FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetic retinopathy complicationsb
Maltese: Kumplikazzjonijiet ta' retinopatija dijabetika b
English: The relevance for humans is considered to be low, but cannot be completely excluded.
Maltese: Ir-rilevanza għall-umani hija kkunsidrata li hi baxxa, iżda ma tistax tiġi esklusa kompletament.
English: HbA1c at baseline was 8.2%, 8.4% and 8.4% for Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively.
Maltese: HbA1c fil-linja bażi kienet 8.2%, 8.4% u 8.4% għal Ozempic 0.5 mg, Ozempic 1 mg, u plaċebo, rispettivament.
English: • Turn the dose selector until the dose counter shows the flow check symbol (
Maltese: • Dawwar is-selettur tad-doża sakemm ilkontatur tad-doża juri s-simbolu talivverifikar tal-fluss (
English: Ozempic 0.5 mg (46% and 13%) and 1 mg (52 - 62% and 21 - 24%) compared with the active comparators sitagliptin (18% and 3%) and exenatide ER (17% and 4%).
Maltese: Wara sena ta' kura, telf tal-piż ta' ≥5% u ≥10% inkiseb għal aktar individwi b'Ozempic 0.5 mg (46% u 13%) u 1 mg (52-62% u 21-24%) meta mqabbel mal-komparaturi attivi sitagliptin (18% u 3%) u exenatide ER (17% u 4%).
English: In patients with type 2 diabetes, semaglutide resulted in the following relative reductions in glucagon compared to placebo: fasting glucagon (8-21%), postprandial glucagon response (14-15%) and mean 24 hour glucagon concentration (12%).
Maltese: F'pazjenti b'dijabete ta' tip 2, semaglutide irriżulta fit-tnaqqis relattiv li ġej tal-glucagon meta mqabbel malplaċebo: glucagon fl-istat sajjem (8-21%), rispons ta' glucagon wara ikla (14-15%), u l-medja talkonċentrazzjoni ta' glucagon fuq 24 siegħa (12%).
English: The efficacy of semaglutide was not impacted by age, gender, race, ethnicity, BMI at baseline, body weight (kg) at baseline, diabetes duration and level of renal function impairment.
Maltese: L-effikaċja ta' semaglutide ma kinitx affettwata mill-età, sess, razza, etniċità, BMI fil-linja bażi, piż tal-ġisem (kg) fil-linja bażi, mit-tul tad-dijabete u mil-livell tal-indeboliment tal-funzjoni renali.
English: Intent-to-Treat (ITT) Population (N) HbA1c (%) Baseline (mean) Change from baseline at week 56 Difference from exenatide [95% CI] -0.6 [-0.8, -0.4]a Patients (%) achieving HbA1c <7% FPG (mmol/L) Baseline (mean) Change from baseline at week 56 Body weight (kg) Baseline (mean) Change from baseline at week 56 Difference from exenatide [95% CI] -3.8 [-4.6, -3.0]a ap <0.0001 (2-sided) for superiority
Maltese: Popolazzjoni b'Intenzjoni li Tiġi Kkurata (ITT, Intent-to-Treat) (N) HbA1c (%) Linja Bażi (medja) Bidla mil-linja bażi f'ġimgħa 56 Differenza minn sitagliptin [95% CI] -0.8 [-0.9, -0.
English: In the 40-week trial versus dulaglutide a weight loss of ≥5% and ≥10% was achieved for more subjects with Ozempic 0.5 mg (44% and 14%) compared with dulaglutide 0.75 mg (23% and 3%) and Ozempic 1 mg (up to 63% and 27%) compared with dulaglutide 1.5 mg (30% and 8%).
Maltese: Fil-prova ta' 40 ġimgħa kontra dulaglutide, tnaqqis fil-piż ta' ≥5% u ≥10% inkiseb f'aktar suġġetti b'Ozempic 0.5 mg (44% u 14%) meta mqabbel ma' dulaglutide 0.75 mg (23% u 3%) u Ozempic 1 mg (sa 63% u 27%) meta mqabbel ma' dulaglutide 1.5 mg (30% u 8%).
English: Table 1 Adverse reactions from long-term controlled phase 3a trials including the cardiovascular outcomes trial
Maltese: Tabella 1 Ir-reazzjonijiet avversi identifikati minn provi fit-tul u kkontrollati ta' fażi 3a, li jinkludu l-prova tar-riżultati kardjovaskulari Sistema talklassifika talorgani MedDRA
English: SUSTAIN 7 - Ozempic vs. dulaglutide both in combination with metformin In a 40-week, open-label trial, 1,201 patients on metformin were randomised 1:1:1:1 to once weekly Ozempic 0.5 mg, dulaglutide 0.75 mg , Ozempic 1 mg or dulaglutide 1.5 mg, respectively.
Maltese: F'prova open-label li damet 40 ġimgħa, 1,201 pazjenti fuq metformin intgħażlu b'mod arbitrarju 1:1:1:1 biex jirċievu darba fil-ġimgħa Ozempic 0.5 mg, dulaglutide 0.75 mg, Ozempic 1 mg jew dulaglutide 1.5 mg rispettivament.
English: Sodium content This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial.
Maltese: L-effett ta' semaglutide fuq ir-repolarizzazzjoni kardijaka ġie ttestjat fi prova bir-reqqa tal-QTc.
English: • feeling sick (nausea) - this usually goes away over time
Maltese: • tħossok imdardar (nawseja) - dan normalment imur maż-żmien
English: A significant and sustained reduction in body weight from baseline to week 104 was observed with Ozempic 0.5 mg and 1 mg vs placebo 0.5 mg and 1 mg, in addition to standard-of-care (-3.6 kg and -4.9 kg vs -0.7 kg and -0.5 kg , respectively) in SUSTAIN 6.
Maltese: F'SUSTAIN 6, ġie osservat tnaqqis sinifikanti fil-piż tal-ġisem u li nżamm mil-linja bażi salġimgħa 104 b'Ozempic 0.5 mg u 1 mg vs plaċebo 0.5 mg u 1 mg, flimkien ma' kura standard (-3.6 kg u -4.9 kg vs -0.7 kg u -0.5 kg , rispettivament).
English: STATEMENT OF ACTIVE SUBSTANCE Each dose (0.19 ml) contains 0.25 mg semaglutide (1.34 mg/ml),
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull doża (0.19 ml) fiha 0.25 mg semaglutide (1.34 mg/ml),
English: Renal impairment did not impact the pharmacokinetics of semaglutide in a clinically relevant manner.
Maltese: L-indeboliment renali ma affettwax il-farmakokinetika ta' semaglutide b'mod li hu klinikament rilevanti.
English: STATEMENT OF ACTIVE SUBSTANCE Each dose (0.37 ml) contains 0.5 mg semaglutide (1.34 mg/ml),
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull doża (0.37 ml) fiha 0.5 mg semaglutide (1.34 mg/ml),
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Maltese: L-użu ta' agonisti tar-riċetturi ta' GLP-1 jistgħu jiġu assoċjati ma' reazzjonijiet avversi gastrointestinali.
English: Abdominal pain Abdominal distension Constipation Dyspepsia Gastritis
Maltese: Nefħa addominali Stitikezza Dispepsja Gastrite
English: Favours Ozempic
Maltese: X'fih Ozempic
English: STATEMENT OF ACTIVE SUBSTANCE Each dose (0.74 ml) contains 1 mg semaglutide (1.34 mg/ml),
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull doża (0.74 ml) fiha 1 mg semaglutide (1.34 mg/ml),
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudji fir-rigward tat-teħid flimkien ma' prodotti mediċinali oħra, l-effetti fuq ilkontroll gliċemiku u avvenimenti kardjovaskulari u l-popolazzjonijiet li ġew studjati, ara sezzjonijiet 4.4, 4.5 u 5
English: If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Maltese: Jekk ma tidher l-ebda qatra, irrepeti pass 2 ‘Iċċekkja l-fluss' għal massimu ta' 6 darbiet.
English: Time since randomisation (week) Ozempic 0.5 mg Sitagliptin
Maltese: Ozempic 0.5 mg Sitagliptin
English: If it shows 0.5, at least 0.5 mg is left in your pen.
Maltese: Jekk juri 0.5, ikun fadal mill-inqas 0.5 mg fil-pinna tiegħek.
English: Caring for your pen
Maltese: Tikketta tal pinna
English: See figure 4 for results on primary and secondary cardiovascular endpoints.
Maltese: Ara figura 4 għar-riżultati fuq l-għanijiet kardjovaskulari primarji u sekondarji.
English: Glucose dependent insulin and glucagon secretion
Maltese: Sekrezzjoni ta' insulina u glucagon dipendenti fuq il-glucose
English: Intent-to-Treat (ITT) Population (N) HbA1c (%)
Maltese: Pazjenti (%) li kisbu HbA1c <7%
English: After first use: Store below 30°C or in a refrigerator (2°C to 8°C).
Maltese: Aħżen f'temperatura taħt 30°C jew fi friġġ (2°C sa 8°C).
English: Due to species differences in yolk sac anatomy and function, and due to lack of GLP-1 receptor expression in the yolk sac of non-human primates, this mechanism is considered unlikely to be of relevance to humans.
Maltese: Minħabba d-differenzi tal-ispeċi fl-anatomija u l-funzjoni tal-yok sac, u minħabba n-nuqqas ta' espressjoni tar-riċetturi ta' GLP-1 fil-yolk sac ta' primati mhux umani, dan il-mekkaniżmu huwa kkunsidrat li mhux probabbli li jkun ta' rilevanza għall-bnedmin.
English: Other medicines and Ozempic
Maltese: Mediċini oħra u Ozempic
English: The pharmacokinetics of semaglutide were evaluated in patients with different degrees of hepatic impairment (mild, moderate, severe) compared with subjects with normal hepatic function in a study with a single-dose of 0.5 mg semaglutide.
Maltese: Il-farmakokinetika ta' semaglutide ġiet evalwata f'pazjenti bi gradi differenti tal-indeboliment tal-fwied (ħafif, moderat, sever) meta mqabbla ma' individwi b'funzjoni tal-fwied normali fi studju b'doża waħda ta' 0.5 mg ta' semaglutide.
English: A 2-year clinical trial investigated 3,297 patients with type 2 diabetes, with high cardiovascular risk, long duration of diabetes and poorly controlled blood glucose.
Maltese: Prova klinika li damet sentejn investigat 3,297 pazjent b'dijabete ta' tip 2, b'riskju kardjovaskulari għoli, li kellhom id-dijabete għal żmien twil, u b'livelli ta' glucose fid-demm mhux ikkontrollati tajjeb.
English: Cholelithiasis
Maltese: Kolelitijażi
English: Treatment with semaglutide demonstrated sustained, statistically superior and clinically meaningful reductions in HbA1c and body weight for up to 2 years compared to placebo and active control treatment (sitagliptin, insulin glargine, exenatide ER and dulaglutide).
Maltese: Il-kura b'semaglutide uriet tnaqqis sostnut, statistikament superjuri u klinikament sinifikanti fittnaqqis fl-HbA1c u fil-piż tal-ġisem għal sa sentejn meta mqabbla mal-plaċebo u kura b'kontroll attiv (sitagliptin, insulin glargine, exenatide ER u dulaglutide).
English: One ml of solution contains 1.34 mg of semaglutide*.
Maltese: Kull millilitru ta' soluzzjoni fih 1.34 mg ta' semaglutide*.
English: The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Maltese: L-iskartoċċ huwa mmuntat f'pinna mimlija għal-lest, li tintrema wara li tintuża, magħmula mill-polypropylene, polyoxymethylene, polycarbonate u acrylonitrile butadiene styrene.
English: Table 2 SUSTAIN 1: Results at week 30
Maltese: Tabella 2 SUSTAIN 1: Riżultati f'ġimgħa 30
English: -3.6 [-4.7, -2.4]a p <0.0001 (2-sided) for superiority
Maltese: -3.6 [-4.7, -2.4]a p <0.
English: This reduces the risk of blocked needles, contamination, infection and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' labar imblukkati, kontaminazzjoni, infezzjoni u dożaġġ mhux preċiż.
English: In a long-term trial in subjects with cardiovascular risk factors, 16% of Ozempic-treated subjects had an increase in heart rate of >10 bpm compared to 11% of subjects on placebo after 2 years of treatment.
Maltese: F'prova fit-tul f'suġġetti b'fatturi ta' riskju kardjovaskulari, 16% tas-suġġetti ttrattati b'Ozempic kellhom żieda fir-rata tal-qalb ta' >10 bpm meta mqabbla ma' 11% tas-suġġetti fuq plaċebo wara sentejn ta' trattament.
English: This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' labar imblukkati, kontaminazzjoni, infezzjoni, tnixxija tas-soluzzjoni u dożaġġ mhux preċiż.
English: The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common).
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod frekwenti waqt il-provi kliniċi kienu disturbi gastrointestinali, li jinkludu nawseja (komuni ħafna), dijarea (komuni ħafna) u rimettar (komuni).
English: Outer needle cap
Maltese: Kemm għandek tuża
English: Number of subjects at risk
Maltese: Numru ta' suġġetti f'riskju
English: 3 ml (4 doses)
Maltese: 3 ml
English: Effects on the digestive system
Maltese: Effetti fuq is-sistema diġestiva
English: Injection site reactions (e.g. injection site rash, erythema) have been reported by 0.6% and 0.5% of patients receiving semaglutide 0.5 mg and 1 mg, respectively.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (eż. raxx fis-sit tal-injezzjoni, eritema) ġew irrappurtati minn 0.6% u 0.5% tal-pazjenti li kienu qed jirċievu semaglutide 0.5 mg u 1 mg, rispettivament.
English: Exposure of ethinylestradiol was not affected; an increase of 20% was observed for levonorgestrel exposure at steady state.
Maltese: L-espożizzjoni ta' ethinylestradiol ma ġietx affettwata; ġiet osservata żieda ta' 20% għall-espożizzjoni ta' levonorgestrel fl-istat stabbli.
English: Ozempic 0.25 mg solution for injection
Maltese: Ozempic 0.25 mg soluzzjoni għall-injezzjoni
English: In SUSTAIN 6 (see subsection Cardiovascular disease) 867 patients were on premix insulin (with or without OAD(s)) at baseline.
Maltese: F'SUSTAIN 6 (ara s-subsezzjoni Mard kardjovaskulari), 867 pazjent kienu fuq insulina mħallta (bi jew mingħajr OAD(s)) fil-linja bażi.
English: Five trials (SUSTAIN 1-5) had the glycaemic efficacy assessment as the primary objective, while one trial (SUSTAIN 6) had cardiovascular outcome as the primary objective.
Maltese: Ħames provi (SUSTAIN 1-5) kellhom evalwazzjoni ta' effikaċja gliċemika bħala l-objettiv primarju, filwaqt li prova waħda (SUSTAIN 6) kellha r-riżultat kardjovaskulari bħala l-objettiv primarju.
English: Each pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg.
Maltese: Kull pinna fiha 1.5 ml ta' soluzzjoni, li tforni 4 dożi ta' 0.25 mg.
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1251/002
Maltese: EU/1/17/1251/005 EU/1/17/1251/006
English: Overdoses of up to 4 mg in a single dose, and up to 4 mg in a week have been reported in clinical trials.
Maltese: Dożi eċċessivi sa 4 mg f'doża waħda, u sa 4 mg f'ġimgħa, ġew irrappurtati fil-provi kliniċi.
English: In a 30-week open-label comparator trial 1,089 patients were randomised to Ozempic 0.5 mg once weekly, Ozempic 1 mg once weekly, or insulin glargine once-daily on a background of metformin (48%) or metformin and sulfonylurea (51%).
Maltese: Fi prova open-label li damet 30 ġimgħa, b'komparatur, 1,089 pazjent ntgħażlu b'mod każwali biex jieħdu Ozempic 0.5 mg darba kull ġimgħa, Ozempic 1 mg darba kull ġimgħa, jew insulin glargine darba kuljum, fuq sfond ta' metformin (48%) jew metformin u sulfonylurea (51%).
English: Table 6 SUSTAIN 4: Results at week 30
Maltese: Tabella 4 SUSTAIN 7:
English: Semaglutide lowered high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose dependent manner.
Maltese: Semaglutide baxxa konċentrazzjonijiet għolja ta' glucose tad-demm billi stimula s-sekrezzjoni talinsulina u baxxa s-sekrezzjoni tal-glucagon b'mod dipendenti fuq il-glucose.
English: Ozempic N (%)
Maltese: N (%)
English: At week 30, the change in HbA1c was -1.3%, -1.8% and0.4% for Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively.
Maltese: F'ġimgħa 30, il-bidla fl-HbA1c kienet -1.3%,-1.8% u -0.4% għal Ozempic 0.5 mg, Ozempic 1 mg, u plaċebo, rispettivament.
English: Clear and colourless or almost colourless, isotonic solution; pH=7.4.
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni) Soluzzjoni isotonika, ċara u mingħajr kulur jew kważi mingħajr kulur; pH=7.4.
English: Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.
Maltese: Semaglutide jaġixxi bħala agonist tar-riċetturi ta' GLP-1 li selettivament jintrabat ma' u jattiva r-riċettur ta' GLP-1, il-mira għal GLP-1 nattiv.
English: 1.5 ml or 3 ml glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) inserted.
Maltese: Skartoċċ tal-ħġieġ ta' 1.5 ml jew 3 ml (ħġieġ ta' tip I) magħluq f'tarf wieħed bi planġer tal-gomma (chlorobutyl) u fit-tarf l-ieħor b'għatu tal-aluminju b'folja laminata tal-gomma (bromobutyl/polyisoprene) imdaħħla.
English: In a 56-week active-controlled double-blind trial, 1,231 patients were randomised to Ozempic 0.5 mg once weekly, Ozempic 1 mg once weekly or sitagliptin 100 mg once daily, all in combination with metformin (94%) and/or thiazolidinediones (6%).
Maltese: Fi prova li damet 56 ġimgħa, ikkontrollata b'mod attiv, double-blind, 1,231 pazjenti ntgħażlu b'mod każwali biex jieħdu Ozempic 0.5 mg darba kull ġimgħa, Ozempic 1 mg darba kull ġimgħa jew sitagliptin 100 mg darba kuljum, kollha flimkien ma' metformin (94%) u/jew thiazolidinediones (6%).
English: Each pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.
Maltese: Kull pinna fiha 1.5 ml ta' soluzzjoni, li tforni 4 dożi ta' 0.5 mg.
English: Ozempic can be administered with needles up to a length of 8 mm.
Maltese: Ozempic jista' jingħata b'labar b'tul sa 8 mm.
English: At week 30, the change in HbA1c was -1.6%, -1.5% and 0.1% for Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively.
Maltese: F'ġimgħa 30, il-bidla fl-HbA1c kienet -1.6%,-1.5% u 0.1% għal Ozempic 0.5 mg, Ozempic 1 mg, u plaċebo, rispettivament.
English: Semaglutide had a beneficial effect on plasma lipids, lowered systolic blood pressure and reduced inflammation in clinical studies.
Maltese: Semaglutide kellu effett benefiku fuq il-lipidi fil-plażma, naqqas il-pressjoni sistolika tad-demm u naqqas l-infjammazzjoni fl-istudji kliniċi.
English: Age had no effect on the pharmacokinetics of semaglutide based on data from phase 3a studies including patients of 20-86 years of age.
Maltese: L-età ma kellha l-ebda effett fuq il-farmakokinetika ta' semaglutide ibbażat fuq dejta minn studji ta' fażi 3a, li kienu jinkludu pazjenti tal-20-86 sena.
English: These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones, sulfonylureas) or insulin.
Maltese: Dawn il-mediċini l-oħra jistgħu jinkludu: antidijabetiċi orali (bħal metformin, thiazolidinediones, sulfonylureas) jew insulina.
English: Non-lethal thyroid C-cell tumours observed in rodents are a class effect for GLP-1 receptor agonists.
Maltese: It-tumuri mhux letali taċ-ċelluli Ċ tat-tirojde li kienu osservati f'annimali gerriema huma effett ta' klassi għal agonisti tar-riċetturi ta' GLP-1.
English: Talk to your doctor for further information.
Maltese: Kellem lit-tabib tiegħek għal aktar informazzjoni.
English: The findings coincided with marked maternal body weight loss of up to 16%.
Maltese: Issejbiet ikkoinċidew ma' telf notevoli fil-piż tal-ġisem tal-omm sa 16%.
English: Postnatal growth and development were evaluated in cynomolgus monkeys.
Maltese: It-tkabbir u l-iżvilupp wara t-twelid ġew evalwati f'xadini cynomolgus.
English: Ozempic 1 mg solution for injection
Maltese: Ozempic 1 mg soluzzjoni għall-injezzjoni
English: After the first use of the pen, store below 30°C.
Maltese: Wara l-ewwel użu tal-pinna, aħżinha f'temperatura taħt 30°C.
English: Each dose contains 0.25 mg of semaglutide in 0.19 ml.
Maltese: Kull doża fiha 0.25 mg ta' semaglutide f'0.19 ml.
English: Hypoglycaemiaa when used with insulin or sulfonylurea
Maltese: Ipogliċemija a meta jintuża ma' insulina jew sulfonylurea
English: Mechanistic evaluations indicated that the embryotoxicity involved a GLP-1 receptor mediated impairment of the nutrient supply to the embryo across the rat yolk sac.
Maltese: Evalwazzjonijiet mekkanistiċi indikaw li l-embrijotossiċità kienet tinvolvi indeboliment medjat minn riċetturi ta' GLP-1 tal-provvista tan-nutrijenti għall-embriju matul il-yolk sac tal-far.
English: • reflux or heartburn - also called ‘gastro-esophageal reflux disease' (GERD)
Maltese: • rifluss jew ħruq ta' stonku - li jissejjaħ ukoll ‘marda tar-rifluss gastroesofageali' (GERD,
English: Body weight
Maltese: SUSTAIN 5
English: 1 pre-filled pen and 4 disposable NovoFine Plus needles
Maltese: Pinna 1 mimlija għal-lest u 4 labar NovoFine Plus li jintremew wara li jintużaw
English: • burping
Maltese: Kalundborg
English: Do not use this medicine after the expiry date which is stated on the pen label and carton after 'EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-pinna u l-kartuna wara ‘JIS'.
English: One ml solution for injection contains 1.34 mg semaglutide.
Maltese: Millilitru ta' soluzzjoni għall-injezzjoni fih 1.34 mg ta' semaglutide.
English: Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg).
Maltese: Semaglutide ma bidilx l-espożizzjoni totali jew is-Cmax ta' digoxin wara l-għoti ta' doża waħda ta' digoxin (0.5 mg).
English: Before first use: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: Your pen is a pre-filled dial-a-dose pen.
Maltese: Qatra ta' soluzzjoni tista' tidher fil-ponta tal-labra.
English: Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life (see section 5.2).
Maltese: Semaglutide għandu jitwaqqaf mill-inqas xahrejn qabel tqala ppjanata minħabba l-half-life twila (ara sezzjoni 5.2).
English: Figure 4 Forest plot: analyses of time to first occurrence of the composite outcome, its components and all cause death (SUSTAIN 6)
Maltese: Figura 4 Skema Forest: analiżi taż-żmien sal-ewwel okkorrenza tar-riżultat kompost, ilkomponenti tiegħu l-mewt mill-kawżi kollha (SUSTAIN 6)
English: -2.3b [-3.0, -1.5]a
Maltese: [-3.0, -1.5]a c
English: The frequencies of the adverse reactions are based on a pool of the phase 3a trials excluding the cardiovascular outcomes trial (see text below the table for additional details).
Maltese: Il-frekwenzi tar-reazzjonijiet avversi huma bbażati fuq grupp tal-provi ta' fażi 3a, ħlief il-prova tar-riżultati kardjovaskulari (ara t-test taħt ittabella għal dettalji addizzjonali).
English: The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide (see section 4.8).
Maltese: Ir-riskju ta' ipogliċemija jista' jitbaxxa permezz ta' tnaqqis fid-doża tas-sulfonylurea jew tal-insulina meta tinbeda l-kura b'semaglutide (ara sezzjoni 4.8).
English: Semaglutide did not change the overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner.
Maltese: Semaglutide ma bidlix l-espożizzjoni totali jew is-Cmax ta' R - u S-warfarin wara doża waħda ta' warfarin (25 mg), u l-effetti farmakodinamiċi ta' warfarin kif imkejla mill-proporzjon normalizzat internazzjonali (INR, international normalised ratio) ma ġewx affettwati b'mod klinikament rilevanti. Madankollu, mal-bidu tal-kura b'semaglutide f'pazjenti li jkunu qed jieħdu l-warfarin jew derivattivi oħra ta' coumarin, hu rakkomandat li l-monitoraġġ tal-INR (International Normalised Ratio) ikun frekwenti.
English: Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.
Maltese: Semaglutide ma bidlix l-espożizzjoni totali jew is-Cmax ta' metformin wara l-għoti ta' doża ta' 500 mg darbtejn kuljum fuq perjodu ta' 3.5 jiem.
English: Ozempic 0.5 mg solution for injection
Maltese: Ozempic 0.5 mg soluzzjoni għall-injezzjoni
English: Each dose contains 0.5 mg of semaglutide in 0.37 ml.
Maltese: Kull doża fiha 0.5 mg ta' semaglutide f'0.37 ml.
English: Figure 3 Kaplan-Meier plot of time to first occurrence of the composite outcome: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (SUSTAIN 6)
Maltese: Figura 3 Skema Kaplan-Meier taż-żmien sal-ewwel okkorrenza tar-riżultat kompost: mewt kardjovaskulari, infart mijokardijaku li ma jkunx fatali jew attakk ta' puplesija li ma tkunx fatali (SUSTAIN 6)
English: Table 4 SUSTAIN 7: Results at week 40 Semaglutide 0.5 mg
Maltese: Riżultati fl-40 ġimgħa Semaglutide 0.5 mg
English: Table 3 SUSTAIN 2: Results at week 56
Maltese: Tabella 3 SUSTAIN 2: Riżultati f'ġimgħa 56
English: This was observed in insulin-treated patients with known diabetic retinopathy.
Maltese: Dan kien osservat f'pazjenti kkurati bl-insulina li kellhom retinopatija dijabetika magħrufa.