FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 14,779 patients with type 2 diabetes mellitus, including 6,448 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, participated in one phase 2 or 13 phase 3 (including the cardiovascular outcomes study) double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of alogliptin on glycaemic control and its safety.
Maltese: Total ta' 14,779 pazjent b'dijabete mellitus ta' tip 2, li jinkludu 6,448 pazjent ikkurati b'alogliptin 25 mg u 2,476 pazjent ikkurati b'alogliptin 12.5 mg, ipparteċipaw fi studju wieħed ta' fażi 2 jew 13-il studju ta' fażi 3 (inkluż l-istudju dwar riżultati kardjovaskulari) li kienu double-blind, ikkontrollati bi plaċebo jew ikkontrollati b'mod attiv li saru biex jiġi evalwat l-effett ta' alogliptin fuq il-kontroll gliċemiku u s-sigurtà tiegħu.
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: Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Maltese: Kull pillola ta' 12.5 mg fiha alogliptin benzoate ekwivalenti għal 12.5 mg ta' alogliptin - Is-sustanzi mhux attivi l-oħra huma: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac u black iron oxide (E172).
English: No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Maltese: L-ebda effett relatat ta' alogliptin ma kien osservat f'firien minorenni wara l-għoti ta' dożi ripetuti għal 4 u 8 ġimgħat.
English: NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 25 mg film-coated tablets
Maltese: Vipidia 6.25 mg pilloli miksija b'rita Vipidia 12.5 mg pilloli miksija b'rita Vipidia 25 mg pilloli miksija b'rita
English: What Vipidia contains - The active substance is alogliptin.
Maltese: X'fih Vipidia - Is-sustanza attiva hi alogliptin.
English: The recommended dose of alogliptin is one tablet of 25 mg once daily as add-on therapy to metformin, a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy with metformin and a thiazolidinedione or insulin.
Maltese: Id-doża rakkomandata ta' alogliptin hija ta' pillola waħda ta' 25 mg darba kuljum bħala terapija miżjuda ma' metformin, thiazolidinedione, sulphonylurea, jew l-insulina jew bħala terapija tripla ma' metformin u thiazolidinedione jew insulina.
English: Vipidia 25 mg film-coated tablets
Maltese: Vipidia 25 mg pilloli alogliptin
English: In a pooled analysis of the data from 13 studies, the overall incidences of adverse events, serious adverse events and adverse events resulting in discontinuation of therapy were comparable in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo.
Maltese: F'analiżi miġbura tat-tagħrif minn 13-il studju, l-inċidenzi globali ta' każijiet avversi, każijiet avversi serji u każijiet avversi li jirriżultaw fit-twaqqif ta' terapija kienu komparabbli f'pazjenti trattati b'25 mg alogliptin, 12.5 mg alogliptin, kontroll attiv jew plaċebo.
English: If an abnormality is found and an alternative etiology is not established, consider discontinuation of alogliptin treatment.
Maltese: Jekk tinstab anormalità u etjoloġija alternattiva ma tiġix stabbilita, ikkunsidra l-waqfien tal-kura b'alogliptin.
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: 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 wara t-tqegħid fis-suq.
English: Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.4 and 5.2).
Maltese: Alogliptin ma ġiex studjat f'pazjenti li jagħmlu dijalisi tal-peritonew (ara sezzjonijiet 4.4 u 5.2).
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 tat-tagħrif minn 12-il studju, l-inċidenza globali ta' kull episodju ta' ipogliċemija kienet simili f'pazjenti ta' ≥ 65 sena kkurati b'alogliptin 25 mg (3.8%) għal dik f'pazjenti ta' < 65 sena (3.6%).
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,835 mg) resulted in improvements from baseline in HbA1c at Week 52 and Week 104.
Maltese: Iż-żieda ta' 25 mg alogliptin darba kuljum ma' terapija ta' metformin hydrochloride (doża medja = 1,835 mg) irriżultat f'titjib mil-linja bażi f'HbA1c f'Ġimgħa 52 u Ġimgħa 104.
English: 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Maltese: B'mod sinifikanti aktar pazjenti li rċevew alogliptin 25 mg flimkien ma' pioglitazone 30 mg u metformin (33.2%) kisbu livelli fil-mira tal-livelli ta' HbA1c ta' ≤ 7.0% meta mqabbla ma' dawk li rċevew pioglitazone 45 mg u metformin (21.3%) f'Ġimgħa 52 (p <0.
English: Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.
Maltese: Vipidia 12.5 mg pilloli miksija b'rita Kull pillola fiha alogliptin benzoate ekwivalenti għal 12.5 mg alogliptin.
English: The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Maltese: Il-farmakokinetika ta' alogliptin fi tfal u adolexxenti ta' <18-il sena għadha ma ġietx determinata s'issa.
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 talawrina 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: Treatment-corrected change from baseline in HbA1c (%)†
Maltese: Bidla mil-linja bażi kkoreġuta bit-trattament f'HbA1c (%)†
English: Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged active substance in the urine.
Maltese: Alogliptin ma jgħaddix minn metaboliżmu estensiv, b'60-70% tad-doża li titneħħa fl-awrina bħala sustanza attiva mhux mibdula.
English: For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets.
Maltese: Għall-korsijiet ta' doża differenti, Vipidia hu disponibbli f'qawwiet ta' pilloli miksija b'rita ta' 25 mg, 12.5 mg u 6.25 mg.
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 fl-istudji kliniċi kienu dożi waħidhom 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: Vipidia 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin.
Maltese: Vipidia 6.25 mg pilloli miksija b'rita Kull pillola fiha alogliptin benzoate ekwivalenti għal 6.25 mg alogliptin.
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 flHbA1c 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: Adverse reaction Infections and infestations upper respiratory tract infections common nasopharyngitis common
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju komuni nażofarinġite 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 lplaċebo (34.0%) f'Ġimgħa 26 (p=0.004).
English: For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered (12.5 mg once daily; see section 5.2).
Maltese: Għal pazjenti b'indeboliment tal-kliewi moderat (CrCl ≥ 30 sa ≤ 50 mL/min), nofs id-doża rakkomandata ta' alogliptin għandha tingħata (12.5 mg darba kuljum; ara sezzjoni 5.2).
English: The studies included 5,744 patients with mild renal impairment, 1,290 patients with moderate renal impairment and 82 patients with severe renal impairment / end-stage renal disease treated with alogliptin.
Maltese: L-istudji kienu jinkludu 5,744-il pazjent b'indeboliment tal-kliewi ħafif, 1,290 pazjent b'indeboliment tal-kliewi moderat u 82 pazjent b'indeboliment tal-kliewi sever/mard tal-kliewi tal-aħħar stadju kkurati b'alogliptin.
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: - Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side.
Maltese: - Il-pilloli miksija b'rita ta' Vipidia 6.25 mg huma ta' lewn roża ċar, f'għamla ovali (madwar 9.1 mm twal b'5.1 mm wiesgħa), imżaqqin fuq iż-żewġ naħat b'“TAK” u “ALG-6.25” stampati bil-griż fuq naħa waħda.
English: Higher rates of hypoglycaemia were observed with triple therapy with 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 ma' insulina, kif osservat b'impedituri oħra ta' DPP-4.
English: The safety and efficacy of Vipidia in children and adolescents < 18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vipidia fi tfal u adolexxenti ta' <18-il sena għadhom ma ġewx determinati s'issa.
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 jimpedixxix u lanqas jinduċi l-iżoformi ta' CYP 450 f'konċentrazzjonijiet miksuba bid-doża rakkomandata ta' 25 mg alogliptin (ara sezzjoni 5.2).
English: Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002).
Maltese: B'mod sinifikanti aktar pazjenti li kienu qed jirċievu 25 mg alogliptin (34.8%) kisbu livelli fil-mira ta' HbA1c ta' ≤ 7.0% meta mqabbla ma' dawk li rċevew plaċebo (18.2%) f'Ġimgħa 26 (p = 0.002).
English: Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.
Maltese: Vipidia 25 mg pilloli miksija b'rita Kull pillola fiha alogliptin benzoate ekwivalenti għal 25 mg alogliptin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate).
Maltese: Kull pillola fiha 12.5 mg alogliptin (bħala benzoate).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 6.25 mg alogliptin (as benzoate).
Maltese: Kull pillola fiha 6.25 mg alogliptin (bħala benzoate).
English: DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucose-dependent insulinotropic polypeptide), which are released by the intestine and levels are increased in response to a meal.
Maltese: DPP-4 hu l-enzima prinċipali involuta fiddegradazzjoni mgħaġġla tal-ormoni ta' incretin, glucagon-like peptide-1 (GLP-1) u GIP (polypeptide insulinotropika li tiddependi fuq il-glucose), li jintreħew mill-imsaren u l-livelli jiżdiedu b'rispons għal xi ikla. 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: Vipidia is not a substitute for insulin in insulin-requiring patients.
Maltese: Vipidia mhux sostitut għall-insulina f'pazjenti li jeħtieġu l-insulina.
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.
English: This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
Maltese: Dan kien iddeterminat bi tnaqqis klinikament rilevanti u statistikament sinifikanti fl-emoglobina glikosilata (HbA1c) u fil-glukosju fil-plażma fl-istat sajjem meta mqabbel ma' kontroll mil-linja bażi sal-punt aħħari tal-istudju.
English: No data are available (see section 4.2).
Maltese: M'hemm l-ebda data disponibbli (ara sezzjoni 4.2).
English: In the pooled pivotal phase 3 controlled clinical studies of alogliptin as monotherapy and as add-on combination therapy involving 5,659 patients, the observed adverse reactions are listed below (Table 1).
Maltese: Fi studji kliniċi kkontrollati, miġbura, u importanti ħafna ta' fażi 3 ta' alogliptin bħala terapija waħedha u bħala terapija kombinata aġġuntiva li kienu jinvolvu 5,659 pazjent, ir-reazzjonijiet avversi osservati huma elenkati hawn taħt (Tabella 1).
English: By Week 104, mean change from baseline in fasting plasma glucose for 25 mg alogliptin and metformin was -3.2 mg/dL compared with 5.4 mg/dL for glipizide and metformin.
Maltese: 001). Sa Ġimgħa 104, il-bidla medja mil-linja bażi fil-glucose fil-plażma waqt is-sawm għal 25 mg alogliptin u metformin kienet ta' -3.2 mg/dL meta mqabbel ma' 5.4 mg/dL għal glipizide u metformin.
English: Experience of alogliptin use in clinical studies in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
Maltese: III u IV ta' New York Heart Association (NYHA) hija limitata u kawtelahija meħtieġa f'dawn il-pazjenti.
English: It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.
Maltese: Għandu jittieħed flimkien ma' mediċini antidijabetiċi oħra, li t-tabib tiegħek ikun ippreskriva lilek, bħal sulphonylureas (eż. glipizide, tolbutamide, glibenclamide), metformin u/jew thiazolidinediones (eż. pioglitazone) u metformin u/jew l-insulina.
English: Alogliptin as add-on therapy to 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 miżjuda ma' thiazolidinedione Iż-żieda ta' alogliptin 25 mg darba kuljum ma' terapija bi pioglitazone (doża medja = 35.0 mg, bi jew mingħajr metformin jew sulphonylurea) irriżultat f'titjib statistikament sinifikanti mil-linja bażi flHbA1c u fil-glukosju fil-plażma wara s-sawm f'Ġimgħa 26 meta mqabbel maż-żieda ta' plaċebo (Tabella 2).
English: No adverse effects of alogliptin were observed upon fertility, reproductive performance, or early embryonic development in rats up to a systemic exposure far above the human exposure at the recommended dose.
Maltese: L-ebda effetti avversi ta' alogliptin ma kienu osservati fuq il-fertilità, prestazzjoni riproduttiva jew żvilupp embrijoniku bikri fil-firien sa esponiment sistemiku ferm ogħla mill-esponiment tal-bniedem fid-doża rrakkomandata.
English: - Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side.
Maltese: - Il-pilloli miksija b'rita ta' Vipidia 12.5 mg huma ta' lewn safrani, f'għamla ovali (madwar 9.1 mm twal b'5.1 mm wiesgħa), imżaqqin fuq iż-żewġ naħat b'“TAK” u “ALG-12.5” stampati b'linka griża fuq naħa waħda.
English: Importantly, despite alogliptin and glipizide having similar HbA1c and fasting plasma glucose changes from baseline, episodes of hypoglycaemia were notably less frequent in patients receiving 25 mg alogliptin (5.4%) compared to those receiving glipizide (26.0%).
Maltese: B'mod importanti, minkejja li alogliptin u glipizide għandhom bidliet fl-HbA1c u fil-glukosju fil-plażma wara s-sawm simili mil-linja bażi, każijiet ta' ipogliċemija kienu notevolment inqas frekwenti f'pazjenti li kienu qed jirċievu 25 mg alogliptin (5.4%) meta mqabbla ma' dawk li kienu qed jirċievu glipizide (26.0%).
English: Mean change from baseline in fasting plasma glucose at Week 26 for 25 mg alogliptin showed a reduction of 8.4 mg/dL compared to an increase of 2.2 mg/dL with placebo.
Maltese: Bidla medja mil-linja bażi fil-glukosju fil-plażma wara s-sawm f'Ġimgħa 26 għal alogliptin 25 mg uriet tnaqqis ta' 8.4 mg/dL meta mqabbel ma' żieda ta' 2.2 mg/dL mal-plaċebo.
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 għola b'mod sinjifikanti l-livell attiv ta' GLP-1 wara l-ikel f'Ġimgħa 16 meta mqabbel mal-plaċebo (p<0.05).
English: NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg tablets alogliptin
Maltese: Vipidia 12.5 mg pilloli miksija b'ritas alogliptin
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 ta' alogliptin, 12.5 mg ta' alogliptin, kontroll attiv jew plaċebo kienu 2, 1, 1 jew 0 każijiet rispettivament għal kull 1,000 sena ta' pazjent.
English: Overall, treatment with the recommended daily dose of 25 mg alogliptin improved glycaemic control when given as monotherapy and as initial or add-on combination therapy.
Maltese: Kollox ma' kollox, it-trattament bid-doża rakkomandata ta' kuljum ta' 25 mg alogliptin tejbet il-kontroll gliċemiku meta mogħtija bħala monoterapija u bħala terapija kombinata inizjali jew aġġuntiva.
English: What Vipidia looks like and contents of the pack - Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side.
Maltese: Kif jidher Vipidia u l-kontenut tal-pakkett - Il-pilloli miksija b'rita ta' Vipidia 25 mg huma ta' lewn ħamrani ċar, f'għamla ovali (madwar 9.1 mm twal b'5.1 mm wiesgħa), imżaqqin fuq iż-żewġ naħat, b'“TAK” u “ALG-25” stampati b'linka griża fuq naħa waħda.
English: However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin.
Maltese: Madankollu, il-pazjenti għandhom ikunu mwissija dwar ir-riskju ta' ipogliċemija speċjalment meta jintuża f'kombinazzjoni ma' sulphonylurea, insulina jew terapija kombinata ma' thiazolidinedione u metformin.
English: NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg tablets alogliptin
Maltese: Vipidia 6.25 mg pilloli miksija b'rita alogliptin
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 mas-sottogruppi differenti li jinkludu indeboliment fil-kliewi, età, sess u l-indiċi tal-massa tal-ġisem, filwaqt li d-differenzi bejn irrazez (eż. Bojod u mhux Bojod) kienu żgħar.
English: Due to the increased risk of hypoglycaemia in combination with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin, a lower dose of these medicinal products may be considered to reduce the risk of hypoglycaemia when these medicinal products are used in combination with alogliptin (see section 4.2).
Maltese: Minħabba r-riskju miżjud ta' ipogliċemija flimkien ma' sulphonylurea, insulina jew terapija kombinata b'thiazolidinedione u metformin, doża aktar baxxa ta' dawn il-prodotti mediċinali tista' titqies li tnaqqas ir-riskju ta' ipogliċemija meta dawn il-prodotti mediċinali jintużaw flimkien ma' alogliptin (ara sezzjoni 4.2).
English: For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of alogliptin is necessary (see section 5.2).
Maltese: Għal pazjenti b'indeboliment renali ħafif (tneħħija ta' kreatinina (CrCl) > 50 sa ≤ 80 mL/min), l-ebda aġġustament fid-doża ta' alogliptin ma huwa meħtieġ (ara sezzjoni 5.2).