FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment in children less than 4 years of age generally starts with a daily dose of 10 mg per kilogram body weight.
Danish: Behandling af børn under 4 år begynder typisk med en daglig dosis på 10 mg pr. kg legemsvægt.
English: Inovelon is used as an add-on to other anti-epileptic medicines.
Danish: Inovelon anvendes som tillægsbehandling til andre antiepileptiske lægemidler.
English: What is Inovelon and what is it used for?
Danish: Hvad er Inovelon, og hvad anvendes det til?
English: Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Danish: Lennox-Gastault-syndrom er en sjælden sygdom, og Inovelon blev udpeget som "lægemiddel til sjældne sygdomme" den 20. oktober 2004.
English: However, other analyses showed that doses based on body weight in children aged 1 to 4 years produced similar levels of the medicine in the body to those seen with standard doses in older patients.
Danish: Andre analyser viste imidlertid, at vægtbaserede doser hos børn i alderen 1-4 år gav samme niveau af lægemidlet i kroppen som standarddoser hos ældre patienter.
English: The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, vomiting, and tiredness.
Danish: De hyppigste bivirkninger ved Inovelon (der kan forekomme hos flere end 1 ud af 10 patienter) er søvnighed, hovedpine, svimmelhed, opkastning og træthed.
English: This dampens down the activity of the brain cells and prevents abnormal electrical activity from spreading through the brain.
Danish: Dette dæmper hjernecellernes aktivitet og forhindrer unormal elektrisk aktivitet i at sprede sig i hjernen.
English: Why is Inovelon authorised in the EU?
Danish: Hvorfor blev Inovelon godkendt i EU?
English: The main measures of effectiveness were the change in the number of seizures in the four weeks after Inovelon or placebo was added, compared with the four weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient's parent or guardian.
Danish: De primære mål for virkning var ændringen i antallet af anfald i en periode på fire uger efter tilføjelsen af Inovelon eller placebo sammenholdt med en periode på fire uger før tilføjelsen samt ændringen i sværhedsgraden af anfald bedømt på en 7-trins skala af patientens forældre eller værge.
English: The medicine should not be used in patients who have severe problems with their liver.
Danish: Inovelon bør ikke anvendes hos patienter, der har alvorlige leverproblemer.
English: In a main study involving 139 patients aged between 4 and 30 years (three quarters of them below 17 years old) Inovelon caused a reduction in the number and severity of seizures.
Danish: I et hovedstudie med deltagelse af 139 patienter i alderen 4-30 år (75 % af dem var under 17 år) medførte Inovelon en reduktion i antallet og sværhedsgraden af anfald.
English: What are the risks associated with Inovelon?
Danish: Hvilke risici er der forbundet med Inovelon?
English: The active substance in Inovelon, rufinamide, acts by attaching to special channels (sodium channels) on brain cells that control their electrical activity.
Danish: Det aktive stof i Inovelon, rufinamid, virker ved at binde til bestemte kanaler (natriumkanaler) på overfladen af hjernecellerne, der styrer cellernes elektriske aktivitet.
English: Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Danish: Symptomerne på dette syndrom omfatter forskellige typer anfald, unormal elektrisk aktivitet i hjernen, indlæringsvanskeligheder og adfærdsproblemer.
English: The study compared the effects of adding Inovelon tablets or adding placebo (a dummy treatment) to the other medicines the patients were taking.
Danish: I studiet sammenlignede man virkningen af at tilføje Inovelontabletter eller placebo (ikke-aktivt stof) til de andre lægemidler, som patienterne tog.
English: Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic' seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo.
Danish: Patienter, der fik tilføjet Inovelon, havde også en reduktion på 42,5 % i antallet af tonisk-atoniske anfald (en almindelig type anfald hos patienter med Lennox-Gastault-syndrom, som ofte medfører, at patienten falder til jorden) sammenholdt med en stigning på 1,9 % hos dem, der fik tilføjet placebo.
English: For the full list of side effects of Inovelon, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Inovelon fremgår af indlægssedlen.
English: Inovelon must not be used in patients who are hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients.
Danish: Inovelon må ikke anvendes hos patienter, der er allergiske over for rufinamid, triazol-derivater (som f.eks. visse lægemidler, der anvendes til at behandle svampeinfektioner) eller et eller flere af indholdsstofferne.
English: Inovelon is an epilepsy medicine used to treat patients aged one year or older who have LennoxGastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood.
Danish: Inovelon er et lægemiddel mod epilepsi, der anvendes til at behandle patienter i alderen 1 år og opefter, som har Lennox-Gastault-syndrom, der er en sjælden type epilepsi, som typisk rammer børn, men som kan fortsætte ind i voksenalderen.
English: Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the four-week period before Inovelon was started.
Danish: Patienter, der fik Inovelon, havde en reduktion på 35,8 % i det samlede antal anfald (i gennemsnit havde de haft 290 anfald i en periode på fire uger op til påbegyndelsen af Inovelon-behandling).
English: An improvement in the severity of seizures was reported for about half of the patients adding Inovelon, compared with a third of those adding placebo.
Danish: Hos omkring halvdelen af de patienter, der fik tilføjet Inovelon, blev der observeret en forbedring af sværhedsgraden af anfald sammenholdt med en tredjedel blandt dem, der fik tilføjet placebo.
English: How is Inovelon used?
Danish: Hvordan anvendes Inovelon?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inovelon have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Inovelon.
English: What benefits of Inovelon have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Inovelon?
English: Inovelon can only be obtained with a prescription and treatment should be started by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders) experienced in the treatment of epilepsy.
Danish: Inovelon udleveres kun på recept, og behandlingen bør iværksættes af en børnelæge eller en neurolog, som har erfaring med at behandle epilepsi.
English: Resolor was generally well tolerated.
Danish: Resolor blev generelt tolereret godt.
English: Steady-state is reached within three to four days.
Danish: Steady state nås inden for tre til fire dage.
English: The absolute oral bioavailability is >90%.
Danish: Den absolutte orale biotilgængelighed er > 90 %.
English: Non-renal elimination contributes to about 35% of total elimination.
Danish: Ikke-renal elimination bidrager til cirka 35 % af den totale elimination.
English: This effect is too small to be clinically relevant.
Danish: Denne virkning er for lille til at være klinisk relevant.
English: The mechanism for this interaction is not clear.
Danish: Mekanismen for denne interaktion er ikke klarlagt.
English: Long-term study
Danish: Længerevarende studie
English: In case of diarrhoea, make sure that you drink enough water.
Danish: I tilfælde af diarré skal du sørge for at drikke rigeligt vand.
English: B-2300 Turnhout Belgium
Danish: B-2300 Turnhout Belgien
English: I-04100 Borgo San Michele (Latina) Italy
Danish: I-04100 Borgo San Michele (Latina) Italien
English: The study is therefore considered to be inconclusive with respect to efficacy.
Danish: Studiet anses derfor for at være inkonklusivt for så vidt angår effekten.
English: - Tell your doctor if you are pregnant or planning to become pregnant.
Danish: − Fortæl det til lægen, hvis du er gravid eller planlægger at blive gravid.
English: There is a limited amount of data from the use of prucalopride in pregnant women.
Danish: Der er en begrænset mængde data fra brugen af prucaloprid hos gravide kvinder.
English: Date of first authorisation: 15 October 2009 Date of latest renewal: 06 June 2014
Danish: Dato for første markedsføringstilladelse: 15. oktober 2009 Dato for seneste fornyelse: 06 juni 2014
English: This effect can be attributed to a diminished renal function in older people.
Danish: Denne virkning kan tilskrives nedsat nyrefunktion hos ældre personer.
English: Its terminal half-life is about one day.
Danish: Den terminale halveringstid for stoffet er cirka én dag.
English: Unchanged active substance made up about 92-94% of the total radioactivity in plasma.
Danish: Uomdannet aktivt stof udgjorde cirka 92-94 % af den totale radioaktivitet i plasma.
English: These are equivalent to the colonic mass movements in humans, and provide the main propulsive force to defecation.
Danish: De svarer til massebevægelserne i tyktarmen hos mennesker og udgør den væsentligste fremdrivende kraft ved defækation.
English: Take Resolor every day for as long as your doctor prescribes it.
Danish: Tag Resolor hver dag i så lang tid, som din læge har ordineret.
English: Taking a higher dose than recommended will not make the product work better.
Danish: Indtagelse af en højere dosis end anbefalet får ikke medicinen til at virke bedre.
English: Resolor with food and drink Resolor can be taken with or without food and drinks, at any time of the day.
Danish: Brug af Resolor sammen med mad og drikke Resolor kan tages sammen med eller uden mad og drikke når som helst i løbet af dagen.
English: Other adverse reactions have been reported occasionally.
Danish: Andre bivirkninger blev rapporteret lejlighedsvist.
English: If you stop taking Resolor If you stop taking Resolor, your constipation symptoms may come back again.
Danish: Hvis du holder op med at tage Resolor Hvis du holder op med at tage Resolor, kan symptomerne på forstoppelse komme igen.
English: Warnings and precautions Talk to your doctor before taking Resolor.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Resolor.
English: If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered.
Danish: Hvis indtagelse af prucaloprid én gang dagligt ikke er effektivt efter 4 ugers behandling, bør patienten undersøges på ny og fordelen ved fortsat behandling vurderes.
English: - If you do become pregnant during treatment with Resolor, tell your doctor.
Danish: − Hvis du bliver gravid under behandlingen med Resolor, skal du fortælle det til lægen.
English: - Use a reliable method of contraception while you're taking Resolor, to prevent pregnancy.
Danish: − Anvend en sikker præventionsmetode, mens du tager Resolor, for at undgå graviditet.
English: The accumulation ratio after once daily dosing ranged from 1.9 to 2.3.
Danish: Akkumulationsratioen efter én gang daglig dosering varierede fra 1,9 til 2,3.
English: Resolor has been shown not to cause rebound phenomena, nor to induce dependency.
Danish: Det er også påvist, at Resolor ikke forårsager rebound-hændelser og heller ikke inducerer afhængighed.
English: Overall, the safety profile of Resolor in children was the same as in adults.
Danish: Sikkerhedsprofilen for Resolor hos børn var overordnet den samme som hos voksne.
English: The doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks and thereafter at regular intervals.
Danish: Lægen vil muligvis undersøge din sygdom og fordelen ved forlænget behandling på ny efter de første 4 uger og derefter med regelmæssige intervaller.
English: Do not take Resolor: - if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Resolor: - hvis du er allergisk over for prucaloprid eller et af de øvrige indholdsstoffer i Resolor (angivet i punkt 6).
English: Prucalopride is extensively distributed, and has a steady-state volume of distribution (Vdss) of 567 litres.
Danish: Prucaloprid distribueres ekstensivt og har et steady state-fordelingsvolumen (Vdss) på 567 liter.
English: The Resolor doses studied in each of these three studies included 2 mg and 4 mg once daily.
Danish: De Resolor-doser, der blev undersøgt i hver af disse tre studier, omfattede 2 mg og 4 mg én gang dagligt.
English: The clinical significance or benefit of this mechanism of action when compared with other laxatives has not been investigated.
Danish: Den kliniske betydning eller fordel ved denne virkningsmekanisme sammenholdt med andre afføringsmidler er ikke undersøgt.
English: Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Danish: Omfattende væsketab ved diarré eller opkastning kan nødvendiggøre korrektion af elektrolytforstyrrelserne.
English: R107504, R084536 and R104065 (formed by O-demethylation) were identified as minor plasma metabolites.
Danish: R107504, R084536 og R104065 (dannet ved O-demethylering) blev identificeret som mindre væsentlige metabolitter i plasma.
English: The usual dose of Resolor for most patients is one 2 mg tablet once a day.
Danish: Den sædvanlige dosis Resolor til de fleste patienter er én 2 mg-tablet én gang dagligt.
English: The majority of adverse events were mild to moderate in intensity.
Danish: Størstedelen af bivirkningerne var lette til moderate i intensitet.
English: The majority of patients continued using prucalopride.
Danish: Størstedelen af patienterne fortsatte behandlingen med prucaloprid.
English: It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow.
Danish: Det udskilles i omfattende grad uændret i urinen (ca. 60 % af dosis) og in vitro-metabolismen er meget langsom.
English: In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Danish: I tilfælde af svær diarré kan virkningen af orale kontraceptiva reduceres, og anvendelse af en ekstra kontraceptionsmetode anbefales for at forebygge et muligt svigt af det orale kontraceptivum (se oplysninger for det pågældende kontraceptivum vedrørende ordination).
English: Always take this medicine exactly as described in this leaflet or as your doctor has told you.
Danish: Tag altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens anvisning.
English: As with any new symptom, patients should discuss the new onset of palpitations with their physician.
Danish: Ligesom ved ethvert andet nyt symptom bør patienten drøfte nyopståede palpitationer med deres læge.
English: It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel.
Danish: Det virker på tarmens muskelvæg og bidrager til at genskabe tarmens normale funktion.
English: The plasma clearance of prucalopride averages 317 ml/min.
Danish: Plasmaclearance af prucaloprid er i gennemsnit 317 ml/min.
English: Resolor is only for adults and should not be taken by children and adolescents up to 18 years.
Danish: Resolor er kun til voksne og bør ikke tages af børn og unge under 18 år.
English: Prucalopride has a low pharmacokinetic interaction potential.
Danish: Prucaloprid har et lavt farmakokinetisk interaktionspotentiale.
English: Specific treatment is not available for Resolor overdose.
Danish: Der findes ingen specifik behandling mod overdosering af Resolor.
English: A significant benefit on a number of Quality of Life measures, such as degree of satisfaction with treatment and with bowel habits, physical and psychosocial discomfort and worries and concerns, was also observed at both the 4 and 12 week assessment time points.
Danish: Der sås også en signifikant fordel på en række målepunkter for livskvalitet såsom grad af tilfredshed med behandlingen og afføringsvaner, fysisk og psykisk ubehag, bekymringer og betænkeligheder, ved vurderingstidspunktet i både uge 4 og uge 12.
English: Tremors, migraine
Danish: Tremor, migræne
English: Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease.
Danish: Din læge kan også anbefale en lavere dosis på én 1 mg-tablet én gang dagligt, hvis du lider af en svær nyresygdom.
English: Manufacturer Sanico NV Veedijk 59
Danish: Fremstiller Sanico NV Veedijk 59
English: The safety profile of Resolor in this 24 week study was consistent with that seen in the previous 12 week studies.
Danish: Sikkerhedsprofilen for Resolor i dette 24-ugers studie stemte overens med det, der er observeret i de tidligere 12-ugers studier.
English: Not for use in children and adolescents younger than 18 years.
Danish: Bør ikke anvendes til børn og unge under 18 år.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Danish: I tilfælde af overdosering skal patienten behandles symptomatisk, og understøttende foranstaltninger skal iværksættes efter behov.
English: In the absence of human data in women who actively breast-fed while taking Resolor, a decision should be made whether to discontinue breast-feeding or to discontinue Resolor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Da der ikke foreligger humane data fra kvinder, der aktivt ammer, mens de tager Resolor, skal det besluttes, om amning eller behandling med Resolor skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Renal excretion of unchanged prucalopride involves both passive filtration and active secretion.
Danish: Renal udskillelse af uomdannet prucaloprid sker ved både passiv filtration og aktiv sekretion.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin.
English: However, the totality of the data including the other double-blind placebo controlled 12 week studies support the efficacy of Resolor.
Danish: De samlede data, herunder de andre 12-ugers dobbeltblindede, placebokontrollerede studier, understøtter imidlertid effekten af Resolor.
English: Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown.
Danish: Der er observeret tilfælde af spontan abort i kliniske studier, men da der også er fundet andre risikofaktorer, vides det ikke, om der er sammenhæng med prucaloprid.
English: Although prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations.
Danish: Selvom prucaloprid kan være et svagt substrat for P-glykoprotein (P-gp), er det ikke en hæmmer af Pgp ved klinisk relevante koncentrationer.
English: It is important to keep to the dose as prescribed by your doctor.
Danish: Det er vigtigt, at du tager præcis den dosis, som din læge har ordineret.
English: Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine.
Danish: Interaktioner af samme størrelsesorden kan forventes med andre potente hæmmere af P-gp såsom verapamil, ciclosporin og quinidin.
English: In a study in healthy volunteers, treatment with prucalopride was well tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose).
Danish: I en undersøgelse af raske frivillige studiepersoner tolereredes behandling med prucaloprid godt, når det blev givet i en optitreringsplan op til 20 mg én gang dagligt (10 gange den anbefalede terapeutiske dosis).
English: Resolor is unlikely to affect your ability to drive or use machines.
Danish: Det er usandsynligt, at Resolor påvirker din evne til at færdes sikkert i trafikken og betjene maskiner.
English: Of these, over 1,500 patients received Resolor at the recommended dose of 2 mg per day, while approximately 1,360 patients were treated with 4 mg prucalopride daily.
Danish: Heraf fik mere end 1.500 patienter Resolor i den anbefalede dosis på 2 mg pr. dag, mens cirka 1.360 patienter blev behandlet med 4 mg prucaloprid dagligt.
English: The plasma protein binding of prucalopride is about 30%.
Danish: Prucaloprids plasmaproteinbinding er cirka 30 %.
English: System/Organ Class
Danish: Systemorganklasse
English: Pharmacotherapeutic group: Other drugs for constipation, ATC code: A06AX05.
Danish: Farmakoterapeutisk klassifikation: Andre laksantia, ATC-kode: A06AX05.
English: Nausea, diarrhoea, abdominal pain
Danish: Kvalme, diarré, abdominalsmerter
English: The pharmacokinetics of prucalopride is dose-proportional within and beyond the therapeutic range (tested up to 20 mg).
Danish: Prucaloprids farmakokinetik er dosisproportional inden for og over det terapeutiske interval (testet op til 20 mg).
English: Pyrexia, malaise
Danish: Pyreksi, utilpashed
English: A population pharmacokinetic analysis showed that the apparent total clearance of prucalopride was correlated with creatinine clearance, but that age, body weight, sex or race had no influence.
Danish: En populationsfarmakokinetisk analyse viste, at den tilsyneladende totale clearance af prucaloprid korrelerede med kreatininclearance, men at alder, kropsvægt, køn og race ingen indflydelse havde.
English: Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities.
Danish: Prucaloprid er et dihydrobenzofurancarboxamid med gastrointestinal prokinetisk aktivitet.
English: Fertility Animal studies indicate that there is no effect on male or female fertility.
Danish: Fertilitet Dyrestudier indikerer, at der ingen påvirkning er af fertiliteten hos hanner eller hunner.
English: Prucalopride is rapidly absorbed; after a single oral dose of 2 mg in healthy subjects, Cmax was attained in 2-3 hours.
Danish: Prucaloprid absorberes hurtigt; efter en enkelt peroral dosis på 2 mg hos raske forsøgspersoner blev Cmax nået i løbet af 2-3 timer.
English: Caution should be exercised when prescribing Resolor to patients with these conditions especially when used in patients with a history of arrhythmias or ischaemic cardiovascular disease.
Danish: Der skal udvises forsigtighed ved ordination af Resolor til patienter med disse sygdomme, især når det anvendes til patienter med arytmier eller iskæmisk hjertekar-sygdom i anamnesen.
English: A thorough QT study was performed to evaluate the effects of Resolor on the QT interval at therapeutic (2 mg) and supratherapeutic doses (10 mg) and compared with the effects of placebo and a positive control.
Danish: Et grundigt QT-studie blev gennemført for at evaluere virkningen af Resolor på QT-intervallet ved terapeutiske (2 mg) og supraterapeutiske (10 mg) doser og sammenlignet med virkningen af placebo og en positiv kontrol.
English: Posology Adults: 2 mg once daily with or without food, at any time of day.
Danish: Dosering Voksne: 2 mg én gang dagligt med eller uden mad på et vilkårligt tidspunkt af dagen.