FrancophonIA/ELRC3.0 huggingface dataset:
English: The SPC states that for the tablet and capsule formulations the clinical trial safety experience shows that the adverse event profile in children up to 16 years of age is generally the same as for adults in short- as well as in long-term treatment and that there is no long-term data on the effects on puberty and growth.
Danish: Produktresuméet anfører, at de sikkerhedsmæssige erfaringer fra de kliniske undersøgelser viser, at bivirkningsprofilen hos børn op til 16 år generelt er den samme som hos voksne ved både kort- og langvarig behandling, og at der ikke er nogen langsigtede data om virkningen på pubertet og vækst.
English: The CHMP was of the opinion that prolonged acid inhibition by PPIs may promote vitamin B12 malabsorption and inserted a warning stating that omeprazole may reduce the absorption of vitamin B12 and that this should be considered in patients on long-term therapy.
Danish: CHMP mente, at PPI'ers forlængede syrehæmmende virkning kan give anledning til malabsorption af B12-vitamin og tilføjede en advarsel om, at omeprazol kan reducere absorptionen af B12-vitamin, samt at dette skal tages med i betragtning hos patienter i langvarig behandling.
English: Nelfinavir coadministration is contraindicated, atazanavir co-administration is not recommended.
Danish: Samtidig administration af nelfinavir er kontraindiceret, mens samtidig administration af atazanavir ikke anbefales.
English: The proposed harmonisations mainly concern the drug product and the MAH provided satisfactory information on the appearance, polymorphisms, specifications and stability of the drug substances (omeprazole magnesium for the MUPS tablets, omeprazole for the capsules and omeprazole sodium for the injection and infusion formulations).
Danish: De harmoniseringer, der ansøges om, omhandler primært lægemidlet, og indehaveren af markedsføringstilladelsen fremlagde tilfredsstillende information om udseende, polymorfismer, specifikationer og stabilitet af lægemiddelstofferne (omeprazolmagnesium for MUPS-tabletterne, omeprazol for kapslerne og omeprazolnatrium for injektions- og infusionsformuleringerne).
English: For most indications, a 40 mg daily dose is recommended, although in patients with Zollinger-Ellison Syndrome the recommended initial dose is 60 mg daily.
Danish: Til de fleste indikationer anbefales en daglig dosis på 40 mg, men til patienter med Zollinger-Ellison-syndrom anbefales en startdosis på 60 mg dagligt.
English: The CHMP considered that the increased occurrence of gastrointestinal bacterial infections due to decreased gastric acidity should be mentioned in the SPC.
Danish: CHMP var af den opfattelse, at den stigende forekomst af gastrointestinale bakterieinfektioner på grund af reduceret mavesyre bør nævnes i produktresuméet.
English: Due to the high potential risk to patients, a statement contraindicating use in patients hypersensitive to omeprazole, substituted benzimidazoles or to any of the excipients was adopted by the CHMP.
Danish: På grund af den høje potentielle risiko for patienterne vedtog CHMP en erklæring om kontraindikation af brug hos patienter med overfølsomhed over for omeprazol, substituerede benzimidazoler eller nogen af hjælpestofferne.
English: The CHMP discussed the association of omeprazole with the occurrence of bone fracture/hip fracture in the elderly, especially osteoporosis affected population.
Danish: CHMP drøftede forbindelsen mellem omeprazol og forekomsten af knoglefraktur/hoftefraktur hos ældre, særligt den del af populationen, som er påvirket af osteoporose.
English: However a number of clarifications were requested, mainly with regards to the Manufacture, Control of Drug Product, Container Closure System and Stability sections, for all formulations.
Danish: CHMP anmodede imidlertid om en uddybning af nogle områder, særligt med hensyn til afsnittene om fremstilling, kontrol med lægemidlet, beholderens lukkesystem og stabilitet, for alle formuleringer.
English: The CHMP considered this indication to be approvable.
Danish: CHMP mente derfor, at denne indikation kunne godkendes.
English: Section 4.6: Pregnancy and lactation - all formulations
Danish: Afsnit 4.6 - Graviditet og amning - alle formuleringer
English: The CHMP noted data showing that omeprazole does not increase the incidence or seriousness of the side effects in the poor metaboliser population and considered that although poor metabolisers show 5 to 10 times higher mean AUC than subjects having a functional CYP2C19 enzyme, there is no evidence that patients who are poor CYP2C19 metabolisers are at increased risk when treated with omeprazole at recommended doses..
Danish: CHMP bemærkede data, som viste, at omeprazol ikke øger forekomsten eller sværhedsgraden af bivirkninger i den del af populationen med dårlig metabolisering og mente, at selvom disse udviser 5 til 10 gange højere middel AUC end personer med et fungerende CYP2C19-enzym, er der ingen ny dokumentation for, at patienter med dårlig CYP2C19-metabolisering har en øget risiko ved behandling med omeprazol i de anbefalede doser.
English: Regarding special populations, dose adjustment is not needed in patients with impaired renal function, as omeprazole is almost completely metabolized by CYP450, renal impairment does therefore not influence the pharmacokinetics.
Danish: Med hensyn til særlige populationer er dosisjustering ikke nødvendig til patienter med nedsat nyrefunktion, da omeprazol metaboliseres næsten fuldstændigt af CYP450.
English: The recommended initial dose is 60 mg daily.
Danish: Den anbefalede startdosis er 60 mg dagligt.
English: The CHMP noted that although Losec is not likely to affect the ability drive or use machines, dizziness and visual disturbances have been observed with the use of Losec, and stated that patients experiencing these adverse drug reactions should not drive or operate machinery.
Danish: CHMP bemærkede, at selvom Losec sandsynligvis ikke påvirker evnen til at føre motorkøretøj eller betjene maskiner, er der observeret svimmelhed og synsforstyrrelser ved brug af Losec, og anførte, at patienter, som oplevede disse lægemiddelbivirkninger, ikke måtte føre motorkøretøj eller betjene maskiner.
English: The CHMP considered that according to almost all existing guidance, all patients with erosions or ulcers associated with H. pylori infection should undergo therapy to eradicate the organism.
Danish: CHMP fandt, at alle patienter med erosioner eller ulcus associeret med H. pylori-infektion i henhold til næsten alle eksisterende retningslinjer bør behandles for at udrydde organismen.
English: The indication and the associated posology were removed from the harmonised SPC.
Danish: Indikationen og den dermed forbundne dosering blev fjernet fra det harmoniserede produktresumé.
English: With this proposal, prescription only tablets and capsules will have the same indications for all strengths (bioequivalence between the tablets and the capsules of same strength has been demonstrated), as will the solutions for infusion and injection.
Danish: Med dette forslag vil receptpligtige tabletter og kapsler have samme indikationer for alle styrker (der er påvist bioækvivalens mellem tabletter og kapsler af samme styrke), og det samme vil gælde for pulver til infusionsvæske, opløsning, og pulver til injektionsvæske, opløsning.
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted harmonised sets of Product Information documents for the various presentations of Losec and associated names, taking into account the pharmaceutical forms and differentiating between the prescription-only and the OTC presentations.
Danish: På baggrund af vurderingen af forslaget fra indehaveren af markedsføringstilladelsen, svarene og udvalgets efterfølgende drøftelser vedtog CHMP således harmoniserede sæt af produktinformationsdokumenter for de forskellige formuleringer af Losec og tilhørende navne under hensyntagen til den farmaceutiske form og differentiering mellem de receptpligtige formuleringer og håndkøbsformuleringerne.
English: Concomitant use of omeprazole and clopidogrel is therefore discouraged
Danish: Samtidig brug af omeprazol og clopidogrel anbefales derfor ikke.
English: Section 5.1: Pharmacodynamic properties
Danish: Afsnit 5.1 - Farmakodynamiske egenskaber
English: The SPC therefore states that omeprazole is a CYP2C19 inhibitor and that inconsistent data has been reported from observational and clinical studies on the clinical implications of the PK/PD interaction in terms of major cardiovascular events.
Danish: Produktresuméet anfører derfor, at omeprazol er en CYP2C19-hæmmer, og at inkonsekvente data er rapporteret fra observations- og kliniske undersøgelser af den kliniske betydning af den farmakokinetiske/farmakodynamiske interaktion, hvad angår større kardiovaskulære hændelser.
English: Prevention of ulcers is currently started on a regular basis in a considerable number of patients using NSAIDs and the superior efficacy PPIs over H2 antagonists in the healing of gastroduodenal ulcers associated with NSAIDs when NSAIDs cannot be discontinued has been demonstrated.
Danish: Forebyggelse af ulcus indledes aktuelt på regelmæssig basis hos et større antal patienter, som bruger NSAID'er, og der er påvist større effekt af PPI'er end H2antagonister på helbredelse af gastroduodenalt ulcus associeret med NSAID'er, når NSAID'er ikke kan seponeres.
English: Similarly, the CHMP considered that there is sufficient evidence from the literature and long-term post marketing experience that omeprazole 20 mg daily is a safe dosage over 14 days.
Danish: CHMP mente også, at der er tilstrækkelig dokumentation i litteraturen og langvarige erfaringer efter markedsføringen for, at omeprazol 20 mg dagligt er en sikker dosering i en periode på 14 dage.
English: • Treatment of Zollinger-Ellison syndrome”
Danish: • Behandling af Zollinger-Ellison-syndrom
English: “Losec gastro-resistant tablets are indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults”
Danish: ”Losec enterotabletter er indicerede til behandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne”.
English: The data submitted by the MAH did not sufficiently support the claimed indication and although no unexpected or new safety concerns emerged from these studies, the CHMP considered this indication to be unacceptable given the undemonstrated efficacy.
Danish: Selvom der ikke opstod nogen uventede eller nye sikkerhedsmæssige problemer i disse undersøgelser, anså CHMP denne indikation for at være uacceptabel, da effekten ikke var påvist.
English: • In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
Danish: • I kombination med antibiotikabehandling ved behandling af duodenalt ulcus forårsaget af H.
English: The likelihood of developing reflux symptoms or oesophageal epithelial injury is a function of a quantitative abnormality of the number of reflux events and/or oesophageal acid exposure.
Danish: Sandsynligheden for at udvikle reflukssymptomer eller skader på øsofagus epitel hænger sammen med et abnormt stort antal reflukshændelser og/eller eksponering for mavesyre.
English: The CHMP considered that the available scientific information sufficiently demonstrates the efficacy of omeprazole in the treatment of heartburn and acid reflux and its superiority to placebo, in particular for the short-term OTC use of 20 mg daily.
Danish: CHMP mente, at den foreliggende faglige dokumentation i tilstrækkelig grad påviser effekten af omeprazol ved behandling af halsbrand og syrerefluks, samt at omeprazol er bedre end placebo, særligt ved kortvarig brug af et håndkøbslægemiddel på 20 mg dagligt.
English: Section 4.1 - Therapeutics indications in adults - powder for injection and powder for infusion
Danish: Afsnit 4.1 - Terapeutiske indikationer for voksne - pulver til injektion og pulver til infusion
English: b) “Treatment of reflux oesophagitis” and “Long-term management of patients with healed reflux oesophagitis”
Danish: b) ”Behandling af refluksøsofagitis” og ”Langvarig behandling af patienter med helbredt refluksøsofagitis”
English: The CHMP concluded that omeprazole is a suitable medication to relief heartburn and acid regurgitation in the OTC setting, provided that the patient complies with the recommended dosing and correct use, as instructed by the SPC and the Patient Leaflet.
Danish: CHMP konkluderede, at omeprazol er et egnet håndkøbslægemiddel til lindring af halsbrand og sure opstød, forudsat at patienten overholder den anbefalede dosering og anvender midlet korrekt i henhold til produktresuméet og indlægssedlen.
English: • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
Danish: • Forebyggelse af NSAID-associeret gastrisk og duodenalt ulcus hos patienter i risikogruppen
English: a) “Treatment of symptomatic gastro-oesophageal reflux disease (GERD)” The MAH proposed that both duodenal and gastric ulcers be presented in individual indications separate from the GERD indication.
Danish: a) ”Behandling af symptomatisk gastroøsofageal reflukssygdom (GERD)” Indehaveren af markedsføringstilladelsen foreslog, at både duodenalt og gastrisk ulcus skulle fremlægges i individuelle indikationer adskilt fra GERD-indikationen.
English: After consultation of the Cardiovascular subgroup of the Efficacy Working Party, the CHMP confirmed that a PK and PD interaction between CYP2C19 inhibitors and clopidogrel is observed, although the clinical implication of this finding is not clear.
Danish: Efter konsultation med undergruppen vedrørende hjerte og kredsløb under arbejdsgruppen vedrørende effekt bekræftede CHMP, at der er påvist en farmakokinetisk og farmakodynamisk interaktion mellem CYP2C19-hæmmere og clopidogrel, selvom den kliniske betydning af dette fund ikke er klar.
English: • Treatment of symptomatic gastro-esophageal reflux disease
Danish: • Behandling af symptomatisk gastroøsofageal reflukssygdom
English: • Long-term management of patients with healed reflux esophagitis
Danish: • Langvarig behandling af patienter med helbredt refluksøsofagitis
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: There have been no reports of serious outcomes following overdoses with omeprazole, and thus, no specific treatment has been needed or can be recommended.
Danish: Der har således ikke været behov for nogen specifik behandling, og der kan ikke anbefales nogen specifik behandling.
English: For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, or of upper GI bleeding) the recommended dose is 20 mg once daily.
Danish: Til forebyggelse af NSAID-associeret gastrisk eller duodenalt ulcus hos patienter i risikogruppen (alder > 60 år, anamnese med gastrisk og duodenalt ulcus eller øvre gastrointestinal blødning) er den anbefalede dosis 20 mg én gang dagligt.
English: For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is 20 mg once daily.
Danish: Til forebyggelse af tilbagefald af duodenalt ulcus hos H. pylori-negative patienter, eller når det ikke er muligt at udrydde H. pylori, er den anbefalede dosis 20 mg én gang dagligt.
English: Initial GERD treatment is managed by a symptom-based approach; an empiric trial of acid suppression can be used.
Danish: Indledende GERD-behandling håndteres med en symptombaseret metode.
English: Section 4.1 - Therapeutics indications in paediatric patients - capsules and tablets
Danish: Afsnit 4.1 - Terapeutiske indikationer hos pædiatriske patienter - kapsler og tabletter
English: c) “Treatment of duodenal ulcers” and “Prevention of relapse of duodenal ulcers” The indication in H. pylori negative ulcers was split from the indication with concomitant H. pylori infection.
Danish: c) “Behandling af duodenalt ulcus” og ”Forebyggelse af tilbagefald af duodenalt ulcus” Indikationen i H. pylori-negative ulcera var adskilt fra indikationen med samtidig H. pylori-infektion.
English: Relief of symptoms after the start of treatment with PPIs may take time, therefore a statement informing patients that 2-3 days might be needed before symptom improvement is perceived was also added.
Danish: Derfor blev der tilføjet en erklæring, som oplyser patienter om, at der kan gå 2-3 dage, før de mærker bedring af symptomerne.
English: Adult posology: capsule and tablet
Danish: Dosering for voksne: kapsel og tablet
English: • Treatment of NSAID-associated gastric and duodenal ulcers
Danish: • Behandling af NSAID-associeret gastrisk og duodenalt ulcus
English: Section 4.1 - Therapeutics indications in adults - capsules and tablets
Danish: Afsnit 4.1 - Terapeutiske indikationer for voksne - kapsler og tabletter
English: Reflux oesophagitis results from the combination of excessive gastro-oesophageal reflux of gastric juice and impaired oesophageal clearance of the refluxate.
Danish: Refluksøsofagitis stammer fra en kombination af for stor gastroøsofageal refluks af mavesyre, og at øsofagus ikke er i stand til at fjerne mavesyren i opstødet.
English: The OTC SPC will diverge most notably in the indications, posology and warnings sections.
Danish: De største afvigelser i produktresuméet for håndkøbslægemidler vil forekomme i afsnittene om indikationer, dosering og advarsler.
English: • Treatment of duodenal ulcers
Danish: • Behandling af duodenalt ulcus
English: In general, the SPC and the PL of the OTC Losec presentation was aligned to that of the Prescription-only products.
Danish: Generelt var produktresumé og indlægsseddel for Losec som håndkøbslægemiddel på linje med de receptpligtige lægemidler.
English: d) “Treatment of gastric ulcers” and “Prevention of relapse of gastric ulcers” The gastric ulcer indications were separated from the duodenal ulcer indications as well as from the NSAID-related and H. pylori positive ulcers.
Danish: d) “Behandling af gastrisk ulcus” og ”Forebyggelse af tilbagefald af gastrisk ulcus” Indikationerne for gastrisk ulcus var adskilt fra både indikationen for duodenalt ulcus og fra de NSAID-relaterede H. pylori-positive ulcera.
English: • Prevention of relapse of duodenal ulcers
Danish: • Forebyggelse af tilbagefald af duodenalt ulcus
English: For long-term management of patients with healed reflux oesophagitis, the recommended dose is 10 mg once daily.
Danish: Til langvarig håndtering af patienter med helbredt refluksøsofagitis er den anbefalede dosis 10 mg én gang dagligt.
English: f) “In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease”
Danish: f) ”Udryddelse af Helicobacter pylori (H. pylori) ved peptisk ulcus i kombination med passende antibiotikabehandling”
English: Paediatric posology: capsule and tablet
Danish: Dosering til børn: kapsel og tablet
English: The SPC therefore states that co-administration of atazanavir and nelfinavir with proton pump inhibitors is not recommended and that if co-administration is judged unavoidable, close clinical monitoring is recommended together with an increase of the anti-retroviral drug dose, as plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.
Danish: Hvis man mener, at samtidig administration er uundgåelig, anbefales tæt klinisk monitorering sammen med øget dosis antiretroviralt lægemiddel, da plasmaniveauer for nelfinavir og atazanavir reduceres, hvis disse stoffer gives samtidig med omeprazol.
English: In patients with severe oesophagitis 40 mg once daily is recommended and healing is usually achieved within eight weeks.
Danish: Hos patienter med svær øsofagitis anbefales 40 mg én gang dagligt, og helbredelsen sker som regel inden for otte uger.
English: PRESCRIPTION-ONLY PRESENTATIONS
Danish: PAKNINGSSTØRRELSER FOR RECEPTPLIGTIGE LÆGEMIDLER
English: The CHMP considered that the prevention of relapse of H. pylori negative gastric ulcers is sufficiently demonstrated and considered these indications to be approvable.
Danish: CHMP anså forebyggelse af tilbagefald af H. pylori-negative gastriske ulcera for at være tilstrækkeligt påvist og mente, at disse indikationer kunne godkendes.
English: The CHMP considered that the prevention of NSAID ulcers is sufficiently demonstrated and considered these indications to be approvable.
Danish: CHMP anså forebyggelse af tilbagefald af NSAID-associeret ulcus for at være tilstrækkeligt påvist og mente, at disse indikationer kunne godkendes.
English: • Treatment of gastric ulcers
Danish: • Behandling af gastrisk ulcus
English: • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
Danish: • I kombination med passende antibiotikabehandling til udryddelse af Helicobacter pylori (H.
English: Treatment of reflux oesophagitis includes acid reduction and PPIs are currently considered the most effective treatment for reflux oesophagitis and the CHMP therefore considered this indication to be approvable.
Danish: Den mest effektive behandling af refluksøsofagitis er at reducere syreniveauet, og PPI'er betragtes aktuelt som den mest effektive behandling af refluksøsofagitis.
English: Regarding the prevention of non-steroidal anti-inflammatory drug (NSAID) -associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients at risk, prevention of ulcer formation in at risk NSAID users is a reasonable course of action, given the high and increasing incidence.
Danish: e) “Behandling af NSAID-associerede gastriske og duodenale ulcera” og “Forebyggelse af NSAID-associerede gastriske og duodenale ulcera hos patienter i risikogruppen” Med hensyn til forebyggelse af gastrisk ulcus, duodenalt ulcus eller gastroduodenale erosioner associeret med non-steroide anti-inflammatoriske lægemidler (NSAID'er) hos patienter i risikogruppen er det på grund af den høje og stigende forekomst en rimelig fremgangsmåde at forebygge ulcus hos NSAID-brugere i risikogruppen.
English: The CHMP considered that there is sufficient information on human experience to state that excretion of omeprazole in milk is low and unlikely to influence the child. Data from epidemiological studies on use of Losec during pregnancy indicates no adverse effects and the CHMP considered that omeprazole can be used during pregnancy.
Danish: Data fra epidemiologiske undersøgelser om brug af Losec under graviditet viser ingen bivirkninger, og CHMP vurderede, at omeprazol kan anvendes under graviditet.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Losec and associated names (see Annex I).
Danish: - Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets faglige drøftelse anbefaler CHMP ændring af markedsføringstilladelserne for Losec og tilknyttede navne (se bilag I).
English: The CHMP considered that prevention of relapse of H. pylori negative duodenal ulcers is sufficiently demonstrated and considered these indications to be approvable.
Danish: CHMP anså forebyggelse af tilbagefald af H. pylori-negative duodenale og gastriske ulcera for at være tilstrækkeligt påvist og mente, at disse indikationer kunne godkendes.
English: • Prevention of relapse of gastric ulcers
Danish: • Forebyggelse af tilbagefald af gastrisk ulcus
English: For prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is 20 mg once daily.
Danish: Til forebyggelse af tilbagefald hos patienter med gastrisk ulcus, som reagerer dårligt på behandling, er den anbefalede dosis 20 mg én gang dagligt.
English: Harmonisation of the SPC and PL for the OTC product
Danish: Harmonisering af produktresumé og indlægsseddel for håndkøbsproduktet