FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM SmithKline Beecham Ltd
English: Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Slovenian: Absolutna biološka uporabnost rosiglitazona po zaužitju tako 4 mg kot 8 mg peroralnega odmerka znaša približno 99 %.
English: Undesirable effects observed in animal studies with possible relevance to clinical use were as follows: An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
Slovenian: Neželeni učinki, ki so bili opaženi pri raziskavah na živalih in bi utegnili imeti posledice za klinično uporabo zdravila, so naslednji: porast volumna plazme, ki ga spremlja znižanje števila eritrocitov in povečanje mase srca.
English: ACE-inhibitors may decrease the blood glucose levels.
Slovenian: ACE inhibitorji lahko zmanjšajo koncentracijo glukoze v krvi.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Slovenian: Ne stimulira sekrecije insulina in potemtakem ne povzroča hipoglikemije.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Slovenian: Največja koncentracija v krvi je manjša kot največja koncentracija v plazmi, pojavita pa se približno ob istem času.
English: Metformin partitions into erythrocytes.
Slovenian: Metformin se porazdeli v eritrocite.
English: (You can also take this dose as two 1 mg/500 mg tablets, twice a day.)
Slovenian: (Takšen odmerek lahko vzamete tudi v obliki dveh 1 mg/500 mg tablet dvakrat na dan.)
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: There are no adequate data from the use of rosiglitazone in pregnant women.
Slovenian: O uporabi rosiglitazona pri nosečnicah ni zadostnih podatkov.
English: Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances metabolised by these P450 enzymes.
Slovenian: Ker z rosiglitazonom ne pride do znatne in vitro inhibicije CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A ali 4A, obstaja le majhna verjetnost pojava značilnih presnovnih interakcij z zdravili, ki jih presnavljajo našteti encimi P450.
English: The Marketing Authorisation Holder (MAH) must ensure that the system of pharmacovigilance, as described in version 7.2 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 7.2, predstavljen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
English: Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Slovenian: Tiazolidindioni lahko povzročijo zastajanje tekočine, ki lahko poslabša ali povzroči znake ali simptome kongestivnega srčnega popuščanja.
English: It cannot be excluded that other inducers (e.g. phenytoin, carbamazepine, phenobarbital, St John's wort) may also affect rosiglitazone exposure.
Slovenian: Možnosti, da lahko tudi drugi induktorji (npr. fenitoin, karbamazepin, fenobarbital, šentjanževka) vplivajo na izpostavljenost rosiglitazonu ne moremo izključiti.
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Slovenian: Če ostanejo vrednosti ALT še naprej več kot 3-krat večje od zgornje meje normalne vrednosti, je potrebno zdravljenje prekiniti.
English: Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Slovenian: Izdelovalec: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Španija.
English: Data with AVANDAMET is also consistent with this combined adverse reaction profile.
Slovenian: Podatki o uporabi zdravila AVANDAMET so tudi v skladu s tem skupnim profilom neželenih učinkov.
English: The majority of the fractures were reported in the upper limbs and distal lower limbs (see section 4.4).
Slovenian: Večina zlomov je bila zabeležena na zgornjih udih in distalnih delih spodnjih udov (glejte poglavje 4.4).
English: Rosiglitazone and metformin work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level.
Slovenian: Rosiglitazon in metformin delujeta skupaj tako, da omogočata boljšo izrabo v telesu nastalega insulina, kar pomaga zmanjšati vrednost krvnega sladkorja na normalno vrednost.
English: • gemfibrozil (used to lower cholesterol)
Slovenian: • gemfibrozil (uporabljamo ga za zniževanje holesterola).
English: If jaundice is observed, therapy should be discontinued.
Slovenian: Če se pojavi zlatenica, je potrebno zdravljenje prekiniti.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Slovenian: Slednje je bilo dokazano v kontroliranih, srednje dolgih ali dolgotrajnejših kliničnih raziskavah z uporabo terapevtskih odmerkov: metformin znižuje skupni holesterol, LDL-holesterol in raven trigliceridov.
English: A total of 564 patients withdrew from cardiovascular follow-up, which accounted for 12.3% of rosiglitazone patients and 13% of control patients; representing 7.2% of patient-years lost for cardiovascular events follow-up and 2.0% of patient-years lost for all cause mortality follow-up.
Slovenian: V celoti je v obdobju spremljanja kardiovaskularnih dogodkov izstopilo 564 bolnikov, 12,3 % tistih z rosiglitazonom in 13 % kontrolnih; to pomeni 7,2 % izgubljenih bolnikov-let spremljanja kardiovaskularnih dogodkov in 2,0 % izgubljenih bolnikov-let za spremljanje umrljivosti zaradi vseh vzrokov.
English: In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute phase (see section 4.3).
Slovenian: Glede na možno tveganje za pojav srčnega popuščanja pri teh bolnikih, se zdravljenja z rosiglitazonom ne sme uvesti pri bolnikih, ki imajo akutni koronarni dogodek, oziroma je treba zdravljenje med akutno fazo prekiniti (glejte poglavje 4.3).
English: However, rosiglitazone promoted differentiation and reversal of mutagenic changes in human colon cancer cells in vitro.
Slovenian: Rosiglitazon je in vitro pospeševal diferenciacijo in preobrat mutagenih sprememb v rakavih celicah humanega debelega črevesa.
English: Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
Slovenian: Zdravilo Avandamet se lahko uporablja samo ali skupaj s sulfonilsečnino, drugim zdravilom za zdravljenje sladkorne bolezni.
English: While you take Avandamet your doctor needs to know:
Slovenian: Med jemanjem zdravila Avandamet morate obvestiti svojega zdravnika:
English: A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Slovenian: Znatno preveliko odmerjanje metformina (ali sočasno tveganje za laktacidozo) lahko vodi do laktacidoze, ki pa je nujni primer in se mora zdraviti hospitalno.
English: The elevated total cholesterol levels were associated with an increase in both LDLc and HDLc, but the ratio of total cholesterol: HDLc was unchanged or improved in long term studies.
Slovenian: Povečane vrednosti skupnega holesterola so bile povezane s povečanjem obeh, LDLc in HDLc, razmerje skupni holesterol proti HDLc pa je ostalo nespremenjeno ali pa se je med dolgotrajnimi študijami izboljšalo.
English: 4 Long-term studies show an increased incidence of bone fracture in patients, particularly female patients, taking rosiglitazone.
Slovenian: 4 Dolgoročne študije kažejo večjo incidenco zlomov kosti pri osebah, zlasti ženskah, ki jemljejo rosiglitazon.
English: • stomach pain, feeling sick (nausea), vomiting, diarrhoea or loss of appetite.
Slovenian: • bolečina v želodcu, siljenje na bruhanje (navzea), bruhanje, driska ali izguba apetita.
English: Early symptoms of low blood sugar are: y shaking, sweating, faintness y nervousness, palpitations y hunger.
Slovenian: Zgodnji simptomi nizkega krvnega sladkorja so: y tresenje, znojenje, vrtoglavica.
English: There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease.
Slovenian: Podatki iz kliničnih preskušanj pri bolnikih z ishemično boleznijo srca in/ali boleznijo perifernih arterij so pomanjkljivi.
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 torej treba skrbno nadzirati in pri tem upoštevati možno povezavo z zastajanjem tekočin, ki je lahko povezano s srčnim popuščanjem.
English: As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly: - at least once a year in patients with normal renal function - at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients.
Slovenian: Zaradi izločanja metformina skozi ledvice je potrebno redno določati koncentracije kreatinina v serumu: - vsaj enkrat letno pri bolnikih z normalnim delovanjem ledvic; - vsaj dvakrat do štirikrat letno pri bolnikih, ki imajo vrednosti kreatinina v serumu na zgornji
English: cardiac ischaemia3*
Slovenian: Pogosti srčna ishemija3*
English: An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVANDAMET or if it occurred at a higher frequency than that listed for a component part.
Slovenian: Neželen učinek kombinacije fiksnega odmerka je naveden le, če pri posamezni sestavini zdravila AVANDAMET ni bil ugotovljen, oziroma je bila njegova pogostnost večja od pogostnosti pri posamezni sestavini.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Slovenian: Študija v katero je bilo vključenih sedem zdravih prostovoljcev je pokazala, da sta se, pri dajanju cimetidina v odmerku 400 mg dvakrat na dan, sistemska izpostavljenost (AUC) metforminu in Cmax metformina povečali, in sicer AUC za 50 %, Cmax pa za 81 %.
English: 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.
Slovenian: 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.
English: Driving and using machines This medicine should not affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost upravljanja vozil in strojev.
English: To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandamet.
Slovenian: Pri zdravljenju sladkorne bolezni je pomembno, da natančno upoštevate vsa zdravnikova navodila, tako o dietni prehrani in življenjskem slogu kot jemanju zdravila Avandamet.
English: Very rare skin reactions (e.g. urticaria, pruritis, rash)
Slovenian: Zelo redki kožne reakcije (npr. urtikarija, srbenje, izpuščaj)
English: The use of AVANDAMET in combination with a sulphonylurea or insulin may be associated with increased risks of fluid retention and heart failure (see section 4.8).
Slovenian: Uporaba zdravila AVANDAMET v kombinaciji s sulfonilsečnino ali insulinom je lahko povezana z večjim tveganjem za pojav zastajanja tekočine in srčnega popuščanja (glejte poglavje 4.8).
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Slovenian: Rosiglitazon je in vitro pokazal zmerno inhibicijo CYP2C8 (IC50 18 μM) in majhno inhibicijo CYP2C9 (IC50 50 μM) (glejte poglavje 4.5).
English: As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance.
Slovenian: Kot posledica izboljšane senzitivnosti na insulin lahko pride do ponovne ovulacije pri bolnicah, pri katerih se je ovulacija zaradi rezistence na insulin prekinila.
English: The contribution of the major metabolite (a para-hydroxy-sulphate) to the overall antihyperglycaemic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
Slovenian: Prispevek glavnega metabolita (parahidroksisulfata) k celotnemu antihiperglikemičnemu delovanju rosiglitazona pri človeku še niso dodobra pojasnili in ni izključeno, da morda tudi ta metabolit prispeva k delovanju.
English: In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
Slovenian: V raziskavah mehanizma delovanja se je pokazalo, da je prišlo do povečevanja telesne mase predvsem na račun povečevanja podkožnega maščevja ob zmanjševanju visceralne in intrahepatične maščobe.
English: 14 tablets 28 tablets 56 tablets 180 tablets
Slovenian: 14 tablet 28 tablet 56 tablet 180 tablet
English: Monitoring of liver function
Slovenian: Spremljanje delovanja jeter
English: Lactic acidosis: An increase in the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of metformin.
Slovenian: Laktacidoza: Zvišanje vrednosti mlečne kisline v krvi (laktacidoza) je zelo redek neželeni učinek metformina.
English: • increase of lactic acid in the blood.
Slovenian: • zvišanje vrednosti mlečne kisline v krvi.
English: • increased weight, increased appetite
Slovenian: • zvečanje telesne mase, povečanje apetita.
English: Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
Slovenian: Opazili so tudi zvečanje mase jeter, porast plazemske ALT (samo pri psih) in zvečano količino maščobnega tkiva.
English: Pharmacotherapeutic group: Combinations of oral blood glucose lowering medicinal products, ATC code: A10BD03
Slovenian: Farmakoterapevtska skupina: Kombinacije bigvanidnih in sulfonamidnih antidiabetikov, Oznaka ATC: A10BD03
English: In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Slovenian: Pri s placebom nadzorovanem enoletnem preskušanju pri bolnikih s kongestivnim srčnim popuščanjem (NYHA razred I-II) se je poslabšanje ali možno poslabšanje srčnega popuščanja pojavilo pri 6,4 % bolnikov, ki so prejemali rosiglitazon in 3,5 % bolnikov, ki so prejemali placebo.
English: Î Check with your doctor if you think any of these apply to you.
Slovenian: Î Posvetujte se s svojim zdravnikom, če menite, da se karkoli od navedenega nanaša na vas.
English: Plasma concentrations are approximately dose proportional over the therapeutic dose range.
Slovenian: Plazemske koncentracije zdravila so glede na razpoložljivo terapevtsko paleto približno sorazmerne z velikostjo odmerka.
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily in dual oral therapy with metformin produced a sustained improvement in glycaemic control (FPG and HbA1c).
Slovenian: V študijah, ki niso trajale več kot tri leta, je rosiglitazon, ki so ga dajali enkrat ali dvakrat dnevno v sklopu peroralnega zdravljenja z dvema zdraviloma skupaj z metforminom, povzročil dolgotrajno izboljšanje glikemičnega nadzora (FPG in HbA1c).
English: Sulphonylurea (background metformin) Glimepiride*
Slovenian: Sulfonilsečnina (osnova: metformin) Glimepirid*
English: In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Slovenian: Poleg tega je rosiglitazon zaviral sintezo estradiola in progesterona v jajčnikih in zmanjševal koncentracijo obeh hormonov v plazmi, kar je posledično vplivalo na estrusne/menstrualne cikluse in plodnost (glejte poglavje 4.4).
English: The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
Slovenian: Od primera do primera je potrebno oceniti morebiten doprinos zastajanja tekočine v telesu k pridobivanju telesne mase, saj so o hitrem in pretiranem pridobivanju telesne mase kot znaku zastajanja tekočine v telesu poročali zelo redko.
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Slovenian: Za laktacidozo so značilne acidozna dispneja, abdominalna bolečina in hipotermija, ki jim sledi koma.
English: Date of latest renewal: 20 October 2008
Slovenian: Datum podaljšanja dovoljenja za promet: 20. oktober 2008
English: The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Slovenian: Antihiperglikemično delovanje rosiglitazona so dokazali na vrsti živalskih modelov s sladkorno boleznijo tipa 2.
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: Oslabljeno delovanje jeter: Pri bolnikih s cirozo in z zmerno oslabljenim delovanjem jeter (Child-Pugh B) sta bili Cmax in AUC nevezane učinkovine 2- do 3-krat višji kot pri zdravih osebah.
English: Table 3 presents adverse reactions by system organ class and by frequency category.
Slovenian: V preglednici 3 so navedeni neželeni učinki glede na organski sistem in kategorijo pogostnosti.
English: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Slovenian: Glukokortikoidi (dani sistemsko ali lokalno), agonisti beta2 in diuretiki imajo intrinzično hiperglikemično aktivnost.
English: Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Slovenian: Î Čimprej obvestite svojega zdravnika, če se pojavi katerikoli od teh simptomov - bodisi prvič
English: Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
Slovenian: Zdravljenje z insulinom se lahko k že uvedenemu zdravljenju z rosiglitazonom uvede le v izjemnih primerih in pod skrbnim zdravniškim nadzorom.
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Slovenian: Rosiglitazon je selektiven agonist za nuklearni receptor PPARγ (peroxisome proliferator activated receptor gamma) in sodi v tiazolidindionsko skupino antidiabetikov.
English: Metabolism and nutrition disorders rapid and excessive weight gain
Slovenian: Presnovne in prehranske motnje hitro in prekomerno povečanje telesne mase
English: • if you have had a heart attack or severe angina, that's being treated in hospital
Slovenian: • če ste doživeli srčni napad ali imate hudo angino pektoris in ste se zaradi tega zdravili
English: Allergic reactions: These are very rare in people taking Avandamet.
Slovenian: Alergijske reakcije: Pri bolnikih, ki se zdravijo z zdravilom Avandamet so alergijske reakcije zelo redke.
English: 28 tablets 56 tablets 112 tablets 360 tablets
Slovenian: 28 tablet 56 tablet 112 tablet 360 tablet
English: The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Slovenian: Pri kombiniranem zdravljenju z insulinom (rosiglitazon, dodan k že vpeljanemu zdravljenju z insulinom) je bila incidenca srčnega popuščanja 2,4 %, pri zdravljenju z insulinom samim pa 1,1 %.
English: For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Slovenian: Pri od odmerka odvisnih neželenih učinkih je kategorija pogostnosti odraz višjega odmerka rosiglitazona.
English: The dose of your medicines may need to be reduced.
Slovenian: Zdravnik bo morda moral zmanjšati odmerke zdravil, ki jih jemljete.
English: • if you are a heavy drinker of alcohol - if you regularly drink a lot, or if you have occasional sessions of heavy drinking (binge drinking)
Slovenian: • če prekomerno uživate alkoholne pijače - redno ali občasno (npr. na zabavah)
English: The most effective method to remove lactate and metformin is haemodialysis, however rosiglitazone is highly protein bound and is not cleared by haemodialysis.
Slovenian: Najučinkovitejši način za odstranitev laktata in metformina je hemodializa, a ker je vezava rosiglitazona na proteine zelo močna, se ta s hemodializo ne odstrani.
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Slovenian: Klinično pomembnih interakcij s substrati ali z zaviralci CYP2C9 ni pričakovati.
English: Eye problems: Swelling of the retina at the back of the eye which can cause blurred vision (macular oedema) can be a problem for people with diabetes.
Slovenian: Težave z očmi: Zaradi otekline mrežnice na očesnem ozadju se lahko pojavi zamegljen vid (makularni edem), kar je težava bolnikov s sladkorno boleznijo.
English: The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Slovenian: Glavni presnovni poti sta N-demetilacija in hidroksilacija, ki jima sledi konjugacija s sulfatom in z glukuronsko kislino.
English: The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih je volumen porazdelitve rosiglitazona znašal približno 14 litrov.
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 pojavnost zvišanja vrednosti ALT nad trikratno vrednost zgornje meje normalne vrednosti enaka kot pri placebu (0,2 %) in manjša kot pri primerjalnih učinkovinah (0,5 % metformin/sulfonilsečnine).
English: The RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) trial was a large (4,447 subjects), open-label, prospective, controlled study (mean follow-up 5.5 years) in which patients with type 2 diabetes inadequately controlled with metformin or sulphonylurea were randomised to add-on rosiglitazone or metformin or sulphonylurea.
Slovenian: Preskušanje RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) je bilo velika (4.447 preiskovancev), odprta prospektivna kontrolirana študija (povprečno spremljanje 5,5 leta), v kateri so bolnike s sladkorno boleznijo tipa 2, neustrezno urejeno z metforminom ali sulfonilsečnino, randomizirali na dodatek rosiglitazona ali metformina ali sulfonilsečnine.
English: Rosiglitazone can cause dose-dependent fluid retention.
Slovenian: Rosiglitazon lahko povzroči od odmerka odvisno zastajanje tekočine.
English: AVANDAMET is contraindicated in patients with:
Slovenian: AVANDAMET je kontraindiciran pri: