natgillin/translations-raw huggingface dataset:
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Tandemact, kot bi smeli Če po nesreči zaužijete preveč tablet ali če kdo drug ali otrok zaužije vaša zdravila, o tem nemudoma obvestite svojega zdravnika ali farmacevta.
Decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes infections more likely) have been reported in patients taking Tandemact rarely (may affect up to 1 in 1,000 people).
O zmanjšanju števila trombocitov (kar poveča tveganje za krvavitve ali modrice), rdečih krvnih telesc (zaradi česar je koža bleda in pojavi se šibkost ali zasoplost) in belih krvnih telesc (zaradi česar se poveča verjetnost okužb), so poročali redko (pri največ 1 od 1.000 bolnikov) pri bolnikih, ki jemljejo zdravilo Tandemact.
If you forget to take Tandemact
Če ste pozabili vzeti zdravilo Tandemact
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Obvestite svojega zdravnika kakor hitro je mogoče, če imate znake srčnega popuščanja, kot so nenavadno težko dihanje ali hitro povečanje telesne mase ali lokalizirano oteklino (edem).
The extrapancreatic effects are for example an improvement of the sensitivity of the peripheral tissue for insulin and a decrease of the insulin uptake by the liver.
Med ekstrapankreatičnimi učinki so, na primer, izboljšanje občutljivosti za insulin v perifernih tkivih in zmanjšanje jetrnega privzema insulina.
In the 3.5 year 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 PROactive študiji je 44/870 (5,1%; 1,0 zlomov na 100 bolniko-let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5%; 0,5 zlomov na 100 bolnikov-let) žensk, zdravljenih s primerjalnim zdravilom.
This leads to insulin release through exocytosis.
To povzroči sprostitev insulina z eksocitozo.
The effect of glimepiride is dose-dependent and reproducible.
Učinek glimepirida je odvisen od odmerka in je ponovljiv.
Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Glimepirid lahko poveča ali zmanjša učinek kumarinskih derivatov.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included in insulin.
V študiji izida pri bolnikih z obstoječo težjo makrovaskularno boleznijo je bila incidenca resnega srčnega popuščanja 1,6% višja pri pioglitazonu kot pri placebu, ko je bil slednji dodan zdravljenju, ki je zajemalo insulin.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolniki, ki so prejemali pioglitazon, so imeli povprečno znižan HbA1c za 0,45%, v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini, zdravljeni s pioglitazonom.
If you stop taking Tandemact
Če ste prenehali jemati zdravilo Tandemact
Insulin release
Izločanje insulina
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.
Da bi bolniki ustrezali kriterijem, so morali imeti v anamnezi eno ali več od naslednjega: miokardni infarkt, kap, perkutano srčno intervencijo ali premostitveno operacijo koronarnih arterij, akutni koronarni sindrom, koronarno arterijsko bolezen ali periferno arterijsko obstrukcijsko bolezen.
Take care if you experience abnormal vision.
Bodite pozorni če imate motnje vida.
Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.
Zdravilo Tandemact vsebuje pioglitazon in glimepirid, ki sta zdravili za zdravljenje sladkorne bolezni in se uporabljata za nadzor ravni sladkorja v krvi.
In some cases weight increase may be a symptom of cardiac failure therefore weight should be closely monitored.
V nekaterih primerih je lahko povišanje telesne mase posledica srčne odpovedi, zato je treba telesno maso skrbno spremljati.
Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
Povprečni razpolovni čas dominantnega seruma je približno 5 do 8 ur, kar je pomembno za serumske koncentracije pod pogoji večkratnega odmerjanja.
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs; ATC code: A10BD06.
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov, oznaka ATC: A10BD06
common uncommon macular oedema not known not known
pogosti občasni makularni edem neznana neznana
Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar lowering action of Tandemact in an unpredictable way.
Izogibajte se alkoholu, ko jemljete zdravilo Tandemact, ker lahko alkohol poveča ali zmanjša učinek zdravila Tandemact na zniževanje ravni sladkorja v krvi na nepredvidljiv način.
Sulphonylurea-derivatives like glimepiride pass into the breast milk.
Derivati sulfonilsečnin, kot je glimepirid, se izločajo v materino mleko.
Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Znotraj organskih sistemov so neželeni učinki navedeni po padajoči pogostnosti, ki ji sledi padajoča resnost.
Symptoms may not be present for up to 24 hours after ingestion.
Simptomi se lahko pojavijo z zamikom do 24 ur po zaužitju.
If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Če ste na posebni dieti za sladkorno bolezen, z dieto med jemanjem zdravila Tandemact nadaljujte.
The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions.
Hipoglikemijo lahko spremljajo nevrološki simptomi kot so nemir, tremor, motnje vida, težave s koordinacijo, zaspanost, koma in konvulzije.
The European Medicines Agency has waived the obligation to submit the results of studies with Tandemact in all subsets of the paediatric population in type 2 diabetes mellitus.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Tandemact za vse podskupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see section 5.1).
Klinične študije so opravili s sočasno uporabo pioglitazona in glimepirida (glejte poglavje 5.1).
Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Po uvedbi zdravljenja z zdravilom Tandemact je priporočeno, da jetrne encime spremljate redno po klinični presoji.
Investigations weight increased9
Preiskave povečanje telesne mase9
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0,8 zlomov na 100 bolnikovih let uporabe.
Musculoskeletal and connective tissue disorders bone fracture7
Bolezni mišično-skeletnega sistema in vezivnega tkiva zlom kosti7
Nausea, vomiting and epigastric pain may occur.
Lahko se pojavijo navzea, bruhanje in epigastrične bolečine.
common common common increased lactic dehydrogenase uncommon decrease in sodium serum concentrations very rare very rare alanine aminotransferase increase10
pogosti pogosti pogosti povišana vrednost laktatne dehidrogenaze občasni znižanje koncentracije natrija v serumu zelo redki zelo redki povišana vrednost alanin aminotransferaze10
Other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Druge reakcije, kot so zlomi kosti, povečanje telesne mase in edem se lahko pojavijo pogosto (≥ 1/100 do < 1/10) (glejte poglavje 4.4).
If you stop using Tandemact, your blood sugar may go up.
Če ste prenehali jemati zdravilo Tandemact, se lahko raven sladkorja v krvi dvigne.
Closing the potassium channel induces depolarisation of the beta cell and results - by opening of calcium channels - in an increased influx of calcium into the cell.
Zaprtje kalijevih kanalčkov povzroči depolarizacijo celic beta in z odprtjem kalcijevih kanalčkov poveča dotok kalcija v celice.
The following statements reflect the information available on the individual active substances (pioglitazone and glimepiride).
Naslednje navedbe odražajo dostopne podatke o posameznih učinkovinah (pioglitazonu in glimepiridu).
7 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials 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.
7 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini, zdravljeni s pioglitazonom in 7.400 v skupini, zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Med zdravljenjem s pioglitazonom se je pojavljalo majhno znižanje povprečne vrednosti hemoglobina (4% relativno znižanje) in hematokrita (4,1% relativno znižanje), skladno s hemodilucijo.
Hepatic impairment Tandemact should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Okvara jeter Zdravila Tandemact se ne sme uporabljati pri bolnikih z okvaro jeter (glejte poglavje 4.3 in 4.4).
General disorders and administration site conditions oedema8
Splošne težave in spremembe na mestu aplikacije edem8
Before you start taking Tandemact you will have a blood sample taken to check your liver function.
Pred začetkom jemanja zdravila Tandemact vam bodo odvzeli vzorec krvi za pregled delovanja jeter.
If you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again.
Če izkusite simptome hipoglikemije, kot so hladno znojenje, utrujenost, glavobol, hitro bitje srca, občutek lakote, razdražljivost, živčnost ali siljenje na bruhanje, zaužijte nekaj sladkorja, da znova povečate raven krvnega sladkorja.
If glimepiride is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Pri sočasnem dajanju glimepirida z nekaterimi drugimi zdravili, lahko pride do neželenega povečanja in zmanjšanja hipoglikemičnega delovanja glimepirida.
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Zaviralci H2, zaviralci beta, klonidin in reserpin lahko učinek na znižanje glukoze v krvi povečajo ali zmanjšajo.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Če kak bolnik razvije simptome, ki kažejo na moteno delovanje jeter, kar lahko vključuje nepojasnjeno navzeo, bruhanje, bolečine v trebuhu, utrujenost, anoreksijo in/ali temen urin, je treba kontrolirati jetrne encime.
Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Zdravilo Tandemact je indicirano kot drugi izbor zdravljenja sladkorne bolezni tipa 2 pri odraslih bolnikih, ki kažejo intoleranco za metformin, ali pri bolnikih, pri katerih je metformin kontraindiciran in se že zdravijo s kombinacijo pioglitazona in glimepirida.
There was no significant difference in effect regardless of whether glimepiride was given 30 minutes or immediately before a meal.
Učinek zdravila se ni pomembno razlikoval, če je bilo uporabljeno 30 minut pred obrokom ali tik pred njim.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
V kontroliranih kliničnih preskušanjih je bila incidenca poročil o srčnem popuščanju ob zdravljenju s pioglitazonom enaka kot v skupinah zdravljenja s placebom, metforminom in sulfonilsečnino, a se je povišala pri kombiniranem zdravljenju z insulinom.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure.
Nekateri bolniki z dalj časa trajajočo sladkorno boleznijo tipa 2 in boleznijo srca ali prebolelo možgansko kapjo, ki so bili zdravljeni z pioglitazonom in insulinom skupaj, so izkusili razvoj srčnega popuščanja.
Frequency of adverse reactions Pioglitazone Glimepiride Tandemact
Pogostnost neželenih učinkov Pioglitazon Glimepirid Tandemact
This may affect your ability to drive or use machines.
To lahko vpliva na sposobnost upravljanja vozil in strojev.
Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Tudi če imate zamegljen vid in se ta simptom poslabša, se čim prej posvetujte s svojim zdravnikom.
Hepatobiliary disorders6 hepatitis very rare very rare impairment of liver function (with cholestasis and jaundice)
Bolezni jeter, žolčnika in žolčevodov6 Hepatitis zelo redki zelo redki okvara delovanja jeter (s holestazo in zlatenico)
You may also experience a reduction in blood count (anaemia).
Lahko se pojavi tudi slabokrvnost (anemija).
3 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
3 V poročilih po pridobitvi dovoljenja za promet so poročali o preobčutljivostnih reakcijah pri bolnikih zdravljenih s pioglitazonom.
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 the available data).
Neželeni učinki, o katerih so poročali v dvojno slepih študijah in izkušnjah iz obdobja trženja zdravila so našteti spodaj in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz obstoječih podatkov).
- The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 ‘Tandemact contains lactose monohydrate'), magnesium stearate and polysorbate 80.
- Druge sestavine zdravila so mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza, laktoza monohidrat (glejte poglavje 2 “Zdravilo Tandemact vsebuje laktozo monohidrat”), magnezijev stearat in polisorbat 80.
Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazon ni povzročil statistično pomembnih povišanj ravni LDL holesterola v primerjavi s placebom, pri metforminu in gliklazidu pa so opazili znižanja teh vrednosti.
Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which is different from the usual sulphonylurea binding site.
Glimepirid se z veliko hitrostjo izmenjave veže na membransko beljakovino celic beta, povezano s kalijevimi kanalčki, občutljivimi za ATP, vendar se mesto njegove vezave razlikuje od običajnega mesta vezave sulfonilsečnin.
Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja z zdravilom Tandemact.
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Obstoječi antidiabetični in kardiovaskularni terapiji so 3,5 leta dodajali pioglitazon ali placebo.
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 antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni študiji kardiovaskularnega izida je bilo 5238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno do 3,5 let zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju.
No unchanged substance was detected in the urine.
V urinu se nespremenjena učinkovina ni pojavila.
Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Farmakokinetiki stanja dinamičnega ravnovesja sta pri bolnikih, starih 65 let in več, ter mladih osebah podobni.
The following data are findings in studies performed with pioglitazone or glimepiride individually.
Naslednji podatki so bili ugotovljeni pri posamičnih raziskavah pioglitazona ali glimepirida.
Rare changes in haematology have been observed with glimepiride treatment (see section 4.8).
Pri zdravljenju z glimepiridom so bile opažene redke spremembe v hematologiji (glejte poglavje 4.8).
Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Obvestite svojega zdravnika kakor hitro je mogoče, če se pojavijo simptomi, ki kažejo na težave z jetri (npr. nepojasnjeno siljenje na bruhanje, bruhanje, bolečine v trebuhu, utrujenost, izguba apetita in/ali temen urin), ker je treba preveriti delovanje jeter.
Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia may occur rarely (≥ 1/10,000 to < 1/1,000) (see section 4.4).
Zmerna do huda trombocitopenija, levkopenija, eritrocitopenija, granulocitopenija, agranulocitoza, hemolitična anemija in pancitopenija se lahko pojavijo redko (≥ 1/10.000 do < 1/1.000) (glejte poglavje 4.4).
Glimepiride increases very rapidly the number of active glucose transport molecules in the plasma membranes of muscle and fat cells, resulting in stimulated glucose uptake.
Glimepirid zelo hitro poveča število molekul za aktivni transport glukoze v plazemskih membranah mišičnih in maščobnih celic; posledica je stimuliran privzem glukoze.
Eye disorders visual disturbance4
Očesne bolezni motnje vida4
In combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one year of 2.8 kg.
V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan sulfonilsečnini, povzročil povprečno povečanje telesne mase v enem letu za 2,8 kg.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Glimepirid poveča aktivnost za glikozil-fosfatidilinozitol specifične fosfolipaze C, kar je morda povezano z indukcijo lipogeneze in glikogeneze, ki jo zdravilo povzroči v izoliranih maščobnih in mišičnih celicah.
9 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 - 3 kg over one year.
9 V kontroliranih preskušanjih s primerjalno učinkovino je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2-3 kg v enem letu.
In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
V kliničnih preskušanjih z monoterapijo ali kombinacijo pioglitazona in sulfonilsečnine so opažali pridobivanje telesne mase, odvisno od odmerka, ki je morda posledica nabiranja maščob, v nekaterih primerih pa je povezano z zastajanjem tekočine.
In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Pri bolnikih z okvaro ledvic so plazemske koncentracije pioglitazona in njegovih presnovkov nižje kot pri osebah z normalnim delovanjem ledvic, vendar je peroralni očistek izvorne učinkovine podoben.
If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.
Bolnike, ki prejemajo pioglitazon v kombinaciji z drugimi sulfonilsečninami (razen glimepirida), je treba pred prehodom na zdravilo Tandemact stabilizirati s hkratnim dajanjem pioglitazona in glimepirida.
Treatment of overdose of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
V primeru prevelikega odmerka zdravila Tandemact je potrebno preprečiti absorpcijo glimepirida s spodbujanjem bruhanja, čemur naj sledi pitje vode ali limonade z aktivnim ogljem (adsorbent) in natrijevim sulfatom (odvajalo).
If a patient wishes to become pregnant, treatment with Tandemact should be discontinued.
Če bolnica želi zanositi, je treba zdravljenje z zdravilom Tandemact prekiniti.
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.
Pitje alkohola lahko nepredvidljivo poveča ali zmanjša hipoglikemično delovanje glimepirida.
It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of liver enzymes.
Zato je priporočeno, da pri bolnikih, zdravljenih z zdravilom Tandemact, redno spremljate vrednosti jetrnih encimov.
Preclinical effects observed occurred at exposures sufficiently in excess of the maximum human exposure as to indicate little relevance to clinical use, or were due to the pharmacodynamic action (hypoglycaemia) of the compound.
Predklinično so učinke glimepirida opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo, ali jih je povzročil njegov farmakodinamični učinek (hipoglikemija).
The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Opazovano povečano tveganje za zlom pri ženskah v skupini s pioglitazonom v tej študiji je torej 0,5 zlomov na 100 bolnikov-let uporabe.