FrancophonIA/ELRC3.0 huggingface dataset:
English: A reduction in systolic blood pressure was observed in the 4 comparator-controlled prolonged-release exenatide studies (2.9 mmHg to 4.7 mmHg).
Maltese: Fl-4 studji ta' exenatide li jerħi l-mediċina bil-mod ikkontrollati bil-plaċebo ġie osservat tnaqqis filpressjoni sistolika tad-demm (2.9 mmHg sa -4.7 mmHg).
English: The medicine should look even throughout (see pictures in Figure G and Figure H, Step 2C).
Maltese: Il-mediċina għandha tidher mifruxa sew kollha (ara l-istampi f'Figura G u Figura H, Pass 2C).
English: The results of the primary composite and secondary cardiovascular endpoints are shown in Figure 2.
Maltese: Ir-riżultati tal-punti ta' tmiem kardjovaskulari komposti primarji u sekondarji huma murija fil-Figura 2.
English: A. Combine the medicine.
Maltese: Ikkombina l-mediċina.
English: Look
Maltese: IEQA
English: This incidence was increased when it was used in combination with a sulphonylurea (26.1 %) compared to no sulphonylurea (0.9%) (see section 4.4).
Maltese: L-inċidenza gloobali ta' ipogliċemija minuri kienet 6.3%. Din l-inċidenza żdiedet meta ntuża flimkien ma' sulphonylurea (26.1%) meta mqabbel mal-ebda sulphonylurea (0.9%) (ara sezzjoni 4.4).
English: Hypoglycaemia (with insulin)
Maltese: Ipogliċemija (blinsulina)
English: Result in symptoms consistent with hypoglycaemia with a concomitant glucose <54 mg/dL (3 mmol/L) prior to treatment.
Maltese: Jirriżultaw f'sintomi konsistenti ma' ipogliċemija b'glukożju konkomitanti <54 mg/dL (3 mmol/L) qabel il-kura.
English: Clean the area with an alcohol swab.
Maltese: Naddaf il-parti bi swab tal-alkoħol.
English: This medicine is available in pack sizes of 4 single-dose kits and 3 packs of 4 single-dose kits.
Maltese: Din il-mediċina tiġi f'pakketti ta' 4 kitts ta' doża waħda u 3 pakketti ta' 4 kitts ta' doża waħda.
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment epatiku M'hemmx bżonn ta' aġġustament fid-doża għal pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: • Swelling of the face, tongue or throat (angioedema)
Maltese: • Nefħa tal-wiċċ, ilsien jew gerżuma (anġjoedema)
English: Hold the pen up straight with the orange cap toward the ceiling.
Maltese: billi tiġbed direttament 'il barra.
English: Amongst patients treated with Bydureon BCise evaluable for antibodies (N = 393), the incidence of potentially immunogenic injection site reactions (most commonly injection site nodule) during the two studies was approximately 20%.
Maltese: Fost pazjenti kkurati b'Bydureon BCise evalwabbli għall-antikorpi (N = 393), l-inċidenza tarreazzjonijiet fis-sit tal-injezzjoni li potenzjalment huma immunoġeniċi (l-iżjed komuni għoqda fis-sit tal-injezzjoni) waqt iż-żewġ studji kienet madwar 20%.
English: Acute pancreatitis Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' agonisti tar-riċettur GLP-1 ġie assoċjat mar-riskju li tiżviluppa pankreatite akuta.
English: • Store flat in the refrigerator between 2°C to 8°C.
Maltese: • Aħżen ċatta fil-friġġ f'temperatura bejn 2°C sa 8°C.
English: Patients with an Event (%)
Maltese: Pazjenti b'Episodju (%)
English: Patients (%) achieving HbA1c ≤ 7% 62
Maltese: Il-pazjenti (%) li kisbu HbA1c ≤7%
English: Across 12 studies of prolonged-release exenatide most episodes (99.9% n = 649) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate.
Maltese: Fit-12-il studju kollha ta' exenatide li jerħi l-mediċina bil-mod, il-parti l-kbira tal-episodji (99.9% n=649) ta' ipogliċemija kienu ħfief u marru bit-teħid ta' karboidrat minn gol-ħalq.
English: Prolonged-release suspension for injection 4 single-dose pre-filled pens (BCise) BCise
Maltese: Suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod. 4 pinen mimlijin għal-lest ta' doża waħda (BCise) BCise
English: In a 28-week open-label study (oral medication-blinded), Bydureon BCise was compared to sitagliptin and placebo in subjects also using metformin ≥ 1,500 mg daily.
Maltese: Fi studju open-label ta' 28 ġimgħa (medikazzjoni orali blinded), Bydureon BCise tqabbel ma' sitagliptin u plaċebo f'individwi li kienu qed jużaw ukoll metformin ≥ 1,500 mg kuljum.
English: Based on hypoglycaemic events that have symptoms consistent with hypoglycaemia with a concomitant glucose value of <54 mg/dl (3 mmol/l) prior to treatment.
Maltese: Ibbażat fuq avvenimenti ipogliċemiċi li għandhom sintomi konsistenti ma' ipogliċemija b'valur tal-glukożju konkomitanti ta' <54 mg/dl (3 mmol/l) qabel il-kura.
English: Paracetamol Cmax decreased by 16% (fasting) and5 % (fed) and tmax was increased from approximately 1 hour in the control period to 1.4 hours (fasting) and 1.3 hours (fed).
Maltese: Is-Cmax ta' paracetamol naqas b'16% (fuq stonku vojt)) u b'5% (wara l-ikel) u t-tmax żdied minn kważi siegħa fil-perijodu ta' kontroll għal 1.4 sigħat (fuq stonku vojt) u 1.3 sigħat (wara l-ikel).
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in fasting plasma glucose was -0.7 mmol/l for the prolonged-release exenatide group and -0.1 mmol/l for the placebo group.
Maltese: Fl-istudju kkontrollat bil-plaċebo b'insulina glargine, il-bidla mil-linja bażi sal-Ġimgħa 28 fil-glukożju filplażma fi stat sajjem kienet ta' -0.7 mmol/l għall-grupp ta' exenatide li jerħi l-mediċina bil-mod u -0.1 mmol/l għall-grupp ta' plaċebo.
English: The concurrent use of prolonged-release exenatide formulations with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied.
Maltese: Ma ġiex studjat l-użu fl-istess ħin ta' exenatide li jerħi l-mediċina bil-mod, mad-derivattivi ta' D-phenylalanine (meglitinides), mal-inibituri ta' alpha-glucosidase, mal-inibituri ta' dipetidyl peptidase-4 jew ma' agonisti oħra tar-riċettur GLP-1.
English: Renal and urinary disorders Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine (see section
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Tibdil fil-funzjoni renali, inkluż insuffiċjenza renali akuta, insuffiċjenza renali kronika li tmur għall-agħar, indeboliment renali, żieda fil-livell talkreatinina fis-serum (ara sezzjoni 4.4).
English: Mean difference in change from baseline versus sitagliptin (95% CI)
Maltese: Il-medja tad-differenza fit-tibdil mil-linja bażi kontra sitagliptin (95% CI)
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 petide-1 (GLP-1) u għandu ħafna mill-azzjonijiet kontra l-ipergliċemija li għandu glucagon-like peptide-1 (GLP-1).
English: It is normal for air bubbles to be in the syringe.
Maltese: Huwa normali li tara ftit qtar ta' likwidu ġol-għatu.
English: This will let the pen warm up to room temperature.
Maltese: Dan iħalli lill-pinna tiegħek tibred għal temperatura ambjentali.
English: Important information about some of the ingredients of Bydureon 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 ta' sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: • Do not use past the expiration date.
Maltese: • Tużax wara d-data ta' skadenza.
English: Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
Maltese: Data tal-aħħar tiġdid: 18 ta' Frar 2016
English: • Hypersensitivity (rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat)
Maltese: • Sensittività eċċessiva (raxxijiet, ħakk u nefħa rapida tat-tessut tal-għonq, wiċċ, ħalq jew griżmejn)
English: In the 4 comparator-controlled studies, the proportion of patients who had both a reduction in weight and HbA1c ranged from 70 to 79% (the proportion of patients who had a reduction of HbA1c ranged from 88 to 96%).
Maltese: Fl-4 studji kkontrollati b'komparatur dan il-persentaġġ tal-pazjenti li kellhom kemm tnaqqis fil-piż u kemm tnaqqis fl-HbA1c varja minn 70 sa 79% (il-persentaġġ tal-pazjenti li kellhom tnaqqis fl-HbA1c varja minn 88 sa 96%).
English: Table 1: Adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports
Maltese: Tabella 1: Reazzjonijiet avversi ta' exenatide li jerħi l-mediċina bil-mod identifikati minn studji kliniċi u rapporti spontanji
English: A mean increase in heart rate (HR) of 2.4 beats per minute (bpm) from baseline (74 bpm) was observed in the controlled period of the Bydureon BCise clinical studies.
Maltese: Ġiet osservata żieda medja fir-rata tat-taħbit tal-qalb (HR) ta' 2.6 taħbita fil-minuta (bpm) mil-linja bażi (74 bpm) fil-perjodu kkontrollat tal-istudji kliniċi ta' Bydureon BCise.
English: Rapid weight loss at a rate of >1.5 kg per week has been reported in patients treated with exenatide.
Maltese: Tnaqqis ta' malajr fil-piż b'rata ta' > 1.5 kg fil-ġimgħa ġie rrapportat f'pazjenti kkurati b'exenatide.
English: During the controlled period of the clinical studies, injection site reactions were observed more frequently in patients treated with Bydureon BCise versus comparator-treated patients (24% versus 4% with immediate-release exenatide).
Maltese: Waqt il-perjodu kkontrollat tal-istudji kliniċi, ir-reazzjonijiet fis-sit tal-injezzjoni ġew osservati b'mod aktar frekwenti f'pazjenti kkurati b'Byrudeon BCise kontra pazjenti kkurati bil-komparatur (24% 4% b'exenatide li jerħi l-mediċina b'mod immedjat).
English: What Bydureon BCise pen contains - The active substance is exenatide.
Maltese: X'fih il-pinna ta' Bydureon BCise - Is-sustanza attiva hi exenatide.
English: Myocardial Infarction
Maltese: Infart Mijakardijaku
English: Injection Button
Maltese: Buttuna ta' Injezzjoni
English: A reduction in systolic blood pressure was observed in the studies with prolonged-release exenatide formulations (0.8 mmHg to 4.7 mmHg).
Maltese: Fl-istudji ta' exenatide li jerħi l-mediċina bil-mod ikkontrollati bil-plaċebo ġie osservat tnaqqis filpressjoni sistolika tad-demm (0.8 mmHg sa 4.7 mmHg).
English: If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection.
Maltese: Jekk qbiżt in-naħa ta' fuq tal-planġer wara din il-linja, għandek tkompli minn pass 4d u tieħu l-injezzjoni.
English: Pull
Maltese: Pum
English: Syringe
Maltese: IĠBE
English: For instructions on the preparation of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Maltese: Għal struzzjonijiet dwar il-preparazzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6 u “L-Istruzzjonijiet għall-Utent”
English: D. Peel off the paper tab,
Maltese: Qaxxar it-tab tal-karti,
English: SOLVENT LABEL
Maltese: TIKKETTA TAS-SOLVENT
English: INR should be monitored during initiation of prolonged-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see sections 4.4 and 4.8).
Maltese: Wieħed għandu joqgħod attent għall-INR fil-bidu tal-kura b'exenatide li jerħi lmediċina bil-mod f'pazjenti fuq warfarin u/jew derivattivi ta' cumarol (ara sezzjonijiet 4.4 u 4.8).
English: Each pre-filled pen contains 2 mg exenatide.
Maltese: Kull kunjett fih 2 mg exenatide.
English: Common Uncommon Rare Very rare Not known
Maltese: Rari ħafna
English: • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea When this medicine is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur.
Maltese: • ipogliċemija (zokkor baxx fid-demm) meta jittieħed ma' mediċina li fiha sulphonylurea Meta din l-mediċina tintuża ma' mediċina li fiha sulphonylurea, jistgħu jseħħu episodji ta' zokkor baxx fid-demm (ipogliċemija, ġeneralment ħafifa għal moderata).
English: This medicine is used in combination with the following diabetes medicines: metformin, sulphonylureas, thiazolidinediones, SGLT2 inhibitors and/or a long-acting insulin.
Maltese: Din il-mediċina tintuża flimkien ma' dawn il-mediċini ta' kontra d-dijabete li ġejjin: metformin, sulphonylureas, thiazolidinediones, inibituri SGLT2 u/jew insulina li taġixxi fit-tul.
English: The 156-week results were consistent with those previously reported in the 26-week interim report.
Maltese: Ir-riżultati ta' 156 ġimgħa kienu konsistenti ma' dawk irrapportati preċedentement fir-rapport temporanju ta' 26 ġimgħa.
English: Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.
Maltese: Exenatide jżid, b'mod dipendenti fuq il-glukożju, is-sekrezzjoni tal-insulina miċ-ċelluli beta tal-frixa.
English: The suspension is packaged in a 2-ml Type I glass cartridge, sealed at one end with a (bromobutyl) rubber seal/cap combination (combiseal), and at the other end with a (bromobuty) rubber plunger.
Maltese: Is-sospensjoni tiġi ppakkjata f'kartriġġ ta' ħġieġ tat-Tip I ta' 2 ml, issiġillat f'tarf wieħed b'kombinazzjoni (combiseal), ta' siġill/tapp tal-gomma (bromobutyl), u fit-tarf l-ieħor bi planġer talgomma (bromobutyl).
English: -Placebo favored->
Maltese: - Preferenza għal plaċebo ->
English: Patients (%) achieving HbA1c < 7%
Maltese: Il-pazjenti (%) li kisbu HbA1c <7%
English: Background therapies in the prolonged-release exenatide clinical trials included diet and exercise, metformin, a sulphonylurea, a thiazolidinedione, a combination of oral glucose-lowering agents or a basal insulin.
Maltese: It-terapiji ta' sfond fil-provi kliniċi b'exenatide li jerħi l-mediċina bil-mod kienu jinkludu dieta u eżerċizzju, metformin, sulphonylurea, thiazolidinedione, taħlita ta' aġenti orali li jbaxxu l-glukożju jew insulina bażi.
English: For instructions on the suspension of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Maltese: Għal struzzjonijiet dwar is-suspensjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6 u “LIstruzzjonijiet għall-Utent”
English: See question number:
Maltese: Ara mistoqsija numru:
English: After suspension, the delivered dose is 2 mg/0.65 ml.
Maltese: Wara s-sospensjoni, id-doża mogħtija hija 2 mg/0.65 ml.
English: Gastroesophageal reflux disease
Maltese: Marda ta' rifluss gastroesofaġeali
English: The mean age at study entry was 62 years (with 8.5% of the patients ≥75 years).
Maltese: L-età medja fid-dħul għall-istudju kienet 62 sena (bi 8.5% tal-pazjenti ≥75 sena).
English: Small subcutaneous injection site nodules were observed very frequently in clinical studies, consistent with the known properties of poly (D,L-lactide co-glycolide) polymer microsphere formulations.
Maltese: Fl-istudji kliniċi, ġew osservati b'mod frekwenti ħafna għoqod żgħar taħt il-ġilda fis-sit tal-injezzjoni, konsisteni mal-karatteristiċi magħrufa tal-formulazzjonijiet magħmula minn mikrosferi polimeriċi poly (D,L-lactide co-glycolide).
English: - The other ingredients are: poly (D,L-lactide-co-glycolide), sucrose and medium chain triglyceride.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: poly (D, L-lactide-co-glycolide), sucrose u trigliċeridi b'katina medja.
English: Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control.
Maltese: Bydureon huwa indikat f'adulti ta' 18-il sena 'l fuq b'dijabete mellitus tat-tip 2 sabiex itejbu l-kontroll gliċemiku flimkien ma' prodotti mediċinali oħra li jbaxxu l-glukożju meta t-terapija użata li jinkludu insulina bażi, flimkien ma' dieta u eżerċizzju, ma tipprovdix kontroll gliċemiku adegwat.
English: • You may need to tap 80 times or more.
Maltese: • Jista' jkollok bżonn li ttaptap 80 darba jew aktar.
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea may be considered (see sections 4.2 and 4.4).
Maltese: Biex tnaqqas ir-riskju tal-ipogliċemija assoċjata mal-użu ta' xi sulphonylurea, wieħed jista' jikkonsidra jnaqqas id-doża tas-sulphonylurea (ara sezzjonijiet 4.2 u 4.4).
English: There were no events of major hypoglycaemia with Bydureon BCise.
Maltese: Ma kien hemm l-ebda avveniment ta' ipogliċemija maġġuri b'Bydureon BCise.
English: Orange Label
Maltese: Tikketta oranġjo
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in systolic blood pressure was -2.6 mmHg for the prolonged-release exenatide group and -0.7 mmHg for the placebo group.
Maltese: Fl-istudju kkontrollat bil-plaċebo b'insulina glargine, il-bidla mil-linja bażi sal-Ġimgħa 28 filpressjoni sistolika tad-demm kienet ta' -2.6 mmHg għall-grupp ta' exenatide li jerħi l-mediċina bilmod u -0.7 mmHg għall-grupp ta' plaċebo.
English: In the 4 comparator-controlled studies, this reduction in body weight was seen in patients treated with prolonged-release exenatide irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction of -2.9 kg to -5.2 kg with nausea versus -2.2 kg to -2.9 kg without nausea).
Maltese: Fl-4 studji kkontrollati b'komparatur dan it-tnaqqis fil-piż tal-ġisem deher fil-pazjenti mogħtija exenatide li jerħi l-mediċina bil-mod irrispettivament jekk kellhomx it-tqalligħ għalkemm it-tnaqqis kien ikbar fil-grupp li kellhom it-tqalligħ (medja ta' tnaqqis ta' -2.9 kg sa -5.2 kg bit-tqalligħ kontra2.2 kg sa -2.9 kg mingħajr tqalligħ).
English: • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea.
Maltese: • ipogliċemija (zokkor baxx fid-demm) meta jittieħed ma' mediċina li fiha sulphonylurea.
English: Part of a multi-pack of 3 x (4 single dose kits).
Maltese: Parti minn pakkett multiplu ta' 3 x (4 settijiet ta' doża waħda).
English: What if the device malfunctions and I cannot remove the orange cap?
Maltese: Inti u ddawwar, qis li żżomm ilkonnekter oranġjo.
English: I am at step 4c.
Maltese: 1b Aħsel idejk.
English: 2 Connecting the parts 3 Mixing the medicine and filling the syringe 4 Injecting the medicine
Maltese: 2 Twaħħil tal-partijiet 3 Taħlit tal-mediċina u mili tas-siringa 4 Injezzjoni tal-mediċina
English: Each pre-filled pen delivers a dose of 2 mg of exenatide in 0.85 ml.
Maltese: Kull pinna mimlija għal-lest tagħti doża ta' 2 mg ta' exenatide f'0.85 ml.
English: B. Open the tray,
Maltese: Iftaħ it-trej,
English: Prolonged-release suspension for injection
Maltese: Disturbi fis-sistema immuni Reazzjoni anafilattika
English: Gastrointestinal disorders Intestinal obstruction Acute pancreatitis (see section 4.4)
Maltese: Żieda fil-proporzjon normalizzat internazzjonali (ara sezzjoni 4.4)
English: • You will probably need less time as you get used to giving yourself injections.
Maltese: • Huwa probabbli li meta tidra tieħu l-injezzjonijiet iddum anqas.
English: STEP 3: Prepare the Pen
Maltese: PASS 3: Ipprepara l-Pinna
English: Table 3: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Maltese: Tabella 3: Ir-riżultati ta' studju wieħed ta' 26 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod kontra insulin glargine flimkien ma' metformin waħdu jew meformin u sulphonylurea (pazjenti b'intenzjoni ta' kura)
English: The Bydureon BCise pen:
Maltese: Sabiex terġa' tara kif:
English: Patients (%) achieving HbA1c ≤ 7% Change in fasting plasma glucose (mmol/l) (± SE) Mean body weight (kg)
Maltese: Il-pazjenti (%) li kisbu HbA1c ≤7% It-tibdil fil-livell tal-glukożju fil-plażma meta wieħed ikun sajjem (mmol/l) ( ± SE)
English: These pharmacokinetic characteristics of exenatide are independent of the dose.
Maltese: Dawn il-karatteristiċi farmakokinetiċi ta' exenatide huma indipendenti middoża.
English: - In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate and water for injection.
Maltese: - Fis-solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen monohydrate, disodium phosphate heptahydrate u ilma għall-injezzjoni.
English: Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Maltese: Pazjenti (%) li jilħqu HbA1c 7% Medja ta' piż tal-ġisem (kg) Linja bażi
English: Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total.
Maltese: Rata bbażata fuq tnax-il studju tal-effikaċja u tas-sigurtà fit-tul ikkompletata b'exenatide li jerħi l-mediċina bilmod n = 2868 total.
English: This medicine is available in a pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Maltese: Din il-mediċina tiġi f'pakkett tad-daqs ta' 4 pinen mimlijin għal-lest ta' doża waħda (BCise) u pakkett multiplu li fih 12 (3 pakketti ta' 4) pinen mimlijin għal-lest ta' doża waħda (BCise).
English: • hypoglycaemia (low blood sugar) when this medicine is used with a medicine that does not contain a sulphonylurea
Maltese: • ipogliċemija (zokkor baxx fid-demm) meta din il-mediċina tintuża ma' mediċina li ma fihiex sulphonylurea
English: After suspension, the delivered dose is 2 mg/0.65 ml
Maltese: Wara s-sospensjoni, id-doża mogħtija hija 2 mg/0.65 ml
English: When I inject, what should I do if I cannot push the plunger all the way down?
Maltese: Wara li nħallat il-mediċina, kemm nista' ndum qabel nieħu l-injezzjoni?
English: After suspension, each pen delivers a dose of 2 mg in 0.65 ml.
Maltese: Wara s-sospensjoni, kull pinna tagħti doża ta' 2 mg f'0.65 ml.
English: Powder: white to off-white powder.
Maltese: billi tiġbed it-tab tar-rokna.
English: A stepwise approach to insulin dose reduction is recommended.
Maltese: Huwa rrakkomandat approċċ gradwali għattnaqqis tad-doża tal-insulina.
English: Each carton also contains one spare needle.
Maltese: Reċipjent mhuwiex inkluż fil-kartuna.
English: Mean difference in change from baseline versus placebo (95% CI)
Maltese: Il-medja tad-differenza fit-tibdil mil-linja bażi kontra plaċebo (95% CI)
English: The mean dose of insulin glargine at the beginning of treatment was 10.1 IU/day rising to 31.1 IU/day for insulin glargine-treated patients.
Maltese: IU/ġurnata li telgħet sa 31.1 IU/ġurnata għal pazjenti kkurati b'insulin glargine.
English: Population pharmacokinetic analysis of renal impaired patients receiving 2 mg prolonged-release exenatide indicate that there may be an increase in systemic exposure of approximately 74% and 23% (median prediction in each group) in moderate (N = 10) and mild (N = 56) renal impaired patients, respectively, as compared to normal (N = 84) renal function patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'indeboliment renali li qed jirċievu exenatide 2 mg li jerħi l-mediċina bil-mod tindika li f'pazjenti b'indeboliment renali moderat (N=10) u ħafif (N=56) jista' jkun hemm żieda fl-espożizzjoni sistemika ta' madwar 74% u 23% (tbassir medjan f'kull grupp) rispettivament meta mqabbel ma' pazjenti b'funzjoni renali normali (N=84).
English: PUSH & HOLD
Maltese: Puh/Tel:
English: Table 4: Results of one 26-week study of prolonged-release exenatide versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients)
Maltese: Tabella 4: Ir-riżultati ta' studju wieħed ta' 26 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod kontra sitagliptin u kontra pioglitazone flimkien ma' metformin (pazjenti b'intenzjoni ta' kura)
English: The effect on HbA1c remained clinically significant over 52 weeks but partially diminished over time in the group that had initially received Bydureon BCise.
Maltese: L-effett fuq HbA1c baqa' klinikament sinifikanti matul 52 ġimgħa iżda naqas parzjelment maż-żmien fil-grupp li fil-bidu rċieva Bydureon BCise.
English: OUTER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - INCLUDING THE BLUE BOX
Maltese: KARTUNA TA' ĠEWWA PAKKETT MULTIPLU TA' 3 X (4 PINEN MIMLIJIN GĦALLEST TA' DOŻA WAĦDA) - MINGĦAJR EBDA KAXXA BLU
English: Nausea
Maltese: Żommha