natgillin/translations-raw huggingface dataset:
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).
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).
If you forget to take Cufence
Ako ste zaboravili uzeti Cufence
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.
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.
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.
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.
Therefore, monitoring for manifestations of overtreatment should be undertaken.
Stoga je potrebno uspostaviti praćenje zbog moguće pojave manifestacija prekomjernog liječenja.
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).
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).
There are only limited data on concomitant use available and no specific dose recommendations can be made.
O istodobnoj upotrebi dostupni su samo ograničeni podaci te nije moguće dati posebnu preporuku o doziranju.
Not known: Lupus-like syndrome
Nepoznato: sindrom nalik na lupus
There is limited clinical data suggesting that trientine is not excreted in breast milk.
Postoje ograničeni klinički podaci koji sugeriraju da se trientin ne izlučuje u majčino mlijeko.
Some positive in vitro mutagenicity data were obtained but in vivo test systems showed no mutagenic activity.
Dobiveni su određeni pozitivni in vitro mutagenski podaci, ali ispitni in vitro sustavi nisu pokazali nikakvu mutagensku aktivnost.
EU/1/19/1365/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1365/001
If you take more medicine than you should, you may get nausea, vomiting and dizziness.
Ako uzmete više lijeka Cufence nego što ste trebali Uzmete li više lijeka nego što ste trebali, možete osjećati mučninu ili omaglicu ili povraćati.
Medicines should not be disposed of via wastewater or household waste.
Nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
Your doctor will decide which treatment and which dose is best in your situation.
Vaš će liječnik odlučiti koje je liječenje i doza najbolja u Vašoj situaciji.
Elimination Trientine and its metabolites are rapidly excreted in the urine.
Eliminacija Trientin i pripadajući metaboliti brzo se izlučuju u urin.
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.
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.
No specific food interaction studies in humans have been performed with trientine.
Nisu provedena specifična ispitivanja interakcija hrane s trientinom u ljudi.
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).
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).
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.
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.
The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Trudnoću treba pomno pratiti da bi se otkrile moguće abnormalnosti fetusa i procijenile razine bakra u serumu majke tijekom trudnoće.
Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Njemačka
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.
Ne preporučuje se kombinacija trientina s cinkom s obzirom da je interakcija cinka s trientinom vjerojatna, što smanjuje učinak obje djelatne tvari.
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).
Preporučene doze lijeka Cufence izražene su u mg baze trientina (tj. ne u mg soli trientindiklorida) (vidjeti dio 4.4).
If you notice these whilst taking Cufence, you must tell your doctor immediately.
Ako što od toga zamijetite tijekom uzimanja lijeka Cufence, smjesta obavijestite svog liječnika.
It is important to tell your doctor if you are breast-feeding or plan to do so.
Važno je da svom liječniku kažete ako dojite ili ako planirate dojiti.
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.
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.
Therefore, iron supplementation may be necessary in some cases.
Stoga će u određenim slučajevima možda biti potrebno uzimanje nadomjestaka željeza.
The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Dozu trientina koja se koristi potrebno je prilagoditi kako bi se razine bakra u serumu održale unutar normalnog raspona.
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.
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.
Nausea can commonly occur on initial treatment and occasionally skin rash can occur.
Mučnina je česta nuspojava prilikom početnog liječenja, a povremeno se može pojaviti i kožni osip.
In cases up to 20 g of trientine base there were no apparent adverse effects reported.
U slučajevima predoziranja dozama do 20 g baze trientina, nisu zabilježene vidljive nuspojave.
Propylene glycol Titanium dioxide (E171) Iron oxide black (E172) Iron oxide yellow (E172)
Tinta za označavanje: šelak propilenglikol titanijev dioksid (E171) željezov oksid crni (E172) željezov oksid žuti (E172)
Trientine is not likely to have an effect on your ability to drive or use machines.
Nije vjerojatno da će trientin imati učinak na Vašu sposobnost upravljanja vozilima i strojevima.
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).
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,
Common: Nausea Not known: Colitis Not known: Duodenitis
Često: mučnina Nepoznato: kolitis Nepoznato: duodenitis
Trientine has no or negligible influence on the ability to drive and use machines.
Trientin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
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.
It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects.
Namijenjen je primjeni u bolesnika koji ne mogu uzimati drugi lijek, D-penicilamin, zbog nuspojava.
Close monitoring is required to optimise the dose or adapt treatment if necessary (see section 4.4).
Potrebno je pomno praćenje radi optimizacije doze ili prilagodbe liječenja po potrebi (vidjeti dio 4.4).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
The combination of trientine with zinc is not recommended.
Ne preporučuje se kombinacija trientina s cinkom.
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.
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.
Close monitoring of renal and/or liver function is also recommended in these patients (see section 4.2).
U ovih se bolesnika također preporuča pomno praćenje funkcije jetre i/ili bubrega (vidjeti dio 4.2).
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.
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.
Trientine doses should be reduced to a more tolerable dose and may be increased again, once side effects have been resolved.
Doze trientina potrebno je smanjiti na podnošljivije doze, a njihovo je povećavanje dopušteno jednom kada se nuspojave povuku.
The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Dozu bi trebalo prilagoditi prema kliničkom odgovoru; na početku terapije primjenjuje se 400-1000 mg (vidjeti dio 4.4).
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.
Pri početku kelacijske terapije može doći do pogoršanja neuroloških simptoma zbog viška slobodnog bakra u serumu tijekom početnog odgovora na liječenje.
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.
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.
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 je kelator s poliaminskom strukturom, a bakar kelira formiranjem stabilnog kompleksa s četiri sastavna dušika u planarnom prstenu.
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).
Iako nema dokaza da antacidi kalcija i magnezija mijenjaju djelotvornost trientina, dobra je praksa odvojiti njihovu primjenu (vidjeti dio 4.4).
Trientine is metabolised by acetylation via spermidine/spermine N-acetyltransferase and not via N-acetyltransferase 2.
Trientin se metabolizira acetilacijom putem spermidin/spermin N-acetiltransferaze, a ne putem N-acetiltransferaze 2.
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).
Početna doza obično treba odgovarati najnižoj preporučenoj dozi te se nakon toga treba prilagođavati u skladu s bolesnikovim kliničkim odgovorom (vidjeti dio 4.4).
Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.
Bebe rođene majkama na liječenju trientinom potrebno je pratiti radi razina bakra u serumu i ceruloplazmina gdje je to potrebno.
Cufence attaches to the copper, which is then passed from the body.
Cufence veže za sebe bakar, koji se potom izlučuje iz tijela.
In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
U slučaju predoziranja potrebno je bolesnika držati na promatranju, izvršiti odgovarajuću biokemijsku analizu i pružiti simptomatsku terapiju.
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.
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.
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).
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).
Following oral administration, trientine absorption is low and variable in patients with Wilson's disease.
Apsorpcija trientina nakon peroralne primjene slaba je i varijabilna u bolesnika s Wilsonovom bolesti.
When trientine doses are adjusted this should be done in small steps.
Doze trientina potrebno je prilagođavati u malenim koracima.
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)
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).
It is advised, however, to monitor patients presenting with hepatic symptoms every two to three weeks after initiation of treatment with Cufence.
Međutim, savjetuje se nadzor bolesnika koji primarno pokazuju simptome bolesti jetre svaka dva do tri tjedna nakon započinjanja liječenja lijekom Cufence.
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).
Nema dokaza da kalcijevi i magnezijevi antacidi mijenjaju djelotvornost trientina, ali je preporučljivo odvojiti njihovu primjenu (vidjeti dio 4.5).
Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Trientin može također kelirati bakar u probavnom traktu i tako inhibirati apsorpciju bakra.
Trientine is absorbed with tmax occurring between 0.5 and 4 hours post-dose in healthy volunteers and patients.
Trientin se u zdravih dobrovoljaca i bolesnika apsorbira s tmax između 0,5 i 4 sata nakon uzimanja doze.
Titanium dioxide (E171)
Ovojnica kapsule: želatina titanijev dioksid (E171)
MedDRA- system organ class database
MedDRA - klasifikacija organskih sustava Nuspojave
Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Svaka tvrda kapsula bijela je i ovalnog oblika veličine 0, s oznakom „Cufence 200” otisnutom sivom tintom.
CARTON/BOTTLE
KUTIJA/BOČICA
Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
Bočica boje jantara s kapicom od polipropilena i indukcijski zavarenom zaštitnom folijom s vrećicom suhog silikagela koji se koristi kao sredstvo za sušenje.
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).
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).
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).
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).
Iron supplementation may be necessary in some cases.
U određenim će slučajevima možda biti potrebno uzimati nadomjestke željeza.
In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor.
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.
Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Manje često: distonija Manje često: tremor Nepoznato: disartrija Nepoznato: ukočenost mišića Nepoznato: neurološko pogoršanje
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.
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.
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).
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).
Your doctor will advise you which treatment and which dose is best in your situation.
Vaš će Vas liječnik savjetovati o liječenju i dozi koji bi bili najbolji u Vašoj situaciji.
Pack size: 1 bottle of 100 hard capsules.
Veličina pakiranja: 1 bočica sa 100 tvrdih kapsula.
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.
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.
Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
- Kožni osip - Anemija (možete se osjećati neuobičajeno umornima)
In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
U pasa su zamijećene ataksija, tremor, nenormalan hod i umanjena aktivnost nakon primjene izrazito visokih razina trientina.
White, oval-shaped size 0 capsule printed with ‘Cufence 200' in grey ink.
Bijela kapsula ovalnog oblika veličine 0, s oznakom „Cufence 200” otisnutom sivom tintom.
Pregnancy There is a limited amount of data from the use of trientine in pregnant women.
Trudnoća Podaci o primjeni trientina u trudnica su ograničeni.
Do not use after the expiry date which is stated on the bottle label and outer carton.
Ovaj se lijek ne smije upotrebljavati nakon isteka roka valjanosti navedenog na naljepnici na bočici i vanjskoj kutiji iza oznake EXP.
Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
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.
How to take Cufence
Kako uzimati Cufence