FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Slovenian: Sočasno dajanje rosiglitazona in rifampicina (induktorja CYP2C8) je posledično za 66 % zmanjšalo koncentracije rosiglitazona v plazmi.
English: Check your weight regularly; if it goes up rapidly, tell your doctor.
Slovenian: Če se telesna masa hitro poveča, o tem obvestite svojega zdravnika.
English: As a consequence of different but complementary mechanisms of action, combination therapy of rosiglitazone with metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Slovenian: Zaradi različnih, vendar komplementarnih mehanizmov delovanja ima kombinirano zdravljenje z rosiglitazonom in metforminom za posledico aditiven učinek na glikemičen nadzor.
English: AVANDAMET should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 135 μmol/l in males and > 110 μmol/l in females and/or creatinine clearance < 70 ml/min (see sections 4.3 and 4.4).
Slovenian: AVANDAMET se ne sme uporabljati pri bolnikih z ledvično odpovedjo ali ledvično disfunkcijo, npr. pri moških s koncentracijo kreatinina v serumu > 135 μmol/l ter ženskah s serumsko koncentracijo kreatinina > 110 μmol/l in/ali z očistkom kreatinina < 70 ml/min (glejte poglavji 4.3 in 4.4).
English: Musculoskeletal and connective tissue disorders bone fractures4
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zlomi kosti4
English: • Don't breast-feed while you are taking Avandamet.
Slovenian: • Med jemanjem zdravila Avandamet ne smete dojiti.
English: Clinical trial data
Slovenian: Podatki iz kliničnih preskušanj
English: It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
Slovenian: Neposredna povezava med uporabo rosiglitazona in edemom makule sicer ni pojasnjena, vendar pa se morajo predpisovalci zavedati, da pri bolnikih z motnjami ostrine vida obstaja možnost pojava edema makule.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Slovenian: Neodvisno od učinkovanja na glikemijo ima metformin pri ljudeh ugoden vpliv na presnovo lipidov.
English: In a monotherapy study, the incidence in females for rosiglitazone was 9.3% (2.7 patients per 100 patient years) vs 5.1% (1.5 patients per 100 patient years) for metformin or 3.5% (1.3 patients per 100 patient years) for glibenclamide.
Slovenian: V študiji monoterapije je bila incidenca pri ženskah, ki so jemale rosiglitazon, 9,3 % (2,7 bolnice na 100 bolnikov-let) v primerjavi s 5,1 % (1,5 bolnice na 100 bolnikov-let) za metformin in s 3,5 % (1,3 bolnice na 100 bolnikov-let) za glibenklamid.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Slovenian: Metformin stimulira znotrajcelično sintezo glikogena tako, da deluje na glikogen sintazo.
English: • inflammation of the liver (hepatitis)
Slovenian: • vnetje jeter (hepatitis).
English: Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Slovenian: Presnova rosiglitazona je zelo obsežna, saj se nobena začetna sestavina ne izloči v nespremenjeni obliki.
English: Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production.
Slovenian: Tiazolidindioni primarno zmanjšujejo insulinsko rezistenco, bigvanidi pa zmanjšujejo endogeno produkcijo glukoze v jetrih.
English: There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of AVANDAMET (see section 4.4).
Slovenian: Ker je v zdravilu AVANDAMET zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
English: Myocardial Ischaemia
Slovenian: Ishemija miokarda
English: The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Slovenian: Razlike med posamezniki so bile zelo velike, AUC nevezane učinkovine se je razlikoval tudi do 7-krat.
English: Cardiac disorders congestive heart failure/pulmonary oedema
Slovenian: Srčne bolezni kongestivno srčno popuščanje/pljučni edem
English: AVANDAMET 1 mg/500 mg film-coated tablets AVANDAMET 2 mg/500 mg film-coated tablets AVANDAMET 2 mg/1000 mg film-coated tablets AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
Slovenian: AVANDAMET 1 mg/500 mg filmsko obložene tablete AVANDAMET 2 mg/500 mg filmsko obložene tablete AVANDAMET 2 mg/1000 mg filmsko obložene tablete AVANDAMET 4 mg/1000 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
English: AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: - who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Slovenian: AVANDAMET je indiciran za zdravljenje sladkorne bolezni tipa 2, še posebno pri bolnikih s čezmerno telesno maso: - pri katerih ni možno vzdrževati primerne koncentracije glukoze v krvi z največjim dovoljenim
English: Excipients: Each tablet contains lactose (approximately 11 mg)
Slovenian: Vsaka tableta vsebuje laktozo (približno 11 mg)
English: HR and CI for key secondary endpoints were: all-cause death (HR 0.86, CI 0.68-1.08), MACE (Major Adverse Cardiac Events - cardiovascular death, acute myocardial infarction, stroke) (HR 0.93, CI 0.74-1.15), cardiovascular death (HR 0.84, CI 0.59-1.18), acute myocardial infarction (HR 1.14, CI 0.80-1.63) and stroke (HR 0.72, CI 0.49-1.06).
Slovenian: Razmerja ogroženosti in intervali zaupanja za sekundarne končne točke so bili: smrt zaradi vseh vzrokov (razmerje ogroženosti 0,86, IZ 0,68-1,08), hudi srčni neželeni učinki ("MACE": Major Adverse Cardiac Events - kardiovaskularna smrt, akutni miokardni infarkt, možganska kap) (razmerje ogroženosti 0,93, IZ 0,74-1,15), kardiovaskularna smrt (razmerje ogroženosti 0,84, IZ 0,59-1,18), akutni miokardni infarkt (razmerje ogroženosti 1,14, IZ 0,80-1,63) in možganska kap (razmerje ogroženosti 0,72, IZ 0,49-1,06).
English: Fluid retention and cardiac failure
Slovenian: Zastajanje tekočine in srčno popuščanje
English: 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.
Slovenian: Jetrne encime je potrebno preveriti pri katerem koli bolniku, če se pojavijo simptomi disfunkcije jeter, in sicer lahko kot nepojasnjena navzea, bruhanje, abdominalna bolečina, utrujenost, anoreksija in/ali temen urin.
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Slovenian: • tekočina v pljučih (edem pljuč), ki povzroči težko dihanje.
English: - in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).
Slovenian: - v sklopu peroralnega zdravljenja s tremi zdravili skupaj s sulfonilsečnino pri bolnikih z nezadostno urejenostjo glikemije kljub peroralnemu zdravljenju z dvema zdraviloma, to je z metforminom in sulfonilsečnino v največjih dovoljenih odmerkih (glejte poglavje 4.4).
English: This helps to reduce any problems with your stomach (including indigestion, nausea, vomiting and diarrhoea).
Slovenian: Pri takšnem jemanju se zmanjša verjetnost želodčnih težav (vključno s slabo prebavo, siljenjem na bruhanje, bruhanjem in drisko).
English: 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.
Slovenian: Poleg tega rosiglitazon v vrsti genotoksičnih raziskav in vivo in in vitro ni pokazal genotoksičnosti pri dveh vrstah glodavcev, ki so jih v sklopu raziskav z rosiglitazonom spremljali vse življenje, prav tako pa niso odkrili nobenih znakov o tumorjih debelega črevesa.
English: - Patients established on triple oral therapy: when appropriate, AVANDAMET may substitute rosiglitazone and metformin doses already being taken.
Slovenian: - Bolniki, ki se jim uvede zdravljenje s tremi zdravili: če je primerno, lahko zdravilo AVANDAMET zamenja odmerke rosiglitazona in metformina, ki jih je bolnik že jemal.
English: Very rare pruritis
Slovenian: Zelo redki srbenje
English: The improved glycaemic control is associated with reductions in both fasting and postprandial glucose.
Slovenian: Izboljšana urejenost glikemije je povezana z zmanjšanjem koncentracije glukoze tako na tešče kot po jedi.
English: The absorption of rosiglitazone is not affected by increases in gastric pH.
Slovenian: Zvišanje želodčne pH-vrednosti ne vpliva na absorpcijo rosiglitazona.
English: In their entirety, the available data on the risk of cardiac ischaemia are inconclusive.
Slovenian: Razpoložljivi podatki v celoti ne omogočajo dokončnega sklepa o tveganju srčne ishemije.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Slovenian: Pogostnost neželenih učinkov metformina na osnovi podatkov iz kliničnih preskušanj in podatkov po pridobitvi dovoljenja za promet
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h. There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Slovenian: Celoten očistek rosiglitazona iz plazme znaša okoli 3 l/uro, končna razpolovna doba izločanja rosiglitazona pa je približno 3 do 4 ure.
English: Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4) - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Slovenian: Peroralno zdravljenje s tremi zdravili (rosiglitazon, metformin in sulfonilsečnina) (glejte poglavje 4.4) - Bolniki, ki se zdravijo z metforminom in s sulfonilsečnino: če je primerno, se zdravilo AVANDAMET lahko uvede v odmerku 4 mg/dan rosiglitazona in odmerku metformina, ki zamenja odmerek metformina, ki ga bolnik že jemlje.
English: Rosiglitazone with metformin and sulphonylurea
Slovenian: Rosiglitazon z metforminom in sulfonilsečnino
English: Packs of 14, 28, 56, 112 (2x56), 168 (3x56) and 180 tablets.
Slovenian: Škatle s 14, 28, 56, 112 (2x56), 168 (3x56) in 180 tabletami.
English: Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Slovenian: Sočasno dajanje rosiglitazona in gemfibrozila (zaviralca CYP2C8) je posledično za dvakrat povečalo koncentracije rosiglitazona v plazmi.
English: The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.
Slovenian: Največji priporočeni dnevni odmerek zdravila AVANDAMET je 8 mg rosiglitazona in 2000 mg metforminijevega klorida.
English: In this study, the adverse events observed were consistent with the known adverse event profile for each of the treatments, including continuing weight gain with rosiglitazone.
Slovenian: V tej študiji so se opaženi neželeni učinki skladali z znanimi značilnostmi neželenih učinkov posameznih zdravil, vključno s stalnim povečanjem telesne mase med uporabo rosiglitazona.
English: Excipients: Each tablet contains lactose (approximately 6 mg).
Slovenian: Vsaka tableta vsebuje laktozo (približno 6 mg)
English: • stomach pain, nausea and vomiting.
Slovenian: • bolečino v želodcu, siljenje na bruhanje in bruhanje.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Slovenian: Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
English: Packs of 28, 56, 112, 336 (3x112) and 360 tablets.
Slovenian: Škatle z 28, 56, 112, 336 (3x112) in 360 tabletami.
English: Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy
Slovenian: Pogostnost neželenega učinka glede na režim zdravljenja Rosiglitazon kot samostojno zdravilo
English: If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Avandamet, kot bi smeli Če po nesreči vzamete preveč tablet, se posvetujte s svojim zdravnikom ali farmacevtom.
English: - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Slovenian: - Bolniki, ki se zdravijo z metforminom in s sulfonilsečnino: če je primerno, se zdravilo AVANDAMET lahko uvede v odmerku 4 mg/dan rosiglitazona in odmerku metformina, ki zamenja odmerek metformina, ki ga bolnik že jemlje.
English: • liver doesn't function as well as it should (increase in liver enzymes).
Slovenian: • okvara delovanja jeter (zvišana vrednost jetrnih encimov).
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Slovenian: Pri starostnikih je zmanjšano delovanje ledvic pogosto in asimptomatsko.
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Slovenian: Študije in vitro so pokazale, da se rosiglitazon pretežno presnavlja s CYP2C8, medtem ko je CYP2C9 zanj le manj pomembna presnovna pot.
English: Administration of iodinated contrast agent
Slovenian: Uporaba jodiranih kontrastnih sredstev
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
Slovenian: Študije in vitro so pokazale, da se rosiglitazon pretežno presnavlja s pomočjo CYP2C8, malenkostno pa pripomore tudi CYP2C9.
English: Therefore, as a precaution, the use of rosiglitazone is not recommended in these patients, particularly those with myocardial ischaemic symptoms.
Slovenian: Pri teh bolnikih, še posebej pri bolnikih s simptomi ishemije miokarda, zaradi previdnosti uporabe rosiglitazona ne priporočamo.
English: Ask your pharmacist how to dispose of tablets you don't need.
Slovenian: O načinu odstranjevanja tablet, ki jih ne potrebujete več, se posvetujte s farmacevtom.
English: Since NSAIDs, insulin and rosiglitazone are all associated with fluid retention, concomitant administration may increase the risk of oedema.
Slovenian: Ker so tako nesteroidna protivnetna zdravila kot tudi insulin in rosiglitazon povezani z zastajanjem tekočine v telesu, lahko njihovo sočasno jemanje poveča tveganje za nastanek edemov.
English: AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Slovenian: Če pride do kakršnega koli poslabšanja v srčnem statusu, je potrebno zdravljenje z zdravilom AVANDAMET prekiniti.
English: In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Slovenian: Poleg tega je rosiglitazon pri živalskih modelih s sladkorno boleznijo tipa 2 ohranjal tudi delovanje β-celic, kar dokazuje zvečanje mase pankreasnih otočkov in vsebnosti insulina, ter preprečeval nastanek očitne hiperglikemije.
English: However, in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Slovenian: V celoti pa razpoložljivi podatki ne omogočajo dokončnega sklepa o tveganju za srčne ishemije(glejte poglavje 4.8).
English: • rapid increase in your weight
Slovenian: • hitro povečanje telesne mase.
English: The major metabolite (a para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mice.
Slovenian: Glavni metabolit (parahidroksisulfat) z močno afiniteto do topnega humanega PPARγ je v raziskavi, ki je preučevala toleranco za glukozo pri debelih miših, izkazal sorazmerno visoko učinkovitost.
English: Clinical trial data (addition of insulin to established AVANDAMET therapy) In a single study (n=322) where insulin was added to patients established on AVANDAMET, no new adverse events were observed in excess of those already defined for either AVANDAMET or rosiglitazone combination therapies.
Slovenian: V eni študiji (n=322), v kateri je bilo bolnikom, ki so se zdravili z zdravilom AVANDAMET, uvedeno še zdravljenje z insulinom, niso opazili novih neželenih dogodkov, ki bi bili pogostejši od že ugotovljenih, bodisi za zdravilo AVANDAMET bodisi za kombinirano zdravljenje z rosiglitazonom.
English: The active substances are rosiglitazone and metformin.
Slovenian: Zdravilni učinkovini sta rosiglitazon in metformin.
English: Skin and subcutaneous tissue disorders (see Immune system disorders) Angioedema
Slovenian: Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem
English: Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Slovenian: Bolnika bo morda treba skrbno nadzirati, odmerek sočasno vzete zdravilne učinkovine pa zmanjšati.
English: 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Slovenian: 2 Če so rosiglitazon dodali k režimu zdravljenja s sulfonilsečnino (bodisi pri zdravljenju z dvema zdraviloma bodisi pri zdravljenju s tremi zdravili), so opazili večjo pojavnost srčnega popuščanja, ki je bila pri 8 mg odmerku rosiglitazona večja kot pri 4 mg odmerku (skupni dnevni odmerek).
English: Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Slovenian: Starostniki: Pri preučevanju farmakokinetike znotraj posameznih skupin bolnikov niso opazili, da bi starost kakor koli pomembneje vplivala na farmakokinetiko rosiglitazona.
English: Adverse reactions are presented below for each of the component parts of AVANDAMET.
Slovenian: V nadaljevanju so navedeni neželeni učinki vsake od sestavin zdravila AVANDAMET.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Slovenian: Študija in vivo je o interakcijah z varfarinom pokazala, da rosiglitazon in vivo s substrati CYP2C2 medsebojno ne učinkuje.
English: AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Slovenian: Zdravilo AVANDAMET je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: rosiglitazonijevega maleata iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.
English: Rosiglitazone was associated with increases in weight.
Slovenian: Rosiglitazon so povezovali s povečevanjem telesne mase.
English: Premenopausal women have received rosiglitazone during clinical studies.
Slovenian: V kliničnih študijah so rosiglitazon dajali ženskam pred menopavzo.
English: There was a significant increase in heart failure (fatal and nonfatal) (HR 2.10, CI 1.35-3.27) and bone fractures (Risk Ratio 1.57, CI 1.26-1.97) in rosiglitazonecontaining treatments compared to active control (see sections 4.4 and 4.8).
Slovenian: Med zdravljenji, ki so vključevala rosiglitazon, so v primerjavi s primerjalno učinkovino ugotovili značilno več srčnega popuščanja (s smrtnim izidom ali brez njega) (razmerje ogroženosti 2,10, IZ 1,35-3,27) in zlomov kosti (razmerje tveganj 1,57, IZ 1,26-1,97) (glejte poglavji 4.4 in 4.8).
English: The relevance of this finding is unknown.
Slovenian: Klinični pomen teh ugotovitev ni poznan.
English: An adjusted mean reduction in HbA1c of 0.24% was seen for patients taking rosiglitazone added to sulphonylurea, versus a reduction in HbA1c of 0.10% for patients taking metformin added to sulphonylurea, (p=0.0083 for treatment difference).
Slovenian: Pri bolnikih, ki so jemali rosiglitazon dodan sulfonilsečnini, so ugotovili korigirano povprečno znižanje HbA1c za 0,24 %, pri bolnikih, ki so jemali metformin dodan sulfonilsečnini, pa znižanje za 0,10 % (p = 0,0083 za razliko med zdravljenji).
English: Not all pack sizes or tablet strengths may be available in your country.
Slovenian: Na trgu ni vseh navedenih pakiranj ali jakosti tablet.
English: Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Slovenian: Med študijo (do 72 mesecev zdravljenja) je zdravljenje z rosiglitazonom statistično značilno zmanjšalo tveganje odpovedi monoterapije (glukoza v plazmi na tešče > 10,0 mmol/l) za 63 % v primerjavi z glibenklamidom (razmerje ogroženosti 0,37, interval zaupanja 0,30-0,45) in za 32 % v primerjavi z metforminom (razmerje ogroženosti 0,68, interval zaupanja 0,55-0,85).
English: If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Slovenian: Če je potrebno, odmerek antidiabetikov prilagodimo bodisi zdravljenju z drugimi zdravili bodisi ukinitvi zdravljenja s takšnimi zdravili.
English: Non-clinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Slovenian: Predklinični podatki o metforminu, ki se naslanjajo na običajne farmakološke raziskave o varnosti, toksičnosti pri večkratnih odmerkih, kancerogenem delovanju in vplivih na sposobnost razmnoževanja, ne kažejo na posebno tveganje za ljudi.
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Slovenian: Pri zdravih posameznikih je absolutna biološka uporabnost 500 mg tablete metformina približno 50 do 60 %.
English: 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.
Slovenian: Insuficienca ledvic: Pri bolnikih z oslabljenim delovanjem ledvic ali v zadnjem stadiju ledvične bolezni in s kronično dializo niso zasledili klinično pomembnih razlik v farmakokinetiki rosiglitazona.
English: In the final analysis at 5 years, an adjusted mean reduction from baseline in HbA1c of 0.14% for patients on rosiglitazone added to metformin versus an increase of 0.17% for patients taking sulphonylurea added to metformin was seen during treatment with randomised dual-combination therapy (p<0.0001 for treatment difference).
Slovenian: V končni analizi po 5 letih so med uporabo randomiziranega dvotirnega kombiniranega zdravljenja pri bolnikih z rosiglitazonom dodanim metforminu ugotovili korigirano povprečno znižanje HbA1c v primerjavi z izhodiščem za 0,14 %, pri bolnikih s sulfonilsečnino dodano metforminu pa zvišanje za 0,17 % (p < 0,0001 za razliko med zdravljenji).