FrancophonIA/ELRC3.0 huggingface dataset:
English: Ryzodeg o.d.or b.i.d demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp 13 times daily after 38 weeks (the estimated mean reductions are -1.17% vs -1.26%).
Maltese: Ryzodeg o.d.jew b.i.d wera kontroll gliċemiku simili (HbA1c) meta mqabbel ma' IGlar o.d. flimkien ma' IAsp 1-3 darbiet kuljum wara 38 ġimgħa (l-istimi medji ta' tnaqqis huma -1.17% vs -1.26%).
English: Ryzodeg o.d. demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp o.d. after 26 weeks (the estimated mean reductions are -1.01% vs -1.09%).
Maltese: Meta pparagunat ma' IGlar o.d. flimkien ma' IAsp o.d, Ryzodeg o.d. wera kontroll gliċemiku (HbA1c) simili wara 26 ġimgħa (l-istimi medji ta' tnaqqis huma -1.01% vs -1.09%).
English: The pen can dial up to a maximum of 80 units.
Maltese: Il-pinna tista' tisselezzjona sa massimu ta' 80 unità.
English: Solution for injection (Penfill) 5 x 3 mL
Maltese: (Penfill) 5 x 3 mL
English: The pharmacokinetic profile for insulin aspart appears 14 minutes after injection with a peak concentration after 72 minutes.
Maltese: Il-profil farmakokinetiku għall-insulina aspart jidher 14-il minuta wara l-injezzjoni, b'konċentrazzjoni massima wara 72 minuta.
English: demonstrated similar glycaemic control (HbA1c) compared with BIAsp 30 b.i.d.
Maltese: Ryzodeg b.i.d. wera kontroll gliċemiku simili (HbA1c) meta mqabbel ma' BIAsp 30 b.i.d. f'pazjenti b'dijabete mellitus ta' tip 2.
English: 1 Twice-daily regimen ± metformin ± pioglitazone ± DPP-4 inhibitor 2 Twice-daily regimen ± metformin
Maltese: 2 Kors ta' darba kuljum + Metformin ± pioglitazone ± inibitur ta' DPP-4
English: The pharmacokinetic properties of Ryzodeg in type 1 diabetes mellitus were investigated in children (6-11 years) and adolescents (12-18 years) and compared to adults after single dose administration.
Maltese: Il-karatteristiċi farmakokinetiċi ta' Ryzodeg f'dijabete mellitus ta' tip 1 ġew investigati fit-tfal (6-11il sena) u fl-adoloxxenti (12-18-il sena) u mqabbla ma' adulti wara l-għoti ta' doża waħda.
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 mgħaġel; għaraq kiesaħ; ġilda kiesħa u pallida; 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: Patients in the Ryzodeg arm included 40 exposed children aged 2-5 years, 61 children aged 6-11 years and 80 adolescents aged 12-17 years.
Maltese: Il-pazjenti fil-fergħa ta' Ryzodeg kienu jinkludu 40 tifel u tifla esposti b'etajiet ta' 2-5 snin, 61 tifel u tifla b'etajiet ta' 6-11-il sena and 80 adolexxent b'etajiet ta' 12-17-il sena.
English: The recommended starting dose of Ryzodeg is 60-70% of the total daily insulin requirements.
Maltese: Fil-bidu, id-doża rrakkomandata ta' Ryzodeg hi ta' 60-70% tal-ħtiġijiet totali ta' kuljum tal-insulina.
English: Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus.
Maltese: Pioglitazone, mediċina orali kontra d-dijabete li tintuża għat-trattament ta' dijabete mellitus ta' tip 2.
English: EU/1/12/806/005 10 pens of 3 mL
Maltese: EU/1/12/806/008 10 skrataċ ta' 3 mL
English: Ryzodeg cartridge 100
Maltese: INFORMAZZJONI BIL-BRAILLE Ryzodeg skartoċċ 100
English: Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (FlexTouch) Pakkett multiplu: 10 (2 pakketti ta' 5) 3 mL pinen mimlijin għal-lest
English: • The other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see section 2).
Maltese: • Is-sustanzi l-oħra huma glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid u sodium hydroxide (għal aġġustament tal-pH) u ilma għall-injezzjonijiet (ara sezzjoni 2).
English: FPG (mmol/L) End of trial Mean change
Maltese: FPG (mmol/L)
English: Avoidance of accidental mix-ups
Maltese: .8 Effetti mhux mixtieqa
English: The steady-state pharmacokinetic properties of the insulin degludec component of Ryzodeg were investigated using a population pharmacokinetic analysis in children down to 1 year of age.
Maltese: Il-karatteristiċi farmakokinetiċi fl-istat fiss tal-komponent insulina degludec ta' Ryzodeg ġew investigati permezz ta' analiżi farmakokinetika tal-popolazzjoni fit-tfal sal-età ta' sena.
English: *Produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *Magħmul f'Saccharomyces cerevisiae permezz tat-teknoloġija tad-DNA rikombinanti
English: Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Maltese: Id-degradazzjoni ta' insulina degludec u insulina aspart hija simili għal dik tal-insulina umana; ilmetaboliti kollha li jiffurmaw huma inattivi.
English: The trial had a median duration of 2 years and compared the cardiovascular safety of insulin degludec vs insulin glargine (100 units/mL) in 7,637 patients with type 2 diabetes mellitus at high risk of cardiovascular events.
Maltese: Il-prova kellha tul medjan ta' żmien ta' sentejn u qabblet is-sigurtà kardjovaskulari ta' insulin degludec vs insulin glargine (100 units/mL) f'7,637 pazjent bid-dijabete mellitus tat-tip 2 f'riskju għoli ta' avvenimenti kardjovaskulari.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill))
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA (100 unità/mL skartoċċ (Penfill))
English: Ryzodeg 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Soluzzjoni ta' 3 ml fi skartoċċ (ħġieġ ta' tip 1), bi planġer (halobutyl) u laminat ta' folja tal-lastku (halobutyl/polyisoprene) f'kaxxa tal-kartun.
English: Ryzodeg administered once daily o.d. was compared to insulin glargine (100 units/mL) (IGlar) o.d. in two trials in type 2 diabetes mellitus (Table 1).
Maltese: Ryzodeg mogħti darba kuljum o.d. ġie pparagunat ma' insulina glargine (100 unità/mL) (IGlar) o.d. f'żewġ provi f'pazjenti b'dijabete mellitus ta' tip 2 (Tabella 1).
English: There are no clinically relevant differences in the pharmacokinetics of Ryzodeg between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Maltese: Ma kien hemm ebda differenza klinikament rilevanti fil-farmakokinetika ta' Ryzodeg bejn pazjenti anzjani u adulti iżgħar, bejn ir-razez jew bejn persuni b'saħħithom u pazjenti b'indeboliment renali jew epatiku.
English: Ryzodeg should be used with special caution in children 2 to 5 years old because data from the clinical trial indicate that there may be a higher risk for severe hypoglycaemia in children in this age group (see sections 4.4, 4.8 and 5.1).
Maltese: Ryzodeg għandu jintuża b'kawtela speċjali fit-tfal bejn sentejn u 5 snin peress li tagħrif mill-prova klinika jindika li jista' jkun hemm riskju ogħla ta' ipogliċemija severa fit-tfal f'dan il-grupp ta' età (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: In two trials combining insulin and OAD treatment in both insulin-naïve (insulin initiation) and insulin-using (insulin intensification) patients with type 2 diabetes mellitus, Ryzodeg o.d. demonstrated similar glycaemic control (HbA1c) compared to IGlar (administered according to label) (Table 1).
Maltese: F'żewġ provi kliniċi fejn ittieħdu flimkien l-insulina u OAD kemmf'pazjenti li qatt ma ħadu insulina (bidu tal-insulina) kif ukoll pazjenti b'dijabete mellitus ta' tip 2 li jużaw l-insulina (intensifikazzjoni tal-insulina), Ryzodeg o.d. wera kontroll gliċemiku simili (HbA1c) meta mqabbel ma' Iglar (mogħti skont it-tikketta) (Tabella 1).
English: 5 units selected
Maltese: Magħżula 5 unitajiet
English: This medicine contains two types of insulin:
Maltese: Din il-mediċina fiha żewġ tipi ta' insulina:
English: Ryzodeg showed a lower rate of nocturnal hypoglycaemia compared to IGlar o.d. plus IAsp during 26 weeks (0.42 vs 0.76 estimated rates per patient year of exposure) and 38 weeks (0.51 vs 0.83 estimated rates per patient year of exposure).
Maltese: Ryzodeg wera rata aktar baxxa ta' ipogliċemija ta' matul il-lejl meta mqabbel ma' IGlar o.d. flimkien ma' IAsp matul 26 ġimgħa (0.42 vs 0.76 stima ta' rati ta' espożizzjoni f'sena għal kull pazjent) u 38 ġimgħa (0.51 vs 0.83 stima ta' rati ta' espożizzjoni f'sena għal kull pazjent).
English: Substances added to Ryzodeg may cause degradation of insulin degludec and/or insulin aspart.
Maltese: Sustanzi miżjuda ma' Ryzodeg jistgħu jikkawżaw id-degradazzjoni ta' insulina degludec u/jew insulina aspart .
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) were aligned with the primary analysis.
Maltese: Ir-riżultati mill-analiżi tas-sottogruppi (e.g. sess, it-tul ta' żmien tad-dijabete, grupp ta' riskju kardjovaskulari (KV) u skeda preċedenti ta' trattament bl-insulina) kienu simili għal dawk tal-analiżi primarja.
English: The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population with the exception of a signal of higher occurrence of severe hypoglycaemia compared to a basalbolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 4.2, 4.4 and 5.1).
Maltese: Il-frekwenza, it-tip u s-severità tar-reazzjonijiet avversi filpopolazzjoni pedjatrika ma jindikawx li hemm xi differenzi minn dawk li dehru fil-popolazzjoni dijabetika ġenerali bl-eċċezzjoni ta' sinjal ta' okkorrenza ogħla ta' ipogliċemija severa meta mqabbel ma' skeda bażali-bolus fil-popolazzjoni pedjatrika, speċjalment fit-tfal minn sentejn sa 5 snin (ara sezzjonijiet 4.2, 4.4 u 5.1)..
English: Mean change
Maltese: Tqala u treddigħ
English: Total exposure and peak concentration of insulin aspart were higher in children than in adults and were similar for adolescents and adults.
Maltese: L-espożizzjoni totali u l-konċentrazzjoni massima ta' insulina aspart kienu ogħla fit-tfal milli fl-adulti u kienu simili għall-adolexxenti u l-adulti.
English: Mean HbA1c (%)
Maltese: Medja ta' HbA1c (%) Fit-tmiem tal-prova Bidla medja
English: Difference: 0.51 [0.09;0.93]
Maltese: Differenza: 0.51 [0.
English: The efficacy and safety of Ryzodeg have been studied in a randomised controlled clinical trial in children and adolescents with diabetes mellitus type 1 for a period of 16 weeks (n=362).
Maltese: L-effikaċja u s-sigurtà ta' Ryzodeg ġew studjati f'prova klinika kkontrollata u magħmula b'mod arbitrarju fit-tfal u fl-adolexxenti bid-dijabete mellitus tat-tip1 għal perijodu ta' 16-il ġimgħa (n=362).
English: At week 16, the mean total daily insulin dose was 0.88 vs 1.01 units/kg in the Ryzodeg and insulin detemir arms, respectively.
Maltese: F'ġimgħa 16, il-medja tad-doża totali ta' kuljum tal-insulina kienet ta' 0.88 vs 1.01 unitajiet /kg fil-fergħat ta' Ryzodeg u insulina detemir rispettivament.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini
English: 1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements 2 Once- or twice-daily regimen + insulin aspart to cover mealtime insulin requirements 3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing third party assistance.
Maltese: 1 Kors ta' darba kuljum + insulina aspart biex ikopri l-ħtiġijiet tal-insulina f'ħin l-ikel 2 Kors ta' darba jew darbtejn kuljum + insulina aspart biex ikopri l-ħtiġijiet tal-insulina f'ħin l-ikel 3 Ipogliċemija kkonfermata kienet definita bħala episodji kkonfermati permezz ta' glukosju fil-plażma ta' < 3.1 mmol/L jew minn pazjent li jkun jeħtieġ għajnuna minn terza parti.
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 ilfertilità.
English: With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Maltese: B'Ryzodeg, reazzjonijiet ta' sensittività eċċessiva (li turi ruħha permezz ta' nefħa fl-ilsien u fixxofftejn, dijarea, nawsja, għeja u ħakk) u urtikarja, ġew irrappurtati b'mod rari.
English: Each cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Maltese: Kull skartoċċ fih 300 unità ta' insulina degludec/insulina aspart f'soluzzjoni ta' 3 mL.
English: Ryzodeg 100 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 multidose disposable pre-filled pen made of polypropylene.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Soluzzjoni ta' 3 ml fi 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, magħmula mill-polypropylene.
English: Ryzodeg pre-filled pen and needle (example) (FlexTouch)
Maltese: Ryzodeg pinna mimlija għal-lest u labra (eżempju) (FlexTouch)
English: Outer needle cap
Maltese: Qabel l-ewwel użu
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm.
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Il-pinna mimlija għal-lest (FlexTouch) hi maħsuba biex tintuża mal-labar tal-injezzjoni NovoFine/NovoTwist b'tul sa 8 mm.
English: In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining meals demonstrated similar glycaemic control (HbA1c and fasting plasma glucose) with a lower rate of nocturnal hypoglycaemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table
Maltese: F'pazjenti b'dijabete mellitus ta' tip 1, il-kura b'Ryzodeg o.d. flimkien ma' IAsp għall-bqija tal-ikliet, uriet kontroll gliċemiku simili (HbA1c u glukosju fil-plażma fl-istat sajjem), b'rata iktar baxxa ta' ipogliċemija ta' matul il-lejl meta mqabbel ma' kors bażilari/bolus b'IDet flimkien ma' IAsp mogħtija fl-ikliet kollha (Tabella 3).
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial focusing on insulin degludec, the long-acting component of Ryzodeg.
Maltese: DEVOTE kien prova klinika mmotivat minn avveniment, magħmul b'mod arbitrarju u double-blind li ffoka fuq insulin degludec, dik il-parti ta' Ryzodeg li taħdem fit-tul.
English: Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
Maltese: Studji dwar ir-riproduzzjoni fl-annimali ma żvelaw l-ebda differenzi bejn insulina degludec u linsulina umana fir-rigward tal-embrijotossiċità u t-teratoġeniċità.
English: When changing from another insulin regimen to Ryzodeg, dose reduction of total insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see section 4.4).
Maltese: Meta tbiddel minn skeda oħra ta' insulina għal Ryzodeg, it-tnaqqis fid-doża tal-insulina totali għandha tiġi meqjusa fuq bażi individwali sabiex tnaqqas kemm jista' jkun ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: Safety and efficacy have been demonstrated in a trial in children aged 2 to less than 18 years.
Maltese: Is-sigurtà u l-effikaċja ġew murija fi prova fit-tfal mill-età ta' sentejn sa inqas minn 18-il sena.
English: IGlar (o.d.)1 Insulin naïve
Maltese: IGlar (o.d.)1 Persuni li qatt ma ħadu insulina
English: Both treatments improved glycaemic control with an estimated mean reduction with Ryzodeg (-1.23%) against IDeg plus IAsp (-1.42%) for the primary endpoint of change from baseline in HbA1c at 26 weeks.
Maltese: IDeg flimkien ma' IAsp (-1.42 %) għall-punt finali primarju ta' bidla mil-linja bażi fl-HbA1c fis-26 ġimgħa.
English: Batch
Maltese: Sess
English: Dose counter Dose pointer
Maltese: Jekk tieqaf tuża Ryzodeg
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart FlexTouch
Maltese: U MNEJN GĦANDU JINGĦATA Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni 70% insulina degludec / 30% insulina aspart FlexTouch
English: Ryzodeg dosed once daily with the main meal plus insulin aspart for the remaining meals showed similar reduction in HbA1c at week 16 and no differences in FPG and SMPG compared to comparator insulin detemir dosed once or twice daily plus mealtime insulin aspart.
Maltese: Ryzodeg f'doża ta' darba kuljum mogħti mal-ikla prinċipali flimkien mal-insulina aspart mogħtija mal-bqija tal-ikliet urew tnaqqis simili fl-HbA1c fil-ġimgħa 16 u ebda differenza fl-FPG u fl-SMPG meta mqabbla malkomparatur insulina detemir f'doża ta' darba jew darbtejn kuljum flimkien mal-insulina aspart mogħtija fil-ħin tal-ikel.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens of 3 mL.
Maltese: Daqsijiet tal-pakketti ta' 1 (bil-labar jew mingħajr), 5 (mingħajr labar) u pakkett multiplu ta' 10 (2 x 5) (mingħajr labar) pinen ta' 3 mL mimlijin għal-lest.
English: Confirmed 3
Maltese: Ikkonfermata 3
English: The pre-filled pen delivers 1-80 units in steps of 1 unit.
Maltese: Il-pinna mimlija għal-lest tforni 1-80 unità f'gradi ta' unità 1.
English: IGlar (o.d.)2 Insulin users
Maltese: IGlar (o.d.)2 Persuni li jużaw l-insulina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL pre-filled pen (FlexTouch))
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-PINNA (100 unità/mL pinna mimlija għal-lest (FlexTouch))
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg.
Maltese: 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) seħħew f'pazjenti kkurati b'Ryzodeg.
English: Ryzodeg b.i.d.
Maltese: Wara l-injezzjoni
English: • In all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Maltese: • F'kull sottogrupp tal-popolazzjoni pedjatrika bid-dijabete mellitus tat-tip 2 (ara sezzjoni 4.2
English: • danazol, for endometriosis
Maltese: • tibda tirremetti
English: Ryzodeg 100 units/mL solution for injection in cartridge 70% insulin degludec / 30% insulin aspart
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni fi skartoċċ 70% insulina degludec / 30% insulina aspart
English: Other medicines and Ryzodeg
Maltese: Mediċini oħra u Ryzodeg
English: was compared to biphasic insulin aspart 30 (BIAsp 30) b.i.d.
Maltese: • acetysalicylic acid (u salicylates oħrajn), użati biex itaffu l-uġigħ u deni ħafif
English: Ryzodeg 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Soluzzjoni għall-injezzjoni (Penfill).
English: Ryzodeg (o.d.)1 Insulin naïve
Maltese: Ryzodeg (o.d.)2 Persuni li jużaw l-insulina
English: Ryzodeg 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Skartoċċ wieħed fih 300 unità ta' insulina degludec/insulina aspart f'soluzzjoni ta' 3 mL.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Maltese: Dawn jistgħu jinkludu għaraq kiesaħ, ġilda pallida u kiesħa, telqa, nervożità jew tregħid, 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: Ryzodeg may be associated with higher occurrence of severe hypoglycaemia compared to a basal-bolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 5.1).
Maltese: Fil-popolazzjoni pedjatrika, Ryzodeg jista' jkun assoċjat ma' frekwenza ogħla ta' ipogliemija severa meta mqabbel ma' skeda bażali-bolus, speċjalment fit-tfal bejn 2 u 5 snin (ara sezzjoni 5.1).
English: After subcutaneous injection, soluble and stable multi-hexamers of insulin degludec are formed creating a depot of insulin in the subcutaneous tissue, while not interfering with the rapid release of insulin aspart monomers into the circulation.
Maltese: Wara injezzjoni taħt il-ġilda, jiffurmaw multi-hexamers ta' insulina degludec li jinħallu u li huma stabbli u joħolqu ħażna ta' insulina fit-tessut taħt il-ġilda, filwaqt li ma jinterferixxux mar-rilaxx mgħaġġel ta' monomers tal-insulina aspart ġoċ-ċirkolazzjoni.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.
Maltese: Daqsijiet tal-pakketti ta' 1 (bil-labar jew mingħajr), 5 (mingħajr labar) u pakkett multiplu li fih 10 (2 pakketti ta' 5) (mingħajr labar) pinen mimlija għal-lest.
English: Needle
Maltese: Penfill
English: was compared with IDeg o.d. plus IAsp (2-4 daily injections) in patients with type 2 diabetes mellitus treated with basal insulin in need of treatment intensification with mealtime insulin.
Maltese: Ryzodeg b.i.d. ġie pparagunat ma' IDeg o.d. flimkien ma' IAsp (2-4 injezzjonijiet kuljum) f'pazjenti bid-dijabete mellitus ta' tip 2 ittrattati b'insulina bażilari li għandhom bżonn ta' intensifikazzjoni tattrattament b'insulina mogħtija fil-ħin tal-ikel.
English: How to store Ryzodeg
Maltese: Tużax Ryzodeg
English: A lower rate of nocturnal hypoglycaemia (defined as episodes between midnight and 6 a.m. confirmed by plasma glucose < 3.1 mmol/L or by patient needing third party assistance) was observed with Ryzodeg relative to IGlar (Table 1).
Maltese: Rata iktar baxxa ta' ipogliċemija matul il-lejl (definita bħala episodji bejn nofsillejl u s-6 a.m. ikkonfermata permezz ta' glukosju fil-plażma ta' < 3.1 mmol/L jew minn pazjent li jkun jeħtieġ għajnuna minn terza persuna) kienet osservata b'Ryzodeg meta mqabbel ma' IGlar (Tabella 1).
English: Gender There is no gender difference in the pharmacokinetic properties of Ryzodeg.
Maltese: Ma kien hemm ebda differenza minħabba s-sess fil-karatteristiċi farmakokinetiċi ta' Ryzodeg.
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m.
Maltese: Ipogliċemija ta' matul illejl ikkonfermata kienet definita bħala episodji bejn nofsillejl u s-6 a.m.
English: • Too high blood sugar (hyperglycaemia)
Maltese: • Livell għoli wisq ta' zokkor fid-demm (ipergliċemija)
English: Ratio: 0.68 [0.52;0.89]
Maltese: Proporzjon: 0.68 [0.