FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single oral dose of aprepitant 165 mg to healthy volunteers, the mean AUC0-∞ of aprepitant was 32.5 µg•hr/mL and the mean maximal aprepitant concentration was 1.67 µg/mL.
Danish: Efter oral administration af en enkelt 165 mg dosis aprepitant til raske frivillige var aprepitants gennemsnitlige AUC0-∞ 32,5 µg•t/ml og aprepitant gennemsnitlige maksimale koncentration var 1,67 µg/ml.
English: The effect is maintained for a few days, thereafter slowly declines and is clinically insignificant by two weeks after end of EMEND treatment.
Danish: Effekten opretholdes i nogle få dage, aftager derefter langsomt og er uden klinisk signifikans to uger efter afslutning af EMEND behandling.
English: Following a single 165 mg aprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g., cyclosporine, tacrolimus, everolimus and sirolimus) is expected.
Danish: Efter en enkelt 165 mg dosis aprepitant kan en forbigående moderat stigning forventes i to dage, muligvis efterfulgt af et let fald, i eksponering af immunosuppressiva, der metaboliseres af CYP3A4 (fx ciclosporin, tacrolimus, everolimus og sirolimus).
English: 1 hard capsule 5 x 1 hard capsule
Danish: 1 hård kapsel 5 x 1 hård kapsel
English: The safety and efficacy of EMEND 165 mg in children and adolescents below 18 years of age has not been established.
Danish: Sikkerhed og virkning af EMEND 165 mg hos børn og unge under 18 år er ikke klarlagt.
English: Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Danish: Aprepitant er en selektiv højaffinitets antagonist på human substans P neurokinin 1 (NK1) receptorer.
English: EMEND 40 mg hard capsules are supplied in the following pack sizes: - Aluminium blister containing one 40 mg capsule - 5 Aluminium blisters each containing one 40 mg capsule
Danish: EMEND 40 mg hårde kapsler fås i følgende pakningsstørrelser: - Aluminiumblister indeholdende 1 stk. 40 mg kapsel - 5 stk. aluminiumblisterpakning hver indeholdende 1 stk. 40 mg kapsel
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: How to give EMEND
Danish: Sådan skal du give EMEND
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 intravenøs administreret 100 mg dosis af [
English: Do not give EMEND 165 mg to children and adolescents under 18 years of age, because the 165 mg capsules have not been studied in this population.
Danish: Giv ikke EMEND 165 mg til børn og unge under 18 år, da 165 mg kapsler ikke er undersøgt hos denne gruppe.
English: If you or the child has taken too many capsules, contact your doctor immediately.
Danish: Hvis du eller barnet har taget for mange kapsler, skal du eller barnet straks kontakte lægen.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, tror du kan være gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: If you feel dizzy or sleepy, you should avoid driving or using machines after taking this medicine (see ‘Possible side effects').
Danish: Hvis du bliver svimmel eller søvnig, skal du undgå at køre bil eller bruge maskiner, efter du har taget dette lægemiddel (se Bivirkninger).
English: Do not give EMEND 40 mg to children and adolescents under 18 years of age, because the 40 mg capsules have not been studied in this population.
Danish: Giv ikke EMEND 40 mg til børn og unge under 18 år, da 40 mg kapsler ikke er undersøgt hos denne gruppe.
English: During treatment for chemotherapy induced nausea and vomiting (CINV), the 3-day 125 mg/80 mg regimen of aprepitant is a moderate inhibitor of CYP3A4.
Danish: Under behandling mod kvalme og opkastning i forbindelse med kemoterapi (CINV) er 3-dages behandlingsregimet med 125 mg/80 mg aprepitant en moderat hæmmer af CYP3A4.
English: - This medicine has been prescribed for the child only.
Danish: - Lægen har ordineret dette lægemiddel til barnet personligt.
English: Effect of aprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Danish: Aprepitants effekt på andre aktive substansers farmakokinetik CYP3A4-hæmning
English: The potential for effects of aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies.
Danish: Aprepitants mulige virkning på fertiliteten er ikke fuldt beskrevet, idet eksponeringsniveauer over den terapeutiske eksponering hos mennesker ikke kunne opnås i dyreforsøg.
English: The most common adverse reaction reported at a greater incidence in adults treated with 40 mg aprepitant (1.1 %) than with ondansetron (1.0 %) was ALT increased.
Danish: Den almindeligste bivirkning, som blev rapporteret med højere incidens hos voksne, der blev behandlet med 40 mg aprepitant (1,1%), end hos dem, der fik behandling med ondansetron (1,0%) var forhøjet ALAT.
English: However, it should be noted that systemic exposure in rodents was similar or even lower than therapeutic exposure in humans at the 125 mg/80 mg dose.
Danish: Det bør imidlertid anføres, at systemisk eksponering til gnavere var den samme eller lavere end terapeutisk eksponering til mennesker ved 125 mg/80 mg dosering.
English: Day 1: - Give this medicine one hour before the start of the chemotherapy session.
Danish: Dag 1: - Giv lægemidlet en time før kemoterapibehandlingen starter.
English: • Pour entire contents of the sachet into the 4.6 mL of water and mix.
Danish: • Hæld hele folieposens indhold ned i 4,6 ml vand og bland.
English: You should not use this medicine during pregnancy unless clearly necessary.
Danish: Du må ikke tage dette lægemiddel under graviditet, medmindre det er klart nødvendigt.
English: One sachet, two oral dispensers, one cap and one mixing cup.
Danish: En foliepose, to dispenseringssprøjter til oral anvendelse, en hætte og et blandebæger.
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: Frekvenser 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: Hydroxypropylcellulose (E 463) Sodium laurilsulfate (E 487) Sucrose
Danish: Hydroxypropylcellulose (E463) Natriumlaurilsulfat (E487) Saccharose
English: What you need to know before you take or give EMEND
Danish: Det skal du vide, før du begynder at tage eller give EMEND
English: EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.
Danish: EMEND gives i 3 dage som del af et behandlingsregime, som også omfatter et kortikosteroid samt en 5-HT3-antagonist.
English: Patients with rare hereditary problems of fructose or galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructose- eller galactoseintolerans, glucosegalactose-malabsorption, Lapp lactasemangel eller sucrase-isomaltasemangel bør ikke tage dette lægemiddel.
English: * The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models.
Danish: * Konfidensintervallerne (CI) er ikke korrigeret for køn (< 55 år, ≥ 55 år) og investigatorgruppe, som var inkluderet i den primære analyse af odds ratio og logistiske modeller.
English: The median peak plasma concentration (Cmax) was approximately 1.2 µg/mL on Day 1, occurring between 5 and 7 hours.
Danish: Den gennemsnitlige peakplasmakoncentration (Cmax) var cirka 1,2 µg/ml på dag 1, og forekom efter mellem 5 og 7 timer.
English: Microcrystalline cellulose (E 460) Hydroxypropylcellulose (E 463) Sodium laurilsulfate
Danish: Mikrokrystallinsk cellulose (E460) Hydroxypropylcellulose (E463) Natriumlaurilsulfat
English: After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Danish: Efter behandlingen med EMEND kan lægen bede dig eller barnet om at fortsætte med at tage andre lægemidler, herunder et kortikosteroid (fx dexamethason) og et "5HT3-antagonist" (fx ondansetron) til at forebygge kvalme og opkastning.
English: If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see ‘Possible side effects').
Danish: Hvis du eller barnet bliver svimmel eller søvnig, skal du eller barnet undgå at køre bil, køre på cykel eller betjene maskiner eller værktøj, efter at have fået dette lægemiddel (se punkt 4 Bivirkninger).
English: Do not give EMEND: - if the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
Danish: Giv ikke EMEND: - hvis barnet er allergisk over for aprepitant eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: COMPOSITE MEASURES
Danish: SAMMENSATTE MÅL
English: Hepatic impairment: Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Danish: Nedsat leverfunktion: Let nedsat leverfunktion (Child-Pugh klasse A) har ingen klinisk relevant indflydelse på farmakokinetikken for aprepitant.
English: Metabolism and nutrition disorders decreased appetite common polydipsia rare
Danish: Metabolisme og ernæring Nedsat appetit
English: EMEND causes a transient mild induction of CYP2C9, CYP3A4 and glucuronidation approximately one week after treatment.
Danish: EMEND forårsager en forbigående mild induktion af CYP2C9, CYP3A4 samt glukuronidering ca. en uge efter behandling.
English: Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.
Danish: Forebyggelse af kvalme og opkastning i forbindelse med højemetogen og moderat emetogen cancerkemoterapi hos børn, småbørn og spædbørn i alderen fra 6 måneder til under 12 år.
English: The median peak plasma concentration (Cmax) was approximately 1.3 µg/mL on Day 1, occurring at approximately 4 hours.
Danish: Den gennemsnitlige peakplasmakoncentration (Cmax) var cirka 1,3 µg/ml på dag 1, hvilken forekom efter cirka 4 timer.
English: Aprepitant, when given as a single dose of 200 mg in the fed state (standard light breakfast) on Day 1 with oral dexamethasone, co-administered orally as 12 mg on Day 1 and 8 mg on Days 2 through 4, increased the AUC0-24hr of dexamethasone by 2.1- and 2.3-fold on Days 1 and 2, to a lesser extent (1.4-fold increase) on Day 3, and had no effect on Day 4 (1.1-fold).
Danish: Når aprepitant blev givet som en enkelt dosis på 200 mg på fuld mave (let normalt morgenmåltid) på dag 1 sammen med oral dexamethason, der blev administreret oralt som 12 mg på dag 1 og 8 mg på dag 2 til og med dag 4, steg dexamethasons AUC0-24t med 2,1 og 2,3 gange på dag 1 og 2, i mindre grad på dag 3 (1,4-gange stigning) og havde ingen virkning på dag 4 (1,1-gang).
English: How to take EMEND
Danish: Sådan skal du tage EMEND
English: Pour the entire contents of the sachet into the 4.6 mL of water in the mixing cup and snap the lid shut.
Danish: Hæld hele folieposens indhold ned i de 4,6 ml vand i blandebægeret og luk låget, så det klikker på plads.
English: *The confidence intervals were calculated with no adjustment for gender and region, which were included in the primary analysis using logistic models.
Danish: *Konfidensintervallerne (CI) blev beregnet uden justering for køn og region, som blev inkluderet i den primære analyse med anvendelse af logistiske modeller.
English: EMEND powder for oral suspension contains sucrose and lactose.
Danish: EMEND pulver til oral suspension indeholder saccharose og lactose.
English: EMEND 40 mg should be used with caution in patients receiving pimozide, terfenadine, astemizole, cisapride, or ergot alkaloid derivatives.
Danish: EMEND 40 mg bør anvendes med forsigtighed til patienter, der får pimozid, terfenadin, astemizol, cisaprid eller sekalealkaloidderivater.
English: In a randomised, double-blind study in a total of 866 adult patients (864 females, 2 males) receiving chemotherapy that included cyclophosphamide 750-1,500 mg/m2; or cyclophosphamide
Danish: I et randomiseret, dobbeltblindet studie omfattende totalt 866 voksne patienter (864 kvinder, 2 mænd), der fik kemoterapi, inkluderende cyclophosphamid 750-1.500 mg/m2; eller cyclophosphamid 500
English: - increased amount of liver enzymes in your blood.
Danish: Stigning i ASAT, øget alkalisk fosfatase i blodet
English: The potential for reproductive toxicity of aprepitant has not been fully characterised, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg and 165 mg doses could not be attained in animal studies.
Danish: Muligheden for reproduktionstoksicitet med aprepitant er ikke fuldt beskrevet, idet eksponeringsniveauer over den terapeutiske eksponering hos mennesker ved doser på 125 mg/80 mg og 165 mg ikke kunne opnås i dyreforsøg.
English: In a juvenile toxicity study in rats treated from post natal day 10 to day 63 aprepitant led to an earlier vaginal opening in females from 250 mg/kg b.i.d.
Danish: I et toksicitetsstudie med unge rotter, som blev behandlet fra dag 10 til dag 63 postnatalt, førte aprepitant til en tidligere vaginalåbning hos hunner fra 250 mg/kg to gange dagligt og til en forsinket præputial separation hos hanner fra 10 mg/kg to gange dagligt.
English: Please talk to your doctor or pharmacist if you are taking any of the following medicines:
Danish: Tal med lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: 165 mg orally
Danish: 165 mg oralt
English: Add the 4.6 mL of water from the oral dispenser back into the mixing cup.
Danish: Sprøjt de 4,6 ml vand fra dispenseringssprøjten tilbage i blandebægeret.
English: Based on a comparable pharmacokinetic/pharmacodynamic profile, the 1-day oral regimen of EMEND 165 mg is anticipated to have a similar safety and tolerability profile to that of the 1-day regimen of fosaprepitant 150 mg and the 3-day oral aprepitant regimen in chemotherapy patients (see section 5.2).
Danish: Baseret på en sammenlignelig farmakokinetisk/farmakodynamisk profil forventes et 1-dags oralt regime med EMEND 165 mg at have den samme profil med hensyn til sikkerhed og tolerabilitet som 1-dags regimet for fosaprepitant 150 mg og det 3-dages regime med oral aprepitant hos patienter i kemoterapibehandling (se pkt.
English: The reduction in risk for a vomiting episode over the 0 to 24 hour period with aprepitant 40 mg relative to ondansetron 4 mg was 53.3 % (95 % C.I.
Danish: En analyse har vist, at risikoreduktionen for at kaste op ved behandling med aprepitant 40 mg i perioden 0 til 24 timer set i forhold til ondansetron 4 mg var 53,3 % (95 % CI: 35,3 til 66,3).
English: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND.
Danish: Virkningen af hormonale kontraceptiva kan være nedsat i op til 28 dage efter administration af EMEND.
English: One patient in the Aprepitant regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses; one patient in the Standard regimen only had data in the delayed phase and was excluded from the overall and acute phase analyses.
Danish: En patient i aprepitantregimet havde kun data i den akutte fase og blev ekskluderet fra analyserne fra den totale og forsinkede fase; en patient i standardregimet havde kun data i den forsinkede fase og blev ekskluderet fra analyserne fra den totale og akutte fase.
English: Each pack of EMEND contains a sachet with the powder for oral suspension, a 1 ml and a 5 ml oral dispenser, one cap and one mixing cup.
Danish: Hver pakning med EMEND indeholder en foliepose med pulver til oral suspension, en 1 ml og en 5 ml dispenseringssprøjte til oral anvendelse, en hætte og et blandebæger.
English: In patients with severe renal impairment, the AUC0- of total aprepitant (unbound and protein bound) decreased by 21 % and Cmax decreased by 32 %, relative to healthy subjects.
Danish: Hos patienter med svært nedsat nyrefunktion faldt AUC0- for total-aprepitant (ubunden og proteinbundet) med 21 % og Cmax faldt med 32 %, set i forhold til raske personer.
English: The aprepitant regimen for children aged 6 months to less than 12 years (n=105) consisted of EMEND powder for oral suspension 3.0 mg/kg (up to 125 mg) orally on Day 1 and 2.0 mg/kg (up to 80 mg) orally on Days 2 and 3 in combination with ondansetron on Day 1.
Danish: Aprepitantregimet for børn i alderen 6 måneder til under 12 år (n=105) bestod af EMEND pulver til oral suspension 3,0 mg/kg (op til 125 mg) oralt på dag 1 og 2,0 mg/kg (op til 80 mg) oralt på dag 2 og 3 i kombination med ondansetron på dag 1.
English: Co-administration of EMEND with active substances that are known to be metabolized by CYP2C9 (e.g., phenytoin, warfarin), may result in lower plasma concentrations of these active substances.
Danish: Samtidig administration af EMEND og aktive substanser, der metaboliseres af CYP2C9 (fx phenytoin, warfarin) kan medføre lavere plasmakoncentrationer af disse substanser.
English: The powder for oral suspension contains sucrose and lactose.
Danish: Pulver til oral suspension indeholder saccharose og lactose.
English: Dexamethasone: The usual oral dexamethasone dose should be reduced by approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen.
Danish: Dexamethason: Den normale orale dexamethasondosis bør reduceres med ca. 50 %, når den samtidig administreres med EMEND 125 mg/80 mg dosisregime.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Danish: Der mangler data vedrørende virkningen på CYP2C8 og CYP2C19.
English: The recommended dose of capsules of EMEND is 125 mg orally on Day 1 and 80 mg orally on Days 2 and 3.
Danish: Den anbefalede dosis for kapsler af EMEND er 125 mg oralt på dag 1 og 80 mg oralt på dag 2 og 3.
English: Fill the 5 mL oral dispenser with 4.6 mL of water from the mixing cup.
Danish: Fyld 5 ml dispenseringssprøjten til oral anvendelse med 4,6 ml vand fra blandebægeret.
English: Data are lacking regarding effects of CYP2C8 and CYP2C19.
Danish: Data mangler vedrørende virkningen af CYP2C8 og CYP2C19.
English: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults.
Danish: Forebyggelse af akut og sen kvalme og opkastning i forbindelse med højemetogen cisplatinbaseret cancerkemoterapi hos voksne.
English: 2-day treatment pack containing: 2 x 80 mg hard capsule
Danish: 2-dages behandlingspakning indeholdende: 2 x 80 mg hårde kapsler
English: During the 3-day CINV regimen, a transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g., cyclosporine, tacrolimus, everolimus and sirolimus) is expected.
Danish: Under det 3-dages CINV-regimen forventes en forbigående moderat stigning efterfulgt af et let fald i eksponeringen af immunsuppressiva, der metaboliseres af CYP3A4 (fx ciclosporin, tacrolimus, everolimus og sirolimus).
English: There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not take EMEND').
Danish: Der er noget medicin, som ikke må tages sammen med EMEND (såsom pimozid, terfenadin, astemizol og cisaprid) eller som kræver justering af dosis (se også "Tag ikke EMEND").
English: Pregnancy and breast-feeding This medicine should not be used during pregnancy and breastfeeding unless clearly necessary.
Danish: Graviditet og amning Lægemidlet må ikke bruges under graviditet eller amning, medmindre det er klart nødvendigt.
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: Interaction studies with aprepitant 165 mg and midazolam have not been conducted; however, the following study with 200 mg of aprepitant should be considered when using EMEND 165 mg with medicinal products metabolised via CYP3A4.
Danish: Der er ikke udført interaktionsstudier med aprepitant 165 mg og midazolam; følgende studie med 200 mg aprepitant bør dog overvejes, når EMEND 165 mg sammen med lægemidler, der metaboliseres gennem CYP3A4.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se pkt 6.1).
English: Based on a comparable pharmacokinetic/pharmacodynamic profile, the 1-day oral regimen of EMEND 165 mg is anticipated to have a similar efficacy profile to that of the 1-day regimen of fosaprepitant 150 mg and 3-day regimen of oral aprepitant (see section 5.2)
Danish: Baseret på en sammenlignelig farmakokinetisk/farmakodynamisk profil forventes EMEND 165 mg 1dags oralt regime at have den samme virkningsprofil som fosaprepitant 150 mg 1-dags regime og oral aprepitant 3-dages regime (se pkt.
English: Because the effect of EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of EMEND on the pharmacokinetics of intravenously administered CYP3A4 substrates, an interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g., etoposide, vinorelbine) cannot be excluded.
Danish: Da effekten af EMEND på oralt administrerede CYP3A4-substraters farmakokinetik er større end EMENDs effekt på intravenøst administrerede CYP3A4-substraters farmakokinetik, kan interaktion med oralt administrerede kemoterapeutika, som metaboliseres primært eller delvist af CYP3A4 (fx etoposid, vinorelbin) ikke udelukkes.
English: Aprepitant regimen n/m (%)
Danish: Aprepitantregime n/m (%)
English: Further studies evaluating the use of aprepitant in paediatric patients are on-going (see section 4.2 for information on paediatric use).
Danish: Yderligere studier til vurdering af anvendelse af aprepitant hos pædiatriske patienter er igangværende (se pkt.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjælden, medfødt fructoseintolerans, glucosegalactosemalabsorption eller sukrase-isomaltasemangel bør ikke tage denne medicin.
English: Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter en enkelt dosis og gentagne doser, genotoksicitet, karcinogentet samt reproduktions- og udviklingstoksicitet.