FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic reactions (manifested with signs and symptoms such as urticaria (0.3% of patients treated with Xultophy), rash (0.7%), pruritus (0.5%) and/or swelling of the face (0.2%)) have been reported for Xultophy.
Maltese: Ġew irrapportati reazzjonijiet allerġiċi għal Xultophy (murija b'sinjali u sintomi bħal urtikarja (0.3% tal-pazjenti kkurati b'Xultophy), raxx (0.2%), ħakk (0.5%) u/jew nefħa tal-wiċċ (0.2%)).
English: Liraglutide is a Glucagon-Like Peptide-1 (GLP-1) analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor (GLP-1R).
Maltese: Liraglutide huwa analogu ta' Peptide-1 li jixbah lil Glucagon (GLP-1 - Glucagon-Like Peptide-1) b'omoloġija ta' 97% fis-sekwenza għall-GLP-1 tal-bniedem li jintrabat ma' u jattiva r-riċettur GLP-1 (GLP-1R).
English: A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%.
Maltese: L-għoti ta' doża waħda ta' lisinopril 20 mg ma' liraglutide, irriżulta fi tnaqqis fl-AUC ta' lisinopril ta' 15%; is-Cmax naqas b'27%.
English: In addition, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence and decreased appetite have been reported in up to 3.6% of patients treated with Xultophy.
Maltese: Barra minn hekk, ġew irrapportati stitikezza, dispepsja, gastrite, uġigħ addominali, mard ta' rifluss gastroesofagali, nefħa addominali, tifwiq, gass u tnaqqis fl-aptit sa 3.6% tal-pazjenti kkurati b'Xultophy.
English: Glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections
Maltese: TA' EĊĊIPJENTI Glycerol, phenol, zinc acetate, hydrochloric acid u sodium hydroxide (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet
English: Nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension
Maltese: Nawsja, dijarea, rimettar, stitikezza, dispepsja, gastrite, uġigħ addominali, mard ta' rifluss gastroesofagali, nefħa addominali
English: 48.7% of patients treated with Xultophy reached the HbA1c target of <7% without confirmed hypoglycaemic episodes.
Maltese: 48.7% tal-pazjenti ttrattati b'Xultophy laħqu l-mira ta' HbA1c ta' <7% mingħajr episodji ipogliċemiċi kkonfermati.
English: The maximum allowed dose was 50 dose steps for Xultophy and 50 units for insulin degludec.
Maltese: Id-doża massima permessa kienet ta' 50 eskalazzjoni fid-doża għal Xultophy u 50 unità għall-insulina degludec.
English: For study results with respect to combinations, effects on glycaemic control, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudji fir-rigward ta' teħid ma' prodotti oħra, effetti fuq il-kontroll gliċemiku u l-popolazzjonijiet li ġew studjata ara sezzjonijiet 4.4,4.5 u 5.1.
English: Age had no clinically relevant effect on the pharmacokinetics of Xultophy based on results from a population pharmacokinetic analysis including adult patients up to 83 years treated with Xultophy.
Maltese: L-età ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' Xultophy abbażi ta' riżultati minn analiżi farmakokinetika tal-popolazzjoni li kienet tinkludi pazjenti adulti sa 83 sena kkurati bi Xultophy.
English: When Xultophy is added to sulfonylurea therapy, a reduction in the dose of sulfonylurea should be considered (see section 4.4).
Maltese: Meta Xultophy jiżdied ma' terapija b'sulfonylurea, għandu jiġi kkunsidrat tnaqqis fid-doża ta' sulfonylurea (ara sezzjoni 4.4).
English: • danazol - medicine affecting ovulation
Maltese: • danazol - mediċina li taffettwa l-ovulazzjoni
English: Transfer from GLP-1 receptor agonist Xultophy
Maltese: Trasferiment minn agonist tar-riċettur GLP-1 Xultophy
English: This was a significantly higher proportion than observed with insulin degludec (15.6%, odds ratio 5.57, p<0.0001).
Maltese: 6%, proporzjon ta' probabbiltà 5.57, p<0.0001).
English: • acetylsalicylic acid (and medicines called ‘salicylates') - for pain and mild fever
Maltese: • acetylsalicylic acid (u mediċini msejħin ‘salicylates') - għal uġigħ u deni ħafif
English: Insulin degludec (units) Liraglutide (mg)
Maltese: Doża Tmiem tal-prova Insulina degludec (unitajiet) Liraglutide (mg)
English: Novo Allé DK-2880 Bagsværd Denmark
Maltese: DK-2880 Bagsværd Id-Danimarka
English: The relevance for humans is likely to be low but cannot be completely excluded.
Maltese: Wisq probabbli r-rilevanza għall-umani hija ftit iżda ma tistax tiġi esklusa kompletament.
English: Transfer from basal insulin therapies
Maltese: Trasferiment minn terapiji b'insulina bażali
English: Investigation
Maltese: Investigazzjonijiet
English: Solution for injection Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Maltese: Pakkett multiplu: 10 (2 pakketti ta' 5) 3 mL pinen mimlijin għal-lest
English: Xultophy is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines).
Maltese: Xultophy jintuża ma' mediċini orali għad-dijabete (bħal metformin, pioglitazone u mediċini sulfonylurea).
English: Transfer of patients from insulin glargine (100 units/mL) to Xultophy or intensification of insulin glargine in patients inadequately controlled on insulin glargine (20-50 units) and metformin were studied in a 26 week trial.
Maltese: It-trasferiment ta' pazjenti minn insulina glargine (100 unitl/ml) għal Xultophy jew l-intensifikazzjoni ta' insulin glargine f'pazjenti li ma kinux ikkontrollati sew b'insulin glargine (20-50 unito) u metformin, ġew studjati f'prova ta' 26 ġimgħa.
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 fi tnaqqis fl-AUC ta' digoxin ta' 16%; is-Cmax naqas b'31%.
English: The MAH shall agree the final content and modality of distribution for the educational materials together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational materials in the Member State.
Maltese: L-MAH għandu jaqbel fuq il-kontenut finali u l-modalità ta' distribuzzjoni għall-materjali edukattivi flimkien mal-pjan ta' komunikazzjoni, mal-Awtorità Nazzjonali Kompetenti f'kull Stat Membru qabel ma ssir id-distribuzzjoni tal-materjali edukattivi fl-Istat Membru.
English: Xultophy with alcohol
Maltese: Xultophy mal-alkoħol
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 IV (DPP-IV) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half-life.
Maltese: Wara l-għoti minn taħt il-ġilda, il-profil imtawwal tal-azzjoni huwa bbażat fuq tliet mekkaniżmi: l-awtoassoċjazzjoni, li tirriżulta f'assorbiment bil-mod; rabta mal-albumina; u stabilità enzimatika ogħla lejn l-enzimi dipeptidyl peptidase IV (DPP-IV) u endopeptidase newtrali (NEP), li tirriżulta f'half-life twila fil-plażma.
English: Increased amylase
Maltese: Żieda fl-amylase
English: The following substances may increase the Xultophy requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones and danazol.
Maltese: Kontraċettivi orali, thiazides, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, l-ormoni tattkabbir u danazol.
English: A 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: Ġie osservat tnaqqis fl-HbA1c mil-linja bażi sax-xahar 36 b'liraglutide vs plaċebo, flimkien ma' kura standard (-1.16% vs -0.77%; stima ta' differenza fil-kura [ETD- estimated treatment difference]
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of Xultophy based on results from a population pharmacokinetic analysis including White, Black, Indian, Asian and Hispanic groups.
Maltese: L-oriġini etnika ma kellha l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' Xultophy abbażi ta' riżultati minn analiżi farmakokinetika tal-popolazzjoni li kienet tinkludi gruppi ta' persuni Bojod, Suwed, Indjani, Asjatiċi u Ispaniċi.
English: Xultophy is a medicine that contains insulin degludec and liraglutide.
Maltese: Xultophy huwa mediċina li fiha insulina degludec u liraglutide.
English: 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a stopper (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polycarbonate and acrylonitrile butadiene styrene.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Soluzzjoni ta' 3 mL fi skartoċċ (ħġieġ tat-tip 1) bi planġer (halobutyl) u tapp (halobutyl/polyisoprene) li jkun f'pinna mimlija bil-lest, b'ħafna dożi, li tintrema wara l-użu magħmula mill-polypropylene, mill-polycarbonate u mill-acrylonitrile butadiene styrene.
English: Insulin glargine, no limitation to dose
Maltese: Insulina glargine, ebda limitazzjoni fid-doża
English: Estimated difference, insulin degludec dose
Maltese: Differenza stmata, doża ta' insulina degludec
English: 1 mL solution contains 100 units insulin degludec* and 3.6 mg liraglutide*.
Maltese: U KWANTITATTIVA 1 mL ta' soluzzjoni fih 100 unità ta' insulina degludec* u 3.6 mg liraglutide*.
English: Combination of pioglitazone and insulin medicinal products
Maltese: Kombinazzjoni ta' pioglitazone u prodotti mediċinali tal-insulina
English: IDegLira obs. rate IDegLira IDeg
Maltese: Eżempji eskalazzjoni jiet fid-doża magħżula eskalazzjoni fid-doża magħżula
English: 2 Check the flow
Maltese: 2 Iċċekkja l-fluss
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function.
Maltese: L-esponiment għal liraglutide tnaqqas f'pazjenti b'indeboliment renali meta mqabbel ma' individwi b'funzjoni normali tal-kliewi.
English: EU/1/14/947/001 1 pre-filled pen EU/1/14/947/002 3 pre-filled pens EU/1/14/947/003 5 pre-filled pens
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/947/001 pinna waħda mimlija għal-lest EU/1/14/947/002 3 pinen mimlijin għal-lest EU/1/14/947/003 5 pinen mimlijin għal-lest
English: • The other ingredients are glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections.
Maltese: • Is-sustanzi l-oħra huma glycerol, phenol, zinc acetate, hydrochloric acid u sodium hydroxide (għal aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: Pioglitazone - tablets used for the treatment of type 2 diabetes mellitus.
Maltese: Pioglitazone - pilloli użati għall-kura tad-dijabete mellitus tat-tip 2.
English: The rate of nocturnal hypoglycaemic events was significantly lower with Xultophy compared to insulin glargine (estimated treatment ratio 0.17, p<0.001).
Maltese: Ir-rata ta' avvenimenti ta' ipogliċemija matul il-lejl kienet aktar baxxa b'mod sinifikanti b'Xultophy meta mqabbla mal-insulina glargine (stima ta' proporzjon ta' trattament 0.17, p>0.001).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL
Maltese: TIKKETTA TA' PAKKETT MULTIPLU
English: Patients (%) achieving HbA1c <7% All patients
Maltese: Pazjenti (%) li kisbu HbA1c <7% Il-pazjenti kollha
English: • medicines called ‘glucocorticoids' such as cortisone - for inflammation
Maltese: • mediċini msejħa ‘glukokortikojdi' bħal cortisone - għal infjammazzjoni
English: Xultophy (dose steps)
Maltese: Xultophy (bidliet fid-doża)
English: The non-clinical development programme for insulin degludec/liraglutide included pivotal combination toxicity studies of up to 90 days duration in a single relevant species (Wistar rats) to support the clinical development programme.
Maltese: Il-programm ta' żvilupp mhux kliniku għall-insulina degludec/liraglutide kien jinkludi studji pivitali ta' tossiċità b'kombinazzjoni li damu sa 90 jum fi speċi rilevanti waħda (firien Wistar) biex isostnu lprogramm ta' żvilupp kliniku.
English: • The active substances are insulin degludec and liraglutide.
Maltese: • Is-sustanzi attivi huma insulina degludec u liraglutide.
English: The overall exposure of insulin degludec was equivalent following administration of Xultophy versus insulin degludec alone while the Cmax was higher by 12%.
Maltese: L-esponiment globali għal-insulina degludec kien ekwivalenti wara l-għoti ta' Xultophy meta mqabbel mal-insulina degludec waħedha filwaqt li s-Cmax kien ogħla bi 12%.
English: • The maximum daily dose of Xultophy is 50 dose steps (50 units of insulin degludec and 1.8 mg of liraglutide).
Maltese: • Id-doża massima ta' kuljum ta' Xultophy hija 50 eskalazzjoni fid-doża (50 unità ta' insulina degludec u 1.8 mg ta' liraglutide).
English: EU/1/14/947/004 10 (2 x 5) pre-filled pens
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/947/004 10 (2 x 5) pinen mimlijin għal-lest
English: Dose End of trial Insulin degludec (units) Liraglutide (mg) Estimated difference, insulin degludec dose
Maltese: Doża Tmiem tal-prova Insulina (unitajiet) Liraglutide (mg) Differenza stmata, doża tal-insulina bażali
English: The 95% confidence interval is stated in ‘[]' *Confirmed hypoglycaemia defined as severe hypoglycaemia (episode requiring assistance of another person) and/or minor hypoglycaemia (plasma glucose <3.1 mmol/L irrespective of symptoms)
Maltese: L-intervall ta' kunfidenza ta' 95% huwa ddikjarat fi ‘[]' *Ipogliċemija kkonfermata definita bħala ipogliċemija severa (episodju li jkun jeħtieġ l-għajnuna ta' persuna oħra) u/jew ipogliċemija ħafifa (glukosju fil-plażma <3.1 mmol/L irrispettivament mis-sintomi)
English: After first opening: Store at a maximum of 30°C or store in a refrigerator (2°C - 8°C).
Maltese: Aħżen f'temperatura massima ta' 30°C jew aħżen fi friġġ (2°C8°C).
English: The mean duration of diabetes was 12.8 years.
Maltese: It-tul ta' żmien tad-dijabete kien medja ta' 12.8 snin.
English: Nausea was reported in 7.8% of patients and was transient in nature for most patients.
Maltese: Kien irrapportat dardir f'7.8% tal-pazjenti u dan kien ta' natura temporanja għal ħafna pazjenti.
English: Xultophy 100 units/mL + 3.6 mg/mL solution for injection.
Maltese: Xultophy 100 unità/mL + 3.6 mg/mL soluzzjoni għall-injezzjoni.
English: Xultophy cannot be recommended for use in patients with end-stage renal disease (see sections 5.1 and 5.2).
Maltese: Xultophy ma jistax jiġi rrakkomandat għall-użu f'pazjenti fl-aħħar stadju ta' mard tal-kliewi (ara sezzjonijiet 5.1 u 5.2).
English: Xultophy contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Maltese: Xultophy fih inqas minn 1 mmol sodium (23 mg) f'kull doża, għalhekk il-mediċina hija essenzjalment ‘mingħajr sodium'.
English: The cardiovascular safety of insulin degludec as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 7).
Maltese: Is-sigurtà kardjovaskulari ta' insulin degludec hekk kif imqabbla ma' insulin glargine ġiet ikkonfermata (HR 0.91 [0.
English: The trial was designed as a non-inferiority trial to exclude a pre-specified risk margin of 1.3 for the hazard ratio (HR) of MACE comparing insulin degludec to insulin glargine.
Maltese: Il-prova ġiet magħmula bħala prova ta' non-inferjorità sabiex jiġi eskluż marġni ta' riskju diġà speċifikat ta' 1.3 għal proporzjon ta' periklu (HR-hazard ratio) ta' MACE meta tqabbel insulin degludec ma' insulin glargine.
English: Administration of Xultophy may cause formation of antibodies against insulin degludec and/or liraglutide.
Maltese: L-għoti ta' Xultophy jista' jikkawża l-formazzjoni ta' antikopri kontra l-insulina degludec u/jew liraglutide.
English: In an open label trial comparing the efficacy and safety of Xultophy and insulin glargine 100 units/mL, both as add-on to SGLT2i ± OAD, Xultophy was superior to insulin glargine in reducing mean HbA1c after 26 weeks by 1.9% (from 8.2% to 6.3%) versus 1.7% (from 8.4% to 6.7%) with an estimated treatment difference of -0.36% [-0.50; -0.21].
Maltese: F'prova open label li qabblet l-effikaċja u s-sigurtà ta' Xultophy u insulin glargine 100 units/mL, ittnejn li huma bħala żieda ma' SGLT2i ± OAD, Xultophy kien superjuri għal insulin glargine b'tnaqqis medju fl-HbA1c wara 26 ġimgħa ta' 1.9% (minn 8.2% għal 6.3%) kontra 1.7% (minn 8.4% għal 6.7%) b'stima ta' differenza fit-trattament ta' -0.36% [-0.50; -0.21]. Meta mqabbel mal-linja bażi, Xultophy ma kkawża ebda tibdil fil-piż medju tal-ġisem meta mqabbel ma' żieda medja fil-piż ta' 2.0 kg għal pazjenti ttrattati b'insulin glargine (stima ta' differenza fit-trattament -1.92 kg [95% CI: -2.64; -1.19]).
English: The rate of nocturnal hypoglycaemic events was similar with Xultophy and insulin degludec treatment.
Maltese: Ir-rata ta' avvenimenti ta' ipogliċemija ta' mal-lejl kienet simili bejn it-trattamenti b'Xultophy u insulin degludec.
English: Treatment with Xultophy compared to a basal-bolus insulin regimen consisting of basal insulin (insulin glargine 100 units/mL) in combination with bolus insulin (insulin aspart) studied in a 26-week trial in patients with type 2 diabetes mellitus inadequately controlled on insulin glargine and metformin demonstrated a similar reduction of HbA1c in the two groups (mean value from 8.2% to 6.7% in both groups).
Maltese: It-trattament bi Xultophy mqabbel ma' skeda ta' insulina bażali flimkien ma' doża ta' insulina mogħtija f'daqqa li tikkonsisti f'insulina bażali (insulina glargine 100 unità/mL) flimkien ma' doża ta' insulina mogħtija f'daqqa (insulina aspart) studjat fi prova ta' 26 ġimgħa f'pazjenti b'dijabete mellitus tat-tip 2 li ma kintix ikkontrollata tajjeb b'insulina glargine u metformin wera tnaqqis simili fl-HbA1c fiż-żewġ gruppi (valur medju minn 8.2% sa 6.7% fiż-żewġ gruppi).
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial with a median duration of 2 years comparing the cardiovascular safety of insulin degludec versus insulin glargine (100 units/mL) in 7,637 patients with type 2 diabetes mellitus at high risk of cardiovascular events.
Maltese: DEVOTE kien studju kliniku magħmul b'mod arbitrarju, double-blind u mmotivat mill-avvenimenti b'tul medjan ta' żmien ta' sentejn li qabbel is-sigurtà kardjovaskulari ta' insulin degludec ma' insulin glargine (100 unità/mL) f'7,637 pazjent bid-dijabete mellitus ta' tip 2 f'riskju għoli ta' avvenimenti kardjovaskulari.
English: The maximum daily dose of Xultophy is 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide).
Maltese: Id-doża massima ta' kuljum ta' Xultophy hija ta' 50 eskalazzjoni fiddoża (50 unità ta' insulina degludec u 1.8 mg liraglutide).
English: Substances added to Xultophy may cause degradation of the active substances.
Maltese: Sustanzi miżjuda ma' Xultophy jistgħu jikkawżaw degradazzjoni tas-sustanzi attivi.
English: Dose counter Dose pointer
Maltese: Kontatur tad-doża Indikatur tad doża
English: • you have had an injection of glucagon
Maltese: • ħadt injezzjoni ta' glucagon
English: GLP-1 receptor agonist
Maltese: Agonist tar-riċettur GLP-1
English: • Serious allergic reaction (anaphylactic reaction) (not known: frequency cannot be estimated from the available data).
Maltese: • Reazzjoni allerġika serja (reazzjoni anafilattika) (mhux magħruf: ma tistax tittieħed stima talfrekwenza mid-dejta disponibbli).
English: This may prevent blocked needles, contamination, infection and inaccurate dosing.
Maltese: Dan jista' jevita labar imblukkati, kontaminazzjoni, infezzjoni u dożaġġ mhux preċiż.
English: The results were similar for Xultophy and liraglutide.
Maltese: Ir-riżultati kienu simili għal Xultophy u għal liraglutide.
English: Gender had no clinically relevant effect on the pharmacokinetics of Xultophy based on results from a population pharmacokinetic analysis.
Maltese: Is-sess ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' Xultophy abbażi ta' riżultati minn analiżi farmakokinetika tal-popolazzjoni.
English: The same titration algorithm was applied for basal insulin comparators.
Maltese: L-istess algoritmu ta' titrazzjoni ġiet applikata għat-trattamenti ta' paragun bl-insulina bażilari.
English: In the LEADER trial, no long-term clinical impact of increased heart rate on the risk of cardiovascular events was observed with liraglutide (a component of Xultophy) (see section 5.1).
Maltese: Fil-prova LEADER, ma ġie osservat ebda impatt kliniku fit-tul minħabba żżieda fir-rata tal-qalb fuq ir-riskju ta' avvenimenti kardjovaskulari b'liraglutide (komponent ta' Xultophy) (ara sezzjoni 5.1)
English: Xultophy 100 units/mL + 3.6 mg/mL solution for injection insulin degludec + liraglutide
Maltese: Xultophy 100 unità/mL + 3.6 mg/mL soluzzjoni għall-injezzjoni insulina degludec + liraglutide
English: Make sure you select the full dose you need.
Maltese: Proporzjon ta' probabbiltà stmata
English: Thyroid adverse events, such as goitre have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, and in particular in patients with pre-existing thyroid disease.
Maltese: Avvenimenti avversi tat-tirojde, bħal goitre, ġew irrapportati f'provi kliniċi b'agonisti tar-riċetturi ta' GLP-1 inkluż liraglutide u b'mod partikulari f'pazjenti li diġà kellhom mard tat-tirojde.
English: Table 4 Results at 26-weeks - Transfer from GLP-1 receptor agonists
Maltese: Tabella 4 Riżultati wara 26 ġimgħa - It-trasferiment minn agonist tar-riċettur GLP-1
English: Transfer from GLP-1 receptor agonist to Xultophy compared to unchanged GLP-1 receptor agonist therapy (dosed according to label) were studied in a 26-weeks randomised, open-label trial in patients with type 2 diabetes mellitus inadequately controlled on a GLP-1 receptor agonist and metformin alone (74.2%) or in combination with pioglitazone (2.5%), sulfonylurea (21.2%) or both (2.1%).
Maltese: It-trasferiment minn agonist tar-riċettur GLP-1 għal Xultophy mqabbel mat-terapija mhux mibdula ta' agonist tar-riċettur GLP-1 (b'doża skont it-tikketta), kienu studjati fi prova randomised, double-blind, u li damet 26 ġimgħa f'pazjenti b'dijabete mellitus tat-tip 2 li ma kinux ikkontrollati b'mod adegwat bl-agonist tar-riċettur ta' GLP-1 u metformin waħdu (74.2 %) jew flimkien ma' pioglitazone (2.5 %), sulfonylurea (21.2 %) jew it-tnejn li huma (2.1 %).
English: The overall exposure of liraglutide was equivalent following administration of Xultophy versus liraglutide alone while Cmax was lower by 23%.
Maltese: L-esponiment globali għal liraglutide kien ekwivalenti wara l-għoti ta' Xultophy meta mqabbel ma' liraglutide waħdu filwat li sCmax kien aktar baxx bi 23%.
English: Table 5 Results at 26-weeks - Transfer from basal insulin
Maltese: Riżultati wara 26 ġimgħa - It-trasferiment minn insulina bażilari
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 19.8% in the Xultophy group and 52.6% in the basal-bolus insulin group, and the estimated rate ratio was 0.11 [95% CI: 0.08-0.17].
Maltese: Il-perċentwal ta' pazjenti li kellhom ipogliċemija bis-sintomi severa jew ikkonfermata mill-glukożju fid-demm kien 19.8% fil-grupp ta' Xultophy u 52.6% fil-grupp tal-insulina bażali flimkien ma' doża tal-insulina mogħtija f'daqqa, u l-istima tar-rata tal-proporzjon kienet 0.11 [CI ta' 95%: 0.08-0.17].
English: When transferring from a GLP-1 receptor agonist, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 5.1).
Maltese: Meta jsir trasferiment minn agonist tar-riċettur ta' GLP-1, id-doża tal-bidu rrakkomandata ta' Xultophy hija ta' 16-il eskalazzjoni fid-doża (16-il unità ta' insulina degludec u 0.6 mg liraglutide) (ara sezzjoni 5.1).