FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance of Siklos passes into human breast-milk.
Danish: Det aktive stof i Siklos passerer ind i menneskets modermælk.
English: The evaluation of the risk-benefit ratio should be made on an individual basis outweighing the respective risk of hydroxycarbamide therapy against the switch to a blood transfusion programme.
Danish: Evalueringen af risici kontra fordele skal foretages på individuel basis, hvor risikoen ved behandling med hydroxycarbamid opvejes mod et skift til et blodtransfusionsprogram.
English: The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment.
Danish: Patientens hæmatologiske status samt nyreog leverfunktion skal fastlægges inden behandlingen og gentagne gange under behandlingen.
English: The time to reach maximum plasma concentration and the percentage of the dose excreted in urine were increased in children compared to adults.
Danish: Tiden indtil den maksimale plasmakoncentration var nået, og den procentdel af dosis, der blev udskilt i urin, var forhøjet hos børn sammenlignet med voksne.
English: Haematologic recovery usually occurs within two weeks.
Danish: Hæmatologisk normalisering sker normalt inden for to uger.
English: Specifically, the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults over 13 years and 352 children older than 2 years and adolescents up to 12 years.
Danish: Sikkerheden ved hydroxycarbamid er specifikt blevet undersøgt retroaktivt i kohorter med 123 voksne over 13 år og 352 børn over 2 år samt unge op til 12 år.
English: When the maximum tolerated dose is not reached transient myelotoxicity usually occurs in less than 10% of patients, while under the maximum tolerated dose more than 50% can experience reversible bone marrow suppression.
Danish: Hvis den maksimalt tolererede dosis ikke nås, opstår der normalt forbigående myelotoksicitet hos mindre end 10 % af patienterne, mens mere end 50 % kan opleve reversibel knoglemarvshæmning under den maksimalt tolererede dosis.
English: Hydroxycarbamide may decrease sperm production in male patients while they are being treated.
Danish: Hydroxycarbamid kan nedsætte sædproduktionen hos mandlige patienter, mens de bliver behandlet.
English: HbF interferes with the polymerisation of HbS and thus impedes the sickling of red blood cell.
Danish: HbF bryder ind i polymeriseringen af HbS og hindrer dermed ”sickling” af røde blodlegemer.
English: Haemoglobin < 4.5 g/dl
Danish: Hæmoglobin < 4,5 g/dl
English: Very rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (frequency cannot be estimated from the available data):
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 brugere) eller bivirkninger af ukendt hyppighed (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: Close monitoring of blood parameters is advised in these patients.
Danish: Hos disse patienter tilrådes nøje overvågning af blodparametrene.
English: Treatment of overdose consists of gastric lavage, followed by symptomatic treatment and control of bone marrow function.
Danish: Behandlingen af overdosering består af maveudskylning efterfulgt af symptomatisk behandling og kontrol af knoglemarvsfunktionen.
English: Prophylactic administration of folic acid is recommended.
Danish: Profylaktisk indgivelse af folinsyre anbefales.
English: Each quarter of tablet is embossed “T” on one side.
Danish: Hver kvarte tablet er præget med “T” på den ene side.
English: Embryotoxicity was characterized by decreased foetal viability, reduced live litter sizes, and developmental delays.
Danish: Embryotoksiciteten var kendetegnet ved nedsat levedygtighed for fosteret, reduceret antal levende kuld samt forsinkelser i udviklingen.
English: People who are not taking Siklos and in particular pregnant women should avoid being in contact with hydroxycarbamide.
Danish: Personer, der ikke tager Siklos, herunder især gravide kvinder, skal undgå kontakt med hydroxycarbamid.
English: Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
Danish: De må ikke køre bil eller arbejde med værktøj eller maskiner, hvis De oplever svimmelhed, mens De tager Siklos.
English: Patients treated with hydroxycarbamide in combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/mm3.
Danish: Patienter, der blev behandlet med hydroxycarbamid i kombination med didanosin, stavudin og indinavir, udviste et gennemsnitligt fald i CD4-celler på cirka 100/mm3.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Also, in rats testicular atrophy with decreased spermatogenesis occurred, while in dogs reversible spermatogenic arrest was noted.
Danish: Desuden opstod der testikelatrofi hos rotter med nedsat spermatogenese, mens der hos hunde blev konstateret reversibel modningshæmning.
English: If you stop taking Siklos
Danish: Hvis De holder op med at tage Siklos
English: The yearly frequency of acute chest syndrome was also reduced by 25 to 33% under hydroxycarbamide in several studies.
Danish: Den årlige hyppighed af akut lungesvigt blev også reduceret med 25 % til 33 % ved behandling med hydroxycarbamid i adskillige studier.
English: Recovery from myelosuppression is usually rapid when therapy is discontinued.
Danish: Restitution efter myelosuppression sker normalt hurtigt, når behandlingen seponeres.
English: Beside the inconstant correlation between reduction of crisis rate and the increase in HbF, the cytoreductive effect of hydroxycarbamide, particularly the drop of neutrophils, was the factor with the strongest correlation to a reduced crisis rate.
Danish: Udover den ustadige sammenhæng mellem reduktionen i krisehyppighed og stigningen i HbF var den cytoreduktive virkning af hydroxycarbamid, især reduktionen af neutrofiler, den faktor, som havde den største sammenhæng med en reduceret krisehyppighed.
English: The sickle cells also get stuck in blood vessels, blocking blood flow.
Danish: Seglcellerne sætter sig endvidere fast i blodkarrene og blokerer blodgennemstrømningen.
English: Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP. Store below 30°C.
Danish: Brug ikke Siklos efter den udløbsdato, der står på æsken og tabletbeholderen efter EXP.
English: Tell your doctor immediately if you notice any of the following serious side effects:
Danish: Fortæl det straks til Deres læge, hvis De oplever en eller flere af følgende alvorlige bivirkninger:
English: There are no data that support specific dose adjustments in patients with hepatic impairment.
Danish: Der findes ingen data, som understøtter særlige dosisjusteringer til patienter med nedsat leverfunktion.
English: In paediatric patients, the half-life was slightly longer and the total clearance related to body weight slightly higher than in adult patients (see section 4.2).
Danish: Hos pædiatriske patienter var halveringstiden en anelse længere, og den samlede clearance i forhold til legemsvægt var en anelse højere end hos voksne patienter (se pkt.
English: During treatment with Siklos, blood counts must be monitored every two weeks at treatment initiation (i.e. for the first two months) and if the daily dose of hydroxycarbamide is up to 35 mg/kg b.w.
Danish: Under behandlingen med Siklos skal blodtællingerne kontrolleres hver anden uge ved behandlingens start (dvs. i de første to måneder), og hvis den daglige dosis hydroxycarbamid er på op til 35 mg/kg legemsvægt.
English: Rarely, ulcers are caused by leukocytoclastic vasculitis.
Danish: Ulcera er i sjældne tilfælde forårsaget af leukocytoklastisk vaskulit.
English: In nearly all clinical studies conducted in Sickle Cell Syndrome, hydroxycarbamide reduced the frequency of vaso-occlusive episodes by 66% to 80%, in children and in adults.
Danish: I næsten alle de kliniske studier, der er gennemført af seglcellesygdom, reducerede hydroxycarbamid hyppigheden af vasookklusive episoder med 66 % til 80 % hos børn og voksne.
English: Depending on these results your doctor will adjust your dose of Siklos.
Danish: Deres læge vil justere Deres dosis af Siklos afhængigt af disse resultater.
English: In case the prescribed dose requires breaking the tablet in halves or quarters, this should be done out of the reach of food.
Danish: Hvis den ordinerede dosis kræver, at tabletten deles i halve eller kvarte, skal dette gøres væk fra madvarer.
English: For patients who are not able to swallow the tablets, these can be disintegrated immediately before use in a small quantity of water in a teaspoon.
Danish: For patienter, der ikke er i stand til at synke tabletterne, kan tabletterne umiddelbart inden brug opløses i en lille smule vand i en teske.
English: Because of the rarity of long term data on treatment with hydroxycarbamide in children less than 2 years of age, dose regimens have not been established and thus, in this population, the treatment with hydroxycarbamide is not recommended.
Danish: På grund af manglende langtidsdata vedrørende behandling med hydroxycarbamid til børn under 2 år er der ikke fastlagt nogen doseringsregimer, og hydroxycarbamid bør derfor ikke bruges til denne population.
English: This includes any possible side effects not listed in this leaflet.
Danish: De får bivirkninger, som ikke er nævnt her.
English: Very common reversible oligo- and azoo-spermia have been observed in man, although these disorders are also associated with the underlying disease.
Danish: Er blevet observeret meget hyppige tilfælde af reversibel oligosermie og azoospermi hos mennesker , selvom disse tilstande også er forbundet med den bagvedliggende sygdom.
English: Any person, in particular pregnant women, who are not taking Siklos should avoid direct contact with the parts when breaking a tablet.
Danish: Alle personer, som ikke bruger Siklos, herunder især gravide kvinder, skal undgå at komme i direkte kontakt med medicinens dele, når en tablet brækkes over.
English: In patients with a creatinine clearance ≤ 60 ml/min the initial Siklos dose should be decreased by 50%.
Danish: For patienter med en kreatininclearance på ≤ 60 ml/min bør initialdosis af Siklos reduceres med 50 %.
English: In the human, according to a retrospective analysis of a cohort of 123 adult patients treated with hydroxycarbamide, twenty-three pregnancies have been reported from 15 women treated with hydroxycarbamide and partners of 3 men treated with hydroxycarbamide.
Danish: Ifølge en retrospektiv analyse af en kohorte på 123 voksne patienter, der blev behandlet med hydroxycarbamid, er 23 graviditeter blevet indberettet fra 15 kvinder, der blev behandlet med hydroxycarbamid, og fra partnere til 3 mænd, der blev behandlet med hydroxycarbamid.
English: Talk to your doctor or pharmacist or nurse before taking Siklos
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før De tager Siklos
English: Hydroxycarbamide distributes rapidly throughout the human body, enters the cerebrospinal fluid, appears in peritoneal fluid and ascites, and concentrates in leukocytes and erythrocytes.
Danish: Hydroxycarbamid distribueres hurtigt i hele kroppen, kommer ind i cerebrospinalvæsken, optræder i peritonealvæske og ascites og koncentreres i leukocytter og erythrocytter.
English: What you need to know before you take Siklos Do not take Siklos
Danish: Det skal De vide, før De begynder at tage Siklos Tag ikke Siklos
English: Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia.
Danish: Nogle celler bliver unormale, stive og får halvmåne- eller seglfacon, hvilket fører til anæmi.
English: Hydroxycarbamide is excreted in human milk.
Danish: Hydroxycarbamid udskilles i human mælk.
English: Patients on hydroxycarbamide should be made aware of the theoretical risks to the foetus.
Danish: Patienter i behandling med hydroxycarbamid skal være opmærksomme på den teoretiske risiko for fosteret.
English: Hydroxycarbamide crosses the placenta barrier and has been demonstrated to be a potent teratogen and embryotoxic in a wide variety of animal models at or below the human therapeutic dose.
Danish: Hydroxycarbamid krydser placenta, og det er påvist, at det er stærkt teratogent og embryotoksisk i en lang række dyremodeller ved eller under den humane terapeutiske dosis.
English: Adding a drop of syrup or mixing with food can mask a possible bitter taste.
Danish: Tilsætning af en dråbe sirup eller opblanding i mad kan skjule en mulig bitter smag.
English: In an open single-dose study in adult patients with Sickle Cell Syndrome (Yan JH et al, 2005) the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Danish: I et åbent forsøg med enkeltdoser til voksne patienter med seglcellesygdom (Yan JH et al, 2005) blev nyrefunktionens betydning for farmakokinetikken for hydroxycarbamid vurderet.
English: An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Danish: Et erythem, som skyldes strålebehandling, kan blive forværret af hydroxycarbamid.
English: EU/1/07/397/002 60 tablets EU/1/07/397/003 90 tablets EU/1/07/397/004 120 tablets
Danish: EU/1/07/397/002 60 tabletter EU/1/07/397/003 90 tabletter EU/1/07/397/004 120 tabletter
English: Male and female patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Danish: Patienter (mænd og kvinder) i behandling med hydroxycarbamid der ønsker at blive gravide, skal om muligt seponere behandlingen 3-6 måneder inden graviditeten.
English: For the storage of unused broken tablets, see section 5 “How to store Siklos”.
Danish: Se afsnittet ”Opbevaring” vedrørende opbevaring af ubrugte, brudte tabletter, se afsnit 5 ”Opbevaring”.
English: Long-term data on the continued use of hydroxycarbamide in patients with Sickle Cell Syndrome are available in children and adolescents, with a follow-up of 12 years in children and adolescents and over 13 years in adults.
Danish: Langtidsdata vedrørende den fortsatte brug af hydroxycarbamid til patienter med seglcellesygdom findes for børn og unge med 12 års opfølgning af børn og unge og mere end 13 års opfølgning af voksne.
English: A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Danish: En vedvarende klinisk fordel blev påvist for patienter, der fortsatte i behandling med hydroxycarbamid i op til 8 år.
English: Women of childbearing potential/Contraception in males and females Women of childbearing age receiving hydroxycarbamide should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Danish: Fødedygtige kvinder/Kontraception til mænd og kvinder Fødedygtige kvinder, der tager hydroxycarbamid, skal rådes til at undgå at blive gravide og omgående at informere den behandlende læge, hvis dette sker.
English: The oral bioavailability of hydroxycarbamide is almost complete as assessed in indications other than Sickle Cell Syndrome.
Danish: Den orale biotilgængelighed af hydroxycarbamid er næsten fuldstændig, hvilket er vurderet for andre indikationer end seglcellesygdom.
English: Siklos is used to prevent painful crises, including sudden chest pain, caused by Sickle Cell disease, in adults, adolescents and children older than 2 years.
Danish: Siklos bruges til at forebygge smertefulde kriser, der skyldes seglcellesygdom, såsom pludselige brystsmerter, hos voksne, unge og børn, der er ældre end 2 år.
English: In patients with Sickle Cell Syndrome, neutropenia was reported in isolated cases of hydroxycarbamide overdose (1.43 times and 8.57 times of the maximum recommended dose of 35 mg/kg b.w./day).
Danish: Hos patienter med seglcellesygdom blev neutropeni indberettet i isolerede tilfælde af overdosering med hydroxycarbamid (1,43 gange og 8,57 gange den anbefalede maksimumdosis på 35 mg/kg legemsvægt/dag).
English: Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase the adverse reaction of the vaccine virus, because normal defence mechanisms may be suppressed by hydroxycarbamide therapy.
Danish: Samtidig anvendelse af hydroxycarbamid med en levende virusvaccine kan forstærke vaccinevirussens replikation og/eller øge vaccinevirussens bivirkning, da de normale forsvarsmekanismer kan være undertrykkede af behandlingen med hydroxycarbamid.
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Danish: Hydroxycarbamid som 30, 100 og 300 µM metaboliseres ikke in vitro af cytochrom P450 i humane levermikrosomer.
English: Acute chest syndrome is a frequent life-threatening complication of Sickle Cell Syndrome and is characterised by chest pain or fever or dyspnoea with recent infiltrate on chest X-ray.
Danish: Akut lungesvigt er en hyppig, livstruende komplikation ved seglcellesygdom og er kendetegnet af brystsmerter eller feber eller dyspnø med nyere infiltrat på thoraxrøntgen.
English: High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit.
Danish: Højdensitetspolyethylen (HDPE) -flaske med børnesikret polypropylen-skruelåg med en tørrende enhed.
English: Reticulocytes < 80,000/mm3 if the haemoglobin concentration < 9 g/dl
Danish: Retikulocytter < 80.000/mm3 hvis hæmoglobinkoncentrationen < 9 g/dl
English: After oral administration of 20 mg/kg of hydroxycarbamide, a rapid absorption is observed with peak plasma levels of about 30 mg/L occurring after 0.75 and 1.2 h in children and adult patients with Sickle Cell Syndrome, respectively.
Danish: Efter oral indgivelse af 20 mg/kg hydroxycarbamid ses en hurtig absorption med maksimale plasmaniveauer på cirka 30 mg/L efter 0,75 og 1,2 timer hos henholdsvis pædiatriske og voksne patienter med seglcellesygdom.
English: If you become pregnant or plan to become pregnant while taking Siklos, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
Danish: Hvis De bliver gravid eller planlægger at blive gravid, mens De tager Siklos, vil Deres læge tale med Dem om de potentielle fordele og risici ved at fortsætte med at tage Siklos.
English: You can add a drop of syrup or mix the content with food to mask a possible bitter taste.
Danish: De kan komme en dråbe sirup i indholdet eller blande indholdet med mad for at skjule en mulig bitter smag.
English: The estimated volume of distribution of hydroxycarbamide approximates total body water.
Danish: Det estimerede distributionsvolumen af hydroxycarbamid ligger tæt på den samlede mængde kropsvand.
English: Under exceptional circumstances a maximum dose of 35 mg/kg b.w./day might be justified under close haematological monitoring (see section 4.4).
Danish: En maksimumdosis på 35 mg/kg legemsvægt/dag kan under ganske særlige omstændigheder være begrundet under nøje hæmatologisk overvågning (se pkt.
English: Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Syndrome include decrease of neutrophils, increase of the water content of erythrocytes, increase of the deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Danish: Andre kendte farmakologiske effekter af hydroxycarbamid, som kan medvirke til lægemidlets fordelagtige virkninger på seglcellesygdom, omfatter reduktion af neutrofiler, forøgelse af eythrocytters vandindhold, forøgelse af seglcellers deformabilitet samt ændret vedhæftning af røde blodlegemer til endotelet.
English: The active substance of Siklos, hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells.
Danish: Det aktive stof i Siklos,hydroxycarbamid, er et stof, som hæmmer væksten og formeringen af visse celler såsom blodlegemer.
English: For male patients taking Siklos, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
Danish: For mandlige patienter, der tager Siklos: Hvis Deres partner bliver gravid eller planlægger at blive gravid, vil Deres læge tale med Dem om de potentielle fordele og risici ved at fortsætte med at tage Siklos.
English: The total exposure up to 24 h post-dose is 124 mg*h/L in children and adolescents and 135 mg*h/L in adult patients.
Danish: Den samlede eksponering indtil 24 timer efter dosering er 124 mg*t/L for børn og unge og 135 mg*t/L for voksne patienter.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til lægen eller apoteket, hvis De tager anden medicin eller har gjort det for nylig.
English: Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxycarbamide in combination with antiretroviral medicinal products, particularly didanosine plus stavudine.
Danish: Potentielt fatal pancreatitis og hepatotoksicitet og svær perifer neuropati er blevet indberettet for HIVinficerede patienter, som fik hydroxycarbamid i kombination med antiretrovirale lægemidler, herunder især didanosin plus stavudin.
English: Systemic and cutaneous lupus erythematous
Danish: Systemisk og kutan lupus erythematosus
English: Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Danish: Siklos 100 mg leveres i plasticflasker, der indeholder 60, 90 eller 120 tabletter.
English: These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy.
Danish: Disse vaskulære toksiciteter blev som oftest indberettet for patienter, som tidligere havde været eller aktuelt var i behandling med interferon.
English: Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13
Danish: Telefon: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13
English: At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (PGP), indicating that hydroxycarbamide is not a PGP substrate.
Danish: I koncentrationer inden for området 10 til 300 µM stimulerer hydroxycarbamid ikke adenosintriphosphatase-aktiviteten in vitro af rekombinant human P-glykoprotein (PGP), hvilket indikerer, at hydroxycarbamid ikke er et PGP-substrat.
English: Hydroxycarbamide administered to male rats at 60 mg/kg b.w./day (about double the recommended usual maximum dose in humans) produced testicular atrophy, decreased spermatogenesis and significantly reduced their ability to impregnate females.
Danish: Hydroxycarbamid, der blev indgivet til hanrotter som 60 mg/kg legemsvægt/dag (cirka det dobbelte af den anbefalede maksimumdosis til mennesker), medførte testikelatrofi, nedsat spermatogenese og reducerede markant rotternes evne til at befrugte hunnerne.
English: Teratogenicity was characterised by partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae.
Danish: Teratogeniciteten var kendetegnet ved delvist ossificerede kranieknogler, manglende øjenhuler, hydrocefali, tvedelt sternebra og manglende lændehvirvler.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen.
English: In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.
Danish: Desuden medfører hydroxycarbamid en øjeblikkelig hæmning af DNA-syntesen ved at fungere som en hæmmer af ribonukleotidreduktase uden at forstyrre syntesen for ribonukleinsyre eller protein.
English: Depending on the dose you take, these tests may be performed every two weeks or every two months.
Danish: Disse prøver vil blive gennemført hver anden uge eller hver anden måned afhængigt af den dosis, De tager.