natgillin/translations-raw huggingface dataset:
The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Odmerek trientina je treba prilagoditi tako, da se serumske ravni bakra ohranjajo v normalnem razponu.
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.
Trientin kaže majhno vezavo na beljakovine v plazmi in je obsežno porazdeljen v tkivih, z relativno visokimi koncentracijami, izmerjenimi v jetrih, srcu in ledvicah pri podganah.
Store in the original container in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
V primeru prevelikega odmerka moramo bolnika opazovati, opraviti ustrezno biokemijsko analizo in dati simptomatsko zdravljenje.
It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects.
Uporabljajo ga bolniki, ki zaradi neželenih učinkov ne morejo jemati drugega zdravila, imenovanega D-penicilamin.
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.
Zdravnik vam bo nato pomagal, da se odločite, ali boste prenehali dojiti ali prenehali jemati zdravilo Cufence, in sicer ob upoštevanju koristi dojenja za otroka in koristi zdravila Cufence za vas.
Trientine should be used in pregnancy only after careful consideration of the benefits compared with the risks of discontinuing treatment in the individual patient.
V nosečnosti se sme trientin uporabljati le po natančni proučitvi razmerja med koristmi in tveganji prekinitve zdravljenja pri posamezni bolnici.
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).
Obstajajo poročila o nevrološkem poslabšanju na začetku zdravljenja bolnikov z Wilsonovo boleznijo, ki so se zdravili z bakrovimi kelatorji, vključno s trientinom, s simptomi, kot so distonija, togost, tremorj in dizartrija (glejte poglavje 4.2).
Q4 2022 PK/PD substudy
4. trimesečje 2022 podštudija FK/FD
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.
Pri bolnikih, ki so se predhodno zdravili z D-penicilaminom, so pri kasnejšem zdravljenju s trientinom poročali reakcijah, podobnih lupusu, vendar vzročne povezave s trientinom ni mogoče ugotoviti.
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).
Vendar pa je treba povečevanje odmerka opraviti zmerno in premišljeno ter ga prilagoditi glede na klinični odziv bolnika, kot je poslabšanje tremorja, saj lahko na začetku zdravljenja obstaja tveganje za poslabšanje nevrološkega stanja (glejte poglavje 4.4).
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.
Doslej niso bila opravljena dolgoročna preskušanja karcinogenosti pri živalih s trientinom po peroralni poti, vendar po dermalni poti ni bilo povečanja pojanvosti raka nad izhodišče.
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.
Kombinacija trientina s cinkom ni priporočljiva, ker je verjetno, da bo interakcija cinka s trientinom zmanjšala učinek obeh učinkovin.
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.
Bolniki, ki prejemajo zdravilo Cufence, morajo biti pod rednim zdravniškim nadzorom, pri spremljanju pa je treba uporabiti vse razpoložljive klinične podatke za ustrezen nadzor kliničnih simptomov in ravni bakra, da se optimizira zdravljenje.
Occasional cases of trientine overdose have been reported.
Opisani so občasni primeri prevelikega odmerjanja trientina.
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.
Na splošno velja, da je pri izboru odmerka potrebna previdnost, zato običajno začnemo z najmanjšim priporočljivim odmerkom za odrasle, zaradi bolj pogoste zmanjšane jetrne, ledvične ali srčne funkcije ter sočasnih bolezni ali zdravljenja z drugimi zdravili.
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.
Učinki v predkliničnih študijah so bili v veliki meri skladni z induciranim pomanjkanjem bakra v plazmi in jetrih živali s predhodno normativnimi vrednostmi bakra in se kot taki lahko pripišejo farmakološkemu delovanju trientina.
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.
pretežno jetrnimi, nevrološkimi ali psihiatričnimi simptomi ter pri pediatričnih bolnikih mora imetnik dovoljenja za promet z zdravilom pridobiti in predložiti rezultate odprte prospektivne študije za raziskovanje kliničnega poteka jetrne, nevrološke in psihiatrične bolezni od začetka zdravljenja s trientinijevim dikloridom do največ 24 mesecev zdravljenja.
Elimination Trientine and its metabolites are rapidly excreted in the urine.
Trientin in njegovi presnovki se hitro izločajo z urinom.
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.
Pri brejih živalih so veliki odmerki trientina, povezani s pomembnim zmanjšanjem serumskega bakra, pokazali zgodnji učinek na preživetje zarodkov in nekoliko manjšo maso ploda.
If you forget to take Cufence
Če ste pozabili vzeti zdravilo Cufence
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).
Trientinijev diklorid je znano dražilen, zlasti za sluznice, zgornje dihalne poti in kožo, ter povzroča preobčutljivost kože pri budrah, miših in človeku (OECD SIDS trietilentetramin 2002).
The usual dose is between 4 and 8 capsules per day, to be taken by mouth.
Običajen odmerek je od 4 do 8 kapsul na dan, ki jih je treba jemati peroralno.
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.
Če se po analizi tveganja in koristi zdravljenje s trientinom nadaljuje, je treba razmisliti o zmanjšanju odmerka trientina na najmanjši učinkoviti odmerek in spremljati, ali se bolnik drži režima zdravljenja.
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).
Začetni odmerek običajno ustreza najmanjšemu priporočljivemu odmerku in ga je treba naknadno prilagoditi glede na bolnikov klinični odziv (glejte poglavje 4.4).
Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
Zdravljenje z zdravilom Cufence sme uvesti le zdravnik specialist z izkušnjami z zdravljenjem Wilsonove bolezni.
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).
Pogostejše spremljanje je priporočljivo v začetni fazi zdravljenja in med fazami napredovanja bolezni ali kadar se izvede prilagoditev odmerka, kot določi zdravnik (glejte poglavje
Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
Prekomerno obdelavo in odvečno odstranjevanje bakra lahko spremljamo z vrednostmi izločanja bakra v urinu in bakra, ki ni vezan na ceruloplazmin.
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.
Odločiti se je treba, ali je treba prenehati z dojenjem ali prenehati/prekiniti zdravljenje s trientinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
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.
Trientin je kelator, selektiven za baker, ki izboljša sistemsko izločanje dvovalentnega bakra s tvorbo stabilnega kompleksa, ki ga ledvice hitro izločajo.
If you stop taking Cufence
Če ste prenehali jemati zdravilo Cufence
Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
Steklenica iz jantarnega stekla s polipropilenskim pokrovčkom in indukcijsko toplotno zavarjenim tesnilom, z vrečico suhega silikagela kot sušilnim sredstvom.
Close monitoring is required to optimise the dose or adapt treatment if necessary (see section 4.4).
Za optimizacijo odmerka ali po potrebi prilagoditev zdravljenja je potreben natančen nadzor (glejte poglavje 4.4).
Close monitoring of renal and/or liver function is also recommended in these patients (see section 4.2).
Pri teh bolnikih je priporočljivo natančno spremljanje delovanja ledvic in/ali jeter (glejte poglavje 4.2).
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).
Sočasno uporabljenoperoralno uporabo železa ali drugih težkih kovin je treba izvajati ob drugem času kot trientin, da se prepreči nastanek kompleksov (glejte poglavje 4.4).
Duodenitis and severe colitis have been reported.
Poročali so o duodenitisu in hudem kolitisu.
It is important to tell your doctor if you are breast-feeding or plan to do so.
Pomembno je, da zdravniku poveste, če dojite ali nameravate dojiti.
Patients with renal and/or hepatic impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Bolniki z okvaro ledvic in/ali jeter, ki prejemajo trientin, morajo biti pod stalnim zdravniškim nadzorom za ustrezen nadzor simptomov in ravni bakra.
Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.
Pri dojenčkih, ki se rodijo materam, zdravljenim s trientinom, je treba po potrebi spremljati serumske ravni bakra in ceruloplazminske ravni.
Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Vsaka trda kapsula je bela, ovalne velikosti 0 in ima siv napis Cufence 200.
Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
šelak propilenglikol titanov dioksid (E171) črni železov oksid (E172) rumeni železov oksid (E172)
What Cufence is and what it is used for
Kaj je zdravilo Cufence in za kaj ga uporabljamo 2.
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).
Ni dokazov, da kalcijevi in magnezijevi antacidi spreminjajo učinkovitost trientina, vendar je priporočljivo ločiti njihovo jemanje (glejte poglavje 4.5).
What Cufence looks like and contents of the pack
Izgled zdravila Cufence in vsebina pakiranja
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)
Ker je baker potreben za primerno rast in duševni razvoj, bo za preprečitev pomanjkanja bakra pri plodu odmerek morda treba prilagoditi, poleg tega je nujno natančno spremljanje bolnice (glejte poglavje 4.4).
The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Odmerek je treba prilagoditi kliničnemu odzivu; na začetku zdravljenja uporabimo odmerek med 400 in 1000 mg (glejte poglavje 4.4).
If you take more medicine than you should, you may get nausea, vomiting and dizziness.
Če ste vzeli večji odmerek zdravila Cufence, kot bi smeli Če ste vzeli več zdravila, kot bi smeli, boste morda izkusili slabost, bruhanje in omotico.
How to take Cufence
Kako jemati zdravilo Cufence
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).
Čeprav ni dokazov, da kalcijevi in magnezijevi antacidi spreminjajo učinkovitost trientina, je dobro ločiti njihovo dajanje (glejte poglavje 4.4).
Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.
Kaj je zdravilo Cufence in za kaj ga uporabljamo Zdravilo Cufence je zdravilo za zdravljenje Wilsonove bolezni pri odraslih, mladostnikih in otrocih, starih 5 let ali več.
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.
Priporočljivo je tudi spremljati bolnike z nevrološkimi simptomi enkrat na teden ali enkrat na dva tedna po začetku zdravljenja z zdravilom Cufence, dokler ni dosežen ciljni odmerek.
White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
Bela ovalna kapsula velikosti 0 z napisom »Cufence 200« v sivi barvi.
Trientine has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Trientin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
There was no evidence of embryo-foetal toxicity at lower dose levels despite dose-related reductions in serum copper.
Pri nižjih odmerkih ni bilo dokazov o toksičnosti za zarodek in plod, kljub znižanju ravni serumskega bakra, odvisnega od odmerka.
Cufence attaches to the copper, which is then passed from the body.
Zdravilo Cufence se veže na baker, ki se nato izloči iz telesa.
Other products
Druga zdravila
Following oral administration, trientine absorption is low and variable in patients with Wilson's disease.
Po peroralni uporabi je pri bolnikih z Wilsonovo boleznijo absorpcija trientina majhna in variabilna.
Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Trientin lahko prav tako kelira baker v prebavnem traktu in na ta način zavira absorpcijo bakra.
Trientine is absorbed with tmax occurring between 0.5 and 4 hours post-dose in healthy volunteers and patients.
Pri zdravih prostovoljcih in bolnikih se trientin absorbira z vrednostjo tmax med 0,5 in 4 urami po odmerku.
In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor.
Uporaba pri otrocih in mladostnikih (od 5 do 17 let) Pri otrocih in mladostnikih je odmerek odvisen od starosti in telesne mase, zdravnik pa ga bo prilagodil.
Nausea can commonly occur on initial treatment and occasionally skin rash can occur.
Na začetku zdravljenja se lahko pojavi navzea, včasih pa se lahko pojavijo tudi kožni izpuščaji.
Cufence contains the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body.
Zdravilo Cufence vsebuje učinkovino trientin, kelator bakra, ki se uporablja za izločanje presežka bakra iz telesa.
Trientine is acetylated in two major metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Biotransformacija Trientin se acetilira v dva glavna presnovka, N(1)-acetiltrietilentetramin (MAT) in
Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
- kožni izpuščaji - slabokrvnost (morda se boste počutili nenavadno utrujeni)
Concomitant oral iron should be administred at a different time than trientine (see section 4.5).
Peroralno železo, ki se uporablja istočasno, je treba vzeti ob drugem času kot trientin (glejte poglavje 4.5).
The measurement of copper excretion in the urine may be performed during therapy.
Med zdravljenjem je mogoče izvajati merjenje izločanja bakra z urinom.
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.
Ob začetku kelacijskega zdravljenja se lahko zaradi presežka prostega bakra v serumu med začetnim odzivom na zdravljenje pojavi poslabšanje nevroloških simptomov.
Pack size: 1 bottle of 100 hard capsules.
Velikost pakiranja: 1 steklenica s 100 trdimi kapsulami.
Pack size: one bottle of 100 hard capsules.
Velikost pakiranja: ena steklenica s 100 trdimi kapsulami.
No interaction studies have been performed on the concomitant administration of trientine with DPenicillamine.
Študij medsebojnega delovanja s sočasno uporabo trientina z D-penicilaminom niso izvedli.
Trientine is a chelating agent which has been found to reduce serum iron levels.
Trientin je kelator, ki dokazano zmanjšuje raven železa v serumu.
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.
Zdravilo Cufence je indicirano za zdravljenje Wilsonove bolezni pri odraslih, mladostnikih in otrocih, starih 5 let ali več, ki ne prenašajo zdravljenja z D-penicilaminom.
Trientine has been found to reduce serum iron levels.
Trientin dokazano znižuje raven železa v serumu.
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.
Predklinični podatki na osnovi različnih študij farmakološke kardiovaskularne varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na embriofetalni razvoj ne kažejo posebnega tveganja za človeka.
Uncommon: Anaemia Uncommon: Aplastic anaemia Uncommon: Sideroblastic anaemia
Občasni: anemija Občasni: aplastična anemija Občasni: sideroblastna anemija
Trientine is not likely to have an effect on your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi trientin vplival na vašo sposobnost upravljanja vozil in strojev.
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).
- trdovratna driska - težave z živčnim sistemom (npr. tresenje, pomanjkanje koordinacije, nerazumljiv govor, togost mišic, poslabšanje mišičnih krčev).
If you become pregnant whilst taking Cufence, talk to your doctor.
Če med zdravljenjem z zdravilom Cufence zanosite, se posvetujte z zdravnikom.
Magnesium stearate Colloidal anhydrous silica
magnezijev stearat koloidni brezvodni silicijev dioksid
Each capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.
Ena kapsula vsebuje 300 mg trientinijevega diklorida, kar ustreza 200 mg trientina.
Common: Nausea Not known: Colitis Not known: Duodenitis
Neznana pogostnost: kolitis Neznana pogostnost: duodenitis
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule:
Each hard capsule contains 300 mg trientine dihydrochloride equivalent to 200 mg trientine.
Ena trda kapsula vsebuje 300 mg trientinijevega diklorida, kar ustreza 200 mg trientina.
The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Za ugotovitev možnih nepravilnosti pri plodu in spremljanje serumskih ravni bakra pri materi v nosečnosti je treba nosečnost skrbno spremljati.
PAES: In order to further characterise the efficacy of trientine dihydrochloride in the treatment of Wilson's disease in patients with predominantly hepatic,
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo karakterizacijo učinkovitosti trientinijevega diklorida za zdravljenje Wilsonove bolezni pri bolnikih s
100 capsules
trda kapsula 100 kapsul
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.
V primeru znakov zmanjšane učinkovitosti, kot so (vztrajno) zvišanje ravni jetrnih encimov in poslabšanje tremorja, je treba razmisliti o prilagoditvi odmerka trientina.
Cufence 200 mg hard capsules trientine
Cufence 200 mg trde kapsule trientin
There is limited information in patients with renal impairment.
Podatkov o uporabi zdravila pri bolnikih z okvaro ledvic je malo.
Unabsorbed trientine is bound to intestinal copper and eliminated through faecal excretion.
Neabsorbirani trientin se veže na črevesni baker in se izloči z blatom.
Therefore the recommended dose in patients with hepatic impairment is the same as for adults.
Priporočen odmerek pri bolnikih s simptomi okvare jeter je enak priporočenemu odmerku za odrasle.
Not known: Lupus-like syndrome
Neznana pogostnost: lupusu podoben sindrom Neznana pogostnost: lupusni nefritis
In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
Pri psih so po uporabi zelo visokih ravni trientina opazili ataksijo, tremor, nenormalno hojo in zmanjšano aktivnost.
Common (may affect up to 1 in 10 people) - Nausea (especially when starting treatment)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
Cufence 200 mg hard capsules
Cufence 200 mg trde kapsule
There is limited information in patients with hepatic impairment.
Podatkov o uporabi zdravila pri bolnikih z okvaro jeter je malo.
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.
baker pa se kelira tako, da tvori stabilen kompleks s štirimi atomi dušika v planarnem obroču.
How to store Cufence
Shranjevanje zdravila Cufence
Other anti-copper agents
Druga zdravila proti bakru
Hepatic impairment
nevrološko poslabšanje
STATEMENT OF ACTIVE SUBSTANCE(S)
N(1)N(10)-diacetiltrietilentetramin (DAT).
Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and
Spodnja tabela je v skladu s klasifikacijo organskih sistemov po MedDRA (po organskih sistemih in ravni prednostnih izrazov).
Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Neznana pogostnost: disartrija Neznana pogostnost: togost mišic
Always take this medicine exactly as your doctor or pharmacist has told you.
Kako jemati zdravilo Cufence Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
Patients primarily presenting neurological symptoms Dose recommendations are the same as for adults.
Bolniki, ki kažejo predvsem nevrološke simptome