FrancophonIA/ELRC3.0 huggingface dataset:
English: H. pylori is a major factor in the development of atrophic gastritis which is associated with an increased risk of developing gastric cancer.
Danish: H. pylori er en vigtig faktor ved udviklingen af atrofisk gastritis, som associeres med en øget risiko for udvikling af ventrikelcancer.
English: Alternative preparation for infusions in flexible containers Use a double-ended transfer needle and attach to the injection membrane of the infusion bag.
Danish: Alternativ fremstilling af infusionvæske i fleksible beholdere Brug en overførselskanyle (dobbeltkanyle) og vedhæft til infusionsposens injektionsmembran.
English: Blister:
Danish: Blisterpakning:
English: For patients with swallowing difficulties
Danish: Patienter, der har svært ved at synke
English: This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.
Danish: Ved langtidsbehandling bør der tages højde for dette hos patienter med reduceret oplagring eller risikofaktorer for reduceret vitamin B12 absorption.
English: • Rifampicin (used to treat tuberculosis)
Danish: • Rifampicin (bruges til behandling af tuberkulose).
English: Your doctor will decide whether you can take Losec during this time.
Danish: Din læge vil tage stilling til, om du kan tage Losec i denne periode.
English: Paediatric patients There is limited experience with Losec for intravenous use in children.
Danish: Børn Der er begrænset erfaring med intravenøs anvendelse af Losec til børn.
English: HDPE bottle: with a tight fitting polypropylene screw-cap equipped with a desiccant capsule.
Danish: HDPE-beholder: Med tætsiddende polypropylen-skruelåg udstyret med tørrekapsel.
English: HDPE bottle:
Danish: HDPE-beholder:
English: The co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300 mg/ritonavir 100 mg once daily.
Danish: Coadministration af omeprazol (20 mg en gang dagligt) med atazanavir 400 mg/ritonavir 100 mg til raske frivillige resulterede i et fald i eksponeringen for atazanavir på ca. 30 % sammenlignet med atazanavir 300 mg/ritonavir 100 mg en gang dagligt.
English: An interaction is observed between clopidogrel and omeprazole (see section 4.5).
Danish: Der er set interaktion mellem clopidogrel og omeprazol (se pkt.
English: • Saquinavir (used to treat HIV infection)
Danish: • Saquinavir (bruges til behandling af HIV)
English: Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme.
Danish: Omeprazol er en moderat inhibitor af CYP2C19, som er det primære enzym i omeprazols metabolisme.
English: Omeprazole has not shown any tendency to accumulate with once daily dosing.
Danish: Omeprazol viser ingen tendens til akkumulering ved dosering en gang dagligt.
English: • Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
Danish: • Ketoconazol, itraconazol eller voriconazol (bruges til behandling af svampeinfektioner).
English: The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) of omeprazole and not to the actual plasma concentration at a given time.
Danish: Hæmningen af syresekretionen er relateret til AUC for omeprazol og ikke til den aktuelle plasmakoncentrationen på et givet tidspunkt.
English: Therapeutic drug monitoring of digoxin should be then be reinforced.
Danish: Serumkoncentrationen af digoxin bør monitoreres.
English: • Changes in blood count including agranulocytosis (lack of white blood cells).
Danish: • Ændringer i blodtælling inklusive nedsat antal hvide blodlegemer (agranulocytose).
English: Losec 40 mg powder and solvent for solution for injection (Powder for injection; and Solvent for reconstitution of solution for injection) comes in a combination pack consisting of a vial containing dry substance (I) and an ampoule containing solvent (II).
Danish: Losec 40 mg pulver og solvens til injektionsvæske (pulver til injektionsvæske og solvens til opblanding af injektionsvæske) er i en kombinationspakning, som indeholder et hætteglas med det tørre pulver (I), og en ampul, som indeholder solvensen (II).
English: As a consequence of reduced acid secretion and intragastric acidity, omeprazole dose-dependently reduces/normalizes acid exposure of the esophagus in patients with gastro-esophageal reflux disease.
Danish: Som en konsekvens af nedsat syreproduktion og nedsat surhedsgrad i ventriklen reducerer/normaliserer omeprazol dosisafhængigt øsofagus eksponering for syre hos patienter med gastroøsofageal reflukssygdom.
English: It is recommended to take Losec capsules in the morning, preferably without food, swallowed whole with half a glass of water.
Danish: Det anbefales at tage Losec kapsler om morgenen, helst uden mad.
English: • The medicine will be given to you as an infusion into one of your veins.
Danish: • Du vil få medicinen som infusion i en blodåre.
English: If you notice any of the following rare but serious side effects, stop using Losec and contact a doctor immediately:
Danish: Hvis du får nogen af følgende sjældne, men alvorlige bivirkninger, skal du stoppe med at få Losec og straks kontakte lægen:
English: Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
Danish: Din læge kan vælge at give dig samme dosis i yderligere 2 uger, hvis dit sår ikke er helet.
English: Impaired hepatic function In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient (see section 5.2).
Danish: Hos patienter med nedsat leverfunktion kan en daglig dosis på 10-20 mg være tilstrækkelig (se pkt.
English: SOC/frequency Adverse reaction
Danish: Organklasse/frekvens Bivirkning
English: Side effects such as dizziness and visual disturbances may occur (see section 4).
Danish: Der kan forekomme bivirkninger som f.eks. svimmelhed og synsforstyrrelser (se pkt.
English: If you notice any of the following rare but serious side effects, stop taking Losec and contact a doctor immediately:
Danish: Hvis du får nogen af følgende sjældne, men alvorlige bivirkninger, skal du stoppe med at tage Losec og straks kontakte lægen:
English: The major part of its metabolism is dependent on the polymorphically expressed CYP2C19, responsible for the formation of hydroxyomeprazole, the major metabolite in plasma.
Danish: Størstedelen af omeprazols metabolisering er afhængig af det polymorft formulerede CYP2C19, som er ansvarligt for dannelsen af hydroxyomeprazol, der er den primære metabolit i plasma.
English: These micro-pellets contain the active substance omeprazole and are enteric coated which protects them from being broken down during passage through the stomach.
Danish: Perlerne indeholder det aktive stof omeprazol og er overtrukne, hvilket beskytter dem mod at blive nedbrudt i maven.
English: Losec solution for injection must be given only as an intravenous injection and it must not be added to infusion solutions.
Danish: Losec injektionsvæske må kun gives som intravenøs injektion og må ikke tilsættes andre infusionsopløsninger.
English: • Phenytoin (used in epilepsy).
Danish: • Phenytoin (bruges til behandling af epilepsi).
English: Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported.
Danish: Der er rapporteret om kvalme, opkastning, svimmelhed, abdominale smerter, diarré og hovedpine.
English: • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
Danish: • De har fået kontinuerlig symptomatisk behandling for fordøjelsesbesvær eller halsbrand i 4 uger eller mere
English: Side effects may occur with certain frequencies, which are defined as follows: Very common:
Danish: Bivirkninger kan forekomme, hyppigheden er defineret som følger: Meget almindelig: forekommer hos flere end 1 ud af 10 behandlede Almindelig:
English: Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
Danish: Din læge kan vælge at give dig samme dosis i yderligere 4 uger, hvis dit sår ikke er helet.
English: For patients with swallowing difficulties and for children who can drink or swallow semi-solid food Patients can break the tablet and disperse it in a spoonful of non-carbonated water and if so wished, mix with some fruit juices or applesauce.
Danish: Patienter, der har svært ved at synke, og børn, der kan drikke eller synke halvfast føde Patienterne kan dele enterotabletten og opslæmme den i en skefuld vand uden kulsyre og - hvis det ønskes - blande med frugtjuice eller æblemos.
English: Always take Losec exactly as your doctor has told you.
Danish: Tag altid Losec nøjagtigt efter lægens anvisning.
English: • If your gullet has not been damaged, the usual dose is 10 mg once a day.
Danish: • Hvis dit spiserør ikke er beskadiget, er den sædvanlige dosis 10 mg én gang dagligt.
English: Solution for infusion reconstituted with sodium chloride 9 mg/ml (0.9%) should be used within 12 hours after preparation.
Danish: Opløsning til infusion opblandet med natriumchlorid 9 mg/ml (0,9 %) bør anvendes inden for 12 timer efter fremstilling.
English: • St John's wort (Hypericum perforatum) (used to treat mild depression)
Danish: • Naturlægemidlet perikon (Hypericum perforatum) (bruges til behandling af milde depressioner)
English: What to do if you or your child have trouble swallowing the tablets
Danish: Hvad du kan gøre, hvis du eller dit barn har svært ved at synke enterotabletterne
English: Vials can however be stored exposed to normal indoor light out side the box for up to 24 hours.
Danish: Hætteglas kan dog opbevares i normal indendørsbelysning uden for yderkartonen i op til 1 døgn.
English: Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5).
Danish: Co-administration af atazanavir med protonoumpehæmmere kan ikke anbefales (se pkt.
English: Losec can also be used to stop ulcers from forming if you are taking NSAIDs.
Danish: Losec kan også bruges til at hindre mavesår, hvis du tager lægemidler af typen NSAID.
English: The interaction may also involve CYP2C19 inhibition.
Danish: Interaktionen kan også involvere hæmning af CYP2C19.
English: Break the tablet and disperse it in a spoonful of non-carbonated water - if so wished, mix with some fruit juices or applesauce.
Danish: Del enterotabletten og opslæm den i en skefuld vand uden kulsyre - og hvis det ønskes, bland med frugtjuice eller æblemos.
English: • They have jaundice or severe liver disease.
Danish: • De har gulsot eller alvorlig leversygdom
English: With omeprazole 20 mg, a mean decrease of at least 80% in 24-hour intragastric acidity is then maintained in duodenal ulcer patients, with the mean decrease in peak acid output after pentagastrin stimulation being about 70% 24 hours after dosing.
Danish: Med omeprazol 20 mg bibeholdes en gennemsnitlig reduktion af ventriklens surhedsgrad på mindst 80 % over 24 timer hos patienter med duodenalt ulcus, mens den gennemsnitlige reduktion af den maksimale syreproduktion efter pentagastrinstimulering er ca. 70 % 24 timer efter dosisindgift.
English: • You get stomach pain or indigestion.
Danish: • Hvis du får mavesmerter eller fordøjelsesbesvær.
English: These findings have no implications for the posology of omeprazole.
Danish: Dette har dog ingen konsekvenser for doseringen af omeprazol.
English: Oral dosing with omeprazole once daily provides for rapid and effective inhibition of daytime and nighttime gastric acid secretion with maximum effect being achieved within 4 days of treatment.
Danish: En oral dosis omeprazol en gang daglig giver en hurtig og effektiv hæmning af mavesyresekretionen i dag- og nattetimerne med maksimal virkning inden for 4 dages behandling.
English: To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
Danish: Til behandling af mavesår og sår på den øverste del tarmen opstået som følge af behandling med NSAID (non-steroide anti-inflammatoriske lægemidler):
English: Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together.
Danish: Den gennemsnitlige hæmning af blodpladeaggregation (IPA) blev reduceret med 47 % (24 timer) og 30 % (dag 5), når clopidogrel og omeprazol blev administreret samtidigt.
English: HOW LOSEC IS GIVEN TO YOU
Danish: SÅDAN SKAL LOSEC GIVES TIL DIG
English: • The medicine will be given to you as an injection into one of your veins.
Danish: • Du vil få medicinen som injektion i en blodårer.
English: To prevent duodenal and stomach ulcers if you are taking NSAIDs: • The usual dose is 20 mg once a day.
Danish: For at forebygge mavesår og sår på den øverste del af tarmen, hvis du tager NSAID: • Den sædvanlige dosis er 20 mg én gang dagligt.
English: This will make it easier to add the remaining solvent.
Danish: Dette letter injektionen af resten af opløsningsmidlet.
English: Draw the omeprazole solution back into the syringe.
Danish: Sug omeprazolopløsningen op i sprøjten igen.
English: Losec for intravenous use is indicated as an alternative to oral therapy for the following indications:
Danish: Losec til intravenøs brug er indiceret som et alternativ til oral terapi til følgende indikationer
English: Ampoule of solvent
Danish: Ampul med solvens:
English: Active substances metabolised by CYP2C19
Danish: Lægemidler, der metaboliseres via CYP2C19
English: • You can take your capsules with food or on an empty stomach.
Danish: • Du kan tage kapslerne sammen med mad eller på tom mave.
English: This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Danish: Dette kan være ledsaget af høj feber og ledsmerter (erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse).
English: During long-term treatment gastric glandular cysts have been reported in a somewhat increased frequency.
Danish: Ved langtidsbehandling er der rapporteret en noget øget frekvens af gastriske, glandulære cyster.
English: • Skin rash on exposure to sunshine.
Danish: • Hududslæt ved udsættelse for sollys.
English: In the presence of any alarm symptoms (eg, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
Danish: Hvis der er nogen form for alarmsymptomer (fx signifikant, utilsigtet vægttab, gentagne opkastninger, dysfagi, hæmatemese eller melæna), og hvis gastrisk ulcus er mistænkt eller bekræftet, skal malign lidelse udelukkes, da behandlingen kan lindre symptomerne og derved forsinke diagnosticering.
English: Concomitant administration of omeprazole with saquinavir/ritonavir resulted in increased plasma levels up to approximately 70% for saquinavir associated with good tolerability in HIV-infected patients.
Danish: Samtidig administration af omeprazol og saquinavir/ritonavir resulterede i øgede plasmakoncentrationer af saquinavir på op til omkring 70 %.
English: Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).
Danish: Behandling med protonpumpehæmmere kan medføre en let forøget risiko for gastrointestinale infektioner såsom Salmonella og Campylobacter (se pkt.
English: INFORMATION IN BRAILLE Hospital pack: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Hospitalspakning: Fritaget for krav om blindeskrift
English: To treat symptoms of GERD such as heartburn and acid regurgitation:
Danish: Til behandling af GERD-symptomer såsom halsbrand og sure opstød:
English: Almost 80% of an oral dose of omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.
Danish: Næsten 80 % af en oral omeprazoldosis udskilles som metabolitter i urinen, den resterende del, som primært stammer fra galdesekretion, i fæces.
English: None was found to be dose-related.
Danish: Ingen var dosisafhængige.
English: If affected, you should not drive or operate machinery.
Danish: Hvis du bliver påvirket af disse, må du ikke føre motorkøretøj eller betjene maskiner.
English: • Shelf life after reconstitution:
Danish: • Holdbarhed efter opløsning:
English: 560 tablets
Danish: 560 enterotabletter
English: • Shelf life after reconstitution: The reconstituted solution should not be stored at temperatures above 25°C and should be used within 4 hours after preparation.
Danish: Opblandet opløsning bør ikke opbevares ved temperaturer over 25 °C og bør anvendes inden for 4 timer efter fremstilling.
English: • Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Danish: • Mavesår, som er opstået ved brug af smertestillende medicin af typen NSAID (non-steroide antiinflammatoriske lægemidler, ”gigtmedicin”).
English: Posology in adults
Danish: Dosering til voksne
English: Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole serum levels by decreasing omeprazole's rate of metabolism.
Danish: Da omeprazol metaboliseres via CYP2C19 og CYP3A4, kan lægemidler, der hæmmer CYP2C19 eller CYP3A4 (såsom clarithromycin og voriconazol), medføre øgede serumniveauer af omprazol, idet omeprazols metaboliseringshastighed falder.
English: Sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion must be used.
Danish: Natriumchloridinfusionsvæske 9 mg/ml (0,9 %) eller glucoseinfusionsvæske 50 mg/ml (5 %) skal anvendes.
English: To treat ulcers in the upper part of the intestine (duodenal ulcer):
Danish: Til behandling af sår på den øverste del af tarmen (duodenalt ulcus):
English: Use only clear, colourless or pale yellowish-brown solutions.
Danish: Kun klare eller svagt gulbrune opløsninger må anvendes.
English: Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract.
Danish: Nedsat gastrisk surhedsgrad, uanset årsag inklusive protonpumpehæmmere, øger antallet af normalt forekommende bakterier i mave-tarm-kanalen.
English: If you forget to take Losec
Danish: Hvis du har glemt at tage Losec
English: Almost 80% of a dose of omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.
Danish: Næsten 80 % af en omeprazoldosis udskilles som metabolitter i urinen, den resterende del, som primært stammer fra galdesekretion, i fæces.
English: Co-administration of omeprazole (40 mg once daily) reduced mean nelvinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%.
Danish: Co-administration af omeprazol (40 mg en gang dagligt) reducerede den gennemsnitlige eksponering for nelfinavir med ca. 40 %, og den gennemsnitlige eksponering for den farmakologisk aktive metabolit M8 blev reduceret med 75-90 %.
English: Children and adolescents over 4 years of age • In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
Danish: Børn og unge over 4 år • Behandling af duodenalt ulcus forårsaget af H. pylori i kombination med antibiotika
English: Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir exposure.
Danish: Samtidig administration af omeprazol (40 mg én gang dagligt) og atazanavir 300 mg/ritonavir 100 mg til raske frivillige resulterede i en reduktion af atazanavir-eksponeringen på 75 %.
English: your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Danish: Hvis du lider af dette, kan din læge også udskrive antibiotika, så infektionen behandles, og såret kan få ro til at hele.
English: • Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
Danish: • Pludseligt åndedrætsbesvær, hævelse af læber, tunge og hals eller andre steder på kroppen, udslæt, besvimelse eller besvær med at synke (alvorlig allergisk reaktion).
English: Some children with chronic illnesses may require long-term treatment although it is not recommended.
Danish: Selvom det ikke er anbefalet kan nogle børn med kroniske sygdomme behøve langvarig behandling.
English: In patients with Zollinger-Ellison Syndrome the recommended initial dose of Losec given intravenously is 60 mg daily.
Danish: Til patienter med Zollinger-Ellisons syndrom er den anbefalede initialdosis Losec 60 mg i.v.
English: Monitoring phenytoin plasma concentration is recommended during the first two weeks after initiating omeprazole treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending omeprazole treatment.
Danish: Det anbefales at monitorere plasmakoncentrationen af phenytoin de to første uger efter initiering af omeprazolbehandling.
English: The recommended initial dose is Losec 60 mg daily.
Danish: Den anbefalede initialdosis er Losec 60 mg dagligt.
English: To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
Danish: Til behandling af for meget mavesyre på grund af en svulst i bugspytkirtlen (Zollinger-Ellisons syndrom):
English: In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days.
Danish: I et klinisk overkrydsningsforsøg blev clopidogrel (300 mg initialdosis efterfulgt af 75 mg dagligt) administreret alene og sammen med omeprazol (80 mg givet samtidig med clopidogrel) i 5 dage.
English: Children:
Danish: Børn
English: Connect the other needle-end from the vial with freeze-dried omeprazole.
Danish: Forbind den anden ende af sprøjten til hætteglasset med frysetørret omeprazol.
English: The AUC of omeprazole increases with repeated administration due to a decrease of systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulphone).
Danish: AUC øges ved gentagen administration af omeprazol på grund af et fald i systemisk clearance, som sandsynligvis skyldes omeprazols og/eller dets metabolitters (f.eks. sulfon) hæmning af CYP2C19enzymet.
English: The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and repeated oral once-daily dosing.
Danish: Halveringstiden for omeprazols elimination fra plasma er som regel under 1 time både efter enkelt og gentagen oral dosering en gang dagligt.
English: • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Danish: • For meget mavesyre på grund af en svulst i bugspytkirtlen (Zollinger-Ellisons syndrom).
English: This time- and dosedependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulphone).
Danish: Denne tids- og dosisafhængighed skyldes et fald i first pass metabolismen og systemisk clearance, som sandsynligvis skyldes omeprazols og/eller dets metabolitters (f.eks. sulfonets) hæmning af CYP2C19-enzymet.
English: Increased sweating
Danish: Øget svedtendens
English: Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole intravenous injection, especially at high doses, but no causal relationship has been established.
Danish: I enkelte tilfælde er der rapporteret om irreversibelt nedsat syn hos alvorligt syge patienter, som har fået intravenøs injektion af omeprazol, især ved høje doser.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige tilstande som galactoseintolerans, Lapp lactasemangel eller glucose-galactosemalabsorbtion bør ikke tage dette lægemiddel.