FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not experience relief, or if you experience a worsening of symptoms, consult your doctor.
Danish: Hvis du ikke får det bedre eller får en forværring af symptomerne, skal du tale med din læge.
English: Especially, patients over 55 years taking any ‘over-the-counter' (OTC, non-prescription) indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Danish: Specielt patienter over 55 år, som dagligt tager ikke-receptpligtige lægemidler mod fordøjelsesbesvær og halsbrand, bør informere deres apotek eller læge.
English: The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing.
Danish: Følgende bivirkninger er påvist eller anset som mulige i omeprazols kliniske forsøgsprogram og postmarketing.
English: Losec is used to treat the following conditions:
Danish: Losec bruges til at behandle følgende:
English: What to do if you or your child have trouble swallowing the capsules
Danish: Hvad du kan gøre, hvis du eller dit barn har svært ved at synke kapslerne
English: • You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
Danish: • Hvis du får svær eller vedvarende diarré, eftersom brug af omeprazol er sat i forbindelse med en let øget risiko for smitsom diarré.
English: The metabolism of omeprazole in patients with liver dysfunction is impaired, resulting in an increased AUC.
Danish: Omeprazols metabolisme er nedsat hos patienter med nedsat leverfunktion, hvilket resulterer i en øget AUC.
English: As high doses of omeprazole have been well-tolerated adjustment of the omeprazole dose is not generally required.
Danish: Eftersom høje doser af omeprazol har været veltolereret, er det typisk ikke nødvendigt at justere omeprazoldosis.
English: However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
Danish: Dog bør dosisjustering overvejes hos patienter med alvorligt nedsat leverfunktion, og hvis langvarig behandling er indiceret.
English: In a single-blind study, children aged 0-24 months with clinically diagnosed gastro-esophageal reflux disease were treated with 0.5, 1.0 or 1.5 mg omeprazole/kg.
Danish: I et enkeltblindet forsøg blev børn mellem 0 og 24 måneder med klinisk diagnosticeret gastroøsofageal reflukssygdom behandlet med 0,5, 1,0 eller 1,5 mg omeprazol/kg.
English: Children over 1 year of age and ≥ 10 kg
Danish: Børn over 1 år og ≥ 10 kg
English: Powder for solution for infusion (Powder for infusion) pH interval in glucose is approximately 8.9-9.5 and in sodium chloride 0.9%, 9.3-10.3
Danish: Pulver til infusionsvæske, opløsning pH-intervallet i glucose er ca. 8,9-9,5 og 9,3-10,3 i natriumchlorid 0,9 %.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Danish: Bivirkningerne er nedenfor anført efter frekvens og organklasse.
English: Like all medicines, Losec can cause side effects, although not everybody gets them.
Danish: Losec kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The solution for infusion is to be administrered in an intravenous infusion for 20-30 minutes.
Danish: Infusionsopløsningen bør gives som en intravenøs infusion i løbet af 20-30 minutter.
English: Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease: The treatment time is 2-4 weeks.
Danish: Symptomatisk behandling af halsbrand og syreregurgitation ved gastroøsofageal reflukssygdom: Behandlingstiden er 2-4 uger.
English: The entire contents of each vial is to be dissolved in approximately 5 ml and then immediately diluted to 100 ml.
Danish: Hele indholdet i et hvert hætteglas opløses i cirka 5 ml og fortyndes umiddelbart efter til 100 ml.
English: The decreased intragastric acidity during treatment with omeprazole might increase or decrease the absorption of active substances with a gastric pH dependent absorption.
Danish: Den nedsatte intragastriske surhedsgrad under behandling med omeprazol kan øge eller nedsætte absorptionen af aktive stoffer med gastrisk pH-afhængig absorption.
English: Absorption of omeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose.
Danish: Absorptionen af omeprazol er hurtig med maksimale plasmakoncentrationer cirka 1-2 timer efter dosering.
English: In such individuals the metabolism of omeprazole is probably mainly catalysed by CYP3A4.
Danish: Sandsynligvis er omeprazols metabolisering hos disse personer hovedsageligt katalyseret af CYP3A4.
English: Withdraw as much air as possible from the vial back into the syringe.
Danish: Sug derefter mest mulig luft ud af hætteglasset og tilbage i sprøjten.
English: • Feeling agitated, confused or depressed.
Danish: • Ophidselse, forvirring eller depression.
English: • Digoxin (used to treat heart problems)
Danish: • Digoxin (bruges til behandling af hjerteproblemer).
English: • if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec.
Danish: • Hvis du er overfølsom (allergisk) over for omeprazol eller et af de øvrige indholdsstoffer.
English: With a syringe draw 5 ml of infusion solution from the 100 ml infusion bottle or bag.
Danish: Med en sprøjte optrækkes 5 ml infusionsvæske fra en infusionsflaske/pose på 100 ml.
English: Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Danish: Omeprazol kan i lighed med alle syrehæmmende midler reducere absorptionen af cyanocobalamin (vitamin B12) på grund af hypo- eller aklorhydri.
English: H. pylori is a major factor in the development of gastritis.
Danish: H. pylori er en vigtig faktor i udvikling af gastritis.
English: They could, however, be considered in cases where known hypersensitivity precludes use of any triple combination.
Danish: De kan dog overvejes i tilfælde, hvor overfølsomhed udelukker 3-stof-terapierne.
English: Active substances with pH dependent absorption
Danish: Lægemidler med pH-afhængig absorption
English: The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together.
Danish: Eksponeringen for den aktive metabolit af clopidogrel blev reduceret med 46 % (dag 1) og 42 % (dag 5), når clopidogrel og omeprazol blev administreret samtidigt.
English: Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.
Danish: Overfølsomhed over for omeprazol, substituerede benzimidazoler eller over for et eller flere af hjælpestofferne.
English: Alternatively patients can suck the capsule and swallow the pellets with half a glass of water.
Danish: Alternativt kan patienter sutte på kapslen og synke enterogranulatet med et halv glas vand.
English: Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+ K+-ATPase - the acid pump.
Danish: Omeprazol er en svag base, der koncentreres og omdannes til den aktive form i det meget sure miljø i parietalcellernes intracellulære canaliculi, hvor det hæmmer enzymet H+,K+-ATPase, syrepumpen.
English: Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%.
Danish: Samtidig behandling med omeprazol (20 mg dagligt) og digoxin til raske frivillige øgede biotilgængeligheden af digoxin med 10 %.
English: The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.
Danish: De almindeligst forekommende bivirkninger (ses hos 1-10 % af patienterne) er hovedpine, abdominalsmerte, obstipation, diarré, flatulens og kvalme/opkastning.
English: When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered.
Danish: Ved start og afslutning af behandling med omeprazol skal risikoen for interaktioner med lægemidler, som metaboliseres via CYP2C19, tages i betragtning.
English: • Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever,
Danish: • Overfølsomhedsreaktioner, til tider meget alvorlige, heriblandt hævelse af læber, tunge og hals,
English: • Tacrolimus (in cases of organ transplantation)
Danish: • Tacrolimus (bruges i forbindelse med organtransplantation).
English: Repeat steps 1-4 to make sure all omeprazole is transferred from the vial into the infusion bag or bottle.
Danish: Gentag trin 1-4 for at sikre, at al omeprazol er overført fra hætteglasset til infusionsflasken/posen.
English: It is important not to damage the pellets.
Danish: Det er vigtigt ikke at ødelægge perlerne (pellets).
English: Improperly prepared solutions can be identified by their yellow to brown discolouration and must not be used.
Danish: Opløsninger, der ikke er fremstillet korrekt, kan identificeres ved en gul til brunlig misfarvning og må ikke anvendes.
English: • Swelling of the feet and ankles.
Danish: • Hævede fødder og ankler.
English: If symptom control has not been achieved after four weeks treatment with Losec 20 mg daily, further investigation is recommended.
Danish: Hvis symptomkontrol ikke er opnået efter 4 ugers behandling med Losec 20 mg dagligt, anbefales yderligere undersøgelser.
English: If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.
Danish: Hvis du er i tvivl, så tal med din læge, sundhedspersonalet eller apoteket, inden du får denne medicin.
English: • ‘Gastro-esophageal reflux disease' (GERD).
Danish: • Gastroøsofageal reflukssygdom (GERD).
English: 10 mg once daily.
Danish: 40 mg én gang daglig.
English: The AUC of omeprazole increases with repeated administration.
Danish: AUC øges ved gentagen administration af omeprazol.
English: • Ulcers which are infected with bacteria called ‘Helicobacter pylori'.
Danish: • Mavesår, som er inficeret med bakterien ‘Helicobacter pylori'.
English: Similar findings have been made after treatment with H2-receptor antagonists, proton pump inhibitors and after partial fundectomy.
Danish: Tilsvarende forandringer er fundet efter behandling med H2-receptorantagonister, protonpumpehæmmere og efter gastrisk fundektomi.
English: Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure.
Danish: Øgning af atazanavir dosis til 400 mg kompenserede ikke for indvirkningen af omeprazol på atazanavir-eksponeringen.
English: However, due to low affinity to CYP3A4, omeprazole has no potential to inhibit the metabolism of other CYP3A4 substrates.
Danish: På grund af den lave affinitet til CYP3A4 har omeprazol dog ikke potentialet til at inhibere metabolismen af andre CYP3A4-substrater.
English: As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.
Danish: Som en forholdsregel frarådes samtidig brug af omeprazol og clopidogrel.
English: These changes are the result of sustained hypergastrinaemia secondary to acid inhibition.
Danish: Disse forandringer er et resultat af langvarig hypergastrinæmi, der er sekundær til syrehæmning.
English: • Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
Danish: • Blodfortyndende medicin, som warfarin eller andre vitamin K hæmmere.
English: Patients should be advised that the dispersion should be taken immediately (or within 30 minutes)and always be stirred just before drinking and rinsed down with half a glass of water.
Danish: Patienterne bør instrueres i, at opslæmningen skal indtages med det samme (eller inden for 30 minutter) og altid omrøres, umiddelbart før den drikkes.
English: For the eradication of H. pylori the selection of antibiotics should consider the individual patient's drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.
Danish: Til eradikation af H. pylori bør valget af antibiotika tages under hensyn til den enkelte patients lægemiddeltolerance og i overensstemmelse med nationale, regionale og lokale resistensmønstre og behandlingsvejledninger.
English: As a consequence of high affinity of omeprazole to CYP2C19, there is a potential for competitive inhibition and metabolic drug-drug interactions with other substrates for CYP2C19.
Danish: Som en konsekvens af omeprazols høje affinitet til CYP2C19 er der potentiale for kompetitiv inhibering og metabolisk lægemiddel-lægemiddel interaktioner med andre substrater for CYP2C19.
English: For posaconazol and erlotinib concomitant use should be avoided.
Danish: Med hensyn til posaconazol og erlonitib bør samtidig anvendelse undgås.
English: • Increased sweating.
Danish: • Øget svedtendens.
English: • You have had previous gastric ulcer or gastrointestinal surgery.
Danish: • De tidligere har haft gastrisk ulcus eller fået foretaget gastrointestinal kirurgi
English: Omeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.
Danish: Omeprazol elimineres fuldstændigt fra plasma mellem doserne uden tendens til akkumulering ved administration en gang dagligt.
English: • It is recommended that you take your tablets in the morning.
Danish: • Det anbefales at tage enterotabletterne om morgenen.
English: You must contact a doctor if your symptoms worsen or do not improve after 14 days.
Danish: - Kontakt lægen, hvis du får det værre, eller hvis du ikke får det bedre inden for 14 dage.
English: Eradication of H. pylori in children
Danish: Eradikation af H. pylori hos børn
English: However, there was no evidence of any clinical benefit with respect to dyspeptic symptoms.
Danish: Med hensyn til dyspeptiske symptomer var der dog ikke evidens for kliniske fordele.
English: • Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Danish: • Diazepam (bruges til behandling af angst, til muskelafslapning og mod epilepsi).
English: • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
Danish: • Sår på den øverste del af tarmen (duodenalt ulcus) eller i maven (gastrisk ulcus).
English: Reflux is the backflow of acid from the stomach into the gullet “foodpipe”, which may become inflamed and painful.
Danish: Refluks er tilbageløb af syre fra maven til spiserøret, som kan blive betændt og smertefuldt.
English: Losec capsules are indicated for:
Danish: Losec kapsler er indiceret til:
English: After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute.
Danish: Efter tilberedning gives injektionen langsomt i løbet af mindst 2½ minut og med en hastighed på maksimalt 4 ml pr. minut.
English: If you are not sure, talk to your doctor or pharmacist before taking Losec.
Danish: Hvis du er i tvivl, så tal med din læge eller apoteket, inden du tager Losec.
English: • Severe liver problems leading to liver failure and inflammation of the brain.
Danish: • Alvorlige leverproblemer, der kan føre til leversvigt og betændelse i hjernen.
English: 280 capsules
Danish: 280 kapsler
English: In a non-controlled study in children (1 to 16 years of age) with severe reflux esophagitis, omeprazole at doses of 0.7 to 1.4 mg/kg improved esophagitis level in 90% of the cases and significantly reduced reflux symptoms.
Danish: I et ikke-kontrolleret forsøg med børn (mellem 1 og 16 år) med svær refluksøsofagitis forbedrede omeprazol i doser mellem 0,7-1,4 mg/kg graden af øsofagitis i 90 % af tilfældene og reducerede reflukssymptomerne signifikant.
English: Intravenous doses of up to 270 mg on a single day and up to 650 mg over a three-day period have been given in clinical trials without any dose-related adverse reactions.
Danish: I kliniske undersøgelser er der givet intravenøse doser på op til 270 mg på en enkelt dag og op til 650 mg over en periode på tre dage uden nogle dosisrelaterede bivirkninger.
English: This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Danish: Det kan give symptomer som en smertefuld, brændende fornemmelse i brystet og op i halsen (halsbrand) og en sur smag i munden (sure opstød).
English: • You lose a lot of weight for no reason and have problems swallowing.
Danish: • Hvis du uventet taber dig meget og har svært ved at synke.
English: Detailed information on this product is available on the website of: {name of MS/Agency} [To be completed nationally]
Danish: Yderligere information om dette lægemiddel er tilgængelig på {Medlemslandets/lægemiddelagenturets navn} hjemmeside} hjemmeside: [Udfyldes nationalt]
English: In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose).
Danish: I litteraturen er doser op til 560 mg beskrevet, og lejlighedsvis er der rapporteret om enkelte orale doser på op til 2.400 mg omeprazol (120 gange større end den sædvanligt anbefalede kliniske dosis).
English: This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Se Bilag I - Udfyldes nationalt]
English: This results in an immediate decrease in intragastric acidity and a mean decrease over 24 hours of approximately 90% for both iv injection and iv infusion.
Danish: Herved falder ventriklens surhedsgrad umiddelbart, og over 24 timer er det gennemsnitlige fald på ca. 90 % både ved intravenøs infusion og injektion.
English: Important information about some of the ingredients of Losec Losec capsules contain lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Losec Losec kapsler indeholder lactose.
English: In order to immediately achieve a similar reduction of intragastric acidity as after repeated dosing with 20 mg orally, a first dose of 40 mg intravenously is recommended.
Danish: For øjeblikkeligt at opnå en hæmning svarende til samme ventrikelsurhedsgrad som efter gentagen indgift af 20 mg oralt anbefales en initialdosis på 40 mg intravenøst.
English: After repeated once-daily administration of 20 mg omeprazole, the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers).
Danish: Efter gentagen administration af 20 mg omeprazol en gang dagligt var middel-AUC 5-10 gange højere hos ”poor metabolisers” end hos individer med et funktionelt CYP2C19-enzym (”extensive metabolisers”).
English: To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
Danish: Til behandling af mavesår forårsaget af infektion med Helicobacter pylori, og for at forebygge, de kommer igen:
English: Treatment of Zollinger-Ellison syndrome
Danish: Behandling af Zollinger-Ellisons syndrom
English: Dissolve the omeprazole substance by pumping the infusion solution back and forward between the infusion bag and the vial.
Danish: Opløs omeprazolpulveret ved at pumpe infusionsopløsningen frem og tilbage mellem infusionspose og hætteglas.
English: Losec is not likely to affect the ability to drive or use machines.
Danish: Losec påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: In each regimen, if the patient is still H. pylori positive, therapy may be repeated.
Danish: Hvert behandlingsregime kan gentages, hvis patienten stadig er H. pylori positiv.
English: Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
Danish: Behandling med syrehæmmende farmaka kan derfor medføre en let forøget risiko for gastrointestinale infektioner såsom Salmonella og Campylobacter.
English: Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.
Danish: Omeprazol givet i doser på 40 mg til raske frivillige i en cross-over undersøgelse øgede Cmax og arealet under plasmakoncentration-tid-kurven (AUC) for cilostazol med henholdsvis 18 % og 26 % og for en af dets aktive metabolitter med henholdsvis 29 % og 69 %.
English: If affected, patients should not drive or operate machinery.
Danish: Hvis patienter påvirkes af disse, må de ikke føre motorkøretøj eller betjene maskiner.
English: Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C after reconstitution with sodium chloride 9 mg/ml (0.9%) solution for infusion and for 6 hours at 25°C after reconstitution with glucose 50 mg/ml (5%) solution for infusion.
Danish: Der er vist kemisk og fysisk stabilitet i 12 timer ved 25 °C efter opblanding med natriumchloridinfusionsvæske 9 mg/ml (0,9 %) og i 6 timer ved 25 °C efter opblanding med glucoseinfusionsvæske 50 mg/ml (5 %).
English: • An infection called “thrush” which can affect the gut and is caused by a fungus.
Danish: • En infektion kaldet trøske, som kan angribe fordøjelseskanalen og er forårsaget af en svamp.
English: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders Rare:
Danish: Overfølsomhedsreaktioner f.eks. feber, angioødem og anafylaktisk reaktion/shock Metabolisme og ernæring Sjælden:
English: Reproductive system and breast disorders Very rare:
Danish: Det reproduktive system og mammae Meget sjælden:
English: When dose exceed Losec 80 mg daily, the dose should be divided and given twice daily.
Danish: Når dosis overskrider Losec 80 mg dagligt, bør dosis deles og gives to gange dagligt.
English: Solution for infusion reconstituted with glucose 50 mg/ml (5%) should be used within 6 hours after preparation.
Danish: Opløsning til infusion opblandet med glucose 50 mg/ml (5 %) bør anvendes inden for 6 timer efter fremstilling.
English: Nelfinavir, atazanavir The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.
Danish: Nelfinavir, atazanavir Plasmakoncentrationerne af nelfinavir og atazanavir reduceres ved co-administration af omeprazol.
English: H. pylori is associated with peptic ulcer disease, including duodenal and gastric ulcer disease.
Danish: H. pylori er associeret med peptisk ulcussygdom, inklusive duodenal og gastrisk ulcussygdom.
English: Your doctor will tell you how many tablets to take and how long to take them for.
Danish: Din læge vil fortælle dig, hvor mange enterotabletter du skal tage, og hvor længe du skal tage dem.
English: The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight.
Danish: Hos raske forsøgspersoner er det tilsyneladende fordelingsvolumen (Vdapp) ca. 0,3 l/kg legemsvægt.
English: Vial of active substance
Danish: Hætteglas med aktiv substans
English: This could be ‘Stevens-Johnson syndrome' or ‘toxic epidermal necrolysis'.
Danish: Dette kan være ”Stevens-Johnsons syndrom” eller ”toksisk epidermal nekrolyse”.
English: When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.
Danish: Behandling af duodenalt ulcus forårsaget af H. pylori Ved valg af relevant kombinationsbehandling bør officielle nationale, regionale og lokale vejledninger vedrørende bakteriel resistens, behandlingsvarighed (som oftest 7 dage, men af og til op til 14 dage), og hensigtsmæssig brug af antibiotika tages i betragtning.
English: Dermatitis, pruritus, rash, urticaria
Danish: Dermatitis, pruritus, hududslæt, urticaria
English: • Treatment of Zollinger-Ellison syndrome
Danish: • Behandling af Zollinger-Ellisons syndrom
English: When doses exceed 60 mg daily, the dose should be divided and given twice daily.
Danish: Hvis dosis overstiger 60 mg daglig, bør dosis deles og administreres 2 gange daglig.