FrancophonIA/ELRC3.0 huggingface dataset:
English: Body weight was reduced by 0.4 kg with an estimated treatment difference between Xultophy and insulin degludec of -2.80 kg (p<0.0001), and the rate of confirmed hypoglycaemia remained 1.8 events per patient year of exposure maintaining a significant reduction in overall risk of confirmed hypoglycaemia compared to insulin degludec.
Maltese: Il-piż tal-ġisem tnaqqas b'0.4 kg b'stima ta' differenza fit-trattament bejn Xultophy u insulin degludec ta' -2.80 kg (p<0.0001), u r-rata ta' ipogliċemija kkonfermata baqgħet ta' 1.8 avvenimenti għal kull sena ta' espożizzjoni kull pazjent u b'hekk inżamm it-tnaqqis sinifikanti fir-riskju totali ta' ipogliċemija kkonfermata meta mqabbel ma'insulin degludec.
English: Other medicines and Xultophy
Maltese: Mediċini oħra u Xultophy
English: Comparator treatments comprised basal insulin, GLP-1 RA therapy, placebo and a basal bolus regimen.
Maltese: Trattamenti ta' paragun kienu jikkonsistu minn insulina bażilari,terapija b'GLP-1 RA, plaċebo u skeda ta' dożaġġ bażilari-bolus..
English: • liraglutide - a ‘GLP-1 analogue' that helps your body make more insulin during meals and lowers the amount of sugar made by your body.
Maltese: • liraglutide - ‘analogu ta' GLP-1' li jgħin lil ġismek jipproduċi iktar insulina waqt l-ikliet u jbaxxi l-ammont ta' zokkor li jipproduċi ġismek.
English: Intensification of therapy with insulin, a component of Xultophy, with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while longterm improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: L-intensifikazzjoni tat-terapija bl-insulina, komponent ta' Xultophy, b'titjib f'daqqa tal-kontroll gliċemiku, tista' tkun assoċjata ma' retinopatija dijabetika li tmur għall-agħar temporanjament, filwaqt li titjib fil-kontroll gliċemiku fit-tul inaqqas ir-riskju tal-progressjoni tar-retinopatija dijabetika.
English: Add-on to oral glucose-lowering medicinal products Adding Xultophy to metformin alone or in combination with pioglitazone in a 26-week randomised, controlled, open-label trial resulted in 60.4% of patients treated with Xultophy reaching a target of HbA1c <7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
Maltese: Żieda ma' prodotti mediċinali li jbaxxu l-glukosju li jittieħdu mill-ħalq Iż-żieda ta' Xultophy ma'metformin waħdu jew flimkien ma' pioglitazone f'prova openlabel ,ikkontrollata, magħmula b'mod arbitrarju u li damet 26 ġimgħa irriżultat f'60.4% tal-pazjenti kkurati b'Xultophy jilħqu mira ta' HbA1c <7% mingħajr episodji ipogliċemiċi kkonfermati wara 26 ġimgħa ta' kura.
English: Overall, the pharmacokinetics of insulin degludec and liraglutide were not affected in a clinically relevant manner when administered as Xultophy compared with independent injections of insulin degludec and liraglutide.
Maltese: B'mod ġenerali, il-farmakokinetika tal-insulina degludec u ta' liraglutide ma kinitx affettwata b'mod klinikament rilevanti meta ngħataw bħala Xultophy meta mqabbla ma' injezzjonijiet indipendenti ta' insulina degludec u ta' liraglutide.
English: The frequency of nausea and diarrhoea was ‘Common' for Xultophy and ‘Very common' for liraglutide.
Maltese: Il-frekwenza ta' dardir u dijarea kienet ‘Komuni' għal Xultophy u ‘Komuni ħafna' għal liraglutide.
English: D The average pre-trial dose of insulin glargine was 32 units
Maltese: D Id-doża medja tal-insulina glargine qabel il-prova kienet ta' 32 unità
English: Before first opening: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: B. PACKAGE LEAFLET
Maltese: Lipodistrofija akkwiżita
English: Injection site reactions (including injection site haematoma, pain, haemmorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) have been reported in 2.6% of patients treated with Xultophy.
Maltese: Ġew irrapportati reazzjonijiet fis-sit tal-injezzjoni (li jinkludu ematoma fis-sit tal-injezzjoni, uġigħ, emorraġija, eritema, noduli, nefħa, tibdil fil-kulur, ħakk, sħana u ebusija fis-sit tal-injezzjoni) f'2.6% tal-pazjenti kkurati b'Xultophy.
English: The reduction in HbA1c from baseline to 52 weeks was 1.84% with Xultophy with an estimated treatment difference of -0.65% compared to liraglutide (p<0.0001) and -0.46% compared to insulin degludec (p<0.0001).
Maltese: It-tnaqqis fl-HbA1c mil-linja bażi sa 52 ġimgħa kien ta' 1.84% b'Xultophy b'stima ta' differenza fit-trattament ta' -0.65% meta mqabbel ma' liraglutide (p<0.
English: One pre-filled pen contains 300 units insulin degludec and 10.8 mg liraglutide in 3 mL solution 1 mL solution contains 100 units of insulin degludec and 3.6 mg liraglutide One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide
Maltese: Millilitru ta' soluzzjoni fih 100 unità ta' insulina degludec u 3.6 mg liraglutide Eskalazzjoni waħda fid-doża fiha unità 1 ta' insulina degludec u 0.
English: If you use GLP-1 treatment
Maltese: GLP-1.
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 12.9% in the Xultophy group and 19.5% in the insulin glargine group (estimated treatment ratio 0.42 [95% CI: 0.23; 0.75]).
Maltese: glukosju fid-demm kien ta' 12.9% fil-grupp ta' Xultophy u ta' 19.5% fil-grupp ta' insulin glargine (stima ta' proporzjon ta' trattament 0.
English: Clear, colourless, isotonic solution.
Maltese: Soluzzjoni isotonika, ċara, mingħajr kulur.
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.00 (0 patients out of 278) for Xultophy and 0.01 (1 patient out of 279) for insulin glargine.
Maltese: Ir-rata ta' ipogliċemija severa, għal kull sena ta' esponiment tal-pazjent (perċentwal ta' pazjenti), kienet ta' 0.00 (0 pazjenti minn 278) għal Xultophy u ta' 0.01 (pazjent 1 minn 279) għall-insulina glargine.
English: Insulin (units) Liraglutide (mg) Estimated difference, basal insulin dose
Maltese: Liraglutide (mg) Differenza stmata, doża ta' insulina degludec
English: The total daily insulin dose at end of trial was 40 units for patients treated with Xultophy and 84 units (52 units of basal insulin and 32 units of bolus insulin) for patients treated with a basal-bolus insulin regimen.
Maltese: Iddoża totali ta' insulina kuljum fi tmiem il-prova kienet 40 unità għall-pazjenti ttrattati bi Xultophy u 84 unità (52 unità ta' insulina bażali u 32 unità ta' insulina mogħtija f'daqqa) għall-pazjenti ttrattati bliskeda ta' insulina bażali flimkien ma' doża ta' insulina mogħtija f'daqqa.
English: Add-on to oral glucose-lowering medicinal products
Maltese: Xultophy u mediċini orali għad-dijabete
English: There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Xultophy is therefore not recommended for use in these patients.
Maltese: M'hemm ebda esperjenza terapewtika f'pazjenti b'insuffiċjenza konġestiva tal-qalb ta' klassi IV skont il-klassifika tan-New York Heart Association (NYHA) u għalhekk Xultophy mhuwiex irrakkomandat għall-użu f'dawn il-pazjenti.
English: Compared to baseline, there was a mean reduction in body weight of 0.9 kg for Xultophy and a mean increase of 2.6 kg for patients treated with a basal-bolus regimen and the estimated treatment difference was -3.57 kg [95% CI:4.19; -2.95].
Maltese: Mqabbel mal-linja bażi, kien hemm tnaqqis medju ta' 0.9 kg fil-piż tal-ġisem għal Xultophy u żieda medja ta' 2.6 kg għall-pazjenti ttrattati bl-iskeda tal-insulina bażali flimkien ma'doża tal-insulina f'daqqa u l-istima tad-differenza fit-trattament kienet -3.57 kg [CI ta' 95%: -4.19; -2.95].
English: You can carry Xultophy with you and keep it at room temperature (no more than 30°C) or in a refrigerator (2°C to 8°C) for up to 21 days.
Maltese: Tista' ġġorr Xultophy miegħek u żżommu f'temperatura ambjentali (mhux iktar minn 30°C) jew fi friġġ (2°C sa 8°C) sa 21 jum.
English: Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Maltese: L-insulina degludec tingħaqad speċifikament mar-riċettur tal-insulina umana u b'hekk tikkawża listess effetti farmakoloġiċi bħal dawk tal-insulina umana.
English: Pancreatitis (including necrotising pancreatitis )
Maltese: Tifwiq, gass Mhux magħrufa Pankreatite (inkluż pankreatite nekrotika)
English: The safety and efficacy of Xultophy were evaluated in seven randomised, controlled, parallel group phase 3 trials in different populations of subjects with type 2 diabetes defined by previous antidiabetes treatment.
Maltese: Is-sigurtà u l-effikaċja ta' Xultophy ġew evalwati f'seba' provi ta' Fażi 3 f'grupp paralell,magħmula b'mod arbitrarju u kkontrollati u li saru f'popolazzjonijiet differenti ta' suġġetti bid-dijabete ta' tip 2 iddefinita minn trattament antidijabetiku preċedenti.
English: In patients inadequately controlled on metformin alone or in combination with pioglitazone, Xultophy reduced mean systolic blood pressure by 1.8 mmHg compared to a reduction of 0.7 mmHg with insulin degludec and 2.7 mmHg with liraglutide.
Maltese: Fil-pazjenti li ma kinux ikkontrollati b'mod adegwat b'metformin waħdu jew flimkien ma' pioglitazone, Xultophy naqqas il-medja tal-pressjoni sistolika tad-demm b'1.8 mmHg meta mqabbel ma' tnaqqis ta' 0.7 mmHg b'insulina degludec u b'2.7 mmHg b'liraglutide.
English: The most frequently reported adverse reactions during treatment with Xultophy were hypoglycaemia and gastrointestinal adverse reactions (see section ‘Description of selected adverse reactions' below).
Maltese: Ir-reazzjonijiet avversi irrapportati b'mod l-aktar frekwenti b'Xultophy kienu ipogliċemija u reazzjonijiet avversi gastronintestinali (ara sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi partikolari' hawn taħt).
English: When transferring from basal insulin therapy, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1).
Maltese: Meta jsir trasferiment minn terapija ta' insulina bażali, id-doża tal-bidu rrakkomandata ta' Xultophy hija ta' 16-il eskalazzjoni fiddoża (16-il unità ta' insulina degludec u 0.6 mg liraglutide) (ara sezzjonijiet 4.4 u 5.1) Id-doża tal-bidu rrakkomandata ma għandhiex tinqabeż.
English: • sulfonamides - for infections
Maltese: • sulfonamides - għal infezzjonijiet
English: Dose counter stopped: 42 dose steps left
Maltese: Kontatur taddożi mwaqqaf: fadal 42 eskalazzjoni tad-doża
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.02 (2 patients out of 288) for Xultophy and 0.00 (0 patients out of 146) for placebo.
Maltese: Ir-rata ta' ipogliċemija severa għal kull sena ta' esponiment tal-pazjent (perċentwal ta' pazjenti) kienet ta' 0.02 (2 pazjenti minn 288) għal Xultophy u 0.00 (0 pazjenti minn 146) għall-plaċebo.
English: • thyroid hormones - for thyroid disease
Maltese: • ormoni tat-tirojde - għal mard tat-tirojde
English: Upon initiation of Xultophy treatment in patients on warfarin or other coumarin derivatives more frequent monitoring of INR (International Normalised Ratio) is recommended.
Maltese: Mal-bidu tal-kura b'Xultophy f'pazjenti li jkunu qegħdin jieħdu l-warfarin jew derivattivi oħrajn ta' coumarin, huwa rrakkomandat li l-monitoraġġ tal-INR (International Normalised Ratio) ikun aktar frekwenti.
English: • Lower appetite, feeling or being sick (nausea or vomiting), diarrhoea, constipation, indigestion (dyspepsia), inflamed lining of the stomach (gastritis), stomach ache, heartburn or bloatingthese usually go away after a few days or weeks.
Maltese: • Aptit imnaqqas, tkun imdardar jew taqla' (dardir jew rimettar), dijarea, stitikezza, indiġestjoni (dispepsja), rita tal-istonku infjammata (gastrite), uġigħ fl-istonku, ħruq ta' stonku jew nefħa fiż-żaqq - dawn normalment jgħaddu wara ftit jiem jew ġimgħat.
English: Figure 1 Mean HbA1c (%) by treatment week (left) and rate of confirmed hypoglycaemia per patient year of exposure vs mean HbA1c (%) (right) in patients with type 2 diabetes mellitus inadequately controlled on metformin alone or in combination with pioglitazone
Maltese: Figura 1 Medja ta' HbA1c (%) skont il-ġimgħa tal-kura (xellug) u r-rata ta' ipogliċemija kkonfermata għal kull sena ta' esponiment tal-pazjent vs il-medja ta' HbA1c (%) (lemin) f'pazjenti b'dijabete mellitus tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'metformin waħdu jew flimkien ma' pioglitazone
English: The potential risk for humans is unknown.
Maltese: jnaqqas ir-riskju ta' dan it-tidil fil-ġilda.
English: Table 2 Titration of Xultophy
Maltese: Jekk tinsa tuża Xultophy
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia defined as an episode requiring assistance of another person was 0.01 (2 patients out of 825) for Xultophy, 0.01 (2 patients out of 412) for insulin degludec and 0.00 (0 patients out of 412) for liraglutide.
Maltese: Ir-rata għal kull sena ta' espożizzjoni għal kull pazjent (persentaġġ ta' pazjenti) ta' ipogliċemija severa definita bħala episodju li jkollu bżonn ta' assistenza minn persuna oħra kienet ta' 0.01 (2 pazjenti minn 825) għal Xultophy, 0.01 (2 pazjenti minn 412) għal insulin degludec u 0.00 (0 pazjenti minn 412) għal liraglutide.
English: Tabulated list of adverse reactions Adverse reactions associated with Xultophy are given below, listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi assoċjati ma' Xultophy huma mogħtija hawn taħt, elenkati skont il-klassi tassistemi u tal-organi u l-frekwenza.
English: Transfer from basal insulin
Maltese: Trasferiment minn insulina bażali
English: Favours Liraglutide Favours Placebo
Maltese: Jiffavorixxi Plaċebo
English: In a second trial, the transfer from basal insulin to Xultophy or insulin degludec was investigated in a 26-week randomised, double-blind trial in patients inadequately controlled on basal insulin (20-40 units) and metformin alone or in combination with sulfonylurea/glinides.
Maltese: F'prova oħra, it-trasferiment minn insulina bażilari għal Xultophy jew insulin degludec ġie investigat f'prova ta' 26 ġimgħa, double-blind,u magħmula b'mod arbitrarju f'pazjenti b'dijabete mellitus tattip 2 li ma kinux ikkontrollati b'mod adegwat bl-insulina bażilari (20-40 unità) u metformin waħdu jew flimkien ma' sulfonylurea/glinides.
English: Package leaflet: Information for the patient Xultophy 100 units/mL + 3.6 mg/mL solution for injection insulin degludec + liraglutide
Maltese: Informazzjoni għall-pazjent Xultophy 100 unità/mL + 3.6 mg/mL soluzzjoni għall-injezzjoni insulina degludec + liraglutide
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.01 (1 patient out of 291) for Xultophy and 0.00 (0 patients out of 199) for GLP-1 receptor agonists.
Maltese: Ir-rata ta' ipogliċemija severa għal kull sena ta' esponiment tal-pazjent (perċentwal ta' pazjenti) kienet ta' 0.01 (pazjent 1 minn 291) għal Xultophy u 0.00 (0 pazjenti minn 199) għall-agonisti tar-riċettur
English: The efficacy and safety of Xultophy were sustained up to 52 weeks of treatment.
Maltese: L-effikaċja u s-sigurtw ta' Xultophy kienu sostnuti sa 52 ġimgħa .
English: PC: SN: NN:
Maltese: Qabel ma tiftħu:
English: Each mL of solution contains 100 units of insulin degludec and 3.6 mg liraglutide.
Maltese: Kull mL tas-soluzzjoni fih 100 unità insulina degludec u 3.6 mg liraglutide.
English: Headache, slurred speech, fast heartbeat, cold sweat, cool pale skin, feeling sick (nausea), feeling very hungry, shaking, feeling nervous or worried, unusually tired, weak and sleepy or confused, difficulty concentrating, short-lasting changes in your sight.
Maltese: Dawn jistgħu jinkludu għaraq kiesaħ, ġilda pallida u kiesħa, telqa, nervi jew rogħda, ansjetà, għeja jew debbulizza mhux tas-soltu, konfużjoni, diffikultà biex tikkonċentra, tħeddil, ħafna ġuħ li ma jkunx normali, tibdil fil-vista, uġigħ ta' ras, dardir u palpitazzjoni.
English: Liraglutide did not change the overall exposure of atorvastatin to a clinical relevant degree following single dose administration of atorvastatin 40 mg.
Maltese: Liraglutide ma bidilx, b'grad li kien klinikament rilevanti, l-espożizzjoni totali ta' atorvastatin wara lgħoti ta' doża waħda ta' atorvastatin 40 mg.
English: See also section 2 ‘Important information about some of the ingredients of Xultophy' for information on sodium.
Maltese: Ara wkoll sezzjoni 2 ‘Tagħrif importanti dwar xi wħud mis-sustanzi ta' Xultophy' għal informazzjoni dwar sodium.
English: HbA1c (%) at end of treatment
Maltese: HbA1c (%)|Żmien mir-Randomisation (Ġimgħa)
English: Xultophy 100 units/mL + 3.6 mg/mL solution for injection insulin degludec + liraglutide SC use
Maltese: Xultophy 100 unità/mL + 3.6 mg/mL soluzzjoni għall-injezzjoni insulina degludec + liraglutide Użu għal taħt il-ġilda
English: There is no difference in the pharmacokinetics of insulin degludec between healthy subjects and patients with renal impairment.
Maltese: Ma hemm l-ebda differenza fil-farmakokinetika tal-insulina degludec bejn persuni f'saħħithom u pazjenti b'indeboliment renali.
English: Alcohol may intensify or reduce the hypoglycaemic effect of Xultophy.
Maltese: Ma saru ebda provi dwar l-effetti kardjovaskulari b'Xultophy.
English: • Get medical help straight away.
Maltese: • Ikseb għajnuna medika minnufih.
English: • beta-blockers - for high blood pressure.
Maltese: • imblokkaturi tar-riċetturi beta - għall-pressjoni għolja fid-demm.
English: • use too much Xultophy.
Maltese: • tuża wisq Xultophy.
English: BATCH NUMBER
Maltese: Figura 5
English: Estimated ratio
Maltese: Differenza stmata
English: IDegLira Unchanged GLP-1 RA
Maltese: GLP-1 RA mhux mibdul
English: Outer needle cap
Maltese: Tużax Xultophy jekk qed tredda'.
English: • Dehydration (loss of fluid from the body) - it is important to drink plenty of fluids to stop dehydration.
Maltese: • Deidratazzjoni (telf ta' fluwidu mill-ġisem) - importanti li tixrob ħafna fluwidi biex twaqqaf id deidratazzjoni.
English: C Count slowly:
Maltese: Waqt l-użu:
English: Eructation, flatulence
Maltese: Jekk tieqaf tuża Xultophy
English: Before opening
Maltese: Novo Allé
English: Insulin degludec and liraglutide exposure increased proportionally with the Xultophy dose within the full dose range based on a population pharmacokinetic analysis.
Maltese: L-esponiment għal insulina degludec u għal liraglutide żdied b'mod proporzjonali mad-doża ta' Xultophy fil-medda sħiħa tad-doża abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: Do not freeze
Maltese: Għatu ta'
English: The mean daily insulin dose at end of trial was 36 units for patients treated with Xultophy and 54 units for patients treated with insulin glargine.
Maltese: Fl-aħħar tal-prova, id-doża medja kuljum tal-insulina kienet ta' 36 unità għal pazjenti ttrattati b'Xultophy u ta' 54 unità għal pazjenti ttrattati b'insulin glargine.
English: • Unscrew the needle and dispose of it carefully as instructed by your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew l-infermier tiegħek.
English: If it shows 50, at least 50 dose steps are left in your pen.
Maltese: Jekk juri 50, tal-inqas fadal 50 eskalazzjoni fid-doża fil-pinna tiegħek.
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 ‘JIS'.
English: Similarly, in a 26-week clinical trial, patients with type 2 diabetes and moderate renal impairment (CrCl 30-59 mL/min) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
Maltese: Bl-istess mod, f'prova klinika ta' 26 ġimgħa, pazjenti bid-dijabete tat-tip 2 u b'indeboliment renali moderat (CrCl 30-59 mL/min) kellhom tnaqqis fl-esponiment għal liraglutide ta' 26% meta mqabbel ma' prova separata li kienet tinkludi pazjenti bid-dijabete tat-tip 2 b'funzjoni renali normali jew b'indeboliment renali ħafif.
English: • Allergic reactions (hypersensitivity) such as rash, itching and swelling of the face.
Maltese: • Reazzjonijiet allerġiċi (sensittività eċċessiva) bħal raxx, ħakk u nefħa fil-wiċċ.
English: • oral contraceptives - birth control pills
Maltese: • kontraċettivi li jittieħdu mill-ħalq - pilloli li jikkontrollaw it-tqala
English: Signs and symptoms of dehydration, including renal impairment and acute renal failure have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, a component of Xultophy.
Maltese: Fi studji kliniċi b'agonisti tar-riċettur GLP-1 inkluż liraglutide, komponent ta' Xultophy, ġew irrapportati sinjali u sintomi ta' deidratazzjoni li jinkludu indeboliment renali u insuffiċjenza renali akuta.
English: The pharmacokinetics of liraglutide was evaluated in patients with varying degrees of hepatic impairment in a single-dose trial.
Maltese: Il-farmakokinetika ta' liraglutide kienet ivvalutata f'pazjenti li kellhom gradi differenti ta' indeboliment tal-fwied fi prova b'doża waħda.
English: Insulins and analogues for injection, long-acting.
Maltese: Insulini u analogi għall-injezzjoni, li jaħdmu fit-tul.
English: 54.3% of patients treated with Xultophy reached the HbA1c target of <7% without confirmed hypoglycaemic episodes compared to 29.4% of patients treated with insulin glargine (odds ratio 3.24, p<0.001).
Maltese: Id-doża massima permessa kienet ta' 50 eskalazzjoni fid-doża għal Xultophy waqt li ma kien hemm ebda doża massima għall-insulina glargine. 54.3% talpazjenti ttrattati b'Xultophy laħqu l-mira ta' HbA1c <7% mingħajr episodji ipogliċemiċi kkonfermati meta mqabbla ma' 29.4 % tal-pazjenti kkurati bl-insulina glargine (proporzjon ta' probabbiltà 3.24, p
English: If it shows less than 50, the number shown is the number of dose steps left in your pen.
Maltese: Jekk juri inqas minn 50, in-numru muri huwa n-numru ta' eskalazzjonijiet fid-doża li fadal fil-pinna tiegħek.
English: • if you have a severe stomach ache which does not go away, tell your doctor - this could be a sign of inflamed pancreas (acute pancreatitis).
Maltese: • jekk għandek uġigħ qawwi fl-istonku li ma jitlaqx, kellem lit-tabib tiegħek - dan jista' jkun sinjal ta' frixa infjammata (pankreatite akuta).
English: Animal reproduction studies with insulin degludec have not revealed any differences between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
Maltese: Studji dwar ir-riproduzzjoni fl-annimali bl-insulina degludec ma żvelaw l-ebda differenza bejn linsulina degludec u l-insulina umana fir-rigward tal-embrijotossiċità u t-teratoġeniċità.
English: Octreotide and lanreotide - used for treatment of acromegaly (a rare illness with too much growth hormone).
Maltese: Octreotide u lanreotide - użati għall-kura ta' akromegalija (marda rari b'ormon tat-tkabbir żejjed).
English: A drop of solution should appear at the needle tip.
Maltese: Tista' tara qatra ta' soluzzjoni fil-ponta tal-labra wara li tinjetta.
English: Interaction studies did not show any clinically relevant delay of absorption.
Maltese: Studji dwar l-interazzjonijiet urew li ma kien hemm ebda dewmien fl-assorbiment li kien klinikament rilevanti.
English: Component of a multipack, can't be sold separately
Maltese: Parti minn pakkett multiplu, ma jistgħux jinbigħu b'mod separat
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 (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).