natgillin/translations-raw huggingface dataset:
These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Ti učinki niso bili odvisni od učinkov pioglitazona na glikemijo in so se statistično pomembno razlikovali od glibenklamida.
Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Bolniki, ki prejemajo pioglitazon v dvojnem zdravljenju s sulfonilsečnino, so lahko izpostavljeni tveganju za od odmerka odvisno hipoglikemijo, in je morda potrebno znižati odmerek sulfonilsečnine.
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Glubrava.
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Glubrava.
Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Po peroralnem dajanju se pioglitazon hitro absorbira, maksimalne plazemske koncentracije nespremenjenega pioglitazona so običajno dosežene 2 uri po dajanju.
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.
Videti je, da pioglitazon deluje prek aktivacije specifičnih jedrnih receptorjev (s peroksisomskim proliferatorjem aktiviran receptor gama), kar povzroča povečano občutljivost za insulin v celicah jeter, maščobnem tkivu ter celicah skeletnih mišic živali.
Dietary acidification significantly decreased but did not abolish the incidence of tumours.
Hrana, ki povzroča zakisanje je signifikantno zmanjšala, vendar ni odpravila incidence tumorjev.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično pomembno znižal razmerje albumin/kreatinin v primerjavi z izhodiščnimi vrednostmi.
Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Glukokortikoidi (dani sistemsko ali lokalno), agonisti beta 2 in diuretiki imajo intrinzično hiperglikemično aktivnost.
If you forget to take Glubrava
Če ste pozabili vzeti zdravilo Glubrava
There are limited amount of data from the use of metformin in pregnant women.
Podatki o uporabi metformina pri nosečnicah so omejeni.
Aluminium/aluminium blisters.
Aluminij/aluminij pretisni omoti.
if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
- če ste pred kratkim doživeli srčni infarkt, imate hujše težave s krvnim obtokom, če ste doživeli šok ali imate težave z dihanjem.
Glubrava may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Zdravilo Glubrava lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunana incidenca zlomov je bila 1,9 zlomov na 100 bolnikov-let pri ženskah, zdravljenih s pioglitazonom in 1,1 zlom na 100 bolnikov-let pri ženskah, zdravljenih s primerjalnim zdravilom.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Po dajanju odmerka 850 mg je bila opažena za 40% manjša največja plazemska koncentracija, za 25% zmanjšana AUC in 35-minutno podaljšanje pri doseganju največje plazemske koncentracije.
Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Tudi, če že imate zamegljen vid in se simptomi poslabšajo, se nemudoma posvetujte s svojim zdravnikom.
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Pioglitazon lahko povzroči zastajanje tekočine, to pa lahko poslabša ali pospeši srčno popuščanje.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18-tedenskem preskušanju pri diabetikih tipa 2.
If ALT levels are increased to 3 x upper limit of normal during Glubrava therapy, liver enzyme levels should be reassessed as soon as possible.
Če se med zdravljenjem z zdravilom Glubrava ravni ALT zvišajo do 3-kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovino(-e) glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon{ime(-na) zdravilne(-ih) učinkovine(učinkovin)} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
2 Long term treatment of metformin has been associated with a decrease of vitamin B12 absorption with decrease of serum levels.
2 Dolgotrajno zdravljenje z metforminom je povezano z zmanjšano absorpcijo vitamina B12 in posledično zmanjšano koncentracijo v serumu.
Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Intrinzični očistek je tako znižan, skupaj z večjim deležem nevezanega pioglitazona.
These reactions include anaphylaxis, angioedema, and urticaria.
Te reakcije vključujejo anafilakso, angioedem in urtikarijo.
In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Glede na možna tveganja pri dolgotrajni terapiji, mora zdravnik potrditi pri rednih rutinskih pregledih, da je korist pioglitazona ohranjena (glejte poglavje 4.4).
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Študije pri človeku ne kažejo nobenih indukcij poglavitnih inducibilnih citokromov P450, 1A, 2C8/9 in 3A4.
Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Laktacidoza je resen neželen učinek, ki se lahko pojavi zelo redko (< 1/10.000) (glejte poglavje 4.4), drugi neželeni učinki, kot so zlomi kosti, povečanje telesne mase in edem, pa se lahko pojavijo pogosto (≥ 1/100 do < 1/10) (glejte poglavje 4.4).
7 In active comparator controlled trials oedema was reported in 6.3% of patients treated with metformin and pioglitazone, whereas the addition of sulphonylurea to metformin treatment resulted in oedema in 2.2% of patients.
7 Kontrolirana preskušanja z aktivno primerjavo poročajo o edemih pri 6,3% bolnikov, zdravljenih z metforminom in pioglitazonom, medtem ko je dodatek sulfonilsečnine metforminu povzročil edeme pri 2,2% bolnikov.
This is because some medicines can weaken or strenghten the effect of Glubrava on the level of sugar in your blood.
To je pomembno, saj lahko nekatera zdravila oslabijo ali okrepijo učinek zdravila Glubrava na raven sladkorja v krvi.
General disorders and administration site conditions oedema7
Splošne težave in spremembe na mestu aplikacije edem7
Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Skoraj vse osebe (95%) so prejemale kardiovaskularna zdravila (zaviralce adrenergičnih receptorjev beta, zaviralce ACE, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, acetilsalicilno kislino, statine, fibrate).
However if you miss a dose, skip the missed dose and just carry on with the next dose as normal.
Če ste pozabili vzeti odmerek, preskočite zamujeni odmerek in nadaljujte z naslednjim odmerkom kot sicer.
Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - bolečina v trebuhu - siljenje na bruhanje (navzea) - bruhanje - driska - izguba apetita
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Ta poteka predvsem preko citokromov P450 2C8, v manjši meri pa so lahko vpletene tudi druge izooblike.
Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment.
Zastrupitev z alkoholom je povezana s povečanim tveganjem za laktacidozo, zlasti ob postenju, podhranjenosti ali okvari jeter.
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
O primerih raka sečnega mehurja so pogosteje poročali v meta-analizi kontroliranih kliničnih preskušanjih s pioglitazonom (19 primerov od 12.506 bolnikov, 0,15%) kot v kontrolnih skupinah (7 primerov od 10.212 bolnikov, 0,07%) HR = 2,64 (95% IZ 1,11-6,31, p = 0,029).
If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Če je potrebno, odmerek antidiabetikov prilagodimo med zdravljenjem z drugimi zdravili in po ukinitvi zdravljenja z njimi.
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 sledečega: miokardni infarkt, kap, perkutano srčno intervencijo ali premostitveno operacijo koronarnih arterij, akutni koronarni sindrom, koronarno arterijsko bolezen ali periferno arterijsko obstrukcijsko bolezen.
Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Drugi dejavniki tveganja za laktacidozo so pretirano uživanje alkohola, jetrna insuficienca, neustrezno nadzorovana sladkorna bolezen, ketoza, dolgotrajno postenje in vsa stanja, povezana s hipoksijo, ter sočasna uporaba zdravil, ki lahko povzročijo laktacidozo (glejte poglavji 4.3 in 4.5).
During treatment with Glubrava, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Med zdravljenjem z zdravilom Glubrava bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
Following initiation of therapy with Glubrava, it is recommended that liver enzymes be monitored periodically according to clinical judgement.
Po uvedbi zdravljenja z zdravilom Glubrava je priporočeno, da jetrne encime spremljate redno po klinični presoji.
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD05.
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov, oznaka ATC: A10BD05.
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 dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni s pioglitazonom in insulinom so doživeli razvoj srčnega popuščanja.
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 Glubrava, 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.
Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in ali zaviralci COX-2, kot sta ibuprofen in celekoksib)
If this happens you must stop taking Glubrava and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
V tem primeru morate prenehati jemati zdravilo Glubrava in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
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 insulin.
V študiji izida bolnikov z že obstoječimi težjimi makrovaskularnimi boleznimi, je bila incidenca resnega srčnega popuščanja 1,6% višja s pioglitazonom kot s placebom, dodanim k zdravljenju, ki je vključevalo insulin.
There have been no formal interaction studies for Glubrava.
Formalne študije interakcij za zdravilo Glubrava niso bile narejene.
Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Zdravniki morajo začeti zdravljenje z najnižjim odmerkom, ki je na voljo in odmerek zviševati postopoma, še posebej, ko se pioglitazon uporablja v kombinaciji z insulinom (glejte poglavje 4.4 Zastajanje tekočine in srčno popuščanje).
Available toxicological data in animals have shown excretion of pioglitazone and metformin in the milk of lactating rats (see section 5.3).
Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje pioglitazona in metformina v mleko doječih podgan (glejte poglavje 5.3).
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Če upoštevamo aktivnost, koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka M-III enak.
5 How to store Glubrava Contents of the pack and other information
5 Shranjevanje zdravila Glubrava Vsebina pakiranja in dodatne informacije
Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Vsako makroskopsko hematurijo je treba preveriti pred začetkom zdravljenja s pioglitazonom.
Stop taking Glubrava for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Za kratek čas prenehajte jemati zdravilo Glubrava, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
What Glubrava is and what it is used for What you need to know before you take Glubrava How to take Glubrava
Kaj je zdravilo Glubrava in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Glubrava Kako jemati zdravilo Glubrava Možni neželeni učinki
In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥ 65 years compared with those less than 65 years (9.7% compared to 4.0%).
V tej študiji so pri bolnikih, ki so se zdravili s pioglitazonom in z insulinom, večji odstotek srčnega popuščanja opazili pri bolnikih, starih 65 let in starejših, v primerjavi z bolniki, mlajšimi od 65 let (9,7% v primerjavi s 4,0%).
180 tablets
180 tablet
Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Pri kationskih zdravilih, ki se izločajo z ledvično tubulno sekrecijo (npr. cimetidin), lahko zaradi tekmovanja za skupne ledvične tubulne transportne sisteme pride do interakcije z metforminom.
The decision whether to continue the patient on therapy with Glubrava should be guided by clinical judgement pending laboratory evaluations.
Odločitev o tem, ali zdravljenje bolnika z zdravilom Glubrava nadaljevati, naj do laboratorijskih vrednotenj temelji na klinični presoji.
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 zlom na 100 bolnikov-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.
In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
V študiji, kontrolirani s placebom, so bili bolniki z nezadostnim nadzorom glikemije, kljub trimesečnemu obdobju optimizacije insulina, 12 mesecev naključno zdravljeni s pioglitazonom ali placebom.
It is used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Uporablja se za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni) pri odraslih, ko zdravljenje samo z metforminom ni zadostno.
The following statements reflect the information available on the individual active substances (pioglitazone and metformin).
Sledeče navedbe odražajo dostopne podatke o posameznih zdravilnih učinkovinah (pioglitazonu in metforminu).
Thus free (unbound) pioglitazone concentration is unchanged.
Torej je koncentracija prostega (nevezanega) pioglitazona nespremenjena.
The following data are findings in studies performed with pioglitazone or metformin individually.
Sledeči podatki so bili ugotovljeni pri posamičnih raziskavah pioglitazona ali metformina.
It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Ni znano, če je med pioglitazonom in makularnim edemom direktna povezava, zato naj bodo zdravniki pozorni na možnost makularnega edema pri bolnikih s poslabšano ostrino vida in naj razmislijo o napotitvi bolnika k oftalmologu.
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, vendar je bila povečana pri uporabi kombiniranega zdravljenju z insulinom.
If you stop taking Glubrava
Če ste prenehali jemati zdravilo Glubrava
Stop taking Glubrava and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Takoj prenehajte jemati zdravilo Glubrava in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
6 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.
6 Opravljena je bila skupna analiza poročil neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8.100 bolnikov v skupini, zdravljeni s pioglitazonom in 7.400 v skupini, zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
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 lokalizirana oteklina (edem).
The clinical relevance of this decrease is unknown.
Klinični pomen teh ugotovitev ni poznan.
Decreased renal function in elderly patients is frequent and asymptomatic.
Pri starejših bolnikih je zmanjšano delovanje ledvic pogosto in asimptomatsko.
Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs)) should be initiated with caution in metformin treated patients.
Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila), je treba pri bolnikih, ki se zdravijo z metforminom, uvesti previdno.
Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region).
Dejavnike tveganja za rak sečnega mehurja je treba oceniti pred začetkom zdravljenja s pioglitazonom (tveganja vključujejo starost, kajenje v anamnezi, izpostavljenost nekaterim poklicnim dejavnikom ali kemoterapiji npr. ciklofosfamidu ali zdravljenje pred obsevanjem v predelu medenice).
common common alanine aminotransferase increased9
pogosti pogosti povišana vrednost alanin aminotransferaze9
if you have severely reduced kidney function.
- če imate hudo oslabljeno delovanje ledvic.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Kardiovaskularno študijo izida s pioglitazonom so opravili pri bolnikih, mlajših od 75 let s sladkorno boleznijo tipa 2 in že obstoječimi težjimi makrovaskularnimi boleznimi.
Before you start taking Glubrava you will have a blood sample taken to check your liver function.
Pred začetkom jemanja zdravila Glubrava vam bodo odvzeli vzorec krvi, da se preveri delovanje jeter.
You may also experience a reduction in blood count (anaemia).
Zmanjša se lahko tudi število krvnih celic (anemija).
if you have liver disease.
- če imate bolezen jeter.
Warnings and precautions Talk to your doctor or pharmacist before taking Glubrava (also see section 4) if you have a problem with your heart.
Pred začetkom jemanja zdravila Glubrava se posvetujte z zdravnikom ali farmacevtom (glejte tudi poglavje 4): - če imate težave s srcem.
These patients may be at risk of pregnancy.
Te bolnice utegnejo zanositi.
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 bolnikov-let uporabe.