FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the potential for decreased renal function the initiation and maintenance of therapy with AVAGLIM in elderly patients should be under close medical supervision due to an increased susceptibility to hypoglycaemia (see section 4.4).
Slovenian: Pri starejših bolnikih mora uvedba in vzdrževanje terapije z AVAGLIMOM zaradi možnosti zmanjšanega delovanja ledvic potekati pod natančnim zdravniškim nadzorom, ker obstaja večja dovzetnost za hipoglikemijo (glejte poglavje 4.4).
English: In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/sulphonylureas).
Slovenian: V dvojno slepih kliničnih preskušanjih z rosiglitazonom je bila incidenca zvišanj ALT na več kot trikratno zgornjo normalno mejo enaka kot pri placebu (0,2 %) in manjša kot pri aktivnem primerjalnem zdravilu (0,5 % z metforminom/sulfonilsečninami).
English: Rare congestive heart failure/pulmonary oedema
Slovenian: Redki kongestivno srčno popuščanje/pljučni edem
English: The rosiglitazone dose may need to be increased.
Slovenian: Potrebno utegne biti povečanje odmerka rosiglitazona.
English: Do not use Avaglim after the expiry date shown on the pack.
Slovenian: Zdravila Avaglim ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Take special care with Avaglim Avaglim is not recommended for people aged under 18, as the safety and effectiveness are not known.
Slovenian: Pri bolnikih, mlajših od 18 let, uporaba zdravila Avaglim ni priporočljiva, saj varnost in učinkovitost zdravila pri njih nista znani.
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 se je učinek na znižanje glukoze, opazen z rosiglitazonom, razvil postopoma; skoraj maksimalno znižanje glukoze v plazmi na tešče (GPT) je bilo opazno po približno 8 tednih terapije.
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 ni bil genotoksičen v skupini študij genotoksičnosti in vivo in in vitro; v vseživljenjskih študijah rosiglitazona pri dveh vrstah glodalcev niso ugotovili znakov tumorjev
English: It is advised that patients established on rosiglitazone and chlorpropamide concomitant therapy should not switch to AVAGLIM as chlorpropamide has a long half-life which may increase the risk of hypoglycaemia.
Slovenian: Bolniki, ki uporabljajo utečeno sočasno terapijo z rosiglitazonom in klorpropamidom, naj ne bi prešli na AVAGLIM, kajti klorpropamid ima dolg razpolovni čas, kar lahko poveča tveganje za hipoglikemijo.
English: Some medicines used to treat high blood pressure (such as beta-blockers, clonidine, guanethidine or reserpine) may make you less aware of the warning signs of low blood sugar (sweating; fast irregular
Slovenian: Nekatera zdravila za zdravljenje visokega krvnnega tlaka (kot so zaviralci beta, klonidin, gvanetidin ali reserpin) vam lahko zmanjšajo zavedanje o nekaterih opozorilnih znakih nizke vrednosti krvnega sladkorja (znojenje, hitro neredno bitje srca).
English: There have been no formal interaction studies for AVAGLIM.
Slovenian: Z AVAGLIMOM niso izvedli formalnih študij medsebojnega delovanja.
English: The tablets are supplied in blister packs containing 14, 28, 56, 84 or 112 film-coated tablets.
Slovenian: Pakiranje vsebuje 14, 28, 56, 84 ali 112 filmsko obloženih
English: Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Slovenian: Po večkratnem odmerjanju je treba pričakovati kopičenje presnovkov v plazmi, zlasti kopičenje glavnega presnovka (parahidroksisulfata), za katerega je predvideno 8-kratno kopičenje.
English: M1, but not M2, possesses about 1/3 of the pharmacological activity as compared to its parent in an animal model.
Slovenian: M1 se nato z enim od več citosolskih encimov presnovi v M2. M1, ne pa tudi M2, ima v živalskem modelu v primerjavi z matično spojino približno 1/3 farmakološke aktivnosti.
English: In very rare cases a fatal outcome has been reported.
Slovenian: V zelo redkih primerih so bolniki umrli.
English: Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Slovenian: Rosiglitazon se v veliki meri presnovi in nič matične spojine se ne izloči nespremenjene.
English: Extrapancreatic effects include an improvement in insulin sensitivity of peripheral tissue and a reduction in hepatic uptake of insulin.
Slovenian: Med zunajpankreatičnimi učinki so izboljšanje občutljivosti za insulin v perifernih tkivih in zmanjšanje
English: AVAGLIM is contraindicated in patients with severe renal impairment (creatinine clearance less than
Slovenian: AVAGLIM je kontraindiciran pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/min,
English: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Slovenian: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija.
English: Closure of the potassium channels leads to depolarisation of the beta cell and results by opening of the calcium channels - to an increased influx of calcium into the cell.
Slovenian: Zaprtje kalijevih kanalčkov povzroči depolarizacijo celic beta in z odprtjem kalcijevih kanalčkov poveča dotok kalcija v celice.
English: Glimepiride very rapidly increases the number of active glucose transport molecules in the plasma membranes of muscle and fat cells, resulting in stimulation of glucose uptake.
Slovenian: Glimepirid zelo hitro poveča število molekul za aktivni prenos glukoze v plazemskih membranah mišičnih in maščobnih celic; posledica je stimuliran privzem glukoze.
English: If a patient wishes to become pregnant or if pregnancy occurs, treatment with AVAGLIM should be
Slovenian: Če bolnica želi zanositi ali če zanosi, je treba zdravljenje z AVAGLIMOM prekiniti.
English: In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic
Slovenian: Študije mehanizma so pokazale, da je povečanje telesne mase pretežno posledica povečanja podkožnega maščevja ob zmanjšanju visceralnega in
English: • fluconazole (used to treat fungal infections).
Slovenian: • flukonazol (uporabljamo ga za zdravljenje glivičnih okužb).
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well
Slovenian: V kliničnih študijah pri prostovoljcih so ti dobro prenesli rosiglitazon, uporabljen v enkratnih peroralnih odmerkih do 20 mg.
English: Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
Slovenian: Podatki dvojno slepih študij potrjujejo, da so varnostne značilnosti skupaj uporabljenega rosiglitazona in glimepirida podobne kombiniranim značilnostim neželenih učinkov obeh zdravilnih učinkovin.
English: Administration of the 4 mg/4 mg combination with food led to an increase in glimepiride exposure compared to that observed on administration in the fasted state.
Slovenian: Uporaba kombinacije 4 mg/4 mg s hrano je povzročila povečanje izpostavljenosti glimepiridu v primerjavi z uporabo na tešče.
English: oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives,
Slovenian: estrogeni in progestogeni, saluretiki, tiazidni diuretiki, sredstva, ki stimulirajo ščitnico, glukokortikoidi, fenotiazinski derivati, klorpromazin, adrenalin in simpatikomimetiki, nikotinska kislina (veliki odmerki) in derivati nikotinske kisline,
English: Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea
Slovenian: Pogostnost neželenega učinka glede na režim zdravljenja Rosiglitazon kot monoterapija Rosiglitazon s sulfonilsečnino
English: Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
Slovenian: Zdravljenje bolnikov, ki imajo pomanjkanje glukoze-6-fosfat-dehidrogenaze (G6PD), z učinkovinami iz skupine sulfonilsečnin lahko vodi do hemolitične anemije.
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Slovenian: Volumen porazdelitve rosiglitazona je pri zdravih prostovoljcih približno 14 l. Vezava rosiglitazona na beljakovine v plazmi je visoka (približno 99,8 %) in koncentracija ali starost nanjo ne vplivata.
English: Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Slovenian: Sočasna uporaba rosiglitazona in rifampicina (induktorja CYP2C8) je povzročila 66 % zmanjšanje koncentracije rosiglitazona v plazmi.
English: Avaglim tablets are a combination of two different medicines called rosiglitazone and glimepiride.
Slovenian: Avaglim tablete vsebujejo kombinacijo dveh zdravilnih učinkovin rosiglitazona in glimepirida.
English: Limited data are available with regard to overdose of rosiglitazone in humans.
Slovenian: Podatki o prevelikem odmerjanju rosiglitazona pri človeku so omejeni.
English: † Patients who took designated treatment as randomised in combination with the correct background
Slovenian: † Bolniki, ki so jemali v skladu z randomizacijo dodeljena zdravila v kombinaciji z ustreznim osnovnim zdravljenjem in so imeli podatke, ki jih je bilo mogoče ovrednotiti.
English: AVAGLIM dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
Slovenian: V poštev pride prilagoditev odmerka AVAGLIMA v skladu s priporočenim odmerjanjem ali sprememba antidiabetične terapije.
English: Rosiglitazone plasma concentrations peak at around 1 h after dosing.
Slovenian: Rosiglitazon doseže največjo koncentracijo v plazmi okrog 1 uro po uporabi.
English: Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Slovenian: Bolnike, ki dobivajo AVAGLIM, lahko ogroža z odmerkom povezana hipoglikemija (glejte poglavje 4.8).
English: For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
Slovenian: Za bolnike, ki niso ustrezno urejeni z monoterapijo z glimepiridom (praviloma 4 mg).
English: Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
Slovenian: Bolnike z blago ali zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/min) lahko bolj ogroža hipoglikemija (glejte poglavja 4.2, 4.3 in 4.4).
English: AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Slovenian: AVAGLIM je indiciran za zdravljenje bolnikov z diabetesom mellitusom tipa 2, ki kljub optimalnemu odmerjanju monoterapije s sulfonilsečnino ne dosežejo zadostne urejenosti glikemije in za katere metformin ni primeren, ker je kontraindiciran ali ga ne prenesejo.
English: Haemolytic anaemia: If you have an inherited condition where your red blood cells don't produce enough of the enzyme G6PD, Avaglim may cause your red blood cells to be destroyed too quickly (haemolytic anaemia).
Slovenian: Hemolitična anemija: Če veste, da vaše rdeče krvne celice ne proizvajajo dovolj encima glukoze-6-fosfat-dehidrohenaze (G6PD), če boste jemali Avaglim, bi lahko tvegali, da boste zboleli za resnim tipom anemije, ker se vaše rdeče krvničke prehitro razkrojijo (hemolitična anemija).
English: The clinical significance of the glucose-lowering effect of M1 is unclear.
Slovenian: Klinični pomen vpliva M1 na zniževanje
English: Î Tell your doctor or pharmacist if you are taking anticoagulants.
Slovenian: Î Povejte svojemu zdravniku ali farmacevtu, če jemljete zdravila proti strjevanju krvi.
English: Moreover in patients with congestive heart failure NYHA class I-II, a placebocontrolled 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.
Slovenian: V enoletnem s placebom kontroliranem preskušanju pri bolnikih s kongestivnim srčnim popuščanjem razredov I in II po NYHA so ugotovili poslabšanje ali možno poslabšanje srčnega popuščanja pri 6,4 % prejemnikov rosiglitazona in pri 3,5 % prejemnikov placeba.
English: AVAGLIM 4 mg/4 mg film-coated tablets AVAGLIM 8 mg/4 mg film-coated tablets rosiglitazone/glimepiride
Slovenian: AVAGLIM 4 mg/4 mg filmsko obložene tablete AVAGLIM 8 mg/4 mg filmsko obložene tablete rosiglitazon/glimepirid
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Slovenian: Boljšo urejenost glikemije je spremljalo tudi pomembno znižanje prostih maščobnih kislin.
English: Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which differs from the usual sulphonylurea binding site.
Slovenian: Glimepirid se z veliko hitrostjo izmenjave veže na membransko beljakovino celic beta, povezano s kalijevimi kanalčki, občutljivimi za ATP, vendar se mesto njegove vezave razlikuje od običajnega
English: Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Slovenian: Rosiglitazon je skladno s svojim mehanizmom delovanja zmanjšal odpornost za insulin in izboljšal delovanje pankreatičnih celic β.
English: Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Slovenian: Ker glimepepirid sodi v kemijsko skupino zdravil, imenovanih sulfonilsečnine, je potrebna previdnost pri bolnikih s pomanjkanjem glukoze-6-fosfat-dehidrogenaze in je potrebno pretehtati o možnosti zdravljenja z zdravili, ki ne sodijo
English: The clinical trial program in support of this fixed dose combination only compared rosiglitazone and glimepiride to glimepiride monotherapy and not to monotherapy with other sulphonylureas.
Slovenian: Program kliničnega preskušanja za podporo tej kombinaciji fiksnih odmerkov je primerjal le rosiglitazon in glimepirid z monoterapijo z glimepiridom, ne pa z monoterapijo z drugimi
English: High doses given to mother rats cause hypoglycaemia in suckling young rats (see section 4.6).
Slovenian: Veliki odmerki, uporabljeni pri samicah-materah povzročijo hipoglikemijo pri dojenih mladičih (glejte poglavje 4.6).
English: Sulphonylureas regulate insulin secretion by closing the ATP-dependent potassium channels in the beta cell membrane.
Slovenian: Sulfonilsečnine uravnavajo izločanje insulina z zaprtjem za ATP odvisnih kalijevih kanalčkov v membrani celic beta.
English: Rosiglitazone and glimepiride are both highly protein bound and would not be expected to be cleared by haemodialysis.
Slovenian: Tako rosiglitazon kot glimepirid sta v veliki meri vezana na beljakovine in ni pričakovati, da bi ju hemodializa odstranila.
English: Allergic reactions: These are very rare in people taking Avaglim.
Slovenian: Alergijske reakcije: Pri bolnikih, ki se zdravijo z zdravilom Avaglim so alergijske reakcije zelo redke.
English: Stop taking Avaglim.
Slovenian: Ne jemljite zdravila Avaglim.
English: Î Check with your doctor, as Avaglim may not be suitable for you.
Slovenian: Î Posvetujte se s svojim zdravnikom, saj zdravilo Avaglim v tem primeru za vas morda ni
English: Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
Slovenian: Telesno maso bolnikov je torej treba skrbno nadzirati in pri tem upoštevati možno povezavo z zastajanjem tekočin, ki je lahko povezano s srčnim
English: These may be signs of liver problems:
Slovenian: Znaki težav z jetri so
English: In diabetic patients, good metabolic control over 24 hours can be
Slovenian: Pri diabetikih je mogoče dobro 24-urno presnovno urejenost doseči z enim samim odmerkom na
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Slovenian: Klinično pomembnih medsebojnih delovanj s substrati CYP2C9 ni pričakovati.
English: Take Avaglim for as long as your doctor recommends.
Slovenian: Zdravilo Avaglim morate jemati tako dolgo kot vam to predpiše zdravnik.
English: Glimepiride acts mainly by stimulating the release of insulin from the beta cells of the pancreas.
Slovenian: Glimepirid deluje predvsem s spodbujanjem izločanja insulina iz celic beta v pankreasu.
English: • stomach pain, bloating, feeling sick (nausea), vomiting or diarrhoea
Slovenian: • bolečine v trebuhu, tiščanje v prebavilih, slabost (siljenje na bruhanje), bruhanje in driska
English: Single oral doses of glimepiride in 14 healthy adult subjects had no clinically significant effect on the steady-state pharmacokinetics of rosiglitazone.
Slovenian: Enkraten peroralni odmerek glimepirida pri 14 zdravih odraslih preiskovancih ni klinično pomembno vplival na farmakokinetiko rosiglitazona v stanju dinamičnega ravnovesja.
English: Immune system disorders (see Skin and subcutaneous tissue disorders)
Slovenian: Bolezni imunskega sistema (glejte Bolezni kože in podkožja)
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: Results from an vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Slovenian: Rezultati interakcijske študije in vivo, opisani v literaturi, kažejo, da flukonazol (eden najmočnejših zaviralcev CYP2C9) približno 2-krat poveča AUC glimepirida.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000 including isolated reports).
Slovenian: Pogostnost je definirana kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000) in zelo redki (< 1/10.000, vključno s posameznimi primeri).
English: The effect of glimepiride is dosedependent and reproducible.
Slovenian: Učinek glimepirida je odvisen od odmerka in je ponovljiv.
English: Approximately 40% of the total radioactivity was recovered in faeces and M1 and M2 (predominant) accounted for about 70% of that recovered in faeces.
Slovenian: V blatu se je izločilo približno 40 % celotne radioaktivnosti; na račun M1 in M2 (pretežno) je šlo okrog 70 % radioaktivnosti, izločene v blatu.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to medical prescription.
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group.
Slovenian: Glimepirid je peroralno aktivno antidiabetično zdravilo, ki spada v skupino sulfonilsečnin.
English: AVAGLIM is contraindicated in patients with hepatic impairment (see section 4.3).
Slovenian: AVAGLIM je kontraindiciran pri bolnikih z okvaro jeter (glejte poglavje 4.3).
English: Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
Slovenian: Pogostnost je definirana kot: redki (≥ 1/10.000, < 1/1.000) in zelo redki (< 1/10.000, vključno s posameznimi primeri).
English: Elimination The elimination half-life of glimepiride is approximately 5 to 8 h. When 14C-glimepiride was given orally, approximately 60% of the total radioactivity was recovered in the urine in seven days and M1 (predominant) and M2 accounted for 80 to 90% of that recovered in the urine.
Slovenian: Po peroralni uporabi 14C-glimepirida se je približno 60 % celotne radioaktivnosti pojavilo v urinu v sedmih dneh; na račun M1 (pretežno) in M2 je šlo od 80 do 90 % radioaktivnosti, izločene v urinu.
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 presnovek (parahidroksisulfat), ki ima veliko afiniteto za topni humani PPARγ, je v preizkusu tolerance za glukozo pri debelih miših pokazal razmeroma veliko moč.
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Slovenian: Rosiglitazon je in vitro pokazal le zmerno zavrtje CYP2C8 (IK50 18 µM) in majhno zavrtje CYP2C9 (IK50 50 µM) (glejte poglavje 4.5).
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone or glimepiride between males and females.
Slovenian: Spol: V kumulativni populacijski farmakokinetični analizi se farmakokinetika rosiglitazona ali glimepirida med moškimi in ženskami ni izrazito razlikovala.
English: AVAGLIM combines two antidiabetic 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 glimepiride, a member of the sulphonylurea class.
Slovenian: AVAGLIM je kombinacija dveh antidiabetikov, ki s komplementarnim mehanizmom delovanja izboljšata urejenost glikemije pri bolnikih z diabetesom tipa 2: rosiglitazonijevega maleata, ki spada med tiazolidindione, in glimepirida, ki spada med sulfonilsečnine.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates
Slovenian: Interakcijska študija z varfarinom in vivo je pokazala, da rosiglitazon in vivo nima medsebojnega delovanja s substrati CYP2C9.
English: Red, biconvex, rounded triangular tablet with “gsk” debossed on one side and “8/4” on the other side
Slovenian: Rdeče, bikonveksne, zaokrožene trikotne tablete z vtisnjeno oznako "gsk" na eni strani in "8/4" na drugi.
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 ugotovili z odmerkom povezano povečanje telesne mase, ki je bilo pri uporabi v kombinaciji z insulinom večje.
English: Rosiglitazone and glimepiride work together so your body makes better use of the insulin it produces, and this helps reduce your blood
Slovenian: Rosiglitazon in glimepirid delujeta skupaj tako, da omogočata boljšo izrabo v telesu nastalega insulina, kar pomaga zmanjšati vrednost krvnega sladkorja na normalno vrednost.
English: − severe renal impairment i.e. creatinine clearance less than 30 ml/min (including renal dialysis).
Slovenian: - hudo okvaro ledvic, tj. očistkom kreatinina manj kot 30 ml/min (vključno z dializo), - diabetično ketoacidozo ali diabetično komo.