FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use with posaconazol and erlotinib should be avoided.
Danish: Det bør undgås at anvende omeprazol sammen med posaconazol og erlotinib.
English: The CHMP noted that heartburn was not included in the definition of dyspepsia agreed upon by an international committee of clinical investigators (Rome III Committee).
Danish: CHMP bemærkede, at halsbrand ikke var inkluderet i definitionen af dyspepsi, som er accepteret af den internationale komité af kliniske investigatorer (Rom III-komitéen).
English: Further information on recommended antibiotic combinations is stated in Section 4.2.
Danish: Yderligere oplysninger om anbefalede antibiotikakombinationer findes i afsnit.
English: Commitments by the MAH were agreed, as listed in the Letter of Undertaking dated 14 December 2009.
Danish: Indehaveren af markedsføringstilladelsens forpligtelser blev vedtaget som anført i tilsagnsbrevet dateret den 14. december 2009.
English: Appropriate information on the drug product was also provided, and the physical appearance, manufacture, specification, stability, shelf-life, storage were covered.
Danish: Relevant information om lægemidlet blev også fremlagt, og det fysiske udseende, fremstilling, specifikation, stabilitet, holdbarhed og opbevaring blev dækket.
English: The prophylactic use of Losec, as distinct from the treatment indications was also discussed and justified.
Danish: Profylaktisk anvendelse af Losec til forskel fra behandlingsindikationer blev også drøftet og begrundet.
English: Patients with impaired hepatic function should be advised by a doctor before taking Losec.
Danish: Patienter med nedsat leverfunktion bør rådgives af en læge, før de tager Losec.
English: The CHMP considered the IV formulations to be alternatives to oral therapy in adult patients where the use of oral medicinal products is inappropriate.
Danish: CHMP anså iv-formuleringerne for at være alternativer til oral behandling hos voksne patienter, hvor anvendelse af orale lægemidler er uegnet.
English: Omeprazole is a substituted benzimidazole belonging to the therapeutic group of proton pump inhibitors (PPIs).
Danish: Omeprazol er et substitueret benzimidazol, som tilhører den terapeutiske gruppe protonpumpehæmmere (PPI'er).
English: When the dose exceeds 80 mg daily, it should be divided and given twice daily.
Danish: Når dosen overstiger 80 mg dagligt, bør den deles op og gives to gange dagligt.
English: While literature data strongly indicates that there is no cross-reactivity between the various substituted benzimidazoles, there is data indicating suspected cross-reactivity.
Danish: Mens data i litteraturen tydeligt peger på, at der ikke findes nogen krydsreaktion mellem de forskellige, substituerede benzimidazoler, er der dokumentation, som peger på en mistænkt krydsreaktion.
English: This section was rewritten in a more reader friendly style by grouping the possible interactions, increasing the visibility of the most severe clinical consequences and indicating the magnitude of the interaction effects.
Danish: Dette afsnit blev skrevet om på en mere læsevenlig måde ved at gruppere de mulige interaktioner, øge synligheden af de mest alvorlige kliniske følger og angive omfanget af interaktionsvirkninger.
English: Increased gastric pH during omeprazole treatment may affect absorption, while other possible interaction mechanisms are via CYP2C19.
Danish: Øget gastrisk pHværdi under behandling med omeprazol kan påvirke absorptionen, mens andre mulige interaktionsmekanismer er via CYP2C19.
English: The CHMP considered that this indication is similar to chemical pneumonia (among others caused by gastric acid aspiration).
Danish: CHMP mente, at denne indikation er den samme som kemisk pneumoni (blandt andet forårsaget af aspiration af mavesyre).
English: Based on the review of data and taking into account the commitments provided by the MAH to submit an update of Module 3 in May 2010, the CHMP adopted a harmonised Module 3.
Danish: Baseret på en gennemgang af data og under hensyntagen til løfterne fra indehaveren af markedsføringstilladelsen om at fremlægge en opdatering af afsnit 3 i maj 2010, vedtog CHMP et harmoniseret afsnit 3.
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 20-120 mg daily.
Danish: Alle patienter med svær sygdom og utilstrækkelig respons på andre behandlinger blev effektivt kontrolleret, og mere end 90 % af patienterne blev holdt på doser på 20-120 mg dagligt.
English: The interaction with tacrolimus and phenytoin were retained and monitoring was recommended but an interaction with methotrexate was considered unwarranted.
Danish: Interaktionen med tacrolimus og phenytoin blev bevaret, og monitorering blev anbefalet, men en angivelse af interaktion med methotrexat blev betragtet som unødvendig.
English: The CHMP agreed on specific dosage and treatment duration recommendations for each individual indication for paediatric patients, taking into account the patients age (≥ 1 year of age, ≥ 2 years of age and children and adolescents over 4 years of age) and weight.
Danish: CHMP enedes om specifikke anbefalinger for dosering og behandlingsvarighed for hver enkelt indikation til pædiatriske patienter under hensyntagen til patienternes alder (≥ 1 år, ≥ 2 år og børn og unge over 4 år) og vægt.
English: Experience on use of intravenous formulations of Losec in paediatric patients is limited, however no specific safety issues are predicted.
Danish: Der er begrænsede erfaringer med brug af intravenøse formuleringer af Losec til pædiatriske patienter, men der forudses dog ingen specifikke sikkerhedsmæssige problemer.
English: Omeprazole has been reported to interact with some antiretroviral drugs.
Danish: Det er rapporteret, at omeprazol interagerer med nogle antiretrovirale lægemidler.
English: Salmonella and Campylobacter are mentioned; however the mention of C. difficile infections was removed, as the available data did not establish a possible causal relationship between C. difficile infection and the use of PPIs.
Danish: Salmonella og campylobacter nævnes, men omtalen af infektioner med C. difficile blev slettet, da de tilgængelige data ikke påviste en mulig årsagsmæssig sammenhæng mellem C. difficile-infektion og brugen af PPI'er.
English: Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.
Danish: Patienter kan have tilstrækkelig respons på 10 mg dagligt, og derfor skal en individuel dosisjustering overvejes.
English: The known safety profile of omeprazole confirms the absence of direct or indirect danger to human health and the cautionary measures restricting the use to 2 weeks treatment are considered acceptable.
Danish: Den kendte sikkerhedsprofil for omeprazol bekræfter, at der ikke er hverken direkte eller indirekte helbredsmæssige farer for mennesker, og de advarselsmæssige forholdsregler, som begrænser brugen til 2 ugers behandling, betragtes som acceptable.
English: An additional statement was inserted for the infusion and injection formulations, stating that based on clinical trials, excessive doses have not led to any dose-related adverse reactions.
Danish: En yderligere erklæring blev tilføjet infusions- og injektionsformuleringerne om, at baseret på kliniske undersøgelser har for store doser ikke medført nogen dosisrelaterede uønskede reaktioner.
English: The legal status of Losec as a ”medicinal products not subject to medical prescription” was considered to be in accordance with the EC Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use.
Danish: Losecs retslige status som et ”ikke-receptpligtigt lægemiddel” blev betragtet som værende i overensstemmelse med Europakommissionens vejledning om ændring af klassifikationen for udlevering af lægemidler til human brug.
English: Section 4.5 - Interactions with other medicinal products and other forms of interactions - all formulations
Danish: Afsnit 4.5 - Interaktion med andre lægemidler og andre former for interaktion - alle formuleringer
English: If symptom control has not been achieved after four weeks treatment with 20 mg daily, further investigation is recommended.
Danish: Hvis der ikke er opnået symptomkontrol efter fire ugers behandling med 20 mg dagligt, anbefales yderligere undersøgelser.
English: This recommendation is based upon overwhelming data showing that the cure of H. pylori infections reduces ulcer recurrence and complications such as bleeding.
Danish: Denne anbefaling er baseret på en overvældende dokumentation, som viser, at helbredelse for H. pylori-infektioner reducerer tilbagefald af ulcus samt komplikationer som f.eks. blødning.
English: 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: Valget af antibiotika skal ske under hensyntagen til den enkelte patients lægemiddeltolerance og i henhold til nationale, regionale og lokale resistensmønstre og retningslinjer for behandling.
English: OVER THE COUNTER PRESENTATIONS: LOSEC 10 AND 20 MG TABLETS (OTC)
Danish: HÅNDKØBSFORMULERINGER: LOSEC 10 OG 20 MG TABLETTER (HÅNDKØB)
English: Regarding the interaction with clopidogrel, in line with the prescription-only recommendation, patients should specifically tell their doctor or pharmacist if they are taking clopidogrel.
Danish: Vedrørende interaktionen med clopidogrel i overensstemmelse med anbefalingen for det receptpligtige lægemiddel bør patienter specifikt fortælle det til lægen eller på apoteket, hvis de tager clopidogrel.
English: The MAH proposed 5 separate SPCs: one for the 10mg, 20 mg, and 40 mg capsules; one for the 10 mg, 20 mg, and 40 mg tablets, one for the 40 mg powder for infusion, one for the 40 mg powder for injection and one for the 10mg and 20 mg tablets for OTC use.
Danish: Indehaveren af markedsføringstilladelsen foreslog 5 separate produktresuméer: et for 10 mg, 20 mg og 40 mg kapsler, et for 10 mg, 20 mg og 40 mg tabletter, et for 40 mg pulver til infusionsvæske, opløsning, et for 40 mg pulver til injektionsvæske, opløsning, og et for 10 mg og 20 mg tabletter i håndkøb.
English: For children and adolescents over 4 years of age treated for duodenal ulcers caused by H. pylori, the selection of the appropriate combination therapy should take into consideration the official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents.
Danish: For børn og unge over 4 år, som er i behandling for duodenalt ulcus forårsaget af H. pylori, bør valg af relevant kombinationsbehandling ske under hensyntagen til de officielle nationale, regionale og lokale retningslinjer for bakterieresistens, behandlingens varighed og relevant brug af antibakterielle stoffer.
English: Based on the European guidelines and literature, and due to the lack of conclusive studies relevant to this indication, this indication and the associated posology was removed from the proposed harmonised SPC.
Danish: Baseret på de europæiske retningslinjer og litteraturen og på grund af manglen på afgørende undersøgelser, som er relevante for denne indikation, blev indikationen og den tilhørende dosering fjernet fra det foreslåede, harmoniserede produktresumé.
English: The CHMP agreed that the available data on administration of the MUPS tablet immediately after a high-fat breakfast shows delayed and decreased absorption of omeprazole.
Danish: CHMP var enige om, at de tilgængelige data om administration af MUPS-tabletten umiddelbart efter en morgenmad med højt fedtindhold udviser en forsinket og reduceret absorption af omeprazol.
English: Regarding the eradication of H. pylori in peptic ulcer disease, a number of triple-regimen therapies (Losec plus two antibiotics) are proposed.
Danish: Med hensyn til udryddelse af H. pylori ved peptisk ulcus-sygdom foreslås flere tredobbelte behandlingsregimer (Losec plus to antibiotika).
English: Based on the above, the CHMP considers the benefit/risk ratio of Losec to be favourable and the harmonised Product Information documents to be approvable.
Danish: På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Losec for positivt og de harmoniserede produktinformationsdokumenter som egnede til godkendelse.
English: g) Acid-related dyspepsia
Danish: g) Syre-relateret dyspepsi
English: For the treatment of Zollinger-Ellison syndrome, the dose should be individually adjusted and treatment continued as long as clinically indicated.
Danish: Til behandling af Zollinger Ellison-syndromet skal dosen justeres individuelt, og behandlingen skal fortsættes så længe, det er klinisk indiceret.
English: The CHMP considered that dual therapies are less effective than triple therapies, but that they could be considered in cases where known hypersensitivity precludes use of any triple combination.
Danish: CHMP mente, at dobbeltbehandlinger er mindre effektive end tredobbelte behandlinger, men at de kunne overvejes i tilfælde, hvor kendt overfølsomhed udelukker brug af tredobbelte kombinationer.
English: Therefore, prevention of relapse of gastric ulcers is a reasonable course of action.
Danish: Derfor er forebyggelse af tilbagefald af gastrisk ulcus en rimelig fremgangsmåde.
English: The CHMP considered that the available data does not allow concluding on whether patients with erosions alone benefit from the treatment with PPI.
Danish: CHMP mente, at de foreliggende data ikke er tilstrækkelige til at konkludere, om patienter med erosioner alene kan have gavn af behandling med PPI.
English: A warning that the H. pylori status should be determined before treatment was included in the SPC.
Danish: En advarsel om, at H. pylori-status skal fastlægges før behandling, blev inkluderet i produktresuméet.
English: The marketing authorisation holder (MAH) also took the opportunity to harmonise Module 3.
Danish: Indehaveren af markedsføringstilladelsen benyttede også lejligheden til at harmonisere afsnit 3.
English: Whilst definition of what constitutes typical reflux disease may differ, in general terms, GERD is applied to patients with symptoms suggestive of reflux or complications thereof, but not necessarily with oesophageal inflammation.
Danish: Selvom der kan være forskellige definitioner af, hvad der indgår i en typisk reflukssygdom, anvendes GERD generelt om patienter med symptomer, som tyder på refluks eller komplikationer heraf, men ikke nødvendigvis med øsofageal inflammation.
English: The CHMP assessed the potential omeprazole-clopidogrel interaction and considered that a warning is warranted, given the potential seriousness of the observed adverse events.
Danish: CHMP vurderede den potentielle interaktion mellem omeprazol og clopidogrel og mente, at en advarsel er påkrævet i betragtning af den potentielle sværhedsgrad af de observerede uønskede hændelser.
English: After discussing the various existing texts in the national SPCs and noting that experience on use of intravenous formulations of Losec in paediatric patients is limited, the CHMP adopted the following harmonised indications in adults for Losec for intravenous use, as an alternative to oral therapy:
Danish: Efter en drøftelse af de forskellige, eksisterende tekster i de nationale produktresuméer og efter at have bemærket, at der er begrænset erfaring med brug af intravenøse formuleringer af Losec hos pædiatriske patienter, vedtog CHMP følgende harmoniserede indikationer hos voksne for Losec til intravenøs brug som et alternativ til oral behandling:
English: THE EMEA
Danish: pylori
English: In most patients healing occurs within two weeks.
Danish: Hos de fleste patienter sker helbredelsen inden for to uger.
English: In patients with impaired hepatic function, however, a daily dose of 10-20 mg may be sufficient.
Danish: Hos patienter med nedsat leverfunktion kan en daglig dosis på 10-20 mg imidlertid være tilstrækkelig.
English: • Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease In children and adolescents over 4 years of age
Danish: • Symptomatisk behandling af halsbrand og sure opstød ved gastroøsofageal reflukssygdom Til børn og unge over 4 år
English: Patients are also instructed to consult a doctor if they have had previous gastric ulcer or gastrointestinal surgery, in case of jaundice, hepatic impairment, or liver disease and if they are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Danish: Patienter instrueres også i at søge læge, hvis de tidligere har haft gastrisk ulcus eller har gennemgået en gastrointestinal operation, i tilfælde af gulsot, nedsat leverfunktion eller leversygdom, og hvis de er i vedvarende symptombehandling for fordøjelsesbesvær eller halsbrand i 4 uger eller derover.
English: Losec (omeprazole) was included in the list of products for SPC harmonisation and a referral was triggered in order to resolve divergences and harmonise the nationally authorised SPCs across Europe.
Danish: Losec (omeprazol) var medtaget på listen over lægemidler, hvor produktresuméet skal harmoniseres, og der blev foretaget en indbringelse for at løse spørgsmål om afvigelser og harmonisere de nationalt godkendte produktresuméer i Europa.
English: Symptoms responding adequately to an acid suppressant and returning upon discontinuation allow a diagnosis of GERD.
Danish: Når symptomerne reagerer tilstrækkeligt på et syrehæmmende middel og vender tilbage ved seponering, kan der stilles en diagnose på GERD.
English: There are currently 4 separate formulations of Losec on the market: gastro-resistant tablets, capsules, powder for solution for infusion and powder for solution for injection.
Danish: Der er i øjeblikket 4 separate formuleringer af Losec på markedet: enterotabletter, kapsler, pulver til infusionvæske, opløsning, og pulver til injektionsvæske, opløsning.
English: The indication for the treatment of Zollinger Ellison syndrome is already harmonised throughout the EU and the CHMP considered this indication to be approvable.
Danish: Indikationen for behandling af Zollinger Ellison-syndrom er allerede harmoniseret i EU, og CHMP mente, at denne indikation kunne godkendes.
English: Proximal gastric ulcers are often large, tend to heal slowly, and may be more prone to recur.
Danish: Proksimale, gastriske ulcera er ofte store, har tendens til at heles langsomt, og der kan være en tendens til, at de kommer igen.
English: A statement on the potential increased or decreased absorption of active substances with a gastric pH dependent absorption due to decreased intragastric acidity was inserted.
Danish: En erklæring blev inkluderet om potentielt øget eller reduceret absorption af aktive stoffer med en gastrisk pH-afhængig absorption på grund af reduceret mavesyre.
English: The most common and effective treatment of peptic oesophagitis or symptomatic GERD is to reduce gastric acid secretion with either H2 blockers or a PPI and the CHMP therefore considered this indication approvable.
Danish: Den mest almindelige og effektive behandling af peptisk øsofagitis eller symptomatisk GERD er at reducere sekretionen af mavesyre med enten H2-blokkere eller en PPI, og CHMP mente derfor, at denne indikation kunne godkendes.
English: Losec MUPS (multiple unit pellet system) tablets are also available as OTC.
Danish: Losec MUPS (multiple unit pellet system)-tabletter fås også i håndkøb.
English: i) Patients considered to be at risk of aspiration of gastric contents during general anaesthesia/Acid aspiration prophylaxis
Danish: i) Patienter, som menes at være i risikogruppen for at aspirere maveindhold under helbedøvelse/syreaspiration-profylakse
English: In most patients healing occurs within four weeks.
Danish: Hos de fleste patienter sker helbredelsen inden for fire uger.
English: It is administered as a prodrug and specifically and dose-proportionally inhibits the gastric H+/K+-ATPase (proton pump) and thereby inhibits H+ ion transfer into the gastric lumen, which is responsible for acid secretion in the parietal cells of the stomach.
Danish: Det administreres som en prodrug og hæmmer specifikt og dosisproportionalt den gastriske H+/K+-ATPase (protonpumpe), hvorved det hæmmer H+ ionoverførsel i det gastriske lumen, som styrer syresekretionen i mavens parietalceller.
English: Information on the need for regular surveillance when exceeding a treatment period of one year was inserted and patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals, especially patients over 55 years as the increasing age is a risk factor for the development of gastric disorders.
Danish: Information om behovet for regelmæssig kontrol, når behandlingsperioden på ét år overskrides, blev tilføjet, og patienter med tilbagevendende, langvarige symptomer på fordøjelsesbesvær eller halsbrand bør regelmæssigt tale med lægen, særligt patienter over 55 år, da den stigende alder er en risikofaktor for udvikling af mavelidelser.
English: h) “Treatment of Zollinger-Ellison syndrome”
Danish: h) “Behandling af Zollinger Ellison-syndrom”
English: Regarding the method of administration of the capsules and tablets, with regards to patients with swallowing difficulties, the CHMP agreed that the capsule can be opened and the contents swallowed based on the in-vivo (bioequivalence) as well as in-vitro studies on the intake as dispersed/suspended tablets/granules of the oral pharmaceutical forms.
Danish: Vedrørende administrationsmetoden for kapsler og tabletter til patienter med synkebesvær godkendte CHMP, at kapslerne kan åbnes og indholdet synkes, baseret på in vivo- (bioækvivalens) samt in vitroundersøgelser af indtagelsen som opløste/suspenderede tabletter/granulater af de orale lægemiddelformer.
English: The cardinal symptoms associated with GERD are heartburn and regurgitation.
Danish: Hovedsymptomerne, som forbindes med GERD, er halsbrand og sure opstød.
English: Peptic ulcers are associated with increased risk of upper gastrointestinal complications, such as bleedings, but the same may not be true for the superficial erosions commonly seen during treatment with NSAIDs.
Danish: Peptisk ulcus er forbundet med en øget risiko for komplikationer i det øvre gastrointestinale system, f.eks. blødninger, men det gælder muligvis ikke for de overfladiske erosioner, der hyppigt ses under behandling med NSAID'er.
English: Section 4.7: Effects on ability to drive and use machines - all formulations
Danish: Afsnit 4.7- Virkning på evnen til at føre motorkøretøj eller betjene maskiner - alle formuleringer
English: The CHMP assessed the MAH proposal taking into account the current national SPCs and scientific knowledge and discussed indications for each individual medical condition.
Danish: CHMP vurderede forslaget fra indehaveren af markedsføringstilladelsen under hensyntagen til de eksisterende, nationale produktresuméer og faglig viden og drøftede indikationerne for hver enkelt medicinsk tilstand.
English: The CHMP noted that study data showed that 20 mg once daily produces a more pronounced and consistent inhibition than the lower doses and therefore agreed on a maximum daily dose of 20 mg. Selftreatment should be limited to a maximum period of 14 days, and the patient should be instructed to consult a doctor if symptoms persist.
Danish: CHMP bemærkede, at undersøgelsesdata viste, at 20 mg en gang dagligt giver en mere udtalt hæmning end de lavere doser, og accepterede derfor en maksimal daglig dosis på 20 mg. Selvbehandling bør være begrænset til en maksimal periode på 14 dage, og patienten skal instrueres om at konsultere en læge, hvis symptomerne varer ved.
English: The SPC also mentions that the benefit-risk of omeprazole treatment in the maintenance setting should be continuously re-evaluated and that patients should be kept under regular surveillance, especially when exceeding a treatment period of 1 year.
Danish: Produktresuméet nævner også, at benefit/risk-forholdet for vedligeholdelsesbehandling med omeprazol bør genevalueres løbende, og at der bør foretages regelmæssig kontrol af patienter, særlig når behandlingsperioden overstiger 1 år.