FrancophonIA/ELRC3.0 huggingface dataset:
English: • You may take Binocrit out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Maltese: • Tista' toħroġ Binocrit mill-friġġ u żżommu f'temperatura tal-kamra (sa 25°C) għal mhux aktar minn 3 ijiem.
English: Major elective orthopaedic surgery
Maltese: Tużax din il-mediċina jekk tinnota
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: Epoetin alfa DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: The use of Binocrit in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Maltese: L-użu ta' Binocrit f'pazjenti skedati għal operazzjoni ortopedika mhux obbligatorja maġġuri u li ma jkunux qegħdin jipparteċipaw fi programm ta' predonazzjoni tad-demm awtologu, huwa kontra indikat f'pazjenti b'mard koronarju, mard tal-arterji periferali, mard tal-karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b'infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Maltese: Il-pazjenti għandhom ikunu mmonitorjati mill-qrib biex ikun żgurat li tintuża l-inqas doża approvata ta' Binocrit biex tipprovdi kontroll adegwat tal-anemija u tas-sintomi tal-anemija.
English: Take special care with Binocrit:
Maltese: Oqgħod attent ħafna bi Binocrit:
English: • in severely anaemic adults not yet undergoing dialysis
Maltese: • f'persuni adulti b'anemija severa li jkunu għadhom mhux qegħdin fuq id-dijalisi
English: Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/410/009
Maltese: Binocrit 5,000 IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: What is psyllium seed?
Maltese: X'inhi żerriegħa tal-psyllium?
English: Further information on the HMPC assessment of psyllium seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini taż-żerriegħa tal-psyllium, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Side effects have been reported with psyllium seed medicines, including flatulence and abdominal distension (swelling of the belly).
Maltese: Effetti sekondarji ġew irrapportati b'mediċini taż-żerriegħa tal-psyllium, inkluż gass u distensjoni addominali (nefħa taż-żaqq).
English: Other information about psyllium seed medicines
Maltese: Aktar informazzjoni dwar il-mediċini taż-żerriegħa tal-psyllium
English: What are the risks associated with psyllium seed medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini taż-żerriegħa tal-psyllium?
English: It can be used in adults or children over the age of 6 years.
Maltese: Tista' tintuża f'adulti jew tfal li għandhom iktar minn 6 snin.
English: In its assessment, the HMPC considered a number of clinical studies with isphagula seed and ispaghula husk which contains similar ingredients to psyllium seed, showing its effect as a mild laxative.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żerriegħa tal-psyllium.
English: The HMPC concluded that psyllium seed can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Maltese: L-HMPC ikkonkluda li ż-żerriegħa tal-psyllium tista' tintuża għall-kura ta' stitikezza abitwali (stitikezza mhux ikkawżata minn tibdil fiżiku għal organu) u f'kundizzjonijiet fejn it-trattib tal-feċi huwa mixtieq sabiex jitnaqqas l-uġigħ meta dan jgħaddi, bħal xquq anali, emorrojdi u wara kirurġija fl-anus jew firrektum.
English: Psyllium seeds contain dietary fibre which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Maltese: Iż-żerriegħa tal-psyllium fiha fibra dietarja li meta titħallat mal-ilma tifforma massa simili għal ġel li taħdem bħala lassattiv ħafif (mediċina użata għall-kura tal-istitikezza).
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.
Maltese: Iż-żerriegħa tal-psyllium huwa l-isem komuni għaż-żerrieġħa tal-pjanta Plantago afra L. et Plantago indica L.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing psyllium seed.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: 50 mg Powder for concentrate for solution for infusion
Maltese: 50 mg
English: Study 204 (CKD ND)
Maltese: Studju 204 (CKD ND)
English: Study 304 (CKD 5D)
Maltese: Studju 304 (CKD 5D)
English: Active Control N=146
Maltese: Kontroll Attiv N=146
English: Dublin 2 Ireland
Maltese: Dublin 11
English: Date of first authorisation: 23 September 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Settembru 2015
English: Tablets are 19 mm long, 7.2 mm thick and 10 mm wide.
Maltese: Il-pilloli huma 19 mm twal, 7.2 mm ħoxnin u 10 mm wiesgħa.
English: for sevelamer only)
Maltese: għal sevelamer biss)
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Maltese: (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); u rari ħafna (< 1/10,000).
English: System Organ Class by MedDRA
Maltese: Sistema tal-klassifika tal-organi skont MedDRA
English: Proportion with ferritin > 500 ng/ml at baseline Proportion with ferritin > 500 ng/ml at Week 12 174 (61.9%)
Maltese: Proporzjon b'ferritin > 500 ng/ml fil-Ġimgħa 12 174 (61.9%)
English: Hgb: haemoglobin; NAP: not applicable; SD: standard deviation; TSAT: transferrin saturation
Maltese: NAP: mhux applikabbli; SD: devjazzjoni standard; TSAT: saturazzjoni ta' transferrin
English: None of the reported serious events in Study 204 were considered to be possibly related to Fexeric.
Maltese: L-ebda avveniment serju rrapportat fl-Istudju 204 ma kien meqjus bħala possibbilment relatat ma' Fexeric.
English: *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
Maltese: *Proporzjon ta' pazjenti li kisbu fosfru fis-serum ≤ 5.5 mg/dl f'pazjenti b'CKD 5D; **Proporzjon ta' pazjenti li kisbu fosfru fis-serum ≤ 4.0 mg/dl f'pazjenti b'CKD ND NAP: mhux applikabbli; SD: devjazzjoni standard
English: From in vitro studies, certain antibiotic (doxycycline, cefdinir), anticonvulsant (valproate sodium), antidepressant (sertraline HCl), bisphosphonate (alendronate sodium), anti-parkinsonian (levodopa)
Maltese: Minn studji in vitro, ċerti antibijotiċi (doxycycline, cefdinir), mediċini antikonvulżivi (valproate sodium), antidipressanti (sertraline HCl), bisfosfonat (alendronat tas-sodju), kontra l-Parkinson (levodopa) u immunosoppressanti (methotrexate) urew il-potenzjal li jinteraġixxu ma' Fexeric:
English: Adverse reactions reported in CKD 5D and CKD ND patients are presented in Tables 1 and 2, respectively.
Maltese: Ir-reazzjonijiet avversi rapportati f'pazjenti b'CKD 5D u b'CKD ND huma preżentati fit-Tabelli 1 u 2, rispettivament.
English: Pulmonary oedema, wheezing
Maltese: Edema pulmonari, tħarħir
English: Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes
Maltese: Disturbi gastrointestinali severi attivi (eż. fsada gastrointestinali) Emokromatożi jew testijiet tal-laboratorju li jindikaw emokromatożi possibbli Sindromi (primarji jew sekondarji) oħra ta' ħadid żejjed
English: 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.
Maltese: F'pazjenti b'CKD 5D, il-valutazzjoni primarja tas-sigurtà hija bbażata fuq l-analiżi integrata tad-data minn 4 studji li fihom ħadu sehem 557 pazjent b'CKD 5D li ngħataw kura b'Fexeric sa sena.
English: 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).
Maltese: Fil-bqija tal-istudji fuq pazjenti li ma kinux fuq dijalisi, total ta' 3 reazzjonijiet avversi serji rapportati f'2 pazjenti kienu ta' natura gastrointestinali (ulċera gastrointestinali, polipi gastriċi u polipi fil-kolon).
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.
Maltese: Is-sigurtà ta' Fexeric għall-kura ta' iperfosfatemija ġiet investigata fi 18-il prova klinika li fihom ħadu sehem total ta' 1388 pazjent b'CKD 5D b'tul ta' kura sa sentejn u 145 pazjent b'CKD ND b'tul ta'
English: All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis).
Maltese: Ir-reazzjonijiet avversi serji kollha kienu ta' natura gastrointestinali (uġigħ addominali, stitikezza, dijarea, gastrite, gastrite erożiva, u ematemesi).
English: Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Maltese: Mill-557 pazjent li kienu qed jirċievu Fexeric fil-popolazzjoni raggruppata tas-sigurtà, kien hemm 67 (12%) pazjent b'evidenza ta' disfunzjoni tal-fwied fil-linja bażi.
English: 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.
Maltese: Fl-istudju pivotali 304 fuq pazjenti fuq dijalisi, il-pazjenti b'CKD 5D li ngħataw kura b'Fexeric, meta mqabbla ma' pazjenti li ngħataw kura b'kontroll attiv, kellhom żidiet sinifikament ogħla fil-livelli ta' ferritin u ta' TSAT wara 52 ġimgħa ta' kura (Tabella 4), u ħadid kumulattiv ġol-vina (96 meta mqabbel ma' 149 mg/fix-xahar) u użu ta' ESA (7,713 meta mqabbel ma' 9,183 IU/fil-ġimgħa)
English: Fexeric contains sunset yellow FCF (E110) and Allura Red AC (E129)
Maltese: Fexeric fih sunset yellow FCF (E110) u Allura Red AC (E129).
English: Experience from clinical studies in patients above the age of 75 years is limited.
Maltese: L-esperjenza minn studji kliniċi fuq pazjenti ta' aktar minn 75 sena hija limitata.
English: Fexeric 1 g film-coated tablets
Maltese: Fexeric 1 g (kartuna biss)
English: Adverse Reaction
Maltese: MANIFATTUR RESPONSABBLI
English: 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.
Maltese: −2.02 ± 2.0 mg/dl għal Fexeric u ta' −2.21 ± 2.18 mg/dl għall-karbonat ta' sevelamer, li juri n-nuqqas ta' inferjorità ta' Fexeric għal sevelamer.
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.
Maltese: Iċ-ċitrat ferriku la kien mutaġeniku fit-test tal-mutazzjoni riversiva batterika (test Ames) u lanqas klastoġeniku fit-test tal-aberrazzjoni kromosomali f'fibroblasti fil ħamster Ċiniż.
English: Placebo N=69
Maltese: N=69
English: Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml.
Maltese: Fexeric għandu jitwaqqaf temporanjament jekk il-ferritin fisserum jaqbeż 800 ng/ml.
English: Effects of other medicinal products on Fexeric
Maltese: Effetti ta' Fexeric fuq prodotti mediċinali oħra
English: Diarrhoea, constipation, discoloured faeces
Maltese: Dijarea, ippurgar skulurit
English: OUTER CARTON AND BOTTLE LABEL
Maltese: TIKKETTA TAL-KARTUNA TA' BARRA U TAL-FLIXKUN
English: 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.
Maltese: Fl-istudju 304 pivotali fuq pazjenti fuq dijalisi, wara perjodu ta' tneħħija (washout) ta' ġimagħtejn-, 441 pazjent b'CKD 5D b'iperfosfatimija kienu randomizzati biex jirċievu Fexeric (n=292) jew kontroll attiv (karbonat ta' sevelamer u/jew aċetat tal-kalċju; n=149) b'tikketta mikxufa għal
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).
Maltese: Kull pillola miksija b'rita fiha 1 g ta' kumpless ta' koordinazzjoni taċ-ċitrat ferriku (ekwivalenti għal 210 mg ta' ħadid ferriku).
English: The iron component reacts with dietary phosphate in the gastrointestinal (GI) tract and precipitates phosphate as ferric phosphate.
Maltese: Ilkomponent tal-ħadid jirreaġixxi mal-fosfat mid-dieta fil-passaġġ gastrointestinali (GI) u jippreċipita lfosfat bħala fosfat ferriku.
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
Maltese: Studju mhux ta' intervent dwar is-sigurtà ta' wara l-awtorizzazzjoni (PASS): multiċentriku, prospettiv, ta' osservazzjoni f'pazjenti b'CKD ikkurati b'Fexeric sabiex tinkiseb data dwar is-sigurtà fit-tul (sentejn) (inklużi avvenimenti ta' tagħbija eċċessiva ta' ħadid, avvenimenti infettivi u gastrointestinali) b'mod partikolari f'pazjenti tal-UE, pazjenti anzjani u anzjani ħafna, pazjenti fuq dijaliżi (HD, PD) u mhux fuq dijaliżi, u b'mod addizzjonali, li jirrifletti r-riskju speċifiku f'sottogruppi ta' livelli ta' ferritin fis-serum ta' > 500 ng/ml u f'pazjenti fil-medda ta' 200 sa < 500 ng/ml.
English: 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)
Maltese: Tabella 3: Sommarju tal-parametri tal-effikaċja fuq l-omeostasi tal-fosfru fil-Ġimgħa 12 u filĠimgħa 52 fl-Istudju 304 (CKD 5D) u fil-Ġimgħa 12 fl-Istudju 204 (CKD ND) Studju 304 (CKD 5D)
English: abdominal pain/discomfort, nausea, vomiting, haemorrhoids, haematochezia, mucous stools, dyspepsia, flatulence, dry mouth
Maltese: uġigħ/skumdità addominali, nawżja, rimettar, murliti, haematochezia, ippurgar mukuż, dispepsja, gass, ħalq xott
English: Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”.
Maltese: Pillola lewn il-ħawħ, b'forma ovali, miksija b'rita, b'“KX52” imnaqqxa fuqha.
English: 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.
Maltese: Ir-reazzjonijiet avversi komunement l-aktar irrapportati f'pazjenti b'CKD li ma kinux dipendenti fuq id-dijalisi (CKD ND) matul il-kura kienu ppurgar skulurit, stitikezza u dijarea li seħħew f'27%, 13% u 11% tal-pazjenti, rispettivament.
English: How to take Fexeric
Maltese: X'fih Fexeric
English: The active substance is ferric citrate coordination complex.
Maltese: Is-sustanza attiva hija l-kumpless ta' koordinazzjoni taċ-ċitrat ferriku.
English: Non-inferiority to sevelamer carbonate was determined at Week 12.
Maltese: In-nuqqas ta' inferjorità għal karbonat ta' sevelamer ġie stabbilit fil-Ġimgħa 12.
English: § Primary endpoint in Study 304; Co-primary endpoint in Study 204.
Maltese: Punt tat-tmiem primarju fl-Istudju 304; Punt tat-tmiem koprimarju fl-Istudju 204.
English: Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Maltese: Fexeric ma biddilx il-bijodisponibbiltà talprodotti mediċinali li ġejjin meta ngħataw b'mod konkomitanti: clopidogrel, digoxin, diltiazem,
English: The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum
Maltese: Id-doża tal-bidu rakkomandata ta' Fexeric hija ta' 3 sa 6 g (3 sa 6 pilloli) kuljum abbażi tal-livelli ta' fosfru fis-serum.
English: By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Maltese: Billi jeħel mal-fosfat fil-passaġġ GI u jnaqqas l assorbiment, Fexeric inaqqas il-livelli tal-fosfru fis-serum.
English: It is unknown whether Fexeric
Maltese: Mediċini oħra u Fexeric
English: No data are available on the potential influence of Fexeric on fertility.
Maltese: Fertilità M'hemmx data disponibbli dwar l-effett potenzjali ta' Fexeric fuq il-fertilità.
English: Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring.
Maltese: Fexeric 1 g pilloli miksijin b'rita kumpless ta' koordinazzjoni taċ-ċitrat ferriku Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: 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.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi komunement l-aktar irrapportati f'pazjenti b'mard kroniku tal-kliewi dipendenti fuq id-dijalisi (CKD 5D) waqt il-kura kienu ppurgar skulurit u dijarea li seħħew fi 18% u 13% tal-pazjenti, rispettivament.
English: Table 1: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD 5D patients on haemodialysis or peritoneal dialysis.
Maltese: Tabella 1: Reazzjonijiet avversi osservati waqt studji kliniċi li fihom Fexeric ingħata lil pazjenti b'CKD 5D fuq emodijalisi jew fuq dijalisi peritoneali.
English: In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
Maltese: F'pazjenti b'CKD li jkunu fuq dijalisi, id-doża massima studjata kienet ta' 12 g (12-il pillola) ta' Fexeric kuljum.
English: The safety and efficacy of Fexeric in children and adolescents aged 0 to 18 years have not yet been
Maltese: Is-sigurtà u l-effikaċja ta' Fexeric fit-tfal u l-adolexxenti sa 18-il sena ma ġewx determinati s'issa.
English: Information on genotoxicity, carcinogenic potential, toxicity to reproduction and development of ferric citrate was bridged from scientific literature.
Maltese: Informazzjoni dwar il-ġenotossiċità, il-potenzjal karċinoġeniku, it-tossiċità għar-riproduzzjoni u l iżvilupp ta' ċitrat ferriku inġabret mid-dokumentazzjoni xjentifika.
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.
Maltese: Hemm data limitata disponibbli għal dożi ogħla minn 9 g (9 pilloli) kuljum f'pazjenti b'CKD li ma jkunux fuq dijalisi; għalhekk f'din il-popolazzjoni dożi ogħla minn 9 g/kuljum għandhom jintużaw b'kawtela.
English: 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
Maltese: Ippurgar mhux normali, ippurgar irregolari, ħalq xott, disgewsja, dispepsja, gass, ippurgar frekwenti,
English: All patients receiving this medicine require at least quarterly monitoring of serum iron storage parameters (serum ferritin and TSAT).
Maltese: Il-pazjenti kollha li jkunu qed jirċievu din il-mediċina jeħtieġu tal-inqas monitoraġġ kull tliet xhur tal parametri tal-ħażna tal-ħadid fis-serum (ferritin u TSAT fis-serum).
English: This medicine contains ferric citrate coordination complex as the active substance.
Maltese: Din il-mediċina fiha l-kumpless ta' koordinazzjoni taċ-ċitrat ferriku bħala s-sustanza attiva.
English: 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.
Maltese: Kull pillola miksija b'rita fiha sunset yellow FCF (E110) (0.99 mg) u Allura Red AC (E129) (0.70 mg).
English: The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Maltese: Id-doża tal-bidu ta' Fexeric kienet ta' 6 pilloli/kuljum (6 g/kuljum), f'dożi maqsumin malikel.
English: Increases in ferritin and TSAT above safety thresholds are observed with Fexeric use.
Maltese: Ġew osservati żidiet fil-ferritin u f'TSAT ogħla mil-limiti ta' sigurtà bl-użu ta' Fexeric.
English: Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Maltese: Fexeric huwa indikat għall-kontroll ta' iperfosfatemija f'pazjenti adulti b'mard kroniku talkliewi (CKD).
English: All other parameters were secondary or exploratory endpoints in the two studies.
Maltese: Il-parametri l-oħra kollha kienu punti tat-tmiem sekondarji jew esploratorji fiż-żewġ studji.
English: Table 2: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD ND patients.
Maltese: Tabella 2: Reazzjonijiet avversi osservati waqt studji kliniċi li fihom Fexeric ingħata lil pazjenti b'CKD ND.
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.
Maltese: Dawn ir-reazzjonijiet avversi serji ma kinux komuni (anqas minn każ 1 kull waħda għal kull 100 pazjent) u kull waħda kienet irrapportata f'0.2% (1/557) tal-pazjenti b'CKD 5D li rċevew
English: Fexeric contains ferric citrate coordination complex as the active ingredient.
Maltese: Fexeric fih il-kumpless ta' koordinazzjoni taċ-ċitrat ferriku bħala s-sustanza attiva.
English: Pruritus, rash Incontinence
Maltese: Reazzjoni Avversa
English: Patients with active, symptomatic inflammatory bowel disease were excluded from clinical trials.
Maltese: Pazjenti b'mard attiv, sintomatiku, infjammatorju tal-imsaren kienu esklużi mill-provi kliniċi.
English: The other ingredients are pregelatinised starch, calcium stearate, hypromellose, titanium dioxide, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.
Maltese: trijaċetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.
English: 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).
Maltese: Tnaqqis fid-doża mhuwiex meqjus neċessarju iżda pazjenti b'indeboliment epatiku għandhom jibdew il-kura bid-doża tal-bidu l-aktar baxxa, 3 g (3 pilloli) kuljum (ara sezzjoni 5.1).