natgillin/translations-raw huggingface dataset:
En øgning af rosiglitazon til 8 mg/dag bør foretages med forsigtighed og i forbindelse med passende kliniske evaluering for at vurdere patientens risiko for at udvikle bivirkninger, der er relateret til væskeretention (se afsnit 4.4 og 4.8).
An increase in the rosiglitazone component 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).
Den kliniske undersøgelse, der understøtter denne fastdosis kombination, sammenlignede kun rosiglitazon og glimepirid med glimepirid monoterapi og ikke monoterapi med andre sulfonylurinstoffer.
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.
Nogle lægemidler til behandling af forhøjet blodtryk (såsom beta-blokkere, clonidin, guanethidin eller reserpin) kan sløre advarselssignaler på for lavt blodsukker (svedtendens og hurtig uregelmæssig hjertebanken).
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
Det vigtigste primære endepunkt var kardiovaskulær indlæggelse (herunder hjerteinsufficiens) og kardiovaskulær død.
The adjudicated primary endpoint was cardiovascular hospitalisation (which included hospitalisations for heart failure) or cardiovascular death.
I dobbeltblinde kliniske undersøgelser med rosiglitazon var forekomsten af stigninger i ALAT på mere end tre gange den øvre normale grænse af samme størrelse som ved placebo (0,2 %) og mindre end ved behandling med de lægemidler, som rosiglitazon blev sammenlignet med (0,5 % metformin/sulfonylurinstof).
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).
• leverbetændelse (hepatitis), gulfarvning af huden (gulsot)
• inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
Den ekstrapankreatiske virkning er f.eks. en øget insulinfølsomhed i de perifere væv og et fald i leverens
Extrapancreatic effects include an improvement in insulin sensitivity of peripheral tissue and a reduction in hepatic uptake of insulin.
Farmakoterapeutisk klassifikation: Antidiabetika, kombinationspræparater, ATC-kode: A10BD04
Pharmacotherapeutic group: Combinations of oral blood glucose lowering drugs, ATC code: A10BD04
Nedsat leverfunktion: Hos cirrhotiske patienter med moderat (Child-Pugh B) nedsat leverfunktion, var ubundet Cmax og AUC 2-3 gange højere end hos normale personer.
Hepatic impairment: Following rosiglitazone treatment in cirrhotic patients with moderate (ChildPugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Glimepirid metaboliseres fuldstændig ved hjælp af oxidativ biotransformation både efter intravenøs indgivelse og efter peroral indtagelse.
Glimepiride is completely metabolised by oxidative biotransformation after either an intravenous or oral dose.
Thiazolidinedionerne virker primært ved at reducere insulinresistens og sulfonylurinstofferne virker primært ved at stimulere insulinfrigivelsen fra β-cellerne i pankreas.
Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas act primarily by stimulating release of insulin from functioning pancreatic β-cells.
Rosiglitazons maksimale plasmakoncentration ses ca. 1 time efter administration.
Rosiglitazone plasma concentrations peak at around 1 h after dosing.
Data fra dobbeltblinde undersøgelser bekræfter, at bivirkningsprofilen for samtidig administration af rosiglitazon og glimepirid er identisk med den kombinerede bivirkningsprofil for de to stoffer.
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.
Frekvensen er defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100, < 1/10), ikke almindelig (≥ 1/1.000, < 1/100), sjælden (≥ 1/10.000, < 1/1.000) og meget sjælden (< 1/10.000) herunder isolerede rapporter).
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).
• fald i antallet af blodlegemer (anæmi), herunder hvide blodlegemer (leukopeni) og blodlegemer der har en koagulerende virkning (thrombocytopeni)
• reduction in blood count (anaemia) low numbers of white blood cells (leucopaenia) and blood cells needed for blood clotting (thrombocytopaenia)
Få tjekket dit blodsukker regelmæssigt, selvom du føler dig rask.
Î Checking your blood sugar levels regularly is especially important if you are taking any of these medicines, even if you are feeling well
Undersøgelser af udvikling af fostre og den pre- og postnatale udvikling viste øjenmisdannelser, skeletanomalier, aborter
Studies on embryofoetal development and pre-and postnatal development revealed eye malformations, skeletal anomalies, abortions, and an increased foetal death rate.
Der er ikke rapporteret tilfælde af overdosering med AVAGLIM.
No data are available with regard to overdose of AVAGLIM.
To andre prospektive, randomiserede, kontrollerede kliniske langtidsundersøgelser (med 9.620 patienter, hver undersøgelse med en varighed på > 3 år), der sammenlignede rosiglitazon og andre godkendte perorale antidiabetika eller placebo, hverken be- eller afkræftede den potentielle risiko for myokardieiskæmi.
Two other long-term prospective randomised controlled clinical trials (9,620 patients, study duration >3 years in each study), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the potential risk of cardiac ischaemia.
Patienter med mild eller moderat nedsat nyrefunktion (kreatininclearance 30 til 80 ml/min) kan have forøget risiko for hypoglykæmi (se afsnit 4.2, 4.3, 4.4).
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).
Glimepirid øger antallet af glukosetransportmolekyler i muskel- og fedtcellernes plasmamembran meget hurtigt, hvilket resulterer i en stimuleret glukoseoptagelse.
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.
Ved peroral indgivelse af 14C-glimepirid blev ca. 60 % af den totale radioaktivitet genvundet i urinen efter 7 dage, og M1 (fremherskende) og M2 udgjorde 80 til 90 % af det, der blev genvundet i urinen.
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.
Avaglim kan medføre at antallet af nogle typer blodlegemer falder.
Avaglim can cause reductions in some types of blood cells.
Glimepirid udskilles i modermælk hos diegivende rotter.
Glimepiride is excreted into the milk of lactating rats.
• hvis du har type 1-diabetes.
• if you have type 1 diabetes - this needs different treatment.
2Der er set en stigning i antallet af hjerteinsufficiens, når rosiglitazon gives i kombination med sulfonylurinstof (enten i kombinations- eller i tripel-kombinationsbehandling), og forekomsten er højere ved 8 mg rosiglitazon sammenlignet med 4 mg rosiglitazon (som total daglig dosis).
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).
Når glykæmisk kontrol er opnået på disse doser, kan eventuel AVAGLIM-behandling påbegyndes med en startdosis på 4 mg rosiglitazon/ 4 mg
Once glycaemic control is stable at these doses, AVAGLIM may be introduced at a starting dose of 4 mg rosiglitazone/4 mg glimepiride
Undersøgelser med enkelte doser hos normale personer og med flere doser hos personer med type 2diabetes mellitus har vist signifikant absorption af glimepirid 1 time efter administration og Cmax ca. 2,5 time efter administration.
Studies with single oral doses in normal subjects and with multiple oral doses in patients with type 2 diabetes mellitus have shown significant absorption of glimepiride within 1 h after administration and Cmax at approximately 2.5 h. There is a linear relationship between dose and both Cmax and AUC.
• mavesmerter, oppustethed, kvalme, opkastning og diarré
• stomach pain, bloating, feeling sick (nausea), vomiting or diarrhoea
Rosiglitazon og glimepirid er begge i høj grad proteinbundet og fjernes ikke ved
Rosiglitazone and glimepiride are both highly protein bound and would not be expected to be cleared by haemodialysis.
Metabolismen sker primært gennem N-demetylering og hydroxylering, efterfulgt af konjugation med sulfat og glukoronsyre.
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Den forbedrede glykæmiske kontrol er forbundet med en reduktion i både fastende og postprandial
The improved glycaemic control is associated with reductions in both fasting and post
En retrospektiv analyse af de samlede data fra 42 kortvarige kliniske forsøg er det blevet antydet, at behandling med rosiglitazon kan sættes i forbindelse med en øget risiko for myokardieiskæmi.
A retrospective analysis of data from 42 pooled short-term clinical studies indicated that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events.
AVAGLIM kombinerer to antidiabetiske stoffer med komplementære virkningsmekanismer til forbedring af den glykæmiske kontrol hos patienter med type 2-diabetes: rosiglitazonmaleat, der hører til thiazolidinedionerne og glimepirid, der hører til sulfonylurinstofferne.
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.
AUC og Cmax for glimepirid forøgedes dosisproportionalt efter administration af rosiglitazonglimepirid 4 mg/1mg, 4 mg/2 mg og 4 mg/4 mg.
The AUC and Cmax of glimepiride increased in a dose-proportional manner following administration of rosiglitazone-glimepiride 4 mg/1 mg, 4 mg/2 mg, and 4 mg/4 mg.
Glimepirid er et hypoglykæmisk stof, der er aktivt peroralt, og som tilhører gruppen sulfonylurinstoffer.
Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE AVAGLIM Det er vigtigt, at du følger din læges råd om diæt og levestil.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your
Nedsat leverfunktion (for eksempel cholestasis og gulsot)
Very rare impairment of liver function (e.g. with cholestasis and jaundice)
En undersøgelse, der sammenlignede AVAGLIM med rosiglitazon eller glimepirid monoterapi, viste bedre glykæmisk kontrol med fastdosis kombinationen i forhold til monoterapi.
A study comparing AVAGLIM to monotherapy rosiglitazone or glimepiride demonstrated incremental benefit in control of glycaemia of the fixed-dose combination over monotherapy.
Nye tilfælde eller forværring af maculaødem er i enkelte tilfælde set hos patienter i behandling med Avaglim og tilsvarende lægemidler.
New or worse cases of macular oedema have occurred on rare occasions in people taking Avaglim and similar medicines.
AVAGLIM kan bruges i stedet for samtidig administration af sulfonylurinstof og rosiglitazon som kombinationsbehandling, forudsat at patienten får mindst halvdelen af maksimal dosis af sulfonyurinstof.
AVAGLIM may be used to substitute concomitant sulphonylurea and rosiglitazone in established dual oral therapy providing the patient has achieved at least half-maximum dose of sulphonylurea.
• øget følsomhed over for sollys med udslæt til følge
• increased sensitivity to the sun causing skin rash
Disse kan påvirke op til 1 ud af 1.000 patienter:
These may affect up to 1 in 1,000 people:
In vitro-undersøgelser har vist, at rosiglitazon primært metaboliseres af CYP2C8 og i mindre omfang
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor
4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies of the effects on the ability to drive and use machines have been performed.
Frekvensen af bivirkninger identificeret fra postmarketingdata med rosiglitazon Bivirkning
The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Sulfonylurinstoffer regulerer insulinsekretionen ved at lukke den ATP-følsomme kaliumkanal i βcellemembranen.
Sulphonylureas regulate insulin secretion by closing the ATP-dependent potassium channels in the beta cell membrane.
Det er bedst at tage Avaglim sammen med et måltid eller umiddelbart før et måltid (gerne det første
It is best to take Avaglim with food, or just before food, usually with your first main meal of the day.
Frekvenserne er defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100, < 1/10) og ikke almindelig (≥ 1/1.000, < 1/100).
Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
Frekvens af bivirkning efter behandlingsregime Rosiglitazon med sulfonylurinstof
Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea
Følgende angivelser henviser til de farmakokinetiske egenskaber for de to enkelte aktive delkomponenter i AVAGLIM.
The following statements reflect the pharmacokinetic properties of the individual components of
Rød, bikonveks, rundede trekantede filmovertrukne tabletter mærket ”gsk” på den ene side og ”8/4”
Red, biconvex, rounded triangular tablet with “gsk” debossed on one side and “8/4” on the other side
Ved doser, som langt overstiger terapeutiske doser til mennesker, er der præklinisk fundet virkninger, som anses for at have ringe klinisk relevans eller som skyldes den farmakodynamiske virkning (hypoglykæmi) af produktet.
Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use or were caused by the pharmacodynamic effect (hypoglycaemia) of the substance.
Under behandling med sympatolytika som beta-blokker, klonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation reduceres eller helt mangle.
Under the influence of sympatholytic drugs such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Samtidig administration af rosiglitazon og gemfibrozil (en hæmmer af CYP2C8) resulterede i en dobbelt stigning i rosiglitazon-plasmakoncentrationer.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Insulin bør kun lægges oven i behandling med rosiglitazon i særlige tilfælde, og patienten bør følges tæt.
Insulin should only be added to established rosiglitazone therapy in exceptional cases
AVAGLIM 4 mg/4 mg, filmovertrukne tabletter AVAGLIM 8 mg/4 mg, filmovertrukne tabletter rosiglitazon/glimepirid
AVAGLIM 4 mg/4 mg film-coated tablets AVAGLIM 8 mg/4 mg film-coated tablets rosiglitazone/glimepiride
Glimepirid virker hovedsageligt ved at stimulere insulinfrigivelsen fra β-cellerne i pankreas.
Glimepiride acts mainly by stimulating the release of insulin from the beta cells of the pancreas.
Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300 Malta
Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Som følge af ændringer i blodglucoseniveauet kan der forekomme forbigående synsforstyrrelser, specielt ved behandlingens start.
Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood
Rosiglitazon reducerede signifikant risikoen for monoterapisvigt (FPG > 10,0 mmol/l) med 63 % i forhold til glibenclamid (HR 0,37; CI 0,30-0,45) og med 32 % i forhold til metformin (HR 0,68; CI 0,55-0,85) i studieforløbet (op til 72 måneders behandling).
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,
1Hypercholesterolæmi blev rapporteret hos op til 5,3 % af de patienter, der blev behandlet med rosiglitazon (oral mono- eller dobbelterapi).
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone
Tag blot næste tablet på det
Just take your next dose at the usual time.
Intet intakt lægemiddel udskilles i urin eller fæces.
No intact active substance is excreted in urine or faeces.
Glimepirid bør anvendes med forsigtighed under samtidig administration af CYP2C9 inhibitorer (f.eks. fluconazol) eller inducerende stoffer (se afsnit 4.5).
Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e.g. fluconazole) or inducers (see section 4.5).
For at mindste risikoen for problemer, skal du være særlig opmærksom på visse symptomer, mens du tager Avaglim.
You must look out for certain symptoms while you are taking Avaglim, to reduce the risk of any problems.
ACE-hæmmere fluconazol fluoxetin allupurinol sympatolytika cyclo-, tro- og iphosphamider
fluoxetine, allopurinol, sympatholytics, cyclo-, tro-and iphosphamides,
Derfor bør leverenzymer kontrolleres forud for indledning af terapi med AVAGLIM hos alle patienter.
Therefore, liver enzymes should be checked prior to the initiation of therapy with AVAGLIM in all patients and periodically thereafter based on clinical judgement.
Bivirkningerne for hver af delkomponenterne i AVAGLIM er beskrevet nedenfor.
Adverse reactions are presented below for each of the component parts of AVAGLIM.
Som en konsekvens af forskellige, men komplementære virkningsmekanismer, resulterede kombinationsbehandling, med rosiglitazon og sulfonylurinstof eller metformin, i additiv effekt på glykæmisk kontrol hos patienter med type 2-diabetes.
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
Grundet muligheden for nedsat nyrefunktion hos ældre bør start og vedligeholdelse af behandling med AVAGLIM hos ældre patienter holdes under tæt lægeligt opsyn, da risikoen for hypoglykæmi er øget
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).
Mild eller moderat nedsat nyrefunktion (kreatininclearance 30 til 80 ml/min): - Patienter, der starter behandling med AVAGLIM, som hidtil har fået andet sulfonylurinstof end glimepirid, kan have forøget risiko for hypoglykæmi (se afsnit 4.4).
Mild or moderate renal impairment (creatinine clearance 30 to 80 ml/min): - Patients changing to AVAGLIM from sulphonylurea therapies other than glimepiride may be at an increased risk of hypoglycaemia (see section 4.4).
Efter markedsføring af rosiglitazon har der været sjældne rapporter med hepatocellulær dysfunktion (se afsnit 4.8).
There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Rosiglitazons plasmaproteinbinding er høj (ca. 99,8 %) og påvirkes ikke af koncentration eller alder. Proteinbindingen af den hyppigst forekommende metabolit (para-hydroxy-sulfat) er meget høj (>99.99 %).
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high (> 99.99%).
9Der kan forekomme forhøjede niveauer af leverenzymer.
9 Elevation of liver enzymes may occur.
Dette bindingsprotein er knyttet til den ATP-følsomme kaliumkanal, men er forskellig fra det almindelige sulfonylurinstofbindingssted.
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.
Disse kan påvirke op til 1 ud af 10.000 patienter:
These may affect up to 1 in 10,000 people:
In vitro studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og af CYP2C9 i mindre omfang.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Mange lægemidler og alkohol kan påvirke den blodsukkersænkende effekt af Avaglim.
Many medicines (or alcohol) can affect the way Avaglim controls the amount of sugar in your blood.
• BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to medical prescription.
Se “Bivirkninger du skal være opmærksom
See ‘Conditions you need to look out for' in Section 4.
østrogener og gestagener saluretika, thiazid-diuretika thyreomimetika, glukokortikoider fenothiazinderivater, chlorpromazin adrenalin og sympatikomimetika nikotinsyre (høje doser) og nikotinsyrederivater laksantia (langtidsbrug)
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives,
Metabolismen er kendt for at påvirkes af samtidig administration af CYP2C9 inducerende stoffer (f.eks. rifampicin) eller hæmmere (f.eks.
Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e.g. rifampicin) or inhibitors (e.g.
I bioækvivalensundersøgelser fandtes under faste at AUC og Cmax for rosiglitazon og AUC for glimipirid efter enkeltdoser 4 mg/4 mg kombinationstablet var bioækvivalent med samtidig administration af rosiglitazon 4 mg og glimepirid 4 mg.
In a bioequivalence study under fasted conditions, the AUC and Cmax of rosiglitazone and the AUC of glimepiride following a single dose of a 4 mg/4 mg combination tablet were bioequivalent to concomitant administration of rosiglitazone 4 mg and glimepiride 4 mg.
Total plasmaclearance af rosiglitazon er omkring 3 liter/time, og den endelige halveringstid er ca. 3-4 timer.
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.
Yderligere skal der indsendes en opdateret RMP: - når der modtages ny information, der kan have indflydelse på nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter - inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller
− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Glimepirid hæmmer leverens glukosedannelse ved at øge den intracellulære koncentration af fruktose-2,6
Glimepiride inhibits the hepatic glucose production by increasing the intracellular concentration of fructose-2,6 bisphosphate, which in turn inhibits gluconeogenesis.
Uomdannet stof blev ikke genfundet i urin Efter intravenøs indgift i patienter observeredes ingen udskillelse af hverken glimepirid eller M1
After intravenous dosing in patients, no significant biliary excretion of glimepiride or its M1 metabolite was observed.