FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Danish: Hypofosfatasi en sjælden, arvelig knoglesygdom, der kan medføre tidligt tab af tænder, misdannede knogler, hyppige knoglebrud og vejrtrækningsbesvær.
English: Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Danish: Patienterne fik Strensiq, enten 2 mg/kg eller 3 mg/kg, tre gange om ugen i 24 uger.
English: This material will include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.
Danish: Materialet skal omfatte en vejledning i selvinjektion for patienter og en vejledning i injektion for omsorgsgivere og forældre til børn med sygdommen.
English: Strensiq contains the active substance asfotase alfa.
Danish: Strensiq indeholder det aktive stof asfotase alfa.
English: Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Danish: Det aktive stof i Strensiq, asfotase alfa, er en udgave af det menneskelige ALP-enzym og virker som erstatning, hvorved indholdet af fungerende ALP stiger.
English: Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones.
Danish: Patienter med hypofosfatasi kan ikke danne tilstrækkeligt af fungerende ALP.
English: Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Danish: Eftersom hypofosfatasi er en yderst sjælden sygdom, kan der kun forventes begrænsede oplysninger om denne patientgruppe.
English: Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.
Danish: Strensiq udleveres kun efter recept, og behandlingen bør indledes af en læge med erfaring i behandling af stofskifte- eller knoglesygdomme.
English: For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Strensiq fremgår af indlægssedlen.
English: Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
Danish: I nogle af undersøgelserne blev der desuden anvendt en dosis af Strensiq på 1 mg/kg seks gange ugentligt.
English: The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Danish: Virksomheden, der markedsfører Strensiq, skal desuden udlevere oplysningsmateriale til patienter og omsorgsgivere for at sikre, at Strensiq anvendes korrekt, og at risikoen for medicineringsfejl minimeres.
English: What information is still awaited for Strensiq?
Danish: Hvilke oplysninger afventes der stadig for Strensiq?
English: How is Strensiq used?
Danish: Hvordan anvendes Strensiq?
English: The medicine is available as a solution for injection.
Danish: Lægemidlet fås som en injektionsvæske, opløsning.
English: What benefits of Strensiq have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Strensiq?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Strensiq.
English: How does Strensiq work?
Danish: Hvordan virker Strensiq?
English: These measures will help to protect the environment.
Danish: Dette vil bidrage til at beskytte miljøet.
English: These medicines include:
Danish: Disse lægemidler omfatter:
English: Safety and efficacy in children have not been established.
Danish: Sikkerhed og effekt hos børn er ikke konstateret.
English: if you are pregnant
Danish: • hvis du er gravid.
English: - stroke in the past six months.
Danish: slagtilfælde inden for de sidste seks måneder.
English: (≥1/10,000 to <1/1000)
Danish: (≥1/10.000 til <1/1000)
English: Patients should be observed and given supportive treatment.
Danish: Patienterne skal observeres og modtage støttebehandling.
English: You should tell your doctor as soon as possible:
Danish: Kontakt din læge så hurtigt som muligt:
English: It is important that you continue the modifications you have made to your life-style whilst taking cilostazol.
Danish: Det er vigtigt, at du fortsætter med de ændringer, du har foretaget i din livsstil, mens du tager cilostazol.
English: Refer to sections 4.3 and 4.5 for further information on bleeding risks.
Danish: 4.3 og 4.5 for yderligere information vedrørende blødningsrisici.
English: Always take your tablets with a drink of water.
Danish: Tag altid dine tabletter sammen med vand.
English: These reactions were usually of mild to moderate intensity and were sometimes alleviated by reducing the dose.
Danish: Disse reaktioner var normalt af mild til moderat intensitet og blev i nogle tilfælde lettet ved at reducere dosis.
English: - if your blood pressure is not well controlled.
Danish: hvis dit blodtryk ikke er godt kontrolleret.
English: Remember to take the pack with you so that it is clear what medicine you have taken.
Danish: Husk at tage pakningen med, så det er tydeligt hvilken medicin, du har taget.
English: - problems with your eyes if you have diabetes.
Danish: problemer med øjnene, hvis du har diabetes.
English: The expiry date refers to the last date of the month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: This effect appeared lower in diabetics than in non-diabetics.
Danish: Denne virkning var tilsyneladende lavere hos diabetikere end hos ikke-diabetikere.
English: Information on acute overdose in humans is limited.
Danish: Oplysningerne om akut overdosering hos mennesker er begrænsede.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Medicin må ikke bortskaffes via spildevand eller husholdningsaffald.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har samme symptomer, som du har.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ikke særlige opbevaringsforhold.
English: This dose does not need to be changed for elderly people.
Danish: Denne dosis skal ikke ændres for ældre personer.
English: This corresponds to a relative improvement of 100% over placebo.
Danish: Dette svarer til en relativ forbedring på 100 % i forhold til placebo.
English: If your blood pressure falls too low, this could cause a fast heartbeat.
Danish: Hvis dit blodtryk falder for meget, kan dette medføre hurtig hjertebanken.
English: DO NOT take a double dose to make up for a forgotten tablet.
Danish: DU MÅ IKKE tage en dobbeltdosis som erstatning for den glemte tablet.
English: 6.6 Special precautions for disposal <and other handling> No special requirements.
Danish: 6.6 Regler for bortskaffelse <og anden håndtering> Ingen særlige forholdsregler.
English: Other frequent causes of discontinuation included palpitation and diarrhoea (both 1.1%).
Danish: Andre hyppige årsager til ophør omfattede palpitation og diare (begge 1,1 %).
English: Based on these data, no dose adjustment is necessary.
Danish: Baseret på disse data er ingen dosisjustering nødvendig.
English: You may need to have some blood tests and your doctor will decide on your further treatment.
Danish: Det kan være nødvendigt at få taget nogle blodprøver, og din læge vil træffe beslutning om din videre behandling.
English: ATC code: B01A C
Danish: ATC-kode: B01AC
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage denne medicin.
English: There are no special dosage requirements for the elderly.
Danish: Der er ingen særlige doseringskrav til ældre.
English: An increase in the frequency of diarrhoea and palpitation has been found in patients older than 70 years.
Danish: En forøgelse i hyppigheden af diarré og palpitationer er set hos patienter, som var ældre end 70 år.
English: The frequencies of reactions observed in the post-marketing period are considered unknown (cannot be estimated from the available data).
Danish: Hyppigheden for reaktioner, der er observeret i perioden efter markedsføring, anses for ukendt (kan ikke vurderes ud fra de tilgængelige data).
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Danish: Meget sjælden (<1/10.000), ikke kendt (kan ikke anslås ud fra de tilgængelige data)
English: Such lesions were not seen in rats or monkeys and are considered species specific.
Danish: Sådanne læsioner sås ikke hos rotter eller aber og anses for artsspecifikke.
English: Cilostazol is not a substitute for such treatments.
Danish: Cilostazol er ikke en erstatning for sådanne behandlinger.
English: BATCH NUMBER
Danish: BATCHNUMMER PARTI
English: The remainder is excreted as metabolites, none of which exceed 5% of the total excreted.
Danish: Resten udskilles som metabolitter, og ingen af disse overstiger 5 % af den samlede udskillelse.
English: Exposure in late pregnancy resulted in an increased frequency of stillbirths and lower offspring weights.
Danish: Eksponering sent i graviditeten medførte øget hyppighed af dødfødsler og lavere vægt for afkommet.
English: In total, 1,439 patients with intermittent claudication and no heart failure have been treated with cilostazol or placebo for up to three years.
Danish: I alt er 1.439 patienter med claudicatio intermittens og uden hjerteinsufficiens behandlet med cilostazol eller placebo i indtil 3 år.
English: if you have problems with your blood pressure.
Danish: • om du har problemer med blodtrykket.
English: The apparent elimination half-life of cilostazol is 10.5 hours.
Danish: Halveringstiden til eliminering for cilostazol er tilsyneladende 10,5 timer.
English: However, some cases of pancytopenia and aplastic anaemia had a fatal outcome.
Danish: Nogle tilfælde af pancytopeni og aplastisk anæmi havde imidlertid dødelig udgang.
English: If you forget to take <Cilostazol-containing medicinal product> If you miss a dose, do not worry; wait until the next dose to take your next tablet and then carry on as normal.
Danish: Hvis du har glemt at tage lægemidlet indeholdende cilostazol Hvis du glemmer en dosis, skal du ikke være bekymret; vent til næste dosis med at tage den næste tablet og fortsæt derefter som normalt.
English: The following side effects have been reported during the use of <Cilostazol-containing medicinal product> but it is not known how frequently they may occur:
Danish: Følgende bivirkninger er indberettet under brug af lægemidlet indeholdende cilostazol, men det vides ikke hvor ofte de kan forekomme:
English: A full blood count should be performed if infection is suspected or there is any other clinical evidence of blood dyscrasia.
Danish: Fuld blodtælling skal udføres, hvis der er mistanke om infektion, eller der er andre kliniske tegn på bloddyskrasi.
English: Acetylsalicylic Acid (ASA)
Danish: Acetylsalicylsyre (ASA)
English: You should also tell your doctor immediately if you have a fever or sore throat.
Danish: Tal også straks med lægen, hvis du får feber eller ondt i halsen.
English: It may still be all right for you to take the above mentioned medicines and <Cilostazol-containing medicinal product> together and your doctor will be able to decide what is suitable for you.
Danish: Det er måske stadig i orden, at du tager ovenstående lægemidler sammen med lægemidlet indeholdende cilostazol, og din læge vil kunne beslutte, hvad der er hensigtsmæssigt for dig.
English: A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with focus on mortality and safety.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret Fase IV-forsøg blev gennemført for at vurdere de langsigtede virkninger af cilostazol med fokus på dødelighed og sikkerhed.
English: There may be a higher risk of bleeding into the eye in people with diabetes.
Danish: Der kan være en øget risiko for blødning i øjet hos mennesker med diabetes.
English: Interstitial pneumonia
Danish: Interstitial pneumoni
English: Refer to sections 4.3 and 4.5.
Danish: 4.3 og 4.5.
English: Allergic reaction
Danish: • allergisk reaktion
English: The elderly
Danish: Ældre
English: Following multiple doses of cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days.
Danish: Efter flere doser cilostazol 100 mg to gange dagligt til patienter med perifer vaskulær sygdom opnås steady state inden for 4 dage.
English: The primary route of elimination is urinary (74%) with the remainder excreted in the faeces.
Danish: Den primære elimineringsvej er via urinen (74 %) og resten udskilles i afføringen.
English: The only adverse event resulting in discontinuation of therapy in  3% of patients treated with cilostazol was headache.
Danish: Den eneste uønskede hændelse, der medførte behandlingsophør hos  3 % af de patienter, der blev behandlet med cilostazol, var hovedpine.
English: The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm; in patients at risk this consequently may induce angina pectoris.
Danish: Forøgelsen af hjerteslag forbundet med cilostazol er cirka 5-7 bpm; hos risikopatienter kan dette derfor inducere angina pectoris.
English: Long-term treatment with cilostazol did not raise safety concerns.
Danish: Langvarig behandling med cilostazol øgede ikke sikkerhedsproblemerne.
English: Consideration should be given to monitoring the bleeding time at intervals.
Danish: Der skal tages højde for overvågning af blødningstid med mellemrum.
English: Oral Anticoagulants like warfarin
Danish: Perorale antikoagulerende midler som warfarin
English: Cilostazol is 95-98% protein bound, predominantly to albumin.
Danish: Cilostazol er 95-98 % proteinbundet, især til albumin.
English: Stop taking <Cilostazol-containing medicinal product> and contact a doctor or go to the nearest hospital immediately.
Danish: Hold op med at tage lægemidlet indeholdende cilostazol og kontakte en læge eller tag straks til det nærmeste hospital.
English: This medicine has been prescribed for you.
Danish: - Lægen har ordineret dette lægemiddel til dig personligt.
English: The pharmacokinetics of cilostazol and its metabolites were not significantly affected by age or gender in healthy subjects aged between 50-80 years.
Danish: Farmakokinetikken for cilostazol og dets metabolitter var ikke i signifikant grad påvirket af alder eller køn blandt raske forsøgsdeltagere mellem 50-80 år.
English: 20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 100 tablets 112 tablets 168 tablets
Danish: 20 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 100 tabletter 112 tabletter 168 tabletter
English: Investigation of QTc in dogs and monkeys showed no prolongation after administration of cilostazol or its metabolites.
Danish: Undersøgelse af QTc hos hunde og aber viste ingen forlængelse efter administration af cilostazol eller dets metabolitter.
English: If any of the following side effects happen, you may need urgent medical attention.
Danish: Hvis en eller flere bivirkninger indtræder, kan du have brug for akut lægebehandling.
English: <Cilostazol-containing medicinal product> may do the same to other medicines.
Danish: Lægemidlet indeholdende cilostazol kan gøre det samme for andre lægemidler.
English: However, caution is advised in patients receiving both cilostazol and any anticoagulant agent, and frequent monitoring is required to reduce the possibility of bleeding.
Danish: Forsigtighed tilrådes imidlertid for patienter, der modtager både cilostazol og et antikoagulerende middel, og hyppig overvågning kræves for at reducere muligheden for blødning.
English: In addition, an increase in foetuses with external, visceral and skeletal abnormalities was noted at high dose levels.
Danish: Desuden forekom en stigning i antallet af fostre med eksterne, viscerale og skeletale unormale forhold ved høje dosisniveauer.
English: The frequencies correspond with: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare
Danish: Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10) Ikke almindelig (≥1/1.000 til <1/100) Sjælden
English: Do not use <Cilostazol-containing medicinal product> after the expiry date which is stated on the carton and blister after "EXP".
Danish: Brug ikke lægemidlet indeholdende cilostazol efter den udløbsdato, der står på pakningen og blisterpakningen efter "EXP".
English: You should specifically inform your doctor if you take some medicines usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take medicines to reduce blood clotting.
Danish: Du skal specifikt fortælle din læge, om du tager lægemidler, der normalt anvendes til behandling af smertefulde og/eller inflammatoriske tilstande i muskler eller led, eller om du tager medicin for at reducere blodets størkning.
English: The most commonly reported adverse reactions in clinical trials were headache (in > 30%), diarrhoea and abnormal stools (in > 15% each).
Danish: De mest almindeligt indberettede uønskede reaktioner i kliniske forsøg var hovedpine (hos > 30 %), diare og unormal afføring (hos > 15 % hver).
English: if you know that you have a condition which increases your risk of bleeding or bruising, such as: - active stomach ulcer(s).
Danish: • hvis du ved, at du har en tilstand, der øger din risiko for blødning eller kontusioner, f.eks.: aktiv(e) mavesår.
English: No dosage adjustment is necessary in patients with mild hepatic disease.
Danish: Doseringsjustering er ikke nødvendig hos patienter med mild leversygdom.
English: A clinically relevant effect on cilostazol is still possible at higher quantities of grapefruit juice.
Danish: En klinisk relevant indvirkning på cilostrazol er stadig mulig ved større mængder grapefrugtjiuce.
English: In addition to reporting episodes of bleeding and easy bruising, patients should be warned to promptly report any other signs which might also suggest the early development of blood dyscrasia such as pyrexia and sore throat.
Danish: Ud over indberetning af tilfælde af blødning og let opstået kontusion skal patienterne anmodes om straks at indberette eventuelle andre tegn, der også kan tyde på tidlig udvikling af bloddyskrasi, f.eks. pyreksi og ondt i halsen.
English: The risk of intraocular bleeding may be higher in patients with diabetes.
Danish: Risikoen for intraokulær blødning kan være højere hos patienter med diabetes.
English: As with other positive inotropic and vasodilator agents, cilostazol produced cardiovascular lesions in dogs.
Danish: Som andre positive inotropiske og vasodilator-midler fremkaldte cilostazol kardiovaskulære læsioner hos hunde.
English: If a patient is to undergo elective surgery and antiplatelet effect is not necessary, cilostazol should be stopped 5 days prior to surgery.
Danish: Hvis en patient skal opereres elektivt, og antitrombocyt-effekt ikke er nødvendig, skal cilostazolbehandlingen afbrydes 5 dage forud for operationen.
English: In in vitro tests on Chinese ovary hamster cells cilostazol produced a weak but significant increase in chromosome aberration frequency.
Danish: I in vitro test på kinesiske hamsterovarieceller fremkaldte cilostazol en svag men signifikant stigning i hyppigheden for kromosomaberration.
English: Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below.
Danish: Uønskede reaktioner, der er rapporteret i kliniske forsøg og i perioden efter markedsføring, fremgår af nedenstående tabel.
English: An increased frequency of retardation of ossification of the sternum was observed in rabbits.
Danish: En øget hyppighed af hæmning af knogledannelsen i sternum blev observeret hos kaniner.
English: Cilostazol did not alter fertility in animal studies.
Danish: Cilostazol ændrede ikke fertiliteten ved dyrestudier.
English: Intermittent claudication is the cramp-like pain in your legs when you walk and is caused by insufficient blood supply in your legs.
Danish: Claudicatio intermittens er den krampelignende smerte i dine ben, når du går, og den skyldes utilstrækkelig blodtilførsel til dine ben.
English: Cilostazol should be taken 30 minutes before breakfast and the evening meal.
Danish: Cilostazol skal indtages 30 minutter før morgenmaden og aftensmåltidet.
English: There are two major metabolites, a dehydro-cilostazol and a 4'-trans-hydroxy cilostazol, both of which have similar apparent half-lives.
Danish: Der er to vigtige metabolitter, et dehydro-cilostazol og et 4`-trans-hydroxy-cilostazol, der begge ser ud til at have tilsvarende halveringstider.
English: No unusual neoplastic outcomes were observed in two-year carcinogenicity studies in rats at oral (dietary) doses up to 500 mg/kg/day, and in mice at doses up to 1000 mg/kg/day.
Danish: Der blev ikke observeret usædvanlige neoplastiske resultater i toårige carcinogenicitetsforsøg med rotter med perorale (diætetiske) doser på op til 500 mg/kg/dag, og hos mus ved doser på op til 1000 mg/kg/dag.
English: <Cilostazol-containing medicinal product> belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
Danish: Lægemidlet indeholdende cilostazol tilhører en gruppe lægemidler, der kaldes fosfodiesterase type 3hæmmere.
English: CONTENTS OF THE PACK AND OTHER INFORMATION
Danish: Pakningsstørrelser og yderligere oplysninger
English: If you are taking such medicines with <Cilostazol-containing medicinal product> your doctor may perform some routine blood tests.
Danish: • Hvis du tager denne form for medicin sammen med lægemiddel indeholdende cilostazol, vil din læge måske udføre nogle rutinemæssige blodprøver.
English: No measurable amount of unchanged cilostazol is excreted in the urine, and less than 2% of the dose is excreted as the dehydro-cilostazol metabolite.
Danish: Der udskilles ikke en målbar mængde uændret cilostazol i urinen, og mindre end 2 % af dosis udskilles som dehydro-cilostazolmetabolit.
English: There were no apparent trends toward a greater frequency of haemorrhagic adverse effects in patients taking cilostazol and ASA compared to patients taking placebo and equivalent doses of ASA.
Danish: Der var tilsyneladende ingen tendenser hen imod større frekvens af hæmoragisk uønskede virkninger hos patienter, der tog cilostazol og ASA, sammenlignet med patienter, der tog placebo og tilsvarende doser ASA.
English: There is no evidence that cilostazol induces hepatic microsomal enzymes.
Danish: Der er ingen tegn på, at cilostazol fremkalder mikrosomale leverenzymer.
English: Your doctor will assess your progress after 3 months of treatment and may recommend that you discontinue cilostazol if the effect of treatment is insufficient.
Danish: Din læge vil vurdere dine resultater efter 3 måneders behandling og kan anbefale, at du holder op med at tage cilostazol, hvis virkningen af behandlingen er utilstrækkelig.
English: Clopidogrel and other antiplatelet drugs
Danish: Clopidogrel og andre antitrombocytmidler
English: Cilostazol may cause dizziness and patients should be warned to exercise caution before they drive or operate machinery.
Danish: Cilostazol kan medføre svimmelhed, og patienterne skal advares om at udvise forsigtighed, før de fører motorkøretøj eller betjener maskiner.
English: If you stop taking <Cilostazol-containing medicinal product> If you stop taking <Cilostazol-containing medicinal product> the pain in your legs may come back or get worse.
Danish: Hvis du holder op med at tage lægemidlet indeholdende cilostazol Hvis du holder op med at tage lægemidlet indeholdende cilostazol, vil smerten i dine ben måske vende tilbage eller blive værre.