FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly patients (≥ 65 years old)
Maltese: Pazjenti anzjani (≥65 sena)
English: Time since bolus injection (min)
Maltese: Ħin mill-injezzjoni bolus (min)
English: Novo Nordisk A/S
Maltese: OĦRAJN Novo Nordisk A/S
English: The safety and efficacy of Fiasp have been established in elderly patients aged 65 to 75 years.
Maltese: Ġew determinati s-sigurtà u l-effikaċja ta' Fiasp f'pazjenti anzjani b'età minn 65 sa 75 sena.
English: EU/1/16/1160/001 EU/1/16/1160/002 EU/1/16/1160/003 EU/1/16/1160/004 EU/1/16/1160/005 EU/1/16/1160/006 EU/1/16/1160/007 EU/1/16/1160/008 EU/1/16/1160/009
Maltese: EU/1/16/1160/005 EU/1/16/1160/006 EU/1/16/1160/007 EU/1/16/1160/008 EU/1/16/1160/009 EU/1/16/1160/010
English: Insulins and analogues for injection, fast-acting ATC code: A10AB05.
Maltese: Insulini u analogi għall-injezzjoni li jaġixxu malajr Kodiċi ATC: A10AB05.
English: EU/1/16/1160/001 1 pen of 3 mL EU/1/16/1160/002 1 pen of 3 mL and 7 NovoFine Plus needles EU/1/16/1160/003 1 pen of 3 mL and 7 NovoFine needles EU/1/16/1160/004 1 pen of 3 mL and 7 NovoTwist needles EU/1/16/1160/005 5 pens of 3 mL
Maltese: EU/1/16/1160/001 pinna 1 ta' 3 mL EU/1/16/1160/002 pinna 1 ta' 3 mL u 7 labar NovoFine Plus EU/1/16/1160/003 pinna 1 ta' 3 mL u 7 labar NovoFine EU/1/16/1160/004 pinna 1 ta' 3 mL u 7 labar NovoTwist EU/1/16/1160/005 5 pinen ta' 3 mL
English: E Statistically significant in favour of Fiasp mealtime
Maltese: Statistikament sinifikanti favur Fiasp
English: 30 months.
Maltese: 30 xahar.
English: 74.8% of patients treated with Fiasp reached a target HbA1c of < 7% compared to 75.9% of patients treated with NovoRapid.
Maltese: 74.8% tal-pazjenti kkurati b'Fiasp laħqu mira ta' HBA1c ta' <7% meta mqabbla ma' 75.9% tal-pazjenti kkurati b'NovoRapid.
English: EU/1/16/1160/010 EU/1/16/1160/011
Maltese: EU/1/16/1160/011
English: *Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *Insulina aspart hi magħmula permezz tat-teknoloġija tad-DNA rikombinanti f'Saccharomyces cerevisiae.
English: (≥ 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Solution for injection 1 x 10 mL
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 1 x 10 mL
English: Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Maltese: Thiazolidinediones għandhom jitwaqqfu jekk jeħżienu s-sintomi kardijaċi.
English: For Fiasp no difference in exposure was found between the racial and ethnic groups investigated.
Maltese: Għal Fiasp, ma nstabet l-ebda differenza fl-espożizzjoni bejn il-gruppi razzjali u l-gruppi etniċi investigati.
English: Insulin aspart concentration (pmol/L)
Maltese: Konċentrazzjoni ta' insulina aspart (pmol/L)
English: The observed effects and the safety profiles were comparable between all age groups.
Maltese: L-effetti osservati u l-profili ta' sigurtà kienu simili bejn il-gruppi kollha ta' età.
English: If no drop appears, repeat steps 2A to 2C up to 6 times.
Maltese: Jekk ma tidher l-ebda qatra, irrepeti passi 2A sa 2C għal massimu ta' 6 darbiet.
English: In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.
Maltese: Fil-popolazzjoni pedjatrika l-lipodistrofija ġiet irrapportata b'frekwenza ta' 2.1% għal Fiasp vs. 1.6% għal NovoRapid.
English: Increase dose by 1 unit
Maltese: Żid id-doża b'unità 1
English: The primary activity of Fiasp is the regulation of glucose metabolism.
Maltese: L-attività primarja ta' Fiasp hija r-regolazzjoni tal-metaboliżmu tal-glukosju .
English: Allergic skin manifestations reported with Fiasp (1.8% vs. 1.5% for comparator) include eczema, rash, rash pruritic, urticaria and dermatitis.
Maltese: Manifestazzjonijiet allerġiċi tal-ġilda rrappurtati b'Fiasp (1.8% vs 1.5% għall-komparatur) jinkludu ekżema, raxx, raxx bil-ħakk, urtikarja u dermatite.
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline - for asthma
Maltese: • simpatomimetiċi bħal epinephrine (adrenaline), salbutamol jew terbutaline - użati fil-kura tal ażżma
English: Degradation of insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Maltese: Id-degradazzjoni ta' insulina aspart hija simili għal dik tal-insulina umana; il-metaboliti kollha li jiffurmaw huma inattivi.
English: There were no microscopically confirmed episodes of infusion set occlusions in either the Fiasp (N=25) or NovoRapid (N=12) groups.
Maltese: Ma kien hemm l-ebda episodji kkonfermati mikroskopikament ta' okklużjonijiet tas-sett tal-infużjoni la fil-grupp ta' Fiasp (N=25) u lanqas f'dak ta' NovoRapid (N=12).
English: In the trial, 519 patients were treated with Fiasp.
Maltese: Fil-prova, 519-il pazjent ġew ittrattati b'Fiasp.
English: Fiasp has been administered to elderly patients for the investigation of pharmacokinetic properties (see section 5.2).
Maltese: Fiasp ingħata lil pazjenti anzjani għall-investigazzjoni ta' proprjetajiet farmakokinetiċi (ara sezzjoni 5.2).
English: The day-to-day variability within-patients in glucose-lowering effect was low for Fiasp both for early (AUCGIR, 0-1h, CV~26%), total (AUCGIR, 0-12h, CV~18%) and maximum glucose-lowering effect (GIRmax, CV~19%).
Maltese: Il-varjabilità minn jum għal jum bejn il-pazjenti nfushom fl-effett tat-tnaqqis tal-livell tal-glukosju kienet baxxa għal Fiasp, kemm għall-effett tat-tnaqqis tal-livell tal-glukosju bikri (AUCGIR, 0-1h, CV~26%), totali (AUCGIR, 0-12h, CV~18%) kif ukoll massimu (GIRmax, CV~19%).
English: • sulphonamides - for infections
Maltese: • sulphonamides - użati fil-kura ta' infezzjonijiet
English: • monoamine oxidase (MAO) inhibitors - for depression
Maltese: • inibituri ta' monoamine oxidase (MAO) - użati fil-kura tad-dipressjoni
English: 2D barcode carrying the unique identifier included
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż
English: Be especially aware of the following:
Maltese: Reazzjonijiet tal-ġilda:
English: It can be very serious.
Maltese: Jista' jkun serju ħafna.
English: 6 Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: General effects from insulin treatment including Fiasp
Maltese: Effetti ġenerali mill-kura bl-insulina inkluż Fiasp
English: • you have been given an injection of glucagon
Maltese: • ingħatajt injezzjoni ta' glucagon
English: Novo Nordisk A/S Hallas Alle 4400 Kalundborg Denmark
Maltese: 4400 Kalundborg
English: Disodium phosphate dihydrate Arginine hydrochloride Nicotinamide (vitamin B3) Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Disodium phosphate dihydrate Arginine hydrochloride Nicotinamide (vitamin B3) Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Oral antidiabetics, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, sulphonamides and GLP-1 receptor agonist.
Maltese: Dawn is-sustanzi li ġejjin jistgħu jnaqqsu l-ħtieġa tal-pazjent għall-insulina: Antidijabetiċi orali, inibituri ta' monoamine oxidase (MAOIs), imblokkaturi tar-riċetturi beta, inibituri tal-enzima li tibdel angiotensin (ACE), salicylates, sterojdi anaboliċi, sulphonamides u agonist tarriċettur GLP-1.
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni, nixxija ta' insulina, labar imblukkati u dożaġġ mhux preċiż.
English: Multipack: 10 (2 packs of 5 x 3 mL) pre-filled pens
Maltese: Pakkett multiplu: 10 (2 pakketti ta' 5 x 3 mL)
English: (AUCGIR, 0-30 min ) was 51 mg/kg with Fiasp and 29 mg/kg with NovoRapid (Fiasp/NovoRapid ratio: 1.74 [1.47;2.10]95% CI).
Maltese: L-effett tat-tnaqqis fil-livell tal-glukosju matul l-ewwel 30 minuta (AUCGIR, 0-30 min ) kien ta' 51 mg/kg bi Fiasp u 29 mg b'NovoRapid (proporzjoni Fiasp/NovoRapid : 1.74 [1.47;2.10]95% CI).
English: Fiasp is a fast-acting insulin aspart formulation.
Maltese: Fiasp hu formulazzjoni ta' insulina aspart li taġixxi malajr.
English: Pack sizes of 5 and 10 cartridges of 3 mL.
Maltese: Daqsijiet tal-pakketti ta' 5 u 10 skrataċ ta' 3 mL.
English: The total insulin exposure was comparable between Fiasp and NovoRapid.
Maltese: L-espożizzjoni totali tal-insulina kienet komparabbli bejn Fiasp u NovoRapid.
English: This means that this medicine is essentially ‘sodium-free'.
Maltese: Dan ifisser li din il-mediċina hi essenzjalment ‘ħielsa mis-sodium'.
English: • Pioglitazone used together with insulin - This may increase the risk of heart failure, see under ‘Other medicines and Fiasp' below.
Maltese: • Pioglitazone użat flimkien mal-insulina - Dan jista' jżid ir-riskju ta' insuffiċjenza kardijaka, ara taħt ‘Mediċini oħra u Fiasp' hawn taħt.
English: 1 mL of the solution contains 100 units of insulin aspart* (equivalent to 3.5 mg).
Maltese: U KWANTITATTIVA Millilitru ta' soluzzjoni fih 100 unità ta' insulina aspart*(ekwivalenti għal 3.5 mg).
English: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Kontraċettivi li jittieħdu mill-ħalq, thiazides, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, lormon tat-tkabbir u danazol.
English: • feeling thirsty
Maltese: Tqala u treddigħ
English: Fiasp has been shown to be stable at room temperature for 24 hours in the infusion fluids such as sodium chloride 9 mg/mL (0.9%) solution or 5% glucose solution.
Maltese: Intwera li Fiasp hu stabbli fit-temperatura tal-kamra għal 24 siegħa fil-fluwidi għall-infużjoni bħal soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) jew soluzzjoni ta' 5% glukosju.
English: There was no statistical significant difference between Fiasp and NovoRapid in the estimated odds of achieving HbA1c < 7%.
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti bejn Fiasp u NovoRapid fil-probabbilitajiet stmati li jinkiseb HBA1c <7%.
English: Total insulin aspart exposure and maximum concentration following administration of Fiasp was 30% higher in elderly subjects compared to younger adult subjects.
Maltese: Espożizzjoni totali ta' insulina aspart u konċentrazzjoni massima wara l-għoti ta' Fiasp kienu 30% ogħla f'individwi anzjani meta mqabbla ma' individwi adulti iżgħar.
English: Lipodystrophy (including lipohypertrophy, lipoatrophy) was reported at the injection/infusion site in patients treated with Fiasp (0.5% vs. 0.2% in comparator).
Maltese: Il-lipodistrofija (fosthom lipoipertrofija, lipoatrofija) ġiet irrappurtata fis-sit tal-injezzjoni/infużjoni f'pazjenti kkurati b'Fiasp (0.5% vs 0.2% fil-komparatur).
English: The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0.5 and 1.0 unit/kg/day.
Maltese: Il-ħtieġa individwali totali ta' kuljum tal-insulina fl-adulti, fl-adolexxenti u fit-tfal tista' tvarja u hija normalment bejn 0.5 u 1.0 unità/kg/jum.
English: The efficacy and safety of Fiasp have been studied in a 1:1:1 randomised active controlled clinical trial in children and adolescents with type 1 diabetes, aged 1 to 18 years, for a period of 26 weeks (N=777).
Maltese: L-effikaċja u s-sigurtà ta' Fiasp ġew studjati f'prova klinika kkontrollata b'mod attiva u magħmula b'mod arbitrarju 1:1:1fit-tfal u fl-adolexxenti bid-dijabete mellitus ta' tip 1, ta' età minn sena sa 18-il sena, għal perjodu ta' 26 ġimgħa (N=777).
English: 1 mL solution contains 100 units of insulin aspart.
Maltese: Millilitru ta' soluzzjoni fih 100 unità ta' insulina aspart.
English: 33.3% of patients treated with mealtime Fiasp reached a target HbA1c of < 7% compared to 23.3% of patients treated with postmeal Fiasp and 28.2% of patients treated with mealtime NovoRapid.
Maltese: 33.3% tal-pazjenti kkurati b'Fiasp fil-ħin tal-ikel laħqu mira ta' HBA1c ta' <7% meta mqabbla ma' 23.3% tal-pazjenti kkurati b'Fiasp wara l-ikel, u 28.2% tal-pazjenti kkurati b'NovoRapid fil-ħin talikel.
English: phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid/sodium hydroxide (for pH adjustment) and water for injections
Maltese: TA' EĊĊIPJENTI phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid/sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet
English: • glucocorticoids such as ‘cortisone' - for inflammation
Maltese: • glukokortikojdi bħal ‘cortisone' - użat fil-kura tal-infjammazzjoni
English: Insulin aspart concentration baseline-adjusted (pmol/L)
Maltese: Konċentrazzjoni ta' insulina aspart aġġustata għal-linja bażi (pmol/L)
English: Dose button
Maltese: Tikketta tal pinna
English: Bodyweight (kg)
Maltese: Piż tal-ġisem (kg)
English: Component of a multipack, cannot be sold separately
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ b'mod separat
English: Half-life after subcutaneous administration of Fiasp is 57 minutes and comparable to NovoRapid.
Maltese: Il-half-life wara l-għoti taħt il-ġilda ta' Fiasp hi ta' 57 minuta u hi komparabbli ma' NovoRapid.
English: Dose counter stopped: 16 units left
Maltese: Il-kontatur tad-doża waqaf:fadal 16-il unità
English: Fiasp administered postmeal showed non-inferior glycaemic control compared to NovoRapid mealtime (ETD: 0.13% [-0.01; 0.26]95% CI).
Maltese: Fiasp mogħti wara l-ikel wera non-inferjorità fil-kontroll gliċemiku meta mqabbel ma' NovoRapid mogħti fil-ħin tal-ikel (ETD: 0.13% [-0.01; 0.26]95% CI).
English: Renal and hepatic impairment
Maltese: Indeboliment renali u epatiku
English: Fiasp has been studied in 2,068 adult patients with type 1 diabetes (1,143 patients) and type 2 diabetes (925 patients) in 3 randomised efficacy and safety trials (18-26 weeks of treatment).
Maltese: Fiasp ġie studjat f'2,068 pazjent adult bid-dijabete mellitus ta' tip 1 (1,143 pazjent) u d-dijabete mellitus ta' tip 2 (925 pazjent) fi 3 provi li saru b'mod arbitrarju dwar l-effikaċja u s-sigurtà (1826 ġimgħa ta' kura).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: The pen can dial up to a maximum of 80 units.
Maltese: Il-pinna tista' tagħżel sa massimu ta' 80 unità.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha anqas minn mmol 1 ta' sodium (23 mg) f'kull doża.
English: less than 4.0
Maltese: inqas minn 4.0
English: Patients in the Fiasp mealtime arm included 16 children aged 2-5 years, 100 children aged 6-11 years and 144 adolescents aged 12-17 years.
Maltese: Il-pazjenti fil-fergħa ta' Fiasp meħud fil-ħin tal-ikel kienu jinkludu 16-it-tifel u tifla ta' età minn sentejn sa 5 snin, 100 tifel u tifla ta' età minn 6 sa 11-il sena u 144 adolexxent ta' età minn 12 sa 17-il sena.
English: If it shows 80, at least 80 units are left in your pen.
Maltese: Jekk juri 80, ikun fadal mill-inqas 80 unità fil-pinna tiegħek.
English: This medicine can also be used for continuous infusion in a pump system.
Maltese: Din il-mediċina tista' tintuża wkoll għall-infużjoni kontinwa f'sistema ta' pompa.
English: Solution for injection Multipack: 5 (5 packs of 1 x 10 mL) vials
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni Pakkett multiplu: 5 (5 pakketti ta' 1 x 10 mL) kunjetti
English: In patients using CSII (N=261): Infusion site reactions (including redness, inflammation, irritation, pain, bruising and itching) were reported in patients treated with Fiasp (10.0% vs. 8.3% in comparator).
Maltese: F'pazjenti li qed jużaw CSII (N=261):Reazzjonijiet fis-sit tal-infużjoni (li jinkludu ħmura, infjammazzjoni, irritazzjoni,uġigħ, tbenġil u ħakk) ġew irrappurtati f'pazjenti kkurati b'Fiasp (10.0% vs 8.3% fil-komparatur).
English: In the three controlled clinical studies, 192 of 1,219 (16%) Fiasp treated patients with type 1 diabetes or type 2 diabetes were ≥ 65 years of age and 24 of 1,219 (2%) were ≥ 75 years of age.
Maltese: Fit-tliet studji kliniċi kkontrollati, 192 minn 1,219 (16%) ta' pazjenti b'dijabete mellitus ta' tip 1 jew b'dijabete mellitus ta' tip 2, ikkurati b'Fiasp, kellhom ≥65 sena, u 24 minn 1,219 (2%) kellhom ≥75 sena.
English: One vial contains 1,000 units of insulin aspart in 10 mL solution.
Maltese: Kunjett wieħed fih 1,000 unità ta' insulina aspart f'soluzzjoni ta' 10 mL.
English: Pack sizes of 1, 5 or a multipack with 5 x (1 x 10 mL) vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 jew pakkett multiplu b'5 x (1 x 10 mL) kunjetti.
English: Fiasp 100 units/mL solution for injection in pre-filled pen Cartridge (type 1 glass) with a plunger (halobutyl) and a stopper (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Maltese: Fiasp 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Skartoċċ (ħġieġ ta' tip 1) bi planġer (halobutyl) u tapp (halobutyl/polyisoprene) f'pinna mimlija għallest, b'ħafna dożi, li tintrema wara li tintuża, magħmula mill-polypropylene, polyoxymethylene, polycarbonate u acrylonitrile butadiene styrene.
English: • It is recommended that you retest your blood glucose levels after 15-20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.
Maltese: • Huwa rrakkomandat li terġa' tiċċekkja l-livelli taz-zokkor fid-demm tiegħek wara 15-20 minuta u terġa' tieħu l-kura jekk il-livelli taz-zokkor fid-demm tiegħek għadhom inqas minn 4 mmol/L.
English: Fiasp has an earlier onset of action compared to NovoRapid (see section 5.2), leading to a subsequent increased glucose-lowering effect.
Maltese: Fiasp jibda jaħdem aktar malajr meta mqabbel ma' NovoRapid (ara sezzjoni 5.2), li sussegwentement iwassal għal żieda fl-effett ta' tnaqqis fil-glukosju.
English: Patients in the Fiasp postmeal arm included 16 children aged 2-5 years, 100 children aged 6-11 years and 143 adolescents aged 12-17 years.
Maltese: Il-pazjenti fil-fergħa ta' Fiasp meħud wara l-ikel kienu jinkludu 16-it-tifel u tifla ta' età minn sentejn sa 5 snin, 100 tifel u tifla ta' età minn 6 sa 11-il sena u 143 adolexxent ta' età minn 12 sa 17-il sena.
English: Following intravenous administration of Fiasp, clearance was rapid (1.0 L/h/kg) and the elimination half-life was 10 minutes.
Maltese: Wara l-għoti ta' Fiasp ġol-vini, it-tneħħija kienet mgħaġġla (1.0 L/h/kg), u l-half-life tal-eliminazzjoni kienet ta' 10 minuti.
English: Injection site reactions (including rash, redness, inflammation, pain and bruising) were reported in patients treated with Fiasp (1.3% vs. 1.0% in comparator).
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (li jinkludu raxx, ħmura, infjammazzjoni, uġigħ u tbenġil) ġew irrappurtati f'pazjenti kkurati b'Fiasp (1.3% vs 1.0% fil-komparatur).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: The potency of insulin analogues, including Fiasp, is expressed in units.
Maltese: Il-qawwa tal-analogi tal-insulina, inkluż Fiasp hi espressa f'unitajiet.
English: If you have poor eyesight, please see section 3 ‘How to use Fiasp'.
Maltese: Jekk għandek vista batuta, jekk jogħġbok ara sezzjoni 3 ‘Kif għandek tuża Fiasp'.
English: Fiasp administered at mealtime showed superior glycaemic control compared to NovoRapid mealtime with regards to change in HbA1c (ETD: -0.17% [-0.30; -0.03]95% CI).
Maltese: Fiasp mogħti fil-ħin tal-ikel wera superjorità fil-kontroll gliċemiku meta mqabbel ma' NovaRapid mogħti fil-ħin tal-ikel fir-rigward ta' tibdil fl-HbA1c (ETD: -0.17% [-0.30; -0.03]95% CI).
English: Pack sizes of 1, 5 or a multipack with 2 x 5 pre-filled pens of 3 mL.
Maltese: Daqsijiet tal-pakketti ta' 1, 5 jew pakkett multiplu bi 2 x 5 pinen mimlija għal-lest ta' 3 mL.
English: The estimated odds of achieving HbA1c < 7% were statistically significantly greater with mealtime Fiasp than with mealtime NovoRapid (odds ratio: 1.47 [1.02; 2.13]95% CI).
Maltese: Il-probabbilitajiet stmati tal-kisba ta' HBA1c ta' <7% kienu akbar b'mod statistikament sinifikanti b'Fiasp mogħti fil-ħin tal-ikel milli b'NovoRapid mogħti fil-ħin tal-ikel (proprzjoni ta' probabbiltà: 1.47 [1.02; 2.13]95% CI).
English: The onset of exposure in a CSII setting (time to reach maximum concentration) was 26 minutes shorter with Fiasp compared to NovoRapid resulting in approximately three times as much insulin available during the first 30 minutes (Figure 2).
Maltese: Il-bidu tal-espożizzjoni fi sfond ta' CSII (ħin biex tintlaħaq il-konċentrazzjoni massima) kien ta' 26 minuta iqsar b'Fiasp meta mqabbel ma' NovoRapid, u dan irriżulta f'madwar tliet darbiet aktar insulina disponibbli matul l-ewwel 30 minuta (Figura 2).
English: B Severe hypoglycaemia (episode requiring assistance of another person) or blood glucose (BG) confirmed hypoglycaemia defined as episodes confirmed by plasma glucose < 3.1 mmol/L irrespective of symptoms C The difference is for Fiasp mealtime - NovoRapid mealtime
Maltese: B Ipogliċemija severa (episodju li jeħtieġ għajnuna ta' persuna oħra) jew ipogliċemija ikkonfermata ta' glukosju fid-demm (BG) definita bħala episodji kkonfermati minn glukosju fil-plażma ta' <3.1 mmol/L, irrispettivament mis-sintomi C
English: Fiasp with alcohol
Maltese: Fiasp mal-alkoħol
English: The onset of appearance was twice as fast (corresponding to 5 minutes earlier), time to 50% maximum concentration was 9 minutes shorter with Fiasp compared to NovoRapid with four times as much insulin available during first 15 minutes and with twice as much insulin available during the first 30 minutes.
Maltese: L-ewwel dehra kienet darbtejn aktar mgħaġġla (li jikkorrispondi għal 5 minuti qabel), il-ħin għal 50% tal-konċentrazzjoni massima kien ta' 9 minuti iqsar b'Fiasp meta mqabbel ma' NovoRapid, b'erba' darbiet aktar insulina disponibbli matul l-ewwel 15-il minuta u d-doppju tal-insulina disponibbli matul l-ewwel 30 minuta.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: • local reactions (e.g., rash, redness and itching) spread to other parts of your body
Maltese: • reazzjonijiet lokali (eż., raxx, ħmura u ħakk) li jinfirxu għal partijiet oħra ta' ġismek
English: In a 2-week cross-over trial, Fiasp showed a greater postmeal glucose-lowering effect after a standardised meal test with regard to 1-hour and 2-hour postmeal glucose response (treatment difference: -0.50 mmol/L [-1.07; 0.07]95% CI and -0.99 mmol/L [-1.95; -0.03]95% CI), respectively compared to NovoRapid in a CSII setting.
Maltese: Fi studju cross-over li dam ġimagħtejn, Fiasp wera effett akbar tat-tnaqqis tal-livell tal-glukosju wara l-ikel wara test tal-ikla standardizzat fir-rigward ta' rispons tal-glukosju wara siegħa u sagħtejn minn ikla (differenza fil-kura: -0.50 mmol/L [-1.07; 0.07]95% CI u -0.99 mmol/L [-1.95; -0.03]95% CI), rispettivament meta mqabbla ma' NovoRapid fi sfond ta' CSII.
English: EU/1/16/1160/009 5 vials of 10 mL
Maltese: EU/1/16/1160/008 5 kunjetti ta' 10 mL