FrancophonIA/ELRC3.0 huggingface dataset:
English: In cell culture studies, anagrelide suppressed expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.
Danish: I cellekulturundersøgelser undertrykte anagrelid ekspressionen af transkriptionsfaktorer, herunder GATA-1 og FOG-1, der er nødvendige for megakaryocytopoiese, hvilket i sidste instans fører til reduceret blodpladeproduktion.
English: Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Danish: Uterine adenokarcinomer med epigenetisk ophav var forbundet med en enzyminduktion af CYP1-familien.
English: CARTON AND BOTTLE LABEL
Danish: ÆSKE OG FLASKEETIKET
English: The contents of the capsules should not be crushed or diluted in a liquid.
Danish: Kapselindholdet må ikke knuses eller fortyndes i en væske.
English: The usual starting dose of this medicine is 1 mg. You take this dose as one capsule of 0.5 mg twice a day, for at least a week.
Danish: Den sædvanlige startdosis af dette lægemiddel er 1 mg. Du tager denne dosis som en kapsel med 0,5 mg to gange dagligt i mindst én uge.
English: Reproductive toxicology
Danish: Reproduktiv toksikologi
English: Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets.
Danish: Essentiel trombocytæmi er en tilstand, der optræder, når knoglemarven producerer for mange af de blodceller, der kaldes blodplader.
English: Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Danish: Efter oral indgivelse af anagrelid til mennesker absorberes mindst 70% fra mavetarmkanalen.
English: Effects on heart rate and QTc interval
Danish: Virkninger på hjerterytmen og QTc-intervallet
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Kun æske:
English: Anagrelide is primarily metabolised by CYP1A2 to form, 3-hydroxy anagrelide, which is further metabolised via CYP1A2 to the inactive metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline.
Danish: Anagrelid metaboliseres primært ved CYP1A2, så der dannes 3-hydroxyanagrelid, som metaboliseres videre via CYP1A2 til den inaktive metabolit, 2-amino-5, 6-dichloro-3, 4-dihydroquinazolin.
English: In vitro studies of human megakaryocytopoiesis established that anagrelide's inhibitory actions on platelet formation in man are mediated via retardation of maturation of megakaryocytes, and reducing their size and ploidy.
Danish: In vitro undersøgelser af human megakaryocytopoiese har fastslået, at anagrelids hæmmende virkning på dannelsen af blodplader hos mennesker fremkaldes via forsinkelse af modningen af megakaryocytter, og ved at reducere deres størrelse og ploidi.
English: For this reason it is used to treat patients with essential thrombocythaemia.
Danish: Derfor anvendes det til behandling af patienter med essentiel trombocytæmi.
English: Moreover, serious cardiovascular adverse events have also occurred in patients without suspected heart disease and with normal pre-treatment cardiovascular examination.
Danish: Alvorlige kardiovaskulære bivirkninger er også forekommet hos patienter uden mistænkt hjertesygdom, og hvor de kardiovaskulære undersøgelser før behandlingen var normale.
English: • CYP1A2 inducers (such as omeprazole) could decrease the exposure of anagrelide increasing its main active metabolite.
Danish: • CYP1A2-induktorer (såsom omeprazol) kan reducere eksponeringen for anagrelid og øge den primære aktive metabolit.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORE OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: In female rats increases in pre- and post-implantation losses and a decrease in the mean number of live embryos was observed at 30 mg/kg/day.
Danish: Hos hunrotter blev der observeret en stigning i præ- og postimplantationstab og en reduktion i det gennemsnitlige antal levende embryoer ved 30 mg/kg/dag.
English: 117 Allée des Parcs Saint-Priest
Danish: 117 Allée des Parcs,
English: • At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function e.g. acetylsalicylic acid.
Danish: • Ved de doser, der anbefales til brug ved behandling af essentiel trombocytæmi, kan anagrelid forstærke virkningen af andre lægemidler, der hæmmer eller modificerer trombocytfunktionen, f.eks. acetylsalicylsyre.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Hårde kapsler
English: Reported symptoms include sinus tachycardia and vomiting.
Danish: De rapporterede symptomer omfatter sinus takykardi og opkastning.
English: Anagrelide, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
Danish: Anagrelid givet ved højere doser end de anbefalede har fremkaldt blodtryksfald med lejlighedsvise tilfælde af hypotension.
English: UNIQUE IDENTIFIER - 2D BARCODE Carton only:
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Kun æske:
English: Repeated dose toxicity
Danish: Toksicitet ved gentagne doser
English: • A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1 mg once daily and acetylsalicylic acid 75 mg once daily may enhance the anti-platelet aggregation effects of each active substance compared with administration of acetylsalicylic acid alone.
Danish: • Et klinisk interaktionsstudie med raske studiedeltagere viste, at samtidig indgift af en gentagen dosis anagrelid 1 mg én gang dagligt og acetylsalicylsyre 75 mg én gang dagligt kan øge den trombocytfunktionshæmmende virkning af hvert aktive stof sammenlignet med indgift af acetylsalicylsyre alene.
English: The reference medicinal product containing anagrelide has been authorised under “exceptional circumstances”.
Danish: Referencelægemidlet, som indeholder anagrelid, er godkendt under ”særlige vilkår”.
English: In this study 34 patients received anagrelide for up to 5 years.
Danish: I denne undersøgelse modtog 34 patienter anagrelid i indtil 5 år.
English: Therefore, it is recommended that patients with moderate or severe hepatic impairment are not treated with anagrelide.
Danish: Det anbefales derfor, at patienter med moderat eller svært nedsat leverfunktion ikke behandles med anagrelid.
English: In an open-label clinical study in 8 children and 10 adolescents (including patients who were anagrelide treatment naïve or who had been receiving anagrelide for up to 5 years pre-study), median platelet counts were decreased to controlled levels after 12 weeks of treatment.
Danish: I et åbent klinisk studie med 8 børn og 10 unge (herunder patienter, der var naive med hensyn til behandling med anagrelid, eller som havde fået anagrelid i op til 5 år inden studiet), faldt det mediane trombocyttal til kontrollerede niveauer efter 12 ugers behandling.
English: It is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal) (see sections 4.2 and 4.3).
Danish: Behandlingen anbefales ikke til patienter med forhøjede aminotransferaser (> 5 gange den øverste grænse for normalområdet) (se pkt.
English: The maximum change in mean heart rate occurred at 2 hours after administration and was +7.8 beats per minute (bpm) for 0.5 mg and +29.1 bpm for 2.5 mg.
Danish: Den maksimale ændring i gennemsnitlig hjerterytme opstod 2 timer efter administration og var +7,8 slag pr. minut (beats per minute, bpm) for 0,5 mg og +29,1 bpm for 2,5 mg.
English: • If you have moderate or severe liver problems;
Danish: • hvis du har moderate eller alvorlige leverproblemer;
English: The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4).
Danish: Virkningen af behandling med anagrelid skal overvåges regelmæssigt (se pkt.
English: Maternally toxic doses of anagrelide in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Danish: Toksiske doser af anagrelid til moderdyr hos rotter og kaniner blev sat i forbindelse med øget fosterresorption og fosterdødelighed.
English: Show them the pack of Anagrelide Mylan.
Danish: Vis dem Anagrelide Mylan emballagen.
English: In the later study 3,660 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
Danish: I den senere undersøgelse blev 3.660 patienter, der modtog anagrelid i en gennemsnitlig dosis på ca. 2 mg/dag, vurderet for sikkerhed.
English: In these studies 22 patients received anagrelide for up to 4 years.
Danish: I disse undersøgelser modtog 22 patienter anagrelid i indtil 4 år.
English: Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Danish: Farmakokinetiske data fra raske personer klarlagde, at mad nedsætter Cmax for anagrelid med 14%, men øger AUC med
English: • In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Danish: • In vivo interaktionsstudier hos mennesker har påvist, at digoxin og warfarin ikke påvirker anagrelids farmakokinetiske egenskaber.
English: Evidence of similar in vivo actions was observed in bone marrow biopsy samples from treated patients.
Danish: Tegn på tilsvarende in vivo virkning er observeret i knoglemarvsbiopsier fra behandlede patienter.
English: Cases of pulmonary hypertension have been reported in patients treated with anagrelide.
Danish: Der er blevet rapporteret tilfælde af pulmonal hypertension hos patienter behandlet med anagrelid.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne anført efter alvorlighedsgrad.
English: Pharmacokinetic data from exposed fasting children and adolescents (age range 7 - 16 years) with essential thrombocythaemia indicate that dose normalised exposure, Cmax and AUC, of anagrelide tended to be higher in children/adolescents compared with adults.
Danish: Farmakokinetiske data fra eksponerede fastende børn og unge (i alderen 7 - 16 år) med essentiel trombocytæmi viser, at dosis-normaliseret eksponering, Cmax og AUC for anagrelid har en tendens til at være højere hos børn/unge i sammenligning med voksne.
English: The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose).
Danish: Den anbefalede startdosis for anagrelid er 1 mg/dag, der skal indgives oralt fordelt på to doser (0,5 mg/dosis).
English: A transient increase in mean QTc was observed for both doses during periods of increasing heart rate and the maximum change in mean QTcF (Fridericia correction) was +5.0 msec occurring at 2 hours for 0.5 mg and +10.0 msec occurring at 1 hour for 2.5 mg.
Danish: Der blev observeret en forbigående forøget gennemsnitlig QTc for begge doser i løbet af perioderne med øget hjerterytme, og den maksimale ændring i gennemsnitlig QTcF (Fridericia-korrektion) var +5,0 msek, der opstod efter 2 timer for 0,5 mg og +10,0 msek., der opstod efter 1 time for 2,5 mg.
English: In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
Danish: I 3 af undersøgelserne blev 942 patienter, der modtog anagrelid i en gennemsnitlig dosis på ca. 2 mg/dag, vurderet for sikkerhed.
English: Pharmacokinetic data from fasting elderly patients with ET (age range 65 - 75 years) compared to fasting adult patients (age range 22 - 50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 3hydroxy anagrelide, were 42% and 37% lower respectively in the elderly patients.
Danish: Farmakokinetiske data fra fastende ældre patienter med ET (i alderen 65 - 75 år) sammenlignet med fastende voksne patienter (i alderen 22 - 50 år) viser, at Cmax og AUC for anagrelid var henholdsvis 36% og 61% højere hos ældre patienter, hvorimod Cmax og AUC for den aktive metabolit 3-hydroxyanagrelid var henholdsvis 42% og 37% lavere hos ældre patienter.
English: If needed, anagrelide dose adjustment could be made.
Danish: Hvis det er nødvendigt, kan der foretages dosisjustering af anagrelid.
English: In a paediatric registry study, median platelet counts were reduced from diagnosis and maintained for up to 18 months in 14 paediatric ET patients (4 children, 10 adolescents) with anagrelide treatment.
Danish: I et pædiatrisk registerstudie blev det mediane trombocyttal nedsat i forhold til diagnosticeringstidspunktet og opretholdt i op til 18 måneder hos 14 pædiatriske ET-patienter (4 børn, 10 unge) i behandling med anagrelid.
English: Post-marketing case reports of intentional overdose with anagrelide have been received.
Danish: Efter markedsføringen er der modtaget rapporter om tilsigtet overdosering af anagrelid.
English: Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during anagrelide therapy.
Danish: Patienter bør evalueres for tegn og symptomer på underliggende kardiopulmonal sygdom, før behandlingen med anagrelid påbegyndes og under behandlingen.
English: You must stop breast-feeding if you are taking Anagrelide Mylan.
Danish: Du skal stoppe med at amme, hvis du tager Anagrelide Mylan.
English: • Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g. condom).
Danish: • Svangerskabsforebyggende tabletter: Hvis du har kraftig diarré, mens du tager dette lægemiddel, kan det nedsætte virkningen af svangerskabsforebyggende tabletter, og det anbefales at benytte en ekstra præventionsmetode (f.eks. kondom).
English: If you take more Anagrelide Mylan than you should If you take more Anagrelide Mylan than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Anagrelide Mylan, eller hvis en anden har taget din medicin, skal du straks underrette din læge eller apoteket.
English: Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), assessment of liver function (ALT and AST), renal function (serum creatinine and urea) and electrolytes (potassium, magnesium and calcium).
Danish: Behandling kræver nøje klinisk overvågning af patienten, hvilket vil omfatte komplet blodtælling (hæmoglobin og hvide blodceller og blodpladetal), vurdering af leverfunktion (ALAT og ASAT), test af nyrefunktion (serum-kreatinin og urea) samt elektrolytter (kalium, magnesium og calcium).
English: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking anagrelide.
Danish: Kvinder, der kan blive gravide, skal sikre, at de anvender effektiv prævention, mens de tager anagrelid.
English: Dose should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Danish: Dosis bør nedsættes eller afbrydes efter behov, til blodpladetallet er tilbage i det normale interval.
English: The safety and efficacy of anagrelide in children has not been established.
Danish: Anagrelids sikkerhed og virkning hos børn er ikke klarlagt.
English: • If you have any problems with your liver or kidneys.
Danish: • Hvis du har problemer med lever eller nyrer.
English: Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1 mg/kg/day or higher in males and females with males being more sensitive.
Danish: Efter gentagen oral indgivelse af anagrelid hos hunde blev der observeret subendokardial blødning og fokal myokardial nekrose ved 1 mg/kg/dag eller derover hos han- og hunhunde, hvor hanhundene var mest følsomme.
English: Do not crush the capsules or dilute the contents in a liquid.
Danish: Du må ikke knuse kapslerne eller fortynde indholdet med væske.
English: Therefore anagrelide is not recommended during pregnancy.
Danish: Derfor bør anagrelid ikke anvendes under graviditet.
English: Patients are advised not to drive or operate machinery while taking anagrelide if dizziness is experienced.
Danish: Patienterne rådes til ikke at føre motorkøretøj eller betjene maskiner, medens de tager anagrelid, hvis de oplever svimmelhed.
English: Care should also be taken in populations that may have a higher maximum plasma concentration (Cmax) of anagrelide or its active metabolite, 3-hydroxy-anagrelide, e.g. hepatic impairment or use with CYP1A2 inhibitors (see section 4.5).
Danish: Der skal også udvises forsigtighed hos populationer, der kan have en højere maksimal plasmakoncentration (Cmax) af anagrelid eller den aktive metabolit, 3-hydroxy-anagrelid, f.eks. nedsat leverfunktion eller anvendelse sammen med CYP1A2-hæmmere (se pkt.
English: Anagrelide Mylan contains the active substance, anagrelide.
Danish: Anagrelide Mylan indeholder det aktive stof, anagrelid.
English: Anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Danish: Anagrelid er indiceret til reduktion af forhøjet blodpladetal hos risikopatienter med essentiel trombocytæmi (ET), der ikke tåler deres nuværende behandling, eller hvis forhøjede blodpladetal ikke reduceres til et acceptabelt niveau med den aktuelle behandling.
English: • Medicines that can alter your heart rhythm e.g. sotalol, amiodarone;
Danish: • Medicin, der kan ændre din hjerterytme, f.eks. sotalol, amiodaron;
English: No human data on the effect of anagrelide on fertility are available.
Danish: Der foreligger ingen data om virkningen af anagrelid på fertiliteten hos mennesker.
English: • Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e.g. theophylline.
Danish: • Anagrelid udviser begrænset hæmmende aktivitet over for CYP1A2, hvilket kan udgøre en teoretisk mulighed for interaktion med andre samtidigt indgivne lægemidler, der har samme clearance mekanisme, f.eks. theophyllin.
English: POL. Las Salinas Sant Boi de Llobregat 08830 Barcelona Spain
Danish: Polígono Las Salinas 08830 Sant Boi de Llobregat Spanien
English: GENERAL CLASSIFICATION FOR SUPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: The average total daily dose of anagrelide across all studies in paediatric ET patients was highly variable, but overall the data suggest that adolescents could follow similar starting and maintenance doses to adults and that a lower starting dose of 0.5 mg/day would be more appropriate for children over 6 years (see sections 4.2, 4.4, 4.8, 5.2).
Danish: Den gennemsnitlige totale daglige anagreliddosis i alle studierne med pædiatriske ET-patienter varierede meget, men samlet tyder data på, at unge kan følge start- og vedligeholdelsesdoser, der ligner dem for voksne, og at en lavere startdosis på 0,5 mg/dag vil være mest hensigtsmæssig for børn over 6 år (se pkt.
English: Available data in animals have shown excretion of anagrelide/metabolites in milk.
Danish: De tilgængelige data fra dyrestudier viser, at anagrelid/metabolitter udskilles i mælk.
English: 100 hard capsules
Danish: 100 hårde kapsler.
English: In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
Danish: I et to-årigt studie af karcinogenitet hos rotter blev der gjort ikke-neoplastiske og neoplastiske observationer, som kunne føres tilbage til en udtalt farmakologisk virkning.
English: Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Danish: Der er fundet dosisproportionalitet i dosisintervallet fra 0,5 mg til 2 mg. Pædiatrisk population
English: Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Danish: Tal med lægen, hvis du ammer eller planlægger at amme dit barn.
English: A pre-treatment cardiovascular examination, including a baseline ECG and echocardiography is recommended for all patients prior to initiating therapy with anagrelide.
Danish: Det anbefales at udføre en kardiovaskulær undersøgelse, herunder baseline-EKG og baselineekkokardiografi, hos alle patienter, før behandlingen med anagrelid påbegyndes.
English: If you forget to take Anagrelide Mylan
Danish: Hvis du har glemt at tage Anagrelide Mylan
English: Anagrelide is a medicine which interferes with the development of platelets.
Danish: Anagrelid er et lægemiddel, der griber ind i udviklingen af blodplader.
English: Platelet targets are assigned on an individual patient basis by the treating physician.
Danish: Mål for trombocyttal fastsættes individuelt for den enkelte patient af den behandlende læge.
English: Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, such as congenital long QT syndrome, a known history of acquired QTc prolongation,
Danish: Der skal udvises forsigtighed, når anagrelid bruges hos patienter med kendte risikofaktorer for forlængelse af QT-intervallet, såsom medfødt langt QT-syndrom, anamnese med erhvervet QTcforlængelse, lægemidler, der kan forlænge QTc-intervallet, samt hypokaliæmi.
English: • Other medicines used to treat conditions affecting the platelets in your blood, e.g. clopidogrel;
Danish: • Anden medicin til behandling af tilstande, der påvirker blodpladerne i dit blod, f.eks.
English: 4.4 Special warnings and precautions for use Hepatic impairment
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Nedsat leverfunktion
English: In a pre- and post-natal development study in female rats, anagrelide at oral doses of ≥ 10 mg/kg produced a non-adverse increase in gestational duration.
Danish: I et præ- og postnatalt udviklingsstudie med hunrotter førte anagrelid ved orale doser på ≥ 10 mg/kg til en ikke negativ forlængelse af gestationsvarigheden.
English: • If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes e.g. potassium, magnesium or calcium (see section
Danish: • Hvis du har medfødt forlænget QT-interval, eller du har det i familien (kan ses på EKG'et, en registrering af hjertets elektriske aktivitet), eller du tager andre lægemidler, der fører til unormale EKG-ændringer, eller du har lavt indhold af salte, f.eks. kalium, magnesium eller calcium (se afsnittet ”Brug af anden medicin sammen med Anagrelide Mylan”);
English: • In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin.
Danish: • In vivo humane undersøgelser af interaktion har påvist, at anagrelid ikke påvirker digoxins eller warfarins farmakokinetiske egenskaber.
English: In some ET patients concomitantly treated by acetylsalicylic acid and anagrelide, major haemorrhages occurred.
Danish: Hos nogle patienter med ET, der samtidigt blev behandlet med acetylsalicylsyre og anagrelid, forekom der større blødninger.
English: The consequences on the safety and efficacy profile of anagrelide are not established.
Danish: Konsekvenserne for sikkerheds- og virkningsprofilen for anagrelid er ikke klarlagt.
English: The lowest dose in males (3 mg/kg/day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Danish: Den laveste dosis hos hanrotter (3 mg/kg/dag) svarer til 37 gange den humane AUC-eksponering efter en dosis på 1 mg to gange dagligt.