natgillin/translations-raw huggingface dataset:
Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Med spremljanjem pioglitazona v obdobju trženja so o primerih srčnega popuščanja poročali redko, vendar pogosteje, če je bil pioglitazon uporabljen v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi.
The co-administration of alogliptin and pioglitazone has been studied as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea) and as add-on therapy to metformin.
Sočasna uporaba alogliptina in pioglitazona je bila raziskana v okviru kombiniranega zdravljenja pri bolnikih, ki so se najprej zdravili samo s pioglitazonom (z metforminom ali s sulfonilsečnino ali brez), in v okviru dodatka k zdravljenju z metforminom.
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.
Rezultati kliničnih študij medsebojnega delovanja kažejo tudi, da gemfibrozil (zaviralec CYP2C8/9), flukonazol (zaviralec CYP2C9), ketokonazol (zaviralec CYP3A4), ciklosporin (zaviralec p-glikoproteina), vogliboza (zaviralec glukozidaze alfa), digoksin, metformin, cimetidin, pioglitazon ali atorvastatin nimajo klinično pomembnih učinkov na farmakokinetiko alogliptina.
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Med zdravljenjem s pioglitazonom so poročali o majhnem zmanjšanju povprečne koncentracije hemoglobina (relativno zmanjšanje za 4 %) in hematokrita (relativno zmanjšanje za 4,1 %), kar se sklada s hemodilucijo.
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.
V večini kliničnih študij so v primerjavi s placebom opažali zmanjšanje celotne koncentracije trigliceridov in prostih maščobnih kislin v plazmi ter povečanje koncentracije holesterola HDL, z majhnimi, a klinično nepomembnimi povečanji koncentracije holesterola LDL.
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).
O dogodku iz sklopa sekundarnega sestavljenega opazovanega dogodka MACE (prvi dogodek kardiovaskularne smrti, neusodnega miokardnega infarkta, neusodne možganske kapi in urgentne revaskularizacije zaradi nestabilne angine pektoris) so poročali pri 703 bolnikih.
The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
V študijah se je z alogliptinom/pioglitazonom zdravilo 1.269 bolnikov z blago okvaro ledvic in 161 bolnikov z zmerno okvaro ledvic.
Musculoskeletal and connective tissues disorders myalgia common fracture bone common
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija pogosti zlomi kosti pogosti
Adults (≥ 18 years old) The dose should be individualised on the basis of the patient's current treatment regimen
Odmerek zdravila je treba določiti pri vsakem bolniku posebej na osnovi bolnikovega trenutnega režima zdravljenja.
Gastrointestinal disorders abdominal pain common common gastroesophageal reflux disease common diarrhoea common dyspepsia common nausea common acute pancreatitis not known
Bolezni prebavil bolečina v trebuhu pogosti pogosti gastroezofagealni refluks pogosti diareja pogosti dispepsija pogosti navzea pogosti akutni pankreatitis neznana
Repeated dosing does not result in accumulation of the compound or metabolites.
Pri ponavljajočem se odmerjanju ne pride do kopičenja učinkovine ali presnovkov.
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).
Tako pri uporabi samega alogliptina v odmerku 25 mg kot tudi v kombinaciji s 30 mg pioglitazona so v 16. tednu ugotovili pomembno zmanjšanje postprandialne vrednosti glukoze in glukagona ob pomembnem povečanju postprandialnih vrednosti aktivnega GLP-1 v primerjavi s placebom (p<0,05).
In studies performed with the individual active substances, both alogliptin and pioglitazone were excreted in the milk of lactating rats.
Pri študijah, izvedenih s posameznima zdravilnima učinkovinama, sta se tako alogliptin kot pioglitazon izločala v mleko doječih podgan.
The risk of fractures should be considered in the long-term care of patients treated with Incresync (see section 4.8).
Pri dolgoročnem zdravljenju z zdravilom Incresync, je pri bolnikih treba upoštevati tveganje za zlome (glejte poglavje 4.8).
General disorders and administration site conditions oedema peripheral common weight increased common
Splošne težave in spremembe na mestu aplikacije periferni edem pogosti povečanje telesne mase pogosti
No adverse effects on fertility were observed in animal studies conducted with alogliptin (see section 5.3).
Pri študijah z alogliptinom pri živalih niso opazili neželenih učinkov na plodnost (glejte poglavje 5.3).
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy, thereby reducing the availability of metabolic substrates for foetal growth.
To je mogoče pripisati vplivu pioglitazona na zmanjšanje hiperinsulinemije pri samici in večji odpornosti proti insulinu med brejostjo, zaradi česar se zmanjša dostopnost presnovnih substratov za rast plodu.
LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
PPS = bolniki po protokolu (“per protocol set”) LOCF = prenos zadnjih opaženih vrednosti naprej (“last observation carried forward”) * Ne-inferiornost in superiornost statistično dokazana † Srednja vrednost najmanjših kvadratov, prilagojena gleda na predhodno antihiperglikemično zdravljenje in vrednosti v izhodišču
- if you suffer from heart disease or fluid retention.
• če imate bolezen srca ali težave z zastajanjem tekočine v telesu.
Mean baseline HbA1c (%) (SD)
Povprečna vrednost HbA1c v izhodišču (%) (SD)
Not known: - Visual disturbances (caused by a condition called macular oedema).
• Motnje vida (ki so posledica edema rumene pege).
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.
Za različne režime odmerjanja je zdravilo Incresync na voljo v različnih jakostih, in sicer v obliki 25 mg/30 mg, 25 mg/45 mg, 12,5 mg/30 mg in 12,5 mg/45 mg filmsko obloženih tablet.
In the cardiovascular outcomes study the rates of pancreatitis reports in patients treated with alogliptin or placebo were 3 or 2 events per 1,000 patient years, respectively.
V študiji kardiovaskularnih izidov je delež poročil o pankreatitisu pri bolnikih, ki so se zdravili z alogliptinom znašal 3, pri bolnikih, ki so prejemali placebo, pa 2 dogodka na 1.000 bolnikov-let.
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Pri mladih podganah pri ponavljajočem se odmerjanju v obdobju 4 in 8 tednov niso opazili vplivov, povezanih z uporabo alogliptina.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Pri sočasni uporabi rifampicina bo odmerek pioglitazona morda treba povečati.
Administration of Incresync with food resulted in no change in overall exposure to alogliptin or pioglitazone.
Pri uporabi zdravila Incresync skupaj s hrano se skupna izpostavljenost alogliptinu ali pioglitazonu ni spremenila.
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Pri bolnikih, predvsem ženskah, ki so jemali samo pioglitazon, so opazili večje število zlomov kosti.
Alogliptin may, therefore, be administered with or without food.
Alogliptin se tako lahko jemlje skupaj s hrano ali brez nje.
- if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
• če ste za uravnavanje vrednosti krvnega sladkorja že jemali druga podobna zdravila in se je pri tem pojavila huda alergijska reakcija.
As there is a need for dose adjustment of alogliptin in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis, appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.2).
Pri bolnikih z zmerno ali s hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo zdravljenje z dializo, je treba odmerek alogliptina prilagoditi, zato pred uvedbo zdravljenja z zdravilom Incresync in v rednih časovnih presledkih med zdravljenjem priporočamo izvedbo ustreznih preiskav za oceno delovanja ledvic (glejte poglavje 4.2).
Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose.
Čeprav vpliva na plodnost ni bilo, so pri samcih pri izpostavljenosti, ki je bila veliko večja od izpostavljenosti človeka pri priporočenem odmerku, opazili rahel statističen porast števila abnormalnih spermijev.
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).
V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (49,2 %), v primerjavi z bolniki, ki so prejemali placebo (34,0 %) (p=0,004).
If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
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.
V toksikoloških študijah so pri večkratnem odmerjanju pri miših, podganah, psih in opicah dosledno opažali povečanje plazemskega volumna s hemodilucijo, anemijo in reverzibilno ekscentrično hipertrofijo srca.
Following oral administration, pioglitazone is rapidly absorbed and peak serum concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Največje koncentracije nespremenjenega pioglitazona v serumu so običajno dosežene 2 uri po uporabi.
What Incresync is used for
Za kaj uporabljamo zdravilo Incresync
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Obseg teh zmanjšanj ni klinično pomemben, zato pri bolnikih z blago do zmerno okvaro jeter (ocena po Child-Pugh-u od 5 do 9) odmerka alogliptina ni treba prilagajati.
mood change or feeling confused.
• Zamegljen ali popačen vid.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and toxicology.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti ne kažejo posebnega tveganja za človeka.
The results of bioequivalence studies in healthy subjects demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Rezultati študij bioekvivalence pri zdravih osebah so pokazali, da so filmsko obložene tablete zdravila Incresync bioekvivalentne ustreznim odmerkom alogliptina in pioglitazona, sočasno uporabljenim v obliki ločenih tablet.
In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Poleg tega je bila povprečna sprememba vrednosti glukoze v plazmi na tešče glede na izhodiščno vrednost v 52. tednu pri uporabi alogliptina v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom pomembno večja od tiste pri uporabi 45 mg pioglitazona in metformina (p<0,001).
Iron oxide black (E172)
črni železov oksid (E172)
Administration with a high-fat meal resulted in no change in total and peak exposure to alogliptin.
Pri uporabi zdravila z obrokom z veliko vsebnostjo maščobe se skupna in največja izpostavljenost alogliptinu ni spremenila.
There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
V obdobju trženja so poročali o primerih srčnega popuščanja pri uporabi pioglitazona v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi.
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Vendar pa so rezultati študij bioekvivalence pokazali, da so filmsko obložene tablete zdravila Incresync bioekvivalentne ustreznim odmerkom alogliptina in pioglitazona, sočasno uporabljenim v obliki ločenih tablet.
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).
Za sočasno uporabo pioglitazona z gemfibrozilom (zaviralec citokroma P450 2C8) ali z rifampicinom (induktor citokroma P450 2C8) so poročali, da je prva kombinacija povečala, druga pa zmanjšala koncentracijo pioglitazona v serumu (glejte poglavje 4.5).
The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Farmakokinetika alogliptina pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
Effects of alogliptin on other medicinal products
Učinki alogliptina na druga zdravila
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
V obdobju trženja so bila pridobljena spontana poročila o pojavu akutnega pankreatitisa.
What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet:
Zdravilo Incresync v eni tableti združuje dve različni zdravilni učinkovini, imenovani alogliptin in pioglitazon:
Iron oxide yellow (E172)
rumeni železov oksid (E172)
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.
Študije in vitro kažejo, da alogliptin pri koncentracijah, doseženih s priporočenim odmerkom 25 mg alogliptina, ne inducira CYP1A2, CYP2B6 in CYP2C9 ter ne zavira CYP1A2, CYP2B6, CYP2C8,
Cardiac failure or history of cardiac failure (NYHA stages I to IV; see section 4.4) Hepatic impairment (see section 4.4)
• Srčno popuščanje ali anamneza srčnega popuščanja (razredi I do IV po NYHA, glejte poglavje 4.4).
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).
Alogliptin kot dodatek k zdravljenju s pioglitazonom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s pioglitazonom (povprečni odmerek = 35,0 mg, v kombinaciji z metforminom ali s sulfonilsečnino ali brez) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
If pancreatitis is suspected, Incresync should be discontinued; if acute pancreatitis is confirmed, Incresync should not be restarted.
Če je akutno vnetje trebušne slinavke potrjeno, se zdravljenja z zdravilom Incresync ne sme več uvesti.
Incresync is not a substitute for insulin in insulin-requiring patients.
Pri bolnikih, ki potrebujejo zdravljenje z insulinom, zdravilo Incresync ne more nadomestiti insulina.
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.
V 3,5-letni študiji kardiovaskularnega tveganja PROactive so o zlomu poročali pri 44 od 870 žensk, ki so se zdravile s pioglitazonom (5,1 %, 1,0 zloma na 100 bolnikov-let), in pri 23 od 905 žensk, ki so prejemale primerjalno zdravilo (2,5 %, 0,5 zloma na 100 bolnikov-let).
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.
Izvedena je bila združena analiza neželenih učinkov v obliki zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih študij, ki so trajala do 3,5 let in zajela več kot 8.100 bolnikov, ki so se zdravili s pioglitazonom, in 7.400 bolnikov, ki so se zdravili s primerjalnim zdravilom.
Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Klinične študije, izvedene z namenom ugotovitve učinkovitosti in varnosti zdravila Incresync, so vrednotile sočasno uporabo alogliptina in pioglitazona v obliki ločenih tablet.
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).
V združeni analizi podatkov iz 12 študij je bila skupna pojavnost kakršne koli epizode hipoglikemije manjša pri bolnikih, zdravljenih z alogliptinom v odmerku 25 mg (3,6 %), kot pri bolnikih, zdravljenih z alogliptinom v odmerku 12,5 mg (4,9 %), s kontrolnim zdravilom (12,9 %) ali placebom (6,2 %).
Nervous system disorders headache common common hypoaesthesia common insomnia uncommon
Bolezni živčevja glavobol pogosti pogosti hipestezija pogosti nespečnost občasni
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
V obdobju trženja so poročali o redkih primerih zvišanja vrednosti jetrnih encimov in hepatocelularne disfunkcije.
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
Incresync 12,5 mg/30 mg filmsko obložene tablete Incresync 12,5 mg/45 mg filmsko obložene tablete Incresync 25 mg/30 mg filmsko obložene tablete Incresync 25 mg/45 mg filmsko obložene tablete
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.
V kliničnih študijah, ki so trajale do dve leti, je pioglitazon v primerjavi s placebom, z metforminom ali gliklazidom znižal celotno koncentracijo plazemskih trigliceridov in prostih maščobnih kislin v plazmi ter povečal koncentracijo holesterola HDL.
Therefore, one tablet of 12.5 mg/30 mg or 12.5 mg/45 mg once daily, depending on the dose of pioglitazone already being taken, is recommended in patients with moderate renal impairment (see section 5.2).
Pri bolnikih z zmerno okvaro ledvic je tako priporočena uporaba ene tablete 12,5 mg/30 mg ali 12,5 mg/45 mg enkrat na dan, odvisno od odmerka pioglitazona, ki ga že jemljejo (glejte poglavje 5.2).
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).
V 52. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom (33,2 %), v primerjavi z bolniki, ki so prejemali 45 mg pioglitazona in metformin (21,3 %) (p<0,001).
Patients should, therefore, be made aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, Incresync treatment should be discontinued (see section 4.6).
Če bolnica želi zanositi ali če zanosi, je treba zdravljenje z zdravilom Incresync prekiniti (glejte poglavje 4.6).
The decision whether to continue the patient on therapy with Incresync should be guided by clinical judgement pending laboratory evaluations.
Dokler laboratorijski izvidi niso na voljo, se je o nadaljevanju zdravljenja z zdravilom Incresync treba odločiti po klinični presoji.
INFORMATION IN BRAILLE Incresync 25 mg/45 mg
PODATKI V BRAILLOVI PISAVI Incresync 25 mg/45 mg
Other reactions such as upper respiratory tract infections, sinusitis, headache, hypoglycaemia, nausea, weight increase and oedema may occur commonly (≥ 1/100 to
Pogosto (≥ 1/100 do < 1/10) se lahko pojavijo druge reakcije, kot so okužbe zgornjih dihal, sinuzitis, glavobol, hipoglikemija, navzea, povečanje telesne mase in edemi.
Due to its pioglitazone component, Incresync should not be used in patients with hepatic impairment (see section 4.2).
Pri bolnikih z okvaro jeter se zdravila Incresync zaradi vsebnosti pioglitazona ne sme uporabljati (glejte poglavje 4.2).
These patients may be at risk of pregnancy.
Pri takšnih bolnicah lahko obstaja možnost zanositve.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone.
Poročali so, da se je pri sočasni uporabi pioglitazona in rifampicina (induktor citokroma P450 2C8) vrednost AUC pioglitazona zmanjšala za 54 %.
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
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
Incresync 12,5 mg/30 mg filmsko obložene tablete Incresync 12,5 mg/45 mg filmsko obložene tablete Incresync 25 mg/30 mg filmsko obložene tablete Incresync 25 mg/45 mg filmsko obložene tablete alogliptin/pioglitazon
The pharmacokinetics of pioglitazone in children and adolescents < 18 years old has not been established.
Farmakokinetika pioglitazona pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
Clinical studies conducted to support the efficacy of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Klinične študije, izvedene z namenom ugotovitve učinkovitosti zdravila Incresync, so vrednotile sočasno uporabo alogliptina in pioglitazona v obliki ločenih tablet.
An approximate 1.7-fold increase in AUC for alogliptin was observed in patients with mild renal impairment.
Pri bolnikih z blago okvaro ledvic je bilo opaženo približno 1,7-kratno povečanje vrednosti AUC alogliptina.
No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2).
Pri bolnikih z blago okvaro ledvic odmerka zdravila Incresync ni treba prilagajati (glejte poglavje 4.2).
Incresync should be discontinued if any deterioration in cardiac status occurs.
Če se pojavi kakršno koli poslabšanje srčnega statusa, je treba zdravljenje z zdravilom Incresync prekiniti.