FrancophonIA/ELRC3.0 huggingface dataset:
English: The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (-1.29% and -1.51% vs -0.88%, p<0.0001).
Maltese: It-tnaqqis fl-HbA1c u s-superjorità vs sitagliptin, osservati wara 26 ġimgħa ta' kura b'liraglutide (1.2 mg u 1.8 mg) inżammu wkoll wara 52 ġimgħa ta' kura (1.29 % u -1.51 % vs -0.88 %, p<0.0001).
English: Each pen contains 3 ml solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni, li tforni 30 doża ta' 0.6 mg, 15-il doża ta' 1.2 mg jew 10 dożi ta' 1.8 mg.
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 biex jiġu ppreżentati 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 aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor).
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod frekwenti waqt il-provi kliniċi kienu disturbi gastrointestinali: nawseja u dijarea kienu komuni ħafna, filwaqt li rimettar, stitikezza, uġigħ addominali, u dispepsja kienu komuni.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Skartoċċ (ħġieġ ta' tip I), bi planger (bromobutyl) u folja laminata tal-lastku (bromobutyl/polyisoprene) f'pinna mimlija għal-lest li tagħti ħafna dożi u li tintrema wara li tintuża, magħmula minn polyolefin u polyacetal.
English: Based on adequate glycaemic control or tolerability, 30% of trial subjects remained on a dose of 0.6 mg, 17% escalated to a dose of 1.2 mg and 53% escalated to a dose of 1.8 mg.
Maltese: Abbażi ta' kontroll gliċemiku adegwat jew tollerabilità, 30% tas-suġġetti fil-prova baqgħu fuq doża ta' 0.6 mg, 17% telgħu għal doża ta' 1.2 mg u 53% telgħu għal doża ta' 1.8 mg.
English: Mean weight change from baseline (kg)
Maltese: Tibdil medju fil-piż millinja bażi (kg)
English: Rate of confirmed hypoglycaemic episodes was higher with liraglutide (0.58 events/patient year) compared to placebo (0.29 events/patient year).
Maltese: Ir-rata ta' episodji kkonfermati ta' ipogliċemija kienet ogħla b'liraglutide (0.58 avvenimenti/sena ta' pazjent) meta mqabbel ma' plaċebo (0.29 avvenimenti/sena ta' pazjent).
English: The risk of hypoglycaemia is low with combined use of basal insulin and liraglutide (1.0 events per patient year, see section 5.1).
Maltese: Ir-riskju ta' ipogliċemija hija baxxa meta l-insulina bażilari u liraglutide jintużaw flimkien (1.0 avvenimenti għal kull pazjent fis-sena, ara taqsima 5.1).
English: Flatulence Abdominal distension Gastroesophageal reflux disease Abdominal discomfort Toothache
Maltese: Gastrite Gass fl istonku Nefħa addominali Mard tarrifluss gastroesofagali
English: Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Maltese: Pazjenti >70 sena jista' jkollhom aktar effetti gastrointestinali meta kkurati b'liraglutide.
English: Following subcutaneous administration, the protracted action profile is based on three mechanisms: self-association, which results in slow absorption; binding to albumin; and higher enzymatic stability towards the dipeptidyl peptidase -4 (DPP-4) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half-life.
Maltese: Wara l-għoti taħt il-ġilda, il-profil imtawwal talazzjoni hu bbażat fuq tliet mekkaniżmi: awto-assoċjazzjoni, li tirriżulta f'assorbiment bil-mod; rabta mal-albumina; u stabbiltà enzimatika ogħla kontra l-enzimi dipeptidyl peptidase -4 (DPP-4) u endopeptidase newtrali (NEP), li jirriżultaw f''half-life itwal fil-plażma .
English: In the LEADER trial, (see subsection Cardiovascular evaluation), 873 patients were on premix insulin (with or without OAD(s)) at baseline and at least for the following 26 weeks.
Maltese: Fil-prova LEADER, (ara sottosezzjoni Evalwazzjoni kardjovaskulari), 873 pazjent kienu fuq insulina mħallta minn qabel (flimkien ma' OAD(s) jew mingħajr) fil-linja bażi u għal mill-inqas is-26 ġimgħa sussegwenti.
English: A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
Maltese: Forma severa ta' stitikezza b'sintomi addizzjonali bħal uġigħ flistonku, nefħa fl-istonku, rimettar eċċ.
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results (LEADER) trial, was a multicentre, placebo-controlled, double-blind clinical trial.
Maltese: Il-prova tal-Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results
English: EU/1/09/529/001-005
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/529/001-005
English: • Beta-cell function
Maltese: fil-linja bażi
English: Age had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results from a pharmacokinetic study in healthy subjects and population pharmacokinetic data analysis of patients (18 to 80 years).
Maltese: L-età ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' liraglutide, ibbażat fuq irriżultati ta' studju dwar il-farmakokinetika f'persuni b'saħħithom, u analiżi dwar id-dejta talfarmakokinetika tal-popolazzjoni tal-pazjenti (minn 18 sa 80 sena).
English: Nasopharyngitis Bronchitis
Maltese: Revaskularizzazzjoni koronarja
English: • Indigestion
Maltese: • Indiġestjoni
English: Urticaria Pruritus
Maltese: Popolazzjoni pedjatrika
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Maltese: Kalundborg Id-Danimarka
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p<0.0001).
Maltese: F'prova open-label li qabblet l-effikaċja u s-sigurtà ta' liraglutide 1.8 mg ma' lixisenatide 20 mcg f'404 pazjenti li ma kinux ikkontrollati b'mod adegwat bit-terapija ta' metformin (medja ta' HbA1c ta' 8.4%) , liraglutide kien superjuri għal lixisenatide biex inaqqas l-HbA1c wara 26 ġimgħa ta' trattament (­1.83% vs -1.21%, p<0.0001).
English: Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score >9).
Maltese: L-espożizzjoni kienet aktar baxxa b'mod sinifikanti (44 %) f'persuni b'indeboliment sever tal-fwied (punteġġ Child Pugh ta' >9).
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA MANIFATTUR RESPONSABBLI
English: Population pharmacokinetic analysis suggests that body mass index (BMI) has no significant effect on the pharmacokinetics of liraglutide.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni tissuġġerixxi li l-indiċi tal-piż tal-ġisem (BMI) ma kellu lebda effett sinifikanti fuq il-farmakokinetika ta' liraglutide.
English: Clinical trials with liraglutide indicate improved beta-cell function based on measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Maltese: (HOMO-B) u l-proporzjon ta' proinsulina mal-insulina, provi kliniċi b'liraglutide juru titjib fil funzjoni taċ-ċelluli beta.
English: • Inflamed gallbladder
Maltese: • Infjammazzjoni fil-bużżieqa tal-marrara
English: After first use: Store below 30°C or store in a refrigerator (2°C-8°C).
Maltese: Aħżen taħt temperatura ta' 30°C jew aħżen fi friġġ (2°C - 8°C).
English: The most frequent adverse reactions leading to withdrawal for liraglutide-treated patients were nausea (2.8% of patients) and vomiting (1.5%).
Maltese: Għal pazjenti kkurati b'liraglutide, l-iktar reazzjonijiet avversi frekwenti li wasslu biex ikollhom jieqfu milli jipparteċipaw fl-istudju kienu nawseja (2.8% tal-pazjenti) u rimettar (1.5%).
English: Tabulated list of adverse reactions
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi
English: The mean duration of diabetes was 12.8 years.
Maltese: żmien tad-dijabete kien medja ta' 12.8 snin.
English: Monotherapy
Maltese: Monoterapija
English: Posology
Maltese: KARTUNA
English: Over the duration of the phase 3a trials, liraglutide decreased the systolic blood pressure on average of 2.3 to 6.7 mmHg from baseline and compared to active comparator the decrease was 1.9 to 4.5 mmHg.
Maltese: Matul il-perijodu tal-provi ta' fażi 3a, liraglutide naqqas il-pressjoni sistolika tad-demm b'medja ta' 2.3 sa 6.7 mmHg mil-linja bażi u meta mqabbel mal-komparatur attiv it-tnaqqis kien ta' 1.9 sa
English: These trials included 3,978 exposed patients with type 2 diabetes mellitus (2,501 patients treated with liraglutide), 53.7% men and 46.3% women, 797 patients (508 treated with liraglutide) were ≥65 years of age and 113 patients (66 treated with liraglutide) were ≥75 years of age.
Maltese: Dawn il-provi kienu jinkludu 3,978 pazjent esposti b'dijabete mellitus ta' tip 2 (2,501 pazjent kkurati b'liraglutide), 53.7% irġiel u 46.3% nisa, 797 pazjent (508 ikkurati b' liraglutide) kellhom ≥65 sena u
English: Delayed gastric emptying
Maltese: Tbattil gastriku mdewwem
English: Addition of liraglutide resulted in a statistically significantly greater reduction of HbA1c (-0.73% for liraglutide vs -0.40% for comparator) and body weight (-3.03 vs 0.72 kg).
Maltese: Iż-żieda ta' liraglutide irriżulta f'tnaqqis akbar fl-HbA1c (-0.73% għal liraglutide vs -0.40% għall-komparatur) u fil-piż tal-ġisem (-3.03 vs 0.
English: Hepatobiliary disorders
Maltese: Indeboliment epatiku
English: Liraglutide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in cyclic adenosine monophosphate (cAMP).
Maltese: L-azzjoni ta' liraglutide issir permezz ta' interazzjoni speċifika mar-riċetturi GLP-1, li twassal għal żieda f'adenosine monophosphate ċikliku (cAMP).
English: Very common Common Uncommon Rare
Maltese: Komuni ħafna Komuni
English: Add-on to metformin (2,000 mg/day) + glimepiride (4 mg/day) Liraglutide 1.8 mg 230 8.3
Maltese: Plaċebo Żieda ma' metformin (2,000 mg/jum) + glimepiride (4 mg/jum)
English: In a double-blind study comparing the efficacy and safety of Victoza 1.8 mg versus placebo as add-on to metformin ± insulin in adolescents and children aged 10 years and above with type 2 diabetes, Victoza was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.06, [-1.65, 0.46]).
Maltese: F'studju double-blind li qabbel l-effikaċja u s-sigurtà ta' Victoza 1.8 mg kontra plaċebo bħala żieda ma' metformin ± insulin f'adolexxenti u tfal ta' 10 snin u 'l fuq bid-dijabete tat-tip 2, Victoza kien superjuri għat-trattament bi plaċebo fit-tnaqqis ta' HbA1c wara 26 ġimgħa (-1.06, [-1.65, 0.46]).
English: ss
Maltese: D.
English: (74.2% vs 45.5%, p<0.0001), as well as the HbA1c target below or equal 6.5% (54.6% vs 26.2%, p<0.0001).
Maltese: Numru sinifikanti iżjed ta' pazjenti laħqu livell ta' HbA1c taħt is-7% b'liraglutide meta mqabbel ma' lixisenatide (74.2% vs 45.5%, p<0.0001), kif ukoll il-mira ta' HbA1c ta' taħt jew ugwali għal 6.5 % (54.6% vs 26.
English: From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose.
Maltese: Fi provi kliniċi u l-użu fis-suq ġew irrapurtati dożi eċċessivi sa 40 darba aktar (72 mg) mid-doża rrakkomandata ta' manteniment.
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Maltese: Konsistenti mal-fatt li prodotti mediċinali li fihom il-proteini u l-peptides jista' jkollhom karatteristiċi immunoġeniċi, il-pazjenti jistgħu jiżviluppaw antikorpi anti-liraglutide wara l-kura b'liraglutide.
English: Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Victoza.
Maltese: Ftit kienu l-każijiet (0.05 %) ta' anġjoedima li ġew irrapportati waqt il-provi kliniċi kollha fit-tul ta' Victoza.
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Maltese: Il-bijodisponibilità assoluta ta' liraglutide wara l-għoti taħt il-ġilda hi ta' madwar 55%.
English: Liraglutide monotherapy for 52 weeks resulted in statistically significant and sustained reductions in HbA1c compared with glimepiride 8 mg (-0.84% for 1.2 mg, -1.14% for 1.8 mg vs -0.51% for comparator) in patients previously treated with either diet and exercise or OAD monotherapy at no more than half-maximal dose (Table 2).
Maltese: Il-monoterapija għal 52 ġimgħa b'liraglutide waslet għal tnaqqis fl-HbA1c li kien statistikament sinifikanti u li baqa' fiż-żmien meta mqabbel ma' glimepiride 8 mg (-0.84% għal 1.2 mg, -1.14% għal 1.8 mg vs -0.51% għall-komparatur) f'pazjenti li qabel kienu ġew ttrattati jew bid-dieta u bl-eżerċizzju jew b'monoterapija ta' OAD b'doża li ma kinitx taqbeż nofs id-doża massima (Tabella 2).
English: 9,340 patients were randomly allocated to either liraglutide (4,668) or placebo (4,672), both in addition to standards of care for HbA1c and cardiovascular (CV) risk factors.
Maltese: (LEADER) kienet prova klinika multiċentrika, double-blind u kkontrollata bil-plaċebo. 9,340 pazjent b'mod arbitrarju ġew magħżula biex jieħdu jew liraglutide (4,668) jew plaċebo (4,672), it-tnejn bħala żieda mal-kura standard għall-HbA1c u għall-fatturi ta' riskji kardjovaskulari (KV).
English: You may need medical treatment.
Maltese: Jista' jkollok bżonn ta' kura medika.
English: Add-on to metformin (2,000 mg/day) + rosiglitazone (4 mg twice daily) Liraglutide 1.2 mg 177 8.48
Maltese: Żieda ma' metformin (2,000 mg/jum) + rosiglitazone (4 mg darbtejn kuljum)
English: The pen is designed to be used with NovoFine or NovoTwist disposable injection needles up to a length of 8 mm and as thin as 32G (0.25/0.23 mm).
Maltese: Il-pinna Victoza hi maħsuba biex tintuża mal-labar għall injezzjoni NovoFine jew NovoTwist li jintremew wara li jintużaw u li jkollhom tul ta' mhux iżjed minn 8 mm u rquqija ta' 32G (0.25/0.23 mm).
English: Patients receiving liraglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia (see section 4.8).
Maltese: Pazjenti li jkunu qed jirċievu liraglutide flimkien ma' xi sulfonylurea jew xi insulina jista' jkollhom żieda fir-riskju ta' ipogliċemija (ara taqsima 4.8).
English: Turn the dose selector in either direction until 0.6 mg or 1.2 mg lines up with the pointer.
Maltese: Dawwar is-selettur tad-doża fi kwalunkwe direzzjoni sakemm 0.6 mg jew 1.2 mg ikun allinjat mal-indikatur.
English: Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with liraglutide.
Maltese: F'pazjenti kkurati b'liraglutide, ġew irrapportati sinjali u sintomi ta' deidratazzjoni li jinkludu indeboliment renali u insuffiċjenza renali akuta.
English: Taking into account the PRAC Assessment Report on the PSUR for liraglutide, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal liraglutide, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Self-measured FPG
Maltese: GĦAMLA KWALITATTIVA
English: MACE: major adverse cardiovascular event %: proportion in percent of subjects with an event N: number of subjects
Maltese: FAS: sett sħiħ ta' analiżi (full analysis se)t CI:intervall ta' kunfidenza (confidence interval) MACE: avvenimenti avversi kardjovaskulari maġġuri %: proporzjon f'persentaġġ ta' suġġetti b'avveniment N: numru ta' suġġetti
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 persuna
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Maltese: Il-pankreatite tista' tkun kundizzjoni medika serja, possibbilment ta' theddida għall-ħajja.
English: Liraglutide 1.2 mg 251 8.18
Maltese: Liraglutide 1.2 mg Liraglutide 1.8 mg
English: Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or faeces (6% and 5%, respectively).
Maltese: Parti żgħira biss tar-radjuattività li ngħatat tneħħiet bħala metaboliti relatati ma' liraglutide fl-awrina jew flippurgar (6% u 5%, rispettivament).
English: 1 ml of solution contains 6 mg of liraglutide*.
Maltese: 1 ml ta' soluzzjoni fih 6 mg ta' liraglutide*.
English: Your pen comes with 18 mg of liraglutide.
Maltese: Il-pinna tiegħek tiġi fornuta bi 18 mg ta' liraglutide.
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudji fir-rigward tat-teħid flimkien ma' prodotti mediċinali oħra, l-effetti fuq ilkontroll gliċemiku u avvenimenti kardjovaskulari u l-popolazzjonijiet li ġew studjati, ara taqsimiet 4.4,
English: Press the dose button to inject until 0 mg lines up with the pointer.
Maltese: Agħfas il-buttuna tal-injezzjoni sakemm 0 mg ikun allinjat mal-indikatur.
English: A stepwise approach to insulin dose reduction is recommended.
Maltese: Huwa rrakkomandat approċċ gradwali għat-tnaqqis tad-doża tal-insulina.
English: Other side effects
Maltese: Effetti sekondarji oħra
English: In the LEADER study, delayed gastric emptying was reported three times more frequently in the liraglutide group compared to the placebo group.
Maltese: Fl-istudju LEADER, dewmien fit-tbattil tal-istonku ġie rrappurtat tliet darbiet aktar frekwenti fil-grupp ta' liraglutide meta mqabbel mal-grupp tal-plaċebo.
English: Pregnancy
Maltese: Obeżità
English: The liraglutide exposure in adolescents and children was comparable to that observed in the adult population.
Maltese: L-espożizzjoni ta' liraglutide fl-adolexxenti u fit-tfal kien simili għal dak osservat fil-popolazzjoni adulta.
English: Headache Dizziness
Maltese: Bijotrasformazzjoni
English: Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin 40 mg.
Maltese: Liraglutide ma bidilx, b'mod li kien klinikament rilevanti, l-espożizzjoni totali ta' atorvastatin wara lgħoti ta' doża waħda ta' atorvastatin 40 mg.
English: The need for treatment intensification with insulin was reduced by 48% with liraglutide vs placebo in insulin-naive patients at baseline (HR 0.52 [0.48;
Maltese: Il-bżonn li l-kura titqawwa biż-żieda tal-insulina naqas b'48% b'liraglutide vs plaċebo f'pazjenti li ma kinux qed jieħdu insulina fil-linja bażi (HR 0.52 [0.
English: Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration.
Maltese: B'kuntrast ma' GLP-1 nattiv, liraglutide għandu profil farmakokinetiku u farmakodinamiku filbnedmin li hu adattat għall-għoti ta' darba kuljum.
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and insulin detemir when administering a single dose of insulin detemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Maltese: Ebda interazzjoni kemm farmakokinetika u kemm farmakodinamika ma ġiet osservata bejn liraglutide u insulin detemir meta, fl-istat fiss, ġiet mogħtija doża waħda ta' insulin detemir 0.5
English: • Hypoglycaemia (low blood sugar).
Maltese: • Ipogliċemija (livell baxx ta' zokkor fid-demm).
English: • Decreased appetite
Maltese: • Gass • Nuqqas t'aptit
English: Dehydration
Maltese: Deidratazzjoni
English: Malaise
Maltese: Tqala
English: In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (-1.24%, -1.50% vs -0.90%, p<0.0001).
Maltese: (inibitur ta' DPP-4, 100 mg) f'pazjenti li ma kinux ikkontrollati b'mod adegwat bit-terapija ta' metformin (medja ta' HbA1c ta' 8.5%) , liraglutide, biż-żewġ dożi, kien statistikament superjuri għallkura b'sitagliptin wara 26 ġimgħa fit-tnaqqis fl-HbA1c (-1.24%, -1.50 % vs - 0.9%, p<0.0001).
English: p<0.001 for non-inferiority p=0.005 for superiority
Maltese: 95% CI 0.78; 0.97 p<0.001 għal mhux inferjuri p=0.005 għas-superjorità
English: In patients treated with insulin prior to a confirmed hypoglycaemic episode the rate was higher with liraglutide (1.82 events/patient year) compared to placebo (0.91 events/patient years).
Maltese: F'pazjenti ttrattati bl-insulina qabel episodju kkonfermat ta' ipogliċemija, ir-rata kienet ogħla b'liraglutide (1.82 avveniment/sena ta' pazjent) meta mqabbel ma' plaċebo (0.91 avvenimenti/sena ta' pazjent).
English: If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.
Maltese: Jekk ma tidher ebda taqtira, irrepeti l-passi E sa G sa erba' darbiet.
English: Estimated maximum liraglutide concentration was 9.4 nmol/l (mean body weight approximately 73 kg) for a subcutaneous single dose of liraglutide 0.6 mg. At 1.8 mg liraglutide, the average steady state concentration of liraglutide (AUCτ/24) reached approximately 34 nmol/l (mean body weight approximately 76 kg).
Maltese: F'doża ta' 1.8 mg liraglutide, il-medja tal-konċentrazzjoni ta' liraglutide fl-istat fiss (AUCτ/24), laħqet madwar 34 nmol/l (piż medju tal-ġisem madwar 76 kg). Lespożizzjoni ta' liraglutide tonqos biż-żieda fil-piż tal-ġisem.
English: Common: may affect up to 1 in 10 people
Maltese: Komuni: jistgħu jaffettwaw sa 1 minn kull 10 persuni
English: Guideline for titration of insulin glargine
Maltese: Linja Gwida għall-Aġġustament fid-dożaġġ ta' Insulin Glargine
English: During the 26 weeks, there were 12 serious events in 235 patients (5.1%) using liraglutide, whereas there were 6 serious adverse events in 232 patients (2.6%) using exenatide.
Maltese: Matul is-26 ġimgħa, kien hemm 12-il avveniment serju f'235 pazjent (5.1 %) li kienu qed jużaw liraglutide, waqt li kien hemm 6 avvenimenti avversi serji f'232 pazjent (2.6 %) li kienu qed jużaw exenatide.
English: In a double-blind trial comparing the efficacy and safety of liraglutide 1.8 mg versus placebo as addon to insulin and/or OAD in patients with type 2 diabetes and moderate renal impairment, liraglutide was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.05% vs -0.38%).
Maltese: F'prova double-blind fejn tqabblu l-effikaċja u s-sigurtà ta' liraglutide 1.8 mg kontra plaċebo meta użati bħala żieda mal-insulina u/jew OAD f'pazjenti bid-dijabete tat-tip 2 u b'indeboliment renali moderat, liraglutide, wara 26 ġimgħa, kien superjuri għall-kura bil-plaċebo fit-tnaqqis fl-HbA1c (1.05% vs -0.38%).
English: In the LEADER trial, the frequency of acute pancreatitis confirmed by adjudication was 0.4% for liraglutide and 0.5% for placebo, respectively (see sections 4.4 and 5.1).
Maltese: Il-pankreatite ġiet irrapportata wkoll waqt li l-prodott kien qed jintuża fis-suq. Filprova LEADER, il-frekwenza ta' pankreatite akuta kkonfermata permezz tal-aġġudikazzjoni kienet ta' 0.4% għal liraglutide u ta' 0.5% għal plaċebo, rispettivament (ara taqsimiet 4.4 u 5.1).
English: The small delay of gastric emptying with liraglutide may influence absorption of concomitantly administered oral medicinal products.
Maltese: Id-dewmien żgħir fit-tbattil gastriku minħabba liraglutide jista' jinfluwenza l-assorbiment ta' prodotti mediċinali orali li jingħataw fl-istess ħin.