FrancophonIA/ELRC3.0 huggingface dataset:
English: In the fed state, Cmax was lower (22% rosiglitazone and 15% metformin) and tmax delayed (by approximately 1.5 h rosiglitazone and 0.5 h metformin).
Slovenian: Po obroku je bila Cmax nižja (22 % za rosiglitazon in 15 % za metformin) in tmax zakasnjen (za približno 1,5 ure pri rosiglitazonu in za 0,5 ure pri metforminu).
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Slovenian: V kliničnih študijah, kjer so prostovoljcem dajali v enkratnih peroralnih odmerkih do 20 mg rosiglitazona, so le-te prostovoljci dobro prenašali.
English: Low blood sugar (hypoglycaemia): If you are taking Avandamet with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Slovenian: Nizek krvni sladkor (hipoglikemija): Če zdravilo Avandamet jemljete skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, je verjetnost za prekomerno zmanjšanje krvnega sladkorja večja.
English: As AVANDAMET contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Slovenian: Ker AVANDAMET vsebuje metforminijev klorid, je potrebno zdravljenje prekiniti 48 ur pred načrtovanim operativnim posegom v splošni anesteziji, z njim pa običajno ne smemo nadaljevati prej kot v 48 urah po posegu.
English: Tell your doctor or pharmacist if you are taking any other medicines, if you've taken any recently, or if you start taking new ones.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste začeli jemati katerokoli novo zdravilo, vključno z zdravili iz zelišč in drugimi zdravili, ki jih lahko dobite brez recepta.
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Slovenian: V nadaljevanju so neželeni učinki za vsakega od režimov zdravljenja navedeni glede na organski sistem in absolutno pogostnost.
English: Rosiglitazone with metformin
Slovenian: Rosiglitazon z metforminom
English: • Avandamet is not recommended during pregnancy.
Slovenian: • Uporaba zdravila Avandamet med nosečnostjo ni priporočljiva.
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasting state.
Slovenian: Če se rosiglitazon zaužije s hrano, ne pride do spremembe celotne izpostavljenosti organizma (AUC), čeprav so v primerjavi z zaužitjem na tešče opazili manjše zmanjšanje Cmax (za približno 20 do 28 %) in zakasnitev tmax (za približno 1,75 ure).
English: Avandamet tablets are a combination of two different medicines called rosiglitazone and metformin.
Slovenian: Avandamet tablete vsebujejo kombinacijo dveh zdravilnih učinkovin - rosiglitazona in metformina.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Slovenian: V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 μg/ml.
English: In a prospective cardiovascular outcomes study (mean follow-up 5.5 years) the primary endpoint events of cardiovascular death or hospitalisation were similar between rosiglitazone and active comparators [HR 0.99 (95% CI 0.85 - 1.16)].
Slovenian: V prospektivni študiji kardiovaskularnih izidov (povprečno spremljanje 5,5 leta) so bili dogodki primarne končne točke - kardiovaskularna smrt ali hospitalizacija - z rosiglitazonom zabeleženi podobno kot s primerjalnimi učinkovinami [razmerje ogroženost 0,99 (95 % IZ 0,85-1,16)].
English: Patients receiving AVANDAMET in combination with a sulphonylurea or insulin may be at risk for dose-related hypoglycaemia.
Slovenian: Pri bolnikih, ki prejemajo zdravilo AVANDAMET v kombinaciji s sulfonilsečnino ali z insulinom lahko obstaja tveganje za pojav od odmerka odvisne hipoglikemije.
English: Speak to your doctor, as you may need to stop taking Avandamet for a short while.
Slovenian: Posvetujte se s svojim zdravnikom, saj boste zdravilo Avandamet morda za nekaj časa morali
English: Concomitant administration of rosiglitazone with the oral antihyperglycaemic agents glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
Slovenian: Sočasno dajanje rosiglitazona s peroralnima antidiabetikoma glibenklamidom in akarbozo ni povzročilo nobenih klinično pomembnih farmakokinetičnih interakcij.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and an increased anion gap and lactate/pyruvate ratio.
Slovenian: Diagnostične laboratorijske ugotovitve so: znižanje pH krvi, koncentracija laktata v plazmi nad 5 mmol/l, zvečana anionska vrzel in zvečano razmerje laktat/piruvat.
English: The following data are findings in studies performed with rosiglitazone or metformin individually.
Slovenian: Sledeči podatki so bili ugotovljeni pri posamičnih raziskavah rosiglitazona ali metformina.
English: Each tablet contains either: 1 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 1000 mg metformin or 4 mg rosiglitazone and 1000 mg metformin.
Slovenian: Ena tableta vsebuje: 1 mg rosiglitazona in 500 mg metformina; 2 mg rosiglitazona in 500 mg metformina; 2 mg rosiglitazona in 1000 mg metformina ali 4 mg rosiglitazona in 1000 mg metformina.
English: AVANDAMET dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
Slovenian: Potrebno je razmisliti o prilagoditvi odmerka zdravila AVANDAMET znotraj priporočenega odmerjanja ali o spremembah pri zdravljenju sladkorne bolezni.
English: The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Slovenian: Intravaskularna uporaba jodiranih kontrastnih sredstev med radiološkimi preiskavami lahko povzroči odpoved ledvic.
English: Metformin should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
Slovenian: Metformin je potrebno ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic.
English: Rosiglitazone (either SU or metformin)
Slovenian: Rosiglitazon (bodisi SS bodisi metformin)
English: • dark-coloured urine.
Slovenian: • temno obarvan urin.
English: Î Check with your doctor, as Avandamet may not be suitable for you.
Slovenian: Î Posvetujte se s svojim zdravnikom, saj zdravilo Avandamet v tem primeru za vas morda ni
English: The risk of fracture should be considered in the care of patients, especially female patients, treated with rosiglitazone.
Slovenian: Pri zdravljenju je treba upoštevati tveganje za pojav zloma, še posebej pri bolnicah, ki se zdravijo z rosiglitazonom.
English: The decision to initiate AVANDAMET in combination with a sulphonylurea should include consideration of alternative therapies.
Slovenian: Pri odločanju o uvedbi zdravljenja z zdravilom AVANDAMET v kombinaciji s sulfonilsečnino je treba razmisliti o alternativnih oblikah zdravljenja.
English: y if you become dehydrated - for example, after severe vomiting, diarrhoea or fever.
Slovenian: y če se pojavi dehidracija - na primer zaradi hudega bruhanja, driske ali visoke telesne temperature.
English: • ACE inhibitors (used to treat high blood pressure), such as enalapril or captopril
Slovenian: • zaviralci ACE (uporabljamo jih pri zdravljenju visokega krvnega tlaka), kot sta enalapril ali kaptopril.
English: (monotherapy, dual or triple oral therapy).
Slovenian: (samostojno zdravljenje, peroralno zdravljenje z dvema ali tremi zdravili).
English: • swelling of the retina at the back of the eye (macular oedema)
Slovenian: • oteklina mrežnice na očesnem ozadju (makularni edem).
English: Avandamet tablets come in different strengths.
Slovenian: Avandamet tablete so na voljo v različnih jakostih.
English: When clinically appropriate, direct change from metformin monotherapy to AVANDAMET may be considered.
Slovenian: Če je klinično sprejemljivo, se sme razmisliti o neposredni zamenjavi iz monoterapije z metforminom na zdravljenje z zdravilom AVANDAMET.
English: No data are available with regard to overdose of AVANDAMET.
Slovenian: Podatki glede prevelikega odmerjanja zdravila AVANDAMET niso na voljo.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Slovenian: V redkih primerih so v postmarketinških izkušnjah z rosiglitazonom naleteli na hepatocelularno disfunkcijo (glejte poglavje 4.8).
English: No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined noninferiority criterion of 1.20 (non-inferiority p = 0.02).
Slovenian: Ugotovili niso nobene razlike v številu presojenih dogodkov primarne končne točke za rosiglitazon (321/2220) v primerjavi s primerjalno učinkovino (323/2227) (razmerje ogroženost 0,99, 95 % IZ 0,85-1,16), s čimer je izpolnjeno vnaprej opredeljeno merilo neinferiornosti 1,20 (p za neinferiornost = 0,02).
English: In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with AVANDAMET.
Slovenian: Pri bolnikih, ki imajo že pred začetkom zdravljenja nizke koncentracije hemoglobina, zdravljenje z zdravilom AVANDAMET poveča tveganje za anemijo.
English: The usual starting dose is one combined tablet (2 mg rosiglitazone and 1000 mg metformin), taken twice a day, morning and evening.
Slovenian: Običajni začetni odmerek je ena kombinirana tableta (2 mg rosiglitazona in 1000 mg metformina) dvakrat na dan (zjutraj in zvečer).
English: Patients with renal impairment
Slovenian: Bolniki z oslabljenim delovanjem ledvic
English: The following statements reflect the information available on the individual active substances (rosiglitazone and metformin).
Slovenian: Sledeče navedbe osvetljujejo dostopne podatke o individualnih zdravilnih učinkovinah (rosiglitazonu in metforminu).
English: What Avandamet is and what it is used for Before you take Avandamet How to take Avandamet Possible side effects
Slovenian: Kaj je zdravilo Avandamet in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Avandamet
English: Any unused product should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Intravascular administration of iodinated contrast agents may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Slovenian: Intravaskularna uporaba jodiranih kontrastnih sredstev lahko povzroči odpoved ledvic, posledično kopičenje metformina in tveganje za laktacidozo.
English: Long-term studies show an increased incidence of bone fractures in patients, particularly female patients, taking rosiglitazone (see section 4.8).
Slovenian: Dolgoročne študije kažejo večjo pojavnost zlomov kosti pri osebah, zlasti ženskah, ki jemljejo rosiglitazon (glejte poglavje 4.8).
English: In a sub-study at 18 months, add-on rosiglitazone dual therapy was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Slovenian: V podštudiji dvotirno zdravljenje z dodanim rosiglitazonom po 18 mesecih ni bilo inferiorno kombinaciji sulfonilsečnine in metformina za znižanje HbA1c.
English: In clinical trials, 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: V kliničnih preskušanjih so se učinki zniževanja ravni krvnega sladkorja zaradi rosiglitazona razvijali postopno, največje znižanje vsebnosti glukoze v plazmi, merjeno na tešče (FPG), se je pokazalo po približno 8 tednih zdravljenja.
English: • if you have heart failure, or have had heart failure in the past
Slovenian: • če imate ali ste kdaj imeli srčno popuščanje.
English: All patients should continue their diet with regular distribution of carbohydrate intake during the day.
Slovenian: Vsi bolniki morajo nadaljevati z dieto, obroki z ogljikovimi hidrati morajo biti razdeljeni skozi ves dan. Bolniki s prekomerno telesno maso morajo nadaljevati z nizko energijsko dieto.
English: Rosiglitazone plasma concentrations peak at around 1 h after dosing.
Slovenian: Rosiglitazon doseže najvišjo koncentracijo v plazmi približno 1 uro po zaužitju.
English: Fluid retention and heart failure: Avandamet can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Slovenian: Zastajanje tekočin in srčno popuščanje: Zdravilo Avandamet lahko povzroči zastajanje vode v telesu (zastajanje tekočin), kar povzroči otekline in zvečanje telesne mase.
English: Metabolism Metformin is excreted unchanged in the urine.
Slovenian: Presnova Metformin se izloča z urinom v nespremenjeni obliki.
English: Metformin (background sulphonylurea)
Slovenian: Metformin (osnova: sulfonilsečnina)
English: Where appropriate, AVANDAMET may be used to substitute concomitant rosiglitazone and metformin in existing dual or triple oral therapy to simplify treatment.
Slovenian: Če je primerno, se lahko z zdravilom AVANDAMET zamenja sočasno zdravljenje z rosiglitazonom in metforminom, če se bolnik že zdravi peroralno z dvema ali tremi zdravili, da bi se tako zdravljenje poenostavilo.
English: For AVANDAMET no preclinical or clinical data on exposed pregnancies or lactation are available.
Slovenian: Predklinični ali klinični podatki o uporabi zdravila AVANDAMET med nosečnostjo ali dojenjem niso na voljo.
English: Furthermore, AVANDAMET should be used with caution during concomitant administration of cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) due to the effect on metformin pharmacokinetics (see section 4.5).
Slovenian: Zdravilo AVANDAMET je treba uporabljati previdno tudi med sočasnim dajanjem kationskih zdravilnih učinkovin, ki se izločajo preko ledvic s tubulno sekrecijo (npr. cimetidin), in sicer zaradi učinka na farmakokinetiko metformina (glejte poglavje 4.5).
English: Patients who are intolerant to lactose or have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z intoleranco za laktozo ali z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Slovenian: Izboljšana urejenost glikemije je bila povezana tudi z značilnim znižanjem prostih maščobnih kislin.
English: • beta-2-agonists (used to treat asthma), such as salbutamol or salmeterol
Slovenian: • agonisti adrenergičnih receptorjev beta-2 (uporabljamo jih pri zdravljenju astme), kot sta salbutamol ali salmeterol.
English: Broken bones: Bone fractures can occur in people with diabetes.
Slovenian: Zlomi kosti: Pri bolnikih s sladkorno boleznijo lahko pride do zlomov kosti.
English: Don't take Avandamet:
Slovenian: Ne jemljite zdravila Avandamet:
English: • if you have liver disease
Slovenian: • če imate bolezen ledvic.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID.
Slovenian: V primerih, ko lahko pride do oslabljenega delovanja ledvic, npr. na začetku zdravljenja z antihipertenzivi, diuretiki ali nesteroidnimi protivnetnimi zdravili (NSAID), je potrebna posebna previdnost.
English: • diuretics (used to get rid of water), such as furosemide or indapamide
Slovenian: • diuretiki (uporabljamo jih za odvajanje vode iz telesa), kot sta furosemid ali indapamid.
English: Rosiglitazone has been reported to cross the human placenta and to be detectable in foetal tissues.
Slovenian: Poročali so, da rosiglitazon prehaja preko človeške placente in se ga lahko dokaže v tkivih ploda.
English: If ALT levels are increased to > 3 times the upper limit of normal during AVANDAMET therapy, liver enzyme levels should be reassessed as soon as possible.
Slovenian: Če med zdravljenjem z zdravilom AVANDAMET ALT doseže vrednosti, ki so več kot 3-krat večje od zgornje meje normalne vrednosti, je potrebno čim prej ponovno oceniti vrednosti jetrnih encimov.
English: • if you are going to have an X-ray using an injected dye.
Slovenian: • če imate predvideno rentgensko preiskavo, pri kateri vam bodo v žilo vbrizgali kontrastno sredstvo.
English: Take special care with Avandamet
Slovenian: Bodite posebno pozorni pri jemanju zdravila Avandamet
English: The risk of fracture appeared to be higher in females relative to control [11.5% vs 6.3%, Risk ratio 1.82 (95% CI 1.37 - 2.41)], than in males relative to control [5.3% vs 4.3%, Risk ratio 1.23 (95% CI 0.85 - 1.77)].
Slovenian: Tveganje zlomov je bilo pri ženskah v primerjavi s kontrolnimi osebami večje [11,5 % v primerjavi s 6,3 %, razmerje tveganj 1,82 (95 % IZ 1,37-2,41)] kot pri moških v primerjavi s kontrolnimi osebami (5,3 % v primerjavi s 4,3 %, razmerje tveganj 1,23 (95 % IZ 0,85-1,77)].
English: Liver problems: Before you start taking Avandamet you will have a blood sample taken to check your liver function.
Slovenian: Težave z jetri: Pred začetkom zdravljenja z zdravilom Avandamet bo zdravnik s krvno preiskavo preveril delovanje jeter.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking AVANDAMET should have their renal function monitored regularly (see sections 4.3 and 4.4).
Slovenian: Zaradi izločanja metformina skozi ledvice in zaradi starostnega nagnjenja k zmanjšanju ledvičnega delovanja je pri starostnikih, ki jemljejo AVANDAMET, potrebno redno spremljati delovanje ledvic (glejte poglavji 4.3 in 4.4).
English: You must look out for certain symptoms while you are taking Avandamet, to reduce the risk of any problems.
Slovenian: Da bi zmanjšali tveganje za pojav kakršnihkoli težav morate biti med jemanjem zdravila Avandamet pozorni na nekatere simptome.
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Slovenian: Poročila o primerih laktacidoze pri zdravljenju z metforminom se primarno nanašajo na diabetike z napredovalo ledvično odpovedjo.
English: • reduction in blood count (anaemia)
Slovenian: • zmanjšanje števila krvnih celic (anemija).
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: Pri sočasnem jemanju digoksina, substrata za CYP2C9 varfarina, substrata za CYP3A4 nifedipina, etinilestradiola ali noretindrona z rosiglitazonom niso opazili klinično pomembnih interakcij.
English: Rosiglitazone
Slovenian: Rosiglitazon
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 posameznih skupin bolnikov ni bilo opaznih razlik med farmakokinetičnimi lastnostmi rosiglitazona pri moških in ženskah.
English: No animal studies have been conducted with the combined products in AVANDAMET.
Slovenian: Študije s kombinacijo učinkovin v zdravilu AVANDAMET na živalih niso bile narejene.
English: Therefore, due to the metformin active substance, AVANDAMET should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Slovenian: Zaradi vsebnosti zdravilne učinkovine metformin je potrebno AVANDAMET ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic (glejte poglavje 4.5).
English: Clinical Trial Data and Post-marketing data
Slovenian: Podatki iz kliničnih preskušanj in podatki po pridobitvi dovoljenja za promet
English: If you forget to take Avandamet Don't take extra tablets to make up for a missed dose.
Slovenian: Ne jemljite dodatnih tablet, da bi tako nadomestili pozabljeni odmerek.
English: An additional observation of an increased incidence of bone fractures was seen in women with rosiglitazone (see sections 4.4 and 4.8).
Slovenian: Dodatno so pri ženskah med uporabo rosiglitazona opazili večjo incidenco zlomov kosti (glejte poglavji 4.4 in 4.8).
English: Don't stop taking Avandamet
Slovenian: Ne prenehajte jemati zdravila Avandamet
English: Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)
Slovenian: Peroralno zdravljenje s tremi zdravili (rosiglitazon, metformin in sulfonilsečnina) (glejte poglavje 4.4)
English: 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 2.00% versus combined active and placebo comparators, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
Slovenian: 3 Pri retrospektivni analizi podatkov iz 42 združenih kratkotrajnih kliničnih študij je bila celotna pojavnost dogodkov, tipično povezanih s srčno ishemijo, višja pri režimih zdravljenja z rosiglitazonom (2,00%) kot pri primerjalni kombinaciji učinkovine in placeba (1,53%) [razmerje ogroženosti 1,30 (95 % interval zaupanja (IZ) 1,004-1,69)].
English: It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.
Slovenian: Koncentracijo glukoze v krvi zmanjšuje tako, da zmanjšuje insulinsko rezistenco v adipoznem tkivu, skeletni muskulaturi in v jetrih.
English: Your doctor will advise you to stop taking Avandamet before the X-ray and for 48 hours after it.
Slovenian: Zdravnik vam bo svetoval, da zdravila Avandamet pred rentgensko preiskavo in še 48 ur po preiskavi ne jemljite.
English: Take Avandamet for as long as your doctor recommends.
Slovenian: Zdravilo Avandamet morate jemati tako dolgo kot vam to predpiše zdravnik.
English: The other ingredients are: sodium starch glycollate, hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, povidone (E1201), magnesium stearate, titanium dioxide (E171), macrogol, iron oxide yellow or red (E172).
Slovenian: Pomožne snovi so: natrijev karboksimetilškrob, hipromeloza (E464), mikrokristalna celuloza (E460), laktoza monohidrat, povidon (E1201), magnezijev stearat, titanov dioksid (E171), makrogol in rdeči ali rumeni železov oksid (E172).
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 študijah vplivov na sposobnosti razmnoževanja so dajanje rosiglitazona podganam v srednjem in poznejšem obdobju brejosti povezovali s smrtjo zarodka in z upočasnitvijo njegovega razvoja.
English: Skin and subcutaneous disorders urticaria
Slovenian: Bolezni kože in podkožja urtikarija
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 preskušanjih z rosiglitazonom so opazili od odmerka odvisno povečevanje telesne mase, ki je bilo pri uporabi v kombinaciji z insulinom večje.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: POSSIBLE SIDE EFFECTS
Slovenian: MOŽNI NEŽELENI UČINKI