natgillin/translations-raw huggingface dataset:
You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Vi i Vaš liječnik trebate detaljno razmotriti moguće koristi liječenja, ali istovremeno uzeti u obzir moguće rizike.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Učestalost se određuje kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.
OPA/Al/PVC-Al blisteri, svaki blister sadrži 8 filmom obloženih tableta.
However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.
Međutim, nije bilo moguće utvrditi je li reakcija uzrokovana trientinom ili prethodnim liječenjem penicilaminom.
Children ≥ 5 years
Djeca ≥ 5 godina
Your doctor will tell you how many tablets you should take and how often in the day.
Liječnik će vam reći koliko tableta trebate uzeti i koliko često tijekom dana.
If this happens, you must tell your doctor.
Ako se to dogodi, obavijestite svog liječnika.
This means that the small amounts of copper from food and drink build up to excessive levels and can lead to liver damage and problems in the nervous system.
To znači da se male količine bakra iz hrane i vode nakupljaju do prekomjerne razine i mogu dovesti do oštećenja jetre i problema u živčanom sustavu.
Warnings and precautions Talk to your doctor or pharmacist before taking Cuprior.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Cuprior.
In particular, you must tell your doctor if you are already taking iron supplements or if you take indigestion remedies (medicines that reduce discomfort after eating).
Posebice morate reći liječniku ako već uzimate nadomjestke željeza ili lijekove za probavu (lijekovi koji smanjuju nelagodu nakon jela).
There are only limited data on concomitant use available and no specific dose recommendations can be made.
O istodobnoj uporabi dostupni su samo ograničeni podatci te preporuka specifične doze nije moguća.
Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration.
Iako nema dokaza da antacidi kalcija ili magnezija mijenjaju djelotvornost trientina, dobra je praksa odvojiti njihovu primjenu.
The overall pharmacokinetic profiles were similar between males and females, although males had higher levels of trientine.
Ukupni farmakokinetički profili bili su slični u žena i muškaraca, iako su muškarci imali više razine trientina.
The dose that you will take is usually lower than for an adult and depends on your age and body weight.
Doza koju ćete uzeti obično je manja od doze za odrasle i ovisi o vašoj dobi i tjelesnoj težini.
However, no food interaction studies have been performed and so the extent of the food effect on systemic trientine exposure is unknown.
Međutim, nisu provedena ispitivanja interakcija s hranom, tako da je opseg učinka hrane na sistemsku izloženost trientinu nepoznat.
What Cuprior contains
Što Cuprior sadrži
Repeat dose toxicity
Toksičnost ponovljene doze
Common (may affect up to 1 in 10 people)
Česte (mogu se pojaviti u do 1 na 10 osoba)
Once you have started the treatment, your doctor may adjust the dose based on the response to treatment.
Nakon što započnete liječenje, liječnik vam može prilagoditi dozu na temelju odgovora na liječenje.
Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could still be detected in the plasma after 20 hours.
Trientin i njegovi metaboliti brzo se izlučuju u urin, iako se niske razine trientina u plazmi mogu uočiti i nakon 20 sati.
The film-coated tablets should be swallowed with water.
Filmom obložene tablete treba progutati s vodom.
The trientine plasma concentration then declined in a multiphasic manner, initially rapidly, followed by a slower elimination phase.
Koncentracija trientina u plazmi zatim se smanjila u više faza, na početku brzo, nakon čega je slijedila faza sporije eliminacije.
Cuprior should only be used in pregnancy after careful consideration of the benefits compared with the risks of treatment in the individual patient.
Cuprior se u trudnoći smije primjenjivati samo nakon pažljivog razmatranja koristi u odnosu na rizike liječenja u pojedine bolesnice.
When your baby is born, the copper level in the baby's blood will also be monitored.
Nakon što rodite dijete, također će se pratiti razina bakra u djetetovoj krvi.
If you take these medicines you may need to take Cuprior at a different time in the day because otherwise Cuprior may not be as effective.
Ako uzimate te lijekove, možda ćete Cuprior trebati uzimati u drugo doba dana jer u suprotnom Cuprior neće biti jednako djelotvoran.
The most reliable index for monitoring therapy is the determination of serum free copper which is 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).
Najpouzdaniji pokazatelj za praćenje liječenja je određivanje slobodnog bakra u serumu čija se razina izračunava pomoću razlike ukupnog bakra i bakra vezanog za ceruloplazmin (normalna razina slobodnog bakra u serumu obično je 100 do 150 mikrograma/l).
No dose adjustment is required in elderly patients.
Prilagodba doze nije potrebna u starijih bolesnika.
What Cuprior is and what it is used for 2.
Što je Cuprior i za što se koristi 2.
Children aged < 5 years
Djeca < 5 godina
The aim of maintenance treatment is to maintain free copper levels in the serum within acceptable limits.
Cilj liječenja održavanja je održati razine slobodnog bakra u serumu u prihvatljivim granicama.
Cuprior is available in packs containing 72 or 96 film-coated tablets.
Cuprior je dostupan u pakiranjima koja sadrže 72 ili 96 filmom obloženih tableta.
Close monitoring is required to optimise the dose or to adapt treatment if necessary.
Potrebno je pažljivo praćenje radi optimizacije doze ili prilagodbe liječenja ako je potrebno.
Overtreatment carries the risk of copper deficiency.
Prekomjerno liječenje dovodi do rizika od nedostatka bakra.
This medicine may also reduce the level of iron in your blood and your doctor may prescribe iron supplements (see section “Other medicines and Cuprior” below).
Ovaj lijek može smanjiti i razinu željeza u krvi te vam liječnik može propisati nadomjestak željeza (vidjeti dio „Drugi lijekovi i Cuprior” u nastavku).
Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Trientin se acetilira u dva glavna metabolita, N(1)-acetiltrietilentetramin (MAT) i N(1),N(10)diacetiltrietilentetramin (DAT).
The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 600 mg and 750 mg trientine in healthy male and female subjects.
Farmakokinetički profil lijeka Cuprior procijenjen je nakon jedne oralne doze od 450, 600 mg i 750 mg trientina u zdravih ispitanika i ispitanica.
The measurement of copper excretion in the urine may be performed during therapy.
Mjerenje izlučivanja bakra u urinu može se provesti tijekom liječenja.
In vivo, trientine was however negative in the mouse micronucleus test.
Međutim, in vivo, trientin je bio negativan u mikronukleus testu u miševa.
Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
Cuprior je indiciran za liječenje Wilsonove bolesti u odraslih, adolescenata i djece ≥ 5 godina koji ne podnose liječenje D-penicilaminom.
This daily total will be divided into 2 to 4 smaller doses to be taken during the day.
Ta se ukupna dnevna doza treba podijeliti u 2 do 4 manje doze koje se uzimaju tijekom dana.
Factors which need to be born in mind include the risks associated with the disease itself, the risk of those alternative treatments which are available and the possible teratogenic effects of trientine (see section 5.3).
Čimbenici koje treba uzeti u obzir uključuju rizike povezane sa samom bolesti, rizike dostupnog zamjenskog liječenja i moguće teratogene učinke trientina (vidjeti dio 5.3).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODATCI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
Linearity/non-linearity Plasma exposures in humans have shown a linear relationship with oral doses of trientine.
Linearnost/nelinearnost Plazmatska izloženost u ljudi pokazala je linearnu povezanost s oralnim dozama trientina.
Since iron and trientine may inhibit absorption of each other, iron supplements should be taken after at least two hours have elapsed from the administration of trientine.
Budući da željezo i trientin mogu međusobno inhibirati apsorpciju, nadomjestak željeza treba uzimati najmanje dva sata nakon primjene trientina.
Wilson's disease is an inherited condition in which the body cannot transport copper around the body in the normal way or remove copper in the normal way as a secretion from the liver into the gut.
Wilsonova bolest nasljedni je poremećaj u kojem tijelo ne može na normalan način prenositi bakar ili ga uklanjati iz tijela normalnim putem, odnosno sekrecijom iz jetre u crijeva.
What Cuprior is and what it is used for
Što je Cuprior i za što se koristi
Plasma levels of trientine rose rapidly following administration with the median peak level reached after 1.25 to 2 hours.
Razine trientina u plazmi brzo su se povećale nakon primjene, pri čemu je medijan vršne razine dosegnut nakon 1,25 do 2 sata.
Fertility It is unknown whether trientine has an effect on human fertility.
Plodnost Nije poznato ima li trientin utjecaja na plodnost ljudi.
MAT may also participate to the overall clinical activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels remains to be determined.
MAT može također sudjelovati i u ukupnom kliničkom djelovanju lijeka Cuprior, međutim doprinos MAT-a u ukupnom učinku lijeka Cuprior na razine bakra još treba utvrditi.
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 pažljivo pratiti da bi se otkrile moguće abnormalnosti fetusa i procijenile razine bakra u serumu majke tijekom trudnoće.
The microscopic changes in lung were considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells.
Mikroskopske promjene na plućima smatraju se pokazateljima trajne upalne reakcije ili trajnog toksičnog učinka na alveolarne stanice.
Distribution Little is known on the distribution of trientine in organs and tissues.
O distribuciji trientina u organe i tkiva malo se zna.
What you need to know before you take Cuprior
Što morate znati prije nego počnete uzimati Cuprior
Cuprior is given to adults, adolescents and children aged 5 years and over who cannot tolerate another medicine that is used to treat this disease, called penicillamine.
Cuprior se daje odraslima, adolescentima i djeci u dobi od 5 godina i starijoj koji ne podnose drugi lijek za liječenje te bolesti koji se naziva penicilamin.
This medicine is not recommended for children aged below 5 years of age.
Ne preporučuje se uporaba lijeka u djece mlađe od 5 godina.
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.
U bolesnika koji su prethodno liječeni D-penicilaminom prijavljene su nuspojave slične lupusu tijekom kasnijeg liječenja trientinom, međutim nije moguće utvrditi postoji li uzročna veza s trientinom.
No specific dose adjustment is required in these patients (see section 4.4).
Nije potrebna posebna prilagodba doze u tih bolesnika (vidjeti dio 4.4).
Cuprior has no or negligible influence on the ability to drive and use machines.
Cuprior ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
It is very important to continue treatment to reduce copper during pregnancy.
Nastavak liječenja vrlo je važan radi smanjenja bakra u tijelu tijekom trudnoće.
Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion.
Trientin je sredstvo za kelaciju bakra, a njegov je glavni mehanizam djelovanja eliminacija apsorbiranog bakra iz tijela formiranjem stabilnog kompleksa koji se tada eliminira izlučivanjem putem urina.
Cuprior is a medicine used to treat Wilson's disease that contains the active substance trientine.
Cuprior je lijek koji se koristi za liječenje Wilsonove bolesti i sadrži djelatnu tvar trientin.
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.
Budući da kelacijska terapija dovodi do povećanja razine bakra u urinu, to može, ali i ne mora točno odraziti višak količine bakra u tijelu, no može biti korisna mjera za suradljivost u liječenju.
The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).
Preporučene doze lijeka Cuprior izražene su u mg baze trientina (tj. ne u miligramima soli trientintetraklorida).
If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.
Ako ste trudni i uzimate Cuprior, kontrolirat će Vas tijekom trudnoće radi mogućeg utjecaja lijeka na dijete ili promjene razine bakra.
Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use as follows:
Neklinički podaci dobiveni za trientin pokazali su nuspojave koje nisu opažene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnima kliničkim razinama izloženosti, a njihova moguća važnost za kliničku primjenu uključuje sljedeće:
50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human therapeutic exposures.
Utvrđen je NOAEL od 50 mg/kg na dan, što je rezultiralo granicama sigurnosti od otprilike 4 u mužjaka i 17 u ženki, u odnosu na terapijsku izloženost u ljudi.
The safety and efficacy of trientine in children aged < 5 years have not been established.
Sigurnost i djelotvornost trientina u djece mlađe od 5 godina nisu još utvrđene.
Your doctor will then help you decide whether to stop breast-feeding or to stop taking Cuprior, considering the benefit of breast-feeding to the baby and the benefit of Cuprior to the mother.
Liječnik će vam tada pomoći da odlučite hoćete li prestati dojiti ili prestati uzimati Cuprior, uzimajući u obzir korist dojenja za dijete i korist lijeka Cuprior za majku.
This maximises the absorption of trientine and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract.
To maksimalno povećava apsorpciju trientina i smanjuje vjerojatnost vezanja lijeka za metale u probavnom traktu.
The NOAEL was established at approximately 92 mg/kg/day for males and 99 mg/kg/day for females.
Utvrđena razina bez štetnih učinaka (NOAEL) iznosila je približno 92 mg/kg na dan za mužjake i 99 mg/kg na dan za ženke.
Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test and genotoxicity tests in mammalian cells.
Trientin je uglavnom pokazao pozitivne učinke u in vitro ispitivanjima genotoksičnosti, uključujući Amesov test i testove genotoksičnosti u stanicama sisavaca.
The starting dose in paediatrics is lower than for adults and depends on age and body weight.
Početna doza u pedijatrijskih bolesnika niža je od početne doze u odraslih i ovisi o dobi i tjelesnoj težini.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX12.
Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX12.
The film-coated tablet can be divided into equal doses.
Filmom obložena tableta se može razdijeliti na jednake doze.
If you take iron supplements, take them at least two hours after taking a dose of Cuprior.
Ako uzimate nadomjestak željeza, uzmite ga barem dva sata nakon što uzmete dozu lijeka Cuprior.
Worsening of clinical symptoms, including neurological deterioration, 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 kliničkih simptoma, uključujući neurološko pogoršanje, zbog viška slobodnog bakra u serumu tijekom početnog odgovora na liječenje.
Other medicines and Cuprior Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
There is no antidote for trientine acute overdose.
Ne postoji protulijek za akutno predoziranje trientinom.
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 nalik na lupus (simptomi mogu uključivati ustrajan osip, vrućicu, bol u zglobovima i umor) zabilježene su u nekih bolesnika koji su nakon primjene penicilamina počeli koristiti trientin.
In adults of all ages, the recommended total daily dose is 3 to 6½ tablets per day (making a total of between 450 and 975 mg).
U odraslih svih dobi, preporučena ukupna dnevna doza je od 3 do 6½ tableta dnevno (što čini ukupno između 450 i 975 mg).
Not known: duodenitis, colitis (including severe colitis).
Često: mučnina Nepoznato: duodenitis, kolitis (uključujući teški kolitis)
Not known: iron deficiency anaemia.
Nepoznato: anemija uzrokovana nedostatkom željeza
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cuprior 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 lijekom Cuprior, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Cuprior is for oral use.
Cuprior je za peroralnu primjenu.
Do not take Cuprior If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Ako ste alergični na trientin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Your doctor will carry out checks more frequently to ensure your copper levels are maintained at a suitable level for normal growth and mental development.
Liječnik će češće kontrolirati vaše razine bakra kako bi provjerio da se održavaju na odgovarajućoj razini za normalan rast i psihički razvoj.
As trientine is poorly absorbed following oral intake and the principal mechanism of action requires its systemic exposure (see section 5.1), it is important that the film-coated tablets are taken on empty stomach at least one hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section 4.2).
Budući da se trientin slabo apsorbira nakon peroralne primjene i da glavni mehanizam djelovanja zahtijeva sistemsku izloženost trientinu (vidjeti dio 5.1), važno je uzeti filmom obložene tablete na prazan želudac barem jedan sat prije obroka ili 2 sata nakon obroka te u razmaku od barem jednog sata od primjene bilo kojeg drugog lijeka, hrane ili mlijeka (vidjeti dio 4.2).
Dogs receiving oral doses of trientine up to 300 mg/kg/day, showed neurological and/or musculo-skeletal clinical symptoms (abnormal gait, ataxia, weak limbs, body tremors) in repeat-dose toxicity studies, attributed to the copper-depleting activity of trientine.
Psi koji su peroralno primali trientin u dozama do 300 mg/kg na dan pokazali su neurološke ili mišićno-koštane kliničke simptome (abnormalni hod, ataksija, slabost u udovima, tremor tijela) u ispitivanjima toksičnosti ponovljene doze, što je pripisano smanjenju razine bakra radi djelovanja trientina.
The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4).
Početna doza obično treba odgovarati najnižoj dozi u rasponu te bi se nakon toga trebala prilagođavati ovisno o kliničkom odgovoru bolesnika (vidjeti dio 4.4).
The absorption of trientine following oral administration is low and variable in patients with Wilson disease.
Apsorpcija trientina nakon peroralne primjene slaba je i varijabilna u bolesnika koji boluju od Wilsonove bolesti.
Tablets can be divided in half if needed.
Prema potrebi tablete se mogu podijeliti na pola.
If you were already taking another trientine medicine, your doctor may modify your daily dose, the number of tablets or the number of intake in the day when switching to Cuprior treatment.
Ako ste već uzimali neki drugi lijek koji sadrži trientin, liječnik vam može prilagoditi dnevnu dozu, broj tableta ili broj dnevnih unosa kada započnete terapiju lijekom Cuprior.
Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.
Žuta, duguljasta, filmom obložena tableta veličine 16 mm x 8 mm s urezom sa svake strane.
Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.
Kronično prekomjerno liječenje može dovesti do nedostatka bakra i reverzibilne sideroblastične anemije.
Taking into account that trientine has irritating properties, it was estimated that the observed chronic interstitial pneumonitis was explained by a cytotoxic effect of trientine upon accumulation into bronchiolar epithelial cells and alveolar pneumocytes.
Uzimajući u obzir da trientin ima nadražujuća svojstva, procijenjeno je da je primijećeni kronični intersticijski pneumonitis objašnjen citotoksičnim učinkom trientina nakon nakupljanja u stanicama bronhijalnog epitela i alveolarnim pneumocitima.
You can find the information also when flashing the QR code below with a smartphone or via the website QR code to be included http://www.cuprior.com
Podatke također možete pronaći na internetskim stranicama ili tako da putem pametnog telefona skenirate sljedeći QR kod treba navesti QR kod http://www.cuprior.com
Your doctor will regularly check your blood and urine to ensure that you receive the right dose of Cuprior to properly control your symptoms and copper levels.
Liječnik će vam redovito kontrolirati krv i mokraću kako bi se osiguralo da primate odgovarajuću dozu lijeka Cuprior koja će pravilno kontrolirati vaše simptome i razine bakra.
When switching a patient from another formulation trientine, caution is advised because doses expressed in trientine base may not be equivalent (see section 4.2).
Ako bolesnik koji je uzimao neku drugu formulaciju trientina počinje uzimati ovaj lijek, savjetuje se oprez jer doze izražene za trientin u obliku baze možda nisu ekvivalentne (vidjeti dio 4.2).
In silico data predict that trientine displays irritating and sensitising properties.
In silico podaci predviđaju da trientin pokazuje nadražujuća i senzibilizirajuća svojstva.
Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) and sodium laurilsulfate
Film ovojnica: poli(vinilni alkohol), talk, titanijev dioksid (E171), glicerolkaprilokaprat (vrsta I), žuti željezov oksid (E172) i natrijev laurilsulfat.