FrancophonIA/ELRC3.0 huggingface dataset:
English: A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Danish: En positiv sammenhæng mellem MRI T2*-værdier og hjertefunktion (som målt ved venstre ventrikulære uddrivningsfraktion (eller LVEF)) er blevet dokumenteret.
English: Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Danish: Efter en dosis på 25 mg/kg er der detekteret lavere spidskoncentrationer i serum hos patienter, der havde indtaget føde (85 µmol/l) end ved fastende tilstand (126 µmol/l), selv om der ikke var noget fald i mængden af absorberet deferipron, da det blev givet sammen med føde.
English: The median time to onset of the first episode of agranulocytosis was 190 days (ranged 22 days- 17.6 years) and median duration was 10 days in clinical trials.
Danish: Mediantiden til den første episode med agranulocytose var 190 dage (22 dage-17,6 år) og medianvarigheden var 10 dage i kliniske forsøg.
English: Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with deferiprone in combination with deferoxamine.
Danish: Dødsfald og livstruende situationer (forårsaget af agranulocytose) er rapporteret med deferipron i kombination med deferoxamin.
English: At the same time point, LVEF had increased from baseline by 3.07 ± 3.58 absolute units (%) in the Ferriprox group and by 0.32 ± 3.38 absolute units (%) in the deferoxamine group (difference between groups; p=0.003).
Danish: På samme tidspunkt var LVEF steget fra baseline med 3,07 ± 3,58 absolutte enheder (%) hos Ferriproxgruppen og med 0,32 ± 3,38 absolutte enheder (%) hos deferoxamin-gruppen (forskel mellem grupperne: p=0,003).
English: Not known (frequency cannot be estimated from the available data): − allergic reactions including skin rash or hives
Danish: Ikke kendt (hyppigheden kan ikke skønnes fra de tilgængelige data): - allergiske reaktioner som f.eks. hududslæt eller nældefeber
English: Fertility No effects on fertility or early embryonic development were noted in animals (see section 5.3).
Danish: Fertilitet Der er ikke observeret nogen virkninger på fertilitet eller tidlig fosterudvikling hos dyr (se pkt.
English: If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time.
Danish: Hvis du har sprunget en dosis over, skal du tage den så snart, du kommer i tanker om det, og så tage den næste dosis til det normalt planlagte tidspunkt.
English: Number of tablets (three times/day)
Danish: Antal tabletter (tre gange daglig)
English: Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Danish: Dosering pr. kilogram legemsvægt bør beregnes til nærmeste 2,5 ml.
English: Discoloration of urine
Danish: Misfarvning af urinen
English: No prenatal and postnatal reproductive studies have been conducted in animals.
Danish: Der er ikke gennemført prænatale og postnatale reproduktionsstudier på dyr.
English: Ferriprox can be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with your meals.
Danish: Ferriprox kan tages med eller uden mad; det kan dog være lettere for dig at huske at tage Ferriprox, hvis du tager det sammen med dine måltider.
English: Increased levels of serum liver enzymes have been reported in some patients taking deferiprone.
Danish: Øgede niveauer af serumleverenzymer er blevet rapporteret hos nogle patienter, der tager deferipron.
English: Doses of Ferriprox in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Danish: Doserne af Ferriprox i disse studier lå mellem 50 og 100 mg/kg/dag og doserne af deferoxamin mellem 40 og 60 mg/kg/dag.
English: In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
Danish: Ved kliniske studier har ugentlig monitorering af neutrofiltallet vist sig effektivt til identifikation af tilfælde af neutropeni og agranulocytose.
English: − This medicine has been prescribed for you only.
Danish: − Lægen har ordineret dette lægemiddel til dig personligt.
English: 500 ml oral solution
Danish: 500 ml oral opløsning
English: For agranulocytosis (ANC < 0.5x109/l):
Danish: I tilfælde af agranulocytose (ANC < 0,5x109/l):
English: There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Danish: Der var ingen signifikant forskel i procentdelen af patienter med kardial dysfunktion ved første vurdering (13% for Ferriprox vs. 16% for deferoxamin).
English: To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox.
Danish: Din læge vil bede dig om at få taget en blodprøve for at undersøge for neutropeni (kontrollere antallet af hvide blodlegemer) regelmæssigt, så ofte som hver uge, mens du behandles med Ferriprox.
English: There was an improvement in cardiac T2* of more than 3 ms in patients treated with Ferriprox compared with a change of about 1 ms in patients treated with deferoxamine.
Danish: Der var en forbedring i kardial T2* på mere end 3 ms hos patienter behandlet med Ferriprox sammenlignet med en forandring på ca. 1 ms hos patienter behandlet med deferoxamin.
English: Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex.
Danish: Patienterne skal informeres om, at deres urin kan udvise en rødlig/brunlig misfarvning på grund af udskillelsen af jerndeferipronkompleks.
English: The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
Danish: Sikkerheden ved samtidig anvendelse af deferipron og C-vitamin er ikke blevet formelt undersøgt.
English: Evaluation of rate of reactions per 100 patient-years of exposure showed that only the rate of diarrhoea was significantly higher in children (11.1) than in adults (2.0, p=0.01).
Danish: Vurdering af antallet af reaktioner pr. 100 patientårs eksponering viste, at kun forekomsten af diarré var signifikant højere hos børn (11,1) end hos voksne (2,0, p=0,01).
English: Have your blood monitored on a weekly basis for the first one year of treatment with Ferriprox and as regularly as your doctor recommends thereafter.
Danish: Få foretaget en blodprøve hver uge i det første år, du er i behandling med Ferriprox, og derefter så ofte, som din læge anbefaler.
English: The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); hydrochloric acid, concentrated (for pH adjustment); artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
Danish: De øvrige indholdsstoffer er: renset vand; hydroxyethylcellulose; glycerol (E422); koncentreret saltsyre (til pH-regulering); kunstig kirsebærsmag; pebermynteolie; Sunset Yellow (E110); sucralose (E955).
English: Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended.
Danish: Ordinerende læger mindes om, at brugen af doser over 100 mg/kg/dag frarådes.
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Danish: Der sås ingen signifikant effekt af nyreinsufficiensen på den systemiske eksponering for deferipron.
English: Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Danish: Lave plasmazinkniveauer er blevet forbundet med deferipron hos et mindre antal patienter.
English: Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Danish: Systemisk eksponering for deferipron og dets metabolit deferipron 3-O-glucuronid blev vurderet med PK-parametrene Cmax og AUC.
English: Dose per kilogram body weight should be calculated to the nearest half tablet.
Danish: Dosering pr. kilogram legemsvægt bør beregnes til nærmeste halve tablet.
English: Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Danish: Eftersom deferipron kan forbindes med neutropeni og agranulocytose, bør behandling af patienter med svækket immunforsvar ikke indledes, medmindre de mulige fordele overstiger de mulige risici.
English: No carcinogenicity studies in animals have been conducted with deferiprone.
Danish: Der er ikke gennemført carcinogenitetsstudier med deferipron på dyr.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse:
English: For neutropenia events (ANC < 1.5x109/l and > 0.5x109/l):
Danish: I tilfælde af neutropeni (ANC < 1,5x109/l og > 0,5x109/l):
English: Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Danish: Det kan derfor ikke anbefales, at indtage aluminium-baserede antacida og deferipron samtidigt.
English: The genotoxic potential of deferiprone was evaluated in a set of in vitro and in vivo tests.
Danish: Deferiprons genotoksiske potentiale blev evalueret i en række in vitro- og in vivo-studier.
English: Ferriprox and deferoxamine were equivalent in promoting a net stabilization or reduction of body iron load, despite the continuous transfusional iron administration in those patients (no difference in proportion of patients with a negative trend in serum ferritin between the two treatment groups by regression analysis; p >0.05).
Danish: Ferriprox og deferoxamin var ækvivalente med hensyn til at fremme en nettostabilisering eller reduktion af kroppens jernophobning, til trods for den kontinuerlige jernindgivelse via transfusion hos disse patienter (ingen forskel i andelen af patienter med en negativ tendens i serumferritin mellem de to behandlingsgrupper ved regressionsanalyse; p >0,05).
English: Method of administration For oral use.
Danish: Indgivelsesmåde Til oral anvendelse.
English: Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
Danish: Deferipron var teratogent og embryotoksisk ved reproduktionsstudier hos ikke-jernbelastede drægtige rotter og kaniner i doser så lave som 25 mg/kg/dag.
English: Neurological disorders
Danish: Neurologiske forstyrrelser
English: Regardless of the degree of renal impairment, the majority of the dose of Ferriprox was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
Danish: Uanset graden af nyreinsufficiens blev størstedelen af Ferriprox-dosen udskilt i urinen som deferipron 3-O-glucuronid over de første 24 timer.
English: HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients.
Danish: HIV-positive eller på anden vis immunudsatte patienter Der findes ingen tilgængelige data om anvendelse af deferipron på patienter, som er HIV-positive eller på anden vis har et defekt immunforsvar.
English: - History of agranulocytosis.
Danish: - Tidligere forekomst af agranulocytose.
English: The risk of agranulocytosis and neutropenia is higher if the baseline ANC is less than 1.5x109/l.
Danish: Risikoen for agranulocytose og neutropeni er højere, hvis ANC-tallet i udgangspunktet er mindre end 1,5 x 109/l.
English: PATIENT/CARER REMINDER CARD ((Front Cover))
Danish: INFORMATIONSKORT TIL PATIENT/PLEJER ((Forside))
English: Provide protective isolation and if clinically indicated, admit patient to the hospital.
Danish: Sørg for beskyttende isolation og indlæg patienten på sygehus, hvis det er klinisk indiceret.
English: Deferiprone is metabolised predominantly to a glucuronide conjugate.
Danish: Deferipron metaboliseres primært til et glukuronidkonjugat.
English: Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Danish: Tilfælde af diarré, som oftest lette og forbigående, er blevet rapporteret hos patienter, der er behandlet med deferipron.
English: If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Danish: Hvis der forekommer vedvarende forøgelse af serumalanin-aminotransferase (ALAT), bør det overvejes at seponere behandlingen med deferipron.
English: Please refer to the patient/carer reminder card attached to this leaflet.
Danish: Referér venligst til det informationskort til patient/plejer, der følger med denne indlægsseddel.
English: Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Danish: Artroser, der strakte sig fra lettere smerter i et eller flere led og op til alvorlig arthritis med effusion og signifikant funktionsnedsættelse er ligeledes blevet rapporteret hos patienter, der har modtaget behandling med deferipron.
English: Study LA37-1111 was conducted to evaluate the effect of single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral doses of deferiprone on the cardiac QT interval duration in healthy subjects.
Danish: Studie LA37-1111 udførtes for at vurdere virkningen af en enkelt terapeutisk (33 mg/kg) eller supraterapeutisk (50 mg/kg) oral dosis af deferipron på varigheden af hjertets QT-interval hos raske forsøgspersoner.
English: The neurological disorders progressively regressed after deferiprone discontinuation.
Danish: De neurologiske forstyrrelser svandt gradvist efter seponering af deferipron.
English: After starting Ferriprox therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Danish: Efter påbegyndelse af Ferriprox-behandling anbefales det, at koncentrationerne af serumferritin eller andre indikatorer for jernophobning i kroppen overvåges hver anden til tredje måned for at vurdere den langsigtede effektivitet af et kelationsregimen til styring af jernophobning i kroppen.
English: Data from the published literature are consistent with the results from the Apotex studies, demonstrating less heart disease and/or increased survival in Ferriprox-treated patients than in those treated with deferoxamine.
Danish: Publicerede data stemmer overens med resultaterne fra Apotex-studiet, der påviste færre hjertesygdomme og/eller forøget overlevelse hos Ferriprox-behandlede patienter end hos dem, der blev behandlet med deferoxamin.
English: Study LA12-9907 compared survival, incidence of cardiac disease, and progression of cardiac disease in 129 patients with thalassaemia major treated for at least 4 years with Ferriprox (N=54) or deferoxamine (N=75).
Danish: Studie LA12-9907 sammenlignede overlevelse, forekomst af kardial sygdom samt progression af kardial sygdom hos 129 talassæmi-patienter, som blev behandlet i mindst 4 år med Ferriprox (N=54) eller deferoxamin (N=75).
English: Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
Danish: Dersom der udvikler sig tegn på infektion samtidigt med neutropenien, skal de aktuelle dyrkninger og diagnostiske procedurer gennemføres, og en egnet behandlingsplan påbegyndes.
English: The incidences of adverse reactions experienced by 18 children and 97 adults treated with combination therapy were not significantly different between the two age groups except in the incidence of arthropathy (11.1% in children vs. none in adults, p=0.02).
Danish: Forekomsten af bivirkninger hos 18 børn og 97 voksne behandlet med kombinationsterapi var ikke signifikant forskellig mellem de to aldersgrupper, undtagen i forekomsten af artrose (11,1 % hos børn vs. ingen hos voksne, p=0,02).
English: Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Danish: Følg ovenstående retningslinjer og sørg for passende behandling, så som granulocytkolonistimulerende faktor, som indledes samme dag som tilfældet identificeres.
English: To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
Danish: For at opnå en dosis på ca. 75 mg/kg/dag anvendes det antal tabletter, der foreslås i følgende skemaer til patientens kropsvægt.
English: Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
Danish: Episoder med hypotoni, ustabilitet, manglende evne til at gå og hypertoni med manglende evne til at bevæge lemmerne er rapporteret hos børn efter markedsføringen ved standarddoser af deferipron.
English: Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily.
Danish: Indhent en komplet blodstælling (CBC) med leukocyttal (WBC) korrigeret for tilstedeværelse af kerneindeholdende erytrocytter, et neutrofiltal og et trombocyttal umiddelbart efter diagnosticering af tilfældet og gentag dernæst daglig.
English: Following randomization, 32 patients received deferoxamine (34.9 mg/kg/day for 5 days/week) and Ferriprox (75 mg/kg/day) and 33 patients received deferoxamine monotherapy (43.4 mg/kg/day for 5 days/week).
Danish: Efter randomisering fik 32 patienter deferoxamin (34,9 mg/kg/dag i 5 dage/uge) og Ferriprox (75 mg/kg/dag), og 33 patienter fik deferoxamin monoterapi (43,4 mg/kg/dag i 5 dage/uge).
English: It is packaged in bottles of 250 ml or 500 ml.
Danish: Den er emballeret i flasker à 250 ml eller 500 ml.
English: If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
Danish: Hvis du får kvalme eller kaster op, kan det måske hjælpe at indtage Ferriprox sammen med mad.
English: Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone.
Danish: Neurologiske forstyrrelser er observeret hos børn, som i flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis, men er også observeret ved standarddoser af deferipron.
English: The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Danish: Den normale dosis er 25 mg/kg, 3 gange daglig, for en total daglig dosis på 75 mg/kg.
English: Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Danish: Baseret på de rapporterede utilsigtede interaktioner, der kan forekomme mellem deferoxamin og Cvitamin, bør der udvises forsigtighed ved samtidig indgivelse af deferipron og C-vitamin.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Danish: Farmakoterapeutisk klassifikation: Jernkelerende stoffer, ATC-kode: V03AC02
English: ml of oral solution (three times/day)
Danish: ml oral opløsning (tre gange daglig)
English: Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Danish: Forsøgsdeltagerne blev inddelt i 3 grupper ud fra Child-Pugh klassifikationsscoren: raske frivillige, let leverinsufficiens (klasse A: 5-6 point) og moderatleverinsufficiens (klasse B: 7-9 point).
English: Number of 1000 mg tablets* Morning
Danish: Antal af 1000 mg tabletter*
English: − if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil)
Danish: − hvis du har haft gentagne episoder med neutropeni (et lavt antal hvide blodlegemer (neutrofiler)).
English: Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Danish: Spidskoncentrationer i serum for glukuronidet forekommer 2 til 3 timer efter indgivelse af deferipron.
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Ferriprox may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Danish: Dosisjusteringer ved anvendelse sammen med andre jernkelerende stoffer Hos patienter, hvor monoterapi er utilstrækkelig, kan Ferriprox anvendes sammen med deferoxamin med en standarddosis (75 mg/kg/dag), men bør ikke overstige 100 mg/kg/dag.
English: For patients whose Ferriprox has not been interrupted during the first year of therapy due to any decrease in the neutrophil count, the frequency of ANC monitoring may be extended to the patient's blood transfusion interval (every 2-4 weeks) after one year of deferiprone therapy.
Danish: For patienter, som ikke har fået afbrudt behandlingen med Ferriprox i løbet af det første år på grund af fald i neutrofiltallet, kan perioden mellem kontrol af det absolutte neutrofiltal efter et års behandling med deferipron forlænges til patientens blodtranfusionsinterval (hver 2.-4. uge).
English: Clinical studies have demonstrated that Ferriprox is effective in promoting iron excretion and that a dose of 25 mg/kg three times per day can prevent the progression of iron accumulation as assessed by serum ferritin, in patients with transfusion-dependent thalassaemia.
Danish: Kliniske studier har vist, at Ferriprox er effektivt til fremme af jernudskillelse, og at en dosis på 25 mg/kg tre gange daglig kan forebygge progression af jernakkumulation vurderet ved serumferritin hos patienter med transfusions-afhængig talassæmi.
English: This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies.
Danish: Denne tilstand, som kaldes svær neutropeni eller agranulocytose, optrådte hos 1 til 2 ud af 100 personer, som tog Ferriprox i kliniske studier.
English: In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Danish: Hos hunner forsinkede en virkning på brunstcyklus tiden til bekræftet parring ved alle testede doser.
English: Common side effects (may affect up to 1 in 10 people): - low white blood cell count (agranulocytosis and neutropenia) - headache - diarrhoea - increase in liver enzymes - fatigue - increase in appetite
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - lavt antal hvide blodlegemer (agranulocytose og neutropeni) - hovedpine - diarré - stigning i leverenzymer - træthed - forøget appetit
English: Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Danish: Gule-polyethylenterephthalat (PET) flasker med børnesikret lukke (polypropylen) og et gradueret målebæger (polypropylen).
English: Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Danish: Omhyggelig monitorering af hjertetilfælde hos patienter, der fik kombinationsterapi, er berettiget (se pkt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket, hvis du er i tvivl.