FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using psyllium seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže sjeme buhačice bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with psyllium seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže sjeme buhačice pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: Psyllium seed is the common name for the seed of the plant Plantago afra L. or Plantago indica L. The plant is cultivated or gathered to obtain the seeds for medicinal use.
Croatian: Sjeme buhačice je uobičajeni naziv za sjeme biljke Plantago afra L. et Plantago indica L.
English: How are psyllium seed medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže sjeme buhačice?
English: advice from a doctor or pharmacist should be sought.
Croatian: Ako zatvor ne prođe u roku od 3 dana, potražite savjet liječnika ili ljekarnika.
English: EU/1/12/792/001
Croatian: EU/1/12/792/001 Dacogen
English: 50 mg Powder for concentrate for solution for infusion
Croatian: Prašak za koncentrat za otopinu za infuziju
English: Date of first authorisation: 23 September 2015
Croatian: Datum prvog odobrenja: 23. rujna 2015.
English: Do not give this medicine to children and adolescents below the age of 18 years.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađim od 18 godina.
English: Both studies were performed in North American and/or Asian patients.
Croatian: Oba su ispitivanja provedena na bolesnicima iz Sjeverne Amerike i/ili Azije.
English: This will allow quick identification of new safety information.
Croatian: Time se omogućuje brza identifikacija novih sigurnosnih informacija.
English: Take the next dose at the usual time with a meal.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme uz obrok.
English: These may cause allergic reactions.
Croatian: Ove boje mogu izazvati alergijske reakcije.
English: Do not take a double dose to make up for a forgotten
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: All other parameters were secondary or exploratory endpoints in the two studies.
Croatian: Svi ostali parametri bili su sekundarni ili eksploratorni ishodi u oba ispitivanja.
English: The safety and efficacy of Fexeric in children and adolescents aged 0 to 18 years have not yet been
Croatian: Sigurnost i djelotvornost Fexerica u djece i adolescenata u dobi od 0 do 18 godina nisu još ustanovljene.
English: If you take more Fexeric than you should
Croatian: Ako uzmete više Fexerica nego što ste trebali
English: Pain, thirst
Croatian: bol, žeđ
English: 54 months after first launch in EU
Croatian: 54 mjeseca nakon prvog stavljanja lijeka u promet u EU
English: What Fexeric is and what it is used for
Croatian: Što je Fexeric i za što se koristi
English: Muscle injury
Croatian: ozljeda mišića
English: Tablets are 19 mm long, 7.2 mm thick and 10 mm wide.
Croatian: Tablete su duge 19 mm, debele 7,2 mm i široke 10 mm.
English: What you need to know before you take Fexeric
Croatian: Što morate znati prije nego počnete uzimati Fexeric
English: Your doctor may want to change the dose of these medicines or advise you to take these medicines 2 hours before or after Fexeric.
Croatian: Vaš liječnik mogao bi promijeniti dozu tih lijekova ili Vam savjetovati da ih uzimate 2 sata prije ili nakon uzimanja Fexerica.
English: Fexeric increases iron levels in your body.
Croatian: Fexeric povećava razine željeza u Vašem tijelu.
English: Contents of the pack and other information What Fexeric contains
Croatian: Sadržaj pakiranja i druge informacije Što Fexeric sadrži
English: Contact a doctor or poison control centre immediately if a child accidentally takes Fexeric.
Croatian: Odmah se obratite liječniku ili centru za kontrolu otrovanja ako dijete slučajno uzme Fexeric.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu dovoljna za zaključke o reproduktivnoj toksičnosti (vidjeti dio 5.3).
English: Active Control N=146
Croatian: Aktivna kontrola N=146
English: Consequently, ciprofloxacin should not be taken at the same time, but at least 2 hours before or after Fexeric.
Croatian: Stoga se ciprofloksacin ne smije uzimati u isto vrijeme, već najmanje 2 sata prije ili nakon uzimanja Fexerica.
English: What Fexeric looks like and contents of the pack
Croatian: Kako Fexeric izgleda i sadržaj pakiranja
English: Your doctor may decrease or increase the starting dose depending on the level of phosphorus in your blood.
Croatian: Vaš liječnik može povećati ili smanjiti početnu dozu ovisno o razini fosfora u Vašoj krvi.
English: How to take Fexeric
Croatian: Kako uzimati Fexeric
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Croatian: (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 to < 1/1000) i vrlo rijetko (< 1/10 000).
English: The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Croatian: Neklinički program temeljio se na 7 toksikoloških ispitivanja ponovljenih doza provedenih na štakorima i psima.
English: This blood test may be part of your routine tests for your
Croatian: Ta krvna pretraga može biti dio Vaših redovitih pretraga za
English: If someone is known or suspected to have accidentally or intentionally ingested an overdose of Fexeric, immediate medical attention should be sought.
Croatian: Ako se za nekoga zna ili sumnja da je nehotično ili namjerno progutao preveliku dozu Fexerica, odmah se mora zatražiti liječničku pomoć.
English: Taking the tablets with meals will help the medicine to work.
Croatian: Uzimanje tableta uz obroke pospješit će djelovanje lijeka.
English: Iron overdose is dangerous, particularly in children, and requires immediate attention.
Croatian: Predoziranje željezom je opasno, osobito za djecu, i mora se odmah liječiti.
English: The starting dose of active control was the patient's dose prior to the washout period.
Croatian: Početna doza aktivne kontrole bila je doza koju je bolesnik primao prije razdoblja ispiranja.
English: This can lead to high phosphorus levels in the blood.
Croatian: To može dovesti do visokih razina fosfora u krvi.
English: Experience from clinical studies in patients above the age of 75 years is limited.
Croatian: Iskustvo iz kliničkih ispitivanja za bolesnike starije od 75 godina je ograničeno.
English: None of the reported serious events in Study 204 were considered to be possibly related to Fexeric.
Croatian: Smatra se da nijedan od ozbiljnih događaja prijavljenih u Ispitivanju 204 nije bio povezan s Fexericom.
English: Take the tablets whole, with one glass of water, with or immediately after meals.
Croatian: Uzmite cijele tablete s jednom čašom vode, uz obroke ili odmah nakon njih.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne - Sačuvajte ovu uputu.
English: If you become pregnant during treatment, you must ask your doctor for advice.
Croatian: Ako ostanete trudni za vrijeme liječenja, morate se obratiti liječniku za savjet.
English: However, there was no interaction when Fexeric and ciprofloxacin were taken 2 hours apart.
Croatian: Međutim, do interakcije nije došlo kada su Fexeric i ciprofloksacin uzimani u razmaku od 2 sata.
English: Fexeric should only be used in these patients following careful assessment of benefit/risk.
Croatian: Fexeric se smije primjenjivati u tih bolesnika samo nakon pažljive procjene koristi i rizika.
English: It is unknown whether Fexeric may pass through breast milk and affect your baby.
Croatian: Nije poznato može li Fexeric prijeći u majčino mlijeko i utjecati na Vaše dijete.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli, ili biste mogli uzeti bilo koje
English: It is important that you continue taking Fexeric for as long as your doctor prescribes the medicine.
Croatian: Važno je da nastavite uzimati Fexeric onoliko dugo koliko Vam je propisao Vaš liječnik.
English: Hgb: haemoglobin; NAP: not applicable; SD: standard deviation; TSAT: transferrin saturation
Croatian: Hgb: hemoglobin; NP: nije primjenjivo; SD: standardna devijacija; TSAT: saturacija transferina
English: Dublin 2 Ireland
Croatian: Dublin 11
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fexeric therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se odlučiti treba li prekinuti dojenje ili prekinuti /suzdržati se od uzimanja terapije Fexerica, uzimajući u obzir korist dojenja za dijete i korist terapije
English: Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately.
Croatian: Bolesnici čiji bubrezi ne funkcioniraju pravilno ne mogu na prikladan način ukloniti fosfor iz tijela.
English: OUTER CARTON AND BOTTLE LABEL
Croatian: VANJSKA KUTIJA I NALJEPNICA NA BOCI
English: Study 204 (CKD ND)
Croatian: Ispitivanje 204 (KBB ND)
English: - if you have haemochromatosis, a condition causing the body to absorb too much iron from the diet - if you have any other disorder associated with too much iron
Croatian: - ako imate hemokromatozu, bolest koja uzrokuje apsorpciju previše željeza iz hrane u tijelo; - ako imate bilo koji drugi poremećaj povezan s prevelikom količinom željeza.
English: Because too much iron is unsafe, your blood will be tested at regular intervals to check iron levels.
Croatian: Budući da je previsoka količina željeza opasna, potrebno je redovito testirati Vašu krv radi praćenja razina željeza.
English: Your doctor will monitor the phosphorus levels regularly.
Croatian: Vaš će liječnik redovito pratiti razine fosfora.
English: Patients with active, symptomatic inflammatory bowel disease were excluded from clinical trials.
Croatian: Bolesnici s aktivnom simptomatskom upalnom bolesti crijeva bili su isključeni iz kliničkih ispitivanja.
English: These serious adverse reactions were uncommon (less than 1 case of each per 100 patients) and were each reported in 0.2% (1/557) of CKD 5D patients who received Fexeric.
Croatian: Te ozbiljne nuspojave bile su manje česte (svaka se pojavila u manje od 1 na 100 bolesnika) i svaka je prijavljena u 0,2 % (1/557) bolesnika s KBB 5D koji su primali Fexeric.
English: Tell your doctor if you wish to breast-feed your baby.
Croatian: Obavijestite svog liječnika ako želite dojiti svoje dijete.
English: There are limited data available for doses higher than 9 g (9 tablets) per day in CKD patients not on dialysis; therefore in this population doses higher than 9 g/day should be used with caution.
Croatian: Dostupni su ograničeni podaci za doze veće od 9 g dnevno (9 tableta) u bolesnika s KBB-om koji se ne liječe dijalizom; stoga se u toj populaciji doze veće od 9 g dnevno moraju primjenjivati s oprezom.
English: If this is the case, you must continue to follow the special diet even if you are taking
Croatian: U tom slučaju morate nastaviti s tom posebnom prehranom iako uzimate Fexeric.
English: Treatment of high blood phosphorus levels is usually required for a long period of time.
Croatian: Obično se liječenje visokih razina fosfora u krvi provodi u duljem vremenskom razdoblju.
English: Since citrate is known to increase aluminium absorption, aluminium-based compounds should be avoided while patients receive Fexeric.
Croatian: Budući da je poznato da citrat povećava apsorpciju aluminija, spojevi na bazi aluminija trebaju se izbjegavati dok bolesnici primaju Fexeric.
English: Study 304 (CKD 5D)
Croatian: Ispitivanje 304 (KBB 5D)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Fexeric in in one or more subsets of the paediatric population in the treatment of hyperphosphataemia related to chronic kidney disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Fexeric u jednoj ili više podskupina pedijatrijske populacije za liječenje hiperfosfatemije povezane s kroničnom bolesti bubrega (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Fexeric 1 g film-coated tablets
Croatian: Fexeric 1 g filmom obložene tablete
English: Patients receiving this medicine should adhere to their prescribed low phosphate diets.
Croatian: Bolesnici koji primaju ovaj lijek trebaju se pridržavati propisane prehrane s niskim udjelom fosfata.
English: Although the potential for interactions with medicinal products seems low, for concomitant treatment with products with a narrow therapeutic window, the clinical effect/adverse events should be monitored on initiation or dose adjustment of Fexeric or the concomitant product.
Croatian: Iako se čini da je potencijal za interakcije s lijekovima nizak, kod istodobnog liječenja lijekovima s uskim terapijskim prozorom, potrebno je pratiti klinički učinak/štetne događaje na početku primjene ili kod prilagodbe doze Fexerica ili istodobno primijenjenog lijeka.
English: Fexeric has been administered to over 400 patients ≥ 65 years of age in studies where the dose was titrated to achieve target serum phosphorus levels.
Croatian: Fexeric je primjenjivalo više od 400 bolesnika u dobi od ≥ 65 godina u ispitivanjima u kojima se titrirala doza kako bi se postigle ciljne razine fosfora u serumu.
English: Formal pharmacokinetic studies have not been performed due to the medicine's predominantly localised primary mechanism of action in the GI tract.
Croatian: Službena farmakokinetička ispitivanja nisu provedena zbog pretežito lokaliziranoga primarnog mehanizma djelovanja lijeka u gastrointestinalnom traktu.
English: No data are available on the potential influence of Fexeric on fertility.
Croatian: Nisu dostupni podaci o mogućem utjecaju Fexerica na plodnost.
English: Fexeric has no influence on the ability to drive and use machines.
Croatian: Fexeric ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Information on genotoxicity, carcinogenic potential, toxicity to reproduction and development of ferric citrate was bridged from scientific literature.
Croatian: Informacije o genotoksičnosti, karcinogenom potencijalu, reproduktivnoj i razvojnoj toksičnosti željezovog citrata preuzete su iz znanstvene literature.
English: This medicine should be used only in the absence of iron overload syndromes and with caution if serum ferritin rises above 500 ng/ml.
Croatian: Ovaj lijek se smije primjenjivati samo kada ne postoje sindromi preopterećenja željezom, i s oprezom ako se feritin u serumu povisi iznad 500 ng/ml.
English: The total daily dose should be divided
Croatian: Ukupna dnevna doza treba se raspodijeliti među dnevnim obrocima.
English: Keeping the phosphorus level normal is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.
Croatian: Održavanje normalne razine fosfora važno je za očuvanje zdravlja kostiju i krvnih žila, te za sprječavanje svrbeža kože, crvenila očiju, boli u kostima i prijeloma kostiju.
English: Since iron-based preparations are known to reduce the absorption of levothyroxine (thyroxine), physicians should consider monitoring suitable markers or clinical signs of efficacy if these medicinal products are concomitantly administered with Fexeric.
Croatian: Budući da je poznato da pripravci na bazi željeza smanjuju apsorpciju levotiroksina (tiroksina), liječnici trebaju razmotriti praćenje odgovarajućih markera ili kliničkih znakova djelotvornosti ako se ti lijekovi uzimaju istodobno s Fexericom.
English: Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
Croatian: neuobičajeni zvuk disanja, povišeni feritin u serumu, povišena saturacija transferina, povećana težina
English: Serum ferritin and TSAT levels increase after intravenous iron administration; hence, blood samples for measurement of iron storage parameters should be obtained at a time appropriate to reflect the patient's iron status after intravenous iron dosing taking into account the product used, the amount of iron given and the frequency of dosing, but a minimum of 7 days after intravenous iron dosing.
Croatian: Razine feritina u serumu i TSAT-a povišene su nakon primjene intravenskog željeza; stoga se uzorci krvi za mjerenje parametara skladištenja željeza moraju uzeti u trenutku u kojem će se jasno vidjeti stanje željeza u bolesnika nakon doziranja intravenskog željeza, pri čemu se uzima u obzir korišteni lijek, količina danog željeza i učestalost doziranja, no najmanje 7 dana nakon doziranja intravenskog željeza.
English: There was no evidence of hepatic impairment or significant alteration of hepatic enzymes across the clinical studies with Fexeric, including the long-term studies.
Croatian: Nema dokaza o oštećenju jetre niti značajnoj promjeni jetrenih enzima u kliničkim ispitivanjima s Fexericom, uključujući dugotrajna ispitivanja.
English: Data from carcinogenicity studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously.
Croatian: Podaci iz ispitivanja kancerogenosti pokazali su da željezov citrat nije kancerogen za miševe i štakore kada se primjenjuje intramuskularno ili supkutano.
English: Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Croatian: Fexeric je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika s kroničnom bolesti bubrega
English: All patients receiving this medicine require at least quarterly monitoring of serum iron storage parameters (serum ferritin and TSAT).
Croatian: Svim bolesnicima koji primaju ovaj lijek moraju se barem svaka tri mjeseca pratiti parametri skladištenja željeza u serumu (feritin u serumu i TSAT).
English: Shelf-life after first opening of the bottle: 60 days
Croatian: Rok valjanosti nakon prvog otvaranja boce: 60 dana
English: Effects of other medicinal products on Fexeric
Croatian: Učinci drugih lijekova na Fexeric
English: The elderly patients were treated according to the recommended dosing regimen without any safety concerns.
Croatian: Stariji bolesnici liječeni su u skladu s preporučenim režimom doziranja bez ikakvih sigurnosnih rizika.
English: Shelf life after first opening of the bottle: 60 days Open date: (Bottle only)
Croatian: Rok valjanosti nakon prvog otvaranja boce: 60 dana Datum otvaranja: (Samo na boci)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Croatian: Fexeric nije promijenio bioraspoloživost sljedećih lijekova prilikom njihove istodobne primjene: klopidogrela, digoksina, diltiazema, glimepirida, losartana.
English: The tablets are packed in plastic bottles with child-resistant caps.
Croatian: Tablete su zapakirane u plastičnim bocama sa sigurnosnim zatvaračem za djecu.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Very common:
Croatian: Manje često:
English: These patients were treated according to the recommended dosing regimen without any safety concerns.
Croatian: Ti bolesnici liječeni su u skladu s preporučenim režimom doziranja bez ikakvih sigurnosnih rizika.
English: In iron replete dogs, microscopic and macroscopic findings in the liver were consistent with signs of iron accumulation.
Croatian: U pasa s viškom željeza mikroskopski i makroskopski nalazi jetre bili su u skladu sa znakovima nakupljanja željeza.
English: • Also tell your doctor or pharmacist if you are taking or might take the medicines below.
Croatian: • Također obavijestite svog liječnika ili ljekarnika ako uzimate ili biste mogli uzeti bilo koje druge lijekove navedene u nastavku.
English: Significantly elevated ferritin levels were observed particularly when concomitant intravenous iron was used.
Croatian: Značajno povišene razine feritina opažene su osobito kod istodobne primjene intravenskog željeza.
English: Fexeric is not recommended during pregnancy and in women of childbearing potential not using contraceptive
Croatian: Ne preporučuje se uzimanje Fexerica tijekom trudnoće niti ženama u reproduktivnoj dobi koje ne koriste
English: Effects of Fexeric on other medicinal products
Croatian: Učinci Fexerica na druge lijekove
English: Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Croatian: Liječenje Fexericom može dovesti do povećanja zaliha željeza, osobito u bolesnika koji istodobno primaju terapiju intravenskim željezom.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake „Rok valjanosti”.
English: Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts.
Croatian: Željezov citrat nije pokazao ni mutageno djelovanje na testu za detekciju povratnih mutacija pomoću bakterija (Amesov test) ni klastogeno djelovanje na testu aberacije kromosoma provedenom na fibroblastima kineskog hrčka.
English: Patients with elevated ferritin levels receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
Croatian: U bolesnika s povećanim razinama feritina koji primaju intravensko željezo može biti potrebno smanjenje doze ili prekid terapije intravenskim željezom.
English: Results from subgroup analyses in the pivotal clinical study in dialysis patients show that the concomitant use of frequently co-prescribed medications in CKD patients (fluoroquinolones, tetracyclines, proton pump inhibitors, thyroid hormones, sertraline, Vitamin D, warfarin, acetylsalicylic acid) do not affect the efficacy of Fexeric with respect to its ability to lower serum
Croatian: Rezultati analiza podskupina u pivotalnom kliničkom ispitivanju bolesnika liječenih dijalizom pokazuju da istodobna primjena često propisivanih lijekova za bolesnike s KBB-om (fluorokinoloni, tetraciklini, inhibitori protonske pumpe, tiroidni hormoni, sertralin, vitamin D, varfarin, acetilsalicilatna kiselina) ne utječe na djelotvornost Fexerica u pogledu njegove sposobnosti smanjivanja razine fosfora u serumu.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje hiperkalijemije i hiperfosfatemije
English: Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Croatian: Fexeric filmom obložene tablete boje su breskve i ovalnog oblika s utisnutom oznakom „KX52” na jednoj strani.