FrancophonIA/ELRC3.0 huggingface dataset:
English: In one-year clinical studies, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Maltese: Fi studji kliniċi ta' sena, pioglitazone konsistentament wera tnaqqis statistiku sinifikanti fil-proporzjon ta' albumina/kreatinina meta mqabbel mal-linja bażi.
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9 and 3A4 in man.
Maltese: M'hemm l-ebda induzzjoni tal-iżoenzimi induċibbli prinċipali ta' P450, 1A, 2C8/9 u 3A4 fil-bniedem.
English: The inter-subject coefficient of variation for alogliptin AUC was small (17%).
Maltese: Il-koeffiċjent ta' varjabilità bejn individwu u ieħor għal alogliptin AUC kien żgħir (17%).
English: What Incresync contains - The active substances are alogliptin and pioglitazone.
Maltese: X'fih Incresync - Is-sustanzi attivi huma alogliptin u pioglitazone.
English: Significantly more patients receiving 25 mg alogliptin plus 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: Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Maltese: Alogliptin jeżisti prinċipalment bħala l-(R)-enantiomer (> 99%) u jgħaddi minn ftit jew xejn konverżjoni kirali in vivo għall-(S)-enantiomer.
English: Use with other antihyperglycaemic medicinal products and hypoglycaemia
Maltese: Użu ma' prodotti mediċinali antipergliċemiċi oħra u l-ipogliċemija
English: Incresync combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and pioglitazone, a member of the thiazolidinedione class.
Maltese: Incresync jikkombina żewġ prodotti mediċinali li jaġixxu kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni kumplimentari u distinti biex jitjieb il-kontroll gliċemiku f'pazjenti b'dijabete mellitus ta' tip 2: alogliptin, impeditur ta' dipeptidyl-peptidase-4 (DPP-4), u pioglitazone, membru tal-klassi ta' thiazolidinediones.
English: Alogliptin as add-on therapy to pioglitazone with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Maltese: Alogliptin bħala terapija aġġuntiva ma' pioglitazone flimkien ma' metformin Iż-żieda ta alogliptin 25 mg darba kuljum ma' terapija bi 30 mg pioglitazone ma' metformin hydrochloride (doża medja = 1,867.9 mg) irriżultat f'titjib mil-linja bażi fl-HbA1c fil-Ġimgħa 52 li t-tnejn ma kinux inferjuri u statistikament superjuri għal dawk prodotti mit-terapija bi pioglitazone 45 mg u metformin (doża medja = 1,847.6 mg, Tabella 3).
English: At baseline, patients had a mean age of 61 years, mean duration of diabetes of 9.2 years, and mean HbA1c of 8.0%.
Maltese: Fil-linja bażi, il-pazjenti kellhom età medja ta' 61 sena, tul medju tad-dijabete ta' 9.2 snin, u HbA1c medju ta' 8.0%.
English: - if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
Maltese: • jekk qed tieħu mediċina antidijabetika magħrufa bħala sulphonylurea (eż. glipizide, tolbutamide, glibenclamide) jew insulina.
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 12.5 mg alogliptin, active-control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively).
Maltese: F'analiżi miġbura tat-tagħrif minn 12-il studju, l-inċidenza globali ta' kull episodju ta' ipogliċemija kien aktar baxx f'pazjenti kkurati b'alogliptin 25 mg milli f'pazjenti kkurati b'alogliptin 12.5 mg, kontroll attiv jew plaċebo (3.6%, 4.6%, 12.9% u 6.2%, rispettivament).
English: Alogliptin as add-on therapy to pioglitazone
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: Fluid retention and cardiac failure
Maltese: Żamma ta' fluwidi u insuffiċjenza kardijaka
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: Studji fil-bniedem jissuġġerixxu li m'hemm l-ebda induzzjoni tas-cytochrome prinċipali induċibbli P450, 1A, 2C8/9 u 3A4.
English: The mean serum elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Maltese: Il-medja tal-half-life ta' eliminazzjoni ta' pioglitazone mhux mibdul fis-serum fil-bniedem hi ta' 5 sa 6 sigħat u għall-metaboliti attivi tiegħu hija ta' bejn 16-il siegħa sa 23 siegħa.
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 in vitro u in vivo dwar il-ġenotossiċità.
English: Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Incresync (see section 4.4).
Maltese: Il-pankreatite akuta hija reazzjoni avversa serja attribwita għall-komponent ta' alogliptin f'Incresync (ara sezzjoni 4.4).
English: Date of latest renewal:
Maltese: Data tal-aħħar awtorizzazzjoni:
English: INFORMATION IN BRAILLE Incresync 25 mg/45 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Incresync 25 mg/45 mg
English: Steady-state pharmacokinetics is similar in patients aged 65 years and over and young subjects (see section 4.2).
Maltese: Il-farmakokinetika fl-istat fiss hija simili f'pazjenti li jkollhom 65 sena jew aktar u ż-żgħażagħ (ara sezzjoni 4.2).
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: Incresync is not a substitute for insulin in insulin-requiring patients.
Maltese: Incresync mhux sostitut għall-insulina f'pazjenti li jeħtieġu l-insulina.
English: In the prospective randomised controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
Maltese: Fl-istudju prospettiv, randomised u kkontrollat dwar riżultati kardjovaskulari, avvenimenti ta' ipogliċemija rrappurtati mill-investigatur kienu simili f'pazjenti li rċevew plaċebo (6.5%) u f'pazjenti li rċevew alogliptin (6.7%) flimkien ma' kura standard.
English: Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Maltese: Is-sintomi jistgħu jinkludu: tregħid, għaraq, ansjetà, vista mċajpra, xufftejn inemnmu, sfurija,
English: In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Maltese: Studji in vitro ma wrew l-ebda impediment fi kwalunkwe sottotip ta' cytochrome P450.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa ≤1/100), rari (≥1/10,000 sa ≤1/1,000), rari ħafna (≤ 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Maltese: Pioglitazone jgħaddi minn metaboliżmu epatiku estensiv ta' idroksilazzjoni tal-gruppi ta' methylene alifatiku.
English: Both of these groups of medicines are “oral anti-diabetics”.
Maltese: Dawn iż-żewġ gruppi ta' mediċini huma “antidijabetiċi orali”.
English: DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucosedependent 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 fid-degradazzjoni 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.
English: The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26- and 39-weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended daily dose of 25 mg alogliptin.
Maltese: Il-livell ta' effetti avversi mhux osservati (NOAEL - no-observed-adverse-effect level) fl-istudji dwar tossiċità b'doża ripetuta fil-firien u l-klieb għal tul ta' sa 26 u 39 ġimgħa, rispettivament, ipproduċa marġni ta' esponiment li kienu madwar 147 u 227 darba, rispettivament, tal-esponiment fil-bniedem fid-doża rakkomandata ta' 25 mg alogliptin.
English: In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
Maltese: Fl-istudju PROactive ta' 3.5 snin, 44/870 (5.1%) ta' nisa pazjenti kkurati bi pioglitazone esperjenzaw ksur meta mqabbla ma' 23/905 (2.5%) tal-pazjenti nisa kkurati bi prodott komparatur.
English: There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Maltese: Kien hemm 703 pazjent li kellhom avveniment fi ħdan il-punt finali sekondarju kompost ta' MACE (l-ewwel avveniment ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, puplesija mhux fatali u vaskularizzazzjoni urġenti mill-ġdid minħabba anġina mhux stabbli).
English: INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Incresync 12.5 mg/30 mg
English: There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Maltese: Kien hemm tnaqqis żgħir fl-emoglobina medja (tnaqqis relattiv ta' 4%) u ematokrit (tnaqqis relattiv ta' 4.1%) waqt terapija bi pioglitazone, konsistenti ma' emodilwizzjoni.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers and HMGCoA reductase inhibitors, are not to be expected.
Maltese: Interazzjonijiet b'sustanzi metabolizzati b'dawn l-enzimi, eż., kontraċettivi orali, cyclosporin, imblokkaturi tal-kanali tal-kalċju u impedituri ta' reductase HMGCoA, mhux mistennija jseħħu.
English: Investigations weight increased common alanine aminotransferase increased not known
Maltese: Investigazzjonijiet żieda fil-piż komuni żieda fil-alanine aminotransferase mhux magħruf
English: Diabetic ketoacidosis
Maltese: • Ketoaċidosi dijabetika
English: INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Incresync 12.5 mg/45 mg
English: Metabolism and nutrition disorders hypoglycaemia common common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni ipogliċemija komuni komuni
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara 5.3).
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Maltese: Jekk il-livelli ta' ALT jibqgħu > 3 x il-limitu ta' fuq tan-normal, it-terapija għandha titwaqqaf.
English: INFORMATION IN BRAILLE Incresync 25 mg/30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Incresync 25 mg/30 mg
English: Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medicinal product dose.
Maltese: Tnaqqis klinikament sinifikanti fl-HbA1c meta mqabbel mal-kontroll kien ukoll osservat irrispettivament mid-doża tal-prodott mediċinali fl-isfond tal-linja bażi.
English: Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 121 mg ta' lactose (bħala monohydrate).
English: Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing.
Maltese: L-inibizzjoni ta' DPP-4 baqgħet ogħla minn 81% wara 24 siegħa u wara 14-il jum ta' dożaġġ.
English: Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets
Maltese: Incresync 12.5 mg/30 mg pilloli miksija b'rita Incresync 12.5 mg/45 mg pilloli miksija b'rita Incresync 25 mg/30 mg pilloli miksija b'rita Incresync 25 mg/45 mg pilloli miksija b'rita
English: In addition, a prospective randomised cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Maltese: Barra dan, sar studju prospettiv u randomised dwar riżultati ta' sigurtà kardjovaskulari b'5,380 pazjent b'riskju kardjovaskulari eżistenti għoli biex jeżamina l-effett ta' alogliptin meta mqabbel mal-plaċebo (meta jiżdied ma' kura standard) fuq avvenimenti kardjovaskulari avversi maġġuri (MACE - major adverse cardiovascular events) inkluż iż-żmien sal-ewwel okkorrenza ta' kwalunkwe avveniment fil-kompożitu ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali u puplesija mhux fatali f'pazjenti b'avveniment koronarju akut reċenti (15 sa 90 jum).
English: Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
Maltese: Alogliptin huwa prinċipalment eliminat mhux mibdul fl-awrina u l-metaboliżmu bis-sistema ta' enzimi ta' cytochrome (CYP) P450 hu negliġibbli (ara sezzjoni 5.2).
English: Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with pioglitazone ± metformin or a sulphonylurea (n=195) FAS = full analysis set LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
Maltese: Studji b'terapija ta' kombinazzjoni aġġuntiva bil-plaċebo bħala kontroll Alogliptin 25 mg darba kuljum ma' pioglitazone  metformin jew sulphonylurea (n=195) FAS = full analysis set - sett ta' analiżi sħiħa LOCF = last observation carried forward - l-aħħar osservazzjoni mmexxija 'l quddiem †
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
Maltese: L-edima kienet irrappurtata f'6-9% tal-pazjenti kkurati bi pioglitazone fuq medda ta' sena fi studji kliniċi kkontrollati.
English: Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Maltese: Incresync 12.5 mg/30 mg pilloli miksija b'rita Incresync 12.5 mg/45 mg pilloli miksija b'rita Incresync 25 mg/30 mg pilloli miksija b'rita Incresync 25 mg/45 mg pilloli miksija b'rita alogliptin/pioglitazone
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 titneħħa bħala sustanza attiva mhux mibdula fl-awrina.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Maltese: Ir-rapporti ta' edima kienu ġeneralment minn ħfief sa moderati u normalment ma kinux jeħtieġu l-waqfien tat-trattament.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8)
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 jew storja medika ta' reazzjoni serja ta' sensittività eċċessiva, li tinkludi reazzjoni anafilattika, xokk anafilattiku, u anġjoedema, għal kwalunkwe inibituri ta' peptidyl-peptidase-4 (DPP-4) (ara sezzjonijiet 4.4 u 4.8)
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Maltese: Pioglitazone jidher li jaħdem permezz ta' attivazzjoni ta' riċetturi nukleari speċifiċi (peroxisome proliferator activated receptor gamma) li jwasslu għal żieda fis-sensittività tal-insulina tal-fwied, ix-xaħam u ċelluli tal-muskoli skeletriċi fl-annimali.
English: No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Maltese: L-ebda effetti relatati ma' alogliptin ma kienu osservati f'firien minorenni wara li ngħataw dożi ripetuti għal 4 u 8 ġimgħat.
English: To be eligible, patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Maltese: Biex ikunu eliġibbli, il-pazjenti ried ikollhom wieħed jew aktar minn dawn li ġejjin: infart mijokardijaku, puplesija, intervent kardijaku perkutanju jew bypass graft tal-arterja koronarja, sindromu koronarju akut, mard tal-arterja koronarja, jew mard ostruttiv tal-arterji periferali.
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone.
Maltese: L-għoti ta' pioglitazone flimkien ma' rifampicin (li jissensitizza cytochrome P450 2C8) huwa rrapportat li jirriżulta fi tnaqqis ta' 54% fl-AUC għal pioglitazone.
English: Total serum concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Maltese: Il-konċentrazzjoni totali ta' pioglitazone fis-serum ma nbidlitx, iżda kien hemm żieda fil-volum ta' distribuzzjoni.
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the serum concentration of pioglitazone (see section 4.5).
Maltese: L-għoti fl-istess ħin ta' pioglitazone ma' gemfibrozil (impeditur ta' cythochrome P450 2C8) jew ma' rifampicin (induttur taċ-ċitokrom P450 2C8) huwa rrappurtat li jżid jew inaqqas, rispettivament, il-konċentrazzjoni ta' pioglitazone fis-serum (ara sezzjoni 4.5).
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' kull episodju ta' ipogliċemija kienet simili f'pazjenti ta' ≥ 65 sena kkurati b'alogliptin 25 mg (3.8%) bħal dik ta' pazjenti ta' < 65 sena (3.6%).
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Maltese: Ebda żieda fil-rata ta' ksur ma kienet osservata f'irġiel ikkurati bi pioglitazone (1.3%) kontra l-komparatur (1.5%).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon or metformin.
Maltese: Studji dwar interazzjonijiet urew li pioglitazone m'għandu l-ebda effett relevanti la fuq il-farmakokinetika jew il-farmakodinamika ta' digoxin, warfarin, phenprocoumon jew metformin.
English: Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared to placebo whilst reductions were observed with metformin and gliclazide.
Maltese: Pioglitazone ma kkawżax żjieda statistikament sinifikanti fil-livelli ta' LDL-kolesterol meta mqabbel mal-plaċebo filwaqt li ġie osservat tnaqqis b'metformin u gliclazide.
English: Excipient(s) with known effect Each tablet contains 105 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 105 mg ta' lactose (bħala monohydrate).
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Maltese: Dawn l-effetti kienu indipendenti mill-effetti ta' pioglitazone fuq il-gliċemija u kienu differenti b'mod statistikament sinifikanti għal glibenclamide.
English: After excluding patients in whom exposure to the medicinal product was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Maltese: Wara li ġew esklużi pazjenti li fihom l-espożizzjoni għall-prodott mediċinali kien inqas minn sena fi żmien id-dijanjosi ta' kanċer tal-bużżieqa, kien hemm 7 każijiet (0.06%) fuq pioglitazone u 2 każijiet (0.02%) fil-gruppi tal-kontroll.
English: No adverse effects on fertility were observed in animal studies conducted with alogliptin (see section 5.3).
Maltese: L-ebda effetti avversi fuq il-fertilità ma kien osservat fi studju fuq annimali (ara sezzjoni 5.3).
English: A total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety.
Maltese: Total ta' 3,504 pazjenti b'dijabete mellitus ta' tip 2 li jinkludu 1,908 pazjenti kkurati b'alogliptin u pioglitazone, ipparteċipaw fl-4 studji ta' fażi 3 li kienu double-blind, b'kontrolli attivi jew bi plaċebo li saru biex jevalwaw l-effetti ta' alogliptin u pioglitazone mogħtija flimkien fuq il-kontroll gliċemiku u s-sigurtà tagħhom.
English: Immune system disorders hypersensitivity not known hypersensitivity and allergic reactions not known
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva mhux magħruf reazzjonijiet ta' sensittività eċċessiva u reazzjonijiet allerġiċi mhux magħruf
English: The following section outlines the interactions observed with the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Maltese: It-taqsima li ġejja tiddeskrivi fil-qosor l-interazzjonijiet osservati bil-komponenti individwali ta' Incresync (alogliptin/pioglitazone) kif irrapportat fis-Sommarju tal-Karatteristiċi tal-Prodott rispettiv tagħhom.