FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Danish: Derfor bør patienterne overvåges for en øget toksicitet af kemoterapeutiske stoffer, der er substrater for CYP3A4, herunder irinotecan.
English: In single dose oral studies, netupitant was measurable in plasma between 15 minutes and 3 hours after dosing.
Danish: I studier med orale enkeltdoser kunne netupitant måles i plasma fra 15 minutter til 3 timer efter dosering.
English: Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Danish: Der rådes til forsigtighed, når netupitant kombineres med et oralt substrat for dette enzym (f.eks. zidovudine, valproinsyre, morfin).
English: Interaction between oral netupitant and oral palonosetron:
Danish: Interaktion mellem oral netupitant og oral palonosetron:
English: Delayed emesis has been associated with the activation of tachykinin family neurokinin 1 (NK1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Danish: En sen emese er blevet forbundet med aktiveringen af takykinin-familiens neurokinin 1 (NK1)receptorer (vidt udbredt i det centrale og perifere nervesystem) af substans P. Som vist i in vitro- og in vivo-studier hæmmer netupitant substans P-medieret respons.
English: A total of 907 patients (62.3%) completed the multiple-cycle extension up to a maximum of eight treatment cycles.
Danish: I alt 907 patienter (62,3 %) gennemførte forlængelsesfasen med flere cyklusser op til maks.
English: Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1
Danish: Tabel 5: Andelen af patienter, der fik kemoterapi med antracyklin og cyklophosphamid, respons pr. behandlingsgruppe og fase - cyklus 1
English: Overall: 0 to 120 hours post-cisplatin treatment.
Danish: Samlet: 0 til 120 timer efter behandling med cisplatin.
English: Approximately half the radioactivity administered orally as [14C]-netupitant was recovered from urine and faeces within 120 h of dosing.
Danish: Ca. halvdelen af radioaktiviteten, der blev administreret oralt som [14C]netupitant, blev genfundet i urin og fæces inden for 120 timer efter dosering.
English: The study demonstrated no clinically important effects on ECG parameters: the largest point estimate of the placebo and baseline corrected QTc interval was 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), observed 16 hours after the administration of supratherapeutic doses (600 mg netupitant and 1.5 mg palonosetron).
Danish: Studiet viste ingen klinisk vigtige virkninger på EKG-parametre: det største punktestimat af placebo- og baselinekorrigeret QTc-interval var 7,0 ms (ensidet øvre 95 % konfidensgrænse 8,8 ms), observeret 16 timer efter administration af supraterapeutiske doser (600 mg netupitant og 1,5 mg palonosetron).
English: Netupitant/palonosetron capsules are contraindicated during pregnancy (see section 4.3).
Danish: Netupitant/palonosetron kapsler er kontraindiceret under graviditeten (se pkt.
English: Chemotherapeutic medicinal products (docetaxel, etoposide, cyclophosphamide) Exposure to docetaxel and etoposide was increased 37% and 21%, respectively, when co-administered with netupitant/palonosetron capsules.
Danish: Kemoterapeutiske lægemidler (docetaxel, etoposid, cyklophosphamid) Eksponering over for docetaxel og etoposid var forhøjet med hhv. 37 % og 21 % ved administration sammen med netupitant/palonosetron kapsler.
English: • decreased blood flow to the heart muscle (myocardial ischemia)
Danish: • nedsat blodforsyning til hjertemusklen (myokardieiskæmi)
English: Netupitant and combination with palonosetron
Danish: Netupitant og kombination med palonosetron
English: • you are allergic to netupitant or palonosetron, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for netupitant eller palonosetron eller et af de øvrige indholdsstoffer i Akynzeo (angivet i punkt 6).
English: Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction.
Danish: Patienter med kendt overfølsomhed over for jordnødder eller soja skal derfor overvåges nøje for tegn på en allergisk reaktion.
English: The significance of these findings in humans is unknown.
Danish: Betydningen af disse fund for mennesker er ukendt.
English: Netupitant tablets Microcrystalline cellulose (E460) Sucrose lauric acid esters Povidone K-30
Danish: Netupitant-tabletter Mikrokrystallinsk cellulose (E460) Saccharoselaurylsyreestere Povidon K-30
English: Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Danish: En nedsat leverfunktion påvirker ikke signifikant den totale legemsclearance for palonosetron sammenlignet med raske personer.
English: Additional interactions
Danish: Yderligere påvirkninger
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.
Danish: Hvis noget af det ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med din læge, apotekspersonalet eller sygeplejersken, før du tager Akynzeo.
English: • midazolam - a sedative used to treat anxiety
Danish: • midazolam - et afslappende middel, der anvendes til at behandle angst
English: Netupitant/palonosetron capsules have moderate influence on the ability to drive and use machines.
Danish: Netupitant/palonosetron kapsler påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: No specific studies were performed to evaluate netupitant in patients with renal impairment.
Danish: Der er ikke udført specifikke studier til at evaluere netupitant hos patienter med nedsat nyrefunktion.
English: Serotonergic medicinal products (e.g. SSRIs and SNRIs)
Danish: Serotonerge lægemidler (f.eks. SSRI'er og SNRI'er)
English: High doses of palonosetron (each dose causing at least 15 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumors, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumors in rats but not in mice.
Danish: (der alle førte til mindst 15 gange den humane terapeutiske eksponering), som blev administreret dagligt i to år forårsagede en øget hyppighed af levertumorer, endokrine neoplasmer (i thyreoidea, hypofyse, pankreas, adrenal medulla) og hudtumorer hos rotter, men ikke hos mus.
English: Hypoaesthesia Somnolence
Danish: Hypoæstesi Somnolens
English: Shellac glaze (partially esterified) Black iron oxide (E172) Propylene glycol (E1520)
Danish: Shellac-glasur (delvist esterificeret) Sort jernoxid (E172) Propylenglycol (E1520)
English: When this medicinal product is used concomitantly with medicinal products that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy.
Danish: Når dette lægemiddel anvendes samtidigt med lægemidler, som inducerer CYP3A4-aktivitet, kan plasmakoncentrationerne af netupitant reduceres, og dette kan føre til en nedsat virkning.
English: Atrioventricular block first degree
Danish: 1. grads atrioventrikulært blok
English: Table 4: Oral Antiemetic treatment regimen - MEC study
Danish: Tabel 4: Oralt antiemetisk behandlingsprogram - MEC-studie
English: An ECG study was conducted in adult male and female healthy volunteers with oral netupitant either 200 or 600 mg administered in combination with oral palonosetron 0.5 or 1.5 mg, respectively.
Danish: Et EKG-studie hos raske, voksne frivillige mænd og kvinder med oral netupitant enten 200 eller 600 mg, administreret i kombination med oral palonosetron hhv. 0,5 eller 1,5 mg.
English: In a pilot dose range finding study in rabbits, cleft palate, microphtalmia and aphakia were observed in four foetuses from one litter in the 30 mg/kg/day group.
Danish: I et pilotstudie udført med henblik på at finde dosisintervallet hos kaniner blev der observeret ganespalte, mikroftalmi og afaki hos fire fostre fra ét kuld i gruppen med 30 mg/kg/dag.
English: - Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Danish: - Forebyggelse af akut og sen kvalme og opkastning i forbindelse med moderat emetogen cancerkemoterapi.
English: Exposure to netupitant (Cmax, AUC0-t and AUC0-∞) compared to matching healthy subjects was 11%, 28% and 19% higher in mild and 70%, 88% and 143% higher in moderate hepaticallyimpaired subjects, respectively.
Danish: Eksponeringen over for netupitant (Cmaks, AUC0-t og AUC0-∞) sammenlignet med hos matchende raske personer var hhv. 11 %, 28 % og 19 % større hos personer med let nedsat leverfunktion og 70 %, 88 % og 143 % større hos personer med moderat nedsat leverfunktion.
English: The hard capsules are opaque with a white body and a caramel cap with ‘HE1' printed on the body.
Danish: De hårde kapsler er uigennemsigtige med en hvid underdel og en karamelfarvet overdel og 'HE1' præget på underdelen.
English: Reproductive studies in animals with netupitant do not indicate direct or indirect harmful effects with respect to fertility, parturition or postnatal development.
Danish: Reproduktionsstudier med netupitant til dyr indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet, fødsel eller postnatal udvikling.
English: Electrocardiogram ST segment depression
Danish: Elektrokardiogram depression i ST-segmentet
English: The relevance of these findings in humans is unknown.
Danish: Relevansen af disse fund for mennesker er ukendt.
English: Flushing Hypotension
Danish: Rødmen Hypotension
English: This medicinal product also contains 20 mg of sucrose in each capsule.
Danish: Dette lægemiddel indeholder også 20 mg saccharose i hver kapsel.
English: • modifications (or disturbances) in heart rhythm
Danish: • ændringer (eller forstyrrelser) af hjerterytmen
English: In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104).
Danish: I et separat studie blev i alt 413 patienter, der gennemgik indledende og gentagne kemoterapicyklusser (herunder programmer med carboplatin, cisplatin, oxaliplatin og doxorubicin) randomiseret til enten af få Akynzeo (n=309) eller aprepitant og palonosetron (n=104).
English: In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established.
Danish: In vitro-data viser, at netupitant hæmmer UGT2B7, og størrelsesordenen for sådan en virkning i klinikken er ikke klarlagt.
English: No consistent effect was seen with cyclophosphamide after netupitant co-administration.
Danish: Der blev ikke set nogen vedvarende virkning med cyklophosphamid efter samtidig administration med netupitant.
English: Each hard capsule contains 7 mg of sorbitol and 20 mg of sucrose.
Danish: Hver hård kapsel indeholder 7 mg sorbitol og 20 mg saccharose.
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Danish: Der er blevet rapporteret serotonergt syndrom med anvendelsen af 5-HT3-antagonister enten alene eller i kombination med andre serotonerge lægemidler (herunder selektive serotoningenoptagshæmmere (SSRI'er) og serotonin-noradrenalingenoptagshæmmere (SNRI'er)).
English: Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body.
Danish: Uigennemsigtig gelatinekapsel af størrelse ”0” (længde 21,7 mm) med en hvid underdel og en karamelfarvet overdel og ”HE1” præget på underdelen.
English: Titanium dioxide (E171)
Danish: 1,4-sorbitan Titandioxid (E171)
English: • problems with the muscles in your heart (cardiomyopathy)
Danish: • problemer med hjertets muskler (kardiomyopati)
English: Table 2: Oral Antiemetic treatment regimen -- HEC study
Danish: Tabel 2: Oralt antiemetisk behandlingsprogram -- HEC-studie
English: In a multicenter, randomized, parallel, double-blind, controlled clinical study of 694 patients, the efficacy and safety of single doses of oral netupitant in combination with oral palonosetron was compared with a single oral dose of palonosetron in cancer patients receiving a chemotherapy regimen that included cisplatin (median dose = 75 mg/m2).
Danish: I et randomiseret, parallelt, dobbeltblindt, kontrolleret klinisk multicenterstudie med 694 patienter blev virkningen og sikkerheden af enkeltdoser af oral netupitant i kombination med oral palonosetron sammenlignet med en enkelt oral dosis af palonosetron til cancerpatienter, der fik et kemoterapiprogram, som omfattede cisplatin (mediandosis = 75 mg/m2).
English: No relevant changes of netupitant and palonosetron pharmacokinetics were observed.
Danish: Der blev ikke observeret nogen relevante ændringer af farmakokinetikken for netupitant og palonosetron.
English: Netupitant/palonosetron capsules should not be used during breast-feeding.
Danish: Netupitant/palonosetron kapsler bør ikke anvendes under amning.
English: Oral administration of Akynzeo in combination with dexamethasone has been shown to prevent acute and delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in two separate pivotal studies.
Danish: Oral administration af Akynzeo i kombination med dexamethason har vist sig at forebygge akut og sen kvalme og opkastning forbundet med højemetogen eller moderat emetogen cancerkemoterapi i to separate, pivotale studier.
English: Following administration of a single oral 0.75 mg dose of [14C]-palonosetron to six healthy subjects, 85% to 93% of the total radioactivity was excreted in urine, and 5% to 8% was eliminated in faeces.
Danish: Efter administration af en enkelt oral dosis med 0,75 mg [14C]palonosetron til seks raske frivillige blev 85 % - 93 % af den totale radioaktivitet udskilt i urinen, og 5 % - 8 % blev udskilt i fæces.
English: The pharmacokinetic profile of netupitant was unaffected by the concomitant administration of either midazolam or erythromycin.
Danish: Den farmakokinetiske profil for netupitant var ikke påvirket af administration sammen med enten midazolam eller erythromycin.
English: This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range (see section 4.5).
Danish: Dette lægemiddel bør anvendes med forsigtighed hos patienter, der samtidigt får oralt administrerede aktive stoffer, som primært metaboliseres via CYP3A4 og har et snævert terapeutisk interval (se pkt.
English: Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Danish: Pakningsstørrelse med 1 hård kapsel eller 4 x 1 hård kapsel i perforerede enkeltdosisblistre.
English: • The active substances are palonosetron and netupitant.
Danish: • Aktive stoffer: palonosetron og netupitant.
English: Chemotherapeutic agents that are substrates for CYP3A4
Danish: Kemoterapeutiske stoffer, der er substrater for CYP3A4
English: Effects in non-clinical studies based on safety pharmacology and single and repeated dose toxicity were observed only at exposures considered in excess of the maximum human exposure, indicating little relevance to clinical use.
Danish: I non-kliniske studier baseret på sikkerhedsfarmakologi og toksicitet efter en enkelt dosis og gentagne doser blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i tilstrækkelig grad.
English: No clinically relevant pharmacokinetic interactions have been observed between oral netupitant and oral palonosetron.
Danish: Der er ikke blevet observeret nogen klinisk relevante farmakokinetiske interaktioner mellem oral netupitant og oral palonosetron.
English: This medicinal product may contain a trace of lecithin derived from soya.
Danish: Dette lægemiddel kan indeholde spor af lecithin, som kommer fra soja.
English: Animal data do not indicate direct or indirect harmful effects of palonosetron with the respect to reproductive toxicity (see section
Danish: Data fra dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger af palonosetron, hvad angår reproduktionstoksicitet (se pkt.
English: In a multicenter, randomized, parallel, double-blind, active-controlled, superiority study, the efficacy and safety of a single oral dose of Akynzeo was compared with a single oral dose of palonosetron 0.5 mg in cancer patients scheduled to receive the first cycle of an anthracycline and cyclophosphamide regimen for the treatment of a solid malignant tumor.
Danish: I et randomiseret, parallelt, dobbeltblindt, aktivt kontrolleret multicenterstudie af superioritet blev virkningen og sikkerheden af en enkel oral dosis af Akynzeo sammenlignet med en enkelt oral dosis af palonosetron 0,5 mg hos cancerpatienter med en planlagt første cyklus af et program med antracyklin og cyklophosphamid til behandling af en fast, malign tumor.
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in patients with severe impairment relative to healthy subjects.
Danish: Total systemisk eksponering over for intravenøs palonosetron blev øget med ca. 28 % hos patienter med svært nedsat nyrefunktion i forhold til raske personer.
English: This medicine contains 7 mg of sorbitol in each hard capsule.
Danish: Dette lægemiddel indeholder 7 mg sorbitol i hver hård kapsel.
English: Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Danish: Non-kliniske studier indikerer, at palonosetron kun ved meget høje koncentrationer kan blokere ionkanaler involveret i ventrikulær de- og repolarisering og forlænge varigheden af aktionspotentialet.
English: In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Danish: Fortæl det især til lægen, apotekspersonalet eller sygeplejersken, hvis du tager nogle af de følgende lægemidler:
English: Administration of the CYP3A4 inhibitor ketoconazole with netupitant/palonosetron capsules increased the AUC of netupitant 1.8 fold and Cmax 1.3 fold when compared to the administration of netupitant/palonosetron capsules alone.
Danish: Administration af CYP3A4-hæmmeren ketoconazol sammen med netupitant/palonosetron kapsler forøgede AUC for netupitant 1,8 gange og Cmaks 1,3 gange sammenlignet med administration af netupitant/palonosetron kapsler alene.
English: Dexamethasone 8 mg once a day
Danish: Dexamethason 8 mg én gang dagligt
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Danish: I non-kliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i tilstrækkelig grad.
English: Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia
Danish: 2. grads atrioventrikulært blok Ledningsforstyrrelse Venstresidigt grenblok Takykardi
English: • dexamethasone - can be used to treat feeling and being sick
Danish: • dexamethason - kan anvendes til at behandle kvalme og opkastning
English: Acute phase: 0 to 24 hours after anthracycline and cyclophosphamide regimen Delayed phase: 25 to 120 hours after anthracycline and cyclophosphamide regimen Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
Danish: ‡Akut fase: 0 til 24 timer efter et behandlingsprogram med anthracyklin og cyklophosphamid Sen fase: 25 til 120 timer efter et behandlingsprogram med anthracyklin og cyklophosphamid Samlet: 0 til 120 timer efter et behandlingsprogram med anthracyklin og cyklophosphamid
English: Moreover, this medicinal product should be used with caution in patients receiving concomitant orally administered active substances with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine.
Danish: Dette lægemiddel bør endvidere anvendes med forsigtighed hos patienter, der samtidigt får oralt administrerede aktive stoffer med et snævert terapeutisk interval, som primært metaboliseres af CYP3A4, såsom ciclosporin, tacrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanyl og quinidin.
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Danish: En let til moderat nedsat nyrefunktion påvirker ikke palonosetrons farmakokinetiske parametre signifikant.
English: When netupitant/palonosetron capsules are used concomitantly with another CYP3A4 inhibitor, netupitant plasma concentrations could be elevated.
Danish: Når netupitant/palonosetron kapsler anvendes sammen med en anden CYP3A4-hæmmer, kan plasmakoncentrationerne af netupitant være forhøjet.
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram and SNRIs such as venlafaxine or duloxetine) (see section
Danish: Der har været rapporter om serotonergt syndrom efter samtidig anvendelse af 5-HT3-antagonister og andre serotonerge lægemidler (herunder SSRI'er, såsom fluoxetin, paroxetin, sertralin, fluvoxamin, citalopram eller escitalopram, og SNRI'er, såsom venlafaxin eller duloxetin) (se pkt.
English: Non-clinical studies indicate that netupitant and its metabolites and the combination with palonosetron only at very high concentrations may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Danish: Non-kliniske studier indikerer, at netupitant og dets metabolitter samt kombinationen med palonosetron kun ved meget høje koncentrationer kan blokere ionkanaler involveret i ventrikulær deog repolarisering og forlænge varigheden af aktionspotentialet.
English: • ECG (electrocardiogram) problems (called ‘ST segment depression', ‘ST-T segment abnormal'
Danish: • problemer på EKG'et (elektrokardiogrammet) (som kaldes ‘ST-segmentdepression', ‘unormalt
English: Palonosetron Degeneration of seminiferous epithelium has been observed in rat study (see section 5.3).
Danish: Palonosetron Degeneration af det seminiferøse epitel er blevet observeret i rottestudier (se pkt.
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 mcg/kg in healthy subjects.
Danish: Efter orale enkeltdoser med en bufret opløsning var de gennemsnitlige maksimale palonosetronkoncentrationer (Cmaks) og arealet under kurven over koncentration versus tid (AUC0-∞) dosisproportionalt over doseringsintervallet fra 3,0 til 80 mikrog/kg hos raske personer.
English: Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Danish: Administration af CYP3A4-induktoren rifampicin sammen med Akynzeo alene reducerede AUC for netupitant 5,2 gange, og Cmaks 2,6 gange.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.