FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 04/11/2009 Date of latest renewal: 22 August 2014
Danish: Dato for første markedsføringstilladelse: 04/11/2009 Dato for seneste fornyelse: 22. august 2014
English: • if you have an infection or a fever,
Danish: • Hvis du har en infektion eller feber,
English: Be aware that the desired effect is not achieved if you stop taking Repaglinide Krka.
Danish: Vær opmærksom på, at den ønskede virkning ikke opnås, hvis du stopper med at tage Repaglinide Krka.
English: • if you have type 1 diabetes.
Danish: • Hvis du har type 1-diabetes
English: No safety concerns were raised.
Danish: Dette gav ikke anledning til bekymring for sikkerhed.
English: The amount of Repaglinide Krka, food or exercise may need to be adjusted.
Danish: Mængden af Repaglinide Krka, mad eller motion skal muligvis justeres.
English: • if you eat more than usual,
Danish: • Hvis du spiser mere end normalt,
English: If any change of your treatment is necessary contact your doctor first.
Danish: Hvis det er nødvendigt at ændre din behandling, skal du først kontakte din læge.
English: At such times, it may be necessary to discontinue repaglinide and treat with insulin on a temporary basis.
Danish: I dette tilfælde kan det blive nødvendigt at afbryde repaglinidbehandlingen og midlertidigt behandle med insulin.
English: Repaglinide was detected in the milk of animals.
Danish: Repaglinid var fundet i mælken hos forsøgsdyr.
English: • if you take other medicines or suffer from liver or kidney problems (see other sections of 2.
Danish: • Hvis du tager anden medicin eller lider af lever- eller nyreproblemer (se andre afsnit under punkt.
English: Repaglinide Krka may not be suitable for you.
Danish: Repaglinide Krka er måske ikke den rigtige løsning for dig.
English: When repaglinide is used together with other medicinal products that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
Danish: Når repaglinid bruges sammen med andre lægemidler, som hovedsageligt udskilles med galden som repaglinid, bør enhver potentiel interaktion overvejes.
English: This may be due to progression of the severity of the diabetes or to diminished responsiveness to the medicinal product.
Danish: Dette kan skyldes en progressiv diabetesforværring eller mindsket respons over for lægemidlet.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienter skal rådgives om at tage forholdsregler for at undgå hypoglykæmi, når de kører.
English: In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly.
Danish: I dette tilfælde skal dosis af metformin bibeholdes og repaglinid skal administreres samtidigt.
English: In type 2 diabetic patients, the insulinotropic response to a meal occurred within 30 minutes after an oral dose of repaglinide.
Danish: Hos patienter med type 2-diabetes indtraf det insulinotrope respons på et måltid inden for 30 minutter efter en oral dosis af repaglinid.
English: • if the acid level in your blood is raised (diabetic ketoacidosis).
Danish: • Hvis syreniveauet i dit blod er forhøjet (diabetisk ketoacidose)
English: Substances that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
Danish: Lægemidler som hæmmer OATP1B1, kan ligeledes have potentialet til at øge plasmakoncentrationer af repaglinid, som det er blevet påvist for ciclosporin (se nedenfor).
English: Repaglinide Krka should be taken with caution.
Danish: Repaglinide Krka skal tages med forsigtighed.
English: In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful dose titration is required to avoid hypoglycaemic reactions.
Danish: Hos svækkede eller fejlernærede patienter bør initial- og vedligeholdelsesdosis være konservativ, og omhyggelig dosistitrering er nødvendig for at undgå hypoglykæmiske reaktioner.
English: Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
Danish: Den intra-individuelle variation er lav til moderat (35%) og da repaglinid titreres efter den kliniske respons, er virkningen ikke påvirket af den inter-individuelle variation.
English: Repaglinide Krka is not recommended in patients with moderate liver disease.
Danish: Repaglinide Krka anbefales ikke til patienter med moderat leversygdom.
English: The total maximum daily dose should not exceed 16 mg.
Danish: Den samlede maksimale døgndosis må ikke overskride 16 mg.
English: They include: increased urination, feeling thirsty, dry skin and dry mouth.
Danish: De inkluderer: øget vandladningstrang; tørstfornemmelse, tør hud og tør mund.
English: Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces.
Danish: Type-2 diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkelig insulin til at regulere dit blodsukker, eller hvor din krop ikke reagerer normalt på insulinet, den producerer.
English: No such cases have led to discontinuation of repaglinide treatment in clinical trials.
Danish: Ingen af disse tilfælde har givet anledning til seponering af behandlingen med repaglinid i kliniske forsøg.
English: • Ciclosporin (used to suppress the immune system).
Danish: • Ciclosporin (anvendes til at undertrykke immunsystemet).
English: Do not take more Repaglinide Krka than your doctor has recommended.
Danish: Tag aldrig en større mængde Repaglinide Krka, end lægen har anbefalet.
English: ), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t1/2) as compared to patients with normal renal function.
Danish: ), viste resultaterne en signifikant stigning til det dobbelte i eksponering (AUC) og halveringstid (t1/2) sammenlignet med personer med normal nyrefunktion.
English: Your body's response to Repaglinide Krka may change if you take other medicines, especially these:
Danish: Din krops reaktion på Repaglinide Krka kan ændres, hvis du tager anden medicin, især følgende:
English: Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
Danish: På grundlag af in vitro-data ser repaglinid ud til at være et substrat for aktivt hepatisk optag (organisk anion-transportprotein OATP1B1).
English: • The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal.
Danish: • Dosis kan justeres af lægen med op til 4 mg, som skal tages umiddelbart før eller op til 30 minutter før hvert hovedmåltid.
English: Rare (may affect up to 1 in 1,000 people): • Acute coronary syndrome (but it may not be due to the medicine)
Danish: Sjældne bivirkninger (kan forekomme hos færre end 1 ud af 1.000 personer) • Akut koronarsyndrom (men det behøver ikke være forårsaget af lægemidlet).
English: Generalised hypersensitivity reactions (e.g. anaphylactic reaction), or immunological reactions such as vasculitis.
Danish: Generaliserede overfølsomhedsreaktioner (f.eks. anafylaktisk reaktion) eller immunologiske reaktioner såsom vaskulitis.
English: A high interindividual variability (60%) in repaglinide plasma concentrations has been detected in the clinical trials.
Danish: Der er set en høj inter-individuel variation (60%) af repaglinid-plasma-koncentration i de kliniske forsøg.
English: Repaglinide was shown not to be teratogenic in animal studies.
Danish: Repaglinid er vist ikke at være teratogent i dyrestudier.
English: Repaglinide should be used with caution or be avoided in patients receiving medicinal products which influence repaglinide metabolism (see section 4.5).
Danish: Repaglinid bør anvendes med forsigtighed eller undgås hos patienter, der får lægemidler, som påvirker repaglinidmetabolismen (se pkt.
English: Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
Danish: Tabletterne sluges sammen med et glas vand før eller op til 30 minutter før hvert hovedmåltid.
English: After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.
Danish: Efter en 5-dages behandling med repaglinid (2 mg x 3/dag) hos patienter med alvorlig nedsat nyrefunktion (kreatinin-clearance: 20-39 ml/min.
English: • Severe liver problems, abnormal liver function, such as increased liver enzymes in your blood.
Danish: • Alvorlige leverproblemer, unormal leverfunktion, såsom stigning i leverenzymer i blodet.
English: 30 tablets 60 tablets 90 tablets 120 tablets 270 tablets 360 tablets
Danish: 30 tabletter 60 tabletter 90 tabletter 120 tabletter 270 tabletter 360 tabletter
English: If patients are transferred from another oral hypoglycaemic medicinal product, the recommended starting dose is 1 mg.
Danish: Hvis patientens behandling ændres fra et andet oralt hypoglykæmisk lægemiddel,, er den anbefalede startdosis 1 mg.
English: Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones
Danish: Kombination med Neutral Protamin Hagedorn (NPH) insulin eller thiazolidinedionerer
English: Repaglinide Krka has no or negligible influence on the ability to drive and use machines but may cause hypoglycaemia.
Danish: Repaglinide Krka har ingen direkte indflydelse på evnen til at føre motorkøretøj eller betjene maskiner, men kan medføre hypoglykæmi.
English: Consequently metabolism, and by that clearance of repaglinide, may be altered by substances which influence these cytochrome P-450 enzymes via inhibition or induction.
Danish: Som en konsekvens kan metabolismen, og hermed udskillelsen af repaglinid, blive ændret af lægemidler, som påvirker cytrochrome P-450 enzymer ved hæmning eller induktion.
English: Repaglinide had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline or warfarin at steady state, when administered to healthy volunteers.
Danish: Repaglinid havde ingen klinisk relevant effekt på de farmakokinetiske egenskaber af digoxin, theofyllin eller warfarin ved regelmæssig administration til frivillige raske personer.
English: • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
Danish: • Nonsteroide antiinflammatoriske midler (NSAID) (en gruppe af smertestillende midler).
English: Blister pack (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 270 and 360 tablets in the box.
Danish: Blisterpakning (OPA/Al/PVC-Al): 30, 60, 90, 120, 270 og 360 tabletter i æsken.
English: However, the benefit risk profile remains to be established when comparing to other combination therapies.
Danish: Dog mangler der at blive udarbejdet en profil, som beskriver fordele og risici i sammenligning med andre kombinationsbehandlinger.
English: • Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
Danish: • Clarithromycin, trimethoprim, rifampicin (antibiotiske lægemidler).
English: As hypoglycaemia in this study was avoided through increased calorie intake, a relative overdose may result in an exaggerated glucose lowering effect with development of hypoglycaemic symptoms (dizziness, sweating, tremor, headache etc.).
Danish: Da hypoglykæmi i denne undersøgelse blev undgået ved hjælp af forøget kalorieindtagelse, kan en relativ overdosering have kraftig glucosenedsættende virkning med udvikling af hypoglykæmiske symptomer (svimmelhed, øget svedproduktion, rysten, hovedpine o.s.v.).
English: • Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
Danish: • Hypersensitivitet (såsom udslæt, kløe, rødmen, hævelse af huden)
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er især vigitgt for patienter, der har nedsat eller ingen advarselstegn på hypoglykæmi eller som hyppigt oplever hypoglykæmi.
English: 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-glucoselowering response after an initial period of effectiveness (i.e. secondary failure).
Danish: 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).
English: When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue repaglinide treatment.
Danish: Når symptomerne på hypoglykæmi er forsvundet og blodsukkerniveauet er stabiliseret, kan du fortsætte behandlingen med repaglinid.
English: When repaglinide was given 24 hours after the last rifampicin dose, an 80% reduction of the repaglinide AUC was observed (effect of induction alone).
Danish: Når repaglinid blev givet 24 timer efter sidste rifampicin-dosis, sås en 80% reduktion af repaglinid AUC (kun effekten af induktion).
English: • Clopidogrel (prevents blood clots).
Danish: • Clopidogrel (forebygger blodpropper)
English: • if you have a severe liver disease.
Danish: • Hvis du har en alvorlig leversygdom
English: Repaglinide Krka should not be taken if you have a severe liver disease (see Do not take Repaglinide Krka).
Danish: Du må ikke tage Repaglinide Krka, hvis du har en alvorlig leversygdom (se Tag ikke Repaglinide Krka)
English: If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Krka.
Danish: Hvis du tager gemfibrozil (anvendes til at sænke kolesterolniveauet i blodet), må du ikke tage Repaglinide Krka.
English: The effect of ketoconazole, a prototype of potent and competitive inhibitors of CYP3A4, on the pharmacokinetics of repaglinide has been studied in healthy subjects.
Danish: Effekten af ketoconazole, en prototype på en stærk og konkurrencedygtig CYP3A4-hæmmer på farmakokinetikken af repaglinid, er blevet undersøgt hos raske personer.
English: • Octreotide (used to treat cancer).
Danish: • Oktreotid (mod kræft).
English: You can take Repaglinide Krka with metformin, another medicine for diabetes, if your doctor prescribes it.
Danish: Du kan tage Repaglinide Krka sammen med metformin, et andet lægemiddel mod sukkersyge, hvis din læge ordinerer det.
English: Less than 1% of repaglinide is recovered in faeces.
Danish: Under 1% af det repaglinid udskilles med afføringen.
English: This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal product is ineffective in an individual patient when first given.
Danish: Fænomenet benævnes sekundært behandlingssvigt i modsætning til primært behandlingssvigt, hvor stoffet allerede fra starten ikke har nogen effekt hos den pågældende patient.
English: • Deferasirox (used to reduce chronic iron overload).
Danish: • Deferasirox (anvedes til at mindske kronisk jernoverskud)
English: The following substances may reduce the hypoglycaemic effect of repaglinide: Oral contraceptives, rifampicin, barbiturates, carbamazepine, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics.
Danish: Følgende stoffer kan svække den hypoglykæmiske virkning af repaglinid: Orale kontraceptiva, rifampicin, barbiturater, carbamazepin, thiazider, kortikosteroider, danazol, thyreoideahormoner og sympatomimetika.
English: Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.
Danish: Repaglinid sænker øjeblikkeligt blodglucoseniveauerne ved at stimulere sekretionen af insulin fra pankreas, en virkning der er afhængig af fungerende β-celler i de Langerhanske øer.
English: If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Danish: • Hvis du har hypoglykæmi som får dig til at besvime, eller hvis du har mange tilfælde af hypoglykæmi, skal du tale med din læge.
English: Rifampicin, a potent inducer of CYP3A4, but also CYP2C8, acts both as an inducer and inhibitor of the metabolism of repaglinide.
Danish: Rifampicin, en potent inducer af CYP3A4, men også CYP2C8, virker både som inducer og hæmmer på repaglinids metabolisme.
English: • Itraconazole, ketokonazole (antifungal medicines).
Danish: • Itraconazol, ketokonazol (svampehæmmende lægemidler).
English: • Steroids (anabolic steroids and corticosteroids - used for anaemia or to treat inflammation).
Danish: • Steroider (anaboliske steroider og kortikosteroider - mod blodmangel eller mod inflammation).
English: • Danazol (used to treat breast cysts and endometriosis).
Danish: • Danazol (mod brystcyster og endometriose).
English: • Salicylates (e.g. aspirin).
Danish: • Salicylater (f.eks. aspirin).
English: 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.
Danish: Samtidig administration af 100 mg itraconazol, en CYP3A4-hæmmer, er også undersøgt hos frivillige raske personer, og øgede AUC 1,4 gange.
English: Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.
Danish: Hypersensibilitetsreaktioner på huden i form af erythem, kløe, udslæt og urticaria kan forekomme.
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
Danish: • Phenytoin, carbamazepin, phenobarbital (mod epilepsi).
English: Repaglinide Krka can also be given with metformin, another medicine for diabetes.
Danish: Repaglinide Krka kan også ordineres sammen med metformin, et andet lægemiddel mod sukkersyge.
English: Repaglinide acts through a distinct binding site with a short action on the β-cells.
Danish: Repaglinid virker via et specifikt bindingssted med en kort virkning på β-celler.
English: 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.
Danish: Halveringstiden blev forlænget fra 1,3 til 3,7 timer, hvilket resulterede i en mulig øgning og forlængelse af repaglinids blodglucosesænkende effekt, og plasmakoncentrationen af repaglinid efter 7 timer øgedes 28,6 gange af gemfibrozil.
English: Repaglinide exposure is increased in patients with hepatic insufficiency and in the elderly type 2 diabetic patients.
Danish: Repaglinid eksponering er øget hos patienter med leverinsufficiens og hos ældre type-2 diabetespatienter.
English: Repaglinide Krka has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.
Danish: Repaglinide Krka er i stand til at sænke blodsukkeret, hvilket kan hjælpe med til at forhindre komplikationer forårsaget af sukkersyge.
English: Please see If you get a hypo on what a hypo is and how to treat it.
Danish: Se venligst Hvis du får hypoglykæmi (lavt blodsukker) med hensyn til hvad hypoglykæmi er, og hvordan det behandles.
English: Seven days pre-treatment with rifampicin (600 mg) followed by coadministration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Danish: Syv dages forbehandling med rifampicin (600 mg), efterfulgt af samtidig administration af repaglinid (en enkelt dosis på 4 mg) på dag 7 resulterede i en 50% lavere AUC (effekt af en kombination af induktion og hæmning).
English: The recommended maximum single dose is 4 mg taken with main meals.
Danish: Den anbefalede maksimale enkeltdosis er 4 mg taget sammen med hovedmåltiderne.
English: What Repaglinide Krka contains
Danish: Repaglinide Krka indeholder:
English: Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4 can be increased if CYP2C8 is inhibited.
Danish: Kliniske data fra raske frivillige understøtter, at CYP2C8 er det vigtigste enzym, som er involveret i repaglinid-metabolismen med CYP3A4 i en underordnet rolle, men den relative virkning af CYP3A4 kan øges, hvis CYP2C8 hæmmes.
English: It cannot be excluded that other inducers, e.g. phenytoin, carbamazepine, phenobarbital, St John's wort, may have a similar effect.
Danish: Det kan ikke udelukkes af andre induktorer, f.eks phenytoin, carbamazepin, barbiturat, hyperikum perforatum, kan have en lignende effekt.
English: Repaglinide Krka is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
Danish: Repaglinide Krka bruges til behandling af type 2-diabetes hos voksne som et supplement til kost og motion: Behandling påbegyndes normalt, hvis diæt, motion og vægttab alene ikke har været tilstrækkeligt til at regulere (eller reducere) blodsukkeret.
English: The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Danish: Følgende stoffer kan forstærke og/eller forlænge den hypoglykæmiske virkning af repaglinid: Gemfibrozil, clarithromycin, itraconazol, ketoconazol, trimethoprim, ciclosporin, deferasirox, clopidogrel, andre antidiabetiske lægemidler, monoaminooxidasehæmmere (MAO-hæmmere), nonselektive betablokkerende, lægemidler, angiotensin konverterende enzym (ACE)-hæmmere, salicylater, NSAIDer, octreotid, alkohol og anabole steroider.
English: When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control.
Danish: Når disse lægemidler administreres til eller seponeres hos patienter, der indtager repaglinid, skal de overvåges grundigt for ændring i blodglucoseregulering.
English: Talk to your doctor before taking Repaglinide Krka:
Danish: Kontakt lægen før du tager Repaglinide Krka.
English: Boxes of 30, 60, 90, 120, 270 or 360 tablets in blister are available.
Danish: Æsker med 30, 60, 90, 120, 270 eller 360 tabletter i blisterpakninger.
English: The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 people (see If you get a hypo in section 2).
Danish: Hypoglykæmi er den mest almindelige bivirkning og kan forekomme hos mellem 1 og 10 ud af 100 personer (se Hvis du får hypoglykæmi (lavt blodsukker) under punkt 2).
English: Plasma repaglinide levels decreased rapidly, and low concentrations were seen in the plasma of Type 2 diabetic patients 4 hours post-administration.
Danish: Plasmarepaglinidkoncentrationen faldt hurtigt og 4 timer efter administration var der kun lave koncentrationer i plasma hos type 2-diabetes patienter.
English: • if you take too little Repaglinide Krka,
Danish: • Hvis du har taget for få Repaglinide Krka,
English: Repaglinide Krka is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Danish: Repaglinide Krka er en tablet, som indeholder repaglinid, til behandling af sukkersyge til oral anvendelse, som får bugspytkirtlen til at producere mere insulin og derved sænker dit blodsukker (glukose).
English: If you miss a dose, take the next dose as usual.
Danish: Hvis du glemmer at tage en dosis, skal du tage den næste dosis som sædvanligt - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
Danish: Repaglinid kan også bruges i kombination med metformin til voksne med type 2-diabetes mellitus patienter, som ikke er tilfredsstillende kontrolleret med metformin alene.
English: • Oral contraceptives (birth control pills).
Danish: • Orale kontraceptiva (p-piller).