natgillin/translations-raw huggingface dataset:
The target organ for primary toxicity of ferric citrate is the GI tract, with evidence of mucosal erosion and acute to sub-acute inflammation of the GI tract in dogs at elevated doses. 
Ciljni organ za primanu toksičnost željezovog citrata je gastrointestinalni trakt uz dokazanu pojavu erozije sluznice i akutne do subakutne upale gastrointestinalnog trakta u pasa pri povišenim dozama.
After 12 weeks of treatment, the mean (± SD) change in serum phosphorus from baseline was −2.02 ± 2.0 mg/dl for Fexeric and −2.21 ± 2.18 mg/dl for sevelamer carbonate, demonstrating non-inferiority of Fexeric to sevelamer. 
Nakon 12 tjedana liječenja srednja vrijednost promjene (± SD) razine fosfora u serumu u odnosu na početnu vrijednost iznosila je −2,02 ± 2,0 mg/dl za Fexeric i −2,21 ± 2,18 mg/dl za sevelamerkarbonat, što dokazuje neinferiornost Fexerica u odnosu na sevelamer.
Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section 
Podaci o dugoročnoj sigurnosti u bolesnika koji se ne liječe dijalizom i peritonejskom dijalizom (PD)
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%. 
U ispitivanjima interakcija lijekova u zdravih muških i ženskih ispitanika, Fexeric je smanjio bioraspoloživost istodobno primijenjenog ciprofloksacina (mjereno površinom ispod krivulje [AUC])
It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk. 
Nije poznato izlučuju li se kompleksni spoj željezovog citrata/metaboliti u majčino mlijeko u ljudi.
In adults with impaired kidney function it is used to lower high blood phosphorus levels. 
Upotrebljava se u odraslih osoba s oštećenjem bubrežne funkcije za snižavanje visokih razina fosfora u krvi.
The most commonly reported adverse reactions in non-dialysis dependent CKD (CKD ND) patients during treatment were discoloured faeces, constipation and diarrhoea occurring in 27%, 13% and 11% of patients, respectively. 
Najčešće prijavljene nuspojave tijekom liječenja bolesnika s kroničnom bolesti bubrega koji se ne liječe dijalizom (KBB ND) bile su promjena boje fecesa, konstipacija i proljev koji su se javili u 27 %, 13 %, odnosno 11 % bolesnika.
Non-inferiority to sevelamer carbonate was determined at Week 12. 
U 12. tjednu utvrđena je neinferiornost u odnosu na sevelamerkarbonat.
Patients treated with Fexeric should not receive concomitant treatment with other oral iron 
Bolesnici koji se liječe Fexericom ne smiju istodobno primati liječenje drugim oralnim pripravcima
In the pivotal dialysis study 304, following a 2-week washout period, 441 CKD 5D patients with hyperphosphatemia were randomised to receive Fexeric (n=292) or active control (sevelamer carbonate and/or calcium acetate; n=149) open-label for 52 weeks. 
U pivotalnom ispitivanju 304 na bolesnicima liječenim dijalizom, nakon 2-tjednog razdoblja ispiranja, 441 bolesnik s KBB 5D i hiperfosfatemijom randomiziran je za primanje Fexerica (n=292) ili aktivne kontrole (sevelamerkarbonat i/ili kalcijev acetat; n=149) tijekom otvorenog ispitivanja u trajanju od 52 tjedna.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Uncommon side effects (may affect up to 1 in 100 people): changes in iron blood test results decreased or increased appetite indigestion, flatulence inflammation of stomach lining, ulcer of mucosal lining of the stomach or the first part of the bowel reflux of stomach juices in the oesophagus abnormal stools, irregularity in bowel movement shortness of breath, wheezing, abnormal breath sounds 
Manje česte nuspojave (mogu se javiti kod do 1 na 100 osoba): promjene u rezultatima krvnih pretraga za željezo smanjen ili povećan apetit probavne smetnje, vjetrovi upala želučane sluznice, čir na sluznici želuca ili prvom dijelu crijeva povrat (refluks) želučane kiseline u jednjak neuobičajene stolice, nepravilnost pražnjenja crijeva niske razine fosfora u serumu suha usta poremećaj okusa niske razine kalija u serumu nedostatak zraka, piskanje, neuobičajeni zvukovi disanja
In the pivotal dialysis study 304, CKD 5D patients treated with Fexeric, compared with patients treated with active control, had significantly higher increases in ferritin and TSAT levels after 52 weeks of treatment (Table 4), and significantly lower cumulative intravenous iron (96 versus 149 mg/month) and ESA use (7,713 versus 9,183 IU/week) during the same period. 
U pivotalnom ispitivanju 304 na bolesnicima liječenim dijalizom, bolesnici s KBB 5D liječeni Fexericom imali su, u usporedbi s bolesnicima liječenim aktivnom kontrolom, značajno viša povećanja razina feritina i TSAT-a nakon 52 tjedna liječenja (Tablica 4) te značajno nižu kumulativnu primjenu intravenskog željeza (96 naspram 149 mg mjesečno) i LSE (7713 naspram 9183 IU tjedno) tijekom istog razdoblja.
Therefore, patients may need a reduction in 
Stoga, bolesnicima može biti potrebno smanjenje doze LSE .
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. 
Po potrebi se doza može povećati ili smanjiti za 1 do 2 g dnevno (1 do 2 tablete) u intervalima od 2 do 4 tjedna do najviše 12 g dnevno (12 tableta)
Each 1 g film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) (0.70 mg) which may cause allergic reaction. 
Svaka filmom obložena tableta od 1 g sadrži boje Sunset Yellow FCF (E110) (0,99 mg) i Allura Red AC (E129) (0,70 mg) koje mogu uzrokovati alergijsku reakciju.
The iron component reacts with dietary phosphate in the gastrointestinal (GI) tract and precipitates phosphate as ferric phosphate. 
Željezo reagira s fosfatom iz prehrane u gastrointestinalnom traktu i taloži fosfat u obliku željezovog fosfata.
These adverse reactions are characteristic of iron-containing medicinal products and abated with time with continued dosing. 
Te nuspojave karakteristične su za lijekove koji sadrže željezo i s vremenom se smanjuju s nastavkom doziranja.
The ability of Fexeric to control serum phosphorus in CKD patients was principally evaluated in one long-term, pivotal Phase III trial (Study 304) in CKD 5D patients, and in one pivotal Phase II, 12 week, placebo-controlled trial (Study 204) in CKD ND patients with anaemia. 
Sposobnost Fexerica da kontrolira razinu fosfora u serumu bolesnika s KBB-om prvotno je ocijenjena u jednom dugotrajnom pivotalnom ispitivanju faze III (Ispitivanje 304) u bolesnika s KBB 5D i u jednom pivotalnom, placebom kontroliranom ispitivanju faze II u trajanju od 12 tjedana (Ispitivanje 204) u bolesnika s KBB ND i anemijom.
The following medicines can affect or be affected by Fexeric: Fexeric contains iron and your doctor may need to adjust the dose of your other iron-containing 
Fexeric sadrži željezo te će Vaš liječnik možda trebati prilagoditi dozu Vaših drugih lijekova koji
Common side effects (may affect up to 1 in 10 people): abdominal distension or bloating nausea, vomiting 
Česte nuspojave (mogu se javiti kod do 1 na 10 osoba): bol/nelagoda u trbuhu nadimanje ili nadutost u trbuhu mučnina, povraćanje
Reductions in ESA use with Fexeric have been observed. 
Opaženo je smanjenje primjene LSE s Fexericom.
During the 12-week treatment period, patients treated with Fexeric had a significant decrease in serum phosphorus, compared to the placebo group (p < 0.001 for treatment difference) (Table 3). 
Tijekom 12-tjednog razdoblja liječenja, bolesnici koji su liječeni Fexericom imali su značajno smanjenje razine fosfora u serumu u usporedbi sa skupinom koja je uzimala placebo (p< 0,001 za razliku u liječenju) (Tablica 3).
Adverse reactions reported in CKD 5D and CKD ND patients are presented in Tables 1 and 2, respectively. 
Nuspojave prijavljene u bolesnika s KBB 5D i KBB ND prikazane su u Tablici 1.,
Name and address of the manufacturer(s) responsible for batch release 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
The Fexeric-bound phosphorus is then excreted from your body in faeces. 
Fosfor vezan na Fexeric tada se izlučuje iz Vašeg tijela stolicom.
Table 2: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD ND patients. 
Tablica 2.: Nuspojave opažene tijekom kliničkih ispitivanja u kojima je Fexeric primijenjen u
System Organ Class by MedDRA 
Klasifikacija organskih sustava prema
Temporarily discontinue Fexeric if the serum phosphorus is < 3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range. 
Ako je razina fosfora u serumu < 3 mg/dl potrebno je privremeno prekinuti primjenu Fexerica i nastaviti s primjenom manje doze nakon što se vrijednost fosfora u serumu vrati unutar ciljnog
The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum 
Preporučena početna doza Fexerica je 3 do 6 g dnevno (3 do 6 tableta), ovisno o razini fosfora u
In the pivotal non-dialysis study 204 CKD ND patients treated with Fexeric had a significant increase in serum TSAT, ferritin and haemoglobin levels compared to the placebo group after 12 weeks of treatment (p< 0.001 for treatment difference for each parameter) (Table 4). 
U pivotalnom ispitivanju 204 na bolesnicima koji nisu na dijalizi, bolesnici s KBB ND liječeni Fexericom imali su značajno povećanje razina TSAT-a, feritina i hemoglobina u serumu u usporedbi sa skupinom liječenom placebom nakon 12 tjedana liječenja (p< 0,001 za razliku u liječenju za svaki parametar) (Tablica 4).
Urinary phosphorus excretion and FGF-23 were also significantly decreased relative to baseline in the CKD ND patients treated with Fexeric compared to patients treated with placebo. 
Izlučivanje fosfora urinom i FGF-23 (engl. fibroblast growth factor 23) također su znatno smanjeni u odnosu na početnu vrijednost u bolesnika s KBB ND koji su liječeni
§ Primary endpoint in Study 304; Co-primary endpoint in Study 204. 
§ Koprimarni ishod u Ispitivanju 204.
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. 
Titracija doze Koncentracije fosfora u serumu trebaju se nadzirati unutar 2 do 4 tjedna od početka ili promjene doze
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili
Table 4: Summary of results on iron homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND) 
Tablica 4: Sažetak rezultata homeostaze željeza u 12. i 52. tjednu Ispitivanja 304 (KBB 5D) te u 12. tjednu Ispitivanja 204 (KBB ND)
Fexeric contains sunset yellow FCF (E110) and Allura Red AC (E129) 
Fexeric sadrži boje Sunset Yellow FCF (E110) i Allura Red AC (E129)
Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or 
Bolesnicima koji nisu na dijalizi potrebna je niža početna doza: 3 tablete dnevno u podijeljenim dozama uz glavne dnevne obroke ili odmah nakon njih.
Table 3: Summary of efficacy parameters on phosphorus homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND) 
Tablica 3: Sažetak parametara djelotvornosti za homeostazu fosfora u 12. i 52. tjednu Ispitivanja 304 (KBB 5D) te u 12. tjednu Ispitivanja 204 (KBB ND)
Diarrhoea, discoloured faeces Abdominal pain/discomfort/distension, constipation, nausea, vomiting Abnormal faeces, bowel movement irregularity, dry mouth, dysgeusia, dyspepsia, flatulence, frequent bowel movements, gastritis, gastritis erosive, gastrooesophageal reflux disease, haematemesis, peptic ulcer 
mučnina, povraćanje neuobičajeni feces, neredovito pražnjenje crijeva, suha usta, disgeuzija, dispepsija, flatulencija, česta pražnjenja crijeva, gastritis, erozivni gastritis, gastroezofagealna refluksna bolest, hematemeza, peptički ulkus
After first opening of the bottle, use within 60 days. 
Upotrijebiti unutar 60 dana od prvog otvaranja boce.
The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also 
Najčešće nuspojave (javljaju se kod više od 1 na 10 osoba) u bolesnika koji nisu na dijalizi također su povezane sa želucem ili crijevima:
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. 
- početna doza za odrasle: 3 do 6 tableta dnevno u podijeljenim dozama uz glavne dnevne obroke ili odmah nakon njih.
In the remaining non-dialysis studies, a total of 3 serious adverse reactions reported in 2 patients were gastrointestinal in nature (gastrointestinal ulcer, gastric polyps and colonic polyps). 
U preostalim ispitivanjima bolesnika koji se ne liječe dijalizom prijavljene su ukupno 3 ozbiljne nuspojave u 2 bolesnika i one su bile gastrointestinalnog karaktera
Following absorption, citrate is converted 
Nakon apsorpcije, tkiva pretvaraju citrat u bikarbonat.
Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”. 
Ovalna filmom obložena tableta boje breskve s utisnutom oznakom „KX52”.
If you are able to become pregnant, you must use birth control during treatment. 
Ako ste žena reproduktivne dobi, za vrijeme liječenja morate upotrebljavati zaštitu od začeća.
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva Manje često:
- maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the 
- maksimalna doza: 12 tableta dnevno u podijeljenim dozama uz glavne dnevne obroke ili
*Proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl in CKD 5D patients; **Proportion of patients achieving serum phosphorus ≤ 4.0 mg/dl in CKD ND patients NAP: not applicable; SD: standard deviation 
§ Primarni ishod Ispitivanja 304; koprimarni ishod Ispitivanja 204. * Udio bolesnika s KBB 5D koji su postigli razinu fosfora u serumu ≤ 5,5 mg/dl ** Udio bolesnika s KBB ND koji su postigli razinu fosfora u serumu ≤ 4,0 mg/dl NP: nije primjenjivo; SD: standardna devijacija
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. 
Doza vezača fosfata bila je titrirana po potrebi, do najviše 12 g dnevno, kako bi se održale razine fosfora u serumu između 3,5 i 5,5 mg/dl.
for sevelamer only) 
Početna razina fosfora u serumu samo za sevelamer)
Decreased appetite, hyperkalaemia, hypophosphataemia, increased appetite Dizziness, headache Palpitations, dyspnoea Malignant hypertension 
povećani apetit omaglica, glavobolja palpitacije, dispneja maligna hipertenzija
Talk to your doctor or pharmacist before taking Fexeric if you have: too much iron in your body bowel inflammation 
Obratite se svom liječniku ili ljekarniku prije nego što uzmete Fexeric ako imate:
There are no data regarding the use of ferric citrate coordination complex in pregnant women. 
Ne postoje podaci o primjeni komplesknog spoja željezovog citrata u trudnica.
NAP 
Nuspojava
Increases in ferritin and TSAT above safety thresholds are observed with Fexeric use. 
Prilikom primjene Fexerica opažena su povišenja feritina i TSAT-a iznad sigurnosnih graničnih vrijednosti.
HDPE bottles with child-resistant closure with desiccant. 
HDPE boce sa sigurnosnim zatvaračem za djecu i sredstvom za sušenje.
All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis). 
Sve su ozbiljne nuspojave bile gastrointestinalnog karaktera (bol u abdomenu, konstipacija,
CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day. 
Bolesnicima s KBB-om koji se ne liječe dijalizom potrebna je niža početna doza od 3 g dnevno (3
Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Fexeric 1 g filmom obložene tablete kompleksni spoj željezovog citrata
Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans. 
Podaci o primarnoj i sekundarnoj farmakodinamici, sigurnosnoj farmakologiji i farmakokinetici
Pregnancy and women of childbearing potential 
4.6 Plodnost, trudnoća i dojenje Trudnoća i žene u reproduktivnoj dobi
Bronchitis 
Nuspojava bronhitis
Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of 
Jedna filmom obložena tableta sadrži 1g kompleksnog spoja željezovog citrata (što odgovara 210 mg
During the subsequent 4-week placebo-controlled period, the serum phosphorus levels remained stable in patients receiving Fexeric (mean decrease of 0.24 mg/dl), whereas patients receiving placebo had a mean increase of 1.79 mg/dl (p < 0.0001 for treatment difference). 
Tijekom narednog 4-tjednog placebom kontroliranog razdoblja razine fosfora u serumu ostale su stabilne u bolesnika koji su primali Fexeric (srednja vrijednost smanjenja od 0,24 mg/dl), dok su bolesnici koji su primali placebo imali srednju vrijednost povećanja od
and immunosuppressant (methotrexate) medications showed the potential to interact with Fexeric: any of these or other medicinal products that have the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric. 
U in vitro ispitivanjima neki su antibiotici (doksiciklin, cefdinir), antikonvulzivi (natrijev valproat), antidepresivi (sertralinklorid), bisfosfonati (natrijev alendronat), antiparkinsonici (levodopa) i imunosupresivi (metotreksat) pokazali potencijal za interakcije s Fexericom: bilo koji od tih lijekova ili drugi lijekovi s potencijalom za interakcije s Fexericom moraju se uzimati najmanje 2 sata prije ili
Monitoring blood levels of these medicines may also be considered: - ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections - valproic acid: a medicine to treat epilepsy and mental disorders - sertraline: a medicine to treat depression - methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis - alendronate: a medicine to treat decreased bone mass and density - levodopa: a medicine to treat Parkinson's disease - levothyroxine: a medicine to treat thyroid hormone deficiency 
- alendronat: lijek za liječenje smanjenja koštane mase i gustoće - levodopa: lijek za liječenje Parkinsonove bolesti - levotiroksin: lijek za liječenje manjka hormona štitnjače
In CKD 5D patients, the primary evaluation of safety is based on the integrated analysis of data from 4 studies involving 557 CKD 5D patients treated with Fexeric for up to 1 year. 
U bolesnika s KBB 5D primarna procjena sigurnosti temelji se na integriranoj analizi podataka iz 4
Pulmonary oedema, wheezing 
pruritus, osip
The active substance is ferric citrate coordination complex. 
Djelatna tvar Fexerica je kompleksni spoj željezovog citrata.
Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes 
Hemokromatoza ili nalazi laboratorijskih pretraga koji ukazuju na moguću hemokromatozu
Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron). 
Jedna filmom obložena tableta sadrži 1 g kompleksnog spoja željezovog citrata (što odgovara 210 mg trovalentnog željeza)
Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml. 
Ako feritin u serumu prelazi 800 ng/ml, primjenu Fexerica treba privremeno prekinuti.
No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1). 
Smatra se da nije nužno smanjenje doze, no bolesnici s oštećenjem jetre trebaju započeti liječenje s nižom početnom dozom od
See the end of section 4 
Za postupak prijavljivanja nuspojava, pogledajte dio 4.
abdominal pain/discomfort, nausea, vomiting, haemorrhoids, haematochezia, mucous stools, dyspepsia, flatulence, dry mouth 
Poremećaji metabolizma i prehrane hipofosfatemija proljev, konstipacija, promjena boje fecesa bol /nelagoda u abdomenu, mučnina, povraćanje, hemoroidi, hematohezija, sluzave stolice, dispepsija, flatulencija, suha usta
Adverse Reaction 
inkontinencija
In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-totreat population (Fexeric: 72 patients; Placebo: 69 patients). 
populacija koju se namjeravalo liječiti (ITT, engl. intent-to-treat) obuhvaćala je 141 bolesnika (Fexeric: 72 bolesnika; placebo: 69 bolesnika).
The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people): 
Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
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. 
Također je ocijenjena sposobnost Fexerica da poveća zalihe željeza kao sekundarni ishod u bolesnika liječenih dijalizom i kao koprimarni ishod u bolesnika koji nisu liječeni dijalizom.
- if you are allergic to ferric citrate coordination complex or any of the other ingredients of this medicine (listed in section 6) - if you have low levels of phosphorus in your blood - if you have a severe stomach or bowel disease such as stomach or bowel bleeding 
- ako imate tešku želučanu ili crijevnu bolest kao što je želučano ili crijevno krvarenje;
Hypophosphataemia 
Klinička djelotvornost
This medicine contains ferric citrate coordination complex as the active substance. 
Djelatna tvar u ovom lijeku jest kompleksni spoj željezovog citrata.
Also contains sunset yellow FCF (E110), Allura Red AC (E129), see the package leaflet for futher 
Također sadrži boje Sunset Yellow FCF (E110) i Allura Red AC (E129).
Uncommon: 
SN: NN:
They are supplied in one pack size of 
Dostavljaju se u pakiranju jedne veličine koje sadrži 200 tableta po boci.
Do not store above 25°C Keep the bottle tightly closed in order to protect from moisture. 
Ne čuvati na temperaturi iznad 25°C.
The most commonly reported adverse reactions in dialysis-dependent chronic kidney disease (CKD 5D) patients during treatment were discoloured faeces and diarrhoea occurring in 18% and 13% of patients, respectively. 
(KBB 5D) bile su promjena boje fecesa koja se javila u 18 %, i proljev koji se javio u 13 % bolesnika.
Clinical consequences are unknown. 
Kliničke posljedice nisu poznate.
Target organ 
Ciljni organ
Other body areas 
Druga područja tijela
<Product name> is approved for use in children above two years of age. 
<Naziv lijeka> je odobren za primjenu u djece starije od dvije godine.
This includes retention in the brain and in other tissues and organs. 
To uključuje zadržavanje u mozgu i drugim tkivima i organima.
Brain and spine 
Mozak i kralješnica
Because of the lack of information on repeated administration, <Product name> injections should not be repeated unless the interval between injections is at least 7 days. 
Zbog nedostatka informacija o ponovljenoj primjeni, injekcije <Naziv lijeka>se ne smiju ponavljati osim ako je interval između injekcija najmanje 7 dana.
• part for healthcare professionals: Post-contrast imaging acquisition: 
• dio za zdravstvene radnike: Dobivanje prikaza nakon kontrasta:
o Accumulation in the body <Product name> works because it contains a metal called gadolinium. 
o Nakupljanje u tijelu <Naziv lijeka> djeluje zato što sadrži metal koji se naziva gadolinij.