FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 20 subjects in each arm of this parallel group study were administered Iffeza 500/20 (fluticasone propionate 500µg and formoterol fumarate 20µg) or GSK fluticasone propionate 500µg pMDI + Novartis formoterol fumarate 24µg pMDI.
Maltese: Madwar 20 suġġett f'kull fergħa ta' dan listudju ta' grupp parallel ingħataw Iffeza 500/20 (fluticasone propionate 500µg u formoterol fumarate
English: However, the specific formulation of a fixed-dose combination of these two well known active substances, fluticasone propionate and formoterol fumarate, is new.
Maltese: Madankollu, il-formulazzjoni speċifika ta' taħlita f'doża fissa ta' dawn iż-żewġ sustanzi attivi magħrufin sew, fluticasone propionate u formoterol fumarate, hija ġdida.
English: The five pivotal Iffeza Phase III studies included approximately 2500 patients and the safety database includes over 1900 Iffeza-treated patients.
Maltese: Il-ħames studji ewlenin tal-Fażi III ta' Iffeza kienu jinkludu madwar 2500 pazjent u d-database tas-sigurtà tinkludi aktar minn 1900 pazjent ikkurat bi Iffeza.
English: The PK study (Study FLT1501) which has given rise to concerns was conducted to evaluate the comparative safety of Iffeza when compared with the marketed monoproduct pMDIs.
Maltese: Dejta farmakokinetika (PK) L-istudju PK (Studju FLT1501) li ħoloq it-tħassib sar sabiex tkun evalwata s-sigurtà komparattiva ta'
English: Asthma control and exacerbations
Maltese: Il-kontroll u l-aggravar tal-attakki tal-ażżma
English: The Applicant should discuss this concern in the light of the relatively short duration of the clinical study and the fact that the formoterol fumarate component in this fixed-dose combination might have masked a loss of control by controlling symptoms and bronchodilatation.”
Maltese: LApplikant għandu jiddiskuti dan it-tħassib fid-dawl taż-żmien relattivament qasir tal-istudju kliniku u l-fatt li l-komponent ta' formoterol fumarate f'din it-taħlita f'doża fissa seta' ħeba nuqqas ta' kontroll bil-kontroll tas-sintomi u bronkodilatazzjoni.
English: The indication sought is the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
Maltese: L-indikazzjoni mfittxija hija l-kura regolari tal-ażżma fejn huwa xieraq l-użu ta' prodott ikkombinat (kortikosterojde li jittieħed man-nifs u agonista β2 b'azzjoni fit-tul):
English: These endpoints were demonstrably inhaled cortocosteroid-driven and/or inhaled corticosteroid dose-responsive and all provided rigorous statistical evidence that the inhaled corticosteroid effects of Iffeza were not less than those of fluticasone propionate + formoterol fumarate.
Maltese: Dawn ilpunti aħħarin kienu biċ-ċar ikkawżati minn kortikosterojde li jittieħed man-nifs u/jew reattivi għaddoża tal-kortikosterojde li jittieħed man-nifs u kollha pprovdew evidenza statistika rigoruża li l-effetti tal-kortikosterojde li jittieħed man-nifs ta' Iffeza ma kinux iżgħar minn dawk ta' fluticasone propionate + formoterol fumarate.
English: Study FLT 3503 also included a comparison with a lower dose of Iffeza and effects seen with this lower dose of Iffeza (100µg/10µg) upon pre-dose FEV1 were similar to those seen with the high dose of GSK fluticasone propionate 500µg (administered both alone or in combination with formoterol fumarate 24µg).
Maltese: L-Istudju FLT 3503 kien jinkludi wkoll tqabbil b'doża aktar baxxa ta' Iffeza u l-effetti li dehru b'din id-doża aktar baxxa ta' Iffeza (100µg/10µg) fuq l-FEV1 ta' qabel id-doża kienu simili għal dawk li dehru bid-doża għolja ta' GSK fluticasone propionate 500µg (mogħti kemm waħdu kif ukoll flimkien ma' formoterol fumarate 24µg).
English: The clinical development programme for Iffeza was set up to evaluate efficacy and safety in the intended patient population.
Maltese: Il-programm ta' żvilupp kliniku għal Iffeza kien stabbilit għall-evalwazzjoni tal-effikaċja u s-sigurtà fil-popolazzjoni tal-pazjenti maħsuba.
English: In addition, the comparison of these PK data with PD data, Study FLT3503, shows that despite the lower relative bioavailability of fluticasone propionate in this new fixed-dose combination product the effect upon predose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Iffeza 500µg/20µg than with GSK fluticasone propionate 500µg (either administered alone or administered together with Novartis formoterol fumarate 24µg).
Maltese: Barra minn hekk, it-tqabbil ta' din id-dejta PK mad-dejta PD, Studju FLT3503, juri li minkejja l-bijodisponibbiltà relattiva aktar baxxa ta' fluticasone propionate f'dan il-prodott ġdid ikkombinat f'doża fissa l-effett fuq l-FEV1 ta'
English: This comparison showed that despite a lower relative fluticasone propionate bioavailability, the effect upon pre-dose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Iffeza 500µg/20µg than with GSK fluticasone propionate 500µg (either alone or in conjunction with Novartis formoterol fumarate 24µg).
Maltese: qabel id-doża (li biċ-ċar kien medjat minn fluticasone propionate waħdu fl-Istudju FLT3503) kien numerikament akbar bi Iffeza 500µg/20µg milli b'GSK fluticasone propionate 500µg (kemm waħdu kif ukoll flimkien ma' Novartis formoterol fumarate 24µg).
English: These data were generated from the five pivotal 8- to 12-week studies and demonstrate the protective benefit of Iffeza against exacerbations compared with fluticasone propionate monotherapy.
Maltese: Din id-dejta kienet iġġenerata mill-ħames studji ewlenin ta' tmienja sa 12-il ġimgħa u turi l-benefiċċju protettiv ta' Iffeza kontra l-attakki gravi meta mqabbel ma' fluticasone propionate bħala monoterapija.
English: Effects with the low dose of Iffeza (100µg/10µg) upon pre-dose FEV1 were similar to those with the high dose of GSK fluticasone propionate 500µg (alone or in combination with formoterol fumarate 24µg).
Maltese: L-effetti bid-doża baxxa ta' Iffeza (100µg/10µg) fuq l-FEV1 ta' qabel id-doża kienu simili għal dawk tad-doża għolja ta'
English: Several endpoints which reflect these different facets of asthma control are modulated by long-acting β-agonists.
Maltese: Diversi punti aħħarin li jirriflettu dawn l-aspetti differenti tal-kontroll tal-ażżma huma modulati minn agonisti β li jaġixxu fit-tul.
English: Further information on Hemlibra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/hemlibra.
Maltese: Aktar informazzjoni dwar Hemlibra tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/human/EPAR/hemlibra.
English: Other information about Hemlibra
Maltese: Informazzjoni oħra dwar Hemlibra
English: Hemlibra received a marketing authorisation valid throughout the EU on 23 February 2018.
Maltese: Hemlibra ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Frar 2018.
English: Hemlibra contains the active substance emicizumab.
Maltese: Hemlibra fih is-sustanza attiva emiċiżumab.
English: What are the risks associated with Hemlibra?
Maltese: X'inhuma r-riskji assoċjati ma' Hemlibra?
English: Abnormal clotting, affecting between 1 and 10 in 1,000 people, may also occur and includes cavernous sinus thrombosis (clotting at the base of the brain) and superficial vein thrombosis (clotting in veins under the skin, usually in the arms or legs) with skin damage.
Maltese: Tista' sseħħ ukoll koagulazzjoni anormali, li taffettwa bejn persuna 1 u 10 minn kull 1 000 persuna u tinkludi trombożi tas-sinus kavernuża (koagulazzjoni fil-bażi tal-moħħ) u trombożi tal-vini superfiċjali (koagulazzjoni fil-vini taħt il-ġilda, normalment fid-dirgħajn jew fir-riġlejn) bi ħsara fil-ġilda.
English: A study in 152 patients showed that Hemlibra is also effective at preventing bleeding in patients with severe haemophilia A without factor VIII inhibitors: patients given Hemlibra for prevention had around 1 bleed per year that needed to be treated, compared with 38 bleeds per year in patients who received no preventive treatment.
Maltese: Studju f'152 pazjent wera li Hemlibra huwa effettiv ukoll biex jipprevjeni l-fsada f'pazjenti b'emofilja A severa li ma jkollhomx inibituri ta' fattur VIII: il-pazjenti li ngħataw Hemlibra għall-prevenzjoni kellhom madwar fsada waħda kull sena li kienet teħtieġ tiġi kkurata, meta mqabbla ma' 38 fsada kull sena f'pazjenti li ma rċevew l-ebda kura preventiva.
English: The company that markets Hemlibra will issue educational materials for healthcare professionals, patients, carers and laboratory professionals about abnormal clotting side effects, the risk of taking Hemlibra at the same time as bypassing agents and how laboratory tests should be carried out for these patients.
Maltese: Il-kumpanija li tqiegħed Hemlibra fis-suq ser toħroġ materjal edukattiv għall-professjonisti fil-qasam tal-kura tas-saħħa, pazjenti, persuni li jindukraw u professjonisti tal-laboratorju dwar l-effetti sekondarji tal-koagulazzjoni anormali, ir-riskju tat-teħid ta' Hemlibra fl-istess ħin ma' aġenti li jaqbżu linibitur u kif għandhom isiru t-testijiet tal-laboratorju għal dawn il-pazjenti.
English: A study in 109 patients showed that Hemlibra is effective at preventing bleeding in patients with haemophilia A of any severity who have factor VIII inhibitors: patients given Hemlibra for prevention had fewer bleeds that needed to be treated (equivalent to 3 per year) than patients who received no preventive treatment (equivalent to 23 per year).
Maltese: Studju f'109 pazjenti wera li Hemlibra huwa effettiv biex jipprevjeni l-fsada f'pazjenti b'emofilja A ta' kwalunkwe severità li jkollhom inibituri ta' fattur VIII: il-pazjenti li ngħataw Hemlibra għall-prevenzjoni kellhom inqas fsada li kienet teħtieġ tiġi kkurata tiġi kkurata (ekwivalenti għal 3 kull sena) minn pazjenti li ma rċevew l-ebda kura preventiva (ekwivalenti għal 23 kull sena).
English: The side effects with Hemlibra are tolerable and information on how to manage the risks of serious side effects is in the prescribing information and educational materials.
Maltese: L-effetti sekondarji b'Hemlibra huma tollerabbli u informazzjoni dwar kif jiġu ġestiti r-riskji tal-effetti sekondarji serji tinsab fl-informazzjoni tal-preskrizzjoni u fil-materjal edukattiv.
English: Patients can then continue with either 1.5 mg/kg once every week, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks.
Maltese: Imbagħad il-pazjenti jkunu jistgħu jkomplu jew b'1.5 mg/kg darba kull ġimgħa, 3 mg/kg kull ġimagħtejn, jew 6 mg/kg kull erba' ġimgħat.
English: The active substance in Hemlibra, emicizumab, is a monoclonal antibody which has been designed to do the work that factor VIII normally does - bringing together 2 clotting factors (IXa and X) as part of a chain of reactions needed for blood to clot.
Maltese: Is-sustanza attiva f'Hemlibra, l-emiċiżumab, hija antikorp monoklonali li tfassal biex jagħmel ix-xogħol li normalment jagħmel fattur VIII - li jiġbor flimkien 2 fatturi tal-koagulazzjoni (IXa u X) bħala parti minn katina ta' reazzjonijiet meħtieġa biex id-demm jagħqad.
English: The most serious side effect is thrombotic microangiopathy (clots in small blood vessels, which may affect up to 1 in 100 people).
Maltese: L-effett sekondarju l-aktar serju huwa mikroanġjopatija trombotika (emboli f'vażi żgħar, li jistgħu jaffettwaw bejn persuna 1 minn kull 100).
English: Hemlibra (emicizumab)
Maltese: Kif jintuża Hemlibra?
English: As for all medicines, data on the use of Hemlibra is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Hemlibra hija ssorveljata kontinwament.
English: How is Hemlibra used?
Maltese: Hemlibra?
English: The most common side effects with Hemlibra (which may affect 1 in 10 people or more) are redness, itching or pain at the place where it is injected, headache and joint pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Hemlibra (li jistgħu jaffettwaw persuna 1 minn kull 10 jew aktar) huma ħmura, ħakk jew uġigħ fil-post fejn jiġi injettat, uġigħ ta' ras u wġigħ fil-ġogi.
English: For the full list of side effects and restrictions with Hemlibra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Hemlibra, ara l-fuljett ta' tagħrif.
English: Side effects reported with Hemlibra are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Hemlibra huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Materials will include product information, guides, and a patient alert card.
Maltese: Il-materjal se jinkludi informazzjoni dwar il-prodott, gwidi u kard ta' twissija tal-pazjent.
English: Because emicizumab has a different structure to factor VIII, it is not affected by factor VIII inhibitors.
Maltese: Minħabba li l-emiċiżumab għandha struttura differenti minn fattur VIII, dan ma jiġix affettwat minn inibituri ta' fattur VIII.
English: The day before starting Hemlibra treatment, patients should stop treatment with bypassing agents (medicines used to prevent bleeding in patients with factor VIII inhibitors, such as activated prothrombin complex concentrate or recombinant factor VIIa).
Maltese: Fil-jum qabel tinbeda l-kura b'Hemlibra, il-pazjenti għandhom iwaqqfu l-kura b'aġenti li jaqbżu linibitur (mediċini li jintużaw biex jipprevjenu l-fsada f'pazjenti b'inibituri ta' fattur VIII, bħal konċentrat kumpless tal-protrombina attivat jew fattur VIIa rikombinanti).
English: [other monocomponent]
Maltese: [monokomponent ieħor]
English: o
Maltese: A.
English: [relevant text]
Maltese: [kitba rilevanti]
English: Additional considerations
Maltese: Konsiderazzjonijiet addizzjonali
English: Adults with normal renal function (GFR≥ 90 mL/min)
Maltese: Adulti b'funzjoni renali normali (GFR≥ 90 mL/min)
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: It-tagħrif dwar il-prodott jista' sussegwentament jiġi aġġornat minn awtoritajjiet kompetenti tal-Istati Membri, flimkien ma Stat Membru ta' Referenza, bi qbil mal-proċeduri deskritti f' Kapitlu 4 a' Titlu III ta' Direttiva 2001/83/EC.
English: In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u fl-anzjani, ilfunzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: Section 4: Possible side effects [Include among the most serious side effects at the top of section 4:]
Maltese: • Sezzjoni 4: Effetti sekondarji possibbli [Inkludi fost l-effetti sekondarji aktar serji fin-naħa ta' fuq ta' sezzjoni 4:]
English: [The dosing table above should be adapted for extended-release products containing metformin as single agent as follows: - The total maximum daily dose for patients with GFR 60-89 mL/min should be the same as the currently approved dose in adults with normal renal function.
Maltese: [It-tabella tad-dożaġġ t'hawn fuq għandha tiġi adattata għal prodotti li jerħu l-mediċina b'mod estiż li fihom metformin bħala mediċina waħda kif ġej: - Id-doża massima totali ta' kuljum għal pazjenti b'GFR ta' 60-89 mL/min, għandha tkun l-istess bħaddoża approvata bħalissa f'adulti b'funzjoni normali tal-kliewi.
English: medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
Maltese: mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib) ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tar-riċetturi ta' angiotensin II)
English: For fixed dose combination products containing metformin:
Maltese: Għal prodotti ta' kombinazzjoni ta' doża fissa li fihom metformin:
English: 4.3 Contraindications [This section should be revised as follows:]
Maltese: 4.3 Kontraindikazzjonijiet [Din is-sezzjoni għandha tiġi riveduta kif ġej:]
English: Maximum daily dose is 2000 mg The starting dose is at most half of the maximum dose.
Maltese: Doża massima ta' kuljum hi 2000 mg L-ogħla doża inizjali hi daqs nofs id-doża massima.
English: Maximum daily dose is 3000 mg Dose reduction may be considered in relation to declining renal function.
Maltese: Doża massima ta' kuljum hi 3000 mg F'konnessjoni ma' funzjoni renali li qed tonqos, jista' jiġi kkunsidrat tnaqqis fiddoża.
English: If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fiddemm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: Talk to your doctor for further instructions.
Maltese: Kellem lit-tabib tiegħek għal aktar istruzzjonijiet.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Maltese: It-terapija tista' terġa' tinbeda mill-ġdid mhux qabel 48 siegħa wara l-kirurġija jew wara li tinbeda millġdid nutrizzjoni orali u bil-patt li l-funzjoni renali tkun ġiet evalwata mill-ġdid u nstabet li hija stabbli.
English: Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Maltese: Metformin irid jitwaqqaf qabel jew fil-ħin tal-proċedura tat-teħid tal-immaġni u m'għandux jerġa' jinbeda qabel mill-inqas 48 siegħa wara, bil-patt li l-funzjoni renali tkun ġiet evalwata mill-ġdid u nstabet li hija stabbli, ara sezzjonijiet 4.2 u 4.4.
English: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Maltese: Sintomi ta' aċidożi lattika jinkludu: rimettar uġigħ fl-istonku (uġigħ addominali) bugħawwieġ fil-muskoli sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa diffikultà biex tieħu n-nifs temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: If no adequate strength of [product name] is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' [isem il-prodott], għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) • Severe renal failure (GFR <30 mL/min)
Maltese: • Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika)
English: Avoid excessive alcohol intake while taking <Product name> since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu <Isem il-prodott> peress li dan jista' jżid irriskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Metformin must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Maltese: Aċidożi lattika hija emerġenza medika u għandha tiġi ttrattata fi sptar.
English: Symptoms of lactic acidosis include:
Maltese: Huwa importanti ħafna li wieħed isemmi dan li ġej:
English: Stop taking <Product name> for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Maltese: Waqqaf it-teħid ta' <Isem il-prodott> għal żmien qasir jekk għandek kundizzjoni li tista' tkun assoċjata ma' deidratazzjoni (telf sinifikanti ta' fluwidi tal-ġisem) bħal rimettar sever, dijarea, deni, esponiment għal sħana jew jekk tixrob inqas fluwidu min-normal.
English: For both products containing metformin as single agent and for fixed dose combination products containing metformin:
Maltese: Għaż-żewġ prodotti li fihom metformin bħala mediċina waħda u għal prodotti ta' kombinazzjoni ta' doża fissa li fihom metformin:
English: A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.
Maltese: Il-GFR għandha tiġi evalwata qabel jinbeda t-trattament bi prodotti li jkun fihom metformin u mill-inqas kull sena wara dan.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.
Maltese: F'każ ta' deidratazzjoni (dijarea severa jew rimettar, deni jew tnaqqis fit-teħid ta' fluwidu), metformin għandu jitwaqqaf b'mod temporanju u huwa rakkomandat kuntatt ma' professjonist fil-kura tas-saħħa.
English: Immediate Packaging
Maltese: Daqs tal-pakkett flixkun (HDPE)l
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja l-uffiċjali tal-istampa tagħna Monika Benstetter jew Martin Harvey
English: The products were authorised in Estonia, France, Italy, Latvia and Lithuania.
Maltese: Il-prodotti kienu awtorizzati fl-Estonia, fi Franza, fil-Latvja u fil-Litwanja.
English: The review of Caustinerf arsenical, Yranicid arsenical and associated names was initiated on 24 October 2013 at the request of the French medicines agency, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati inbdiet fl-24 ta' Ottubru 2013 fuq it-talba tal-aġenzija tal-mediċini Franċiża, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: In vitro studies with Caustinerf arsenical and Yranicid arsenical have confirmed a clastogenic/aneugenic potential and there are published data showing that arsenic compounds have a toxic effect on reproduction in animals.
Maltese: Studji in vitro bi Caustinerf arsenical u Yranicid arsenical ikkonfermaw potenzjal klastoġeniku/anewġeniku u hemm dejta ppublikata li turi li komposti ta' arseniku għandhom effett tossiku fuq ir-riproduzzjoni fl-annimali.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision on 11 July 2014.
Maltese: L-opinjoni tas-CHMP ġiet mgħoddija lill-Kummissjoni Ewropea, li approvatha u ħarġet deċiżjoni finali li torbot legalment fil-11 ta' Lulju 2014.
English: The EMA recommendations are based on a review of data indicating a potential genotoxic effect of the products due to the presence of arsenic trioxide (arsenous anhydride).
Maltese: Ir-rakkomandazzjonijiet tal-EMA huwa bbażati fuq reviżjoni ta' dejta li tindika effetti ġenotossiċi potenzjali tal-prodotti minħabba l-preżenza ta' arsenic trioxide (arsenous anhydride).