FrancophonIA/ELRC3.0 huggingface dataset:
English: No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Nisu provedena formalna neklinička ispitivanja sigurnosti, međutim podaci iz literature ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti jedne doze, toksičnosti ponovljenih doza, genotoksičnosti, i kancerogenog potencijala.
English: Please discuss suitable contraceptive methods with your doctor.
Croatian: Razgovarajte sa svojim liječnikom o odgovarajućim metodama kontracepcije.
English: However, cholic acid is still formed via an alternate microsomal pathway.
Croatian: Međutim, kolatna kiselina se još uvijek stvara kroz alternativni mikrosomski put.
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Croatian: Reapsorpcija kenodeoksikolatne kiseline varira (29 - 84 %).
English: Women of childbearing potential should use an effective method of contraception.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovitu metodu kontracepcije.
English: - if you are allergic to chenodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6)
Croatian: - ako ste alergični na kenodeoksikolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u djelu 6).
English: The events were transitory and did not interfere with the therapy.
Croatian: Nuspojave su bile prolazne i nisu ometale liječenje.
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: This deficiency blocks the synthesis of primary bile acids via the classical (neutral pathway) and the alternative (acidic) pathway.
Croatian: Taj nedostatak blokira sintezu primarnih žučnih kiselina kroz klasični (neutralni put) i alternativni (kiseli) put.
English: Your doctor may decide to increase your dose depending on how your body responds to treatment.
Croatian: Liječnik može odlučiti povećati Vašu dozu ovisno o tome kako Vaše tijelo reagira na liječenje.
English: In two non-interventional studies with chenodeoxycholic acid a total of three adverse reactions were reported in three out of 63 patients (safety population).
Croatian: U dva neintervencijska ispitivanja s kenodeoksikolatnom kiselinom prijavljene su ukupno tri nuspojave kod tri od 63 bolesnika (sigurnosna populacija).
English: The suspension is formed quite easily and is ready when there are no visible lumps or powder left.
Croatian: Suspenziju je prilično lako napraviti, a spremna je kad nema više vidljivih grudica ili zaostalog praha.
English: Chenodeoxycholic acid supplementation was re-started and maintained at a lower dose of 5 mg/kg/day with no further complications.
Croatian: Nadomještanje kenodeoksikolatne kiseline je ponovno započeto i nastavljeno s nižom dozom od 5 mg/kg/dan bez daljnjih komplikacija.
English: The three adverse reactions were all nonserious.
Croatian: Niti jedna od tri nuspojave nije bila ozbiljna.
English: 100 hard capsules
Croatian: 100 tvrdih kapsula
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Croatian: Telefaks: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
English: You should contact your doctor for advice if you or your child has taken more than the amount prescribed.
Croatian: Obratite se svom liječniku za savjet ako Vi ili Vaše dijete uzmete više lijeka nego što Vam je propisano.
English: The only infant enrolled presented with raised liver function tests within six weeks of treatment start.
Croatian: Jedino dojenče koje je bilo uključeno u ispitivanje imalo je povišene rezultate na testovima funkcije jetre unutar 6 tjedana od početka liječenja.
English: The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
Croatian: Pripremljena suspenzija sadrži 22,9 mg natrija po ml, što treba uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: The doctor should provide information on the dose to be received according to the weight of the child.
Croatian: Liječnik treba dati informacije o tome koju dozu dijete treba primiti, ovisno o djetetovoj težini.
English: This substance is normally produced by the liver from cholesterol.
Croatian: Tu tvar obično stvara jetra iz kolesterola.
English: Disease signs and symptoms resolved, improved or stabilised in a majority of patients over the course of the study.
Croatian: Znakovi i simptomi bolesti su se povukli, poboljšali ili stabilizirali kod većine bolesnika tijekom trajanja ispitivanja.
English: Further information is provided in the package leaflet under Information for Healthcare Professionals Only.
Croatian: Dodatne informacije nalaze se u uputi o lijeku u dijelu Informacije samo za zdravstvene radnike.
English: Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Croatian: Kapsule su pakirane u blistere od polivinilklorida (PVC) zatvorene aluminijskom folijom i zapakirane u kartonske kutije.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da postoji reproduktivna toksičnost (vidjeti dio
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izviješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: Oral contraceptives are not recommended.
Croatian: Oralna kontracepcija se ne preporuča.
English: The safety and efficacy of Chenodeoxycholic acid Leadiant has not been studied in babies less than one month of age.
Croatian: Sigurnost i djelotvornost lijeka Chenodeoxycholic acid Leadiant nije ispitana na bebama mlađim od mjesec dana.
English: Study resultsPSUR and annual reassessments
Croatian: PSUR i godišnje ponovne procjene
English: Your doctor may change the dose depending on how your child responds to treatment.
Croatian: Liječnik može promijeniti dozu ovisno o tome kako Vaše dijete reagira na liječenje.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER PACKS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER PAKIRANJE
English: All paediatric patients received 15 mg/kg/day as their starting dose.
Croatian: Svi pedijatrijski bolesnici primili su 15 mg/kg/dan kao početnu dozu.
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Croatian: Proljev je nestao kod 100 % (23/23) bolesnika koji su imali taj simptom na početku.
English: Maternal effects in the rhesus monkeys, but not baboons, included diarrhoea, emesis, weight loss and reduction in food consumption.
Croatian: Učinci na majku kod rezus majmuna, ali ne kod babuna, uključivali su pojavu proljeva, povraćanja, gubitka težine i smanjenu konzumaciju hrane.
English: Patients with CTX and high cholestanol have been shown to have adverse outcomes during pregnancy.
Croatian: Pokazalo se da bolesnice s CTX-om i visokom razinom kolestanola imaju štetne ishode za vrijeme trudnoće.
English: None of the patients had treatment-related adverse events and chenodeoxycholic acid exhibited a satisfactory safety profile in relation to routine safety laboratory parameters (haematology and clinical chemistry).
Croatian: Niti jedan bolesnik nije imao štetne događaje vezane uz liječenje, a kenodeoksikolatna kiselina je pokazala zadovoljavajući sigurnosni profil s obzirom na rutinske sigurnosne laboratorijske parametre (hematologija i klinička biokemija).
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blister pakiranju iza oznake „Rok valjanosti“/"EXP".
English: Due to the rarity of CTX, the available literature is not sufficient to detect a difference in the safety of chenodeoxycholic acid within paediatric age groups or between paediatric patients and adults.
Croatian: Radi rijetkih slučajeva CTX-a, literatura na raspolaganju nije dovoljna kako bi se utvrdila razlika u sigurnosti primjene kenodeoksikolatne kiseline između različitih pedijatrijskih dobnih skupina ili između pedijatrijskih bolesnika i odraslih.
English: Colestipol and antacid medicinal products
Croatian: Kolestipol i antacidi
English: Do not stop taking Chenodeoxycholic acid Leadiant without first speaking with your doctor.
Croatian: Nemojte prestati uzimati Chenodeoxycholic acid Leadiant bez da prije toga ne razgovarate sa svojim liječnikom.
English: Take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Developmental toxicity studies in rats, hamsters and primates showed an absence of teratogenic effects.
Croatian: Reproduktivna toksičnost Ispitivanja razvojne toksičnosti kod štakora, hrčaka i primata pokazala su odsustvo teratogenih učinaka.
English: In addition to sulfation, bile acid can also be detoxified through glucronidation.
Croatian: Uz sulfataciju, žučna kiselina se može također detoksificirati kroz glukronidaciju.
English: Mean Rankin and EDSS scores showed a very small increase (worsening) from baseline to clinical current visit at 0.08 ± 0.74 and 0.27 ± 1.24 in the overall population and this increase was not statistically significant.
Croatian: Srednje vrijednosti rezultata na ljestvicama Rankin i EDSS pokazale su vrlo malo povećanje (pogoršanje) od početka ispitivanja do zadnjeg kliničkog posjeta od 0,08 ± 0,74 i 0,27 ± 1,24 u cjelokupnoj populaciji i to povećanje nije bilo statistički značajno.
English: The maximum dose is one 250 mg capsule four times a day.
Croatian: Maksimalna doza je jedna kapsula od 250 mg četiri puta na dan.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from chenodeoxycholic acid therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman
Croatian: Treba donijeti odluku hoće li se prestati s dojenjem ili prestati/odustati od liječenja kenodeoksikolatnom kiselinom uzimajući u obzir koristi dojenja za dijete i koristi liječenja za ženu.
English: It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food.
Croatian: Dio je žuči, tekućine koja pomaže probavljanje masnoća i vitamina iz hrane.
English: In contrast, Lithocholic acid sulfate conjugation in humans prevents the overt hepatotoxicity, as seen in animal toxicity species after repeat dosing.
Croatian: Nasuprot tome, sulfatna konjugacija litokolatne kiseline kod ljudi sprječava očitu hepatoksičnost, kao što je pokazano u ispitivanjima toksičnosti kod životinja nakon ponovljenih doza.
English: The primary pharmacodynamic effects of chenodeoxycholic acid are: 1.
Croatian: Primarni farmakodinamički učinci kenodeoksikolatne kiseline su: 1.
English: There was a resolution, improvement or stabilisation in 88.9% (16/18) of patients with cognitive impairment.
Croatian: Došlo je do povlačenja, poboljšanja ili stabilizacije kod 88,9 % (16/18) bolesnika s kognitivnim poremećajima.
English: The mean age of the patient population in the pivotal study was younger at 25.8 years than the supporting study population at 35 years which also reflected the level of disability present in the two cohorts prior to treatment start, with the supporting study having a higher disability score at baseline.
Croatian: Srednja dob populacije bolesnika u pivotalnom ispitivanju bila je manja, 25,8 godina, u odnosu na populaciju u potpornom ispitivanju gdje je srednja dob bila 35 godina, što se također odrazilo na razinu onesposobljenosti prisutnu u dvije kohorte prije početka liječenja, s time da je u potpornom ispitivanju bio veći stupanj onesposobljenosti na početku ispitivanja.
English: The starting dose in children is 5 mg/kg/day in three divided doses.
Croatian: Početna doza kod djece je 5 mg/kg/dan u tri podijeljene doze.
English: Pyramidal dysfunction improved or stabilised in 60% (10/15) and cerebellar dysfunction in 88.7% (12/14).
Croatian: Piramidalna disfunkcija se poboljšala ili stabilizirala kod 60 % (10/15), a cerebelarna disfunkcija u 88,7 % (12/14) bolesnika.
English: Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder.
Croatian: Kapsula veličine 0, dužine 21,7 mm sa žutim tijelom i narančastom kapicom, sadrži bijeli komprimirani prah.
English: The potential for harm from overdose is considered extremely low, as accumulation of chenodeoxycholic acid is unlikely due to an efficient endogenous mechanism of elimination and excretion.
Croatian: Mogućnost da dođe do problema zbog predoziranja smatra se izuzetno niskom, jer je akumulacija kenodeoksikolatne kiseline malo vjerojatna zbog učinkovitog endogenog mehanizma eliminacije i izlučivanja.
English: Women of childbearing potential should use an effective method of contraception, see section 4.6 for further details.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovitu metodu kontracepcije, pogledajte dio 4.6 za dodatne informacije.
English: Rankin and EDSS scores remained stable in 61.5% and 50% of patients respectively, however there was an overall worsening of the mean score from baseline.
Croatian: Rezultati na Rankin i EDSS ljestvici ostali su stabilni kod 61,5 % odnosno 50 % bolesnika, međutim došlo je do općenitog pogoršanja srednjih vrijednosti rezultata u odnosu na početne vrijednosti.
English: Increases in bone mineral density (Z-score) were observed at lumbar spine at both post-treatment visits and at total hip at post-treatment at post-treatment Visit 2.
Croatian: Povećanje u mineralnoj gustoći kosti (Z-vrijednost) primijećeno je u lumbalnoj kralješnici prilikom oba posjeta nakon liječenja i kod ukupnog kuka prilikom 2. posjeta nakon liječenja.
English: During the initiation of therapy and dose adjustment, serum cholestanol levels and/or urine bile alcohols should be monitored every 3 months till metabolic control and then annually.
Croatian: Tijekom početka liječenja i prilagođavanja doze, razine kolestanola u serumu i/ili žučnih alkohola u urinu treba nadzirati svaka 3 mjeseca do metaboličke kontrole, a nakon toga jednom godišnje.
English: Ciclosporin and sirolimus
Croatian: Ciklosporin i sirolimus
English: The usual starting dose in adults is one 250 mg capsule three times a day.
Croatian: Uobičajena početna doza za odrasle je jedna kapsula od 250 mg tri puta na dan.
English: The corresponding amount of suspension to give = (50 mg x 1 ml) = 5 ml 10 mg *number of divided doses dependant on advice from doctor.
Croatian: Odgovarajuća količina suspenzije koju treba dati = (50 mg x 1 ml) = 5 ml 10 mg *broj podijeljenih doza ovisi o savjetu liječnika.
English: In case of persistent lack of therapeutic response to chenodeoxycholic acid monotherapy, other treatment options should be considered.
Croatian: U slučaju ustrajnog izostanka odgovora na monoterapijsko liječenje kenodeoksikolatnom kiselinom treba razmotriti druge načine liječenja.
English: Biological half-life of chenodeoxycholic acid is about 4 days.
Croatian: Biološki poluvijek kenodeoksikolatne kiseline iznosi otprilike 4 dana.
English: The mean levels of 7α-hydroxy-4-cholesten-3one significantly decreased from baseline to post-baseline Visits 1 and 2.
Croatian: Srednje vrijednosti 7α-hidroksi4-kolesten-3ona znatno su se smanjile od početnih vrijednosti do kasnijeg 1. i 2. posjeta.
English: The presented safety information for hepatic adverse reactions is derived from paediatric patients.
Croatian: Prikazane informacije o sigurnosti primjene u vezi s nuspojavama vezanim uz jetru dobivene su od pedijatrijskih bolesnika.
English: Additional or more frequent investigations may need to be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Croatian: Dodatne ili češće pretrage možda će trebati napraviti kako bi se pratilo liječenje za vrijeme perioda brzog rasta, istodobne bolesti ili trudnoće
English: It is recommended that this suspension is prepared at the pharmacy and instructions given to the parent on how to administer the suspension.
Croatian: Preporuča se da se ova suspenzija pripremi u ljekarni, te da se daju upute roditelju kako primijeniti suspenziju.
English: Neurological disability scale scores (Rankin and EDSS) stabilised or improved by the clinical current visit in 84.6% and 76.9% of patients respectively.
Croatian: Rezultati na ljestvicama neurološke onesposobljenosti (Rankin i EDSS) stabilizirali su se ili su se poboljšali do zadnjeg kliničkog posjeta kod 84,6% odnosno 76,9% bolesnika.
English: Urinary bile level alcohol levels decreased.
Croatian: Razine žučnog alkohola u urinu su se smanjile.
English: Pathological effects on adrenals and kidneys were also seen in rhesus monkey foetuses.
Croatian: Patološki učinci na nadbubrežne žlijezde i bubrege također su primijećeni kod fetusa rezus majmuna.
English: The starting dose will be calculated at 5 mg per kg per day.
Croatian: Početna doza izračunat će se kao 5 mg po kg na dan.
English: Vitamin D and PTH levels decreased from baseline to both post-treatment visits and mean pyruvate levels decrease from baseline to the first post-treatment visit.
Croatian: Razine vitamina D i PTH-a su se smanjile od početnih vrijednosti do oba posjeta nakon liječenja, a srednje vrijednosti piruvata smanjile su se od početnih vrijednosti do prvog posjeta nakon liječenja.
English: Adverse reactions in patients (both adults and children) receiving Chenodeoxycholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
Croatian: Nuspojave kod bolesnika (i odraslih i djece) koji primaju kenodeoksikolatnu kiselinu su uglavnom blage do umjerene težine, glavne reakcije koje su primijećene navedene su u donjoj tablici.
English: Chenodeoxycholic acid is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Kenodeoksikolatna kiselina se ne preporučuje za vrijeme trudnoće ni kod žena reproduktivne dobi koje ne koriste kontracepciju.
English: Oral contraceptives may affect the way in which Chenodeoxycholic acid Leadiant works making it less effective.
Croatian: Oralna kontracepcija može utjecati na to kako Chenodeoxycholic acid Leadiant djeluje i učiniti je manje učinkovitom.
English: Diarrhoea improved or disappeared in 64.3% of the patients who had this symptom present at baseline.
Croatian: Proljev se popravio ili potpuno nestao kod 64,3 % bolesnika koji su imali taj simptom na početku ispitivanja.
English: The corresponding amount of suspension to give = (5 mg x 1 ml) = 1 ml
Croatian: Odgovarajuća količina suspenzije koju treba dati = (5 mg x 1 ml) = 1 ml
English: Psychiatric impairment resolved, improved or stabilised in 85.7% (6/7) of patients.
Croatian: Psihijatrijske poteškoće su se povukle, poboljšale ili stabilizirale kod 85,7 % (6/7) bolesnika.
English: For the other medicines in this list, take them either 2 hours before or 2 hours after taking Chenodeoxycholic acid Leadiant.
Croatian: Druge lijekove s ovog popisa uzmite 2 sata prije ili 2 sata nakon uzimanja lijeka Chenodeoxycholic acid Leadiant.
English: Titanium dioxide Quinoline yellow Erythrosine
Croatian: Titanijev dioksid Kinolin žuti Eritrozin
English: Babies
Croatian: Bebe
English: After reabsorption in the intestine, the bile acid is nearly completely conjugated to the amino acids glycine and taurine and then excreted again in the bile.
Croatian: Nakon reapsorpcije u crijevu, žučna kiselina se skoro potpuno konjugira s aminokiselinama, glicinom i taurinom i nakon toga izlučuje ponovno u žuč.
English: Chenodeoxycholic acid is an endogenous bile acid used for replacement therapy and it is anticipated to have no effects on fertility at therapeutic doses.
Croatian: Kenodeoksikolatna kiselina je endogena žučna kiselina koja se koristi kao nadomjesna terapija i očekuje se da neće imati nikakav učinak na plodnost pri terapijskim dozama.
English: The capsules consist of a yellow body and an orange cap containing a white compressed powder.
Croatian: Kapsule se sastoje od žutog tijela i narančaste kapice, i sadrže bijeli komprimirani prah.
English: The daily dose can be subsequently increased in 250 mg increments to a maximum of 1000 mg/ day if the serum cholestanol and/or urine bile alcohols remain elevated.
Croatian: Dnevna doza se može naknadno povećati za 250 mg do maksimalno 1000 mg/dan ako serumski kolestanol i/ili žučni alkoholi u urinu ostanu povišeni.
English: The lowest dose of chenodeoxycholic acid that effectively reduces the serum cholestanol and/or urine bile alcohols levels to within the normal range should be chosen.
Croatian: Treba odabrati najnižu dozu kenodeoksikolatne kiseline koja učinkovito snižava razinu serumskog kolestanola i/ili žučnih alkohola u urinu na raspon normalnih vrijednosti.
English: In two-non interventional studies with chenodeoxycholic acid, a total of 14 paediatric patients with CTX were treated with Chenodeoxycholic acid: 1 infant (0 to < 2 years), 6 children (2 to < 12 years) and 7 adolescents (12 to < 18 years).
Croatian: U dva neintervencijska ispitivanja s kenodeoksikolatnom kiselinom, kenodeoksikolatnom kiselinom je liječeno ukupno 14 pedijatrijskih bolesnika s CTX-om: 1 dojenče (0 do < 2 godine), 6 djece (2 do
English: The pharmacy should provide oral dose syringes of appropriate volume and grading for administering the suspension.
Croatian: Ljekarna bi trebala dati štrcaljke za usta odgovarajućeg volumena i gradacije za primjenu suspenzije.
English: Patients with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a buildup of fatty deposits in various areas of the body.
Croatian: Bolesnici s rijetkom bolešću koja se zove cerebrotendinozna ksantomatoza (CTX) ne mogu stvarati kenodeoksikolatnu kiselinu, a to dovodi do nakupljanja masnih naslaga u raznim dijelovima tijela.
English: Reduced production of atypical bile alcohols and bile acids: through restoration of feedback inhibition of primary bile acid synthesis (action on CYP7A1)
Croatian: Smanjeno stvaranje atipičnih žučnih alkohola i žučnih kiselina: kroz obnavljanje inhibicije povratnom spregom u sintezi primarnih žučnih kiselina (djelovanje na CYP7A1).
English: This instance of hepatic adverse reactions in an infant presented with multiple confounders, such as concomitant parechovirus infection, co-administration of medicinal products known to affect liver function (acyclovir and phenobarbital) and presence of hyperbilirubinemia at birth.
Croatian: Ovaj slučaj nuspojave vezane uz jetru kod dojenčeta pojavio se s višestrukim zbunjujućim čimbenicima (engl. confounders) kao što su istodobna infekcija parehovirusom, istodobna primjena lijekova za koje se zna da utječu na funkciju jetre (aciklovir i fenobarbital) te prisutnost hiperbilirubinemije pri rođenju.
English: In rhesus monkey and baboon studies it was demonstrated that chenodeoxycholic acid dose to pregnant animals (at 5-120 mg/kg/day for rhesus monkey; at 18-38 mg/kg/day for baboons) produced liver pathology in the developing foetus.
Croatian: U ispitivanjima na rezus majmunima i babunima pokazano je da doza kenodeoksikolatne kiseline za gravidne životinje (5-120 mg/kg/dan za rezus majmune; 18-38 mg/kg/dan za babune) dovela do patologije u jetri kod fetusa u razvoju.
English: It is not recommended to take Chenodeoxycholic acid Leadiant during pregnancy and breast-feeding.
Croatian: Nije preporučljivo uzimati lijek Chenodeoxycholic acid Leadiant tijekom trudnoće i dojenja.