FrancophonIA/ELRC3.0 huggingface dataset:
English: Hydroxycarbamide is unequivocally genotoxic and although conventional long-term carcinogenicity studies have not been conducted, hydroxycarbamide is presumed to be a transspecies carcinogen which implies a carcinogenic risk to humans.
Danish: Hydroxycarbamid er entydigt genotoksisk, og selvom der ikke er gennemført konventionelle langsigtede karcinogenicitetsstudier, formodes hydroxycarbamid at indebære karcinogen risiko hos alle arter, herunder hos mennesker.
English: The volume of distribution following oral dosing of hydroxycarbamide is approximately equal to total body water: adult values of 0.48 - 0.90 L/kg have been reported, whilst in children a population estimate of 0.7 L/kg has been reported.
Danish: Fordelingsvolumenet efter oral administration af hydroxycarbamid svarer omtrent til det samlede vandinhold: Der er rapporteret om værdier hos voksne på 0,48-0,90 l/kg, mens der hos børn er rapporteret om et populationsestimat på 0,7 l/kg.
English: Do not breastfeed while taking Xromi.
Danish: Du må ikke amme, mens du tager Xromi.
English: In patients with Sickle Cell Disease, 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 body weight/ day).
Danish: Hos patienter med seglcelleanæmi er der rapporteret om neutropeni i forbindelse med isolerede tilfælde af hydroxycarbamid-overdosering (1,43 gange og 8,57 gange den maksimale anbefalede dosis på 35 mg/kg legemsvægt/dag).
English: If you stop taking Xromi
Danish: Hvis du holder op med at tage Xromi
English: Hydroxycarbamide treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with Sickle Cell Disease.
Danish: Behandling med hydroxycarbamid bør overvåges af en læge eller anden sundhedsperson med erfaring i behandling af patienter med seglcelleanæmi.
English: Severe renal impairment (CrCl < 30 ml/min).
Danish: Svært nedsat nyrefunktion (CrCl < 30 ml/min).
English: Do not stop taking your medicine unless advised by your doctor.
Danish: Du må ikke holde op med at tage medicinen uden at tale med lægen.
English: Hydroxycarbamide may also delay plasma iron clearance and reduce the rate of iron utilisation by erythrocytes but it does not appear to alter the red blood cell survival time.
Danish: Hydroxycarbamid kan også forsinke clearance af plasmajern og reducere erytrocytternes jernanvendelse, men ser ikke ud til at ændre de røde blodlegemers overlevelsestid.
English: - Store in a refrigerator (2 °C - 8 °C)
Danish: - Opbevares i køleskab (2-8 °C).
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Danish: Hydroxycarbamid i 30, 100 og 300 µM metaboliseres ikke in vitro af cytokrom P450-systemet i humane levermikrosomer.
English: To decrease the risk of exposure disposable gloves should be used when handling Xromi.
Danish: For at mindske risikoen for eksponering bør der anvendes engangshandsker ved håndtering af Xromi.
English: Evidence for the efficacy of hydroxycarbamide in reducing the vaso-occlusive complications of Sickle Cell Disease in patients older than 2 years comes from four randomised controlled trials (Charache et al 1995 [MSH Study]; Jain et al 2012, Ferster et al 1996; Ware et al 2015 [TWiTCH]).
Danish: Evidens for effekten af hydroxycarbamid til mindskelse af vasookklusive komplikationer ved seglcelleanæmi hos patienter over 2 år stammer fra fire randomiserede, kontrollerede studier (Charache et al. 1995 [MSH-studiet], Jain et al. 2012, Ferster et al. 1996, Ware et al. 2015 [TWiTCH]).
English: Patients on hydroxycarbamide should be made aware of the theoretical risks to the foetus.
Danish: Patienter, der får hydroxycarbamid, bør gøres opmærksomme på den teoretiske risiko for fosteret.
English: Generally, the patient's antibody response to vaccines may be decreased.
Danish: Generelt kan patientens antistofrespons på vacciner være nedsat.
English: Blood parameters for renal and hepatic impairment should be closely monitored, and hydroxycarbamide should be discontinued if necessary.
Danish: Blodparametre for nedsat nyre- og leverfunktion bør overvåges tæt, og hydroxycarbamid bør om nødvendigt seponeres.
English: There was a statistically significant reduction in time to peak concentration with hydroxycarbamide oral solution compared to the reference 500 mg capsule (0.5 versus 0.75 hours, p = 0.0467), indicating a faster rate of absorption.
Danish: Der sås en statistisk signifikant reduktion i tid til maksimal koncentration med hydroxycarbamid oral opløsning sammenholdt med referencekapslen på 500 mg (0,5 versus 0,75 timer, p = 0,0467), hvilket indikerer en hurtigere absorptionshastighed.
English: Turn the bottle upside down (figure 4).
Danish: Vend flasken på hovedet (figur 4).
English: Studies have shown that there is an analytical interference of hydroxycarbamide with the enzymes (urease, uricase, and lactic dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxycarbamide.
Danish: Studier har vist, at der er analytisk interferens mellem hydroxycarbamid og de enzymer (urease, uricase og laktatdehydrogenase), der anvendes til bestemmelse af urinstof, urinsyre og mælkesyre, hvilket giver falsk forhøjede værdier af disse hos patienter i behandling med hydroxycarbamid.
English: Hydroxycarbamide can cause foetal harm when administered to a pregnant woman.
Danish: Hydroxycarbamid kan forårsage fosterskader, hvis det gives til en gravid kvinde.
English: The morphologic change resembles pernicious anaemia, but is not related to vitamin B12 or folic acid deficiency.
Danish: Den morfologiske ændring minder om perniciøs anæmi, men er ikke relateret til mangel på vitamin B12 eller folinsyre.
English: Close monitoring of blood parameters is advised in these patients.
Danish: Tæt overvågning af blodparametre anbefales hos disse patienter.
English: In addition, there was a reduction in mean hospital stay; 5.3 days in the hydroxycarbamide group and 15.2 days in the placebo group.
Danish: Desuden sås en reduktion i den gennemsnitlige indlæggelsesvarighed (5,3 dage i hydroxycarbamid-gruppen og 15,2 dage i placebo-gruppen).
English: Gradual dose titration is recommended to avoid more severe bone marrow suppressions (see section 4.2).
Danish: Gradvis dosistitrering anbefales for at undgå alvorligere tilfælde af knoglemarvsdepression (se pkt.
English: Recently, hydroxycarbamide has shown to be associated with the generation of nitric oxide suggesting that nitric oxide stimulates cyclic guanosine monophosphatase (cGMP) production, which then activates a protein kinase and increases the production of HbF.
Danish: Det er for nylig påvist, at hydroxycarbamid er forbundet med generering af nitrogenoxid, hvilket tyder på, at nitrogenoxid stimulerer produktionen af cyklisk guanosinmonofosfat (cGMP), som derefter aktiverer en proteinkinase og øger produktionen af HbF.
English: Once a maximum tolerated dose is established, laboratory safety monitoring should include full blood cell count with white cell differential, reticulocyte count, and platelet count every 2-3 months.
Danish: Når den maksimalt tolererede dosis er fastlagt, bør de sikkerhedsmæssige laboratorieanalyser omfatte fuld blodtælling, herunder retikulocyttal, trombocyttal og differentialtælling af hvide blodlegemer, hver 2.-3. måned.
English: Hydroxycarbamide has minor influence on the ability to drive and use machines.
Danish: Hydroxycarbamid påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Disease include decrease of neutrophils, improved deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Danish: Andre kendte farmakologiske virkninger ved hydroxycarbamid, der muligvis bidrager til dets gavnlige effekt ved seglcelleanæmi, omfatter et fald i neutrofiler, en forbedret evne i seglceller til at ændre form og ændret adhæsion til endotel af røde blodlegemer.
English: If you take more Xromi than you should, tell your doctor or go to a hospital immediately.
Danish: Hvis du har taget for meget Xromi, skal du straks sige det til lægen eller tage på skadestuen.
English: Oligospermia and azoospermia caused by hydroxycarbamide are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
Danish: Oligospermi og azoospermi forårsaget af hydroxycarbamid, er normalt reversibel, men der skal tages hensyn hertil, hvis patienten ønsker at få børn (se pkt.
English: Put the cap back on the bottle with the adaptor left in place.
Danish: Sæt låget tilbage på flasken (lad adapteren blive siddende).
English: Ask your doctor or pharmacist for advice.
Danish: Spørg lægen eller sundhedspersonalet til råds.
English: Xromi is used to prevent the complications of blocked blood vessels caused by Sickle Cell Disease in patients over 2 years of age.
Danish: Xromi anvendes til at forebygge komplikationer ved blokerede blodkar, der forårsages af seglcelleanæmi hos patienter over 2 år.
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 fordeles hurtigt i kroppen, passerer til cerebrospinalvæsken, i peritonealvæske og ascites og koncentreres i leukocytter og erytrocytter.
English: Xromi contains hydroxycarbamide, a substance which reduces the growth and multiplication of some cells in the bone marrow.
Danish: Xromi indeholder hydroxycarbamid, som er et stof, der nedsætter væksten og formeringen af visse celler i knoglemarven.
English: Teratogenic effects manifested as partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae.
Danish: Teratogen effekt i form af delvist ossificerede kranieknogler, manglende øjenhuler, hydrocefali, tvedelt brystben og manglende lændehvirvler.
English: Before
Danish: Før
English: One of the mechanisms by which hydroxycarbamide acts is the elevation of HbF concentrations in Sickle Cell Disease patients.
Danish: En af mekanismerne bag hydroxycarbamids effekt er en forhøjelse af HbF-koncentrationen hos patienter med seglcelleanæmi.
English: At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (P-gp), indicating that hydroxycarbamide is not a P-gp substrate.
Danish: I koncentrationer fra 10-300 µM stimulerer hydroxycarbamid ikke ATPase-aktiviteten af rekombinant humant Pglykoprotein (P-gp) in vitro, hvilket indikerer, at hydroxycarbamid ikke er et substrat for P-gp.
English: In patients, whose CrCl was below 60 ml/min or patients with End Stage Renal Disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.
Danish: Hos patienter med CrCl under 60 ml/min eller patienter med terminal nyresygdom var den gennemsnitlige eksponering for hydroxycarbamid ca. 64 % højere end hos patienter med normal nyrefunktion.
English: You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with hydroxycarbamide.
Danish: Du skal beskytte din hud mod solen og selv tjekke din hud regelmæssigt under og efter behandlingen med hydroxycarbamid.
English: Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Danish: Samtidig anvendelse af hydroxycarbamid og andre myelosuppressive lægemidler eller strålebehandling kan øge knoglemarvsdepression, gastrointestinale forstyrrelser eller mucositis.
English: Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.
Danish: Xromi er indiceret til forebyggelse af vasookklusive komplikationer ved seglcelleanæmi hos patienter over 2 år.
English: In a comparative bioavailability study in healthy adult volunteers (n=28), 500 mg of hydroxycarbamide oral solution was demonstrated to be bioequivalent to the reference 500 mg capsule, with respect to both the peak concentration and area under the curve.
Danish: I et komparativt studie af biotilgængeligheden hos raske forsøgspersoner (n = 28) blev det påvist, at 500 mg hydroxycarbamid oral opløsning er bioækvivalent med referencekapslen på 500 mg, både hvad angår maksimal koncentration og areal under kurven.
English: The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during, treatment.
Danish: Vurdering af fuld blodstatus, herunder eventuelt knoglemarvsvurdering, og vurdering af nyre- og leverfunktion bør foretages før og gentagne gange under behandlingen.
English: In children, the fraction of hydroxycarbamide excreted unchanged into the urine comprised about 50%.
Danish: Hos børn er den fraktion af hydroxycarbamid, der udskilles uomdannet i urin, ca. 50 %.
English: In a study of children with Sickle Cell Disease, liquid and capsule formulations resulted in similar area under the curve, peak concentrations, and half-life.
Danish: I et studie af børn med seglcelleanæmi havde flydende og kapselbaserede formuleringer samme areal under kurven, samme maksimale koncentration og samme halveringstid.
English: The total body clearance of hydroxycarbamide in adult patients with Sickle Cell Disease is 0.17L/h/kg.
Danish: Elimination Hydroxycarbamids totale clearance hos voksne patienter med seglcelleanæmi er 0,17 l/t/kg.
English: It appears that nitroxyl, the corresponding carboxylic acid and nitric oxide are metabolites: Urea has also been shown to be a metabolite of hydroxycarbamide.
Danish: Det er påvist, at nitroxyl, den tilsvarende carboxylsyre og nitrogenoxid er metabolitter: Det er også dokumenteret, at urinstof er en metabolit af hydroxycarbamid.
English: Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
Danish: Flasken skal holdes tæt lukket for at beskytte lægemidlets kvalitet og minimere risikoen for utilsigtet spild.
English: The MSH study showed increased haematological toxicity resulting in a dose reduction in the hydroxycarbamide group as compared with placebo, but there were no infections related to neutropenia or bleeding episodes due to thrombocytopenia.
Danish: MSH-studiet viste øget hæmatologisk toksicitet, der førte til dosisreduktion i hydroxycarbamid-gruppen sammenholdt med placebogruppen, men der var ingen infektioner relateret til neutropeni eller blødningsepisoder som følge af trombocytopeni.
English: There are no data that support specific guidance for dose adjustment in patients with hepatic impairment, but, due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Der foreligger ingen data, der specifikt understøtter dosisjustering hos patienter med nedsat leverfunktion, men af hensyn til sikkerheden er hydroxycarbamid kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Mean corpuscular haemoglobin concentration (MCHC) (%)
Danish: Middelcellehæmoglobinkoncentration (MCHC) (%)
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Xromi 100 mg/ml oral opløsning
English: The most common symptoms of overdose with Xromi are: - Redness of the skin, - Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly, - Skin becoming strongly pigmented (locally changes of colour), - Soreness or swelling in the mouth.
Danish: De hyppigste symptomer ved overdosering af Xromi er: - Hudrødme - Ømhed (ved berøring) og hævelse af håndflader og fodsåler efterfulgt af afskalning på hænder og fødder - Kraftig pigmentering af huden (lokale farveforandringer) - Ømhed eller hævelse i munden.
English: Hydroxycarbamide is cytotoxic.
Danish: Hydroxycarbamid er cytotoksisk.
English: In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal.
Danish: Hos voksne med normal nyrefunktion er der rapporteret om urinudskillelse af uomdannet lægemiddel svarende til ca. 37 % af den orale dosis.
English: It is recommended that the starting dose is reduced by 50% in patients with CrCl <60 ml/min (see sections 4.2 and 4.3).
Danish: Det anbefales, at startdosis reduceres med 50 % hos patienter med CrCl < 60 ml/min (se pkt.
English: The usual starting dose of hydroxycarbamide is 15 mg/kg/day and usual maintenance dose is between 20-25 mg/kg.
Danish: Den sædvanlige startdosis af hydroxycarbamid er 15 mg/kg/dag, og den sædvanlige vedligeholdelsesdosis er 20-25 mg/kg.
English: Adverse reactions affecting the skin and subcutaneous tissue such as darkening of the skin nail beds, dry skin, skin ulcers, and alopecia tend to occur following several years of long-term daily maintenance therapy.
Danish: Bivirkninger, der påvirker huden og det subkutane væv, f.eks. mørkfarvning af huden ved negleroden, tør hud, hudsår og alopeci, opstår typisk efter flere års daglig vedligeholdelsesbehandling.
English: Hydroxycarbamide (n=22)
Danish: Hydroxycarbamid (n = 22)
English: Ensure that the cap is tightly closed.
Danish: Låget skal være tæt lukket.
English: When blood counts have recovered, hydroxycarbamide should be reinstated at a dose 5 mg/kg/day lower than the dose given before onset of cytopenias.
Danish: Når blodtallene er blevet bedre, bør behandlingen med hydroxycarbamid genoptages i en dosis, der er 5 mg/kg/dag lavere end den dosis, der blev givet før cytopeniens debut.
English: The digital distribution of these vasculitic ulcerations and progressive clinical behaviour of peripheral vasculitic insufficiency leading to digital infarct or gangrene were distinctly different than the typical skin ulcers generally described with Hydroxycarbamide.
Danish: Fordelingen af vaskulitsår på fingre og tæer og den progressive kliniske adfærd ved perifer vaskulær insufficiens, der fører til digitalt infarkt eller gangræn, var helt anderledes end de typiske hudsår, der normalt beskrives ved hydroxycarbamid.
English: Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anaemia.
Danish: Nogle celler bliver unormale og stive og antager form som en halvmåne eller et segl, så der opstår anæmi (blodmangel).
English: The patient's antibody response to vaccines may be decreased.
Danish: Patientens antistofrespons på vacciner kan være nedsat.
English: Hydroxycarbamide administered to male rats at 60 mg/kg body weight/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 administreret til hanrotter i en dosis på 60 mg/kg legemsvægt/dag (ca. dobbelt så meget som den maksimale anbefalede dosis til mennesker) gav testikelatrofi, nedsat spermatogenese samt betydeligt nedsat evne til at gøre hunner drægtige.
English: The use of live vaccines should be avoided during treatment and for at least six months after treatment has finished and individual specialist advice sought (see section 4.5).
Danish: Anvendelse af levende vacciner bør undgås under behandling med hydroxycarbamid og i mindst 6 måneder efter behandlingens afslutning; en speciallæge bør tages med på råd i hvert enkelt tilfælde (se pkt.
English: Erythrocytic abnormalities; megaloblastic erythropoiesis, which is selflimiting, is often seen early in the course of hydroxycarbamide therapy.
Danish: Erytrocyt-relaterede anomalier, herunder megaloblastisk erytropoiese, der er selvbegrænsende, ses ofte tidligt i forløbet ved behandling med hydroxycarbamid.
English: Your doctor or pharmacist will advise you of the correct syringe to use, either the 3 ml (red syringe) or the 12 ml (white syringe) in order to give the correct dose.
Danish: Lægen eller apotekspersonalet vil fortælle dig, hvilken sprøjte du skal bruge for at indgive den rigtige dosis, dvs. enten den røde (3 ml) eller den hvide (12 ml).
English: This medicinal product contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Danish: Dette lægemiddel indeholder methylparahydroxybenzoat (E218), der kan forårsage allergiske reaktioner (eventuelt forsinkede).
English: Hydroxycarbamide is an orally active antineoplastic agent.
Danish: Hydroxycarbamid er et oralt aktivt antineoplastisk stof.
English: If Xromi comes into contact with skin, eyes or nose, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Xromi kommer i kontakt med hud, øjne eller næse, skal det eksponerede område straks vaskes grundigt med vand og sæbe.
English: Very common: may affect more than 1 in 10 people - Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter): - Lavt antal eller fravær af sædceller i sædvæsken (oligospermi eller azoospermi).
English: Hydroxycarbamide did not reduce rates of hepatic or splenic sequestration when compared with placebo.
Danish: Hydroxycarbamid reducerede ikke hyppigheden af lever- eller miltsekvestrering sammenholdt med placebo.
English: Final model-based TCD velocities were 143 cm/s (95% CI 140-146) in children who received standard transfusions and 138 cm/s (95% CI 135-142) in those who received hydroxycarbamide, with a difference of 4.54 cm/s (95% CI 0.10-8.98).
Danish: De endelige modelbaserede TCD-hastigheder var 143 cm/s (95 %-KI: 140-146) hos børn, der fik standardtransfusioner, og 138 cm/s (95 %-KI: 135-142) hos dem, der fik hydroxycarbamid (en difference på 4,54 cm/s (95 %-KI: 0,10-8,98)).
English: Red blood cell (RBC), mean cell volume (MCV), and foetal haemoglobin (HbF) levels should be monitored for evidence of consistent or progressive laboratory response.
Danish: Erytrocyttal, middelcellevolumen (MCV) og niveauet af føtalt hæmoglobin (HbF) bør overvåges for tegn på konsistente eller progressive laboratorieværdier.
English: Swallow the dose of oral solution then drink some water, making sure no medicine is left in your mouth.
Danish: 10. Synk medicinen og drik lidt vand, så der ikke er noget medicin tilbage i munden.
English: • A patient/carer guide
Danish: • En vejledning til patienter/omsorgspersoner
English: Clear, colourless to pale yellow viscous liquid.
Danish: Klar, farveløs til bleggul, viskøs væske.
English: Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 ml of oral solution.
Danish: Ravgul type III-glasflaske med en forseglet og børnesikret lukning (HDPE med foring af ekspanderet polyethylen) indeholdende 150 ml oral opløsning.
English: • Full blood cell count with white cell differential and reticulocyte count to be monitored at least every 4 weeks when adjusting dosage.
Danish: • Fuld blodtælling, herunder retikulocyttal og differentialtælling af hvide blodlegemer, bør monitoreres mindst hver 4. uge under justeringen af dosis.
English: Full blood cell count with white cell differential and reticulocyte count should be monitored every 2 weeks for the first 2 months following treatment initiation.
Danish: Fuld blodtælling, herunder retikulocyttal og differentialtælling af hvide blodlegemer, bør monitoreres hver 2. uge i de første 2 måneder efter behandlingsstart.
English: Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at a dosage several times greater than that recommended.
Danish: Der er indberettet om akut mukokutan toksicitet hos patienter, som har fået hydroxycarbamid i en dosis, der lå flere gange over den anbefalede.