FrancophonIA/ELRC3.0 huggingface dataset:
English: 50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human therapeutic exposures.
Croatian: 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.
English: The safety and efficacy of trientine in children aged < 5 years have not been established.
Croatian: Sigurnost i djelotvornost trientina u djece mlađe od 5 godina nisu još utvrđene.
English: 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.
Croatian: 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.
English: This maximises the absorption of trientine and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract.
Croatian: To maksimalno povećava apsorpciju trientina i smanjuje vjerojatnost vezanja lijeka za metale u probavnom traktu.
English: The NOAEL was established at approximately 92 mg/kg/day for males and 99 mg/kg/day for females.
Croatian: Utvrđena razina bez štetnih učinaka (NOAEL) iznosila je približno 92 mg/kg na dan za mužjake i 99 mg/kg na dan za ženke.
English: Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test and genotoxicity tests in mammalian cells.
Croatian: Trientin je uglavnom pokazao pozitivne učinke u in vitro ispitivanjima genotoksičnosti, uključujući Amesov test i testove genotoksičnosti u stanicama sisavaca.
English: The starting dose in paediatrics is lower than for adults and depends on age and body weight.
Croatian: Početna doza u pedijatrijskih bolesnika niža je od početne doze u odraslih i ovisi o dobi i tjelesnoj težini.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX12.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX12.
English: The film-coated tablet can be divided into equal doses.
Croatian: Filmom obložena tableta se može razdijeliti na jednake doze.
English: If you take iron supplements, take them at least two hours after taking a dose of Cuprior.
Croatian: Ako uzimate nadomjestak željeza, uzmite ga barem dva sata nakon što uzmete dozu lijeka Cuprior.
English: 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.
Croatian: Pri početku kelacijske terapije može doći do pogoršanja kliničkih simptoma, uključujući neurološko pogoršanje, zbog viška slobodnog bakra u serumu tijekom početnog odgovora na liječenje.
English: Other medicines and Cuprior Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: There is no antidote for trientine acute overdose.
Croatian: Ne postoji protulijek za akutno predoziranje trientinom.
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 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.
English: 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).
Croatian: U odraslih svih dobi, preporučena ukupna dnevna doza je od 3 do 6½ tableta dnevno (što čini ukupno između 450 i 975 mg).
English: Not known: duodenitis, colitis (including severe colitis).
Croatian: Često: mučnina Nepoznato: duodenitis, kolitis (uključujući teški kolitis)
English: Not known: iron deficiency anaemia.
Croatian: Nepoznato: anemija uzrokovana nedostatkom željeza
English: 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.
Croatian: 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.
English: Cuprior is for oral use.
Croatian: Cuprior je za peroralnu primjenu.
English: Do not take Cuprior If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na trientin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: 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.
Croatian: Liječnik će češće kontrolirati vaše razine bakra kako bi provjerio da se održavaju na odgovarajućoj razini za normalan rast i psihički razvoj.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: The absorption of trientine following oral administration is low and variable in patients with Wilson disease.
Croatian: Apsorpcija trientina nakon peroralne primjene slaba je i varijabilna u bolesnika koji boluju od Wilsonove bolesti.
English: Tablets can be divided in half if needed.
Croatian: Prema potrebi tablete se mogu podijeliti na pola.
English: 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.
Croatian: 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.
English: Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.
Croatian: Žuta, duguljasta, filmom obložena tableta veličine 16 mm x 8 mm s urezom sa svake strane.
English: Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.
Croatian: Kronično prekomjerno liječenje može dovesti do nedostatka bakra i reverzibilne sideroblastične anemije.
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: In silico data predict that trientine displays irritating and sensitising properties.
Croatian: In silico podaci predviđaju da trientin pokazuje nadražujuća i senzibilizirajuća svojstva.
English: Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) and sodium laurilsulfate
Croatian: Film ovojnica: poli(vinilni alkohol), talk, titanijev dioksid (E171), glicerolkaprilokaprat (vrsta I), žuti željezov oksid (E172) i natrijev laurilsulfat.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti" odnosno „EXP“.
English: Pack size: 72 or 96 film-coated tablets.
Croatian: Veličina pakiranja: 72 ili 96 filmom obloženih tableta.
English: Close monitoring is required to optimise the dose or to adapt treatment if necessary (see section 4.4).
Croatian: Potrebno je pažljivo praćenje radi optimizacije doze ili prilagodbe liječenja po potrebi (vidjeti dio 4.4).
English: The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range.
Croatian: Dozu trientina treba prilagoditi kako bi se razine bakra u serumu održale u normalnom rasponu.
English: Iron supplements may be necessary in case of iron deficiency anaemia and should be administered at a different time (see section 4.5).
Croatian: U slučaju anemije uzrokovane nedostatkom željeza, možda će biti potrebno uzimati nadomjestke željeza, a treba ih uzimati u drugo vrijeme (vidjeti dio 4.5).
English: It may also attach to copper in the gut and so reduce the amount taken up into the body.
Croatian: Može se vezati za bakar i u crijevima i na taj način smanjiti količinu koju tijelo preuzima.
English: You should tell your doctor if you get any side effects as this may indicate that your dose of Cuprior needs to be adjusted up or down.
Croatian: Morate obavijestite svog liječnika u slučaju nuspojava jer to može ukazivati da dozu lijeka Cuprior treba povećati ili smanjiti.
English: If you have kidney problems, your doctor will regularly check that the treatment dose is appropriate and does not affect the functioning of your kidney.
Croatian: Ako imate problema s bubrezima, liječnik će redovito provjeravati je li vaša doza odgovarajuća i utječe li na rad bubrega.
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 ograničeni su.
English: If you take iron supplements, make sure that at least two hours have passed between taking Cuprior and taking your iron supplements.
Croatian: Ako uzimate nadomjestke željeza, provjerite jesu li prošla barem dva sata između uzimanja lijeka Cuprior i uzimanja nadomjestka željeza.
English: The pharmaceutical form is not suitable for administration to children < 5 years.
Croatian: Farmaceutski oblik nije prikladan za primjenu u djece mlađe od 5 godina.
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 prekomjerno uklanjanje bakra može se pratiti pomoću vrijednosti bakra koji se izlučuje urinom i bakra koji nije vezan za ceruloplazmin.
English: The most commonly reported adverse reaction with trientine is nausea.
Croatian: Najčešće prijavljena nuspojava pri primjeni trientina je mučnina.
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 psihički razvoj, možda će trebati prilagoditi dozu kako bi se osiguralo da u fetusa ne nastupi manjak bakra te je važno pažljivo pratiti bolesnicu (vidjeti dio 4.4).
English: Patients receiving Cuprior should remain under regular medical supervision and be monitored for appropriate control of symptoms and copper levels in order to optimise the dose (see section 4.2).
Croatian: Bolesnici koji primaju Cuprior trebaju biti pod redovitim medicinskim nadzorom i treba ih pratiti radi odgovarajuće kontrole simptoma i razina bakra te optimizacije doze (vidjeti dio 4.2).
English: Your doctor will advise you which treatment and which dose is best in your situation.
Croatian: Liječnik će Vas savjetovati o najboljem liječenju i najboljoj dozi za Vašu situaciju.
English: Your doctor will decide which treatment and which dose is best in your situation.
Croatian: Liječnik će odlučiti o najboljem liječenju i najboljoj dozi za vašu situaciju.
English: - skin rashes - itching
Croatian: - kožni osip - svrbež
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Croatian: Važno je obavijestiti liječnika ako dojite ili namjeravate dojiti.
English: If you stop taking Cuprior
Croatian: Ako prestanete uzimati Cuprior
English: Close monitoring of renal function is also recommended in these patients (see section 4.2).
Croatian: U tih bolesnika preporučuje se i pažljivo praćenje funkcije bubrega (vidjeti dio 4.2).
English: In rats administered oral trientines doses, up to 600 mg/kg/day for 26 weeks, histopathology revealed a dose-related incidence and severity of focal chronic interstitial pneumonitis accompanied by fibrosis of the alveolar wall.
Croatian: U štakora koji su peroralno primali doze trientina do 600 mg/kg na dan tijekom 26 tjedana, histopatološki je otkrivena s dozom povezana incidencija i težina fokalnog kroničnog intersticijskog pneumonitisa popraćenog fibrozom alveolarne stijenke.
English: Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron supplements may be required.
Croatian: Pokazalo se da trientin smanjuje razinu željeza u serumu, vjerojatno smanjivanjem njegove apsorpcije, te će možda će biti potrebno uzimanje nadomjestaka željeza.
English: Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Croatian: Trientin može kelirati bakar i u probavnom traktu i tako inhibirati apsorpciju bakra.
English: 96 film-coated tablets
Croatian: 96 filmom obloženih tableta
English: Tablet core: mannitol, colloidal anhydrous silica and glycerol dibehenate.
Croatian: Jezgra tablete: manitol, bezvodni koloidni silicijev dioksid i gliceroldibehenat.
English: DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux France
Croatian: DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux Francuska
English: If you think you may have taken more Cuprior than you were told to, contact your doctor or pharmacist.
Croatian: Ako mislite da ste uzeli više lijeka Cuprior nego što ste trebali, obratite se svom liječniku ili ljekarniku.
English: Unabsorbed trientine is eliminated through faecal excretion.
Croatian: Neapsorbirani trientin eliminira se izlučivanjem u stolici.
English: If you forget to take Cuprior
Croatian: Ako ste zaboravili uzeti Cuprior
English: 72 film-coated tablets
Croatian: 72 filmom obložene tablete
English: Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Paris, France
Croatian: Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Paris, Francuska
English: The association of trientine with another medicine that contains zinc is not recommended.
Croatian: Ne preporučuje se kombiniranje trientina s drugim lijekom koji sadrži cink.
English: It is not known if Cuprior can pass into breast milk.
Croatian: Nije poznato izlučuje li se Cuprior u majčino mlijeko.
English: This medicine mainly works by attaching to copper in the body which then allows it to be removed in the urine instead, helping to lower copper levels.
Croatian: Ovaj lijek uglavnom djeluje vezanjem bakra u tijelu kako bi se mogao izlučiti putem mokraće, što pomaže u smanjenju razine bakra.
English: The following adverse reactions have been reported with the use of trientine for Wilson's disease.
Croatian: Sljedeće nuspojave zabilježene su tijekom primjene trientina za liječenje Wilsonove bolesti.
English: The usual total daily dose is between 225 and 600 mg (1½ to 4 tablets daily), which will be divided into 2 to 4 smaller doses to be taken during the day.
Croatian: Uobičajena ukupna dnevna doza je između 225 i 600 mg (1½ do 4 tablete na dan) koja će se podijeliti na 2 do 4 manje doze koje se uzimaju tijekom dana.
English: Cuprior 150 mg film-coated tablets trientine
Croatian: Cuprior 150 mg filmom obložene tablete trientin
English: - inflammation of the gut which may lead to e.g. abdominal pain, recurring diarrhoea and blood in stools (colitis) - decrease in the number of red blood cells due to low iron level in your blood (iron deficiency anaemia) - urticaria (nettle rash or hives).
Croatian: - smanjenje broja crvenih krvnih stanica zbog niske razine željeza u krvi (anemija uzrokovana nedostatkom željeza) - urtikarija (koprivnjača).
English: Babies born to mothers being treated with trientine should be monitored for serum copper levels where appropriate.
Croatian: U serumu novorođenčadi čije se majke liječe trientinom, potrebno je pratiti razinu bakra gdje je prikladno.
English: The rat NOAEL was considered 50 mg/kg/day for females, a NOAEL was not established for males.
Croatian: Utvrđeno je da je NOAEL u ženki štakora iznosio 50 mg/kg na dan, dok za mužjake NOAEL nije utvrđen.
English: Patients with renal impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Croatian: Bolesnici s oštećenjem funkcije bubrega koji primaju trientin trebaju ostati pod redovitim medicinskim praćenjem radi odgovarajućeg nadzora simptoma i razina bakra.
English: These effects are possibly due to trientine induced-copper and zinc deficiency.
Croatian: Ti su učinci vjerojatno povezani s deficijencijom bakra i cinka izazvanom trientinom.
English: Just take your next dose at its regularly scheduled time.
Croatian: Uzmite sljedeću dozu u vrijeme kada biste je inače uzeli.
English: NAME OF THE MEDICINAL PRODUCT Cuprior 150 mg film-coated tablets
Croatian: NAZIV LIJEKA Cuprior 150 mg filmom obložene tablete
English: NAME OF THE MARKETING AUTHORISATION HOLDER gmp-orphan SA
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET gmp-orphan SA
English: How to take Cuprior
Croatian: Kako uzimati Cuprior
English: The recommended dose is between 450 mg and 975 mg (3 to 6½ film-coated tablets) per day in 2 to 4 divided doses.
Croatian: Preporučena doza je između 450 mg i 975 mg (3 do 6½ filmom obloženih tableta) dnevno podijeljena u 2 do 4 doze.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Take on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicine, food, or milk.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Uzimajte na prazan želudac barem jedan sat prije obroka ili dva sata nakon obroka te u razmaku od barem jednog sata od uzimanja bilo kojeg drugog lijeka, hrane ili mlijeka.
English: Swallow the tablets with water on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicines, food, or milk.
Croatian: Progutajte tablete s vodom na prazan želudac barem jedan sat prije obroka ili dva sata nakon obroka te u razmaku od barem jednog sata od uzimanja bilo kojeg drugog lijeka, hrane ili mlijeka.
English: Marketing Authorisation Holder gmp-orphan SA
Croatian: Nositelj odobrenja za stavljanje lijeka u promet gmp-orphan SA
English: Package leaflet online at QR code to be included http://www.cuprior.com Oral use.
Croatian: Uputa o lijeku na internetu treba navesti QR kod http://www.cuprior.com Primjena kroz usta.
English: In mice administered in drinking water, trientine displayed increased frequencies of inflammation of the lung interstitium and liver periportal fatty infiltration.
Croatian: U miševa koji su primali trientin putem vode za piće došlo je do povećane učestalosti intersticijske upale pluća i periportalne masne infiltracije jetre.
English: The dose is usually between 225 mg and 600 mg per day (1½ to 4 film-coated tablets) in 2 to 4 divided doses.
Croatian: Doza obično iznosi između 225 mg i 600 mg dnevno (1½ do 4 filmom obložene tablete) podijeljena u 2 do 4 doze.
English: Driving and using machines Cuprior is not expected to affect your ability to drive a car or use any tools or machines.
Croatian: Ne očekuje se da Cuprior utječe na vašu sposobnost upravljanja vozilima i strojevima.
English: The active substance is trientine.
Croatian: Djelatna tvar je trientin.
English: Monitoring for manifestations of overtreatment should be undertaken, particularly when copper requirements may change, such as in pregnancy (see section 4.6) and in children where appropriate control of copper levels are required to ensure proper growth and mental development.
Croatian: na primjer u trudnoći (vidjeti dio 4.6) i u djece u koje je odgovarajuća kontrola razine bakra u tijelu potrebna kako bi se osigurao normalan rast i psihički razvoj.
English: It is unknown whether trientine is excreted in human milk.
Croatian: Nije poznato izlučuje li se trientin u majčino mlijeko.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Uncommon: skin rash, pruritus, erythema.
Croatian: Manje često: kožni osip, svrbež, eritem Nepoznato: urtikarija
English: It is important that Cuprior is given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section
Croatian: Važno je uzimati Cuprior na prazan želudac barem jedan sat prije obroka ili dva sata nakon obroka te u razmaku od barem jednog sata od uzimanja bilo kojeg drugog lijeka, hrane ili mlijeka (vidjeti dio 4.5).
English: Serious iron deficiency anaemia and severe colitis may occur during treatment.
Croatian: Tijekom liječenja mogu se pojaviti ozbiljna anemija uzrokovana nedostatkom željeza i teški kolitis.
English: When rodents were fed throughout pregnancy a diet containing trientine, the frequency of resorptions and the frequency of abnormal fetuses at term showed a dose-related increase.
Croatian: Kada su skotne ženke glodavaca hranjene hranom koja sadrži trientin, pokazalo se da se učestalost resorpcije i učestalost broja abnormalnih fetusa povećava s dozom.