FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving Cufence should remain under regular medical supervision and be monitored using all available clinical data for appropriate control of clinical symptoms and copper levels in order to optimise treatment.
Croatian: Bolesnici koji primaju Cufence trebaju biti pod redovitim liječničkim nadzorom i njihovo stanje potrebno je pratiti uz sve dostupne kliničke podatke radi odgovarajuće kontrole kliničkih simptoma i razina bakra, kako bi se optimiziralo liječenje.
English: It is further advised to monitor patients presenting with neurological symptoms every one to two weeks after initiation of treatment with Cufence until target dose is reached.
Croatian: Nadalje se savjetuje nadzor bolesnika koji pokazuju neurološke simptome svaki tjedan do dva tjedna nakon započinjanja liječenja lijekom Cufence dok se ne postigne ciljna doza.
English: In general, dose selection should be cautious, usually starting at the low end of the dosing range as recommended for adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Croatian: Općenito, treba biti oprezan u odabiru doze i obično treba početi na donjem kraju raspona doziranja prema preporukama za odrasle, s obzirom na veću učestalost smanjene funkcije jetre, bubrega ili srca te popratne bolesti ili druge terapije lijekovima.
English: The combination of trientine with zinc is not recommended.
Croatian: Ne preporučuje se kombinacija trientina s cinkom.
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.
Croatian: Ako bolesnik koji je uzimao neku drugu formulaciju trientina počinje uzimati ovaj lijek, savjetuje se oprez jer postoje razne soli trientina koje mogu imati drugačiji sadržaj trientina (baza) i drugačiju bioraspoloživost.
English: Close monitoring of renal and/or liver function is also recommended in these patients (see section 4.2).
Croatian: U ovih se bolesnika također preporuča pomno praćenje funkcije jetre i/ili bubrega (vidjeti dio 4.2).
English: Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Croatian: Reakcije slične lupusu (simptomi mogu uključivati dugotrajan osip, vrućicu, bol u zglobovima i umor) zabilježene su u nekih bolesnika koji su se nakon liječenja penicilaminom prebacili na trientin.
English: Trientine doses should be reduced to a more tolerable dose and may be increased again, once side effects have been resolved.
Croatian: Doze trientina potrebno je smanjiti na podnošljivije doze, a njihovo je povećavanje dopušteno jednom kada se nuspojave povuku.
English: The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Croatian: Dozu bi trebalo prilagoditi prema kliničkom odgovoru; na početku terapije primjenjuje se 400-1000 mg (vidjeti dio 4.4).
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.
Croatian: Pri početku kelacijske terapije može doći do pogoršanja neuroloških simptoma zbog viška slobodnog bakra u serumu tijekom početnog odgovora na liječenje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from trientine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja trientinom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Trientine is a chelator with a polyamine-like structure and copper is chelated by forming a stable complex with the four constituent nitrogens in a planar ring.
Croatian: Trientin je kelator s poliaminskom strukturom, a bakar kelira formiranjem stabilnog kompleksa s četiri sastavna dušika u planarnom prstenu.
English: Although there is no evidence that calcium and magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration (see section 4.4).
Croatian: Iako nema dokaza da antacidi kalcija i magnezija mijenjaju djelotvornost trientina, dobra je praksa odvojiti njihovu primjenu (vidjeti dio 4.4).
English: Trientine is metabolised by acetylation via spermidine/spermine N-acetyltransferase and not via N-acetyltransferase 2.
Croatian: Trientin se metabolizira acetilacijom putem spermidin/spermin N-acetiltransferaze, a ne putem N-acetiltransferaze 2.
English: The starting dose would usually correspond to the lowest recommended dose and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4).
Croatian: Početna doza obično treba odgovarati najnižoj preporučenoj dozi te se nakon toga treba prilagođavati u skladu s bolesnikovim kliničkim odgovorom (vidjeti dio 4.4).
English: Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.
Croatian: Bebe rođene majkama na liječenju trientinom potrebno je pratiti radi razina bakra u serumu i ceruloplazmina gdje je to potrebno.
English: Cufence attaches to the copper, which is then passed from the body.
Croatian: Cufence veže za sebe bakar, koji se potom izlučuje iz tijela.
English: In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
Croatian: U slučaju predoziranja potrebno je bolesnika držati na promatranju, izvršiti odgovarajuću biokemijsku analizu i pružiti simptomatsku terapiju.
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.
Croatian: U slučaju nastavka liječenja trientinom nakon analize rizika i koristi, posebnu bi pozornost trebalo dati smanjenju doze trientina na najmanju djelotvornu dozu te praćenju pridržavanja režima liječenja.
English: However, up titration should be done with moderation and consideration, and adapted according to the patient's clinical response such as worsening of tremor as patients could be at risk of neurological deterioration at initiation of treatment (see section 4.4).
Croatian: Međutim, potrebno je titrirati na višu dozu na umjeren i pažljiv način, te prilagođavati u skladu s bolesnikovim kliničkim odgovorom, kao u slučaju pogoršanja tremora, s obzirom da postoji rizik od neurološkog pogoršanja na početku liječenja (vidjeti dio 4.4).
English: Following oral administration, trientine absorption is low and variable in patients with Wilson's disease.
Croatian: Apsorpcija trientina nakon peroralne primjene slaba je i varijabilna u bolesnika s Wilsonovom bolesti.
English: When trientine doses are adjusted this should be done in small steps.
Croatian: Doze trientina potrebno je prilagođavati u malenim koracima.
English: Since copper is required for proper growth and mental development, dose adjustments may be required to ensure that the foetus will not become copper deficient and close monitoring of the patient is essential (see section 4.4)
Croatian: Budući da je bakar potreban za pravilan rast i mentalni razvoj, možda će trebati prilagoditi dozu kako bi se osiguralo da ne nastupi manjak bakra za fetus, pri čemu je pomno praćenje bolesnice ključno (vidjeti dio 4.4).
English: It is advised, however, to monitor patients presenting with hepatic symptoms every two to three weeks after initiation of treatment with Cufence.
Croatian: Međutim, savjetuje se nadzor bolesnika koji primarno pokazuju simptome bolesti jetre svaka dva do tri tjedna nakon započinjanja liječenja lijekom Cufence.
English: 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).
Croatian: Nema dokaza da kalcijevi i magnezijevi antacidi mijenjaju djelotvornost trientina, ali je preporučljivo odvojiti njihovu primjenu (vidjeti dio 4.5).
English: Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Croatian: Trientin može također kelirati bakar u probavnom traktu i tako inhibirati apsorpciju bakra.
English: Trientine is absorbed with tmax occurring between 0.5 and 4 hours post-dose in healthy volunteers and patients.
Croatian: Trientin se u zdravih dobrovoljaca i bolesnika apsorbira s tmax između 0,5 i 4 sata nakon uzimanja doze.
English: Titanium dioxide (E171)
Croatian: Ovojnica kapsule: želatina titanijev dioksid (E171)
English: MedDRA- system organ class database
Croatian: MedDRA - klasifikacija organskih sustava Nuspojave
English: Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Croatian: Svaka tvrda kapsula bijela je i ovalnog oblika veličine 0, s oznakom „Cufence 200” otisnutom sivom tintom.
English: CARTON/BOTTLE
Croatian: KUTIJA/BOČICA
English: Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
Croatian: Bočica boje jantara s kapicom od polipropilena i indukcijski zavarenom zaštitnom folijom s vrećicom suhog silikagela koji se koristi kao sredstvo za sušenje.
English: More frequent monitoring is advised during the initial phase of treatment and during phases of disease progression or when dose adjustments are made as to be decided by the treating physician (see section 4.2).
Croatian: Učestalije praćenje savjetuje se tijekom početne faze liječenja i tijekom faza progresije bolesti ili u slučaju prilagodbe doze u skladu s odlukama nadležnog liječnika (vidjeti dio 4.2).
English: Concomitant oral iron or other heavy metals should be administred at a different time than trientine to prevent the formation of complexes (see section 4.4).
Croatian: Željezo i drugi teški metali koji se istodobno upotrebljavaju peroralnim putem moraju se davati u drugo vrijeme od trientina kako bi se spriječilo formiranje kompleksa (vidjeti dio 4.4).
English: Iron supplementation may be necessary in some cases.
Croatian: U određenim će slučajevima možda biti potrebno uzimati nadomjestke željeza.
English: In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor.
Croatian: Primjena u djece i adolescenata (od 5 do 17 godina) Kod djece i adolescenata doza ovisi o dobi i tjelesnoj težini i prilagođava je Vaš liječnik.
English: Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Croatian: Manje često: distonija Manje često: tremor Nepoznato: disartrija Nepoznato: ukočenost mišića Nepoznato: neurološko pogoršanje
English: Effects in non-clinical studies were largely consistent with induced copper deficiency in the plasma and liver of previously copper normative animals and as such could be attributed to the pharmacological action of trientine.
Croatian: Učinci u nekliničkim ispitivanjima u velikoj su mjeri konzistentni s induciranim manjkom bakra u plazmi i jetri u životinja s inače normalnom količinom bakra, te ih je kao takve moguće povezati s farmakološkim djelovanjem trientina.
English: There have been reports of neurological deterioration at the start of treatment in Wilson's disease patients treated with copper chelators including trientine, with symptoms of, for example, dystonia, rigidity, tremor and dysarthria (see section 4.2).
Croatian: U bolesnika s Wilsonovom bolesti zabilježeni su slučajevi neurološkog pogoršanja na početku liječenja kelatorima bakra, uključujući trientin, sa simptomima, primjerice, distonije, ukočenosti, tremora i disartrije (vidjeti dio 4.2).
English: Your doctor will advise you which treatment and which dose is best in your situation.
Croatian: Vaš će Vas liječnik savjetovati o liječenju i dozi koji bi bili najbolji u Vašoj situaciji.
English: Pack size: 1 bottle of 100 hard capsules.
Croatian: Veličina pakiranja: 1 bočica sa 100 tvrdih kapsula.
English: No long term animal carcinogenicity trials have to date been performed with trientine via the oral route, but via the dermal route, there was no increases in cancers above baseline.
Croatian: Dosada nisu provedena dugotrajna ispitivanja kancerogenog potencijala u životinja s trientinom koji je primijenjen peroralno, ali uz dermalnu primjenu nije bilo povećanja karcinoma iznad početne vrijednosti.
English: Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
Croatian: - Kožni osip - Anemija (možete se osjećati neuobičajeno umornima)
English: In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
Croatian: U pasa su zamijećene ataksija, tremor, nenormalan hod i umanjena aktivnost nakon primjene izrazito visokih razina trientina.
English: White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
Croatian: Bijela kapsula ovalnog oblika veličine 0, s oznakom „Cufence 200” otisnutom sivom tintom.
English: Pregnancy There is a limited amount of data from the use of trientine in pregnant women.
Croatian: Trudnoća Podaci o primjeni trientina u trudnica su ograničeni.
English: Do not use after the expiry date which is stated on the bottle label and outer carton.
Croatian: Ovaj se lijek ne smije upotrebljavati nakon isteka roka valjanosti navedenog na naljepnici na bočici i vanjskoj kutiji iza oznake EXP.
English: Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
Croatian: Prekomjerno liječenje i uklanjanje viška bakra moguće je pratiti s pomoću vrijednosti bakra koji se izlučuje u urinu i bakra koji nije vezan za ceruloplazmin.
English: How to take Cufence
Croatian: Kako uzimati Cufence
English: Trientine is a copper-selective chelator that enhances systemic elimination of divalent copper by forming a stable complex that is readily excreted by the kidneys.
Croatian: Trientin je kelator selektivan za bakar koji pospješuje sistemsko uklanjanje dvovalentnog bakra iz tijela formiranjem stabilnog kompleksa koji se lako izlučuje putem bubrega.
English: Cufence contains the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body.
Croatian: Cufence sadrži djelatnu tvar trientin, kelirajuće sredstvo za bakar koje se upotrebljava u svrhu izvlačenja viška bakra iz tijela.
English: Concomitant oral iron should be administred at a different time than trientine (see section 4.5).
Croatian: Željezo koje se istodobno primjenjuje peroralnim putem trebalo bi se uzimati u različito vrijeme od trientina (vidjeti dio 4.5).
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.
Croatian: Nije utvrđeno koliko MAT i DAT utječu na cjelokupni učinak lijeka Cufence na razine bakra u bolesnika s Wilsonovom bolesti.
English: The trientine dose may also be reduced in case of side effects of trientine, such as gastrointestinal complaints and haematological changes.
Croatian: Dozu trientina moguće je isto smanjiti u slučaju nuspojava trientina, poput probavnih smetnji ili hematoloških promjena.
English: How to store Cufence
Croatian: Kako čuvati Cufence
English: EXP After first opening the bottle can be kept for 3 months.
Croatian: EXP Bočicu treba upotrijebiti u roku od 3 mjeseca nakon prvog otvaranja.
English: Patients with renal and/or hepatic impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Croatian: Bolesnike s oštećenjima funkcije jetre i/ili bubrega koji primaju trientin potrebno je držati pod redovitim liječničkim nadzorom radi odgovarajuće kontrole simptoma i razina bakra.
English: Cufence 200 mg hard capsules trientine
Croatian: Cufence 200 mg tvrde kapsule trientin
English: Pack size: one bottle of 100 hard capsules.
Croatian: Veličina pakiranja: bočica sa 100 tvrdih kapsula.
English: Trientine is a chelating agent which has been found to reduce serum iron levels.
Croatian: Trientin je kelacijsko sredstvo za koje je utvrđeno da smanjuje razine željeza u serumu.
English: Cufence 200 mg hard capsules
Croatian: Cufence 200 mg tvrde kapsule
English: Zinc
Croatian: Cink
English: Duodenitis and severe colitis have been reported.
Croatian: Zabilježeni su i slučajevi duodenitisa i težeg oblika kolitisa.
English: Trientine has been found to reduce serum iron levels.
Croatian: Ustanovljeno je da trientin smanjuje razine željeza u serumu.
English: In patients who were previously treated with D-Penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Croatian: U bolesnika koji su prethodno liječeni D-penicilaminom zabilježene su reakcije slične lupusu tijekom kasnijeg liječenja trientinom.
English: Magnesium stearate Colloidal anhydrous silica
Croatian: magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: 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.
Croatian: Do datuma promet (PAES): u svrhu daljnje karakterizacije djelotvornosti trientindiklorida u liječenju Wilsonove bolesti u bolesnika koji primarno pokazuju simptome bolesti jetre, neurološke ili psihijatrijske simptome, kao i u pedijatrijskih bolesnika, nositelj odobrenja dužan je provesti i dostaviti rezultate otvorenog, prospektivnog ispitivanja kako bi se istražio klinički tijek bolesti jetre te neuroloških i psihijatrijskih poremećaja od trenutka započinjanja liječenja trientindikloridom, u trajanju do 24 mjeseca liječenja.
English: Each capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.
Croatian: Jedna kapsula sadrži 300 mg trientindiklorida, što je ekvivalentno 200 mg trientina.
English: Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and
Croatian: Tablica u nastavku je u skladu s klasifikacijom organskih sustava prema MedDRA-i (klasa organskih sustava i razina preporučenih pojmova).
English: Contents of the pack and other information What Cufence contains
Croatian: Sadržaj pakiranja i druge informacije Što Cufence sadrži - Djelatna tvar je trientin.
English: Patients primarily presenting hepatic symptoms The recommended dose in patients primarily presenting hepatic symptoms is the same as the recommended adult dose.
Croatian: U bolesnika koji primarno pokazuju simptome bolesti jetre preporučena doza ista je kao i za odrasle.
English: Special populations
Croatian: Posebne populacije Stariji bolesnici
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.There are also links to other websites about rare diseases and treatments.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Common (may affect up to 1 in 10 people) - Nausea (especially when starting treatment)
Croatian: - Mučnina (posebice prilikom započinjanja liječenja)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule:
English: No interaction studies have been performed on the concomitant administration of trientine with DPenicillamine.
Croatian: Druge tvari koje snižavaju bakar Nisu provedena ispitivanja interakcija u pogledu istodobne primjene trientina s D-penicilaminom.
English: Uncommon: Anaemia Uncommon: Aplastic anaemia Uncommon: Sideroblastic anaemia
Croatian: Manje često: anemija Manje često: aplastična anemija
English: Capsule content:
Croatian: - Drugi sastojci su Sadržaj kapsule:
English: Unabsorbed trientine is bound to intestinal copper and eliminated through faecal excretion.
Croatian: Neapsorbirani trientin veže se za bakar u probavnom traktu i eliminira izlučivanjem u stolici.
English: There is limited information in patients with hepatic impairment.
Croatian: Za bolesnike s oštećenjem funkcije bubrega podaci su ograničeni.
English: Each hard capsule contains 300 mg trientine dihydrochloride equivalent to 200 mg trientine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 300 mg trientindiklorida, što je ekvivalentno 200 mg trientina.
English: Q4 2022 PK/PD substudy
Croatian: Farmakokinetičko/ farmakodinamičko (PK/PD) podispitivanje
English: What Cufence is and what it is used for What you need to know before you take Cufence How to take Cufence
Croatian: Što morate znati prije nego počnete uzimati Cufence 3.
English: Therefore the recommended dose in patients with hepatic impairment is the same as for adults.
Croatian: Stoga je u bolesnika s oštećenjem funkcije bubrega preporučena doza ista kao i za odrasle.
English: Uncommon: Rash
Croatian: Manje često: osip
English: Therefore, the recommended dose in patients with renal impairment is the same as for adults.
Croatian: Preporučene doze iste su kao i za odrasle.
English: Colloidal anhydrous silica
Croatian: Manje često: sideroblastična anemija
English: Date of first authorisation: 29 March 2017
Croatian: Datum prvog odobrenja: 29. ožujka 2017.
English: Ask your doctor for advice.
Croatian: Pitajte svojeg liječnika za savjet.
English: This leaflet was last revised in
Croatian: Ova uputa zadnji je puta revidirana u
English: You must talk to a doctor if you do not feel better or if you feel worse
Croatian: Morate se obratiti liječniku ako se ne osjećate bolje ili ako se osjećate lošije.
English: Contains E214 and E219.
Croatian: Sadrži E214 i E219.
English: − weakness in movements, also only limited to the left or right side of the body
Croatian: − slabost pri pokretima, također ograničeno samo na lijevu ili desnu stranu tijela
English: From the date of notification of the Commission Decision*
Croatian: Od datuma obavijesti o odluci Komisije*
English: The doctor will decide whether any treatment is needed.
Croatian: Liječnik će odlučiti je li potrebno bilo kakvo liječenje.
English: *Referral EMEA/H/A-31/1463
Croatian: * Postupak upućivanja EMEA/H/A-31/1463
English: Never change the dose on your own.
Croatian: Nikada sami ne mijenjajte dozu.
English: This event may also be associated with vasculitis and other comorbidities.
Croatian: Ovaj događaj također se može povezati s vaskulitisom i ostalim komorbiditetima.
English: See also section 4 “Possible side effects”.
Croatian: Pogledajte također dio 4 “Moguće nuspojave”.
English: Most adverse reactions are reversible if they are detected early.
Croatian: Većina nuspojava je reverzibilna ako se otkriju rano.
English: Therefore you must ensure that you are taking effective contraception for the whole of this period (see also section "Warnings and precautions").
Croatian: Stoga morate biti sigurni da primjenjujete učinkovitu kontracepciju cijelo ovo razdoblje (pogledajte također dio "Upozorenja i mjere opreza").
English: Do not miss your blood test appointments.
Croatian: Nemojte propuštati zakazane pretrage krvi.
English: Do not use Jylamvo if you are trying to become pregnant.
Croatian: Ne uzimajte Jylamvo ako pokušavate zatrudnjeti.
English: − small red spots on the skin
Croatian: − male crvene mrlje na koži
English: After first opening, throw away any unused medicine after 3 months.
Croatian: Nakon prvog otvaranja, bacite sav neiskorišteni lijek nakon 3 mjeseca.
English: Medical staff and patients must be clearly instructed.
Croatian: Medicinsko osoblje i bolesnici moraju dobiti jasne upute.
English: Jylamvo is for use in the following indications:
Croatian: Jylamvo se primjenjuje u sljedećim indikacijama: