FrancophonIA/ELRC3.0 huggingface dataset:
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemslandet/medlemslandene eller referencelandet/referencelandene skal i givet fald sikre, at følgende betingelser opfyldes af indehaveren/indehaverne af markedsføringstilladelsen:
English: The MAH should perform a PK study assessing the effect of renal impairment and age on trimetazidine pharmacokinetics according to the CHMP agreed protocol.
Danish: Indehaveren af markedsføringstilladelsen skal udføre en farmakokinetisk undersøgelse for at vurdere indvirkningen af nyreinsufficiens og alder på trimetazidin farmakokinetik ifølge den protokol, som CHMP har vedtaget.
English: The final study report will be submitted to MSs/RMS by:
Danish: Den endelige undersøgelsesrapport indsendes til medlemslandene/referencelandene den:
English: The final study report will be submitted to NCAs/RMS by:
Danish: Den endelige undersøgelsesrapport indsendes til de nationale kompetente myndigheder i medlemslandene eller referencelandene den:
English: The final study results will be submitted to NCAs/RMS by:
Danish: De endelige resultater af undersøgelsen indsendes til de nationale kompetente myndigheder i medlemslandene eller referencelandene den:
English: The study should be conducted according to an agreed protocol.
Danish: Studiet skal gennemføres i henhold til en aftalt protokol.
English: Date of first authorisation: 25 July 2019
Danish: Dato for første markedsføringstilladelse: 25. juli 2019
English: Electrocardiography was also unaffected.
Danish: Elektrokardiografi var heller ikke berørt.
English: Adults (including the elderly)
Danish: Voksne (herunder ældre patienter)
English: However, a risk to the newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan dog ikke udelukkes.
English: There is no antidote.
Danish: Der er ingen modgift.
English: Use in children and adolescents (5 to 17 years)
Danish: Brug til børn og unge (5-17 år)
English: Do not take it with other drinks or food because they may reduce the medicine's effect.
Danish: Tag det ikke sammen med andre drikkevarer eller mad, eftersom dette kan nedsætte lægemidlets virkning.
English: Take this medicine with water only.
Danish: Tag kun dette lægemiddel sammen med vand.
English: Frequency of monitoring is recommended to be at least twice a year.
Danish: Overvågningen skal foregå mindst to gange om året.
English: Cufence with food and drink
Danish: Brug af Cufence sammen med mad og drikke
English: Capsules should be swallowed whole with water.
Danish: Kapslerne skal sluges hele med vand.
English: Therefore, monitoring for manifestations of overtreatment should be undertaken.
Danish: Derfor skal manifestationer på overbehandling overvåges.
English: Do not stop or change your treatment without speaking with your doctor even if you feel better.
Danish: Stop ikke behandlingen uden at tale med lægen om det, heller ikke selvom du får det bedre.
English: Moreover, there was some doubt about the relationship to trientine, as the lung findings were also observed in most of the control dogs in the 26 week study.
Danish: Der var derudover nogen tvivl om forholdet til trientin, eftersom lungefundene også blev observeret hos de fleste kontrolhunde i studiet på 26 uger.
English: Neurological deterioration can occur at the start of the treatment.
Danish: Neurologisk forværring kan forekomme i starten af behandlingen.
English: Other products
Danish: Andre produkter
English: Exposure seems to be highly variable between subjects.
Danish: Eksponering lader til at variere betydeligt mellem forsøgspersoner.
English: It is possible that this effect may be more evident in patients with pre-existing neurological symptoms.
Danish: Denne effekt kan være mere fremtrædende hos patienter med eksisterende neurologiske symptomer.
English: Do not use after the expiry date which is stated on the bottle label and outer carton.
Danish: Må ikke anvendes efter udløbsdatoen angivet på flaskens etiket og ydre karton.
English: Patients who have difficulties swallowing should contact their doctor.
Danish: Patienter, som har svært ved at synke, skal kontakte deres læge.
English: If you forget to take a dose take your next dose at its usual scheduled time.
Danish: Hvis du har glemt at tage en dosis, skal du tage din næste dosis til den planlagte tid.
English: Not known: Lupus nephritis
Danish: Ikke kendt: Lupus nephritis
English: Final report: Q4 2025 (main study)
Danish: Endelig rapport: 4. kvartal 2025 (hovedstudie)
English: You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Danish: Du og din læge skal tale om alle de mulige fordele ved behandlingen og tage højde for eventuelle mulige risici.
English: Do not use if the capsules become sticky or wet.
Danish: Tag ikke kapslerne, hvis de er klæbrige eller våde.
English: The dose is lower than for adults and depends on age and body weight.
Danish: Dosis er lavere end til voksne og afhænger af alder og legemsvægt.
English: You must contact your doctor or another health care provider immediately.
Danish: Du skal straks kontakte lægen eller andet sundhedspersonale.
English: 100 capsules
Danish: 100 kapsler
English: Store in a refrigerator (2ºC-8ºC).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: Therefore, iron supplementation may be necessary in some cases.
Danish: Derfor kan jerntilskud i nogle tilfælde være nødvendigt.
English: At the start of treatment the dose varies between 2 and 5 capsules per day.
Danish: I starten af behandlingen varierer dosis mellem 2 og 5 kapsler dagligt.
English: EXP After first opening the bottle can be kept for 3 months.
Danish: EXP Efter anbrud kan flasken opbevares i 3 måneder.
English: There are only limited data on concomitant use available and no specific dose recommendations can be made.
Danish: Der foreligger kun begrænsede data om samtidig anvendelse, og der kan ikke gives specifikke anbefalinger om dosis.
English: This medicine is for long-term use because Wilson's disease is a life-long condition.
Danish: Dette lægemiddel er til langtidsbehandling, fordi Wilsons sygdom er en livsvarig sygdom.
English: Pregnancy There is a limited amount of data from the use of trientine in pregnant women.
Danish: Graviditet Der er begrænsede data fra anvendelse af trientin hos gravide kvinder.
English: If you notice these whilst taking Cufence, you must tell your doctor immediately.
Danish: Hvis du bemærker dette, mens du tager Cufence, skal du straks fortælle det til din læge.
English: The OECD SIDS triethylenetetramine 2002 classifies the genotoxic profile of trientine as low priority/concern.
Danish: OECD SIDS triethylenetetramin 2002 klassificerer trientins genotoksiske profil som lavprioritet/mindre problem.
English: Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
Danish: Behandling bør kun iværksættes af speciallæger med erfaring i behandling af Wilsons sygdom.
English: However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.
Danish: Det har dog ikke været muligt at afgøre, om reaktionen skyldtes trientin eller tidligere behandling med penicillamin.
English: Univar Solutions BV Schouwburgplein 30 3012 CL Rotterdam The Netherlands
Danish: Univar Solutions BV Schouwburgplein 30 3012 CL Rotterdam Holland
English: Children < 5 years
Danish: Børn under 5 år
English: Moreover, there is evidence to suggest that trientine actually reduces endogenous DNA damage in a strain of rat (Long-Evans Cinnamon) considered to represent an appropriate model of Wilson's disease.
Danish: Der er desuden evidens, der tyder på, at trientin rent faktisk reducerer endogene DNA-skader i en rottestamme (Long-Evans Cinnamon), der anses for at repræsentere en passende model af Wilsons sygdom.
English: Following oral administration, trientine absorption is low and variable in patients with Wilson's disease.
Danish: Efter oral administration er absorptionen af trientin lav og varierende hos patienter med Wilsons sygdom.
English: There is insufficient clinical information available for Cufence to determine whether there exist differences in responses between the elderly and younger patients.
Danish: Der foreligger ikke tilstrækkeligt med kliniske oplysninger om Cufence til at afgøre, om der er forskellig respons hos ældre og yngre patienter.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>.
English: In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor.
Danish: Hos børn og unge afhænger dosis af alder og legemsvægt, og den justeres af lægen.
English: Trientine is absorbed with tmax occurring between 0.5 and 4 hours post-dose in healthy volunteers and patients.
Danish: Trientin absorberes med tmax mellem 0,5 og 4 timer efter dosis hos raske frivillige og patienter.
English: Occasionally (frequency unknown; cannot be estimated from available data), treatment with this medicine can cause inflammation of the small intestine or colon.
Danish: Undertiden (hyppighed ukendt; kan ikke estimeres ud fra de foreliggende data) kan behandling med dette lægemiddel forårsage inflammation i tyndtarmen eller endetarmen.
English: Your doctor will need to regularly check for symptoms of the disease and copper levels in your blood and urine.
Danish: Din læge skal regelmæssigt kontrollere dig for symptomer på sygdommen og kobberniveauerne i dit blod og din urin.
English: CARTON/BOTTLE
Danish: KARTON/FLASKE
English: Your doctor will decide the correct dose for you.
Danish: Din læge fastsætter den rette dosis til dig.
English: However as trientine is poorly absorbed following oral intake, food may inhibit absorption.
Danish: Eftersom trientin absorberes dårligt efter oral indtagelse, kan mad hæmme absorptionen.
English: The recommended dose is 800-1,600 mg (4-8 capsules) daily in 2 to 4 divided doses.
Danish: Den anbefalede dosis er 800-1.600 mg (4-8 kapsler) dagligt inddelt i 2-4 doser.
English: Common (may affect up to 1 in 10 people) - Nausea (especially when starting treatment)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) - Kvalme (især i starten af behandlingen)
English: Fertility It is unknown whether trientine has an effect on human fertility.
Danish: Fertilitet Det vides ikke, om trientin påvirker den menneskelige fertilitet.
English: Q4 2022 PK/PD substudy
Danish: 4. kvartal 2022 PK/PDdelstudie
English: Regular monitoring is especially important at the start of your treatment or when your dose is changed, in growing children and pregnant women to ensure that copper levels are maintained at a suitable level.
Danish: Regelmæssig overvågning er især vigtig i starten af behandlingen, eller når din dosis ændres, hos børn i vækst og gravide kvinder for at sikre, at kobberniveauerne holdes på et passende niveau.
English: It is very important to continue treatment to maintain normal copper levels during pregnancy.
Danish: Det er meget vigtigt at fortsætte behandlingen for at opretholde normale kobberniveauer under graviditeten.
English: What you need to know before you take Cufence Do not take Cufence:
Danish: Det skal du vide, før du begynder at tage Cufence Tag ikke Cufence:
English: Some positive in vitro mutagenicity data were obtained but in vivo test systems showed no mutagenic activity.
Danish: Der blev indhentet nogle positive in vitro-mutagenicitetsdata, men testsystemer in vivo viste ingen mutagen aktivitet.
English: It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects.
Danish: Det bruges af patienter, som ikke kan tage anden medicin (D-penicillamin) på grund af bivirkninger.
English: Elimination Trientine and its metabolites are rapidly excreted in the urine.
Danish: Elimination Trientin og dets metabolitter udskilles hurtigt i urinen.
English: The total daily dose can be divided into 2 to 4 smaller doses, as indicated by your doctor.
Danish: Den samlede daglige dosis kan deles i 2 til 4 mindre doser efter lægens anvisning.
English: When switching a patient from another trientine formulation, caution is advised because different trientine salts are available which may have a different trientine content (base) and a different bioavailability.
Danish: Når en patient skiftes fra en anden formulering af trientin, tilrådes forsigtighed, da der kan fås forskellige trientinsalte, som kan have et forskelligt trientinindhold (base) og en forskellig biotilgængelighed.
English: It is recommended to monitor patients closely for such signs and symptoms and to consider careful titration to reach the recommended therapeutic dose and to reduce dose when necessary.
Danish: Det anbefales at overvåge patienterne tæt for sådanne tegn og symptomer samt overveje omhyggelig titrering for at nå den anbefalede terapeutiske dosis og reducere dosis, når det er nødvendigt.
English: The limited information available suggests that Cufence does not pass into breast milk, but it is not certain that there is no risk to the baby.
Danish: De begrænsede tilgængelige oplysninger tyder på, at Cufence ikke udskilles i modermælk, men det er ikke sikkert, at der ikke er nogen risiko for barnet.
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Danish: Det er vigtigt at fortælle lægen, om du ammer eller har til hensigt at gøre det.
English: The safety and efficacy of Cufence in children aged 0 to 5 years have not yet been established.
Danish: Cufences sikkerhed og virkning til børn i alderen 0-5 år er endnu ikke klarlagt.
English: If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for trientin eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: If you take more medicine than you should, you may get nausea, vomiting and dizziness.
Danish: Hvis du tager mere lægemiddel, end du skal, kan du få kvalme, kaste op eller blive svimmel.
English: The determination of serum free copper, 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), can be a useful index for monitoring therapy.
Danish: Bestemmelse af serumfrit kobber, der beregnes ved hjælp af forskellen mellem kobber i alt og det ceruloplasminbundne kopper (det normale niveau af frit kobber i serum er sædvanligvis 100150 mikrogram/l), kan være et nyttigt indeks til overvågning af behandlingen.
English: Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and
Danish: Bivirkningstabel Tabellen nedenfor er præsenteret i henhold til MedDRA-systemets organklassificering (SOC og
English: The usual dose is between 4 and 8 capsules per day, to be taken by mouth.
Danish: Den sædvanlige dosis er mellem 4 og 8 kapsler dagligt, der skal tages gennem munden.
English: Iron supplementation may be necessary in some cases.
Danish: I nogle tilfælde kan jerntilskud være nødvendigt.
English: Store in the original container in order to protect from moisture.
Danish: Opbevares i den originale beholder for at beskytte mod fugt.
English: The extent of MAT and DAT's contribution to the overall effect of Cufence on copper levels in Wilson's Disease patients remains to be determined.
Danish: Omfanget af MAT's og DAT's bidrag til den samlede virkning af Cufence på kobberniveauer hos patienter med Wilsons sygdom er endnu ikke fastlagt.
English: Clinical trials with Cufence including a limited number of children in the age range of 5 to 17 years at the start of treatment indicate that frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Kliniske forsøg med Cufence, herunder et begrænset antal børn i alderen 5 til 17 år i starten af behandlingen tyder på, at hyppigheden, typen og sværhedsgraden af bivirkninger hos børn forventes at være de samme som for voksne.
English: 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.
Danish: 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.
English: Trientine doses should be reduced to a more tolerable dose and may be increased again, once side effects have been resolved.
Danish: Trientindoserne skal reduceres til en mere tolererbar dosis og kan øges igen, når bivirkningerne er forsvundet.
English: There are insufficient data to support the concomitant use of zinc and trientine.
Danish: Der er utilstrækkelige data til at underbygge samtidig brug af zink og trientin.
English: Duodenitis and severe colitis have been reported.
Danish: Der er rapporteret duodenitis og svær kolitis.
English: This suggests a reduced carcinogenic risk for Wilson's disease patients as a result of trientine therapy.
Danish: Dette tyder på en reduceret karcinogen risiko for patienter med Wilsons sygdom som følge af behandling med trientin.
English: Trientine is metabolised by acetylation via spermidine/spermine N-acetyltransferase and not via N-acetyltransferase 2.
Danish: Trientin metaboliseres ved acetylering via spermidin/spermin N-acetyltransferase og ikke via N-acetyltransferase 2.
English: Swallow the capsules whole with a drink of water on an empty stomach, at least 1 hour before or 2 hours after food.
Danish: Kapslerne skal synkes hele med et glas vand på tom mave mindst 1 time før eller 2 timer efter et måltid.
English: Chronic overtreatment can lead to copper deficiency and reversible sideroblastic anaemia.
Danish: Kronisk overbehandling kan medføre kobbermangel og reversibel sideroblastisk anæmi.
English: There was no evidence of embryo-foetal toxicity at lower dose levels despite dose-related reductions in serum copper.
Danish: Der var ikke evidens for embryoføtal toksicitet ved lavere dosisniveauer trods dosisrelaterede reduktioner i kobber i serum.
English: Occasional cases of trientine overdose have been reported.
Danish: Der har været rapporteret lejlighedsvise tilfælde af overdosering med trientin.
English: Signs of an allergic reaction include rash, itching, swelling of the face, fainting and breathing problems.
Danish: Tegn på en allergisk reaktion omfatter hududslæt, kløe, hævelse i ansigtet, besvimelse og vejrtrækningsproblemer.
English: Some functional neurological abnormalities were also identified, particularly in severly affected animals, however no associated nerve damage was observed.
Danish: Der blev også identificeret visse funktionelle neurologiske abnormiteter, særligt hos svært ramte dyr.
English: 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.
Danish: 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.
English: Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - Hududslæt - Anæmi (du kan føle dig usædvanlig træt)
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: 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.
English: 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.
Danish: Neurologiske symptomer kan forværres i begyndelsen af chelatbehandlingen på grund af overskuddet af frit kobber i serum i den initiale respons på behandlingen.
English: Trientine should be used in pregnancy only after careful consideration of the benefits compared with the risks of discontinuing treatment in the individual patient.
Danish: Trientin bør kun anvendes ved graviditet efter nøje afvejning af fordelene i forhold til risiciene ved at afbryde behandlingen hos den enkelte patient.
English: In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
Danish: I tilfælde af overdosering skal patienten overvåges, passende biokemisk analyse udføres, og symptomatisk behandling gives.
English: Close monitoring is required to optimise the dose or adapt treatment if necessary (see section 4.4).
Danish: Tæt overvågning er nødvendig for at optimere dosis eller tilpasse behandlingen, hvis det er nødvendigt (se pkt.
English: The use of appropriate copper parameter target ranges is described in clinical practice guidelines related to Wilson's disease.
Danish: Brugen af passende målintervaller for kobberparametre er beskrevet i de kliniske retningslinjer for Wilsons sygdom.
English: Avoid eating or drinking for 1 hour before, or 2 hours after taking Cufence.
Danish: Undgå at spise eller drikke i 1 time før eller 2 timer, efter du tager Cufence.
English: 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.
Danish: 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.
English: The study will also contain a PK/PD sub-study to evaluate the doseresponse relationship especially during the up-titration phase.
Danish: Tidsfrist indeholde et PK/PD-delstudie for at vurdere forholdet mellem dosis og respons, især under optitreringsfasen.
English: Zinc
Danish: Zink
English: 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.
Danish: 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.
English: Close monitoring of renal and/or liver function is also recommended in these patients (see section 4.2).
Danish: Desuden anbefales tæt overvågning af nyre- og/eller leverfunktionen hos disse patienter (se pkt.
English: Your doctor will decide which treatment and which dose is best in your situation.
Danish: Lægen vil afgøre, hvilken behandling og hvilken dosis der er bedst i din situation.
English: - The active substance is trientine.
Danish: - Aktivt stof: trientin.
English: Your doctor will advise you which treatment and which dose is best in your situation.
Danish: Lægen vil rådgive dig om, hvilken behandling og hvilken dosis der er bedst i din situation.
English: 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.
Danish: Det frarådes at kombinere trientin med zink på grund af zinks sandsynlige interaktion med trientin, hvorved effekten af begge aktive stoffer reduceres.
English: There is limited clinical data suggesting that trientine is not excreted in breast milk.
Danish: Der er begrænsede kliniske data, der tyder på, at trientin ikke udskilles i modermælk.
English: The doctor may need to increase or decrease your dose of Cufence.
Danish: Lægen skal eventuelt justere din dosis af Cufence op eller ned.