natgillin/translations-raw huggingface dataset:
Udseende og pakningsstørrelse på NovoMix 70 Injektionsvæske, suspension leveres som en hvid suspension i pakninger med 1, 5 eller 10 fyldte penne a 3 ml (ikke alle pakningsstørrelser er nødvendigvis markedsført).
What NovoMix 70 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
118 Vejledning
116 Introduction
Læs denne brugervejledning omhyggeligt, inden De tager NovoMix 70 FlexPen i brug.
Please read the following instructions carefully before using your NovoMix 70 FlexPen.
Farven på Deres FlexPen kan være forskellig fra den på illustrationen NovoMix 70 FlexPen Penhætte
The colour of the pen in the illustrations differs from your FlexPen.
12
12 Glass Cartridge Residual
Glas
Pointer
Cylinder Restdosis
Dose
Markør
Push-
Klargøring af Deres NovoMix 70 FlexPen
Preparing your NovoMix 70 FlexPen
Kontroller på etiketten at Deres FlexPen indeholder den korrekte insulintype.
Check the label to make sure that your FlexPen contains the correct type of insulin.
119 Træk penhætten af.
117 Pull off the pen cap.
120 D
118 D
H Hold Deres FlexPen så nålen vender opad og bank let på cylinderampullen med fingeren et par gange, så eventuelle luftbobler samles i toppen af cylinderampullen.
119 Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
121 H
H
122 J
120 J
123 M
121 M
124
122
Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse Tablet Oral anvendelse
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu) blisterpakning (alu/ alu)
blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
30 tabletter 90 tabletter 120 tabletter 360 tabletter 30 tabletter 90 tabletter 120 tabletter 360 tabletter 30 tabletter 90 tabletter 120 tabletter 360 tabletter 270 tabletter 270 tabletter 270 tabletter
30 tablets 90 tablets 120 tablets 360 tablets 30 tablets 90 tablets 120 tablets 360 tablets 30 tablets 90 tablets 120 tablets 360 tablets 270 tablets 270 tablets 270 tablets
Des fås som runde tabletter (hvid:
It is available as round tablets (white:
0, 5 mg, gul:
0.5 mg; yellow:
1mg, ferskenfarvet:
1 mg; peach:
2mg).
2 mg).
NovoNorm anvendes til patienter, som har type 2- diabetes (ikke- insulinkrævende diabetes).
NovoNorm is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
NovoNorm kan også anvendes med metformin (et andet lægemiddel mod diabetes) til type 2 - diabetespatienter, hvis blodglukosekoncentrationer ikke er reguleret tilfredsstillende med metformin alene.
NovoNorm may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Patientens blodglukose skal regelmæssigt kontrolleres af en læge for at fastsætte den effektive minimumsdosis.
A doctor should regularly test the patient ’ s blood glucose to find the lowest effective dose.
NovoNorm kan også anvendes til type 2- diabetespatienter, hvis blodglukosekoncentrationer normalt reguleres tilfredsstillende med diæt, men hvor blodglukosekoncentrationen midlertidigt er ude af kontrol.
NovoNorm can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Den anbefalede startdosis er 0, 5 mg.
The recommended starting dose is 0.5 mg.
Type 2- diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets glukosekoncentration, eller når kroppen ikke kan udnytte insulinen effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
NovoNorm får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til regulering af type 2- diabetes.
NovoNorm helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
I hovedundersøgelserne blev NovoNorm sammenlignet med andre lægemidler, som anvendes til type 2- diabetes (glibenclamid, glipizid eller gliclazid).
The main studies compared NovoNorm with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
I alle undersøgelser medførte NovoNorm et fald i HbA1c- niveauet, hvilket tydede på, at blodglukosekoncentrationerne var blevet reguleret til et niveau, der svarede til det, der var iagttaget for de øvrige sammenligningspræparater.
In all studies, NovoNorm led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
NovoNorm fremkaldte en tilfredsstillende insulinrespons på et måltid inden for 30 minutter, efter at en dosis var blevet indtaget af patienter med type 2- diabetes.
NovoNorm produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Dette fremkaldte en blodglukosenedsættende virkning under hele måltidets varighed.
The raised insulin levels returned to normal after the meal.
Det må heller ikke anvendes til patienter, der har type 1- diabetes (insulinkrævende), og som ikke har ‘ C- peptid ’ i blodet (en markør for type 1- diabetes).
It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘ C-peptide ’ in their blood (a marker of type 1 diabetes).
Udvalget for humanmedicinske lægemidler (CHMP) konkluderede, at fordelene ved NovoNorm var større end risiciene ved behandling af type 2 - diabetes.
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NovoNorm til Novo Nordisk A/ S den 17. august 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/ S on 17 August 1998.
NovoNorm 0, 5 mg tabletter
NovoNorm 0.5 mg tablets
Hver tablet indeholder 0, 5 mg repaglinid.
Each tablet contains 0.5 mg of repaglinide.
Repaglinid tabletter er hvide, runde og konvekse og er præget med Novo Nordisk logo (Apis- tyren).
Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
Repaglinid er indiceret til behandling af patienter med type 2- diabetes mellitus (ikke- insulinkrævende diabetes mellitus (NIDDM)), hvis hyperglykæmi ikke længere kan kontrolleres tilfredsstillende med diæt, vægttab og motion.
Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Repaglinid kan også bruges i kombination med metformin til type 2 patienter, som ikke er tilfredsstillende kontrolleret med metformin alene.
Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Ud over patientens sædvanlige hjemmekontrol af glucose i blod og/ eller urin skal patientens blodglucose også kontrolleres regelmæssigt af lægen for at fastsætte mindste effektive dosis for patienten.
In addition to the usual self-monitoring by the patient of blood and/ or urinary glucose, the patient ’ s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Koncentrationen af glykosyleret hæmoglobin kan også være værdifuld til kontrol af patientens behandlingsrespons.
Glycosylated haemoglobin levels are also of value in monitoring the patient’ s response to therapy.
Regelmæssig kontrol er nødvendig for at opdage utilstrækkelig reduktion af blodglucoseniveauet ved den maksimalt anbefalede dosis (dvs. primært behandlingssvigt) samt manglende blodglucosereduktion efter en indledende effektiv periode (dvs. sekundært behandlingssvigt).
Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i. e. primary failure) and to detect loss of adequate blood glucose- lowering response after an initial period of effectiveness (i. e. secondary failure).
Korttidsbehandling med repaglinid kan være tilstrækkelig i kortvarige perioder med dårlig kontrol hos patienter med type 2- diabetes, der normalt reguleres tilfredsstillende med diæt.
Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet.
Repaglinid bør indtages før hovedmåltiderne (dvs. præprandielt).
Repaglinide should be taken before main meals (i. e. preprandially).
Doser tages normalt inden for 15 minutter i forbindelse med måltidet, men tidspunktet kan variere fra umiddelbart efter måltidet og så langt som til 30 minutter før måltidet (dvs. preprandielt to, tre eller fire gange per dag).
Doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal (i. e. preprandially 2, 3, or 4 meals a day).
4. 4 og 4. 5 for at bestemme dosis.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess the dosage.
Initialdosis Dosis fastlægges af lægen i henhold til patientens behov.
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
Den anbefalede startdosis er på 0, 5 mg.
The recommended starting dose is 0.5 mg.
2 Hvis patientens behandling ændres ved skift fra et andet oralt antidiabeticum, er den anbefalede startdosis 1 mg.
If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is
Vedligeholdelsesdosis Den anbefalede maksimale enkeltdosis er 4 mg taget i forbindelse med hovedmåltiderne.
Maintenance The recommended maximum single dose is 4 mg taken with main meals.
Særlige patientgrupper Repaglinid udskilles hovedsagelig via galden og udskillelsen er derfor ikke følsom overfor nyredysfunktion.
Specific patient groups Repaglinide is primarily excreted via the bile and excretion is therefore not affected by renal disorders.
4. 4).
No clinical studies have been conducted in patients > 75 years of age or in patients with hepatic insufficiency (see section 4.4).
Brug af repaglinid anbefales ikke til børn under 18 år grundet manglende data omkring sikkerhed og/ eller virkning.
Repaglinide is not recommended for use in children below age 18 due to a lack of data on safety and/ or efficacy.
Hos svækkede eller fejlernærede patienter bør initial - og vedligeholdelsesdosis være konservativ, og der kræves en omhyggelig optrapning af dosis for at undgå hypoglykæmiske reaktioner.
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful dose titration is required to avoid hypoglycaemic reactions.
Patienter, der indtager andre orale hypoglykæmiske lægemidler Patienterne kan skifte direkte fra andre orale hypoglykæmiske lægemidler til repaglinid.
Patients receiving other oral hypoglycaemic agents (OHAs) Patients can be transferred directly from other oral hypoglycaemic agents to repaglinide.
Der eksisterer dog intet nøjagtigt doseringsforhold mellem repaglinid og de øvrige orale hypoglykæmiske lægemidler.
However, no exact dosage relationship exists between repaglinide and the other oral hypoglycaemic agents.
Titrering udføres i forhold til blodglucoserespons som for monoterapi.
The starting dose of repaglinide is 0.5 mg, taken before main meals; titration is according to blood glucose response as for monotherapy.
• Overfølsomhed over for repaglinid eller over for et eller flere af hjælpestofferne i NovoNorm • C- peptid negativ type 1- diabetes (insulinkrævende diabetes mellitus:
• Hypersensitivity to repaglinide or to any of the excipients in NovoNorm • Type 1 diabetes (Insulin-Dependent Diabetes Mellitus:
4. 5).
IDDM), C-peptide negative • Diabetic ketoacidosis, with or without coma • Severe hepatic function disorder • Concomitant use of gemfibrozil (see section 4.5).
Generelt Repaglinid bør kun ordineres, hvis der efter behandling med diæt, motion og vægttab stadig er ringe blodglucosekontrol og symptomer på diabetes mellitus.
General Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction.
Repaglinid kan, som andre β- celle stimulerende orale antidiabetica, forårsage hypoglykæmi.
Repaglinide like other insulin secretagogues, is capable of producing hypoglycaemia.
Orale antidiabetica blodglucosenedsættende virkning mindskes hos mange patienter med tiden.
The blood glucose-lowering effect of oral hypoglycaemic agents decreases in many patients over time.
Dette kan skyldes en progressiv diabetesforværring eller mindsket respons over for produktet.
This may be due to progression of the severity of the diabetes or to diminished responsiveness to the product.
Fænomenet benævnes sekundært behandlingssvigt i modsætning til primært behandlingssvigt, hvor lægemidlet allerede fra starten ingen effekt har hos den pågældende patient.
This phenomenon is known as secondary failure, to distinguish it from primary failure, where the drug is ineffective in an individual patient when first given.
3 Repaglinid virker via et specifikt bindingsted med en kort virkning på β- celler.
Repaglinide acts through a distinct binding site with a short action on the β -cells.
Brugen af repaglinid til patienter med sekundært behandlingssvigt overfor andre β- celle stimulerende orale antidiabetica er ikke undersøgt i kliniske studier.
Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Kombinationsbehandling med andre β- celle stimulerende orale antidiabetica og acarbose er ikke undersøgt klinisk.
Trials investigating the combination with other insulin secretagogues and acarbose have not been
Kombinationsbehandling med Neutral Protamin Hagedorn (NPH) insulin eller thiazolidinedioner er undersøgt klinisk.
Trials of combination therapy with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones have been performed.
Når en patient, der er stabiliseret på en oral antidiabetisk behandling, udsættes for stress i form af feber, traume, infektion eller operation, kan blodglucosereguleringen forringes.
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
I sådanne tilfælde kan det blive nødvendigt at seponere repaglinid og behandle med insulin i en periode.
At such times, it may be necessary to discontinue repaglinide and treat with insulin on a temporary basis.
4. 8 og 5. 1).
The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e. g. myocardial infarction) (see sections 4.8 and 5.1).
4. 5).
Concomitant use Repaglinide should be used with caution or be avoided in patients receiving drugs which influence repaglinide metabolism (see section 4.5).
Særlige patientgrupper Der er ikke udført kliniske studier i patienter med forringet lever funktion.
Specific patient groups No clinical studies have been conducted in patients with impaired hepatic function.
Der er ingen klinisk erfaring med behandling af børn og unge < 18 år eller i patienter > 75 år.
No clinical studies have been performed in children and adolescents < 18 years of age or in patients > 75 years of age.
Behandling af disse patientgrupper anbefales derfor ikke.
Therefore, treatment is not recommended in these patient groups.
Omhyggelig dosistitrering anbefales til svækkede eller fejlernærede patienter.
Careful dose titration is recommended in debilitated or malnourished patients.
4. 2).
The initial and maintenance dosages should be conservative (see section 4.2).
En række lægemidler har indflydelse på repaglinidmetabolismen.
A number of drugs are known to influence repaglinide metabolism.
In- vitro data indikerer, at repaglinid bliver metaboliseret fortrinsvis af CYP2C8 men også af CYP3A4.
In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4.
Som en konsekvens kan metabolismen, og hermed udskillelsen af repaglinid, blive ændret af stoffer, som påvirker cytrochrome P- 450 enzymer ved hæmning eller induktion.
Consequently metabolism, and by that clearance of repaglinide, may be altered by drugs which influence these cytochrome P-450 enzymes via inhibition or induction.
Der bør udvises speciel opmærksomhed, når hæmmere af CYP2C8 og 3A4 er anvendt samtidig med repaglinid.
Special care should be taken when both inhibitors of CYP2C8 and 3A4 are co- administered simultaneously with repaglinide.
På grundlag af in vitro- data ser repaglinid ud til at være et substrat for aktivt hepatisk optag (organisk anion- transportprotein OATP1B1).
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
Præparater som inhiberer OATP1B1, kan ligeledes have potentialet til at øge plasmakoncentrationer af repaglinid, som det er blevet påvist for ciclosporin (se nedenfor).
Drugs that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
Følgende stoffer kan forstærke og/ eller forlænge den hypoglykæmiske virkning af repaglinid:
The following substances may enhance and/ or prolong the hypoglycaemic effect of repaglinide:
Gemfibrozil, clarithromycin, itraconazol, ketoconazol, trimetroprim, ciclosporin, andre antidiabetiske stoffer, monoaminooxidasehæmmere (MAO- hæmmere), non- selektive betablokkere, angiotensin konverterende enzym (ACE) - hæmmere, NSAIDS, salicylater, octreotide, alkohol og anaboliske steroider.
Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, other antidiabetic agents, monoamine oxidase inhibitors (MAOI), non selective beta blocking agents, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Samtidig indtagelse af gemfibrozil (600 mg 2 gange dagligt), en CYP2C8- hæmmer, og repaglinid (en enkelt dosis på 0, 25 mg) øgede repaglinidoptagelsen (AUC) med 8, 1 gange og Cmax med 2, 4 gange hos frivillige raske personer.
Co-administration of gemfibrozil, (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
4 mulig øgning og forlængelse af repaglinids blodglucosesænkende effekt, og plasmarepaglinidkoncentrationen efter 7 timer øgedes 28, 6 gange af gemfibrozil.
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
4. 3).
The concomitant use of gemfibrozil and repaglinide is contraindicated (see section 4.3).
Samtidig anvendelse af trimetoprim (160 mg 2 gange dagligt), en moderat CYP2C8- hæmmer, og repaglinid (en enkelt dosis på 0, 25 mg) øger repaglinid AUC, Cmax og t½ (henholdsvis 1, 6, 1, 4 og 1, 2 gange) uden statistisk signifikans på blodglucoseniveauerne.
Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and
Eftersom sikkerhedsprofilen af denne kombination ikke er blevet fastlagt for doser over 0, 25 mg repaglinid og 320 mg trimetoprim, bør samtidig brug af trimetoprim og repaglinid undgås.
Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided.
4. 4).
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).
2 uger efter ophør med rifampicin, hvor den induktive effekt af rifampicin ikke længere er til stede.
When repaglinide was given 24 hours after the last rifampicin dose, an 80% reduction of the repaglinide AUC was observed (effect of induction alone). Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Det kan ikke udelukkes af andre induktorer, f. eks phenytoin, kabamazepin, barbiturat, perikon, kan have en lignende effekt.
It can not be excluded that other inducers, e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort, may have a similar effect.
Effekten af ketoconazole, en prototype på en stærk og konkurrencedygtig CYP3A4- hæmmer på repaglinid- farmakokinetikken, er blevet undersøgt hos raske forsøgspersoner.
The effect of ketoconazole, a prototype of potent and competitive inhibitors of CYP3A4, on the pharmacokinetics of repaglinide has been studied in healthy subjects.
Samtidig indtagelse af 200 mg ketoconazole øger repaglinidoptagelsen (AUC og Cmax) med 1, 2 gange med ændring på mindre end 8% af blodglucoseprofilerne (en enkelt dosis på 4 mg repaglinid).
Co-administration of 200 mg ketoconazole increased the repaglinide (AUC and Cmax) by 1.2-fold with profiles of blood glucose concentrations altered by less than 8% when administered concomitantly (a single dose of 4 mg repaglinide).
Samtidig indtagelse af 100 mg itraconazol, en CYP3A4- hæmmer, er også undersøgt hos frivillige raske personer, og øgede repaglinidoptagelsen (AUC) 1, 4 gange.
Co-administration of 100 mg itraconazole, an inhibitor of CYP3A4, has also been studied in healthy volunteers, and increased the AUC by 1.4-fold.
I et interaktionsstudie med raske frivillige vistes, at samtidig indtagelse af 250 mg clarithromycin, en potent mekanismebaseret CYP3A4- hæmmer, øgede repaglinidoptagelsen (AUC) 1, 4 gange og Cmax 1, 7 gange samt øgede den gennemsnitlige tilvækst i repaglinidoptagelsen AUC af serum insulin 1, 5 gange og maksimumkoncentrationen 1, 6 gange.
In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
I et studie udført på frivillige raske personer, øgede samtidig administration af repaglinid (en enkelt dosis på 0, 25 mg) og ciclosporin (gentagen dosis på 100 mg) AUC og Cmax for repaglinid omkring 2, 5 gange og 1, 8 gange respektivt.
In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.