FrancophonIA/ELRC3.0 huggingface dataset:
English: BRINAVESS may be available in different vial sizes [available vial sizes to be inserted locally].
Maltese: BRINAVESS jista' jkun disponibbli f'kunjetti ta' daqsijiet differenti [daqsijiet tal-kunjetti disponibbli għandhom jiddaħħlu lokalment].
English: • Patients with severe aortic stenosis, patients with systolic blood pressure <100 mm Hg, and patients with heart failure class NYHA III and NYHA IV.
Maltese: • Pazjenti bi stenożi severa tal-aorta, pazjenti bi pressjoni tad-demm sistolika ta' <100 mm Hg u pazjenti b'insuffiċjenza tal-qalb klassi NYHA III u NYHA IV.
English: • Patients with prolonged QT at baseline (uncorrected > 440 msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker.
Maltese: • Pazjenti bi QT prolongat fil-linja bażi (mhux ikkorreġut > 440 msec), jew bradikardja severa, disfunzjoni fin-nodu tas-sinus jew imblokk tal-qalb tat-tieni u tat-tielet grad finnuqqas ta' pacemaker.
English: - Alert HCP for adverse events, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Maltese: - Wissi lill-HCP dwar episodji avversi, li jistgħu jseħħu wara l-għoti ta' BRINAVESS, inkluż pressjoni baxxa, bradikardja, palpitazzjonijiet atrijali jew arrittmija ventrikulari.
English: Instructions on dose calculation, preparation of the solution for infusion, and method of administration.
Maltese: Struzzjonijiet dwar il-kalkolazzjoni tad-doża, preparazzjoni tas-soluzzjoni għal infużjoni, u metodu ta' għoti.
English: Risk of atrial flutter may be increased in patients receiving class I AADs.
Maltese: Ir-riskju ta' palpitazzjoni atrijali jista' jiżdied f'pazjenti li jirċievu AADs ta' klassi I.
English: • BRINAVESS can not be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Maltese: BRINAVESS ma jistax jiġi rrakkomandat f'pazjenti li qabel kienu ngħataw AADs (klassi I u III) 4-24 siegħa qabel vernakalant minħabba nuqqas ta' dejta.
English: The Marketing Authorisation Holder shall ensure that all Healthcare Professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li l-Professjonisti tal-Kura tasSaħħa (HCP) kollha involuti fl-għoti ta' BRINAVESS jiġu pprovduti b'pakkett ta' informazzjoni għall-professjonisti tal-kura tas-saħħa li jkun fih dan li ġej:
English: Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Maltese: Kriterji tal-għażla tal-pazjenti, inkluż kontra-indikazzjonijiet, twissijiet speċjali u prekawzjonijiet għall-użu u informazzjoni dwar il-popolazzjonijiet tal-pazjenti b'informazzjoni limitata minn provi kliniċi
English: Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).
Maltese: Professjonist fil-qasam tal-kura tas-saħħa kkwalifikat sewwa biss għandu jagħti BRINAVESS u għandu jimmonitorja b'mod frekwenti lill-pazjent matul l-infużjoni kollha u għal millinqas 15-il minuta wara li tintemm l-infużjoni għal sinjali u sintomi ta' tnaqqis f'daqqa tal-pressjoni jew tar-rata ta' taħbit tal-qalb (ara sezzjoni 4.4).
English: • BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Maltese: BRINAVESS għandu jintuża b'kawtela f'pazjenti fuq AADs orali (klassi I u III), minħabba esperjenza limitata.
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Maltese: BRINAVESS għandu jingħata permezz ta' infużjoni fil-vini f'ambjent kliniku mmonitorjat xieraq għal kardjoverżjoni.
English: - Alert HCP for use of AADs (anti-arrhythmic drugs) prior to or after BRINAVESS.
Maltese: Wissi lill-HCP dwar l-użu ta' AADs (mediċini kontra arritmija) qabel jew wara BRINAVESS.
English: Educational material for Healthcare Professionals Summary of Product Characteristics, Package Leaflet and Labelling
Maltese: Materjal Edukattiv għall-Professjonisti tal-Kura tas-Saħħa Sommarju tal-Karatteristiċi tal-Prodott, Fuljett ta' Tagħrif u Tikketta
English: Key elements to be included in the educational material:
Maltese: Elementi ewlenin li għandhom jiġu nklużi fil-materjal edukattiv:
English: The full EPAR for Adenuric can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (80 and 120 mg).
Maltese: Jiġi bħala pilloli (80 u 120 mg).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mg kull deċilitru) wara perjodu ta' bejn ġimagħtejn u erba' ġimgħat.
English: Adenuric is a medicine that contains the active substance febuxostat.
Maltese: Adenuric huwa mediċina li fiha s-sustanza attiva febuxostat.
English: In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements.
Maltese: Fl-ewwel studju, 48% tal-pazjenti li ħadu 80 mg Adenuric darba kuljum (126 minn 262) u 65% tal-pazjenti li ħadu 120 mg darba kuljum (175 minn 269) kellhom livelli ta' aċidu uriku anqas minn 6 mg/dl fl-aħħar tliet darbiet ta' kejl.
English: This is a summary of the European public assessment report (EPAR) for Adenuric.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Adenuric.
English: In patients with blood cancer who were undergoing chemotherapy, Adenuric was as effective as allopurinol in controlling blood levels of uric acid: in 98.3 % of patients (170 out of 173) on Adenuric blood levels of uric acid normalised compared with 96 % (166 out of 173) of patients on allopurinol.
Maltese: F'pazjenti b'kanċer fid-demm li kieku qed jieħdu l-kimoterapija, Aduneric kien effikaċi daqs allopurinol fil-kontroll tal-livelli tad-demm b'aċidu uriku: f'98.3% tal-pazjenti (170 minn 173) li ħadu Aduneric, illivelli tad-demm b'aċidu uriku ġew normalizzati meta mqabbla ma' 96% (166 minn 173) tal-pazjenti li ħadu allopurinol.
English: Other information about Adenuric
Maltese: Informazzjoni oħra dwar Adenuric
English: The most commonly reported side effects with Adenuric are gout flare-ups, abnormal liver test results, diarrhoea, nausea (feeling sick), headache, rash and oedema (swelling).
Maltese: L-effetti sekondarji l-aktar komuni rrapportati b'Adenuric huma żieda f'daqqa tal-gotta, riżultati ta' testijiet tal-fwied anomali, dijarrea, nawżja (dardir), uġigħ ta' ras, raxx u edema (nefħa).
English: The active substance in Adenuric, febuxostat, reduces the formation of uric acid.
Maltese: Is-sustanza attiva f'Adenuric, il-feboxustat, tnaqqas il-formazzjoni tal-aċidu uriku.
English: The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia).
Maltese: L-ewwel studju, li fih ħadu sehem 1,072 pazjent, qabbel tliet dożi ta' Adenuric (80, 120 u 240 mg darba kuljum) ma' plaċebo (kura finta) u allopurinol (mediċina oħra użata fil-kura tal-iperuriċemija).
English: For the treatment of hyperuricaemia and gout, Adenuric has been studied in two main studies involving a total of 1,834 patients.
Maltese: Għall-kura ta' iperuriċemija u gotta, Adenuric ġie studjat f'żewġ studji ewlenin li fihom b'kollox ħadu sehem total ta' 1,834 pazjent.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Adenuric fil-21 ta' April 2008.
English: Adenuric is used in patients who already have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Maltese: Adenuric jintuża f'pazjenti li diġà jkollhom sinjali ta' akkumulu ta' kristalli, inkluż l-artrite gotta (gouty) (uġigħ u infjammazzjoni fil-ġogi) jew tofi (tophi), ('ġebliet', depożiti akbar ta' kristalli tal-urat li jistgħu jikkawżaw ħsara fil-ġogi u fl-għadam).
English: Why has Adenuric been approved?
Maltese: Għaliex ġie approvat Adenuric?
English: What is Adenuric?
Maltese: X'inhu Adenuric?
English: For the treatment of long-term hyperuricaemia, the recommended dose of Adenuric is 80 mg once a day.
Maltese: Għall-kura ta' iperuriċemija fit-tul, id-doża rakkomandata ta' Adenuric hija ta' 80 mg darba kuljum.
English: This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo.
Maltese: Dan tqabbel ma' 22% tal-pazjenti li ħadu allopurinol (60 minn 268) u ħadd mill-134 pazjent li kienu qed jieħdu l-plaċebo.
English: What is the risk associated with Adenuric?
Maltese: X'inhu r-riskju assoċjat ma' Adenuric?
English: In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg.
Maltese: Fiż-żewġ studji, allopurinol intuża f'doża ta' 300 mg darba kuljum, minbarra f'pazjenti bi problemi filkliewi, li ħadu doża ta' 100 mg.
English: The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
Maltese: It-tieni studju qabbel żewġ dożi ta' Adenuric (80 u 120 mg darba kuljum) ma' allopurinol fuq perjodu ta' sena f'762 pazjent.
English: Adenuric is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Maltese: Adenuric jintuża wkoll biex jikkura u jipprevjeni livelli għoljin ta' aċidu uriku fid-demm fl-adutli b'kanċer fid-demm li qed jieħdu l-kimoterapija u qegħdin f'riskju tas-sindromu tat-tumur ta' lisi (tumour lysis syndrome - kumplikazzjoni li tiġi mit-tkissir ta' ċelloli tal-kanċer li tikkawża żieda f'salt tal-aċidu uriku fid-demm li tista' tikkawża ħsara lill-kliewi).
English: Rare serious hypersensitivity (allergic) reactions to Adenuric have occurred post-marketing.
Maltese: Wara li saret il-kampanja talkummerċjalizzazzjoni, dehru reazzjonijiet (allerġiċi) ta' ipersensittività serji u rari għal Adenuric.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Maltese: Hija taħdem billi timblokka enzim magħruf bħala ksantinossidażi (xanthine oxidase), li huwa meħtieġ biex jiġi prodott laċidu uriku fil-ġisem.
English: The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels including in patients undergoing chemotherapy , but that it could carry a greater risk of side effects affecting the heart and blood vessels.
Maltese: Is-CHMP ikkonkluda li Adenuric kien aktar effikaċi mill-allopurinol fit-tnaqqis tal-livelli ta' aċidu uriku fid-demm anke f'pazjenti li kienu qed jieħdu l-kimoterapija, iżda li jista' jkollu riskju akbar ta' effetti sekondarji li jaffettwaw il-qalb u l-vażijiet.
English: Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Maltese: Adenuric jintuża fil-kura ta' adulti li jbatu bl-iperuriċemija fit-tul (livelli għoljin ta' aċidu uriku jew‘ urat' fid-demm).
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, Adenuric has been studied in one main study involving 346 adult patients undergoing chemotherapy for blood cancer.
Maltese: Għall-prevenzjoni u l-kura ta' iperuriċemija f'pazjenti li kienu qed jieħdu l-kimoterapija, Adenuric ġie studjat fi studju ewlieni wieħed li fih ħadu sehem 346 pazjent adult li kienu qed jieħdu l-kimoterapija għall-kanċer fid-demm.
English: For the full list of all side effects and restrictions with Adenuric, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Adenuric, ara l-fuljett ta' tagħrif.
English: By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Maltese: Bit-tnaqqis fil-produzzjoni tal-aċidu uriku, Adenuric jista' jbaxxi l-livelli ta' aċidu uriku fid-demm u jżommhom baxxi, u jwaqqaf il-kristalli milli jakkumulaw.
English: CY The Star Medicines Importers Co. Ltd.
Maltese: CY The Star Medicines Importers Co.
English: 2333 CN Leiden Netherlands
Maltese: 2333 CN Leiden L-Olanda
English: Keizersgracht 311 1016 EE Amsterdam Netherlands
Maltese: Keizersgracht 311 1016 EE Amsterdam L-Olanda
English: Methylcellulose USP A15LV
Maltese: Methylcellulose USP A15LV Crospovidone
English: Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
Maltese: Eurofins PROXY Laboratories B.V. Archimedesweg 25
English: CHIESI ROMÂNIA S.R.L.
Maltese: ROMÂNIA S.R.L.
English: Plasma Zn2+ concentration
Maltese: Konċentrazzjoni Zn2+ fil-plażma
English: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Maltese: Kull ml ta' soluzzjoni orali fih 0.4 mg Sunset Yellow (E110).
English: For agranulocytosis (ANC < 0.5x109/l):
Maltese: Għal agranuloċitożi (ANC < 0.5x109/l):
English: 3 years.
Maltese: 3 sigħat.
English: - Pregnancy (see section 4.6).
Maltese: - Tqala (ara sezzjoni 4.6).
English: Carcinogenicity/mutagenicity
Maltese: Karċinoġeneċità/mutaġeniċità
English: The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds iron in a 3:1 molar ratio.
Maltese: Is-sustanza attiva hi deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), ligand bidentali li jintrabat mal-ħadid fi proporzjon molari ta' 3:1.
English: Limited information is available regarding rechallenge.
Maltese: Informazzjoni limitata hi disponibbli dwar ir-rechallenge.
English: Hypromellose 2910 USP/EP
Maltese: Hypromellose 2910
English: Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Maltese: Il-qalba tal-pillola: Methylcellulose, Crospovidone, Magnesium stearate.
English: Ferriprox contains the active substance deferiprone.
Maltese: Ferriprox fih is-sustanza attiva deferiprone.
English: Renal impairment
Maltese: Indeboliment Renali
English: For neutropenia events (ANC < 1.5x109/l and > 0.5x109/l):
Maltese: Għal każijiet ta' newtropenja (ANC < 1.5x109/l u > 0.5x109/l):
English: Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Maltese: klassifikazzjoni Child-Pugh: voluntiera f'saħħithom, indeboliment epatiku ħafif (Klassi A: 5- 6 punti), indeboliment epatiku moderat (Klassi B: 7-9 punti).
English: At the same time point, LVEF had increased from baseline by 3.07 ± 3.58 absolute units (%) in the Ferriprox group and by 0.32 ± 3.38 absolute units (%) in the deferoxamine group (difference between groups; p=0.003).
Maltese: unitajiet assoluti (%) fil-grupp Ferriprox b'0.32±3.38 unitajiet assoluti (%) fil-grupp ta' deferoxamine (differenza bejn il-gruppi, p=0.003).
English: Coating: Hypromellose, Macrogol, Titanium dioxide.
Maltese: Hypromellose, Macrogol, Titanium dioxide.
English: 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Maltese: 90 mL/min/1.73m2), indeboliment renali ħafif (eGFR 60-89 mL/min/1.73m2), indeboliment renali moderat (eGFR 30-59 mL/min/1.73m2), u indeboliment renali sever (eGFR 15-29 mL/min/1.73m2).
English: Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Maltese: Hypromellose, Hydroxylpropyl cellulose, Macrogol, Titanium dioxide.
English: Total daily dose (mg)
Maltese: Doża Totali ta' Kuljum (mg)
English: Neutropenia/Agranulocytosis
Maltese: Newtropenija/Agranuloċitosi
English: - Breast-feeding (see section 4.6).
Maltese: - Treddigħ (ara sezzjoni 4.6).
English: ml of oral solution (three times/day)
Maltese: ml ta' soluzzjoni orali (tliet darbiet/jum)
English: Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Maltese: Ferriprox 1000 mg pilloli miksija b'rita EU/1/99/108/004
English: Deferiprone is metabolised predominantly to a glucuronide conjugate.
Maltese: Deferiprone hu metabolizzat l-aktar għall-konjugat glucuronide.
English: (≥1/100 to <1/10)
Maltese: KOMUNI (≥1/100 SA
English: Study LA37-1111 was conducted to evaluate the effect of single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral doses of deferiprone on the cardiac QT interval duration in healthy subjects.
Maltese: L-istudju LA37-1111 sar biex jivvaluta l-effetti ta' dożi orali terapewtiċi uniċi (33 mg/kg) u sopraterapewtiċi (50 mg/kg) ta' deferiprone fuq it-tul tal-intervall QT kardijaka f'individwi b'saħħithom.
English: The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Maltese: Id-disturbi newroloġiċi naqsu b'mod progressiv wara t-twaqqif ta' deferiprone (ara sezzjonijiet 4.4 u 4.9).
English: Sucralose (E955)
Maltese: Sunset Yellow (E110) Sucralose (E955)
English: Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
Maltese: Deferiprone-3-O-glucuronide AUC tnaqqas b'10% u Cmax b'20% f'individwi indeboliti b'mod ħafif jew moderat meta mqabbla ma' voluntieri b'saħħithom.
English: Tel: + 385 1 4874 500
Maltese: Providens d.o.o. Tel: + 385 1 4874 500
English: Each 500 mg tablet contains 500 mg deferiprone.
Maltese: Kull pillola ta' 500 mg fiha 500 mg deferiprone.
English: Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Maltese: Esponiment sistemiku għal deferiprone u l-metabolit tiegħu deferiprone 3-O-glucuronide kien assessjat bil-parametri farmakokinetiċi Cmax u AUC.
English: Date of latest renewal: 21 September 2009
Maltese: Data tal-ewwel awtorizzazzjoni: 25 t'Awwissu 1999 Data tal-aħħar tiġdid: 21 t'Settembru 2009
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq bhejjem urew tossiċità riproduttiva (ara sezzjoni 5.3).
English: ((Inside 1))
Maltese: ((Fuq ġewwa 1))
English: Number of tablets (three times/day)
Maltese: Numru ta' Pilloli (tliet darbiet/jum)
English: Ferriprox 100 mg/ml oral solution deferiprone
Maltese: Ferriprox 100 mg/ml soluzzjoni orali deferiprone
English: The maximum difference between the LS means of the therapeutic dose and placebo was 3.01 ms (95% one-sided UCL: 5.01 ms), and between the LS means of the supratherapeutic dose and placebo was 5.23 ms (95% one-sided UCL: 7.19 ms).
Maltese: Id-differenza massima bejn il-medji ta' LS tad-doża terapewtika u l-plaċebo kienet ta' 3.01 ms (95% ta' UCL fuq naħa waħda: 5.01 ms), u bejn il-medji LS tad-doża supraterapewtika u lplaċebo kienet ta' 5.23 ms (95% ta' UCL fuq naħa waħda: 7.19 ms).
English: Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of Ferriprox with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Maltese: L-istudji LA16-0102, LA-01 u LA08-9701 qabblu l-effikaċja ta' Ferriprox ma' dik ta' deferoxamine biex jikkontrollaw il-ferritin fis serum f'pazjenti bit-talassimja dipendenti mit-trasfużjoni.
English: Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
Maltese: Ferriprox soluzzjoni orali fih l-aġent li jlewwem Sunset Yellow (E110) li jista' jikkaġuna reazzjonijiet allerġiċi.
English: SYSTEM ORGAN CLASS VERY COMMON
Maltese: TAL-KLASSIFIKA TALORGANI
English: The genotoxic potential of deferiprone was evaluated in a set of in vitro and in vivo tests.
Maltese: Il-potenzjal ġenotossiku ta' deferiprone kien evalwat f'sett ta' testijiet in vitro u in vivo.
English: INFORMATION IN BRAILLE Ferriprox 1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ferriprox 1000 mg
English: Data from the pooled safety database from clinical trials (1343 patient-years exposure to Ferriprox monotherapy and 244 patient-years exposure to Ferriprox and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders", "Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders".
Maltese: Tagħrif mid-database ta' sikurezza ppuljat minn provi kliniċi (1343 sena ta' esponiment ta' pazjenti għal monoterapija b'Ferriprox u 244 sena ta' esponiment ta' pazjenti b'Ferriprox u deferoxamine) wera differenzi statistikament sinifikanti (p<0.05) fl-inċidenza ta' reazzjonijiet avversi abbażi tasSistema tal-Klassifikazzjoni tal-Organi għal “Disturbi fil-Qalb”, “Disturbi Muskoluskeletriċi u tatTessuti Konnettivi” u “Disturbi fil-Kliewi u fis-Sistema Urinarja”.
English: MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Maltese: Ferriprox 500 mg pilloli miksija b'rita EU/1/99/108/001
English: BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
Maltese: 250 ml soluzzjoni orali 500 ml soluzzjoni orali
English: Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Maltese: Intwera li deferiprone jikkawża n-newtropenija, li tinkludi agranuloċitosi (ara sezzjoni 4.8 ‘‘Deskrizzjoni ta' reazzjonijiet avversi magħżula”).
English: INFORMATION IN BRAILLE Ferriprox 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ferriprox 500 mg
English: BOTTLE OF 100 TABLETS
Maltese: FLIXKUN TA' 100 PILLOLA
English: INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Maltese: INFORMAZZJONI BIL-BRAILLE Ferriprox 100 mg/ml
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni orali fih 100 mg deferiprone (25 g defetprone f'250 ml u 50 g deferiprone f'500 ml).
English: Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Maltese: Assorbiment Deferiprone hu assorbit malajr mill-parti ta' fuq tal-apparat gastrointestinali.
English: ((Inside 2))
Maltese: ((Fuq ġewwa 2))