FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, in vitro data cannot be sole proof that the clinical data from the submitted studies are applicable to Furosemide Vitabalans.
Maltese: Barra minn hekk, dejta in vitro ma tistax tkun l-unika prova li d-dejta klinika mill-istudji sottomessi hija applikabbli għal Furosemide Vitabalans.
English: • CHMP conclusion on grounds for re-examination
Maltese: • Il-konklużjonijiet tas-CHMP dwar raġunijiet għal eżaminazzjoni mill-ġdid
English: The group considered that manufacturing methods or dissolution data could not predict how the product would behave in vivo.
Maltese: Il-grupp ikkunsidra li l-metodi ta' manifattura jew id-dejta dwar id-dissoluzzjoni ma setgħux jipprevedu kif il-prodott sejjer jaġixxi in vivo.
English: On the basis of the bibliographic data submitted, taken together with additional pharmaceutical documentation, the applicant failed to establish the relevance of these data to demonstrate the safety and efficacy of Furosemide Vitabalans and associated names.
Maltese: Abbażi tad-dejta biblijografika sottomessa, meħuda flimkien ma' dokumentazzjoni farmaċewtika addizzjonali, l-applikant naqas milli jistabbilixxi r-rilevanza ta' din id-dejta biex juri s-sigurtà u leffikaċja ta' Furosemide Vitabalans u ismijiet assoċjati.
English: The ad-hoc expert group considered that the published literature and the dissolution data provided by the applicant were not sufficient to prove the safety and efficacy of Furosemide Vitabalans.
Maltese: Il-grupp ta' esperti ad-hoc ikkunsidra li rreċensjoni ppubblikata u d-dejta dwar id-dissoluzzjoni pprovduta mill-applikant ma kinux biżżejjed biex juru s-sigurtà u l-effikaċja ta' Furosemide Vitabalans.
English: The applicant's argument that traditional manufacturing methods as well as excipients widely used are sufficient to demonstrate the bridging between Furosemide Vitabalans and other furosemide products cannot be accepted.
Maltese: L-argument tal-applikant li l-metodi tradizzjonali ta' manifattura kif ukoll l-eċċipjenti użati b'mod wiesa' huma suffiċjenti biex juru r-rabta bejn Furosemide Vitabalans u prodotti oħra ta' furosemide ma jistax jiġi aċċettat.
English: Based only on published literature data, it is not possible to conclude that the pharmacokinetic parameters of Furosemide Vitabalans would be within the same range than other furosemide 40 mg tablets referred to.
Maltese: Abbażi biss ta' dejta minn reċensjoni ppubblikata, mhuwiex possibbli li jiġi konkluż li l-parametri farmakokinetiċi ta' Furosemide Vitabalans sejrin ikunu fl-istess firxa tal-pilloli l-oħra ta' furosemide 40 mg imsemmija.
English: In order to show the relevance of the bibliographic data used in support of the application for Furosemide Vitabalans, the applicant made reference to:
Maltese: Sabiex juri r-rilevanza tad-dejta biblijografika użata b'appoġġ għall-applikazzjoni għal Furosemide Vitabalans, l-applikant għamel referenza għal:
English: It was considered necessary to have in vivo data especially with a drug exhibiting such wide range of pharmacokinetic values.
Maltese: Kien meqjus neċessarju li jkun hemm dejta in vivo speċjalment b'mediċina li turi firxa daqshekk wiesgħa ta' valuri farmakokinetiċi.
English: The decentralised procedure was closed on day 210, with most of the Concerned Member States agreeing with the conclusions of the Reference Member State's assessment report except Poland and Lithuania which raised a potential serious risk to public health (PSRPH).
Maltese: Il-proċedura deċentralizzata ngħalqet fil-jum 210, b'ħafna mill-Istati Membri Kkonċernati jaqblu malkonklużjonijiet tar-rapport ta' valutazzjoni tal-Istat Membru ta' Referenza ħlief il-Polonja u l-Litwanja li qajmu riskju serju potenzjali għas-saħħa pubblika (PSRPH).
English: A scientifically valid approach such as the demonstration of comparable pharmacokinetics was considered necessary to bridge Furosemide Vitabalans to a similar product.
Maltese: Approċċ xjentifikament validu bħat-turija ta' farmakokinetika komparabbli kien ikkunsidrat meħtieġ biex jorbot lil Furosemide Vitabalans ma' prodott simili.
English: 10 micrograms
Maltese: 10 mikrogrammi
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Maltese: Manifatturat fuq ċelluli umani tat-tip diploid (MRC-5) Adsorbit fuq aluminium hydroxide, idratat
English: Hepatitis B surface antigen3,4
Maltese: Antiġen tas-superfiċje tal-epatite B
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Maltese: Manifatturat fuq ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA Adsorbit fuq aluminium phosphate
English: 1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Maltese: 10 siringi mimlijin għal-lest + 20labra doża 1 (0.5 ml): Virus tal-epatite A (inattivat)
English: 1 pre-filled syringe + 1 needle
Maltese: 1 siringa mimlija għal-lest + labra 1
English: EMA procedure number
Maltese: Numru talproċedura talEMA>
English: The full EPAR for Ryzodeg 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: The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ryzodeg fil-21 ta' Jannar 2013.
English: Ryzodeg has been studied in one main study involving 548 adults with type 1 diabetes and in four main studies involving 1,866 adults with type 2 diabetes.
Maltese: Ryzodeg ġie studjat fi studju ewlieni wieħed li fih ħadu sehem 548 pazjent bid-dijabete tat-tip 1 u f'erba' studji ewlenin li fihom ħadu sehem 1,866 adult bid-dijabete tat-tip 2.
English: Other information about Ryzodeg
Maltese: Informazzjoni oħra dwar Ryzodeg
English: This is a summary of the European public assessment report (EPAR) for Ryzodeg.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ryzodeg.
English: The reduction in HbA1c levels (in percentage points) was 0.7 in patients with type 1 diabetes and between 1 and 1.7 across the trials in patients with type 2 diabetes.
Maltese: Ittnaqqis fil-livelli tal-HbA1c (f'punti perċentwali) kien ta' 0.7 f'pazjenti bid-dijabete tat-tip 1 u bejn 1 u 1.7 fost il-provi f'pazjenti bid-dijabete tat-tip 2.
English: Ryzodeg insulin degludec / insulin aspart
Maltese: Sommarju tal-EPAR għall-pubbliku insulina degludec / insulina aspart
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml).
Maltese: Jiġi bħala soluzzjoni għal injezzjoni fi skartoċċ (100 unità/ml) u f'pinna mimlija minn qabel (100 unità/ml).
English: The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes the yeast able to produce them.
Maltese: Is-sustanzi attivi f'Ryzodeg, l-insulina degludec u l-insulina aspart, huma magħmula minn metodu magħruf bħala 'teknoloġija rikombitanti tad-DNA': dawn huma magħmula minn ħmira li tkun irċeviet ġene (DNA), li tagħmel il-ħmira kapaċi tipproduċihom.
English: In the study in children, the combined used of Ryzodeg and insulin aspart was at least as effective as insulin detemir and insulin aspart, with average HbA1c reductions of 0.27 and 0.23 percentage points respectively.
Maltese: Fl-istudi fuq it-tfal, l-użu kkombinat ta' Ryzodeg u linsulina aspart tal-inqas kien effettiv daqs l-insulina detemir u l-insulina aspart bi tnaqqis HbA1c medju ta' 0.27 u 0.23 punti perċentwali rispettivament.
English: Ryzodeg has also been studied in one main study in 362 children aged between 1 and 17 years with type 1 diabetes.
Maltese: Ryzodeg ġie studjat ukoll fi studju ewlieni wieħed fi 362 tifel u tifla fl-età ta' bejn sena u 17-il sena bid-dijabete tat-tip 1.
English: Insulin degludec and insulin aspart are slightly different from human insulin.
Maltese: L-insulina degludec u l-insulina aspart huma kemxejn differenti mill-insulina umana.
English: Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart.
Maltese: Ryzodeg huwa mediċina li fiha s-sustanzi attivi, l-insulina degludec u l-insulina aspart.
English: The studies compared Ryzodeg given at mealtimes with insulin glargine or insulin detemir (long-acting insulins), or with biphasic insulin (an insulin formulation consisting of a mixture of intermediate- and rapid-acting insulin).
Maltese: L-istudji qabblu Ryzodeg mogħti waqt il-ħin tal-ikel mal-insulina glargine jew mal-insulina detemir (insulini li jaġixxu fit-tul), jew mal-insulina biphasica (formulazzjoni tal-insulina li fiha taħlita ta' insulina li taġixxi b'mod intermedjarju u malajr).
English: The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes.
Maltese: Is-CHMP ikkonkluda li Ryzodeg huwa effettiv fil-kontroll tal-livelli ta' glukożju fid-demm f'adulti, adoloxxenti u tfal minn sentejn 'il fuq bid-dijabete.
English: What is Ryzodeg?
Maltese: Kif jaħdem Ryzodeg?
English: What benefit has Ryzodeg shown during the studies?
Maltese: Liema benefiċċju wera Ryzodeg waqt l-istudji mwettqa?
English: The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues.
Maltese: Il-Kumitat ikkonkluda li Ryzodeg huwa ġeneralment sigur u l-effetti sekondarji tiegħu huma komparabbli ma' dawk ta' analogi oħra tal-insulina.
English: The studies in adults showed that Ryzodeg was at least as effective as long-acting insulins and biphasic insulin in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Maltese: L-istudji fl-adulti wrew li Ryzodeg kien tal-inqas effettiv daqs insulini li jaġixxu fit-tul u l-insulina biphasica fil-kontroll tal-livelli tal-glukożju fid-demm f'pazjenti bid-dijabete tat-tip 1 u tat-tip 2.
English: How has Ryzodeg been studied?
Maltese: Kif ġie studjat Ryzodeg?
English: What is the risk associated with Ryzodeg?
Maltese: X'inhu r-riskju assoċjat ma' Ryzodeg?
English: Ryzodeg was given once a day at mealtime with insulin aspart given at other mealtimes and this treatment was compared with treatment comprising insulin detemir given once or twice a day with insulin aspart given at all mealtimes.
Maltese: Ryzodeg ingħata darba kuljum waqt l-ikel mal-insulina aspart li tingħata f'ħinijiet oħra tal-ikel u din il-kura tqabblet ma' kura li fiha l-insulina detemir li tingħata darba jew darbtejn kuljum mal-insulina aspart li tingħata waqt kull ikla.
English: How does Ryzodeg work?
Maltese: X'inhu Ryzodeg?
English: In the studies in type 2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
Maltese: Fl-istudji fuq id-dijabete tat-tip 2, Ryzodeg ingħata jew waħdu jew f'kombinazzjoni ma' mediċini oħra kontra d-dijabete.
English: Why has Ryzodeg been approved?
Maltese: Għaliex ġie approvat Ryzodeg?
English: Ryzodeg is a replacement insulin for the insulin normally made by the body.
Maltese: Ryzodeg huwa insulina sostituttiva għall-insulina li normalment jipproduċi l-ġisem.
English: How is Ryzodeg used?
Maltese: Kif jintuża Ryzodeg?
English: All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Maltese: L-istudji kollha kejlu l-livell ta' emoglobina glikosilata (HbA1c), li hija l-perċentwal ta' emoglobina fiddemm imwaħħla ma' glukożju.
English: The differences mean that insulin degludec is absorbed more slowly by the body.
Maltese: Id-differenzi jfissru li l-insulina degludec tiġi assorbita aktar bil-mod mill-ġisem.
English: Injecting Ryzodeg at a main meal provides long-acting insulin to control blood sugar until the next dose as well as short-acting insulin to help deal with the extra sugar from the meal.
Maltese: Meta Ryzodeg jiġi injettat f'ikla prinċipali, dan jipprovdi insulina li taġixxi fit-tul biex tikkontrolla z-zokkor fid-demm ssad-doża li jkun imiss kif ukoll bħala insulina li taġixxi malajr biex tgħin biex tikkontrolla z-zokkor żejjed mill-ikel.
English: It also noted that in the studies with adults Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2diabetes.
Maltese: Ġie nnotat ukoll li fl-istudji fuq ladulti, Ryzodeg inaqqas ir-riskju ta' ipogliċemija matul il-lejl f'pazjenti bid-dijabete tat-tip 1 u tat-tip 2.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: Haematuria, enuresis
Maltese: Ematurija, enuresi
English: Co. Armagh BT63 5UA
Maltese: Armagh BT63 5UA
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Maltese: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD l-Irlanda
English: 44% worsening
Maltese: Aggravar ta' 44%
English: D04 EE70
Maltese: D04 EE70 l-Irlanda
English: adefovir treatment of chronic hepatitis B and/or HIV
Maltese: adefovir kura ta' epatite B kronika u/jew HIV
English: Placebo (N=114)
Maltese: Plaċebo (N=57)
English: 26% worsening
Maltese: Aggravar ta' 26%
English: Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Maltese: Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD Ir-Renju Unit
English: Cough, epistaxis
Maltese: Sogħla, epistassi
English: Females were not studied in nmDMD clinical trials.
Maltese: In-nisa ma ġewx studjati fi provi kliniċi nmDMD.
English: TRANSLARNA 10 mg/kg, 10 mg/kg, 20 mg/kg (N=57) Placebo (N=57)
Maltese: TRANSLARNA 10, 10, 20 mg/kg (N=57)
English: Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1)
Maltese: Kaplan-Meier taż-Żmien għal Aggravar ta' 10% 6MWD Persistenti (Studju 1)
English: Weight Range (kg)
Maltese: Medda ta' Piż (kg)
English: Pack of 30 sachets.
Maltese: Pakkett ta' 30 qartas.
English: Frequency groupings are defined to the following convention: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Maltese: Il-gruppi ta' frekwenza huma definiti fil-konvenzjoni li ġejja: komuni ħafna (≥ 1/10) u komuni (≥ 1/100 sa < 1/10).
English: The other ingredients are: polydextrose (E1200), macrogol, poloxamer, mannitol (E421), crospovidone, hydroxyethyl cellulose, artificial vanilla flavour (maltodextrin, artificial flavours and propylene glycol), silica, colloidal anhydrous (E551), magnesium stearate.
Maltese: L-ingredjenti l-oħra huma: polydextrose (E1200), macrogol, poloxamer, mannitol (E421), crospovidone, hydroxyethyl cellulose, togħma artifiċjali ta' vanilla (maltodextrin, artificial flavours u propylene glycol), silica, colloidal anhydrous (E551), magnesium stearate.
English: 6MWD Results in Patients with a Baseline 6MWD < 350 meters.
Maltese: 6MWD Riżultati f'Pazjenti b'Linja Bażi 6MWD < 350 metri.
English: Mean Change in 6-Minute Walk Distance (Study 2)
Maltese: Bidla Medja fid-Distanza tal-Mixja ta' 6 Minuti (Studju 2)
English: In a statistical based model the estimated mean difference was 31.7 meters (adjusted p=0.0367).
Maltese: Fi stima ta' mudell statistiku, id-differenza medja kienet ta' 31.7 metri (p aġġustata=0.0367).
English: Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).
Maltese: L-użu konkomitanti ta' aminoglikosidi ġol-vina (ara sezzjonijiet 4.4 u 4.5).
English: A higher frequency of malaise (7.1%), pyrexia (42.9%), ear infection (28.6%), and rash (21.4%) were reported in patients aged 2-5 years compared with patients 5 years of age and older.
Maltese: Frekwenza ogħla ta' telqa (7.1%), deni (42.9%), infezzjoni fil-widnejn (28.6%), u raxx (21.4%) kienu rrappurtati f'pazjenti minn 2 sa 5 snin meta mqabbla ma' pazjenti ta' 5 snin u aktar.
English: How to store Translarna 6.
Maltese: Kif taħżen Translarna 6.
English: Medicinal products that affect the p-glycoprotein transporter
Maltese: Prodotti mediċinali li jaffettwaw it-trasportatur ta' p-glycoprotein
English: Translarna is available in packs containing 30 sachets.
Maltese: Translarna huwa disponibbli f'pakketti li fihom 30 qartas.
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services Ltd.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Almac Pharma Services Ltd.
English: A standard package of reproduction toxicity studies was available.
Maltese: Kien hemm disponibbli pakkett standard ta' studji fuq it-tossiċità tar-riproduzzjoni.
English: Effect of ataluren on pharmacokinetics of other medicinal products Based on in vitro studies, ataluren has the potential to inhibit UGT1A9, organic anion transporter 1 (OAT1), organic anion transporter 3 (OAT3) and organic anion transporting polypeptide 1B3 (OATP1B3).
Maltese: L-effett ta' ataluren fuq il-farmakokinetika ta' prodotti mediċinali oħra Abbażi ta' studji in vitro, ataluren għandu l-potenzjal li jinibixxi UGT1A9, trasportatur tal-anjonu organiku 1 (OAT1), trasportatur tal-anjonu organiku 3 (OAT3) u anjonu organiku li jittrasporta polypeptide 1B3 (OATP1B3).
English: The pharmacokinetics of ataluren has been evaluated in study PTC124-GD-030 over a duration of 4 weeks.
Maltese: Il-farmakokinetiċi ta' ataluren ġew evalwati fl-istudju PTC124-GD-030 għal tul ta' 4 ġimgħat.
English: Artificial vanilla flavour: maltodextrin, artificial flavours and propylene glycol.
Maltese: Togħma artifiċjali ta' vanilla: maltodextrin, togħmiet artifiċjali u propylene glycol.
English: Serum lipids
Maltese: Lipidi fis-serum
English: A nonsense mutation in DNA results in a premature stop codon within an mRNA.
Maltese: Mutazzjoni nonsense fir-riżultati tad-DNA fi stop codon prematur f'mRNA.
English: In the ITT population, the hazard ratio for ataluren versus placebo was 0.75 (p=0.160), representing a 25% reduction in the risk of 10% 6MWD worsening.
Maltese: Fil-popolazzjoni ITT, il-proporzjon ta' periklu għal ataluren kontra plaċebo kien ta' 0.75 (p=0.160), li jirrappreżenta tnaqqis ta' 25% fir-riskju ta' aggravament ta' 10% fis-6MWD.
English: An increase in serum lipids, i.e. cholesterol and triglycerides, was observed.
Maltese: Ġiet osservata żieda fil-lipidi tas-serum, jiġifieri kolesterol u trigliċeridi.
English: The efficacy and safety of Translarna were assessed in 2 randomised, double-blind, placebo-controlled, trials in nmDMD.
Maltese: L-effikaċja u s-sigurtà ta' Translarna kienu evalwati f'2 provi randomizzati, double-blind, ikkontrollati bi plaċebo, dwar nmDMD.
English: The majority of patients in all treatment groups were Caucasian (90%).
Maltese: Il-maġġoranza tal-pazjenti fil-gruppi ta' kura kollha kienu Kawkasi (90%).
English: Translarna 125 mg
Maltese: INDIVIDWALI 125 mg
English: In vitro, ataluren is 99.6% bound to human plasma proteins and the binding is independent of plasma concentration.
Maltese: In vitro, ataluren jeħel 99.6% mal-proteini fil-plażma tal-bniedem u t-twaħħil huwa indipendenti millkonċentrazzjoni fil-plażma.
English: Study 2 evaluated 230 male patients, ages 7 to 14 years.
Maltese: Studju 2 evalwa 230 pazjenti rġiel, li kellhom minn 7 sa 14-il sena.
English: Figure 5.
Maltese: Figura 5.
English: In vitro, ataluren is not a substrate for the p-glycoprotein transporter.
Maltese: In vitro, ataluren mhuwiex sottostrat għat-trasportatur ta' p-glycoprotein.
English: Date of first authorisation: 31 July 2014 Date of latest renewal: 19 July 2018
Maltese: Data tal-aħħar tiġdid: 19 ta' Lulju, 2018
English: Other medicines and Translarna
Maltese: Mediċini oħra u Translarna
English: Non-ambulatory
Maltese: Mhux ambulatorji
English: The safety profile of ataluren is based on pooled data from two randomised, double-blind, 48-week placebo-controlled studies conducted in a total of 232 male patients with Duchenne muscular dystrophy (nmDMD) caused by a nonsense mutation treated at the recommended dose of 40 mg/kg/day (10, 10, 20 mg/kg; n=172) or at a dose of 80 mg/kg/day (20, 20, 40 mg/kg; n=60), as compared to placebo-treated patients (n=172).
Maltese: Il-profil tas-sigurtà ta' ataluren hu bbażat fuq dejta miġbura minn żewġ studji double-blind li damu 48 ġimgħa, li fihom il-parteċipanti ntgħażlu b'mod każwali, ikkontrollati bil-plaċebo, li twettqu f'total ta' 232 pazjenti rġiel b'distrofija muskolari ta' Duchenne (nmDMD) ikkawżata minn mutazzjoni nonsense, ikkurati bid-doża rakkomandata ta' 40 mg/kg/jum (10, 10, 20 mg/kg; n=172), jew f'doża ta' 80 mg/kg/jum (20, 20, 40 mg/kg; n=60), meta mqabbla ma' pazjenti kkurati bil-plaċebo (n=172).
English: Lot
Maltese: Lot Lott
English: In a separate clinical study, the extent of exposure for adefovir was 60% higher in the presence of ataluren.
Maltese: Fi studju kliniku separat, il-grad ta' esponiment għal adefovir kien 60% ogħla fil-preżenza ta' ataluren.
English: In a clinical study to evaluate the potential for ataluren to inhibit the OATP1B3 transport system using a single-dose of 80 mg telmisartan, an in-vitro selective OATP1B3 substrate, ataluren increased the exposure to telmisartan by 28%.
Maltese: Fi studju kliniku biex jevalwa l-potenzjal ta' ataluren biex jinibixxi s-sistema ta' trasport ta' OATP1B3 permezz ta' doża waħda ta' 80 mg telmisartan, substrat ta' OATP1B3 selettiv in-vitro, ataluren żied l-esponiment għal telmisartan bi 28 %.
English: In a pharmacokinetic study in subjects with varying degrees of renal impairment, following a single dose administration, ataluren plasma exposure changed by -13%, 27%, and 61% for the mild, moderate and severe groups, respectively, and 46% for the end-stage renal disease group compared with the normal renal function group.
Maltese: Fi studju farmakokinetiku f'individwi bi gradi varji ta' indeboliment tal-kliewi, wara amministrazzjoni ta' doża waħda, l-esponiment għal ataluren fil-plażma nbidel b'-13%, 27%, u 61% għall-gruppi b'indeboliment ħafif, moderat u sever, rispettivament, u 46% għall-grupp b'mard renali fl-aħħar stadju meta mqabbel mal-grupp b'funzjoni renali normali.
English: Translarna 250 mg
Maltese: INDIVIDWALI 250 mg
English: Description of selected adverse reactions (laboratory abnormalities)
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula (anormalitajiet tal-laboratorju)
English: atorvastatin lipid-lowering benzylpenicillin severe infections bumetanide treatment or prevention of congestive heart failure captopril treatment or prevention of congestive heart failure ciprofloxacin treatment of infections famotidine treatment of active duodenal ulcer, gastroesophageal reflux disease furosemide treatment or prevention of congestive heart failure methotrexate rheumatoid arthritis, psoriasis olmesartan essential hypertension in adults oseltamivir prevention of influenza phenobarbital sleep-inducing, prevention of seizures pitavastatin lipid-lowering pravastatin lipid-lowering rifampicin treatment for tuberculosis rosuvastatin lipid-lowering sitagliptin type 2 diabetes valsartan treatment or prevention of congestive heart failure Some of these medicines were not tested together with Translarna and your doctor may decide to monitor you closely.
Maltese: atorvastatin tnaqqis tal-lipidi benzylpenicillin infezzjonijiet severi bumetanide kura jew prevenzjoni ta' insuffiċjenza konġestiva tal-qalb captopril kura jew prevenzjoni ta' insuffiċjenza konġestiva tal-qalb ciprofloxacin kura ta' infezzjonijiet famotidine kura ta' ulċeri duwodenali attivi, marda ta' rifluss gastroesofagali furosemide kura jew prevenzjoni ta' insuffiċjenza konġestiva tal-qalb methotrexate artrite rewmatika, psorjasi olmesartan pressjoni għolja essenzjali fl-adulti oseltamivir prevenzjoni ta' influwenza phenobarbital li jinduċu l-irqad, jipprevjenu l-aċċessjonijiet pitavastatin tnaqqis tal-lipidi pravastatin tnaqqis tal-lipidi rifampicin kura għat-tuberkolożi rosuvastatin tnaqqis tal-lipidi sitagliptin dijabete tat-tip 2
English: Ataluren is metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes, predominantly UGT1A9 in liver, intestine and kidney.
Maltese: Ataluren huwa metabolizzat bil-konjugazzjoni permezz tal-enzimi uridine diphosphate glucuronosyltransferase (UGT), prinċipalment UGT1A9 fil-fwied, intestini u kliewi.