FrancophonIA/ELRC3.0 huggingface dataset:
English: Injury, Poisoning and Procedural Complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih
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.
Slovenian: Zdravnik bo morda spremenil odmerek teh zdravil ali vam svetoval, da ta zdravila vzamete 2 uri pred zdravilom Fexeric ali 2 uri po njem.
English: This blood test may be part of your routine tests for your kidney disease.
Slovenian: Te krvne preiskave so lahko del vaših rednih preiskav zaradi bolezni ledvic.
English: What Fexeric is and what it is used for 2.
Slovenian: Kaj je zdravilo Fexeric in za kaj ga uporabljamo 2.
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Slovenian: občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: If someone is known or suspected to have accidentally or intentionally ingested an overdose of Fexeric, immediate medical attention should be sought.
Slovenian: Če veste ali sumite, da je prišlo do nenamernega ali namernega zaužitja prevelikega odmerka zdravila Fexeric, je treba takoj poiskati zdravniško pomoč.
English: However, there was no interaction when Fexeric and ciprofloxacin were taken 2 hours apart.
Slovenian: Vendar tega medsebojnega delovanja ni bilo, kadar sta se zdravilo Fexeric in ciprofloksacin dajala v presledku 2 ur.
English: Study 204 (CKD ND)
Slovenian: Študija 204 (KLB ND)
English: 54 months after first launch in EU
Slovenian: 54 mesecev po prvem dajanju zdravila v promet v EU.
English: Hgb: haemoglobin; NAP: not applicable; SD: standard deviation; TSAT: transferrin saturation
Slovenian: Hgb: hemoglobin, /: navedba smiselno ni potrebna, SD: standardni odklon, TSAT: saturacija transferina
English: Formal pharmacokinetic studies have not been performed due to the medicine's predominantly localised primary mechanism of action in the GI tract.
Slovenian: Uradnih farmakokinetičnih študij niso izvedli zaradi pretežno lokaliziranega primarnega mehanizma delovanja zdravila Fexeric v prebavilih.
English: What you need to know before you take Fexeric
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Fexeric
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli
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.
Slovenian: Razpoložljivi podatki za odmerke, večje od 9 g (9 tablet) na dan, pri bolnikih s KLB, ki niso na dializi, so omejeni, zato je treba pri tej populaciji odmerke, večje od 9 g/dan, uporabljati previdno.
English: Dublin 2 Ireland
Slovenian: Dublin 11
English: Treatment of high blood phosphorus levels is usually required for a long period of time.
Slovenian: Zdravljenje visokih ravni fosforja v krvi je navadno dolgotrajno.
English: All patients receiving this medicine require at least quarterly monitoring of serum iron storage parameters (serum ferritin and TSAT).
Slovenian: Pri vseh bolnikih, ki prejemajo to zdravilo, je treba izvajati vsaj četrtletno spremljanje parametrov zaloge železa v serumu (feritina v serumu in TSAT).
English: Data from carcinogenicity studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously.
Slovenian: Podatki iz študij kancerogenega potenciala so pokazale, da železov citrat ni bil kancerogen pri miših in podganah, kadar se je uporabljal intramuskularno ali subkutano.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „Uporabno do“.
English: Patients with active, symptomatic inflammatory bowel disease were excluded from clinical trials.
Slovenian: Bolnike z aktivno simptomatsko vnetno črevesno boleznijo so izključili iz kliničnih preskušanj.
English: Contents of the pack and other information What Fexeric contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Fexeric
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Fexeric, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Study 304 (CKD 5D)
Slovenian: Študija 304 (KLB 5D)
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
Slovenian: - če imate hemokromatozo, pri kateri telo absorbira preveč železa iz hrane, - če imate kakršno koli drugo bolezen, povezano s preveliko količino železa.
English: None of the reported serious events in Study 204 were considered to be possibly related to Fexeric.
Slovenian: Noben od poročanih resnih neželenih dogodkov v študiji 204 ni bil povezan z zdravilom Fexeric.
English: Fexeric is not recommended during pregnancy and in women of childbearing potential not using contraceptive
Slovenian: Zdravila Fexeric ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite
English: Fexeric should only be used in these patients following careful assessment of benefit/risk.
Slovenian: Zdravilo Fexeric se sme pri teh bolnikih uporabljati samo po skrbni oceni razmerja med tveganji in
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.
Slovenian: Ti resni neželeni učinki so bili občasni (manj kot 1 primer na 100 bolnikov), o njih pa so poročali pri 0,2 % (1/557) bolnikov s KLB 5D, ki so prejemali zdravilo Fexeric.
English: Fexeric should not be taken at the same time as aluminium containing medicines.
Slovenian: Zdravilo Fexeric se ne sme jemati sočasno z zdravili, ki vsebujejo aluminij.
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.
Slovenian: Ker je znano, da pripravki na osnovi železa zmanjšajo absorpcijo levotiroksina (tiroksina), morajo zdravniki razmisliti o spremljanju ustreznih označevalcev ali kliničnih znakov učinkovitosti, če se ta zdravila dajejo sočasno z zdravilom Fexeric.
English: Serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Fexeric, and approximately every 2-3 months when stable.
Slovenian: Koncentracije fosforja v serumu je treba spremljati v od 2 do 4 tednih od uvedbe ali spremembe odmerjanja zdravila Fexeric, nato pa približno vsake 2-3 mesece, če je koncentracija stabilna.
English: The total daily dose should be divided
Slovenian: Skupni dnevni odmerek je treba
English: Tablets are 19 mm long,
Slovenian: Dolžina tablete je 19 mm, debelina
English: It is important that you continue taking Fexeric for as long as your doctor prescribes the medicine.
Slovenian: Pomembno je, da zdravilo Fexeric jemljete toliko časa, kot vam predpiše zdravnik.
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.
Slovenian: Po intravenski uporabi železa se povečajo ravni feritina v serumu in TSAT, zato je treba krvne vzorce za meritev parametrov zaloge železa pridobiti ob ustreznem času, da bodo pravilno odražali bolnikovo stanje železa po intravenskem odmerjanju železa, pri čemer je treba upoštevati uporabljeno zdravilo, količino danega železa in pogostnost odmerjanja, vendar najmanj 7 dni po intravenskem odmerjanju železa.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: Patients receiving this medicine should adhere to their prescribed low phosphate diets.
Slovenian: Bolniki, ki prejemajo to zdravilo, morajo upoštevati predpisano dieto z majhno vsebnostjo fosfatov.
English: Fexeric has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Fexeric nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: How to take Fexeric
Slovenian: Kako jemati zdravilo Fexeric
English: In iron replete dogs, microscopic and macroscopic findings in the liver were consistent with signs of iron accumulation.
Slovenian: napolnjenih z železom, so bile mikro- in makroskopske ugotovitve skladne z znaki kopičenja železa.
English: What Fexeric is and what it is used for
Slovenian: Kaj je zdravilo Fexeric in za kaj ga uporabljamo
English: Take the tablets whole, with one glass of water, with or immediately after meals.
Slovenian: Tablete zaužijte cele, s kozarcem vode, ob obrokih ali takoj po njih.
English: The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Slovenian: Predklinični program je temeljil na sedmih študijah toksičnosti večkratnega odmerjanja na podganah in psih.
English: Phosphorus is contained in many foods.
Slovenian: Mnogo živil vsebuje fosfor.
English: Experience from clinical studies in patients with hepatic impairment is limited.
Slovenian: Izkušnje iz kliničnih študij pri bolnikih z okvaro jeter so omejene.
English: Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately.
Slovenian: Bolniki s poslabšanim delovanjem ledvic niso zmožni zadostno izločati fosforja iz telesa.
English: Significantly elevated ferritin levels were observed particularly when concomitant intravenous iron was used.
Slovenian: Opazili so pomembno zvišane ravni feritina, predvsem pri sočasni uporabi intravenskega železa.
English: As a secondary endpoint in dialysis patients, and a co-primary endpoint in non-dialysis patients, the ability of Fexeric to increase iron stores was also evaluated.
Slovenian: Kot sekundarni opazovani dogodek pri bolnikih na dializi in sočasni primarni opazovani dogodek pri bolnikih, ki niso na dializi, so prav tako ocenili zmožnost zdravila Fexeric za povečanje zalog železa.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje hiperkaliemije in hiperfosfatemije
English: No data are available on the potential influence of Fexeric on fertility.
Slovenian: Podatkov o morebitnem vplivu zdravila Fexeric na plodnost ni.
English: Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes
Slovenian: aktivne hude bolezni prebavil (npr. krvavitev v prebavilih), hemokromatoza ali laboratorijske preiskave, ki kažejo na morebitno hemokromatozo, drugi (primarni in sekundarni) sindromi preobremenitve z železom.
English: Frequencies of adverse reactions are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Slovenian: Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti(≥ 1/10), pogosti (≥ 1/100 do < 1/10),
English: Patients with elevated ferritin levels receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
Slovenian: Pri bolnikih s povišanimi ravnmi feritina, ki prejemajo intravensko železo, bo morda treba zmanjšati odmerek ali prekiniti intravensko zdravljenje
English: Effects of other medicinal products on Fexeric
Slovenian: Vpliv drugih zdravil na zdravilo Fexeric
English: These patients were treated according to the recommended dosing regimen without any safety concerns.
Slovenian: Te bolnike so zdravili skladno s priporočenim režimom odmerjanja in niso odkrili nobenih težav z varnostjo.
English: In drug-drug interaction studies in healthy male and female subjects, Fexeric decreased the bioavailability of concomitantly administered ciprofloxacin (as measured by the area under the curve [AUC]) by approximately 45%.
Slovenian: V študijah medsebojnega delovanja med zdravili pri zdravih moških in ženskah je zdravilo Fexeric zmanjšalo biološko uporabnost sočasno apliciranega ciprofloksacina (izmerjeno s površino pod krivuljo (AUC)) za približno 45 %.
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.
Slovenian: Čeprav je možnost za medsebojno delovanje z zdravili majhna, je treba pri sočasnem zdravljenju z zdravili z ozkim terapevtskim oknom spremljati klinični učinek/neželene učinke pri uvedbi ali prilagajanju odmerka zdravila Fexeric ali sočasno vzetega zdravila.
English: The starting dose of active control was the patient's dose prior to the washout period.
Slovenian: Začetni odmerek pri aktivni kontrolni skupini je bil bolnikov odmerek pred
English: The elderly patients were treated according to the recommended dosing regimen without any safety concerns.
Slovenian: Starejše bolnike so zdravili skladno s priporočenim režimom odmerjanja in niso odkrili nobenih težav z varnostjo.
English: There are no data regarding the use of ferric citrate coordination complex in pregnant women.
Slovenian: Podatkov o uporabi koordinacijskega kompleksa železovega citrata pri nosečnicah ni.
English: In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
Slovenian: Pri bolnikih s KLB je bil največji preučevani odmerek 12 g (12 tablet) zdravila Fexeric na dan.
English: If you are able to become pregnant, you must use birth control during treatment.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem uporabljati kontracepcijo.
English: Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Slovenian: Od 557 bolnikov, ki so prejemali zdravilo Fexeric in so bili vključeni v zbrano populacijo za oceno varnosti, jih je imelo 67 (12 %) ob izhodišču dokaze jetrne disfunkcije.
English: Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Slovenian: Zdravilo Fexeric je indicirano za nadzorovanje hiperfosfatemije pri odraslih bolnikih s kronično
English: In CKD ND patients, the primary evaluation of safety is based on data from the pivotal study (Study 204), where 75 patients were treated with Fexeric for 12 weeks.
Slovenian: Pri bolnikih s KLB ND je primarna ocena varnosti temeljila na podatkih iz ključne študije (študije 204), v kateri so 75 bolnikov 12 tednov zdravili z zdravilom Fexeric.
English: The dose can be increased or decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day.
Slovenian: Odmerek je mogoče povečati ali zmanjšati za 1 do 2 g (1 do 2 tableti) na dan v 2- do 4-tedenskih presledkih, kot je potrebno za vzdrževanje priporočenih ciljnih ravni fosforja v serumu, do največ 12 g
English: Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Slovenian: Ob sočasni uporabi zdravilo Fexeric ni spremenilo biološke uporabnosti naslednjih zdravil: klopidogrela, digoksina, diltiazema, glimepirida, losartana.
English: Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
Slovenian: nenormalni zvoki pri dihanju, povišana raven feritina v serumu, povečana saturacija transferina, povečana telesna masa
English: No data are available regarding overdose of Fexeric in humans.
Slovenian: Podatki o prevelikem odmerjanju zdravila Fexeric pri človeku niso na voljo.
English: The safety of Fexeric for the treatment of hyperphosphataemia has been investigated in 18 clinical trials involving a total of 1388 CKD 5D patients with treatment duration of up to 2 years and 145 CKD ND patients with treatment duration of 12 weeks to 1 year.
Slovenian: Preglednica z neželenimi učinki Varnost zdravila Fexeric pri zdravljenju hiperfosfatemije so preučevali v 18 kliničnih preskušanjih, ki so vključila skupno 1.388 bolnikov s KLB 5D, pri katerih je zdravljenje trajalo do dve leti, in 145 bolnikov s KLB ND, pri katerih je zdravljenje trajalo od 12 tednov do enega leta.
English: If you become pregnant during treatment, you must ask your doctor for advice.
Slovenian: Če med zdravljenjem zanosite, se morate posvetovati z zdravnikom.
English: Shelf-life after first opening of the bottle: 60 days
Slovenian: Rok uporabnosti po prvem odprtju plastenke: 60 dni
English: Patients must take Fexeric with or immediately after meals.
Slovenian: Bolniki morajo zdravilo Fexeric jemati z obroki ali takoj po njih.
English: Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Fexeric 1 g filmsko obložene tablete koordinacijski kompleks železovega citrata Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Therefore, patients may need reduction in, or discontinuation of, intravenous iron
Slovenian: Bolniki bodo torej morda potrebovali zmanjšanje ali prekinitev vnosa intravenskega železa in/ali ESA.
English: If this is the case, you must continue to follow the special diet even if you are taking
Slovenian: V tem primeru se morate še naprej držati te posebne diete, tudi če jemljete zdravilo Fexeric.
English: It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se koordinacijski kompleks železovega citrata/njegovi presnovki izločajo v materino mleko pri človeku.
English: Non-interventional post-authorisation safety study (PASS): prospective, observational, multicentre study in CKD patients treated with Fexeric in order to gain long-term (2 years) safety data (including iron overload events, infective and gastrointestinal events) particularly in EU patients, elderly and very elderly patients, dialysed (HD, PD) and non-dialysed patients, and in addition reflecting the specific risks in subgroups of serum ferritin levels > 500 ng/ml and in patients
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): prospektivna, opazovalna, multicentrična študija pri bolnikih s KLB, zdravljenih z zdravilom Fexeric, da bi pridobili podatke o dolgoročni (dve leti) varnosti (vključno z dogodki preobremenitve z železom, infekcijskimi in gastrointestinalnimi dogodki), in sicer zlasti pri bolnikih v EU, starejših in zelo starih bolnikih, bolnikih na dializi (HD, PD)
English: The tablets are packed in plastic bottles with child-resistant caps.
Slovenian: Tablete so pakirane v plastenkah, ki imajo za otroke varno zaporko.
English: Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Slovenian: Zdravljenje z zdravilo Fexeric lahko povzroči povečanje zalog železa, predvsem pri bolnikih, ki sočasno prejemajo intravensko zdravljenje z železom.
English: The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Slovenian: Simptomi akutnega prevelikega odmerjanja železa vključujejo bruhanje, diarejo, bolečino v trebuhu, iritabilnost in dremavost.
English: This compound is insoluble and is excreted in the stool, reducing the amount of phosphate that is absorbed from the GI tract.
Slovenian: Ta spojina ni topna in se izloči z blatom, kar zmanjša količino fosfata, ki se absorbira iz prebavil.
English: The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Pri zdravilu Fexeric in bolnikih na dializi so poročali o naslednjih neželenih učinkih: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: During the overall 52-week active-controlled period, the decrease in serum phosphorus (approximately 2.0 mg/dl following up to a 2 week washout period) and the percentage of patients who achieved and maintained serum phosphorus ≤ 5.5 mg/dl (approximately 62%) were comparable in both the Fexeric and the active control groups (Table 3).
Slovenian: Med skupnim 52-tedenskim obdobjem z aktivno kontrolo sta bila znižanje ravni fosforja v serumu (približno 2,0 mg/dl po največ 2-tedenskem obdobju izplavljanja) in odstotek bolnikov, ki so dosegli in vzdrževali ravni fosforja v serumu ≤ 5,5 mg/dl (približno 62 %), primerljiva v skupini z zdravilom Fexeric in aktivni kontrolni skupini (preglednica 3).
English: Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Slovenian: Filmsko obložene tablete zdravila Fexeric so ovalne tablete breskove barve z oznako „KX52“ na eni strani.
English: Do not take a double dose to make up for a forgotten
Slovenian: Ne vzemite dvojnega odmerka, če ste
English: Fexeric N=281
Slovenian: zdravilo Fexeric N = 281
English: You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels.
Slovenian: Morda vam je zdravnik svetoval posebno dieto za preprečevanje zvišanja ravni fosforja v krvi.
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.
Slovenian: Železov citrat ni bil mutagen pri preiskavi bakterijskih reverznih mutacij (preiskavi Ames) in ni bil klastogen pri preiskavi kromosomskih aberacij na rdeče barvilo AC (E129)
English: These adverse reactions are characteristic of iron-containing medicinal products and abated with time with continued dosing.
Slovenian: Ta neželena učinka sta značilna za zdravila, ki vsebujejo železo, in sta se med nadaljevanjem odmerjanja sčasoma ublažila.
English: Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Slovenian: Zdravilo Fexeric se v prebavilih veže na fosfor v hrani, s čimer prepreči njegovo absorpcijo v kri.
English: Fexeric N=72
Slovenian: zdravilo Fexeric N = 72
English: The dose of phosphate binder was titrated as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl, to a maximum of 12 g/day.
Slovenian: Odmerek zdravila, ki veže fosfate, je bil titriran, kot je bilo potrebno za vzdrževanje ravni fosforja v serumu med 3,5 in 5,5 mg/dl, do največjega odmerka 12 g/dan.
English: Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed.
Slovenian: Pri uporabi tega zdravila so opazili zmanjšano uporabo intravenskega železa in eritropoezo stimulirajočih snovi (ESA- erythropoiesis-stimulating agent).
English: The recommended dose is: - starting dose for adults: 3 to 6 tablets daily, in separated doses, with or immediately after main meals of the day.
Slovenian: Priporočeni odmerek je: - začetni odmerek pri odraslih: od 3 do 6 tablet na dan, v ločenih odmerkih, ob glavnih obrokih ali takoj po njih.