FrancophonIA/ELRC3.0 huggingface dataset:
English: • monoamine oxidase (MAO) inhibitors, for depression
Maltese: • inibituri ta' monoamine oxidase (MAO), użati fil-kura tad-dipressjoni
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: episodji ipogliċemiċi (għal kull sena li pazjent jiġi espost) kienet sinifikament aktar baxxa b'mod statistiku meta żdied liraglutide mqabbel ma' meta żdiedet doża waħda ta' insulina aspart (1.0 vs 8.15; proporzjon: 0.13; 95% CI: 0.08 sa 0.21).
English: Hypersensitivity Urticaria
Maltese: Sensittività eċċessiva
English: Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Maltese: Tresiba ngħata lil tfal u adolexxenti sal-età ta' 18-il sena għall-investigazzjoni ta' propjetajiet farmakokinetiċi (ara sezzjoni 5.2).
English: Patients in the Tresiba arm included 43 children aged 1-5 years, 70 children aged 6-11 years and 61 adolescents aged 12-17 years.
Maltese: Il-pazjenti fil-fergħa ta' Tresiba kienu jinkludu 43 tifel u tifla b'etajiet bejn 1-5 snin, 70 tifel u tifla b'etajiet bejn 6-11-il sena u 61 adolexxent b'etajiet bejn 12-17-il sena.
English: Pack sizes of 5 and 10 cartridges.
Maltese: Daqsijiet tal-pakkett ta' 5 u 10 skrataċ.
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Difference: -0.33 [-1.03; 0.36]
Maltese: Differenza: -0.33 [-1.03; 0.36]
English: AUCGIR,2-24h: metabolic effect in last 22 hours of dosing interval (i.e., not influenced by i.v.
Maltese: AUCGIR,2-24h: effett metaboliku fl-aħħar 22 siegħa tal-intervall tad-dożaġġ (i.e., mhux influwenzat minn insulina i.v. matul ilperjodu clamp run-in)
English: • sulfonamides, for infections
Maltese: • sulfonamides, użati fil-kura ta' infezzjonijiet
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) 3 x 3 mL.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni (FlexTouch) 3 x 3 mL.
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Maltese: L-affinità ta' insulina degludec għall-albumina fis-serum tikkorrispondi għal rabta mal-proteina fil plażma ta' > 99% fil-plażma umana.
English: • Pioglitazone used together with insulin, see ‘Pioglitazone' below.
Maltese: • Pioglitazone użat flimkien mal-insulina, ara ‘Pioglitazone' aktar 'l isfel.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) 5 x 3 mL.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni (FlexTouch) 5 x 3 mL.
English: Ratio: 0.86 [0.58; 1.28]
Maltese: Proporzjon: 0.86 [0.58;1.28]
English: 1 Once-daily regimen + metformin ± DPP-IV inhibitor
Maltese: 1 Kors ta' darba kuljum + metformin ± inibitur ta' DPP-IV
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Glycerol
English: EU/1/12/807/009 EU/1/12/807/006 EU/1/12/807/010 EU/1/12/807/012 EU/1/12/807/013 EU/1/12/807/015 EU/1/12/807/016
Maltese: EU/1/12/807/012 EU/1/12/807/013 EU/1/12/807/015 EU/1/12/807/016
English: Ratio: 1.07 [0.89; 1.28]
Maltese: Proporzjon: 1.07 [0.89;1.28]
English: In direct comparison, requirements for bioequivalence are met for Tresiba 100 units/mL and Tresiba 200 units/mL (based on AUCIDeg,τ,SS and Cmax,IDeg,SS).
Maltese: F'paragun dirett, ir-rekwiżiti għal bijoekwivalenza għal Tresiba 100 unità/ml u Tresiba 200 unità/ml ġew milħuqa (ibbażat fuq AUCIDeg,τ,SS u Cmax,IDeg,SS).
English: Degradation of insulin degludec is similar to that of human insulin; all metabolites formed are inactive.
Maltese: Id-degradazzjoni ta' insulina degludec hija simili għal dik tal-insulina umana; il-metaboliti kollha li jiffurmaw huma inattivi.
English: During a period of 24 hours with once-daily treatment, the glucose-lowering effect of Tresiba, in contrast to insulin glargine, was evenly distributed between the first and second 12 hours (AUCGIR,0-12h,SS/AUCGIR,total,SS = 0.5).
Maltese: Matul perijodu ta' 24 siegħa b'kura ta' darba kuljum, l-effett ta' Tresiba li tbaxxi l-livell tal-glukosju, b'kuntrast mal-insulina glargine, kien imqassam b'mod uniformi bejn l-ewwel u t-tieni 12-il siegħa (AUCGIR,0-12h,SS/AUCGIR,totali,SS = 0.5).
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aggustament tal-pH) Sodium hydroxide (għall-aggustament tal-pH)
English: Ratio: 0.65 [0.48; 0.89]
Maltese: Proporzjon: 0.65 [0.48; 0.89]
English: Dose counter stopped: 52 units left
Maltese: Ilkontatur tad-doża waqaf: fadal 52 unità
English: Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus.
Maltese: Pioglitazone, mediċina orali kontra d-dijabete li tintuża għall-kura ta' dijabete mellitus ta' tip 2.
English: Pharmacokinetic properties of insulin degludec in children (1-11 years) and adolescents (12-18 years) were at steady state comparable to those observed in adults with type 1 diabetes mellitus.
Maltese: Il-karatteristiċi farmakokinetiċi ta' insulina degludec fl-istat fiss fit-tfal (1-11-il sena) u fl-adoloxxenti (12-18-il sena) kienu simili għal dawk osservati fl-adulti bid-dijabete mellitus ta' tip 1.
English: Difference: -0.43 [-0.74; -0.13]
Maltese: Differenza: -0.43 [-0.74; -0.13]
English: Insulin glargine (100 units/mL) (N27) (CV%)
Maltese: (100 unità/mL) (N27) (CV%)
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Maltese: Novo Allé DK-2880 Bagsværd Id-Danimarka
English: Flexibility in dosing time
Maltese: Dożaġġ flessibbli
English: • glucocorticoids such as ‘cortisone', for inflammation
Maltese: • glukokortikojdi bħal 'cortisone', użat fil-kura tal-infjammazzjoni
English: Ratio: 0.75 [0.59; 0.96]
Maltese: Proporzjon: 0.75 [0.59;0.96]
English: 11 multinational clinical trials of 26 or 52 weeks' duration were conducted as controlled, open-label, randomised, parallel, treat-to-target trials exposing 4,275 patients to Tresiba (1,102 in type 1 diabetes mellitus and 3,173 in type 2 diabetes mellitus).
Maltese: Twettqu 11-il prova klinika multinazzjonali li damu 26 jew 52 ġimgħa bħala provi kkontrollati, openlabel li fihom il-parteċipanti ntgħażlu b'mod każwali, paralleli, tat-tip treat-to-target, li esponew 4,275 pazjent għal Tresiba (1,102 individwu b'dijabete mellitus ta' tip 1 u 3,173 individwu b'dijabete mellitus ta' tip 2) .
English: Ratio: 0.64 [0.56; 0.73]
Maltese: Proporzjon: 0.64 [0.56; 0.73]
English: Difference: -0.29 [-0.65; 0.06]
Maltese: Differenza: -0.29 [-0.65; 0.06]
English: Difference: 0.08 [-0.05; 0.21]
Maltese: Differenza: 0.08 [-0.05; 0.21]
English: Difference: -0.43 [-0.61; -0.24]
Maltese: Differenza: -0.43 [-0.61; -0.24]
English: The trials evaluated the rate of hypoglycaemia upon treatment with Tresiba compared to insulin glargine (100 units/mL) (see Table 7).
Maltese: Il-provi stmaw ir-rata ta' ipogliċemija bittrattament bi Tresiba meta mqabbel ma' insulina glargine (100 unità/mL) (ara Tabella 7).
English: The rate of hyperglycaemic episodes with ketosis was significantly lower for Tresiba versus insulin detemir, 0.68 and 1.09, respectively.
Maltese: Irrata ta' episodji ta' ipergliċemija b'ketosi kienet aktar baxxa b'mod sinifikanti għal Tresiba kontra insulin detemir, 0.68 u 1.09, rispettivament.
English: • With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered.
Maltese: • B'Tresiba 100 unità/mL doża ta' 1-80 unità f'kull injezzjoni, tista' tingħata f'żidiet ta' unità 1.
English: 2 units selected
Maltese: 2 unitajiet.
English: The pen can dial up to a maximum of 160 units.
Maltese: Il-pinna tista' tagħżel sa massimu ta' 160 unità.
English: Tresiba with alcohol
Maltese: Tresiba mal-alkoħol
English: Ratio: 0.75 [0.58; 0.99]
Maltese: Proporzjon: 0.75 [0.58;0.99]
English: Difference: 0.09 [-0.04; 0.22]
Maltese: Differenza: 0.09 [-0.04; 0.22]
English: Make sure to have a minimum of 8 hours between the doses.
Maltese: Dejjem żgura li jkun hemm minimu ta' 8 sigħat bejn id-dożi.
English: 1 In a once-daily regimen + insulin aspart to cover mealtime insulin requirements 2 In a once-daily regimen ± OADs (any combination of metformin, dipeptidyl peptidase-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sodium glucose cotransporter-2 inhibitor) 3 Per patient year of exposure
Maltese: 1 F'kors ta' darba kuljum + insulin aspart biex ikopri l-ħtiġijiet tal-insulina f'ħin l-ikel 2 F'kors ta' darba kuljum ± OADs (kwalunkwe kombinazzjoni ta' metformin, inibitur ta' dipeptidyl peptidase-4, inibitur ta' alpha-glucosidase, thiazolidinediones, u inibitur tal-kotrasportatur 2 ta' sodium glucose)
English: Nocturnal severe2
Maltese: Severa mal-lejl2
English: Glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Maltese: TA' EĊĊIPJENTI Glycerol, metacresol, phenol, zinc acetate, hydrochloric acid u sodium hydroxide (għal aġġustament tal-pH) u ilma għall-injezzjonijiet
English: EU/1/12/807/001 1 pen of 3 mL EU/1/12/807/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/004 5 pens of 3 mL
Maltese: EU/1/12/807/001 Pinna 1 ta' 3 mL EU/1/12/807/002 Pinna 1 ta' 3 mL u 7 labar NovoFine EU/1/12/807/003 Pinna 1 ta' 3 mL u 7 labar NovoTwist EU/1/12/807/004 5 pinen ta' 3 mL
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni (FlexTouch) Pakkett multiplu: 10 (2 pakketti ta' 5) 3 mL pinen mimlijin għal-lest
English: This means that the medicine is essentially ‘sodium-free'.
Maltese: Dan ifisser li din il-mediċina hi essenzjalment ‘ħielsa mis-sodium'.
English: One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.
Maltese: unità 1 ta' insulina glargine (100 unità/mL) jew unità 1 ta' insulina detemir.
English: In patients with type 2 diabetes mellitus, this medicinal product can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see section 5.1).
Maltese: F'pazjenti b'dijabete mellitus ta' tip 2, dan il-prodott mediċinali jista' jingħata waħdu jew fi kwalunkwe kombinazzjoni ma' prodotti mediċinali antidijabetiċi orali, agonisti tar-riċettur GLP-1 u insulina mogħtija bħala bolus (ara sezzjoni 5.1).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 6 (2 packs of 3) 3 mL pre-filled pens
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni (FlexTouch) Pakkett multiplu: 6 (2 pakketti ta' 3) 3 mL pinen mimlijin għal-lest
English: It can be very serious.
Maltese: Tista' tkun serja ħafna.
English: 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
Maltese: Millitru ta' soluzzjoni fih 100 unità ta' insulina degludec* (ekwivalenti għal 3.66 mg ta' insulina degludec).
English: - Keep this leaflet.
Maltese: Għatu tal pinna
English: Tresiba pre-filled pen and needle (example) (FlexTouch)
Maltese: Tresiba pinna mimlija għal-lest u labra (eżempju) (FlexTouch)
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 200 units/mL
Maltese: INFORMAZZJONI BIL-BRAILLE Tresiba pinna mimlija għal-lest 200 unità/mL
English: Addition of liraglutide resulted in a statistically significantly greater reduction of HbA1c (-0.73% for liraglutide vs -0.40% for comparator, estimated means) and body weight (-3.03 vs 0.72 kg, estimated means).
Maltese: Iż-żieda ta' liraglutide wasslet għal tnaqqis akbar ta' HbA1c li kien statistikament sinifikanti (-0.73% għal liraglutide vs -0.40% għal dak li tqabbel miegħu, stima tal-medji) u l-piż tal-ġisem (-3.03 vs 0.
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL
Maltese: INFORMAZZJONI BIL-BRAILLE Tresiba pinna mimlija għal-lest 100 unità/mL
English: “Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.
Maltese: “Tresiba 100 unità/mL” jew “Tresiba 200 unità/mL” huwa mmarkat sew fuq it-tikketta tal-pinna u l-pakkett.
English: *Produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *Magħmul permezz tat-teknoloġija tad-DNA rikombinanti f'Saccharomyces cerevisiae.
English: Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
Maltese: Uġigħ ta' ras; diskors ma jiftiehemx; taħbit tal-qalb mgħaġġel; għaraq kiesaħ; ġilda kiesħa u pallida;tirrimetti, tħossok bil-ġuħ ħafna; rogħda jew tħossok nervuż jew inkwetat; tħoss għeja, dgħufija jew ngħas mhux tas-soltu; tħossok konfuż; diffikultà biex tikkonċentra; tibdil temporanju fil-vista.
English: A minimum of 8 hours between injections should always be ensured.
Maltese: Kun ċert li dejjem ikun hemm minimu ta' 8 sigħat bejn l injezzjonijiet.
English: Tresiba pre-filled pen 200 units/mL
Maltese: Tresiba pinna mimlija għal-lest 200 unità/mL
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Novo Nordisk A/S
English: Table 8 Results from DEVOTE
Maltese: Tabella 8 Riżultati minn DEVOTE Tresiba1
English: FPG (mmol/L) End of trial Mean change from baseline
Maltese: FPG (mmol/L) Linja bażi
English: Pen label Dose counter Dose pointer
Maltese: Kontatur tad-doża Indikatur tad-doża Selettur tad-doża
English: - The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units.
Maltese: - Il-pinna mimlija għal-lest ta' 200 unità/ml tforni 2-160 unità f'żidiet ta' 2 unitajiet.
English: The efficacy and safety of Tresiba have been studied in a 1:1 randomised controlled clinical trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks (n=350), followed by a 26-week extension period (n=280).
Maltese: L-effikaċja u s-sigurtà ta' Tresiba ġew studjati f'prova klinika kkontrollata u magħmula b'mod arbitrarju ta' 1:1 fit-tfal u fl-adolexxenti bid-dijabete mellitus tat-tip 1 għal perijodu ta' 26 ġimgħa (n=350), segwit minn perijodu ta' estensjoni ta' 26 ġimgħa (n=280).
English: Insulin glargine (100 units/mL)1
Maltese: Insulin glargine (100 unità/mL)1
English: • in insulin infusion pumps.
Maltese: • f'pompi tal-infużjoni tal-insulina.
English: Insulin glargine (100 units/mL)2
Maltese: Insulin glargine (100 unità/mL)2
English: Ratio: 0.82 [0.69; 0.99]
Maltese: Proporzjon: 0.82 [0.69;0.99]
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial with a median duration of 2 years comparing the cardiovascular safety of Tresiba 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' Tresiba ma' insulin glargine (100 unità/mL) f'7,637 pazjent bid-dijabete mellitus ta' tip 2 f'riskju għoli ta' avvenimenti kardjovaskulari.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa 1 persuna minn kull 1,000)
English: 4 Episodes from week 16 in each treatment period
Maltese: 4 Episodji minn ġimgħa 16 f'kull perjodu ta' trattament 5
English: Batch
Maltese: kawża
English: 5 Blood glucose (BG) confirmed symptomatic hypoglycaemia was defined as episodes confirmed by a plasma glucose value of less than 3.1 mmol/L, with symptoms consistent with hypoglycaemia.
Maltese: Ipogliċemija bis-sintomi kkonfermata permezz tal-glukożju fid-demm (BG, blood glucose) kienet iddefinita bħala episodji kkonfermati permezz ta' valur ta' glukożju fil-plażma ta' anqas minn 3.1 mmol/L, b'sintomi konsistenti mal-ipogliċemija.
English: The cardiovascular safety of Tresiba as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 2).
Maltese: Is-sigurtà kardjovaskulari ta' Tresiba hekk kif imqabbla ma' insulin glargine ġiet ikkonfermata (HR 0.91 [0.
English: The insulin degludec glucose-lowering action at steady state shows four times lower day-to-day variability in terms of Coefficients of Variation (CV) for the glucose-lowering effect during 0-24 hours (AUCGIR,τ,SS) and 2-24 hours (AUCGIR2-24h,SS) as compared to insulin glargine, see Table 1.
Maltese: Fl-istat fiss, l-effett tal-insulina degludec li jbaxxi l-livell tal-glukosju juri varjabilità ta' erba' darbiet iktar baxxa minn jum għal jum f'termini ta' Koeffiċjenti tal-Varjazzjoni (CV) għall-effett tat-tnaqqis tal-livell tal-glukosju matul 0-24 siegħa (AUCGIR,τ,SS) u 2-24 siegħa (AUCGIR2-24h,SS) meta mqabbel mal-insulina glargine ¸ ara Tabella 1.
English: - The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
Maltese: - Il-pinna mimlija għal-lest ta' 100 unità/ml tforni 1-80 unità f'żidiet ta' unità waħda.
English: There is no clinically relevant difference in the pharmacodynamics of this medicinal product between elderly and younger adult patients.
Maltese: M'hemm l-ebda differenza klinika rilevanti fil-farmakokinetika ta' dan il-prodott mediċinali bejn pazjenti anzjani u pazjenti adulti iżgħar.
English: Rate ratio: 0.60 [0.48; 0.76]
Maltese: Proporzjon ta' rata: 0.60 [0.48; 0.76]
English: Ratio: 0.64 [0.30; 1.37]
Maltese: Proporzjon: 0.64 [0.30;1.
English: In the open-label trials the effect of Tresiba was tested in patients with type 1 diabetes mellitus (Table 3), in insulin naïve patients (insulin initiation in type 2 diabetes mellitus, Table 4) and in previous insulin users (insulin intensification in type 2 diabetes mellitus, Table 5) with fixed as well as flexible dosing time (Table 6), and the reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior in all trials against all comparators (insulin detemir and insulin glargine (100 units/mL)).
Maltese: Fil-provi fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża l-effett ta' Tresiba ġie ttestjat f'pazjenti bid-dijabete mellitus ta' tip 1 (Tabella 3), f'pazjenti li qatt ma' ħadu insulina (l-ewwel darba b'insulina f'dijabete mellitus ta' tip 2, Tabella 4) u f'pazjenti li diġà kienu jieħdu l-insulina (intensifikazzjoni b'insulina f'dijabete mellitus ta' tip 2, Tabella 5) b'ħinijiet ta' dożaġġ fissi kif ukoll flessibbli (Tabella 6) u t-tnaqqis fl- HbA1c mil-linja bażi sat-tmiem tal-prova kien ikkonfermat li ma kienx inferjuri fil-provi kollha kontra l-komparaturi kollha (insulina detemir u insulina glargine (100 unità/mL)).
English: It must not be refilled.
Maltese: AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ.
English: Each mL of solution contains 200 units of insulin degludec.
Maltese: Kull mL ta' soluzzjoni fih 200 unità ta' insulina degludec .
English: DPP-4 inhibitor 2 Flexible once-daily regimen (intervals of approximately 8-40 hours between doses) + one or two of the following oral antidiabetes agents SU, metformin or DPP-4 inhibitor 3 Once-daily regimen + one or two of the following oral antidiabetes agents: SU, metformin or DPP-4 inhibitor
Maltese: 2 Kors flessibbli ta' darba kuljum (intervalli ta' madwar 8-40 siegħa bejn id-dożi) + mediċina waħda jew żewġ mediċini antidijabetiċi orali minn dawn li ġejjin:
English: In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with Tresiba (insulin degludec) in combination with metformin achieved a target HbA1c <7.0%, and the remaining patients continued in a 26-week open-label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
Maltese: Fi prova klinika ta' 104 ġimgħat, 57% tal-pazjenti b'dijabete tat-tip 2 ikkurati bi Tresiba (insulina degludec) flimkien ma' metformin kisbu mira ta' HbA1c ta' <7.0%, u l-bqija tal-pazjenti komplew fi prova ta' 26 ġimgħa open label fejn intagħżlu b'mod każwali biex iżidu liraglutide jew doża waħda ta'
English: Fertility Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Maltese: Studji dwar ir-riproduzzjoni fl-annimali b'insulina degludec ma żvelaw l-ebda effetti avversi fuq il fertilità.
English: Table 2 Hypoglycaemia meta-analysis outcomes
Maltese: Dijabete mellitus tat-Tip 2
English: Pen cap
Maltese: Bidla medja
English: Tresiba 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Maltese: Tresiba 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ L-iskartoċċ (Penfill) hu magħmul biex jintuża mas-sistemi tal-għoti Novo Nordisk (strumenti li jservu fit-tul għall-użu ripetut mhumiex inklużi f'dan il-pakkett) u labar tal-injezzjoni NovoFine/NovoTwist b'tul ta' mhux iżjed minn 8 mm.
English: Be especially aware of the following:
Maltese: Oqgħod attent:
English: Insulin glargine (100 units/mL)3
Maltese: Insulina glargine (100 unità/mL)3
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 Tresiba 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
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) was aligned with the primary analysis.
Maltese: Ir-riżultati mill-analiżi tas-sottogruppi (e.ż. sess, it-tul ta' żmien tad-dijabete, il-grupp ta' riskju KV u lis-skeda ta' dożaġġ preċedenti tal-insulina) ġew allinjati mal-analiżi primarja.
English: Type 2 diabetes mellitus Maintenance period b
Maltese: Perjodu ta' manteniment b
English: • Always follow your doctor's recommendation for dose.
Maltese: • Ikseb għajnuna medika minnufih.
English: Important information about some of the ingredients of Tresiba This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Tagħrif importanti dwar xi ingredjenti f'Tresiba Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża.
English: Tresiba dosed once daily showed similar reduction in HbA1c at week 52 and greater reduction in FPG from baseline versus the comparator insulin detemir dosed once or twice daily.
Maltese: Tresiba b'doża ta' darba kuljum wera tnaqqis simili fl-HbA1c fil-52 ġimgħa u tnaqqis akbar fl-FPG mil-linja bażi meta mqabbel mal-komparatur insulin detemir b'dożaġġ ta' darba jew darbtejn kuljum.
English: In the insulin degludec + liraglutide arm, the insulin dose was reduced by 20% in order to minimise the risk of hypoglycaemia.
Maltese: Fil-fergħa tal-insulina degludec + liraglutide, id-doża tal-insulina tnaqqset b'20% sabiex jitnaqqas ir-riskju ta' ipogliċemija.
English: 5 units selected
Maltese: fadal 52 unità
English: How to inject
Maltese: Buttuna tal injezzjoni
English: Store in a refrigerator (2°C - 8°C)
Maltese: Aħżen fi friġġ (2°C - 8°C)
English: Tresiba 200 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Maltese: Tresiba 200 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Soluzzjoni ta' 3 mL f'skartoċċ (ħġieġ ta' tip 1), bi planġer (halobutyl) u laminat ta' folja tal-lastku (halobutyl/polyisoprene) f'pinna mimlija għal-lest, b'ħafna dożi, li tintrema wara li tintuża u magħmula mill-polypropylene.
English: • the local reactions spread to other parts of your body
Maltese: • ir-reazzjonijiet lokali jinfirxu għal partijiet oħra ta' ġismek
English: Cardiovascular evaluation
Maltese: Evalwazzjoni kardjovaskulari