natgillin/translations-raw huggingface dataset:
Som en konsekvens af forskellige, men komplementære, virkningsmekanismer, resulterede kombinationsbehandling med rosiglitazon og metformin i additiv effekt på den glykæmiske kontrol hos patienter med type 2- diabetes.
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.
En morbiditets/ mortalitet undersøgelse er ikke afsluttet med rosiglitazon, og langtidsfordelene forbundet med forbedret glykæmisk kontrol er derfor ikke blevet påvist.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control of rosiglitazone have not been demonstrated.
Efter 18 måneder i en igangværende sammenlignende langtidsundersøgelse var rosiglitazon i oral kombinationsbehandling med metformin ikke- inferior over for kombinationen af sulfonylurinstof og metformin med hensyn til at sænke HbA1c.
At 18 months, in an ongoing long term comparator study, rosiglitazone in dual oral therapy with metformin was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Et aktivt kontrolleret klinisk forsøg (rosiglitazon op til 8 mg daglig eller metformin op til 2000 mg daglig) blev udført med 197 børn i alderen 10- 17 år med type 2- diabetes i 24 uger.
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.
Rosiglitazon viste ikke non- inferioritet over for metformin.
Rosiglitazone failed to demonstrate non-inferiority to metformin.
Efterfølgende handling med rosiglitazon viste ingen yderligere sikkerhedsproblemer blandt børn i forhold til voksne med type 2- diabetes mellitus.
Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
Der er ingen langvarige effekt - og sikkerhedsdata tilgængelig hos børn.
No long-term efficacy and safety data are available in paediatric patients.
Der er ingen afsluttede outcome undersøgelser, som vurderer den kardiovaskulære langtidseffekt hos patienter, som får rosiglitazon i kombination med metformin.
12 There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone in combination with metformin.
Metformin Metformin er et biguanid med antidiabetisk virkninger, som sænker både basal og postprandial plasmaglucose.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
- ved at reducere den hepatiske glucoseproduktion ved hæmning af gluconeogenese og
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
- i muskler, ved forøgelse af insulinfølsomheden, forbedring af perifer glucoseoptagelse og
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
13 - udnyttelse,
utilisation,
- ved at forsinke den intestinale glucoseabsorption.
- by delaying intestinal glucose absorption.
Metformin øger transportkapaciteten af specifikke membranglucosetransportører (GLUT- 1 og GLUT- 4).
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske undersøgelser: metformin reducerer total- kolesterol, LDLc og triglyceridniveauer.
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Den prospektive randomiserede undersøgelse (UKPDS) har påvist langtidsfordele af intensiv blodsukkerkontrol ved type 2- diabetes.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
- en signifikant reduktion i den absolutte risiko for enhver diabetes- relateret komplikation i
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin
metformingruppen (28, 9 tilfælde/ 1. 000 patientår) versus diæt alene (43, 3 tilfælde/ 1. 000 patientår), p=0, 0023, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (40, 1 tilfælde/ 1. 000 patientår), p=0, 0034
group (29.8 events/ 1,000 patient-years) versus diet alone (43.3 events/ 1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/ 1,000 patient-years), p=0.0034
- en signifikant reduktion i den absolutte risiko for diabetes- relateret mortalitet: metformin (7, 5
- a significant reduction of the absolute risk of diabetes-related mortality: metformin
tilfælde/ 1. 000 patientår), diæt alene (12, 7 tilfælde/ 1. 000 patientår), p=0, 017
7.5 events/ 1,000 patient-years, diet alone 12.7 events/ 1,000 patient-years, p=0.017
- en signifikant reduktion i den absolutte risiko for overordnet mortalitet: metformin (13, 5
- a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/ 1,000
tilfælde/ 1. 000 patientår) versus diæt alene (20, 6 tilfælde/ 1. 000 patientår), p=0, 011, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (18, 9 tilfælde/ 1. 000 patientår), p=0, 021
patient-years versus diet alone 20.6 events/ 1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient-years (p=0.021)
- en signifikant reduktion i den absolutte risiko for myokardieinfarkt: metformin (11
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/ 1,000
tilfælde/ 1. 000 patientår), diæt alene (18 tilfælde/ 1. 000 patientår), p=0, 01.
patient-years, diet alone 18 events/ 1,000 patient-years (p=0.01).
AVANDAMET Absorption Der er ikke set statistisk signifikant forskel på absorptions karakteristika for rosiglitazon og metformin fra AVANDAMET tabletten og data for henholdsvis rosiglitazonmaleat og metforminhydrochlorid.
AVANDAMET Absorption No statistically significant difference was observed between the absorption characteristics of rosiglitazone and metformin from the AVANDAMET tablet and those obtained from rosiglitazone maleate and metformin hydrochloride tablets, respectively.
Fødeindtagelse medførte en lavere Cmax (22% for rosiglitazon og 15% for metformin) samt forsinket tmax (med cirka 1, 5 time for rosiglitazon og 0, 5 time for metformin).
In the fed state, Cmax was lower (22% rosiglitazone and 15% metformin) and tmax delayed (by approximately 1.5 h rosiglitazone and 0.5 h metformin).
Denne føde- påvirkning er ikke vurderet som værende klinisk signifikant.
This food-effect is not considered clinically significant.
Rosiglitazon Absorption Rosiglitazons absolutte biotilgængelighed efter både en 4 mg og 8 mg oral dosis er cirka 99%.
13 Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Administration af rosiglitazon sammen med føde resulterede ikke i nogen ændring i den generelle optagelse (AUC), selvom der sås et svagt fald i Cmax (cirka 20- 28%) og en forsinkelse i tmax (cirka 1, 75 time) sammenlignet med administration i fastende tilstand.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasting state.
Distribution Rosiglitazons distributionsvolumen er cirka 14 l hos raske frivillige.
Distribution The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Rosiglitazons plasma - proteinbinding er høj (cirka 99, 8%) og påvirkes ikke af koncentration eller alder.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
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%).
14 Metabolisme Rosiglitazons metabolisme er omfattende, og intet af det oprindelig stof udskilles uændret.
Metabolism Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Metabolismen sker primært gennem N- demetylation og hydroxylation, 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.
Bidraget fra den hyppigst forekommende metabolit (para- hydroxy- sulfat) til den samlede antidiabetiske aktivitet af rosiglitazon er ikke fuldt ud belyst hos mennesket, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
The contribution of the major metabolite (a para-hydroxy-sulphate) to the overall antihyperglycaemic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
In vitro- studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og i mindre omfang af CYP2C9.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
Idet der ikke ses nogen væsentlig in vitro hæmning af CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A eller 4A med rosiglitazon, er der lille sandsynlighed for signifikant metabolismebaserede interaktioner med substanser, der metaboliseres af disse P450- enzymer.
Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances metabolised by these P450 enzymes.
Rosiglitazon udviste moderat inhibition af CYP2C8 (IC50 18 μM) og lav inhibition af CYP2C9 (IC50 50 μM) in vitro (se afsnit 4. 5).
Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
En in vivo - interaktionsundersøgelse med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9 - substrater in vivo.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Elimination Total plasmaclearance af rosiglitazon er omkring 3 l/ time, og den endelige halveringstid er cirka 3- 4 timer.
Elimination Total plasma clearance of rosiglitazone is around 3 l/ h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h.
Udskillelse sker primært i urinen med cirka 2/ 3, og gennem fæces med cirka 25% af doseringen.
The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Akkumulering af metabolitter i plasma kan forventes efter gentagen dosering, specielt hvad angår den hyppigste metabolit (para- hydroxy- sulfat), hvor en 8- dobling kan forventes.
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.
I den farmakokinetiske analyse med poolet population sås ingen klar forskel i rosiglitazons farmakokinetik hos kvinder og mænd.
In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females.
I den farmakokinetiske analyse med poolet population havde alder ikke nogen signifikant indflydelse på farmakokinetikken.
In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
En farmakokinetisk befolkningsanalyse med 96 patienter i alderen 10- 18 år i vægtklassen 35- 178 kg, viste samme middelværdi for CL/ F hos både børn og voksne.
Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/ F in children and adults.
Hos patienterne mellem 10 og 18 år var den individuelle CL/ F i samme størrelsesorden som hos voksne.
Individual CL/ F in the paediatric population was in the same range as individual adult data.
CL/ F forekom uafhængig af alder, men blev forøget med vægten hos patienterne mellem 10 og 18 år.
CL/ F seemed to be independent of age, but increased with weight in the paediatric population.
Nedsat leverfunktion:
14 Hepatic impairment:
Hos cirrhotiske patienter med moderat (Child- Pugh B) nedsat leverfunktion var ubundet Cmax og AUC 2- 3 gange højere end hos normale personer.
In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Den interpersonelle variation var stor med en 7– dobling forskel i ubundet AUC mellem patienterne.
The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Metformin Absorption Efter en oral dosis metformin når tmax efter 2, 5 timer.
Metformin Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Absolut biotilgængelighed af en 500 mg metfomin- tablet er cirka 50- 60% hos raske personer.
Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Efter en oral dosis var den genfundne ikke - absorberede fraktion i fæces 20- 30%.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Det antages, at farmakokinetikken for metforminabsorption er non- lineær.
It is assumed that the pharmacokinetics of metformin absorption is non-linear.
15 doseringsskemaer nås steady state plasmakoncentrationer indenfor 24- 48 timer, og de er sædvanligvis mindre end 1 μg/ ml.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
I kontrollerede kliniske undersøgelser overskred de maksimale metformin plasmakoncentrationer (Cmax) ikke 4 μg/ ml, selv ved maksimale doser.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
Efter administration af en dosis på 850 mg så man en 40% lavere maksimal plasmakoncentration, en 25% mindskelse i AUC og en forlængelse på 35 min før den maksimale plasmakoncentration opnåedes.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Fordeling Plasmaproteinbindingen er ubetydelig.
Distribution Plasma protein binding is negligible.
Elimination Renal clearance af metformin er > 400 ml/ min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
Elimination Renal clearance of metformin is > 400 ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Efter en oral dosis er den tilsyneladende terminale eliminationshalveringstid cirka 6, 5 timer.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Rosiglitazon Bivirkningerne, der blev observeret i dyreforsøg med mulig relevans for klinisk brug var følgende:
Rosiglitazone Undesirable effects observed in animal studies with possible relevance to clinical use were as follows:
Desuden hæmmede rosiglitazon den østradiole og progesterone syntese i ovarierne og sænkede plasmaniveauet af disse hormoner, hvilket resulterede i effekter på østrus/ menstruationscyklus og fertilitet (se afsnit 4. 4).
In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/ menstrual cycles and fertility (see section 4.4).
Rosiglitazon fremmede dog differentiering og ændring af mutagene ændringer i humane coloncancer- celler in vitro.
15 changes in human colon cancer cells in vitro.
Metformin Ikke- kliniske data for metformin viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion.
Metformin 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.
Natriumstivelsesglycollat Hypromellose (E464) Mikrokrystallinsk cellulose (E460) Lactosemonohydrat Povidon (E1201) Magnesiumstearat.
Sodium starch glycollate Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Povidone (E1201) Magnesium stearate.
Hypromellose (E464) Titandioxid (E171) Macrogol Gul jernoxid (E172).
Hypromellose (E464) Titanium dioxide (E171) Macrogol Iron oxide yellow (E172).
Uigennemsigtige blisterpakninger (PVC/ PVdC/ aluminium).
Opaque blisters (PVC/ PVdC/ aluminium).
20. oktober 2003 Dato for seneste fornyelse:
20 October 2003 Date of latest renewal:
AVANDAMET 2 mg/ 500 mg filmovertrukne tabletter
AVANDAMET 2 mg/ 500 mg film-coated tablets
11 mg).
Each tablet contains lactose (approximately 11 mg)
Svagt pink filmovertrukne tabletter mærker ” gsk ” på den ene side og ” 2/ 500 ” på den anden.
Pale pink film-coated tablets marked "gsk" on one side and "2/ 500" on the other.
19 Oral tripel- kombinationsbehandling (rosiglitazon, metformin og sulfonylurinstof) (se afsnit 4. 4)
Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)
AVANDAMET må ikke anvendes til patienter med nyresvigt eller nedsat nyrefunktion, f. eks. serumkreatinin niveau > 135 μmol/ l hos mænd og > 110 μmol/ l hos kvinder og/ eller kreatininclearance < 70 ml/ min (se afsnit 4. 3 og 4. 4).
Patients with renal impairment AVANDAMET should not be used in patients with renal failure or renal dysfunction e. g. serum creatinine levels > 135 μ mol/ l in males and > 110 μ mol/ l in females and/ or creatinine clearance < 70 ml/ min (see sections 4.3 and 4.4).
- overfølsomhed over for rosiglitazon, over for metforminhydrochlorid eller over for et eller flere
- hypersensitivity to rosiglitazone, metformin hydrochloride or to any of the excipients
> 110 μmol/ l hos kvinder og/ eller kreatininclearance < 70 ml/ min (se afsnit 4. 3 og 4. 4)
> 110 µmol/ l in females and/ or creatinine clearance < 70 ml/ min (see section 4.4)
20 er primært forekommet hos diabetes patienter med betydeligt nedsat nyrefunktion.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
21 Akut koronarsyndrom (AKS) Der har ikke været inkluderet patienter med AKS i kontrollerede kliniske forsøg med rosiglitazon.
20 Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
22 Knoglelidelser I et langtidsstudie blev der observeret en øget forekomst af frakturer (fødder, hænder og arme) hos kvindelige patienter, der blev behandlet med rosiglitazon som monoterapi (se afsnit 4. 8).
21 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).
Kationiske lægemidler, der elimineres via renal tubulær sekretion (f. eks. cimetidin), kan interagere med metformin ved at konkurrere om almindelige almindelige renale tubulære transportsystemer.
Cationic medicinal products that are eliminated by renal tubular secretion (e. g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
In vitro -- undersøgelser har vist, at rosiglitazon primært metaboliseres af CYP2C8, med CYP2C9 som en mindre metaboliseringsvej.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
23 Samtidig administration af rosiglitazon og rifampicin (en inducer af CYP2C8) resulterede i et fald på 66% i rosiglitazon plasmakoncentrationer.
22 Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
24 Bivirkningerne fra hvert behandlingsregime er listet nedenfor efter organklasse og absolut frekvens.
23 Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Data fra kliniske undersøgelser Bivirkninger fra hvert behandlingsregime er listet under organklasser og absolutte frekvenser.
Clinical trial data Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
25 Tabel 1.
24 Table 1.
Blod - og lymfesystem
Blood and the lymphatic system disorders Anaemia granulocytopaenia
Anæmi Agranulocytose
Common Common
Hyperlipidæmi Vægtøgning Øget appetit
Hyperlipaemia weight increase increased appetite
Obstipation
Gastrointestinal disorders Constipation
* Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra placebogrupper fra kliniske undersøgelser, er ” Almindelig ”.
*The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is'common '.
26 En placebokontrolleret, etårig undersøgelse af patienter, der lider af hjertesvigt NYHA- klasse I- II, har vist en forværring eller mulig forværring af hjertesvigt hos 6, 4% af patienterne i behandling med rosiglitazon, sammenlignet med 3, 5% for placebo.
In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
1, 99% for rosiglitazon over for 1, 51% for komparatorerne [Hazard ratio 1, 31 (95% konfidensinterval 1, 01 – 1, 70)].
25 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, 1.99% versus combined active and placebo comparators, 1.51% [Hazard ratio 1.31 (95% confidence interval 1.01 - 1.70)].
27 Tabel 2.
Table 2.
28 Tabel 3.
Table 3.
Nældefeber Erytem Hudkløe 6
urticaria Erythema Pruritis 6
5. 1 Farmakodynamiske egenskaber
27 5.1 Pharmacodynamic properties
29 virker primært ved at reducere insulinresistens og biguaniderne virker primært ved at mindske den endogene hepatiske glucoseproduktion.
Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production.
Som en konsekvens af forskellige, men komplementære, virkningsmekanismer, resulterede oral kombinationsbehandling med rosiglitazon og metformin i additiv effekt på den glykæmiske kontrol hos patienter med type 2- diabetes.
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.
Der er ingen afsluttede outcome undersøgelser, som vurderer den kardiovaskulære langtidseffekt hos patienter, som får rosiglitazon i kombination med metformin.
28 There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone in combination with metformin.
Metformin Metformin er et biguanid med antidiabetisk virkninger, som sænker både basal og postprandial plasmaglucose.
29 Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
- ved at reducere den hepatiske glucoseproduktion ved hæmning af gluconeogenese og
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
30 - udnyttelse,
utilisation
Rosiglitazon Absorption Rosiglitazons absolutte biotilgængelighed efter både en 4 mg og 8 mg oral dosis er cirka 99%.
Rosiglitazone Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Rosiglitazons maksimale plasmakoncentration ses cirka 1 time efter administration.
Plasma concentrations are approximately dose proportional over the therapeutic dose range.