FrancophonIA/ELRC3.0 huggingface dataset:
English: The symptoms described have been transient, and no serious outcome has been reported.
Danish: De beskrevne symptomer har været forbigående, og der er ikke rapporteret om alvorlige følgevirkninger.
English: • Generally feeling unwell and lacking energy.
Danish: • Generel utilpashed og mangel på energi.
English: • Enlarged breasts in men.
Danish: • Forstørrede bryster hos mænd.
English: You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Danish: Du skal indberette alle nye og usædvanlige symptomer eller forhold, når du ser din læge.
English: • Disturbed sleep (insomnia).
Danish: • Forstyrret søvn (søvnløshed).
English: Concomitant intake of food has no influence on the bioavailability.
Danish: Samtidig indtagelse af føde påvirker ikke biotilgængeligheden.
English: Then drink the mixture straight away or within 30 minutes.
Danish: Drik blandingen med det samme eller inden for 30 minutter.
English: • Losec will be given to you by a doctor who will decide how much you need.
Danish: • Du vil få Losec af en læge, som vil vurdere, hvor meget du har brug for.
English: If symptom control has not been achieved after 2-4 weeks the patient should be investigated further.
Danish: Hvis symptomkontrol ikke er opnået efter 2-4 uger, bør patienten undersøges yderligere.
English: The frequency of vomiting/regurgitation episodes decreased by 50% after 8 weeks of treatment irrespective of the dose.
Danish: Hyppigheden af episoder med opkastning/regurgitation faldt med 50 % efter 8 ugers behandling uanset dosis.
English: It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.
Danish: Det kan være nødvendigt at tage tabletterne i 2-3 på hinanden følgende dage for at opnå en bedring af symptomerne.
English: Capsule, hard (capsule).
Danish: Kapsler, hårde (kapsler).
English: The adverse event profile was generally the same as for adults in short- as well as in long-term treatment.
Danish: Bivirkningsprofilen var generelt den samme som hos voksne i både korttids- og langtidsbehandling.
English: Alternative to oral therapy
Danish: Alternativ til oral terapi
English: There are no long term data regarding the effects of omeprazole treatment on puberty and growth.
Danish: Der er ingen langtidsdata vedrørende effekten af omeprazolbehandling på pubertet og vækst.
English: Once complete relief of symptoms has occurred, treatment should be discontinued.
Danish: Når der er fuldstændig lindring af symptomer, skal behandlingen seponeres.
English: From a microbiological point of view, the product should be used immediately unless it has been reconstituted under controlled and validated aseptic conditions.
Danish: Fra en mikrobiologisk synsvinkel bør produktet anvendes straks, medmindre det er opblandet under kontrollerede og validerede aseptiske forhold.
English: frequency cannot be estimated from the available data
Danish: Hyppigheden kan ikke vurderes ud fra forhåndenværende data
English: • It is recommended that you take your capsules in the morning.
Danish: • Det anbefales at tage kapslerne om morgenen.
English: • You begin to vomit food or blood.
Danish: • Hvis du kaster mad eller blod op.
English: As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Danish: Som ved al langtidsbehandling, især når behandlingsvarigheden overstiger et år, bør patienterne tilses regelmæssigt.
English: The dispersion should be taken immediately (or within 30 minutes).
Danish: Opslæmningen skal indtages med det samme (eller inden for 30 minutter).
English: Also apathy, depression and confusion have been described in single cases.
Danish: I enkelte tilfælde er apati, depression og konfusion også blevet beskrevet.
English: This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration.
Danish: Denne øgning er dosisafhængig og resulterer i et ikke-lineært dosis-AUC-forhold efter gentagen administration.
English: Patients should not take omeprazole as a preventative medication.
Danish: Patienterne bør ikke tage omeprazol som et forebyggende lægemiddel.
English: • Eyesight problems such as blurred vision.
Danish: • Synsproblemer såsom uklart syn.
English: Higher daily doses may be required and the dose should be adjusted individually.
Danish: Højere doser kan være nødvendige, og dosis bør justeres individuelt.
English: Dual therapies have been tested and found to be less effective than triple therapies.
Danish: 2-stof-terapier er blevet gennemprøvet og vurderes at være mindre effektive end 3-stof-terapier.
English: There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
Danish: Der kan også være alvorlig blæredannelse og blødning fra læber, øjne, mund, næse og kønsorganer.
English: • Children aged over 4 years may take Losec.
Danish: • Børn over 4 år kan tage Losec.
English: Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.
Danish: Eksempler på sådanne lægemidler er R-warfarin og andre vitamin K-antagonister, cilostazol, diazepam og phenytoin.
English: • They are aged over 55 years with new or recently changed symptoms.
Danish: • De er over 55 år og får nye eller nyligt ændrede symptomer
English: Aluminium blister.
Danish: Aluminium-blisterpakning.
English: • Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.
Danish: • Din læge vil tilpasse dosis efter dit behov og tage stilling til, hvor lang tid du skal tage medicinen.
English: Total plasma clearance is about 30-40 l/h after a single dose.
Danish: Den totale plasmaclearance er omkring 30-40 l/time efter en enkelt dosis.
English: Thus, these changes are not from a direct effect of any individual active substance.
Danish: Disse ændringer er derfor ikke en direkte effekt af et enkelt lægemiddel.
English: Approximately 3% of the Caucasian population and 15-20% of Asian populations lack a functional CYP2C19 enzyme and are called poor metabolisers.
Danish: Ca. 3 % af den kaukasiske befolkning og 15-20 % af den asiatiske befolkning mangler et funktionelt CYP2C19-enzym og kaldes ”poor metabolisers”.
English: Always take Losec exactly as described in this leaflet.
Danish: Tag altid Losec nøjagtigt som beskrevet her.
English: In children younger than 6 months, clearance of omeprazole is low due to low capacity to metabolise omeprazole.
Danish: Hos børn yngre end 6 måneder er omeprazols clearance lav på grund af lav metaboliseringskapacitet for omeprazol.
English: The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease.
Danish: Omeprazols sikkerhed er undersøgt hos i alt 310 børn mellem 0 og 16 år med syrerelateret sygdom.
English: The systemic availability (bioavailability) from a single oral dose of omeprazole is approximately 40%.
Danish: Den systemiske tilgængelighed (biotilgængelighed) af omeprazol efter en enkel oral dosis er ca. 40 %.
English: These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.
Danish: Disse ændringer, der er en fysiologisk konsekvens af udtalt hæmning af syresekretionen, er godartede og synes at være reversible.
English: Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.
Danish: Inkonsistente data vedrørende de kliniske konsekvenser af denne farmakokinetiske/farmakodynamiske interaktion med hensyn til større kardiovaskulære hændelser er blevet rapporteret fra observatoriske og kliniske undersøgelser.
English: If you take Losec on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance.
Danish: Hvis du tager Losec i længere tid (over 1 år), vil lægen sandsynligvis gerne se dig regelmæssigt.
English: However caution should be exercised when omeprazole is given at high doses in elderly patients.
Danish: Dog bør der udvises forsigtighed, når omeprazol gives i høje doser til ældre patienter.
English: Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.
Danish: Omeprazol udskilles i modermælk, men det er ikke sandsynligt, at barnet påvirkes, når der anvendes terapeutiske doser.
English: You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi)).
Danish: Du skal især fortælle din læge eller på apoteket, hvis du tager clopidogrel (for at forebygge blodpropper).
English: Elderly The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).
Danish: Ældre Omeprazols metabolisme er noget nedsat hos ældre personer (75-79 år).
English: Agitation, confusion, depression
Danish: Agitation, konfusion, depression
English: Mean peak plasma concentrations were also higher, by 3 to 5 times.
Danish: De gennemsnitlige peakplasmakoncentrationer var også 3-5 gange højere.
English: Omeprazole is completely metabolised by the cytochrome P450 system (CYP).
Danish: Omeprazol metaboliseres fuldstændigt af cytochrom P-450-systemet (CYP).
English: All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of Losec 20-120 mg daily.
Danish: Alle patienter med svær sygdom og utilstrækkeligt respons på anden behandling er blevet effektivt kontrolleret, og mere end 90 % af patienterne bibeholdt Losec 20-120 mg dagligt.
English: In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated.
Danish: Hos patienter med Zollinger-Ellisons syndrom bør dosis tilpasses individuelt, og behandlingen bør fortsætte så længe, det er klinisk indiceret.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Bemærk: Produktresume, etikettering og indlægsseddel herunder er den gældende version på tidspunktet for Kommissionens beslutning.
English: The majority of patients achieve complete relief of heartburn within 7 days.
Danish: De fleste patienter fik fuldstændig lindring af halsbrand inden for 7 dage.
English: Absorption of omeprazole takes place in the small intestine and is usually completed within 3-6 hours.
Danish: Absorption af omeprazol finder sted i tyndtarmen og er sædvanligvis fuldstændig i løbet af 3-6 timer.
English: In addition, omeprazole lacks an inhibitory effect on the main CYP enzymes.
Danish: Endvidere mangler omeprazol en hæmmende virkning på de vigtigste CYP-enzymer.
English: If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Losec to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Danish: Hvis din læge har ordineret de to antibiotika amoxicillin og clarithromycin sammen med Losec for at behandle mavesår forårsaget af en Helicobacter pylori-infektion, er det meget vigtigt, at du fortæller din læge, hvilken anden medicin du tager.
English: The rate of elimination was unchanged (first order kinetics) with increased doses.
Danish: Elimininationshastigheden var uændret ved øgede doser (1. ordens kinetik).
English: • Low levels of sodium in the blood.
Danish: • Lavt natriumindhold i blodet.
English: In some patients a daily dose of 10 mg may be sufficient.
Danish: Hos nogle patienter kan en daglig dosis på 10 mg være tilstrækkelig.
English: • Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.
Danish: • Din læge vil også ordinere to typer antibiotika kaldet amoxicillin og clarithromycin til dit barn.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC01
Danish: Farmakoterapeutisk klassifikation: protonpumpehæmmer, ATC-kode: A02B C01
English: It belongs to a group of medicines called ‘proton pump inhibitors'.
Danish: Det tilhører en gruppe lægemidler, som kaldes protonpumpehæmmere.
English: frequency cannot be estimated from the available data.
Danish: hyppigheden kan ikke vurderes ud fra forhåndenværende data
English: • Children over 1 year of age and with a body weight of more than 10 kg may take Losec.
Danish: • Børn over 1 år med en legemsvægt på over 10 kg kan tage Losec.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl din læge eller på apoteket, hvis du tager nogle af følgende lægemidler:
English: • Blood problems such as a reduced number of white cells or platelets.
Danish: • Blodproblemer såsom nedsat antal hvide blodlegemer og blodplader.
English: This medicinal product should not be mixed with other medicinal products than those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: During treatment with the recommended doses to children from the age of 1 year, similar plasma concentrations were obtained as compared to adults.
Danish: Ved behandling med de anbefalede doser til børn fra 1 år, sås tilsvarende plasmakoncentrationer som hos voksne.
English: It is important for you to give information about your medicine at this time.
Danish: Det er vigtigt, at du oplyser om den medicin, du tager.
English: • You are aged over 55 years with new or recently changed symptoms.
Danish: • Hvis du er over 55 år med nye symptomer eller symptomer, der for nyligt har ændret sig.
English: Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Danish: Patienter med langvarige tilbagevendende symptomer på fordøjelsesbesvær eller halsbrand bør konsultere deres læge med regelmæssige intervaller.
English: Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.
Danish: Nogle patienter kan respondere tilstrækkeligt på 10 mg dagligt, og individuel dosisjustering bør derfor overvejes.
English: Reflux esophagitis: The treatment time is 4-8 weeks.
Danish: Refluksøsofagitis: Behandlingstiden er 4-8 uger
English: The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly reduced and thus clinical efficacy may be impaired.
Danish: Absorptionen af posaconazol, erlotinib, ketoconazol og itraconazol reduceres signifikant, og den kliniske effekt kan være nedsat.
English: No tachyphylaxis has been observed during treatment with omeprazole.
Danish: Der er ikke set takyfylaksi under behandling med omeprazol.
English: • Severe kidney problems (interstitial nephritis).
Danish: • Alvorlige nyreproblemer (interstitiel nefritis).
English: Patients with impaired hepatic function should be advised by a doctor before taking Losec (see section 5.2).
Danish: Patienter med nedsat leverfunktion skal rådgives af en læge, inden de tager Losec (se pkt.
English: Losec may hide the symptoms of other diseases.
Danish: Losec kan maskere symptomerne på andre sygdomme.
English: The pellets release the active ingredient in the intestine, where it is absorbed by your body to give an effect.
Danish: Perlerne frigiver det aktive stof i tarmen, hvor det optages i kroppen for at give effekt.
English: Omeprazole and omeprazole magnesium are acid labile and are therefore administered orally as enteric-coated granules in capsules or tablets.
Danish: Omeprazol og omeprazolmagnesium er syrelabile og administreres derfor oralt som enterocoatede granulater i kapsler eller tabletter.
English: Losec may in very rare cases affect the white blood cells leading to immune deficiency.
Danish: Losec kan i meget sjældne tilfælde påvirke de hvide blodlegemer og derved føre til en svækkelse af immunforsvaret.
English: • Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Danish: • Gullig hud, mørk urin og træthed, som kan være symptomer på leverproblemer.
English: • Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Danish: • Leverproblemer, inklusive gulsot, som kan forårsage gullig hud, mørk urin og træthed.
English: No other solvent should be used.
Danish: Der må ikke anvendes andre opløsningsmidler.
English: After repeated once-daily administration, the bioavailability increases to about 60%.
Danish: Efter gentagen dosering en gang dagligt øges biotilgængeligheden til ca. 60 %.
English: This effect on the final step of the gastric acid formation process is dose-dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.
Danish: Denne virkning på det sidste trin i processen for dannelse af mavesyre er dosisafhængig og sikrer en meget effektiv hæmning af såvel basal som stimuleret syresekretion, uanset stimuli.
English: Frequency categories are defined according to the following 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: Frekvenskategorierne er defineret som følger: 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: Concomitant voriconazole treatment resulted in more than doubling of the omeprazole exposure.
Danish: Samtidig behandling med voriconazol resulterede i mere end en fordobling af omeprazoleksponeringen.
English: Your doctor will tell you how many capsules to take and how long to take them for.
Danish: Din læge vil fortælle dig, hvor mange kapsler du skal tage, og hvor længe du skal tage dem.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25oC after reconstitution.
Danish: Der er vist kemisk og fysisk stabilitet i 4 timer ved 25 °C efter rekonstitution.
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 være sikker på, at du har drukket al medicinen, skal du skylle glasset grundigt efter med et halvt glas vand og drikke det.
English: In case of therapy failure, the dose can be increased to 40 mg.
Danish: I tilfælde af behandlingssvigt kan dosis øges til 40 mg.
English: Make sure all omeprazole is dissolved.
Danish: Vær sikker på, at al omeprazol er opløst.
English: - Always stir the mixture just before drinking (the mixture will not be clear).
Danish: - Rør altid rundt, umiddelbart før du drikker (blandingen bliver ikke klar).
English: The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of omeprazole sulphone.
Danish: Den resterende del er afhængig af en anden specifik isoform CYP3A4, som er ansvarlig for dannelsen af omeprazolsulfon.
English: Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with omeprazole.
Danish: Gastrisk ECL-celle-hyperplasi og karcinoider er observeret i livslange studier hos rotter behandlet med omeprazol.
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 som feber med en alvorligt påvirket almentilstand eller feber med symptomer på en lokal infektion såsom smerter i nakke, hals eller mund, eller du har svært ved at komme af med urinen, skal du hurtigst muligt kontakte din læge, så mangel på hvide blodlegemer (agranulocytose) kan udelukkes ved en blodprøve.
English: Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.
Danish: Resultater fra tre prospektive, epidemiologiske undersøgelser (med resultater fra mere end 1.000 eksponeringer) viser ingen skadelige virkninger af omeprazol på graviditeten eller på fostrets/det nyfødte barns sundhedstilstand.
English: Effect on H. pylori
Danish: Virkning på H. pylori
English: Preparation
Danish: Tilberedning
English: There is limited information available on the effects of overdoses of omeprazole in humans.
Danish: Der er begrænset information til rådighed om virkningerne af overdosering med omeprazol hos mennesker.
English: This is because Losec can affect the way some medicines work and some medicines can have an effect on Losec.
Danish: Det skyldes, at Losec kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Losec.
English: Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased.
Danish: Derfor kan metabolismen af aktive stoffer, der indtages samtidig og metaboliseres af CYP2C19, nedsættes, og den systemiske eksponering for disse lægemidler øges.
English: Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action.
Danish: Omeprazol, en racemisk blanding af to enantiomerer, nedsætter sekretionen af mavesyre ved en yderst målrettet virkningsmekanisme.
English: Losec is to be administered in an intravenous infusion for 20-30 minutes.
Danish: Losec skal administreres som en intravenøs infusion i løbet af 20-30 minutter.
English: It is a specific inhibitor of the acid pump in the parietal cell.
Danish: Det er en specifik inhibitor af syrepumpen i parietalcellerne.
English: In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
Danish: I et andet forsøg blev det påvist, at administration af clopidogrel og omeprazol på forskellige tidspunkter ikke forhindrede deres interaktion, hvilket formodentlig skyldes omeprazols hæmmende virkning på CYP2C19.
English: The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.
Danish: Omeprazols farmakokinetik inklusive systemiske biotilgængelighed og eliminationshastighed er uændret hos patienter med nedsat nyrefunktion.
English: Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus.
Danish: Det er rapporteret, at samtidig administration af omeprazol øger serumniveauet af tacrolimus.
English: There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive esophagitis for up to 749 days.
Danish: Der er begrænsede langtids-sikkerhedsdata fra 46 børn, som i op til 749 dage fik omeprazol som vedligeholdelsesbehandling i et klinisk forsøg for svær erosiv øsofagitis.
English: In children: Children over 1 year of age and ≥ 10 kg
Danish: Hos børn: Børn over 1 år og ≥ 10 kg
English: A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.
Danish: Koncentrationen af tacrolimus samt nyrefunktionen (kreatininclearance) bør monitoreres, og tacrolimusdosis justeres om nødvendigt.
English: • You have severe liver problems.
Danish: • Hvis du har alvorlige leverproblemer.
English: Pharmacodynamic effects All pharmacodynamic effects observed can be explained by the effect of omeprazole on acid secretion.
Danish: Alle observerede farmakodynamiske virkninger kan forklares ved omeprazols virkning på syresekretionen.
English: No metabolite has been found to have any effect on gastric acid secretion.
Danish: Der er ikke fundet metabolitter med effekt på den gastriske syresekretion.