natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
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).
Erytrocyt-relaterede anomalier, herunder megaloblastisk erytropoiese, der er selvbegrænsende, ses ofte tidligt i forløbet ved behandling med hydroxycarbamid.
Erythrocytic abnormalities; megaloblastic erythropoiesis, which is selflimiting, is often seen early in the course of hydroxycarbamide therapy.
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).
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.
Dette lægemiddel indeholder methylparahydroxybenzoat (E218), der kan forårsage allergiske reaktioner (eventuelt forsinkede).
This medicinal product contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Hydroxycarbamid er et oralt aktivt antineoplastisk stof.
Hydroxycarbamide is an orally active antineoplastic agent.
Hvis Xromi kommer i kontakt med hud, øjne eller næse, skal det eksponerede område straks vaskes grundigt med vand og sæbe.
If Xromi comes into contact with skin, eyes or nose, it should be washed immediately and thoroughly with soap and water.
Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter): - Lavt antal eller fravær af sædceller i sædvæsken (oligospermi eller azoospermi).
Very common: may affect more than 1 in 10 people - Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Hydroxycarbamid reducerede ikke hyppigheden af lever- eller miltsekvestrering sammenholdt med placebo.
Hydroxycarbamide did not reduce rates of hepatic or splenic sequestration when compared with placebo.
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)).
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).
Erytrocyttal, middelcellevolumen (MCV) og niveauet af føtalt hæmoglobin (HbF) bør overvåges for tegn på konsistente eller progressive laboratorieværdier.
Red blood cell (RBC), mean cell volume (MCV), and foetal haemoglobin (HbF) levels should be monitored for evidence of consistent or progressive laboratory response.
10. Synk medicinen og drik lidt vand, så der ikke er noget medicin tilbage i munden.
Swallow the dose of oral solution then drink some water, making sure no medicine is left in your mouth.
• En vejledning til patienter/omsorgspersoner
• A patient/carer guide
Klar, farveløs til bleggul, viskøs væske.
Clear, colourless to pale yellow viscous liquid.
Ravgul type III-glasflaske med en forseglet og børnesikret lukning (HDPE med foring af ekspanderet polyethylen) indeholdende 150 ml oral opløsning.
Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 ml of oral solution.
• Fuld blodtælling, herunder retikulocyttal og differentialtælling af hvide blodlegemer, bør monitoreres mindst hver 4. uge under justeringen af dosis.
• Full blood cell count with white cell differential and reticulocyte count to be monitored at least every 4 weeks when adjusting dosage.
Fuld blodtælling, herunder retikulocyttal og differentialtælling af hvide blodlegemer, bør monitoreres hver 2. uge i de første 2 måneder efter behandlingsstart.
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.
Der er indberettet om akut mukokutan toksicitet hos patienter, som har fået hydroxycarbamid i en dosis, der lå flere gange over den anbefalede.
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at a dosage several times greater than that recommended.
Ved seglcelle-anæmi hjælper hydroxycarbamid også med at forhindre de røde blodlegemer i at antage den unormale segl-form.
In Sickle Cell Disease, hydroxycarbamide also helps to prevent red blood cells from taking the abnormal sickle shape.
Hydroxycarbamid udskilles i human mælk.
Hydroxycarbamide is excreted in human breast milk.
Studiet viste også en statistisk signifikant stigning i HbF og Hb og et fald i hæmolytiske markører i den gruppe, der fik hydroxycarbamid.
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.
Seglcelle-anæmi er en nedarvet blodsygdom, der påvirker de skiveformede røde blodlegemer i blodet.
Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Vend flasken til opret stilling, og fjern forsigtigt sprøjten fra adapteren ved at holde i sprøjtens krop, ikke i stemplet.
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.
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.
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.
Svær anæmi skal korrigeres med substitutionsbehandling med fuldblod, før behandling med hydroxycarbamid iværksættes.
Severe anaemia must be corrected with whole blood replacement before initiating therapy with hydroxycarbamide.
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:
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:
2 under "Xromi indeholder methylparahydroxybenzoat".
See section 2 “Xromi contains methyl parahydroxybenzoate”.
Advarsler og forsigtighedsregler
Warnings and precautions Test and checks
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Oral opløsning.
PHARMACEUTICAL FORM AND CONTENTS Oral solution.
Makrocytosen kan maskere eventuel udvikling af folinsyremangel, og derfor anbefales regelmæssig vurdering af folinsyre i serum.
The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended.
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.
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.