FrancophonIA/ELRC3.0 huggingface dataset:
English: Enyglid with alcohol
Danish: Brug af Enyglid sammen med alkohol
English: Your doctor will work out your dose.
Danish: Lægen vil bestemme din dosis.
English: Do not take more Enyglid than your doctor has recommended.
Danish: Tag aldrig en større mængde Enyglid, end lægen har anbefalet.
English: Do not use this medicine after the expiry date which is stated on the blister and outer carton.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterpakningen og den ydre æske.
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: Patients who skip a meal (or add an extra meal) should be instructed to skip (or add) a dose for that meal.
Danish: Patienter, som springer et måltid over (eller tilføjer et ekstra måltid), bør instrueres i at springe en dosis over (eller tilføje en dosis) i stedet for dette måltid.
English: Do not take this medicine if you are under 18 years of age.
Danish: Børn og teenagere Tag ikke dette lægemiddel hvis du er under 18 år.
English: • if you are about to have major surgery or you have recently suffered a severe illness or infection.
Danish: • Hvis du står over for en stor operation eller lige har overstået en alvorlig sygdom eller infektion.
English: V. Holjevca 20/E 10450 Jastrebarsko Croatia
Danish: V. Holjevca 20/E 10450 Jastrebarsko Kroatien
English: Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Danish: Repaglinid er blevet givet med ugentlig optrapning af dosis fra 4 mg til 20 mg fire gange dagligt i en periode på 6 uger.
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: A small fraction (less than 8%) of the administered dose appears in the urine, primarily as metabolites.
Danish: En lille del (under 8%) af den indtagne dosis er til stede i urinen, fortrinsvis som metabolitter.
English: Most cases were mild and transient, and very few patients discontinued treatment due to increased liver enzymes.
Danish: De fleste tilfælde var milde og forbigående, og meget få patienter ophørte med behandlingen på grund af leverenzymstigning.
English: This lack of pharmacodynamic effect was observed with a sub-therapeutic dose of repaglinide.
Danish: Denne manglende farmakodynamiske effekt blev observeret med subterapeutiske doser af repaglinid.
English: Such disturbances have only been reported in very few cases after initiation of repaglinide treatment.
Danish: Synsforstyrrelser er kun rapporteret i meget få tilfælde efter påbegyndelse af behandling med repaglinid.
English: Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%).
Danish: Farmakokinetikken for repaglinid er karakteriseret ved en gennemsnitlig absolut biotilgængelighed på 63% (CV 11%).
English: However, no exact dosage relationship exists between repaglinide and the other oral hypoglycaemic medicinal products.
Danish: Der eksisterer dog intet nøjagtigt doseringsforhold mellem repaglinid og de øvrige orale hypoglykæmiske lægemidler.
English: After reaching a maximum, the plasma level decreases rapidly.
Danish: Efter at maksimum er nået, falder plasmakoncentrationen hurtigt.
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 2.
English: Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
Danish: Kombinationsbehandling med metformin er forbundet med en øget risiko for hypoglykæmi.
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: • if the acid level in your blood is raised (diabetic ketoacidosis).
Danish: • Hvis syreniveauet i dit blod er forhøjet (diabetisk ketoacidose).
English: No such cases have led to discontinuation of repaglinide treatment in clinical trials.
Danish: Ingen af disse tilfælde har givet anledning til at standse behandlingen med repaglinid i kliniske forsøg.
English: Special patient groups
Danish: Særlige patientgrupper
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: • have few or no warning signs of hypos.
Danish: • Har få eller ingen advarselstegn på hypoglykæmi.
English: A small, significant decrease in blood glucose values was observed.
Danish: Der blev observeret et mindre, men signifikant fald i blodglucoseværdier.
English: Enyglid should not be taken if you have a severe liver disease (see Do not take Enyglid).
Danish: Du må ikke tage Enyglid, hvis du har en alvorlig leversygdom (se Tag ikke Enyglid).
English: 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.
Danish: 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.
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 produktet.
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 man overveje eventuel interaktion.
English: Enyglid has no or negligible influence on the ability to drive and use machines but may cause hypoglycaemia.
Danish: Enyglid har ingen direkte indflydelse på evnen til at føre motorkøretøj eller betjene maskiner, men kan medføre hypoglykæmi.
English: Clinical study results have shown that repaglinide is optimally dosed in relation to main meals (preprandial dosing).
Danish: Resultater af kliniske undersøgelser har vist, at repaglinid doseres optimalt i forbindelse med hovedmåltiderne (præprandial dosering).
English: No significant effect on the glucose level in healthy volunteers was observed.
Danish: Der blev ikke observeret nogen signifikant effekt på glucoseniveauet hos frivillige raske personer.
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: The occurrence of such reactions depends on individual factors, such as dietary habits, dosage, exercise and stress.
Danish: Forekomsten af sådanne bivirkninger afhænger af individuelle faktorer, såsom kostvaner, dosering, motion og stress.
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: Præparater som inhiberer OATP1B1, kan ligeledes have potentialet til at øge plasmakoncentrationer af repaglinid, som det er blevet påvist for ciclosporin (se nedenfor).
English: Acute coronary syndrome
Danish: Akut koronarsyndrom
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 oral dosering af repaglinid.
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: Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: - Common (1/100 to <1/10) - Uncommon (1/1,000 to <1/100) - Rare (1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data)
Danish: På baggrund af erfaringerne med repaglinid og andre hypoglykæmiske lægemidler er følgende bivirkninger set: Frekvenser er angivet som følger: - Almindelig (≥1/100 til <1/10) - Ikke almindelig (≥1/1.000 til <1/100) - Sjælden (≥1/10.000 til <1/1.000) - Meget sjælden (<1/10.000) - Ikke kendt (kan ikke estimeres ud fra tilgængeligt data).
English: Repaglinide is given preprandially and is titrated individually to optimise glycaemic control.
Danish: Repaglinid tages præprandialt og titreres individuelt for at optimere den glykæmiske kontrol.
English: Enyglid is not recommended in patients with moderate liver disease.
Danish: Enyglid anbefales ikke til patienter med moderat leversygdom.
English: Hypoglycaemic reactions are generally mild/moderate but may occasionally develop into hypoglycaemic unconsciousness or coma.
Danish: Hypoglykæmiske reaktioner er sædvanligvis milde til moderate, men kan i nogle tilfælde udvikle sig til hypoglykæmisk bevidstløshed eller koma.
English: - Diabetes mellitus type 1, C-peptide negative.
Danish: - C-peptid negativ type 1-diabetes mellitus.
English: Hypersensitivity*
Danish: Hypersensitivitet*
English: No clinically relevant differences were seen in the pharmacokinetics of repaglinide, when repaglinide was administered 0, 15 or 30 minutes before a meal or in fasting state.
Danish: Der blev ikke observeret klinisk relevante forskelle i de farmakokinetiske parametre, når repaglinid blev givet 0, 15, 30 minutter før et måltid eller i forbindelse med fastende tilstand.
English: The blood glucose-lowering effect of oral hypoglycaemic medicinal products decreases in many patients over time.
Danish: Orale hypoglykæmiske lægemidlers blodglucosenedsættende virkning mindskes hos mange patienter med tiden.
English: Magnesium stearate
Danish: Magnesiumstearat Meglumin
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Danish: Behandlingen bør påbegyndes som et tillæg til diæt og motion for at sænke blodglucose i forbindelse med måltiderne.
English: They include: increased urination, feeling thirsty, dry skin and dry mouth.
Danish: De inkluderer: øget vandladningstrang, tørstfornemmelse, tør hud og tør mund.
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 medicin, som påvirker repaglinidmetabolismen (se pkt.
English: This resulted in a blood glucose-lowering effect throughout the meal period.
Danish: Dette havde en blodglucosenedsættende virkning under hele måltidets varighed.
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: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Danish: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Tyskland
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 undersøgelser.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og potentiel karcinogenicitet.
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: Generalised hypersensitivity reactions (e.g. anaphylactic reaction), or immunological reactions such as vasculitis.
Danish: Generaliserede hypersensitive reaktioner (f.eks. anafylaktisk reaktion) eller immunologiske reaktioner såsom vaskulit.
English: • The active substance is repaglinide.
Danish: • Aktivt stof: Repaglinid.
English: This depolarises the β-cell and leads to an opening of the calcium channels.
Danish: Dermed depolariseres β-cellen, hvilket medfører en åbning af calciumkanalerne.
English: At such times diabetic control may be lost.
Danish: I sådanne tilfælde kan diabetesreguleringen muligvis gå tabt.
English: The total maximum daily dose should not exceed 16 mg.
Danish: Den maksimale døgndosis må ikke overskride 16 mg.
English: Patients receiving other oral hypoglycaemic medicinal products Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide.
Danish: Patienter, der indtager andre orale hypoglykæmiske lægemidler Patienterne kan skifte direkte fra andre orale hypoglykæmiske lægemidler til repaglinid.
English: They must not give you any food or drink.
Danish: Du må ikke få mad eller drikke, da du kan blive kvalt.
English: Allergic reactions*
Danish: Allergiske reaktioner*
English: • Ciclosporin (used to suppress the immune system).
Danish: • Ciclosporin (anvendes til at undertrykke immunsystemet)
English: • if you exercise less than usual.
Danish: • Hvis du motionerer mindre end normalt.
English: • if you eat more than usual,
Danish: • Hvis du spiser mere end normalt
English: Data from animal studies investigating effects on embryofetal and offspring development as well as excretion in milk is described in section 5.3.
Danish: Data fra dyrestudier, som undersøger effekten på embryoføtal udvikling og udviklingen hos afkom, såvel som udskillelse i mælk er beskrevet i pkt.
English: Repaglinide was shown not to be teratogenic in animal studies.
Danish: Repaglinid er vist ikke at være teratogene i studier med dyr.
English: Embryotoxicity, abnormal limb development in rat foetuses and new born pups, was observed in female rats exposed to high doses in the last stage of pregnancy and during the lactation period.
Danish: Embryotoksicitet i form af abnorm udvikling af ekstremiteter blev observeret hos rottefostre og nyfødte unger, der var udsat for høje doser i sidste stadie af graviditeten og i diegivningsperioden.
English: The maximum recommended daily dose is 16 mg.
Danish: Den højeste anbefalede daglige dosis er 16 mg.
English: Alcohol can change the ability of Enyglid to reduce the blood sugar.
Danish: Alkohol kan ændre den virkning, som Enyglid har til at sænke blodsukkeret.
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 (t½) i sammenligning med patienter med normal nyrefunktion.
English: Repaglinide exposure is increased in patients with hepatic insufficiency and in the elderly type 2 diabetic patients.
Danish: Repaglinid eksponering er øget i patienter med lever insufficiens og i de ældre type 2 diabetiske patienter.
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 doseres under optrapning til den ønskede effekt, er effekten ikke påvirket af den inter-individuelle variation.
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 svær nyredysfunktion (kreatinin-clearance: 20-39 ml/min.)
English: Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the active substance.
Danish: Repaglinid absorberes hurtigt fra mave-tarmkanalen, hvilket medfører hurtig stigning i plasmakoncentrationen af det aktive stof.
English: Should these symptoms occur, adequate action should be taken to correct the low blood glucose (oral carbohydrates).
Danish: Skulle disse symptomer opstå, bør de nødvendige forholdsregler træffes med henblik på at korrigere det lave blodglucoseniveau (orale kulhydrater).
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 stoffer, som påvirker cytrochrome P-450 enzymer ved hæmning eller induktion.
English: Adjustment of dose and adherence to diet and exercise should be assessed before classifying a patient as a secondary failure.
Danish: Justering af dosis og overholdelse af diæt og motionsplan bør vurderes, før en patient klassificeres med sekundært behandlingssvigt.
English: • if you take too little Enyglid,
Danish: • Hvis du har taget for få Enyglid,
English: Your ability to drive or use a machine may be affected if your blood sugar is low or high.
Danish: Din evne til at køre bil, motorcykel eller cykle samt arbejde med maskiner, kan muligvis være påvirket, hvis dit blodsukker er for lavt eller for højt.
English: Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones
Danish: Kombination med Neutral Protamin Hagedorn (NPH) insulin eller thiazolidinedioner
English: What Enyglid contains
Danish: Enyglid indeholder:
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 væsentligt for patienter der har nedsat eller ingen advarselstegn på hypoglykæmier eller som oplever hyppige hypoglykæmir.
English: The most frequently reported adverse reactions are changes in blood glucose levels, i.e. hypoglycaemia.
Danish: De oftest rapporterede bivirkninger er ændringer i blodglucoseniveauer, f.eks. hypoglykæmi.
English: When a patient stabilised on any oral hypoglycaemic medicinal product is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Danish: Når en patient, som er stabiliseret på et oralt hypoglykæmisk lægemiddel, udsættes for stress såsom feber, traume, infektion eller kirurgisk indgreb, kan nedsat glykæmisk kontrol forekomme.
English: • The normal starting dose is 0.5 mg before each main meal.
Danish: • Den sædvanlige startdosis er 0,5 mg før hvert hovedmåltid.
English: Doses are usually taken within 15 minutes of the meal, but the time may vary from immediately preceding the meal to as long as 30 minutes before the meal.
Danish: Dosis tages almindeligvis indenfor 15 minutter før måltidet, men tidspunktet kan variere fra umiddelbart før måltidet til så længe som 30 minutter før måltidet.
English: You can take Enyglid with metformin, another medicine for diabetes, if your doctor prescribes it.
Danish: Du kan tage Enyglid sammen med metformin, et andet lægemiddel mod sukkersyge, hvis din læge ordinerer det.
English: - Severe hepatic function disorder.
Danish: - Alvorlig leverdysfunktion.
English: • Clopidogrel (prevents blood clots)
Danish: • Clopidogrel (forebygger blodpropper)
English: • Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
Danish: • Hypersensitivitet (såsom udslæt, kløe, rødmen, hævelse af huden)
English: Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away.
Danish: Fortæl din omgangskreds at du har sukkersyge, og at du - hvis du mister bevidstheden (besvimer) på grund af hypoglykæmi - skal vendes om på siden, og der straks skal tilkaldes lægehjælp.
English: 30 tablets 60 tablets 90 tablets 120 tablets 180 tablets 270 tablets 360 tablets
Danish: 30 tabletter 60 tabletter 90 tabletter 120 tabletter 180 tabletter 270 tabletter 360 tabletter
English: Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
Danish: • sammen med et glas vand før eller op til 30 minutter før hvert hovedmåltid.
English: 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).
Danish: 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).
English: • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
Danish: • Nonsteroide antiinflammatoriske midler (NSAID) (en gruppe af smertestillende midler)
English: • if you have a severe liver disease.
Danish: • Hvis du har en alvorlig leversygdom.
English: In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly.
Danish: I dette tilfælde skal metformindosis bibeholdes samtidig med administration af repaglinid.
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-glucose lowering 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: 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, teofyllin eller warfarin ved regelmæssig administration til frivillige raske personer.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu/.
English: Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Danish: Ændringer i blodglucoseniveauer har i nogle tilfælde medført forbigående synsforstyrrelser, især initialt i behandlingen.