FrancophonIA/ELRC3.0 huggingface dataset:
English: In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
Maltese: F'kombinazzjoni ma' prodotti mediċinali oħra li jbaxxu l-glukożju inkluża l-insulina ba żali, meta dawn, flimkien mad-dieta u l-eżerċizzju, ma jipprovdux kontroll gliċemiku adegwat (ara sezzjoni 4.4 u 5.1 għal dejta disponibbli dwar kombinazzjonijiet differenti).
English: 4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).
Maltese: 4a Għal darb'oħra, bil-mod u bil-galbu ċaqlaq il-pinna minn naħa għall-oħra 5 darbiet (bħal waxer tal-windskrin) (Figura J).
English: The efficacy of Eperzan was evaluated in a randomised, double-blind, active-controlled 52-week study in 486 patients with mild, moderate, and severe renal impairment inadequately controlled on a current regimen of diet and exercise or other antidiabetic therapy.
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, bi blindaġġ doppju, ikkontrollat attivament fuq 52 ġimgħa fuq 486 pazjent b'indeboliment renali ħafif, moderat, u sever mhux adegwatament ikkontrollati fuq reġimen attwali ta' dieta u eżerċizzju jew terapija oħra kontra d-dijabete.
English: Outer Needle Cap Inner Needle Cap Needle
Maltese: Eperzan mhux rakkomandat jekk għandek dawn
English: Albiglutide also produced dose-dependent increases in serum calcitonin levels in a 21-day study in mice, suggesting that thyroid tumours in rodents are a theoretical possibility for albiglutide as well.
Maltese: Albiglutide ipproduċa wkoll żidiet dipendenti fuq id-doża fil-livelli ta' calcitonin fis-serum fi studju ta' 21 jum filġrieden, li jissuġġerixxi li t-tumuri tat-tirojde f'annimali gerriema huma possibilità teoretika għal albiglutide ukoll.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għall-preżentazzjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe tibdil sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Placebo Metformin 1,500 mg daily
Maltese: Metformin 1,500 mg kuljum
English: Patients were randomised (1:1:1) to Eperzan 30 mg once weekly, Eperzan 30 mg once weekly uptitrated to 50 mg once weekly at week 12, or placebo.
Maltese: Ilpazjenti kienu randomizzati (1:1:1) għal Eperzan30 mg darba fil-ġimgħa, Eperzan 30 mg darba fil-ġimgħa titrat 'il fuq għal 50 mg darba fil-ġimgħa f'ġimgħa 12, jew plaċebo.
English: Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to pioglitazone 30 mg daily (with optional titration to 45 mg/day) as add-on therapy in patients inadequately controlled on metformin + sulphonylurea (glimepiride 4 mg daily)
Maltese: Ir-riżultati fil-ġimgħa 52 fi studju kkontrollat bi plaċebo li qabbel Eperzan 30 mg taħt il-ġilda filġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg fil-ġimgħa) ma' pioglitazone 30 mg kuljum (b'possibbiltà ta' titrazzjoni għal 45 mg/kuljum) bħala terapija miżjuda f'pazjenti mhux adegwatament ikkontrollati fuq metformin + sulfonilurea (glimepiride 4 mg kuljum)
English: In patients who were treated for at least 104 weeks, the adjusted mean change in baseline in HbA1c was -0.97% for Eperzan (N = 182) and -1.04% for insulin glargine (N = 102).
Maltese: F'pazjenti li rċevew kura għal mill-inqas 104 ġimgħat, il-bidla medja aġġustata fil-linja bażi fl-HBA1c kienet ta' -0.97% għal Eperzan (N = 182) u ta' -1.04% għall-insulina glargine (N = 102).
English: It may be necessary to reduce the dose of concomitantly administered insulin secretagogues (such as sulphonylureas) or insulin to reduce the risk of hypoglycaemia when starting Eperzan (see sections 4.4 and 4.8).
Maltese: Jista' jkun hemm il-ħtieġa li d-doża ta' sekretagogi tal-insulina li jingħataw b'mod konkomitanti titnaqqas (bħal sulphonylureas) jew insulina biex jitnaqqas ir-riskju ta' ipogliċemija meta jinbeda Eperzan (ara sezzjonijiet 4.4 u 4.8).
English: Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly as add-on therapy in patients inadequately controlled on pioglitazone >30 mg daily  metformin >1,500 mg daily
Maltese: Ir-riżultati fil-ġimgħa 52 fi studju kkontrollat bi plaċebo li qabbel Eperzan 30 mg taħt il-ġilda filġimgħa bħala terapija miżjuda f'pazjenti mhux ikkontrollati adegwatament fuq pioglitazone > 30 mg kuljum  metformin > 1,500 mg kuljum
English: anhydrous (see section 2 under ‘Sodium content'), trehalose dihydrate, mannitol, polysorbate 80.
Maltese: - Is-sustanzi l-oħra huma: sodium dihydrogen phosphate monohydrate u disodium phosphate, anhydrous (ara sezzjoni 2 taħt ‘Kontenut ta' sodju'), trehalose dihydrate, mannitol, polysorbate 80.
English: Patient frequencies are defined as: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the available data).
Maltese: ≥1/10,000 sa <1/1,000; rari ħafna: <1/10,000 u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: The mean apparent clearance of albiglutide is 67 ml/h with an elimination half-life of approximately 5 days based on estimations from the population PK analyses from phase III patient studies and measured values.
Maltese: It-tneħħija medja apparenti ta' albiglutide hija ta' 67 ml/h b'half-life ta' eliminazzjoni ta' madwar 5 ijiem abbażi ta' stimi mill-analiżi PK tal-popolazzjoni minn studji tal-fażi
English: The adjusted mean change in body weight from baseline at 52 weeks was -1.0 kg for Eperzan (N = 122) and +1.7 kg for insulin lispro (N = 141).
Maltese: Il-bidla medja aġġustata fil-piż tal-ġisem mil-linja bażi fit-52 ġimgħa kienet ta' -1.0 kg għal Eperzan (N = 122) u ta' 1.7 kg għall-insulina lispro (N = 141).
English: No clinical studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of Eperzan.
Maltese: L-ebda studji kliniċi ma saru biex jeżaminaw l-effetti ta' indeboliment epatiku fuq il-farmakokinetika ta' Eperzan.
English: Albiglutide also slows gastric emptying.
Maltese: Albiglutide inaqqas ukoll it-tbattil gastriku.
English: Frequency categories below reflect combined data for the 2 doses of Eperzan, 30 mg or 50 mg weekly subcutaneously.
Maltese: Il-kategoriji ta' frekwenza ta' hawn taħt jirriflettu dejta kkombinata għaż-2 dożi ta' Eperzan, 30 mg jew 50 mg fil-ġimgħa taħt il-ġilda.
English: Eperzan 30 mg/50 mg Weekly
Maltese: Eperzan 30 mg/50 mg Darba filġimgħa
English: On background therapy of metformin 1,500 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to sitagliptin 100 mg daily, glimepiride 2 mg daily (with optional titration to 4 mg daily), or placebo.
Maltese: Dwar terapija ta' sfond ta' metformin 1,500 mg kuljum, Eperzan 30 mg taħt il-ġilda kull ġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg fil-ġimgħa wara minimu ta' 4 ġimgħat) tqabbel ma' sitagliptin 100 mg kuljum, glimepiride 2 mg kuljum (b'possibbiltà ta' titrazzjoni sa 4 mg kuljum), jew plaċebo.
English: Gastrointestinal events with Eperzan occurred more frequently in patients with moderate to severe renal impairment (eGFR 15 to 59 ml/min/1.73 m2) than in those with mild renal impairment or normal renal function.
Maltese: Avvenimenti gastrointestinali b'Eperzan seħħew b'mod aktar frekwenti f'pazjenti b'indeboliment renali moderat għal sever (eGFR 15 sa 59 ml/min/1.73 m2) milli f'dawk b'indeboliment renali ħafif jew b'funzjoni renali normali.
English: Intent to Treat Population (N)
Maltese: Popolazzjoni b'intenzjoni li tiġi kkurata (N)
English: Nederland GlaxoSmithKline BV
Maltese: United Kingdom GlaxoSmithKline UK
English: Powder: lyophilised white to yellow powder.
Maltese: Soluzzjoni ċara u bla kulur.
English: Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients treated with albiglutide and has occurred in patients without gastrointestinal side effects.
Maltese: Id-deidrazzjoni, li xi kultant twassal għal indeboliment renali u insuffiċjenza tal-kliewi akuta, ġiet irrappurtata f'pazjenti kkurati b'albiglutide u seħħet f'pazjenti mingħajr effetti gastrointestinali.
English: INFORMATION IN BRAILLE eperzan 30
Maltese: eperzan 30
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 657).
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, bi blindaġġ doppju u multiċentriku fuq 3 snin (n = 657).
English: The most serious adverse reaction in clinical trials was acute pancreatitis (see section 4.4).
Maltese: L-aktar reazzjoni avversa serja fil-provi kliniċi kienet pankreatite akuta (ara sezzjoni 4.4).
English: In a thorough QT study in healthy subjects, an increase in heart rate (6 to 8 bpm) was observed after repeat dosing with albiglutide 50 mg compared to baseline values.
Maltese: Fi studju komprensiv tal-QT fuq individwi b'saħħithom, kienet osservata żieda fir-rata tal-qalb (6 sa 8 bpm) wara dożi ripetuti b'albiglutide 50 mg meta mqabbla mal-valuri fil-linja bażi.
English: Marketing Authorisation Holder GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, L-Irlanda
English: Results at 104 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to sitagliptin 100 mg daily and glimepiride 2 to 4 mg daily as add-on therapy in patients inadequately controlled on metformin >1,500 mg daily
Maltese: Tabella 3 Ir-riżultati fil-ġimgħa 104 fi studju kkontrollat bi plaċebo li qabbel Eperzan 30 mg taħt il-ġilda filġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg fil-ġimgħa) ma' sitagliptin 100 mg kuljum u glimepiride 2 sa 4 mg kuljum bħala terapija miżjuda f'pazjenti mhux adegwatament ikkontrollati fuq metformin > 1,500 mg kuljum
English: Eperzan 30 mg Weekly + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily)
Maltese: Eperzan30mg Darba fil-ġimgħa + Pioglitazone 30 mg kuljum (+/- Metformin 1,500 mg kuljum)
English: In addition no clinically relevant effects on luteinizing hormone, follicle-stimulating hormone, or progesterone were observed when albiglutide and a combination oral contraceptive were co-administered.
Maltese: Barra minn hekk, l-ebda effett klinikament rilevanti ma kien osservat fuq lormon lewtanizzanti, l-ormon li jistimula l-follikuli, jew proġesteron meta albiglutide u kontraċettiv orali kkombinat ingħataw flimkien.
English: Avoid shaking as this can result in foaming.
Maltese: Evita li tħawwad peress li dan jista' jwassal għal formazzjoni ta' ragħwa.
English: However, in healthy volunteers following 50 mg the steady state concentration was 7.39 µg/ml at day 36, thus higher than population PK analyses from phase III patient studies predicted.
Maltese: Madankollu, f'voluntiera b'saħħithom wara l-50 mg il-konċentrazzjoni fi stat stabbli kienet ta' 7.39 µg/ml fil-jum 36, u għalhekk ogħla mill-analiżi PK tal-popolazzjoni prevista minn studji tal-fażi
English: Proportion Achieving HbA1c <7% Body Weight (kg) Baseline (mean)
Maltese: Proporzjon li laħqu HbA1c <7% Piż tal-Ġisem (kg) Linja bażi (medja)
English: • Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks.
Maltese: Aħżen il-pinen tiegħek f'temperatura ambjentali, li ma taqbiżx 30 C, sa 4 ġimgħat.
English: None of these antibodies were shown to neutralise the activity of albiglutide in an in vitro assay and antibody formation was generally transient and was not associated with reduced efficacy (HbA1c and FPG).
Maltese: Lebda wieħed minn dawn l-antikorpi ma ntwera li jinnewtralizza l-attività ta' albiglutide f'analiżi in vitro u lformazzjoni ta' antikorpi kienet ġeneralment temporanja u ma kinitx assoċjata ma' tnaqqis fl-effikaċja (HbA1c u FPG).
English: Eperzan 30 mg/50 mg Weekly  Metformin (with or without sulphonylurea)
Maltese: 30 mg/50 mg Darba filġimgħa Metformin (bi jew mingħajr sulfonilurea)
English: The durability of glycaemic control for Eperzan over time relative to other classes of type 2 antidiabetic agents and placebo is shown in Figure 1 as add-on to metformin.
Maltese: Id-durabilità tal-kontroll gliċemiku għal Eperzan maż-żmien relattiv għal klassijiet oħra ta' aġenti kontra ddijabete tat-tip 2 u plaċebo hija murija fil-Figura 1 bħala miżjud ma' metformin.
English: Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles).
Maltese: Pakkett multiplu li fih 12-il pinna ta' doża waħda u 12-il labra tal-pinen (3 pakketti ta' 4 pinen u 4 labriet).
English: Eperzan demonstrated glycaemic lowering and was statistically superior in reduction in HbA1c from baseline compared to placebo, sitagliptin, or glimepiride (see Table 3).
Maltese: Eperzan wera tnaqqis gliċemiku u kien statistikament superjuri fit-tnaqqis tal-HBA1c mil-linja bażi meta mqabbel ma' plaċebo, sitagliptin, jew glimepiride (ara Tabella 3).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: These types of gastrointestinal events may lead to dehydration, and worsen renal function.
Maltese: Dawn it-tipi ta' avvenimenti gastrointestinali jistgħu jwasslu għal deidrazzjoni, u jaggravaw il-funzjoni renali.
English: Sitagliptin was dosed according to creatinine clearance estimated by Cockcroft-Gault formula (100 mg daily in mild, 50 mg daily in moderate, and 25 mg daily in severe renal impairment) The primary endpoint was change in HbA1c from baseline at 26 weeks.
Maltese: Sitagliptin ingħata f'doża skont l-eliminazzjoni tal-kreatinina stmata mill-formula Cockcroft-Gault (100 mg kuljum f'indeboliment renali ħafif, 50 mg kuljum f'indeboliment renali moderat, u 25 mg kuljum f'indeboliment renali sever).
English: Difference from placebo + metforminb, (95% CI)
Maltese: Differenza minn plaċebo + metforminb, (95% CI)
English: Injection site reactions (typically including rash, erythema, or itching at the injection site) occurred in 15% of patients treated with Eperzan compared to 7% with all comparators and led to discontinuation in 2% of all patients treated with Eperzan.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (normalment kienu jinkludu raxx, eritema jew ħakk fis-sit tal-injezzjoni) seħħew fi 15% tal-pazjenti kkurati b'Eperzan meta mqabbel ma' 7% bil-komparaturi kollha u wasslu għal waqfien fi 2% tal-pazjenti kollha kkurati b'Eperzan.
English: The duration of studies ranged from 32 weeks to up to 3 years.
Maltese: It-tul tal-istudji kien ivarja minn 32 ġimgħa sa 3 snin.
English: Read package leaflet
Maltese: TAĦLIT
English: There is no experience in patients with NYHA class III-IV cardiac failure.
Maltese: M'hemmx esperjenza f'pazjenti b'insuffiċjenza tal-qalb NYHA tal-klassi III-IV.
English: IMPORTANT: There are two needle caps, an outer and inner needle cap. 7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R).
Maltese: Hemm żewġ għotjien tal-labra, għatu tal-labra ta' barra u ta' ġewwa. 7b Waqt li żżomm il-pinna fl-arja, neħħi l-għatu tal-labra ta' barra (Figura Q) u l-għatu tal-labra ta' ġewwa (Figura R).
English: The efficacy of Eperzan was evaluated in a 52 week, randomised, open-label, multicentre noninferiority study (n = 563).
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, b'tikketta mikxufa, multiċentriku ta' nuqqas ta' inferjorità fuq 52 ġimgħa (n = 563).
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Maltese: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
English: Proportion Achieving HbA1c <7% Body Weight (kg)
Maltese: Proporzjon li laħqu HbA1c <7% Piż tal-Ġisem (kg)
English: The majority of the observed reduction in fasting plasma glucose occurs after a single dose, consistent with the pharmacokinetic profile of albiglutide.
Maltese: Il-maġġoranza tat-tnaqqis osservat fil-glukożju fil-plasma waqt is-sawm iseħħ wara doża unika, b'mod konsistenti malprofil farmakokinetiku ta' albiglutide.
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 299).
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, bi blindaġġ doppju u multiċentriku fuq 3 snin (n = 299).
English: The efficacy of Eperzan was evaluated in a 32-week, randomised, open-label, liraglutide-controlled noninferiority study (N = 805).
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, b'tikketta mikxufa, ikkontrollat b'liraglutide ta' nuqqas ta' inferjorità fuq 32-ġimgħa (N = 805).
English: MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2-3) What if I do not wait 15 minutes after turning the pen to the Number 2?
Maltese: X'jiġri jekk ma nistenniex għal 15-il minuta wara li ndawwar il-pinna għan-Numru 2?
English: On background therapy of metformin 1,500 mg daily plus glimepiride 4 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to placebo or pioglitazone 30 mg daily (with optional titration to 45 mg/day).
Maltese: Dwar terapija ta' sfond ta' metformin 1,500 mg kuljum flimkien ma' glimepiride 4 mg kuljum, Eperzan 30 mg taħt il-ġilda fil-ġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg fil-ġimgħa wara minimu ta' 4 ġimgħat) tqabbel ma' plaċebo jew pioglitazone 30 mg kuljum (b'possibbiltà ta' titrazzjoni għal 45 mg/kuljum).
English: 9b Immediately put the pen (with needle attached) in a container for pen disposal.
Maltese: 9b Poġġi l-pinna (bil-labra mweħħla) f'kontenitur għar-rimi talpinna immedjatament.
English: In patients who completed the study (52 weeks), the adjusted mean change in baseline in HbA1c was -1.0% for Eperzan (N = 121) and -0.9% for insulin lispro (N = 141).
Maltese: F'pazjenti li temmew l-istudju (52 ġimgħa), il-bidla medja aġġustata fil-linja bażi fl-HBA1c kienet ta' -1.0% għal Eperzan (N = 121) u ta' -0.9% għall-insulina lispro (N = 141).
English: The efficacy of Eperzan was evaluated in a 3-year randomised, double-blind, placebo-controlled, multicentre study (n = 296) in patients inadequately controlled on diet and exercise.
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, bi blindaġġ doppju, ikkontrollat bi plaċebo u multiċentriku fuq 3 snin (n = 296) f'pazjenti mhux adegwatament ikkontrollati fuq dieta u eżerċizzju.
English: The median daily dose of insulin glargine used prior to hyperglycaemic rescue was 10 units (range 2 to 40 units) at study start and 30 units (range 3 to 230 units) at Week 52.
Maltese: Id-doża medjana ta' kuljum ta' insulina glargine użata qabel salvataġġ ipergliċemiku kienet ta' 10 unitajiet (firxa minn 2 sa 40 unità) fil-bidu tal-istudju u ta' 30 unità (firxa minn 3 sa 230 unità) fil-Ġimgħa 52.
English: • low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or sulphonylurea.
Maltese: • zokkor baxx fid-demm (ipogliċemija) meta tuża Eperzan flimkien mal-insulina jew ma' sulfonilurea.
English: If there is a possibility that you could become pregnant, you must use effective contraception while using this medicine.
Maltese: Jekk hemm possibbiltà li tista' toħroġ tqila, għandek tuża kontraċezzjoni effettiva waqt li tkun qed tuża din il-mediċina.
English: Given that albiglutide is an albumin-based protein therapeutic agent, it is likely to be present in human milk.
Maltese: Minħabba li albiglutide huwa aġent terapewtiku ta' proteina bbażata fuq l-albumina, huwa probabbli li jkun preżenti fil-ħalib uman.
English: On background therapy of insulin glargine (started at 10 units and titrated to  20 units per day), Eperzan 30 mg SC once weekly (with uptitration to 50 mg if inadequately controlled after Week 8) was compared to prandial insulin lispro (administered daily at mealtimes, started according to standard of care and titrated to effect).
Maltese: Dwar terapija ta' sfond ta' insulina glargine (li nbdiet f'10 unitajiet u ġiet titrata għal  20 unità kuljum), Eperzan 30 mg taħt il-ġilda darba fil-ġimgħa (b'titrazzjoni 'l fuq għal 50 mg jekk ma kienx hemm kontroll adegwat wara l-Ġimgħa 8) tqabbel ma' prandial insulin lispro (mogħti kuljum waqt l-ikel, mibdi skont standard ta' kura u titrat għall-effett).
English: Each pen delivers a single 30 mg or 50 mg dose of Eperzan in a volume of 0.5 ml.
Maltese: Kull pinna tagħti do ża unika ta' 30 mg jew 50 mg ta' Eperzan f'volum ta' 0.5 ml.
English: The change from baseline in HbA1c at the 6 month timepoint was also statistically significant for the 30 mg (0.9%) and 50 mg (1.1%) weekly doses of Eperzan (see Table 2).
Maltese: Il-bidla mil-linja bażi fl-HBA1c fis-6 xahar kienet ukoll statistikament sinifikanti għad-dożi ta' 30 mg (0.9%) u 50 mg (1.1%) fil-ġimgħa ta' Eperzan (ara Tabella 2).
English: MIXING YOUR MEDICINE AND WAITING 30 MINUTES (STEPS 2-3) What if I do not wait 30 minutes after turning the pen to the Number 2?
Maltese: X'jiġri jekk ma nistenniex 30 minuta wara li ndawwar il-pinna għan-Numru 2?
English: Difference from sitagliptin + metforminb , (95% CI)
Maltese: Differenza minn sitagliptin + metformin (95% CI)
English: On background therapy of metformin 1,500 mg daily (with or without sulphonylurea), Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) was compared to insulin glargine (started at 10 units and titrated weekly per prescribing information).
Maltese: Dwar terapija fl-isfond ta' metformin 1,500 mg kuljum (bi jew mingħajr sulfonilurea), Eperzan 30 mg taħt il-ġilda fil-ġimgħa (b'possibbiltà ta' titrazzjoni 'l fuq għal 50 mg fil-ġimgħa) ġie mqabbel ma' insulina glargine (mibdija f'10 unitajiet u titrata kull ġimgħa skont l-informazzjoni dwar il-preskrizzjoni).
English: Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.
Maltese: Il-pinen jiġu fornuti f'pakketti ta' 4 pinen u 4 labriet u pakketti multipli, kull wieħed fih 4 pinen u 4 labriet.
English: At 26 weeks, the between-treatment difference in HbA1c of 0.2% for Eperzan and insulin lispro met the pre-specified noninferiority margin (0.4%).
Maltese: Fil-ġimgħa 26, id-differenza bejn il-kuri fl-HbA1c ta' 0.2% għal Eperzan u insulina lispro laħqet il-marġini speċifikat minn qabel ta' nuqqas ta' inferjorità (0.4%).
English: (See ‘Very common side effects' in section 4 for signs of low blood sugar).
Maltese: (Ara ‘Effetti sekondarji komuni ħafna' fis-sezzjoni 4 għal sinjali
English: Twist Pen to Mix Medicine
Maltese: .8 Effetti mhux mixtieqa
English: Difference from pioglitazone + met + glimb (95% CI)
Maltese: Differenza minn pioglitazone + met + glim c
English: The mean estimate of apparent volume of distribution of albiglutide following SC administration is 11 litres.
Maltese: L-istima medja tal-volum apparenti ta' distribuzzjoni ta' albiglutide wara l-għoti taħt il-ġilda hija ta' 11-il litru.
English: In clinical trials of at least 2 years duration, 8% of subjects in the Eperzan group discontinued active treatment because of an adverse event compared with 6% in the all comparators group.
Maltese: Irtirar Fi provi kliniċi li mill-inqas damu għaddejjin sentejn , 8% tal-individwi fil-grupp ta' Eperzan waqqfu l-kura attiva minħabba avveniment avvers meta mqabbla ma' 6% f'kull grupp ta' komparaturi.