FrancophonIA/ELRC3.0 huggingface dataset:
English: To prevent them, it is recommended that metformin be taken in 2 daily doses during or after meals.
Danish: For at undgå dem anbefales det, at metformin tages i 2 daglige doser under eller efter måltid.
English: Assessment of each individual MACE component showed no increased risk (similar M-H RR).
Danish: En vurdering af hver enkelt MACE komponent viste ingen øget risiko (ens M-H RR).
English: This type of diabetes is also known as non-insulin-dependent diabetes mellitus.
Danish: Denne type diabetes kaldes også ikke-insulinkrævende diabetes mellitus.
English: Your doctor will test your blood and urine for sugar regularly.
Danish: Lægen vil regelmæssigt teste dit blod og din urin for sukker.
English: When and how to take Zomarist - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food.
Danish: Hvornår og hvordan du skal tage Zomarist - Tabletterne synkes hele med et glas vand - Tag én tablet om morgenen og den anden om aftenen sammen med eller lige efter mad.
English: They were reversible despite continued treatment and were not associated with histopathological abnormalities.
Danish: De var reversible på trods af fortsat behandling og var ikke associeret med histopatologiske abnormiteter.
English: - Do not use this medicine after the expiry date which is stated on the blister and carton after
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og pakningen efter
English: Zomarist is not a substitute for insulin.
Danish: Zomarist kan ikke erstatte insulin.
English: Diabetic skin lesions are a common complication of diabetes.
Danish: Diabetiske hudlæsioner er en almindelig komplikation ved diabetes.
English: Should these occur, you should promptly consult your doctor.
Danish: Skulle dette ske, skal du straks kontakte din læge.
English: Metallic taste
Danish: Metallisk smag
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Graviditet og amning - Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration er metformins absorption mætbar og ufuldstændig.
English: It can also develop if the body produces too much glucagon.
Danish: Du kan også få det, hvis kroppen producerer for meget glucagon.
English: Additional information on the individual active substances of the fixed combination
Danish: Yderligere oplysninger om de enkelte aktive stoffer i den faste kombination
English: Cardiovascular risk
Danish: Kardiovaskulær risiko
English: If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Danish: Hvis du glemmer at tage en tablet, skal du tage den sammen med det næste måltid, med mindre du alligevel skal tage en tablet på det pågældende tidspunkt.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Danish: Patienten skal informeres, og der skal udføres mere hyppig overvågning af blodsukker, især i begyndelsen af behandlingen.
English: Insulin helps to lower the level of sugar in the blood, especially after meals.
Danish: Insulin er med til at sænke blodsukkeret, især efter måltiderne.
English: Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar.
Danish: Bliv ved med at tage dette lægemiddel så længe din læge ordinerer det, så dit blodsukker vedbliver kontrolleret.
English: Ethnic group: Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Danish: Etnisk gruppe: Begrænsede data antyder, at race ikke har nogen større betydning for vildagliptins farmakokinetik.
English: Animal studies of up to 13-week duration have been conducted with the combined substances in Zomarist.
Danish: Dyreforsøg af indtil 13 ugers varighed er gennemført med de kombinerede stoffer i Zomarist.
English: Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration.
Danish: Renal udskillelse af uændret vildagliptin udgjorde 23 % af dosis efter oral administration.
English: In particular, if you are following a diabetic weight control diet, continue with this while you are taking Zomarist.
Danish: Især hvis du følger en diabetesdiæt med vægtkontrol, skal du fortsat følge denne, mens du tager Zomarist.
English: Biotransformation Metformin is excreted unchanged in the urine.
Danish: Biotransformation Metformin udskilles uændret i urinen.
English: The following statements reflect the information available on the individual active substances.
Danish: De følgende udsagn afspejler derfor den tilgængelige information om de individuelle aktive substanser.
English: No metabolites have been identified in humans.
Danish: Ingen metabolitter er identificeret hos mennesker.
English: No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose.
Danish: Der blev ikke fundet nogen forbindelse mellem bivirkninger og alder, etnicitet, eksponeringsvarighed eller daglig dosis.
English: Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.
Danish: Hensyntagen til en sådan ætiologi anbefales, hvis en patient udviser megaloblastisk anæmi.
English: Therefore, you should not receive Zomarist for the treatment of type 1 diabetes.
Danish: Du bør derfor ikke få Zomarist til behandling af type 1-diabetes.
English: LFTs should be performed prior to the initiation of treatment with Zomarist in order to know the patient's baseline value.
Danish: LFTs skal udføres før initiering af behandling med Zomarist for at kende patientens baseline-værdi.
English: During treatment with Zomarist, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Danish: Under behandlingen med Zomarist vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
Danish: Din læge vil tale med dig om de mulige risici ved at tage Zomarist under graviditet.
English: Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Danish: Metabolisering er den vigtigste eliminationsvej for vildagliptin hos mennesker, idet den redegør for 69 % af dosis.
English: Embryofoetal toxicity was evaluated in rats and rabbits.
Danish: Den embryoføtale toksicitet blev evalueret hos rotter og kaniner.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Danish: Hos patienter med øget risiko for yderligere progression af nyreinsufficiens og hos ældre bør nyrefunktionen vurderes oftere, f.eks. hver 3.-6. måned.
English: Not to be sold separately.
Danish: Må ikke sælges seperat.
English: No new toxicities associated with the combination were identified.
Danish: Der blev ikke identificeret nye typer toksicitet i forbindelse med kombinationen.
English: - Do not use Zomarist if you are pregnant or breast-feeding (see also “Do not take Zomarist”).
Danish: - Tag ikke Zomarist, hvis du er gravid eller ammer (se også ”Tag ikke Zomarist”).
English: Characteristics in patients
Danish: Karakteristika hos patienterne
English: - if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems.
Danish: - hvis du for nylig har haft et hjerteanfald, eller hvis du har haft hjertesvigt eller alvorlige problemer med blodcirkulationen eller åndedrætsbesvær, hvilket kan være tegn på hjerteproblemer.
English: Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Danish: Du får type 2-diabetes, hvis kroppen ikke producerer insulin nok, eller hvis det insulin kroppen producerer, ikke fungerer så godt, som det skulle.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis var den ikke-absorberede fraktion, der blev genfundet i fæces, 20-30 %.
English: Food slightly delays the time to peak plasma concentration to 2.5 hours, but does not alter the overall exposure (AUC).
Danish: Mad forsinker tiden til maksimal plasmakoncentration en anelse til 2,5 time, men ændrer ikke den samlede eksponering (AUC).
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Danish: Det antages, at farmakokinetikken for metformins absorption er ikke-lineær.
English: Hydroxypropylcellulose Magnesium stearate
Danish: Hydroxypropylcellulose Magnesiumstearat
English: How Zomarist works
Danish: Hvordan Zomarist virker
English: Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Danish: Zomarist er ikke en erstatning for insulin til insulinkrævende patienter og må ikke anvendes til patienter med type 1-diabetes.
English: If no adequate strength of Zomarist is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Zomarist, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Taking the tablet just after food will lower the risk of an upset stomach.
Danish: Hvis du tager tabletten lige efter mad, vil det nedsætte risikoen for maveproblemer.
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Danish: Ved initiering eller brug af sådanne præparater i kombination med metformin skal nyrefunktionen monitoreres tæt.
English: The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the longterm benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive, randomiserede studie UKPDS (UK Prospective Diabetes Study) har fastslået den langsigtede fordel ved intensiv styring af blodsukker ved type 2-diabetes.
English: Metformin is contraindicated.
Danish: Metformin er kontraindiceret.
English: The following data are findings from studies performed with vildagliptin or metformin individually.
Danish: Følgende data er resultater fra studier, der er udført med vildagliptin eller metformin hver for sig.
English: Frequencies are defined as very common (≥1/10); 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: Hyppigheden defineres som meget almindelig (≥1/10), 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 forhåndenværende data).
English: Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
Danish: Selvom der ikke er set øget forekomst af hudlæsioner i kliniske forsøg, var der begrænset erfaring med patienter med diabetiske hudkomplikationer.
English: Both insulin and glucagon are made in the pancreas.
Danish: Både insulin og glucagon produceres i bugspytkirtlen.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Danish: Vildagliptin har lavt potentiale for interaktioner med samtidigt administrerede lægemidler.
English: This is so that signs of increased liver enzymes can be detected as early as possible.
Danish: Dette gøres for at opdage tegn på forhøjede leverenzymer så hurtigt som muligt.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Danish: C] vildagliptin blev ca. 85 % af dosis udskilt i urinen, og 15 % af dosis genfindes i fæces.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces serum levels of total cholesterol, LDL cholesterol and triglycerides.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langsigtede kliniske studier: metformin reducerer serum-niveauer af total kolesterol, LDL-kolesterol og triglycerider.
English: Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.
Danish: Din læge kan ordinere denne medicin alene eller sammen med visse andre lægemidler, som sænker blodsukkeret.
English: Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions.
Danish: Derudover er der efter markedsføringen rapporteret om bulløse og eksfoliative hudlæsioner.
English: If you think you may be allergic to any of these, talk to your doctor before taking Zomarist.
Danish: Hvis du tror, at du måske er allergisk over for et eller flere af disse stoffer, så tal med din læge, før du begynder at tage Zomarist.
English: Do not take Zomarist - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Zomarist - hvis du er allergisk over for vildagliptin, metformin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Danish: Følgende udsagn afspejler de farmakokinetiske egenskaber for de enkelte aktive stoffer i Zomarist.
English: Gastrointestinal adverse reactions occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale bivirkninger opstår oftest i begyndelsen af behandlingen og ophører spontant i de fleste tilfælde.
English: Other side effects Some patients have experienced the following side effects while taking Zomarist:
Danish: Andre bivirkninger Nogle patienter har oplevet følgende bivirkninger, mens de har taget Zomarist:
English: Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Danish: Tre andre forsøgspersoner oplevede ødem i fødderne med paræstesi i to tilfælde.
English: - if you are breast-feeding (see also “Pregnancy and breast-feeding”).
Danish: - hvis du ammer (se også ”Graviditet og amning”).
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Danish: Vildagliptins gennemsnitlige fordelingsvolumen ved steady state efter intravenøs administration (Vss) er 71 liter, hvilket indikerer ekstravaskulær fordeling.
English: receptor antagonists) - certain medicines affecting the thyroid, or - certain medicines affecting the nervous system.
Danish: receptorantagonister) - en bestemt type medicin, der påvirker skjoldbruskkirtlen eller - en bestemt type medicin, der påvirker nervesystemet.
English: Table 5 Adverse reactions for metformin component
Danish: Tabel 5 Bivirkninger for metforminkomponenten
English: - if you have severely reduced kidney function.
Danish: - hvis du har du har alvorligt nedsat nyrefunktion.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Danish: I kontrollerede kliniske forsøg oversteg de maksimale metformin plasmaværdier (Cmax) ikke 4 µg/ml, selv ikke ved maksimumdoser.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Danish: Ved de normale metformindoser og doseringsplaner nås steady-state plasmakoncentrationer inden for 24-48 timer og er generelt mindre end 1 µg/ml.
English: The elimination half-life after oral administration is approximately 3 hours.
Danish: Eliminationshalveringstiden efter oral administration er ca. 3 timer.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Danish: KARTON FOR DELPAKNING AF MULTIPAKNINGER (UDEN BLUE BOX)
English: Some patients have had the following side effects while taking Zomarist and insulin:
Danish: Nogle patienter har haft følgende bivirkninger, mens de har taget Zomarist og insulin:
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal.
Danish: Patienter, som udvikler forhøjede transaminaseniveauer, skal monitoreres med en sekundær evaluering af leverfunktionen for at bekræfte resultatet og skal derefter følges med hyppige LFTs, indtil abnormaliteten/-erne er tilbage på normalen.
English: The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Danish: Den kendte virkning at forhøjede GLP-1-niveauer forsinker ventrikeltømningen blev ikke observeret med vildagliptin-behandling.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia or increased weight gain.
Danish: Det stimulerer ikke insulinsekretionen og fremkalder derfor ikke hypoglykæmi eller forhøjet vægtøgning.
English: Adverse reactions listed in Table 5 are based on information available from the metformin Summary of Product Characteristics available in the EU.
Danish: De bivirkninger, der er anført i tabel 5, er baseret på oplysninger, der er til rådighed i det produktresume for metformin, der er tilgængeligt i EU.
English: See section 4
Danish: Se punkt 4.
English: It is unknown whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts.
Danish: Det er ukendt, om vildagliptin udskilles i human mælk, men metformin udskilles i små mængder i human mælk.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Zomarist before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Zomarist forud for eller på tidspunktet for injektionen.
English: Following withdrawal of treatment with Zomarist and LFT normalisation, treatment with Zomarist should not be re-initiated.
Danish: Efter behandlingsophør med Zomarist og normalisering af LFT, bør behandling med Zomarist ikke genoptages.
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Danish: Du bør følge de anbefalinger med hensyn til hud- og fodpleje, som du får af din læge eller sygeplejerske.
English: At study endpoint (2 years), the HbA1c was similar to baseline values in both treatment groups and the body weight changes and hypoglycaemia differences were maintained.
Danish: Ved forsøgets afslutning (2 år) var HbA1c sammenlignelig med baseline-værdier i begge behandlingsgrupper og ændringerne i kropsvægt og hypoglykæmi blev opretholdt.
English: The majority of adverse reactions were mild and transient, not requiring treatment discontinuations.
Danish: De fleste bivirkninger var milde og forbigående og krævede ikke afbrydelser af behandlingen.
English: All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
Danish: Alle symptomer og laboratorieabnormaliteter blev afhjulpet uden behandling efter seponering af forsøgsmedicinen.
English: Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.
Danish: Glucagon får leveren til at producere sukker, hvilket får blodsukkeret til at stige.
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min., hvilket er tegn på at metformin elimineres ved glomerular filtrering og tubulær sekretion.
English: Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state.
Danish: Administration af vildagliptin sammen med mad resulterede i et fald i Cmax (19 %) sammenlignet med dosering i den fastende tilstand.
English: The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Danish: De aktive stoffer i Zomarist, vildagliptin og metformin, tilhører en gruppe lægemidler, der kaldes ”orale antidiabetika”.
English: If you need to have major surgery you must stop taking Zomarist during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Zomarist under indgrebet og i nogen tid herefter.
English: As with other oral antidiabetic medicinal products the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
Danish: Som ved andre orale antidiabetika kan den hypoglykæmiske virkning af vildagliptin mindskes af visse aktive stoffer, herunder thiazider, kortikosteroider, thyroideaprodukter og sympatomimetika.
English: This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.
Danish: Dette lægemiddel har vist sig at reducere blodsukkerniveauet, og dette kan medføre, at du undgår komplikationer, som opstår på grund af sukkersyge.
English: Zomarist may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Zomarist kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
English: Information on the likely symptoms of overdose with vildagliptin was taken from a rising dose tolerability study in healthy subjects given vildagliptin for 10 days.
Danish: Oplysningerne om de sandsynlige symptomer på overdosering med vildagliptin er taget fra et studie af tolerabilitet af stigende doser hos raske forsøgspersoner, som fik vildagliptin i 10 dage.
English: Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Danish: Derfor vil vildagliptin sandsynligvis ikke påvirke den metaboliske clearance af samtidigt administrerede præparater, som metaboliseres af CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 eller CYP 3A4/5.
English: However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can.
Danish: Vildagliptin kan imidlertid ikke fjernes via hæmodialyse, selv om hydrolysens hovedmetabolit (LAY 151) kan fjernes ved hæmodialyse.
English: Plasma protein binding is negligible.
Danish: Plasmaproteinbindingen er forsvindende lille.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendte opdatering af RMP.
English: Food slightly delays and decreases the extent of the absorption of metformin.
Danish: Mad forsinker og reducerer omfanget af absorptionen af metformin en smule.