natgillin/translations-raw huggingface dataset:
Der blev ikke observeret klinisk relevante ændringer i vitale tegn eller i EKG (inklusive i QTc - intervallet) ved behandling med sitagliptin.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with sitagliptin treatment.
Efter markedsføring
Post-marketing data
Hypersensitivitetsreaktioner inklusive anafylaksi, angioødem, udslæt, urticaria og eksfoliative hudreaktioner, herunder Stevens- Johnsons syndrom (se pkt.
During post-marketing experience of Efficib or sitagliptin, one of the active substances of Efficib, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
4. 4).
Metformin
Metformin Data fra kliniske undersøgelser og efter markedsføring
Clinical Trial Data and Post-marketing data
Tabel 2 viser bivirkninger inddelt i systemorganklasse og i henhold til frekvens.
Table 2 presents adverse reactions by system organ class and by frequency category.
8 Tabel 2.
Table 2.
Bivirkningsfrekvensen for metformin identificeret i kliniske undersøgelser og efter marketing
The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Metallisk smag i munden
metallic taste
Mave- tarmkanalen Symptomer fra mave- tarmkanalena
Gastrointestinal disorders
Meget almindelig
gastrointestinal symptomsa
Urticaria, erythema, pruritis
Skin and subcutaneous disorders urticaria, erythema, pruritis
Metabolisme og ernæring Laktacidose B12- vitaminmangelb B
Metabolism and nutrition disorders
Meget sjælden Meget sjælden
lactic acidosis vitamin B12 deficiencyb
Lever og galdeveje
Very rare Very rare
Leverinsufficiens, hepatitis a
Hepatobiliary disorders liver function disorders, hepatitis a
Symptomer fra mave- tarmkanalen som kvalme, opkastning, diarré, mavesmerter
Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in b
og tab af appetit
and loss of appetite most cases.
forekommer hyppigst ved initiering af behandlingen og forsvinder spontant i de fleste tilfælde. b Langvarig behandling med metformin er blevet associeret med nedsat absorption af B12- vitamin, som meget sjældent medfører klinisk signifikant B12- vitaminmangel (f. eks. megaloblastær anæmi).
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e. g., megaloblastic anaemia).
Der findes ingen tilgængelige data vedrørende overdosering af Efficib.
No data are available with regard to overdose of Efficib.
Under kontrollerede kliniske undersøgelser med raske personer var enkeltdoser på op til 800 mg sitagliptin generelt veltålt.
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated.
Minimale stigninger i QTc- intervallet blev observeret i en undersøgelse med en 800 mg dosis sitagliptin, men blev ikke anset for at være klinisk relevante.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Der er ingen erfaring med doser over 800 mg til mennesker.
There is no experience with doses above 800 mg in humans.
I Fase- I flerdosisundersøgelser blev der ikke observeret dosisrelaterede kliniske bivirkninger med sitagliptin ved doser op til 600 mg/ dag i 10 dage og 400 mg/ dag i perioder op til 28 dage.
In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for 10 days and 400 mg per day for periods of up to 28 days.
Sitagliptin er kun moderat dialyserbart.
Sitagliptin is modestly dialyzable.
13, 5% af dosis fjernet i løbet af en hæmodialysesession på 3- 4 timer.
In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session.
Det vides ikke, om sitagliptin er dialyserbart ved peritonealdialyse.
It is not known if sitagliptin is dialyzable by peritoneal dialysis.
I tilfælde af overdosering er det hensigtsmæssigt at benytte de sædvanlige understøttende forholdsregler, f. eks. fjerne uabsorberet materiale fra mave - og tarmkanalen, sørge for klinisk monitorering (inklusive elektrokardiogram) og igangsætte understøttende behandling om nødvendigt.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Kombinationer af orale blodglucosesænkende præparater, ATC - kode:
Combinations of oral blood glucose lowering drugs, ATC code:
Sitagliptinphosphat, en dipeptylpeptidase- 4- hæmmer (DPP- 4), og metforminhydrochlorid, der tilhører biguanidklassen.
Efficib combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Sitagliptin Sitagliptinphosphat er en oralt aktiv, potent og højselektiv hæmmer af DPP- 4- enzymet til behandling af type 2- diabetes.
9 Sitagliptin Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
DPP- 4- hæmmerne er en klasse af præparater, der virker som inkretinenhancers.
The DPP-4 inhibitors are a class of agents that act as incretin enhancers.
Ved at hæmme DPP- 4- enzymet øger sitagliptin niveauerne for de to kendte aktive inkretinhormoner, glucagonlignende peptid 1 (GLP- 1) og glucoseafhængigt insulinotropt polypeptid (GIP).
By inhibiting the DPP-4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Når blodglucosekoncentrationen er normal eller forhøjet, bevirker GLP- 1 og GIP en øget insulinsyntese og frigørelse af insulin fra de pankreatiske betaceller.
When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells.
Desuden sænker GLP- 1 glucagonsekretionen fra pankreatiske alfaceller, som fører til reduceret hepatisk glucoseproduktion.
GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production.
Sitagliptin er en potent og høj- selektiv hæmmer af enzymet DPP- 4 og hæmmer ikke de nært beslægtede enzymer DPP- 8 eller DPP- 9 ved terapeutiske koncentrationer.
Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin adskiller sig i kemisk struktur og farmakologisk virkning fra GLP- 1- analoger, insulin, sulfonylurinstoffer eller meglitinider, biguanider, peroxisom- proliferatoraktiverede receptorgammaagonister (PPARγ), alfaglucosidasehæmmere og amylinanaloger.
Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulphonylureas or meglitinides, biguanides, peroxisome proliferator-activated receptor gamma (PPARγ) agonists, alpha- glucosidase inhibitors, and amylin analogues.
Målt som klinisk relevante reduktioner i HbA1c i forhold til baseline ved study endpoint (se Tabel 3) forbedrede sitagliptin totalt set den glykæmiske kontrol, når det blev givet i kombination med metformin (initialt eller som tillægsterapi) og i kombination med sulfonylurinstof/ metformin.
Overall, sitagliptin improved glycaemic control when used in combination with metformin (as initial or add-on therapy) and in combination with a sulphonylurea and metformin, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 3).
I kliniske undersøgelser forbedrede sitagliptin som monoterapi den glykæmiske kontrol ved signifikant reduktion af hæmoglobin A1c (HbA1c) samt faste - og postprandial glucose.
In clinical trials, sitagliptin as monotherapy improved glycaemic control with significant reductions in haemoglobin A1c (HbA1c) and fasting and postprandial glucose.
Reduktionen i faste- plasma glucose (FPG) blev observeret efter 3 uger, det første tidspunkt hvor FPG blev målt.
Reduction in fasting plasma glucose (FPG) was observed at 3 weeks, the first time point at which FPG was measured.
Forbedring af surrogatmarkører for betacellefunktionen, inklusive HOMA- β (Homøostatisk modelvurdering af β - cellefunktionen), proinsulin/ insulin ratio samt resultater fra en frequently sampled meal tolerance test blev observeret.
Improvements in surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Undersøgelser af sitagliptin i kombination med metformin I en 24- ugers placebokontrolleret klinisk undersøgelse til vurdering af effekt og sikkerhed ved sitagliptin 100 mg én gang dagligt som supplement til metformin gav sitagliptin signifikant forbedring af glykæmiske parametre sammenlignet med placebo.
Studies of sitagliptin in combination with metformin In a 24-week, placebo-controlled clinical study to evaluate the efficacy and safety of the addition of sitagliptin 100 mg once daily to ongoing metformin, sitagliptin provided significant improvements in glycaemic parameters compared with placebo.
I en 24- ugers placebokontrolleret faktoriel undersøgelse af initialbehandling gav sitagliptin 50 mg to gange dagligt i kombination med metformin (500 mg eller 1. 000 mg to gange dagligt) en signifikant forbedring af glykæmiske parametre sammenlignet med monoterapi med enten det ene eller det andet stof.
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Der var ingen ændring i forhold til baseline for patienter, der fik sitagliptin alene.
The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
10 Undersøgelse af sitagliptin i kombination med metformin og et sulfonylurinstof En 24- ugers placebo- kontrolleret undersøgelse blev designet til at vurdere effekt og sikkerhed af sitagliptin (100 mg én gang dagligt) som supplement til glimepirid (alene eller i kombination med metformin).
Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Patienter, der blev behandlet med sitagliptin, havde en moderat vægtøgning (+1, 1 kg) sammenlignet med de patienter, der fik placebo.
Patients treated with sitagliptin had a modest increase in body weight (+1.1 kg) compared to those given placebo.
Tabel 3:
10 Table 3:
HbA1c resultater i placebokontrollerede undersøgelser af kombinationsbehandling med sitagliptin og metformin *
HbA1c results in placebo-controlled combination therapy studies of sitagliptin and metformin*
Gennemsnitlig
Mean baseline
Gennemsnitlig
Mean change from
ændring i HbA1c
Placebo-corrected mean change
baseline
HbA1c (%)
ændring fra baseline
baseline HbA1c (%)
(%) i 24. uge †
in HbA1c (%) at Week 24†
i 24. uge †
at Week 24†
dagligt som supplement til
Sitagliptin 100 mg once daily added to ongoing metformin
- 0, 7 ‡
-0.7‡
metforminbehandling (N=453) Sitagliptin 100 mg én gang dagligt som supplement til
therapy (N=453) Sitagliptin 100 mg once daily
(- 0, 8, - 0, 5) - 0, 9 ‡
(-0.8, -0.5)
glimepirid + metforminbehandling (N=115) Initialbehandling (to gange
added to ongoing glimepiride + metformin therapy (N=115) Initial Therapy (twice daily):
Sitagliptin 50 mg + metformin 500 mg (N=183) Initialbehandling (to gange
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial Therapy (twice daily):
Sitagliptin 50 mg + metformin 1. 000 mg (N=178) *
Sitagliptin 50 mg + metformin 1000 mg (N=178)
Population: alle behandlede patienter (analyse med henblik på behandling) † Least squares means justeret mht tidligere antihyperglykæmisk behandlingsstatus og baseline- værdi. ‡ p < 0, 001 sammenlignet med placebo eller placebo + kombinationsbehandling.
* All Patients Treated Population (an intention-to-treat analysis). † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value. ‡ p < 0.001 compared to placebo or placebo + combination treatment.
7, 5% i begge grupper).
In a 52-week study, comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c (-0.7% mean change from baselines at week 52, with baseline HbA1c of approximately 7.5% in both groups).
40% af patienterne havde behov for en glipiziddosis på ≤5 mg/ dag i hele undersøgelsesperioden.
The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40% of patients requiring a glipizide dose of ≤ 5 mg/ day throughout the study.
De patienter, der blev behandlet med sitagliptin, udviste et signifikant gennemsnitligt fald i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtøgning hos patientgruppen, der fik glipizid (- 1, 5 versus +1, 1 kg).
Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight (-1.5 kg) compared to a significant weight gain in patients administered glipizide (+1.1 kg).
I denne undersøgelse forbedredes proinsulin/ insulinratioen, der er en markør for effektiviteten af insulinsyntese og - sekretion, med sitagliptin og forværredes med glipizidbehandling.
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
Incidensen af hypoglykæmi i gruppen, som blev behandlet med sitagliptin, var signifikant lavere end i glipizidgruppen (4, 9% versus 32, 0%).
The incidence of hypoglycaemia in the sitagliptin group (4.9%) was significantly lower than that in the glipizide group (32.0%).
Metformin Metformin er et biguanid med antihyperglykæmisk virkning, som sænker både basal og postprandial plasmaglucose.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
- ved reduktion af hepatisk glucoseproduktion gennem hæmning af glukoneogenese og
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
- i musklerne, ved let øgning af følsomheden over for insulin, ved forbedring af perifer
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
glucoseoptagelse og ved udnyttelse af glucose.
utilisation
- ved forsinkelse af intestinal glucoseabsorption.
- by delaying intestinal glucose absorption.
Metformin øger transportkapaciteten for specifikke typer af membranglucosetransportører (GLUT- 1 og GLUT- 4).
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Metformin reducerer totalkolesterol, LDL- kolesterol og triglyceridniveauerne.
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 fastslået den langvarige, gunstige effekt af intensiv blodglucosekontrol ved type 2- diabetes.
11 The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
- signifikant reduktion af den absolutte risiko for diabetesrelaterede komplikationer i
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin
metformingruppen (29, 8 hændelser/ 1. 000 patientår) versus diæt alene (43, 3 hændelser/ 1. 000 patientår), p=0, 0023, og versus den kombinerede sulfonylurinstof/ insulinmonoterapigruppe (40, 1 hændelser/ 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
Metformin 7, 5
- a significant reduction of the absolute risk of any diabetes-related mortality: metformin
hændelser/ 1. 000 patientår, diæt alene 12, 7 hændelser/ 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
Metformin 13, 5
- a significant reduction of the absolute risk of overall mortality: metformin
hændelser/ 1. 000 patientår versus diæt alene 20, 6 hændelser/ 1. 000 patientår, (p=0, 011), og versus den kombinerede sulfonylurinstof/ insulinmonoterapigruppe 18, 9 hændelser/ 1. 000 patientår (p=0, 021).
13.5 events/ 1,000 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)
Metformin 11
- a significant reduction in the absolute risk of myocardial infarction: metformin
hændelser/ 1. 000 patientår, diæt alene 18 hændelser/ 1. 000 patientår, (p=0, 01).
11 events/ 1,000 patient-years, diet alone 18 events/ 1,000 patient-years, (p=0.01).
Efficib En bioækvivalensundersøgelse med raske forsøgspersoner viste, at Efficib (sitagliptin/ metforminhydrochlorid) kombinationstabletter er bioækvivalente med samtidig administration af sitagliptinphosphat og metforminhydrochlorid som individuelle tabletter.
Efficib A bioequivalence study in healthy subjects demonstrated that the Efficib (sitagliptin/ metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Sitagliptin Absorption Efter oral administration af en 100 mg dosis til raske forsøgspersoner absorberedes sitagliptin hurtigt med peak- plasmakoncentrationer (median Tmax) 1- 4 timer efter dosering, gennemsnitlig plasma- AUC for sitagliptin var 8, 52 µM• hr, Cmax var 950 nM.
Sitagliptin Absorption Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 μ M• hr, Cmax was 950 nM.
87%.
The absolute bioavailability of sitagliptin is approximately 87%.
Sitagliptins plasma- AUC steg proportionalt med dosis.
Plasma AUC of sitagliptin increased in a dose-proportional manner.
198 l.
Distribution The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 litres.
Den fraktion af sitagliptin, som er reversibelt bundet til plasmaproteiner, er lav (38%).
The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
Ca.
Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
79% af sitagliptin udskilles uændret i urinen.
Approximately 79% of sitagliptin is excreted unchanged in the urine.
16% af radioaktiviteten som sitagliptinmetabolitter.
Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
Seks metabolitter blev påvist på sporstofniveau og forventes ikke at bidrage til sitagliptins DPP- 4 -
Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
In vitro- undersøgelser indikerede, at det enzym, der primært er ansvarlig for sitagliptins begrænsede metabolisering, er CYP3A4, med medvirken fra CYP2C8.
In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.
In vitro- data viste, at sitagliptin ikke er en hæmmer af CYP- isozymerne CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 eller 2B6, og det inducerer ikke CYP3A4 og CYP1A2.
In vitro data showed that sitagliptin is not an inhibitor of CYP isoenzymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
100% af den administrerede radioaktivitet i fæces (13%) eller urin (87%) inden for en uge efter dosering.
12 Elimination Following administration of an oral [14C]sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Den tilsyneladende terminale halveringstid (t½) efter indgift af en 100 mg oral dosis sitagliptin var ca.
The apparent terminal t½ following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Sitagliptin er et substrat for humant organisk aniontransporter- 3 (hOAT- 3), som kan være involveret i den renale elimination af sitagliptin.
Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Den kliniske relevans af hOAT- 3 i sitagliptin- transport er ikke fastslået.
The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Sitagliptin er også et substrat for p- glykoprotein, som også kan være involveret i sitagliptins renale elimination.
Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Ciclosporin, en p- glykoproteinhæmmer, reducerede dog ikke sitagliptins renale clearance.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Sitagliptin er ikke et substrat for OCT2, OAT1 eller PEPT1/ 2 transportere.
Sitagliptin is not a substrate for OCT2 or OAT1 or PEPT1/ 2 transporters.
In vitro hæmmede sitagliptin ikke OAT3 (IC50=160 µM) eller p- glycoprotein (op til 250 µM) medieret transport ved terapeutisk relevante plasmakoncentrationer.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
I en klinisk undersøgelse havde sitagliptin en lille effekt på digoxinkoncentrationerne i plasma, hvilket tyder på, at sitagliptin kan være en mild hæmmer af p- glycoprotein.
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Patientkarakteristika Sitagliptins farmakokinetik var generelt den samme hos raske personer som hos patienter med type 2 - diabetes.
Characteristics in patients The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Nyreinsufficiens I en åben undersøgelse med enkeltdosis blev farmakokinetikken for en reduceret dosis sitagliptin (50 mg) vurderet hos patienter med varierende grader af kronisk nyreinsufficiens sammenlignet med normale raske kontrolpersoner.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50 mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Undersøgelsen omfattede patienter med nyreinsufficiens klassificeret på basis af kreatinin- clearance som mild (50 til < 80 ml/ min), moderat (30 til < 50 ml/ min) og svær (< 30 ml/ min) samt patienter med ESRD i hæmodialyse.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on haemodialysis.