FrancophonIA/ELRC3.0 huggingface dataset:
English: When your baby is born, the copper level in the baby's blood will also be monitored.
Danish: Når du har født dit barn, vil kobberindholdet i barnets blod ligeledes blive overvåget.
English: It is very important to continue treatment to reduce copper during pregnancy.
Danish: Det er meget vigtigt at fortsætte behandlingen for at nedsætte kobberkoncentrationen under graviditeten.
English: If this happens, you must tell your doctor.
Danish: Hvis det sker, skal du kontakte til lægen.
English: Distribution Little is known on the distribution of trientine in organs and tissues.
Danish: Fordeling Der er meget lidt kendskab til fordelingen af trientin i organer og væv.
English: The trientine plasma concentration then declined in a multiphasic manner, initially rapidly, followed by a slower elimination phase.
Danish: Plasmakoncentrationen af trientin aftog derefter multifasisk, først hurtigt, derefter i en langsommere eliminationsfase.
English: Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could still be detected in the plasma after 20 hours.
Danish: Trientin og dets metabolitter udskilles hurtigt i urinen, skønt der stadig kunne påvises lave koncentrationer af trientin i plasma efter 20 timer.
English: Children aged < 5 years
Danish: Børn < 5 år
English: Factors which need to be born in mind include the risks associated with the disease itself, the risk of those alternative treatments which are available and the possible teratogenic effects of trientine (see section 5.3).
Danish: Faktorer, der bør tages i betragtning, er risiciene forbundet med selve sygdommen, risiciene ved de tilgængelige andre behandlingsmuligheder, samt de mulige teratogene virkninger af trientin (se pkt.
English: The most reliable index for monitoring therapy is the determination of serum free copper which is calculated using the difference between the total copper and the ceruloplasmin-bound copper (normal level of free copper in the serum is usually 100 to 150 microgram/L).
Danish: Det mest pålidelige indeks til overvågning af behandlingen er bestemmelse af frit kobber i serum, der beregnes som differencen mellem totalt kobber og ceruloplasmin-bundet kobber (det normale indhold af frit kobber i serum er 100-150 µg/l).
English: The film-coated tablets should be swallowed with water.
Danish: De filmovertrukne tabletter synkes med vand.
English: Overtreatment carries the risk of copper deficiency.
Danish: Overbehandling medfører risiko for kobbermangel.
English: In vivo, trientine was however negative in the mouse micronucleus test.
Danish: In vivo var trientin imidlertid negativ ved micronucleus-testen i mus.
English: Linearity/non-linearity Plasma exposures in humans have shown a linear relationship with oral doses of trientine.
Danish: Linearitet/ikke-linearitet Plasmaeksponeringen hos mennesker har vist lineær sammenhæng med orale doser af trientin.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Cuprior.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Cuprior.
English: You can find the information also when flashing the QR code below with a smartphone or via the website QR code to be included http://www.cuprior.com
Danish: Du kan også finde oplysningerne ved at aflæse nedenstående QR-kode med en smartphone, eller gennem webstedet QR code to be included http://www.cuprior.com
English: Iron supplements may be necessary in case of iron deficiency anaemia and should be administered at a different time (see section 4.5).
Danish: Jerntilskud kan være nødvendigt i tilfælde af jernmangelanæmi og bør administreres på et andet tidspunkt (se pkt.
English: If you take these medicines you may need to take Cuprior at a different time in the day because otherwise Cuprior may not be as effective.
Danish: Hvis du får sådanne lægemidler, er du måske nødt til at tage Cuprior på et andet tidspunkt af dagen, da Cuprior måske ellers ikke er så effektivt.
English: The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).
Danish: De anbefalede doser af Cuprior er angivet i mg trientin base (dvs. ikke i mg trientintetrahydrochloridsalt).
English: The aim of maintenance treatment is to maintain free copper levels in the serum within acceptable limits.
Danish: Formålet med vedligeholdelsesbehandlingen er at holde koncentrationen af frit kobber i serum inden for acceptable grænser.
English: Since iron and trientine may inhibit absorption of each other, iron supplements should be taken after at least two hours have elapsed from the administration of trientine.
Danish: Da jern og trientin kan hæmme absorptionen af hinanden, bør jerntilskud tages mindst to timer efter administration af trientin.
English: The starting dose in paediatrics is lower than for adults and depends on age and body weight.
Danish: Startdosis hos pædiatriske patienter er lavere end hos voksne og afhænger af alder og legemsvægt.
English: You should tell your doctor if you get any side effects as this may indicate that your dose of Cuprior needs to be adjusted up or down.
Danish: Du skal kontakte lægen, hvis du får bivirkninger, da det kan være tegn på, at din dosis af Cuprior behøver justeres op eller ned.
English: Package leaflet online at QR code to be included http://www.cuprior.com Oral use.
Danish: Online indlægsseddel på QR code to be included http://www.cuprior.com Oral anvendelse.
English: However, no food interaction studies have been performed and so the extent of the food effect on systemic trientine exposure is unknown.
Danish: Der er imidlertid ikke foretaget undersøgelser af interaktion med fødeindtagelse, hvorfor størrelsen af fødeindtagelsens virkning på den systemiske eksponering for trientin ikke kendes.
English: Cuprior is a medicine used to treat Wilson's disease that contains the active substance trientine.
Danish: Cuprior er et lægemiddel til behandling af Wilsons sygdom og indeholder det aktive stof trientin.
English: Wilson's disease is an inherited condition in which the body cannot transport copper around the body in the normal way or remove copper in the normal way as a secretion from the liver into the gut.
Danish: Wilsons sygdom er en arvelig sygdom, hvor kroppen ikke kan transportere kobber rundt i organismen på normal måde eller fjerne kobber på normal måde ved at udskille det fra leveren til tarmen.
English: In patients who were previously treated with D-penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Danish: Hos patienter, der tidligere er behandlet med D-penicillamin, er indberettet lupuslignende reaktioner under efterfølgende behandling med trientin, men det kan ikke fastslås, om der er årsagssammenhæng med trientin.
English: Serious iron deficiency anaemia and severe colitis may occur during treatment.
Danish: Der kan opstå alvorlig jernmangelanæmi og svær colitis under behandlingen.
English: If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.
Danish: Hvis du er gravid og får Cuprior, vil du blive overvåget gennem hele graviditeten med hensyn til eventuel påvirkning af barnet og ændringer i din kobberværdi.
English: Talc.
Danish: Talcum.
English: Close monitoring is required to optimise the dose or to adapt treatment if necessary.
Danish: Der kræves tæt overvågning for at optimere dosis eller om nødvendigt tilpasse behandlingen.
English: Glycerol dibehenate.
Danish: Glyceroldibehenat.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (forekommer hos op til 1 ud af 10 personer):
English: Do not take Cuprior If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Cuprior hvis du er allergisk over for trientin eller et af de øvrige indholdsstoffer i Cuprior (angivet i afsnit 6).
English: It is not known if Cuprior can pass into breast milk.
Danish: Det vides ikke, om Cuprior kan gå over i modermælken.
English: Tablets can be divided in half if needed.
Danish: Tabletten kan om nødvendigt deles i to halvdele.
English: The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 600 mg and 750 mg trientine in healthy male and female subjects.
Danish: Den farmakokinetiske profil af Cuprior er vurderet efter en oral enkeltdosis på 450, 600 og 750 mg trientin til raske mandlige og kvindelige forsøgspersoner.
English: PC: {number} SN: {number} NN: {number}
Danish: SN (serienummer): {nummer}
English: There is no antidote for trientine acute overdose.
Danish: Der er ingen modgift mod akut overdosering med trientin.
English: The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4).
Danish: Startdosis vil sædvanligvis svare til den laveste dosis i dosisområdet, og dosis bør efterfølgende tilpasses patientens kliniske respons (se pkt.
English: Plasma levels of trientine rose rapidly following administration with the median peak level reached after 1.25 to 2 hours.
Danish: Plasmaindholdet af trientin steg hurtigt efter administrationen, og den mediane maksimalkoncentration blev nået efter 1,25-2 timer.
English: Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
Danish: Cuprior er indiceret til behandling af Wilsons sygdom hos voksne, unge og børn ≥ 5 år, der ikke tåler behandling med D-penicillamin.
English: The safety and efficacy of trientine in children aged < 5 years have not been established.
Danish: Trientins sikkerhed og virkning hos børn < 5 år er ikke klarlagt.
English: The measurement of copper excretion in the urine may be performed during therapy.
Danish: Måling af udskillelsen af kobber i urinen kan foretages under behandlingen.
English: Once you have started the treatment, your doctor may adjust the dose based on the response to treatment.
Danish: Efter at du er begyndt på behandlingen, vil lægen måske tilpasse dosis afhængigt af reaktionen på behandlingen.
English: The scored filmcoated tablet can be divided in two equal halves, if required, to provide a more precise dose or facilitate administration.
Danish: Den filmovertrukne tablet kan ved hjælp af delekærven deles i to lige store halvdele for at give en mere nøjagtig dosis eller lette administrationen.
English: Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion.
Danish: Trientin er et kobber-chelatdannende middel, hvis hovedvirkningsmekanisme er at udskille absorberet kobber fra kroppen ved at danne et stabilt kompleks, der derefter udskilles gennem urinen.
English: Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration.
Danish: Skønt der ikke er evidens for, at antacida af calcium- eller magnesiumtypen ændrer virkningen af trientin, må det anses for god praksis at undgå samtidig administration.
English: Repeat dose toxicity
Danish: Toksicitet ved gentagen dosering
English: It may also attach to copper in the gut and so reduce the amount taken up into the body.
Danish: Det kan desuden bindes til kobber i tarmen og derved mindske den mængde, der optages i kroppen.
English: Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test and genotoxicity tests in mammalian cells.
Danish: Overordnet har trientin givet positiv reaktion ved in vitro-genotoksicitetsundersøgelser, herunder Ames test og genotoksicitetstests i pattedyrceller.
English: This daily total will be divided into 2 to 4 smaller doses to be taken during the day.
Danish: Den totale dagsdosis fordeles på 2-4 mindre doser, der tages i løbet af dagen.
English: If you have kidney problems, your doctor will regularly check that the treatment dose is appropriate and does not affect the functioning of your kidney.
Danish: Hvis du har nyreproblemer, vil lægen regelmæssigt kontrollere, at behandlingsdosis er passende og ikke påvirker din nyrefunktion.
English: Uncommon: skin rash, pruritus, erythema.
Danish: Ikke almindelig: udslæt, pruritus, erytem.
English: Your doctor will carry out checks more frequently to ensure your copper levels are maintained at a suitable level for normal growth and mental development.
Danish: Lægen vil oftere foretage undersøgelser for at sikre, at din koncentration af kobber holdes på et passende niveau med henblik på normal vækst og mental udvikling.
English: If you were already taking another trientine medicine, your doctor may modify your daily dose, the number of tablets or the number of intake in the day when switching to Cuprior treatment.
Danish: Hvis du i forvejen er i behandling med et andet lægemiddel med trientin, vil din læge måske ændre din daglige dosis, antallet af tabletter eller det antal gange, du dagligt indtager dem, når du skifter til behandling med Cuprior.
English: Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) and sodium laurilsulfate
Danish: Tablettens filmovertræk: polyvinylalkohol, talcum, titandioxid (E171), glycerolmonocaprylocaprat (Type I), gul jernoxid (E172) og natriumlaurilsulfat
English: This medicine may also reduce the level of iron in your blood and your doctor may prescribe iron supplements (see section “Other medicines and Cuprior” below).
Danish: Dette lægemiddel kan desuden nedsætte indholdet af jern i blodet, og lægen vil måske ordinere jerntilskud (se afsnittet "Brug af anden medicin sammen med Cuprior" nedenfor).
English: Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Danish: Trientin acetyleres til de to hovedmetabolitter N(1)-acetyltriethylentetramin (MAT) og N(1),N(10)diacetyltriethylentetramin (DAT).
English: The NOAEL was established at approximately 92 mg/kg/day for males and 99 mg/kg/day for females.
Danish: NOAEL-værdien blev bestemt til ca. 92 mg/kg/dag for handyr og 99 mg/kg/dag for hundyr.
English: The following adverse reactions have been reported with the use of trientine for Wilson's disease.
Danish: Følgende bivirkninger er indberettet i forbindelse med brug af trientin mod Wilsons sygdom.
English: Cuprior has no or negligible influence on the ability to drive and use machines.
Danish: Cuprior påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: In silico data predict that trientine displays irritating and sensitising properties.
Danish: In silico-data forudsiger, at trientin har irriterende og sensibiliserende egenskaber.
English: What you need to know before you take Cuprior 3.
Danish: Det skal du vide, før du begynder at tage Cuprior 3.
English: MAT may also participate to the overall clinical activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels remains to be determined.
Danish: MAT bidrager muligvis også til den overordnede kliniske aktivitet af Cuprior, men størrelsen af dette bidrag til den samlede virkning af Cuprior på koncentrationen af kobber er endnu ikke fastlagt.
English: Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of chelation therapy due to excess of free serum copper during the initial response to treatment.
Danish: I begyndelsen af chelatbehandlingen kan de kliniske symptomer, herunder neurologiske, forværres pga. overskuddet af frit kobber i serum under den initiale respons på behandlingen.
English: Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron supplements may be required.
Danish: Det er fundet eksempler på, at Trientin kan nedsætte jernindholdet i serum, muligvis ved at nedsætte absorptionen, og jerntilskud kan være nødvendigt.
English: The microscopic changes in lung were considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells.
Danish: De mikroskopiske forandringer i lungerne ansås for at tyde på en persisterende inflammatorisk reaktion eller persisterende toksisk påvirkning af alveolecellerne.
English: This maximises the absorption of trientine and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract.
Danish: Dette maksimerer absorptionen af trientin og mindsker sandsynligheden for, at lægemidlet bindes til metaller i mave-tarmkanalen.
English: Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
Danish: Overbehandling og for stærk fjernelse af kobber kan overvåges ved hjælp af tal for kobberudskillelsen i urinen og for ikke-ceruloplasminbundet kobber.
English: Sodium laurilsulfate.
Danish: Natriumlaurilsulfat
English: When switching a patient from another formulation trientine, caution is advised because doses expressed in trientine base may not be equivalent (see section 4.2).
Danish: Når en patient skiftes fra en anden formulering af trientin, tilrådes forsigtighed, da doser angivet som trientin base ikke nødvendigvis er ækvivalente (se pkt.
English: Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.
Danish: Kronisk overdosering kan medføre kobbermangel og reversibel sideroblastisk anæmi.
English: Since chelation therapy leads to an increase in urinary copper levels, this may/will not give an accurate reflection of the excess copper load in the body but may be a useful measure of treatment compliance.
Danish: Da chelatbehandling medfører en stigning i indholdet af kobber i urinen, afspejler dette ikke nødvendigvis nøjagtigt overskuddet af kobber i kroppen, men kan være et nyttigt mål for kompliansen med behandlingen.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (forekommer hos op til 1 ud af 100 personer):
English: These effects are possibly due to trientine induced-copper and zinc deficiency.
Danish: Disse effekter skyldes muligvis trientin-induceret kobber- og zinkmangel.
English: Positive results for sensitization potential in Guinea pig maximization tests were reported.
Danish: Der blev beskrevet positive resultater for sensibiliseringspotentialet ved maksimeringstests på marsvin.
English: Babies born to mothers being treated with trientine should be monitored for serum copper levels where appropriate.
Danish: Spædbørn født af mødre i behandling med trientin bør overvåges for indholdet af kobber i serum, når det er hensigtsmæssigt.
English: Since copper is required for proper growth and mental development, dose adjustments may be required to ensure that the foetus will not become copper deficient and close monitoring of the patient is essential (see section 4.4).
Danish: Da kobber behøves til normal vækst og mental udvikling, kan det være nødvendigt med dosisjusteringer for at sikre, at fosteret ikke kommer til at mangle kobber, og tæt overvågning af patienten er afgørende nødvendig (se pkt.
English: Your doctor will regularly check your blood and urine to ensure that you receive the right dose of Cuprior to properly control your symptoms and copper levels.
Danish: Lægen vil regelmæssigt kontrollere dit blod og din urin for at sikre, at du får en passende dosis af Cuprior til at kontrollere dine symptomer og din kobberkoncentration.
English: Dogs receiving oral doses of trientine up to 300 mg/kg/day, showed neurological and/or musculo-skeletal clinical symptoms (abnormal gait, ataxia, weak limbs, body tremors) in repeat-dose toxicity studies, attributed to the copper-depleting activity of trientine.
Danish: Hunde, der fik orale doser af trientin op til 300 mg/kg/dag, udviste neurologiske og/eller muskuloskeletale kliniske symptomer (abnorm gang, ataksi, svage lemmer, tremor) i toksicitetsundersøgelser med gentagen dosering, hvilket blev tillagt trientins kobberdepleterende virkning.
English: Cuprior is available in packs containing 72 or 96 film-coated tablets.
Danish: Cuprior fås i pakninger med 72 eller 96 filmovertrukne tabletter.
English: The most commonly reported adverse reaction with trientine is nausea.
Danish: Den hyppigst indberettede bivirkning med trientin er kvalme.
English: The overall pharmacokinetic profiles were similar between males and females, although males had higher levels of trientine.
Danish: Den overordnede farmakokinetiske profil var den samme hos mænd og kvinder, dog var koncentrationen af trientin højere hos mænd.
English: Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Danish: Der er beskrevet lupuslignende reaktioner (med symptomer, der kan bestå i vedholdende udslæt, feber, ledsmerter og træthed) hos nogle patienter, som har skiftet til lægemidler indeholdende trientin efter at have fået penicillamin.
English: If you take iron supplements, take them at least two hours after taking a dose of Cuprior.
Danish: Hvis du tager jerntilskud, skal du tage det mindst to timer efter at have taget en dosis af Cuprior.
English: Not known: iron deficiency anaemia.
Danish: Ikke kendt: jernmangelanæmi
English: Cuprior is given to adults, adolescents and children aged 5 years and over who cannot tolerate another medicine that is used to treat this disease, called penicillamine.
Danish: Cuprior gives til voksne og børn over 5 år, som ikke tåler et andet lægemiddel (penicillamin), der anvendes til behandling af sygdommen.
English: This medicine is not recommended for children aged below 5 years of age.
Danish: Det frarådes at anvende lægemidlet til børn under 5 år.
English: Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Danish: Dyreundersøgelser har vist reproduktionstoksicitet, antagelig som følge af kobbermangel, der er induceret af trientin (se pkt.
English: In adults of all ages, the recommended total daily dose is 3 to 6½ tablets per day (making a total of between 450 and 975 mg).
Danish: Hos voksne i alle aldre er den anbefalede totale dagsdosis 3 til 6½ tabletter (svarende til i alt mellem 450 og 975 mg).
English: The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Danish: Dosis af trientin bør justeres for at holde koncentrationen af kobber i serum inden for normalområdet.
English: 96 film-coated tablets
Danish: 96 filmovertrukne tabletter
English: Your doctor will then help you decide whether to stop breast-feeding or to stop taking Cuprior, considering the benefit of breast-feeding to the baby and the benefit of Cuprior to the mother.
Danish: Lægen vil så hjælpe dig med at afgøre, om du skal holde op med at amme eller holde op med at tage Cuprior, ud fra fordelen ved amning for barnet og fordelen ved Cuprior for dig.
English: What Cuprior contains
Danish: Cuprior indeholder:
English: Close monitoring of renal function is also recommended in these patients (see section 4.2).
Danish: Desuden tilrådes tæt overvågning af nyrefunktionen hos disse patienter (se pkt.
English: No specific dose adjustment is required in these patients (see section 4.4).
Danish: Der behøves ikke særlig dosisjustering hos disse patienter (se pkt.
English: 72 film-coated tablets
Danish: 72 filmovertrukne tabletter
English: Patients receiving Cuprior should remain under regular medical supervision and be monitored for appropriate control of symptoms and copper levels in order to optimise the dose (see section 4.2).
Danish: Patienter, der får Cuprior, skal være under regelmæssig lægeligt opsyn og skal overvåges med henblik på tilstrækkelig kontrol af symptomer og kobberkoncentration for at optimere dosis (se pkt.
English: Pack size: 72 or 96 film-coated tablets.
Danish: Pakningsstørrelse: 72 eller 96 filmovertrukne tabletter.