FrancophonIA/ELRC3.0 huggingface dataset:
English: • H. pylori eradication in stomach and duodenum ulcer disease in combination with antibiotics,
Maltese: • qerda ta' H. pylori fil-mard ta' ulċeri tal-istonku u tad-duwodenu f'kombinazzjoni ma' antibijotiċi,
English: The CHMP acknowledged that the differences existed because of differences in the availability of, and pattern of resistance to, various antibiotics between Member States.
Maltese: Is-CHMP għaraf li d-differenzi jeżistu minħabba differenzi fid-disponibiltà ta', u l-mudell ta' reżistenza għal, antibijotiċi varji bejn Stati Membri.
English: Losec was also indicated for use before surgery to prevent acid aspiration (acid moving from the gullet into the lungs during anaesthesia, causing pneumonia).
Maltese: Losec kien indikat ukoll għall-użu qabel kirurġiji biex jipprevjeni l-aspirazzjoni tal-aċidu (aċidu jimxi mill-gerżuma għall-pulmuni waqt anestesija, u jikkawża polmonite).
English: • Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach).
Maltese: • sindromu ta' Zollinger-Ellison (kundizzjoni kkawżata minn produzzjoni eċċessiva ta' aċidu fl istonku).
English: However, if the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended while high doses of PPI should be avoided.
Maltese: Madankollu, jekk il-kombinazzjoni ta' atazanavir ma' PPI titqies inevitabbli, huwa rrakkomandat li jsir monitoraġġ kliniku mill-qrib (eż. ammont ta' virusijiet) filwaqt li jiġu evitati dożi għoljin ta' PPI.
English: • reflux oesophagitis (inflammation of the gullet, due to acid),
Maltese: • rifluss gastro-esofagali (infjammazzjoni tal-gerżuma, minħabba aċidu),
English: Losec can also be used for the prevention and treatment of the stomach ulcers that are caused by medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Maltese: Losec jista' jintuża wkoll għall-prevenzjoni u l-kura tal-ulċeri tal-istonku kkawżati minn mediċini użati għall-kura ta' uġigħ u infjammazzjonijiet msejħa mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs) mhux selettivi, fejn il-pazjent jeħtieġ kura kontinwa bl-NSAID.
English: The way the medicine is taken has been harmonised, clarifying the starting doses and maintenance doses for all the recommended indications.
Maltese: Il-mod ta' kif il-mediċina tittieħed ġie armonizzat, bid-dożi inizjali u d-dożi ta' manteniment għallindikazzjonijiet kollha rrakkomandati ikkjarifikati.
English: Together with antibiotics, it can be used to help rid the stomach of a bacterium called Helicobacter pylori (H. pylori), which is known to cause stomach ulcers.
Maltese: Flimkien ma' antibijotiċi, jista' jintuża biex jgħin lill-istonku jeħles minn batterju msejjaħ Helicobacter pylori (H. pylori), li huwa magħruf li jikkawża ulċeri tal-istonku.
English: • NSAID associated ulcers (treatment and prevention),
Maltese: • ulċeri assoċjati ma' NSAID (kura u prevenzjoni),
English: The CHMP also noted that there was some interaction with clopidogrel, but the clinical implications of this is not clear.
Maltese: Is-CHMP innota wkoll li kien hemm xi interazzjoni ma' clopidogrel, iżda l-implikazzjonijiet kliniċi ta' dan mhumiex ċari.
English: • stomach ulcers (treatment and prevention of relapse),
Maltese: • ulċeri tal-istonku (kura u prevenzjoni ta' rikaduta),
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Maltese: Din taħdem billi timblokka l-‘pompi tal-proton', proteini li jinstabu f'ċelloli speċjalizzati fil-kisja tal-istonku li jippompjaw aċidu fl-istonku.
English: • reflux oesophagitis (treatment, including long-term management after healing),
Maltese: • esofaġite ta' rifluss (kura, inkluż immaniġġar fit-tul wara fejqan),
English: The CHMP noted that, due to interactions, the concomitant use of PPIs may affect the efficacy of atazanavir and other HIV medications whose absorption is pH-dependent.
Maltese: Is-CHMP innota li, minħabba interazzjonijiet, l-użu konkomittanti ta' PPIs jista' jaffettwa l-effikaċja ta' atazanavir u ta' xi mediċini oħrajn tal-HIV li l-assorbiment tagħhom jiddependi fuq il-pH.
English: Why was Losec reviewed?
Maltese: Għaliex ġie rivedut Losec?
English: The European Medicines Agency has completed a review of Losec.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet ir-reviżjoni ta' Losec.
English: The Committee noted that there were differences between Member States regarding the use of Losec in H. pylori eradication treatment, especially with regards to the number of antibiotics to combine with Losec (either one or two), and the recommended antibiotics and their doses.
Maltese: Il-Kumitat innota li kien hemm differenzi bejn l-Istati Membri dwar l-użu ta' Losec fil-kura li teqred H. pylori, speċjalment fir-rigward tan-numru ta' antibijotiċi li jistgħu jiġu kkombinati ma' Losec (jew wieħed jew tnejn), u l-antibijotiċi rrakkomandati u d-dożi tagħhom.
English: The CHMP harmonised the SmPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
Maltese: Is-CHMP armonizza s-sezzjonijiet tal-SmPC dwar it-tqala u t-treddigħ, il-ħila biex issuq u tħaddem magni, effetti mhux mixtieqa u doża eċċessiva.
English: The CHMP agreed that the indications for the injectable form of Losec should be the same as for the tablets, but that the injection should only be used when the administration of the tablets or capsules is not possible.
Maltese: Ġiet armonizzata wkoll l-informazzjoni dwar kif jiġi ġestit l-għoti tal-mediċina f'pazjenti li ma jistgħux jibilgħu l-pilloli u l-kapsuli.
English: • heartburn and acid regurgitation in gastro-oesophageal reflux disease.
Maltese: • ħruq ta' stonku u regurġitazzjoni ta' aċidu f'marda ta' rifluss gastroesofagali.
English: The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used).
Maltese: Is-CHMP aċċetta wkoll formolazzjoni ta' kliem armonizzata għall-kontra-indikazzjonijiet (sitwazzjonijiet fejn il-mediċina ma għandiex tintuża).
English: By blocking the pumps, omeprazole reduces acid production.
Maltese: Minħabba li jimblokka l-pompi, omeprazole jnaqqas il-produzzjoni tal-aċidu.
English: • reflux oesophagitis,
Maltese: • esofaġite ta' rifluss,
English: ATC code: A10BD09.
Maltese: A10BD09.
English: (-infinity, -0.28)
Maltese: (-infinità, -0.28)
English: Placebo N=2,701 N=2,679
Maltese: Plaċebo N=2,701 N=2,679
English: (-infinity, -0.35)
Maltese: (-infinità, -0.35)
English: Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery
Maltese: Manifattur Takeda Ireland Limited Bray Business Park Kilruddery
English: Alogliptin is 20-30% bound to plasma proteins.
Maltese: Alogliptin huwa 20-30% marbut ma' proteini tal-plażma.
English: Absolute bioavailability is greater than 80%.
Maltese: Il-bijodisponibilità assoluta hi aktar minn 80%.
English: Elderly (≥ 65 years old)
Maltese: Anzjani (≥ 65 sena)
English: See section 2 “Incresync contains lactose”.
Maltese: Ara sezzjoni 2 “Incresync fih lactose”.
English: Frequency of adverse reactions Alogliptin Pioglitazone Incresync
Maltese: Frekwenza ta' reazzjonijiet avversi Alogliptin Pioglitazone Incresync
English: Carnauba wax Glycerol mono-oleate Glycerol mono-oleate
Maltese: Glycerol mono-oleate Glycerol mono-oleate
English: Alogliptin 25 mg
Maltese: 25 mg
English: Takeda Polska Sp. z o.o.
Maltese: Takeda Polska Sp. z o.o tel.
English: Co. Wicklow Ireland
Maltese: Wicklow L-Irlanda
English: Three of the six identified pioglitazone metabolites are active (M-II, M-III, and M-IV).
Maltese: Tlieta mis-sitt metaboliti identifikati ta' pioglitazone huma attivi (M-II, M-III, u M-IV).
English: Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 10, 14, 28, 30, 56, 60, 90, 98 jew 100 pillola miksija b'rita.
English: Risk related to pioglitazone
Maltese: Riskju relatat ma' pioglitazone
English: Incresync is available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets.
Maltese: Incresync huwa disponibbli f'pakketti b'folji li fihom 10, 14, 28, 30, 56, 60, 90, 98 jew 100 pillola.
English: Change at Week 52 (n=303)
Maltese: Bidla f'Ġimgħa 52 (n = 303)
English: Age, gender, race, body weight
Maltese: Età, sess, razza, piż tal-ġisem
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Maltese: Pioglitazone u l-metaboliti attivi huma estensivament marbuta ma' proteina fil-plażma (> 99%).
English: Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Ireland
Maltese: Bray Business Park Kilruddery Co Wicklow L-Irlanda
English: Effects of other medicinal products on alogliptin
Maltese: Effetti ta' prodotti mediċinali oħra fuq alogliptin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 September 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19/09/2013
English: Incresync contains lactose
Maltese: Incresync fih lactose
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Maltese: Żewġ metaboliti minuri nstabu wara l-għoti ta' doża orali ta' [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% tal-kompost ġenitur), u N-acetylated alogliptin, M-II (< 6% tal-kompost ġenitur).
English: This is similar to that seen in a sulphonylurea active comparator group.
Maltese: Dan huwa simili għal dak osservat fi grupp ta' komparatur attiv għal sulphonylurea.
English: Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke]
Maltese: Punt Finali Primarju Kompost [L-Ewwel Avveniment ta' Mewt CV, MI Mhux Fatali u Puplesija Mhux Fatali]
English: In studies in vitro, alogliptin was not an inhibitor of the following renal transporters; OAT1, OAT3 and OCT2.
Maltese: Fi studji in vitro, alogliptin ma kienx inibitur tat-trasportaturi tal-kliewi li ġejjin; OAT1, OAT3 u OCT2.
English: Risk related to alogliptin
Maltese: Riskju relatat ma' alogliptin
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Maltese: Ir-rati ta' edema għal gruppi komparaturi (sulphonylurea, metformin) kienu 2-5%.
English: Combination of alogliptin with other anti-diabetic medicinal products
Maltese: Kombinazzjoni ta' alogliptin ma' prodotti mediċinali antidijabetiċi oħra
English: In the alogliptin group, 12.7% (344 subjects) experienced an event within the secondary MACE composite endpoint, compared with 13.4% (359 subjects) in the placebo group [Hazard Ratio = 0.95; 1-sided 99% Confidence Interval: 0-1.14].
Maltese: Fil-grupp ta' alogliptin, 12.7% (344 individwu) kellhom episodju fi ħdan il-punt finali sekondarju kompost ta' MACE, meta mqabbel ma' 13.4% (359 individwu) fil-grupp tal-plaċebo [Proporzjon ta' Periklu = 0.95; Intervall ta' kunfidenza ta' 99% fuq naħa waħda: 0-1.14].
English: Similar changes were seen in metformin- (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea- and insulin- (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative-controlled studies with pioglitazone.
Maltese: Tibdiliet simili dehru f'metformin - (tnaqqis relattiv fl-emoglobina ta' 3-4% u fl-ematokrit ta' 3.6-4.1%) u fi grad anqas f'pazjenti trattati b'sulphonylurea u insulina (tnaqqis relattiv fl-emoglobina ta' 1-2% u fl-ematokrit ta' 1-3.2% relattiv) fi studji kliniċi kkontrollati bi pioglitazone.
English: Other medicines and Incresync
Maltese: Mediċini oħra u Incresync
English: - pioglitazone belongs to a group of medicines called thiazolidinediones.
Maltese: - pioglitazone jappartjeni għal grupp ta' mediċini msejħa thiazolidinediones.
English: Absorption The absolute bioavailability of alogliptin is approximately 100%.
Maltese: Assorbiment Il-bijodisponibilità assoluta ta' alogliptin hija ta' madwar 100%.
English: Results from alogliptin studies with metformin, pioglitazone (thiazolidinedione), voglibose (alphaglucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Maltese: Riżultati minn studji b'metformin, pioglitazone (thiazolidinedione), voglibose (impeditur alpha-glucosidase) u glyburide (sulphonylurea) ma wrew l-ebda interazzjoni farmakokinetika klinikament rilevanti.
English: In clinical studies, alogliptin had no clinically relevant effect on the pharmacokinetics of caffeine, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, an oral contraceptive (norethindrone and ethinyl oestradiol), digoxin, fexofenadine, metformin, or cimetidine, thus providing in vivo evidence of a low propensity to cause interaction with substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2.
Maltese: Fi studji kliniċi, alogliptin ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika tal-kaffeina, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, kontraċettiv orali (norethindrone u ethinyl oestradiol), digoxin, fexofenadine, metformin, jew cimetidine, u b'hekk ingħatat evidenza in vivo ta' tendenza baxxa għal reazzjonijiet interattivi ma' sottostrati ta' CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, u OCT2.
English: Following administration of an oral dose of [14C] alogliptin, 76% of total radioactivity was eliminated in the urine and 13% was recovered in the faeces.
Maltese: Wara l-għoti orali ta' [14C] alogliptin, 76% tar-radjuattività totali ġiet eliminata fl-awrina u 13% kienet irkuprata fl-ippurgar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/842/001-036
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/842/001-036
English: Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Maltese: Eliminazzjoni Alogliptin jiġi eliminat b'half-life terminali medju (T1/2) ta' madwar 21 siegħa.
English: Cardiac failure or history of cardiac failure (NYHA stages I to IV; see section 4.4) Hepatic impairment (see section 4.4)
Maltese: • Insuffiċjenza kardijaka jew storja ta' insuffiċjenza kardijaka (NYHA fi stadji minn I sa IV; ara sezzjoni 4.4)
English: In studies in vitro, alogliptin was found to be neither a substrate nor an inhibitor of key transporters associated with disposition of the active substance in the kidney: organic anion transporter-1, organic anion transporter-3 or organic cationic transporter-2 (OCT2).
Maltese: Studji in vitro, jissuġerixxu li alogliptin instab li la huwa sottostrat u lanqas impeditur ta' trasportaturi ewlenin assoċjati ma' disposizzjoni tas-sustanza attiva fil-kliewi: trasportatur anijoniku organiku-1, trasportatur anijoniku organiku-3 jew trasportatur katijoniku organiku-2 (OCT2 - organic cationic transporter-2).
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical studies with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Maltese: Każijiet ta' kanċer tal-bużżieqa tal-awrina kienu rrappurtati b'mod aktar frekwenti f'metaanaliżi ta' studji kliniċi kkontrollati bi pioglitazone (19-il każ minn 12,506 pazjent, 0.15%) milli fil-gruppi ta' kontroll (7 każi minn 10,212-il pazjent, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
English: Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing.
Maltese: Espożizzjoni totali (AUC(0-inf)) għal alogliptin wara l-għoti ta' doża waħda kien simili għall-espożizzjoni matul intervall ta' doża waħda (AUC(0-24)) wara 6 ijiem ta' dożaġġ ta' darba kuljum.
English: Film-coating
Maltese: Żieda fil-piż
English: No data are available (see section 4.2).
Maltese: Dejta mhux disponibbli (ara sezzjoni 4.2).
English: Mean baseline HbA1c (%) (SD)
Maltese: Linja bażi medja ta' HbA1c (%)(SD)
English: Cardiovascular Safety
Maltese: Sigurtà Kardjovaskulari
English: Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9.
Maltese: Alogliptin hu inibitur selettiv ħafna u potenti ta' DPP-4, >10,000 darba iktar selettiv għal DPP-4 minn enzimi oħrajn relatati li jinkludu DPP-8 u DPP-9.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Maltese: Kważi l-individwi kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi beta, impedituri għal enzima li tikkonverti angiotensin (ACE-angiotensin-converting-enzyme), antagonisti ta' angiotensin II, imblokkaturi tal-kanal tal-kalċju, nitrati, dijuretiċi, acetylsalicylic acid, statins, fibrates).
English: The study demonstrated that alogliptin did not increase the risk of having a MACE compared to placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16].
Maltese: L-istudju wera li alogliptin ma żiedx r-riskju li wieħed ikollu MACE meta mqabbel mal-plaċebo [Proporzjon ta' Periklu: 0.96; Intervall ta' Kunfidenza ta' 99% fuq naħa waħda: 0-1.16].
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: België/Belgique/Belgien/ Luxembourg/Luxemburg Takeda Belgium Tél/Tel:
English: In the alogliptin group, 11.3% of patients experienced a MACE compared to 11.8% of patients in the placebo group.
Maltese: Fil-grupp ta' alogliptin, 11.3% tal-pazjenti kellhom MACE meta mqabbel ma' 11.8% tal-pazjenti fil-grupp tal-plaċebo.
English: Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality)
Maltese: Mewt Karjdovaskulari* Infart Mijokardijaku Mhux Fatali Puplesija Mhux Fatali * B'kollox kien hemm 153 individwu (5.7%) fil-grupp ta' alogliptin u 173 individwu (6.5%) fil-grupp tal-plaċebo li mietu (mortalità minn kull kawża)
English: In vitro studies indicate that alogliptin does not induce CYP1A2, CYP2B6 and CYP2C9 and does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations achieved with the recommended dose of 25 mg alogliptin.
Maltese: Studji in vitro jindikaw li alogliptin ma jinduċix CYP1A2, CYP2B6 u CYP2C9 u ma jinibixxix CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP3A4 f'konċentrazzjonijiet miksuba bid-doża rakkomandata ta' 25 mg alogliptin.
English: A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis.
Maltese: Doża waħda ta' 50 mg alogliptin kienet mogħtija lil 4 gruppi ta' pazjenti bi gradi diversi ta' indeboliment tal-kliewi (CrCl permezz tal-formula Cockcroft-Gault): ħfief (CrCl = > 50 sa ≤ 80 mL/min), moderati (CrCl = ≥ 30 sa ≤ 50 mL/min), severi (CrCl = < 30 mL/min) u mard tal-kliewi tal-aħħar stadju fuq emodijalisi.
English: Iron oxide red (E172) Iron oxide red (E172) Iron oxide black (E172)
Maltese: Iron oxide red (E172) Iron oxide red (E172)
English: - alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Maltese: - alogliptin jappartjeni għal grupp ta' mediċini li jissejħu impedituri DPP-4 (impedituri ta' dipeptidyl peptidase-4).
English: Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Incresync (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluż is-sindrome ta' Stevens-Johnson, reazzjonijiet anafilattiċi, u anġjoedema huma serji u attribwiti għall-komponent ta' alogliptin f'Incresync (ara sezzjoni 4.4).
English: Table 2: Change in HbA1c (%) from baseline with alogliptin 25 mg at Week 26 by placebo-controlled study (FAS, LOCF)
Maltese: Tabella 2: Studju ta' bidla fl-HbA1c (%) mil-linja bażi ma' alogliptin 25 mg f'Ġimgħa 26 bilplaċebo bħala kontroll (FAS, LOCF)
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Maltese: 10 pilloli miksija b'rita 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita
English: Total and peak exposure to alogliptin increased proportionately across single doses of 6.25 mg up to 100 mg alogliptin (covering the therapeutic dose range).
Maltese: L-esponiment totali u massimu għal alogliptin żdiedu proporzjonalment f'dożi singoli ta' 6.25 mg sa 100 mg alogliptin (li jkopru medda ta' dożi terapewtiċi).
English: Table 1: Adverse reactions System organ class Adverse reaction
Maltese: Tabella 1: Reazzjonijiet avversi
English: Table 3: Change in HbA1c (%) from baseline with alogliptin 25 mg by active-controlled study (PPS, LOCF)
Maltese: Tabella 3: Studju dwar il-bidla fl-HbA1c (%) mil-linja bażi b'alogliptin 25 mg b'kontroll attiv (PPS, LOCF)
English: Distribution The estimated volume of distribution in humans is 19 L.
Maltese: Distribuzzjoni Il-volum stmat ta' distribuzzjoni fil-bnedmin huwa ta' 19 L.
English: Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Maltese: L-età (65-81 sena), is-sess tal-persuna, ir-razza (bojod, suwed u Asjatiċi) u l-piż tal-ġisem ma kellhom l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' alogliptin.
English: Studies in vitro have shown alogliptin to be a mild inducer of CYP3A4, but alogliptin has not been shown to induce CYP3A4 in studies in vivo.
Maltese: Studji in vitro wrew li alogliptin hu induttur ħafif ta' CYP3A4 iżda ma ntweriex li alogliptin jinduċi CYP3A4 fi studji in vivo.
English: Results from clinical interaction studies also demonstrate that there are no clinically relevant effects of gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 inhibitor), cyclosporine (a p-glycoprotein inhibitor), voglibose (an alpha-glucosidase inhibitor), digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin.
Maltese: Riżultati minn studji ta' interazzjoni klinika juru wkoll li m'hemm l-ebda effetti klinikament rilevanti ta' gemfibrozil (impeditur ta ‘CYP2C8/9), fluconazole (impeditur ta' CYP2C9), ketoconazole (impeditur ta' CYP3A4), cyclosporine (impeditur ta' p-glycoprotein), voglibose (impeditur ta' alfa-glucosidase), digoxin, metformin, cimetidine, pioglitazone jew atorvastatin fuq il-farmakokinetika ta' alogliptin.
English: Not known: - Visual disturbances (caused by a condition called macular oedema).
Maltese: • Disturbi fil-vista (ikkawżati minn kundizzjoni msejħa edema makulari).
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' impedituri ta' DPP-4 ġie assoċjat ma' riskju li jiżviluppa pankreatite akuta.
English: It is not known if alogliptin is removed by peritoneal dialysis.
Maltese: Mhux magħruf jekk alogliptin jiġix eliminat b'dijaliżi peritoneali.
English: Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.
Maltese: Wara t-tqegħid fis-suq kienu rrappurtati wkoll każijiet ta' edima periferali u insuffiċjenza kardijaka f'pazjenti li jużaw pioglitazone flimkien ma' mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inkluż inibituri selettivi ta' COX-2.