FrancophonIA/ELRC3.0 huggingface dataset:
English: • Avoid fizzy drinks, coffee, chocolate and alcohol.
Danish: • Undgå kulsyreholdige drikke, kaffe, chokolade og alkohol.
English: The clinical importance and the mechanisms behind these reported interactions are not always known.
Danish: Den kliniske betydning og mekanismerne bag disse rapporterede interaktioner kendes ikke altid.
English: Treatment should be symptomatic and general supportive measures should be utilised.
Danish: Behandlingen bør være symptomatisk, og almindelige understøttende foranstaltninger bør følges.
English: Therapeutic monitoring of digoxin should then be reinforced.
Danish: Terapeutisk monitorering af digoxin skal derfor øges.
English: Do not take this medicine if any of the above apply to you.
Danish: Du må ikke tage dette lægemiddel, hvis noget af det ovenstående gælder for dig.
English: • Seeing, feeling or hearing things that are not there (hallucinations)
Danish: • Se, føle eller høre ting, der ikke er der (hallucinationer)
English: What are the symptoms of heartburn?
Danish: Hvad er symptomerne på halsbrand?
English: This increase is dose-dependent and results in a more than dose proportional increase in AUC after repeated administration.
Danish: Denne øgning er dosisafhængig og resulterer i mere end en dosisproportional øgning i AUC efter gentagen administration.
English: The majority of these rated the importance of this change to be Important to Extremely Important in performing their activities of daily living (79 - 86% at week 2).
Danish: Størstedelen af dem klassificerede vigtigheden af denne ændring til at være vigtig til særdeles vigtig i forbindelse med udførelse af deres daglige aktiviteter (79-86 % i uge 2).
English: In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.
Danish: Derudover er sikkerhedsprofilen ens for forskellige formuleringer, behandlingsindikationer, aldersgrupper og patientgrupper.
English: Glycerol monostearate 40-55
Danish: Glycerolmonostearat 40-55
English: Patients should not take another PPI or H2 antagonist concomitantly.
Danish: Patienter bør ikke samtidig tage en anden PPI eller H2-antagonist.
English: Do not use any other liquids.
Danish: Du må ikke bruge andre væsker
English: General Patients should be instructed to consult a doctor if:
Danish: Generelt Patienterne skal instrueres i at kontakte lægen, hvis:
English: Combination with other medicinal products
Danish: Kombination med andre lægemidler
English: The liquid with the pellets should be drunk immediately or within 30 minutes.
Danish: Væsken med pellets skal drikkes straks eller inden for 30 minutter.
English: Less than 1% of the parent compound is found in urine.
Danish: Mindre end 1 % af modersubstansen findes i urin.
English: This could be ‘Stevens-Johnson syndrome' or ‘toxic epidermal necrolysis', seen very rarely.
Danish: Dette kan være “Stevens-Johnson syndrom” eller ”toksisk epidermal nekrolyse”, der ses meget sjældent
English: • You have problems or pain when swallowing.
Danish: • Du har problemer eller smerter, når du synker
English: +K+-ATPase
Danish: +K+-ATPase (syrepumpen),
English: Synthetic Paraffin
Danish: Syntetisk paraffin
English: • Generally feeling unwell and lacking energy.
Danish: • Generel utilpashed og manglende energi
English: The clinical relevance of this interaction is uncertain.
Danish: Den kliniske relevans af denne interaktion er ukendt.
English: However, caution should be exercised when esomeprazole is given at high doses in elderly patients.
Danish: Der skal dog udvises forsigtighed, når esomeprazol gives i høje doser til ældre patienter.
English: In vivo conversion to the R-isomer is negligible.
Danish: In vivo-omdannelse til R-isomeren er ubetydelig.
English: If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Danish: Hvis der ikke opnås symptomlindring inden for 2 ugers kontinuerlig behandling, skal patienten instrueres i at søge læge.
English: A dose adjustment of esomeprazole is not regularly required in either of these situations.
Danish: En dosistilpasning af esomeprazol er normalt ikke nødvendig i nogen af disse situationer.
English: Medicinal products with pH dependent absorption
Danish: Lægemidler med pH-afhængig absorption
English: It is important not to damage the pellets.
Danish: Det er vigtigt ikke at ødelægge disse pellets
English: • You have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea.
Danish: • Du har alvorlig eller vedvarende diarré; esomeprazol er blevet forbundet med en let øget risiko for infektiøs diarré
English: The water should be stirred until the tablet disintegrates.
Danish: Vandet skal omrøres indtil tabletten går i opløsning.
English: Once complete relief of symptoms has occurred, treatment should be discontinued.
Danish: Når fuldstændig symptomlindring er opnået, bør behandlingen afbrydes.
English: • Blood problems such as a reduced number of white blood cells or platelets.
Danish: • Problemer med blodet, såsom nedsat antal hvide blodlegemer eller blodplader.
English: • Hair loss (alopecia).
Danish: • Hårtab (alopeci)
English: Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Danish: Uoverensstemmende data vedrørende kliniske implikationer af denne PK-/PD-interaktion, hvad angår større kardiovaskulære hændelser, er rapporteret fra både observationsundersøgelser og kliniske undersøgelser.
English: Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).
Danish: På grund af begrænset erfaring med patienter med svær nyreinsufficiens, skal disse patienter behandles med forsigtighed (se pkt.
English: However, the maximum levels of inhibition of (ADP induced) platelet aggregation in these subjects were the same in both groups.
Danish: De maksimale niveauer for hæmning af (ADP-induceret) blodpladeaggregering hos disse forsøgspersoner var imidlertid ens i begge grupper.
English: Non-clinical data reveal no particular hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: If you have very low levels of magnesium, you may also have low levels of calcium and/or potassium in your blood.
Danish: Hvis du har meget lave magnesiumkoncentrationer, kan du også have lave koncentrationer af calcium og/eller kalium i blodet
English: The reactions are classified according to MedDRA frequency convention: 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: Bivirkningerne er opstillet ifølge MedDRA-konventionen om hyppighed: 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: • Try to lose weight.
Danish: • Forsøg at tabe dig
English: The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole.
Danish: Det let forlængede QTc-interval, som blev observeret efter administration af cisaprid alene, var ikke yderligere forlænget, når cisaprid blev givet i kombination med esomeprazol.
English: Naproxen or rofecoxib
Danish: Naproxen eller rofecoxib
English: • Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime.
Danish: • Spis sundere mad, forsøg at undgå krydret eller fed mad og store måltider sent om aftenen,
English: For 20 mg esomeprazole the corresponding values are 50% and 68% respectively.
Danish: For 20 mg esomeprazol er de tilsvarende værdier henholdsvis 50 % og 68 %.
English: Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italy.
Danish: Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italien.
English: If you are overweight or smoke you increase the probability of suffering from heartburn.
Danish: Hvis du er overvægtig eller ryger, øger det sandsynligheden for halsbrand.
English: Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking lots of alcohol.
Danish: Halsbrand kan skyldes, at du har spist for meget, har spist mad med et højt fedtindhold, har spist for hurtigt, eller at du har drukket meget alkohol.
English: You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
Danish: Det er særligt vigtigt, at du fortæller din læge eller apotekspersonalet, hvis du tager clopidogrel (anvendes til forebyggelse af blodpropper).
English: Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.
Danish: Dyreforsøg med den racemiske blanding af omeprazol, givet ved oral administration, indikerer ingen virkninger med hensyn til fertilitet.
English: Elderly patients (≥65 years old) The metabolism of esomeprazole is not significantly changed in elderly patients (71-80 years of age).
Danish: Ældre (≥ 65 år) Esomeprazols metabolisme ændres ikke væsentligt hos ældre personer (71-80 år).
English: If you notice any of the following serious side effects, stop taking Nexium Control and contact a doctor immediately:
Danish: Hvis du bemærker nogen af følgende alvorlige bivirkninger, skal du stoppe med at tage Nexium Control og straks kontakte lægen:
English: Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical studies (and also from post-marketing use).
Danish: Hovedpine, mavesmerter, diarré og kvalme er blandt de mest almindeligt indberettede bivirkninger i kliniske studier (og også ved brug efter markedsføring).
English: If you have persistent or longstanding, frequently recurring symptoms even after treatment with this medicine, you should contact your doctor.
Danish: Hvis du har vedvarende eller længerevarende hyppigt tilbagevendende symptomer, selv efter behandling med dette lægemiddel, skal du kontakte din læge.
English: The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight.
Danish: Det tilsyneladende fordelingsvolumen ved steady state i raske forsøgspersoner er ca. 0,22 l/kg legemsvægt.
English: Almost 80% of an oral dose of esomeprazole is excreted as metabolites in the urine, the remainder in the faeces.
Danish: Næsten 80 % af en oral dosis af esomeprazol udskilles som metabolitter i urinen, den resterende del i fæces.
English: • You can take your tablet at any time of the day either with food or on an empty stomach.
Danish: • Du kan tage din tablet når som helst på dagen, enten sammen med mad eller på tom mave
English: Take one tablet once a day.
Danish: Tag 1 tablet én gang dagligt.
English: • Stop smoking.
Danish: • Hold op med at ryge
English: • Eyesight problems such as blurred vision.
Danish: • Synsproblemer, såsom sløret syn
English: FURTHER HELPFUL INFORMATION
Danish: ANDRE NYTTIGE OPLYSNINGER
English: Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H
Danish: Esomeprazol er en svag base, der koncentreres og omdannes til den aktive form i det stærkt sure miljø i de sekretoriske canaliculi i parietalcellen, hvor det hæmmer enzymet H
English: It is unknown whether esomeprazole/metabolites are excreted in human milk.
Danish: Det er ukendt, om esomeprazol/metabolitter udskilles i modermælk.
English: Indigo carmine (E132) Erythrosine (E127) Allura red AC (E129)
Danish: Indigocarmin (E132) Erythrosin (E127) Allura red AC (E129)
English: One tablet daily Lasts 24 hours
Danish: 1 tablet dagligt Effekt i 24 timer
English: You may also notice that when you lie down, that your heartburn gets worse.
Danish: Måske oplever du også, at din halsbrand forværres, når du ligger ned.
English: Esomeprazole is completely metabolised by the cytochrome P450 system (CYP).
Danish: Esomeprazol bliver metaboliseret fuldstændigt af cytochrom P450-systemet (CYP).
English: • You can take your capsule at any time of the day either with food or on an empty stomach.
Danish: • Du kan tage din kapsel når som helst på dagen, enten sammen med mad eller på tom mave
English: Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies.
Danish: Forsøg, der evaluerede samtidig administration af esomeprazol og enten naproxen eller rofecoxib viste ikke nogen klinisk relevante farmakokinetiske interaktioner under kortvarige forsøg.
English: Your doctor may adjust your dose of Nexium Control if you also have severe liver problems and are treated for a long period of time.
Danish: Din læge kan tilpasse din dosis af Nexium Control, hvis du også har alvorlige leverproblemer og bliver behandlet i en længere periode.
English: May take 2-3 days for full effect.
Danish: Det kan tage 2-3 dage at opnå fuld virkning.
English: • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
Danish: • For at sikre, at du har drukket al medicinen, skal du skylle glasset godt med et halvt glas vand og drikke det.
English: A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and the dose of tacrolimus adjusted if needed.
Danish: Der skal udføres øget monitorering af tacrolimuskoncentrationer samt nyrefunktionen (kreatininclearance), og om nødvendigt skal tacrolimusdosen justeres.
English: Absorption of esomeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose.
Danish: Absorptionen af esomeprazol sker hurtigt med peak plasmakoncentration omtrent 1-2 timer efter dosering.
English: • Increased liver enzymes shown in blood tests that check how the liver is working.
Danish: • Højere niveauer af enzymer i de blodprøver, der viser, hvordan leveren fungerer
English: Aluminium blister.
Danish: Aluminiumblister.
English: Mean peak plasma concentrations were 60% higher.
Danish: Middel peak plasmakoncentrationer var øget med ca. 60 %.
English: Carcinogenicity studies in the rat with the racemic mixture have shown gastric ECL-cell hyperplasia and carcinoids.
Danish: Karcinogenicitetsstudier med rotter med den racemiske blanding har vist gastrisk ECL-cellehyperplasi og carcinoider.
English: Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of acid secretion and exposure has been shown.
Danish: Ved anvendelse af AUC som surrogatparameter for plasmakoncentrationen blev der vist en sammenhæng mellem syresekretionshæmning og eksponering.
English: If affected, patients should not drive or use machines.
Danish: Hvis de forekommer, må patienterne ikke føre motorkøretøj eller betjene maskiner.
English: Symptoms associated with acid reflux (such as heartburn and acid regurgitation) were evaluated retrospectively over a 24 hour period.
Danish: Symptomerne, der var forbundet med syrerefluks (såsom halsbrand og sure opstød), blev evalueret retrospektivt i en 24-timers periode.
English: When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered.
Danish: Når behandlingen med esomeprazol indledes eller afsluttes, skal muligheden for interaktion med lægemidler, der metaboliseres via CYP2C19, overvejes.
English: After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour.
Danish: Efter oral dosering med esomeprazol 20 mg og 40 mg opnås virkning inden for én time.
English: It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn.
Danish: Det anbefales at monitorere plasmakoncentrationerne af phenytoin, når behandling med esomeprazol påbegyndes eller afsluttes.
English: The absolute bioavailability is 64% after a single dose of 40 mg and increases to 89% after repeated once-daily administration.
Danish: Den absolutte biotilgængelighed er 64 % efter enkelt dosering med 40 mg og stiger til 89 % efter gentagen dosering en gang dagligt.
English: No other liquids should be used as the enteric coating may be dissolved.
Danish: Der bør ikke anvendes nogen anden væske til opløsning, da entero-overtrækket derved kan blive opløst.
English: • You are taking any medicines listed in the package leaflet.
Danish: • Du tager medicin, der er nævnt i indlægssedlen
English: Take one capsule once a day.
Danish: Tag 1 kapsel en gang dagligt.
English: Alternatively, the tablet can be dispersed in half a glass of non-carbonated water.
Danish: Alternativt kan tabletten opløses i et halvt glas vand uden kuldioxid.
English: Metabolism and nutrition disorders peripheral oedema hyponatraemia hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia; hypomagnesaemia may also result in hypokalaemia
Danish: Metabolisme og ernæring perifere ødemer hyponatriæmi hypomagnesiæmi, alvorlig hypomagnesiæmi kan korrelere med hypocalcæmi; hypomagnesiæmi kan også føre til hypokaliæmi
English: To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Danish: For at undgå denne interferens bør Nexium Control seponeres mindst 5 dage inden måling af CgA (se pkt.
English: The major metabolites of esomeprazole have no effect on gastric acid secretion.
Danish: Esomeprazols hovedmetabolitter har ingen effekt på den gastriske syresekretion.
English: The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma.
Danish: Den resterende del er afhængig af en anden specifik isoform, CYP3A4, som er ansvarlig for dannelsen af esomeprazolsulfon, der er den primære metabolit i plasma.
English: Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Danish: Patienter over 55 år, som dagligt tager ikke-receptpligtige lægemidler mod fordøjelsesbesvær eller halsbrand, bør informere apotekspersonalet eller deres læge.
English: Nexium Control is not meant to bring immediate relief.
Danish: Nexium Control ikke beregnet til at give øjeblikkelig lindring.
English: Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives.
Danish: Monitorering anbefales ved initiering og afslutning af samtidig esomeprazolbehandling under behandling med warfarin eller andre coumarinderivater.
English: The symptoms described in connection with 280 mg esomeprazole were gastrointestinal symptoms and weakness.
Danish: Symptomer beskrevet i forbindelse med 280 mg var gastrointestinale symptomer samt svaghed.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Patienter med sjældne arvelige tilstande som fruktoseintolerans, glukose-galaktosemalabsorption eller sukrase-isomaltaseinsufficiens bør ikke tage dette lægemiddel.
English: In case of clopidogrel, a prodrug which is transformed into its active metabolite via CYP2C19, the plasma concentrations of the active metabolite may be decreased.
Danish: I tilfældet clopidogrel, som er et prodrug, der transformeres til den aktive metabolit via CYP2C19, kan plasmakoncentrationen af den aktive metabolit være nedsat.
English: The area under the plasma concentration-time curve increases with repeated administration of esomeprazole.
Danish: Arealet under plasmakoncentrationstidskurven øges ved gentagen administration af esomeprazol.
English: This could be a sign of a serious condition with your heart.
Danish: Dette kan være tegn på alvorlige hjerteproblemer.
English: No dose-related adverse reactions have been identified.
Danish: Der er ikke identificeret nogen dosisrelaterede bivirkninger.
English: Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.
Danish: Esomeprazol elimineres fuldstændigt fra plasma mellem doserne uden tendens til akkumulering ved administration én gang dagligt.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of esomeprazole.
Danish: Data fra anvendelse af esomeprazol hos et begrænset antal gravide kvinder (mellem 300 og 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af esomeprazol.
English: • You get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Nexium Control.
Danish: • Hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest muligt sige det til lægen, da du kan være nødt til at holde op med at tage Nexium Control.
English: Pharmacotherapeutic group: Drugs for acid related disorders, proton pump inhibitors, ATC code: A02BC05.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til syrerelaterede sygdomme, protonpumpehæmmere, ATC-kode: A02BC05.
English: Elderly patients (≥65 years old) Dose adjustment is not required in elderly patients.
Danish: Ældre(≥ 65 år) Der er ikke behov for dosisjustering hos ældre patienter.
English: There is insufficient information on the effects of esomeprazole in newborns/infants.
Danish: Data for virkningen af esomeprazol hos nyfødte/spædbørn er utilstrækkelige.
English: The median time to first resolution of night-time heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) and approaching significance in the other (p=0.069).
Danish: Den gennemsnitlige tid til første ophør af natlig halsbrand var 1 dag, statistisk signifikant sammenlignet med placebo i det ene forsøg (p=0,048) og tilnærmelsesvis signifikant i det andet (p=0,069).
English: • The recommended dose is one tablet a day.
Danish: • Den anbefalede dosis er 1 tablet om dagen
English: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, substituerede benzimidazoler eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Both the Rand S-isomer of omeprazole have similar pharmacodynamic activity.
Danish: Omeprazols Rog S-isomer har begge samme farmakodynamiske aktivitet.
English: Keep the container tightly closed to protect from moisture.
Danish: Hold beholderen tæt lukket for at beskytte mod fugt.
English: The bottle also contains a sealed container with silica gel desiccant.
Danish: Flasken indeholder også en forseglet beholder med silicagel som tørremiddel.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Følgende bivirkninger er ikke set i kliniske forsøg, men i dyreforsøg efter eksponering for koncentrationer, der svarer til eksponering i kliniske forsøg, og anses for at være relevante for den kliniske anvendelse: