natgillin/translations-raw huggingface dataset:
Incresync should not be used in patients with type 1 diabetes mellitus.
Incresync se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa
Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Simptomi mogu uključivati: drhtavicu, znojenje, tjeskobu, zamućen vid, trnce u usnicama,
Film-coating
Film-ovojnica
Carnauba wax Glycerol mono-oleate Glycerol mono-oleate
karnauba vosak karnauba vosak glicerolmonooleat glicerolmonooleat
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week study in type 2 diabetics.
Učinak pioglitazona (45 mg monoterapija naspram placeba) ispitivao se u malom ispitivanju u trajanju od 18 tjedana u bolesnika sa šećernom bolešću tipa
Incresync may, therefore, be administered with or without food.
Incresync se stoga može primijeniti s hranom ili bez nje.
Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Pioglitazon nije pokazao genotoksični potencijal u sveobuhvatnom setu testova genotoksičnosti in vivo i in vitro.
Caution should be exercised in patients with a history of pancreatitis.
Nužan je oprez u bolesnika s pankreatitisom u anamnezi.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Incresync.
Kad uzimate Incresync možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
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.
Nisu opažene nuspojave na plodnost, reprodukciju ili rani embrionalni razvoj štakora sve do sistemske izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi.
No information is available on pioglitazone and alogliptin use in dialysed patients and, therefore, co-administered alogliptin plus pioglitazone should not be used in such patients (see sections 4.2 and 5.2).
Budući da nema dostupnih informacija o primjeni pioglitazona i alogliptina kod bolesnika na dijalizi, kod njih se alogliptin i pioglitazon ne smiju primjenjivati istodobno. (vidjeti dijelove 4.2 i 5.2).
Table 3: Change in HbA1c (%) from baseline with alogliptin 25 mg by active-controlled study (PPS, LOCF)
Tablica 6: Promjena HbA1c (%) od početne vrijednosti za alogliptin 25 mg u ispitivanju kontroliranom aktivnom kontrolom (PPS, LOCF)
Mean baseline HbA1c (%) (SD)
Srednja početna vrijednost HbA1c (%) (SD)
Animal studies of up to 13-weeks duration have been conducted with the combined substances in Incresync.
Kombinirane tvari sadržane u lijeku Incresync ispitane su u ispitivanjima na životinjama u trajanju od 13 tjedana.
In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing anti-diabetic and cardiovascular therapy, for up to 3.5 years.
U PROactive ispitivanju kardiovaskularnih ishoda, 5238 bolesnika sa šećernom bolešću tipa 2 i već postojećom velikom makrovaskularnom bolešću bilo je randomizirano u skupinu koja je primala pioglitazon i onu koja je primala placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju u trajanju do 3,5 godine.
It is recommended, therefore, that patients treated with Incresync undergo periodic monitoring of liver enzymes.
Stoga se u bolesnika liječenih Incresyncom preporučuje povremeno pratiti jetrene enzime.
Incresync is not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
Incresync se ne preporučuje bolesnicima s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili završnim stadijem bolesti bubrega koji zahtijevaju dijalizu.
No adverse effects on fertility were observed in animal studies conducted with alogliptin (see section 5.3).
U ispitivanjima na životinjama provedenim s alogliptinom nisu opažene nuspojave na plodnost (vidjeti dio 5.3).
There is no experience of using Incresync in pregnant women or during breast-feeding.
Nema iskustava s primjenom lijeka Incresync u trudnica ili tijekom dojenja.
Fasting and postprandial glycaemic control is improved following treatment with pioglitazone in patients with type 2 diabetes mellitus.
Poboljšava se kontrola glikemije natašte i nakon obroka nakon liječenja pioglitazonom u bolesnika sa šećernom bolešću tipa
There are no data from the use of Incresync in pregnant women.
Nema podataka o primjeni Incresynca u trudnica.
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).
In vitro ispitivanja pokazuju da, u koncentracijama koje se postižu preporučenom dozom od 25 mg alogliptina ne inhibira niti inducira CYP 450 izoenzime (vidjeti dio 5.2).
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).
S obzirom na potrebu prilagodbe doze alogliptina u bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega koji zahtijeva dijalizu, prije početka i povremeno tijekom liječenja Incresyncom potrebna je odgovarajuća procjena funkcije bubrega (vidjeti dio 4.2).
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double-blind clinical studies in over 8,100 pioglitazoneand 7,400 comparator-treated patients, on treatment for up to 3.5 years.
Povećana incidencija prijeloma kostiju u žena opažena je u analizi objedinjenih podataka o prijelomima kostiju kao nuspojave u randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima na više od 8100 bolesnika liječenih pioglitazonom i 7400 bolesnika liječenih usporednim lijekom u trajanju do 3,5 godine.
Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis (see section 4.2).
Incresync se ne preporučuje bolesnicima sa teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega koji zahtijeva dijalizu (vidjeti dio 4.2).
No dose adjustment is necessary based on age (see section 4.4).
Nije potrebna prilagodba doze s obzirom na dob (vidjeti dio 4.4).
Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Pokazalo se da liječenje pioglitazonom smanjuje otpuštanje glukoze iz jetre i povećava perifernu dostupnost glukoze u slučaju inzulinske rezistencije.
See leaflet for further information.
Time se omogućuje brzo otkrivanje novih sigurnosnih informacija.
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.
U PROactive ispitivanju u trajanju od 3,5 godine, 44/870 (5,1%) bolesnica liječenih pioglitazonom doživjelo je prijelome u usporedbi s 23/905 (2,5%; %) bolesnica liječenih usporednim lijekom.
In a pooled analysis of the data from 13 studies, the overall incidences of cardiovascular death, non fatal myocardial infarction and non-fatal stroke were comparable in patients treated with 25 mg alogliptin, active control or placebo.
U analizi objedinjenih podataka iz 13 ispitivanja, ukupne incidencije kardiovaskularne smrti, infarkta miokarda bez smrtnog ishoda i moždanog udara bez smrtnog ishoda bile su usporedive u bolesnika liječenih s 25 mg alogliptina, aktivnom kontrolom ili placebom.
Table 2: Change in HbA1c (%) from baseline with alogliptin 25 mg at Week 26 by placebo-controlled study (FAS, LOCF)
Tablica 5: Promjena HbA1c (%) od početne vrijednosti za alogliptin 25 mg u 26. tjednu u ispitivanju kontroliranom placebom (FAS, LOCF)
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
In vitro ispitivanja nisu dokazala da pioglitazon inhibira bilo koji podtip citokroma P450.
For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered.
Za bolesnike s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 do ≤ 50 ml/min) potrebno je primijeniti polovicu preporučene doze alogliptina.
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.
U PROactive ispitivanju kardiovaskularnog rizika u trajanju od 3,5 godine, 44/870 (5,1%; 1,0 prijelom na 100 bolesnik-godina) bolesnica liječenih pioglitazonom imalo je prijelome u usporedbi s 23/905 (2,5%; 0,5 prijeloma na 100 bolesnik-godina) bolesnica liječenih usporednim lijekom.
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.
U usporednim kontroliranim ispitivanjima pioglitazona slične su promjene opažene u bolesnika liječenih metforminom (relativno smanjenje hemoglobina za 3-4% i hematokrita za 3,6-4,1%) i u manjoj mjeri u bolesnika liječenih sulfonilurejom i inzulinom (relativno smanjenje hemoglobina za 1-2% i hematokrita za 1-3,2%).
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.
In vitro ispitivanja pokazuju da u koncentracijama koje se postižu preporučenom dozom od 25 mg, alogliptin ne inducira CYP1A2, CYP2B6 i CYP2C9 niti inhibira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4.
In vitro studies have shown no inhibition of any subtype of cytochrome P450.
In vitro ispitivanja pokazala su da nema inhibicije bilo kojeg podtipa citokroma P450.
In these studies, 312 alogliptin/pioglitazone-treated patients were ≥ 65 years old.
U tim je ispitivanjima 312 bolesnika liječenih alogliptinom/pioglitazonom bilo u dobi
Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Lactose monohydrate
Jezgra tablete manitol celuloza, mikrokristalična hidroksipropilceluloza karmelozanatrij, umrežena magnezijev stearat laktoza hidrat
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).
U analizi objedinjenih podataka iz 12 ispitivanja, ukupna incidencija epizoda hipoglikemije bila je niža u bolesnika liječenih s 25 mg alogliptina nego u bolesnika liječenih s 12,5 mg alogliptina, aktivnom kontrolom ili placebom (3,6%, 4,6%, 12,9% i 6,2%, istim redoslijedom).
Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
U bolesnika s umjerenim oštećenjem jetre ukupna izloženost alogliptinu bila je približno 10% niža, a vršna izloženost bila je približno 8% niža u usporedbi s kontrolnim ispitanicima.
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.
Istodobna primjena alogliptina i pioglitazona ispitana je kao dvojna terapija u bolesnika koji su inicijalno liječeni samo pioglitazonom (s ili bez metformina ili sulfonilureje), te kao dodatak terapiji metforminom.
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.
Ukupno 3504 bolesnika sa šećernom bolešću tipa 2, uključujući 1908 bolesnika liječenih alogliptinom i pioglitazonom, sudjelovalo je u 4 dvostruko slijepih ispitivanja faze 3 kontroliranih placebom ili aktivnom kontrolom u kojima su procijenjeni učinci istodobno primijenjenih alogliptina i pioglitazona na kontrolu glikemije i njihova sigurnost.
Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate).
Pomoćna(e) tvar(i) s poznatim učinkom: Jedna tableta sadrži 121 mg laktoze (u obliku hidrata)
These studies evaluated the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea), and as add-on therapy to metformin.
U tim ispitivanjima procijenjeni su učinci istodobno primijenjenih alogliptina i pioglitazona na kontrolu glikemije, te njihova sigurnost kao inicijalne kombinirane terapije, kao dvojne terapije u bolesnika koji su inicijalno liječeni samo pioglitazonom (s ili bez metformina ili sulfonilureje), te kao dodatak terapiji metforminom.
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).
Alogliptin kao dodatak terapiji pioglitazonu s metforminom Dodavanje 25 mg alogliptina jedanput na dan terapiji s 30 mg pioglitazona u kombinaciji s terapijom metforminkloridom (srednja vrijednost doze = 1867,9 mg) dovelo je u 52. tjednu do poboljšanja HbA1c koje se pokazalo neinferiornim i statistički superiornim onome postignutom terapijom s 45 mg pioglitazona u kombinaciji s metforminkloridom (srednja vrijednost doze = 1847,6 mg, tablica 6).
There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
Nakon stavljanja pioglitazona u promet prijavljeni su rijetki slučajevi hepatocelularne disfunkcije (vidjeti dio 4.8).
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.
Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
Alogliptin as add-on therapy to pioglitazone
Alogliptin kao dodatak terapiji pioglitazonom
There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
Hiperplazija mokraćnog mjehura nije opažena u pasa i majmuna liječenih pioglitazonom u trajanju do 12 mjeseci.
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.
U analizi objedinjenih podataka iz 13 ispitivanja, ukupne stope prijavljenih pankreatitisa u bolesnika liječenih s 25 mg alogliptina, 12,5 mg alogliptina, aktivnom kontrolom ili placebom bila je 2, 1, 1 odnosno 0 događaja na 1000 bolesnik godina.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi novonastalog ili pogoršanje postojećeg dijabetičkog makularnog edema sa smanjenjem oštrine vida kod uzimanja tiazolidindiona, uključujući pioglitazon.
The pharmacokinetics of pioglitazone in children and adolescents < 18 years old has not been established.
Farmakokinetika alogliptina u djece i adolescenata < 18 godina starosti nije ispitana.
For patients with moderate renal impairment, Incresync 12.5 mg/30 mg or 12.5 mg/45 mg should be administered once daily.
Bolesnicima s umjerenim oštećenjem bubrega treba primijeniti Incresync 12,5 mg/30 mg ili 12,5 mg/45 mg jedanput na dan.
The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies.
Podaci se temelje na iskustvu na ukupno 3504 bolesnika sa šećernom bolešću tipa 2, uključujući 1908 bolesnika liječenih alogliptinom i pioglitazonom, koji su sudjelovali u 4 dvostruko-slijepa, klinička ispitivanja faze 3 kontrolirana placebom ili aktivnom kontrolom.
Iron oxide black (E172)
željezov oksid, crni (E172)
SN:
Česte:
Excipient(s) with known effect Each tablet contains 105 mg of lactose (as monohydrate).
Pomoćna(e) tvar(i) s poznatim učinkom: Jedna tableta sadrži 105 mg laktoze (u obliku hidrata)
The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.
Simptomi mogu uključivati: osip, koprivnjaču, teškoće pri gutanju ili disanju, oticanje usnica, lica, grla ili jezika, te osjećaj nesvjestice.
Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Klinička ispitivanja provedena za potvrdu djelotvornosti i sigurnosti Incresynca uključivala su istodobnu primjenu alogliptina i pioglitazona kao zasebnih tableta.
Iron oxide yellow (E172)
željezov oksid, žuti (E172)
Risk related to alogliptin
Rizik vezan uz alogliptin
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).
Dodavanje 25 mg alogliptina jedanput na dan terapiji pioglitazonom (srednja vrijednost doze = 35,0 mg, s ili bez metformina ili sulfonilureje) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 5).
In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo.
Dodatno, 25 mg alogliptina, samog ili u kombinaciji s 30 mg pioglitazona, dovelo je u 16. tjednu u usporedbi s placebom do statistički značajnih (p<0,001) sniženja ukupnih triglicerida izmjerenih kao postprandijalna inkrementalna promjena AUC(0-8) od početne vrijednosti.
Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Proporcionalno povišenje koncentracije u serumu bilo je primijećeno kod doza od 2-60 mg.
Incresync should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Incresync treba primjenjivati s oprezom tijekom istodobne primjene inhibitora (npr. gemfibrozil) ili induktora (npr. rifampicin) citokroma P450 2C8.
The following section outlines the interactions observed with the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Sljedeći dio navodi interakcije opažene za pojedinačne tvari u Incresyncu (alogliptin/pioglitazon) kako su navedene u Sažetku opisa svojstava lijeka svakog od njih.
In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
In vitro podaci pokazuju da ograničenom metabolizmu alogliptina pridonose CYP2D6 i CYP3A4.
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
U mladih štakora nakon ponovljene primjene tijekom 4 i 8 tjedana nisu opaženi učinci povezani s alogliptinom.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone.
Prijavljeno je da istodobna primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira smanjenjem AUC-a pioglitazona za 54%.
Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.
Temeljem srednjih vrijednosti koncentracija dijalizata, u 3-satnoj hemodijalizi ukloni se približno 7% lijeka.
This indicates no time-dependency in the kinetics of alogliptin after multiple dosing.
To ukazuje da kinetika alogliptina ne ovisi o vremenu ni nakon višekratnog doziranja.
The following section outlines the pharmacokinetic properties of the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
U sljedećem dijelu navedene se farmakokinetička svojstva pojedinačnih sastojaka Incresynca (alogliptin/pioglitazon) kako su navedene u Sažetku opisa svojstava lijeka svakog od njih.
NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda
Clinical studies conducted to support the efficacy of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Klinička ispitivanja provedena za potvrdu djelotvornosti Incresynca uključivala su istodobnu primjenu alogliptina i pioglitazona kao zasebnih tableta.
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.
U toksikološkim ispitivanjima nakon ponovljenog doziranja u miševa, štakora, pasa i majmuna dosljedno su primijećeni povećanje volumena plazme s hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca.
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).
Značajna sniženja HbA1c opažena s 25 mg alogliptina s 30 mg pioglitazona i metforminom u usporedbi s 45 mg pioglitazona s metforminom bio je dosljedno tijekom čitavog 52-tjednog razdoblja liječenja (p<0,001 u svim vremenskim točkama).
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.
Iako plodnost nije bila oštećena, u mužjaka pri izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi opaženo je blago, statističko povećanje broja abnormalnih spermija.
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).
Stoga se bolesnicima s umjerenim oštećenjem bubrega preporučuje jedna tableta od 12,5/30 mg ili 12,5/45 mg jedanput na dan, ovisno o dozi pioglitazona koju bolesnik već uzima (vidjeti dio 5.2).
How to store Incresync
Kako čuvati Incresync
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 različite režime doziranja Incresync je dostupan kao filmom obložene tablete u jačinama od 25 mg/30mg, 25 mg/45 mg, 12,5 mg/30 mg i 12,5 mg/45 mg.