FrancophonIA/ELRC3.0 huggingface dataset:
English: Shake for at least 15 seconds.
Maltese: Ħawwad għal tal-inqas 15-il sekonda.
English: The mean HbA1c was 8.1%.
Maltese: L-HbA1c medja kienet 8.1%.
English: Based on hypoglycaemic events that 1.
Maltese: Ibbażat fuq avvenimenti ipogliċemiċi li 1.
English: Table 1: Adverse reactions of Bydureon BCise identified from clinical studies
Maltese: Tabella 1: Reazzjonijiet avversi ta' Bydureon BCise identifikati minn studji kliniċi
English: Glycaemic control Bydureon BCise
Maltese: Kontroll glikimiku Bydureon BCise
English: Exenatide Placebo
Maltese: Exenatide Plaċebo
English: Bydureon contains the active substance exenatide.
Maltese: Bydureon fih is-sustanza attiva exenatide.
English: 9 (see section
Maltese: 9 (ara sezzjoni 4.4)
English: §nominal p-value <0.001.
Maltese: §valur p nominali <0.001.
English: Plasma/serum glucose
Maltese: Il-glukożju fil-plażma/serum
English: Beta-cell function
Maltese: Il-funzjoni taċ-ċellula beta
English: After a standard meal tolerance test.
Maltese: Wara test ta' tolleranza ta' ikla normali.
English: Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Maltese: Mediċini użati fid-dijabete, analogi ta' glucagon-like peptide-1 (GLP-1), Kodiċi ATC:
English: Event Rate HR (95% CI)1
Maltese: HR (95% CI)1
English: Date of first authorisation: 17 June 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Ġunju 2011
English: • Remove the needle cover and give the injection, see steps 4e to 4g
Maltese: • Taqla' l-għatu tal-labra u tieħu l-injezzjoni, ara passi 4e sa 4ġ
English: Abdominal distension Eructation
Maltese: Distensjoni addominali
English: Hypoglycaemia (without a sulphonylurea)
Maltese: Ipogliċemija (mingħajr sulphonylurea)
English: • Remove the blue cap of the needle, see step 1d
Maltese: • Taqla' t-tapp il-blu tal-labra, ara pass 1d
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi eċċipjenti, ara sezzjoni 6.1.
English: • loss of energy and strength
Maltese: • nuqqas ta' enerġija u saħħa
English: • hives
Maltese: • gass
English: Event Rate n (%)
Maltese: Rata ta' Episodji n (%)
English: STEP 4: Inject the Dose
Maltese: PASS 4: Injetta d-Doża
English: The mean BMI was 32.7 kg/m2 and the mean duration of diabetes was 13.1 years.
Maltese: Il-BMI medju kien 32.7 kg/m2 u t-tul medju tad-dijabete kien ta' 13.1 sena.
English: Figure 2: Forest Plot: Analysis of Primary and Secondary Endpoints (intent to treat patients)
Maltese: Figura 2: Plott Forest:
English: C. Check the suspension.
Maltese: Iċċekkja s-sospensjoni.
English: ≥30 to ≤59 mL/min/1.73 m2).
Maltese: kellhom indeboliment renali moderat (eGFR ≥30 sa ≤59 mL/min/1.73 m2).
English: • intestinal obstruction (blockage in intestine)
Maltese: • imblokk intestinali (sadd tal-imsaren)
English: Paediatric population Interaction studies with exenatide have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni b'exenatide twettqu biss f'adulti.
English: (This question relates to the steps shown in sections 3a to 3d).
Maltese: (Din il-mistoqsija hija relatata mal-passi murija fis-sezzjonijiet 3a sa 3d).
English: Dysgeusia
Maltese: Disgweżja
English: Orange connector
Maltese: Konnekter Oranġjo
English: Hold Upright
Maltese: Tapp Aħdar
English: STEP 2: Mix the medicine
Maltese: PASS 2: Ħallat il-mediċina
English: The primary safety (noninferiority) and efficacy (superiority) endpoint in EXSCEL was the time to first confirmed Major Adverse Cardiac Event (MACE): cardiovascular (CV)-related death, nonfatal myocardial infarction (MI) or nonfatal stroke.
Maltese: Il-punt tat-tmiem tas-sigurtà primarja (noninferjorità) u tal-effikaċja (superjorità) fl-EXSCEL kien iżżmien għall-ewwel Avveniment Kardijaku Avvers Maġġuri Kkonfermat (MACE, Major Adverse Cardiac Event): mewta relatata ma' episodju kardjovaskulari (CV), infart mijokardijaku (MI, myocardial infarction) mhux fatali jew puplesija mhux fatali.
English: A reduction in HbA1c was observed over the course of the trial with an overall treatment difference of -0.53% (prolonged-release exenatide vs. placebo).
Maltese: Tnaqqis fl-HbA1c ġie osservat tul il-kors tal-prova b'differenza fil-kura ġenerali ta' -0.53% (exenatide b'rilaxx prolongat vs. plaċebo).
English: WAIT
Maltese: STOP
English: Mean HbA1c (%)
Maltese: Medja ta' HbA1c (%)
English: Seconds
Maltese: Sekondi
English: Includes acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine.
Maltese: Tinkluldi insuffiċjenza akuta tal-kliew, insuffiċjenza tal-kliewi kronika aggravata, indeboliment tal-kliewi, żieda fil-kreatinina fis-seru.
English: active medicinal product (95 % CI)
Maltese: HR (95% CI)
English: Rate based on completed long-term safety and efficacy studies (n = 526), unless other indicated.
Maltese: Rata bbażata fuq studji tal-effikaċja u tas-sigurtà fit-tul ikkompletati (n = 526), sakemm mhux speċifikat mod ieħor.
English: Even mix
Maltese: Mhux komuni
English: *p-value < 0.01.
Maltese: p <0.01.
English: • Attach the needle, see step 4a
Maltese: • Twaħħal il-labra, ara pass 4a
English: The results of two studies with Bydureon BCise and six long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1766 subjects (556 treated with Bydureon BCise), 53% men and 47% women, 304 subjects (17%) were ≥ 65 years of age.
Maltese: Ir-riżultati ta' żewġ studji kliniċi b'Bydureon BCise u sitt studji kliniċi fit-tul ta' exenatide li jerħi lmediċina bil-mod huma murija hawn taħt; dawn l-istudji kienu jikkonsistu minn 1766 individwu (556 kkurati b'Bydureon BCise), 53% irġiel u 47% nisa, 304 individwi (17%) kellhom ≥ 65 sena.
English: Treatment with prolonged-release exenatide and dapagliflozin combination at Week 28 resulted in a significant mean change reduction of -4.3±0.8 mmHg in systolic blood pressure compared to prolonged-release exenatide alone of -1.2±0.8 mmHg (p<0.01) or to dapagliflozin alone of -1.8±0.8 mmHg (p<0.05).
Maltese: 3±0.8 mmHg fi pressjoni tad-demm sistolika meta mqabbel ma' exenatide li jerħi l-mediċina bil-mod waħdu ta' -1.2±0.8 mmHg (p<0.01) jew ma' dapagliflozin waħdu ta' -1.8±0.8 mmHg (p<0.05).
English: Vehicle Medium chain triglycerides (MCT)
Maltese: Veikolu Trigliċeridi b'katina medja (Medium chain triglycerides, MCT)
English: Insulin glargine was dosed to a target glucose concentration of 4.0 to 5.5 mmol/l (72 to 100 mg/dl).
Maltese: Insulina glargine ngħatat bħala doża għal konċentrazzjon ta' glukożju fil-mira ta' 4.0 sa 5.5 mmol/l (72 sa 100 mg/dl).
English: Last Observation Carried Forward (LOCF).
Maltese: L-Aħħar Osservazzjoni Mressqa Quddiem (LOCF).
English: Patients on pioglitazone gained weight (Table 6).
Maltese: Pazjenti fuq pioglitazone żdiedu fil-piż (Tabella 6).
English: VIAL LABEL
Maltese: Qoxra tal-karti
English: The two chambers are separated by a second chlorobutyl rubber piston.
Maltese: Iż-żewġ kompartimenti huma sseparati minn tieni pistun talgomma tal-chlorobutyl.
English: <-Exenatide favored
Maltese: <-Preferenza għal exenatide
English: Gender, race and body weight Gender, race and body weight have no clinically relevant influence on exenatide pharmacokinetics.
Maltese: Is-sess, ir-razza u l-piż tal-ġisem m'għandhom l-ebda influwenza klinikament relevanti fuq ilfarmakokinetika ta' exenatide.
English: No clinically relevant effects on Cmax or AUC were observed.
Maltese: Ma kien osservat ebda effett klinikament rilevanti fis-Cmax jew fl-AUC.
English: • Keep holding the pen against the skin for 15 seconds.
Maltese: • Kompli żomm il-pinna mal-ġilda għal 15-il sekonda.
English: Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total (patients on sulphonylurea n = 1002).
Maltese: Rata bbażata fuq tnax-il studju tal-effikaċja u tas-sigurtà fit-tul ikkompletati b'exenatide li jerħi l-mediċina bilmod. n= 2868 total, (pazjenti fuq sulphonylurea n= 1002).
English: Approximately 49.3% had mild renal impairment (estimated glomerular filtration rate [eGFR] ≥60 to ≤89 mL/min/1.73 m 2) and 21.6% had moderate renal impairment (eGFR
Maltese: Bejn wieħed u ieħor 49.3% kellhom indeboliment renali ħafif (rata ta' filtrazzjoni glomerulari stmata [eGFR] ≥60 sa ≤89 mL/min/1.73 m 2) u 21.6%
English: Decreased appetite
Maltese: Pożizzjoni Msakkra
English: Examination of antibody-positive specimens revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Maltese: Eżami ta' kampjuni pożittivi għall-antikorpi ma wera l-ebda reattività sinifikanti għall-peptidi endoġeni simili (glucagon jew GLP-1).
English: What Bydureon contains - The active substance is exenatide.
Maltese: X'fih Bydureon - Is-sustanza attiva hi exenatide.
English: Approximately 49.3% had mild renal impairment (estimated glomerular filtration rate [eGFR] ≥60 to ≤89 mL/min/1.73 m2) and 21.6% had moderate renal impairment (eGFR
Maltese: Bejn wieħed u ieħor 49.3% kellhom indeboliment renali ħafif (rata ta' filtrazzjoni glomerulari stmata [eGFR] ≥60 sa ≤89 mL/min/1.73 m2) u 21.6%
English: The most frequent adverse reactions during the clinical studies were gastrointestinal-related (mainly nausea (8 %), which tended to dissipate with continued treatment), headache (4 %) and injection site reactions, such as injection site pruritus (3 %) and injection site erythema (2 %).
Maltese: L-aktar reazzjonijiet avversi frekwenti tal-mediċina waqt l-istudji kliniċi kienu dawk gastrointestinali (l-aktar tqalligħ (8%), li kellha tendenza li titnaqqas b'kura kontinwa), uġigħ ta' ras (4%) u reazzjonijiet fis-sit tal-injezzjoni, bħal pruritu fis-sit tal-injezzjoni (3%) u eritema fis-sit tal-injezzjoni (2%).
English: In clinical studies of Bydureon BCise, acute pancreatitis occurred in 0.4% of patients.
Maltese: Fl-istudji kliniċi ta' Bydureon BCise, pankreatite akuta ġiet osservata f'0.4% tal-pazjenti.
English: Overall, the level of glycaemic control (HbA1c) was comparable to that observed in those without antibody titres.
Maltese: In ġenerali, il-livell tal-kontroll gliċemiku (HbA1c) kien simili għal dak osservat f'dawk li ma kellhomx l-antikorpi.
English: Frequency reported from the 28-week controlled treatment period of the prolonged-release exenatide as add-on to insulin glargine study (N=231).
Maltese: Frekwenza rrappurtata mill-perjodu ta' kura kkontrollat ta' 28 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod bħala żieda mal-istudju tal-insulin glargine (N=231).
English: (This question relates to step 4a.)
Maltese: (Din il-mistoqsija hija relatata ma' pass 4a.)
English: Frequency of occurrence
Maltese: Rata ta' Episodji
English: Tap!
Maltese: Taptap!
English: Hydroxy methyl glutaryl coenzyme A reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and tmax was delayed about 4 h when immediate-release exenatide was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Maltese: Inibituri ta' hydroxy methyl glutaryl coenzyme A reductase L-AUC u s-Cmax ta' lovastatin tnaqqsu b'madwar 40% u 28%, rispettivament u kien hemm dewmien ta' madwar 4 sigħat fit-tmax meta exenatide li jerħi l-mediċina b'mod immedjat ingħata flimkien ma' doża waħda ta' lovastatin (40 mg) meta mqabbel mat-teħid ta' lovastatin waħdu.
English: The need for additional antihyperglycaemic medication was reduced by 33% % with the prolongedrelease exenatide group (exposure-adjusted incidence of 10.5 per 100 pt-year) compared to the placebo group (exposure-adjusted incidence of 15.7 per 100 pt-year).
Maltese: Il-ħtieġa għal medikazzjoni anti-ipergliċemika addizzjonali tnaqqset bi 33% bil-grupp ta' exenatide b'rilaxx prolongat (inċidenza aġġustata għall-espożizzjoni ta' 10.5 għal kull 100 pt-sena) meta mqabbel mal-grupp ta' plaċebo (inċidenza aġġustata għall-espożizzjoni ta' 15.7 għal kull 100 pt-sena).
English: Patients on pioglitazone gained weight (Table 4).
Maltese: Pazjenti fuq pioglitazone żdiedu fil-piż (Tabella 4).
English: For more information, please see Figure N in Step 3B in the Instructions for the User.
Maltese: Għal aktar informazzjoni, jekk jogħġbok ara Figura N f'Pass 3B fl-Istruzzjonijiet għall-Utent.
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2 ºC - 8 ºC).
English: Renal and urinary disorders Altered renal function
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Tibdil fil-funzjoni renali
English: Overall, 26.9% of patients did not have any prior CV event, 73.1% had at least one prior CV event.
Maltese: B'kollox, 26.9% talpazjenti ma kellhom ebda episodju CV preċedenti, 73.1% kellhom għallinqas episodju CV preċedenti wieħed.
English: Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with a sulphonylurea)
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipogliċemija (b'sulphonylurea)
English: The vital status was known at the end of the study for 98.9% and 98.8% of the patients in the prolonged-release exenatide and placebo group, respectively.
Maltese: L-istatus vitali kien magħruf fit-tmiem tal-istudju għal 98.9% u 98.8% tal-pazjenti fil-grupp ta' exenatide b'rilaxx prolongat u fil-grupp ta' plaċebo rispettivament.
English: Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Maltese: Studji mhux kliniċi wrew li fil-parti l-kbira tiegħu exenatide jiġi eliminat permezz tal-filtrazzjoni glomerulari u sussegwentement b'degradazzjoni proteolitika.
English: Overall, the level of glycaemic control (HbA1c) in patients treated with Bydureon BCise with low titre antibodies at the last visit (-1.1% to -1.5%) was comparable to that observed in those without antibody titres (-1.1% to -1.4%).
Maltese: B'mod ġenerali, illivell tal-kontroll gliċemiku (HbA1c) f'pazjenti kkurati b'Bydureon BCise b'livell baxx ta' antikorpi flaħħar vista (-1.1% sa -1.5%) kien komparabbli għal dak osservat f'dawk mingħajr livelli ta' antikorpi (-1.1% sa -1.4%).
English: Prolonged-release exenatide 2 mg + Insulin glargine
Maltese: Exenatide 2 mg li jerħi l-mediċina bil-mod + Insulina glargine
English: Administration of the oral contraceptive 35 minutes after exenatide did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Maltese: L-għoti tal-kontraċettiv orali 35 minuta wara exenatide m'affettwax l-AUC iżda rriżulta fi tnaqqis fis-Cmax ta' ethinyl estradiol b'45%, u fis-Cmax ta' levonorgestrel b'27-41%, u kien hemm dewmien ta' 2-4 sigħat fit-tmax minħabba dewmien fl-iżvojtar tal-istonku.
English: - The other ingredients are: - In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
Maltese: - Fit-trab: poly (D, L-lactide-co-glycolide) u sucrose.
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Maltese: L-għoti ta' kontraċettiv orali kkombinat (30 µg ethinyl estradiol flimkien ma' 150 µg levonorgestrel) siegħa qabel exenatide li jerħi b'mod immedjat ma biddel l-AUC, is-Cmax jew is-Cmin la ta' ethinyl estradiol u lanqas ta' levonorgestrel.
English: Frequencies reported in pooled data from the controlled periods of the two phase 3 clinical studies (n = 410).
Maltese: Frekwenzi rrappurtati f'data miġbura mill-perjodi kkontrollati taż-żewġ studji kliniċi ta' fażi 3 (n = 410).
English: Multi-pack of 3 x (4 single dose kits).
Maltese: Pakkett multiplu ta' 3 x (4 settijiet ta' doża waħda).
English: However, as renal function generally declines with age, consideration should be given to the patient's renal function (see Renal impairment) (see section 5.2).
Maltese: Madankollu, minħabba li l-funzjoni renali tonqos bl-età, wieħed irid joqgħod attent għall-funzjoni renali tal-pazjent (ara Indeboliment renali) (ara sezzjoni 5.2).
English: CARTON - 4 SINGLE-DOSE KITS
Maltese: KARTUNA - 4 settijiet ta' doża waħda
English: D. Inject the medicine.
Maltese: Injetta l-mediċina.
English: No clinically meaningful differences were observed in steady state exenatide concentrations or tolerability in patients with mild to moderate renal impairment (eGFR 30 to 89 ml/min/1.73m receiving Bydureon BCise, compared to those with normal renal function.
Maltese: Ma ġiet osservata l-ebda differenza klinikament sinifikanti fil-konċentrazzjonijiet ta' exenatide fi stat fiss jew it-tolerabilità f'pazjenti b'indeboliment renali ħafif sa moderat (eGFR 30 sa 89 ml/min/1.73m2) li rċivew Bydureon BCise, meta mqabbel ma' dawk b'funzjoni renali normali.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2°C sa 8°C)..
English: Remove 1 pen from the refrigerator and rest it flat for 15 minutes.
Maltese: Neħħi pinna 1 mill-friġġ u ħalliha ċatta għal 15-il minuta.
English: A total of 14,752 patients were randomised 1:1 to either prolonged-release exenatide 2 mg once weekly or placebo, added to the current usual care which could include SGLT2 inhibitors.
Maltese: Total ta' 14,752 pazjent ġew randomizzati 1:1 għal jew exenatide 2 mg b'rilaxx prolongat darba fil-ġimgħa jew għal plaċebo, miżjuda mal-kura normali attwali li tista' tinkludi wkoll inibituri SGLT2.
English: In a pharmacokinetic study of immediate-release exenatide in patients with type 2 diabetes, administration of exenatide (10 mcg) resulted in a mean increase of exenatide AUC by 36% in 15 elderly subjects aged 75 to 85 years compared to 15 subjects aged 45 to 65 years likely related to reduced renal function in the older age group (see section 4.2).
Maltese: Fi studju farmakokinetiku ta' exenatide li jerħi l-mediċina b'mod immedjat f'pazjenti bid-dijabete ta' tip 2, l-għoti ta' exenatide (10 mcg) irriżulta f'żieda medja ta' 36% fl-AUC ta' exenatide fi 15-il suġġett anzjan ta' età bejn 75 u 85 sena meta mqabbel ma' 15-il suġġett ta' età bejn 45 u 65 sena li aktarx huwa relatat ma' tnaqqis fil-funzjoni renali fil-grupp aktar anzjan (ara sezzjoni 4.2).
English: The pen contains an integrated needle.
Maltese: Il-pinna fiha labra integrata.
English: Solvent for Bydureon
Maltese: Solvent għal Bydureon
English: The reduction in Cmax is of limited clinical relevance and no adjustment of dosing of oral contraceptives is required.
Maltese: Ir-rilevanza klinika tat-tnaqqis fis-Cmax hija minima u m'hemmx bżonn ta' tnaqqis fid-doża tal-kontraċettivi orali.
English: How do I know I gave myself the full dose of medicine?
Maltese: Kif inkun naf li l-mediċina hija mħallta sew?
English: While patients with high titre antibodies at the last visit had an attenuated HbA1c response, HbA1c reductions in these patients were clinically relevant (-0.6% to -0.7%).
Maltese: Filwaqt li pazjenti b'livelli għoljin ta' antikorpi fl-aħħar vista kellhom rispons għal HbA1c attenwat, it-tnaqqis fl-HbA1c f'dawn il-pazjenti kien klinikament rilevanti (-0.6% sa -0.7%).
English: Overall, 9.3% of patients treated with Bydureon BCise reported nausea during the controlled period of both clinical studies.
Maltese: B'mod ġenerali, 9.3% tal-pazjentikkurati b'Bydureon BCise rrapportaw tqalligħ matul il-perjodu kkontrollat taż-żewġ studji kliniċi.
English: Thigh
Maltese: Tajjeb
English: Mean HbA1c (%) Baseline
Maltese: HbA1c medja (%) Linja bażi
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, non-steroidal anti-inflammatory medicinal products and diuretics.
Maltese: Prodotti mediċinali li ttieħdu flimkien kienu jinkludu l-inibituri tal-enzimi li jikkonvertu anġjotensin, l-antagonisti ta' anġjotensin-II, prodotti mediċinali antiinfjammatorji li mhumiex sterojdi u d-dijuretiċi.
English: The “Instructions for the User”, provided in the carton, must be followed carefully.
Maltese: “L-Istruzzjonijiet għallUtent”, li hemm ipprovduti fil-kaxxa, għandhom jiġu segwiti bir-reqqa.
English: Vial connector
Maltese: Konnekter tal-kunjett (vial connector)
English: It will be easier to mix the medicine if the pen is at room temperature.
Maltese: Ikun aktar faċli li tħallat il-mediċina jekk il-pinna tkun f'temperatura ambjentali.
English: ACS=acute coronary syndrome; CI=confidence interval; CV=cardiovascular; HF=heart failure; HR=hazard ratio; MACE=major adverse cardiac event; MI=myocardial infarction; n=number of patients with an event; N=number of patients in treatment group.
Maltese: HF=kollass tal-qalb; HR=proporzjon ta' periklu; MACE=episodju kardijaku avvers maġġuri;
English: • has a lid,
Maltese: • għandu għatu,
English: Macular or papular rash
Maltese: Raxx makulari jew papulari
English: Prolonged-release exenatide was associated with a significantly lower incidence of episodes of hypoglycaemia than basal insulin in patients also receiving metformin therapy (3% versus 19%) and in patients also receiving metformin plus sulphonylurea therapy (20% versus 42%).
Maltese: Exenatide li jerħi l-mediċina bil-modkien assoċjat ma' tnaqqis sinifikanti fl-inċidenza ta' episodji ta' ipogliċemija meta mqabbel ma' insulin basali f'pazjenti li kienu qed jirċievu wkoll it-terapija b'metformin (3% kontra 19%) u f'pazjenti li kienu qed jirċievu wkoll it-terapija b'metformin flimkien mas-sulphonylurea (20% kontra 42%).
English: Bydureon 2 mg powder for injection exenatide
Maltese: Bydureon 2 mg trab għall-injezzjoni exenatide
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: Għal riżultati tal-istudju fir-rigward tal-kombinazzjonijiet, effetti fuq il-kontroll gliċemiku u avvenimenti kardjovaskulari u l-popolazzjonijiet studjati, ara s-sezzjonijiet 4.4, 4.5 u 5
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to  1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: 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: Do not over tighten.
Maltese: Tissikkax iżżejjed.
English: Clinical experience in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min) is limited (see section 5.2).
Maltese: L-esperjenza klinika f'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina bejn 30 sa 50 ml/min) hija limitat (ara sezzjoni 5.2).
English: The incidence of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea (24.0% versus 5.4%) (see section 4.4).
Maltese: L-inċidenza tal-ipogliċemija żdiedet meta exenatide li jerħi l-mediċina bil-mod intuża flimkien ma' xi sulphonylurea (24.0% kontra 5.4%) (ara sezzjoni 4.4).
English: Rare side effects • feeling jittery
Maltese: Effetti sekondarji rari • tħossok nervuż
English: Patients were followed as in routine clinical practice for a median of 38.7 months with a median treatment duration of 27.8 months.
Maltese: Il-pazjenti ġew segwiti bħal fi prattika klinika ta' rutina għal medja ta' 38.7 xhur b'tul ta' kura medjana ta' 27.8 xhur.
English: Remove one pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
Maltese: Oħroġ pinna waħda mill-friġġ u ħalliha toqgħod f'temperatura ambjentali għal tal-inqas 15-il minuta.
English: The dose of a sulphonylurea may require adjustment due to the increased risk of hypoglycaemia associated with sulphonylurea therapy (see sections 4.2 and 4.4).
Maltese: Id-doża ta' sulphonylurea jaf tkun teħtieġ aġġustament minħabba ż-żieda fir-riskju ta' ipogliċemija assoċjata ma' terapija bis-sulphonylurea (ara sezzjonijiet 4.2 and 4.4).
English: Insulin glargine was dosed targeting a fasting plasma glucose of 4.0 to 5.5 mmol/l (72 to 99 mg/dl).
Maltese: L-insulina glargine kienet iddożata mmirata lejn il-glukożju fil-plażma fi stat sajjem ta' 4.0 sa 5.5 mmol/l (72 sa 99 mg/dl).