FrancophonIA/ELRC3.0 huggingface dataset:
English: In Sickle Cell Disease, hydroxycarbamide also helps to prevent red blood cells from taking the abnormal sickle shape.
Danish: Ved seglcelle-anæmi hjælper hydroxycarbamid også med at forhindre de røde blodlegemer i at antage den unormale segl-form.
English: Hydroxycarbamide is excreted in human breast milk.
Danish: Hydroxycarbamid udskilles i human mælk.
English: The study also showed a statistically significant increase in HbF and Hb levels and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Danish: Studiet viste også en statistisk signifikant stigning i HbF og Hb og et fald i hæmolytiske markører i den gruppe, der fik hydroxycarbamid.
English: Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Danish: Seglcelle-anæmi er en nedarvet blodsygdom, der påvirker de skiveformede røde blodlegemer i blodet.
English: Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding it by the barrel rather than the plunger.
Danish: Vend flasken til opret stilling, og fjern forsigtigt sprøjten fra adapteren ved at holde i sprøjtens krop, ikke i stemplet.
English: Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.
Danish: Der blev observeret ømhed, violet erytem, ødem i håndflader og fodsåler efterfulgt af afskalning på hænder og fødder, kraftig generaliseret hyperpigmentering af huden og svær akut stomatitis.
English: Severe anaemia must be corrected with whole blood replacement before initiating therapy with hydroxycarbamide.
Danish: Svær anæmi skal korrigeres med substitutionsbehandling med fuldblod, før behandling med hydroxycarbamid iværksættes.
English: The MAH shall ensure that in each Member State where Xromi is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Xromi have access to/are provided with the following educational package to be disseminated through professional bodies:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedspersoner og alle patienter/omsorgspersoner, der forventes at skulle håndtere Xromi (dvs. ordinere eller bruge), i alle medlemsstater, hvor Xromi markedsføres, har adgang til eller får udleveret følgende informationsmateriale:
English: Ulysses House Foley Street, Dublin 1 D01 W2T2
Danish: Foley Street, Dublin 1
English: See section 2 “Xromi contains methyl parahydroxybenzoate”.
Danish: 2 under "Xromi indeholder methylparahydroxybenzoat".
English: Warnings and precautions Test and checks
Danish: Advarsler og forsigtighedsregler
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Oral opløsning.
English: The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended.
Danish: Makrocytosen kan maskere eventuel udvikling af folinsyremangel, og derfor anbefales regelmæssig vurdering af folinsyre i serum.
English: Multi-centre study of hydroxycarbamide in Sickle Cell Anaemia (MSH) The MSH study was a multicentre, randomised, and double-blind study, which compared hydroxycarbamide with placebo in adults with Sickle Cell Anaemia (HbSS genotype only) with the objective of reducing the frequency of pain crises.
Danish: Multicenterstudie af hydroxycarbamid ved seglcelleanæmi (MSH) MSH-studiet er et randomiseret, dobbeltblindet multicenterstudie, hvor hydroxycarbamid blev sammenlignet med placebo hos voksne med seglcelleanæmi (kun genotype HbSS) med henblik på at mindske hyppigheden af smertefulde kriser.
English: An increase in HbF and a decrease in absolute neutrophil count were reported in the hydroxycarbamide group.
Danish: Der blev rapporteret om en stigning i HbF og et fald i absolut neutrofiltal i hydroxycarbamidgruppen.
English: Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe.
Danish: Træk sprøjtens stempel tilbage, så medicinen trækkes ind i sprøjten.
English: The use of effective contraception is strongly recommended for both male and female patients.
Danish: Det anbefales kraftigt, at både mandlige og kvindelige patienter anvender sikker prævention.
English: Put on disposable hand gloves before handling Xromi.
Danish: Tag engangshandsker på før håndtering af Xromi.
English: - If you have bleeding or bruise easily, which may be symptoms of low levels of cells in the blood known as platelets.
Danish: - hvis du nemt kommer til at bløde eller få blå mærker, da det kan være tegn på lavt antal blodplader i blodet.
English: Store syringes in a hygienic place with the medicine.
Danish: Opbevar sprøjterne et hygiejnisk sted sammen med medicinen.
English: Your doctor will prescribe the correct dose for you.
Danish: Lægen vil ordinere den dosis, som du skal have.
English: Similar decreases were seen in blood transfusion rates, a surrogate for life-threatening illness.
Danish: Der sås et tilsvarende fald i hyppigheden af blodtransfusioner (surrogat for livstruende tilstande).
English: Patients with normal (CrCl> 90 ml/min), mild (CrCl 60-89 ml/min), moderate (CrCl 3059 ml/min), severe (CrCl 15-29 ml/min) renal impairment, and End Stage Renal Disease (CrCL < 15 ml/min) received hydroxycarbamide as a single dose of 15 mg/kg body weight.
Danish: Patienter med normal (CrCl > 90 ml/min), let nedsat (CrCl 60-89 ml/min), moderat nedsat (CrCl 30-59 ml/min) og svært nedsat (CrCl 15-29 ml/min) nyrefunktion eller terminal nyresygdom (CrCL < 15 ml/min) fik hydroxycarbamid i en enkeltdosis på 15 mg/kg legemsvægt.
English: LIST OF EXCIPIENTS Also contains: methyl parahydroxybenzoate (E218).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: methylparahydroxybenzoat (E218).
English: If bone marrow function is depressed, treatment with hydroxycarbamide should not be initiated.
Danish: Hvis der konstateres knoglemarvsdepression, bør behandling med hydroxycarbamid ikke iværksættes.
English: Once the blood count had recovered, treatment was restarted at 2.5 mg/kg per day less than the toxic dose.
Danish: Da blodtallene var bedret, blev behandlingen genoptaget ved en daglig dosis, der lå 2,5 mg/kg under den toksiske dosis.
English: Weight gain observed during treatment with hydroxycarbamide may be an effect of improved general conditions.
Danish: Vægtøgning, der er set under behandling med hydroxycarbamid, kan skyldes en forbedret almentilstand.
English: - Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Danish: - Flasken skal være tæt lukket for at beskytte lægemidlet mod ødelæggelse og nedsætte risikoen for utilsigtet spild.
English: Hydroxycarbamide
Danish: Hydroxycarbamid
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Danish: Hvis du er usikker på, om noget af ovenstående gælder for dig, skal du tale med lægen eller apotekspersonalet, før du tager Xromi.
English: Subjects assigned to standard treatment (n = 61) continued to receive monthly blood transfusions to maintain 30% HbS or lower, while those assigned to the alternative treatment (n = 60), after having received blood transfusions for a mean duration of 4.5 years (±2.8), started oral hydroxycarbamide at 20 mg/kg/day, which was escalated to each participant's maximum tolerated dose.
Danish: De patienter, der fik standardbehandling (n = 61), fortsatte med at få månedlige blodtransfusioner for at opretholde en HbS-værdi på 30 % eller derunder, mens dem, der fik anden behandling (n = 60)efter at have fået blodtransfusioner i gennemsnitligt 4,5 år (±2,8) - startede på oralt hydroxycarbamid i en dosis på 20 mg/kg/dag, der blev eskaleret til den enkelte deltagers maksimalt tolererede dosis.
English: The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
Danish: Makrocytose forårsaget af hydroxycarbamid, er ikke relateret til vitamin B12 eller folinsyre.
English: In the event of bone marrow suppression, haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
Danish: Ved knoglemarvsdepression ses der normalt hæmatologisk bedring inden for to uger efter seponering af hydroxycarbamid.
English: Two dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml) are provided for accurate measurement of the prescribed dose of the oral solution.
Danish: Der medfølger to doseringssprøjter (en rød sprøjte gradueret til 3 ml og en hvid sprøjte gradueret til 12 ml) for at sikre nøjagtig afmåling af den ordinerede dosis oral opløsning.
English: Hydroxycarbamide was started at low dose (15 mg/kg per day) and increased at 12- weekly intervals by 5 mg/kg per day until mild bone marrow depression was achieved, as judged by either neutropenia or thrombocytopenia.
Danish: Behandling med hydroxycarbamid blev påbegyndt ved en lav dosis (15 mg/kg dagligt), der blev øget med 5 mg/kg dagligt hver 12. uge, indtil der sås let knoglemarvsdepression i henhold til neutropeni- eller trombocytopenivurdering.
English: As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of hydroxycarbamide in patients with renal impairment.
Danish: Da renal udskillelse er en af eliminationsvejene, bør det overvejes at reducere dosen af hydroxycarbamid hos patienter med nedsat nyrefunktion.
English: Close monitoring of blood parameters is advised in patients with hepatic impairment.
Danish: Tæt overvågning af blodparametre anbefales hos patienter med nedsat leverfunktion.
English: Platelets (×109/L)
Danish: Trombocytter (x 10 9/l)
English: Take as directed by your doctor using the dosing syringes provided.
Danish: Tages efter lægens anvisninger ved hjælp af de medfølgende doseringssprøjter.
English: WBC (×109/L) HbF (%) Reticulocytes (%)
Danish: Hvide blodlegemer (x 109/l) HbF (%)
English: The other ingredients are xanthan gum, sucralose (E955), strawberry flavour, methyl parahydroxybenzoate (E218), sodium hydroxide, and purified water.
Danish: Øvrige indholdsstoffer: xanthangummi, sucralose (E955), jordbæraroma, methylparahydroxybenzoat (E218), natriumhydroxid og renset vand.
English: Patients should be advised not to drive or operate machines, if dizziness is experienced while taking hydroxycarbamide.
Danish: Patienterne bør oplyses om, at de ikke bør føre motorkøretøj eller betjene maskiner, hvis de føler sig svimle under behandlingen med hydroxycarbamid.
English: Cross-over comparison with placebo (Ferster et al 1996) A randomized cross-over study was conducted in 25 children and young adults (age range: 2 to 22 years) with homozygous sickle cell anaemia and severe clinical manifestations (defined as >3 vasoocclusive crises in the year before study entry and/or with previous history of stroke, acute chest syndrome, recurrent crises without a free interval, or splenic sequestration).
Danish: Overkrydsningssammenligning med placebo (Ferster et al. 1996) Der er udført et randomiseret overkrydsningsstudie med 25 børn og unge voksne (aldersinterval: 222 år) med homozygot seglcelleanæmi og svære kliniske manifestationer (defineret som > 3 vasookklusive kriser i året før inklusion i studiet og/eller tidligere slagtilfælde, akut brystsyndrom, tilbagevendende kriser uden krisefri perioder eller miltsekvestrering).
English: The study also showed an increase in median time from the initiation of treatment to first painful crisis (2.76 months in the hydroxycarbamide arm compared with 1.35 months on placebo (p = 0.014), second painful crisis (6.58 months in the hydroxycarbamide group compared with 4.13 months on placebo (p < 0.0024), and third painful crisis (11.9 months in the hydroxycarbamide group compared with 7.04 months on placebo (p = 0.0002).
Danish: Studiet viste også en forlængelse i median tid fra behandlingsstart til første smertefulde krise (2,76 måneder i hydroxycarbamid-gruppen vs. 1,35 måneder i placebo-gruppen (p = 0,014)), anden smertefulde krise (6,58 måneder i hydroxycarbamid-gruppen vs. 4,13 måneder i placebo-gruppen (p < 0,0024)) og tredje smertefulde krise (11,9 måneder i hydroxycarbamid-gruppen vs. 7,04 måneder i placebo-gruppen (p = 0,0002)).
English: In an open single-dose study in adult patients with Sickle Cell Disease the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Danish: I et åbent enkeltdosisstudie af voksne patienter med seglcelleanæmi blev nyrefunktionens betydning for hydroxycarbamids farmakokinetik vurderet.
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle after
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: P value2 Vaso-occlusive crises 12.13 ± 8.56 0.6 ± 1.37 11.46 ± 3.01 10.2 ± 3.24 0.10 <0.001 Blood transfusions 2.43 ± 0.69 0.13 ± 0.43 2.13 ± 0.98 1.98 ± 0.82 0.25 <0.001 Hospitalisations P value is for comparison between hydroxycarbamide and placebo groups at baseline P value is for comparison between hydroxycarbamide and placebo groups at 18 months Primary stroke prevention (TWiTCH study) Transcranial Doppler (TCD) with Transfusions Changing to Hydroxycarbamide (TWiTCH) was an
Danish: Vasookklusive kriser 12,13 ± 8,56 0,6 ± 1,37 11,46 ± 3,01 10,2 ± 3,24 0,10 < 0,001 Blodtransfusioner 2,43 ± 0,69 0,13 ± 0,43 2,13 ± 0,98 1,98 ± 0,82 0,25 < 0,001 Indlæggelser P-værdien gælder sammenligning af hydroxycarbamid-gruppen og placebo-gruppen ved baseline P-værdien gælder sammenligning af hydroxycarbamid-gruppen og placebo-gruppen efter 18 måneder
English: Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infection.
Danish: Vaccination med en levende vaccine hos en patient, der får hydroxycarbamid, kan medføre svær infektion.
English: Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections.
Danish: Vaccination med en levende vaccine hos en patient, der får hydroxycarbamid, kan medføre svære infektioner.
English: An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Danish: Erytem forårsaget af strålebehandling kan forværres ved brug af hydroxycarbamid.
English: The estimated volume of distribution of hydroxycarbamide approximates total body water.
Danish: Hydroxycarbamids estimerede fordelingsvolumen ligger tæt på det samlede fordelingsvolumen.
English: Your doctor or pharmacist will advise which syringe to use depending on the dose that has been prescribed.
Danish: Lægen eller apotekspersonalet vil fortælle dig, hvilken sprøjte du skal bruge (afhænger af, hvilken dosis du skal have).
English: Hydroxycarbamide therapy can then be re-initiated at a lower dose (see section 4.2).
Danish: Derefter kan behandlingen med hydroxycarbamid genoptages i en lavere dosis (se pkt.
English: In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:
Danish: Det er især vigtigt, at du fortæller det til lægen, sundhedspersonalet eller apotekspersonalet, hvis du i forvejen får en eller flere af nedenstående behandlinger:
English: After oral administration hydroxycarbamide is readily absorbed from the gastrointestinal tract.
Danish: Efter oral administration absorberes hydroxycarbamid hurtigt fra mave-tarm-kanalen.
English: What you need to know before you take Xromi
Danish: Det skal du vide, før du begynder at tage Xromi
English: Other medicines and Xromi
Danish: Brug af anden medicin sammen med Xromi
English: Women of childbearing potential/Contraception in males and females Medicinal products which affect DNA synthesis, such as hydroxycarbamide, may be potent mutagenic active substances.
Danish: Lægemidler, der påvirker DNA-syntesen, f.eks. hydroxycarbamid, kan være potente mutagene aktive stoffer.
English: Hydroxycarbamide may cause hepatotoxicity and liver function tests should be monitored during treatment.
Danish: Hydroxycarbamid kan forårsage levertoksicitet, og derfor bør der foretages leverfunktionstest under behandlingen.
English: At lower doses, mild, transient and reversible cytopenias are commonly reported in Sickle Cell Disease patients which is expected based on the pharmacology of hydroxycarbamide.
Danish: Ved lavere doser er der hyppigt rapporteret om let, forbigående og reversibel cytopeni hos patienter med seglcelleanæmi, hvilket formodes at skyldes hydroxycarbamids farmakologi.
English: Fatal and non-fatal pancreatitis has occurred in HIV-infected patients during therapy with hydroxycarbamide and didanosine, with or without stavudine.
Danish: Letal og ikke-letal pankreatitis er set hos hivsmittede patienter under behandling med hydroxycarbamid og didanosin, med eller uden stavudin.
English: Xromi contains methyl parahydroxybenzoate (E218) Xromi contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Danish: Xromi indeholder methylparahydroxybenzoat (E218) Xromi indeholder methylparahydroxybenzoat (E218), der kan forårsage allergiske reaktioner (eventuelt forsinkede).
English: If you are not sure how much medicine to take, always ask your doctor or nurse.
Danish: Hvis du er i tvivl om, hvor meget medicin du skal have, skal du altid spørge lægen eller sundhedspersonalet.
English: Iron overload improved more in the hydroxycarbamide than the transfusion arm, with a greater average change in serum ferritin (-1805 versus -38 ng/mL; p < 0.0001) and liver iron concentration (average = -1.9 mg/g versus +2.4 mg/g dry weight liver; p = 0.0011).
Danish: Der sås større bedring af jernophobningen i hydroxycarbamidgruppen end i transfusionsgruppen med en større gennemsnitlig ændring i serumferritin (-1.805 versus -38 ng/ml; p < 0,0001) og jernkoncentrationen i leveren (gennemsnit = -1,9 mg/g versus +2,4 mg/g tørvægt, p = 0,0011).
English: When you use the medicine follow the instructions below:
Danish: Følg nedenstående anvisninger for anvendelsen af lægemidlet:
English: The risk of vasculitic toxicities is increased in patients who receive prior or concomitant interferon therapy.
Danish: Risikoen for toksiciteter, der er forbundet med vaskulitis, er øget hos patienter, der tidligere har været eller aktuelt er i behandling med interferon.
English: Hydroxycarbamide, the active substance of Xromi, passes into human breast milk.
Danish: Hydroxycarbamid, det aktive stof i Xromi, udskilles i modermælk.
English: The larger 12 ml syringe (white), marked 1 ml to 12 ml, is for measuring doses of more than 3 ml.
Danish: Den store 12-ml-sprøjte (den hvide), der er markeret fra 1-12 ml, er til afmåling af doser på mere end 3 ml.
English: Bone-marrow suppression is the major toxic effect of hydroxycarbamide and is dose related.
Danish: Knoglemarvsdepression, der er den væsentligste toksiske virkning ved hydroxycarbamid, er dosisrelateret.
English: Wigston, Leicester LE18 4YL
Danish: Nova Laboratories Limited Martin House Gloucester Crescent Wigston, Leicester LE18 4YL
English: If the solution comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water (see section 6.6).
Danish: Hvis opløsningen kommer i kontakt med hud eller slimhinder, skal den straks vaskes grundigt af med vand og sæbe (se pkt.
English: Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase some of the adverse reactions of the vaccine virus because normal defence mechanisms may be suppressed by hydroxycarbamide.
Danish: Samtidig anvendelse af hydroxycarbamid og en levende virusvaccine kan potensere replikationen af vaccinevirusset og/eller forstærke nogle af bivirkningerne ved vaccinevirusset, da de normale forsvarsmekanismer kan blive supprimeret af hydroxycarbamid.
English: The recovery from myelosuppression is rapid when hydroxycarbamide therapy is interrupted.
Danish: Myelosuppression bedres hurtigt efter afbrydelse af behandlingen med hydroxycarbamid.
English: Hydroxycarbamide may produce bone marrow suppression; leukopenia is generally its first and most common manifestation.
Danish: Hydroxycarbamid kan medføre knoglemarvsdepression, hvor leukopeni typisk er det første og mest almindelige symptom.
English: This syringe should be recommended for doses greater than 3 ml (each graduation of 0.25 ml contains 25 mg of hydroxycarbamide).
Danish: Denne sprøjte bør anbefales til doser på mere end 3 ml (hver 0,25 ml-graduering svarer til 25 mg hydroxycarbamid).
English: The Guide for healthcare professionals shall contain the following key elements: - Indication, dosage and dose adjustment; - Description of safe handling of Xromi, including the risk of medication error due to the use of two different dosing syringes; - Warnings about important risks associated with using Xromi: o Switching patients from capsule and tablet to liquid formulation; o Haematological toxicity, use of other myelosuppressive agent or radiation therapy; o Concomitant use of nucleoside analogue reverse transcriptase inhibitors; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer); o Teratogenicity and male fertility; Need for contraception; Breast feeding; o Adverse drug reactions most frequently reported; - Follow-up of patients treated with Xromi: o Haematological follow-up and dose adjustment; o Follow-up of patients with renal and/or hepatic impairment; o Growth follow-up in children;
Danish: Vejledningen til sundhedspersoner skal indeholde følgende hovedpunkter: - Indikation, dosering og dosisjustering - Beskrivelse af sikker håndtering af Xromi, herunder advarsel om risikoen for fejlmedicinering på grund af de to forskellige doseringssprøjter - Advarsler om væsentlige risici ved brug af Xromi: o Skift af patienter fra kapsel og tablet til flydende formulering o Hæmatologisk toksicitet, brug af andre myelosuppressive stoffer eller strålebehandling o Samtidig anvendelse af nukleosidanaloge revers transkriptasehæmmere o Hudsår og vaskulitis, bensår o Langsigtet sikkerhed, navnlig udvikling af maligniteter (leukæmi, hudkræft) o Teratogenicitet og fertilitet hos mænd, prævention, amning o De hyppigst indberettede bivirkninger - Opfølgning af patienter behandlet med Xromi: o Hæmatologisk opfølgning og dosisjustering o Opfølgning af patienter med nedsat nyre- og/eller leverfunktion o Opfølgning af væksten hos børn
English: Hydroxycarbamide should be used with caution in patients with marked renal dysfunction.
Danish: Hydroxycarbamid bør anvendes med forsigtighed hos patienter med markant nedsat nyrefunktion.
English: Leg ulcers are a common complication of Sickle Cell Disease, but have also been reported in patients treated with hydroxycarbamide.
Danish: Bensår er en almindelig komplikation ved seglcelleanæmi, men der er også rapporteret om bensår hos patienter behandlet med hydroxycarbamid.
English: If, during treatment, anaemia occurs, correct without interrupting hydroxycarbamide therapy.
Danish: Hvis der under behandlingen opstår anæmi, skal anæmien korrigeres uden at afbryde behandlingen med hydroxycarbamid.
English: Patients who have received irradiation therapy in the past may have an exacerbation of post irradiation erythema when hydroxycarbamide is given.
Danish: Patienter, der tidligere har fået strålebehandling, kan opleve en forværring af strålebehandlingsrelateret erytem ved administration af hydroxycarbamid.
English: P value1
Danish: P-værdi2
English: Common: may affect up to 1 in 10 people - Nausea - Headache - Dizziness - Constipation - Darkening of the skin, nails and mouth - Dry skin - Hair loss
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter): - Kvalme - Hovedpine - Svimmelhed - Forstoppelse - Mørkfarvning af hud, negle og mund - Tør hud - Hårtab