FrancophonIA/ELRC3.0 huggingface dataset:
English: Translarna 1000 mg
Maltese: INDIVIDWALI 1000 mg
English: Aminoglycosides
Maltese: Aminoglikosidi
English: In a clinical study, the extent of exposure for ciprofloxacin was 32% higher in the presence of ataluren.
Maltese: Fi studju kliniku, il-grad tal-esponiment għal ciprofloxacin kien 32% ogħla fil-preżenza ta' ataluren.
English: In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4.
Maltese: F'mudell ibbażat fuq l-istatistika, iddifferenza medja stmata kienet ta' 13-il metru (p=0.213), Figura 4.
English: Patients were randomised in a 1:1:1 ratio and received ataluren or placebo 3 times per day (morning, midday, and evening), with 57 receiving ataluren 40 mg/kg/day (10, 10, 20 mg/kg), 60 receiving ataluren 80 mg/kg/day (20, 20, 40 mg/kg), and 57 receiving placebo.
Maltese: Il-pazjenti kienu randomizzati fi proporzjon ta' 1:1:1 u rċevew ataluren jew plaċebo 3 darbiet kuljum (filgħodu, nofsinhar, u filgħaxija), b'57 li rċevew ataluren 40 mg/kg/jum (10-, 10-, 20-mg/kg), 60 li rċevew ataluren 80 mg/kg/jum (20-, 20-, 40 mg/kg), u 57 li rċivew placebo.
English: Patients who do not have a nonsense mutation
Maltese: Pazjenti li ma għandhomx mutazzjoni nonsense
English: B a s e lin e
Maltese: Il-pazjenti għandhom jieħdu d-doża sħiħa.
English: There was no difference between ataluren 80 mg/kg/day and placebo.
Maltese: Ma kien hemm l-ebda differenza bejn ataluren 80 mg/kg/jum u plaċebo.
English: Safety data from 28 weeks of therapy showed a similar safety profile of ataluren in patients 2-5 years as compared with patients aged 5 years and older.
Maltese: Id-dejta dwar is-sigurtà minn 28 ġimgħa ta' terapija wriet profil ta' sigurtà simili ta' ataluren f'pazjenti minn 2 sa 5 snin meta mqabbla ma' pazjenti ta' 5 snin u aktar.
English: Translarna is available in sachets of 125 mg, 250 mg or 1000 mg.
Maltese: Translarna huwa disponibbli fi qratas ta' 125 mg, 250 mg jew 1000 mg.
English: Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products (eg oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
Maltese: Għalhekk, għandha tiġi eżerċitata l-kawtela meta ataluren jingħata flimkien ma' prodotti mediċinali li huma sottostrati ta' OAT1 jew OATP1B3 minħabba r-riskju ta' konċetrazzjoni miżjuda ta' dawn ilprodotti mediċinali (eż. oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
English: Patients were randomised in a 1:1 ratio and received ataluren 40 mg/kg/day (n=115) or placebo (n=115) 3 times per day (morning, midday, and evening).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 u rċivew ataluren 40 mg/kg/jum (n=115) jew plaċebo (n=115) 3 darbiet kuljum (filgħodu, f'nofsinhar, u filgħaxija).
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (eg rifampicin).
Maltese: Għandha tiġi eżerċitata kawtela meta ataluren jingħata flimkien ma' prodotti mediċinali li huma indutturi ta' UGT1A9 (eż. rifampicin).
English: Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older (see section 5.1).
Maltese: Translarna huwa indikat għall-kura ta' distrofija muskolari ta' Duchenne li tirriżulta minn mutazzjoni nonsense fil-ġene ta' dystrophin, f'pazjenti ambulatorji li għandhom sentejn u aktar (ara sezzjoni 5.1).
English: Steady-state plasma concentrations are dose-proportional for ataluren doses between 10 and 50 mg/kg, and no accumulation is observed after repeated dosing.
Maltese: Il-konċentrazzjonijiet fil-plażma fi stat fiss huma proporzjonali għaddożi ta' ataluren bejn 10 u 50 mg/kg, u ma hija osservata ebda akkumulazzjoni wara dożaġġ ripetut.
English: For example, you might take Translarna at 7:00 AM in the morning with breakfast, at 1:00 PM in the afternoon with lunch, and again at around 7:00 PM in the evening with dinner.
Maltese: Pereżempju, trid tieħu Translarna fis-7:00 AM filgħodu mal-kolazzjon, fis-1:00 PM wara nofsinhar mal-ikla, u għal darb'oħra fis7:00 PM filgħaxija mal-pranzu.
English: Change in renal function tests (increased creatinine, blood urea nitrogen, cystatin C)
Maltese: Bidla fit-testijiet talfunzjoni tal-kliewi (żieda fil-krejatinina, in-nitroġenu fl-urea tad-demm, cystatin C)
English: In both studies, 1/232 (0.43%) patients treated with ataluren discontinued due to an adverse reaction of constipation and 1/172 (0.58%) placebo patients discontinued treatment due to an adverse reaction of disease progression (loss of ambulation).
Maltese: Fiż-żewġ studji, 1/232 (0.43%) tal-pazjenti kkurati b'ataluren ma komplewx il-kura minħabba reazzjoni avversa ta' stitikezza, u 1/172 (0.58%) tal-pazjenti fuq il-plaċebo waqqfu lkura minħabba reazzjoni avversa ta' progressjoni tal-marda (telf ta' ambulazzjoni).
English: Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (coloring and polyester/foil bond), aluminum foil (moisture barrier), adhesive (polyurethane class), copolymer of ethylene and methacrylic acid (sealant resin for packaging integrity).
Maltese: In-natura tal-kontenitur u ta'dak li hemm ġo fih Qartas tal-fojl tal-aluminju laminat issiġillat bis-sħana: polyethylene terephthalate (reżistenza għattfal), polyethylene (kulur u rabta bejn il-polyester u l-fojl), fojl tal-aluminju (ostaklu tal-umdità), kolla (klassi tal-polyurethane), kopolimeru ta' ethylene u l-aċidu metakriliku (reżina siġillanti għall-integrità tal-imballaġġ).
English: It is important to take the correct dose.
Maltese: Huwa importanti li tingħata d-doża ttajba.
English: In the urine, unchanged ataluren and the acyl glucuronide metabolite account for <1% and 49%, respectively, of the administered dose.
Maltese: Fl-awrina, ataluren mhux mibdul u l-metabolit acyl glucuronide jammontaw għal <1% u 49%, rispettivament, tad-doża mogħtija.
English: ≥75 meters without the need for assistive devices during a screening 6-Minute Walk Test (6MWT).
Maltese: Il-pazjenti kollha kienu meħtieġa li kienu kapaċi jimxu ≥75 metru mingħajr il-ħtieġa ta' apparat ta' għajnuna matul skrinjar ta' Test tal-Mixi ta' 6 Minuti (6MWT).
English: An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Maltese: Żieda fl-esponiment għal ataluren u fil-metabolit ta' ataluren ġiet irrappurtata f'pazjenti b'indeboliment renali sever (eGFR <30 mL/min).
English: Due to the low number of other races included in the clinical studies, no conclusions can be drawn on the effect of UGT1A9 in other ethnic groups.
Maltese: Minħabba n-numru baxx ta' razez oħra inklużi flistudji kliniċi, ma jistgħux jittieħdu konklużjonijiet dwar l-effett ta' UGT1A9 fi gruppi etniċi oħra.
English: Each sachet contains 125 mg of ataluren
Maltese: Kull qartas fih 125 mg ataluren
English: Ataluren enables ribosomal readthrough of mRNA containing such a premature stop codon, resulting in production of a full-length protein.
Maltese: Ataluren jippermetti r-readthrough ta' ribosomal ta' mRNA li jkun fihom tali stop codon prematur, li jirriżulta fil-produzzjoni ta' proteina b'tul sħiħ.
English: A 1-year study in 10-12 weeks old dogs demonstrated findings in the adrenal gland (focal inflammation and degeneration in the glucocorticoid-producing regions of the cortex) and a mild compromise of cortisol production after exogenous stimulation with adrenocorticotropic hormone.
Maltese: Studju ta' sena fuq klieb f'eta ta' 10-12-il ġimgħa wera sejbiet fil-glandola adrenali (infjammazzjoni fokali u deġenerazzjoni fir-reġjuni li jipproduċu l-glukokortikojdi tal-kortiċi) u kompromess ħafif talproduzzjoni ta' kortisol wara stimulazzjoni eżoġena b'ormon adrenokortikotropiku.
English: At a single tested, relatively low, maternal dose of 30 mg/kg, the concentration of foetal radioactivity was ≤ 27% of the maternal concentration.
Maltese: F'doża materna relattivament baxxa, ittestjata darba ta' 30 mg/kg, il-konċentrazzjoni ta' radjuattività tal-fetu kienet ≤27 % tal-konċentrazzjoni materna.
English: This effect is considered clinically not relevant.
Maltese: Dan l-effett jitqies bħala klinikament mhux rilevanti.
English: Pharmacotherapeutic group:Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX03
Maltese: Mediċini oħrajn għal disturbi tas-sistema muskoloskeletali, kodiċi ATC:
English: An open-label study was performed including patients aged 2-5 years (n=14) to evaluate the PK and safety of ataluren.
Maltese: Sar studju open-label li jinkludi pazjenti minn 2 sa 5 snin (n = 14) biex jevalwa l-PK u s-sigurtà ta' ataluren.
English: Translarna 1000 mg granules for oral suspension EU/1/13/902/003
Maltese: Translarna 1000 mg bċejjeċ żgħar li jitħalltu ma' likwidu biex jittieħed mill-ħalq EU/1/13/902/003
English: The safety, pharmacokinetics and exploratory effectiveness of Translarna were assessed in an openlabel study in children between 2 and 5 years of age with nmDMD.
Maltese: Is-sigurtà, il-farmakokinetika u l-effikaċja esploratorja ta' Translarna ġew evalwati fi studju open-label fi tfal bejn 2 u 5 snin b'nmDMD.
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in observed time to run/walk 10 meters (better by 1.2 seconds, p=0.117), time to climb 4 stairs (better by 1.8 seconds, p=0.058), and time to descend 4 stairs (better by 1.8 seconds, p=0.012), Figure 5.
Maltese: Il-bidla medja fit-testijiet tal-funzjoni li fihom ittieħdet nota tal-ħin, mil-linja bażi sa Ġimgħa 48, kienet aħjar fil-parti tal-istudju dwar ataluren 40 mg/kg/jum milli fil-plaċebo, fil-ħin osservat biex persuna tiġri/timxi 10 metri (aħjar b'1.2 sekondi, p=0.117), u l-ħin biex titla' 4 tarġiet (aħjar b'1.8 sekondi, p=0.058), u l-ħin biex tinżel 4 tarġiet (aħjar b'1.8 sekondi, p=0.012), Figura 5.
English: Usually prescribed for acyclovir treatment of chickenpox [varicella]
Maltese: Li ġeneralment tiġi ordnata għal aciclovir kura ta' ġidri r-riħ [variċella]
English: Translarna is a medicine that contains the active substance ataluren.
Maltese: Translarna huwa mediċina li fiha s-sustanza attiva ataluren.
English: A post-hoc analysis of time to persistent 10% worsening in 6MWD showed that 26% of patients in the ataluren 40 mg/kg/day arm had progressed at Week 48 compared to 44% in the placebo group (p=0.0652) (Figure 2).
Maltese: Analiżi post-hoc taż-żmien għal 10 % aggravar persistenti f'6MWD uriet li 26 % tal-pazjenti fil-fergħa ta' ataluren 40 mg/kg/jum għamlu progress fit-48 Ġimgħa meta mqabbla ma' 44 % fil-grupp ta' plaċebo (p=0.0652) (Figura 2).
English: Pain in extremity, musculoskeletal chest pain
Maltese: Uġigħ flestremitajiet, uġigħ muskuloskeletali fissider
English: Aminoglycosides have been shown to reduce the readthrough activity of ataluren in vitro.
Maltese: L-aminoglikosidi ntwerew li jnaqqsu l-attività readthrough ta' ataluren in vitro.
English: Higher ataluren exposure was associated with potential decrease in efficacy.
Maltese: Esponiment ogħla għal ataluren kienet assoċjata ma' tnaqqis potenzjali fl-effikaċja.
English: The pharmacokinetics of ataluren are unlikely to be affected by medicinal products that inhibit the p-glycoprotein transporter.
Maltese: Il-farmakokinetika ta' ataluren hija improbabbli li tiġi affettwata minn prodotti mediċinali li jinibixxu t-trasportatur ta' pglycoprotein.
English: Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3).
Maltese: Ataluren ma għandux jingħata flimkien ma' aminoglikosidi ġol-vina, abbażi ta' każijiet ta' tnaqqis filfunzjoni tal-kliewi osservati fi prova klinika f'pazjenti b'nmCF (ara sezzjoni 4.3 ).
English: Co-administration of rifampicin, a strong inducer of metabolic enzymes including UGT1A9, decreased ataluren exposure by 29%.
Maltese: L-għoti flimkien ta' rifampicin, induttur qawwi ta' enzimi metaboliċi li jinkludu UGT1A9, naqqas l-esponiment ta' ataluren b'29%.
English: Translarna 250 mg granules for oral suspension EU/1/13/902/002
Maltese: Translarna 250 mg bċejjeċ żgħar li jitħalltu ma' likwidu biex jittieħed mill-ħalq EU/1/13/902/002
English: Translarna is available in the following sachet strengths: 125 mg, 250 mg and 1000 mg of ataluren per sachet.
Maltese: Translarna huwa disponibbli fil-qawwiet ta' qratas li ġejjin: 125 mg, 250 mg u 1000 mg ta' ataluren f'kull qartas.
English: Hypertension with use of concomitant systemic corticosteroids
Maltese: Pressjoni għolja bl-użu ta' kortikosterojdi sistemiċi konkomitanti
English: Study 1 evaluated 174 male patients, ages 5 to 20 years.
Maltese: Studju 1 evalwa 174 pazjent raġel li għandhom bejn il-5 snin u l-20 sena.
English: Effect of other medicinal products on ataluren pharmacokinetics Based on in vitro studies, ataluren is a substrate of UGT1A9.
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq il-farmakokinetika ta' ataluren Abbażi ta' studji in vitro, ataluren huwa sottostrat ta' UGT1A9.
English: Renal function tests
Maltese: Testijiet tal-funzjoni tal-kliewi
English: In vivo, the only metabolite detected in plasma after oral administration of radio-labelled ataluren was the ataluren-O-1β-acyl glucuronide; exposure to this metabolite in humans was approximately 8% of the plasma AUC of ataluren.
Maltese: In vivo, l-unika metabolit misjub fil-plażma wara għoti orali ta' ataluren radjutikkettat kien ataluren-O1β-acyl glucuronide; l-espożizzjoni ta' dan il-metabolit fil-bniedem kienet madwar 8% tal-AUC filplażma ta' ataluren.
English: Renal toxicity (nephrosis in the distal nephron) occurred in repeat oral dose studies in mice at systemic exposure equivalent to 0.3 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 10-, 10-, 20-mg/kg and higher.
Maltese: Seħħet tossiċità tal-kliewi (nefrożi fid-distal nephron) fi studji b'doża orali ripetuta fil-ġrieden b'espożizzjoni sistemika ekwivalenti għal 0.3 darbiet l-AUC fi stat fiss f'pazjenti li ngħataw Translarna rispettivament fid-dożi ta' filgħodu, nofsinhar, u filgħaxija ta' 10-, 10-, 20-mg/kg u ogħla.
English: In particular do not take Translarna with the antibiotics gentamicin, tobramycin, or streptomycin given by injection.
Maltese: B'mod partikolari tiħux Translarma mal-antibijotiċi gentamicin, tobramycin, jew streptomycin li jingħataw b'injezzjoni.
English: In patients with a baseline 6MWD <350 meters, the mean change in observed 6MWD from baseline to Week 48 was 68 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.0053).
Maltese: F'pazjenti b'linja bażi 6MWD < 350 metru, il-bidla medja fis-6MWD osservata mil-linja bażi sa 48 Ġimgħa kienet 68 metru aħjar mill-fergħa ta' 40 mg/kg/jum ta' ataluren milli mill-fergħa ta' plaċebo (p=0.0053).
English: White to off-white granules.
Maltese: - Żomm dan il-fuljett.
English: 125 mg sachets
Maltese: 125 mg qratas ta'
English: An approximately 40% decrease of mean total ataluren exposure in the moderate hepatic impairment group versus the control group was noted probably due to the small sample size and variability.
Maltese: Ġie osservat tnaqqis ta' bejn wieħed u ieħor 40% fil-medja talesponiment totali ta' ataluren fil-grupp ta' dawk b'indeboliment moderat tal-fwied kontra l-gruppi talkontroll, probabbilment minħabba d-daqs żgħir tal-kampjun u l-varjabilità.
English: Translarna 125 mg granules for oral suspension EU/1/13/902/001
Maltese: Translarna 125 mg bċejjeċ żgħar li jitħalltu ma' likwidu biex jittieħed mill-ħalq EU/1/13/902/001
English: The differences favoring ataluren versus placebo in mean changes in timed function tests at Week 48 in the ITT population reached the threshold for a clinically meaningful difference (changes ~1 to 1.5 seconds).
Maltese: ITT, laħqu l-limitu għal differenza klinikament sinifikanti (bidliet minn ~1 sa 1.5 sekondi).
English: Mean Change in 6-Minute Walk Distance (Study 1)
Maltese: Il-Bidla Medja f'Distanza ta' Mixi ta' 6 Minuti (Studju 1)
English: Translarna is used to treat Duchenne muscular dystrophy resulting from a specific genetic defect that affects normal muscle function.
Maltese: Translarna jintuża biex jikkura distrofija muskolari ta' Duchenne li tirriżulta minn difett ġenetiku speċifiku li jaffettwa l-funzjoni normali tal-muskoli.
English: In the clinical program investigating the efficacy and safety of monotherapy ataluren in patients with nonsense mutation cystic fibrosis, no statistically significant effect was observed in the primary and key secondary clinical outcome measures (ppFEV1 and pulmonary exacerbation rate) in adults and children aged 6 years and older.
Maltese: Fil-programm kliniku li kien qed jinvestiga l-effikaċja u s-sigurtà ta' monoterapija b'ataluren f'pazjenti b'fibrożi ċistika bil-mutazzjoni nonsense, ma kien osservat l-ebda effett statistikament sinifikanti fil-kejl tar-riżultati kliniċi primarji u sekondarji ewlenin (ppFEV1 u r-rata ta' aggravament pulmonari) fl-adulti u tfal li kellhom 6 snin jew aktar.
English: Translarna is available in 3 strengths, each containing 125 mg, 250 mg and 1000 mg of the active substance, called ataluren.
Maltese: Translarna huwa disponibbli fi 3 qawwiet, li kull waħda minnhom fiha 125 mg, 250 mg u 1000 mg tas-sustanza attiva, imsejħa ataluren.
English: How to store Translarna
Maltese: X'fih Translarna
English: Each sachet contains 250 mg of ataluren
Maltese: Kull qartas fih 250 mg ataluren
English: Efficacy has not been demonstrated in non-ambulatory patients.
Maltese: L-effikaċja ma ntwerietx f'pazjenti mhux ambulatorji.
English: The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Maltese: L-effikaċja ta' Translarna fit-tfal ta' bejn 2 u 5 snin ġiet stabbilita fuq estrapolazzjoni minn pazjenti ta' età ta' > 5 snin.
English: Co-administration of ataluren with mycophenolate mofetil in healthy subjects did not affect the exposure of its active metabolite, mycophenolic acid (a substrate of UGT1A9).
Maltese: L-għoti flimkien ta' ataluren ma' mycophenolate mofetil f'individwi b'saħħithom ma affettwax l-esponiment tal-metabolit attiv tiegħu, mycophenolic acid (sottostrat ta' UGT1A9).
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Each sachet contains 1000 mg of ataluren
Maltese: Kull qartas fih 1000 mg ataluren LISTA
English: At a single, relatively low, maternal dose of 30 mg/kg radiolabelled ataluren, the highest measured concentration of radioactivity in rat milk was 37% of the maternal plasma concentration.
Maltese: F'doża materna waħda, relattivament baxxa, ta' 30 mg/kg ta' ataluren radjutikkettat, l-ogħla konċentrazzjoni mkejla ta' radjuattività fil-ħalib tal-firien kienet 37% tal-konċentrazzjoni fil-plażma materna.
English: Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Maltese: L-għoti ta' kortikosterojdi (deflazacort, prednisone jew prednisolone) flimkien ma' ataluren ma affettwax il-konċentrazzjonijiet fil-plażma ta' ataluren.
English: Changes in lipid profile
Maltese: Bidliet fil-profil tal-lipidi
English: Adverse reactions reported in >1 patient in the 40 mg/kg/day group at a frequency greater than that of the placebo group are presented by MedDRA System Organ Class, Preferred Term, and frequency.
Maltese: Reazzjonijiet avversi rrappurtati f'>1 pazjent fil-grupp ta' 40 mg/kg/jum, bi frekwenza li kienet akbar minn dik tal-grupp tal-plaċebo, huma ppreżentati skont is-Sistema tal-Klassifika tal-Organi
English: Exposure at the no observed adverse effect level (NOAEL) was similar to (rabbit) or 4 times (rat) the systemic exposure in humans (40 mg/kg/day).
Maltese: L-espożizzjoni fil-livell fejn ma ġie osservat ebda effett avvers (NOAEL) kienet simili għal (fniek) jew 4 darbiet (firien) l-espożizzjoni sistemika fil-bniedem (40 mg/kg/jum).
English: If this is unavoidable (e.g. vancomycin to treat MRSA) careful monitoring of renal function is advised (see section 4.5).
Maltese: Jekk dan ma jkunx jista' jiġi evitat (eż. vancomycin biex tiġi kkurata MRSA), hija rrakkomandata sorveljanza b'attenzjoni tal-funzjoni tal-kliewi (ara sezzjoni 4.5)
English: In timed function tests (TFTs), tests of time to run/walk 10 meters, time to climb 4 stairs, and time to descend 4 stairs, ataluren-treated patients demonstrated smaller increases in the time it takes to run/walk 10 meters, climb 4 stairs, and descend 4 steps, indicating slowing of nmDMD progression relative to placebo.
Maltese: F'testijiet ta' funzjoni bil-ħin (TFTs), testijiet ta' ħin għal ġirja/mixja ta' 10 metri, ħin biex pazjent jitla' 4 tarġiet, u l-ħin biex jinżel 4 tarġiet, il-pazjenti kkurati b'ataluren urew żidiet iżgħar fil-ħin li jieħdu biex jiġru/jimxu 10 metri, tlugħ ta' 4 tarġiet, u nżul ta' 4 tarġiet, li tindika tnaqqis filprogressjoni nmDMD relattiv għal plaċebo.
English: Treatment of patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease is not recommended (see sections 4.4 and 5.2).
Maltese: Mhux irrakkomandat trattament ta' pazjenti b'indeboliment renali sever (eGFR <30 mL/min) jew mard renali fl-aħħar stadju (ara sezzjonijiet 4.4 u 5.2).
English: Meters (±SE)
Maltese: TA' EĊĊIPJENTI
English: Ataluren-treated patients experienced clinical benefit as measured by numerically favorable differences versus placebo across the primary and secondary efficacy endpoints.
Maltese: Pazjenti kkurati b'ataluren kellhom benefiċċju kliniku kif imkejjel minn differenzi numerikament favorevoli kontra l-plaċebo fil-punti aħħarin kollha primarji u sekondarji tal-effikaċja.
English: In the event of a suspected overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Maltese: Fil-każ ta' doża eċċessiva suspettata, għandha tiġi pprovduta kura medika ta' appoġġ inkluż konsultazzjoni ma' professjonist tal-kura tas-saħħa u osservazzjoni mill-qrib tal-istatus kliniku tal-pazjent.
English: Following multiple dosing, the increase in ataluren and ataluren metabolite is anticipated to be higher in patients with severe renal impairment and end-stage renal disease when compared with patients with normal renal function at steady state.
Maltese: Wara dożi multipli, iż-żieda f'ataluren u fil-metabolit ta' ataluren hija mistennija li tkun ogħla f'pazjenti b'indeboliment renali sever u b'mard renali fl-aħħar stadju meta mqabbla ma' pazjenti b'funzjoni renali normali fi stat fiss.
English: In a rat distribution study a high adrenal concentration of ataluren was observed.
Maltese: Fi studju tad-distribuzzjoni tal-firien, kienet osservata konċentrazzjoni adrenali għolja ta' ataluren.
English: The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Maltese: Il-preżenza ta' mutazzjoni nonsense fil-ġene ta' dystrophin għandha tiġi ddeterminata minn ittestjar ġenetiku (ara sezzjoni 4.4).
English: Treatment should not be initiated in previously untreated patients with eGFR <30 ml/min (see sections 4.2 and 5.2).
Maltese: It-trattament m'għandux jinbeda f'pazjenti li ma kinux ittrattati qabel b'EGFR <30 mL/min (ara sezzjonijiet 4.2 u 5.2).