natgillin/translations-raw huggingface dataset:
Combination with other antidiabetes medicines led to further decreases in the level of HbA1c, indicating that blood glucose levels had been further reduced.
Kombiniranje z drugimi zdravili proti sladkorni bolezni je še nadalje znižalo koncentracijo HbA1c, kar kaže, da se je koncentracija glukoze v krvi dodatno znižala.
The most common side effects with Avandia (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), hyperlipaemia (high blood levels of lipids, another type of fat), weight increase, increased appetite, cardiac ischaemia (reduced oxygen supply to the heart muscle), constipation, bone fractures (broken bones), hypoglycaemia (low blood glucose) and oedema (swelling).
Najpogostejši neželeni učinki zdravila Avandia (opaženi pri 1 do 10 bolnikih izmed 100) so anemija (nizko število rdečih krvnih celic), hiperholesterolemija (visoke ravni holesterola v krvi), hipertrigliceridemija (visoke ravni trigliceridov, vrste maščob, v krvi), hiperlipemija (visoke ravni lipidov, druge vrste maščob, v krvi), povečanje telesne mase, povečan tek, srčna ishemija (zmanjšan dotok kisika v srčno mišico), zaprtje, zlomi kosti, hipoglikemija (nizka koncentracija glukoze v krvi), in edemi (otekanje).
It should not be used in patients who have heart failure, problems with their liver, an ‘ acute coronary syndrome’ such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, or complications of diabetes (diabetic ketoacidosis or diabetic precoma).
Uporabljati ga ne smejo bolniki s srčnim popuščanjem, obolenji jeter, „ akutnim koronarnim sindromom “, kot so nestabilna angina pektoris (huda vrsta bolečine v prsih, katere jakost se naglo spreminja) ali določene oblike srčnega napada, ali zapleti sladkorne bolezni (diabetično ketoacidozo ali diabetično predkomo).
The doses of Avandia may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Odmerke zdravila Avandia bo morda treba prilagoditi, kadar ga uporabljamo z nekaterimi drugimi zdravili, na primer gemfibrozilom ali rifampicinom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avandia’ s benefits are greater than its risks for the treatment of type 2 diabetes mellitus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Avandia pri zdravljenju sladkorne bolezni tipa 2 večje od z njim povezanih tveganj.
The Committee recommended that Avandia be given marketing authorisation.
Zato je priporočil, da se za zdravilo Avandia odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Avandia to SmithKline Beecham plc on 11 July 2000.
Evropska komisija je dovoljenje za promet z zdravilom Avandia, veljavno po vsej Evropski uniji, odobrila družbi SmithKline Beecham plc dne 11. julija 2000.
The marketing authorisation was renewed on 11 July 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 11. julija 2005.
This summary was last updated in 02-2008.
Povzetek je bil nazadnje posodobljen 03- 2008.
Excipient Contains lactose (approximately 108 mg).
Pomožna snov Vsebuje laktozo (približno 108 mg)
Pink film-coated tablets debossed with “ GSK” on one side and "2" on the other side.
Rožnate filmsko obložene tablete, označene z “ GSK ” na eni in “ 2 ” na drugi strani.
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
Rosiglitazon je indiciran za zdravljenje sladkorne bolezni tipa 2:
as monotherapy – in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
kot samostojno zdravilo – pri bolnikih (še posebej bolnikih s prekomerno telesno maso), ki z dieto in telesno vadbo niso zadostno nadzorovani in pri katerih uporaba metformina zaradi kontraindikacij ali intolerance ni primerna.
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
kot del peroralnega zdravljenja z dvema zdraviloma v kombinaciji – z metforminom, pri bolnikih (še posebej bolnikih s prekomerno telesno maso) z nezadostno urejenostjo glikemije kljub zdravljenju z največjim dovoljenim odmerkom metformina samega. – 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 sulfonilsečnino samo.
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).
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 (glejte poglavje 4. 4).
Experience from clinical trials with rosiglitazone is currently limited to three years.
Do sedaj imamo z rosiglitazonom samo tri leta kliničnih izkušenj.
The long-term benefits of therapy with rosiglitazone have not been demonstrated (see section 5.1).
Dolgoročna korist zdravljenja z rosiglitazonom še ni bila dokazana (glejte poglavje 5. 1).
Rosiglitazone therapy is usually initiated at 4 mg/ day.
Začetni odmerek rosiglitazona je običajno 4 mg/ dan.
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.
In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/ day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Pred tem je treba opraviti ustrezen klinični pregled in oceniti bolnikovo ogroženost za pojav neželenih učinkov, povezanih z zastajanjem tekočine (glejte poglavji 4. 4 in 4. 8).
Rosiglitazone may be taken with or without food.
2 Rosiglitazon se lahko jemlje s hrano ali brez nje.
2 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.
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.
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.
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.
Children and adolescents There are no data available on the use of rosiglitazone in patients under 10 years of age.
Otroci in mladostniki Podatki o uporabi rosiglitazona pri bolnikih, mlajših od 10 let niso na voljo.
For children aged 10 to 17 years, there are limited data on rosiglitazone as monotherapy (see sections 5.1 and 5.2).
Podatki o uporabi rosiglitazona kot samostojnega zdravila pri otrocih, starih od 10 do 17 let so skopi (glejte poglavji 5. 1 in 5. 2).
− hepatic impairment
- z motnjami v delovanju jeter.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
3 Kombinirano zdravljenje z insulinom V kliničnih preskušanjih so pri sočasni uporabi rosiglitazona in insulina poročali o večji pojavnosti srčnega popuščanja.
3 Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Ishemija miokarda Razpoložljivi podatki kažejo, da je zdravljenje z rosiglitazonom lahko povezano z večjim tveganjem za pojav ishemičnih miokardnih dogodkov (glejte poglavje 4. 8).
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Nadziranje delovanja jeter V redkih primerih so v postmarketinških izkušnjah naleteli na hepatocelularno disfunkcijo (glejte poglavje 4. 8).
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.
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.
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.
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.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Če se pri kakšnem bolniku pojavijo simptomi, ki kažejo na motnje jetrnega delovanja, kar lahko vključuje tudi nepojasnjeno navzeo, bruhanje, bolečine v trebuhu, utrujenost, anoreksijo in/ ali temen seč, je treba bolniku preveriti jetrne encime.
Weight gain In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Povečevanje telesne mase V kliničnih študijah z rosiglitazonom so pri bolnikih opazili od odmerka odvisno povečanje telesne mase, ki je bilo pri sočasni uporabi insulina večje.
Anaemia Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Anemija Zdravljenje z rosiglitazonom povezujejo z od odmerka odvisnim zmanjšanjem koncentracije hemoglobina.
Hypoglycaemia Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
4 Pri bolnikih, ki prejemajo rosiglitazon skupaj s sulfonilsečnino ali z insulinom obstaja tveganje za pojav od odmerka odvisne hipoglikemije.
Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Odmerek sočasno uporabljenega zdravila bo morda treba zmanjšati.
Triple oral therapy The use of rosiglitazone in triple oral therapy, in combination with metformin and a sulphonylurea, may be associated with increased risks for fluid retention and heart failure, as well as hypoglycaemia (see section 4.8).
Peroralno zdravljenje s tremi zdravili Uporaba rosiglitazona pri peroralnem zdravljenju s tremi zdravili, v kombinaciji z metforminom in s sulfonilsečnino, je lahko povezana s povečanim tveganjem za zastajanje tekočine in srčno popuščanje, kot tudi za hipoglikemijo (glejte poglavje 4. 8).
4 Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Bolezni kosti V dolgotrajni študiji so pri bolnicah, ki so jemale rosiglitazon kot samostojno zdravilo, opazili večjo pojavnost zlomov kosti (nog, rok in nadlakti) (glejte poglavje 4. 8).
Others Premenopausal women have received rosiglitazone during clinical studies.
Drugo V kliničnih študijah so rosiglitazon dajali ženskam pred menopavzo.
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Čeprav so v predkliničnih študijah opazili hormonsko neravnovesje (glejte poglavje 5. 3), pa tu niso opazili nobenih značilnih neželenih učinkov v zvezi z menstrualnimi motnjami.
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs the treatment should be discontinued (see section 4.6).
Takšne bolnice se morajo zavedati tveganja, da lahko zanosijo, in če bi bolnica želela zanositi ali zanosi, je potrebno zdravljenje prekiniti (glejte poglavje 4. 6).
Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/ min).
Rosiglitazon je potrebno uporabljati previdno pri bolnikih s hudo ledvično insuficienco (očistek kreatinina < 30 ml/ min).
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.
Rosiglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Potrebno je razmisliti o prilagoditvi odmerka rosiglitazona znotraj priporočenega odmerjanja ali o spremembah pri zdravljenju sladkorne bolezni (glejte poglavje 4. 5).
AVANDIA tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Bolniki z redkimi dednimi težavami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/ galaktoze tega zdravila ne smejo jemati.
Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
5 Sočasno dajanje s peroralnimi antidiabetiki metforminom, glibenklamidom in akarbozo ni povzročilo nobenih klinično pomembnih farmakokinetičnih interakcij z rosiglitazonom.
5 shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Frequencies are defined as: very common ≥ 1/ 10; common ≥ 1/ 100, < 1/ 10; and uncommon ≥ 1/ 1000, < 1/ 100.
Pogostnost je definirana kot: zelo pogosti ≥ 1/ 10; pogosti ≥ 1/ 100, < 1/ 10; in občasni ≥ 1/ 1. 000, < 1/ 100.
6 Table 1.
6 Preglednica 1.
RSG + MET
Pogostnost neželenih učinkov glede RSG RSG + MET
RSG + SU
na režim zdravljenja RSG + SU RSG +MET +SU
RSG +MET +SU
Bolezni krvi in limfatičnega sistema
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia granulocytopaenia
anemija levkopenija trombocitopenija granulocitopenija
Common Common Common Common Common
Pogosti Pogosti Pogosti
Metabolism and nutrition disorders hypercholesterolaemia1 hypertriglyceridaemia
Presnovne in prehranske motnje
Common Common Common
Pogosti Pogosti
hyperlipaemia weight increase increased appetite
hiperlipemija povečanje telesne mase
Common Common Common Common Common
Pogosti Pogosti
Common Common Uncommon
Pogosti Pogosti
Common Common
Pogosti
Musculoskeletal and connective tissue disorders bone fractures myalgia*
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Common Common Very common Very common
Pogosti Pogosti
The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus 7 sulphonylurea dual therapy.
Pri
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
7 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%.
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.
Pri enoletnem s placebom nadzorovanim kliničnem preskušanju pri bolnikih s kongestivnim srčnim popuščanjem (I. - II. 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.
In a large observational study where patients were well-matched at baseline, the incidence of the composite endpoint myocardial infarction and coronary revascularization was 17.46 events per 1000 person years for rosiglitazone containing regimens and 17.57 events per 1000 person years for other anti-diabetic agents [Hazard ratio 0.93 (95% confidence interval 0.80 - 1.10)].
V obsežni opazovalni študiji, ki je vključevala bolnike z zelo identičnim zdravstvenim stanjem v izhodišču, je bila pojavnost sestavljenega opazovanega dogodka - miokardnega infarkta in koronarne revaskularizacije - pri režimih zdravljenja z rosiglitazonom 17, 46 dogodkov na 1. 000 oseb - let (“ person years ”), pri drugih antidiabetikih pa 17, 57 dogodkov na 1. 000 oseb- let [razmerje tveganja 0, 93 (95% interval zaupanja; 0, 80 - 1, 10)].
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).
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).
The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Pogostnost vseh neželenih učinkov, povezanih z jetri in žolčnim sistemom je bila < 1, 5% v katerikoli skupini zdravljenja in podobna pogostnosti pri placebu.
Frequencies are defined as: rare ≥ 1/ 10,000, < 1/ 1000 and very rare < 1/ 10,000 including isolated reports.
Pogostnost je definirana kot: redki ≥ 1/ 10. 000, < 1/ 1. 000 in zelo redki < 1/ 10. 000, vključno s posameznimi primeri.
8 Table 2.
8 Preglednica 2.
Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Bolezni imunskega sistema (glejte Bolezni kože in podkožja)
Cardiac disorders congestive heart failure/ pulmonary oedema
kongestivno srčno popuščanje/ pljučni edem
Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema skin reactions (e. g. urticaria, pruritus, rash) 5
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) 5
Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code:
Farmakoterapevtska skupina: peroralni antidiabetiki, tiazolidindioni, Oznaka ATC:
Preclinical data The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Predklinični podatki Antihiperglikemično delovanje rosiglitazona so dokazali na vrsti živalskih modelov s sladkorno boleznijo tipa 2.
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
The clinical relevance of this observation has not been fully elucidated.
9 debelih miših, izkazal sorazmerno visoko učinkovitost.
9 Clinical trials data 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.
At 18 months, in an ongoing long term comparator study, rosiglitazone in dual oral therapy with metformin or a sulphonylurea was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
V še potekajoči dolgoročni primerjalni raziskavi po 18 mesecih rosiglitazon pri dvojnem peroralnem zdravljenju z metforminom ali s sulfonilsečnino pri zmanjševanju HbA1c ni bil manjvreden od kombinacije sulfonilsečnina in metformin.
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).
There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone.
Raziskave, ki bi ocenjevale dolgoročne kardiovaskularne učinke pri bolnikih, ki jemljejo rosiglitazon v kombinaciji s sulfonilsečnino ali z metforminom še niso dokončane.
Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Absorpcija Absolutna biološka uporabnost rosiglitazona po zaužitju tako 4 mg kot 8 mg peroralnega odmerka znaša približno 99%.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20% to 28%) and a delay in tmax (ca.1.75 h) were observed compared to dosing in the fasting state.
Če rosiglitazon zaužijemo s hrano, ne pride do spremembe celotne izpostavljenosti organizma (AUC), čeprav so v primerjavi z zaužitjem na tešče opazili majhno zmanjšanje Cmax (za približno 20 do 28%) in zakasnitev tmax (približno 1, 75 ure).
Distribution The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
10 Porazdelitev Volumen porazdelitve rosiglitazona je pri zdravih prostovoljcih znašal približno 14 litrov.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Stopnja vezave rosiglitazona na plazemske proteine je zelo visoka (približno 99, 8%) in nanjo ne vplivata koncentracija zdravila ali bolnikova starost.
The protein binding of the major metabolite (para-hydroxy-sulphate) is very high (> 99.99%).
Stopnja vezave glavnega presnovka (parahidroksisulfata) na proteine je zelo visoka (> 99, 99%).
Metabolism Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Presnova Presnova rosiglitazona je obsežna, saj se nobena začetna spojina ne izloči v nespremenjeni obliki.
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Glavni presnovni poti sta N- demetilacija in hidroksilacija, ki jima sledi konjugacija s sulfatom in glukuronsko kislino.