FrancophonIA/ELRC3.0 huggingface dataset:
English: The signs and symptoms can be anticipated to be severe headache, diarrhoea, tachycardia and possibly cardiac arrhythmias.
Danish: Tegn og symptomer kan forventes at være svær hovedpine, diare, takykardi og eventuelt hjertearytmi.
English: There are no adequate data in the use of cilostazol in pregnant women.
Danish: Der findes ikke tilstrækkelige data vedrørende brug af cilostazol hos gravide.
English: Concomitant administration of cilostazol and clopidogrel did not have any effect on platelet count, prothrombin time (PT) or activated partial thromboplastin time (aPTT).
Danish: Samtidig administration af cilostazol og clopidogrel havde ingen effekt på trombocyttal, protrombintid (PT) eller aktiveret partiel tromboplastintid (aPTT).
English: Due to the potential harmful effect in the newborn child breast fed by a treated mother, the use of <Cilostazol-containing medicinal product> is not recommended during breast feeding.
Danish: På grund af de potentielle skadelige virkninger hos det nyfødte barn, der ammes af en behandlet mor, anbefales brugen af <lægemidlet indeholdende cilostazol> ikke under amning.
English: Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites.
Danish: Cilostazol elimineres hovedsagelig ved metabolisme og efterfølgende afsondring af metabolitter via urinen.
English: However, the AUC for cilostazol and its metabolites increase approximately proportionately with dose.
Danish: AUC for cilostazol og dets metabolitter stiger imidlertid omtrent proportionalt med dosis.
English: The recommended dosage of cilostazol is 100 mg twice a day.
Danish: Den anbefalede dosis cilostazol er 100 mg 2 gange dagligt.
English: <Cilostazol-containing medicinal product> can increase the distance you can walk without pain since it improves the blood circulation in your legs.
Danish: Lægemidlet indeholdende cilostazol kan øge den distance, du kan gå uden smerte, idet medicinen forbedrer blodomløbet i dine ben.
English: Rhinitis, pharyngitis
Danish: Rhinitis, faryngitis
English: Approximately 30% of the dose is excreted in the urine as the 4'-trans-hydroxy metabolite.
Danish: Ca. 30 % af dosis udskilles i urinen som 4`-trans-hydroxy-metabolit.
English: • acetylsalicylic acid
Danish: • Acetylsalicylsyre
English: Like all medicines, <Cilostazol-containing medicinal product> can cause side effects, although not everybody gets them.
Danish: Lægemidlet indeholdende cilostazol kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Animal studies have shown cilostazol to have vasodilator effects and this has been demonstrated in small studies in man where ankle blood flow was measured by strain gauge plethysmography.
Danish: Dyreforsøg har vist, at cilostazol har vasodilatorvirkninger, og dette er påvist i små forsøg med mennesker, hvor blodgennemstrømningen i anklen blev målt ved plethysmografi med belastningsmåler.
English: Studies in animals have shown reproductive toxicity (see Section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet (se pkt.
English: All healthy subjects in the study had a prolongation of bleeding time on clopidogrel alone and concomitant administration with cilostazol did not result in a significant additional effect on bleeding time.
Danish: Alle raske forsøgsdeltagere i forsøget havde en forlængelse af blødningstiden på clopidogrel alene, og samtidig administration af cilostazol medførte ikke en signifikant yderligere virkning på blødningstiden.
English: With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95%CI of 2.8 to 8.4%) on cilostazol and 6.8% (95% CI of 1.9 to 11.5%) on placebo.
Danish: Med hensyn til dødelighed var den observerede 36 månders Kaplan-Meier hændelsesrate for dødsfald på forsøgsmedicin med en mediantid på forsøgsmedicinen på 18 måneder 5,6 % (95 % CI på 2,8 til 8,4 %) på cilostazol og 6,8 % (95 % af CI på 1,9 til 11,5 %) på placebo.
English: Patients with unstable angina pectoris, myocardial infarction within the last 6 months, or a coronary intervention in the last 6 months.
Danish: • Patienter med ustabiliseret angina pectoris, myokardieinfarkt inden for de sseneste 6 måneder eller hjerteindgreb inden for de seneste 6 måneder.
English: Unknown
Danish: Ukendte
English: There are no data in patients with moderate or severe hepatic impairment.
Danish: Der findes ingen data for patienter med moderat eller svær leverinsufficiens.
English: Some benefits of taking <Cilostazol-containing medicinal product> may be felt within 4-12 weeks of treatment.
Danish: I nogle tilfælde mærkes virkningen af lægemidlet indeholdende cilostazol inden for 4-12 ugers behandling.
English: The inhibition is effective against a range of aggregants (including shear stress, arachidonic acid, collagen, ADP and adrenaline); in man the inhibition lasts for up to 12 hours, and on cessation of administration of cilostazol recovery of aggregation occurred within 48-96 hours, without rebound hyperaggregability.
Danish: Hæmningen er effektiv imod en række aggreganter (herunder forskydningsspænding, arachinsyre, kollagen, ADP og adrenalin); hos mennesker varer hæmningen i indtil 12 timer, og efter ophør med administration af cilostazol forekom regenerationen af aggregation inden for 48-96 timer uden genbundet hyperaggregation.
English: if you have the condition "heart failure".
Danish: • hvis du har tilstanden "hjerteinsufficiens".
English: They may either increase the side effects of <Cilostazol-containing medicinal product> or make <Cilostazol-containing medicinal product> less effective.
Danish: De kan enten øge bivirkningerne af lægemidlet indeholdende cilostazol eller gøre lægemidlet indeholdende cilostazol mindre effektivt.
English: Effects on circulating plasma lipids have been examined in patients taking <Cilostazol-containing medicinal product>.
Danish: Virkningerne på cirkulerende plasmalipider er undersøgt blandt patienter, der tog <lægemidlet indeholdende cilostazol>.
English: In a single-dose clinical study, no inhibition of the metabolism of warfarin or an effect on the coagulation parameters (PT, aPTT, bleeding time) was observed.
Danish: I et klinisk enkeldosisforsøg blev der ikke observeret hæmning af warfarins metabolisme eller en virkning på koagulationsparametrene (PT, aPTT, blødningstid).
English: An increase in the frequency of palpitation and peripheral oedema was observed when cilostazol was combined with other vasodilators that cause reflex tachycardia e.g. dihydropyridine calcium channel blockers.
Danish: En stigning i hyppigheden af palpitation og perifert ødem blev observeret, når cilostazol blev kombineret med andre vasodilatorer, der medfører refleks takykardi, f.eks dibydropyridin calcium-kanalblokkere.
English: Administration of a single dose of 100 mg cilostazol with 240 ml grapefruit juice (an inhibitor of intestinal CYP3A4) did not have a notable effect on the pharmacokinetics of cilostazol.
Danish: Administration af en enkelt dosis på 100 mg cilostazol med 240 ml grapefrugtjuice (en intestinal CYP3A4hæmmer) havde ikke mærkbar effekt på cilostazols farmakokinetik.
English: A higher rate of haemorrhage was observed with the concomitant use of clopidogrel, ASA and cilostazol in the CASTLE trial.
Danish: En højere forekomst af vlødning blev observeret ved samtidig anvendelse af clopidogrel, ASA og cilostazol i CASTLE-forsøget.
English: Patients with any known predisposition to bleeding (e.g. active peptic ulceration, recent [within six months] haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
Danish: • Patienter med kendt tilbøjelighed til blødning (f.eks. aktivt peptisk mavesår, nyere [inden for seks måneder] hæmoragisk slagtilfælde, proliferativ diabetisk retinopati, dårligt kontrolleret hypertension)
English: Cilostazol and several of its metabolites are phosphodiesterase III inhibitors which suppress cyclic AMP degradation, resulting in increased cAMP in a variety of tissues including platelets and blood vessels.
Danish: Cilostazol og flere af dets metabolitter er fosfodiesterase III-hæmmere, der undertrykker cyklisk AMPnedbrydning, hvilket medfører øget cAMP i forskellige væv, herunder trombocytter og blodkar.
English: It has several actions which include widening of some blood vessels and reducing the clotting activity (clumping) of some blood cells called platelets inside your vessels.
Danish: Det virker på flere måder, herunder ved at udvide nogle blodkar og reducere koagulationsaktiviteten (sammenklumpning) for de blodceller, der kaldes trombocytter, i dine blodkar.
English: If you are pregnant, think you may be pregnant or if you are breast-feeding ask your doctor or pharmacist for advice before taking any medicine.
Danish: Hvis du er gravid eller ammer eller har mistanke om, at du er gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: The Cmax of cilostazol and its primary circulating metabolites increase less than proportionally with increasing doses.
Danish: for cilostazol og dets primære cirkulerende metabolitter stiger mindre end proportionalt med stigende doser.
English: Studies in animals and in man (in vivo and ex vivo) have shown that cilostazol causes reversible inhibition of platelet aggregation.
Danish: Forsøg med dyr og mennesker (in vivo og ex vivo) har vist, at cilostazol medfører reversibel hæmning af trombocytaggregation.
English: The dehydro metabolite and 4'-transhydroxy metabolite are 97.4% and 66% protein bound respectively.
Danish: Dehydro-metabolitten og 4`-trans-hydroxymetabolitten er henholdsvis 97,4 % og 66 % proteinbundet.
English: In case of retinal bleeding administration of cilostazol should be stopped.
Danish: I tilfælde af retinal blødning skal administration af cilostazol afbrydes.
English: The antiplatelet effect may theoretically be altered and should be carefully monitored when cilostazol is co-administered with CYP3A4 and CYP2C19 inducers.
Danish: Antitrombocyt-effekten kan teoretisk blive ændret og bør overvåges nøje, når cilostazol administreres sammen med CYP3A4- og CYP2C19-inducere.
English: Cilostazol should be discontinued promptly if there is clinical or laboratory evidence of haematological abnormalities.
Danish: Cilostazol skal straks seponeres, hvis der er kliniske eller laboratoriemæssige tegn på hæmatologisk unormale forhold.
English: Based on its mechanism of action, cilostazol may induce tachycardia, palpitation, tachyarrhythmia and/or hypotension.
Danish: Baseret på dets virkemekanisme kan cilostazol inducere takykardi, palpitationer, takyarytmi og/eller hypotension.
English: However, your doctor may prescribe a lower dose if you are taking other medicines which may have an effect on <Cilostazol-containing medicinal product>.
Danish: Din læge kan dog ordinere en lavere dosis, hvis du får andre lægemidler, der kan påvirke virkningen af <lægemidler indeholdende cilostazol>.
English: The stomach should be emptied by induced vomiting or gastric lavage, as appropriate.
Danish: Maven skal tømmes ved at fremkalde opkastning eller ved maveudskylning, alt efter hvad der er relevant.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til peroral anvendelse
English: Cilostazol per se may carry an increased risk of bleeding and this risk may be potentiated by coadministration with any other agent with such potential.
Danish: Cilostazol i sig selv kan medføre en øget blødningsrisiko, og denne risiko kan blive forstærket ved samtidig administration af andre midler med et sådant potentiale.
English: There are no data in patients with moderate to severe hepatic impairment and since cilostazol is extensively metabolised by hepatic enzymes, the medicine must not be used in such patients (see section 4.3).
Danish: Der findes ingen data for patienter med moderat til svær leverinsufficiens, og da cilostazol metaboliseres i høj grad af leverenzymer, bør medicinen ikke anvendes til sådanne patienter (se pkt.
English: Before you start taking <Cilostazol-containing medicinal product>, please inform your doctor if you are taking medicines for high blood pressure because <Cilostazol-containing medicinal product> may have an additional lowering effect on your blood pressure.
Danish: Før du begynder at tage <lægemidlet indeholdende cilostazol>, skal du fortælle din læge det, hvis du tager medicin for højt blodtryk, idet lægemidlet indeholdende cilostazol kan sænke dit blodtryk yderligere.
English: If you take more <Cilostazol-containing medicinal product> than you should If for any reason you have taken more <Cilostazol-containing medicinal product> tablets than you should, you may have signs and symptoms such as severe headache, diarrhoea, a fall in blood pressure and irregularities of your heartbeat.
Danish: Hvis du af en eller anden grund har taget flere tabletter indeholdende cilostazol end du skulle, kan du opleve tegn og symptomer som svær hovedpine, diare, et fald i blodtrykket og uregelmæssige hjerteslag.
English: Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making life-style modifications (such as stopping smoking and increasing exercise) and after other appropriate interventions.
Danish: Cilostazol anbefales kun til patienter, hvis symptomer ikke er blevet tilstrækkeligt bedret efter at have foretaget livsstilsændringer (så som rygestop og øget motion) og efter andre egnede foranstaltninger.
English: Plasma concentrations (as measured by AUC) of the dehydro and 4`-trans-hydroxy metabolites are ~41% and ~12% of cilostazol concentrations.
Danish: Plasmakoncentrationerne (målt ved AUC) for dehydro og 4`trans-hydroxy metabolitterne er 41 % og 12 % af cilostazol-koncentrationerne.
English: The dehydro metabolite is 4-7 times as active a platelet antiaggregant as the parent compound and the 4'-trans-hydroxy metabolite is one fifth as active.
Danish: Dehydro metabolitten er 4-7 gange så aktiv som trombocyt antiaggregant som moderstoffet, og 4`-transhydroxy metabolitten er en femtedel så aktiv.
English: Congestive heart failure
Danish: • Kongestiv hjerteinsufficiens
English: Patients with any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, whether or not adequately treated, and in patients with prolongation of the QTc interval
Danish: • Patienter med ventrikulær takykardi, ventrikulær fibrillation eller multifokal ventrikulær ektopi i anamnesen, uanset om dette er behandlet tilstrækkeligt eller ej, og patienter med forlænget QTc interval.
English: Cilostazol is a PDE III inhibitor with antiplatelet activity.
Danish: Cilostazol er en PDE III-hæmmer med antitrombocyt-aktivitet.
English: Uric acid level increased, blood urea increased, blood creatinine increased
Danish: Forhøjet urinsyreniveau, urinstof i blodet, forhøjet blodkreatinin
English: Therefore, you should only stop taking <Cilostazol-containing medicinal product> if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Danish: Derfor skal du kun holde op med at tage lægemidlet indeholdende cilostazol, hvis du bemærker bivirkninger, der kræver akut lægebehandling (se pkt.
English: A meta-analysis based on weighted mean differences across the nine studies indicated that there was a significant absolute overall post-baseline improvement of 42 m in maximal walking distance (ACD) for cilostazol 100 mg b.i.d.
Danish: En metaanalyse på basis af vægtede middelværdiforskelle på tværs af de 9 forsøg viste, at der var en signifikant, absolut samlet post-baseline forbedring på 42 m i den distance, en person maksimalt kunne gå (ACD) for cilostazol 100 mg to gange dagligt i forhold til den forbedring, der sås ved placebo.
English: Cilostazol is contraindicated in patients with a creatinine clearance of  25 ml/min.
Danish: Cilostazol er kontraindiceret til patienter med kreatinin clearance på  25 ml/min.
English: <Cilostazol-containing medicinal product> is for second-line use, in patients in whom lifestyle modifications (including stopping smoking and [supervised] exercise programs) and other appropriate interventions have failed to sufficiently improve their intermittent claudication symptoms.
Danish: <Lægemidlet indeholdende cilostazol> er til sekundær anvendelse hos patienter, hos hvem livsstilsændringer (inklusive rygestop og [overvågede] øvelsesprogrammer) og andre passende indgreb ikke i tilstrækkelig grad har forbedret deres symptomer på claudicatio intermittens.
English: Taking <Cilostazol-containing medicinal product> with food and drink <Cilostazol-containing medicinal product> tablets should be taken 30 minutes before breakfast and the evening meal.
Danish: Brug af lægemidlet indeholdende cilostazol sammen med mad og drikke Lægemidlet indeholdende cilostazol skal indtages 30 minutter før morgenmaden og aftensmåltidet.
English: The physician should reassess the patient after 3 months of treatment with a view to discontinuing cilostazol where an inadequate effect is observed or symptoms have not been improved.
Danish: Lægen skal vurdere patienten efter s3 måneders behandling med hensyn til seponering af cilostazol, hvis der observeres utilstrækkelig effekt, eller symptomerne ikke er bedret.
English: Caution is needed when co-administering cilostazol with any other agent which has the potential to reduce blood pressure due to the possibility that there may be an additive hypotensive effect with a reflex tachycardia.
Danish: Forsigtighed er påkrævet ved samtidig administration af cilostrazol og ethvert andet middel, der potentielt kan nedsætte blodtrykket, på grund af muligheden for, at der kan være en ekstra hypotensiv virkning med en refleks-takykardi.
English: Your medicine is supplied in packs of 14, 20, 28, 30, 50, 56, 98, 100, 112 or 168 tablets or hospital packs with 70 (5x14) tablets.
Danish: Din medicin leveres i pakninger med 14, 20, 28, 30, 50, 56, 98, 100, 112 eller 168 tabletter eller som hospitalspakninger med 70 (5x14) tabletter.
English: Patients should be warned to report any episode of bleeding or easy bruising whilst on therapy.
Danish: Patienterne skal anmodes om at indberette enhver blødningsepisode eller let opstået kontusion under behandlingen.
English: The excretion of cilostazol in human milk is unknown.
Danish: Udvindingen af cilostazol i modermælk kendes ikke.
English: Patients who may be at increased risk for serious cardiac adverse events as a result of increased heart rate, e.g. patients with stable coronary disease, should be closely monitored during treatment with cilostazol, while the use of cilostazol in patients with unstable angina pectoris, or myocardial infarction/coronary intervention within the last 6 months, or a history of severe tachyarrhythmia is contraindicated (see section 4.3).
Danish: Patienter, som kan være udsat for ekstra risiko for alvorlige hjertehændelser som følge af forhøjet puls, fx patienter med stabiliseret koronarsygdom, skal monitoreres nøje under behandling med cilostazol, mens brug af cilostazol hos patienter med ustabiliseret angina pectoris eller mykoardieinfarkt/koronarindgreb inden for de seneste 6 måneder eller svære takyarrytmier i anamnesen er kontraindiceret (se pkt.
English: Caution is advised when cilostazol is co-administered with CYP3A4 substrates with a narrow therapeutic index (e.g., cisapride, halofantrine, pimozide, ergot derivates).
Danish: Forsigtighed tilrådes, når cilostazol administreres sammen med CYP3A4-substrater med snævert terapeutisk indeks (f.eks. cisaprid, halofantrin, pimozid, ergot-derivater).
English: In rats dosed during pregnancy, foetal weights were decreased.
Danish: Hos rotter, der modtog doser under drægtighed, var fostervægten reduceret.
English: <Cilostazol-containing medicinal product> is indicated for the improvement of the maximal and painfree walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II).
Danish: <Lægemidlet indeholdende cilostazol> er indiceret til forbedring af den distance, som patienter med claudicatio intermittens, der ikke har smerter i hvile, og som ikke har tegn på perifer vævsnekrose (perifer arteriesygdom Fontaine trin II) maksimalt kan gå uden smerter.
English: Patients receiving treatment with cilostazol should continue with their life-style modifications (smoking cessation and exercise), and pharmacological interventions (such as lipid lowering and antiplatelet treatment) to reduce the risk of cardiovascular events.
Danish: Patienter, der modtager behandling med cilostazol, skal fortsætte med deres livsstilsændringer (rygestop og træning) samt farmakologiske indgreb (så som lipidsænkning pg antotrombocytbehandling) for at reducere risikoen for kardiovaskulære hændelser.
English: Cartons containing 14, 20, 28, 30, 50, 56, 98, 100, 112 and 168 tablets as well as hospital packs with 70 (5x14) tablets packed in PVC/Aluminium blisters.
Danish: Pakninger med 14, 20, 28, 30, 50, 56, 98, 100, 112 og 168 tabletter samt hospitalspakninger med 70 (5x14) tabletter i PVC/aluminium-blisterpakninger.
English: Paresis, hypoaesthesia
Danish: Parese, hypoæstesi
English: The usual dose is two 50 mg tablets twice a day (morning and evening).
Danish: • Den normale dosis er to 50 mg tabletter to gange dagligt (morgen og aften).
English: Due to cilostazol's platelet aggregation inhibitory effect it is possible that an increased bleeding risk occurs in combination with surgery (including minor invasive measurements like tooth extraction).
Danish: På grund af cilostazols hæmmende virkning på trombocytaggregation kan der eventuelt forekomme en øget blødningsrisiko i forbindelse med operation (herunder mindre invasive indgreb som f.eks. tandudtrækning).
English: Mutagenicity studies were negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation and mouse in vivo bone marrow chromosomal aberrations.
Danish: Mutagenicitetsforsøg var negative for bakteriel genmutation, bakteriel DNA-reparation, cellegenmutation hos pattedyr og kromosomaberration i in vivo knoglemarv hos mus.
English: • angiotensin II receptor blockers (e.g., valsartan, candesartan)
Danish: • Angiotensin II-recetorblokkere (fx valsartan, candesartan)
English: increases in mean ACD ranged from 60.4 - 129.1 metres, whilst mean ICD increases ranged from 47.3 - 93.6 metres.
Danish: Efter 24 ugers behandling med cilostazol 100 mg to gange dagligt varierede stigningerne i middelværdien for ACD fra 60,4 - 129,1 meter, mens middelværdien for stigningerne i ICD varierede fra 47,3 - 93,6 meter.
English: You have been prescribed <Cilostazol-containing medicinal product> for "intermittent claudication".
Danish: Du har fået ordineret lægemidlet indeholdende cilostazol for "claudicatio intermittens".
English: Short term (4 days) co-administration of ASA with cilostazol suggested a 23-25% increase in inhibition of ADP-induced ex vivo platelet aggregation when compared to ASA alone.
Danish: Kortvarig ( 4 dage) administration af ASA sammen med cilostazol tydede på en 23-25 % stigning i hæmningen af ADP-fremkaldt ex vivo trombocytaggregation sammenlignet med ASA alene.
English: The usual dose is one 100 mg tablet twice a day (morning and evening).
Danish: • Den normale dosis er én 100 mg tablet to gange dagligt (morgen og aften).
English: Caution should be exercised when prescribing cilostazol for patients with atrial or ventricular ectopy and patients with atrial fibrillation or flutter.
Danish: Der skal udvises forsigtighed ved ordinering af cilostazol til patienter med atrie- eller ventrikelektopi og patienter med atrieflimren eller -flagren.
English: Certain medicines may interfere with the effect of <Cilostazol-containing medicinal product> when taken together.
Danish: Visse typer medicin kan gribe forstyrrende ind i virkningen af lægemidlet indeholdende cilostazol, hvis de tages samtidig.
English: The primary isoenzymes involved in its metabolism are cytochrome P-450 CYP3A4, to a lesser extent, CYP2C19, and to an even lesser extent CYP1A2.
Danish: De primære isoenzymer, der er involveret i metabolismen, er cytokrom P-450 CYP3A4, i mindre omfang CYP2C19 og i endnu mindre grad CYP1A2.