FrancophonIA/ELRC3.0 huggingface dataset:
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Slovenian: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Španija
English: Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
Slovenian: Sočasno dajanje s peroralnimi antidiabetiki metforminom, glibenklamidom in akarbozo ni povzročilo nobenih klinično pomembnih farmakokinetičnih interakcij z rosiglitazonom.
English: Avandia is not recommended for people aged under 18, as the effectiveness in children has not been shown.
Slovenian: Pri bolnikih, mlajših od 18 let, uporaba zdravila Avandia ni priporočljiva, saj varnost in učinkovitost zdravila pri njih nista znani.
English: Hepatic impairment: In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Slovenian: Bolniki z jetrno okvaro: Pri bolnikih z jetrno cirozo z zmerno motnjo jetrnega delovanja (Child-Pugh B), sta bili Cmax in AUC nevezane učinkovine 2- do 3-krat večji kot pri zdravih bolnikih.
English: The relevance of this finding is unknown.
Slovenian: Pomen izsledkov še ni pojasnjen.
English: − cardiac failure or history of cardiac failure (NYHA class I to IV)
Slovenian: - s srčnim popuščanjem ali s srčnim popuščanjem v anamnezi (NYHA razred I do IV)
English: Limited data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min) and therefore rosiglitazone should be used with caution in these patients.
Slovenian: O uporabi rosiglitazona pri bolnikih s hudo ledvično insuficienco (očistek kreatinina < 30 ml/min) je na voljo malo podatkov, zato je potrebno pri teh bolnikih rosiglitazon uporabljati previdno.
English: In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/sulphonylureas).
Slovenian: V dvojno slepih kliničnih preskušanjih rosiglitazona je bila incidenca zvišanja vrednosti ALT nad trikratno vrednost zgornje meje normalne vrednosti enaka kot pri placebu (0,2 %) in manjša kot pri primerjalnih učinkovinah (0,5 % pri metforminu/sulfonilsečninah).
English: Rosiglitazone therapy is usually initiated at 4 mg/day.
Slovenian: Začetni odmerek rosiglitazona je običajno 4 mg/dan.
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Slovenian: Izboljšan nadzor glikemije je bil povezan tudi z značilnim znižanjem prostih maščobnih kislin.
English: • rapid and excessive weight gain caused by fluid retention.
Slovenian: • hitro in močno povečanje telesne mase zaradi kopičenja tekočine v telesu.
English: The active substance is rosiglitazone.
Slovenian: Zdravilna učinkovina je rosiglitazon.
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Slovenian: Na osnovi izkušenj iz kliničnih preskušanj, določene kategorije pojavnosti neželenih učinkov morda ne odražajo pogostnosti neželenih dogodkov, ki se lahko pojavijo med običajno klinično prakso.
English: in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Slovenian: V celoti pa razpoložljivi podatki ne omogočajo dokončnega sklepa o tveganju za srčne ishemije (glejte poglavje 4.8).
English: The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Slovenian: Glavna pot izločanja je s sečem, s katerim se izločita približno dve tretjini zaužitega odmerka.
English: − known hypersensitivity to rosiglitazone or to any of the excipients
Slovenian: - z znano preobčutljivostjo za rosiglitazon ali katerokoli pomožno snov
English: Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code: A10 BG 02
Slovenian: Farmakoterapevtska skupina: peroralni antidiabetiki, tiazolidindioni, Oznaka ATC: A10 BG 02
English: Very rare side effects These may affect up to 1 in 10,000 people:
Slovenian: Zelo redki neželeni učinki Pojavijo se lahko pri do 1 od 10.000 bolnikov:
English: Plasma concentrations are approximately dose proportional over the therapeutic dose range.
Slovenian: V območju terapevtskih odmerkov so plazemske koncentracije zdravila približno sorazmerne z odmerkom.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Slovenian: V redkih primerih so v postmarketinških izkušnjah naleteli na hepatocelularno disfunkcijo (glejte poglavje 4.8).
English: Fluid retention and heart failure: Avandia can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Slovenian: Zastajanje tekočin in srčno popuščanje: Zdravilo Avandia lahko povzroči zastajanje vode v telesu (zastajanje tekočin), kar povzroči otekline in zvečanje telesne mase.
English: Early symptoms of low blood sugar are: y shaking, sweating, faintness y nervousness, palpitations y hunger.
Slovenian: y tresenje, znojenje, vrtoglavica y živčnost, palpitacije y lakota.
English: Rosiglitazone plasma concentrations peak at around 1 hour after dosing.
Slovenian: Rosiglitazon doseže najvišjo koncentracijo v plazmi 1 uro po zaužitju.
English: Moderate ingestion of alcohol with rosiglitazone has no effect on glycaemic control.
Slovenian: Zmerno pitje alkohola med jemanjem rosiglitazona ni vplivalo na glikemični nadzor.
English: The improved glycaemic control is associated with reductions in both fasting and post-prandial glucose.
Slovenian: Izboljšan nadzor glikemije je povezan z zniževanjem glukoze tako na tešče kot po jedi.
English: Contains lactose (approximately 108 mg).
Slovenian: Vsebuje laktozo (približno 108 mg)
English: If ALT levels remain >3X the upper limit of normal, therapy should be discontinued.
Slovenian: Če ostane vrednost ALT še naprej več kot trikrat večja od zgornje meje normalne vrednosti, je treba z zdravljenjem prenehati.
English: What Avandia is and what it is used for Before you take Avandia How to take Avandia Possible side effects
Slovenian: Kaj je zdravilo Avandia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Avandia
English: As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance.
Slovenian: Ker rosiglitazon izboljšuje odzivnost organizma na insulin, lahko pride do ponovne ovulacije pri bolnicah, ki zaradi odpornosti proti insulinu ne ovulirajo več.
English: Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema
Slovenian: Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females.
Slovenian: Spol: Pri preučevanju farmakokinetike znotraj skupin bolnikov ni bilo opaznih razlik med farmakokinetičnimi lastnostmi rosiglitazona pri moških in ženskah.
English: • swelling (oedema) due to water retention.
Slovenian: • oteklina (edem) zaradi zastajanja vode v telesu.
English: Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Slovenian: Pri ponavljajočih odmerkih je pričakovati kopičenje presnovkov v plazmi, še posebno glavnega presnovka rosiglitazona (parahidroksisulfata), ki naj bi se nakopičil v predvidoma 8-kratni količini.
English: Common Common headache*
Slovenian: glavobol*
English: CL/F seemed to be independent of age, but increased with weight in the paediatric population.
Slovenian: CL/F predvidoma ni odvisen od starosti, vendar pa se pri otrocih povečuje s telesno maso.
English: In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with rosiglitazone.
Slovenian: Pri bolnikih, ki imajo že pred začetkom zdravljenja nizke koncentracije hemoglobina, zdravljenje z rosiglitazonom poveča tveganje za anemijo.
English: − When new information is received that may impact on the current Safety Specification,
Slovenian: − kadar imetnik dovoljenja za promet prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali aktivnosti za zmanjšanje tveganja.
English: Patients with hepatic impairment Rosiglitazone should not be used in patients with hepatic impairment.
Slovenian: Bolniki z motnjami delovanja jeter Rosiglitazona bolniki z motnjami delovanja jeter ne smejo uporabljati.
English: Take Avandia for as long as your doctor recommends.
Slovenian: Zdravilo Avandia morate jemati tako dolgo kot vam to predpiše zdravnik.
English: Liver problems: Before you start taking Avandia you will have a blood sample taken to check your liver function.
Slovenian: Težave z jetri: Pred začetkom zdravljenja z zdravilom Avandia bo zdravnik s krvno preiskavo preveril delovanje jeter.
English: The frequency of adverse reactions identified from post-marketing data
Slovenian: Pogostnost neželenih učinkov na osnovi podatkov po pridobitvi dovoljenja za promet
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Slovenian: • tekočina v pljučih (edem pljuč), ki povzroči težko dihanje
English: You must look out for certain symptoms while you are taking Avandia, to reduce the risk of any problems.
Slovenian: Da bi zmanjšali tveganje za pojav kakršnihkoli težav morate biti med jemanjem zdravila Avandia pozorni na nekatere simptome.
English: Limited data are available with regard to overdose in humans.
Slovenian: O zaužitju prevelikega odmerka pri človeku je na voljo le malo podatkov.
English: EU/1/00/137/010 7 tablets EU/1/00/137/011 28 tablets EU/1/00/137/015 84 tablets EU/1/00/137/018 90 tablets EU/1/00/137/012 112 tablets
Slovenian: EU/1/00/137/010 7 tablet EU/1/00/137/011 28 tablet EU/1/00/137/015 84 tablet EU/1/00/137/018 90 tablet EU/1/00/137/012 112 tablet
English: No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
Slovenian: Po sočasnem jemanju digoksina, substrata CYP2C9 varfarina, substrata CYP3A4 nifedipina, etinilestradiola ali noretindrona z rosiglitazonom niso opazili klinično pomembnih interakcij.
English: Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Slovenian: Zastajanje tekočine in srčno popuščanje Tiazolidindioni lahko povzročijo zastajanje tekočine, ki lahko poslabša ali povzroči znake ali simptome kongestivnega srčnega popuščanja.
English: Common weight increase
Slovenian: Povečevanje telesne mase
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 112 filmsko obloženih tablet
English: Frequency of adverse reaction by treatment regimen RSG RSG + MET
Slovenian: Pogostnost neželenih učinkov glede na režim zdravljenja RSG
English: If you forget to take Avandia Don't take extra tablets to make up for a missed dose.
Slovenian: Ne jemljite dodatnih tablet, da bi tako nadomestili pozabljeni odmerek.
English: In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
Slovenian: V raziskavah vplivov na sposobnost razmnoževanja so dajanje rosiglitazona podganam v srednjem in poznejšem obdobju brejosti povezovali s smrtjo zarodka in upočasnitvijo njegovega razvoja.
English: To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia.
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVANDIA Pri zdravljenju sladkorne bolezni je pomembno, da natančno upoštevate vsa zdravnikova navodila, tako o dietni prehrani in življenjskem slogu kot jemanju zdravila Avandia.
English: Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Slovenian: Jedro tablete: natrijev karboksimetilškrob (vrsta A) hipromeloza mikrokristalna celuloza laktoza monohidrat magnezijev stearat
English: Take special care with Avandia
Slovenian: Bodite posebno pozorni pri jemanju zdravila Avandia
English: The dose of your medicines may need to be reduced.
Slovenian: Odmerek sočasno uporabljenega zdravila bo morda treba zmanjšati.
English: The other ingredients are: sodium starch glycollate (Type A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 3000, glycerol triacetate and iron oxide red (E172).
Slovenian: Pomožne snovi so: natrijev karboksimetilškrob (vrsta A), hipromeloza (E464), hipromeloza 6cP, mikrokristalna celuloza (E460), laktoza monohidrat, magnezijev stearat, titanov dioksid (E171), makrogol 3000, triacetin in rdeči železov oksid (E172).
English: • rifampicin (used to treat tuberculosis and other infections) Î Tell a doctor or pharmacist if you are taking any of these.
Slovenian: • rifampicin (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb).
English: Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Slovenian: Presnova rosiglitazona je obsežna, saj se nobena začetna spojina ne izloči v nespremenjeni obliki.
English: The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Slovenian: Razlike med posamezniki so bile zelo velike, AUC nevezane učinkovine se je razlikoval tudi do sedemkrat.
English: If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Slovenian: Če med zdravljenjem z rosiglitazonom ALT doseže vrednosti, ki so za več kot trikrat večje od zgornje meje normalne vrednosti, je treba vrednosti jetrnih encimov čim prej znova oceniti.
English: Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
Slovenian: Pri bolnikih, ki prejemajo rosiglitazon skupaj s sulfonilsečnino ali z insulinom obstaja tveganje za pojav od odmerka odvisne hipoglikemije.
English: Clinical trials data
Slovenian: Podatki iz kliničnih preskušanj
English: The major metabolite (para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mouse.
Slovenian: Glavni presnovek (parahidroksisulfat) z visoko afiniteto do topnega človeškega PPARγ je v raziskavi, ki je preučevala toleranco za glukozo pri debelih miših, izkazal sorazmerno visoko učinkovitost.
English: Patients with renal impairment (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in patients with mild and moderate renal insufficiency.
Slovenian: Bolniki z motnjami delovanja ledvic (glejte poglavje 4.4 Zastajanje tekočine in srčno popuščanje) Bolnikom z blago in zmerno ledvično insuficienco ni potrebno prilagajati odmerka.
English: Don't take Avandia:
Slovenian: Ne jemljite zdravila Avandia:
English: • Don't breast-feed while you are taking Avandia.
Slovenian: • Med jemanjem zdravila Avandia ne smete dojiti.
English: Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
Slovenian: Telesno maso je treba skrbno nadzirati in upoštevati možnost, da je povečanje telesne mase lahko posledica zastajanja tekočine, kar je lahko povezano s srčnim popuščanjem.
English: Rosiglitazone is highly protein bound and is not cleared by haemodialysis.
Slovenian: Rosiglitazon se v zelo veliki meri veže na proteine in ga s hemodializo ne moremo odstraniti iz telesa.
English: Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Slovenian: Starostniki (glejte poglavje 4.4 Zastajanje tekočine in srčno popuščanje) Starostnikom ni potrebno posebej prilagajati odmerka.
English: Don't stop taking Avandia
Slovenian: Ne prenehajte jemati zdravila Avandia
English: This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required.
Slovenian: Če je potrebna boljša urejenost glikemije, se ta odmerek lahko po osmih tednih poveča na 8 mg/dan.
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Slovenian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-infor@gsk.com
English: Blood and the lymphatic system disorders anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija levkopenija trombocitopenija granulocitopenija
English: HOW TO TAKE AVANDIA
Slovenian: KAKO JEMATI ZDRAVILO AVANDIA
English: Nervous system disorders dizziness*
Slovenian: Bolezni živčevja omotica*
English: In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Slovenian: Poleg tega je rosiglitazon pri živalskih modelih s sladkorno boleznijo tipa 2 ohranjal tudi delovanje celic beta, kar dokazuje zvečanje mase pankreatičnih otočkov in vsebnosti insulina, ter preprečeval nastanek očitne hiperglikemije.
English: Driving and using machines This medicine should not affect your ability to drive or use machines.
Slovenian: To zdravilo ne vpliva na sposobnost upravljanja vozil in strojev.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Slovenian: Raziskava in vivo o interakcijah z varfarinom je pokazala, da rosiglitazon in vivo s substrati CYP2C9 medsebojno ne učinkuje.
English: The absorption of rosiglitazone is not affected by increases in gastric pH.
Slovenian: Zvišanje vrednosti želodčnega pH ne vpliva na absorpcijo rosiglitazona.
English: In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Slovenian: V kliničnih študijah z rosiglitazonom so pri bolnikih opazili od odmerka odvisno povečanje telesne mase, ki je bilo pri sočasni uporabi insulina večje.
English: As a consequence of different but complementary mechanisms of action, dual oral therapy of rosiglitazone with a sulphonylurea or metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Slovenian: Dvojno peroralno zdravljenje z rosiglitazonom in sulfonilsečnino ali z metforminom je pri bolnikih s sladkorno boleznijo tipa 2 zaradi različnega, vendar komplementarnega mehanizma delovanja, privedla do aditivnega učinka na glikemični nadzor.
English: The frequency of adverse reactions identified from clinical trial data
Slovenian: Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj Neželeni učinki
English: 56 film-coated tablets, unit dose pack
Slovenian: 56 filmsko obloženih tablet, pakiranje po enoti odmerka
English: AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone
Slovenian: AVANDIA 2 mg filmsko obložene tablete AVANDIA 4 mg filmsko obložene tablete AVANDIA 8 mg filmsko obložene tablete rosiglitazon
English: Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
Slovenian: V primerjavi z odraslimi bolniki s sladkorno boleznijo tipa 2, pri otrocih po zdravljenju z rosiglitazonom niso opazili dodatnih težav, povezanih z varnostjo.
English: An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Slovenian: Pri 197 otrocih s sladkorno boleznijo tipa 2 (starih od 10 do 17 let) je bila izvedena 24-tedenska aktivno nadzorovana klinična raziskava (rosiglitazon v odmerku do 8 mg na dan ali metformin v odmerku do 2000 mg na dan).
English: Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Slovenian: Starostniki: Pri preučevanju farmakokinetike zdravila znotraj skupin bolnikov niso opazili, da bi starost kakorkoli pomembneje vplivala na farmakokinetiko rosiglitazona.
English: Rosiglitazone should be discontinued if any deterioration in cardiac status occurs.
Slovenian: Če bi prišlo do kakršnega koli poslabšanja delovanja srca, je treba zdravljenje z rosiglitazonom prekiniti.
English: The glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Slovenian: Največje znižanje vsebnosti glukoze v plazmi, merjeno na tešče (FPG), se je pokazalo po približno 8 tednih zdravljenja.
English: − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
Slovenian: - z akutnim koronarnim sindromom (nestabilna angina pektoris, NSTEMI in STEMI) (glejte
English: as monotherapy - in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with - metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Slovenian: - s sulfonilsečnino, vendar le pri bolnikih z intoleranco za metformin ali bolnikih pri katerih je metformin kontraindiciran in pri katerih je urejenost glikemije nezadostna kljub zdravljenju s kot del peroralnega zdravljenja s tremi zdravili v kombinaciji - z metforminom in s sulfonilsečnino, pri bolnikih (še posebej bolnikih s prekomerno telesno maso) z nezadostno urejenostjo glikemije kljub peroralnemu zdravljenju z dvema zdraviloma
English: Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Slovenian: Zdravljenje z rosiglitazonom povezujejo z od odmerka odvisnim zmanjšanjem koncentracije hemoglobina.
English: Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Slovenian: Med študijo (do 72 mesecev zdravljenja) je zdravljenje z rosiglitazonom statistično značilno zmanjšalo tveganje odpovedi monoterapije (glukoza v plazmi na tešče > 10,0 mmol/l) za 63 % v primerjavi z glibenklamidom (razmerje ogroženosti 0,37, interval zaupanja 0,30-0,45) in za 32 % v primerjavi z metforminom (razmerje ogroženosti 0,68, interval zaupanja 0,550,85).
English: Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
Slovenian: Pri bolnikih, ki se že zdravijo z rosiglitazonom, se zdravljenje z insulinom laho uvede le v izjemnih primerih in pod skrbnim zdravniškim nadzorom.