FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.
Danish: På grund af de begrænsede sikkerhedsdata for patienter, der har været i vedligeholdelsesbehandling i mere end 1 år, skal der regelmæssigt foretages en gennemgang af behandlingen og en grundig afvejning af risici/fordele for disse patienter.
English: Germany (referring Member State) identified the following issues, each affecting several sections of the SPC.
Danish: Tyskland (referencemedlemsstaten) udpegede følgende spørgsmål, der hver især har indflydelse på flere af afsnittene i produktresuméet.
English: To give your medicine the best chance of working, take it at the right time and do not miss a dose.
Danish: For at give medicinen den bedste mulighed for at fungere, skal De tage den på det rigtige tidspunkt og aldrig springe en dosis over.
English: Also contains sucrose and mannitol (E421).
Danish: Indeholder også saccharose og mannitol (E421).
English: 30,400 00040 Pomezia, Roma, Italy
Danish: 30,400 00040 Pomezia, Roma, Italien
English: Via Elio Vittorini 129 00144 Roma, Italy
Danish: Via Elio Vittorini 129 00144 Roma, Italien
English: The factor that would influence the bioavailability the most would be if the granules were mixed with a vehicle of pH>7.
Danish: Den faktor, der ville påvirke biotilgængeligheden mest, ville være, hvis granulaterne blev blandet med et blandemiddel med en pH > 7.
English: Furthermore, at both timepoints, there was a trend for better efficacy of the 30 mg dose.
Danish: Endvidere var der på begge tidspunkter en tendens til større virkning af dosen på 30 mg.
English: A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.
Danish: En daglig dosis på 30 mg til ældre må ikke overskrides, medmindre der er tvingende kliniske indikationer herfor.
English: • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • det produktresumé og den etiketteringen og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelsen, er blevet vurderet på basis af den fremlagte dokumentation og den faglige drøftelse i udvalget,
English: The recommended dose should be 15-30 mg o.d. with recommendations regarding further investigation, should the patient not respond within 4 weeks.
Danish: Den anbefalede dosis er 15-30 mg od med anbefalinger om yderligere undersøgelser, hvis patienten ikke responderer inden for 4 uger.
English: Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.
Danish: Deres tilstand er måske endnu ikke fuldstændigt helbredt og kan vende tilbage, hvis De ikke gennemfører hele behandlingsforløbet.
English: Different disease concepts for “symptomatic gastroesophageal reflux disease” and other “functional diseases” e.g. “dyspepsia”, are established throughout Europe and reflected in different labelling.
Danish: Forskellige sygdomskoncepter for "symptomatisk gastroøsofageal reflukssygdom" og andre "funktionelle sygdomme", f.eks. "dyspepsi", er ved at blive opstillet i hele Europa og giver sig udtryk i forskellig etikettering.
English: Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements.
Danish: På grund af nedsat clearance af lansoprazol hos ældre kan en justering af dosis være nødvendig baseret på individuelle behov.
English: Lower eradication rates were seen using this combination than in regimens involving clarithromycin.
Danish: Lavere eradikationsrater blev set ved brug af denne kombination end ved regimener, der omfattede clarithromycin.
English: If the required daily dose exceeds 120 mg, it should be given in two divided doses.
Danish: Hvis den krævede daglige dosis overstiger 120 mg, skal den fordeles på to doser.
English: The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given.
Danish: Effekterne af overdosering med lansoprazol hos mennesker kendes ikke (selvom den akutte toksicitet sandsynligvis er lav), og der kan derfor ikke gives nogen behandlingsvejledning.
English: The clinical relevance of this is unknown.
Danish: Den kliniske relevans af dette kendes ikke.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AGOPTON AND ASSOCIATED NAMES
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF AGOPTON OG TILKNYTTEDE NAVNE
English: Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
Danish: Deres læge kan foretage eller har måske foretaget en yderligere undersøgelse, der kaldes en endoskopi, for at kunne stille en diagnose og/eller udelukke alvorlig sygdom.
English: However, higher values for exposure will be expected in children below 1 year of age with the pharmaceutical forms that are commercially available.
Danish: Der må dog forventes højere eksponeringer hos børn under 1 år med de farmaceutiske former, der findes i handlen i dag.
English: If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Danish: Hvis symptomerne ikke lindres i løbet af 4 uger med en daglig dosis på 30 mg, anbefales yderligere undersøgelser.
English: These metabolites have very little or no antisecretory activity.
Danish: Disse metabolitter har en meget lille eller ingen antisekrerende effekt.
English: • Symptomatic gastroesophageal reflux disease (4.1 and 4.2)
Danish: • Symptomatisk gastroøsofageal reflukssygdom (4.1 og 4.2)
English: You may get best results if you take Agopton first thing in the morning.
Danish: De vil muligvis opnå de bedste resultater, hvis De tager Agopton som det første om morgenen.
English: Capsules should be swallowed whole with liquid.
Danish: Kapslerne skal sluges hele sammen med væske.
English: • 4.5 Interaction with other medicinal products and other forms of interaction
Danish: • 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
Danish: En blodprøve vil blive taget for at undersøge, om antallet af hvide blodlegemer eventuelt er faldet (agranulocytose).
English: The Maastricht Consensus states that treatment regimens for eradication of H. pylori should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis.
Danish: I Maastricht Consensus hedder det, at behandlingsregimer til eradikation af H. pylori skal være enkle, veltolererede og opnå en eradikationsrate på over 80 % på basis af en behandlingsintention.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket, hvad De skal gøre ved medicin, der ikke længere er nødvendig.
English: As regards the relief of symptoms, this was examined in both studies through the use of diary cards and investigator interviews.
Danish: Symptomlindringen blev undersøgt i begge undersøgelser ved anvendelse af dagbogskort og samtaler med investigator.
English: See enclosed leaflet for further information.
Danish: Se vedlagte indlægsseddel for at få yderligere oplysninger.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}.
English: If symptoms persist you should report to your doctor.
Danish: Hvis symptomerne varer ved, skal De fortælle det til Deres læge.
English: Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.
Danish: Prækliniske data viser ingen særlige risici for mennesker baseret på konventionelle forsøg vedrørende sikkerhedsfarmakologi, gentagen dosistoksicitet, toksicitet over for reproduktion eller genotoksicitet.
English: It was agreed that the indication should only mention “symptomatic gastroesophageal reflux disease”.
Danish: Der var enighed om, at indikationen kun skulle nævne "symptomatisk gastroøsofageal reflukssygdom".
English: Almirall Prodesfarma, S.A. General Mitre, 151 08022 -Barcelona, Spain
Danish: Almirall Prodesfarma, S.A. General Mitre, 151 08022 -Barcelona, Spanien
English: There was no baseline stratification for H. pylori status, reflecting clinical practice at the time.
Danish: Der var ingen baselinestratifikation af H. pylori-status, hvilket afspejlede den kliniske praksis på daværende tidspunkt.
English: Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme and have a narrow therapeutic window.
Danish: Forsigtighed tilrådes ved kombination af lansoprazol med lægemidler, der metaboliseres af dette enzym og har et snævert terapeutisk vindue.
English: - Ask you pharmacist if you need more information or advice.
Danish: - Spørg på apoteket, hvis De har behov for flere oplysninger eller yderligere rådgivning.
English: The overall relief of the primary symptoms (epigastric pain and heartburn) were assessed.
Danish: Den samlede lindring af de primære symptomer (epigastriske smerter og halsbrand) blev vurderet.
English: Very rarely cases of colitis have been reported in patients taking lansoprazole.
Danish: Der er rapporteret om meget sjældne tilfælde af colitis hos patienter, der tager lansoprazol.
English: A restriction regarding food intake is necessary, since effects of food consumption on the pharmacokinetic profile has been observed.
Danish: Det er nødvendigt at begrænse fødeindtagelsen, eftersom der er blevet observeret indvirkninger af fødeindtagelse på den farmakokinetiske profil.
English: The submitted data for the indication “symptomatic gastroesophageal reflux disease” support this the indication.
Danish: De fremlagte data for indikationen "symptomatisk gastroøsofageal reflukssygdom" understøtter denne indikation.
English: Sub-optimal results were obtained for children 1-11 years of age and pharmacodynamic as well as the efficacy results make dosing recommendations difficult.
Danish: Suboptimale resultater blev opnået for børn i alderen 1-11 år, og resultaterne vedrørende farmakodynamik samt virkning gør det vanskeligt at anbefale doseringer.
English: [To be included nationally if applicable]
Danish: [Inkluderes nationalt, hvis det er relevant]
English: Lansoprazole has not been marketed for use in children or adolescents in the EU.
Danish: Lansoprazol er ikke blevet markedsført i EU til behandling af børn eller unge.
English: The usual doses of Agopton for adults are given below.
Danish: De normale doser Agopton til voksne er angivet nedenfor.
English: The treatment duration is most commonly 7 days but sometimes up to 14 days.
Danish: Behandlingsforløbet varer normalt 7 dage, men kan nogle gange vare op til 14 dage.
English: The studies support the use of lansoprazole 30 mg o.d for 4-8 weeks for this indication.
Danish: Undersøgelserne understøtter brugen af lansoprazol 30 mg od i 4-8 uger i forbindelse med denne indikation.
English: Also contains lactose and aspartame.
Danish: Indeholder også lactose og aspartam.
English: If you are taking Agopton twice a day, you should have the first dose in the morning and the second dose in the evening.
Danish: Hvis De tager Agopton to gange dagligt, skal De tage den første dosis om morgenen og den anden dosis om aftenen.
English: It can be expected that normally under fasting conditions gastric emptying of a formulation has taken place 30 minutes post-dose.
Danish: Det kan forventes, at ventrikeltømning af en formulering i fastende tilstand normalt har fundet sted 30 minutter efter administration af dosis.
English: If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine.
Danish: Hvis De har svært ved at synke kapslerne, kan Deres læge vejlede Dem i andre måder at tage medicinen på.
English: Ketoconazole and itraconazole:
Danish: Ketoconazol og itraconazol:
English: Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Danish: Tal med læge, sygeplejerske eller apotek, hvis De er i tvivl om noget.
English: Please tell your doctor if you have serious liver disease.
Danish: Tal med Deres læge, hvis De har en alvorlig leversygdom.
English: While the results for the two doses of lansoprazole and for misoprostol are very similar, all three treatments were markedly better than placebo and this is confirmed by statistical analysis (p<0.001 for each active vs. placebo comparison).
Danish: Mens resultaterne for de to doser lansoprazol og for misoprostol lignede hinanden meget, var alle tre behandlinger markant bedre sammenlignet med placebo, og dette er bekræftet ved statistisk analyse (p < 0,001 for hver sammenligning mellem aktiv behandling og placebo).
English: Sulphone, sulphide and 5-hydroxyl derivatives of lansoprazole have been identified in plasma.
Danish: Sulfon-, sulfid- og 5hydroxylderivater af lansoprazol er blevet fundet i plasma.
English: If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated.
Danish: Hvis De behandles mod infektion, fordi de har mavesår, er det usandsynligt, at Deres mavesår vil komme igen, hvis behandlingen af infektionen er vellykket.
English: The dose of Agopton depends on your condition.
Danish: Den ordinerede dosis Agopton afhænger af Deres tilstand.
English: Higher exposure for lansoprazole was also seen in newborns and babies up to an age of approx. 10 weeks.
Danish: Højere eksponering for lansoprazol blev også set hos nyfødte og spædbørn i alderen op til cirka 10 uger.
English: CYP2C19 is subject to genetic polymorphism and 2-6 % of the population, called poor metabolisers (PMs), are homozygote for a mutant CYP2C19 allele and therefore lacks a functional CYP2C19 enzyme.
Danish: CYP2C19 er genstand for genetisk polymorfisme, og 2-6 % af befolkningen, der har en ringe metaboliseringsevne, er homozygoter for en mutant CYP2C19-allel og mangler derfor et funktionelt CYP2C19-enzym.
English: It is unlikely that the proposed vehicles, even if not of the same brand, would be of such pH and therefore affect the granule coating.
Danish: Det er ikke sandsynligt, at de foreslåede blandemidler, endda selvom de ikke er af samme mærke, ville have en pH > 7 og derfor påvirke det materiale, granulatet er overtrukket med.
English: In the third study, no effect of food was observed when the food was taken 30 minutes after administration.
Danish: I den tredje undersøgelse blev der ikke observeret nogen virkning af føde, når den blev indtaget 30 minutter efter administration af lansoprazol.
English: Due to the fact that Agopton and associated names (lansoprazole) does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union as a result of divergent national decisions, a harmonisation of the SPC for Agopton and associated names, throughout Europe has become necessary.
Danish: Da produktresuméet for Agopton og tilknyttede navne (lansoprazol) ikke er enslydende i de forskellige EU-medlemsstater på grund af divergerende nationale beslutninger, er det nødvendigt at harmonisere produktresuméet for Agopton og tilknyttede navne i Europa.
English: Further reductions are not practically possible and data may not allow simulations of PK/PD regarding the increase the dose-interval.
Danish: Yderligere reduktioner er ikke praktisk mulige, og data vil måske ikke muliggøre simuleringer af farmakokinetikken/farmakodynamikken med hensyn til øgningen af dosisintervallet.
English: A study with 14C labelled lansoprazole indicated that approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the faeces.
Danish: Et forsøg med 14C-mærket lansoprazol indikerede, at cirka en tredjedel af den administrerede strålebehandling blev udskilt i urinen, og to tredjedele blev fundet i fæces.
English: Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
Danish: Behandling med lansoprazol kan medføre en let forhøjet risiko for gastrointestinale infektioner som for eksempel med Salmonella og Campylobacter.
English: The marketing authorisation holder is: <{Name and address}> <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelse: <{Navn og adresse}> <{tlf.}> <{fax}> <{e-mail}>
English: Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, France
Danish: Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, Frankrig
English: It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.
Danish: Regimenet kan være velegnet til patienter, der ikke er i stand til at tage clarithromycin som en del af en eradikationsbehandling, når de lokale resistensrater for metronidazol er lave.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE MED NAVNE, LÆGEMIDDELFORMER, LÆGEMIDDELSTYRKER, INDGIVELSESMÅDE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
English: Peak plasma levels occur within 1.5 to 2.0 hours.
Danish: Maksimale plasmakoncentrationer opnås i løbet af 1,5 til 2,0 timer.
English: Please refer to section 4.8 for possible symptoms of lansoprazole overdose.
Danish: 4.8 for at få yderligere oplysninger om mulige symptomer på overdosering med lansoprazol.
English: 46 quai de la Papee 75601 Paris Cedex 12, France
Danish: 46 quai de la Papee 75601 Paris Cedex 12, Frankrig
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Undersøgelser hos dyr viser ikke nogen direkte eller indirekte skadelige virkninger på graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: • the scope of the referral was the harmonisation of the Summary of Products Characteristics,
Danish: • Henvisningen drejede sig om harmonisering af produktresuméet,
English: Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.
Danish: Seks måneder efter vellykket eradikationsbehandling er risikoen for en ny infektion lav, og tilbagefald er derfor usandsynligt.
English: Although all treatments resulted in equivalent AUC of lansoprazole, it has to be noted that the studies were performed with certain brands of the different vehicles.
Danish: Selvom alle behandlinger resulterede i ækvivalente AUC-værdier af lansoprazol, skal det bemærkes, at undersøgelserne blev udført med bestemte produktmærker inden for de forskellige blandemidler.
English: There is no evidence of accumulation following multiple doses in healthy subjects.
Danish: Der er ikke tegn på akkumulering efter multiple doser administreret til raske personer.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of lansoprazole therapy to the woman.
Danish: En beslutning om, hvorvidt amning skal fortsættes/afbrydes, eller om behandling med lansoprazol skal fortsættes/afbrydes, skal tages under hensyntagen til barnets fordel af amning og kvindens fordel af behandling med lansoprazol.
English: If you are taking Agopton once a day, try to take it at the same time each day.
Danish: Hvis De tager Agopton én gang dagligt, skal De så vidt muligt tage det på samme tidspunkt hver dag.
English: Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose.
Danish: Lansoprazol reducerer plasmakoncentrationen af theophyllin, hvilket kan formindske den forventede kliniske effekt af dosis.
English: The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”.
Danish: Dataene understøtter ikke indikationen "forebyggelse af symptomer" og heller ikke "profylakse af gastroduodenale erosioner".
English: The following instructions should be followed if administered via syringe: It is important that the appropriateness of the selected syringe is carefully tested.
Danish: Nedenstående instruktioner skal følges, hvis Agopton administreres ved hjælp af en sprøjte: Det er vigtigt at kontrollere omhyggeligt, om den valgte sprøjte er passende.
English: A statement indicating the experience with the medicinal product in children is required under section 4.2 of the SPC.
Danish: En angivelse af, hvor stor erfaring der foreligger med administration af lægemidlet til børn, er påkrævet under punkt 4.2 i produktresuméet.
English: Agopton is strawberry flavoured and should be placed on the tongue and gently sucked.
Danish: Agopton har jordbærsmag og skal placeres på tungen og suges let på.
English: However the trial design and the results of the studies were not adequate to recommend the use of lansoprazole in for the treatment of oesophagitis in children.
Danish: Undersøgelsens udformning og resultater var dog ikke tilstrækkelige til at anbefale brugen af lansoprazol til behandling af øsofagitis hos børn.
English: Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
Danish: Patienter med moderat eller svær leversygdom skal overvåges regelmæssigt, og der anbefales en reduktion på 50 % af den daglige dosis (se pkt.
English: The following side effects are very rare (occur in less than 1 in 10000 patients): - severe hypersensitivity reactions including shock.
Danish: Følgende bivirkninger er meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter): - alvorlige overfølsomhedsreaktioner samt shock.
English: Proton pump inhibitors reduce the amount of acid that your stomach makes.
Danish: Protonpumpehæmmere nedsætter mængden af syre, som Deres mave danner.
English: Taking Agopton with food and drink
Danish: Hvordan man anvender Agopton sammen med mad og drikkevarer
English: Read the package leaflet before use
Danish: Læs indlægssedlen før brug.
English: Do not use Agopton after the expiry date which is stated on the blister and carton.
Danish: Anvend ikke Agopton efter udløbsdatoen, som er angivet på pakningen.
English: In conclusion, the efficacy data are considered too weak to support a paediatric indication of oesophagitis in children and adolescents.
Danish: Konklusionen er, at dataene vedrørende virkningen anses for at være for svage til at understøtte en pædiatrisk indikation af øsofagitis hos børn og unge.
English: When selecting appropriate combination therapy consideration should be given to official 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: Når der skal vælges en passende kombinationsbehandling, er det vigtigt at tage officielle lokale retningslinjer i betragtning med hensyn til bakteriel resistens, varighed af behandling (normalt 7 dage, men nogle gange op til 14 dage) og hensigtsmæssig brug af antibakterielle midler.
English: The usually recommended dose in patients with normal hepatic function is 30 mg q.d.
Danish: Den normale anbefalede dosis til patienter med normal leverfunktion er 30 mg qd.
English: Administration of lansoprazole may result in sub-therapeutic concentrations of ketoconazole and itraconazole and the combination should be avoided.
Danish: Administration af lansoprazol kan resultere i subterapeutiske koncentrationer af ketoconazol og itraconazol, og kombinationen skal undgås.
English: Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.
Danish: I tilfælde af svær og/eller vedvarende diarré skal det derfor overvejes at seponere behandlingen.