FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you use the correct dosing syringe for your medicine.
Danish: Det er vigtigt, at du bruger den rigtige doseringssprøjte til din medicin.
English: You should not take Xromi if you have severe kidney disease.
Danish: Du bør ikke tage Xromi, hvis du har en alvorlig nyresygdom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: Håndteres med forsigtighed.
English: Anyone handling hydroxycarbamide should wash their hands before and after administering a dose.
Danish: Alle, der håndterer hydroxycarbamid, bør vaske hænder før og efter administration af en dosis.
English: However, a lack of increase in MCV, HbF, or both, is not an indication to discontinue therapy if the patient responds clinically (e.g. decreased incidence of pain or hospitalisation).
Danish: En manglende stigning i MCV eller HbF (eller begge dele) er dog ikke en indikation for at ophøre med behandlingen, hvis patienten udviser klinisk respons (f.eks. lavere forekomst af smerter eller færre indlæggelser).
English: Patients should be monitored for vital signs, blood and urine chemistry, renal and hepatic function and full blood counts for at least 3 weeks.
Danish: Patienterne bør monitoreres med hensyn til vitale tegn, blod- og urinkemi, nyre- og leverfunktion samt fuld blodtælling i mindst 3 uger.
English: You may be more sensitive to the effects of Xromi and your doctor may need to give you a lower dose.
Danish: Du kan være mere følsom over for virkningen af Xromi, og lægen vil muligvis give dig en lavere dosis.
English: Hydroxycarbamide is unequivocally genotoxic in a wide range of test systems.
Danish: Hydroxycarbamid er utvetydigt genotoksisk i en lang række testsystemer.
English: You should not drive or operate any machinery unless it has been shown not to affect you and you have discussed it with your doctor.
Danish: Du bør ikke føre motorkøretøj eller betjene maskiner, medmindre du har konstateret, at du ikke føler dig påvirket - tal med lægen om det.
English: The posology should be based on the patient's body weight (kg).
Danish: Doseringen beregnes ud fra patientens legemsvægt (kg).
English: Number of days in hospital
Danish: Antal hospitalsdage
English: Do not shake the bottle.
Danish: Flasken må ikke rystes.
English: Xromi may harm your sperm or eggs.
Danish: Xromi kan være skadeligt for sæd og æg.
English: The safety and efficacy of hydroxycarbamide in children from birth up to 2 years have not yet been established.
Danish: Sikkerheden og virkningen ved hydroxycarbamid hos børn i alderen 0 til 2 år er endnu ikke klarlagt.
English: The respective value in children was similar, 0.22 L/h/kg.
Danish: Den tilsvarende værdi hos børn er sammenlignelig (0,22 l/t/kg).
English: Repeat the above for each dose as instructed by your doctor or pharmacist.
Danish: Gentag ovenstående for hver dosis som anvist af lægen eller apotekspersonalet.
English: Xanthan gum (E415) Sucralose (E955)
Danish: Xanthangummi (E415) Sucralose (E955)
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX05.
English: It is recommended that the healthcare professional advises the patient or carer which syringe to use to ensure that the correct volume is administered.
Danish: Det anbefales, at sundhedspersonen fortæller patienten eller omsorgspersonen, hvilken sprøjte der skal anvendes, så det sikres, at den rigtige mængde administreres.
English: Dose was reduced by 50% for bone marrow toxicity.
Danish: Dosen blev reduceret med 50 % ved knoglemarvstoksicitet.
English: - if you have a liver disease (additional monitoring may be needed) - if you have a kidney disease (the dose may be adjusted) - if you have leg ulcers - if you have a known lack of vitamin B12 or folate
Danish: - hvis du har en leversygdom (det kan være nødvendigt med ekstra overvågning) - hvis du har en nyresygdom (din dosis kan blive justeret) - hvis du har bensår - hvis du har kendt mangel på B12-vitamin eller folat
English: • Dose to be increased by 5 mg/kg/day increments every 8 weeks
Danish: • Dosen bør øges med trin a 5 mg/kg/dag hver 8. uge
English: If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose.
Danish: Hvis du som forælder eller omsorgsperson indgiver lægemidlet, skal du vaske hænder før og efter indgivelsen af en dosis.
English: Push the tip of the dosing syringe into the hole in the adaptor (figure 3).
Danish: Tryk spidsen af doseringssprøjten ind i hullet i adapteren (figur 3).
English: Toxic ranges of myelosuppression as described in section 4.2.
Danish: Toksiske niveauer af myelosuppression som beskrevet i pkt.
English: To minimise air bubbles, the bottle should not be shaken prior to dosing.
Danish: For at minimere forekomsten af luftbobler må flasken ikke rystes før dosering.
English: 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: følgende hyppighedskategorier: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients were randomly assigned to receive either hydroxycarbamide first for 6 months, followed by placebo for 6 months, or placebo first, followed by hydroxycarbamide for 6 months.
Danish: Patienterne var tilfældigt randomiseret til at få enten hydroxycarbamid først i 6 måneder efterfulgt af placebo i 6 måneder eller placebo først efterfulgt af hydroxycarbamid i 6 måneder.
English: Severe hepatic impairment (Child-Pugh classification C).
Danish: Svært nedsat leverfunktion (Child-Pugh C).
English: For male patients taking Xromi, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Xromi.
Danish: Hvis mandlige patienter, der tager Xromi, har en partner, som bliver gravid eller planlægger at blive gravid, skal de tale med lægen om de mulige fordele og risici ved at fortsætte behandling med Xromi.
English: In some species cardiovascular and haematological effects have also been observed.
Danish: Hos nogle arter er der også set kardiovaskulære og hæmatologiske bivirkninger.
English: Table 4: Comparison of the Number of Clinical Events before and after Intervention in the Hydroxycarbamide and Placebo Groups
Danish: Tabel 4: Sammenligning af antallet af kliniske hændelser før og efter indgreb i hydroxycarbamidgruppen og placebo-gruppen
English: Weight gain, vitamin D deficiency
Danish: Vægtøgning, D-vitaminmangel
English: 2,000/μL to 4,000/μL) is achieved, up to a maximum of 35 mg/kg/day.
Danish: 4.000/μl), op til maksimalt 35 mg/kg/dag.
English: A significant fraction of hydroxycarbamide is eliminated by nonrenal (mainly hepatic) mechanisms.
Danish: En signifikant fraktion af hydroxycarbamid elimineres ved ikke-renale (fortrinsvis hepatiske) mekanismer.
English: It is unknown whether this leukaemogenic effect is secondary to hydroxycarbamide or associated with the patient's underlying disease.
Danish: Det vides ikke, om denne leukæmogene effekt er en sekundær virkning ved hydroxycarbamid eller forbundet med patientens underliggende sygdom.
English: - Depending on these results your doctor may change your dose of Xromi.
Danish: - Ud fra resultaterne kan lægen ændre din dosis af Xromi.
English: HbF interferes with the polymerisation of HbS (sickle haemoglobin) and thus impedes the sickling of red blood cell.
Danish: HbF interfererer med polymeriseringen af HbS (seglcellehæmoglobin) og hindrer dermed sickling af røde blodlegemer.
English: Always use the syringes provided to take your medicine.
Danish: Brug altid de medfølgende sprøjter til at tage lægemidlet.
English: There are no data that support specific dose adjustments in patients with hepatic impairment.
Danish: Der er ingen data, der understøtter specifik dosisjustering hos patienter med nedsat leverfunktion.
English: In adult cancer patients, hydroxycarbamide was eliminated with a half-life of approximately 2-3 hours.
Danish: Hos voksne kræftpatienter blev hydroxycarbamid elimineret med en halveringstid på ca. 2-3 timer.
English: Do not take Xromi - if you are allergic (hypersensitive) to hydroxycarbamide or any of the other ingredients of Xromi
Danish: Tag ikke Xromi - hvis du er allergisk over for hydroxycarbamid eller et af de øvrige indholdsstoffer i Xromi
English: A total of 299 participants were randomised; 152 to hydroxycarbamide and 147 to matching placebo.
Danish: I alt 299 deltagere var randomiseret; 152 til hydroxycarbamid og 147 til placebo.
English: Spillages must be wiped immediately.
Danish: Spild skal straks tørres op.
English: Women who are pregnant, planning to be or breast-feeding should not handle hydroxycarbamide.
Danish: Kvinder, som er gravide, planlægger graviditet eller ammer, bør ikke håndtere hydroxycarbamid.
English: Secondary outcomes included the decrease in frequency of blood transfusions and hospitalizations, and increase in HbF levels.
Danish: De sekundære endepunkter omfattede faldet i hyppigheden af blodtransfusioner og indlæggelser samt stigningen i HbF.
English: Male patients should be informed by their healthcare professionals about the possibility of sperm conservation (cryopreservation) before the start of therapy.
Danish: Sundhedspersoner bør underrette mandlige patienter om muligheden for opbevaring af sæd (kryopræservering) inden behandlingsstart.
English: Let the syringe dry completely before you use that syringe again for dosing.
Danish: Lad sprøjten tørre helt, før du bruger den til dosering igen.
English: These effects lead to a reduction of circulating red, white and coagulation blood cells.
Danish: Denne effekt medfører en nedsættelse af cirkulerende røde og hvide blodlegemer samt blodplader.
English: Gastrointestinal disturbances, gastrointestinal ulcer, severe hypomagnesaemia
Danish: Gastrointestinale forstyrrelser, gastrointestinale sår, svær hypomagnesiæmi
English: The patient information pack should contain:
Danish: Informationsmaterialet til patienter bør omfatte:
English: Discard 12 weeks after first opening.
Danish: Kasseres 12 måneder efter første åbning.
English: Haemoglobin (Hb) (g/dL)
Danish: Hæmoglobin (Hb) (g/dl)
English: If you forget to take Xromi Tell your doctor.
Danish: Hvis du har glemt at tage Xromi Sig det til lægen.
English: Xromi can make you feel drowsy.
Danish: Xromi kan gøre dig døsig.
English: Hydroxycarbamide was administered at an initial dose of 20 mg/kg/day.
Danish: Hydroxycarbamid blev administreret i en startdosis på 20 mg/kg/dag.
English: The educational programme is aimed to ensure the safe and effective use of the product, to minimise the risks listed below and to reduce the burden of adverse reactions with Xromi.
Danish: Formålet med informationsmaterialet er at sikre risikofri og effektiv anvendelse af lægemidlet, minimere nedenfor beskrevne risici og reducere bivirkningsbyrden ved Xromi.
English: Overall, exposure to hydroxycarbamide produces abnormalities in several experimental animal species and affects the reproductive capacity of male and female animals.
Danish: Eksponering for hydroxycarbamid medfører generelt anomalier hos flere arter forsøgsdyr og påvirker reproduktionsevnen hos han- og hundyr.
English: - Low Vitamin D level in blood test - Low magnesium level in blood test
Danish: Lavt D-vitamin i blodet Lavt magnesium i blodet Blødning
English: To assist accurate and consistent dose delivery to the stomach water should be taken after each dose of Xromi.
Danish: For at sikre korrekt og konsistent dosisafgivelse til maven, bør patienten drikke vand efter hver dosis Xromi.
English: Talk to your doctor, pharmacist or nurse before taking Xromi:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Xromi:
English: The largest difference in the pharmacokinetic profile was a trend towards a shorter time to peak concentration following ingestion of the liquid compared with the capsule, but that difference did not reach statistical significance (0.74 versus 0.97 hours, p = 0.14).
Danish: Den største forskel i farmakokinetisk profil var en tendens til en kortere tid til maksimal koncentration efter indtagelse i væskeform sammenholdt med indtagelse i kapselform, men denne forskel nåede ikke statistisk signifikans (0,74 versus 0,97 timer, p = 0,14).
English: - to check your blood count before and during treatment with Xromi - to monitor your liver before and during treatment with Xromi - to monitor your kidneys before and during treatment with Xromi
Danish: Lægen vil tage blodprøver: - for at tjekke dine blodtal før og under behandlingen med Xromi - for at overvåge din lever før og under behandlingen med Xromi - for at overvåge dine nyrer før og under behandlingen med Xromi
English: Bottle adaptor
Danish: Flaskeadapter
English: Although there is no evidence of an age effect on the pharmacokinetic-pharmacodynamic relationship, elderly patients may be more sensitive to the effects of hydroxycarbamide and therefore consideration should be given to starting with a lower initial dose and more cautious dose escalation.
Danish: Selvom der ikke er evidens for alders indvirkning på farmakokinetik/farmakodynamik-forholdet, kan ældre patienter være mere følsomme over for hydroxycarbamids effekt, og derfor bør det overvejes at begynde med en lavere startdosis og foretage en mere forsigtig dosiseskalering.
English: Very common reversible oligo- and azoo-spermia have been observed in man, although these disorders are also associated with the underlying disease.
Danish: Der er meget hyppigt set reversibel oligoog azoospermi hos mænd, om end disse forstyrrelser også kan være forbundet med den underliggende sygdom.
English: Systemic and cutaneous lupus erythematosus
Danish: Systemisk og kutan lupus erythematosus
English: Table 3: Mean Haematologic Values Before and After 6 Months of Treatment with hydroxycarbamide (Ferster et al, 1996)
Danish: Tabel 3: Hæmatologiske middelværdier før og efter 6 måneders behandling med hydroxycarbamid (Ferster et al., 1996)
English: Treatment with hydroxycarbamide and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks (see section 4.4).
Danish: Behandling med hydroxycarbamid og samtidig immunisering med levende vacciner bør kun ske, hvis fordelene klart opvejer de potentielle risici (se pkt.
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 i behandling med hydroxycarbamid i kombination med didanosin, stavudin og indinavir udviste et mediant fald i CD4-celler på ca. 100/mm3.
English: Hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean.
Danish: Hold sprøjten under det rindende vand, mens du bevæger stemplet frem og tilbage flere gange for at sikre, at sprøjtens inderside bliver ren.
English: Accidental ingestion can be lethal for children.
Danish: Utilsigtet indtagelse kan være dødeligt for børn.
English: Xromi is a clear, colourless to pale yellow, oral solution.
Danish: Xromi er en klar, farveløs til bleggul oral opløsning.
English: Xromi should only be given to you by a specialist doctor who is experienced in treating blood problems.
Danish: Xromi må kun ordineres til dig af en speciallæge med erfaring i behandling af blodsygdomme.
English: Prior to launch of Xromi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden Xromi lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den nationale kompetente myndighed om indholdet og formatet af informationsmaterialet, herunder kommunikationsmedier, distributionsmåder og lignende.
English: If neutropenia or thrombocytopenia occurs, hydroxycarbamide dosing should be temporarily withheld and full blood cell count with white cell differential should be monitored weekly.
Danish: Hvis der opstår neutropeni eller trombocytopeni, bør administration af hydroxycarbamid midlertidigt pauseres, og fuld blodtælling med differentialtælling af hvide blodlegemer bør monitoreres ugentligt.
English: Embryotoxicity manifesting as decreased foetal viability, reduced live litter sizes, and developmental delays has been reported in species including mice, hamsters, cats, dogs, and monkeys at doses comparable to human doses.
Danish: Der er rapporteret om embryotoksicitet i form af nedsat levedygtighed hos fostre, reduceret kuldstørrelse og forsinket udvikling hos arter som mus, hamstere, katte, hunde og aber i doser svarende til de humane doser.
English: Safe handling of the solution
Danish: Sikker håndtering af opløsningen
English: PHARMACEUTICAL FORM Oral solution.
Danish: LÆGEMIDDELFORM Oral opløsning.
English: Xromi should be stopped 3 to 6 months prior to becoming pregnant, if possible.
Danish: Xromi-behandling bør om muligt ophøre 3-6 måneder, inden du bliver gravid.
English: The study reported 16 patients out of 22 (73%) did not require any hospitalisation for painful episodes when treated with hydroxycarbamide as compared with only 3 of 22 (14%) when treated with placebo.
Danish: I studiet blev det rapporteret, at 16 ud af 22 patienter (73 %) i hydroxycarbamid-gruppen ikke krævede indlæggelse for smertefulde episoder, sammenholdt med kun 3 ud af 22 patienter (14 %) i placebo-gruppen.
English: Toxicology studies have also demonstrated testicular atrophy with decreased spermatogenesis and sperm count in rats and decreased testis weight and reduced sperm counts in mice as well.
Danish: Toksikologiske studier har også vist testikelatrofi med nedsat spermatogenese og nedsat antal sædceller hos rotter samt nedsat testikelvægt og nedsat antal sædceller hos mus.
English: Patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Danish: Patienter i behandling med hydroxycarbamid, der ønsker at få børn, bør om muligt være ophørt med behandlingen i 3-6 måneder, før de bliver gravide.
English: Other commonly reported adverse effects also include nausea, constipation, headache, and dizziness.
Danish: Andre hyppigt indberettede bivirkninger omfatter kvalme, forstoppelse, hovedpine og svimmelhed.
English: Thrombocytopenia, anaemia
Danish: Trombocytopeni, anæmi
English: Rarely leg ulcers and very rarely systemic lupus erythematosus have been reported.
Danish: Der er rapporteret om sjældne tilfælde af bensår og meget sjældne tilfælde af systemisk lupus erythematosus.
English: Nova Laboratories Ireland Limited
Danish: Nova Laboratories Ireland Limited 3rd Floor
English: The sickle cells also get stuck in blood vessels, blocking blood flow.
Danish: Seglceller kan også sætte sig fast i blodkarrene og blokere for blodstrømmen.
English: Safe handling
Danish: Sikker håndtering
English: Hydroxycarbamide affects spermatogenesis, and hence oligospermia and azoospermia are very commonly reported.
Danish: Hydroxycarbamid påvirker spermatogenesen, og der er derfor meget hyppigt rapporteret om oligospermi og azoospermi.
English: Immediate treatment consists of gastric lavage, followed by supportive therapy for the cardiorespiratory systems if required.
Danish: Den øjeblikkelige behandling består af maveskylning, om nødvendigt efterfulgt af understøttende behandling af de kardiorespiratoriske systemer.
English: Stomatitis, diarrhoea, vomiting
Danish: Stomatitis, diarré, opkastning
English: The physician educational material should contain:
Danish: Informationsmaterialet til læger bør omfatte:
English: The extent of protein binding of hydroxycarbamide is unknown.
Danish: Omfanget af hydroxycarbamids proteinbinding kendes ikke.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: While in dogs reversible spermatogenic arrest was noted.
Danish: Hos hunde er der set reversibelt spermatogenesestop.
English: In a single dose study in children with Sickle Cell Disease, the mean half-life was reported to be 1.7 hours.
Danish: I et enkeltdosisstudie af børn med seglcelleanæmi var den gennemsnitlige halveringstid 1,7 timer.
English: This study used a non-inferiority trial design with a primary endpoint of TCD velocity at 24 months, controlling for baseline (enrollment) values.
Danish: Studiet havde et noninferioritetsdesign, hvor det primære endepunkt var TCD-hastigheden efter 24 måneder i forhold til værdierne ved baseline (inklusionstidspunktet).
English: The anaemia commonly observed has mainly been due to an infection with Parvovirus or a splenic sequestration.
Danish: De almindeligt observerede tilfælde af anæmi har fortrinsvis skyldtes infektion med parvovirus eller miltsekvestrering.
English: Elderly patients may be more sensitive to the myelosuppressive effects of hydroxycarbamide, and may require a lower dosage regimen.
Danish: Ældre patienter kan være mere følsomme over for den myelosuppressive effekt af hydroxycarbamid og kan have behov for en lavere dosering.
English: Although the mechanism of action has not yet been clearly defined, hydroxycarbamide appears to act by interfering with synthesis of DNA by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.
Danish: Selvom virkningsmekanismen endnu ikke er klart defineret, ser det ud til, at hydroxycarbamid virker ved at interferere med DNA-syntesen via funktion som en hæmmer af ribonukleotidreduktase uden at interferere med ribonukleinsyre- eller proteinsyntesen.
English: A clinical response to treatment with hydroxycarbamide may take 3-6 months and therefore, a 6month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure (whether due to lack of adherence or failure to respond to therapy).
Danish: Det kan tage 3-6 måneder at opnå klinisk respons ved behandling med hydroxycarbamid, og derfor er det nødvendigt med en afprøvning af den maksimalt tolererede dosis i 6 måneder, inden seponering overvejes ved behandlingssvigt (uanset om dette skyldes manglende komplians eller manglende behandlingsrespons).
English: In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%.
Danish: Hos patienter med en kreatininclearance (CrCl) ≤ 60 ml/min bør den indledende dosis af hydroxycarbamid reduceres med 50 %.
English: Both male and female patients should be advised to use contraceptive measures before and during treatment with hydroxycarbamide.
Danish: Både mandlige og kvindelige patienter bør rådes til at anvende sikker prævention før og under behandlingen med hydroxycarbamid.
English: The usual starting dose for adults, adolescents and children over the age of 2 years is 15 mg/kg each day and the usual maintenance dose is between 20-25 mg/kg.
Danish: Den sædvanlige startdosis for voksne, unge og børn over 2 år er 15 mg/kg dagligt, og den sædvanlige vedligeholdelsesdosis er 20-25 mg/kg.
English: Remove the bottle cap (figure 1) and push the adaptor firmly into the top of the bottle and leave in place for future doses (figure 2).
Danish: Tag låget af flasken (figur 1), og sæt adapteren godt fast på flaskens top - lad den sidde med henblik på senere doseringer (figur 2).
English: The myelosuppressive activity may be potentiated by previous or concomitant radiotherapy or cytotoxic therapy.
Danish: Den myelosuppressive aktivitet kan potenseres af tidligere eller samtidig strålebehandling eller cytotoksisk kemoterapi.