FrancophonIA/ELRC3.0 huggingface dataset:
English: • oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter
Maltese: • antidijabetiċi orali (bħal metformin, pioglitazone, sulfonylurea, inibitur ta' sodium-glucose kotrasportatur 2 (SGLT2i)) u/jew l-insulina.
English: Glimepiride 8 mg/day 248 8.23
Maltese: Glimepiride 8 mg/jum 248 8.23
English: Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor.
Maltese: Liraglutide hu analogu ta' GLP-1 b'omoloġija fis-sekwenza għal GLP-1 uman ta' 97% u li jintrabat ma', u jattiva r-riċettur GLP-1.
English: The relevance for humans is likely to be low but cannot be completely excluded.
Maltese: Wisq probabbli r-rilevanza għall-umani hija baxxa iżda ma tistax tiġi esklusa kompletament.
English: The study population included patients ≥65 years (n=4,329) and ≥75 years (n=836) and patients with mild (n=3,907), moderate (n=1,934) or severe (n=224) renal impairment.
Maltese: Il-popolazzjoni taħt studju kienu jinkludu pazjenti ≥65 sena (n=4,329) u ≥75 years (n=836) u pazjenti b'indeboliment renali ħafif (n=3,907), moderat (n=1,934) jew sever (n=224).
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26% in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min), and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Maltese: L-espożizzjoni ta' liraglutide tbaxxiet bi 33%, 14%, 27% u 28%, rispettivament, f'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-krejatinina, CrCl 5080 ml/min), moderat (CrCl 30-50 ml/min), u sever (CrCl <30 ml/min) u meta kien hemm mard talkliewi li wasal fl-aħħar stadju u li kien jeħtieġ id-dijalisi.
English: • Injection site reactions (such as bruising, pain, irritation, itching and rash)
Maltese: • Reazzjonijiet fis-sit tal-injezzjoni (bħal tbenġil, uġigħ, irritazzjoni, ħakk u raxx)
English: Primary outcome or vital status at end of trial was available for 99.7% and 99.6% of participants randomised to liraglutide and placebo, respectively.
Maltese: Ir-riżultat primarju jew l-istat vitali fl-aħħar tal-prova kien disponibbli għal 99.7% u 99.6% tal-parteċipanti li b'mod arbitrarju ġew mogħtija liraglutide u plaċebo, rispettivament.
English: Liraglutide is metabolised in a similar manner to large proteins without a specific organ having been identified as major route of elimination.
Maltese: Liraglutide hu metabolizzat b'mod simili għal proteini kbar mingħajr ma jiġi identifikat organu speċifiku li jservi bħala l-mezz ewlieni ta' eliminazzjoni.
English: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u n nutrizzjoni
English: Patients with an event (%)
Maltese: Pazjenti b'avveniment (%)
English: Store away from the freezer compartment.
Maltese: Aħżen 'il bogħod mill-kompartiment tal-friża.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw sa 1 minn kull 1,000 persuna
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 and plasma protein binding.
Maltese: In vitro, liraglutide wera potenzjal baxx ħafna li jkun involut f'interazzjonijiet farmakokinetiċi ma' sustanzi attivi oħrajn relatati ma' ċitokrom P450 u li jintrabat mal-proteini fil-plażma.
English: Liraglutide reduced postprandial glucose across all three daily meals by 31-49 mg/dl (1.682.71 mmol/l).
Maltese: Liraglutide naqqas il-glucose wara l-ikel fit-tlett ikliet kollha ta' kuljum b'31-49 mg/dl (1.682.71 mmol/l).
English: Treatment with liraglutide alone and in combination with one or two oral antidiabetic drugs resulted in a reduction in fasting plasma glucose of 13-43.5 mg/dl (0.72-2.42 mmol/l).
Maltese: Il-kura b'liraglutide waħdu u flimkien ma' waħda jew tnejn mill-mediċini orali kontra d-dijabete irriżultat fi tnaqqis fil-glucose fil-plażma fl-istat sajjem ta' 13-43.5 mg/dl (0.72-2.42 mmol/l).
English: Glimepiride 4 mg/day 242 8.4
Maltese: Glimepiride 4 mg/jum 242 8.4
English: • before using Victoza.
Maltese: • qabel tuża Victoza.
English: Investigations
Maltese: Investigazzjonijiet
English: Add-on to metformin (2,000 mg/day)
Maltese: Żieda ma' metformin (2,000 mg/jum)
English: • Glycaemic control
Maltese: • Kontroll gliċemiku
English: 1 ml contains 6 mg of liraglutide.
Maltese: 1 ml fih 6 mg ta' liraglutide.
English: N Mean baseline HbA1c (%)
Maltese: li kisbu HbA1c<7%
English: Disodium phosphate dihydrate, propylene glycol, phenol, water for injections
Maltese: TA' EĊĊIPJENTI Disodium phosphate dihydrate, propylene glycol, phenol, ilma għall-injezzjonijiet
English: Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Maltese: Soluzzjoni isotonika, ċara u mingħajr kulur jew kważi mingħajr kulur; pH=8.15.
English: You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.
Maltese: Tista' tagħżel dożi ta' 0.6 mg, 1.2 mg u 1.8 mg.
English: The mean HbA1c at baseline was 8.7% for liraglutide and placebo.
Maltese: Fil-linja bażi l-medja tal-HbA1c kienet ta' 8.7% għal liraglutide u plaċebo.
English: There was a comparable risk of hypoglycaemic episodes between the two treatment groups.
Maltese: Ir-riskju ta' episodji ipogliċemiċi kien simili bejn iż-żewġ gruppi ta' kura.
English: A significant and sustained reduction in HbA1c from baseline to month 36 was observed with liraglutide vs placebo, in addition to standard of care (-1.16% vs -0.77%; estimated treatment difference [ETD] -0.40% [-0.45; -0.34]).
Maltese: flimkien ma' kura standard (-1.16% vs -0.77%; stima ta' differenza fil-kura [ETD- estimated treatment difference] -0.40% [-0.45; -0.34]).
English: Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Maltese: It-tmax medjan ta' lisinopril ittardja minn 6 sigħat għal 8 sigħat b'liraglutide.
English: Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues.
Maltese: Mediċini użati fid-dijabete, analogi ta' peptide-1 (GLP-1) li jxbħu lil glucagon.
English: In the LEADER trial, the frequency of cholelithiasis and cholecystitis was 1.5% and 1.1% for liraglutide and 1.1% and 0.7% for placebo, respectively (see section 5.1).
Maltese: koleċistite kienu ta' 1.5% u 1.1% għal liraglutide u ta' 1.1% u 0.7% għal plaċebo, rispettivament (ara taqsima 5.1).
English: Patients with mild and moderate renal impairment (creatinine clearance 60-90 ml/min and 3059 ml/min, respectively) may experience more gastrointestinal effects when treated with liraglutide.
Maltese: Pazjenti b'indeboliment renali ħafif u moderat (tneħħija tal-kreatinina 60-90 ml/min u 30-59 ml/min, rispettivament) jista' jkollhom aktar effetti gastrointestinali meta kkurati b'liraglutide.
English: Combination therapy with sulfonylurea is only valid for adult patients.
Maltese: Terapija flimkien ma' sulfonylurea hija valida biss għal pazjenti adulti.
English: Liraglutide in combination with metformin, glimepiride, metformin and rosiglitazone or SGLT2i ± metformin resulted in a statistically significant greater proportion of patients achieving an HbA1c ≤6.5% at 26 weeks compared with patients receiving these agents alone.
Maltese: It-teħid ta' liraglutide flimkien ma' metformin, glimepiride, metformin u rosiglitazone jew SGLT2i ± metformin irriżulta, b'mod statistikament sinifikanti, fi proporzjon akbar ta' pazjenti li kisbu HbA1c ta' ≤6.5% wara 26 ġimgħa meta mqabbel ma' pazjenti li kienu qed jirċievu dawn il-mediċini waħidhom.
English: In both groups a decrease in body weight was seen: -2.4 kg with liraglutide vs -1.09 kg with placebo.
Maltese: Fiż-żewġ gruppi ġie osservat tnaqqis fil-piż tal-ġisem:2.4 kg b'liraglutide vs -1.09 kg bil-plaċebo.
English: • Cases of inflammation of the pancreas (pancreatitis).
Maltese: • Każijiet ta' infjammazzjoni tal-frixa (pankreatite).
English: The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod frekwenti kienu disturbi gastrointestinali, infezzjonijiet u infestazzjonijiet.
English: Significantly more patients achieved HbA1c below 7% with liraglutide compared with exenatide (54.2% vs 43.4%, p=0.0015).
Maltese: Numru sinifikanti iżjed ta' pazjenti laħqu livell ta' HbA1c taħt is-7% b'liraglutide meta mqabbel ma' exanatide (54.2% vs 43.4%, p=0.0015).
English: Switching patients from sitagliptin to liraglutide after 52 weeks of treatment resulted in additional and statistically significant reduction in HbA1c (-0.24% and -0.45%, 95% CI: -0.41 to -0.07 and -0.67 to -0.23) at week 78, but a formal control group was not available.
Maltese: Meta pazjenti nqalbu minn sitagliptin għal liraglutide wara 52 ġimgħa ta' kura kien hemm tnaqqis addizzjonali u statistikament sinifikanti fl- HbA1c (­0.24% u ­0.45%, 95% CI: ­0.41 sa ­0.07 u -0.67 sa ­0.23) fit-78 ġimgħa, iżda ma kienx hemm grupp formali ta' kontroll.
English: Increase in insulin glargine dose (IU)
Maltese: Żieda did-doża ta' insulin glargine (UI)
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw sa 1 minn kull 10,000 persuna
English: • A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc.
Maltese: • Forma severa ta' reazzjoni allerġika (reazzjoni anafilattika) b'sintomi addizzjonali oħra bħal problemi fin-nifs, nefħa fil-griżmejn u l-wiċċ, rata mgħaġġla tal-qalb, eċċ.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: On average, 8.6% of patients developed antibodies.
Maltese: Bħala medja, 8.6% tal-pazjenti żviluppaw antikorpi.
English: Pharmacokinetic properties were assessed in clinical studies in the paediatric population with type 2 diabetes aged 10 years and above.
Maltese: Il-karatteristiċi farmakokinetiċi ġew evalwati f'studji kliniċi fil-popolazzjoni pedjatrika bid-dijabete tat-tip 2 ta' età minn 10 snin 'l fuq.
English: OTHER
Maltese: JIS
English: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Victoza.
Maltese: Reazzjonijiet allerġiċi inkluż urtikarja, raxx u ħakk ġew irrapurtati mill-użu ta' Victoza fis-suq.
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulfonylurea therapy (mean HbA1c 8.3%), liraglutide was statistically superior to exenatide treatment in reducing HbA1c after 26 weeks (-1.12% vs -0.79%; estimated treatment difference: -0.33; 95% CI: -0.47 to -0.18).
Maltese: F'prova open-label li qabblet l-effikaċja u s-sigurtà ta' liraglutide 1.8 mg u exenatide 10 mcg darbtejn kuljum f'pazjenti li ma kinux ikkontrollati b'mod adegwat bit-terapija ta' metformin u/jew sulfonylurea (medja ta' HbA1c ta' 8.3%) , liraglutide, kien statistikament superjuri għall-kura b'exenatide wara 26 ġimgħa fit-tnaqqis fl-HbA1c (­1.12% vs ­0.79%; stima tad-differenza fil-kura: ­0.33; 95% CI: ­0.47 sa ­0.18).
English: Patients treated with liraglutide had a significant decrease in body weight compared to that of patients treated with sitagliptin (-2.9 kg and -3.4 kg vs -1.0 kg, p<0.0001).
Maltese: Ilpazjenti kkurati b'liraglutide kellhom tnaqqis sinifikanti fil-piż tal-ġisem meta mqabbel ma' dak talpazjenti kkurati b'sitagliptin (-2.9 kg u -3.4 kg vs -1.0 kg, p< 0.0001).
English: Common • Vomiting.
Maltese: Injetta d-doża.
English: • Toothache
Maltese: • Stitikezza
English: The rate of hypoglycaemic episodes (per patient year of exposure) was statistically significantly lower when adding liraglutide compared to adding a single dose of insulin aspart (1.0 vs 8.15; ratio: 0.13; 95% CI: 0.08 to 0.21).
Maltese: Ir-rata ta' episodji ipogliċemiċi (għal kull sena ta' espożizzjoni tal-pazjent) kienet inqas b'mod statistikament sinifikanti meta żdied liraglutide meta mqabbel maż-żieda ta' doża waħda ta' insulin aspart (1.0 vs 8.15; proporzjon: 0.13; 95% CI: 0.08 sa
English: Liraglutide exposure increased proportionally with dose.
Maltese: L-espożizzjoni għal liraglutide żdiedet proporzjonalment mad-doża.
English: In the LEADER trial, severe hypoglycaemic episodes were reported at a lower rate with liraglutide vs placebo (1.0 vs 1.5 events per 100 patient years; estimated rate ratio 0.69 [0.51 to 0.93]) (see section 5.1).
Maltese: 1.5 avvenimenti għal kull 100 pazjent kull sena; stima ta' proporzjoni ta' rata ta' 0.69 [0.51 to 0.93])
English: Then follow the instructions below:
Maltese: Taqsam id-doża tiegħek f'żewġ injezzjonijiet:
English: Treatment with liraglutide in combination with metformin, metformin and glimepiride, metformin and rosiglitazone or SGLT2i with or without metformin was associated with a sustained weight reduction in the range from 0.86 kg to 2.62 kg compared with placebo.
Maltese: • Piż tal-ġisem It-trattament b'liraglutide flimkien ma' metformin, metformin u glimepiride, metformin u rosiglitazone jew SGLT2i bi jew mingħajr metformin, kien assoċjat ma' tnaqqis sostnut fil-piż li varja minn 0.86 kg sa 2.62 kg meta mqabbel ma' plaċebo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fit taqsima 6.1
English: Treatment with liraglutide produced clinically and statistically significant improvements in glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose and postprandial glucose compared with placebo.
Maltese: Il-kura b'liraglutide ġabet titjib klinikament u statistikament sinifikanti fl-emoglobina A1c glikosilata (HbA1c), fil-glucose fil-plażma fl-istat sajjem u fil-glucose wara t-teħid tal-ikel meta mqabbel mal-plaċebo.
English: Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide.
Maltese: Ġew irrapportati xi każijiet ta' kolelitijażi (0.4%) u koleċistite (0.1%) matul il-provi kliniċi kkontrollati u fit-tul ta' fażi 3a b'liraglutide.
English: Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-pinna u l-kartuna wara ‘EXP'.
English: The efficacy and safety profile of Victoza was comparable to that observed in the adult population treated with Victoza.
Maltese: Il-profil ta' effikaċja u sigurtà ta' Victoza kien simili għal dak osservat fil-popolazzjoni adulta ttrattata b'Victoza.
English: Victoza is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Maltese: Victoza mhuwiex irrakkomandat għal pazjenti b'indeboliment epatiku sever (ara taqsima 5.2).
English: Few cases of acute pancreatitis (<0.2%) have been reported during long-term, controlled phase 3 clinical trials with Victoza.
Maltese: Ftit każijiet (<0.2%) ta' pankreatite akuta kienu rrappurtati waqt provi kliniċi kkontrollati u fit-tul ta' fażi 3 b'Victoza.
English: Substances added to Victoza may cause degradation of liraglutide.
Maltese: Sustanzi miżjuda ma' Victoza jistgħu jikkawżaw id-degradazzjoni ta' liraglutide.
English: In the insulin degludec + liraglutide arm, the insulin dose was reduced by 20% in order to minimize the risk of hypoglycaemia.
Maltese: Fil-fergħa tal-insulin degludec + liraglutide, id-doża tal-insulina ġiet imnaqqsa b'20% sabiex jitnaqqas ir-riskju ta' ipogliċemija.
English: HR: 0.87 95% CI [0.78; 0.97]
Maltese: HR: 0.87
English: No data are available for children below 10 years of age (see sections 5.1 and 5.2).
Maltese: M'hemmx tagħrif disponibbli għal tfal taħt l-10 snin (ara taqsimiet 5.1 u 5.2).
English: Immune system disorders
Maltese: Disturbi fis sistema immuni
English: Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with liraglutide.
Maltese: Is-Cmax ta' atorvastatin tnaqqas bi 38%, u t-tmax medjan ittardja minn siegħa għal 3 sigħat b'liraglutide.
English: Victoza contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Maltese: Victoza fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: Additional trials were conducted with liraglutide that included 1,901 patients in four unblinded, randomised, controlled clinical trials (including 464, 658, 323 and 177 patients per trial) and one double-blind, randomised, controlled clinical trial in patients with type 2 diabetes mellitus and moderate renal impairment (279 patients).
Maltese: Saru provi oħra b'liraglutide li kienu jinkludu 1,901 pazjent f'erba' provi kliniċi unblinded, randomised u kkontrollati (li kienu jinkludu 464, 658, 323 u 177 pazjent għal kull prova) u prova klinika waħda double-blind, randomised u kkontrollata f'pazjenti bid-dijabete mellitus tat-tip 2 u b'indeboliment renali moderat (279 pazjent).
English: Liraglutide also significantly reduced the risk of expanded MACE (primary MACE, unstable angina pectoris leading to hospitalisation, coronary revascularisation, or hospitalisation due to heart failure) and other secondary endpoints (Figure 2).
Maltese: Liraglutide naqqas ukoll b'mod sinifikanti r-riskju ta' MACE mwassa'(MACE primarju, angina pectoris li mhijiex stabbli u li twassal għat-teħid fl-isptar, revaskularizzazzjoni koronarja jew it-teħid lisptar minħabba insuffiċjenza tal-qalb) u għanijiet sekondarji oħra (Figura 2).
English: This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni,telf ta' liraglutide, labar ibblokkati u dożaġġ li ma jkunx preċiż.
English: Post-hoc analysis of serious major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke) from all intermediate and long-term phase 2 and 3 trials (ranging from 26 and up to 100 weeks duration) including 5,607 patients (3,651 exposed to liraglutide), showed no increase in cardiovascular risk (incidence ratio of 0.75 (95% CI 0.35; 1.63)) for liraglutide versus all comparators.
Maltese: Analiżi post-hoc ta' avvenimenti kardjovaskulari avversi serji u maġġuri (mewt kardjovaskulari, infart mijokardijaku, attakk ta' puplesija) miġbura mill-provi kollha intermedji u fit-tul ta' fażi 2 u 3 (b'tul tal-provi li kien ivarja minn 26 sa 100 gimgħa) li kienu jinkludu 5,607 pazjenti (3,651 esposti għal liraglutide), ma wrew ebda żieda fir-riskju kardjovaskulari (proporzjon ta' inċidenza ta' 0.75 (95% CI 0.35; 1.63) għal liraglutide meta mqabbel mal-komparaturi kollha
English: • Proportion of patients achieving reductions in HbA1c Liraglutide alone resulted in a statistically significant greater proportion of patients achieving HbA1c ≤6.5% at 52 weeks compared with patients receiving glimepiride (37.6% for 1.8 mg and 28.0% for 1.2 mg vs 16.2% for comparator).
Maltese: It-teħid ta' liraglutide waħdu irriżulta fi proporzjon akbar ta' pazjenti, li kien statistikament sinifikanti, li kisbu HbA1c ta' ≤6.5% wara 52 ġimgħa meta mqabbel ma' pazjenti li kienu qed jirċievu glimepiride (37.6% għal 1.8 mg u 28.0% għal 1.2 mg vs 16.2% għall-komparatur).
English: Liraglutide in combination therapy, for 26 weeks, with metformin, glimepiride or metformin and rosiglitazone or SGLT2i ± metformin resulted in statistically significant and sustained reductions in HbA1c compared with patients receiving placebo (Table 2).
Maltese: Liraglutide meta mogħti f'terapija kkombinata għal 26 ġimgħa, ma' metformin, glimepiride jew metformin u rosiglitazone jew SGLT2i ± metformin, irriżulta fi tnaqqis statistikament sinifikanti u sostnut fl-HbA1c meta mqabbel ma' pazjenti li kienu qed jirċievu l-plaċebo (Tabella 2).
English: The apparent volume of distribution after subcutaneous administration is 11-17 l. The mean volume of distribution after intravenous administration of liraglutide is 0.07 l/kg.
Maltese: Il-medja tal-volum tad distribuzzjoni wara l-għoti ġol-vini ta' liraglutide hu ta' 0.07 l/kg.
English: A mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed with liraglutide in long-term clinical trials including LEADER.
Maltese: Ġiet osservata żieda medja fir-rata tal-qalb mil-linja bażi ta' 2 sa 3 taħbitiet kull minuta b'liraglutide f'provi kliniċi fit-tul inkluż LEADER.
English: Hypoglycaemia
Maltese: Ipogliċemija
English: In a 52-week clinical trial, the addition of insulin detemir to liraglutide 1.8 mg and metformin in patients not achieving glycaemic targets on liraglutide and metformin alone resulted in a HbA1c decrease from baseline of 0.54%, compared to 0.20% in the liraglutide 1.8 mg and metformin control group.
Maltese: F'prova klinika ta' 52 ġimgħa, iż-żieda ta' insulin detemir ma' liraglutide 1.8 mg u metformin f'pazjenti li ma laħqux il-miri gliċemiċi b'liraglutide u metformin waħidhom irriżulta f'tnaqqis flHbA1c mil-linja bażi ta' 0.54%, meta mqabbel ma' 0.20% fil-grupp ta' kontroll ta' liraglutide 1.8 mg u metformin.
English: Significantly more patients achieved HbA1c below 7% with liraglutide compared with placebo (52.8% vs 19.5%).
Maltese: Ammont sinifikanti iżjed ta' pazjenti laħqu livell ta' HbA1c taħt is-7% b'liraglutide meta mqabbel mal-plaċebo (52.8% vs 19.5%).
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included patients of White, Black, Asian and Hispanic groups.
Maltese: L-oriġini etnika ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' liraglutide, ibbażat fuq ir-riżultati tal-analiżi farmakokinetika tal-popolazzjoni, li kienet tinkludi pazjenti minn gruppi Bojod, Suwed, Asjatiċi u Ispaniċi.
English: Pack sizes of 1, 2, 3, 5 or 10 pre-filled pens.
Maltese: Daqsijiet tal-pakkett ta' 1, 3, 5 jew 10 siringi mimlija għal-lest.
English: There was a small increase in the rate of minor hypoglycaemic episodes (0.23 versus 0.03 events per patient years).
Maltese: Kien hemm żieda żgħira fir-rata ta' episodji ipogliċemiċi minuri (0.23 kontra 0.03 avvenimenti għal kull pazjent fis-sena).
English: A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%.
Maltese: L-għoti ta' doża waħda ta' digoxin 1 mg ma' liraglutide, irriżulta f'tnaqqis fl-AUC ta' digoxin ta' 16%; is-Cmax naqas b'31%.
English: • in addition to other medicinal products for the treatment of diabetes.
Maltese: • bħala żieda ma' prodotti mediċinali oħra għat-trattament tad-dijabete.
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 hu l-mira għal GLP-1 nattiv, ormon inkretin endoġenu li jżid is-sekrezzjoni tal-insulina miċ-ċelluli beta pankreatiċi u li tiddependi mill-glucose.
English: Switching patients from exenatide to liraglutide after 26 weeks of treatment resulted in an additional and statistically significant reduction in HbA1c (-0.32%, 95% CI: -0.41 to -0.24) at week 40, but a formal control group was not available.
Maltese: Meta pazjenti nqalbu minn exenatide għal liraglutide wara 26 ġimgħa ta' kura kien hemm tnaqqis addizzjonali u statistikament sinifikanti flHbA1c (­0.32%, 95% CI: ­0.41 sa ­0.24) fl-40 ġimgħa, iżda ma kienx hemm grupp formali ta' kontroll.
English: The HR for liraglutide vs placebo was 0.78 [0.67, 0.92] for time to first nephropathy event and 1.15 [0.87, 1.52] for time to first retinopathy event.
Maltese: 67, 0.92] għaż-żmien sal-ewwel avveniment nefropatiku u 1.15 [0.87, 1.52] għaż-żmien sal-ewwel avveniment retinopatiku.
English: Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2).
Maltese: Ġiet irrappurtata ketoaċidożi dijabetika fil-pazjenti li jiddependu mill-insulina wara waqfien jew tnaqqis rapidu tad-doża tal-insulina (ara sezzjoni 4.2).