FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose is between 4 and 8 capsules per day, to be taken by mouth.
Croatian: Uobičajena doza je između 4 i 8 kapsula dnevno koje se uzimaju kroz usta.
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.
Croatian: Kao kod svih agensa koji snižavaju bakar, prekomjerno liječenje nosi rizik od nedostatka bakra, što je posebice štetno za djecu i trudnice (vidjeti dio 4.6) jer je bakar potreban za pravilni rast i mentalni razvoj.
English: Store in the original container in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od vlage.
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.
Croatian: Prema trenutno dostupnim ograničenim informacijama, čini se da Cufence ne prelazi u majčino mlijeko, ali nije sigurno nosi li rizik za bebu.
English: The OECD SIDS triethylenetetramine 2002 classifies the genotoxic profile of trientine as low priority/concern.
Croatian: Prema izvješću OECD SIDS iz 2002. godine o trietilentetraminu, genotoksični profil trientina klasificiran je kao niskog prioriteta/niske važnosti.
English: Neurological deterioration can occur at the start of the treatment.
Croatian: Do neurološkog pogoršanja može doći na početku liječenja.
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.
Croatian: Štoviše, postoje sumnje u pogledu uzročne povezanosti s trientinom, s obzirom da su plućni nalazi također zapaženi kod većine kontrolnih pasa u 26-tjednom ispitivanju.
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.
Croatian: Utvrđivanje slobodnog bakra u serumu koji se izračunava razlikom između ukupnog bakra i bakra vezanog za ceruloplazmin (normalna razina slobodnog bakra u serumu obično iznosi 100 do 150 mikrograma/l) može biti koristan indeks za praćenje terapije.
English: Other products
Croatian: Drugi proizvodi
English: Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
Croatian: Liječenje smije započeti samo liječnik specijalist s iskustvom u liječenju Wilsonove bolesti.
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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju niza ispitivanja kardiovaskularne sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i embriofetalne toksičnosti.
English: Not known: Lupus nephritis
Croatian: Nepoznato: lupus nefritis
English: These effects were observed only at exposures sufficiently in excess of maximum human exposure to indicate little relevance to clinical use.
Croatian: Ovi su učinci zamijećeni samo pri izloženostima dovoljno iznad maksimalne ljudske izloženosti da imaju manju relevantnost za kliničku primjenu.
English: This medicine is for long-term use because Wilson's disease is a life-long condition.
Croatian: Ovaj je lijek namijenjen dugotrajnoj primjeni jer je Wilsonova bolest doživotna.
English: Patients who have difficulties swallowing should contact their doctor.
Croatian: Bolesnici koji otežano gutaju moraju se obratiti svom liječniku.
English: Trientine is acetylated in two major metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Croatian: Trientin se acetilira u dva glavna metabolita, N(1)-acetiltrietilentetramin (MAT) i N(1),N(10)-diacetiltrietilentetramin (DAT).
English: There is no antidote.
Croatian: Ne postoji protulijek.
English: 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.
Croatian: Svi su učinci bili reverzibilni s izuzetkom plućnih nalaza; međutim, razine doze u slučajevima gdje su ovi učinci uočeni daleko su veće od onih koje su korištene klinički.
English: This suggests a reduced carcinogenic risk for Wilson's disease patients as a result of trientine therapy.
Croatian: Ovo sugerira smanjeni kancerogeni rizik za bolesnike koji boluju od Wilsonove bolesti kao rezultat liječenja trientinom.
English: If you become pregnant whilst taking Cufence, talk to your doctor.
Croatian: Ako zatrudnite dok uzimate Cufence, obratite se svom liječniku.
English: There are insufficient data to support the concomitant use of zinc and trientine.
Croatian: Nema dovoljno podataka koji bi podržali istodobnu upotrebu cinka i trientina.
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.
Croatian: Stoga, farmakodinamičko djelovanje trientina ovisi o njegovom kemijskom svojstvu keliranja bakra, a ne o interakciji s receptorima, enzimskim sustavima ili drugim biološkim sustavima koji se mogu razlikovati među vrstama.
English: Use within 3 months after first opening the bottle.
Croatian: Upotrijebite lijek u roku od 3 mjeseca nakon prvog otvaranja bočice.
English: It is very important to continue treatment to maintain normal copper levels during pregnancy.
Croatian: Vrlo je važno da nastavite s liječenjem zbog održavanja normalnih razina bakra tijekom trudnoće.
English: Avoid eating or drinking for 1 hour before, or 2 hours after taking Cufence.
Croatian: Izbjegavajte jesti ili piti 1 sat prije ili 2 sata poslije uzimanja lijeka Cufence.
English: If you stop taking Cufence
Croatian: Ako prestanete uzimati Cufence
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.
Croatian: Ako ste trudni i uzimate Cufence, Vaše će se stanje pratiti u tijeku trudnoće radi učinaka na bebu ili promjena u Vašim razinama bakra.
English: Your doctor will need to regularly check for symptoms of the disease and copper levels in your blood and urine.
Croatian: Vaš liječnik treba redovito provjeravati razvijate li simptome bolesti, kao i razinu bakra u krvi i urinu.
English: Dose adjustment may be required (see section 4.2).
Croatian: Možda je potrebna prilagodba doze (vidjeti dio 4.2).
English: However as trientine is poorly absorbed following oral intake, food may inhibit absorption.
Croatian: Međutim, budući da se trientin slabo apsorbira nakon peroralne primjene, hrana bi mogla inhibirati apsorpciju.
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.
Croatian: Nisu dostupni podaci o plodnosti, ali estrusna cikličnost bila je bez promjene, a reproduktivni organi nisu utvrđeni kao ciljni organi u generalnim ispitivanjima toksičnosti ponovljenih doza.
English: The measurement of copper excretion in the urine may be performed during therapy.
Croatian: Mjerenje izlučivanja bakra u urinu može se provoditi tijekom terapije.
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.
Croatian: Trientin se u trudnoći smije koristiti samo nakon pažljivog razmatranja koristi u odnosu na rizike prekidanja liječenja u pojedine bolesnice.
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.
Croatian: Prilagodbe u dozi trientina potrebno je razmotriti u slučaju znakova smanjene djelotvornosti, poput (perzistentnog) povećavanja jetrenih enzima i pogoršanja tremora.
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.
Croatian: Budući da kelacijska terapija dovodi do povećanja razine bakra u urinu, to (možda) neće dati točan prikaz viška količine bakra u tijelu, no može biti korisna mjera pridržavanja liječenja.
English: There was no evidence of embryo-foetal toxicity at lower dose levels despite dose-related reductions in serum copper.
Croatian: Nema dokaza o embriofetalnoj toksičnosti pri nižim dozama lijeka unatoč smanjenjima bakra u serumu povezanima s dozom.
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).
Croatian: Važno je uzimati Cufence na prazan želudac, barem jedan sat prije jela ili dva sata nakon jela te u razmaku od barem jednog sata od uzimanja bilo kojeg drugog lijeka, hrane ili mlijeka (vidjeti dio 4.5).
English: Final report: Q4 2025 (main study)
Croatian: do 4. kvartala 2025. (glavno ispitivanje)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism, various alimentary tract and metabolism products, ATC code: A16AX12
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni trakt i metabolizam, razni lijekovi za probavni trakt i metabolizam, ATK oznaka: A16AX12
English: Signs of an allergic reaction include rash, itching, swelling of the face, fainting and breathing problems.
Croatian: Znakovi alergijske reakcije uključuju osip, svrbež, oticanje lica, gubitak svijesti i probleme s disanjem.
English: Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.
Croatian: Cufence je lijek koji se upotrebljava za liječenje Wilsonove bolesti u odraslih, adolescenata i djece u dobi od 5 godina ili starije.
English: Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, što je vjerojatno rezultat manjka bakra uzrokovanog trientinom (vidjeti dio 5.3).
English: Occasional cases of trientine overdose have been reported.
Croatian: Povremeno su zabilježeni slučajevi predoziranja trientinom.
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.
Croatian: Nadalje, postoje dokazi koji sugeriraju da trientin zapravo smanjuje endogeno oštećenje DNA u soju štakora (LongEvans Cinnamon) za koji se smatra da predstavlja odgovarajući model za Wilsonovu bolest.
English: Chronic overtreatment can lead to copper deficiency and reversible sideroblastic anaemia.
Croatian: Kronično prekomjerno liječenje može dovesti do nedostatka bakra i reverzibilne sideroblastične anemije.
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.
Croatian: Preporuča se pomno pratiti bolesnike radi tih znakova i simptoma te razmotriti pažljivu titraciju kako bi se dostigla preporučena terapijska doza i po potrebi smanjila doza.
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.
Croatian: Mogu se pojaviti problemi sa živčanim sustavom (primjerice nevoljno drhtanje, manjak koordinacije, otežan govor, ukočenost mišića, pogoršanje grčeva mišića), posebice u bolesnika koji upravo započinju svoje liječenje lijekom Cufence.
English: The study will also contain a PK/PD sub-study to evaluate the doseresponse relationship especially during the up-titration phase.
Croatian: U sklopu ispitivanja provest će se i PK/PD podispitivanje u svrhu procjene odnosa doze i odgovora, posebno za vrijeme faze titracije na višu dozu.
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).
Croatian: Glavni toksikološki nalazi povezani s trientinom, koji su općenito zapaženi za sve ispitivane vrste, uključivali su gubitak tjelesne težine ili smanjeni dobitak težine, izmijenjene razine elektrolita u urinu, niske razine bakra u plazmi i razne histopatološke promjene u plućima (primarno intersticijski pneumonitis).
English: If you forget to take Cufence
Croatian: Ako ste zaboravili uzeti 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.
Croatian: Cilj je terapije održavanja održati razine slobodnog bakra u plazmi (poznat i kao bakar u plazmi koji nije vezan na ceruloplazmin) i izlučivanje bakra u urinu u prihvatljivim granicama.
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.
Croatian: Klinička ispitivanja s lijekom Cufence koja su uključila ograničen broj djece u rasponu dobi od 5 do 17 godina na početku liječenja ukazuju na to da bi učestalost, tip i težina nuspojava u djece trebala biti ista kao u odraslih.
English: Therefore, monitoring for manifestations of overtreatment should be undertaken.
Croatian: Stoga je potrebno uspostaviti praćenje zbog moguće pojave manifestacija prekomjernog liječenja.
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).
Croatian: Čimbenici koje treba uzeti u obzir uključuju poznate rizike povezane s neliječenom ili nedovoljno liječenom Wilsonovom bolesti, rizike povezane sa stupnjem bolesti, rizik dostupnih zamjenskih liječenja i moguće učinke trientina (vidjeti dio 5.3).
English: There are only limited data on concomitant use available and no specific dose recommendations can be made.
Croatian: O istodobnoj upotrebi dostupni su samo ograničeni podaci te nije moguće dati posebnu preporuku o doziranju.
English: Not known: Lupus-like syndrome
Croatian: Nepoznato: sindrom nalik na lupus
English: There is limited clinical data suggesting that trientine is not excreted in breast milk.
Croatian: Postoje ograničeni klinički podaci koji sugeriraju da se trientin ne izlučuje u majčino mlijeko.
English: Some positive in vitro mutagenicity data were obtained but in vivo test systems showed no mutagenic activity.
Croatian: Dobiveni su određeni pozitivni in vitro mutagenski podaci, ali ispitni in vitro sustavi nisu pokazali nikakvu mutagensku aktivnost.
English: EU/1/19/1365/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1365/001
English: If you take more medicine than you should, you may get nausea, vomiting and dizziness.
Croatian: Ako uzmete više lijeka Cufence nego što ste trebali Uzmete li više lijeka nego što ste trebali, možete osjećati mučninu ili omaglicu ili povraćati.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Your doctor will decide which treatment and which dose is best in your situation.
Croatian: Vaš će liječnik odlučiti koje je liječenje i doza najbolja u Vašoj situaciji.
English: Elimination Trientine and its metabolites are rapidly excreted in the urine.
Croatian: Eliminacija Trientin i pripadajući metaboliti brzo se izlučuju u urin.
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.
Croatian: U tom će Vam slučaju Vaš liječnik pomoći odlučiti je li potrebno prestati dojiti ili uzimati Cufence, s obzirom na korist dojenja za bebu i korist lijeka Cufence za majku.
English: No specific food interaction studies in humans have been performed with trientine.
Croatian: Nisu provedena specifična ispitivanja interakcija hrane s trientinom u ljudi.
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).
Croatian: Prvenstveni mehanizam djelovanja trientina zahtijeva njegovu sistemsku izloženost (vidjeti dio 5.1), stoga se preporuča uzimanje trientina barem 1 sat prije jela ili 2 sata nakon jela te u razmaku od barem jedan sat od uzimanja bilo kojih drugih lijekova, hrane ili mlijeka kako bi se osigurala maksimalna apsorpcija trientina i smanjila vjerojatnost formiranja kompleksa vezanjem lijeka na metale u probavnom traktu (vidjeti dio 4.2).
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.
Croatian: Redovito je praćenje od izrazite važnosti na početku Vašeg liječenja ili prilikom promjene doze, u djece u razvoju i trudnica, u svrhu održavanja razina bakra na odgovarajućoj razini.
English: The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Croatian: Trudnoću treba pomno pratiti da bi se otkrile moguće abnormalnosti fetusa i procijenile razine bakra u serumu majke tijekom trudnoće.
English: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Croatian: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Njemačka
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.
Croatian: Ne preporučuje se kombinacija trientina s cinkom s obzirom da je interakcija cinka s trientinom vjerojatna, što smanjuje učinak obje djelatne tvari.
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).
Croatian: Preporučene doze lijeka Cufence izražene su u mg baze trientina (tj. ne u mg soli trientindiklorida) (vidjeti dio 4.4).
English: If you notice these whilst taking Cufence, you must tell your doctor immediately.
Croatian: Ako što od toga zamijetite tijekom uzimanja lijeka Cufence, smjesta obavijestite svog liječnika.
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Croatian: Važno je da svom liječniku kažete ako dojite ili ako planirate dojiti.
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.
Croatian: U trudnih životinja velika doza trientina povezana sa znatnim smanjenjem bakra u serumu pokazala je rani učinak na preživljavanje embrija i marginalno nižu težinu fetusa.
English: Therefore, iron supplementation may be necessary in some cases.
Croatian: Stoga će u određenim slučajevima možda biti potrebno uzimanje nadomjestaka željeza.
English: The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Croatian: Dozu trientina koja se koristi potrebno je prilagoditi kako bi se razine bakra u serumu održale unutar normalnog raspona.
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.
Croatian: Vezivanje trientina za proteine ljudske plazme je nisko, a trientin se široko distribuira u tkiva, s relativno visokim koncentracijama izmjerenima u jetri, srcu i bubregu štakora.
English: Nausea can commonly occur on initial treatment and occasionally skin rash can occur.
Croatian: Mučnina je česta nuspojava prilikom početnog liječenja, a povremeno se može pojaviti i kožni osip.
English: In cases up to 20 g of trientine base there were no apparent adverse effects reported.
Croatian: U slučajevima predoziranja dozama do 20 g baze trientina, nisu zabilježene vidljive nuspojave.
English: Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
Croatian: Tinta za označavanje: šelak propilenglikol titanijev dioksid (E171) željezov oksid crni (E172) željezov oksid žuti (E172)
English: Trientine is not likely to have an effect on your ability to drive or use machines.
Croatian: Nije vjerojatno da će trientin imati učinak na Vašu sposobnost upravljanja vozilima i strojevima.
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).
Croatian: Ako imate bilo koju od sljedećih nuspojava, smjesta se obratite svom liječniku: - Jaka bol u trbuhu - Trajan proljev - Problemi sa živčanim sustavom (primjerice nevoljno drhtanje, manjak koordinacije, otežan govor,
English: Common: Nausea Not known: Colitis Not known: Duodenitis
Croatian: Često: mučnina Nepoznato: kolitis Nepoznato: duodenitis
English: Trientine has no or negligible influence on the ability to drive and use machines.
Croatian: Trientin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Predoziranje velikom dozom od 40 g baze trientina izazvalo je samoograničavajuću omaglicu i povraćanje, pri čemu nisu bile zabilježene druge kliničke posljedice ili značajni biokemijski poremećaji.
English: It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects.
Croatian: Namijenjen je primjeni u bolesnika koji ne mogu uzimati drugi lijek, D-penicilamin, zbog nuspojava.
English: Close monitoring is required to optimise the dose or adapt treatment if necessary (see section 4.4).
Croatian: Potrebno je pomno praćenje radi optimizacije doze ili prilagodbe liječenja po potrebi (vidjeti dio 4.4).
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).
Croatian: Trientindiklorid je poznat kao nadražujuće sredstvo, posebice na sluznice, gornji respiratorni trakt i kožu, te on inducira kožnu osjetljivost u zamoraca, miševa i čovjeka (izvješće OECD SIDS za trietilentetramin iz 2002. godine).
English: 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.
Croatian: Cufence je indiciran za liječenje Wilsonove bolesti u bolesnika s intolerancijom na D-penicilamin, u odraslih, adolescenata i djece u dobi od 5 godina ili starije.