natgillin/translations-raw huggingface dataset:
Fluid retention and heart failure: Avandia can cause you to retain water (fluid retention) which leads to swelling and weight gain. 
Zastajanje tekočin in srčno popuščanje: Zdravilo Avandia lahko povzroči zastajanje vode v telesu (zastajanje tekočin), kar povzroči otekline in zvečanje telesne mase.
Early symptoms of low blood sugar are: y shaking, sweating, faintness y nervousness, palpitations y hunger. 
y tresenje, znojenje, vrtoglavica y živčnost, palpitacije y lakota.
Rosiglitazone plasma concentrations peak at around 1 hour after dosing. 
Rosiglitazon doseže najvišjo koncentracijo v plazmi 1 uro po zaužitju.
Moderate ingestion of alcohol with rosiglitazone has no effect on glycaemic control. 
Zmerno pitje alkohola med jemanjem rosiglitazona ni vplivalo na glikemični nadzor.
The improved glycaemic control is associated with reductions in both fasting and post-prandial glucose. 
Izboljšan nadzor glikemije je povezan z zniževanjem glukoze tako na tešče kot po jedi.
Contains lactose (approximately 108 mg). 
Vsebuje laktozo (približno 108 mg)
If ALT levels remain >3X the upper limit of normal, therapy should be discontinued. 
Če ostane vrednost ALT še naprej več kot trikrat večja od zgornje meje normalne vrednosti, je treba z zdravljenjem prenehati.
What Avandia is and what it is used for Before you take Avandia How to take Avandia Possible side effects 
Kaj je zdravilo Avandia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Avandia
As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance. 
Ker rosiglitazon izboljšuje odzivnost organizma na insulin, lahko pride do ponovne ovulacije pri bolnicah, ki zaradi odpornosti proti insulinu ne ovulirajo več.
Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema 
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem
Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females. 
Spol: Pri preučevanju farmakokinetike znotraj skupin bolnikov ni bilo opaznih razlik med farmakokinetičnimi lastnostmi rosiglitazona pri moških in ženskah.
• swelling (oedema) due to water retention. 
• oteklina (edem) zaradi zastajanja vode v telesu.
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. 
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.
Common Common headache* 
glavobol*
CL/F seemed to be independent of age, but increased with weight in the paediatric population. 
CL/F predvidoma ni odvisen od starosti, vendar pa se pri otrocih povečuje s telesno maso.
In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with rosiglitazone. 
Pri bolnikih, ki imajo že pred začetkom zdravljenja nizke koncentracije hemoglobina, zdravljenje z rosiglitazonom poveča tveganje za anemijo.
− When new information is received that may impact on the current Safety Specification, 
− kadar imetnik dovoljenja za promet prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali aktivnosti za zmanjšanje tveganja.
Patients with hepatic impairment Rosiglitazone should not be used in patients with hepatic impairment. 
Bolniki z motnjami delovanja jeter Rosiglitazona bolniki z motnjami delovanja jeter ne smejo uporabljati.
Take Avandia for as long as your doctor recommends. 
Zdravilo Avandia morate jemati tako dolgo kot vam to predpiše zdravnik.
Liver problems: Before you start taking Avandia you will have a blood sample taken to check your liver function. 
Težave z jetri: Pred začetkom zdravljenja z zdravilom Avandia bo zdravnik s krvno preiskavo preveril delovanje jeter.
The frequency of adverse reactions identified from post-marketing data 
Pogostnost neželenih učinkov na osnovi podatkov po pridobitvi dovoljenja za promet
• fluid in the lungs (pulmonary oedema) causing breathlessness 
• tekočina v pljučih (edem pljuč), ki povzroči težko dihanje
You must look out for certain symptoms while you are taking Avandia, to reduce the risk of any problems. 
Da bi zmanjšali tveganje za pojav kakršnihkoli težav morate biti med jemanjem zdravila Avandia pozorni na nekatere simptome.
Limited data are available with regard to overdose in humans. 
O zaužitju prevelikega odmerka pri človeku je na voljo le malo podatkov.
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 
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
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone. 
Po sočasnem jemanju digoksina, substrata CYP2C9 varfarina, substrata CYP3A4 nifedipina, etinilestradiola ali noretindrona z rosiglitazonom niso opazili klinično pomembnih interakcij.
Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure. 
Zastajanje tekočine in srčno popuščanje Tiazolidindioni lahko povzročijo zastajanje tekočine, ki lahko poslabša ali povzroči znake ali simptome kongestivnega srčnega popuščanja.
Common weight increase 
Povečevanje telesne mase
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets 
7 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 112 filmsko obloženih tablet
Frequency of adverse reaction by treatment regimen RSG RSG + MET 
Pogostnost neželenih učinkov glede na režim zdravljenja RSG
If you forget to take Avandia Don't take extra tablets to make up for a missed dose. 
Ne jemljite dodatnih tablet, da bi tako nadomestili pozabljeni odmerek.
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development. 
V raziskavah vplivov na sposobnost razmnoževanja so dajanje rosiglitazona podganam v srednjem in poznejšem obdobju brejosti povezovali s smrtjo zarodka in upočasnitvijo njegovega razvoja.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia. 
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.
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate. 
Jedro tablete: natrijev karboksimetilškrob (vrsta A) hipromeloza mikrokristalna celuloza laktoza monohidrat magnezijev stearat
Take special care with Avandia 
Bodite posebno pozorni pri jemanju zdravila Avandia
The dose of your medicines may need to be reduced. 
Odmerek sočasno uporabljenega zdravila bo morda treba zmanjšati.
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). 
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).
• rifampicin (used to treat tuberculosis and other infections) Î Tell a doctor or pharmacist if you are taking any of these. 
• rifampicin (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb).
Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged. 
Presnova rosiglitazona je obsežna, saj se nobena začetna spojina ne izloči v nespremenjeni obliki.
The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients. 
Razlike med posamezniki so bile zelo velike, AUC nevezane učinkovine se je razlikoval tudi do sedemkrat.
If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible. 
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.
Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia. 
Pri bolnikih, ki prejemajo rosiglitazon skupaj s sulfonilsečnino ali z insulinom obstaja tveganje za pojav od odmerka odvisne hipoglikemije.
Clinical trials data 
Podatki iz kliničnih preskušanj
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. 
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.
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. 
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.
Don't take Avandia: 
Ne jemljite zdravila Avandia:
• Don't breast-feed while you are taking Avandia. 
• Med jemanjem zdravila Avandia ne smete dojiti.
Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure. 
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.
Rosiglitazone is highly protein bound and is not cleared by haemodialysis. 
Rosiglitazon se v zelo veliki meri veže na proteine in ga s hemodializo ne moremo odstraniti iz telesa.
Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly. 
Starostniki (glejte poglavje 4.4 Zastajanje tekočine in srčno popuščanje) Starostnikom ni potrebno posebej prilagajati odmerka.
Don't stop taking Avandia 
Ne prenehajte jemati zdravila Avandia
This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required. 
Če je potrebna boljša urejenost glikemije, se ta odmerek lahko po osmih tednih poveča na 8 mg/dan.
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com 
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-infor@gsk.com
Blood and the lymphatic system disorders anaemia 
Bolezni krvi in limfatičnega sistema anemija levkopenija trombocitopenija granulocitopenija
HOW TO TAKE AVANDIA 
KAKO JEMATI ZDRAVILO AVANDIA
Nervous system disorders dizziness* 
Bolezni živčevja omotica*
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. 
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.
Driving and using machines This medicine should not affect your ability to drive or use machines. 
To zdravilo ne vpliva na sposobnost upravljanja vozil in strojev.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo. 
Raziskava in vivo o interakcijah z varfarinom je pokazala, da rosiglitazon in vivo s substrati CYP2C9 medsebojno ne učinkuje.
The absorption of rosiglitazone is not affected by increases in gastric pH. 
Zvišanje vrednosti želodčnega pH ne vpliva na absorpcijo rosiglitazona.
In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin. 
V kliničnih študijah z rosiglitazonom so pri bolnikih opazili od odmerka odvisno povečanje telesne mase, ki je bilo pri sočasni uporabi insulina večje.
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. 
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.
The frequency of adverse reactions identified from clinical trial data 
Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj Neželeni učinki
56 film-coated tablets, unit dose pack 
56 filmsko obloženih tablet, pakiranje po enoti odmerka
AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone 
AVANDIA 2 mg filmsko obložene tablete AVANDIA 4 mg filmsko obložene tablete AVANDIA 8 mg filmsko obložene tablete rosiglitazon
Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus. 
V primerjavi z odraslimi bolniki s sladkorno boleznijo tipa 2, pri otrocih po zdravljenju z rosiglitazonom niso opazili dodatnih težav, povezanih z varnostjo.
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. 
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).
Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent. 
Starostniki: Pri preučevanju farmakokinetike zdravila znotraj skupin bolnikov niso opazili, da bi starost kakorkoli pomembneje vplivala na farmakokinetiko rosiglitazona.
Rosiglitazone should be discontinued if any deterioration in cardiac status occurs. 
Če bi prišlo do kakršnega koli poslabšanja delovanja srca, je treba zdravljenje z rosiglitazonom prekiniti.
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. 
Največje znižanje vsebnosti glukoze v plazmi, merjeno na tešče (FPG), se je pokazalo po približno 8 tednih zdravljenja.
− an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) 
- z akutnim koronarnim sindromom (nestabilna angina pektoris, NSTEMI in STEMI) (glejte
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). 
- 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
Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels. 
Zdravljenje z rosiglitazonom povezujejo z od odmerka odvisnim zmanjšanjem koncentracije hemoglobina.
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). 
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).
Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision. 
Pri bolnikih, ki se že zdravijo z rosiglitazonom, se zdravljenje z insulinom laho uvede le v izjemnih primerih in pod skrbnim zdravniškim nadzorom.
In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species. 
Poleg tega rosiglitazon v vrsti raziskav genotoksičnosti in vivo ter in vitro ni pokazal genotoksičnosti pri dveh vrstah glodalcev, ki so jih v sklopu raziskav z rosiglitazonom spremljali vse življenje; prav tako niso odkrili nobenih znakov črevesnega raka.
No intact drug is excreted in urine or faeces. 
Zdravilo se z urinom in blatom ne izloča v nespremenjeni obliki.
Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice. 
Rosiglitazon pri miših in podganah ni spodbujal izločanja insulina iz trebušne slinavke ali pri njih sprožal hipoglikemije.
The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets. 
Tablete so na voljo v pretisnih omotih po 7, 28, 84, 90 ali 112 filmsko obloženih tablet.
Rosiglitazone failed to demonstrate non-inferiority to metformin. 
Enakovrednosti rosiglitazona metforminu niso dokazali.
General disorders and administration site conditions oedema 
Splošne težave in spremembe na mestu aplikacije edem
Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare 
Bolezni jeter, žolčnika in žolčevodov disfunkcija jeter, ki se prvenstveno kaže s povišanjem vrednosti jetrnih encimov5
Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure. 
O pojavu edemov in srčnega popuščanja so pogosteje poročali tudi pri starostnikih in pri bolnikih z blagimi do zmernimi motnjami delovanja ledvic.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema. 
Ker nesteroidna protivnetna zdravila in rosiglitazon povezujejo z zastajanjem tekočine v telesu, lahko sočasno jemanje poveča tveganje nastanka edemov.
INFORMATION IN BRAILLE avandia 8 mg 
avandia 8 mg
Moreover in patients with congestive heart failure NYHA class I-II, a placebo-controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo. 
razred po NYHA) so poslabšanje ali možno poslabšanje srčnega popuščanja ugotovili pri 6,4 % bolnikov, ki so prejemali rosiglitazon in pri 3,5 % bolnikov, ki so prejemali placebo.
Avandia contains lactose 
Zdravilo Avandia vsebuje laktozo
Therefore, liver enzymes should be checked prior to the initiation of therapy with rosiglitazone in all patients and periodically thereafter based on clinical judgement. 
Pri bolnikih z zvišanimi vrednostmi jetrnih encimov (ALT > 2,5-krat od zgornje meje normalne vrednosti) so izkušnje z rosiglitazonom omejene, zato je pred pričetkom zdravljenja z rosiglitazonom pri vseh bolnikih potrebno preveriti jetrne encime in jih nato na osnovi klinične presoje preverjati periodično.
Uncommon hypoglycaemia 
Občasni hipoglikemija
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)]. 
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)].
• shortness of breath, waking up short of breath at night 
Simptomi srčnega popuščanja vključujejo: težko dihanje, prebujanje ponoči zaradi težkega dihanja.
Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis. 
Bolniki z ledvično okvaro: Pri bolnikih z ledvično okvaro ali v zadnjem stadiju ledvične bolezni, ki so kronično na dializi, niso zasledili klinično pomembnih razlik v farmakokinetiki rosiglitazona.
INFORMATION IN BRAILLE avandia 4 mg 
avandia 4 mg
INFORMATION IN BRAILLE avandia 2 mg 
avandia 2 mg
Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). 
V primeru sočasnega dajanja zaviralcev CYP2C8 (npr. gemfibrozil) ali induktorjev CYP2C8 (npr. rifampicin) je potrebno rosiglitazon uporabljati previdno.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
The tablets are provided in blister packs containing 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets in a unit dose pack. 
Tablete so na voljo v pretisnih omotih po 56, 112, 168 ali 180 filmsko obloženih tablet ali 65 filmsko obloženih tablet v enem vsebniku.
EU/1/00/137/016 180 tablets 
EU/1/00/137/016 180 tablet
Therapy with rosiglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal) or with any other evidence of liver disease. 
Pri bolnikih, z zvišanimi osnovnimi vrednostmi jetrnih encimov (ALT > 2,5-krat večji od zgornje meje normalne vrednosti) ali s katerimikoli drugimi znaki jetrnega obolenja, zdravljenja z rosiglitazonom ne smemo uvesti.
Symptoms of heart failure include: 
Zgodnji simptomi nizkega krvnega sladkorja so:
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin. 
Bolnike, ki rosiglitazon uporabljajo v kombinaciji z metforminom in insulinom, je treba skrbno nadzirati.
If jaundice is observed, drug therapy should be discontinued. 
Če dobi bolnik zlatenico, moramo z dajanjem zdravila prenehati.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
EU/1/00/137/013 168 tablets 
EU/1/00/137/013 168 tablet