FrancophonIA/ELRC3.0 huggingface dataset:
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9).
Maltese: Alogliptin ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever (punteġġ ta' Child-Pugh ta' >9).
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies; metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Maltese: Dan intwera fid-dożi terapewtiċi fi studji kliniċi kkontrollati ta' terminu medju jew twil, li metformin inaqqas il-livelli ta' kolesterol totali, kolesterol LDL u trigliċeridi.
English: Use with other antihyperglycaemic medicinal products and hypoglycaemia
Maltese: Użu ma' prodotti mediċinali oħrajn kontra l-ipergliċemija u l-ipogliċemija
English: What Vipdomet contains - The active substances are alogliptin and metformin hydrochloride.
Maltese: X'fih Vipdomet Is-sustanzi attivi huma alogliptin u metformin hydrochloride.
English: Add-on combination therapy studies Alogliptin 25 mg once daily with metformin vs a sulphonylurea + metformin
Maltese: Studji b'terapija ta' kombinazzjoni aġġuntiva Alogliptin 25 mg darba kuljum ma' metformin vs sulphonylurea u metformin
English: Maximum daily dose is 12.5 mg
Maltese: Id-doża massima ta' kuljum hi ta' 12.5 mg
English: Following oral administration of an 850 mg metformin hydrochloride tablet, the peak plasma concentration was 40% lower, AUC was decreased by 25% and the time to peak plasma concentration (Tmax) was prolonged by 35 minutes.
Maltese: Wara l-għoti mill-ħalq ta' pillola ta' 850 mg ta' metformin hydrochloride, il-konċentrazzjoni massima fil-plażma kienet ta' 40% aktar baxxa, l-AUC tnaqqas b'25% u ż-żmien sa x'ħin tintlaħaq konċentrazzjoni massima fil-plażma (Tmax) kien imtawwal b'35 minuta.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (<7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/L) u żieda fl-anion gap u lproporzjon ta' lactate/pyruvate.
English: After an oral dose of metformin, the maximum plasma concentration (Cmax) is reached in approximately 2.5 hours (Tmax).
Maltese: Wara doża orali ta' metformin, il-konċentrazzjoni massima fil-plażma (Cmax) tintlaħaq f'madwar 2.5 sigħat (Tmax).
English: - Vipdomet 12.5 mg/1,000 mg film-coated tablets (tablets) are pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side.
Maltese: - Vipdomet 12.5 mg/1,000 mg pilloli miksija b'rita (pilloli) huma ta' lewn isfar ċar, oblongi (madwar 22.3 mm fit-tul u 10.7 mm wiesgħa), imżaqqin fuq żewġ naħat bi “12.5/1000” imnaqqxa fuq naħa waħda u “322M” imnaqqxa fuq in-naħa l-oħra.
English: The average renal clearance of alogliptin (170 mL/min) was greater than the average estimated glomerular filtration rate (approx. 120 mL/min), suggesting some active renal excretion.
Maltese: It-tneħħija medja mill-kliewi ta' alogliptin (170 mL/min) kienet akbar mir-rata medja ta' filtrazzjoni glomerulari stmata (madwar 120 mL/min), li tissuġġerixxi eliminazzjoni attiva mill-kliewi.
English: Overall, treatment with the recommended total daily dose of 25 mg alogliptin in combination with metformin improved glycaemic control.
Maltese: Globalment, it-trattament bid-doża rakkomandata ta' kuljum ta' 25 mg alogliptin flimkien ma' metformin tejjeb il-kontroll gliċemiku.
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities.
Maltese: Dejta limitata dwar l-użu ta' metformin f'nisa tqal ma jindikax żieda fir-riskju ta' anormalitajiet konġenitali.
English: Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001).
Maltese: B'mod sinifikanti kienu aktar il-pazjenti li rċevew alogliptin 25 mg (44.4%) li kisbu livelli fil-mira ta' HbA1c ta' ≤7.0% meta mqabbla ma' dawk li rċevew plaċebo (18.3%) f'Ġimgħa 26 (p<0.001).
English: No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Maltese: L-ebda effett relatat ma' alogliptin ma kien osservati f'firien minorenni wara l-għoti ta' dożi ripetuti għal 4 u 8 ġimgħat.
English: Co-administration of 100 mg alogliptin once daily and 1,000 mg metformin hydrochloride twice daily for 6 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogliptin or metformin.
Maltese: L-għoti konġunt ta' 100 mg alogliptin darba kuljum u 1,000 mg metformin hydrochloride darbtejn kuljum għal 6 ijiem f'individwi b'saħħithom ma kellux effetti klinikament rilevanti fuq il-farmakokinetika ta' alogliptin jew metformin.
English: - A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Maltese: - Reazzjoni allerġika severa: leżjonijiet tal-ġilda jew tikek fuq il-ġilda tiegħek, li jistgħu jagħmlu progress għall selħiet mdawra minn ċrieki ħomor, nfafet u / jew tqaxxir tal-ġilda possibilment b'sintomi bħal ħakk, deni, tħossok marid in ġenerali, uġigħ fil-ġogi, problemi filvista, ħruq, uġigħ jew ħakk fl-għajnejn u selħiet fil-ħalq (sindromu ta' Stevens-Johnson u Eritema multiforme).
English: The following section outlines the pharmacokinetic properties of the individual components of Vipdomet (alogliptin/metformin) as reported in their respective Summary of Product Characteristics.
Maltese: Is-sezzjoni li ġejja tiddeskrivi l-karatteristiċi farmakokinetiċi tal-komponenti individwali ta' Vipdomet (alogliptin/metformin) kif irrapportat fis-Sommarju tal-Karatteristiċi tal-Prodott rispettiv tagħhom.
English: In a clinical trial of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another trial as add-on to a sulphonylurea.
Maltese: Fi prova klinika ta' alogliptin bħala monoterapija, l-inċidenza ta' ipogliċemija kienet simili għal dik tal-plaċebo, u inqas mill-plaċebo fi prova oħra bħala terapija aġġuntiva ma' sulphonylurea.
English: More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (0.8%) at Week 26.
Maltese: Aktar pazjenti li kienu qed jirċievu alogliptin 25 mg (7.8%) kisbu livelli fil-mira ta' HbA1c ta' ≤7.0% meta mqabbla ma' dawk li rċevew plaċebo (0.8%) f'Ġimgħa 26.
English: For patients inadequately controlled on dual therapy with a maximal tolerated dose of metformin and pioglitazone, the dose of pioglitazone should be maintained, and Vipdomet administered concomitantly; alogliptin should be dosed at 12.5 mg twice daily (25 mg total daily dose) and metformin hydrochloride at a similar dose (either 850 mg or 1,000 mg twice daily) to that already being taken.
Maltese: Għal pazjenti mhux ikkontrollati adegwatament fuq terapija doppja b'doża massima ttollerata ta' metformin u pioglitazone, id-doża ta' pioglitazone għandha tinżamm, u Vipdomet għandu jingħata fl-istess ħin; alogliptin għandu jingħata f'doża ta' 12.5 mg darbtejn kuljum (25 mg doża totali ta' kuljum) u metformin hydrochloride f'doża simili (jew 850 mg jew 1,000 mg darbtejn kuljum) ma' dik li diġà qed jittieħed.
English: Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
Maltese: Kemm alogliptin 25 mg waħdu u flimkien ma' pioglitazone 30 mg urew tnaqqis sinifikanti fil-glucose wara l-ikel u glucagon wara l-ikel filwaqt li għollew b'mod sinjifikanti l-livelli attivi ta' GLP-1 wara l-ikel f'Ġimgħa 16 meta mqabbla mal-plaċebo (p<0.05).
English: Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1000 mg film-coated tablets alogliptin/metformin hydrochloride
Maltese: Vipdomet 12.5 mg/850 mg pilloli miksija b'rita Vipdomet 12.5 mg/1,000 mg pilloli miksija b'rita alogliptin/metformin hydrochloride
English: For patients inadequately controlled on the maximal tolerated dose of metformin hydrochloride alone, the recommended dose is one tablet of 12.5 mg/850 mg or 12.5 mg/1,000 mg twice daily, corresponding to 25 mg alogliptin plus 1,700 mg or 2,000 mg metformin hydrochloride daily, depending on the dose of metformin hydrochloride already being taken.
Maltese: Għal pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin waħdu, id-doża rakkomandata ta' Vipdomet hi ta' pillola waħda ta' 12.5 mg/850 mg jew 12.5 mg/1,000 mg darbtejn kuljum li tikkorrispondi għal 25 mg ta' alogliptin flimkien ma' 1,700 mg jew 2,000 mg ta' metformin hydrochloride kuljum, skont id-doża ta' metformin hydrochloride li diġà qed tittieħed.
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/1,000 mg tablets alogliptin/metformin hydrochloride
Maltese: IL-PRODOTT MEDIĊINALI Vipdomet 12.5 mg/1,000 mg pilloli alogliptin/metformin hydrochloride
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥65 years old treated with 25 mg alogliptin (3.8%) to that in patients <65 years old (3.6%).
Maltese: F'analiżi miġbura tad-dejta minn 12-il studju, l-inċidenza globali ta' kwalunkw episodju ta' ipogliċemija kienet simili f'pazjenti ta' ≥65 sena kkurati b'alogliptin 25 mg (3.8%) bħal dik f'pazjenti ta' <65 sena (3.6%).
English: biscuits or sugary fruit juice.
Maltese: glukożju periferali.
English: Alogliptin as add-on therapy to metformin with a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Maltese: Alogliptin bħala terapija aġġuntiva ma' metformin ma' thiazolidinedione Iż-żieda ta' alogliptin 25 mg darba kuljum mat-terapja bi pioglitazone (doża medja = 35.0 mg, bi jew mingħajr metformin jew sulphonylurea) irriżultat f'titjib statistikament sinifikanti mil-linja bażi fl-HbA1c u fil-glukosju fil-plażma wara s-sawm f'Ġimgħa 26 meta mqabbel maż-żieda ta' plaċebo (Tabella 2).
English: Vipdomet 12.5 mg/850 mg film-coated tablets
Maltese: Vipdomet 12.5 mg/850 mg pilloli miksija b'rita
English: The safety and efficacy of Vipdomet in children and adolescents <18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vipdomet fit-tfal u adolexxenti ta' <18-il sena għadhom ma ġewx determinati s'issa.
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelluli ħomor tad-demm x'aktarx jirrappreżentaw kompartament sekondarju ta' distribuzzjoni.
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg tablets alogliptin/metformin hydrochloride
Maltese: IL-PRODOTT MEDIĊINALI Vipdomet 12.5 mg/850 mg pilloli alogliptin/metformin hydrochloride
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1,000 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Vipdomet 12.5 mg/850 mg pilloli miksija b'rita Vipdomet 12.5 mg/1,000 mg pilloli miksija b'rita
English: Infections and infestations upper respiratory tract infections common common nasopharyngitis common common
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju komuni komuni nażofarinġite komuni komuni
English: Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).
Maltese: B'mod sinifikanti aktar pazjenti li kienu qed jirċievu alogliptin 25 mg (49.2%) kisbu l-livelli fil-mira ta' HbA1c ta' ≤7.0% meta mqabbla ma' dawk li kienu qed jirċievu l-plaċebo (34.0%) f'Ġimgħa 26 (p=0.004).
English: Gastrointestinal symptoms occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Maltese: Sintomi gastrointestinali jseħħu bl-aktar mod frekwenti waqt il-bidu tat-terapija u jirriżolvu ruħhom spontanjament fil-maġġoranza tal-każijiet.
English: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, li jinkludu reazzjonijiet anafilattiċi, anġjoedema u kondizzjonijiet tal-ġilda li titqaxxar li jinkludu s-Sindromu ta' Stevens-Johnson u eritema multiforme ġew osservati għal impedituri ta' DPP-4 u ġew irrapportati b'mod spontanju għal alogliptin fl-isfond ta' wara t-tqegħid fis-suq.
English: Higher rates of hypoglycaemia were observed with triple therapy with a thiazolidinedione and metformin and in combination with insulin, as observed with other DPP-4 inhibitors.
Maltese: Rati ogħla ta' ipogliċemija kienu osservati bit-terapija tripla ma' thiazolidinedione u metformin u flimkien mal-insulina, kif osservat b'impedituri oħra ta' DPP-4.
English: The majority of these episodes were mild to moderate in intensity.
Maltese: Il-maġġoranza ta' dawn l-episodji kienu ħfief sa moderati fl-intensità.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Sustanzi katijoniċi li huma eliminati permezz ta' tnixxija tubulari tal-kliewi (eż. cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu mas-sistemi ta' trasport tubulari komuni tal-kliewi.
English: As Vipdomet contains metformin it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Maltese: Peress li Vipdomet fih metformin dan għandu jitwaqqaf fi żmien il-kirurġija taħt anestesija ġenerali, spinali jew epidurali.
English: No adverse effects on fertility were observed in animal studies conducted with alogliptin or with metformin (see section 5.3).
Maltese: L-ebda effetti avversi fuq il-fertilità ma kienu osservati fi studju fuq annimali (ara sezzjoni 5.3).
English: In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively.
Maltese: F'analiżi miġbura tad-dejta minn 13-il studju, ir-rati globali ta' rapporti ta' pankreatite f'pazjenti kkurati b'25 mg alogliptin, 12.5 mg alogliptin, kontroll attiv jew plaċebo kienu 2, 1, 1 jew 0 każijiet għal kull 1,000 sena ta' pazjent, rispettivament.
English: Metformin partitions into erythrocytes.
Maltese: Metformin jinqasam f'eritroċiti.
English: What Vipdomet looks like and contents of the pack - Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
Maltese: Kif jidher Vipdomet u l-kontenut tal-pakkett - Vipdomet 12.5 mg/850 mg miksija b'rita (pilloli) huma ta' lewn isfar ċar, oblongi (madwar 21.0 mm fit-tul b'10.1 mm wiesgħa), imżaqqin fuq iż-żewġ naħat bi “12.5/850” imnaqqxa fuq naħa waħda u “322M” imnaqqxa fuq in-naħa l-oħra.
English: Hepatic impairment Vipdomet must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Indeboliment tal-fwied Vipdomet m'għandux jintuża f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: It is especially important to mention the following: - hydrocortisone and prednisolone (corticosteroids), used to treat diseases that involve inflammation like asthma and arthritis - cimetidine, used to treat stomach problems - bronchodilators (beta-2 agonists), used to treat asthma - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib), - certain medicines used for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists) - medicines containing alcohol.
Maltese: Huwa importanti ħafna li wieħed isemmi dan li ġej: - hydrocortisone u prednisolone (kortikosterojdi) użati biex jikkuraw mard li jinvolvi infjammazzjoni bħal ażma u artrite - cimetidine, użat biex jittratta problemi fl-istonku - bronkodilaturi (agonisti ta' beta-2) li jintużaw għall-kura ta' ażma - mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) - mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib) - ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tar-riċetturi ta'
English: The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Maltese: It-tnaqqis sinifikanti fl-HbA1c osservat b'alogliptin 25 mg flimkien ma' pioglitazone 30 mg u metformin kien konsistenti tul il-perjodu kollu tat-trattament ta' 52 ġimgħa meta mqabbel ma' pioglitazone 45 mg u metformin (p<0.001 fil-punti kollha taż-żmien).
English: The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended total daily dose of 25 mg alogliptin, respectively).
Maltese: L-ogħla dożi ta' alogliptin mogħtija fl-istudji kliniċi kienu dożi waħdenin ta' 800 mg li ngħataw lil individwi b'saħħithom u dożi ta' 400 mg darba kuljum għal 14-il jum lil pazjenti b'dijabete mellitus ta' tip 2 (ekwivalenti għal 32 darba u 16-il darba d-doża rakkomandata ta' kuljum ta' 25 mg alogliptin, rispettivament).
English: Gastrointestinal disorders gastroenteritis common abdominal pain common very common common diarrhoea common very common common vomiting very common common gastritis common gastroesophageal reflux disease common common loss of appetite very common nausea very common acute pancreatitis not known
Maltese: Disturbi gastrointestinali gastroenterite komuni uġigħ addominali komuni komuni ħafna komuni dijarea komuni komuni ħafna komuni rimettar komuni ħafna komuni gastrite komuni mard tar-rifluss gastroesofagali komuni komuni nuqqas t'aptit komuni ħafna dardir komuni ħafna pankreatite akuta mhux magħruf
English: A total of 7,151 patients with type 2 diabetes mellitus, including 4,202 patients treated with alogliptin and metformin, participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and metformin on glycaemic control and their safety.
Maltese: Total ta' 7,151 pazjent b'dijabete mellitus ta' tip 2, li kienu jinkludu 4,202 pazjent ikkurati b'alogliptin u metformin, ipparteċipaw f'7 studji kliniċi double-blind b'kontroll attiv jew plaċebo ta' fażi 3 li saru biex jevalwaw l-effetti ta' alogliptin u metformin mogħtija flimkien fuq il-kontroll gliċemiku u s-sigurtà tagħhom.
English: Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Maltese: Vipdomet 12.5 mg/850 mg pilloli miksija b'rita Kull pillola fiha alogliptin benzoate ekwivalenti għal 12.5 mg alogliptin u 850 mg metformin hydrochloride.
English: Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha 12.5 mg alogliptin (bħala benzoate) u 850 mg metformin hydrochloride.
English: The following section outlines the interactions observed with the individual components of Vipdomet (alogliptin/metformin) as reported in their respective Summary of Product Characteristics.
Maltese: Is-sezzjoni li ġejja tiddeskrivi fil-qosor l-interazzjonijiet osservati bil-komponenti individwali ta' Vipdomet (alogliptin/metformin) kif irrapportat fis-Sommarju tal-Karatteristiċi tal-Prodott rispettiv tagħhom.
English: Each 12.5 mg/1,000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1,000 mg metformin hydrochloride.
Maltese: Kull pillola miksija b'rita ta' 12.5 mg/1,000 mg fiha alogliptin benzoate ekwivalenti għal 12.5 mg alogliptin u 1,000 mg metformin hydrochloride.
English: The inter-subject coefficient of variation for alogliptin AUC was small (17%).
Maltese: Il-koeffiċjent ta' varjanza bejn individwu u ieħor għall-AUC ta' alogliptin kien żgħir (17%).
English: Placebo-corrected change from baseline in HbA1c (%)†
Maltese: Bidla medja mil-linja bażi flHbA1c (%)†
English: Alogliptin was not genotoxic in a standard battery of in vitro and in vivo genotoxicity studies.
Maltese: Alogliptin ma kienx ġenotossiku f'sensiela standard ta' studji ġenotossiċi li saru in vitro u in vivo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 1,000 mg metformin hydrochloride.
Maltese: Kull pillola fiha 12.5 mg alogliptin (bħala benzoate) u 1,000 mg metformin hydrochloride.
English: Maximum daily dose is 6.25 mg * Alogliptin dose adjustment is based on a pharmacokinetic study where kidney function was assessed using creatinine clearance (CrCl) levels estimated from the Cockcroft-Gault equation.
Maltese: * L-aġġustament tad-doża ta' alogliptin hi bażata fuq studju farmakokinetiku fejn il-funzjoni tal-kliewi ġew assessjati permezz tal-livelli ta' tneħħija ta' kreatinina (CrCl) stmati mill-formula ta' Cockcroft-Gault.
English: Skin and subcutaneous tissue disorders pruritus common very rare common rash common common erythema very rare exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known very rare
Maltese: Għalkemm il-fertilità ma kinitx affettwata, żieda statistika żgħira ta' sperma anormali ġiet osservata fl-irġiel f'esponiment ferm aktar għolja mill-massimu ta' espożiżżjoni fil-bniedem fid-doża rrakkomandata.
English: Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3 hour haemodialysis session).
Maltese: Ammonti minimi ta' alogliptin tneħħew bl-emodijalisi (madwar 7% tas-sustanza tneħħiet matul sessjoni ta' emodijaliżi ta' 3 sigħat).
English: Not known (frequency cannot be estimated from the available data): - An allergic reaction.
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli): - Reazzjoni allerġika.
English: Avoid excessive alcohol intake while taking Vipdomet since this may increase the risk of lactic acidosis - see section “Warnings and precautions”.
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Vipdomet peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Maltese: It-tnaqqis fl-HbA1c kien simili fis-sottogruppi differenti li kienu jinkludu indeboliment tal-kliewi, età, sess u l-indiċi tal-massa talġisem, filwaqt li d-differenzi bejn ir-razez (eż. Bojod u mhux Bojod) kienu żgħar.