FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja, wara EXP.
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 daily dose of 25 mg alogliptin, respectively).
Maltese: L-ogħla dożi ta' alogliptin mogħtija fi studji kliniċi kienu dożi singoli ta' 800 mg 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 ta' kuljum rakkomandata ta' 25 mg alogliptin, rispettivament).
English: The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
Maltese: L-istudji kienu jinkludu 1,269 pazjent b'indeboliment tal-kliewi ħafif u 161 pazjent b'indeboliment tal-kliewi moderat ikkurati b'alogliptin/pioglitazone.
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 fil-vista, ħruq, uġigħ jew ħakk fl-għajnejn u selħiet fil-ħalq (sindromu ta' Stevens-Johnson u Eritema multiforme).
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone.
Maltese: L-għoti ta' pioglitazone flimkien ma' gemfibrozil (impeditur ta' cytochrome P450 2C8) huwa rrappurtat li jirriżulta f'żieda ta' 3 darbiet fl-AUC għal pioglitazone.
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 ta' ġilda qed titqaxxar li jinkludi s-sindromu ta' Stevens-Johnson syndrome u eritema multiforme ġew osservati għal impedituri DPP-4 u ġew spontanjament rapportati għal alogliptin fl-isfond ta' wara t-tqegħid fis-suq.
English: The safety and efficacy of Incresync in children and adolescents < 18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Incresync fi tfal u adolexxenti ta' <18-il sena għadhom ma ġewx determinati s'issa.
English: • The risk of bladder cancer and relevant risk minimisation advice.
Maltese: • Ir-riskju ta' riskju tal-kanċer tal-bużżieqa tal-awrina u parir rilevanti għat-tnaqqis tar-riskju.
English: Interaction with substrates of CYP 450 isoforms are thus not expected and have not been shown.
Maltese: Għalhekk, interazzjoni ma' sottostrati ta' iżoformi ta' CYP 450 mhumiex mistennija u ma ġewx osservati.
English: - if you are elderly and are taking insulin, because you may have an increased risk of heart problems.
Maltese: • jekk inti anzjan u qed tieħu l-insulina, peress li inti tista' tkun f'riskju ogħla ta' problemi fil-qalb.
English: Minimal to mild simple transitional cell hyperplasia was seen in the urinary bladder of male rats at the lowest dose used (27 times the human exposure) without establishment of a clear NOEL (no observed effect level).
Maltese: Iperplasija sempliċi transizzjonali taċ-ċelluli minima sa ħafifa ġiet osservata fil-bużżieqa tal-awrina ta' firien irġiel fl-inqas doża li ntużat (27 darba tal-esponiment uman) mingħajr ma ġie stabbilit NOEL ċar (livell ta' ebda effett osservat).
English: The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Maltese: Il-farmakokinetiċi ta' alogliptin fi tfal u adolexxenti ta' <18-il sena ma ġiex determinata s'issa.
English: • in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
Maltese: • f'kombinazzjoni ma' metformin (i.e. terapija ta' kombinazzjoni triplika) bħala mediċina aġġuntiva mad-dieta u l-eżerċizzju biex jitjieb il-kontroll gliċemiku f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) li ma ġewx ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u pioglitazone.
English: - Incresync 25 mg/45 mg film-coated tablets (tablets) are red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/45” printed in grey ink on one side.
Maltese: - Incresync 25 mg/45 mg pilloli miksija b'rita huma ħomor f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “25/45” stampati b'linka griża fuq naħa waħda.
English: Specific pharmacokinetic drug interaction studies have not been performed with Incresync.
Maltese: Studji farmakokinetiċi speċifiċi dwar l-interazzjoni tal-mediċina ma sarux b'Incresync.
English: In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
Maltese: Tagħrif in vitro jindika li CYP2D6 u CYP3A4 jikkontribwixxu għall-metabiliżmu ristrett ta' alogliptin.
English: In vitro studies suggest that alogliptin does not inhibit nor induce CYP 450 isoforms at concentrations achieved with the recommended dose of 25 mg alogliptin (see section 5.2).
Maltese: Studji in vitro jissuġġerixxu li alogliptin ma jfixkilx u lanqas jinduċi l-iżoformi ta' CYP 450 f'konċentrazzjonijiet miksuba bid-doża rakkomandata ta' 25 mg alogliptin (ara sezzjoni 5.2).
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 25 mg ta' alogliptin mogħti waħdu kif ukoll flimkien ma' 30 mg ta' pioglitazone wera tnaqqis sinifikanti fil-livell ta' glucose wara l-ikel u ta' glucagon wara l-ikel filwaqt li żied b'mod sinifikanti il-livelli attivi ta' GLP-1 wara l-ikel f'Ġimgħa 16 meta mqabbel mal-plaċebo (p<0.05).
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'alogliptin 25 mg, 12.5 alogliptin mg, kontroll attiv jew plaċebo kienu 2, 1, 1 jew 0 każijiet għal kull 1,000 sena ta' pazjent.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Maltese: Pioglitazone ma kellux potenzjal ġenotossiku f'sensiela komprensiva ta' assaġġi ġenotossiċi in vivo u in vitro.
English: The incidence of hypoglycaemia was greater when alogliptin was used as triple therapy with pioglitazone and metformin (compared to active-control).
Maltese: L-inċidenza ta' ipogliċemija kienet akbar meta alogliptin intuża bħala terapija tripla ma' pioglitazone u metformin (meta mqabbla ma' kontroll attiv).
English: In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Maltese: Fil-gruppi tal-komparatur, iż-żieda ta' sulphonylurea ma' metformin wasslet għal medja ta' żieda fil-piż ta' 1.3 kg u ż-żieda ta' metformin ma' sulphonylurea għal medja ta' telf fil-piż ta' 1.0 kg.
English: The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies.
Maltese: L-informazzjoni provduta hija bbażata fuq total ta' 3,504 pazjenti b'dijabete mellitus ta' tip 2, li jinkludu 1,908 pazjenti kkurati b'alogliptin u pioglitazone, li pparteċipaw f'4 studji kliniċi ta' fażi 3 li kienu double-blind, bil-kontrolli ta' plaċebo jew b'mod attiv.
English: Effects of alogliptin on other medicinal products
Maltese: Effetti ta' alogliptin fuq prodotti mediċinali oħra
English: The (S)-enantiomer is not detectable at therapeutic doses.
Maltese: L-(S)-enantiomer ma jistax jiġi osservat f'dożi terapewtiċi.
English: HOMA analysis shows that pioglitazone improves beta-cell function as well as increasing insulin sensitivity.
Maltese: HOMA turi li pioglitazone itejjeb kemm il-funzjoni taċ-ċelluli beta kif ukoll iżid is-sensittività tal-insulina.
English: Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
Maltese: L-espożizzjoni totali għal alogliptin kienet ta' madwar 10% aktar baxxa u l-espożizzjoni massima kienet madwar 8% aktar baxxa f'pazjenti b'indeboliment tal-fwied moderat meta mqabbel ma' individwi bħala kontroll.
English: Incresync should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Maltese: Incresync għandu jintuża b'attenzjoni waqt l-għoti fl-istess waqt ta' impedituri ta' cytochrome P450 2C8 (eż. gemfibrozil) jew indutturi (eż. rifampicin).
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs and monkeys.
Maltese: Fi studji tossikoloġiċi, l-espansjoni fil-volum tal-plażma b'emodilwazzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienu konsistentement apparenti wara dożi ripetuti fil-ġrieden, firien, klieb u xadini.
English: Study
Maltese: Analiżi
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: In most clinical studies, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo with small, but not clinically significant, increases in LDL-cholesterol levels.
Maltese: Fil-maġġoranza tal-istudji kliniċi, tnaqqis totali fit-trigliċeridi fil-plażma u aċidi ta' grass liberu, u żieda fil-livelli ta' HDH-kolesterol kienu osservati meta mqabbla ma' plaċebo b'żidiet żgħar imma mhux klinikament sinifikanti fil-livelli ta' LDL-kolesterol.
English: Pioglitazone or placebo was added to existing anti-diabetic and cardiovascular therapy for up to 3.5 years.
Maltese: Pioglitazone jew il-plaċebo ġie miżjud mat-terapija antidijabetika u kardjovaskulari eżistenti għal sa 3.5 snin.
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
Maltese: Incresync 12.5 mg/45 mg pilloli alogliptin/pioglitazone
English: MACE Reported in cardiovascular outcomes study Number of Patients (%)
Maltese: Numru ta' Pazjenti (%) Alogliptin
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
Maltese: Incresync 25 mg/45 mg pilloli alogliptin/pioglitazone
English: Nylon/aluminium/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' nylon/aluminium polyvinyl chloride (PVC) b'fojl tal-aluminju li tista' timbuttah biex toħroġ il-pillola.
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 tneħħija renali attiva.
English: GLP-1 and GIP increases insulin biosynthesis and secretion from pancreatic beta cells, while GLP-1 also inhibits glucagon secretion and hepatic glucose production.
Maltese: GLP-1 u GIP iżidu l-bijosintesi tal-insulina u t-tnixxija miċ-ċelluli beta pankreatiċi, filwaqt li GLP-1 jinibixxi wkoll it-tnixxija ta' glucagon u l-produzzjoni ta' glucose fil-fwied.
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
Maltese: Incresync 25 mg/30 mg pilloli alogliptin/pioglitazone
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week study in type 2 diabetics.
Maltese: L-effett ta' pioglitazone (45 mg bħala monoterapija kontra l-plaċebo) kien studjat fi studju kliniku żgħir ta' 18-il ġimgħa f'pazjenti dijabetiċi ta' tip 2.
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Maltese: Fl-istudju tar-riskju kardjovaskulari PROactive ta' 3.5 snin, 44/870 (5.1%; 1.0 ksur għal kull 100 sena ta' pazjent) ta' pazjenti nisa kkurati bi pioglitazone, dawn esperjenzaw ksur meta mqabbla ma' 23/905
English: Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
Maltese: • Ematurja makroskopika mhux mistħarrġa (ara sezzjoni 4.4)
English: M-I is an active metabolite and is a highly selective inhibitor of DPP-4 similar to alogliptin; M-II does not display any inhibitory activity towards DPP-4 or other DPP-related enzymes.
Maltese: M-I huwa metabolit attiv u huwa impeditur selettiv ħafna ta' DPP-4 simili għal alogliptin;
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
Maltese: Incresync 12.5 mg/30 mg pilloli Alogliptin/pioglitazone
English: In clinical studies of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels compared to placebo, metformin or gliclazide.
Maltese: Fi studji kliniċi li damu sejrin sa sentejn, pioglitazone naqqas it-total ta' trigliċeridi fil-plażma u aċidi ta' grass liberu, u żieda l-livelli ta' HDL-kolesterol meta mqabbel ma' placebo, metformin jew gliclazide.
English: Co-administration of 25 mg alogliptin once daily and 45 mg pioglitazone once daily for 12 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogliptin, pioglitazone or their active metabolites.
Maltese: L-għoti ta 25 mg alogliptin darba kuljum u 45 mg pioglitazone darba kuljum għal 12-il jum f'individwi b'saħħithom ma kellux effetti klinikament rilevanti fuq il-farmakokinetika ta' alogliptin, pioglitazone jew il-metaboliti attivi tagħhom.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: Il-popolazzjoni tal-istudju kellha età medja ta' 62 sena; iż-żmien medju ta' kemm kien ilha d-dijabete kien ta' 9.5 snin.
English: For the different dose regimens Incresync is available in strengths of 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/30 mg and 12.5 mg/45 mg film-coated tablets.
Maltese: Għall-korsijiet ta' doża differenti, Incresync hu disponibbli f'qawwiet ta' pilloli miksija b'rita ta' 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/30 mg u 12.5 mg/45 mg.
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator-controlled, double-blind clinical studies in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: Saret analiżi miġbura ta' reazzjonijiet avversi ta' ksur tal-għadam minn studji kliniċi li fihom il-parteċipanti ntagħżlu b'mod każwali, ikkontrolli b'komparatur, u double-blind, fuq aktar minn 8,100 pazjent fil-gruppi li qed jiġu kkurati bi pioglitazone u 7,400 fil-gruppi trattati b'komparatur li damu għal perjodu ta' sa 3.5 snin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 25 mg alogliptin (bħala benzoate) u 45 mg pioglitazone (bħala hydrochloride).
English: Add-on combination therapy studies Alogliptin 25 mg once daily with pioglitazone + metformin vs titrating pioglitazone + metformin
Maltese: Studji b'terapija ta' kombinazzjoni aġġuntiva Alogliptin 25 mg darba kuljum bi pioglitazone  metformin vs pioglitazone ttitrat + metformin Bidla f'Ġimgħa 26 (n = 303)
English: Caution should be exercised when alogliptin is used in combination with metformin and a thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see section 4.4).
Maltese: Għandu jkun hemm kawtela meta alogliptin jintuża flimkien ma' metformin u thiazolidinedione għax ġie osservat riskju miżjud ta' ipogliċemija b'din it-terapija tripla (ara sezzjoni 4.4).
English: What Incresync looks like and contents of the pack - Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/30” printed in grey ink on one side.
Maltese: Kif jidher Incresync u l-kontenut tal-pakkett - Incresync 25 mg/30 mg pilloli miksija b'rita huma lewn il-ħawħ, f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “25/30” stampati b'linka griża fuq naħa waħda.
English: The pharmacokinetics of pioglitazone in children and adolescents < 18 years old has not been established.
Maltese: Il-farmakokinetiċi ta' pioglitazone fi tfal u adolexxenti ta' <18-il sena għadhom ma ġewx determinati s'issa.
English: Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Maltese: Bidliet simili fid-distribuzzjoni ta' grass korporali bi pioglitazone kienu akkumpanjati b'titjib fis-sensittività tal-insulina.
English: In an animal model of familial adenomatous polyposis, treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Maltese: F'mudell fuq l-annimali ta' polipożi adenomatuża familjali, kura b'żewġ thiazolidinediones oħra, kien hemm żieda fil-multipliċità ta' tumuri fil-kolon.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 12.5 mg alogliptin (bħala benzoate) u 45 mg pioglitazone (bħala hydrochloride).
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Maltese: Għalkemm l-istudju falla rigward il-punt aħħari primarju tiegħu, li kien kompost ta' mortalità dovuta għal kull kawża, infart mijokardjali mhux fatali, puplesija, sindromu koronarju akut, amputazzjoni maġġuri tar-riġlejn, rivaskularizzazzjoni koronarja u rivaskularizzazzjoni tar-riġlejn, ir-riżultati jissuġġerixxu li m'hemm l-ebda tħassib kardjovaskulari fuq tul ta' żmien dwar l-użu ta' pioglitazone.
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 jinkludu indeboliment fil-kliewi, età, sess u l-indiċi tal-massa tal-ġisem, filwaqt li d-differenzi bejn ir-razez (eż. Bojod u mhux Bojod) kienu żgħar.
English: Thus, free (unbound) pioglitazone concentration is unchanged (see section 4.2).
Maltese: Għalhekk, il-konċentrazzjoni ta' pioglitazone mhux marbut (liberu) ma tinbidilx (ara sezzjoni 4.2).
English: How to store Incresync
Maltese: Tiħux Incresync:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 25 mg alogliptin (bħala benzoate) u 30 mg pioglitazone (bħala hydrochloride).
English: Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Maltese: Kull pillola fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 12.5 mg alogliptin u 30 mg pioglitazone.
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 jitneħħew bl-emodijalisi (madwar 7% tas-sustanza tneħħiet matul sessjoni ta' emodijaliżi ta' 3 sigħat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 12.5 mg alogliptin (bħala benzoate) u 30 mg pioglitazone (bħala hydrochloride).
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Takeda Pharma A/S
English: Incresync tablets contain lactose.
Maltese: Il-pilloli ta' Incresync fihom lactose.
English: Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Maltese: Kull pillola miksija b'rita ta' 25 mg/45 mg fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 25 mg ta' alogliptin u 45 mg ta' pioglitazone.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Maltese: Kull pillola fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 12.5 mg alogliptin u 45 mg pioglitazone.
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Maltese: L-ogħla doża rapportata ta' 120 mg/jum għal erbat ijiem, imbagħad 180 mg/jum għal sebat ijiem ma kinetx assoċjata ma' xi sintomi.
English: In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Maltese: F'individwi b'saħħithom, alogliptin ma kellu l-ebda effett fuq il-prothrombin time jew International Normalised Ratio (INR) meta ngħata flimkien ma' warfarin.
English: and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Maltese: L-inċidenza globali ta' episodji ta' ipogliċemija severa kienet komparabbli f'pazjenti kkurati b'alogliptin 25 mg jew alogliptin 12.5 mg, u inqas mill-inċidenza f'pazjenti kkurati b'kontroll attiv jew plaċebo (0.1%, 0.1%, 0.4% u 0.4%, rispettivament).
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 > 9, ara sezzjoni 4.2).
English: Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side.
Maltese: Pilloli ħomor f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “25/45” stampati b'linka griża fuq naħa waħda.