Netupitant er ikke mutagent.
English: Maximum concentrations and total exposure of netupitant were increased in subjects with mild (n=8), moderate (n=8), and severe (n=2) hepatic impairment compared to matching healthy subjects, although there was pronounced individual variability in both hepatically-impaired and healthy subjects.
Danish: Maksimale koncentrationer og total eksponering af netupitant var øget hos personer med let (n=8), moderat (n=8) og svært (n=2) nedsat leverfunktion sammenlignet med matchende raske personer, selvom der var en udpræget individuel variabilitet både hos personer med nedsat leverfunktion og hos raske personer.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Human plasma protein binding of netupitant and its two major metabolites M1 and M3 is > 99% at concentrations ranging from 10 to 1500 ng/mL.
Danish: Den humane plasmaproteinbinding af netupitant og de to metabolitter, M1 og M3, er > 99 % ved koncentrationer i intervallet fra 10 til 1500 ng/ml.
English: • medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine,
Danish: • lægemidler, der kan forårsage en unormal puls, såsom amiodaron, nicardipin, quinidin,
English: Mean Cmax was approximately 11%, 47% and 16% of the parent for M1, M2 and M3 respectively; M2 had the lowest AUC relative to the parent (14%) whereas M1 and M3 AUC were approximately 29% and 33% of the parent, respectively.
Danish: Gennemsnitligt Cmaks var ca. 11 %, 47 % og 16 % af udgangsstoffet for hhv. M1, M2 og M3. M2 havde den laveste AUC relativt til udgangsstoffet (14 %), hvorimod AUC for M1 og M3 var hhv. ca. 29 % og 33 % af udgangsstoffet.
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these active substances with netupitant/palonosetron capsules.
Danish: Den mulige virkning af forhøjede plasmakoncentrationer af midazolam eller andre benzodiazepiner, som metaboliseres via CYP3A4 (alprazolam, triazolam), bør overvejes ved administration af disse aktive stoffer sammen med netupitant/palonosetron kapsler.
English: After a single oral 300 mg dose administration in cancer patients, netupitant disposition was characterised by a two compartment model with an estimated median systemic clearance of 20.5 L/h and a large distribution volume in the central compartment (486 L).
Danish: Efter en enkelt oral 300 mg dosisadministration hos cancerpatienter var fordelingen af netupitant karakteriseret ved en model med to compartments med en estimeret median systemisk clearance på 20,5 l/t og et stort fordelingsvolumen i den centrale compartment (486 l).
English: The pharmacokinetics of palonosetron or netupitant has not been studied in subjects with end-stage renal disease requiring hemodialysis and no data on the effectiveness or safety of netupitant/palonosetron capsules in these patients are available.
Danish: Farmakokinetikken af palonosetron eller netupitant er ikke blevet undersøgt hos personer med nyresygdom i slutstadiet med behov for hæmodialyse, og der foreligger ingen data om virkningen og sikkerheden af netupitant/palonosetron kapsler hos disse patienter.
English: Based on the experience with healthy subjects exposed to oral netupitant 600 mg in combination with palonosetron 1.50 mg the potential acute symptoms of overdose are headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Danish: På baggrund af erfaringen med raske forsøgspersoner eksponeret for oral netupitant 600 mg i kombination med palonosetron 1,50 mg er de potentielle akutte symptomer på overdosering hovedpine, svimmelhed, forstoppelse, angst, palpitationer, euforisk humør og smerter i benene.
English: Three metabolites have been detected in human plasma at netupitant oral doses of 30 mg and higher (the desmethyl derivative, M1; the N-oxide derivative, M2; the OH-methyl derivative, M3).
Danish: Der er blevet detekteret tre metabolitter i humant plasma ved orale doser af netupitant på 30 mg og derover (desmethylderivatet M1, N-oxidderivatet M2, OH-methylderivatet M3).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: The primary efficacy endpoint was the CR rate in the delayed phase, 25-120 hours after the start of the chemotherapy administration.
Danish: Det primære endepunkt for virkning var CR-hyppigheden i den sene fase, 25-120 timer efter administrationen af kemoterapi blev påbegyndt.
English: Palonosetron is eliminated from the body through both renal excretion and metabolic pathways, with the latter mediated via multiple CYP enzymes.
Danish: Palonosetron elimineres fra kroppen via både nyreudskillelse og metaboliske processer, hvor sidstnævnte medieres via flere CYP-enzymer.
English: Palonosetron soft capsule
Danish: Palonosetron blød kapsel
English: An increased incidence of positional foetal abnormalities of the limbs and paws, fused sternebrae and agenesis of accessory lung lobe were observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher during the period of organogenesis.
Danish: En øget forekomst af positionale føtale anomalier af lemmer og poter, fusionerede sternebrae samt agenese af den accessoriske lungelap blev observeret efter daglig administration af netupitant til kaniner ved 10 mg/kg/dag og derover i løbet af perioden med organogenese.
English: This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
Danish: Dette lægemiddel kan øge plasmakoncentrationerne af samtidigt administrerede lægemidler, der metaboliseres via CYP3A4.
English: • The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).
Danish: • Øvrige indholdsstoffer: mikrokrystallinsk cellulose (E460), saccharoselaurylsyreestere, povidon K-30, croscarmellosenatrium, kolloid silica, natriumstearylfumarat, magnesiumstearat, glycerolmonocaprylocaproat (type I), glycerol, polyglyceryloleat, renset vand, butylhydroxyanisol (E320), gelatine, sorbitol, 1,4-sorbitan, titandioxid (E171), shellac-glasur (delvist esterificeret), gul, rød og sort jernoxid (E172), propylenglycol (E1520).
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Danish: Baseret på in vitro-studier hæmmer eller inducerer palonosetron ikke cytokrom P450-isoenzym ved klinisk relevante koncentrationer.
English: Furthermore, the population PK study showed no correlation between PK parameters of netupitant and markers of renal dysfunction.
Danish: Desuden viste populationsfarmakokinetikstudiet ingen korrelation mellem farmakokinetiske parametre for netupitant og markører for nyredysfunktion.
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Danish: Selvom den terminale elimineringshalveringstid og den gennemsnitlige systemiske eksponering over for palonosetron er forhøjet hos personer med svært nedsat leverfunktion, kræver dette ikke en dosisreduktion.
English: The pharmacokinetic profile of netupitant was unchanged when administered in combination with dexamethasone.
Danish: Den farmakokinetiske profil for netupitant var uændret, når det blev administreret sammen med dexamethason.
English: Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
Danish: Der foreligger kun begrænsede data fra dyreforsøg angående placental overførsel (se pkt.
English: Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Danish: Eksponering over for erythromycin og midazolam blev forhøjet hhv. ca. 1,3 og 2,4 gange ved administration af hver af dem sammen med netupitant.
English: Common (≥1/100 to <1/10),
Danish: Almindelig (≥ 1/100 til < 1/10),
English: As use in patients with severe hepatic impairment may be associated with increased exposure of netupitant, this medicinal product should be used with caution in these patients (see sections 4.4 and
Danish: Da anvendelsen til patienter med svært nedsat leverfunktion kan være forbundet med en forøget eksponering over for netupitant, bør dette lægemiddel anvendes med forsigtighed hos disse patienter (se pkt.
English: No data from animal studies with netupitant are available regarding placental transfer and lactation.
Danish: Der foreligger ingen data fra dyreforsøg med netupitant, hvad angår placental overførsel og laktation.
English: Inhibition of the efflux transported BCRP and glucuronidation isozyme UGT2B7 by netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance.
Danish: Hæmning af effluks af -transporteren BCRP og glukuroniderings-isozym UGT2B7 ved hjælp af netupitant og dets metabolitter er ikke sandsynlig, og hvis det forekommer, er det af ubetydelig klinisk relevans.
English: This medicinal product contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hård kapsel, dvs. det er i det væsentlige natrium-frit.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.
Danish: De kliniske farmakokinetiske parametre er dog ikke signifikant forskellige mellem stoffer, der metaboliserer CYP2D6-substrater i mindre eller udbredt grad.
English: Co-administration of a single dose of 300 mg netupitant with a dexamethasone regimen (20 mg on Day 1, followed by 8 mg twice daily from Day 2 to Day 4) significantly increased the exposure to dexamethasone in a time and dose dependent manner.
Danish: Administration af en enkeltdosis med 300 mg netupitant sammen med et behandlingsprogram med dexamethason (20 mg på Dag 1, efterfulgt af 8 mg to gange dagligt fra Dag 2 til Dag 4) øgede eksponeringen over for dexamethason signifikant på en tids- og dosisafhængig måde.
English: Netupitant/palonosetron capsules are unlikely to interact with medicinal products which are P-gp substrates.
Danish: Det er ikke sandsynligt, at netupitant/palonosetron kapsler påvirker lægemidler, som er P-gpsubstrater.
English: At the time of the study, anthracyclinecyclophosphamide containing chemotherapy regimens were considered to be moderately emetogenic.
Danish: På studietidspunktet blev antracyklincyklophosphamid-indeholdende kemoterapiprogrammer anset for at være moderat emetogene.
English: As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration (see section
Danish: Da palonosetron kan forlænge transittiden i tyktarmen, bør patienter med tidligere forstoppelse eller tegn på subakut tarmobstruktion overvåges efter administration (se pkt.
English: The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Danish: Tegnene kan omfatte tremor, agitation, svedtendens, myokloniske bevægelser, hypertoni og feber.