FrancophonIA/ELRC3.0 huggingface dataset:
English: In rats and rabbits embryo-foetal toxicity (e.g. increased early resorptions, postimplantation loss, decreased viable foetuses) and signs of delayed development (increased skeletal variations) were found in the presence of maternal toxicity.
Maltese: Fil-firien u l-fniek instabu tossiċità embrijofetali (eż. żieda firriassorbimenti bikrija, telf wara impjantazzjoni, tnaqqis fil-feti vijabbli) u sinjali ta' ttardjar fl-iżvilupp (żieda fil-varjazzjonijiet skeletali) fil-preżenza ta' tossiċità materna.
English: Nonclinical in vitro experiments in nonsense mutation cellular assays and fish larvae cultured in an ataluren solution have shown that ataluren enabled ribosomal readthroughwith a bell-shaped (inverted-U shaped) concentration-response relationship.
Maltese: L-esperimenti in vitro mhux kliniċi f'analiżijiet ta' ċelloli b'mutazzjoni nonsense u larvi tal-ħut ikkultivati f'soluzzjoni ta' ataluren urew li ataluren ippermetta r-readthrough ta' ribosomal b'relazzjoni ta' rispons fil-konċentrazzjoni f'forma ta' qanpiena (forma ta' U bil-maqlub).
English: EXPIRY DATE
Maltese: EXP JIS
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9, or substrates of OAT1 or OAT3 (see section 4.5).
Maltese: Għandha tiġi eżerċitata kawtela meta ataluren jingħata flimkien ma' prodotti mediċinali oħra li huma indutturi ta' UGT1A9, jew sottostrati ta' OAT1 jew OAT3 (ara sezzjoni 4.5).
English: Change in lipid profile (increased triglycerides and cholesterol)
Maltese: Bidla fil-profili tal lipidi (żieda fittrigliċeridi u lkolesterol)
English: Elevations of serum creatinine occurred in several nmCF patients treated with ataluren and intravenous aminoglycosides together with other antibiotics for cystic fibrosis exacerbations.
Maltese: Seħħew elevazzjonijiet fil-krejatinina fis-serum f'diversi pazjenti nmCF kkurati b'ataluren u aminoglikosidi ġol-vina flimkien ma' antibijotiċi oħra għall-aggravar ta' fibrożi ċistika.
English: It is unlikely that the pharmacokinetics of ataluren are significantly affected by UGT1A9 polymorphisms in a Caucasian population.
Maltese: Huwa improbabbli li l-farmakokinetika ta' ataluren tiġi affettwata b'mod sinifikanti minn polimorfiżmi UGT1A9 f'popolazzjoni Kawkasa.
English: Ireland 12.
Maltese: Dublin 4
English: Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea.
Maltese: Il-voluntiera b'saħħithom li jirċievu doża orali unika ta' 200 mg/kg ta' ataluren esperjenzaw sintomi, temporanji bi grad baxx ta' uġigħ ta' ras, nawseja, rimettar u dijarea.
English: In addition, a 3 to 8 fold increase in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Maltese: Barra minn hekk, żieda ta' minn 3 sa 8 darbiet filmetabolit ta' ataluren ġiet irrappurtata f'pazjenti b'indeboliment renali sever (eGFR <30 mL/min).
English: Ataluren plasma concentrations in patients from 2 to less than 5 years old were consistent with those seen in patients above the age of 5 years receiving the 10/10/20 mg/kg dose regimen.
Maltese: Ilkonċentrazzjonijiet ta' Ataluren fil-plażma f'pazjenti minn sentejn sa inqas minn 5 snin kienu konsistenti ma' dawk li dehru f'pazjenti 'l fuq mill-età ta' 5 snin li rċivew il-kors ta' 10/10/20 mg/kg doża.
English: Posology table
Maltese: Tabella tal-pożoloġija
English: 250 mg
Maltese: 250 mg qratas ta'
English: Based on the in vitro studies, ataluren is not expected to be an inhibitor of neither p-gp mediated transport nor of cytochrome P450 mediated metabolism.
Maltese: Abbażi ta' studji in vitro, ataluren mhuwiex mistenni li jkun inibitur la ta' trasport medjat b'p-gp u lanqas ta' mataboliżmu medjat b'ċitokromju P450.
English: The primary efficacy endpoint in both trials was change in 6 Minute Walk Distance (6MWD) at Week 48.
Maltese: Il-punt aħħari primarju tal-effikaċja fiż-żewġ provi kienet bidla fidDistanza tal-Mixja ta' 6 Minuti (6MWD, 6 Minute Walk Distance) f'Ġimgħa 48.
English: Adverse reactions were generally mild or moderate in severity, and no treatment-related serious adverse events were reported among ataluren-treated patients in these 2 studies.
Maltese: Ir-reazzjonijiet avversi ġeneralment kienu ħfief jew moderati fis-severità, u l-ebda avvenimenti avversi serji relatati mal-kura ma ġew irrappurtati fost pazjenti kkurati b'ataluren f'dawn iż-2 studji.
English: In the ITT population, the difference between the ataluren and placebo arms in mean change in observed 6MWD from baseline to Week 48 was 15.4 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm.
Maltese: Fil-popolazzjoni ITT, id-differenza bejn il-partijiet tal-istudju dwar ataluren u l-plaċebo fil-bidla medja fis-6MWD osservata mil-linja bażi sa Ġimgħa 48, kienet ta' 15.4 metri aħjar fil-parti tal-istudju dwar ataluren 40 mg/kg/jum milli fil-parti tal-istudju dwar plaċebo.
English: Mean Change in Timed Function Tests (Study 1)
Maltese: Figura 3. Bidla Medja fit-Testijiet tal-Funzjoni bil-Ħin (Studju 1)
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ataluren/metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli fl-annimali wriet li kien hemm eliminazzjoni ta' ataluren/metaboliti fil-ħalib tas-sider (ara sezzjoni 5.3). Ir-riskju gћat-trabi tat-twelid li jiġu mreddgħin mhux eskluż.
English: Final study report to be submitted Due date:
Maltese: Data mistennija:
English: Evening mg sachets mg sachets mg sachets
Maltese: Is-sinifikat għall-bnedmin mhijiex magħrufa.
English: Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva biss f'dożijiet li rriżulta f'tossiċità materna (ara sezzjoni 5.3).
English: The European Medicines Agency has waived the obligation to submit the results of studies with ataluren in two subsets of the paediatric population from birth to less than 28 days and infants from 28 days to less than 6 months in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'ataluren f'żewġ sottosetti tal-popolazzjoni pedjatrika mit-twelid għal anqas minn 28 jum u t-trabi minn 28 jum għal anqas minn 6 xhur f'nmDMD, skont id-deċiżjoni tal-Pjan ta' Investigazzjoni Pedjatrika (PIP) fl-indikazzjoni mogħtija (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: A. LABELLING
Maltese: A.TIKKETTAR
English: In Study 1, a post hoc analysis of the primary endpoint showed that from baseline to Week 48, patients receiving ataluren 40 mg/kg/day had a 12.9 meters mean decline in 6MWD, and patients receiving placebo had a 44.1-meter mean decline in 6MWD (Figure 1).
Maltese: Fi Studju 1, analiżi post hoc tal-punt aħħari primarju wriet li mil-linja bażi sat-48 Ġimgħa, il-pazjenti li rċevew ataluren 40 mg/kg/jum kellhom tnaqqis medju ta' 12.9 metru f'6MWD, u l-pazjenti li rċevew plaċebo kellhom tnaqqis medju ta' 44.1 metru f'6MWD (Figura 1).
English: The adverse reactions reported in patients with nmDMD treated with the recommended daily dose of 40 mg/kg/day ataluren in the 2 placebo-controlled studies are presented in Table 1.
Maltese: Ir-reazzjonijiet avversi rrapportati f'pazjenti b'nmDMD ikkurati bid-doża rakkomandata ta' kuljum ta' 40 mg/kg/jum ta' ataluren fiż-2 studji kkontrollati bil-plaċebo huma ppreżentati f'Tabella 1.
English: Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Maltese: Bl-istess mod, ataluren mhuwiex mistenni in vivo li jkun induttur ta' isoenzimi taċ-ċitokromju P450.
English: W eeks
Maltese: U LUŻU
English: The prepared dose should be discarded if not consumed within 24 hours of preparation if kept refrigerated (2 - 8 °C), or within 3 hours at room temperature (15 - 30 °C).
Maltese: Armi d-doża ppreparata jekk ma teħodiex fi żmien 24 siegħa mill-preparazzjoni jekk tinżamm ġo friġġ (2 - 8°C), jew fi żmien 3 sigħat f'temperatura ambjentali (15 - 30°C).
English: Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren.
Maltese: U KWANTITATTIVA Translarna 125 mg bċejjeċ żgħar li jitħalltu ma' likwidu biex jittieħed mill-ħalq Kull qartas fih 125 mg ataluren.
English: Do not use this medicine after the expiry date, which is stated on the carton and sachet after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-qartas wara EXP/JIS.
English: The safety and efficacy of Translarna in children <12kg and aged 6 months to 2 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Translarna fi tfal <12 kg u li għandhom bejn 6 xhur u sentejn ma ġewx determinati s'issa.
English: Placental transfer was shown of radiolabelled ataluren in rats.
Maltese: Ixrob ilma jew likwidi oħra b'mod regolari biex tevita deidrazzjoni meta tuża Translarna.
English: In addition, ataluren was found to increase nephrotoxicity of intravenous aminoglycosides.
Maltese: Barra minn hekk, ataluren instab li jżid in-nefrotossiċità ta' aminoglikosidi ġol-vina.
English: Nonclinical in vitro studies suggest that continuous exposure to ataluren may be important for maximizing activity and that effects of the active substance on ribosomal read-through of premature stop codons reverse shortly after withdrawal of ataluren.
Maltese: Studji in vitro mhux kliniċi jissuġġerixxu li espożizzjoni kontinwa għal ataluren tista' tkun importanti biex tiġi mmassimizzata l-attività u li l-effetti tas-sustanza attiva fuq ir-read-through ta' ribosomal ta' stop codons prematuri jerġgħu lura għalli kienu ftit wara l-irtirar ta' ataluren.
English: Because small increases in mean serum creatinine, blood urea nitrogen (BUN), and cystatin C were observed in the controlled studies of nmDMD, it is recommended that serum creatinine, BUN, and cystatin C be monitored every 6 to 12 months in nmDMD patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Maltese: Minħabba li ġew osservati żidiet żgħar fil-medja tal-krejatinina fis-serum, nitroġenu fl-urea tad-demm (BUN) u cystatin C fi studji kkontrollati ta' nmDMD, huwa rrakkomandat li l-krejatinina fis-serum, BUN, u cystatin C jiġu ssorveljati kull 6 sa 12-il xahar f'pazjenti nmDMD li jirċievu ataluren, jew aktar spiss kif meħtieġ abbażi tal-istatus kliniku tal-pazjent.
English: Rash erythematous
Maltese: OĦRAJN
English: However, the magnitude of this effect could be larger for the 40 mg dose of telmisartan.
Maltese: Madankollu, id-daqs ta' dan l-effett jista' jkun ikbar għad-doża ta' 40 mg ta' telmisartan.
English: In order to confirm the efficacy and safety of ataluren in the treatment of ambulant patients with nmDMD aged 5 years or older, the MAH should conduct and submit the results of a multicentre, randomised, double-blind, 18-month, placebocontrolled study, followed by a 18-month open label extension, according to an agreed protocol.
Maltese: Sabiex jikkonferma l-effikaċja u sigurtà ta' ataluren fil-kura ta' pazjenti ambulanti b'nmDMD li jkollhom 5 snin jew aktar, l-MAH għandu jwettaq u jissottometti rriżultati ta' studju multiċentriku, li fih il-parteċipanti jintagħżlu b'mod każwali, double-blind, li jdum 18-il xahar, ikkontrollat bi plaċebo, segwit minn estensjoni open-label ta' 18-il xahar, skont il-Protokoll miftiehem.
English: Patients were required to have documented confirmation of the presence of a nonsense mutation in the dystrophin gene as determined by gene sequencing.
Maltese: Il-pazjenti kienu meħtieġa li jkollhom konferma dokumentata tal-preżenza ta' mutazzjoni nonsense fil-ġene dystrophin kif determinat missekwenzar tal-ġeni.
English: The full contents of each sachet should be mixed with, at least 30 ml of liquid (water, milk, fruit juice) or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Maltese: Il-kontenut sħiħ ta' kull qartas għandu jitħallat ma', tal-anqas 30 ml ta' likwidu (ilma, ħalib, meraq tal-frott), jew 3 imgħaref ta' ikel semisolidu (jogurt jew zalza tat-tuffieħ).
English: The elimination of ataluren is likely dependent on hepatic and renal glucuronidation of ataluren followed by renal and hepatic excretion of the resulting glucuronide metabolite.
Maltese: Mhux magħruf jekk ataluren/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight).
Maltese: Id-doża rakkomandata hija 10 mg/kg piż tal-ġisem filgħodu, 10 mg/kg piż tal-ġisem f'nofsinhar, u 20 mg/kg piż tal-ġisem filgħaxija (għal doża ta' kuljum totali ta' 40 mg/kg piż tal-ġisem).
English: Thus, the mean change in observed 6MWD from baseline to Week 48 was 31.3 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.056).
Maltese: Għalhekk, il-bidla medja fis-6MWD osservata mil-linja bażi sat-48 Ġimgħa kienet 31.3 metru aħjar fil-fergħa ta' ataluren 40 mg/kg/jum milli fil-fergħa ta' plaċebo (p=0.056).
English: In a 26-week transgenic mouse model for carcinogenicity, no evidence of carcinogenicity was found.
Maltese: F'mudell ta'ġurdien transġeniku ta' 26 ġimgħa għal karċinoġenità, ma nstabet ebda evidenza ta' karċinoġenità.
English: Take each prepared dose immediately after preparation.
Maltese: Ħu kull doża ppreparata eżattament wara l-preparazzjoni.
English: Time to 10% worsening in 6MWD was defined as the last time that 6MWD was not 10% worse than baseline.
Maltese: Ħin għal aggravament ta' 10% fis-6MWD kien definit bħala l-aħħar ħin li s-6MWD ma kinitx agħar b'10% mil-linja bażi.
English: Characteristic in specific groups of subjects or patients
Maltese: Karatteristiċi fil-gruppi speċifiċi ta' suġġetti jew pazjenti
English: Translarna 250 mg granules for oral suspension Each sachet contains 250 mg ataluren.
Maltese: Translarna 250 mg bċejjeċ żgħar li jitħalltu ma' likwidu biex jittieħed mill-ħalq Kull qartas fih 250 mg ataluren.
English: Breastfeeding
Maltese: Settembru
English: Since the mechanism by which ataluren increases nephrotoxicity of intravenous aminoglycosides is not known, concomitant use of other nephrotoxic medicinal products with ataluren is not recommended.
Maltese: L-effett tal-għoti ta' ataluren flimkien ma' prodotti mediċinali nefrotossiċi oħra mhuwiex magħruf.
English: Peak plasma levels of ataluren are attained approximately 1.5 hours after dosing in subjects who received medicinal product within 30 minutes of a meal.
Maltese: L-ogħla livelli fil-plażma ta' ataluren jintlaħqu madwar 1.5 siegħa wara d-dożaġġ f'individwi li jkunu rċevew prodott mediċinali fi żmien 30 minuta minn ikla.
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice), or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Maltese: Il-kontenut kollu ta' kull qartas għandu jitħallat ma' mill-inqas 30 ml ta' likwidu (ilma, ħalib, meraq tal-frott), jew fi 3 imgħaref ta' ikel semisolidu (jogurt jew zalza tat-tuffieħ).
English: No clinically relevant change in the plasma concentrations of corticosteroids was seen with co-administration of ataluren.
Maltese: Ma ġiet osservata l-ebda bidla klinikament rilevanti fil-konċentrazzjonijiet fil-plażma ta' kortikosterojdi bl-għoti flimkien ta' ataluren.
English: “Click”
Maltese: “Klikk”
English: Belgique/Belgien
Maltese: België/Belgique/Belgien
English: (122 mild, 99 moderate, 15 severe)a
Maltese: (122 ħafif, 99 moderata, 15 severa)a
English: Race and ethnicity
Maltese: Razza u etniċità
English: ATC code: A10BJ04
Maltese: A10BJ04
English: Figure T -------WAIT!
Maltese: Figura T -------STENNA!
English: Gastric motility
Maltese: Motilità gastrika
English: System organ class
Maltese: Sistema ta' Klassifika talOrgani
English: Count to 5------
Maltese: Għodd sa 5------
English: Figure Q Figure R
Maltese: Figura Q Figura R
English: Pancreatitis, intestinal obstruction
Maltese: Pankreatite, ostruzzjoni intestinali
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Limited (Li Tinnegozja bħala Glaxo Wellcome Operations) Harmire Road
English: Don't use Eperzan:
Maltese: Tużax Eperzan:
English: Sixty seven percent of patients were Caucasian, 15% African American/African heritage and 11% Asian; 26% of patients were Hispanic/Latino.
Maltese: Sebgħa u sittin fil-mija tal-pazjenti kienu Kawkasi, 15% Afrikani Amerikani/b'dixxendenza Afrikana u 11% Asjatiċi; 26% tal-pazjenti kienu Ispaniċi/Latino.
English: Eperzan 50 mg weekly
Maltese: 50 mg weekly
English: Glucagon-like peptide-1 (GLP-1) analogues.
Maltese: Analogu ta' glucagon-like peptide-1 (GLP-1) Kodiċi ATC:
English: There is limited experience of albiglutide when combined with thiazolidinediones alone, sulphonylureas + thiazolidinediones, and metformin + sulphonylureas + thiazolidinediones.
Maltese: Hemm esperjenza limitata ta' albiglutide meta kkombinat ma' thiazolidinediones weħidhom, sulphonylureas + thiazolidinediones, u metformin + sulphonylureas + thiazolidinediones.
English: Step 2
Maltese: Pass 2
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Marzu 2014
English: Liraglutide 1.8 mg Daily
Maltese: Liraglutide 1.8 mg Kuljum
English: The hazard ratio for Eperzan versus comparators for MACE+ was 1.0 (95% CI 0.68, 1.49).
Maltese: Il-proporzjon ta' periklu għal Eperzan kontra l-komparaturi għal MACE+ kien ta' 1.0 (95% CI 0.68, 1.49).
English: Elderly patients (>65 years)
Maltese: Pazjenti anzjani (>65 sena)
English: min. sec.
Maltese: Darbiet min. sek.
English: • A new pen (Figure A).
Maltese: • Pinna ġdida (Figura A).
English: 6.2 Incompatibilities
Maltese: .2 Inkompatibblitajiet
English: Eperzan Insulin glargine ( 20 units per day)
Maltese: Insulina glargine ( 20 unità kuljum)
English: Pneumonia
Maltese: Pulmonite
English: Otherwise, the pattern of adverse events was generally similar for antibody positive and negative patients.
Maltese: Altrimenti, il-mudell ta' avvenimenti avversi kien ġeneralment simili għall-pazjenti pożittivi u negattivi għall-antikorpi.
English: Step 1
Maltese: Pass 1
English: Gastrointestinal events occurred with a higher frequency for Eperzan compared to all comparators (38% versus 32%).
Maltese: Avvenimenti gastrointestinali seħħew bi frekwenza ogħla għal Eperzan meta mqabbla mal-komparaturi kollha (38% kontra 32%).
English: Store refrigerated at 2C to 8C.
Maltese: Aħżen fi friġġ f'temperatura minn 2C sa 8C.
English: Atrial fibrillation/flutter
Maltese: Fibrillazzjoni atrijali/palpitazzjoni
English: For solids, gastric emptying t1/2 increased from 1.14 h to 2.23 h (p=0.0112).
Maltese: Għas-solidi, it-t1/2 għat-tbattil gastriku żdied minn 1.14 h għal 2.23 h (p=0.0112).
English: The percentage of patients who developed antibodies to albiglutide on treatment was 4% (137/3,267).
Maltese: Il-perċentwal ta' pazjenti li żviluppaw antikorpi għal albiglutide waqt il-kura kien ta' 4% (137/3, 267).
English: Albiglutide (50 mg weekly at steady-state) had no clinically relevant effects on the steady-state pharmacokinetics of a combination oral contraceptive containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg.
Maltese: Albiglutide (50 mg fil-ġimgħa fi stat stabbli) ma kellu l-ebda effetti klinikament rilevanti fuq ilfarmakokinetika fi stat stabbli ta' kontraċettiv orali kkombinat li kien fih 0.5 mg ta' norethindrone u 0.035 mg ta' ethinyl estradiol.
English: Diarrhoea (13% versus 9%), nausea (12% versus 11%), vomiting (5% versus 4%), and constipation (5% versus 4%) were the most frequently reported, and the majority of events occurred within the first 6 months.
Maltese: Dijarea (13% kontra 9%), dardir (12% kontra 11%), rimettar (5% kontra 4%) u stitikezza (5% kontra 4%) ġew irrapportati l-aktar frekwenti u l-maġġoranza tal-avvenimenti seħħew flewwel 6 xhur.
English: Injection Button*
Maltese: Buttuna tal-Injezzjoni*
English: Simvastatin AUC was decreased by 40% and simvastatin Cmax was increased by 18%.
Maltese: L-AUC ta' Simvastatin tnaqqset b'40% u s-Cmax ta' simvastatin żdiedet b'18%.
English: Placebo Sitagliptin Glimepiride Albiglutide x axis; Weeks (Rescue free), y axis; Probability of event
Maltese: Placebo Sitagliptin Glimepiride Albiglutide assi x; Ġimgħat (Mingħajr Salvataġġ), assi y; Probabbiltà ta' avveniment
English: Eperzan has not been studied in combination with prandial insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, or sodium/glucose cotransporter 2 (SGLT2) inhibitors.
Maltese: Eperzan ma ġiex studjat f'kombinazzjoni mal-insulina prandial, inibituri ta' dipeptidyl peptidase-4 (DPP-4), jew inibituri tal-kotrasportatur 2 tas-sodju/glukożju (SGLT2) .
English: DL12 8DT
Maltese: 2 ĦALLAT
English: When Eperzan was used as monotherapy, the incidence of symptomatic hypoglycaemia (<3.9 mmol/l) was similar for Eperzan 30 mg (2%), Eperzan 50 mg (1%) and placebo (3%).
Maltese: Meta Eperzan intuża bħala monoterapija, l-inċidenza ta' ipogliċemija sintomatika (<3.9 mmol/l) kienet simili għal Eperzan 30 mg (2%), Eperzan 50 mg (1%) u plaċebo (3%).
English: Albiglutide is produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Maltese: Albiglutide jiġi prodotti f'ċelloli Saccharomyces cerevisiae permezz ta' teknoloġija rikombinanti tad-DNA.
English: For liquids, gastric emptying t1/2 increased from 0.28 h to 0.69 h (p=0.0018).
Maltese: Għal likwidi, it-t1/2 għat-tbattil gastriku żdied minn 0.28 h għal 0.69 h (p=0.0018).
English: The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 (n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate (eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR <30 ml/min/1.73m2) renal impairment, respectively (see Table 9).
Maltese: It-tnaqqis medju aġġustat skont il-mudell fl-HBA1c mil-linja bażi b'Eperzan kien ta' -0.80 (n = 125), -0.83 (n = 98), u -1.08 (n = 19) f'pazjenti b'indeboliment renali ħafif (eGFR 60 sa 89 ml/min/1.73m2), u sever (eGFR <30 ml/min/1.73 m rispettivament (ara Tabella 9).
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 għal kif tirrapporta reazzjonijiet avversi.
English: Complete dissolution for the 50 mg pen usually occurs within 7 minutes but may take up to 10 minutes.
Maltese: Xoljiment komplet għall-pinna ta' 50 mg normalment iseħħ fi żmien 7 minuti iżda jista' jieħu sa 10 minuti.
English: Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections
Maltese: Fih ukoll: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, ilma għall-injezzjonijiet
English: Disodium phosphate, anhydrous
Maltese: Sodium dihydrogen phosphate monohydrate Disodium phosphate, anhydrous Trehalose dihydrate
English: Active-controlled study versus sitagliptin in patients with type 2 diabetes and different degrees of renal impairment
Maltese: Studju ikkontrollat attivament kontra sitagliptin f'pazjenti bid-dijabete tat-tip 2 u gradi differenti ta' indeboliment renali
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Maltese: L-użu ta' agonisti tar-riċettur GLP-1 jista' jkun assoċjati ma' reazzjonijiet gastrointestinali avversi.
English: 1c Check that the pen has a [1] in the number window (Figure F).
Maltese: 1ċ Iċċekkja li l-pinna għandha [1] fit-tieqa tan-numru (Figura F).
English: Add-on to metformin
Maltese: Miżjud ma' metformin