FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines.
Maltese: Barra minn hekk, il-kanċer telaq parzjalment jew kompletament f'79 % tal-pazjenti kkurati bil-kombinazzjoni ta' Empliciti meta mqabbel ma' 66 % tal-pazjenti kkurati biż-żewġ mediċini l-oħra.
English: Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow).
Maltese: Empliciti huwa mediċina li tintuża għall-kura ta' mijeloma multipla (kanċer tal-mudullun).
English: Treatment is given in 28-day cycles.
Maltese: Il-kura tingħata f'ċikli ta' 28 jum.
English: To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion.
Maltese: Sabiex jiġu evitati r-reazzjonijiet għall-infużjoni, il-pazjent jingħata mediċina antiinfjammatorja, antistamina u paraċetamol qabel kull infużjoni.
English: How is Empliciti used?
Maltese: Empliciti?
English: The average time before the disease got worse was 18.5 months in patients treated with the Empliciti combination compared with 14.3 months in those treated with just lenalidomide and dexamethasone.
Maltese: Iż-żmien medju qabel ma l-marda marret għall-agħar kien 18.5 xhur f'pazjenti kkurati bil-kombinazzjoni ta' Empliciti meta mqabbel ma' 14.3 xhur f'dawk ikkurati b'lenalidomide u dexamethasone biss.
English: As for all medicines, data on the use of Empliciti are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Empliciti hija ssorveljata kontinwament.
English: The active substance in Empliciti, elotuzumab, is a monoclonal antibody that attaches to SLAMF7, a protein on immune cells, causing the cells to attack the multiple myeloma cancer cells and thereby slow down the disease.
Maltese: Is-sustanza attiva f'Empliciti, l-eletużumab, hija antikorp monoklonali li jeħel ma' SLAMF7, proteina fuq iċ-ċelloli immuni, u dan jikkawża liċ-ċelloli biex jattakkaw iċ-ċelloli tal-kanċer tal-mijeloma multipla u b'hekk titnaqqas il-veloċità tal-marda.
English: A second main study involved 117 multiple myeloma patients who had received at least two other treatments previously, including a proteasome inhibitor and lenalidomide.
Maltese: It-tieni studju ewlieni involva 117-il pazjent b'mijeloma multipla li fil-passat kienu rċevew minn talinqas żewġ kuri oħrajn, inkluż inibitur tal-proteasome u lenalidomide.
English: For the full list of side effects and restrictions of Empliciti, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Empliciti, ara l-fuljett ta' tagħrif.
English: Patients treated with a combination of Empliciti plus pomalidomide and dexamethasone lived on average for over 5.5 months longer without their disease getting worse compared with patients treated with pomalidomide and dexamethasone.
Maltese: Il-pazjenti kkurati b'kombinazzjoni ta' Empliciti flimkien ma' pomalidomide u dexamethasone għexu medja ta' aktar minn 5.5 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' pazjenti kkurati b'pomalidomide u dexamethasone.
English: Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells.
Maltese: L-elotużumab teħel ukoll ma' SLAMF7 fuq iċ-ċelluli tal-kanċer, u dan jagħmilhom aktar vulnerabbli għall-attakk miċ-ċelloli immuni.
English: In patients who had already been treated with at least two treatments including a proteasome inhibitor and lenalidomide (and the treatment had not worked or the disease had come back), Empliciti plus pomalidomide and dexamethasone delayed worsening of the disease, compared with just pomalidomide and dexamethasone.
Maltese: F'pazjenti li kienu diġà ġew ikkurati b'minn tal-inqas żewġ kuri li jinkludu inibitur tal-proteasome u lenalidomide (u l-kura ma kinitx ħadmet jew ilmarda reġgħet feġġet), Empliciti flimkien ma' pomalidomide u dexamethasone ttardjaw iddeterjorament tal-marda, meta mqabbla ma' pomalidomide u dexamethasone biss.
English: It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Maltese: Dan jintuża flimkien ma' żewġ mediċini oħra (lenalidomide u dexamethasone) u jingħata lill-adulti li fil-passat ikunu rċevew tal-inqas kura waħda kontra l-kanċer.
English: Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Empliciti huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland
Maltese: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare L-Irlanda
English: Digoxin, lisinopril and warfarin
Maltese: Digoxin, lisinopril u warfarin
English: See Table 2.
Maltese: Ara Tabella 2.
English: 60 doses (2.4 ml)
Maltese: 60 doża (2.4 ml)
English: System organ class /adverse reaction terms
Maltese: Sistema tal-klassifika tal-organi/termini tarreazzjonijiet avversi
English: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA United Kingdom
Maltese: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA Ir-Renju Unit
English: 60 doses (1.2 ml)
Maltese: 60 doża (1.2 ml)
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2006 Data tal-aħħar tiġdid: 22 ta' Lulju 2016
English: Gärtunaporten (B 674:5) SE-151 85 Södertälje Sweden
Maltese: Gärtunaporten (B 674:5) SE-151 85 Södertälje L-Iżvezja
English: 6.1 List of excipients metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections
Maltese: 6.1 Lista ta' eċċipjenti metacresol mannitol glacial acetic acid sodium acetate trihydrate ilma għall-injezzjonijiet
English: Metformin or sulphonylureas
Maltese: Metformin jew sulphonylureas
English: The injection is complete when:
Maltese: L-injezzjoni tkun kompleta meta:
English: Rare Very rare Not known
Maltese: Rari ħafna
English: Mannitol, glacial acetic acid, sodium acetate trihydrate, water for injections.
Maltese: Mannitol, glacial acetic acid, sodium acetate trihydrate, ilma għall-injezzjonijiet.
English: There have been spontaneously reported events of acute pancreatitis with exenatide.
Maltese: Ġew irrapportati avvenimenti spontanji ta' pankreatite akuta b'exenatide.
English: Solution for injection 1 pen (60 doses) 3 pens (3 x 60 doses)
Maltese: Soluzzjoni għall-injezzjoni Pinna 1 (60 doża) 3 pinen (3 x 60 doża)
English: Byetta contains the active substance exenatide.
Maltese: Byetta fih is-sustanza attiva exenatide.
English: Two strengths of Byetta are available: Byetta 5 micrograms and Byetta 10 micrograms.
Maltese: Byeta hija disponibbli f'żewġ dożi: Byetta 5 mikrogrammi u Byetta 10 mikrogrammi.
English: Pharmacotherapeutic group: Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Maltese: Analogi glucagon-like-peptide-1 (GLP-1), Kodiċi ATC:
English: - The active substance is exenatide.
Maltese: - Is-sustanza attiva huwa exenatide.
English: Byetta 10 mcg injection exenatide
Maltese: Byetta 10 mcg injezzjoni exenatide
English: Immediate-release exenatide lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Maltese: Exenatide b'rilaxx immedjat tnaqqas l-HbA1c minn 8.21 % (n=228) u 8.6 % (n=222) b'1.13 % u 1.01 % filwaqt li insulin glargine naqsu minn 8.24% (n=227) b'1.10% u insulin aspart bifażiku minn 8.67 % (n=224) b'0.86 %.
English: Byetta 5 mcg injection exenatide
Maltese: Byetta 5 mcg injezzjoni exenatide
English: Rate based on immediate-release exenatide completed long-term efficacy and safety studies n=5763 total (patients on sulphonylurea n=2971).
Maltese: n=5763 total, (pazjenti fuq sulphonylurea n=2971).
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 < 1/1,000), 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-dejta disponibbli).
English: When 1000 mg paracetamol was given with 10 mcg immediate-release exenatide (0 h) and 1 h, 2 h and 4 h after immediate-release exenatide injection, paracetamol AUCs were decreased by 21%, 23%, 24% and 14% respectively; Cmax was decreased by 37%, 56%, 54% and 41%, respectively; tmax was increased from 0.6 h in the control period to 0.9 h, 4.2 h, 3.3 h, and 1.6 h, respectively.
Maltese: Meta ngħataw 1000 mg paracetamol ma' 10 mcg exenatide b'rilaxx immedjat (0 sigħat) u siegħa 1, sagħtejn u 4 sigħat wara l-injezzjoni ta' exenatide b'rilaxx immedjat, l-AUCs ta' paracetamol naqsu b'21 %, 23 %, 24 % u 14 % rispettivament; Cmax naqas b'37 %, 56 %, 54 % u 41 %, rispettivament; tmax żdied minn 0.6 sigħat fil-perijodu ta' kontroll għal 0.9 sigħat, 4.2 sigħat, 3.3 sigħat, and 1.6 sigħat, rispettivament.
English: Becton, Dickinson and Company needles are suitable to use with the Byetta pen.
Maltese: Il-labar Becton, Dickinson u Company huma tajbin biex jintużaw mal-pinna Byetta.
English: The amino acid sequence of exenatide partially overlaps that of human GLP-1.
Maltese: Is-sekwenza tal-aminoaċidi ta' exenatide tikkoinċidi parzjalment ma' dik ta' GLP-1 uman.
English: Immediate-release exenatide has shown no adverse effects on lipid parameters.
Maltese: Exenatide b'rilaxx immedjat ma weriex effetti avversi fuq il-parametri tal-lipidi.
English: How can I tell when the injection is complete?
Maltese: Kif inkun naf li l-injezzjoni tkun kompleta?
English: Beta-cell function
Maltese: Il-funzjoni taċ-ċelluli beta
English: Table 1: Adverse reactions of immediate-release exenatide identified from clinical trials and spontaneous reports
Maltese: Tabella 1: Reazzjonijiet avversi ta' exenatide b'rilaxx immedjat identifikati minn provi kliniċi u rapporti spontanji
English: Gender and race Gender and race have no clinically relevant influence on exenatide pharmacokinetics.
Maltese: Is-sess u r-razza m'għandhom l-ebda influwenza klinikament relevanti fuq il-farmakokinetika ta' exenatide.
English: The clinical studies comprised 3945 subjects (2997 treated with exenatide), 56% men and 44% women, 319 subjects (230 treated with exenatide) were ≥ 70 years of age and 34 subjects (27 treated with exenatide) were ≥ 75 years of age.
Maltese: L-istudji kliniċi kienu kostitwiti minn 3945 suġġett (2997 fuq kura ta' exenatide), 56% rġiel u 44% nisa, 319-il suġġett (230 fuq kura ta' exenatide) kienu ≥70 sena u 34 suġġett (27 fuq kura ta' exenatide) kienu ≥75 sena.
English: IU/day, range 3-78 IU/day, at the end of study).
Maltese: IU/ġurnata, medda ta' 3-78 IU/ġurnata, fi tmiem l-istudju).
English: Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Maltese: Kull doża fiha 44 mcg metacresol.
English: The mean age of subjects was 59 years and the mean duration of diabetes was 12.3 years.
Maltese: L-età medja tal-pazjenti kienet 59 sena u n-numru medju ta' snin ta' dijabete kien ta' 12.3 snin.
English: • Do not use Byettaafter the expiry date, which is stated on the label and the carton after ‘EXP'.
Maltese: • Tużax Byetta wara d-data ta' skadenza li tidher fuq it-tikketta u fuq il-kartuna wara ‘EXP'.
English: Baseline HbA1c (%) HbA1c (%) change from base line
Maltese: Linja bażi ta' HbA1c(%) 8.48 Bidla f'HbA1c(%) millinja bażi
English: • loss of energy and strength
Maltese: • nuqqas ta' enerġija u ta' saħħa
English: Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that exhibits several antihyperglycaemic actions of glucagon-like peptide-1 (GLP-1).
Maltese: Exenatide huwa agonist tar-riċettur glucagon-like peptide-1 (GLP-1) li juri diversi azzjonijiet kontra lipergliċemija li juri glucagon-like peptide-1 (GLP-1).
English: Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres (mcl), (0.25 mg exenatide per ml).
Maltese: Kull doża fiha 5 mikrogrammi (mcg) ta' exenatide f'20 mikrolitru (mcl), (0.25 mg exenatide kull ml).
English: The proportion of patients achieving HbA1c < 7% was 47.9% with immediate-release exenatide and 42.8% with insulin lispro.
Maltese: Il-proporzjon ta' pazjenti li laħqu HbA1c < 7% kien 47.9% b'exenatide b'rilaxx immedjat u 42.8% b'insulin lispro.
English: Byetta 10 mcg: Each dose contains 88 mcg metacresol.
Maltese: Kull doża fiha 88 mcg metacresol.
English: Each dose contains 10 micrograms exenatide.
Maltese: Kull doża fiha 10 mikrogrammi ta' exenatide.
English: • When it is time for your next routine dose, go to Section3, Step 1, and repeat Steps 1 -7.
Maltese: • Meta jasal il-waqt għad-doża ta' rutina li jmiss, mur f'Sezzjoni 3, Proċedura 1, u rrepeti lProċeduri 1 - 7.
English: - Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
Maltese: - Kull millilitru (ml) ta' soluzzjoni għall-injezzjoni fih 0.25 milligrammi (mg) ta' exenatide.
English: (See section 3 “How to use Byetta”).
Maltese: (Ara sezzjoni 3 “Kif għandek tuża Byetta).
English: Pack size of 1 and 3 pens.
Maltese: Id-daqsijiet tal-pakketti huma ta' pinna 1 u ta' 3 pinen.
English: In patients treated with 5 mcg or 10 mcg immediate-release exenatide, 36% reported at least one episode of nausea.
Maltese: F'pazjenti kkurati b'5 mcg jew b'10 mcg exenatide b'rilaxx immedjat, ġeneralment 36% irrapportaw mill-anqas episodju wieħed ta' tqalligħ.
English: • hypoglycaemia
Maltese: • ipogliċemija
English: Hydroxy Methyl Glutaryl Coenzyme A (HMG CoA) reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and tmax was delayed about 4 h when immediate-release exenatide (10 mcg BID) was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Maltese: Inibituri ta' Hydroxy Methyl Glutaryl Coenzyme A (HMG CoA) reductase L-AUC u Cmax ta' lovastatin naqsu b'madwar 40 % u 28 %, rispettivament, u kien hemm dewmien ta' madwar 4 sigħat f'tmax meta exenatide b'rilaxx immedjat (10 mcg BID) ingħata fl-istess waqt ma' doża waħda ta' lovastatin (40 mg) mqabbel ma' meta lovastatin ingħata waħdu.
English: Weight loss of 2.6 kg from a baseline of 89.9 kg was observed with immediate-release exenatide whereas a weight gain of 1.9 kg from a baseline of 89.3 kg was observed with insulin lispro.
Maltese: Ġie osservat telf fil-piż ta' 2.6 kg minn linja bażi ta' 89.9 kg b'exenatide b'rilaxx immedjat filwaqt li ġie osservat żieda ta' 1.9 kg fil-piż minn linja bażi ta' 89.3 kg b'insulin lispro.
English: In a pharmacokinetic study 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: F'studju farmakokinetiku 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 84 sena meta mqabbel ma' 15-il suġġett ta' età bejn 45 u 65 sena u dan wisq probabbli minħabba t-tnaqqis fil-funzjoni renali fil-grupp aktar anzjan (ara sezzjoni 4.2).
English: Also contains metacresol.
Maltese: Fih ukoll metacresol.
English: Spontaneous reports data (unknown denominator)
Maltese: Dejta minn rapporti spontanji (denominatur mhux magħruf)
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide (10 mcg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Maltese: It-teħid ta' kontraċettiv orali kompost (30 mcg ethinyl estradiol flimkien ma' 150 mcg levonorgestrel) siegħa qabel exenatide b'rilaxx immedjat (10 mcg BID) ma ġabx tibdil fl-AUC, fis-Cmax jew fis-Cmin ta' ethinyl estradiol jew ta' levonorgestrel.
English: See Commonly Asked Questions, numbers 5 and 9, in Section 4 of this user manual.
Maltese: Ara Mistoqsijiet Magħmula ta' Spiss, numri 5 u 9, f'Sezzjoni 4 ta' dan il-manwal.
English: Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: - metformin - sulphonylureas - thiazolidinediones - metformin and a sulphonylurea - metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Maltese: Byetta hija indikata fil-kura tad-dijabete mellitus tip 2 flimkien ma': - metformin - sulphonylureas - thiazolidinediones - metformin u xi sulphonylurea - metformin u xi thiazolidinedione f'adulti li ma kisbux kontroll gliċemiku xieraq b'dożi massimi tollerabbli ta' dawn it-terapiji orali.
English: At the end of the study, immediate-release exenatide (n=137) demonstrated a statistically significant reduction in the HbA1c and weight compared to placebo (n=122).
Maltese: Fl-aħħar stadju tal-istudju, exenatide b'rilaxx immedjat (n = 137) wera tnaqqis statistikament sinifikanti fil-HbA1c u fil-piż meta mqabbel mal-plaċebo (n = 122).
English: Other medicines and Byetta
Maltese: Mediċini oħra u Byetta
English: Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres (mcl), (0.25 mg exenatide per ml).
Maltese: Kull doża fiha 10 mikrogrammi (mcg) ta' exenatide f'20 mikrolitru (mcl), (0.25 mg exenatide kull ml)
English: Tabulated list of adverse reactions
Maltese: Lista b'forma tabulari tar-reazzjonijiet avversi
English: After four weeks, their dose was increased to 10 mcg BID.
Maltese: Mhux irrakkomandati dożi ta' aktar minn 10 mcg BID.
English: In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin, metformin and sulphonylurea or metformin and pioglitazone, HbA1c was lowered by 1.2% (n=170) and by 1.4% (n=167) respectively from a baseline of 8.2%.
Maltese: Fi studju li dam sejjer 24 ġimgħa, fejn ġie mogħti jew insulin lispro protamine f'suspensjoni jew insulin glargine flimkien ma' terapija eżistenti ta' exenatide b'rilaxx immedjat u metformin, metformin u sulphonylurea jew metformin u pioglitazone, HbA1c ġie mnaqqas b'1.2% (n = 170) u b'1.4% (n = 167) rispettivament minn linja bażi ta' 8.2%.
English: Table 1 lists adverse reactions reported of immediate-release exenatide from clinical trials and spontaneous reports (not observed in clinical trials, frequency not known).
Maltese: Tabella 1 tagħti r-reazzjonijiet avversi rrapportati ta' exenatide b'rilaxx immedjat minn provi kliniċi u rapporti spontanji (mhux osservati fi provi kliniċi, frekwenza mhux magħrufa).
English: • Swelling of theface, tongue or throat(angioedema)
Maltese: • Nefħa tal-wiċċ,ilsien jew gerżuma (anġjoedema)
English: Once in use: Store below 25 ºC for 30 days.
Maltese: Aħżen f'temperatura taħt 25 °C għal 30 ġurnata.
English: In the three placebo-controlled trials (n=963) 38% of patients had low titre anti-exenatide antibodies at 30 weeks.
Maltese: Fit-tliet studji kkontrollati bil-plaċebo (n=963) 38 % tal-pazjenti kellhom ammont baxx ta' anti-korpi kontra exenatide mat-30 ġimgħa.
English: Store in a refrigerator (2 ºC - 8 ºC).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: • Yes.
Maltese: • Le.
English: - The other ingredients are metacresol, (44micrograms/dose in Byetta 5micrograms solution for injection and 88 micrograms/dose in Byetta 10 micrograms solution for injection), mannitol,
Maltese: - Is-sustanzi l-oħra huma metacresol (44 mikrogramma/doża f'Byetta 5 mikrogrammi soluzzjoni għall-injezzjoni u 88 mikrogramma/doża f'Byetta 10 mikrogrammi soluzzjoni għall-injezzjoni), mannitol, glacial acetic acid, sodium acetate trihydrate u ilma għall-injezzjonijiet (ara sezzjoni 2).
English: In a 30-week, open-label, active comparator-controlled, noninferiority study, the safety and efficacy of immediate-release exenatide (n=315) versus titrated insulin lispro three times daily (n=312) on a background of optimized basal insulin glargine and metformin in patients with type 2 diabetes was evaluated.
Maltese: Fi studju ta' non-inferjorità ta' 30 ġimgħa, b'tikketta mikxufa, bil-komparatur attiv ikkontrollat ġew evalwati s-sigurtà u l-effikaċja ta' exenatide b'rilaxx immedjat (n=315) meta mqabbel ma' insulin lispro titrat tliet darbiet kuljum (n=312) fuq sfond ta' insulin glargine basali ottimizzat u metformin f'pazjenti b'dijabete tip 2.
English: - If you have ever had inflammation of the pancreas (pancreatitis) (see section 4).
Maltese: - Jekk qatt kellek infjammazzjoni tal-frixa (pankreatite) (ara sezzjoni 4).
English: Exenatide exposure increased proportionally over the therapeutic dose range of 5 mcg to 10 mcg.
Maltese: L-espożizzjoni għal exenatide żdiedet b'mod proporzjonali maż-żieda fid-doża terapewtika minn 5 mcg sa 10 mcg.
English: The 26-week study showed similar results with statistically significant reductions from baseline HbA1c compared to placebo (-0.8% versus -0.1%).
Maltese: L-istudju ta' 26 ġimgħa wera riżultati simili b'tnaqqis statistikament sinifikanti mil-linja bażi ta' HbA1c meta mqabbel mal-plaċebo (-0.8% kontra -0.1%).
English: Exenatide is not a substitute for insulin.
Maltese: Exenatide mhuwiex sostitut għall-insulina.
English: Weight increase of 0.2 kg was observed for patients on insulin lispro protamine suspension and 0.6 kg for insulin glargine treated patients from a baseline of 102 kg and 103 kg respectively.
Maltese: Kien hemm żieda fil-piż ta' 0.2 kg f'pazjenti li ġew mogħtija insulin lispro protamine f'suspensjoni u żieda ta' 0.6 kg f'pazjenti li ġew mogħtija insulin glargine minn linja bażi ta' 102 kg u 103 kg rispettivament.
English: Proportion of patients (%) achieving HbA1c ≤ 7% (patients completing studies) Baseline weight (kg) Change of weight from baseline (kg)
Maltese: Proporzjon ta' pazjenti (%) li kisbu HbA1c ≤7% Proporzjon ta' pazjenti (%)li kisbu HbA1c ≤7% (pazjenti li temmew listudji)
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Marketing Authorisation Holder AstraZeneca AB
Maltese: Manifattur AstraZeneca AB
English: The immediate-release exenatide arm compared to placebo had significantly lowered postprandial blood glucose excursions at the morning meal (- 2.0 versus0.2 mmol/l) and evening meal (- 1.6 versus + 0.1 mmol/l), there was no difference between treatments at midday.
Maltese: Il-grupp ta' exenatide b'rilaxx immedjat meta mqabbel mal-plaċebo kellu tnaqqis sinifikanti fil-livell ta' glucose fid-demm wara l-ikel ta' filgħodu (- 2.0 kontra -0,2 mmol/l) u wara l-ikel ta' filgħaxija (- 1.6 kontra +0.1 mmol/l), ma kien hemm l-ebda differenza bejn it-terapiji f'nofsinhar.
English: See Commonly Asked Question 4.
Maltese: Ara Mistoqsijiet Magħmula ta' Spiss 4.
English: Immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) resulted in statistically significant reductions from baseline HbA1c compared to placebo (-0.7% versus +0.1%) as well as significant reductions in body weight (-1.5 versus 0 kg) in the 16 week study.
Maltese: Exenatide b'rilaxx immedjat (5 mcg BID għal 4 ġimgħat, segwit b'10 mcg BID) irriżulta f'tnaqqis statistikament sinifikanti mil-linja bażi ta' HbA1c meta mqabbel mal-plaċebo (-0.7% kontra +0.1%) kif ukoll tnaqqis sinifikanti fil-piż tal-ġisem (-1.5 kontra 0 kg) fl-istudju ta' 16-il ġimgħa.
English: - Each dose of Byetta 10micrograms solution for injection (injection) contains 10micrograms exenatide in 40 microlitre.
Maltese: - Kull doża ta' Byetta 10 mikrogrammi soluzzjoni għall-injezzjoni (injezzjoni) fiha 10 mikrogrammi exenatide f'40 mikrolitru.