FrancophonIA/ELRC3.0 huggingface dataset:
English: Feraccru (N=64) 1.06 (0.08)*** 1.79 (0.11)*** 66 Placebo (N=64) 0.02 (0.08) * Hb at Baseline mean (SE): Feraccru 11.0 (1.027) g/dL, Placebo 11.1 (0.851) g/dL; ***p<0.0001 compared to placebo group;
Maltese: Feraccru (N=64) 1.06 (0.08)*** 1.06 (0.08)*** 66 Plaċebo (N=64) 0.02 (0.08) * Hb fil-medja tal-Linja bażi (SE): Feraccru 11.0 (1.027) g/dL, Plaċebo 11.1 (0.851) g/dL; ***p<0.0001 imqabbel ma' grupp bi plaċebo;
English: BE\ LU
Maltese: BE\
English: • Some antibiotics, such as ciprofloxacin and tetracycline.
Maltese: • Ċerti antibijotiċi, bħal ciprofloxacin u tetracycline.
English: NN: {number}>
Maltese: {numru} >
English: Impact of Feraccru on absorption of other medicinal products Oral iron is known to reduce the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) moxifloxacin, mycophenolate, norfloxacin and ofloxacin.
Maltese: L-effett ta' Feraccru fuq l-assorbiment ta' prodotti mediċinali oħra Il-ħadid orali huwa magħruf li jnaqqas l-assorbiment ta' penicillamine, bisfosfonati, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine), moxifloxacin, mycophenolate, norfloxacin u ofloxacin.
English: UNCOMMON (≥ 1/1000 to < 1/100)
Maltese: MHUX KOMUNI (≥ 1/1,000 sa < 1/100)
English: No data are available (see section 4.4).
Maltese: Data mhux disponibbli (ara sezzjoni 4.4).
English: Red capsule (19 mm long x 7 mm diameter).
Maltese: Kapsula ħamra (tul ta' 19 mm x dijametru ta' 7 mm).
English: Ferric maltol
Maltese: Maltol ferriku
English: Each bottle contains 56 capsules.
Maltese: Kull flixkun fih 56 kapsula.
English: The maltol appeared to be rapidly metabolised to maltol glucuronide (Cmax = 4677 + 1613 ng/mL).
Maltese: Il-maltol deher li kien metabolizzat malajr f'maltol glucuronide (Cmax = 4677 + 1613 ng/mL).
English: Adults (18 years and over in age)
Maltese: Adulti (ta' 18-il sena u aktar)
English: Titanium dioxide (E171)
Maltese: Diossidu tat-titanju (E171)
English: Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110).
Maltese: Kull kapsula fiha 91.5 mg lattożju, 0.5 mg Allura Red AC (E129) u 0.3 mg Sunset Yellow FCF (E110).
English: Reported severe adverse reactions were abdominal pain [4%], constipation [0.9%] and diarrhoea [0.9%].
Maltese: Reazzjonijiet avversi severi rrapportati kienu wġigħ addominali [4%], stitikezza [0.9%] u dijarea [0.9%].
English: Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal.
Maltese: L-inġestjoni ta' 20 mg/kg ta' ħadid elementali hija potenzjalment tossika u 200 - 250 mg/kg hija potenzjalment fatali.
English: MARKETING AUTHORISATION NUMBER EU/1/15/1075/001
Maltese: EU/1/15/1075/001
English: • Titanium dioxide (E171)
Maltese: • Diossidu tat-titanju (E171)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoloskeletali u tat-tessuti konnettivi
English: Adverse reaction frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10000).
Maltese: Il-frekwenzi ta' reazzjonijiet avversi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1,000, <1/100), rari (≥1/10,000, <1/1,000) jew rari ħafna (<1/10000).
English: • Penicillamine (used to bind metals).
Maltese: • Penicillamine (użat biex jorbot il-metalli).
English: Of the total maltol ingested, a mean of between 39.8 % and 60.0 % was excreted as maltol glucuronide.
Maltese: Mill-maltol kollu inġestit, medja ta' bejn 39.8 % u 60.0 % ġie eliminat bħala maltol glucuronide.
English: The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%]/distension [2%] and diarrhoea [3%]) and these were mainly mild to moderate in severity.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod frekwenti kienu sintomi gastrointestinali (uġigħ addominali [8%], gass [4%], stitikezza [4%], skonfort addominali [2%], nefħa [2%] u dijarea [3%]) u dawn prinċipalment kellhom severità ħafifa sa moderata.
English: • Sunset Yellow FCF (E110) (see section 2)
Maltese: • Sunset Yellow FCF (E110) (ara sezzjoni 2)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Frar, 2016
English: Pharmacotherapeutic group: Iron trivalent, oral preparation, ATC code: B03AB10.
Maltese: Kategorija farmakoterapewtika: ħadid trivalenti, preparazzjoni orali, Kodiċi ATC:
English: The maltol appeared to be rapidly metabolised to maltol glucuronide (AUC0-t between 9.83 and 30.9 h.µg/mL across all dosage regimens).
Maltese: Il-maltol deher li kien metabolizzat malajr f'maltol glucuronide (AUC0-t bejn 9.83 u 30.9 h.µg/mL fl-iskedi kollha taddożaġġ).
English: • Allura Red AC (E129) (see section 2)
Maltese: • Allura Red AC (E129) (ara sezzjoni 2)
English: • Mycophenolate (used with other medicines to prevent the body rejecting transplanted organs).
Maltese: • Mycophenolate (użat ma' mediċini oħra biex jiġi evitat li l-ġisem jirriġetta organi trapjantati).
English: At doses of 500 mg/kg/day testicular degeneration and toxic signs indicative of iron chelation were recorded.
Maltese: F'dożi ta' 500 mg/kg/kuljum ġiet reġistrata deġenerazzjoni tat-testikoli u sinjali tossiċi indikattivi ta' kelazzjoni tal-ħadid.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Ipersensittività għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Abdominal pain (including upper abdomen) Flatulence
Maltese: Uġigħ addominali (inkluż fladdome ta' fuq)
English: Table 2: Summary of Other Key Efficacy Endpoints (AEGIS 1/2)
Maltese: Tabella 2: Sommarju tal-Punti tat-Tmiem Ewlenin Oħra tal-Effikaċja (AEGIS 1/2)
English: Mean(SE)
Maltese: Medja(SE)
English: Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2).
Maltese: Ibbażat fuq studju in vitro, maltol jiġi glukoronizzat permezz ta' UGT1A6 (ara sezzjoni 5.2).
English: SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10)
Maltese: KOMUNI (≥ 1/100 sa < 1/10)
English: Sunset Yellow (E110) and Allura Red (E129): may cause allergic reactions.
Maltese: Sunset Yellow (E110) u Allura Red (E129): jistgħu jikkawżaw reazzjonijiet allerġiċi.
English: PHARMACEUTICAL FORM Capsules, hard.
Maltese: GĦAMLA FARMAĊEWTIKA Kapsuli, ibsin.
English: • Lactose monohydrate (see section 2)
Maltese: • Monoidrat tal-lattożju (ara sezzjoni 2)
English: Feraccru capsules contain lactose, Sunset Yellow FCF (E110) and Allura Red AC (E129).
Maltese: Il-kapsuli ta' Feraccru fihom il-lattożju, Sunset Yellow FCF (E110) u Allura Red AC (E129).
English: Feraccru has not been studied in patients with impaired renal and/or hepatic function.
Maltese: Feraccru ma ġiex studjat f'pazjenti b'indeboliment tal-funzjoni renali u/jew epatika.
English: All patients had discontinued from prior oral ferrous product (OFP) treatment: more than 60 % of the subjects stopped taking prior OFP due to adverse events.
Maltese: Il-pazjenti kollha kienu waqfu minn kura preċedenti bi prodott ferruż orali (OFP): aktar minn 60 % tal-individwi waqfu jieħdu l-OFP preċedenti minħabba avvenimenti avversi.
English: A possible potential genotoxic potential for maltol could not be fully ruled out.
Maltese: Ma setax jiġi kompletament eskluż potenzjal ġenotossiku għal maltol.
English: Feraccru 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Feraccru 30 mg
English: LIST OF EXCIPIENTS Contains lactose, Sunset Yellow (E110) and Allura Red (E129).
Maltese: TA' EĊĊIPJENTI Fih il-lattożju, Sunset Yellow (E110) u Allura Red (E129).
English: • Gelatin
Maltese: • Ġelatina
English: Non-clinical studies have shown that maltol is metabolised through UGT1A6 and by sulphation.
Maltese: Studji mhux kliniċi wrew li maltol jiġi metabolizzat permezz ta' UGT1A6 u permezz ta' sulphation.
English: Northumberland NE61 3YA, UK
Maltese: Northumberland NE61 3YA, Ir-Renju Unit
English: Abdominal discomfort/ distension
Maltese: Skonfort/nefħa addominali Dijarrea
English: Maltol was again transiently measured in plasma with a half-life of 0.7 hours, with a Cmax of 67.3 + 28.3 ng/mL.
Maltese: Għal darb'oħra Maltol reġa' tkejjel b'mod temporanju fil-plażma b'half-life ta' 0.7 sigħat, b'Cmax ta' 67.3 + 28.3 ng/mL.
English: • Some medicines used to treat Parkinson's disease (entacapone, levodopa) and thyroid problems
Maltese: • Ċerti mediċini li jintużaw fil-kura tal-marda ta' Parkinson (entacapone, levodopa) u problemi fit tirojde (levothyroxine).
English: Faeces discolouration was observed in patients treated with ferric maltol in clinical trials.
Maltese: Ippurgar bla kulur kien osservat f'pazjenti ttrattati bil-ferric maltol fi provi kliniċi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1075/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1075/001
English: IBD Studies
Maltese: Studji dwar IBD
English: The pharmacokinetic profiles of maltol/maltol glucuronide and iron parameters were independent of one another.
Maltese: Il-profili farmakokinetiċi ta' maltol/maltol glucuronide u l-parametri tal-ħadid kienu indipendenti minn xulxin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules
Maltese: Feraccru 30 mg kapsuli ibsin
English: TSAT and total serum iron profiles were comparable between Day 1 and Day 8.
Maltese: Il-profili tat-TSAT u tal-ħadid totali fis-serum kienu komparabbli bejn Jum 1 u Jum 8.
English: Feraccru contains iron (as ferric maltol).
Maltese: Feraccru fih il-ħadid (bħala ferric maltol).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew talmediċini.
English: Deposition of iron in the reticulo-endothelial system, liver and spleen was recorded in dogs administered 250 mg/kg/day ferric maltol.
Maltese: Id-depożitar ta' ħadid fis-sistema retikulo-endoteljali, fil-fwied u fil-milsa ġie reġistrat fil-klieb li ngħataw 250 mg/kg/kuljum ta' ferric maltol.
English: Table 1: Adverse reactions observed during clinical studies to date.
Maltese: Tabella 1: Reazzjonijiet avversi osservati matul l-istudji kliniċi sal-lum.
English: Blood thyroid stimulating hormone increased Gamma-glutamyltransferase increased
Maltese: Żieda fil-gammaglutamyltransferase
English: Norgine Italia S.r.l.
Maltese: Norgine de España, S.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: INFORMAZZJONI BIL-BRAILLE IDENTIFIKATUR UNIKU - BARCODE 2D IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: 1083 HP Amsterdam Netherlands
Maltese: Antonio Vivaldistraat 150 1083 HP Amsterdam L-Olanda
English: Haemosiderin was observed in Kupffer cells of dogs administered 250 mg/kg/day maltol.
Maltese: Emosiderina kienet osservata fiċ-ċelloli Kupffer ta' klieb li kienu ngħataw 250 mg/kg/kuljum ta' maltol.
English: This medicinal product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110): these may cause allergic reactions.
Maltese: Dan il-prodott mediċinali fih ukoll Allura Red AC (E129) u Sunset Yellow FCF (E110): jistgħu jikkawżaw reazzjonijiet allerġiċi.
English: 21months
Maltese: 45 jum.
English: The pharmacokinetic properties of Feraccru were also investigated at steady state in 15 subjects who were already participating in the AEGIS1/2 study described above and who had been in the open-label treatment phase for at least 7 days (Feraccru 30 mg twice daily).
Maltese: Il-proprjetajiet farmakokinetiċi ta' Feraccru ġew investigati wkoll fi stat fiss fi 15-il individwu li diġà kienu qed jipparteċipaw fl-istudju AEGIS1/2 deskritt hawn fuq u li kienu ilhom tal-inqas 7 ijiem fil-fażi ta' kura b'tikketta mikxufa (Feraccru 30 mg darbtejn kuljum).
English: The safety and efficacy of Feraccru for the treatment of iron deficiency anaemia was studied in 128 patients (age range 18-76 years; 45 males and 83 females) with inactive to mildly active IBD (58 patients with Ulcerative Colitis [UC] and 70 patients with Crohn's disease [CD]) and baseline Hb concentrations between 9.5 g/dL and 12 / 13 g/dL for females / males.
Maltese: Is-sigurtà u l-effikaċja ta' Feraccru għall-kura ta' anemija kkawżata minn defiċjenza ta' ħadid ġiet studjata fuq 128 pazjent (medda ta' etajiet minn 18 sa 76 sena; 45 raġel u 83 mara) b'IBD inattiv sa ftit attiv (58 pazjent b'Kolite Ulċerattiva
English: How to store Feraccru
Maltese: Tiħux Feraccru:
English: In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity.
Maltese: F'każijiet ħfief is-sintomi bikrin jitjiebu iżda f'każijiet aktar serji jista' jkun hemm evidenza ta' ipoperfużjoni (periferiji kesħin u pressjoni baxxa), aċidożi metabolika u tossiċità sistemika.
English: The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p<0.0001).
Maltese: Id-differenza bejn il-bidla mil-linja bażi għal Feraccru meta mqabbla mal-plaċebo fil-ġimgħa 12 kienet ta' 2.25 g/dL (p<0.0001).
English: Feraccru is available in bottles, each containing 56 capsules.
Maltese: Feraccru huwa disponibbli fi fliexken, b'kull wieħed fih 56 kapsula.
English: It is not known if medical products that inhibit UGT enzymes have the potential to increase maltol concentration (see section 4.5).
Maltese: Mhux magħruf jekk prodotti mediċinali li jinibixxu l-enzimi ta' UGT għandhomx il-potenzjal li jżidu l-konċentrazzjoni ta' maltol (ara sezzjoni 4.5).
English: Do not give Feraccru to children or adolescents 17 years and under as it has not been studied in this age group.
Maltese: Tagħtix Feraccru lil tfal jew adolexxenti ta' 17-il sena u inqas peress li ma ġiex studjat f'dan il-grupp ta' età.
English: The pharmacokinetic properties of Feraccru was assessed through measurement of plasma and urine concentrations of maltol and maltol glucuronide, together with serum iron parameters after a single dose and at steady state (after 1 week) in 24 subjects with iron deficiency, randomised to receive 30 mg, 60 mg or 90 mg Feraccru twice daily.
Maltese: Il-proprjetajiet farmakokinetiċi ta' Feraccru ġew ivvalutati permezz tal-kejl tal-konċentrazzjonijiet ta' maltol u ta' glucuronide maltol fil-plażma u fl-awrina, flimkien mal-parametri tal-ħadid fis-serum wara doża waħda u fi stat fiss (wara ġimgħa) f'24 individwu b'defiċjenza tal-ħadid, randomizzati biex jirċievu 30 mg, 60 mg jew 90 mg ta' Feraccru darbtejn kuljum.
English: An increase of ≥1 g/dL change in Hb at Week 12 was achieved in 90 % and 69 % of the ulcerative colitis (N=29) and Crohn's Disease (N=35) subgroups, respectively.
Maltese: Fil-Ġimgħa 12, 90 % u 69 % tas-sottogruppi b'kolite ulċerattiva (N=29) u bil-marda ta' Crohn (N=35) rispettivament kisbu bidla ta' ≥1 g/dL aktar fl-Hb.
English: Feraccru is indicated in adults for the treatment of iron deficiency.
Maltese: Feraccru huwa indikat fl-adulti għall-kura ta' defiċjenza ta' ħadid.
English: Ferritin continued to rise over long-term treatment with Feraccru (mean 68.9 μg/L [SD 96.24] at 64 weeks, a mean overall improvement of 60.3 μg/L).
Maltese: Il-livell ta' ferritin kompla jogħla bil-kura fit-tul b'Feraccru (medja ta' 68.9 μg/L [SD 96.24] wara 64 ġimgħa, titjib medju globali ta' 60.43 μg/L).
English: 38300 Bourgoin-Jallieu
Maltese: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Franza
English: As a precautionary measure, it is preferable to avoid the use of Feraccru during pregnancy.
Maltese: Bћala miżura ta' prekawzjoni hu preferribli, li jiġi evitat l-użu ta' Feraccru waqt it-tqala.
English: PHARMACEUTICAL FORM AND CONTENTS 56 capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: FARMAĊEWTIKA U KONTENUT 56 kapsula MOD TA' KIF U MNEJN JINGĦATA
English: The median time since last dose of OFP was 22 months in the experimental group and 17 months in the placebo arm. 52 % of the patients in AEGIS 1 and 33 % in AEGIS 2 had a disease flare in the previous 6 months.
Maltese: Iż-żmien medjan mill-aħħar doża ta' OFP kien ta' 22 xahar fil-grupp sperimentali u ta' 17-il xahar fil-grupp tal-plaċebo. 52 % tal-pazjenti f'AEGIS 1 u 33 % f'AEGIS 2 kellhom aggravar tal-marda fis-6 xhur ta' qabel.
English: medinfoitaly@norgine.com
Maltese: MedInfo@norgine.com
English: Mean ferritin (μg/L) levels in subjects taking feraccru improved steadily from baseline (mean 8.6 μg/L [SD 6.77]) to Week 12 (mean 26.0 μg/L [SD 30.57]), a mean overall improvement of 17.4 μg/L.
Maltese: 0 μg/L [SD 30.57]), titjib medju globali ta' 17.4 μg/L.
English: Peak transferrin saturation (TSAT) and total serum iron values were reached 1.5 to 3 hours after oral administration of Feraccru.
Maltese: Il-valuri massimi tassaturazzjoni ta' transferrin (TSAT) u tal-ħadid totali fis-serum inkisbu 1.5 sa 3 sigħat wara l-għoti ta' Feraccru mill-ħalq.
English: This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Il-prodott mediċinali fih il-lattożju: pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The most common side effects (may affect up to 1 in 10 people) of Feraccru are:
Maltese: L-effetti sekondarji l-aktar komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) ta' Feraccru huma:
English: Tabulated list of adverse reactions Table 1 presents all adverse reactions occurring during clinical studies to date with Feraccru.
Maltese: Lista f'tabella tar-reazzjonijiet avversi Tabella 1 tippreżenta r-reazzjonijiet avversi kollha li seħħew matul l-istudji kliniċi sal-lum b'Feraccru.
English: Do not store the capsules above 25°C.
Maltese: Taħżinx il-kapsuli f'temperatura 'l fuq minn 25°C.
English: Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBDpatients with haemoglobin (Hb) <9.5 g/dl.
Maltese: Feraccru m'għandux jintuża f'pazjenti bl-aggravar tal-mard infjammatorju tal-musrana (IBD) jew f'pazjenti b'IBD b'emoglobina (Hb) <9.5 g/dl.
English: Acne Erythema
Maltese: Konklużjonijiet xjentifiċi
English: Definitive animal studies are not available for maltol with respect to reproductive toxicity.
Maltese: M'hemmx studji definittivi disponibbli f'annimali għal maltol fir-rigward ta' tossiċità riproduttiva.
English: Exposure to maltol glucuronide increased dose proportionally over the Feraccru 30 to 90 mg twice daily dosing range and there was no significant accumulation of either after 7 days treatment with Feraccru.
Maltese: Esponiment għal maltol glucuronide żied il-proporzjonalità tad-doża fuq il-medda tad-dożaġġ ta' Feraccru ta' 30 sa 90 mg darbtejn kuljum u ma kien hemm ebda akkumulazzjoni ta' ebda wieħed minnhom wara 7 ijiem ta' kura b'Feraccru.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg iron (as ferric maltol).
Maltese: Kull kapsula fiha 30 mg ħadid (bħala ferric maltol).
English: Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Maltese: Rarament, ċikatriċi gastriċi li jikkawżaw kontrazzjoni jew stenożi pilorika (waħedhom jew flimkien) jistgħu jwasslu għal ostruzzjoni parzjali jew totali tal-musrana 2-5 ġimgħat wara l-inġestjoni.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ferric maltol, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal ferric maltol, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: An increase of ≥2 g/dL change in Hb at Week 12 was achieved in 62 % and 51 % of the ulcerative colitis and Crohn's Disease subgroups, respectively.
Maltese: Fil-Ġimgħa 12, 62 % u 51 % tas-sottogruppi b'kolite ulċerattiva u bil-marda ta' Crohn rispettivament kisbu bidla ta' ≥2 g/dL aktar fl-Hb.
English: What Feraccru contains The active substance is 30 mg of iron as ferric maltol.
Maltese: Is-sustanza attiva hija 30 mg ta' ħadid bħala ferric maltol.
English: Package leaflet: Information for the patient Feraccru 30 mg hard capsules Iron (as ferric maltol)
Maltese: Feraccru 30 mg kapsuli ibsin Ħadid (bħala ferric maltol)
English: Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis.
Maltese: F'dan listadju titfaċċa evidenza ta' nekrożi epatoċellulari b'suffejra, fsada, ipogliċemija, enċefalopatija u aċidożi metabolika b'distakk pożittiv bejn l-anjoni.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules Iron (as ferric maltol) STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg iron (as ferric maltol).
Maltese: Feraccru 30 mg kapsuli ibsin Ħadid (bħala ferric maltol) DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Diarrhoea
Maltese: FARMAĊEWTIKU
English: MARKETING AUTHORISATION HOLDER Norgine B.V.
Maltese: Norgine B.V.
English: Breastfeeding
Maltese: IL-PROVVISTA
English: • Haemochromatosis and other iron overload syndromes.
Maltese: • Emokromatożi u sindromi oħra ta' akkumulazzjoni żejda ta' ħadid.
English: • Periodic safety update reports
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM < PC:
English: Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk.
Maltese: Ferric maltol mhuwiex disponibbli sistemikament u għalhekk huwa improbabbli li jgħaddi fil-ħalib tal-omm.
English: Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand.
Maltese: Feraccru fih il-ħadid fi stat ferriku stabbli bħala kumpless b'ligand ta' trimaltol.
English: Proportion of subjects that achieved normalised Hb at Week
Maltese: Proporzjon ta' individwi li kisbu Hb normalizzata fil
English: Serum samples were assayed for iron parameters.
Maltese: Il-kampjuni tas-serum ġew analizzati għall-parametri tal-ħadid.
English: Norgine de España, S.L.U iberiamedinfo@norgine.com
Maltese: L.U iberiamedinfo@norgine.com
English: What Feraccru looks like and contents of the pack Feraccru is a red hard capsule containing a reddish-brown powder.
Maltese: Feraccru huwa kapsula iebsa ħamra li fiha trab ħamrani fil-kannella.
English: Gelatin
Maltese: Ġelatina
English: Blood tests may show increased levels of proteins that break down chemicals in the blood and of a hormone that stimulates the thyroid gland.
Maltese: Testijiet tad-demm jistgħu juru żieda fil-livelli ta' proteini li jkissru l-kimiċi fiddemm u ta' ormon li jistimula l-glandola tat-tirojde.
English: • Flatulence (wind)
Maltese: • Dardir (rimettar)
English: The safety and efficacy of Feraccru in children (17 years and under) has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Feraccru fit-tfal (17-il sena u inqas) ma ġewx determinati s'issa.
English: In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion.
Maltese: F'każijiet serji jista' jkun hemm rikorrenza ta' rimettar u fsada gastrointestinali, 12-il siegħa wara l-inġestjoni.