natgillin/translations-raw huggingface dataset:
Hvis du er gravid og tager Cufence, vil du blive overvåget gennem hele graviditeten med hensyn til eventuel påvirkning af barnet eller ændringer i dine kobberniveauer.
If you are pregnant and taking Cufence, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.
Trientindoserne skal reduceres til en mere tolererbar dosis og kan øges igen, når bivirkningerne er forsvundet.
Trientine doses should be reduced to a more tolerable dose and may be increased again, once side effects have been resolved.
Der er utilstrækkelige data til at underbygge samtidig brug af zink og trientin.
There are insufficient data to support the concomitant use of zinc and trientine.
Der er rapporteret duodenitis og svær kolitis.
Duodenitis and severe colitis have been reported.
Dette tyder på en reduceret karcinogen risiko for patienter med Wilsons sygdom som følge af behandling med trientin.
This suggests a reduced carcinogenic risk for Wilson's disease patients as a result of trientine therapy.
Trientin metaboliseres ved acetylering via spermidin/spermin N-acetyltransferase og ikke via N-acetyltransferase 2.
Trientine is metabolised by acetylation via spermidine/spermine N-acetyltransferase and not via N-acetyltransferase 2.
Kapslerne skal synkes hele med et glas vand på tom mave mindst 1 time før eller 2 timer efter et måltid.
Swallow the capsules whole with a drink of water on an empty stomach, at least 1 hour before or 2 hours after food.
Kronisk overbehandling kan medføre kobbermangel og reversibel sideroblastisk anæmi.
Chronic overtreatment can lead to copper deficiency and reversible sideroblastic anaemia.
Der var ikke evidens for embryoføtal toksicitet ved lavere dosisniveauer trods dosisrelaterede reduktioner i kobber i serum.
There was no evidence of embryo-foetal toxicity at lower dose levels despite dose-related reductions in serum copper.
Der har været rapporteret lejlighedsvise tilfælde af overdosering med trientin.
Occasional cases of trientine overdose have been reported.
Tegn på en allergisk reaktion omfatter hududslæt, kløe, hævelse i ansigtet, besvimelse og vejrtrækningsproblemer.
Signs of an allergic reaction include rash, itching, swelling of the face, fainting and breathing problems.
Der blev også identificeret visse funktionelle neurologiske abnormiteter, særligt hos svært ramte dyr.
Some functional neurological abnormalities were also identified, particularly in severly affected animals, however no associated nerve damage was observed.
Hvis behandling med trientin skal fortsættes efter en risk-benefit-analyse, skal det overvejes at reducere trientindosis til den laveste effektive dosis og overvåge komplians med behandlingsregimet.
If treatment with trientine is to be continued following a risk-benefit analysis, consideration should be given to reducing the dose of trientine to the lowest effective dose and monitoring compliance with the treatment regimen.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - Hududslæt - Anæmi (du kan føle dig usædvanlig træt)
Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
Eftersom chelatbehandling øger niveauet af kobber i urinen, kan/vil dette ikke præcist afspejle overskuddet af kobber i kroppen, men det kan være et brugbart mål for behandlingskomplians.
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.
Neurologiske symptomer kan forværres i begyndelsen af chelatbehandlingen på grund af overskuddet af frit kobber i serum i den initiale respons på behandlingen.
Worsening of neurological symptoms may occur at the beginning of chelation therapy due to excess of free serum copper during the initial response to treatment.
Trientin bør kun anvendes ved graviditet efter nøje afvejning af fordelene i forhold til risiciene ved at afbryde behandlingen hos den enkelte patient.
Trientine should be used in pregnancy only after careful consideration of the benefits compared with the risks of discontinuing treatment in the individual patient.
I tilfælde af overdosering skal patienten overvåges, passende biokemisk analyse udføres, og symptomatisk behandling gives.
In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
Tæt overvågning er nødvendig for at optimere dosis eller tilpasse behandlingen, hvis det er nødvendigt (se pkt.
Close monitoring is required to optimise the dose or adapt treatment if necessary (see section 4.4).
Brugen af passende målintervaller for kobberparametre er beskrevet i de kliniske retningslinjer for Wilsons sygdom.
The use of appropriate copper parameter target ranges is described in clinical practice guidelines related to Wilson's disease.
Undgå at spise eller drikke i 1 time før eller 2 timer, efter du tager Cufence.
Avoid eating or drinking for 1 hour before, or 2 hours after taking Cufence.
Formålet med vedligeholdelsesbehandlingen er at holde niveauet af frit kobber i plasma (også kaldet ikke-ceruloplasmin plasmakobber) og udskillelsen af kobber i urinen inden for acceptable grænser som anført nedenfor.
The aim of maintenance treatment is to maintain free copper levels in plasma (also known as nonceruloplasmin plasma copper) and the urinary copper excretion within the acceptable limits.
Tidsfrist indeholde et PK/PD-delstudie for at vurdere forholdet mellem dosis og respons, især under optitreringsfasen.
The study will also contain a PK/PD sub-study to evaluate the doseresponse relationship especially during the up-titration phase.
Zink
Zinc
Hvis du tager jerntabletter eller mavesyreneutraliserende lægemidler, skal der gå mindst 2 timer, før eller efter du har taget Cufence, fordi de kan nedsætte virkningen af Cufence.
If you are taking iron tablets or medicines that neutralise the acid in your stomach, leave at least 2 hours before or after you have taken Cufence because they may reduce Cufence's effect.
Desuden anbefales tæt overvågning af nyre- og/eller leverfunktionen hos disse patienter (se pkt.
Close monitoring of renal and/or liver function is also recommended in these patients (see section 4.2).
Lægen vil afgøre, hvilken behandling og hvilken dosis der er bedst i din situation.
Your doctor will decide which treatment and which dose is best in your situation.
- Aktivt stof: trientin.
- The active substance is trientine.
Lægen vil rådgive dig om, hvilken behandling og hvilken dosis der er bedst i din situation.
Your doctor will advise you which treatment and which dose is best in your situation.
Det frarådes at kombinere trientin med zink på grund af zinks sandsynlige interaktion med trientin, hvorved effekten af begge aktive stoffer reduceres.
The combination of trientine with zinc is not recommended as interaction of zinc with trientine is likely, thereby reducing the effect of both active substances.
Der er begrænsede kliniske data, der tyder på, at trientin ikke udskilles i modermælk.
There is limited clinical data suggesting that trientine is not excreted in breast milk.
Lægen skal eventuelt justere din dosis af Cufence op eller ned.
The doctor may need to increase or decrease your dose of Cufence.
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.
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.
Hos hunde blev der observeret ataksi, rysten (tremor), unormal gang og underaktivitet efter administration at meget høje trientinniveauer.
In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
Trientin acetyleres til de to hovedmetabolitter N(1)-acetyltriethylentetramin (MAT) og N(1),N(10)-diacetyltriethylentetramin (DAT).
Trientine is acetylated in two major metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Cufence er et lægemiddel til behandling af Wilsons sygdom hos voksne, unge og børn i alderen 5 år og derover.
Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.
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.
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)
Dosisjustering kan være nødvendig (se pkt.
Dose adjustment may be required (see section 4.2).
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.
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.
En stor overdosering af 40 g trientin base førte til selvbegrænsende svimmelhed og opkastning uden rapportering om andre kliniske følgevirkninger eller signifikante biokemiske abnormaliteter.
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.
Trientin har en lav human plasmaproteinbinding og fordeles jævnt i væv med forholdsvis høje koncentrationer, målt i lever, hjerte og nyrer hos rotter.
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.
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.
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.
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,
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).
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.
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.
De anbefalede doser Cufence udtrykkes som mg trientin base (dvs. ikke i mg trientindihydrochloridsalt) (se pkt.
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).
Samtidig oralt jern eller andre tungmetaller skal administreres på et andet tidspunkt end trientin for at forebygge dannelsen af komplekser (se pkt.
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).
Overbehandling og for stor fjernelse af kobber kan overvåges ved hjælp af tal for kobberudskillelse i urinen og ikke-ceruloplasminbundet kobber.
Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
Ikke almindelig: Dystoni Ikke almindelig: Tremor Ikke kendt: Dysartri Ikke kendt: Muskelstivhed Ikke kendt: Neurologisk forværring
Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Startdosis vil sædvanligvis svare til den laveste anbefalede dosis i dosisområdet, og dosis bør efterfølgende tilpasses patientens kliniske respons (se pkt.
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).
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.
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).
Systemorganklasser i henhold til MedDRAdatabasen
MedDRA- system organ class database
Almindelig: Kvalme Ikke kendt: Kolitis Ikke kendt: Duodenitis
Common: Nausea Not known: Colitis Not known: Duodenitis
Der foreligger ingen fertilitetsdata, men østralperioderne var upåvirkede, og reproduktionsorganerne blev ikke identificeret som målorganer i generelle toksicitetsstudier med gentagen dosering.
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.
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).
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).
Trientin vil sandsynligvis ikke påvirke din evne til at føre motorkøretøj eller betjene maskiner.
Trientine is not likely to have an effect on your ability to drive or use machines.
Der er ikke udført specifikke interaktionsstudier med mad og trientin hos mennesker.
No specific food interaction studies in humans have been performed with trientine.
Cufence binder sig til kobberet, der derefter udskilles fra kroppen.
Cufence attaches to the copper, which is then passed from the body.
Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Tyskland
Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Hyppigere overvågning tilrådes i behandlingens indledende fase, under sygdomsprogression, eller når dosisjusteringerne foretages og besluttes af den behandlende læge (se pkt.
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).
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.
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.
Trientin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Trientine has no or negligible influence on the ability to drive and use machines.
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.
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.
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.
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).
Farmakoterapeutisk klassifikation: Div. midler til fordøjelsesorganer og stofskifte, ATC-kode: A16AX12
Pharmacotherapeutic group: Other alimentary tract and metabolism, various alimentary tract and metabolism products, ATC code: A16AX12
Spædbørn født af mødre i behandling med trientin bør overvåges for indholdet af kobber i serum og ceruloplasminniveauer, når det er relevant.
Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.
Dosisjusteringer af trientindosis skal overvejes ved tegn på nedsat virkning såsom (vedvarende) stigning i levertal og forværring af tremor.
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.
Cufence indeholder det aktive stof trientin, der er et kobber-chelatdannende stof, der bruges til at fjerne overskydende kobber fra kroppen.
Cufence contains the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body.
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.
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).
Graviditeten bør overvåges tæt for at opdage evt. fostermisdannelse og for at vurdere den maternelle koncentration af kobber gennem hele graviditeten.
The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Gul glasflaske med polypropylenhætte og varmeinduceret forseglingsindsats med en pose tørret silicagel som tørremiddel.
Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
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.
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.
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.
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).
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
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to
Pakningsstørrelser og yderligere oplysninger Cufence indeholder:
Contents of the pack and other information What Cufence contains
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).
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).
Propylenglykol Titandioxid (E171) Sort jernoxid (E 172) Gul jernoxid (E172)
Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
Ikke kendt: Lupuslignende syndrom
Not known: Lupus-like syndrome
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.
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.
Hver hård kapsel er hvid, oval, størrelse 0 med Cufence 200 trykt med gråt blæk.
Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Der kan ofte forekomme kvalme i den indledende behandling, og der kan undertiden forekomme hududslæt.
Nausea can commonly occur on initial treatment and occasionally skin rash can occur.
Kobberudskillelsen i urinen kan måles under behandlingen.
The measurement of copper excretion in the urine may be performed during therapy.
Trientin er et kobber-chelatdannende middel, der forstærker systemisk eliminering af divalent kobber ved at danne et stabilt kompleks, der problemfrit udskilles af nyrerne.
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.
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.
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.
Pakningsstørrelser: 1 flaske med 100 hårde kapsler.
Pack size: 1 bottle of 100 hard capsules.
Dyreforsøg har påvist reproduktionstoksicitet, antageligt som følge af trientin-induceret kobbermangel (se pkt.
Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Hvis du har glemt at tage Cufence
If you forget to take Cufence
Efter anbrud: 3 måneder.
After first opening the bottle: 3 months.
Det frarådes at kombinere trientin med zink.
The combination of trientine with zinc is not recommended.
Samtidig oralt jern skal administreres på et andet tidspunkt end trientin (se pkt.
Concomitant oral iron should be administred at a different time than trientine (see section 4.5).
Der er begrænsede oplysninger om patienter med nedsat nyrefunktion.
There is limited information in patients with renal impairment.
Trientindosis bør justeres for at holde koncentrationen af kobber i serum inden for normalområdet.
The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Hvis du holder op med at tage Cufence
If you stop taking Cufence
Hos patienter, som tidligere er blevet behandlet med D-Penicillamin, er der rapporteret lupuslignende reaktioner under efterfølgende behandling med trientin.
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.