FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women.
Danish: Virkningen af palonosetron på QTc-intervallet blev undersøgt i et dobbeltblindet, randomiseret, parallelt, placebo- og positivkontrolleret studie (moxifloxacin) i mænd og kvinder.
English: The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies.
Danish: Virkningen af palonosetron på blodtryk, hjerterytme og ekg-parametre, herunder QTc, var sammelignelig med ondansetron og dolasetron i de kliniske CINV-studier.
English: In the palonosetron 10 µg/kg, 20 µg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Danish: I grupperne med palonosetron 10 µg/kg, 20 µg/kg og ondansetron var andelen af patienter med CR0-24t henholdsvis 54,2 %, 59,4 % og 58,6 %.
English: There is no experience of palonosetron in human pregnancy.
Danish: Der er ingen erfaring med palonosetron ved graviditet hos mennesker.
English: Upon opening of the vial, use immediately and discard any unused solution.
Danish: Efter åbning af hætteglasset skal produktet anvendes med det samme, og ikke-anvendt opløsning kasseres.
English: This belongs to a group of medicines called ‘serotonin (5HT3) antagonists'.
Danish: Det hører til en gruppe af lægemidler, der kaldes ”serotonin (5HT3)- antagonister”.
English: t½, hours
Danish: AUC0-∞, t·µg/l t½, timer
English: • impaired vision or eye irritation
Danish: • Nedsat syn eller øjenirritation
English: The pivotal studies were not designed to assess efficacy of palonosetron in delayed onset nausea and vomiting.
Danish: De væsentlige studier var ikke designet til at vurdere effekten af palonosetron ved sent indsættende kvalme og opkastning.
English: No dosage adjustment is necessary based on gender.
Danish: Det er ikke nødvendigt med dosisjustering på grund af køn.
English: As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Danish: Da der ikke findes data vedrørende udskillelsen af palonosetron i mælk, bør amning ophøre under behandlingen.
English: INFORMATION IN BRAILLE Aloxi 500 micrograms
Danish: INFORMATION I BRAILLESKRIFT Aloxi 500 mikrogram
English: d Vss is reported for paediatric cancer patients, whereas Vz is reported for adult cancer patients.
Danish: d Vss (steady state) er rapporteret for pædiatriske cancerpatienter, hvorimod Vz (terminal state) er rapporteret for voksne cancerpatienter.
English: Aloxi contains the active substance palonosetron.
Danish: Aloxi indeholder det aktive stof palonosetron.
English: CYP2D6 inducers and inhibitors
Danish: CYP2D6-induktorer og -hæmmere
English: See package leaflet for further information.
Danish: Se indlægsseddel for yderligere oplysninger.
English: Elimination After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance.
Danish: Elimination Efter en enkelt intravenøs dosis på 10 mikrogram/kg [14C]-palonosetron blev ca. 80 % af dosis genfundet indenfor 144 timer i urinen med palonosetron udgørende ca. 40 % af den indgivne dosis som uændret aktivt stof.
English: The safety and efficacy of Aloxi in children aged less than 1 month have not been established.
Danish: Aloxis sikkerhed og virkning hos børn i alderen under 1 måned er ikke klarlagt.
English: • change in the colour of the vein and veins becoming larger
Danish: • Ændring i blodårens farve og/eller blodårerne bliver større
English: Efficacy after palonosetron 10 µg/kg compared to palonosetron 3µg/kg was 54.1% and 37.1% respectively.
Danish: Virkningen af palonosetron 10 µg/kg sammenlignet med palonosetron 3 µg/kg var henholdsvis 54,1 % og 37,1 %.
English: ° From post-marketing experience
Danish: ° Baseret på erfaring opnået efter markedsføring.
English: The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Danish: Formålet var at undersøge ekg-virkningen af intravenøst palonosetron ved enkeltdoser på 0,25, 0,75 eller 2,25 mg i 221 raske studiedeltagere.
English: Corticosteroids Palonosetron has been administered safely with corticosteroids.
Danish: Kortikosteroider Palonosetron er indgivet sikkert sammen med kortikosteroider.
English: If you decide not to take Aloxi (or other similar medicines), it is likely your chemotherapy will cause you to feel sick or be sick (nausea and vomiting).
Danish: Hvis De beslutter Dem for ikke at tage Aloxi (eller andre lignende lægemidler), er det sandsynligt, at Deres kemoterapi vil give Dem kvalme eller medføre opkastning.
English: If you take more Aloxi than you should If you think you may have taken more than you should, tell your doctor straight away.
Danish: Hvis De har taget for meget Aloxi Hvis De mener, De har taget for meget, skal De straks fortælle det til lægen.
English: Polyamide/aluminium/PVC blister containing one or five soft capsules.
Danish: Polyamid/aluminium/PVC-blisterpakninger med én eller fem bløde kapsler.
English: A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1).
Danish: Et specifikt og grundigt QT/QTc-studie med raske frivillige blev gennemført med henblik på at opnå definitive data for palonosetrons virkning på QT/QTc (se pkt.
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Danish: Let til moderat nedsat nyrefunktion påvirker ikke signifikant palonosetrons farmakokinetiske parametre.
English: Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Citronsyremonohydrat Natriumhydroxid (til justering af pH) Saltsyre (til justering af pH) Vand til injektionsvæsker
English: Dizziness, dyskinesia
Danish: Svimmelhed, dyskinesi
English: In post marketing very rare cases (<1/10,000) of hypersensitivity reactions occurred with palonosetron solution for injection for intravenous use.
Danish: Efter markedsføring har der været meget sjældne tilfælde (< 1/10.000) af overfølsomhedsreaktioner i forbindelse med palonosetron, injektionsvæske, opløsning til intravenøs anvendelse.
English: PHARMACEUTICAL FORM AND CONTENTS 1 soft capsule.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 1 blød kapsel
English: You will not be given Aloxi if any of the above apply to you.
Danish: De vil ikke få Aloxi, hvis noget af det ovenstående gælder for Dem.
English: Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
Danish: Da palonosetron kan fremkalde svimmelhed, døsighed og træthed, skal patienterne advares, når de fører motorkøretøj eller betjener maskiner.
English: Most patients were non-naïve to chemotherapy (78.5%) across all treatment groups.
Danish: De fleste patienter på tværs af alle behandlingsgrupper var ikke kemoterapinaive (78,5 %).
English: Atrioventricular block first degree, atrioventricular block second degree
Danish: Atroventrikulært blok af 1. grad, atroventrikulært blok af 2. grad
English: • Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og kartonen efter EXP.
English: • constipation, diarrhoea.
Danish: • Forstoppelse og diaré.
English: • high levels of the pigment bilirubin in the blood
Danish: • Høje niveauer af pigmentet bilirubin i blodet
English: • high levels of the pigment ‘bilirubin' (a marker of liver problems) in the blood
Danish: • Høje niveauer af pigmentet bilirubin (tegn på leverproblemer) i blodet
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Danish: Forebyggelse af kemoterapiinduceret kvalme og opkastning (CINV):
English: Aloxi may contain traces of lecithin which comes from soya.
Danish: Aloxi kan indeholde spor af lecithin, som udvindes af soja.
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Danish: 24 - 120 timer 0 - 120 timer Ingen kvalme (Likert skala)
English: As shown in Table 1, oral Aloxi capsules 500 micrograms demonstrated non-inferiority to the active comparator during the 0 to 24 hour and 0 to 120 hour time intervals; however, for the 24 to 120 hour time period, non-inferiority was not shown.
Danish: Som det fremgår af tabel 1, viste orale Aloxi-kapsler 500 mikrogram noninferioritet i forhold til sammenligningsproduktet i løbet af 0-24 timers- og 0-120 timers-intervallerne, men for 24-120 timersperioden blev der ikke vist nogen noninferioritet.
English: Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
Danish: Døsighed, insomni, paræstesier, søvntrang, perifer sensorisk neuropati
English: • abnormally high or low levels of potassium in the blood
Danish: • Unormalt høje eller lave niveauer af kalium i blodet
English: In a multicentre, randomised, double-blind active control clinical trial of 635 patients set to receive moderately emetogenic cancer chemotherapy.
Danish: I et randomiseret dobbeltblindet aktivkontrolleret klinisk multicenterstudie fik 635 patienter moderat kvalmefremkaldende cancerkemoterapi.
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Danish: Der har været rapporter om serotonergt syndrom ved anvendelse af 5-HT3-antagonister, enten alene eller i kombination med andre serotoninerge lægemidler (herunder selektive serotoningenoptagshæmmere (selective serotonin reuptake inhibitors, SSRI'er) og serotoninnoradrenalingenoptagshæmmere (serotonin noradrenaline reuptake inhibitors, SNRI'er).
English: b PK parameters expressed as Arithmetic mean (SD)
Danish: Farmakokinetiske parametre udtrykt som aritmetiske gennemsnit (SD).
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Danish: I pædiatriske kliniske studier af forebyggelse af kvalme og opkastning induceret af kemoterapi med moderat eller kraftig kvalmefremkaldende virkning fik 402 patienter en enkelt dosis palonosetron (3, 10 eller 20 mikrog/kg).
English: Elevated transaminases-, electrocardiogram QT prolonged
Danish: Forhøjede transaminaser, QT-forlængelse i elektrokardiogrammet
English: Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Danish: Glycerolmonocaprylocaproat (type I)
English: LIST OF EXCIPIENTS Also contains sorbitol.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også sorbitol.
English: 0 - 24 hours
Danish: 0 - 24 timer
English: Dolasetron 100 milligrams (n= 191)
Danish: Dolasetron 100 milligram (n= 191)
English: Biotransformation Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Danish: Ca. 40 % elimineres gennem nyrerne og ca. 50 % metaboliseres, således at der dannes to primære metabolitter, som har mindre end 1% af palonosetrons 5HT3-receptor antagonistvirkning.
English: Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
Danish: Farmakokinetiske simuleringer indikerer, at den overordnede eksponering (AUC0-∞) af 0,25 mg intravenøst palonosetron én gang dagligt i 3 dage i træk var sammenlignelig med en enkelt iv-dosis på 0,75 mg, selvom Cmax for 0,75 mg enkeltdosen var højere.
English: Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical studies, 875 patients enrolled in the three phase 3 trials continued in an open label safety study and were treated with palonosetron 750 micrograms for up to 9 additional cycles of chemotherapy.
Danish: Selvom den relative virkning af palonosetron ved multiple behandlingscykler ikke er blevet demonstreret i kontrollerede kliniske studier, fortsatte 875 patienter, der var inkluderet i de tre fase tre studier, i et åbent sikkerhedsstudie og blev behandlet med palonosetron 750 mikrogram i op til 9 yderligere cykler med kemoterapi.
English: The efficacy of Aloxi for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an i.v.
Danish: Aloxis virkning til forebyggelse af kemoterapifremkaldt kvalme og opkastning hos pædiatriske cancerpatienter blev vist i et andet pivotalt non-inferioritetsstudie, der sammenlignede en enkelt intravenøs infusion med palonosetron versus et regime med i.v.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RETRICTIONS REGARDING SUPPLY AND USE
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: 1 x 5 ml vial
Danish: 1 x 5 ml-hætteglas
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. at det i det væsentlige er natriumfrit.
English: Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Danish: Med den præspecificerede noninferioritetsmargin på -10 % var det stratumjusterede Mantel-Haenszel statistiske noninferioritets-konfidensinterval for forskellen i det primære endepunkt, fuldstændigt respons (CR), [-10,5; 1,7 %], og derfor blev noninferioritet ikke påvist.
English: Urinary retention, glycosuria
Danish: Urinretention, glukosuri
English: Single use only
Danish: Kun til engangsbrug
English: The primary efficacy variable was the proportion of patients with a complete response (CR, defined as no emetic episode and no rescue medication) during the first 24 hours after the start of chemotherapy administration.
Danish: Den primære effektvariable var andelen af patienter med komplet respons (CR, defineret som ingen emetisk episode og ingen behovsmedicin) i de første 24 timer efter påbegyndelse af kemoterapi.
English: In clinical studies at a dose of 500 micrograms (total 161 patients) the most frequently observed adverse reaction, at least possibly related to Aloxi, was headache (3.7 %).
Danish: I kliniske studier med en dosering på 500 mikrogram (totalt 161 patienter) var den hyppigst observerede bivirkning, der i det mindste muligvis var relateret til Aloxi, hovedpine (3,7 %).
English: The second paediatric,trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing i.v.
Danish: Det andet pædiatriske studie var et multicenter, dobbeltblindet, dobbelt-dummy, randomiseret enkeltdosis-noninferioritetsstudie med parallelle grupper og aktiv kontrol, der sammenlignede i.v.
English: In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Danish: I en populations-farmakokinetisk analyse er det blevet vist, at der ikke var nogen signifikant virkning på palonosetrons clearance, når det blev givet sammen med CYP2D6-induktorer (dexamethason og rifampicin) og hæmmere (herunder amiodaron, celecoxib, chlorpromazin, cimetidin, doxorubicin, fluoxetin, haloperidol, paroxetin, quinidin, ranitidin, ritonavir, sertralin eller terbinafin).
English: No new safety concerns were raised in either treatment group.
Danish: Ingen nye sikkerhedsproblemer blev identificeret i nogen af behandlingsgrupperne.
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.
Danish: Da palonosetron kan øge passagetiden i tyktarmen, skal patienter med en anamnese med obstipation eller tegn på subakut tarmobstruktion overvåges efter indgiften.
English: If you are pregnant or think you might be pregnant, your doctor will not give you Aloxi unless it is clearly necessary.
Danish: Hvis De er gravid eller har mistanke om, at De er gravid, vil Deres læge ikke give Dem Aloxi, medmindre det er strengt nødvendigt.
English: • medicines called SNRIs (‘serotonin noradrenaline reuptake inhibitors') - such as venlafaxine, duloxetine (can lead to the development of serotonin syndrome and should be used with caution).
Danish: • lægemidler, der kaldes SNRI'er (”serotonin-noradrenalingenoptagshæmmere”), såsom venlafaxin, duloxetin (kan føre til udvikling af serotoninsyndrom og bør anvendes med forsigtighed).
English: Aloxi contains sorbitol.
Danish: Aloxi indeholder sorbitol.
English: Aloxi contains sodium
Danish: Aloxi indeholder natrium
English: 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
Danish: 20 mikrogram/kg (den maksimale totale dosis bør ikke overskride 1500 mikrogram) palonosetron administreret som en enkelt 15-minutters intravenøs infusion, der begynder ca. 30 minutter før påbegyndelse af kemoterapi.
English: • allergic reaction - the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, an itchy, lumpy rash (hives).
Danish: • Allergisk reaktion - tegnene kan omfatte hævelse af læber, ansigt, tunge eller hals, vejrtrækningsbesvær eller kollaps, kløende, ujævnt udslæt (nældefeber).
English: Excipient(s):
Danish: Hjælpestof(fer):
English: • numbness, burning, prickling or tingling sensations on the skin
Danish: • Følelsesløshed, brændende, prikkende eller stikkende fornemmelse på huden
English: Aloxi pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 µg/kg or 20 µg/kg.
Danish: Aloxi blev indhentet fra en undergruppe af pædiatriske cancerpatienter (n=280), der fik 10 µg/kg eller 20 µg/kg.
English: • weakness, feeling tired, fever or flu like symptoms
Danish: • Svaghed, træthedsfølelse, feber eller influenza-lignende symptomer
English: The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarization.
Danish: Studiet viste ingen virkning på varigheden af QT/QTc-intervallet eller noget andet ekg-interval ved doser på op til 2,25 mg. Der blev ikke fundet nogen kliniske signifkant ændring af hjerterytmen, den atrioventrikulære overledning og repolariseringen af hjertet.
English: Elimination Following administration of a single oral 750 micrograms 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 feces.
Danish: Elimination Efter administration af en enkelt oral dosis på 750 mikrogram/kg [14C]-palonosetron hos seks raske studiepersoner blev ca. 85 % til 93 % af den samlede radioaktivitet udskilt i urinen, og 5 % til 8 % blev udskilt via fæces.
English: • headache.
Danish: • Hovedpine.
English: Available in packs of 1 vial containing 5 ml of solution.
Danish: Findes i pakninger med 1 hætteglas indeholdende 5 ml opløsning.
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Danish: Palonosetron metaboliseres hovedsageligt af CYP2D6, med et mindre bidrag af CYP3A4 og CYP1A2 isoenzymer.
English: Aloxi capsules may also contain a trace of lecithin derived from soya.
Danish: Aloxikapsler kan også indeholde spor af lecithin udvundet af soja.
English: thioridazine
Danish: thioridazin
English: Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 μg/kg in healthy subjects and in cancer patients.
Danish: Middel maksimal plasmakoncentration (Cmax) og arealet under koncentrations-tids kurven (AUC0-∞) er overvejende dosis-proportional i dosisområdet fra 0,3-90 μg/kg hos sunde studiepersoner og hos cancerpatienter.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included> 18.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to
Danish: De blev klassificeret som almindelige (≥1/100 til <1/10) eller ikke almindelige (≥1/1.000 til <1/100).
English: Other medicines and Aloxi
Danish: Brug af anden medicin sammen med Aloxi
English: If you forget to take Aloxi
Danish: Hvis De har glemt at tage Aloxi
English: • The active substance is palonosetron (as hydrochloride).
Danish: • Aktivt stof: palonosetron (som hydrochlorid).
English: Non-inferiority criteria were met if the lower bound of the twosided 98.3 % confidence interval for the difference in complete response rates of oral palonosetron dose minus approved intravenous formulation was larger than -15 %.
Danish: Kriterierne for noninferioritet var overholdt, hvis den nedre grænse for det to-sidede 98,3 %-konfidensinterval for forskellen mellem de samlede responsrater for oral palonosetron-dosen minus den godkendte intravenøse formulering var højere end -15 %.
English: Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Danish: Virkning var baseret på påvisning af noninferioritet af intravenøs palonosetron sammenlignet med intravenøs ondansetron.
English: • Do not use this medicine after the expiry date which is stated on the blister and carton after
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter EXP.
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QT corrected (QTc) interval.
Danish: Ved alle testede dosisniveauer fremkaldte palonosetron ikke klinisk relevant forlængelse af det korrigerede QT-interval (QTc).
English: Uncommon side effects shown in tests: may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger påvist ved analyser: kan forekomme hos op til 1 ud af 100 personer
English: Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 µg /kg and 20 µg /kg dose groups combined.
Danish: Clearance og fordelingsvolumen hos pædiatriske patienter blev beregnet med vægtjustering fra de kombinerede dosisgrupper med 10 µg/kg og 20 µg/kg.