FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects in non-clinical studies were largely consistent with induced copper deficiency in the plasma and liver of previously copper normative animals and as such could be attributed to the pharmacological action of trientine.
Danish: Virkningerne i ikke-kliniske studier var stort set overensstemmende med induceret kobbermangel i plasma og lever hos tidligere kobbernormative dyr og kunne som sådan tilskrives trientins farmakologiske virkning.
English: In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
Danish: Hos hunde blev der observeret ataksi, rysten (tremor), unormal gang og underaktivitet efter administration at meget høje trientinniveauer.
English: Trientine is acetylated in two major 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: Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.
Danish: Cufence er et lægemiddel til behandling af Wilsons sygdom hos voksne, unge og børn i alderen 5 år og derover.
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: Eftersom kobber er nødvendigt for normal vækst og psykisk udvikling, kan dosisjusteringer være nødvendige for at sikre, at fosteret ikke kommer til at mangle kobber, og tæt overvågning af patienten er absolut nødvendig (se pkt.
English: Dose adjustment may be required (see section 4.2).
Danish: Dosisjustering kan være nødvendig (se pkt.
English: Non-clinical data reveal no special hazard for humans based on a series of studies investigating cardiovascular safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to embryofoetal development.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og embryo-føtal udviklingstoksicitet.
English: A large overdose of 40 g of trientine base resulted in selflimiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported.
Danish: En stor overdosering af 40 g trientin base førte til selvbegrænsende svimmelhed og opkastning uden rapportering om andre kliniske følgevirkninger eller signifikante biokemiske abnormaliteter.
English: Trientine has low human plasma protein binding and is widely distributed in tissues with relatively high concentrations measured in liver, heart, and kidney in the rat.
Danish: Trientin har en lav human plasmaproteinbinding og fordeles jævnt i væv med forholdsvis høje koncentrationer, målt i lever, hjerte og nyrer hos rotter.
English: In pregnant animals, high dose trientine associated with significant reductions in serum copper, revealed an early effect on embryo survival and a marginally lower foetal weight.
Danish: Hos drægtige dyr viste høje doser trientin med væsentlige reduktioner af kobber i serum en tidlig virkning på fostres overlevelse og en marginalt lavere fostervægt.
English: If you have any of the following side effects contact your doctor immediately: - Severe stomach pains - Persistent diarrhoea - Nervous system problems (for example shaking, lack of coordination, slurred speech, muscle stiffness, worsening of muscle spasms).
Danish: Hvis du får nogen af følgende bivirkninger, skal du øjeblikkeligt kontakte lægen: - Stærke mavesmerter - Vedvarende diarré - Problemer med nervesystemet (f.eks. rysten, manglende koordination, sløret tale, muskelstivhed,
English: Nervous system problems can occur (for example, shaking, lack of coordination, slurred speech, muscle stiffness and worsening of muscle spasms), especially in patients just starting treatment with Cufence.
Danish: Der kan forekomme problemer med nervesystemet (f.eks. rysten, manglende koordination, sløret tale, muskelstivhed og forværring af muskelspasmer), særligt hos patienter, som starter behandling med Cufence.
English: The recommended doses of Cufence are expressed as mg of trientine base (i.e. not in mg of the trientine dihydrochloride salt) (see section 4.4).
Danish: De anbefalede doser Cufence udtrykkes som mg trientin base (dvs. ikke i mg trientindihydrochloridsalt) (se pkt.
English: Concomitant oral iron or other heavy metals should be administred at a different time than trientine to prevent the formation of complexes (see section 4.4).
Danish: Samtidig oralt jern eller andre tungmetaller skal administreres på et andet tidspunkt end trientin for at forebygge dannelsen af komplekser (se pkt.
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 stor fjernelse af kobber kan overvåges ved hjælp af tal for kobberudskillelse i urinen og ikke-ceruloplasminbundet kobber.
English: Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Danish: Ikke almindelig: Dystoni Ikke almindelig: Tremor Ikke kendt: Dysartri Ikke kendt: Muskelstivhed Ikke kendt: Neurologisk forværring
English: The starting dose would usually correspond to the lowest recommended dose 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 anbefalede dosis i dosisområdet, og dosis bør efterfølgende tilpasses patientens kliniske respons (se pkt.
English: Factors to consider include the known risks associated with untreated or undertreated Wilson's disease, risks associated with the stage of disease, the risk of those alternative treatments which are available and the possible effects of trientine (see section 5.3).
Danish: Der skal bl.a. tages højde for kendte risici i forbindelse med ubehandlet eller underbehandlet Wilsons sygdom, risici i forbindelse med sygdomsfase, risikoen ved de tilgængelige alternative behandlinger og trientins mulige virkninger (se pkt.
English: MedDRA- system organ class database
Danish: Systemorganklasser i henhold til MedDRAdatabasen
English: Common: Nausea Not known: Colitis Not known: Duodenitis
Danish: Almindelig: Kvalme Ikke kendt: Kolitis Ikke kendt: Duodenitis
English: No fertility data are available but estrous cyclicity was unaffected and reproductive organs were not identified as target organs in general repeat dose toxicity studies.
Danish: Der foreligger ingen fertilitetsdata, men østralperioderne var upåvirkede, og reproduktionsorganerne blev ikke identificeret som målorganer i generelle toksicitetsstudier med gentagen dosering.
English: The main toxicological findings associated with trientine, which were generally seen across all species examined, included body weight loss or lower body weight gain, altered urinary electrolytes, low plasma copper levels and various histopathological changes in the lungs (mainly interstitial pneumonitis).
Danish: De vigtigste toksikologiske fund i forbindelse med trientin, der generelt blev set hos alle undersøgte arter, omfattede vægttab eller nedsat tilvækst, ændrede elektrolytter i urinen, lave kobberniveauer i plasma og forskellige histopatologiske ændringer i lungerne (fortrinsvis interstitial pneumonitis).
English: Trientine is not likely to have an effect on your ability to drive or use machines.
Danish: Trientin vil sandsynligvis ikke påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: No specific food interaction studies in humans have been performed with trientine.
Danish: Der er ikke udført specifikke interaktionsstudier med mad og trientin hos mennesker.
English: Cufence attaches to the copper, which is then passed from the body.
Danish: Cufence binder sig til kobberet, der derefter udskilles fra kroppen.
English: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Danish: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Tyskland
English: More frequent monitoring is advised during the initial phase of treatment and during phases of disease progression or when dose adjustments are made as to be decided by the treating physician (see section 4.2).
Danish: Hyppigere overvågning tilrådes i behandlingens indledende fase, under sygdomsprogression, eller når dosisjusteringerne foretages og besluttes af den behandlende læge (se pkt.
English: Trientine is a chelator with a polyamine-like structure and copper is chelated by forming a stable complex with the four constituent nitrogens in a planar ring.
Danish: Trientin er et chelatdannende middel med en polyaminlignende struktur, og kobber chelateres ved at danne et stabilt kompleks med de fire indgående nitrogener i en plan ring.
English: Trientine has no or negligible influence on the ability to drive and use machines.
Danish: Trientin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: No long term animal carcinogenicity trials have to date been performed with trientine via the oral route, but via the dermal route, there was no increases in cancers above baseline.
Danish: Der er indtil nu ikke udført langsigtede dyreforsøg af karcinogenicitet med trientin indtaget oralt, men dermalt var der ingen stigning i cancertilfælde i forhold til baseline.
English: However, up titration should be done with moderation and consideration, and adapted according to the patient's clinical response such as worsening of tremor as patients could be at risk of neurological deterioration at initiation of treatment (see section 4.4).
Danish: Optitrering skal dog foregå moderat, velovervejet samt tilpasset i forhold til patientens kliniske respons, såsom forværring af tremor, på grund af risikoen for neurologisk forværring hos patienter i forbindelse med iværksættelse af behandlingen (se pkt.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism, various alimentary tract and metabolism products, ATC code: A16AX12
Danish: Farmakoterapeutisk klassifikation: Div. midler til fordøjelsesorganer og stofskifte, ATC-kode: A16AX12
English: Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.
Danish: Spædbørn født af mødre i behandling med trientin bør overvåges for indholdet af kobber i serum og ceruloplasminniveauer, når det er relevant.
English: Dose adjustments in the trientine dose should be considered in case of signs of reduced efficacy such as (persistent) increase in liver enzymes, and worsening of tremor.
Danish: Dosisjusteringer af trientindosis skal overvejes ved tegn på nedsat virkning såsom (vedvarende) stigning i levertal og forværring af tremor.
English: Cufence contains the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body.
Danish: Cufence indeholder det aktive stof trientin, der er et kobber-chelatdannende stof, der bruges til at fjerne overskydende kobber fra kroppen.
English: There have been reports of neurological deterioration at the start of treatment in Wilson's disease patients treated with copper chelators including trientine, with symptoms of, for example, dystonia, rigidity, tremor and dysarthria (see section 4.2).
Danish: Der har været rapporter om neurologisk forværring i starten af behandlingen hos patienter med Wilsons sygdom, som behandles med kobberchelat, herunder trientin, med symptomer på f.eks. dystoni, stivhed, tremor og dysartri (se pkt.
English: The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Danish: Graviditeten bør overvåges tæt for at opdage evt. fostermisdannelse og for at vurdere den maternelle koncentration af kobber gennem hele graviditeten.
English: Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
Danish: Gul glasflaske med polypropylenhætte og varmeinduceret forseglingsindsats med en pose tørret silicagel som tørremiddel.
English: Your doctor will then help you decide whether to stop breast-feeding or to stop taking Cufence, considering the benefit of breast-feeding to the baby and the benefit of Cufence 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 Cufence, ud fra fordelen ved amning for barnet og fordelen ved Cufence for dig.
English: It is important that Cufence is given on an empty stomach, at least one hour before meals or two hours after meals, and at least one hour apart from any other medicinal product, food or milk (see section 4.5).
Danish: Det er vigtigt, at Cufence gives på tom mave mindst én time før et måltid eller mindst to timer efter et måltid, og mindst én time før eller efter ethvert andet lægemiddel, mad eller mælk (se pkt.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to
Danish: Hyppigheder er defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden
English: Contents of the pack and other information What Cufence contains
Danish: Pakningsstørrelser og yderligere oplysninger Cufence indeholder:
English: Trientine dihydrochloride is a known irritant, especially to mucus membranes, upper respiratory tract and skin, and induces skin sensitisation in guinea pigs, mice and man (OECD SIDS triethylenetetramine 2002).
Danish: Trientindihydrochlorid er et kendt lokalirriterende stof, især for slimhinder, øvre luftveje og hud, og inducerer hudsensibilisering hos marsvin, mus og mennesker (OECD SIDS triethylenetetramin 2002).
English: Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
Danish: Propylenglykol Titandioxid (E171) Sort jernoxid (E 172) Gul jernoxid (E172)
English: Not known: Lupus-like syndrome
Danish: Ikke kendt: Lupuslignende syndrom
English: Patients receiving Cufence should remain under regular medical supervision and be monitored using all available clinical data for appropriate control of clinical symptoms and copper levels in order to optimise treatment.
Danish: Patienter, som får Cufence, skal være under regelmæssigt lægeligt opsyn og overvåges ved hjælp af alle tilgængelige kliniske data med henblik på tilstrækkelig kontrol af kliniske symptomer og kobberkoncentrationer for at optimere behandlingen.
English: Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Danish: Hver hård kapsel er hvid, oval, størrelse 0 med Cufence 200 trykt med gråt blæk.
English: Nausea can commonly occur on initial treatment and occasionally skin rash can occur.
Danish: Der kan ofte forekomme kvalme i den indledende behandling, og der kan undertiden forekomme hududslæt.
English: The measurement of copper excretion in the urine may be performed during therapy.
Danish: Kobberudskillelsen i urinen kan måles under behandlingen.
English: Trientine is a copper-selective chelator that enhances systemic elimination of divalent copper by forming a stable complex that is readily excreted by the kidneys.
Danish: Trientin er et kobber-chelatdannende middel, der forstærker systemisk eliminering af divalent kobber ved at danne et stabilt kompleks, der problemfrit udskilles af nyrerne.
English: In general, dose selection should be cautious, usually starting at the low end of the dosing range as recommended for adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Danish: I forbindelse med dosisvalg anbefales det generelt at udvise forsigtighed og begynde i den lave ende af det dosisinterval, der anbefales, og tage højde for den øgede hyppighed af nedsat lever-, nyre- eller hjertefunktion, og af ledsagesygdom eller anden lægemiddelbehandling.
English: Pack size: 1 bottle of 100 hard capsules.
Danish: Pakningsstørrelser: 1 flaske med 100 hårde kapsler.
English: Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, antageligt som følge af trientin-induceret kobbermangel (se pkt.
English: If you forget to take Cufence
Danish: Hvis du har glemt at tage Cufence
English: After first opening the bottle: 3 months.
Danish: Efter anbrud: 3 måneder.
English: The combination of trientine with zinc is not recommended.
Danish: Det frarådes at kombinere trientin med zink.
English: Concomitant oral iron should be administred at a different time than trientine (see section 4.5).
Danish: Samtidig oralt jern skal administreres på et andet tidspunkt end trientin (se pkt.
English: There is limited information in patients with renal impairment.
Danish: Der er begrænsede oplysninger om patienter med nedsat nyrefunktion.
English: The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Danish: Trientindosis bør justeres for at holde koncentrationen af kobber i serum inden for normalområdet.
English: If you stop taking Cufence
Danish: Hvis du holder op med at tage Cufence
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, som tidligere er blevet behandlet med D-Penicillamin, er der rapporteret lupuslignende reaktioner under efterfølgende behandling med trientin.
English: No interaction studies have been performed on the concomitant administration of trientine with DPenicillamine.
Danish: Andre anti-kobberpræparater Der er ikke udført interaktionsstudier med samtidig administration af trientin og D-penicillamin.
English: White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
Danish: Hvid, oval kapsel i størrelse 0 påtrykt "Cufence 200" med gråt blæk.
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: Lupuslignende reaktioner (symptomer kan omfatte vedvarende hududslæt, feber, ledsmerter og træthed) er rapporteret hos nogle patienter, som er gået over til et lægemiddel, der indeholder trientin efter brug af et lægemiddel, der indeholder penicillamin.
English: Trientine has been found to reduce serum iron levels.
Danish: Trientin har vist sig at reducere jernniveauer i serum.
English: Pack size: one bottle of 100 hard capsules.
Danish: Pakningsstørrelser: En flaske med 100 hårde kapsler.
English: Each capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.
Danish: Hver kapsel indeholder 300 mg trientindihydrochlorid svarende til 200 mg trientin.
English: The principal mechanism of action of trientine requires its systemic exposure (see section 5.1) so it is recommended that trientine be taken at least 1 hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk to allow for maximum absorption and reduce the likelihood of the formation of complexes by metal binding in the gastrointestinal tract (see section 4.2).
Danish: 5.1), og det anbefales derfor, at trientin tages mindst 1 time før et måltid eller 2 timer efter et måltid, og mindst 1 time før eller efter ethvert andet lægemiddel, mad eller mælk for at tillade maksimal absorption og reducere sandsynligheden for dannelse af komplekser ved metalbinding i mave-tarm-kanalen (se pkt.
English: It is further advised to monitor patients presenting with neurological symptoms every one to two weeks after initiation of treatment with Cufence until target dose is reached.
Danish: Patienter med neurologiske symptomer bør desuden monitoreres hver eller hver anden uge efter iværksættelse af behandling med Cufence, indtil måldosis er nået.
English: Like with all anti-copper agents, overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women (see section 4.6) since copper is required for proper growth and mental development.
Danish: Som med alle anti-kobberpræparater kan overbehandling medføre en risiko for kobbermangel, der især er skadelig for børn og gravide kvinder (se pkt.
English: Each hard capsule contains 300 mg trientine dihydrochloride equivalent to 200 mg trientine.
Danish: Hver hårde kapsel indeholder 300 mg trientindihydrochlorid svarende til 200 mg trientin.
English: Package leaflet: Information for the patient Cufence 200 mg hard capsules trientine
Danish: Indlægsseddel: Information til patienten Cufence 200 mg hårde kapsler trientin
English: Thus, the pharmacodynamic action of trientine is dependent on its chemical property of chelating copper and not on its interaction with receptors, enzyme systems or any other biological system that might differ between species.
Danish: Trientins farmakodynamiske virkning afhænger dermed af dens kemiske evne til at chelatere kobber og ikke af dens interaktion med receptorer, enzymsystemer eller andet biologisk system, der kan være forskellige fra art til art. Trientin kan også chelatere kobber i tarmkanalen og dermed hæmme absorptionen af kobber.
English: Although there is no evidence that calcium and magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration (see section 4.4).
Danish: Selvom der ikke er evidens for, at calcium- og magnesiumantacida ændrer trientins virkning, anses det som god praksis at give dem på forskellige tidspunkter (se pkt.
English: Trientine is a chelating agent which has been found to reduce serum iron levels.
Danish: Trientin er et chelatdannende middel, der er fundet at nedsætte indholdet af jern i serum.
English: The trientine dose may also be reduced in case of side effects of trientine, such as gastrointestinal complaints and haematological changes.
Danish: Når trientindosis justeres, skal det ske i små trin. Trientindosis kan også reduceres, hvis der opstår bivirkninger ved trientin såsom gastrointestinale problemer og hæmatologiske ændringer.
English: It is advised, however, to monitor patients presenting with hepatic symptoms every two to three weeks after initiation of treatment with Cufence.
Danish: Patienter primært med leversymptomer bør dog monitoreres hver anden til tredje uge efter iværksættelse af behandling med Cufence.
English: Patients with renal and/or hepatic impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Danish: Patienter, der har nedsat nyre- og/eller leverfunktion og er i behandling med trientin, skal fortsat være under regelmæssigt lægeligt opsyn for at kontrollere symptomer og kobberniveauer tilstrækkeligt.
English: These effects were observed only at exposures sufficiently in excess of maximum human exposure to indicate little relevance to clinical use.
Danish: Disse virkninger blev kun set efter doser, der i væsentlig grad overstiger den maksimale humane eksponering.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from trientine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med trientin seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.