natgillin/translations-raw huggingface dataset:
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.
Andre anti-kobberpræparater Der er ikke udført interaktionsstudier med samtidig administration af trientin og D-penicillamin. 
No interaction studies have been performed on the concomitant administration of trientine with DPenicillamine.
Hvid, oval kapsel i størrelse 0 påtrykt "Cufence 200" med gråt blæk. 
White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
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. 
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.
Trientin har vist sig at reducere jernniveauer i serum. 
Trientine has been found to reduce serum iron levels.
Pakningsstørrelser: En flaske med 100 hårde kapsler. 
Pack size: one bottle of 100 hard capsules.
Hver kapsel indeholder 300 mg trientindihydrochlorid svarende til 200 mg trientin. 
Each capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.
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. 
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).
Patienter med neurologiske symptomer bør desuden monitoreres hver eller hver anden uge efter iværksættelse af behandling med Cufence, indtil måldosis er nået. 
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.
Som med alle anti-kobberpræparater kan overbehandling medføre en risiko for kobbermangel, der især er skadelig for børn og gravide kvinder (se pkt. 
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.
Hver hårde kapsel indeholder 300 mg trientindihydrochlorid svarende til 200 mg trientin. 
Each hard capsule contains 300 mg trientine dihydrochloride equivalent to 200 mg trientine.
Indlægsseddel: Information til patienten Cufence 200 mg hårde kapsler trientin 
Package leaflet: Information for the patient Cufence 200 mg hard capsules trientine
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. 
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.
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. 
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).
Trientin er et chelatdannende middel, der er fundet at nedsætte indholdet af jern i serum. 
Trientine is a chelating agent which has been found to reduce serum iron levels.
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. 
The trientine dose may also be reduced in case of side effects of trientine, such as gastrointestinal complaints and haematological changes.
Patienter primært med leversymptomer bør dog monitoreres hver anden til tredje uge efter iværksættelse af behandling med Cufence. 
It is advised, however, to monitor patients presenting with hepatic symptoms every two to three weeks after initiation of treatment with Cufence.
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. 
Patients with renal and/or hepatic impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Disse virkninger blev kun set efter doser, der i væsentlig grad overstiger den maksimale humane eksponering. 
These effects were observed only at exposures sufficiently in excess of maximum human exposure to indicate little relevance to clinical use.
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. 
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.
PAES: For yderligere at karakterisere virkningen af trientindihydrochlorid i behandlingen af Wilsons sygdom hos patienter med overvejende lever-, neurologiske eller psykiatriske symptomer samt hos pædiatriske patienter skal indehaveren af markedsføringstilladelsen gennemføre og indsende resultaterne af et ublindet, prospektivt studie, der undersøger det kliniske forløb af lever-, neurologisk og psykiatrisk sygdom fra tidspunktet for iværksættelse af behandling med trientindihydrochlorid op til 24 måneders behandling. 
Due date neurologic or psychiatric symptoms as well as in paediatric patients, the MAH should conduct and submit the results of an open label, prospective study to investigate the clinical course of hepatic, neurological and psychiatric disease from the time of initiation of treatment with trientine dihydrochloride up to 24 months of therapy.
Der blev ikke rapporteret tydelige bivirkninger i tilfælde med op til 20 g trientin base. 
In cases up to 20 g of trientine base there were no apparent adverse effects reported.
Cufence 200 mg hårde kapsler 
Cufence 200 mg hard capsules
Cufence 200 mg hårde kapsler trientin 
Cufence 200 mg hard capsules trientine
Der er ingen evidens for, at calcium- og magnesiumantacida ændrer trientins virkning, men de bør gives på forskellige tidspunkter (se pkt. 
There is no evidence that calcium and magnesium antacids alter the efficacy of trientine but it is recommended to separate their administration (see section 4.5).
Anvendes senest 3 måneder efter anbrud. 
Use within 3 months after first opening the bottle.
400-1.000 mg har været anvendt ved behandlingens start (se pkt. 
The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Sådan skal du tage Cufence 
How to take Cufence
Tal med lægen, hvis du bliver gravid, mens du tager Cufence. 
If you become pregnant whilst taking Cufence, talk to your doctor.
De dosisniveauer, hvor disse virkninger blev observeret, er dog langt højere end de klinisk anvendte doser. 
All effects were reversible with the exception of the lung findings; however the dose levels where these effects were observed are far in excess of those used clinically.
Ikke almindelig: Anæmi Ikke almindelig: Aplastisk anæmi 
Uncommon: Anaemia Uncommon: Aplastic anaemia Uncommon: Sideroblastic anaemia
Cufence er indiceret til behandling af Wilsons sygdom hos voksne, unge og børn i alderen 5 år og derover, som ikke tåler behandling med D-penicillamin. 
Cufence is indicated for the treatment of Wilson's disease in patients intolerant to D-Penicillamine therapy, in adults, adolescents and children aged 5 years or older.
Uabsorberet trientin bindes til intestinalt kobber og udskilles gennem fæces. 
Unabsorbed trientine is bound to intestinal copper and eliminated through faecal excretion.
(<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Kapslens skal: 
Capsule shell:
Den anbefalede dosis til patienter med nedsat leverfunktion er derfor den samme som til voksne. 
Therefore, the recommended dose in patients with renal impairment is the same as for adults.
Den anbefalede dosis til patienter primært med leversymptomer er den samme som den anbefalede dosis til voksne. 
Patients primarily presenting hepatic symptoms The recommended dose in patients primarily presenting hepatic symptoms is the same as the recommended adult dose.
Brug af anden medicin sammen med Cufence 
Other medicines and Cufence
Overfølsomhed over for det eller de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Udseende og pakningsstørrelser 
What Cufence looks like and contents of the pack
Hvis du har taget for meget Cufence 
If you take more Cufence than you should
Dato for første markedsføringstilladelse: 29. marts 2017 
Date of first authorisation: 29 March 2017
Fra datoen for kundgørelse af Kommissionens afgørelse* 
From the date of notification of the Commission Decision*
Uåbnet flaske 15 måneder 
Unopened bottle 15 months.
* Indbringelsesprocedure EMEA/H/A-31/1463 
*Referral EMEA/H/A-31/1463
Det kan udløse allergiske reaktioner (eventuelt forsinkede). 
It may cause allergic reactions (possibly delayed).
Lægen vil afgøre, om behandling er nødvendig. 
The doctor will decide whether any treatment is needed.
Børn, unge og ældre 
Children, adolescents and elderly
% af dosis, som skal administreres 
% of dose to be administered
Opportunistiske infektioner (undertiden dødelige) 
Opportunistic infections (sometimes fatal)
En risiko kan dog ikke udelukkes helt og der findes ingen oplysninger om højere methotrexatdoser. 
However, a risk cannot be completely excluded and there is no information regarding higher methotrexate doses.
(Se monitorering af nyrefunktionen) 
(See renal function monitoring)
Du må aldrig selv ændre dosis. 
Never change the dose on your own.
Brug ikke Jylamvo, hvis du prøver på at blive gravid. 
Do not use Jylamvo if you are trying to become pregnant.
Når det ønskede behandlingsresultat er opnået, bør dosis gradvis nedsættes til den lavest mulige effektive vedligeholdelsesdosis. 
After the desired treatment outcome is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.
• Alkoholmisbrug 
• Alcohol abuse
Jylamvo må ikke administreres. 
Jylamvo must not be administered.
Du skal derfor bruge effektiv prævention i hele denne periode (se også punktet "Advarsler og forsigtighedsregler"). 
Therefore you must ensure that you are taking effective contraception for the whole of this period (see also section "Warnings and precautions").
De fleste bivirkninger er reversible, hvis de opdages tidligt. 
Most adverse reactions are reversible if they are detected early.
Vitaminprodukter 
Vitamin products
Under behandlingen 
During treatment
Det vides ikke, om methotrexat er til stede i sæd. 
It is not known if methotrexate is present in semen.
Kontakt lægen, hvis du ikke får det bedre, eller hvis du får det værre. 
You must talk to a doctor if you do not feel better or if you feel worse
Der kan blive taget andre prøver før og efter behandlingen. 
Other tests may possibly be performed before and after treatment.
For den onkologiske indikation bør man desuden følge anbefalingerne i publicerede protokoller. 
For the oncology indication recommendations in published protocols should also apply.
Tag aldrig en dobbeltdosis som erstatning for den glemte dosis, men fortsæt med den ordinerede dosis. 
Never take a double dose to make up for a forgotten dose but continue with the prescribed dose.
Før behandlingen påbegyndes 
Before the beginning of treatment
• en redegørelse vedrørende den ordinerende læges ansvar for at afgøre, hvilke patienter der kan være egnede til hjemme- eller selvadministration af Jylamvo. 
• A statement about the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Jylamvo.
Teratogenicitet - Reproduktiv risiko 
Teratogenicity - Reproductive risk
Jylamvo er indiceret ved følgende indikationer: 
Jylamvo is for use in the following indications:
Kvindelige patienter med reproduktivt potentiale skal rådgives om graviditetsforebyggelse og planlægning. 
Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Mutagent og karcinogent potentiale 
Mutagenic and carcinogenic potential
Maksimal serumkoncentration nås inden for 1‐2 timer. 
Peak serum concentrations are attained within 1-2 hours.
Patienten skal sidde eller stå, før medicinen gives. 
Ensure that the patient is sitting up or standing before giving the medicine.