FrancophonIA/ELRC3.0 huggingface dataset:
English: The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required.
Maltese: It-tnaqqis f'Cmax għandu rilevanza klinika limitata u m'hemmx bżonn ta' ebda aġġustament fid-doża talkontraċettivi orali.
English: Following administration of a single dose of an oral contraceptive medicinal product (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) 1 hour before or 11 hours after 10 mcg lixisenatide, the Cmax, AUC, t1/2 and tmax of ethinylestradiol and levonorgestrel were unchanged.
Maltese: Wara l-għoti ta' doża waħda ta' kontraċettiv orali (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) siegħa qabel jew 11-il siegħa wara 10 mcg lixisenatide, Cmax, l-AUC, t1/2 u tmax ta' ethinylestradiol u levonorgestrel ma nbidlux.
English: Lixisenatide provided significant improvements in HbA1c (-0.64% change compared to placebo; 95% CI: -0.810% to -0.464%; p<0.0001), from a mean baseline HbA1c of 8.0%.
Maltese: Lixisenatide ipprovda titjib sinifikanti fl-HbA1c (tibdil ta' -0.64% meta mqabbel mal-plaċebo; 95% CI:0.810% sa -0.
English: MI
Maltese: JIS
English: After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Maltese: Wara li ngħata warfarin 25 mg flimkien ma' doża ripetuta ta' lixisenatide 20 mcg, ma kienx hemm effetti fuq l-AUC jew l-INR (International Normalised Ratio) filwaqt li Cmax naqas b'19% u tmax kien ittardjat b'7
English: As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Maltese: Bħala peptide, lixisenatide jiġi eliminat permezz ta' filtrazzjoni glomerulari, segwit minn riassorbiment tubulari u degradazzjoni metabolika, li jirriżulta f'peptidi iżgħar u amino acids, li huma introdotti mill ġdid fil-metaboliżmu tal-proteina.
English: (pancreatitis).
Maltese: (snin)
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Maltese: L-użu ta' agonisti tar-riċetturi GLP-1 jista' jkun assoċjat ma' reazzjonijiet avversi gastrointestinali.
English: 1 pre-filled pen of 3 ml (14 doses) 2 pre-filled pens of 3 ml (2x14 doses) 6 pre-filled pens of 3 ml (6x14 doses)
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni Pinna 1 mimlija għal-lest ta' 3 ml (14-il doża) 2 pinen mimlijin għal-lest ta' 3 ml (2x 14-il doża) 6 pinen mimlijin għal-lest ta' 3 ml (6x14-il doża)
English: Metformin as background therapy
Maltese: Metformin bħala terapija eżistenti
English: When administered 1 or 4 hours after 10 mcg lixisenatide, Cmax of paracetamol was decreased by 29% and 31% respectively and median tmax was delayed by 2.0 and 1.75 hours respectively.
Maltese: Meta ngħata siegħa jew 4 sigħat wara 10 mcg ta' lixisenatide, Cmax ta' paracetamol kien imnaqqas bi 29 % u 31 % rispettivament u tmax medjan kien ittardjat bi 2.0 u 1.75 siegħa rispettivament.
English: Frequencies of adverse reactions 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).
Maltese: mhux komuni: ≥1/1, 000 sa <1/100; rari:
English: Lyxumia 20 micrograms solution for injection EU/1/12/811/002 (1 pre-filled pen) EU/1/12/811/003 (2 pre-filled pens) EU/1/12/811/004 (6 pre-filled pens)
Maltese: EU/1/12/811/002 (pinna 1 mimlija għal-lest) EU/1/12/811/003 (2 pinen mimlijin għal-lest) EU/1/12/811/004 (6 pinen mimlijin għal-lest)
English: Clinical studies with Lyxumia indicate improved beta-cell function as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Maltese: Studji kliniċi b'Lyxumia wrew li l-funzjoni taċ-ċelloli beta ġiet mtejba kif ġiet imkejla mill-evalwazzjoni tal-mudell omeostatiku għall-funzjoni taċ-ċelloli beta (HOMA-β).
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-lixisenatide antibodies following treatment with Lyxumia and, at the end of the main 24-week treatment period in placebo-controlled studies, 69.8% of lixisenatide patients had a positive antibody status.
Maltese: B'mod konsistenti mal-proprjetajiet immunoġenitiċi potenzjali ta' prodotti mediċinali li fihom proteini jew peptidi, il-pazjenti jistgħu jiżviluppaw antikorpi li huma anti-lixisenatide wara trattament b'Lyxumia u, fl-aħħar tal-perjodu prinċipali ta' kura ta' 24 ġimgħa fi studji kkontrollati bi plaċebo, 69.8% tal-pazjenti lixisenatide kienu pożittivi għall-antikorpi.
English: When lixisenatide 20 mcg and atorvastatin 40 mg were co-administered in the morning for 6 days, the exposure to atorvastatin was not affected, while Cmax was decreased by 31% and tmax was delayed by 3.25 hours.
Maltese: Meta lixisenatide 20 mcg u atorvastatin 40 mg ġew mogħtija flimkien fil-għodu għal 6 ijiem, l espożizzjoni għal atorvastatin ma kienx affettwat, filwaqt li Cmax naqas b'31% u tmax kien ittardjat bi 3.25 siegħa.
English: The apparent volume of distribution after subcutaneous administration of lixisenatide (Vz/F) is approximately 100 L.
Maltese: Il-volum apparenti tad-distribuzzjoni wara l-amministrazzjoni ta' lixisenatide taħt il-ġilda (Vz/F) hija ta' madwar 100 L.
English: When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Maltese: Meta Lyxumia ngħata ma' xi sulphonylurea u xi insulina bażilari, kien hemm l-ipogliċemija sintomatika f'47.2% talpazjenti kkurati b'lixisenatide meta mqabbla ma' 21.6% bi plaċebo (differenza assoluta ta' 25.
English: The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' lixisenatide fit-tfal u adoloxxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Patients with hepatic impairment No dose adjustment is needed in patients with hepatic impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' ebda aġġustament fid-doża f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Upper respiratory tract infection
Maltese: Influwenza Infezzjonijiet tal-parti ta' fuq tas-sistema respiratorja
English: Mean body weight (kg) Baseline
Maltese: Piż tal-ġisem medju (kg) Linja Bażi
English: The reductions with Lyxumia ranged from 4.51 to 7.96 mmol/L (81.2 to 143.3 mg/dl) from baseline at the end of the main 24-week treatment period across all studies in which post-prandial glucose was measured; 26.2% to 46.8% of patients had a 2-hour post-prandial glucose value below 7.8 mmol/L (140.4 mg/dl).
Maltese: It-tnaqqis ma' Lyxumia varja minn 4.51 sa 7.96 mmol/L (81.2 sa 143.3 mg/dl) mil-linja bażi fl-aħħar parti tal-perijodu prinċipali ta' kura ta' 24 ġimgħa fl-istudji kollha li fihom il-glukosju ta' wara l-ikel kien imkejjel; minn 26.2% sa 46.8% tal-pazjenti kellhom livell tal-glukosju ta' wara l-ikel wara sagħtejn taħt 7.8 mmol/L (140.4 mg/dl).
English: Hypoglycaemia (in combination with a sulphonylurea and / or a basal insulin)
Maltese: Ipogliċemija (flimkien ma' sulphonylurea u/jew insulina bażilari)
English: • Only use needles that are compatible for use with Lyxumia pen (see “Instructions for Use”).
Maltese: • Uża biss labar li huma kompatibbli mal-pinna Lyxumia (ara “Istruzzjonijiet għall-Użu”).
English: No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Maltese: Din iż-żieda għal tmax ma ġietx osservata meta atorvastatin ingħata filgħaxija u lixisenatide filgħodu, iżda l-AUC u Cmax ta' atorvastatin żdiedu b'27% u 66% rispettivament.
English: New pen (orange window)
Maltese: Pinna Ġdida (tieqa oranġjo)
English: Pack sizes of 1, 2 or 6 pre-filled pens.
Maltese: Pakketti li fihom 1,2 u 6 pinen mimlijin għal-lest.
English: Placebo (N= 166)
Maltese: (N= 166)
English: Hydrochloric acid (for pH adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' agonisti tar-riċetturi ta' glucagon li jixbah peptide-1 (GLP-1) ġie assoċjat ma' riskju ta' żvilupp ta' pankreatite akuta.
English: Mean HbA1c (%) Baseline
Maltese: HbA1c Medju (%) Linja Bażi
English: • Store your unused Lyxumia pens in the refrigerator, 2°C to 8°C.
Maltese: • Aħżen il-pinen Lyxumia li m'intix qed tuża fil-friġġ, f'temperatura ta' 2°C sa 8°C.
English: • Diarrhoea
Maltese: • Dijarrea
English: Add-on combination therapy with oral antidiabetics
Maltese: Terapija miżjuda flimkien ma' antidijabetiċi orali
English: Other medicines and Lyxumia
Maltese: Mediċini oħra u Lyxumia
English: Sulfonylureas or glinides were not used with basal insulin as background therapy.
Maltese: Sulfonylureas jew glinides ma ntużawx malinsulina bażali bħala terapija ta' sfond.
English: In an active-controlled study, Lyxumia once daily showed an HbA1c reduction of -0.79% compared to -0.96% with exenatide twice daily at the end of the main 24-week treatment period with a mean treatment difference of 0.17% (95%CI: 0.033, 0.297) and a similar percentage of patients achieved an HbA1c less than 7% in the lixisenatide group (48.5%) and in the exenatide group (49.8%).
Maltese: ġimgħa b'medja ta' differenza fil-kura ta' 0.17% (95% CI: 0.033, 0.297 u persentaġġ simili ta' pazjenti kisbu HbA1c anqas minn 7% fil-grupp ta' lixisenatide (48.5%) u fil-grupp ta' exenatide (49.8%).
English: Insulin glulisine QD
Maltese: Insulin glulisine
English: EU/1/12/811/004 - 6 pens
Maltese: EU/1/12/811/002 pinna 1 EU/1/12/811/003 2 pinen EU/1/12/811/004 6 pinen
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 webportal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar- 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 l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Frail patients, including patients at risk for malnutrition, patients with recent cardiovascular events and patients with moderate to severe cognitive impairment were excluded.
Maltese: Pazjenti debboli, inklużi pazjenti f'riskju ta' malnutrizzjoni, pazjenti b'avvenimenti kardjovaskulari reċenti u pazjenti b'indeboliment konjittiv moderat għal sever kienu esklużi.
English: Nausea was reported in 14.7% and 15.5% of patients, and symptomatic hypoglycaemia in 5.8% and 2.2% of patients, main meal group and breakfast group, respectively.
Maltese: 5% tal-pazjenti u ipogliċemija sintomatika f'5.8% u 2.2% tal-pazjenti, fil-grupp tal-ikla prinċipali u fil-grupp tal-kolazzjoni, rispettivament.
English: Pen cap
Maltese: Kappa ta'
English: Type I glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the inside and polyisoprene on the outside).
Maltese: Skartoċċ tal-ħġieġ tat-tip I bi planġer tal-gomma (bromobutyl), tappijiet flanġ (aluminju) b'diski laminati li jissiġillaw (lastku tal-bromobutyl fuq in-naħa ta' ġewwa u polyisoprene fuq barra).
English: Injection button
Maltese: Buttuna ta' injezzjoni
English: Patients with type 2 diabetes with basal insulin combined with 1-3 oral anti-diabetic agents were enrolled in an open-label randomised study for insulin intensification.
Maltese: Pazjenti bid-dijabete tat-tip 2 li qed jieħdu insulina bażilari flimkien ma' 1-3 sustanzi anti-dijabetiċi orali ġew imdaħħla f'studju magħmul b'mod arbitrarju u open-label għall-intensifikazzjoni tal-insulina.
English: About Your Treatment Initiation pack
Maltese: Pakkett inizjali ta' kura
English: This medicinal product contains metacresol, which may cause allergic reactions.
Maltese: Din il-mediċina fiha metacresol li jista' jikkawża reazzjonijiet allergiċi.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Maltese: Il-pazjenti għandhom ikunu infurmati bis-sintomi tipiċi ta' pankreatite akuta: uġigħ addominali sever u persistenti.
English: • Handle your Lyxumia pen with care.
Maltese: • Immaniġġja l-pinna Lyxumia tiegħek b'attenzjoni.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Maltese: • Uġigħ sever u persistenti fl-addome (fin-naħa tal-istonku) li jista' jwassal sa dahrek, kif ukoll dardir u rimettar, għax jista' jkun sinjal ta' frixa infjammata (pankreatite).
English: The ELIXA study was a randomized, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Maltese: L-istudju ELIXA kien studju multinazzjonali, ikkontrollat bil-plaċebo, double-blind u magħmul b'mod arbitrarju li evalwa l-konsegwenzi kardjovaskulari(KV) waqt trattament b'lixisenatide f'pazjenti biddijabete mellitus tat-tip 2 wara Sindromu Koronarju Akut reċenti.
English: Lyxumia can be used with 29 to 32 gauge disposable pen needles.
Maltese: Lyxumia jista' jintuża ma' labar ta' 29 sa 32 gauge u li jistgħu jintremew.
English: During the 24-week treatment period, 22.4% lixisenatide patients reported at least one symptomatic hypoglycaemic event compared to 13.5% in the placebo group.
Maltese: Matul il-perijodu ta' kura ta' 24-ġimgħa, 22.4% tal-pazjenti fuq lixisenatide irrapportaw għallinqas avveniment wieħed ta' ipogliċemija sintomatika meta mqabbel ma' 13.5% fil-grupp tal-plaċebo.
English: Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39% respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Maltese: ta' ethinylestradiol u levonorgestrel, filwaqt li Cmax ta' ethinylestradiol naqas bi 52% u 39% rispettivament u Cmax ta' levonorgestrel naqas b'46% u 20%, rispettivament u tmax medjan kien ittardjat b'siegħa sa 3 sigħat.
English: The incidence of nausea was 24.5% in the lixisenatide group compared to 35.1% in the exenatide twice daily group and the incidence of symptomatic hypoglycaemia with lixisenatide was 2.5% during the 24-week main treatment period compared to 7.9% in the exenatide group.
Maltese: L-inċidenza ta' dardir kienet ta' 24.5% fil-grupp ta' lixisenatide meta mqabbla ma' 35.1% fil-grupp exenatide darbtejn kuljum u l-inċidenza ta' ipogliċemija sintomatika b'lixisenatide kienet 2.5% matul ilperijodu prinċipali ta' kura ta' 24 ġimgħa meta mqabbel ma' 7.9% fil-grupp exenatide.
English: Lixisenatide 20 mcg Placebo (N= 170)
Maltese: Lixisenatide 20 mcg Plaċebo
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Maltese: L-età m'għandha l-ebda effett kliniku rilevanti fuq il-farmakokinetika ta' lixisenatide.
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
Maltese: Ir-riċettur GLP-1 huwa l-mira għal GLP-1 nativ, li hu ormon endoġenu tal-klassi incretin li jsaħħaħ is-sekrezzjoni tal-insulina miċ-ċelloli beta tal-pancreas li tiddependi fuq il-glukosju.
English: At the end of the 24-week treatment period, 56.3% of the lixisenatide patients achieved an HbA1c less than 7 % compared to 38.5% in the placebo group.
Maltese: Flaħħar tal-perijodu ta' kura ta' 24-ġimgħa, 56.3% tal-pazjenti fuq lixisenatide kisbu livell ta' HbA1c linqas minn 7 % meta mqabbel ma' 38.5% fil-grupp tal-plaċebo.
English: In patients taking Lyxumia in combination with a sulphonylurea and metformin, symptomatic hypoglycaemia occurred in 22.0% of lixisenatide treated patients and in 18.4% of placebo treated patients during the entire treatment period (3.6% absolute difference).
Maltese: F'pazjenti li kienu qed jieħdu Lyxumia flimkien ma' xi sulphonylurea u metformin, l-ipogliċemija sintomatika seħħet f'22.0% tal-pazjenti kkurati b'lixisenatide u f'18.4% tal-pazjenti kkurati bil-plaċebo matul il-perijodu kollu ta' kura (differenza assoluta ta' 3.6%).
English: Excipient(s) with known effects
Maltese: Eċċipjent(i) b'effetti magħrufa
English: After concomitant administration of lixisenatide 20 mcg and ramipril 5 mg during 6 days, the AUC of ramipril was increased by 21% while the Cmax was decreased by 63%.
Maltese: Wara l-għoti konkomitanti ta' lixisenatide 20 mcg u ramipril 5 mg għal 6 ijiem, l-AUC ta' ramipril ġie miżjud b'21% filwaqt li Cmax naqas bi 63%.
English: Lixisenatide 20 mcg (N= 160)
Maltese: Lixisenatide 20 mcg
English: The pen can be used for 14 days when stored at a temperature below 30°C.
Maltese: Il-pinna tista' tintuża għal 14-il ġurnata meta tinħażen f'temperatura taħt 30°C.
English: The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment.
Maltese: Il-maġġoranza tar-reazzjonijiet kienu ħfief fl-intensità u normalment ma wasslux għall waqfien tat-trattament.
English: Viral infection
Maltese: Ċistite Infezzjoni virali
English: Metabolism and nutrition disorders
Maltese: Disturbi talmetaboliżmu u tannutriment
English: The reductions in fasting plasma glucose obtained with Lyxumia treatment ranged from 0.42 mmol/L to 1.19 mmol/L (7.6 to 21.4 mg/dl) from baseline at the end of the main 24-week treatment period in placebo-controlled studies.
Maltese: 42 mmol/L sa 1.19 mmol/L (7.6 sa 21.4 mg/dl) mil-linja bażi fl-aħħar parti tal-perijodu prinċipali ta' kura ta' 24 ġimgħa fi studji kkontrollati bil-plaċebo.
English: • Body weight
Maltese: • Influwenza
English: Allergic reactions possibly associated with lixisenatide (such as anaphylactic reaction, angioedema and urticaria) have been reported in 0.4% of lixisenatide patients while possibly associated allergic reactions occurred in less than 0.1% of placebo patients during the main 24-week treatment period.
Maltese: Reazzjonijiet allerġiċi, wisq probabbli assoċjati ma' lixisenatide (bħal reazzjoni anafilattika, anġjoedema u urtikarja) kienu rrapportati f'0.4% tal-pazjenti fuq lixisenatide waqt li reazzjonijiet allerġiċi wisq probabbli assoċjati mal-kura seħħew f'inqas minn 0.1% tal-pazjenti fuq plaċebo matul il-perjodu prinċipali ta' kura ta' 24 ġimgħa.
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Maltese: Wara l-għoti konkomitanti ta' lixisenatide 20 mcg u digoxin 0.25 mg fi stat fiss, l-AUC ta' digoxin ma kienx affettwat.
English: In parallel, glucagon secretion is suppressed.
Maltese: B'mod simili, is-sekrezzjoni ta' glucagon hija mrażżna.
English: • Viral infection
Maltese: • Ċistite • Infezzjoni virali
English: There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Maltese: Ma kien hemm l-ebda differenza fil-profil tas-sigurtà globali f'pazjenti irrispettivament mill-istat tagħhom tal-antikorpi b'eċċezzjoni ta' żieda fl-inċidenza ta' reazzjonijiet fis-sit tal-injezzjoni (4.7% f'pazjenti li kienu pożittivi għall-antikorpi mqabbel ma' 2.5% tal-pazjenti negattivi għall-anti-korpi matul il-perijodu kollu ta' kura).
English: Patients (%) achieving HbA1c <7.0% Mean body weight (kg) Baseline
Maltese: Pazjenti (%) li laħqu HbA1c < 7.0 %
English: During clinical studies, doses up to 30 mcg of lixisenatide twice a day were administered to type 2 diabetic patients in a 13-week study.
Maltese: Waqt studji kliniċi, dożi sa 30 mcg ta' lixisenatide darbtejn kuljum ingħataw lil pazjenti bid-dijabete tat tip 2 fi studju li dam 13-il ġimgħa.
English: An increased incidence of gastrointestinal disorders was observed.
Maltese: Kien hemm żjieda fl-inċidenza ta' disturbi gastrointestinali.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Water for injections
Maltese: hydrochloric acid (għall-aġġustament tal-pH ), soluzzjoni ta' sodium hydroxide (għall-aġġustament tal-pH ) u ilma għall-injezzjonijiet.
English: People aged ≥70 years The efficacy and safety of lixisenatide in people aged ≥70 years with type 2 diabetes was evaluated in a double-blind, placebo-controlled study of 24 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' lixisenatide f'nies ta' età ≥70 sena bid-dijabete mellitus tat-tip 2 ġew evalwati f'studju kkontrollat bil-plaċebo, double-blind u li dam 24 ġimgħa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 20 micrograms lixisenatide (100 micrograms per ml).
Maltese: Kull doża (0.2 ml) fiha 20 mikrogramma lixisenatide (100 mikrogramma kull ml).
English: If it is orange, go to Section 2.
Maltese: Segwi l-proċeduri kollha f'Sezzjoni 2.
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Maltese: Huwa mistenni li jkun hemm aktar dewmien għat-tmax u aktar tnaqqis fis-Cmax ta' paracetamol bid-doża ta' manteniment ta' 20 mcg.
English: Efficacy of Lyxumia was also assessed in two randomised, open-label, active-controlled study (versus exenatide or versus insulin glulisine) and in a meal time study (in total 1,067 patients randomised to lixisenatide).
Maltese: L-effikaċja ta' Lyxumia ġiet ukoll eżaminata f'żewġ studji magħmula b'mod arbitrarju, open-label u kkontrollati b'mod attiv (kontra exenatide jew kontra insulin glulisine) u f'studju magħmul fil-ħin tal-ikel (fit-total, b'mod arbitrarju ntagħżlu 1,067 pazjent għal ma' lixisenatide).
English: Table 4: Placebo-controlled studies in combination with a basal insulin (24-week results) Basal insulin as background therapy Alone or in combination with metformin
Maltese: Tabella 4: Studji kkontrollati bi plaċebo flimkien ma' insulina bażilari (riżultati wara 24 ġimgħa)
English: • Feeling dizzy
Maltese: • Piż tal-ġisem
English: Turn over
Maltese: sek klikk
English: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).
Maltese: Lyxumia hu indikat għall-kura tal-adulti b'dijabete mellitus tat-tip 2 biex jinkiseb kontroll gliċemiku flimkien ma' prodotti mediċinali orali li jnaqqsu l-livell tal-glukosju fid-demm u/jew insulina bażilari meta dawn, flimkien mad-dieta u l-eżerċizzju ma jipprovdux kontroll gliċemiku adegwat (ara sezzjonijiet 4.4 u 5.1 għal tagħrif li hemm dwar it-teħid flimkien ta' prodotti differenti).
English: Ninety-six percent of the patients in both treatment groups completed the study in accordance with the protocol and the vital status was known at the end of the study for 99.0% and 98.6% of the patients in the lixisenatide and placebo group, respectively.
Maltese: Sitta u disgħin fil-mija tal-pazjenti fiż-żewġ gruppi ta' trattament lestew l-istudju skont il-protokoll u listat vitali fl-aħħar tal-istudju kien magħruf għal 99.0% u 98.6% tal-pazjenti fil-grupp ta' lixisenatide u talplaċebo, rispettivament.