FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Danish: Data fra et studie anvendt som historisk kontrol (van Spronsen et al., 1994) viste følgende sandsynligheder for overlevelse.
English: Please contact your doctor if you plan to become pregnant.
Danish: Kontakt Deres læge, hvis De planlægger at blive gravid.
English: The capsules are packaged in plastic bottles.
Danish: Kapslerne er pakket i plasticflasker.
English: Do not forget to mark the date on the bottle, when removed from the refrigerator.
Danish: Glem ikke at mærke flasken med datoen for, hvornår den fjernes fra køleskabet.
English: Do not change the dose or stop the treatment without talking to your doctor.
Danish: De må ikke ændre dosis eller stoppe behandlingen uden at have talt med Deres læge.
English: Store in the original bottle in order to protect from light.
Danish: Opbevares i den originale beholder for at beskytte mod lys.
English: A dose of 2 mg/kg body weight/day may be needed based on the evaluation of all biochemical parameters.
Danish: 2 mg/kg legemsvægt/dag kan være nødvendig baseret på evalueringen af alle biokemiske parametre.
English: - The other ingredients are:
Danish: Øvrige indholdsstoffer:
English: During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.
Danish: Under behandlingen vil der blive taget blodprøver, for at Deres læge kan kontrollere, om behandlingen er tilstrækkelig, og for at sikre, at der ikke er nogen mulige bivirkninger, der medfører sygdomme i blodet.
English: Probability of no HCC (95% confidence interval) at
Danish: Sandsynlighed for fravær af HCC (95 % konfidensinterval)
English: If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Danish: Hvis det biokemiske respons er tilfredsstillende, bør dosis kun justeres i henhold til øgning i legemsvægt.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
Danish: Tilgængelige data fra en klinisk studie indikerer, at hos mere end 90 % af patienterne blev succinylacetone i urinen normaliseret under den første uges behandling.
English: NTBC study (N=250)
Danish: NTBC-studiet (N=250)
English: Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Danish: Opfølgningsbesøg bør foretages hver 6. måned; kortere interval mellem hvert besøg anbefales hvis der optræder bivirkninger.
English: Each bottle contains 60 capsules.
Danish: Hver flaske indeholder 60 kapsler.
English: Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Danish: Behandlingen af alle sygdommens genotyper bør startes så hurtigt som muligt for at øge den totale overlevelse og undgå komplikationer, såsom leversvigt, levercancer og nyresygdomme.
English: The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Danish: Clearance og halveringstid blev bestemt til at være henholdsvis 0,0956 l/kg legemsvægt/dag og 52,1 timer.
English: Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Danish: Der fås andre lægemiddelformer til pædiatriske patienter, som har problemer med at sluge kapsler.
English: From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Danish: Ud fra de kliniske studier og data efter markedsføringen er der ikke noget, der tyder på, at sikkerhedsprofilen er forskellig i forskellige undergrupper af den pædiatriske population eller forskellig fra sikkerhedsprofilen hos voksne patienter.
English: Data is, however, limited in patients with body weight <20 kg.
Danish: Der foreligger imidlertid begrænsede data for patienter med legemsvægt < 20 kg.
English: The dosing frequency in the study was twice daily.
Danish: Doseringshyppigheden i studiet var to gange dagligt.
English: If you experience any side effects, shorter intervals are recommended.
Danish: Hvis De oplever bivirkninger, anbefales kortere intervaller.
English: You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
Danish: De skal følge en speciel diæt, når De tager lægemidlet, fordi tyrosin forbliver i kroppen.
English: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Danish: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Det Forenede Kongerige
English: Date when removed from refrigerator:
Danish: Dato for udtagning fra køleskab:
English: However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Danish: Hvis De imidlertid oplever bivirkninger, der påvirker synet, bør De ikke køre bil eller betjene maskiner, før synet igen er normalt (se punkt 4 ”Bivirkninger”).
English: Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Danish: Øjenlågsbetændelse (blepharitis) er en ikke almindelig bivirkning (kan ramme op til 1 ud af 100 personer).
English: It is recommended to administer the dose once daily.
Danish: Det anbefales at administrere dosis én gang dagligt.
English: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Danish: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Det Forenede Kongerige
English: There are no adequate data from the use of nitisinone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af nitisinon til gravide kvinder.
English: If you have the impression that the medicine is not working properly, talk to your doctor.
Danish: Hvis De har indtryk af, at lægemidlet ikke virker korrekt, så tal med Deres læge.
English: If you become pregnant you should contact your doctor immediately.
Danish: Hvis De bliver gravid, bør De straks kontakte Deres læge.
English: In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
Danish: I kliniske studier var granulocytopeni kun ikke almindeligt alvorlig (<0,5 x 109/l) og ikke associeret med infektioner.
English: The dose of nitisinone should be adjusted individually.
Danish: Dosis af nitisinon bør justeres individuelt.
English: Frequency is 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), very rare
Danish: Hyppigheden 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: Each carton pack contains one bottle.
Danish: Hver æske indeholder en flaske.
English: MedDRA system organ class Frequency
Danish: MedDRA-systemorganklasse Hyppighed
English: Your doctor will adjust the dose individually.
Danish: Lægen vil justere dosis individuelt.
English: The safety of this medicine has not been studied in pregnant and breast-feeding women.
Danish: Sikkerheden ved lægemidlet er ikke blevet undersøgt hos gravide og ammende kvinder.
English: If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Danish: Hvis De har taget mere af dette lægemiddel, end De bør, skal De kontakte Deres læge eller apotek så hurtigt som muligt.
English: Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Danish: Øgning i koncentrationen af serum alfa-føtoprotein kan være et tegn på utilstrækkelig behandling.
English: The dose recommendation in mg/kg body weight is the same in children and adults.
Danish: Dosisanbefalingen i mg/kg legemsvægt er den samme hos børn og voksne.
English: Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Danish: En populationsfarmakokinetisk analyse af en population er blevet gennemført på en gruppe på 207 HT-1 patienter.
English: Your liver will be checked at regular intervals because the disease affects the liver.
Danish: Deres lever vil blive kontrolleret med regelmæssige mellemrum, fordi sygdommen påvirker leveren.
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
Danish: Sandsynlighederne for overlevelse efter 2, 4 og 6 års behandling med nitisinon er opsummeret i nedenstående tabel.
English: In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Danish: I et internationalt studie af patienter med HT-1, hvor kostrestriktioner var eneste behandling, blev det fundet, at HCC var blevet diagnosticeret hos 18 % af alle patienter i alderen 2 år og derover.
English: No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Danish: Der blev ikke observeret mutagen, men svag klastogen aktivitet i in vitro studier.
English: Monitoring of plasma tyrosine levels
Danish: Monitorering af plasma-tyrosin-niveauerne
English: Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Danish: Dyrestudier har vist postnatale bivirkninger via eksponering over for nitisinon i mælk.
English: There were no clinically important differences in AEs or other safety assessments between once and twice daily dosing.
Danish: Der var ingen klinisk vigtige forskelle i bivirkninger eller andre sikkerhedsvurderinger mellem dosering én og to gange dagligt.
English: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Danish: Nitisinon viste ikke karcinogenicitet i et 26-ugers karcinogenicitetsstudie hos transgene mus (TgrasH2).
English: It is unknown whether nitisinone is excreted in human breast milk.
Danish: Det er ukendt, om nitisinon udskilles i human mælk.
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Danish: Det anbefales, at en undersøgelse af øjnene med en spaltelampe udføres, inden der indledes behandling med nitisinon, og derefter regelmæssigt, mindst én gang årligt.
English: Nitisinone MDK should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Danish: Nitisinone MDK bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med nitisinon.
English: No patient had detectable succinylacetone (SA) levels at the end of the once-daily treatment period.
Danish: Ingen patienter havde detekterbart niveau af succinylacetone (SA) ved slutningen af behandlingsperioden med dosering én gang dagligt.
English: However, nitisinone has been co-administered with food during the generation of efficacy and safety data.
Danish: Nitisinon har imidlertid været givet samtidig med mad under indsamling af effekt- og sikkerhedsdata.
English: It was found that the early initiation of treatment resulted in a further reduced risk for the development of hepatocellular carcinoma.
Danish: Man fandt ud af, at tidlig indledning af behandling resulterede i en yderligere nedsat risiko for udvikling af hepatocellulært karcinom.
English: Patients with increasing alpha-fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Danish: Patienter med øgende alfa-føtoprotein eller tegn på knuder i leveren bør altid evalueres for hepatisk malignitet.
English: It is recommended to also monitor serum alpha-fetoprotein concentrations.
Danish: Det anbefales også at monitorere koncentrationen af serum alfa-føtoprotein.
English: If you have problems with swallowing the capsules, you may open the capsule and mix the powder with a small amount of water or formula diet just before you take it.
Danish: Hvis De har problemer med at synke kapslerne, kan De åbne kapslen og blande pulveret med en lille smule vand eller diætpulver lige inden indtagelse.
English: Nitisinone MDK blocks the breakdown of tyrosine and the harmful substances are not formed.
Danish: Nitisinone MDK blokerer nedbrydningen af tyrosin og de skadelige stoffer dannes derfor ikke.
English: Nitisinone MDK may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Danish: Nitisinone MDK kan påvirke virkningen af andre lægemidler såsom: - Lægemidler mod epilepsi (såsom phenytoin) - Lægemidler mod blodpropper (såsom warfarin)
English: It should be established that the patient is adhering to his/her dietary regimen and the plasma tyrosine concentration should be measured.
Danish: Det bør fastslås, om patienten følger sit kostprogram, og plasma-tyrosinkoncentrationen bør måles.
English: It is not recommended to lower the plasma tyrosine concentration by reduction or discontinuation of nitisinone, since the metabolic defect may result in deterioration of the patient's clinical condition.
Danish: Det anbefales ikke at sænke plasmatyrosinkoncentrationen ved reduktion eller afbrydelse af nitisinon, da den metaboliske defekt kan resultere i forværring af patientens kliniske tilstand.
English: Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Danish: Der er ikke udført formelle studier af absorption, fordeling, metabolisme og elimination med nitisinon.
English: However, in addition to the tests above, during the initiation of therapy, switch from twice daily to once daily dosing or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Danish: Udover de ovenfor nævnte tests kan det imidlertid i forbindelse med indledning af behandlingen, efter skift fra dosering to gange dagligt til én gang dagligt, eller hvis der optræder forværring, være nødvendigt at følge alle tilgængelige biokemiske parametre nøjere (dvs. plasma-succinylacetone, urin5-aminolevulinsyre (ALA) og erytrocyt-porfobilinogen (PBG)-syntaseaktivitet).
English: Concomitant use with other medicinal products
Danish: Anvendelse sammen med andre lægemidler
English: If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination.
Danish: Hvis De får røde øjne eller andre tegn på påvirkninger på øjnene,skal De straks kontakte Deres læge for en øjenundersøgelse.
English: If the vision is affected the patient should not drive or use machines until the event has subsided.
Danish: Hvis synet er påvirket, bør patienten ikke føre motorkøretøj eller betjene maskiner, indtil reaktionen forbedres.
English: The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
Danish: 2, 4 og 6 års sandsynligheden for, at HCC ikke udvikles under nitisinonbehandling for patienter på 24 måneder og derunder ved behandlingsstart, og for patienter over 24 måneder ved behandlingsstart vises i følgende tabel:
English: Fertility There are no data on nitisinone affecting fertility.
Danish: Fertilitet Der foreligger ingen data vedrørende nitisinons indvirkning på fertilitet.
English: If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Danish: Hvis succinylacetone stadig kan måles i urinen én måned efter start på behandling med nitisinon, bør dosis af nitisinon øges til 1,5 mg/kg legemsvægt/dag.
English: In 10 healthy male volunteers, after administration of a single dose of nitisinone capsules (1 mg/kg body weight) the terminal half-life (median) of nitisinone in plasma was 54 hours (ranging from 39 to 86 hours).
Danish: Hos 10 raske, mandlige frivillige var, efter administration af en enkelt dosis nitisinon kapsler (1 mg/kg legemsvægt), den terminale halveringstid (median) af nitisinon i plasma 54 timer (spændende fra 39 til 86 timer).
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/L.
Danish: En kost med mere begrænset tyrosin og fenylalanin bør implementeres i tilfælde af, at niveauet af plasma-tyrosin er over 500 mikromol/L.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
Danish: Lægemidlet anvendes til behandling af en sjælden sygdom, der kaldes arvelig tyrosinæmi type 1 hos voksne, unge og børn (i alle aldersgrupper).
English: There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Danish: Der er ingen specifikke dosisanbefalinger for ældre patienter eller patienter med nedsat nyre- eller leverfunktion.
English: Capsule content ˗ Pregelatinised starch (maize)
Danish: Kapslens indhold Prægelatiniseret stivelse (majs)
English: No formal food interactions studies have been performed with Nitisinone MDK hard capsules.
Danish: Der er ikke udført formelle studier om fødevareinteraktioner med Nitisinone MDK hårde kapsler.
English: Nitisinone does not inhibit CYP2D6 since metoprolol AUC∞ was not affected by the administration of nitisinone.
Danish: Nitisinon hæmmer ikke CYP 2D6, da metoprolol AUC∞ ikke blev påvirket af administrationen af nitisinon.
English: 60 capsules
Danish: 60 kapsler
English: The safety profile is mainly based on the paediatric population since nitisinone treatment should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been established.
Danish: Sikkerhedsprofilen baserer sig hovedsageligt på den pædiatriske population, eftersom nitisinonbehandling bør iværksættes, så snart diagnosen arvelig tyrosinæmi type 1 (HT-1) er blevet stillet.
English: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for nitisinon eller et af de øvrige indholdsstoffer i Nitisinone MDK (angivet i punkt 6).
English: 6 years
Danish: 6 år
English: Elevated tyrosine levels
Danish: Forhøjede tyrosinniveauer
English: However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.
Danish: Da der imidlertid kun foreligger begrænsede data for patienter med en legemsvægt < 20 kg, anbefales det at dele den totale daglige dosis på to daglige doser hos denne patientpopulation.
English: Exfoliative dermatitis may occur uncommonly.
Danish: Eksfoliativ dermatitis kan forekomme ikke almindeligt.
English: Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted.
Danish: Succinylacetone skulle ikke kunne måles i urin eller plasma, når dosis af nitisinon er korrekt justeret.
English: In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Danish: Hos patienter med HT1, omdannes disse mellemprodukter til de toksiske metabolitter succinylacetone og succinylacetoacetat.
English: The capsule contains a white to off-white powder.
Danish: Kapslen indeholder et hvidt til cremefarvet pulver.
English: It is recommended that platelet and WBC counts are monitored regularly, as a few cases of reversible thrombocytopenia and leucopenia were observed during clinical evaluation.
Danish: Det anbefales at monitorere trombocytter og leukocytter regelmæssigt, da nogle få tilfælde af reversibel trombocytopeni og leukopeni blev observeret under den kliniske evaluering.
English: This special diet is based on low tyrosine and phenylalanine (another amino acid) content.
Danish: Denne særlige diæt er baseret på et lavt indhold af tyrosin og fenylalanin (en anden aminosyre).
English: 60 hard capsules
Danish: 60 hårde kapsler
English: Liver monitoring
Danish: Levermonitorering
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
Danish: In vitro-studier med brug af menneskelige levermikrosomer og cDNA-udtrykte P450 enzymer har vist begrænset CYP 3A4-medieret metabolisme.
English: A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist.
Danish: En patient, der udviser visuelle forstyrrelser under behandling med nitisinon, bør uden forsinkelse undersøges af en oftalmolog.
English: Nitisinone MDK with food and drink
Danish: Brug af Nitisinone MDK sammen med mad og drikke
English: Nitisinone treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolized through CYP2C9, such as warfarin and phenytoin, should be carefully monitored.
Danish: Patienter behandlet med nitisinon, som samtidigt behandles med lægemidler med et snævert terapeutisk vindue, der metaboliseres via CYP 2C9, såsom warfarin og phenytoin, bør derfor monitoreres nøje.
English: Nitisinone has minor influence on the ability to drive and use machines.
Danish: Nitisinon påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Elevated tyrosine levels have been associated with toxicity to eyes, skin, and the nervous system.
Danish: Forhøjede niveauer af tyrosin er blevet forbundet med toksicitet for øjnene, huden og nervesystemet.
English: In this disease your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances.
Danish: Denne sygdom er kendetegnet ved, at kroppen ikke er i stand til fuldstændig at nedbryde aminosyren tyrosin (aminosyrer er de byggesten, som proteiner består af) hvilket medfører, at der dannes en række skadelige stoffer.
English: 2 - 6 months > 6 months
Danish: < 2 måneder > 2-6 måneder > 6 måneder
English: Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels.
Danish: Nitisinon har vist embryo-føtal toksicitet hos mus og kanin ved klinisk relevante dosisniveauer.
English: There was no evidence of in vivo genotoxicity (mouse micronucleus assay and mouse liver unscheduled DNA synthesis assay).
Danish: Der fandtes intet bevis for in vivo genotoksicitet (mikronukleustest på mus og UDS-test (unscheduled DNA-syntese) med museleverceller).
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5.
Danish: Baseret på in vitro-studier forventes nitisinon ikke at hæmme CYP 1A2-, 2C19- eller 3A4-medieret metabolisme eller at inducere CYP 1A2, 2B6 eller 3A4/5.
English: Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
Danish: Behandling med nitisinon bør startes og overvåges af en læge, der har erfaring med behandlingen af HT-1-patienter.
English: The liver function should be monitored regularly by liver function tests and liver imaging.
Danish: Leverfunktionen bør monitoreres regelmæssigt med leverfunktionstests og afbildning af leveren.
English: Succinylacetone inhibits the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate.
Danish: Succinylacetone hæmmer porfyrinsyntesevejen, der leder til akkumulering af 5-aminolevulinat.
English: If you start Nitisinone MDK treatment by taking it with food, it is recommended that you carry on taking it with food throughout your course of treatment.
Danish: Hvis De begynder med at tage behandlingen med Nitisinone MDK sammen med mad, anbefales det at fortsætte med at tage det sammen med mad igennem hele behandlingsforløbet.