natgillin/translations-raw huggingface dataset:
Xromi-behandling bør om muligt ophøre 3-6 måneder, inden du bliver gravid. 
Xromi should be stopped 3 to 6 months prior to becoming pregnant, if possible.
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. 
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.
Toksikologiske studier har også vist testikelatrofi med nedsat spermatogenese og nedsat antal sædceller hos rotter samt nedsat testikelvægt og nedsat antal sædceller hos mus. 
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.
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. 
Patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Andre hyppigt indberettede bivirkninger omfatter kvalme, forstoppelse, hovedpine og svimmelhed. 
Other commonly reported adverse effects also include nausea, constipation, headache, and dizziness.
Trombocytopeni, anæmi 
Thrombocytopenia, anaemia
Der er rapporteret om sjældne tilfælde af bensår og meget sjældne tilfælde af systemisk lupus erythematosus. 
Rarely leg ulcers and very rarely systemic lupus erythematosus have been reported.
Seglceller kan også sætte sig fast i blodkarrene og blokere for blodstrømmen. 
The sickle cells also get stuck in blood vessels, blocking blood flow.
Sikker håndtering 
Safe handling
Hydroxycarbamid påvirker spermatogenesen, og der er derfor meget hyppigt rapporteret om oligospermi og azoospermi. 
Hydroxycarbamide affects spermatogenesis, and hence oligospermia and azoospermia are very commonly reported.
Den øjeblikkelige behandling består af maveskylning, om nødvendigt efterfulgt af understøttende behandling af de kardiorespiratoriske systemer. 
Immediate treatment consists of gastric lavage, followed by supportive therapy for the cardiorespiratory systems if required.
Stomatitis, diarré, opkastning 
Stomatitis, diarrhoea, vomiting
Informationsmaterialet til læger bør omfatte: 
The physician educational material should contain:
Omfanget af hydroxycarbamids proteinbinding kendes ikke. 
The extent of protein binding of hydroxycarbamide is unknown.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Hos hunde er der set reversibelt spermatogenesestop. 
While in dogs reversible spermatogenic arrest was noted.
I et enkeltdosisstudie af børn med seglcelleanæmi var den gennemsnitlige halveringstid 1,7 timer. 
In a single dose study in children with Sickle Cell Disease, the mean half-life was reported to be 1.7 hours.
Studiet havde et noninferioritetsdesign, hvor det primære endepunkt var TCD-hastigheden efter 24 måneder i forhold til værdierne ved baseline (inklusionstidspunktet). 
This study used a non-inferiority trial design with a primary endpoint of TCD velocity at 24 months, controlling for baseline (enrollment) values.
De almindeligt observerede tilfælde af anæmi har fortrinsvis skyldtes infektion med parvovirus eller miltsekvestrering. 
The anaemia commonly observed has mainly been due to an infection with Parvovirus or a splenic sequestration.
Ældre patienter kan være mere følsomme over for den myelosuppressive effekt af hydroxycarbamid og kan have behov for en lavere dosering. 
Elderly patients may be more sensitive to the myelosuppressive effects of hydroxycarbamide, and may require a lower dosage regimen.
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. 
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.
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). 
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).
Hos patienter med en kreatininclearance (CrCl) ≤ 60 ml/min bør den indledende dosis af hydroxycarbamid reduceres med 50 %. 
In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%.
Både mandlige og kvindelige patienter bør rådes til at anvende sikker prævention før og under behandlingen med hydroxycarbamid. 
Both male and female patients should be advised to use contraceptive measures before and during treatment with hydroxycarbamide.
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. 
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.
Tag låget af flasken (figur 1), og sæt adapteren godt fast på flaskens top - lad den sidde med henblik på senere doseringer (figur 2). 
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).
Den myelosuppressive aktivitet kan potenseres af tidligere eller samtidig strålebehandling eller cytotoksisk kemoterapi. 
The myelosuppressive activity may be potentiated by previous or concomitant radiotherapy or cytotoxic therapy.
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. 
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.
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. 
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.
Du må ikke amme, mens du tager Xromi. 
Do not breastfeed while taking Xromi.
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). 
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).
Hvis du holder op med at tage Xromi 
If you stop taking Xromi
Behandling med hydroxycarbamid bør overvåges af en læge eller anden sundhedsperson med erfaring i behandling af patienter med seglcelleanæmi. 
Hydroxycarbamide treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with Sickle Cell Disease.
Svært nedsat nyrefunktion (CrCl < 30 ml/min). 
Severe renal impairment (CrCl < 30 ml/min).
Du må ikke holde op med at tage medicinen uden at tale med lægen. 
Do not stop taking your medicine unless advised by your doctor.
Hydroxycarbamid kan også forsinke clearance af plasmajern og reducere erytrocytternes jernanvendelse, men ser ikke ud til at ændre de røde blodlegemers overlevelsestid. 
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.
- Opbevares i køleskab (2-8 °C). 
- Store in a refrigerator (2 °C - 8 °C)
Hydroxycarbamid i 30, 100 og 300 µM metaboliseres ikke in vitro af cytokrom P450-systemet i humane levermikrosomer. 
Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
For at mindske risikoen for eksponering bør der anvendes engangshandsker ved håndtering af Xromi. 
To decrease the risk of exposure disposable gloves should be used when handling Xromi.
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]). 
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]).
Patienter, der får hydroxycarbamid, bør gøres opmærksomme på den teoretiske risiko for fosteret. 
Patients on hydroxycarbamide should be made aware of the theoretical risks to the foetus.
Generelt kan patientens antistofrespons på vacciner være nedsat. 
Generally, the patient's antibody response to vaccines may be decreased.
Blodparametre for nedsat nyre- og leverfunktion bør overvåges tæt, og hydroxycarbamid bør om nødvendigt seponeres. 
Blood parameters for renal and hepatic impairment should be closely monitored, and hydroxycarbamide should be discontinued if necessary.
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. 
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.
Vend flasken på hovedet (figur 4). 
Turn the bottle upside down (figure 4).
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. 
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.
Hydroxycarbamid kan forårsage fosterskader, hvis det gives til en gravid kvinde. 
Hydroxycarbamide can cause foetal harm when administered to a pregnant woman.
Den morfologiske ændring minder om perniciøs anæmi, men er ikke relateret til mangel på vitamin B12 eller folinsyre. 
The morphologic change resembles pernicious anaemia, but is not related to vitamin B12 or folic acid deficiency.
Tæt overvågning af blodparametre anbefales hos disse patienter. 
Close monitoring of blood parameters is advised in these patients.
Desuden sås en reduktion i den gennemsnitlige indlæggelsesvarighed (5,3 dage i hydroxycarbamid-gruppen og 15,2 dage i placebo-gruppen). 
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.
Gradvis dosistitrering anbefales for at undgå alvorligere tilfælde af knoglemarvsdepression (se pkt. 
Gradual dose titration is recommended to avoid more severe bone marrow suppressions (see section 4.2).
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. 
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.
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. 
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.
Hydroxycarbamid påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Hydroxycarbamide has minor influence on the ability to drive and use machines.
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. 
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.
Hvis du har taget for meget Xromi, skal du straks sige det til lægen eller tage på skadestuen. 
If you take more Xromi than you should, tell your doctor or go to a hospital immediately.
Oligospermi og azoospermi forårsaget af hydroxycarbamid, er normalt reversibel, men der skal tages hensyn hertil, hvis patienten ønsker at få børn (se pkt. 
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).
Sæt låget tilbage på flasken (lad adapteren blive siddende). 
Put the cap back on the bottle with the adaptor left in place.
Spørg lægen eller sundhedspersonalet til råds. 
Ask your doctor or pharmacist for advice.
Xromi anvendes til at forebygge komplikationer ved blokerede blodkar, der forårsages af seglcelleanæmi hos patienter over 2 år. 
Xromi is used to prevent the complications of blocked blood vessels caused by Sickle Cell Disease in patients over 2 years of age.
Hydroxycarbamid fordeles hurtigt i kroppen, passerer til cerebrospinalvæsken, i peritonealvæske og ascites og koncentreres i leukocytter og erytrocytter. 
Hydroxycarbamide distributes rapidly throughout the human body, enters the cerebrospinal fluid, appears in peritoneal fluid and ascites, and concentrates in leukocytes and erythrocytes.
Xromi indeholder hydroxycarbamid, som er et stof, der nedsætter væksten og formeringen af visse celler i knoglemarven. 
Xromi contains hydroxycarbamide, a substance which reduces the growth and multiplication of some cells in the bone marrow.
Teratogen effekt i form af delvist ossificerede kranieknogler, manglende øjenhuler, hydrocefali, tvedelt brystben og manglende lændehvirvler. 
Teratogenic effects manifested as partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae.
Før 
Before
En af mekanismerne bag hydroxycarbamids effekt er en forhøjelse af HbF-koncentrationen hos patienter med seglcelleanæmi. 
One of the mechanisms by which hydroxycarbamide acts is the elevation of HbF concentrations in Sickle Cell Disease patients.
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. 
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.
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. 
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.
Du skal beskytte din hud mod solen og selv tjekke din hud regelmæssigt under og efter behandlingen med hydroxycarbamid. 
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.
Samtidig anvendelse af hydroxycarbamid og andre myelosuppressive lægemidler eller strålebehandling kan øge knoglemarvsdepression, gastrointestinale forstyrrelser eller mucositis. 
Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Xromi er indiceret til forebyggelse af vasookklusive komplikationer ved seglcelleanæmi hos patienter over 2 år. 
Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.
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. 
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.
Vurdering af fuld blodstatus, herunder eventuelt knoglemarvsvurdering, og vurdering af nyre- og leverfunktion bør foretages før og gentagne gange under behandlingen. 
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.
Hos børn er den fraktion af hydroxycarbamid, der udskilles uomdannet i urin, ca. 50 %. 
In children, the fraction of hydroxycarbamide excreted unchanged into the urine comprised about 50%.
I et studie af børn med seglcelleanæmi havde flydende og kapselbaserede formuleringer samme areal under kurven, samme maksimale koncentration og samme halveringstid. 
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.
Elimination Hydroxycarbamids totale clearance hos voksne patienter med seglcelleanæmi er 0,17 l/t/kg. 
The total body clearance of hydroxycarbamide in adult patients with Sickle Cell Disease is 0.17L/h/kg.
Det er påvist, at nitroxyl, den tilsvarende carboxylsyre og nitrogenoxid er metabolitter: Det er også dokumenteret, at urinstof er en metabolit af hydroxycarbamid. 
It appears that nitroxyl, the corresponding carboxylic acid and nitric oxide are metabolites: Urea has also been shown to be a metabolite of hydroxycarbamide.
Flasken skal holdes tæt lukket for at beskytte lægemidlets kvalitet og minimere risikoen for utilsigtet spild. 
Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
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. 
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.
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. 
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).
Middelcellehæmoglobinkoncentration (MCHC) (%) 
Mean corpuscular haemoglobin concentration (MCHC) (%)
LÆGEMIDLETS NAVN Xromi 100 mg/ml oral opløsning 
NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution
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. 
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.
Hydroxycarbamid er cytotoksisk. 
Hydroxycarbamide is cytotoxic.
Hos voksne med normal nyrefunktion er der rapporteret om urinudskillelse af uomdannet lægemiddel svarende til ca. 37 % af den orale dosis. 
In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal.
Det anbefales, at startdosis reduceres med 50 % hos patienter med CrCl < 60 ml/min (se pkt. 
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).
Den sædvanlige startdosis af hydroxycarbamid er 15 mg/kg/dag, og den sædvanlige vedligeholdelsesdosis er 20-25 mg/kg. 
The usual starting dose of hydroxycarbamide is 15 mg/kg/day and usual maintenance dose is between 20-25 mg/kg.
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. 
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.
Hydroxycarbamid (n = 22) 
Hydroxycarbamide (n=22)
Låget skal være tæt lukket. 
Ensure that the cap is tightly closed.
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. 
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.
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. 
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.
Nogle celler bliver unormale og stive og antager form som en halvmåne eller et segl, så der opstår anæmi (blodmangel). 
Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anaemia.
Patientens antistofrespons på vacciner kan være nedsat. 
The patient's antibody response to vaccines may be decreased.