FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24-week open-label study, lixisenatide administered before the main meal of the day was non-inferior to lixisenatide administered before breakfast in terms of HbA1c reduction (LS mean change from baseline: -0.65% versus -0.74%).
Maltese: F'studju open-label li dam 24 ġimgħa, lixisenatide mogħti qabel l-ikla prinċipali tal-ġurnata kien mhux inferjuri għal lixisenatide mogħti qabel il-kolazzjon f'dak li għandu x'jaqsam it-tnaqqis fl-HbA1c (bidla medja LS mil-linja bażi: -0.65% kontra -0.74%).
English: The table also includes adverse reactions with a frequency ≥1% in the Lyxumia group if the frequency was greater than 2 times the frequency for all comparators group.
Maltese: It-tabella tinkludi wkoll reazzjonijiet avversi bi frekwenza ≥1% fil-grupp Lyxumia jekk il-frekwenza kienet aktar minn darbtejn il-frekwenza ta' kull grupp ta' komparaturi.
English: The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age).
Maltese: L-effikaċja klinika u s-sigurtà ta' Lyxumia ġew evalwati f'disa' studji kliniċi magħmula b'mod arbitrarju, ikkontrollati bil-plaċebo u double-blind li inkludew 4,508 pazjenti bid-dijabete tat-tip 2 (2,869 pazjent intagħżlu b'mod arbitrarju għal ma' lixisenatide, 47.
English: Lyxumia 20 micrograms solution for injection Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml).
Maltese: Kull doża (0.2ml) fiha 20 mikrogramma (mcg) ta' lixisenatide (100 mcg għal kull ml).
English: This effect on HbA1c was sustained in long term studies for up to 76 weeks.
Maltese: Dan l-effett fuq HbA1c kien sostnut fi studji fit-tul sa 76 ġimgħa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 micrograms lixisenatide (50 micrograms per ml).
Maltese: Kull doża (0.2 ml) fiha 10 mikrogrammi lixisenatide (50 mikrogramma kull ml).
English: Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection lixisenatide
Maltese: Lyxumia 10 mikrogrammi soluzzjoni għall-injezzjoni Lyxumia 20 mikrogramma soluzzjoni għall-injezzjoni Lixisenatide
English: Add-on combination therapy with a basal insulin
Maltese: Terapija miżjuda ma' insulina bażilari
English: In the subset of patients (5.2%) with the highest antibody concentrations, the mean improvement in HbA1c at Week 24 and at Week 76 was in a clinically relevant range; however there was variability in the glycaemic response and 1.9% had no decrease in HbA1c.
Maltese: Fis-sottogrupp ta' pazjenti (5.2%) bl-akbar konċentrazzjonijiet għoljin ta' antikorpi, it-titjib medju fl-HbA1c fl-24 Ġimgħa u fis-76 Ġimgħa kien fl-iskala klinikament rilevanti; madankollu kien hemm varjabilità fir-rispons gliċemiku u 1.9% ma kellhom ebda tnaqqis fl-HbA1c .
English: Efficacy and safety of Lyxumia in patients older than 70 years was addressed in a specifically dedicated placebo-controlled study (176 patients randomised to lixisenatide, including 62 patients ≥75 years of age).
Maltese: L-effikaċja u s-sigurtà ta' Lyxumia f'pazjenti ikbar minn 70 sena ġew indirizzati b'studju kkontrollat bilplaċebo ddedikat speċifikament għalihom (176 pazjent intagħżlu b'mod arbitrarju għal ma' lixisenatide, li inkludew 62 pazjent ≥75 sena ta' età).
English: Following administration of a single dose of paracetamol 1,000 mg, paracetamol AUC and t1/2 were unchanged whatever the timing of its administration (before or after the lixisenatide injection).
Maltese: Wara l-għoti ta' doża waħda ta' 1000mg ta' paracetamol, il-paracetamol AUC u t1/2 kienu l-istess irrispettivament mill-ħin tal-amministrazzjoni (qabel jew wara l-injezzjoni tal-lixisenatide).
English: • Low blood sugar (hypoglycaemia (“hypo”) especially when Lyxumia is used with insulin or a sulphonylurea
Maltese: • Livell baxx ta' zokkor fid-demm (Ipogliċemija (“ipo”) speċjalment meta Lyxumia jintuża ma' l insulina jew xi sulphonylurea.
English: Overall, 6068 patients were randomized 1:1 to either placebo or lixisenatide 20 mcg (following a starting dose of 10 mcg during the first 2 weeks).
Maltese: Fit-total, 6068 pazjent intagħżlu b'mod arbitrarju 1:1 għal jew plaċebo jew lixisenatide 20 mcg (wara doża inizjali ta' 10 mcg għall-ewwel ġimgħatejn).
English: Overall, the incidence of severe symptomatic hypoglycaemia was uncommon (0.4% in lixisenatide patients and 0.2% in placebo patients) during the entire treatment period of the Phase III placebo-controlled studies.
Maltese: B'mod ġenerali, l-inċidenza ta' ipogliċemija severa sintomatika ma kinitx komuni (0.4% f'pazjenti fuq lixisenatide u 0.2% f'pazjenti fuq plaċebo) matul il-perijodu kollu ta' kura tal-istudji tat-Tielet Fażi kkontrollati bi plaċebo.
English: This is done once and is called the ‘activation' process.
Maltese: Din ssir darba u tissejjaħ il-proċess t'“attivazzjoni”.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Maltese: Id-dewmien tat-tbattil gastriku b'lixisenatide jista' jnaqqas ir-rata ta' assorbiment ta' prodotti mediċinali li jittieħdu b'mod orali.
English: Median treatment duration was 22.4 months in the lixisenatide group and 23.3 months in the placebo group, and the median duration of study follow-up was 25.8 and 25.7 months, respectively.
Maltese: 23.3 xhur fil-grupp tal-plaċebo, u ż-żmien medjan tal-istudju sussegwenti kien ta' 25.8 u 25.
English: • Beta cell function
Maltese: • Il-funzjoni taċ-ċelloli beta
English: In patients taking Lyxumia in monotherapy, symptomatic hypoglycaemia occurred in 1.7% of lixisenatide treated patients and in 1.6% of placebo treated patients.
Maltese: Meta Lyxumia ntuża waħdu bħala kura, kien hemm ipogliċemija sintomatika f'1.7% tal-pazjenti kkurati b'lixisenatide u f'1.6% tal-pazjenti kkurati bil-plaċebo.
English: Step 3 Pull injection button out
Maltese: Proċedura 3 Iġbed il-buttuna tal-injezzjoni 'l barra
English: In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
Maltese: F'studji ta' żvilupp embriju-fetali , ritardazzjoni fliżvilupp, ossifikazzjoni mtawla u effetti skeletriċi ġew osservati b'lixisenatide, fil-firien f'kull doża (proporzjon ta' espożizzjoni ta' 5 darbiet meta mqabbel mal-espożizzjoni umana) u fil-fniek, f'dożi għoljin (proporzjon ta' espożizzjoni ta' 32 darba meta mqabbel mal-espożizzjoni umana) .
English: Evening (N= 255)
Maltese: Filgħaxija (N= 255)
English: Important information about some of the ingredients of Lyxumia This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Tagħrif importanti dwar xi ingredjenti ta' Lyxumia Din il-mediċina fiha inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e. bażikament “mingħajr sodium”.
English: • The purple pen contains 14 pre-set doses; each dose contains 20 micrograms of Lyxumia.
Maltese: • Il-pinna l-vjola fiha 14-il doża mqassma minn qabel ; kull doża fiha 20 micrograms ta' Lyxumia.
English: BATCH NUMBER BN
Maltese: (kg) Linja Bażi
English: At the end of the study, 43.6% (main meal group) and 42.8% (breakfast group) of patients achieved an HbA1c less than 7%.
Maltese: Fl-a ħħar tal-istudju, 43.6% (grupp tal-ikla prinċipali) u 42.8% (grupp tal-kolazzjon) tal-pazjenti kisbu HbA1c ta' inqas minn 7%.
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15-30 ml/min), AUC was increased by 46%, 51% and 87%, respectively.
Maltese: F'individwi b'indeboliment renali ħafif (it-tneħħija tal-krejatinina kkalkulata bil-formula Cockcroft-Gault 60-90 ml/min), moderat (tneħħija tal-krejatinina 30-60 ml/min) u sever (tneħħija tal-krejatinina 15
English: In addition, a double-blind, placebo-controlled cardiovascular outcome study (ELIXA) enrolled 6,068 type 2 diabetes patients with previous acute coronary syndrome (3,034 randomised to lixisenatide,
Maltese: daħħal 6,068 pazjent bid-dijabete tat-tip 2 li diġà kellhom sindromu koronarju akut (3,034 intagħżlu b'mod arbitrarju għal ma' lixisenatide, li inkludew 198 pazjent ≥75 sena ta' età u 655 pazjent b'indeboliment renali moderat).
English: Headache
Maltese: Twaqqif
English: Placebo (N= 157)
Maltese: (N= 157)
English: OTHER
Maltese: IMPORTANTI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 (1 pre-filled pen + 1 pre-filled pen)
Maltese: EU/1/12/811/005 (pinna 1 mimlija għal-lest + pinna 1 mimlija għal-lest)
English: INFORMATION IN BRAILLE Lyxumia
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Maltese: L-oriġini etnika ma kellha l-ebda effett kliniku rilevanti fuq il-farmakokinetika ta' lixisenatide wara analiżi tar-riżultati ta' studji farmakokinetiċi fuq individwi Kawkasi, Ġappuniżi u Ċiniżi.
English: Placebo (N= 159)
Maltese: (N = 159)
English: Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
Maltese: Formulazzjonijiet gastro-reżistenti li fihom sustanzi sensittivi għad-degradazzjoni fl-istonku, għandhom jingħataw siegħa qabel jew 4 sigħat wara l-injezzjoni tal-lixisenatide.
English: Rubber seal
Maltese: Żomm Armi
English: Black plunger
Maltese: Buttuna talinjezzjoni
English: Lyxumia 20 micrograms solution for injection Lixisenatide
Maltese: Lyxumia 20 mikrogramma soluzzjoni għall-injezzjoni Lixisenatide
English: Treatment with Lyxumia in combination with metformin and/or a sulphonylurea resulted in a sustained body weight change from baseline in all controlled studies in a range from -1.76 kg to2.96 kg at the end of the main 24-week treatment period.
Maltese: Kura b'Lyxumia flimkien ma' metformin u/jew xi sulphonylurea wassal għal bidla sostnuta fil-piż talġisem mil-linja bażi fl-istudji kollha kkontrollati f'firxa minn -1.76 kg sa -2.96 kg fl-aħħar tal-perijodu prinċipali ta' kura ta' 24 ġimgħa.
English: Body weight change from baseline in a range from -0.38 kg to -1.80 kg was also observed in lixisenatide patients receiving stable basal insulin dose, alone or in combination with metformin or a sulphonylurea.
Maltese: 38 kg sa -1.80 kg kienet osservata wkoll f'pazjenti fuq lixisenatide li kienu qed jirċievu doża stabbli ta' insulina bażilari, waħidha jew flimkien ma' metformin jew xi sulphonylurea.
English: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg.
Maltese: 3ml soluzzjoni, u tagħti 14-il doża ta' 10mcg.
English: Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 20 micrograms.
Maltese: Kull pinna vjola ta' Lyxumia 20 mikrogramma soluzzjoni għall-injezzjoni fiha 3 ml ta' soluzzjoni, li tagħti 14-il doża ta' 20 mikrogramma.
English: • Do not use Lyxumia after the expiry date which is stated on the label and on the carton.
Maltese: • Tużax Lyxumia wara d-data ta' meta tiskadi li tidher fuq it-tikketta u fuq il-kartuna.
English: Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 10 micrograms.
Maltese: Kull pinna ħadra ta' Lyxumia 10 mikrogrammi soluzzjoni għall-injezzjoni fiha 3 ml ta' soluzzjoni, li tagħti 14-il doża ta' 10 mikrogrammi.
English: Anaphylactic reactions were reported in 0.2% of the lixisenatide treated patients vs. none in the placebo group.
Maltese: Reazzjonijiet anafilattiċi ġew irrapportati f'0.2% tal-pazjenti kkurati b'lixisenatide kontra ebda rapport fil-grupp tal-plaċebo.
English: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg.
Maltese: 3ml soluzzjoni, u tagħti 14-il doża ta' 20mcg.
English: Purple 20 microgram Lyxumia pen
Maltese: Lyxumia 20 mcg injezzjoni Lixisenatide
English: Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15.
Maltese: Doża ta' manteniment: doża fissa ta' manteniment ta' 20 mcg lixisenatide darba kuljum tinbeda fil-15-il ġurnata.
English: At the end of the 24-week main treatment period, 52.3% of the lixisenatide patients achieved an HbA1c less than 7% compared to 26.4% in the placebo group.
Maltese: Fl-aħħar tal-perijodu prinċipali ta' kura ta' 24-ġimgħa, 52.3% tal-pazjenti fuq lixisenatide kisbu livell ta' HbA1c inqas minn 7% meta mqabbel ma' 26.4% fil-grupp talplaċebo.
English: Click secs
Maltese: Klikk sekondi
English: • Once your Lyxumia pen is activated it can be used for up to 14 days.
Maltese: • Ladarba l-pinna Lyxumia tiegħek ġiet attivata tista' tintuża għal 14-il ġurnata.
English: The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period.
Maltese: L-inċidenza ta' twaqqif tal-kura minħabba avvenimenti avversi kienet 7.4% għal Lyxumia meta mqabbla ma' 3.2% fil-grupp plaċebo matul il-perjodu prinċipali ta' kura ta' 24 ġimgħ.
English: What if there are air bubbles in the container?
Maltese: X'nagħmel jekk hemm il-bżieżaq tal-arja fil-kontenitur?
English: Table 5: Active-controlled study in combination with basal insulin with or without metformin (26-week results) - (mITT) and safety population
Maltese: Studju b'kontroll attiv flimkien ma' insulina bażilari b'metformin jew mingħajr (riżultati ta' 26-ġimgħa) - (mITT) u popolazzjoni ta' sigurtà
English: One purple 20 microgram pen (Lyxumia 20 micrograms solution for injection), each dose contains 20 micrograms in 0.2 ml.
Maltese: Pinna waħda vjola ta' 20 mikrogramma (Lyxumia 20 mikrogramma soluzzjoni għall-injezzjoni), kull doża fiha 20 mikrogramma f'0.2 ml
English: Lyxumia should not be used with a combination of both basal insulin and sulphonylurea
Maltese: Lyxumia m'għandux jintuża f'taħlita fejn hemm kemm l-insulina bażilari u sulphonylurea.
English: The addition of lixisenatide led to a significantly greater HbA1c decrease of 0.71% in the lixisenatide group compared to 0.40% in the placebo group.
Maltese: Iż-żieda ta' lixisenatide wassal għal ammont akbar u sinifikanti ta' tnaqqis fl-HbA1c ta' 0.71% fil-grupp ta' lixisenatide meta mqabbel ma' 0.4% fil-grupp tal-plaċebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lyxumia 10 micrograms solution for injection Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).
Maltese: Kull doża (0.2ml) fiha 10 mikrogrammi (mcg) ta' lixisenatide (50 mcg kull ml).
English: Step D. Press and hold the injection button to inject the dose
Maltese: Dan jgħin sabiex tippreveni l-kontaminazzjoni ta'
English: Patients received stable dose(s) of oral antidiabetic drug(s) (OAD) and/or basal insulin as background therapy.
Maltese: Il-pazjenti rċevew doża(i) stabbli ta' mediċina(i) orali kontra ddijabete (OAD) u/jew insulin bażali bħala terapija ta' sfond.
English: Nausea
Maltese: Pinna
English: The most common adverse reactions which led to treatment discontinuation in the lixisenatide group were nausea (3.1%) and vomiting (1.2%).
Maltese: Ir-reazzjonijiet avversi l aktar komuni li wasslu għal waqfien tal-kura fil-grupp ta' lixisenatide kienu dardir (3.1%) u rimettar
English: Purple 20 micrograms pen activation The purple 20 micrograms Lyxumia pen must also be activated before use.
Maltese: Il-pinna Lyxumia l-vjola ta' 20 mikrogramma trid tiġi wkoll attivata qabel ma tintuża.
English: Table 2: Placebo-controlled studies in combination with metformin (24-week results).
Maltese: Terapija miżjuda ma' metformin waħdu Tabella 2: Studji kkontrollati bi plaċebo flimkien ma' metformin (riżultati wara 24 ġimgħa)
English: • The green pen contains 14 pre-set doses; each dose contains 10 micrograms of Lyxumia.
Maltese: • Il-pinna l-ħadra fiha 14-il doża mqassma minn qabel ; kull doża fiha 10 micrograms ta' Lyxumia.
English: Hospitalization for unstable angina
Maltese: Ilma għall-injezzjoni
English: 2 years.
Maltese: 2% bi plaċebo.
English: Coronary revascularization 368 (12.1%) 356 (11.7%) procedure
Maltese: primarju + HF + Revasc 661 (21.8%) 659 (21.7%)
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Maltese: Studji fl-annimali ma jindikawx effetti diretti ta' ħsara fuq il-fertilità.
English: Dizziness Somnolence
Maltese: Reazzjonijiet allerġiċi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lyxumia 10 mcg injection
Maltese: Lyxumia 10 mcg injezzjoni Lixisenatide
English: Within each system organ class, adverse reactions are presented in order of decreasing frequency.
Maltese: F'kull sistema tal-klassifika tal-organi, ir-reazzjonijiet avversi huma pprezentati f'ordni li l-anqas frekwenti jiġi l-aħħar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 - 2 pens
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/811/005 2 pinen
English: The change in HbA1c from baseline was similar regardless of the antibody status (positive or negative).
Maltese: Il-bidla fil-HbA1c mil-linja bażi kienet simili irrispettivament mill-istat tal-antikorpi (pożittivi jew negattivi).
English: After 12-week of optimal insulin glargine titration with or without metformin, inadequately controlled patients were randomised to add single dose of lixisenatide or a single dose (QD) of insulin glulisine (both before the largest meal) or insulin glulisine administered three times a day (TID) for 26 weeks.
Maltese: Wara 12-il ġimgħa ta' titrazzjoni mill-aħjar possibbli permezz ta' insulin glargine flimkien jew mingħajr metformin, pazjenti li ma kinux ikkontrollati b'mod adegwat, b'mod arbitrarju, ġew mogħtija wkoll doża waħda ta' lixisenatide jew doża waħda (QD) ta' insulin glulisine (it-tnejn qabel l-akbar ikla) jew insulin glulisine mogħti tliet darbiet kuljum (TID) għal 26 ġimgħa.
English: - The other ingredients are glycerol 85 %, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment), sodium hydroxide solution (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma glycerol 85 %, sodium acetate trihydrate, methionine, metacresol,
English: • Each Lyxumia pen contains 14 pre-set doses.
Maltese: • Kull pinna Lyxumia fiha 14-il doża mqassma minn qabel.
English: Then use the purple 20 micrograms Lyxumia pen.
Maltese: Imbagħad uża l-pinna Lyxumia l-vjola ta' 20 mikrogramma.
English: One case of anaphylactoid reaction was reported during clinical trials with lixisenatide.
Maltese: Disfunzjoni tal-fwied mhux mistennija li taffettwa lfarmakokinetika ta' lixisenatide.
English: Click
Maltese: Lott
English: This effect on post-prandial glucose was confirmed in a 4-week study versus liraglutide 1.8 mg once a day in combination with metformin.
Maltese: Dan l-effett fuq il-glukosju wara l-ikel kien ikkonfermat fi studju li dam sejjer 4 ġimgħat kontra liraglutide 1.8 mg darba kuljum flimkien ma' metformin.
English: One green 10 microgram pen (Lyxumia 10 micrograms solution for injection), each dose contains 10 micrograms in 0.2 ml.
Maltese: Pinna waħda ħadra ta' 10 mikrogrammi (Lyxumia 10 mikrogrammi soluzzjoni għall-injezzjoni), kull doża fiha 10 mikrogrammi f'0.2 ml.
English: Uncommon side effect: may affect up to 1 in 100 people • Hives (urticaria)
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa persuna 1 minn kull 100
English: BN
Maltese: QD
English: INFORMATION IN BRAILLE Lyxumia 20
Maltese: Jekk tinsa tuża Lyxumia
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Pack size of 1 pre-filled pen.
Maltese: Iċċekkja n-numru ta' dożi fil-pinna.
English: Both pens are used in the same way.
Maltese: Kull pinna fiha qawwa differenti ta' Lyxumia.
English: Reduction of the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia (see section 4.2).
Maltese: Għandu jiġi kkunsidrat tnaqqis tad-doża tas-sulphonylurea jew tal-insulina bażilari biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.2).
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 1530 ml/min) AUC was increased by 46%, 51% and 87%, respectively.
Maltese: 30 ml/min) l-AUC żdied b'46%, 51% u 87% rispettivament.
English: In a clinical study, the addition of lixisenatide to pioglitazone with or without metformin, in patients not adequately controlled with pioglitazone, resulted in an HbA1c decrease from baseline of 0.90%, compared to a decrease from baseline of 0.34% in the placebo group at the end of the 24-week main treatment period.
Maltese: F'studju kliniku, iż-żieda ta' lixisenatide ma' pioglitazone flimkien ma' metformin jew mingħajru, f'pazjenti li ma kinux ikkontrollati b'mod adegwat b'pioglitazone, wassal għal tnaqqis fl-HbA1c ta' 0.90% mil-linja bażi meta mqabbel ma' tnaqqis ta' 0.34% mil-linja bażi fil-grupp tal-plaċebo fl-aħħar talperijodu prinċipali ta' kura ta' 24-ġimgħa.
English: Injections site reactions were reported in 3.9% of the patients receiving Lyxumia while they were reported in 1.4% of patients receiving placebo during the main 24-week treatment period.
Maltese: Reazzjonijiet fis-sit tal-injezzjonijiet kienu rrapportati fi 3.9% tal-pazjenti li kienu qed jieħdu Lyxumia filwaqt li dawn kienu rrappurtati f'1.4% tal-pazjenti li rċevew plaċebo matul il-perjodu ta' kura prinċipali li dam 24 ġimgħa.
English: Sulphonylurea as background therapy with or without metformin Lixisenatide 20 mcg (N= 570)
Maltese: Terapija miżjuda ma' xi sulphonylurea waħdu jew flimkien ma'metformin Tabella 3: Studju kkontrollat bi plaċebo flimkien ma' xi sulphonylurea (riżultati wara 24 ġimgħa)
English: - you suffer from heart problems which can cause shortness of breath or ankle swelling, since there is limited experience in this population.
Maltese: tbati minn problemi fil-qalb li jistgħu jikkawża qtugħ ta' nifs jew nefħa fl-għekiesi peress li lesperjenza hija limitata f'din il-popolazzjoni.
English: Paracetamol was used as a model medicinal product to evaluate the effect of lixisenatide on gastric emptying.
Maltese: Paracetamol kien użat bħala mudell ta' prodott mediċinali biex jiġi evalwat l-effett ta' lixisenatide fuq ittbattil tal-istonku.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Maltese: Jekk le, tużax dan il-pakkett Inizjali ta' Kura.
English: During the 24-week main treatment period, nausea was reported in 23.5% in the lixisenatide group compared to 10.6% in the placebo group and symptomatic hypoglycaemia was reported in 3.4% of the lixisenatide patients compared to 1.2% in the placebo group.
Maltese: 6% tal-grupp tal-plaċebo u l-ipogliċemija sintomatika kienet irrapportata f'3.4% tal-pazjenti fuq lixisenatide meta mqabbel ma' 1.2% fil-grupp tal-plaċebo.
English: Purple 20 microgram pen Use
Maltese: Kull doża fiha 20 mikrogramma ta'
English: The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heart beat and feeling jittery.
Maltese: Is-sinjali ta' twissija ta' livell baxx ta' zokkor fid-demm jistgħu jinkludu għaraq kiesaħ, ġilda pallida u kiesħa, uġigħ ta' ras, tħossok imħeddel/la, għajjien/a, sturdut/a, konfuż/a jew irritabbli, tħossok bil-ġuħ, ilqalb tħabbat b'ritmu mgħaġġel u tħossok nervuż.
English: Arrow window
Maltese: TAGĦRIF
English: This helps prevent contamination of Lyxumia or possible needle blockage.
Maltese: Dan jgħin biex jiġu evitati l kontaminazzjoni u potenzjalment l-imblukkar tal-labra.
English: INFORMATION IN BRAILLE Lyxumia 10
Maltese: Lyxumia 10