FrancophonIA/ELRC3.0 huggingface dataset:
English: Saxenda Placebo Last observation carried forward (LOCF)
Maltese: Saxenda Plaċebo L-aħħar osservazzjoni miġjuba 'l quddiem (LOCF - Last observation carried forward)
English: Change in Body Weight (%) Saxenda Placebo
Maltese: Bidla fil-piż tal-ġisem (%) Saxenda Plaċebo
English: Description of selected adverse reactions:
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari:
English: - Keep this leaflet.
Maltese: Sett Sħiħ ta' Analiżi.
English: Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events.
Maltese: Fost il-pazjenti ttrattati fl-istess ħin b'sulfonylurea, 60.9% tal-pazjenti ttrattati b'liraglutide 3.0 mg/jum u 60.0% tal-pazjenti ttrattati bi plaċebo rrapportaw avvenimenti ipogliċemiċi sintomatiċi ddokumentati.
English: The effect on rate of gastric emptying was equivalent between liraglutide 1.8 mg and 3.0 mg, (paracetamol AUC0-300 min).
Maltese: L-effett fuq ir-rata ta' tbattil gastriku kien ekwivalenti bejn liraglutide 1.8 mg u 3.0 mg, (AUC ta' paracetamol0-300 min).
English: • a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems
Maltese: • BMI ta' 27 kg/m² u inqas minn 30 kg/m² (piż żejjed) u problemi tas-saħħa relatati mal-piż
English: • Difficulty sleeping (insomnia).
Maltese: • Diffikultà biex torqod (insomnja).
English: ATC code: A10BJ02
Maltese: A10BJ02 Mekkaniżmu ta' azzjoni
English: Saxenda (N=412) Placebo (N=211) Saxenda vs. placebo
Maltese: Saxenda (N=412) Plaċebo (N=211) Saxenda vs. plaċebo
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 (CYP) 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 is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination.
Maltese: Liraglutide hu metabolizzat b'mod endoġenu b'mod simili għal proteini kbar mingħajr ma jiġi identifikat organu speċifiku li jservi bħala l-mezz ewlieni ta' eliminazzjoni.
English: The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Saxenda fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Substances added to Saxenda may cause degradation of liraglutide.
Maltese: Sustanzi miżjuda ma' Saxenda jistgħu jikkawżaw id-degradazzjoni ta' liraglutide.
English: If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Maltese: Jekk ma tidher l-ebda qatra, irrepeti pass 2 ‘Iċċekkja l-fluss' sa 6 darbiet.
English: Saxenda is a weight loss medicine that contains the active substance liraglutide.
Maltese: Saxenda hu mediċina li tnaqqas il-piż li fiha s-sustanza attiva liraglutide.
English: Hypersensitivity to liraglutide or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal liraglutide jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Maltese: It-tmax medjan ta' lisinopril ittardja minn 6 għal 8 sigħat b'liraglutide.
English: Saxenda (N=207) Placebo (N=206) Saxenda vs. placebo
Maltese: Saxenda (N=207) Plaċebo (N=206) Saxenda vs. plaċebo
English: Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead to discontinuation of therapy.
Maltese: Il-biċċa l-kbira tal-avvenimenti gastrointestinali kienu minn ħfief sa moderati, temporanji, u lmaġġoranza tagħhom ma wasslux għat-twaqqif tat-terpaija.
English: Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of
Maltese: Saxenda hu indikat biex jintuża ma' dieta b'kaloriji mnaqqsa u żieda fl-attività fiżika għall immaniġġjar tal-piż f'pazjenti adulti b'Indiċi tal-Massa tal-Ġisem (BMI - Body Mass Index) inizjali ta'
English: Saxenda (N=2437) Placebo (N=1225) Saxenda vs. placebo
Maltese: Saxenda (N=2437) Plaċebo (N=1225) Saxenda vs. plaċebo
English: In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo.
Maltese: F'din il-prova, ipogliċemija sintomatika ddokumentata (definita bħala glukożju fil-plażma ta' ≤3.9 mmol/L flimkien ma' sintomi) ġiet irrapportata f'47.2% tal-pazjenti ttrattati b'liraglutide 3.0 mg/jum u minn 51.8% tal-pazjenti ttrattati bi plaċebo.
English: Pancreatitis is a serious, potentially life-threatening medical condition.
Maltese: Il-pankreatite hi kundizzjoni medika serja, possibbilment ta' theddida għallħajja.
English: Figure 2 Cumulative distribution of weight change (%) after 56 weeks of treatment in trial 1 Table 5 Trial 2: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 56
Maltese: Figura 3 Distribuzzjoni kumulattiva tal-bidla fil-piż (%) wara 56 ġimgħa ta' kura fi prova 1 Tabella 5 Prova 2: Tibdil mil-linja bażi fil-piż tal-ġisem, gliċemija u parametri kardjometaboliċi f'ġimgħa 56
English: Disodium phosphate dihydrate Propylene glycol
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Disodium phosphate dihydrate Propylene glycol
English: • Loss of fluids (dehydration).
Maltese: • Telf ta' fluwidi (deidratazzjoni).
English: Baseline Change Baseline Change Apnoea-Hypopnoea Index, events/hour 49.0 -12.2 49.3 -6.1 -6.1* (-11.0; -1.2) Full Analysis Set.
Maltese: Pressjoni sistolika tad-demm, mmHg 128.9 -3.0 129.2 -0.4 -2.6* (-4.6; -0.6)
English: Contents of the pack and other information What Saxenda contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Saxenda
English: This may prevent blocked needles, contamination, infection and inaccurate dosing.
Maltese: Dan jista' jilqa' kontra labar imblukkati, kontaminazzjoni, infezzjoni u dożaġġ żbaljat.
English: EU/1/15/992/001 1 x 3 ml EU/1/15/992/002 3 x 3 ml EU/1/15/992/003 5 x 3 ml
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/992/001 1 x 3 ml
English: In all the long-term clinical trials with Saxenda, there were 6 MACE for patients treated with liraglutide and 10 MACE for placebo-treated patients.
Maltese: Fil-provi kliniċi kollha fit-tul b'Saxenda, kien hemm 6 MACE għal pazjenti kkurati b'liraglutide u 10 MACE għal pazjenti kkurati bi plaċebo.
English: Mean change at week 160, % (95% CI) Mean change at week 160, kg (95% CI)
Maltese: Bidla medja f'ġimgħa 160, % (95% CI) Bidla medja f'ġimgħa 160, kg (95% CI)
English: • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Maltese: • ≥27 kg/m² sa <30 kg/m² (piż żejjed) fil-preżenza ta' mill-inqas komorbidità waħda relatata malpiż bħal disgliċemija (predijabete jew dijabete mellitus ta' tip 2), pressjoni għolja, dislipidemija jew apnea ostruttiva waqt l-irqad.
English: • Gallstones
Maltese: • Sturdament
English: Pharmacokinetic properties were assessed in clinical pharmacology studies in the paediatric population with obesity aged 12-17 years (14 patients, body weight 80-122 kg) and 7-11 years (16 patients, body weight 45-87 kg) respectively.
Maltese: Il-proprjetajiet farmakokinetiċi ġew evalwati f'studji ta' farmakoloġija klinika fil-popolazzjoni pedjatrika obeża b'etajiet minn 12-17-il sena (14-il pazjent, piż tal-ġisem 80-122 kg) u 7-11-il sena
English: Age had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results from a population pharmacokinetic analysis of data from overweight and obese patients (18 to 82 years).
Maltese: L-età ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' liraglutide, ibbażat fuq irriżultati minn analiżi dwar id-dejta tal-farmakokinetika tal-popolazzjoni ta' pazjenti li kellhom piż żejjed u obeżità (minn 18 sa 82 sena).
English: Patients were randomly allocated to either liraglutide on a daily dose of up to 1.8 mg (4,668) or placebo (4,672), both on a background of standard of care.
Maltese: B'mod arbitrarju l-pazjenti ġew mogħtija jew liraglutide b'doża sa 1.8 mg kuljum (4,668) jew plaċebo (4,672), it-tnejn li huma b'bażi ta' kura standard.
English: • Acute kidney failure.
Maltese: • Insuffiċjenza akuta tal-kliewi.
English: The average liraglutide steady state concentration (AUCτ/24) reached approximately 31 nmol/L in obese (BMI 30-40 kg/m2) patients following administration of 3 mg liraglutide.
Maltese: Il-medja tal-konċentrazzjoni ta' liraglutide flistat fiss (AUCτ/24) laħqet madwar 31 nmol/L f'pazjenti li kellhom obeżità (BMI 30-40 kg/m2) wara lgħoti ta' 3 mg ta' liraglutide.
English: In trial 2, 50.4% achieved ≥5% weight loss after 12 weeks.
Maltese: Fi prova 2, 50.4% kisbu telf fil-piż ta' ≥5% wara 12-il ġimgħa.
English: The 3.0 mg daily dose of liraglutide provided adequate systemic exposures over the body weight range of 60-234 kg evaluated for exposure response in the clinical trials.
Maltese: Id-doża ta' 3.0 mg kuljum ta' liraglutide, ipprovdiet espożizzjonijiet sistemiċi adegwati fuq il-firxa tal-piż tal-ġisem ta' 60234 kg evalwata għar-rispons għall-espożizzjoni fil-provi kliniċi.
English: Flow check symbol
Maltese: Simbolu tal verifika tal-fluss
English: • Trial 3 (SCALE Sleep Apnoea - 3970): A 32-week trial assessing sleep apnoea severity and body weight loss in 359 randomised (276 completers) obese patients with moderate or severe obstructive sleep apnoea.
Maltese: • Prova 3 (SCALE Apnea waqt l-Irqad - 3970): Prova li damet 32 ġimgħa li evalwat is-severità tal-apnea waqt l-irqad u t-telf fil-piż tal-ġisem fi 359 pazjent li kellhom obeżità, li ntgħażlu b'mod każwali (276 temmew il-prova), b'apnea ostruttiva waqt l-irqad moderata jew severa.
English: The urine and faeces radioactivity was mainly excreted during the first 6-8 days and corresponded to three minor metabolites, respectively.
Maltese: Ir-radjuattività tal-awrina u l-ippurgar tneħħiet primarjament matul l-ewwel 6-8 ijiem u kienet tikkorrispondi għal tliet metaboliti minuri, rispettivament.
English: An increase in heart rate was observed with liraglutide in clinical trials (see section 5.1).
Maltese: Żieda fir-rata ta' taħbit tal-qalb ġiet osservata b'liraglutide fi provi kliniċi (ara sezzjoni 5.1.
English: In clinical trials, tachycardia was reported in 0.6% of patients treated with Saxenda and in 0.1% of patients treated with placebo.
Maltese: Fi provi kliniċi, takikardija ġiet irrappurtata f'0.6% tal-pazjenti kkurati b'Saxenda u f'0.1% talpazjenti kkurati bi plaċebo.
English: Figure 1 Change from baseline in body weight (%) by time in trial 1 (0-56 weeks)
Maltese: Figura 1 Bidla mil-linja bażi fil-piż tal-ġisem (%) skont iż-żmien fi prova 1 (0-56 ġimgħa)
English: This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Maltese: Dan jista' jilqa' kontra labar imblukkati, kontaminazzjoni, infezzjoni, tnixxija ta' soluzzjoni u dożaġġ żbaljat.
English: With continued treatment with liraglutide, 86.2% of these early responders are predicted to achieve a weight loss of ≥5% and 51% are predicted to achieve a weight loss of ≥10%
Maltese: Bit-tkomplija tal-kura b'liraglutide, 86.2% ta' dawk li rrispondew kmieni huma mbassra li se jiksbu telf fil-piż ta' ≥5%, u 51% huma mbassra li se jiksbu telf fil-piż ta' ≥10% wara sena ta' kura.
English: Saxenda was evaluated for safety in 5 double-blind, placebo controlled trials that enrolled 5,813 obese patients or overweight patients with at least one weight-related comorbidity.
Maltese: Saxenda ġie evalwat għas-sigurtà f'5 provi kkontrollati bil-plaċebo u double-blind li rreġistraw 5,813il pazjent obeżu jew pazjenti bi piż żejjed b'mill-inqas komorbidità waħda relatata mal-piż.
English: The safety and efficacy of liraglutide for weight management have not been established in patients: - aged 75 years or more, - treated with other products for weight management, - with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, - with severe renal impairment, - with severe hepatic impairment.
Maltese: Is-sigurtà u l-effikaċja ta' liraglutide għall-immaniġġjar tal-piż ma ġewx determinati s'issa f'pazjenti: - b'età ta' 75 sena jew aktar, - ikkurati bi prodotti oħrajn għall-immaniġġjar tal-piż, - b'obeżità sekondarja għal disturbi endokrinoloġiċi jew tal-ikel jew għal kura bi prodotti mediċinali li jistgħu jikkawżaw żieda fil-piż, - b'indeboliment renali sever, - b'indeboliment epatiku sever.
English: The 56-week part of trial 1 assessed body weight loss in all the 3,731 randomised patients (2,590 completers).
Maltese: Il-parti ta' prova 1 li damet 56 ġimgħa evalwat it-tnaqqis fil-piż tal-ġisem f'kull wieħed mit3,731 pazjent li ntgħażlu b'mod arbitrarju (2,590 temmew il-prova).
English: Dose injected
Maltese: Doża injettata
English: In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day.
Maltese: F'prova klinika f'pazjenti b'piż żejjed jew obeżi bid-dijabete mellitus ta' tip 2 ittrattati bl-insulina u liraglutide 3.0 mg/jum flimkien ma' dieta u eżerċizzju u sa 2 OADs, ipogliċemija severa (fejn kien hemm il-bżonn ta' għajnuna minn terza persuna) ġiet irrapportata minn 1.5% tal-pazjenti ttrattati b'liraglutide 3.0 mg/jum.
English: In rats, a no observed adverse effect level (NOAEL) was not observed.
Maltese: Fil-firien, livell ta' ebda osservazzjoni ta' effett avvers (NOAEL - no observed adverse effect level) ma ġiex osservat.
English: The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea.
Maltese: Ir-riskju ta' ipogliċemija jista' jitbaxxa permezz ta' tnaqqis fid-doża tal-insulina u/jew tas-sulfonylurea.
English: Table 4 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 160
Maltese: Tabella 4 Prova 1: Tibdil mil-linja bażi fil-piż tal-ġisem, gliċemija u parametri kardjometaboliċi f'ġimgħa 160
English: • Reduced kidney function
Maltese: • Tnaqqis fil-funzjoni tal-kliewi
English: It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Maltese: Fiha 18-il mg ta' liraglutide u tforni dożi ta' 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg u 3.0 mg.
English: Saxenda contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Maltese: Saxenda fih anqas minn 1 mmol sodium (23 mg) f'kull doża, għalhekk il-prodott mediċinali huwa essenzjalment ‘ħieles mis-sodium'.
English: Exposure associated with 3.0 mg liraglutide was found to be comparable between the children aged 7 to 11, adolescents and adult subjects, after correction for body weight.
Maltese: Instab li l-espożizzjoni assoċjata ma' 3 mg liraglutide kienet komparabbli bejn it-tfal ta' età ta' 7 sa 11-il sena, adolexxenti u suġġetti adulti, wara li tikkoreġi għall-piż tal-ġisem.
English: Symptoms of hypoglycaemic events were reported by 1.6 % of patients treated with Saxenda and 1.1% of patients treated with placebo; however, these events were not confirmed by blood glucose measurements.
Maltese: Sintomi ta' avvenimenti ta' ipogliċemija ġew irrappurtati minn 1.6% tal-pazjenti kkurati b'Saxenda u 1.1% tal-pazjenti kkurati bi plaċebo; madankollu, dawn lavvenimenti ma kinux ikkonfermati permezz ta' kejl tal-glucose fid-demm.
English: Week 5 onwards
Maltese: Minn Ġimgħa 5 'il quddiem
English: The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial (0.75 mg).
Maltese: Il-farmakokinetika ta' liraglutide kienet evalwata f'pazjenti li kellhom gradi differenti ta' indeboliment tal-fwied fi studju b'doża waħda (0.75 mg).
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included overweight and obese patients of White, Black, Asian and Hispanic/non-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 li kellhom piż żejjed u obeżità minn gruppi Bojod, Suwed, Asjatiċi u Ispaniċi/mhux Ispaniċi.
English: If it shows 3.0, at least 3.0 mg are left in your pen.
Maltese: Jekk juri 3.0, ikun għad fadal mill-inqas 3.0 mg fil-pinna tiegħek.
English: Table 3 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 56
Maltese: Tabella 3 Prova 1: Tibdil mil-linja bażi fil-piż tal-ġisem, gliċemija u parametri kardjometaboliċi f'ġimgħa 56
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function in a single-dose trial (0.75 mg).
Maltese: L-espożizzjoni ta' liraglutide tnaqqset f'pazjenti b'indeboliment tal-kliewi meta mqabbel ma' individwi b'funzjoni normali tal-kliewi fi prova b'doża waħda (0.75 mg).
English: Dry mouth Dyspepsia Gastritis
Maltese: Dispepsja Gastrite Mard tar-rifluss gastroesofagali
English: The estimated time to onset of type 2 diabetes mellitus for patients treated with liraglutide 3.0 mg was 2.7 times longer (with a 95% confidence interval of [1.9, 3.9]), and the hazard ratio for risk of developing type 2 diabetes mellitus was 0.2 for liraglutide versus placebo.
Maltese: Il-ħin stmat sakemm ħareġ id-dijabete mellitus ta' tip 2 għall-pazjenti ttrattati b'liraglutide 3.0 mg kien 2.7 darbiet iżjed (b'intervall ta' kunfidenza ta' 95% ta' [1.9, 3.9]), u l-proporzjon ta' periklu għar-riskju tal-iżvilupp tad-dijabete mellitus tat-tip 2 kien ta' 0.2 għal liraglutide kontra plaċebo.
English: 1 ml contains 6 mg of liraglutide.
Maltese: Millilitru fih 6 mg ta' liraglutide.
English: ≥30 kg/m²) or with overweight (BMI ≥27 kg/m²) with dyslipidaemia and/or hypertension were stratified according to pre-diabetes status at screening and BMI at baseline (≥30 kg/m² or
Maltese: • Prova 1 (SCALE Obeżità u Predijabete - 1839): Total ta' 3,731 pazjent li kienu obeżi (BMI ≥30 kg/m²) jew li kellhom piż żejjed (BMI ≥27 kg/m²) b'dislipidimja u/jew ipertensjoni ġew organizzati skont l-istat ta' predijabete fil-ħin tal-evalwazzjoni u l-BMI fil-linja bażi (≥30 kg/m² jew <30 kg/m²).
English: • Trial 2 (SCALE Diabetes - 1922): A 56-week trial assessing body weight loss in 846 randomised (628 completers) obese and overweight patients with insufficiently controlled type 2 diabetes mellitus (HbA1c range 7-10%).
Maltese: Prova li damet 56 ġimgħa li evalwat it-telf fil-piż tal-ġisem fi 846 pazjent li kellhom obeżità u piż żejjed, li ntgħażlu b'mod każwali (628 temmew il-prova) b'dijabete mellitus ta' tip 2 li ma kinitx ikkontrollata biżżejjed (HbA1c firxa 7-10%).
English: Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score >9).
Maltese: Lespożizzjoni kienet aktar baxxa b'mod sinifikanti (44%) f'persuni b'indeboliment sever tal-fwied (punteġġ Child Pugh ta' >9).
English: Example 0.6 mg selected
Maltese: 0.6 mg darba kuljum
English: Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with GLP-1 receptor agonists.
Maltese: F'pazjenti kkurati b'agonisti għar-riċetturi ta' GLP-1, ġew irrapportati sinjali u sintomi ta' deidratazzjoni li jinkludu indeboliment renali u insuffiċjenza renali akuta.
English: Liraglutide exposure was not studied in patients with body weight >234 kg.
Maltese: L-espożizzjoni ta' liraglutide ma ġietx studjata f'pazjenti b'piż tal-ġisem ta' >234 kg.
English: A mean increase in heart rate from baseline of 2.5 beats per minute (ranging across trials from 1.6 to 3.6 beats per minute) has been observed with liraglutide in clinical phase 3 trials.
Maltese: Żieda medja fir-rata ta' taħbit tal-qalb mil-linja bażi ta' 2.5 taħbitiet kull minuta (li varjat fil-provi minn 1.6 sa 3.6 taħbitiet kull minuta) ġiet osservata b'liraglutide fil-provi kliniċi ta' fażi 3. Ir-rata ta' taħbit tal-qalb laħqet ilmassimu tagħha wara madwar 6 ġimgħat.
English: • Do not mix Saxenda up with other medicines that you inject (e.g. insulins).
Maltese: • Tħallatx Saxenda ma' mediċini oħrajn li tinjetta (eż. insulini).
English: One pre-filled pen contains 18 mg liraglutide in 3 ml.
Maltese: Pinna mimlija għal-lest fiha 18 mg ta' liraglutide f'3 ml.
English: Patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min) may experience more gastrointestinal effects when treated with Saxenda.
Maltese: Pazjenti b'indeboliment renali ħafif jew moderat (tneħħija tal-kreatinina ≥30 ml/min) jista' jkollhom aktar effetti gastrointestinali meta jiġu kkurati b'Saxenda.
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Maltese: Konsistenti mal-fatt li prodotti farmaċewtiċi li fihom il-proteini u l-peptides jista' jkollhom karatteristiċi immunoġeniċi, il-pazjenti jistgħu jiżviluppaw antikorpi kontra liraglutide wara l-kura b'liraglutide.
English: In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, severe hypoglycaemia (requiring third party assistance) was reported by 0.7% of patients treated with Saxenda and only in patients concomitantly treated with sulfonylurea.
Maltese: Fi prova klinika f'pazjenti li kellhom piż żejjed jew obeżità, b'dijabete mellitus ta' tip 2, ikkurati b'Saxenda flimkien ma' dieta u eżerċizzju, ġiet irrappurtata ipogliċemija severa (li teħtieġ assistenza ta' parti terza) minn 0.7% tal-pazjenti kkurati b'Saxenda u f'pazjenti biss li kienu ikkurati fl-istess ħin b'sulfonylurea.
English: When your pen contains less than 3.0 mg the dose counter stops before 3.0 is shown.
Maltese: Dożi ta' kuljum ogħla minn 3.0 mg mhumiex rakkomandati.
English: Heart rate should be monitored at regular intervals consistent with usual clinical practice.
Maltese: Ir-rata ta' taħbit tal-qalb għandha tiġi mmonitorjata f'intervalli regolari b'mod konsistenti mal-prattika klinika tas-soltu.
English: There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
Maltese: M'hemm l-ebda esperjenza klinika f'pazjenti b'insuffiċjenza konġestiva tal-qalb ta' klassi IV skont ilklassifika tan-New York Heart Association (NYHA) u għalhekk liraglutide mhuwiex irrakkomandat għall-użu f'dawn il-pazjenti.
English: • Turn the dose selector until the dose counter shows the flow check symbol (
Maltese: • Dawwar is-selettur tad-doża sakemm il-kejl tad-doża juri s-simbolu talverifika tal-fluss (
English: Liraglutide did not change the overall exposure of atorvastatin following single dose administration of atorvastatin 40 mg.
Maltese: Liraglutide ma bidilx l-espożizzjoni totali ta' atorvastatin wara l-għoti ta' doża waħda ta' atorvastatin 40 mg.
English: In the 56-week part of trial 1, 67.5% achieved ≥5% weight loss after 12 weeks.
Maltese: Fil-parti ta' prova 1 li damet 56 ġimgħa, 67.5% kisbu telf fil-piż ta' ≥5% wara 12-il ġimgħa.
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 tarradjuattività li ngħatat tneħħiet bħala metaboliti relatati ma' liraglutide fl-awrina jew fl-ippurgar (6% u 5%, rispettivament).