FrancophonIA/ELRC3.0 huggingface dataset:
English: Within the system organ classes they are listed under the following headings: 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 (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Inden for de enkelte systemorganklasser er de listet under følgende overskrifter: 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
English: During clinical development doses of 10 mg/day have been used.
Danish: Under den kliniske udvikling er der anvendt doser på 10 mg/dag.
English: • a platelet count > 1,000 x 109/l or
Danish: • et blodpladetal på > 1.000 x 109/l eller
English: Patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Danish: Patienter med moderat eller svær nyreinsufficiens (kreatinin clearance < 50 ml/min).
English: • Certain types of antibiotic, such as enoxacin, used to treat infections;
Danish: • Visse former for antibiotika, såsom enoxacin, som anvendes til behandling af infektioner;
English: METHOD AND ROUTE OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Any abnormalities should be evaluated promptly and appropriate measures taken, which may also include dose reduction, interruption or discontinuation.
Danish: Alle anomalier bør evalueres prompte, og der skal tages passende foranstaltninger, hvilket også kan omfatte dosisreduktion, -afbrydelse eller -seponering.
English: However, safety data are limited and do not allow a meaningful comparison between adult and paediatric patients to be made (see section 4.4).
Danish: Der er imidlertid begrænsede sikkerhedsdata, og de tillader ikke, at der udføres en meningsfyldt sammenligning mellem voksne og pædiatriske patienter (se pkt.
English: The safety of anagrelide has been examined in 4 open label clinical studies.
Danish: Sikkerheden for anagrelid er undersøgt i 4 kliniske open-label-studier.
English: Anagrelide or these medicines may not work properly if taken together.
Danish: Anagrelide Mylan eller disse lægemidler virker måske ikke korrekt, hvis de tages samtidigt.
English: Clinically relevant interactions
Danish: Klinisk relevante interaktioner
English: Mutagenic and carcinogenic potential
Danish: Mutagent potentiale og karcinogenicitet
English: Adverse reactions arising from clinical studies, post-authorisation safety studies and spontaneous reports are presented in the table below.
Danish: Bivirkninger fra kliniske studier, sikkerhedsstudier efter markedsføringstilladelse og spontane rapporter fremlægges i nedenstående tabel.
English: Additionally these results show no evidence of auto-induction of the anagrelide clearance.
Danish: Desuden viser disse resultater ikke evidens for autoinduktion af anagrelids clearance.
English: Your capsules should be swallowed whole with a glass of water.
Danish: Du skal sluge kapslerne hele med et glas vand.
English: Rare: Kidney failure (when you pass little or no urine), heart attack.
Danish: Sjælden: Nyresvigt (du udskiller kun lidt eller ingen urin), hjerteanfald.
English: Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well.
Danish: Din læge vil bede dig få taget blodprøver med jævne mellemrum for at kontrollere, at medicinen virker effektivt, og at din lever og nyrer fungerer, som de skal.
English: Less than 1% is recovered in the urine as anagrelide.
Danish: Under 1% genfindes i urinen som anagrelid.
English: The plasma half-life of anagrelide is short, approximately 1.3 hours and as expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Danish: Halveringstiden i plasma af anagrelid er kort, ca. 1,3 timer, og som det forventes fra halveringstiden, er der ikke evidens for akkumulation af anagrelid i plasma.
English: However, hepatic metabolism represents the major route of anagrelide clearance and liver function may therefore be expected to influence this process.
Danish: Hepatisk metabolisme udgør imidlertid den vigtigste metode til clearance af anagrelid, og leverfunktionen kan derfor forventes at have indflydelse på denne proces.
English: In studies 700-012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Danish: I undersøgelserne 700-012, 700-014, 700-999 og undersøgelse 13970-301 varierede tiden til komplet respons fra 4 til 12 uger.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxy-anagrelide, by 29%, although it had no effect on the AUC.
Danish: Mad reducerede også Cmax for den aktive metabolit, 3-hydroxyanagrelid, med 29%, selvom det ikke havde nogen virkning på AUC.
English: During clinical development approximately 50% of the patients treated with anagrelide were over 60 years of age and no age specific alterations in dose were required in these patients.
Danish: Under den kliniske udvikling var ca. 50 % af de patienter, der blev behandlet med anagrelid, over 60 år, og der var ikke behov for nogen aldersspecifikke ændringer i dosis for disse patienter.
English: It is unknown whether anagrelide/metabolites are excreted in human milk.
Danish: Det er ukendt, om anagrelid/metabolitter udskilles i human mælk.
English: After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 109/l and ideally at levels between 150 x 109/l and 400 x 109/l.
Danish: Efter en uge kan dosis titreres på individuel basis, så man opnår den laveste, effektive dosis, der er nødvendig for at reducere og/eller opretholde et blodpladetal på under 600 x 109/l og ideelt på et niveau mellem 150 x 109/l og 400 x 109/l.
English: Currently available data are described in sections 4.4, 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 4.4, 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: If you are worried, speak to your doctor.
Danish: Hvis du er bekymret herfor, skal du kontakte din læge.
English: If anagrelide is used during pregnancy, or if the patient becomes pregnant while using the medicinal product, she should be advised of the potential risk to the foetus.
Danish: Hvis anagrelid anvendes under graviditet, eller hvis patienten bliver gravid under brug af lægemidlet, skal hun underrettes om den potentielle risiko for fosteret.
English: Limited pharmacokinetic and/or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Danish: Der er kun gennemført begrænsede farmakokinetiske og/eller farmakodynamiske undersøgelser af eventuelle interaktioner mellem anagrelid og andre lægemidler.
English: Therefore, clinical and biological monitoring is recommended in patients taking concomitant CYP1A2 inducers.
Danish: Derfor anbefales en klinisk og biologisk overvågning hos patienter, der samtidig tager CYP1A2-induktorer.
English: • The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Danish: • Virkningen af fødeindtagelse på biotilgængeligheden anses ikke for klinisk relevant for brugen af anagrelid.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Danish: Se anvisninger i indlægssedlen for den svangerskabsforebyggende tablet, som du tager.
English: A specific antidote for anagrelide has not been identified.
Danish: Der er ikke identificeret en specifik modgift mod anagrelid.
English: The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Danish: Den gennemsnitlige genfinding af 2-amino-5, 6-dichloro-3, 4-dihydroquinazolin i urinen er ca. 18-35% af den administrerede dosis.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX35.
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, ATC-kode: L01XX35.
English: In the absence of specific paediatric guidelines, WHO diagnostic criteria for adult diagnosis of ET are considered to be of relevance to the paediatric population.
Danish: Da der ikke foreligger specifikke pædiatriske retningslinjer, anses de diagnostiske kriterier fra WHO for diagnosticering af ET hos voksne for at have relevans for den pædiatriske population.
English: An at risk essential thrombocythaemia patient is defined by one or more of the following features:
Danish: En patient i risikogruppe for essentiel trombocytæmi defineres ved hjælp af én eller flere af følgende egenskaber:
English: Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.
Danish: Et stort antal blodplader i blodet kan medføre alvorlige problemer med blodcirkulationen og dannelse af blodpropper.
English: Do not drive or use machines if you feel dizzy.
Danish: Kør ikke bil og betjen ikke maskiner, hvis du føler dig svimmel.
English: Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Danish: Undersøgelser vedrørende anagrelids genotoksiske potentiale har ikke identificeret nogen mutagene eller klastogene virkninger.
English: Tell your doctor if you are taking any of the following medicines:
Danish: Fortæl din læge, om du tager en eller flere slags anden medicin:
English: 4.7 Effects on ability to drive and use machines In clinical development, dizziness was commonly reported.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Under den kliniske udvikling blev svimmelhed ofte indberettet.
English: • Food delays the absorption of anagrelide, but does not significantly alter systemic exposure.
Danish: • Føde forsinker absorberingen af anagrelid, men ændrer ikke signifikant den systemiske eksponering.
English: All patients should be monitored regularly during treatment (e.g. ECG or echocardiography) for evidence of cardiovascular effects that may require further cardiovascular examination and investigation.
Danish: Alle patienterne bør monitoreres regelmæssigt under behandlingen (f.eks. EKG eller ekkokardiografi) for tegn på kardiovaskulære virkninger, der kan kræve yderligere kardiovaskulær undersøgelse.
English: Anagrelide treatment should only be initiated when the patient shows signs of disease progression or suffers from thrombosis.
Danish: Behandling med anagrelid bør kun påbegyndes, når patienten viser tegn på sygdomsprogression eller lider af trombose.
English: It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level.
Danish: Det reducerer det antal blodplader, som knoglemarven danner, hvilket medfører et fald i antallet af blodplader i blodet hen imod et mere normalt niveau.
English: Effects of anagrelide on other active substances
Danish: Anagrelids virkning på andre aktive stoffer
English: A single 5 mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Danish: En enkelt 5 mg dosis anagrelid kan medføre blodtryksfald, normalt ledsaget af svimmelhed.
English: Typically cytoreductive therapy is considered in high risk paediatric patients.
Danish: Typisk cytoreduktiv behandling skal overvejes hos pædiatriske patienter med høj risiko.
English: Children should be monitored regularly for disease progression according to standard clinical practices, such as physical examination, assessment of relevant disease markers and bone marrow biopsy.
Danish: Børn bør overvåges regelmæssigt for sygdomsprogression i henhold til klinisk standardpraksis såsom lægeundersøgelse, vurdering af relevante sygdomsmarkører og knoglemarvsbiopsi.
English: Gradual dose titration may help diminish these effects (see section 4.2).
Danish: Gradvis dosistitrering kan måske være med til at formindske disse bivirkninger (se pkt.
English: Symptoms resolved with conservative management.
Danish: Symptomerne forsvandt med konservativ behandling.
English: The capsule is filled with a white to off-white powder.
Danish: Kapslen er fyldt med et hvidt til råhvidt pulver.
English: In fasted subjects, peak plasma levels occur about 1 hour after administration.
Danish: Hos fastende patienter opstod højeste plasmaniveauer ca. 1 time efter administration.
English: If the starting dose is > 1 mg/day platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until a stable maintenance dose is reached.
Danish: Hvis startdosis er > 1 mg/dag, skal der udføres blodpladetælling hver anden dag i den første uges behandling og mindst ugentlig derefter, til en stabil vedligeholdelsesdosis er nået.
English: 48 patients aged 6-17 years (19 children and 29 adolescents) have received anagrelide for up to 6.5 years either in clinical studies or as part of a disease registry (see section 5.1).
Danish: 48 patienter i alderen 6-17 år (19 børn og 29 unge) har fået anagrelid i op til 6,5 år, enten i kliniske studier eller som led i et registerstudie (se pkt.
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for Anagrelide Mylan, such as this leaflet.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om referencelægemidlet, og enhver opdatering for referencelægemidlet vil, hvis det skønnes relevant, også blive implementeret i produktinformationen for Anagrelide Mylan, f.eks. i denne indlægsseddel.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to anagrelide administration and should be monitored periodically during therapy.
Danish: Hypokaliæmi eller hypomagnesæmi skal korrigeres før administration af anagrelid og bør monitoreres periodisk under behandlingen.
English: • Inflammation of the kidneys (tubulointerstitial nephritis).
Danish: • Inflammation i nyrerne (tubulointerstitiel nefritis).
English: • Omeprazole, used to reduce the amount of acid produced in the stomach;
Danish: • Omeprazol, som anvendes til at reducere mængden af syre, der dannes i maven;
English: There are no adequate data from the use of anagrelide in pregnant women.
Danish: Der er ikke tilstrækkelige data om brug af anagrelid hos gravide kvinder.
English: Anagrelide should only be used if the potential benefits of therapy outweigh the potential risks.
Danish: Anagrelid bør kun anvendes, hvis de mulige fordele ved behandlingen opvejer de mulige risici.
English: If treatment is initiated, the benefits and risks of treatment with anagrelide must be monitored regularly and the need for ongoing treatment evaluated periodically.
Danish: Hvis behandlingen påbegyndes, skal fordele og risici ved behandlingen med anagrelid overvåges regelmæssigt og behovet for videre behandling evalueres regelmæssigt.
English: These differences were likely to be caused by lower presystemic metabolism of anagrelide to 3-hydroxy anagrelide in the elderly patients.
Danish: Disse forskelle skyldtes sandsynligvis en lavere præsystemisk metabolisme af anagrelid end af 3-hydroxyanagrelid hos ældre patienter.
English: Interstitial lung disease including pneumonitis and allergic alveolitis
Danish: Interstitiel lungesygdom, herunder pneumonitis og allergisk alveolitis
English: • Potentially life-threatening, irregular heart beat (torsade de pointes);
Danish: • Uregelmæssig hjerterytme, der kan være livstruende (torsades de pointes);
English: • Anagrelide is primarily metabolised by CYP1A2.
Danish: • Anagrelid metaboliseres primært af CYP1A2.
English: In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x 109/l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Danish: Hos patienter med essentiel trombocytæmi blev komplet respons defineret som et fald i blodpladetallet til ≤ 600 x109/l eller en ≥ 50% reduktion i forhold til baseline og opretholdelse af reduktionen i mindst 4 uger.
English: Manufacturer Synthon Hispania SL, C/ Castelló no1, POL. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain.
Danish: Fremstiller Synthon Hispania SL, C/ Castelló no1, POL. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spanien
English: • Theophylline, used to treat severe asthma and breathing problems;
Danish: • Theophyllin, som anvendes til behandling af svær astma og vejrtrækningsproblemer;
English: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, France
Danish: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, Frankrig
English: The precise mechanism by which anagrelide reduces blood platelet count is unknown.
Danish: Den præcise mekanisme, hvorved anagrelid reducerer antallet af blodplader, er ukendt.
English: As with the adult population, a full blood count and assessment of cardiac, hepatic and renal function should be undertaken before treatment and regularly during treatment.
Danish: Som hos den voksne population bør der udføres en komplet blodtælling, og hjerte-, lever- og nyrefunktionen bør vurderes før behandlingen og regelmæssigt under behandlingen.
English: The reference medicine for Anagrelide Mylan has been authorised under ‘exceptional circumstances'
Danish: Referencelægemidlet til Anagrelide Mylan er godkendt under ”særlige vilkår”.
English: An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath;
Danish: En allergisk reaktion kan genkendes som udslæt, kløe, hævet ansigt eller læber eller stakåndethed;
English: Marketing Authorisation Holder Mylan S.A.S
Danish: Indehaver af markedsføringstilladelsen Mylan S.A.S
English: • Fluvoxamine, used to treat depression;
Danish: • Fluvoxamin, som anvendes til behandling af depression;
English: The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four openlabel, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4,000 patients with myeloproliferative neoplasms (MPNs).
Danish: Anagrelids sikkerhed og virkning som et middel til reduktion af blodpladerne er vurderet i fire open label, ikke-kontrollerede kliniske undersøgelser (undersøgelsesnummer 700-012, 700-014, 700-999 og 13970-301), der omfattede mere end 4.000 patienter med myeloproliferative neoplasmer (MPN).
English: It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and enoxacin, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Danish: Det vides, at CYP1A2 hæmmes af flere lægemidler, herunder fluvoxamin og enoxacin, og sådanne lægemidler kunne teoretisk påvirke anagrelid clearance negativt.
English: Clinical benefit in terms of thrombohaemorrhagic events has not been convincingly demonstrated.
Danish: Kliniske fordele mht. trombohæmoragiske hændelser er ikke påvist overbevisende.
English: Treatment with anagrelide should be initiated by a clinician with experience in the management of essential thrombocythaemia.
Danish: Behandling med anagrelid skal startes af en kliniker med erfaring i styring af essentiel trombocytæmi.
English: Your doctor may do a blood test which may show an increase in your liver enzymes.
Danish: Din læge vil muligvis tage en blodprøve, som eventuelt kan vise forhøjede leverenzymer.
English: The capsule size is approximately 14.3 x 5.3 mm.
Danish: Størrelsen på kapslen er ca. 14,3 x 5,3 mm.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flaskens etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In case of overdose, close clinical supervision of the patient is required; this includes monitoring of the platelet count for thrombocytopenia.
Danish: I tilfælde af overdosering er nøje klinisk overvågning af patienten påkrævet; dette omfatter også overvågning af blodpladetallet for trombycytopeni.
English: The most commonly reported adverse reactions associated with anagrelide were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6% and diarrhoea occurring at 5%.
Danish: De hyppigst indberettede bivirkninger forbundet med anagrelid var hovedpine, der optrådte hos ca. 14%, palpitationer hos ca. 9%, væskeophobning og kvalme forekom begge hos ca. 6%, og diarré forekom hos 5%.
English: In earlier, open-label studies, median platelet count reductions were observed in 7 children and 9 adolescents treated for between 3 months and 6.5 years.
Danish: I tidligere åbne studier blev fald i mediane trombocyttal observeret hos 7 børn og 9 unge, der blev behandlet i en periode fra 3 måneder til 6,5 år.
English: Typically, a fall in the platelet count will be observed within 14 to 21 days of starting treatment and in most patients an adequate therapeutic response will be observed and maintained at a dose of 1 to 3 mg/day (for further information on the clinical effects refer to section 5.1).
Danish: Typisk ses et fald i blodpladetallet inden for 14 til 21 dage efter behandlingsstart, og for de fleste patienter observeres og opretholdes en tilstrækkelig terapeutisk respons ved en dosis på 1 til 3 mg/dag (for yderligere oplysninger om de kliniske virkninger henvises til pkt.
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic and chronotropic effects, anagrelide should be used with caution in patients of any age with known or suspected heart disease.
Danish: Anagrelid hæmmer cyklisk AMP-fosfodiesterase III, og på grund af dets positive inotrope og kronotrope virkninger skal anagrelid anvendes med forsigtighed hos patienter med kendt eller mistænkt hjertesygdom uanset alder.
English: The experience in children and adolescents is very limited; anagrelide should be used in this patient group with caution.
Danish: Erfaringen med behandling af børn og unge er meget begrænset: Anagrelid bør anvendes med forsigtighed i denne patientgruppe.
English: Each bottle contains 100 hard capsules.
Danish: Flasken indeholder 100 hårde kapsler.
English: Tell your doctor if you are pregnant or are planning to become pregnant.
Danish: Tal med lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: The dose increment must not exceed more than 0.5 mg/day in any one-week and the recommended maximum single dose should not exceed 2.5 mg (see section 4.9).
Danish: Dosisforhøjelsen må ikke overstige 0,5 mg/dag i en given uge, og den anbefalede, maksimale enkeltdosis bør ikke overstige 2,5 mg (se pkt.
English: • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Danish: • Anagrelid kan medføre intestinal forstyrrelse hos nogle patienter og skade absorberingen af hormonel, oral antikonception.
English: The effect of two dose levels of anagrelide (0.5 mg and 2.5 mg single doses) on the heart rate and QTc interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adult men and women.
Danish: Virkningen af to dosisniveauer af anagrelid (0,5 mg og 2,5 mg enkeltdoser) på hjerterytmen og QTcintervallet blev evalueret i et dobbeltblindet, randomiseret, placebo- og aktivt kontrolleret overkrydsningsstudie hos raske, voksne mænd og kvinder.
English: Diagnostic guidelines for essential thrombocythaemia should be followed carefully and diagnosis reassessed periodically in cases of uncertainty, with effort made to distinguish from hereditary or secondary thrombocytosis, which may include genetic analysis and bone marrow biopsy.
Danish: Diagnostiske retningslinjer for essentiel trombocytæmi bør følges nøje, og ved usikkerhed bør diagnosen revurderes regelmæssigt med bestræbelser på at differentiere mellem hereditær og sekundær trombocytose, hvilket kan omfatte genetisk analyse og knoglemarvsbiopsi.
English: Talk to your doctor before taking Anagrelide Mylan:
Danish: Kontakt lægen, før du tager Anagrelide Mylan: