FrancophonIA/ELRC3.0 huggingface dataset:
English: • Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Maltese: • Episodji ipoglikemiċi serji, meta l-pazjent ma jkunx jista' jikkura lilu nnifsu, jistgħu jiġu ttrattati bi glucagon (0.5 sa 1 mg) mogħti ġol-muskoli jew taħt il-ġilda minn persuna mħarrġa, jew bilglukosju li jingħata ġol-vina minn professjonist fil-kura tas-saħħa.
English: The half-life of Tresiba is approximately 25 hours independent of dose.
Maltese: Il-half-life ta' Tresiba hi ta' madwar 25 siegħa indipendentement mid-doża.
English: MARKETING AUTHORISATION NUMBER EU/1/12/807/005 10 pens of 3 mL
Maltese: EU/1/12/807/005 10 pinen ta' 3 mL
English: MARKETING AUTHORISATION NUMBER EU/1/12/807/015 6 pens of 3 mL
Maltese: EU/1/12/807/015 6 pinen ta' 3 mL
English: Component of a multipack, cannot be sold separately
Maltese: Parti minn pakkett multiplu, ma jistgħux jinbigħu b'mod separat
English: Tresiba 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 pre-filled multidose disposable pen made of polypropylene.
Maltese: Tresiba 100 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: Insulins and analogues for injection, long-acting.
Maltese: Insulini u anaolgi għall-injezzjoni, jaħdmu fit-tul.
English: • The other ingredients are glycerol, metacresol, phenol, 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, zinc acetate, hydrochloric acid, sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet (ara sezzjoni 2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (200 units/mL pre-filled pen (FlexTouch))
Maltese: KARTUNA GĦAL PAKKETT MULTIPLU (200 unità/mL pinna mimlija għal-lest (FlexTouch))
English: If it shows less than 80, the number shown is the number of units left in your pen.
Maltese: Jekk ikun hemm inqas minn 80, in-numru muri jkun in-numru ta' unitajiet li jkun fadal filpinna tiegħek.
English: STATEMENT OF ACTIVE SUBSTANCE One pre-filled pen contains 300 units of insulin degludec in 3 mL solution 1 mL solution contains 100 units of insulin degludec (equivalent to 3.66 mg)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pinna waħda mimlija għal-lest fiha 300 unità ta' insulina degludec f'soluzzjoni ta' 3 mL 1 mL ta' soluzzjoni fih 100 unità ta' insulina degludec (ekwivalenti għal 3.66 mg)
English: Ratio: 0.66 [0.49; 0.88]
Maltese: Proporzjon: 0.66 [0.49;0.
English: *Statistically significant a Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Maltese: *Statistikament sinifikanti a Ipogliċemija kkonfermata kienet definita bħala episodji kkonfermati permezz ta' glukosju filplażma ta' <3.1 mmol/L jew minn pazjent li jkun jeħtieġ għajnuna minn terza parti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (100 units/mL pre-filled pen (FlexTouch))
Maltese: KARTUNA GĦAL PAKKETT MULTIPLU (100 unità/mL pinna mimlija għal-lest (FlexTouch))
English: Each mL of solution contains 100 units of insulin degludec.
Maltese: Kull mL ta' soluzzjoni fih 100 unità ta' insulina degludec.
English: A numerically higher rate of severe hypoglycaemia in children aged 6-11 years in the Tresiba arm was observed.
Maltese: Ġiet osservata rata numerikament ogħla ta' ipogliċemija severa fil-fergħa ta' Tresiba fit-tfal b'etajiet bejn 6-11-il sena.
English: • With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered.
Maltese: • B'Tresiba 200 unità/mL doża ta' 2-160 unità f'kull injezzjoni, tista' tingħata f'żidiet ta'
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: L-intensifikazzjoni tat-terapija bl-insulina b'titjib f'daqqa tal-kontroll gliċemiku, tista' tkun assoċjata ma' retinopatija dijabetika li tmur għall-agħar temporanjament, filwaqt li titjib fil-kontroll gliċemiku fit-tul inaqqas ir-riskju tal-progressjoni tar-retinopatija dijabetika.
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. b Episodes from week 16.
Maltese: Ipogliċemija ta' matul il-lejl ikkonfermata kienet definita bħala episodji bejn nofsillejl u s-6 a.m b Episodji minn ġimgħa 16
English: In a prospectively planned meta-analysis across seven open-label treat-to-target confirmatory trials in patients with type 1 and type 2 diabetes mellitus, Tresiba was superior in terms of a lower number of treatment-emergent confirmed hypoglycaemic episodes (driven by a benefit in type 2 diabetes mellitus, see Table 2) and nocturnal confirmed hypoglycaemic episodes compared to insulin glargine (100 units/ml) (administered according to label).
Maltese: F'metaanaliżi ppjanata prospettivament li saret fuq medda ta' seba' provi konfermatorji tat-tip treat-to target fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża f'pazjenti b'dijabete mellitus ta' tip 1 u tip 2, Tresiba kien superjuri f'termini ta' numru iktar baxx ta' episodji ipogliċemiċi kkonfermati li jiżviluppaw mit-trattament (xprunati minn benefiċċju f'pazjenti b'dijabete mellitus ta' tip 2 - ara Tabella 2) u episodji ipogliċemiċi kkonfermati matul il-lejl, meta mqabbel ma' insulina glargine (100 unità/mL) (mogħti skont it-tikketta).
English: Geriatric patients ≥65 years Type 1 diabetes mellitus Maintenance period b
Maltese: Pazjenti ġerjatriċi ≥65 sena
English: Examples
Maltese: MANIFATTURI
English: 24 units selected
Maltese: 24 unità magħżula
English: MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL
Maltese: EU/1/12/807/007 5 skrataċ ta' 3 mL EU/1/12/807/008 10 skrataċ ta' 3 mL
English: HbA1c (%) End of trial Mean change
Maltese: HbA1c (%) Linja bażi
English: End of treatment Rate of severe hypoglycaemia3
Maltese: Skala talinsulina Tieqa talinsulina
English: Ratio: 1.03 [0.75; 1.40]
Maltese: Proporzjon: 1.03 [0.75;1.40] Proporzjon: 1.10 [0.79;1.52]
English: While improvements in HbA1c were non-inferior compared to other insulin products, against sitagliptin Tresiba was statistically significantly superior in reducing HbA1c (Table 5).
Maltese: Waqt li t-titjib fl- HbA1c ma kienx inferjuri meta mqabbel mal prodotti l-oħra tal-insulina kontra sitagliptin Tresiba kien superjuri b'mod statistikament sinifikanti biex inaqqas HbA1c(Tabella 5).
English: Solution for injection (FlexTouch)
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni . (FlexTouch).
English: Contents of the pack and other information What Tresiba contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Tresiba
English: A number of medicinal products are known to interact with glucose metabolism.
Maltese: Numru ta' prodotti mediċinali huma magħrufa li jagħmlu interazzjoni mal-metaboliżmu tal-glucose.
English: Other medicines and Tresiba
Maltese: Mediċini oħra u Tresiba
English: Nocturnal
Maltese: Urtikarja
English: Outer needle cap
Maltese: UŻATI JEW SKART MINN DAWN
English: • acetylsalicylic acid (and other salicylates), for pain and mild fever
Maltese: • acetysalicylic acid (u salicylates oħrajn), użati biex itaffu l-uġigħ u deni ħafif
English: Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Maltese: Il-glukosju għandu jingħata ġolvina jekk il-pazjent ma jirrispondix għal glucagon fi żmien 10 sa 15-il minuta.
English: • thyroid hormones, for thyroid problems
Maltese: • ormoni tat-tirojde, użati għal problemi fil-glandola tat-tirojde
English: If it shows 160, at least 160 units are left in your pen.
Maltese: Jekk juri 160, ikun fadal mill-inqas 160 unità fil-pinna tiegħek.
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack of 6 (2 x 3) (without needles) pre-filled pens of 3 mL.
Maltese: Daqsijiet tal-pakketti ta' 1 (bil-labar jew mingħajr), 2 (mingħajr labar), 3 (mingħajr labar), 5 (mingħajr labar) u pakkett multiplu ta' 6 (2 x 3) (mingħajr labar) pinen mimlijin għal-lest ta' 3 ml.
English: Transfer from other insulin medicinal products
Maltese: It-trasferiment minn prodotti mediċinali oħra ta' insulina
English: Steady state will occur after 2-3 days of dose administration.
Maltese: L-istat fiss se jseħħ wara 2-3 ijiem mill-għoti tad-doża.
English: Tresiba 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
Maltese: Tresiba 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Skartoċċ fih 300 unità ta' insulina degludec f'3 ml ta' soluzzjoni.
English: The signs may include: pain, redness, hives, swelling and itching.
Maltese: Is-sinjali jistgħu jinkludu: uġigħ, ħmura, urtikarja, nefħa u ħakk.
English: Tresiba 100 units/mL solution for injection in cartridge insulin degludec
Maltese: Tresiba 100 unità/ml soluzzjoni għall-injezzjoni fi skartoċċ. insulina degludec
English: 1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements ± metformin ± pioglitazone 2 Once-daily regimen ± metformin SU/glinide ± pioglitazone
Maltese: 1 F'kors ta' darba kuljum + insulina aspart biex ikopri l-ħtiġijiet tal-insulina f'ħin l-ikel.
English: Substances added to Tresiba may cause degradation of insulin degludec.
Maltese: Sustanzi miżjuda ma' Tresiba jistgħu jikkawżaw id-degradazzjoni ta' insulina degludec.
English: If it shows less than 160, the number shown is the number of units left in your pen.
Maltese: Jekk ikun hemm inqas minn 160, in-numru muri jkun in-numru ta' unitajiet li jkun fadal filpinna tiegħek.
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 Tresiba.
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 bi Tresiba.
English: Tresiba 100 units/mL solution for injection in a cartridge Tresiba comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
Maltese: Tresiba 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ Tresiba jiġi fi skartoċċ (Penfill) magħmul biex jintuża mas-sistemi li jfornu l-insulina Novo Nordisk u mal-labar tal-injezzjoni NovoFine jew NovoTwist. 4.3 Kontraindikazzjonijiet
English: Confirmed hypoglycaemiaa
Maltese: Ipogliċemija kkonfermataa
English: The duration of action of Tresiba is beyond 42 hours within the therapeutic dose range.
Maltese: It-tul tal-azzjoni ta' Tresiba hu aktar minn 42 siegħa fil-marġni tad-doża terapewtika.
English: Tresiba 200 units/mL solution for injection in pre-filled pen One pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
Maltese: Tresiba 200 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Pinna waħda mimlija għal-lest fiha 600 unità ta' insulina degludec f'3 ml ta' soluzzjoni.
English: 1 mL solution contains 200 units insulin degludec* (equivalent to 7.32 mg insulin degludec).
Maltese: 1 mL ta' soluzzjoni fih 200 unità ta' insulina degludec(ekwivalenti għal 7.
English: NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL solution for injection in cartridge
Maltese: Barra minn hekk, ilpakkett u t-tikketta ta' Tresiba 100 unità/mL huma ħodor ċari u l-pakkett u t-tikketta ta' Tresiba
English: When adding GLP-1 receptor agonists to Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimise the risk of hypoglycaemia.
Maltese: Meta żżid agonisti tar-riċettur GLP-1 ma' Tresiba, huwa rrakkomandat li tnaqqas id-doża ta' Tresiba b'20% biex jitnaqqas ir-riskju ta' ipogliċemija.
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens.
Maltese: Daqsijiet ta' pakketti ta' 1 (bil-labar jew mingħajr), 2 (mingħajr labar), 3 (mingħajr labar) 5 (mingħajr labar) u pakkett multiplu li fih 6 (2 pakketti ta' 3) (mingħajr labar) pinen mimlija għal-lest.
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.5, 4.8 and 4.9).
Maltese: L-ipogliċemija tista' sseħħ jekk id-doża tal-insulina tkun għolja wisq meta mqabbla mal-ħtieġa tal insulina (ara sezzjonijiet 4.5, 4.8 u 4.9).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 100 units/mL solution for injection insulin degludec
Maltese: Informazzjoni għall-pazjent Tresiba 100 unità/ml soluzzjoni għall-injezzjoni f'skartoċċ insulina degludec
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 differenza bejn l-insulina degludec u linsulina umana fir-rigward tal-embrijotossiċità u t-teratoġeniċità.
English: Tresiba is a long-acting basal insulin called insulin degludec.
Maltese: Tresiba hu insulina bażilari li jaħdem fit-tul u li jissejjaħ insulina degludec.
English: Odds ratio: 0.73 [0.60; 0.89]
Maltese: Proporzjon ta' probabbiltà: 0.73 [0.60;
English: The potency of insulin analogues, including insulin degludec, is expressed in units.
Maltese: Il-qawwa tal-analogi tal-insulina inkluż l-insulina degludec hija rrappreżentata permezz ta' unitajiet.
English: Nocturnal confirmed4
Maltese: Severa Ikkonfermata4
English: CV: Cardiovascular.
Maltese: Mediċini użati fid-dijabete.
English: Basal only therapy in previously insulin-naïve
Maltese: Antikorpi kontra l-insulina
English: Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
Maltese: NovoFine/NovoTwist b'tul ta' mhux iżjed minn 8 mm.
English: Very common Hypoglycaemia
Maltese: GĦAMLA KWALITATTIVA
English: Baseline
Maltese: Eżempji
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, nervi 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: Confirmed3
Maltese: Ikkonfermata3
English: • turn you on your side
Maltese: Proporzjon ta'
English: For detailed instructions for use, see the package leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. 5 The difference is for Tresiba Flex - Tresiba
Maltese: Id-differenza hi għal Tresiba Flex - Tresiba
English: Make sure the dose counter shows 2.
Maltese: Kun ċert li l-kontatur tad-doża juri 2.
English: N: Number of subjects with a first EAC confirmed event during trial.
Maltese: Numru ta' suġġetti bl-ewwel avveniment ikkonfermat ta' EAC waqt il-prova.
English: Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Maltese: Tresiba 200 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest It-tikketta u l-pakkett ta' Tresiba 200 unità/mL huma ħodor skuri bi strixxi b'kaxxa ħamra li tiġbed l attenzjoni għall-qawwa tal-formulazzjoni.
English: • Tresiba is given as an injection under the skin (subcutaneous injection).
Maltese: • Tresiba jingħata bħala injezzjoni taħt il-ġilda (injezzjoni subkutanea).
English: Tresiba can be used in renal and hepatic impaired patients.
Maltese: Tresiba jista' jintuża f'pazjenti b'indeboliment renali u epatiku.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 200 units/mL solution for injection insulin degludec
Maltese: U MNEJN GĦANDU JINGĦATA Tresiba 200 unità/ml soluzzjoni għall-injezzjoni insulina degludec
English: Patients were randomised to either Tresiba or insulin glargine (100 units/mL) followed by cross-over.
Maltese: - jkun hemm bidla għal Tresiba minn insulina glargine (300 unità/mL)
English: There is no clinically relevant development of insulin antibodies after long-term treatment with Tresiba.
Maltese: M'hemm l-ebda żvilupp klinikament sinifikanti ta' antikorpi tal-insulina wara kura fit-tul bi Tresiba.
English: Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL packaging and label are light green.
Maltese: It-tikketta u l-pakkett ta' Tresiba 100 unità/mL huma ħodor ċari.
English: Tresiba 200 units/mL solution for injection in pre-filled pen insulin degludec
Maltese: Tresiba 200 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest insulina degludec
English: Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Maltese: L-insulina degludec jingħaqad speċifikament mar-riċettur tal-insulina umana u b'hekk jikkawża listess effetti farmakoloġiċi bħal dawk tal-insulina umana.
English: Each pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
Maltese: Pinna 1 mimlija għal-lest fiha 300 unità ta' insulina degludec f'soluzzjoni ta' 3 mL.
English: You can carry your Tresiba cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 8 weeks.
Maltese: Tista' ġġorr l-iskartoċċ (Penfill) Tresiba tiegħek miegħek u żżommu fit temperatura tal-kamra (mhux aktar minn 30°C) sa perijodu ta' 8 ġimgħat.
English: INSTRUCTIONS ON USE
Maltese: U MANIFATTUR RESPONSABBLI
English: Tresiba 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Maltese: Tresiba 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Soluzzjoni għall-injezzjoni (FlexTouch).
English: With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Maltese: Bi Tresiba, reazzjonijiet ta' sensittività eċċessiva (li turi ruħha permezz ta' nefħa fl-ilsien u fix-xofftejn, dijarea, nawsja, għeja u ħakk) u urtikarja, ġew irrappurtati b'mod rari.
English: Ratio: 0.64 [0.42; 0.98]
Maltese: Proporzjon: 0.64 [0.42;0.
English: During a period of 24 hours with once-daily treatment, the exposure of insulin degludec was evenly distributed between the first and second 12 hours.
Maltese: Waqt perijodu ta' 24 siegħa b'kura ta' darba kuljum, l-espożizzjoni ta' insulina degludec kienet distribwita b'mod ugwali bejn l-ewwel u t-tieni 12-il siegħa.
English: Tresiba 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: Soluzzjoni ta' 3 mL f'skartoċċ (ħġieġ ta' tip 1), bi planġer (halobutyl) u laminat ta' folja tal-lastku
English: Rate of severe or BG confirmed symptomatic hypoglycaemia3,5 Maintenance period4
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: The dose is provided in half the volume of 100 units/mL basal insulin products.
Maltese: Id-doża tingħata f'nofs il-volum ta' prodotti tal-insulina bażilari ta' 100 unità/mL.
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: 2 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Maltese: 2 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: Table 4 Results from open-label clinical trials in insulin naïve type 2 diabetes mellitus (insulin initiation)
Maltese: Tabella 4 Riżultati ta' provi kliniċi fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża li saru fuq pazjenti b'dijabete ta' tip 2 li qatt ma ħadu insulina (bidu ta' insulina)
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m.
Maltese: Ipogliċemija ta' matul il-lejl ikkonfermata kienet definita bħala episodji bejn nofsillejl u s-6 a.m.
English: The Poster for pharmacies/diabetic units shall contain the following key elements: - That Tresiba is available in 2 strengths; - Key differences in the design of the packages and the pre-filled pen devices; - When prescribing to make sure that the correct strength is mentioned in the prescription slip; - Always check the insulin label before dispensing to make sure the correct strength is delivered to the patient; - Always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Tresiba; - Do not use outside of the pre-filled pen device (e.g. syringes); - Reporting of medication errors or any side effects.
Maltese: Livell għoli wisq ta' zokkor fid-demm jista' jseħħ jekk inti: tiekol aktar jew tagħmel inqas eżerċizzju mis-soltu; tixrob l-alkoħol; ikollok infezzjoni jew deni; ma tinjettax insulina biżżejjed; tieħu inqas insulina milli għandek bżonn ripetutament; tinsa tieħu linsulina jew tieqaf tieħu l-insulina mingħajr ma tkellem lit-tabib tiegħek.
English: E
Maltese: L
English: Type 1 + Type 2 diabetes mellitus (pooled) Maintenance period b
Maltese: Dijabete mellitus ta' Tip 1 + Tip 2 (miġbura)
English: < 8.0% ≥ 8% to < 9.0% ≥ 9.0%
Maltese: < 8.0% ≥ 8% sa < 9.0% ≥ 9.0%
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Maltese: Trasportaturi tal-katjon organiku (OCT) Metformin huwa substrat taż-żewġ trasportaturi OCT1 u OCT2.
English: The mean Vd ranged between 63-276 L.
Maltese: Il-Vd varja bejn 63-276 L.
English: oedema peripheral
Maltese: edema periferali
English: Magnesium stearate (E470b) Cellulose, microcrystalline (E460i) Silica, dental type (E551)
Maltese: Magnesium stearate (E470b) Cellulose, microcrystalline (E460i) Silica, tip dentali (E551)
English: Treatments
Maltese: Trattamenti
English: HbA1c (%) at week 24
Maltese: HbA1c (%) f'Ġimgħa 24
English: The volume of distribution of saxagliptin was 205 L.
Maltese: Ilvolum ta' distribuzzjoni ta' saxagliptin kien 205 L.
English: nd study, 18.5% for the combination therapy versus 43.1% for glimepiride plus metformin.
Maltese: ni studju, 18.5 % għat-terapija kombinata kontra 43.1 % għal glimepiride u metformin.
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay
Maltese: Interferenza ma' assaġġ ta' 1,5-anhydroglucitol (1,5-AG)
English: Dysuria polyuria
Maltese: Diżurja polijurja
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċiu tat-tessuti konnettivi
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Maltese: Irreazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi (SOC) u l-frekwenza.
English: The corresponding plasma Cmax values were 24 ng/mL and 47 ng/mL, respectively.
Maltese: Il-valuri ta' Cmax filplażma korrispondenti kienu 24 ng/mL u 47 ng/mL, rispettivament.
English: Sequential add-on clinical trials Study MB102129
Maltese: Provi kliniċi ta' żieda sekwenzjali Studju MB102129