FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
Maltese: Abbażi tar-riżultati ta' analiżi farmakokinetika tal-popolazzjoni li kienet tinkludi pazjenti Kawkasi, Afrikani Amerikani/Afrikani, Asjatiċi u Ispaniċi/Mhux Ispaniċi, ir-razza u l-etniċità ma kellhom l-ebda effett klinikament sinifikanti fuq il-farmakokinetika tat-tneħħija ta' Eperzan.
English: • heartburn (gastro-oesophageal reflux)
Maltese: • ħruq ta' stonku (rifluss gastro-esofagali)
English: County Cork
Maltese: County Cork, L-Irlanda
English: Pack sizes:
Maltese: Popolazzjoni pedjatrika:
English: Exposures at the 30 mg and 50 mg dose levels were consistent with a dose-proportional increase.
Maltese: Espożizzjonijiet fil-livelli tad-doża ta' 30 mg u ta' 50 mg kienu konsistenti ma' żieda proporzjonali fid-doża.
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Maltese: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork , L-Irlanda
English: Wait 15 Minutes
Maltese: Stenna 15-il minuta
English: Age had no clinically relevant effect on the pharmacokinetics of albiglutide based on a population pharmacokinetic analysis of subjects aged 24-83 years (see section 4.2).
Maltese: L-età ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' albiglutide abbażi ta' analiżi farmakokinetika tal-popolazzjoni ta' individwi b'età minn 24 sa 83 sena (ara sezzjoni 4.2).
English: A total of 2,365 patients with type 2 diabetes were treated with Eperzan and 2,530 received other study medications in 8 active and placebo-controlled phase III clinical trials.
Maltese: Total ta' 2,365 pazjent bid-dijabete tat-tip 2 ingħataw kura b'Eperzan u 2,530 irċevew mediċini oħra taħt studju fi 8 provi kliniċi tal-fażi
English: Insulin glargine  Metformin (with or without sulphonylurea)
Maltese: Insulina glargine Metformin (bi jew mingħajr sulfonilurea)
English: BATCH NUMBER
Maltese: Tieqa tan-Numru
English: Durability of glycaemic control
Maltese: Durabilità tal-kontroll gliċemiku
English: Difference from insulin glargineb (95% CI) P value (noninferiority) Proportion Achieving HbA1c <7% Body Weight (kg)
Maltese: Differenza minn insulina glargineb (95% CI) Valur p (nuqqas ta' inferjorità) Proporzjon li laħqu HbA1c <7% Piż tal-Ġisem (kg)
English: Compared to placebo, treatment with Eperzan resulted in statistically significant reductions from baseline in HbA1c (-0.8% for Eperzan versus -0.1% for placebo, p<0.05) and FPG (-1.3 mmol/l for Eperzan versus +0.4 mmol/l for placebo, p<0.05) at 52 weeks.
Maltese: Meta mqabbla ma' plaċebo, kura b'Eperzan wasslet għal tnaqqis statistikament sinifikanti mil-linja bażi flHBA1c (-0.8% għal Eperzan kontra -0.1% għall-plaċebo, p<0.05) u fl-FPG (-1.3 mmol/l għal Eperzan kontra +0.4 mmol/l għall-plaċebo, p<0.05) fil-ġimgħa 52.
English: The clinical experience in patients >75 years is very limited (see section 5.2).
Maltese: L-esperjenza klinika f'pazjenti > 75 sena hija limitata ħafna (ara sezzjoni 5.2).
English: The incidence rates observed for first MACE+ were 1.2 and 1.1 events per 100 person-years for Eperzan versus all comparators, respectively.
Maltese: Ir-rati ta' inċidenza osservati għall-ewwel MACE+ kienu ta' 1.2 u 1.1 avvenimenti kull 100 persuna-snin għal Eperzan kontra lkomparaturi kollha, rispettivament.
English: Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or sulphonylurea (as monotherapy or dual therapy)
Maltese: Studju ikkontrollat attivament kontra liraglutide f'kombinazzjoni ma' metformin, thiazolidinedione jew sulfonilurea (bħala monoterapija jew terapija doppja)
English: Figure 1: Kaplan-Meier curve showing durability of glycaemic control (measured by time to rescue) for Eperzan, relative to two active controls (sitagliptin and glimepiride) and placebo
Maltese: Kaplan-Meier li turi d-durabilità tal-kontroll gliċemiku (imkejjel mill-ħin għas-salvataġġ) għal Eperzan, relattiva għal żewġ kontrolli attivi (sitagliptin u glimepiride) u plaċebo
English: SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: The incidence of pancreatitis (adjudicated as likely to be related to therapy) in the clinical studies was 0.3% for Eperzan compared to 0% for placebo and 0.1% for comparators (i.e. liraglutide, pioglitazone, glimepiride, sitagliptin, and insulin glargine) with or without additional background antidiabetic therapy (e.g. metformin).
Maltese: L-inċidenza ta' pankreatite (aġġudikata bħala li x'aktarx hija relatata mat-terapija) fl-istudji kliniċi kienet ta' 0.3% għal Eperzan meta mqabbla ma' 0% għall-plaċebo u 0.1% għall-komparaturi (jiġifieri, liraglutide, pioglitazone, glimepiride, sitagliptin, u insulina glargine) bi jew mingħajr terapija addizzjonali ta' sfond kontra d-dijabete (eż.metformin).
English: lv-epasts@gsk.com customercontactuk@gsk.com
Maltese: info.lt@gsk.com
English: Placebo + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily)
Maltese: Plaċebo + Pioglitazone 30 mg kuljum (+/- Metformin 1,500 mg kuljum)
English: Add-on to insulin glargine
Maltese: Żieda mal-insulina glargine
English: No dose adjustment is necessary for patients with mild and moderate renal impairment (eGFR 60 to 89 and 30 to 59 ml/min/1.73m2, respectively) (see sections 4.4, 4.8, 5.1, 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament tad-doża għal pazjenti b'indeboliment renali ħafif u moderat (eGFR 60 sa 89 u 30 sa 59 ml/min/1.73m2) rispettivament) (ara sezzjonijiet 4.4, 4.8, 5.1, 5.2).
English: Acarbose is contraindicated in patients with intestinal obstruction.
Maltese: Acarbose huwa kontraidnikat f'pazjenti b'ostruzzjoni intestinali.
English: Step 3 Wait 15 minutes
Maltese: 3 STENNA 15-IL MINUTA
English: Although most patients with injection site reactions were antibody negative (~85%), injection site reactions were reported more frequently for antibody positive (41%, N = 116) than antibody negative patients (14%, N = 1,927).
Maltese: Għalkemm ħafna mill-pazjenti b'reazzjonijiet fis-sit tal-injezzjoni kienu negattivi għallantikorpi (~85%), reazzjonijiet fis-sit tal-injezzjoni ġew irrapportati b'mod aktar frekwenti għal pazjenti pożittivi għall-antikorpi (41%, N = 116) milli f'pazjenti negattivi għall-antikorpi (14%, N = 1,927).
English: Other side effects reported with Eperzan
Maltese: Effetti sekondarji oħra li ġew irrapportati b'Eperzan
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' agonisti tar-riċettur GLP-1 ġie assoċjat ma' riskju għall-iżvilupp ta' pankreatite akuta.
English: Inspect the pen for ‘1' in the number window and expiration date.
Maltese: Spezzjona l-pinna għal ‘1' fit-tieqa tan-numru u d-data ta' skadenza.
English: Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion.
Maltese: Albiglutide huwa agonista tar-riċettur GLP-1 u jikkumplimenta s-sekrezzjoni tal-insulina li tiddependi millglukożju.
English: Albiglutide is a recombinant fusion protein consisting of two copies of a 30-amino acid sequence of modified human glucagon-like peptide 1 genetically fused in series to human albumin.
Maltese: Albiglutide huwa proteina tal-fużjoni rikombinanti li jikkonsisti minn żewġ kopji ta' sekwenza ta'30 aċidu aminniku ta' peptid 1 uman modifikat li jixbaħ lil glukagon ġenetikament marbut f'serje mal-albumina umana.
English: Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with dyspnoea, have been reported with albiglutide.
Maltese: Reazzjonijiet ta' sensittività eċċessiva possibbli inkluż anġjoedema, eritema, ħakk, ħakk ġeneralizzat u raxx b'dispnea, ġew irrapportati b'albiglutide.
English: Step 3 Wait 30 minutes
Maltese: 3 STENNA 30 MINUTA
English: An endpoint called MACE+ (major adverse cardiac events plus) included hospitalisation for unstable angina in addition to the MACE endpoints (acute myocardial infarction, stroke, and CV death).
Maltese: Endpoint imsejjaħ MACE+ (avvenimenti kardijaċi avversi maġġuri plus) kien jinkludi kura l-isptar għal anġina instabbli flimkien mal-endpoints MACE (infart mijokardijaku akut, puplesija, u mewt CV).
English: Glucose control
Maltese: Kontroll tal-glukożju
English: • irregular heartbeat
Maltese: • taħbita irregolari tal-qalb
English: The adjusted mean change in body weight from baseline at 104 weeks was -2.6 kg for Eperzan (N = 184) and +1.4 kg for insulin glargine (N = 104).
Maltese: Il-bidla medja aġġustata fil-piż mil-linja bażi fil-ġimgħa 104 kienet ta' -2.6 kg għal Eperzan (N = 184) u ta' +1.4 kg għall-insulina glargine (N = 104).
English: A single dose of simvastatin (80 mg) was administered with steady-state albiglutide (50 mg weekly).
Maltese: Doża unika ta' simvastatin (80 mg) ingħatat ma' albiglutide fi stat stabbli (50 mg fil-ġimgħa).
English: In clinical trials, acute pancreatitis has been reported in association with Eperzan (see section 4.8).
Maltese: Fi provi kliniċi, pankreatite akuta kienet irrapportata f'rabta ma' Eperzan u (ara sezzjoni 4.8).
English: No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg weekly).
Maltese: L-ebda effett klinikament rilevanti ma kien osservat fuq il-farmakokinetika ta' enantjomeri-R u -S ta' warfarin meta doża unika ta' warfarin raċemiku (25 mg) ingħatat ma' albiglutide fi stat stabbli (50 mg filġimgħa).
English: Among patients randomised to other comparators, the incidence of symptomatic hypoglycaemia was 7% to 33% when used with a sulphonylurea or insulin and 2% to 4% in combinations without these medicinal products.
Maltese: Fost il-pazjenti randomizzati għal komparaturi oħra, l-inċidenza ta' ipogliċemija sintomatika kienet ta' 7% sa 33% meta ntuża ma' sulfonilurea jew mal-insulina u 2% sa 4% f'kombinazzjonijiet mingħajr dawn il-prodotti mediċinali.
English: Step 8 Deliver injection 8a Insert needle straight into the injection site.
Maltese: 8a Daħħal il-labra direttament fis-sit tal-injezzjoni.
English: Viewing Window Number Window Injection Button* Pen Body
Maltese: Tieqa tan-Numru Buttuna tal-Injezzjoni*
English: Wait 30 Minutes
Maltese: Stenna 30-il minuta
English: Effects on embryo-foetal development (embryo-foetal lethality and skeletal variations) were observed at 50 mg/kg/day (at low multiple of clinical exposure).
Maltese: Effetti fuq l-iżvilupp embriju-fetali (letalità embriju-fetali u varjazzjonijiet skeletali) kienu osservati f'50 mg/kg/kuljum (f'multiplu baxx ta' espożizzjoni klinika).
English: Glimepiride 2 to 4 mg daily + Metformin 1,500 mgd aily
Maltese: Glimepiride 2 sa 4 mg kuljum + Metformin 1,500 mg kuljum
English: Add-on to metformin plus sulphonylurea
Maltese: Miżjud ma' metformin flimkien ma' sulfonilurea
English: 2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).
Maltese: 2b Bil-mod u bil-galbu ċaqlaq il-pinna minn naħa għal oħra 5 darbiet (bħal waxer tal-windskrin) (Figura H).
English: Non-clinical data reveal no special hazards for humans based on studies of safety pharmacology or repeatdose toxicity.
Maltese: Dejta mhux klinika ma turi l-ebda periklu speċjali għall-bnedmin abbażi ta' studji ta' sigurtà farmakoloġika jew tossiċità b'dożi ripetuti.
English: The rate of symptomatic hypoglycaemia was higher for Eperzan when used in combination with a sulphonylurea (15% to 22%) or with insulin (18%) compared to combinations not including a sulphonylurea or insulin (1% to 4%).
Maltese: Ir-rata ta' ipogliċemija sintomatika kienet ogħla għal Eperzan meta ntuża flimkien ma' sulfonilurea (15% sa 22%) jew mal-insulina (18%) meta mqabbla ma' kombinazzjonijiet li ma kinux jinkludu sulfonilurea jew insulina (1% sa 4%).
English: After mixing, wait 15 minutes before injection
Maltese: Wara li tħallat, stenna 15-il minuta qabel l-injezzjoni.
English: Store in a refrigerator (between 2C and 8C).
Maltese: Aħżen fi friġġ (bejn 2C u 8C).
English: No overall differences in glycaemic effectiveness or body weight were observed across demographic subgroups (age, gender, race/ethnicity, duration of diabetes).
Maltese: L-ebda differenzi globali ma kienu osservati fl-effikaċja gliċemika jew fil-piż tal-ġisem fis-sottogruppi demografiċi (età, sess, razza/etniċità, tul tad-dijabete).
English: Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against liraglutide for HbA1c (see Table 8).
Maltese: Il-kura b'Eperzan ma ssodisfatx il-marġni speċifikat minn qabel ta' nuqqas ta' inferjorità (0.3%) kontra liraglutide għall-HBA1c (ara Tabella 8).
English: A single dose of albiglutide 50 mg did not impair the glucagon, epinephrine, norepinephrine, cortisol or growth hormone counter-regulatory hormone response to hypoglycaemia.
Maltese: Doża unika ta' albiglutide 50 mg ma fixklitx ir-rispons tal-ormon kontro-regolatorju ta' glukagon, epinephrine, norepinephrine, kortisol jew l-ormon tat-tkabbir għal ipogliċemija.
English: The mean daily dose of insulin lispro at Week 26 was 31 IU, and at Week 52, 69% of patients treated with Eperzan were on 50 mg weekly.
Maltese: Id-doża medja ta' kuljum ta' insulina lispro fil-Ġimgħa 26 kienet ta' 31 IU, u f'Ġimgħa 52, 69% tal-pazjenti li ngħataw kura b'Eperzan kienu fuq 50 mg fil-ġimgħa.
English: As albiglutide is an albumin fusion molecule, plasma protein binding has not been assessed.
Maltese: Peress li albiglutide huwa molekula bil-fużjoni tal-albumina, l-irbit mal-proteina fil-plasma ma ġiex ivvalutat.
English: Background therapies in these studies included diet and exercise, metformin, sulphonylurea, thiazolidinedione, insulin glargine, or a combination of antidiabetic medicinal products.
Maltese: Terapiji ta' sfond f'dawn l-istudji kienu jinkludu dieta u eżerċizzju, metformin, sulfonilurea, thiazolidinedione, insulina glargine, jew kombinazzjoni ta' prodotti mediċinali kontra d-dijabete.
English: The starting total daily dose of insulin glargine ranged between 2 and 40 units (median daily dose of 10 units) and ranged between 3 and 230 units (median daily dose of 30 units) at Week 52.
Maltese: Id-doża tal-bidu totali ta' kuljum ta' insulina glargine kienet tvarja bejn 2 u 40 unità (doża medjana ta' kuljum ta' 10 unitajiet) u kienet tvarja bejn 3 u 230 unità (doża medjana ta' kuljum ta' 30 unità) f'Ġimgħa 52.
English: 1a Wash your hands (Figure D).
Maltese: 1a Aħsel idejk (Figura D).
English: Add-on combination therapy
Maltese: Terapija ta' Kombinazzjoni
English: Add-on to pioglitazone
Maltese: Żieda ma' pioglitazone
English: Active-controlled study versus insulin glargine as add-on to metformin  sulphonylurea The efficacy of Eperzan was evaluated in a 3-year, randomised (2:1), open-label, insulin glargine-controlled noninferiority study (n = 735).
Maltese: Studju attiv-ikkontrollat kontra insulina glargine bħala żieda ma' metformin sulfonilurea L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat (2:1), b'tikketta mikxufa, ikkontrollat b'insulina glargine ta' nuqqas ta' inferjorità fuq 3 snin (n = 735).
English: Over 2,300 patients have received Eperzan in 8 placebo- or active-controlled phase III studies.
Maltese: Aktar minn 2,300 pazjent irċevew Eperzan fi 8 studji ikkontrollati plaċebo jew ikkontrollati attivament talfażi III.
English: Difference from placebo + pioglitazoneb (95% CI)
Maltese: Differenza minn plaċebo + pioglitazone (95% CI)
English: GlaxoSmithKline AB Tel: + 46 (0)31 67 09 00 info.produkt@gsk.com
Maltese: Tel: + 46 (0)31 67 09 00 info.produkt@gsk.com
English: The between-treatment difference in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the prespecified noninferiority margin (0.3%).
Maltese: Id-differenza bejn il-kuri fl-HBA1c ta' 0.1% (-0.04, 0.27) mil-linja bażi fil-ġimgħa 52 għal Eperzan u insulina glargine issodisfat il-marġini speċifikat minn qabel ta' nuqqas ta' inferjorità (0.3%) .
English: Stop taking Eperzan.
Maltese: Ieqaf ħu Eperzan.
English: Rare: may affect up to 1 in 1000 people:
Maltese: Rari: jistgħu jaffettwaw sa persuna 1 minn kull 1000:
English: Albiglutide is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Maltese: Albiglutide huwa proteina li r-rotta metabolika mistennija tiegħu hija d-degradazzjoni għal peptidi żgħar u aċidi amminiċi individwali permezz ta' enzimi proteolitiċi preżenti kullimkien.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 4 pen pack
Maltese: KARTUNA - Pakkett ta' 4 pinen
English: The average weekly steady state concentrations following SC administration of 30 mg or 50 mg albiglutide estimated in the population PK analyses from phase III patient studies were approximately 2.6 mcg/ml and 4.4 mcg/ml, respectively.
Maltese: Ilkonċentrazzjonijiet medji fi stat stabbli fil-ġimgħa wara l-għoti ta' 30 mg jew 50 mg ta' albiglutide taħt ilġilda stmati fl-analiżi PK tal-popolazzjoni minn studji tal-fażi III fuq pazjenti kienu ta' madwar 2.6 mcg/ml u 4.4 mcg/ml, rispettivament.
English: Albiglutide did not meaningfully alter the pharmacokinetics of a single-dose of digoxin (0.5 mg) when coadministered with steady-state albiglutide (50 mg weekly).
Maltese: Albiglutide ma biddilx b'mod sinifikanti l-farmakokinetika ta' doża unika ta' digoxin (0.5 mg) meta ngħata flimkien ma' albiglutide fi stat stabbli (50 mg fil-ġimgħa).
English: Eperzan 30 mg powder and solvent for solution for injection albiglutide
Maltese: Eperzan 30 mg trab u solvent għal soluzzjoni għall-injezzjoni albiglutide
English: Change at Week 26b Difference from lispro insulinb (95% CI)
Maltese: Differenza minn insulina lispro b (95% CI)
English: Description of selected adverse reactions:
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula:
English: Sitagliptin 100 mg daily + Metformin 1,500 mg daily
Maltese: Sitagliptin 100 mg kuljum + Metformin 1,500 mg kuljum
English: In patients with type 2 diabetes who received 2 doses of albiglutide 32 mg (Day 1 and 8), a statistically significant reduction (24%) in postprandial glucose AUC(0.5-4.5 h) was observed compared to placebo following a standardised breakfast meal on Day 9.
Maltese: F'pazjenti b'dijabete tat-tip 2 li rċevew 2 dożi ta' albiglutide 32 mg (Jum 1 u 8), ġie osservat tnaqqis statistikament sinifikanti (24%) fl-AUC tal-glukożju postprandjali (0.5-4.5 h) meta mqabbel ma' plaċebo wara kolazzjon standardizzat f'Jum 9.
English: Outer Needle Cap Inner Needle Cap Needle Tab
Maltese: X'għandek tkun taf qabel ma tuża Eperzan
English: Carton of 4 single-dose pens and 4 pen needles.
Maltese: Kartuna ta' 4 pinen b'doża unika u 4 labar tal-pinna.
English: No effects were seen at 5 mg/kg/day (at exposures similar to clinical exposure).
Maltese: Ma dehru l-ebda effetti f'5 mg/kg/kuljum (f'espożizzjonijiet simili għall-espożizzjoni klinika).
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 999).
Maltese: L-effikaċja ta' Eperzan kienet ivvalutata fi studju randomizzat, bi blindaġġ doppju u multiċentriku fuq 3 snin (n = 999).
English: Pioglitazone + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Maltese: Pioglitazone + Metformin 1,500 mg kuljum + Glimepiride 4 mg kuljum
English: Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Maltese: Eperzan 30 mg/50 mg Darba fil-ġimgħa + Metformin 1,500 mg kuljum + Glimepiride 4 mg
English: Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly at Week 6) was compared to liraglutide 1.8 mg daily (titrated up from 0.6 mg at Week 1 and 1.2 mg at Week 1 to Week 2) in patients inadequately controlled on monotherapy or combination oral antidiabetic therapy (metformin, thiazolidinedione, or sulphonylureas).
Maltese: Eperzan 30 mg taħt il-ġilda fil-ġimgħa (b'titrazzjoni ‘l fuq għal 50 mg fil-ġimgħa fil-Ġimgħa 6) tqabbel ma' liraglutide 1.8 mg kuljum (titrat ‘il fuq minn 0.6 mg f'Ġimgħa 1 u 1.2 mg f'Ġimgħa 1 sa Ġimgħa 2) f'pazjenti mhux adegwatament ikkontrollati fuq monoterapija jew fuq terapija orali ta' kombinazzjoni kontra d-dijabete (metformin, thiazolidinedione, jew sulphonylureas).
English: • A clean empty cup (Figure C).
Maltese: • Labra ġdida (Figura B).
English: Therapeutic proteins such as albiglutide are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of Eperzan (see section 4.2).
Maltese: Proteini terapewtiċi bħal albiglutide jiġu katabolizzati minn enzimi proteolitiċi distribwiti b'mod wiesa', li mhumiex ristretti għat-tessut tal-fwied, għalhekk, tibdil fil-funzjoni tal-fwied mhux probabbli li jkollu xi effett fuq l-eliminazzjoni ta' Eperzan (ara sezzjoni 4.2).
English: Severe gastrointestinal disease
Maltese: Mard gastrointestinali sever
English: The most frequent adverse reactions during clinical trials which occurred in 5% of patients receiving Eperzan were diarrhoea, nausea, and injection site reactions including rash, erythema, or itching at the injection site.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti waqt il-provi kliniċi li seħħew f'5% tal-pazjenti li kienu qed jirċievu Eperzan kienu dijarea, dardir u reazzjonijiet fis-sit tal-injezzjoni inklużi raxx, eritema, jew ħakk fissit tal-injezzjoni.
English: GlaxoSmithKline BV Tel: + 31 (0)30 6938100
Maltese: GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk.com
English: Eperzan 50 mg powder and solvent for solution for injection albiglutide
Maltese: Eperzan 50 mg trab u solvent għal soluzzjoni għall-injezzjoni albiglutide
English: Across the 8 clinical trials, and including subjects in all treatment groups, a total of 19% of patients (N = 937) were 65 years of age and older, and 2% (N = 112) were 75 years of age and older, 52%
Maltese: Fost it-8 provi kliniċi, u inkluż l-individwi fil-gruppi kollha ta' kura, total ta' 19% tal-pazjenti (N = 937) kellhom aktar minn 65 sena, u 2% (N = 112) kellhom aktar minn 75 sena, 52% kienu rġiel, b'indiċi medju tal-massa tal-ġisem (BMI) ta' 33 kg/m2.
English: Placebo + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Maltese: Plaċebo + Metformin 1,500 mg kuljum + Glimepiride 4 mg kuljum
English: Change at Week 32b Difference from liraglutideb (95% CI)
Maltese: Differenza minn liraglutideb (95% CI)
English: After mixing, wait 30 minutes before injection
Maltese: Wara li tħallat, stenna 30 minuta qabel l-injezzjoni
English: Dual Chamber Cartridge (DCC) composed of a Type 1 glass barrel sealed with bromobutyl rubber stoppers and a bromobutyl rubber closure disc encased in a polypropylene snap on cap. Each cartridge is assembled into a disposable single use plastic pen injector (pen).
Maltese: Skartoċċ b'żewġ Kompartimenti (DCC) magħmul minn kanna tal-ħġieġ tat-Tip 1 issiġillat b'tappijiet tallasktu bromobutyl u diska għall-għeluq tal-gomma tal-bromobutyl magħluqa f'għatu tal-polypropylene tattip snap on .
English: Results of an active-controlled trial of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly) versus liraglutide 1.8 mg daily at 32 weeksa
Maltese: Riżultati ta' prova ikkontrollat attivamenta ta' Eperzan 30 mg taħt il-ġilda fil-ġimgħa (b'titrazzjoni 'l fuq għal 50 mg fil-ġimgħa) kontra liraglutide 1.8 mg kuljum fil-ġimgħa 32
English: Atrial fibrillation/flutter occurred in 1% of patients receiving Eperzan and 0.5% of patients in the all comparators group.
Maltese: Fibrillazzjoni atrijali/palpitazzjoni seħħet f'1% tal-pazjenti li kienu qed jirċievu Eperzanu 0.5% tal-pazjenti f'kull grupp ta' komparaturi.