FrancophonIA/ELRC3.0 huggingface dataset:
English: Significance level at α=0.05.
Danish: 2-test. Signifikansniveau α=0,05.
English: (as hydrochloride).
Danish: (som hydrochlorid).
English: This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Danish: Lægemidlet bør indgives af sundhedspersonale under passende lægelig supervision.
English: The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Danish: De følgende almindelige eller ikke almindelige bivirkninger blev rapporteret for palonosetron, ingen blev rapporteret med en hyppighed på >1 %.
English: Approximately 62 % of palonosetron is bound to plasma proteins.
Danish: Ca. 62 % af palonosetron er bundet til plasmaproteiner.
English: Do not stop taking this medicine without talking to your doctor.
Danish: De må ikke holde op med at tage dette lægemiddel uden at tale med lægen.
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97 %.
Danish: Efter oral indgift absorberes palonosetron godt, idet dets absolutte biotilgængelighed når 97 %.
English: p-value c
Danish: p-værdi c
English: Patients were randomised to either dexamethasone or placebo in addition to their assigned treatment.
Danish: Patienterne blev randomiseret til enten dexamethason eller placebo i tillæg til den tildelte behandling.
English: Each vial contains one dose.
Danish: Hvert hætteglas indeholder én dosis.
English: No Nausea (Likert Scale)
Danish: Ingen kvalme (Likert skala)
English: There are no apparent differences in volume of distribution when expressed as L/kg.
Danish: Der er tilsyneladende ingen forskelle i fordelingsvolumen, når det udtrykkes i l/kg.
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Danish: Der rådes til passende observation af patienter med serotonergt syndrom-lignende symptomer.
English: * Includes the following: burning, induration, discomfort and pain
Danish: * Omfatter følgende: brænden, induration, ubehag og smerter.
English: The AUC was 30 % higher in cancer patients than in healthy subjects.
Danish: AUC var 30 % højere hos cancerpatienter end hos raske studiepersoner.
English: Date of latest renewal: 23 March 2010
Danish: Dato for første markedsføringstilladelse: 22. marts 2005 Dato for seneste fornyelse: 23. marts 2010
English: • pain at the site of infusion.
Danish: • Smerter på infusionsstedet.
English: • It is given as an injection into a vein.
Danish: • Det gives som en injektion i en blodåre.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: In adults, different dose levels are indicated in column title.
Danish: Hos voksne er de forskellige dosisniveauer indikeret i overskriften for søjlen.
English: • you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium.
Danish: • De har en ubalance af visse mineraler i Deres blod, som ikke er blevet behandlet, såsom kalium eller magnesium.
English: • you have a blocked bowel or have had repeated constipation in the past
Danish: • De har en blokeret tarm eller tidligere har haft gentagne tilfælde med forstoppelse
English: • high or low blood pressure
Danish: • For højt eller lavt blodtryk
English: Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/kg.
Danish: Palonosetron i den anbefalede dosering fordeles i vid udstrækning i kroppen med et fordelingsvolumen på ca. 6,9 to 7,9 l/kg.
English: Aloxi contains sorbitol and may contain traces of soya This medicine contains 7 mg sorbitol (a type of sugar) in each capsule.
Danish: Aloxi indeholder sorbitol og kan indeholde spor af soja Dette lægemiddel indeholder 7 mg sorbitol (en form for sukker) i hver kapsel.
English: Ten percent of patients have a mean terminal elimination half-life greater than 100 hours.
Danish: Ti procent af patienterne har en middel terminal eliminationshalveringstid, der er længere end 100 timer.
English: • decrease or loss of appetite
Danish: • Nedsat appetit eller tab af appetit
English: • Aloxi will be given as a drip (a slow infusion into a vein).
Danish: • Aloxi vil blive givet som et drop (langsom infusion i en blodåre).
English: Aloxi is indicated in paediatric patients 1 month of age and older for:
Danish: Aloxi er hos pædiatriske patienter i alderen 1 måned og ældre indiceret til:
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Danish: Imidlertid skal der som for andre 5-HT3 antagonister udvises forsigtighed ved anvendelse af palonosetron hos patienter, som har eller som muligvis vil udvikle forlænget QT-interval.
English: However, in general the antiemetic effect for the 0-24 hour interval was similar throughout the consecutively repeated cycles and the overall safety was maintained during all cycles.
Danish: Generelt var den kvalmestillende virkning i 0-24 timers-intervallet dog den samme i efterfølgende gentagne cykler, og den samlede sikkerhed blev opretholdt gennem alle cyklerne.
English: Complete Response was not formally evaluated for the repeat cycle application.
Danish: Det samlede respons blev ikke formelt evalueret ved behandling i gentagne cykler.
English: The study was designed to show non-inferiority.
Danish: Studiet var designet til at vise ikke dårligere kvalitet.
English: In the unlikely event of overdose with Aloxi, this should be managed with supportive care.
Danish: I det usandsynlige tilfælde, at der skulle ske en overdosering med Aloxi, skal dette håndteres med understøttende behandling.
English: Therefore, Aloxi capsules may be taken without regard to meals.
Danish: Aloxi-kapsler kan derfor tages uden hensyn til måltider.
English: CONDITIONS OR RETRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • you have had heart problems or heart problems run in your family, such as changes in your heart beat (‘QT prolongation')
Danish: • De har haft hjerteproblemer, eller hvis der er tendens til hjerteproblemer i Deres familie, såsom ændringer af Deres hjerteslag (”QT-forlængelse”)
English: Significance levels at alpha 0.0167 (adjusted for multiple comparisons).
Danish: c Chi2-test. Signifikansniveauer ved alfa 0,0167 (justeret for multiple sammenligninger).
English: Intent-to-treat cohort b
Danish: Hensigt-til-at-behandle kohorte b
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since Aloxi is intended for single application in humans, these findings are not considered relevant for clinical use.
Danish: De tilgrundliggende mekanismer er ikke helt forstået, men på grund af de høje anvendte doser og da Aloxi er beregnet til enkelt dosering hos mennesker, betragtes disse fund ikke som værende relevante i forhold til klinisk anvendelse.
English: Do not take Aloxi if:
Danish: Tag ikke Aloxi, hvis:
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 (allergi) over for jordnødder eller soja bør derfor overvåges nøje for tegn på allergisk reaktion.
English: Soft capsule.
Danish: Blød kapsel.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik i specielle populationer
English: However, if you think you have forgotten to take your dose, tell your doctor straight away.
Danish: Hvis De mener, De har glemt at tage Deres dosis, skal De fortælle det til lægen med det samme.
English: • high levels of sugar in the blood or sugar in the urine
Danish: • Høje niveauer af sukker i blodet eller urinen
English: Children Do not give this medicine to children
Danish: Børn Dette lægemiddel må ikke gives til børn.
English: Clearance c, L/h/kg Volume of distribution c, d, L/kg 6.08
Danish: Clearance c, l/t/kg Fordelingsvolumen c, d, l/kg a
English: The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed.
Danish: Gruppen, der fik den højeste dosis, udviste en lignende bivirkningsfrekvens sammenlignet med de andre dosisgrupper, og der blev ikke observeret nogen dosis-respons virkninger.
English: Aloxi is indicated in adults for:
Danish: Aloxi er hos voksne indiceret til:
English: Children and Adolescents (aged 1 month to 17 years):
Danish: Børn og unge (i alderen 1 måned til 17 år):
English: While this study demonstrated that paediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults (see section 4.8).
Danish: Mens dette studie viste, at pædiatriske patienter har behov for en højere palonosetrondosis end voksne for at forhindre kemoterapifremkaldt kvalme og opkastning, er sikkerhedsprofilen i overensstemmelse med den fastlagte profil hos voksne (se pkt.
English: Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.
Danish: Hypokaliæmi og hypomagnesiæmi skal korrigeres før administration af en 5HT3-antagonist.
English: Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Danish: Palonosetron bør derfor ikke anvendes til gravide kvinder, medmindre det af lægen anses for tvingende nødvendigt.
English: Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 µg/kg.
Danish: Den mediane halveringstid var 29,5 timer i de samlede aldersgrupper, og i intervallet fra ca. 20 til 30 timer over alle aldersgrupper efter administration af 20 µg/kg.
English: When the dose was increased from10 µg/kg to 20 µg/kg a dose-proportional increase in mean AUC was observed.
Danish: Når dosis blev øget fra 10 µg/kg til 20 µg/kg, blev der observeret en dosisproportional forhøjelse i gennemsnitlig AUC.
English: • abnormal electrical impulses in the heart
Danish: • Unormale elektriske impulser i hjertet
English: The majority of patients in the study were women (73 %), white (69 %), and naïve to previous chemotherapy (59 %).
Danish: De fleste patienter i studiet var kvinder (73 %), hvide (69 %) og kemoterapibehandlingsnaive (59 %).
English: Injection site reaction*
Danish: Reaktion på injektionsstedet*
English: Palonosetron is not mutagenic.
Danish: Palonosetron er ikke mutagent.
English: Butylhydroxyanisole
Danish: Butylhydroxyanisol
English: Children and young people (aged 1 month to 17 years)
Danish: Børn og unge mennesker (i alderen 1 måned til 17 år)
English: Method of administration For intravenous use.
Danish: Administration Til intravenøs anvendelse.
English: Very rare: may affect up to 1 in 10,000 people • Burning, pain or redness at the injection site
Danish: Meget sjældne: kan forekomme hos op til 1 ud af 10.000 personer • Brændende fornemmelse, smerter eller rødme på injektionsstedet.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Danish: Den antiemetiske virkning blev iagttaget over 0-24 timer, 24-120 timer og 0-120 timer.
English: No case of overdose has been reported in paediatric clinical studies.
Danish: Der er ikke indberettet tilfælde af overdosering i pædiatriske kliniske studier.
English: Medicines that can affect your heart beat
Danish: Lægemidler, der kan påvirke Deres hjerteslag
English: • The maximum dose is 1500 micrograms.
Danish: • Den maksimale dosis er 1500 mikrogram.
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Danish: Fertilitet Der foreligger ingen data om effekten af palonosetron på fertilitet.
English: The amount of unchanged palonosetron excreted in the urine represented approximately 40 % of the administered dose.
Danish: Mængden af uændret palonosetron, der blev udskilt i urinen, udgjorde ca. 40 % af den indgivne dosis.
English: There are limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.
Danish: Der foreligger begrænsede data om anvendelse af Aloxi til forebyggelse af kvalme og opkastning hos børn under 2 år.
English: Results for the studies on moderately emetogenic chemotherapy and for the study on highly emetogenic chemotherapy are summarised in the following tables.
Danish: Resultaterne af studierne omhandlende moderat kvalmefremkaldende kemoterapi og for studiet omhandlende kraftigt kvalmefremkaldende kemoterapi er opsummeret i de følgende tabeller.
English: You may feel dizzy or tired after taking this medicine.
Danish: De kan føle Dem svimmel eller træt, efter De har taget dette lægemiddel.
English: It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit.
Danish: Det virker ved at blokere virkningen af et kemisk stof, der kaldes serotonin, som kan give kvalme eller medføre opkastning.
English: Motion sickness, tinnitus
Danish: Transportsyge, tinnitus
English: Capsule content:
Danish: Kapselindhold:
English: • The recommended dose is one capsule (500 micrograms).
Danish: • Den anbefalede dosis er én kapsel (500 mikrogram).
English: The total body clearance (L/h/kg) in patients 12 to 17 years old was similar to that in healthy adults.
Danish: Den totale legemsclearance (l/t/kg) hos patienter fra 12 til 17 år var sammenlignelig med clearance hos raske voksne.
English: Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
Danish: Palonosetron er en selektiv receptorantagonist med høj affinitet til 5HT3-receptoren.
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
Danish: I de kliniske studier blev følgende bivirkninger observeret som mulige eller sandsynlige i forbindelse med Aloxi.
English: Do not take Aloxi if any of the above applies to you.
Danish: De må ikke tage Aloxi, hvis noget af det ovenstående gælder for Dem.
English: Each capsule contains 7 mg sorbitol.
Danish: Hver kapsel indeholder 7 mg sorbitol.
English: • medicines for infections such as moxifloxacin, erythromycin
Danish: • lægemidler mod infektioner, såsom moxifloxacin, erythromycin
English: • You will normally take the capsule about 60 minutes before the start of your chemotherapy.
Danish: • De skal normalt tage kapslen ca. 60 minutter før starten af Deres kemoterapi,
English: • jerky body movements
Danish: • Rykvise kropsbevægelser
English: • you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Danish: • De er allergisk over for palonosetron eller et af de øvrige indholdsstoffer i Aloxi (angivet i punkt 6).
English: 5 soft capsules.
Danish: 5 bløde kapsler
English: The low total body clearance and large volume of distribution resulted in a terminal elimination half-life in plasma of approximately 40 hours.
Danish: Den lave totalkropsclearance og det store fordelingsvolumen førte til en terminal eliminationshalveringstid i plasma på ca. 40 timer.
English: Aloxi should be used only before chemotherapy administration.
Danish: Aloxi bør kun anvendes før indgift af kemoterapi.
English: • abnormal heart rate or lack of blood flow to the heart
Danish: • Anormal hjerterytme eller mangel på blodtilførsel til hjertet
English: Dexamethasone was administered prophylactically before chemotherapy in 67 % of patients.
Danish: Dexamethason blev givet profylaktisk før kemoterapi hos 67 % af patienterne.
English: Any unused solution should be discarded.
Danish: Ikke-anvendt opløsning skal kasseres.
English: Blood bilirubin increased
Danish: Forhøjet blodbilirubin
English: Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Danish: Bivirkningerne blev evalueret hos pædiatriske patienter, der fik palonosetron i op til 4 kemoterapicyklusser.
English: Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
Danish: To tilfælde af obstipation med fækal sammenpresning, der krævede hospitalisering, er blevet rapporteret i forbindelse med 750 mikrogram palonosetron.
English: Prevention of Post Operative Nausea and Vomiting (PONV):
Danish: Forebyggelse af postoperativ kvalme og opkastning (PONV):
English: • The recommended dose of Aloxi is 250 micrograms.
Danish: • Den anbefalede dosis af Aloxi er 250 mikrogram.
English: Adjuvant corticosteroids, including dexamethasone, were administered with chemotherapy in 55% of patients.
Danish: Adjuverende behandling med kortikosteroider, herunder dexamethason, blev administreret sammen med kemoterapi hos 55 % af patienterne.
English: A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Danish: I alt 670 pædiatriske, kirurgiske patienter i alderen 30 dage til 16,9 år deltog.
English: Approximately 74 % of patients also received single dose oral or intravenous dexamethasone 30 minutes before chemotherapy.
Danish: Ca. 74 % af patienterne fik også enkeltdoser oral eller intravenøs dexamethason 30 minutter før kemoterapien.
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: Medens den terminale eliminationshalveringstid og middel systemisk eksposition for palonosetron er øget hos patienter med svært nedsat leverfunktion, giver dette ikke anledning til dosisreduktion.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 µg/kg or 3 µg/kg (88% vs 84%).
Danish: Andelen af patienter uden emesis 0-72 timer efter operation var den samme efter palonosetron 1 µg/kg og 3 µg/kg (88 % versus 84 %).
English: Following intravenous administration, an initial decline in plasma concentrations is followed by slow elimination from the body with a mean terminal elimination half-life of approximately 40 hours.
Danish: Efter intravenøs indgift efterfølges et initialt fald i plasmakoncentrationen af en langsom elimination fra kroppen med en middel terminal eliminationshalveringstid på ca. 40 timer.
English: • low levels of calcium in the blood
Danish: • Lave niveauer af kalcium i blodet
English: Aloxi soft capsules: Medicinal product subject to medical prescription.
Danish: Aloxi bløde kapsler: Lægemidlet er receptpligtigt.
English: • You will be given the medicine about 30 minutes before the start of chemotherapy.
Danish: • De vil få lægemidlet ca. 30 minutter før starten på kemoterapi.
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Danish: Dette omfatter patienter med en personlig anamnese eller familieanamnese med QT-forlængelse, elektrolytforstyrrelser, kronisk hjertesvigt, bradyarytmi, eller ledningsforstyrrelser og patienter, der tager antiarytmika eller andre lægemidler, der kan medføre QT-forlængelse eller elektrolytforstyrrelser.
English: Eye irritation, amblyopia
Danish: Øjenirritation, amblyopi
English: Doses of up to 6 mg have been used in clinical trials.
Danish: Doser på op til 6 mg har været anvendt i kliniske studier.
English: They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.
Danish: De leveres i polyamid/aluminium/PVC-blisterpakninger med én eller fem kapsler.
English: Cough, dyspnoea, epistaxis
Danish: Hoste, dyspnø, epistaxis
English: A lower bound greater than -15 % demonstrates non-inferiority between Aloxi and comparator.
Danish: En nedre grænse større end - 15 % viser ikke dårligere kvalitet mellem Aloxi og kontrollen.
English: The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group.
Danish: Det primære virkningsendepunkt, fuldstændigt respons (CR: ingen opkastning, ingen opkastningsfornemmelser og ingen antiemetisk nødmedicin) i løbet af de første 24 timer efter operationen, blev nået hos 78,2 % af patienterne i palonosetron-gruppen, og hos 82,7 % i ondansetron-gruppen.
English: Elderly people
Danish: Ældre personer
English: A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Danish: Et måltid med højt fedtindhold påvirkede ikke Cmax og AUC for oral palonosetron.
English: Following single dose intravenous infusion of Aloxi 20 µg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Danish: Efter en enkelt intravenøs infusion med Aloxi 20 µg/kg var de rapporterede, maksimale plasmakoncentrationer (CT) ved slutningen af den 15-minutters infusion meget variable for alle aldersgrupper, og de havde en tendens til at være lavere hos patienter < 6 år end hos ældre pædiatriske patienter.
English: You may feel dizzy or tired after being given this medicine.
Danish: De kan føle Dem svimmel eller træt, efter De har fået dette lægemiddel.
English: See your doctor straight away if you notice any signs of an allergic reaction.
Danish: De skal konsultere Deres læge med det samme, hvis De bemærker et eller flere tegn på allergisk reaktion.
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 kvindelige studiepersoner (n=18) var gennemsnitligt AUC 35 % højere, og det gennemsnitlige Cmax var 26 % højere end hos mandlige studiepersoner (n=18).
English: • medicines for heart problems such as amiodarone, nicardipine, quinidine
Danish: • lægemidler mod hjerteproblemer, såsom amiodaron, nicardipin, quinidin
English: • medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine,
Danish: • lægemidler mod alvorlige psykiske problemer, såsom haloperidol, chlorpromazin, quetiapin,
English: 0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea)
Danish: 0 - 24 timer 24 - 120 timer 0 - 120 timer Fuld kontrol (Fuldt respons og ikke mere end let kvalme)
English: • ringing in the ear
Danish: • Ringen for øret
English: Doses of up to 6 mg have been used in adult clinical studies.
Danish: Doser på op til 6 mg har været anvendt i kliniske studier hos voksne.
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Danish: I et klinisk studie blev der ikke påvist nogen farmakokinetisk interaktion mellem en enkelt intravenøs dosis palonosetron og steady state koncentration af oral metoclopramid, som er en CYP2D6 inhibitor.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen inden brug
English: Other side effects Tell your doctor if you notice any of the following side effects: Common: may affect up to 1 in 10 people
Danish: Andre bivirkninger Fortæl det til lægen, hvis De bemærker en eller flere af de følgende bivirkninger: Almindelige: kan forekomme hos op til 1 ud af 10 personer
English: Anxiety, euphoric mood
Danish: Angst, euforisk stemning
English: Complete Response (No Emesis and No Rescue Medication)
Danish: Delta Fuldt respons (Ingen kvalme eller opkastning og ingen behovsmedicin)