FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects of esomeprazole on the pharmacokinetics of other medicinal products As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions reported with omeprazole.
Danish: Esomeprazols virkninger på andre lægemidlers farmakokinetik Da esomeprazol er en enantiomer af omeprazol, er det hensigtsmæssigt at oplyse om interaktioner, som er rapporteret med omeprazol.
English: Propylene glycol Shellac
Danish: Propylenglycol Shellac
English: • Do not take more than this recommended dose of one tablet (20 mg) a day, even if you don't feel an improvement immediately.
Danish: • Du må ikke tage mere end den anbefalede dosis på 1 tablet (20 mg) om dagen, selv om du ikke straks mærker en forbedring
English: • Do not take more than this recommended dose of one capsule (20 mg) a day, even if you don't feel an improvement immediately.
Danish: • Du må ikke tage mere end den anbefalede dosis på 1 kapsel (20 mg) om dagen, selv om du ikke straks mærker en forbedring
English: • Disturbed sleep (insomnia), feeling sleepy.
Danish: • Forstyrret søvn (søvnløshed), træthedsfølelse
English: It is important for you to give information about your medicine at this time.
Danish: Det er vigtigt, at du samtidig oplyser, hvilken medicin, du tager.
English: Concomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus.
Danish: Det er blevet rapporteret, at samtidig administration af esomeprazol øger serumniveauerne for tacrolimus.
English: However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
Danish: Dog bør dosistilpasning overvejes hos patienter med svært nedsat leverfunktion, og hvis langvarig behandling er indiceret.
English: Tell your doctor immediately before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease.
Danish: Kontakt straks lægen før eller efter du har taget Nexium Control, hvis du bemærker nogen af følgende symptomer, som kan være tegn på en anden, mere alvorlig, sygdom.
English: Corresponding proportions for esomeprazole 40 mg were 97%, 92% and 56%.
Danish: Tilsvarende for esomeprazol 40 mg var 97 %, 92 % og 56 %.
English: An interaction is observed between clopidogrel and esomeprazole.
Danish: Der er blevet observeret interaktion mellem clopidogrel og esomeprazol.
English: The glass should be rinsed with half a glass of water and the water drunk.
Danish: Glasset skal skylles med et halvt glas vand og vandet drikkes.
English: Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure.
Danish: Øgning af atazanavirdosis til 400 mg kompenserede ikke for indvirkningen af omeprazol på atazanavireksponeringen.
English: In these individuals the metabolism of esomeprazole is probably mainly catalysed by CYP3A4.
Danish: Sandsynligvis er esomeprazols metabolisering hos disse personer hovedsageligt katalyseret af CYP3A4.
English: Investigated medicinal products with no clinically relevant interaction Amoxicillin and quinidine
Danish: Undersøgte lægemidler uden klinisk relevante interaktioner Amoxicillin og quinidin
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager noget af følgende medicin:
English: • Yellow skin, dark urine and tiredness, which can be symptoms of liver problems, seen rarely.
Danish: • Gullig hud, mørk urin og træthed, hvilket kan være symptomer på leverproblemer, der ses sjældent
English: Do not store above 30°C Store in the original package in order to protect from moisture.
Danish: Må ikke opbevares ved temperaturer over 30 °C Opbevares i den originale yderpakning for at beskytte mod fugt.
English: • They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Danish: • de har været i vedvarende symptomatisk behandling for fordøjelsesbesvær eller halsbrand, som varer i 4 uger eller længere
English: The absorption of medicinal products taken orally such as ketoconazole, itraconazole and erlotinib can decrease during treatment with esomeprazole and the absorption of digoxin can increase during treatment with esomeprazole.
Danish: Absorptionen af oralt administrerede lægemidler såsom ketoconazol, itraconazol og erlotinib kan mindskes under behandling med esomeprazol, og absorptionen af digoxin kan øges under behandling med esomeprazol.
English: No gender difference is seen after repeated once-daily administration.
Danish: Der ses ingen kønsrelaterede forskelle efter gentagen dosering én gang dagligt.
English: • The recommended dose is one capsule a day.
Danish: • Den anbefalede dosis er 1 kapsel om dagen
English: • Low numbers of red blood cells, white blood cells, and platelets (a condition called pancytopenia)
Danish: • Lavt antal røde blodlegemer, hvide blodlegemer og blodplader (en sygdom, der kaldes pancytopeni)
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium Control.
Danish: Hvis sådanne hudreaktioner optræder, navnlig på hudområder udsat for sol, og er ledsaget af artralgi, bør patienten straks søge læge, og lægen bør overveje at seponere Nexium Control.
English: • If you are suffering from any of the side effects detailed in Section 4 which require medical attention.
Danish: • Hvis du får nogen af bivirkningerne i punkt 4, som kræver lægehjælp.
English: Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over a 24 hour period and during the night compared to placebo.
Danish: Andre sekundære mål støttede det primære mål, inklusive lindring af halsbrand i uge 1 og uge 2, procentdelen af hele døgn uden halsbrand i uge 1 og uge 2, den gennemsnitlige sværhedsgrad af halsbrand i uge 1 og uge 2 og tiden til første og vedvarende ophør af halsbrand i en 24-timers periode og om natten sammenlignet med placebo.
English: Psychiatric disorders insomnia agitation, confusion, depression aggression, hallucinations
Danish: Psykiske forstyrrelser søvnløshed agitation, konfusion, depression aggression, hallucinationer
English: As a precautionary measure, you should preferably avoid the use of Nexium Control during pregnancy.
Danish: Som en forebyggende foranstaltning bør du fortrinsvis undgå at bruge Nexium Control under graviditet.
English: Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors.
Danish: Øget gastrisk pH under omeprazolbehandling kan ændre absorptionen af proteasehæmmerne.
English: Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two out of ten subjects).
Danish: Samtidig behandling med omeprazol (20 mg dagligt) og digoxin hos raske forsøgspersoner, øgede digoxins biotilgængelighed med 10 % (op til 30 % hos to ud af ti forsøgspersoner).
English: If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
Danish: Hvis kombinationen af atazanavir og en protonpumpehæmmer vurderes at være uundgåelig, anbefales tæt klinisk overvågning i kombination med øgning af atazanavirdosis til 400 mg med 100 mg ritonavir.
English: Nexium Control has a low likelihood of affecting your ability to drive or use machines.
Danish: Der er en lille sandsynlighed for, at Nexium Control kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Thus, when esomeprazole is combined with medicinal products metabolised by CYP2C19, such as warfarin, phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these medicinal products may be increased and a dose reduction could be needed.
Danish: Når esomeprazol kombineres med lægemidler, som metaboliseres af CYP2C19, f.eks.warfarin, phenytoin, citalopram, imipramin, clomipramin, diazepam etc., kan plasmakoncentrationen af disse lægemidler derfor øges, og det kan være nødvendigt med en dosisreduktion.
English: In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be considered.
Danish: Ved administration af methotrexat i høje doser kan det overvejes midlertidigt at seponere esomeprazol.
English: Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin and quinidine.
Danish: Esomeprazol har ikke vist nogen klinisk relevant virkning på farmakokinetikken af amoxicillin og quinidin.
English: However, post-marketing, a few isolated cases of elevated INR of clinical significance have been reported during concomitant treatment.
Danish: Få isolerede postmarketingrapporter har dog rapporteret om klinisk signifikant øget INR ved samtidig behandling.
English: If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test.
Danish: Hvis du har en infektion med symptomer, såsom feber med alvorligt nedsat almen helbredstilstand eller feber med symptomer på en lokal infektion, såsom smerter i nakke, hals eller mund eller besvær med at lade vandet, skal du gå til lægen hurtigst muligt, så mangel på hvide blodlegemer (agranulocytose) kan udelukkes med en blodprøve.
English: If affected, you should not drive or use machines.
Danish: Hvis du er påvirket af dette, må du ikke føre motorkøretøj eller betjene maskiner.
English: This time and dose-dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by esomeprazole and/or its sulphone metabolite.
Danish: Denne tids- og dosisafhængighed skyldes et fald i first pass-metabolismen og systemisk clearance, som sandsynligvis skyldes esomeprazols og/eller dets sulfonmetabolits hæmning af CYP2C19-enzymet.
English: Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration.
Danish: Den totale plasmaclearance er ca. 17 l/time efter enkeltdosis og ca. 9 l/time efter gentagen dosering.
English: Esomeprazole has minor influence on the ability to drive or use machines.
Danish: Esomeprazol påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Blood and lymphatic system disorders leukopenia, thrombocytopenia agranulocytosis, pancytopenia
Danish: Blod og lymfesystem leukopeni, trombocytopeni agranulocytose, pancytopeni
English: Methacrylic acid ethylacrylate copolymer (1:1) dispersion 30 per cent Cellulose microcrystalline
Danish: Methacrylsyre-ethylacrylat copolymer (1:1) 30 % opløsning Mikrokrystallinsk cellulose
English: • They have jaundice or severe liver disease.
Danish: • de har gulsot eller svær leversygdom
English: Nexium Control contains sugar spheres, which contain sucrose, a type of sugar.
Danish: Nexium Control indeholder sukkerkugler, som indeholder saccharose, en sukkerart.
English: Do not take this medicine if you are also taking a medicine containing nelfinavir (used to treat HIV infection).
Danish: Du må ikke tage denne medicin, hvis du også tager medicin, der indeholder nelfinavir (anvendes til behandling af hiv-infektion).
English: • Severe liver problems leading to liver failure and inflammation of the brain.
Danish: • Alvorlige leverproblemer, der fører til leversvigt og betændelse i hjernen
English: The parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 enzyme, extensive metabolisers.
Danish: Nedenstående parametre afspejler hovedsagelig farmakokinetikken i individer med et funktionelt CYP2C19-enzym, ”extensive metabolisers”.
English: • Low levels of magnesium in the blood.
Danish: • Lav magnesiumkoncentration i blodet.
English: Do not take this medicine with other medicines that limit the amount of acid produced in your stomach such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an H2 antagonist (e.g. ranitidine or famotidine).
Danish: Du må ikke tage dette lægemiddel sammen med anden medicin, der begrænser produktionen af mavesyre, såsom protonpumpehæmmere (f.eks. pantoprazol, lansoprazol, rabeprazol eller omeprazol) eller en H2-antagonist (f.eks. ranitidin eller famotidin).
English: • Medicines that are used to thin your blood, such as warfarin.
Danish: • Blodfortyndende medicin, såsom warfarin.
English: Food intake both delays and decreases the absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on intragastric acidity.
Danish: Fødeindtagelse både forsinker og mindsker esomeprazols absorption, dog uden signifikant indflydelse på esomeprazols virkning på surhedsgraden i mavesækken.
English: The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing.
Danish: Plasmahalveringstiden er ca. 1,3 timer efter gentagen dosering en gang dagligt.
English: You may experience symptoms such as diarrhoea, stomach ache, constipation, feeling or being sick and weakness.
Danish: Du kan få symptomer, så som diarré, mavesmerter, forstoppelse, kvalme eller opkastning og svaghed.
English: The following adverse reactions have been identified or suspected in the clinical studies programme for esomeprazole and post-marketing.
Danish: Følgende bivirkninger er påvist eller er anset som mulige i esomeprazols kliniske studieprogram og efter markedsføring.
English: The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt by 280%.
Danish: CYP2C19- og CYP3A4-inhibitoren voriconazol øgede omeprazol AUCt med 280 %.
English: As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Danish: Som sikkerhedsforanstaltning bør samtidig brug af esomeprazol og clopidogrel frarådes.
English: Esomeprazole must not be used concomitantly with nelfinavir (see section 4.5).
Danish: Esomeprazol må ikke anvendes samtidigt med nelfinavir (se pkt.
English: You are taking any medicines listed in the package leaflet You are over 55 and have new or recently changed reflux symptoms.
Danish: Du tager medicin, der er nævnt i indlægssedlen Du er over 55 år og har nye eller nyligt forandrede reflukssymptomer.
English: For short-term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 or over.
Danish: Til kortvarig behandling af reflukssymptomer (halsbrand, sure opstød) til voksne på 18 år eller derover.
English: Omeprazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUCτ by 15% and 41%, respectively.
Danish: Omeprazol (40 mg én gang dagligt) øgede voriconazol (et CYP2C19-substrat) Cmax og AUCτ med henholdsvis 15 % og 41 %.
English: The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole.
Danish: Størstedelen af esomeprazols metabolisering er afhængig af det polymorfe CYP2C19, der er ansvarlig for dannelsen af esomeprazols hydroxy- og desmethylmetabolitter.
English: OUTER CARTON
Danish: Ydre karton
English: The capsule has a yellow centre band, and contains yellow and purple enteric coated pellets.
Danish: Kapslen har et gult bånd om midten, og indeholder gule og lilla enterobelagte kugler.
English: After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid output after pentagastrin stimulation is decreased 90% when measured 6-7 hours after dosing on day five.
Danish: Efter gentagen administration med 20 mg esomeprazol én gang dagligt i fem dage mindskes gennemsnitligt peak-syreoutput efter pentagastrinstimulation med 90 % målt 6-7 timer efter dosering på dag fem.
English: Concomitant administration of 30 mg esomeprazole resulted in a 45% decrease in clearance of the CYP2C19 substrate diazepam.
Danish: Samtidig administration af 30 mg esomeprazol medførte et fald på 45 % i clearance af CYP2C19-substratet diazepam.
English: Talk to your doctor before taking Nexium Control if:
Danish: Kontakt lægen, før du tager Nexium Control, hvis:
English: • Swelling of the feet and ankles.
Danish: • Hævede fødder og ankler
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Patients should not take Nexium Control as a long term preventive medicinal product.
Danish: Nexium Control må ikke tages som forebyggende lægemiddel over længere tid.
English: Esomeprazole is acid labile and is administered orally as enteric-coated granules.
Danish: Esomeprazol er syrelabil og administreres oralt som entero-overtrukne granulater.
English: Esomeprazole is 97% plasma protein bound.
Danish: Plasmaproteinbindingen af esomeprazol er 97 %.
English: Concomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical study showed that coagulation times were within the accepted range.
Danish: Et klinisk studie viste samtidig administration af 40 mg esomeprazol til patienter i warfarinbehandling, at koagulationstiden lå indenfor det accepterede tidsinterval.
English: Other possible interaction mechanisms are via inhibition of CYP2C19.
Danish: Andre mulige interaktionsmekanismer er via hæmning af CYP2C19.
English: Esomeprazole or its major metabolites do not show any tendency to accumulate with once-daily dosing.
Danish: Esomeprazol eller dets hovedmetabolitter viser ingen tendens til akkumulation ved dosering én gang dagligt.
English: In two multicentre, randomised, double-blind, placebo-controlled pivotal studies 234 subjects with a recent history of frequent heartburn were treated with 20 mg esomeprazole for 4 weeks.
Danish: I to randomiserede, dobbeltblindede, placebokontrollerede pivotale multicenterforsøg blev 234 forsøgspersoner med nylig forekomst af hyppig halsbrand behandlet med 20 mg esomeprazol i 4 uger.
English: Skin and subcutaneous tissue disorders dermatitis, pruritus, rash urticaria alopecia, photosensitivity erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (TEN)
Danish: Hud og subkutane væv dermatitis, pruritus, udslæt, urticaria alopeci, fotosensibilitet erythema multiforme, StevensJohnson syndrom, toksisk epidermal nekrolyse (TEN)
English: Nexium Control contains the active substance esomeprazole.
Danish: Nexium Control indeholder det aktive stof esomeprazol.
English: Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated (see section 4.3 and 4.4).
Danish: På grund af lignende farmakodynamiske effekter og farmakokinetiske egenskaber for omeprazol og esomeprazol, kan samtidig administration af esomeprazol og atazanavir ikke anbefales, og samtidig administration af esomeprazol og nelfinavir er kontraindiceret (se pkt.
English: • An infection called “thrush” which can affect the gut and is caused by a fungus.
Danish: • En infektion kaldet ”trøske”, der kan angribe fordøjelseskanalen, og som er forårsaget af svamp
English: Talk to your pharmacist or doctor if:
Danish: Kontakt lægen eller apotekspersonalet, hvis:
English: The solid pieces contain the medicine - do not chew or crush them.
Danish: De faste partikler indeholder medicin - de må ikke tygges eller knuses
English: You may take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or combinations of these) if needed.
Danish: Du må gerne tage dette lægemiddel samtidig med antacida (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller en kombination af disse), hvis du har behov for det.
English: Approximately 78% of the subjects on 20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared to 52 - 58% for placebo.
Danish: Ca. 78 % af forsøgspersonerne på 20 mg esomeprazol rapporterede første ophør af halsbrand inden for den første behandlingsuge sammenlignet med 52 - 58 % for placebo.
English: Immune system disorders hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Danish: Immunsystemet hypersensitivitetsreaktioner, f.eks. feber, angioødem og anafylaktisk reaktion /shock
English: Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Danish: Patienter med tilbagevendende symptomer på fordøjelsesbesvær eller halsbrand, skal gå til lægen regelmæssigt.
English: Esomeprazole is extensively plasma protein bound and is therefore not readily dialysable.
Danish: Esomeprazol er stærkt plasmaproteinbundet, hvilket vanskeliggør dialyse.
English: • If your reflux symptoms get worse or do not improve after taking this medicine for 14 days in a row, you should consult a doctor.
Danish: • Hvis dine reflukssymptomer bliver forværret eller ikke bliver forbedret, efter du har taget dette lægemiddel i 14 dage i træk, skal du kontakte din læge
English: For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg once a day).
Danish: For saquinavir (med samtidig administration af ritonavir) har der været rapporteret om øgede serumværdier (80-100 %) under samtidig behandling med omeprazol (40 mg én gang dagligt).
English: Hypromellose 2910 (6 mPa·s)
Danish: Hypromellose 2910 (6 mPa·s) Magnesiumstearat
English: • If you experience any of the symptoms detailed in Section 2 of this leaflet and it advises you to talk to your doctor or pharmacist.
Danish: • Hvis du får nogen af de symptomer, der er nævnt i punkt 2 i denne indlægsseddel, og hvis det anbefales, at du kontakter lægen eller apotekspersonalet.
English: After repeated once-daily administration of 40 mg esomeprazole, the mean area under the plasma concentration-time curve was approximately 100% higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers).
Danish: Efter gentagen administration af 40 mg esomeprazol var middelarealet under plasmakoncentrationstidskurven ca. 100 % højere i ”poor metabolisers” end i individer med et funktionelt CYP2C19-enzym (”extensive metabolisers”).
English: For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
Danish: For atazanavir og nelfinavir har der været rapporteret om nedsatte serumværdier ved samtidig administration med omeprazol, hvorfor samtidig administration ikke kan anbefales.
English: Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger, apotekspersonalet har givet dig.
English: Hepatobiliary disorders increased liver enzymes hepatitis with or without jaundice hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease
Danish: Lever og galdeveje forhøjede leverenzymer hepatitis med eller uden gulsot leversvigt, hepatisk encephalopati hos patienter med forudeksisterende leversygdom
English: The proportion of patients maintaining an intragastric pH above 4 for at least 8, 12 and 16 hours respectively were for esomeprazole 20 mg 76%, 54%, and 24%.
Danish: Andelen af patienter, der opretholdt en intergastrisk pH på 4 i mindst 8, 12 eller 16 timer, var for esomeprazol 20 mg 76 %, 54 % henholdsvis 24 %.
English: However, patients with severe liver impairment should be advised by a doctor before taking Nexium Control (see sections 4.4 and 5.2).
Danish: Patienter med svært nedsat leverfunktion bør dog rådgives af en læge, inden de tager Nexium Control (se pkt.