natgillin/translations-raw huggingface dataset:
Formal pharmacokinetic studies have not been performed due to the medicine's predominantly localised primary mechanism of action in the GI tract.
Službena farmakokinetička ispitivanja nisu provedena zbog pretežito lokaliziranoga primarnog mehanizma djelovanja lijeka u gastrointestinalnom traktu.
No data are available on the potential influence of Fexeric on fertility.
Nisu dostupni podaci o mogućem utjecaju Fexerica na plodnost.
Fexeric has no influence on the ability to drive and use machines.
Fexeric ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Information on genotoxicity, carcinogenic potential, toxicity to reproduction and development of ferric citrate was bridged from scientific literature.
Informacije o genotoksičnosti, karcinogenom potencijalu, reproduktivnoj i razvojnoj toksičnosti željezovog citrata preuzete su iz znanstvene literature.
This medicine should be used only in the absence of iron overload syndromes and with caution if serum ferritin rises above 500 ng/ml.
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.
The total daily dose should be divided
Ukupna dnevna doza treba se raspodijeliti među dnevnim obrocima.
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.
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.
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.
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.
Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
neuobičajeni zvuk disanja, povišeni feritin u serumu, povišena saturacija transferina, povećana težina
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.
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.
There was no evidence of hepatic impairment or significant alteration of hepatic enzymes across the clinical studies with Fexeric, including the long-term studies.
Nema dokaza o oštećenju jetre niti značajnoj promjeni jetrenih enzima u kliničkim ispitivanjima s Fexericom, uključujući dugotrajna ispitivanja.
Data from carcinogenicity studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously.
Podaci iz ispitivanja kancerogenosti pokazali su da željezov citrat nije kancerogen za miševe i štakore kada se primjenjuje intramuskularno ili supkutano.
Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Fexeric je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika s kroničnom bolesti bubrega
All patients receiving this medicine require at least quarterly monitoring of serum iron storage parameters (serum ferritin and TSAT).
Svim bolesnicima koji primaju ovaj lijek moraju se barem svaka tri mjeseca pratiti parametri skladištenja željeza u serumu (feritin u serumu i TSAT).
Shelf-life after first opening of the bottle: 60 days
Rok valjanosti nakon prvog otvaranja boce: 60 dana
Effects of other medicinal products on Fexeric
Učinci drugih lijekova na Fexeric
The elderly patients were treated according to the recommended dosing regimen without any safety concerns.
Stariji bolesnici liječeni su u skladu s preporučenim režimom doziranja bez ikakvih sigurnosnih rizika.
Shelf life after first opening of the bottle: 60 days Open date: (Bottle only)
Rok valjanosti nakon prvog otvaranja boce: 60 dana Datum otvaranja: (Samo na boci)
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Fexeric nije promijenio bioraspoloživost sljedećih lijekova prilikom njihove istodobne primjene: klopidogrela, digoksina, diltiazema, glimepirida, losartana.
The tablets are packed in plastic bottles with child-resistant caps.
Tablete su zapakirane u plastičnim bocama sa sigurnosnim zatvaračem za djecu.
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
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.
Very common:
Manje često:
These patients were treated according to the recommended dosing regimen without any safety concerns.
Ti bolesnici liječeni su u skladu s preporučenim režimom doziranja bez ikakvih sigurnosnih rizika.
In iron replete dogs, microscopic and macroscopic findings in the liver were consistent with signs of iron accumulation.
U pasa s viškom željeza mikroskopski i makroskopski nalazi jetre bili su u skladu sa znakovima nakupljanja željeza.
• Also tell your doctor or pharmacist if you are taking or might take the medicines below.
• Također obavijestite svog liječnika ili ljekarnika ako uzimate ili biste mogli uzeti bilo koje druge lijekove navedene u nastavku.
Significantly elevated ferritin levels were observed particularly when concomitant intravenous iron was used.
Značajno povišene razine feritina opažene su osobito kod istodobne primjene intravenskog željeza.
Fexeric is not recommended during pregnancy and in women of childbearing potential not using contraceptive
Ne preporučuje se uzimanje Fexerica tijekom trudnoće niti ženama u reproduktivnoj dobi koje ne koriste
Effects of Fexeric on other medicinal products
Učinci Fexerica na druge lijekove
Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Liječenje Fexericom može dovesti do povećanja zaliha željeza, osobito u bolesnika koji istodobno primaju terapiju intravenskim željezom.
Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake „Rok valjanosti”.
Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts.
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.
Patients with elevated ferritin levels receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
U bolesnika s povećanim razinama feritina koji primaju intravensko željezo može biti potrebno smanjenje doze ili prekid terapije intravenskim željezom.
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
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.
Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Farmakoterapijska skupina: Lijekovi za liječenje hiperkalijemije i hiperfosfatemije
Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Fexeric filmom obložene tablete boje su breskve i ovalnog oblika s utisnutom oznakom „KX52” na jednoj strani.
Examination of serum iron storage parameters has shown that there is low systemic absorption of iron
Istraživanje parametara skladištenja serumskog željeza pokazalo je postojanje niske sustavne apsorpcije željeza iz Fexerica od otprilike 1 %.
The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Simptomi akutnog predoziranja željezom uključuju povraćanje, proljev, bol u abdomenu, razdražljivost i omamljenost.
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.
Sigurnost Fexerica u liječenju hiperfosfatemije ispitivana je u 18 kliničkih ispitivanja kojima je obuhvaćeno ukupno 1388 bolesnika s KBB 5D čije je liječenje trajalo najviše 2 godine i 145 bolesnika s KBB ND s trajanjem liječenja od 12 tjedana do 1 godine.
Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed.
Opažena su smanjenja u upotrebi intravenskog željeza i lijekova za stimulaciju eritropoeze (LSE) kod primjene ovog lijeka.
Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Od 557 bolesnika iz objedinjene populacije za ocjenu sigurnosti primjene koji su primali Fexeric, 67 (12 %) bolesnika imalo je dokazanu disfunkciju jetre na početku.ispitivanja
You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels.
Možda ste dobili savjet da se držite posebne prehrane kako biste spriječili visoke razine fosfora u krvi.
No data are available regarding overdose of Fexeric in humans.
Nema dostupnih podataka o predoziranju Fexericom u ljudi.
Phosphorus is contained in many foods.
Mnoge prehrambene namirnice sadrže fosfor.
The safety and effectiveness of Fexeric have not been studied in this population.
Fexerica nisu ispitane u toj populaciji.
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
prospektivno, opservacijsko, multicentrično ispitivanje na bolesnicima s KBB-om koji se liječe Fexericom , kako bi se prikupili dugoročni (dvogodišnji) podaci o sigurnosti primjene (uključujući događaje preopterećenja željezom , infektivne i gastrointestinalne događaje) naročito u bolesnika na području EU-a, starijih i vrlo starih bolesnika, bolesnika na dijalizi (HD, PD) i bolesnika koji nisu na dijalizi, te koje dodatno odražava specifične rizike u podskupinama s razinama feritina u serumu > 500 ng/ml i kod bolesnika u rasponu od 200 do < 500 ng/ml.
In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
U bolesnika s KBB-om, maksimalna ispitivana doza iznosila je 12 g (12 tableta) Fexerica dnevno.
Table 1: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD 5D patients on haemodialysis or peritoneal dialysis.
Tablica 1: Nuspojave opažene tijekom kliničkih ispitivanja u kojima je Fexeric primijenjen u bolesnika s KBB 5D na hemodijalizi ili peritonejskoj dijalizi.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
• Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
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).
Tijekom cjelokupnog 52-tjednog razdoblja aktivne kontrole smanjenje razine fosfora u serumu (otprilike 2,0 mg/dl nakon 2tjednog razdbolja ispiranja) i postotak bolesnika koji su postigli i održali razinu fosfora u serumu ≤ 5,5 mg/dl (otprilike 62 %) bili su usporedivi u skupini koja je uzimala Fexeric i onoj koja je uzimala aktivnu kontrolu (Tablica 3).
Experience from clinical studies in patients with hepatic impairment is limited.
Iskustvo iz kliničkih ispitivanja za bolesnike s oštećenjem jetre je ograničeno.
During the 52-week treatment period, haemoglobin remained relatively stable in the Fexeric group compared to
Tijekom razdoblja liječenja od 52 tjedna, razina hemoglobina ostala je relativno stabilna u skupini liječenoj Fexericom u usporedbi sa skupinom liječenom aktivnom
Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g
Bolesnici koji su prethodno uzimali druge vezače fosfata, a prebačeni su na Fexeric trebaju početi uzimati 3 do 6 g dnevno (3 do 6 tableta).
By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Vezivanjem fosfata u gastrointestinalnom traktu i smanjenjem apsorpcije, Fexeric smanjuje razine fosfora u serumu.
Fexeric must be taken in divided doses with or immediately after meals of the day.
Fexeric se mora uzimati u podijeljenim dozama uz dnevne obroke ili neposredno nakon njih.
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.
U bolesnika s KBB ND primarna procjena sigurnosti temelji se na analizi podataka iz pivotalnog ispitivanja (Ispitivanje 204) kojim je obuhvaćeno 75 bolesnika koji su liječeni Fexericom tijekom 12 tjedana.
Increases in ferritin and transferrin saturation (TSAT) are observed with Fexeric use.
Opažena su povećanja feritina i saturacije transferina (TSAT) prilikom primjene Fexerica.
Therefore, patients may need reduction in, or discontinuation of, intravenous iron
Stoga, bolesnicima može biti potrebno smanjenje ili prekid primjene intravenskog željeza i/ili LSE.
The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Početna doza Fexerica bila je 6 tableta dnevno (6 g dnevno) u podijeljenim dozama uz obroke.
Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Fexeric veže fosfor iz hrane u Vašem probavnom traktu radi sprječavanja njegove apsorpcije u krv.
The other ingredients are pregelatinised starch, calcium stearate, hypromellose, titanium dioxide, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.
Ostali sastojci su prethodno geliran škrob, kalcijev stearat, hipromeloza, titanijev dioksid, triacetin i boje sunset yellow FCF (E110), allura red AC (E129) i indigo carmine.
Following completion of the 52-week active-controlled period, patients were eligible to enter a 4-week placebo-controlled period in which they were re-randomized to receive Fexeric (n=96)
Nakon što je završilo razdoblje aktivne kontrole u trajanju od 52 tjedna, bolesnici su mogli početi s 4-tjednim placebom kontroliranim razdobljem u kojem su ponovno randomizirani za primanje Fexerica (n=96) ili placeba (n=96).
Fexeric should not be taken at the same time as aluminium containing medicines.
• lijekovi koji sadrže aluminij Fexeric se ne smije uzimati istodobno s lijekovima koji sadrže aluminij.
Patients must take Fexeric with or immediately after meals.
Bolesnici moraju uzeti Fexeric tijekom obroka ili neposredno nakon njih.
Proportion with ferritin > 500 ng/ml at baseline Proportion with ferritin > 500 ng/ml at Week 12 174 (61.9%)
> 500 ng/ml u 12. tjednu 174 (61,9%) > 500 ng/ml u 52. tjednu 160 (56,9%)
This compound is insoluble and is excreted in the stool, reducing the amount of phosphate that is absorbed from the GI tract.
Taj je spoj netopljiv i izlučuje se stolicom, smanjujući količinu fosfata koja se apsorbira iz gastrointestinalnog trakta.
The starting dose of Fexeric was 3 tablets a day (3 g/day) in divided doses with meals and was adjusted as needed to a maximum of 12 g/day in order to maintain serum phosphorus levels between 3.0 and 3.5 mg/dl.
Početna doza Fexerica bila je 3 tablete dnevno (3 g dnevno) u podijeljenim dozama uz obroke i po potrebi je prilagođena do najviše 12 g dnevno kako bi se razine fosfora u serumu održale između 3,0 i 3,5 mg/dl.
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.