FrancophonIA/ELRC3.0 huggingface dataset:
English: What Agopton is and what it is used for 2.
Danish: Hvad Agopton er, og hvad det anvendes til 2.
English: Therefore the 15 mg dose cannot be recommended for healing of NSAID-associated gastric ulcers.
Danish: Derfor kan dosen på 15 mg ikke anbefales til heling af NSAID-relaterede gastriske ulcera.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03
Danish: Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC03
English: A single oral dose of 30 mg reduces basal secretion by about 70%, and the patients' symptoms are consequently relieved starting from the very first dose.
Danish: En enkelt peroral dosis på 30 mg reducerer den basale sekretion med cirka 70 %, og patienternes symptomer lindres derfor fra den allerførste dosis.
English: Cyanamid of Great Briain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, UK
Danish: Cyanamid of Great Briain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, Storbritannien
English: As short-term antisecretory treatment combined with eradication therapy is known to be associated with significantly improved healing rates over antisecretory treatment alone, testing for and eradication of H. pylori would be considered mandatory.
Danish: Da kortvarig antisekretorisk behandling kombineret med eradikationsterapi er kendt for at give en signifikant bedre heling end antisekretorisk behandling alene, må test for og eradikation af H. pylori anses for obligatorisk.
English: Medicinal products transported by P-glycoprotein Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
Danish: Lægemidler, der transporteres af P-glycoprotein Det er observeret, at lansoprazol hæmmer transportproteinet P-glycoprotein (P-gp) in vitro.
English: A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
Danish: Et forsøg har vist, at samtidig administration af lansoprazol (60 mg én gang dagligt) og atazanavir 400 mg til raske frivillige medførte en væsentlig reduktion af atazanavireksponeringen (en reduktion af AUC og Cmax på cirka 90 %).
English: No clinically relevant difference in ulcer prevention between the 15 and 30 mg dose of lansoprazole could be demonstrated.
Danish: Ingen klinisk relevant forskel i forebyggelse af ulcera kunne påvises mellem dosen på 15 mg og 30 mg lansoprazol.
English: For optimal effect, Agopton should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.
Danish: For at opnå optimal effekt skal Agopton tages én gang dagligt om morgenen, undtagen når det anvendes til eradikation af H. pylori, hvor midlet skal tages to gange dagligt (morgen og aften).
English: Limited data, well known-clinical facts about duodenal ulceration and an class effect of PPIs support the inclusion of duodenal ulcers into the indication.
Danish: Begrænsede data, velkendte kliniske fakta om duodenal ulceration og en klasseeffekt af PPI'er understøtter inklusionen af duodenale ulcera i indikationen.
English: Lansoprazole is a racemate of two active enantiomers that are biotransformed into the active form in the acidic environment of the parietal cells.
Danish: Lansoprazol er et racemat af to aktive enantiomerer, der biotransformeres til den aktive form i parietalcellernes sure miljø.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: Note: This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 30 referral for lansoprazole containing medicinal products.
Danish: Bemærkning: Dette produktresumé og denne etikettering og indlægsseddel er de samme som dem, der var vedlagt Kommissionens afgørelse af denne artikel 30-indbringelse vedrørende lægemidler indeholdende lansoprazol.
English: This might be attributed to high rates of metronidazole resistence.
Danish: Dette kan muligvis forklares ved en høj resistens mod metronidazol.
English: John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH UK
Danish: John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Storbritannien
English: In addition the CHMP identified the additional points to be harmonised in the various SPC sections.
Danish: Herudover identificerede Udvalget for Humanmedicinske Lægemidler (CHMP) de andre punkter, der skal harmoniseres i de forskellige afsnit i produktresuméet.
English: For patients requiring 15 mg lansoprazole daily, either Agopton 15 mg capsules or Agopton 15 mg oro-dispersible tablets should be used.
Danish: Hos patienter, som kræver 15 mg lansoprazol dagligt, anvendes enten Agopton 15 mg kapsler eller Agopton 15 mg orodispersible tabletter.
English: Medicinal products metabolised by P450 enzymes Lansoprazole may increase plasma concentrations of drugs that are metabolised by CYP3A4.
Danish: Lægemidler, der metaboliseres af P450-enzymer Lansoprazol kan øge plasmakoncentrationerne af lægemidler, der metaboliseres af CYP3A4.
English: The proportion remaining healed at 12 months in evaluable patients was 39% on placebo vs. 84 % on lansoprazole15 mg maintenance.
Danish: Andelen af evaluerbare patienter, som forblev raske efter 12 måneder, var 39 % ved placebo i forhold til 84 % ved vedligeholdelsesbehandling med lansoprazol 15 mg.
English: - You must contact a doctor if your symptoms worsen or do not improve after 14 days.
Danish: - De bør søge lægehjælp, hvis Deres symptomer forværres, eller hvis de ikke aftager efter 14 dage.
English: Increase in cholesterol and triglyceride levels, hyponatremia
Danish: Stigning i kolesterol- og triglyceridniveauer, hyponatriæmi
English: Intake of food slows the absorption rate of lansoprazole and reduces the bioavailabilty by about 50%.
Danish: Indtagelse af føde sænker lansoprazols absorptionshastighed og reducerer dets biotilgængelighed med cirka 50 %.
English: Effects of other drugs on lansoprazole
Danish: Andre lægemidlers effekt på lansoprazol
English: However, you still need to take Agopton carefully to get the best results from it.
Danish: De er imidlertid nødt til at anvende Agopton omhyggeligt for at opnå de bedste resultater af lægemidlet.
English: However, at 4 weeks, the efficacy of the 15 mg dose was less than for the comparator at 8 weeks.
Danish: Virkningen af dosen på 15 mg efter 4 uger var dog mindre end virkningen af komparatoren efter 8 uger.
English: Agopton contains mannitol, which may have a mild laxative effect.
Danish: Agopton indeholder mannitol, som kan have en mildt laksativ effekt.
English: Each single dose sachet contains <fine pink granules containing white to off-white pellets>.
Danish: Hver enkeltdosispakke indeholder <fine, lyserøde granulater, der indeholder hvide til offwhite piller>.
English: Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to:
Danish: På grundlag af den dokumentation, der er fremlagt af indehaveren af markedsføringstilladelsen, og udvalgets faglige drøftelse, er CHMP af den opfattelse, at Agopton og tilknyttede navne udviste et gunstigt benefit/risk-forhold til:
English: However, the pharmacokinetic and pharmacodynamic data as well as clinical data for the use of lansoprazole in children are available in the literature.
Danish: Der findes dog i litteraturen farmakokinetiske og farmakodynamiske data samt kliniske data vedrørende anvendelse af lansoprazol til børn.
English: Agranulocytosis, pancytopenia
Danish: Agranulocytose, pancytopeni
English: The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid.
Danish: Absorptionen af ketoconazol og itraconazol fra gastrointestinalkanalen forstærkes af tilstedeværelsen af mavesyre.
English: The submitted data needs to be viewed in the context of current clinical practice, which would mandate H. pylori screening and eradication therapy in the treatment of duodenal ulcers.
Danish: De forelagte data skal ses i sammenhæng med den nuværende kliniske praksis, der kræver screening for H. pylori og eradikationsterapi ved behandlingen af duodenale ulcera.
English: • 4.3 Contraindication
Danish: • 4.3 Kontraindikationer
English: Fever, hyperhidrosis, angioedema, anorexia, impotence
Danish: Feber, hyperhidrose, angioødem, anoreksi, impotens
English: <Read all of this leaflet carefully because it contains important information for you.
Danish: <Læs hele denne indlægsseddel omhyggeligt, da den indeholder vigtige oplysninger til Dem.
English: The divergences identified at the start of the referral have been resolved.
Danish: De afvigelser, der fandtes, da indbringelsen fandt sted, er bragt i orden.
English: Steven-Johnson syndrome, toxic epidermal necrolysis
Danish: Stevens-Johnsonsyndrom, toksisk epidermal nekrolyse
English: If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.
Danish: Hvis lansoprazol anvendes i kombination med antibiotika til eradikationsbehandling af H. pylori, skal anvisningerne for brugen af disse antibiotika også følges.
English: If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Danish: Hvis det er nødvendigt, anbefales ventrikeltømning, aktivt kul og symptomatisk behandling.
English: 15 mg once daily.
Danish: 15 mg én gang dagligt.
English: Only a small minority of patients developed duodenal ulcers
Danish: Kun meget få af patienterne udviklede duodenale ulcera.
English: Agopton should be taken at least 30 minutes before food (see section 5.2).
Danish: Agopton skal tages mindst 30 minutter før indtagelse af føde (se pkt.
English: The plasma levels of digoxin should therefore be monitored and the dose of digoxin adjusted if necessary when initiating and ending lansoprazole treatment.
Danish: Plasmakoncentrationerne af digoxin skal derfor overvåges og dosis af digoxin justeres, hvis det er nødvendigt, når behandling med lansoprazol påbegyndes og afsluttes.
English: The use of Agopton is not recommended in children as clinical data are limited (see also section 5.2).
Danish: Det anbefales ikke at anvende Agopton til børn, da kliniske data er begrænsede (se også pkt.
English: Insomnia, hallucination, confusion
Danish: Søvnmangel, hallucinationer, konfusion
English: Eradication of H. pylori has been shown to be a definitive cure for duodenum ulcer and most gastric ulcers.
Danish: Eradikation af H. pylori har vist sig at være en definitiv kur mod duodenale ulcera og de fleste gastriske ulcera.
English: By reducing gastric acidity, lansoprazole creates an environment in which appropriate antibiotics can be effective against H. pylori.
Danish: Ved at reducere ventrikelaciditeten skaber lansoprazol et miljø, i hvilket passende antibiotika kan være effektive mod H. pylori.
English: The CHMP agrees that no information regarding the lansoprazole effects on phenytoin or carbamazepine is needed in the SPC.
Danish: CHMP er enige om, at oplysninger vedrørende lansoprazols indvirkning på phenytoin eller carbamazepin ikke er nødvendige i produktresuméet.
English: The evaluation of the symptoms yielded less clear results than for the healing of the ulceration, and the results are inconsistent across the different symptoms/parameters and methods used to assess the symptoms.
Danish: hvordan ulcerationen helede, og resultaterne er inkonsistente på tværs af de forskellige symptomer/parametre og metoder, der er benyttet til vurdering af symptomerne.
English: The orodispersible tablets can be dispersed in a small amount of water and administered via a nasogastric tube or oral syringe.
Danish: De orodispersible tabletter kan opløses i en smule vand og administreres gennem en nasogastrisk sonde eller en oral sprøjte.
English: Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate).
Danish: Samtidig administration af lansoprazol øger plasmakoncentrationerne af tacrolimus (et CYP3A- og Pgp-substrat).
English: The inhibition is dosedependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Danish: Hæmningen er dosisafhængig og reversibel, og effekten gælder både den basale og den stimulerede sekretion af mavesyre.
English: For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.
Danish: Risikopatienter eller patienter med mavesår, der er vanskelige at få til at hele, skal sandsynligvis behandles i længere tid og/eller have en højere dosis.
English: Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Danish: Eksponering for lansoprazol forhøjede gennemsnitseksponeringen for tacrolimus med op til 81 %.
English: Glossitis, candidiasis of the oesophagus, pancreatitis, taste disturbances
Danish: Glossitis, candidiasis oesophagi, pankreatitis, smagsforstyrrelser
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERPAKNING
English: Eradication of Helicobacter pylori:
Danish: Eradikation af Helicobacter pylori:
English: Important information about some of the ingredients of Agopton
Danish: Vigtige oplysninger om visse af indholdsstofferne i Agopton
English: Peak plasma levels were not increased in the elderly.
Danish: De maksimale plasmakoncentrationer steg ikke hos ældre patienter.
English: There is no need for a dose adjustment in patients with impaired renal function.
Danish: Det er ikke nødvendigt at justere dosis til patienter med nedsat nyrefunktion.
English: Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity.
Danish: Lansoprazol akkumuleres i parietalcellerne og aktiveres i deres sure miljø, hvorefter det reagerer med sulfhydrylgruppen af H+/K+-ATPase og dermed hæmmer enzymaktiviteten.
English: The enzyme CYP3A4 also contributes to the metabolism.
Danish: Enzymet CYP3A4 bidrager også til biotransformationen.
English: • 4.6 Pregnancy and lactation
Danish: • 4.6 Graviditet og amning
English: Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: Aspartam er en fenylalaninkilde, som kan være skadelig for personer, der lider af Føllings sygdom (fenylketonuri).
English: Your doctor might instruct you to take the tablet with a syringe, in case you have serious difficulties with swallowing.
Danish: Lægen vil muligvis instruere Dem i at tage tabletten ved hjælp af en sprøjte, hvis De har svært ved at synke den.
English: Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lanzoprazole is initiated or ended.
Danish: Overvågning af plasmakoncentrationerne af tacrolimus tilrådes, når samtidig behandling med lansoprazol påbegyndes og afsluttes.
English: A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine.
Danish: En reduktion af dosis kan overvejes, når lansoprazol kombineres med CYP2C19-hæmmeren fluvoxamin.
English: You should check with your doctor if you are not sure how to take your medicine.
Danish: Tal med lægen, hvis De er i tvivl om, hvordan De skal tage medicinen.
English: Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Danish: Enzyminducere, der påvirker CYP2C19 og CYP3A4, som for eksempel rifampicin og prikbladet perikum (hypericum perforatum), kan reducere plasmakoncentrationerne af lansoprazol markant.
English: WHAT AGOPTON IS AND WHAT IT IS USED FOR
Danish: HVAD AGOPTON ER, OG HVAD DET ANVENDES TIL
English: • Dosage recommendation for the eradication of H. pylori differences: inclusion of specific recommendations on the antibiotics to be used
Danish: • Forskelle i dosisanbefalingen til eradikation af H. pylori: indføjelse af specifikke anbefalinger til, hvilke antibiotika der skal benyttes
English: This study was a randomized, parallel-group, active- and placebo-controlled, multi-center, multinational study to evaluate the use of lansoprazole, misoprostol and placebo in the prevention of ulcers and erosions in patients continuing to take NSAIDs.
Danish: Denne undersøgelse var en randomiseret, multinational, aktiv- og placebokontrolleret multicenterundersøgelse med parallelgrupper til vurdering af anvendelsen af lansoprazol, misoprostol og placebo til forebyggelse af ulcera og erosioner hos patienter, der fortsat tager NSAID'er.
English: After repeated daily administration for seven days, about 90% inhibition of gastric acid secretion is achieved.
Danish: Efter gentagen daglig administration i syv dage opnås der en hæmning af mavesyresekretionen på cirka 90 %.
English: You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Danish: De skal informere Deres læge om nye og ualmindelige symptomer og omstændigheder.
English: Sucralfate/Antacids may decrease the bioavailability of lansoprazole.
Danish: Sukralfat/antacider kan nedsætte lansoprazols biotilgængelighed.
English: In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
Danish: Hos patienter med gastroduodenalsår skal muligheden for en infektion med H. pylori overvejes som en ætiologisk faktor.
English: Pharmacokinetics in elderly patients
Danish: Farmakokinetik hos ældre patienter
English: • Eradication of Helicobacter pylori
Danish: • Eradikation af Helicobacter pylori
English: If diarrhoea occurs during the treatment with Agopton contact your doctor immediately, as Agopton has been associated with a small increase in infectious diarrhoea.
Danish: Søg omgående læge, hvis der opstår diarré, mens De tager Agopton, da Agopton er blevet forbundet med en lille stigning i forekomsten af infektiøs diarré.
English: Swallow the capsule whole with a glass of water.
Danish: Slug kapslerne hele med et glas vand.
English: The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy subjects.
Danish: Elimineringshalveringstiden i plasma ligger mellem 1 til 2 timer hos raske personer efter administration af enkle eller multiple doser.
English: Due to a marked reduction in atazanavir trough concentrations observed during concomitant use of omeprazole, use of PPIs is contraindicated in the SPC for Rayataz (atazanavir).
Danish: På grund af den markante reduktion af atazanavir, der er observeret ved samtidig brug af omeprazol, er anvendelse af PPI'er kontraindiceret i produktresuméet ved brug af Reyataz (atazanavir).
English: Studies have shown that granules from opened capsules give equivalent AUC as the intact capsule if the granules are suspended in a small amount of orange juice, apple juice, or tomato juice mixed with a tablespoon of apple or pear puree or sprinkled on a tablespoon of yoghurt, pudding or cottage cheese.
Danish: Forsøg har vist, at granulater fra åbnede kapsler giver samme AUC som den intakte kapsel, hvis granulaterne blandes med en lille mængde appelsinjuice, æblejuice eller tomatjuice, der er blandet med en spiseskefuld æble- eller pæremos eller strøs over en spiseskefuld yoghurt, budding eller hytteost.
English: Therapeutic Indications
Danish: Terapeutiske indikationer
English: Co-administration of lansoprazole and digoxin may lead to increased digoxin plasma levels.
Danish: Samtidig administration af lansoprazol og digoxin kan medføre forhøjede plasmakoncentrationer af digoxin.
English: Read all of this leaflet carefully because it contains important information for you.
Danish: Læs hele denne indlægsseddel omhyggeligt, da den indeholder vigtige oplysninger til Dem.
English: Do not take a double dose to make up for a forgotten capsule.
Danish: De må ikke tage en dobbeltdosis som erstatning for en glemt kapsel.
English: This is reflected in section 4.2, 4.4 and 5.2 of the SPC.
Danish: Dette er omhandlet under punkt 4.2, 4.4 og 5.2 i produktresuméet.
English: The investigation of a dose of 17 mg/m2 body surface or 1 mg/kg body weight also resulted in comparable exposure of lansoprazole in children aged 2-3 months up to one year of age compared to adults.
Danish: Undersøgelsen af en dosis på 17 mg/m2 kropsoverflade eller 1 mg/kg kropsvægt viste også en lignende eksponering for lansoprazol hos børn i alderen 2-3 måneder op til 1 år sammenlignet med voksne.
English: Read all the information in this leaflet for guidance.
Danish: Læs hele denne indlægsseddel for at få vejledning.
English: Three studies were submitted addressing the pharmacokinetics in lansoprazole in patients with different levels of (mild, moderate and severe) liver impairment
Danish: Der blev fremlagt tre undersøgelser vedrørende farmakokinetikken af lansoprazol hos patienter med forskellige grader (mild, moderat og svær) af nedsat leverfunktion.
English: Lansoprazole (like misoprostol) is effective in reducing the risk of gastric or duodenal ulcers in patients who need to continue NSAIDs.
Danish: Lansoprazol er (ligesom misoprostol) effektivt til at reducere risikoen for gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID-behandling.
English: The MAH has provided three bioequivalence studies as background documentation on the effect of food intake on the bioavailability of lansoprazole.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt tre undersøgelser vedrørende bioækvivalens som baggrundsdokumentation for indvirkningen af fødeindtagelse på lansoprazols biotilgængelighed.
English: The clinical trials showed consistently gastric acid suppression and relief of symptoms in children and adolescents when treated with lansoprazole.
Danish: De kliniske undersøgelser viste konsistent mavesyrehæmning og symptomlindring hos børn og unge, når de blev behandlet med lansoprazol.
English: Lansoprazole should not be co-administered with atazanavir (see section
Danish: Lansoprazol må ikke administreres sammen med atazanavir (se pkt.
English: Drugs which induces CYP2C19 and CYP3A4
Danish: Lægemidler, der inducerer CYP2C19 og CYP3A4
English: Medicinal products with pH dependent absorption Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavailability.
Danish: Lægemidler med pH-afhængig absorption Lansoprazol kan påvirke absorptionen af lægemidler, for hvilke gastrisk pH er vigtig for biotilgængeligheden.
English: Both the lansoprazole 15 and 30 mg dose are effective and the dosing recommendations proposed by the MAH are acceptable.
Danish: Både doser på 15 mg og 30 mg lansoprazol er effektive, og doseringsanbefalingerne fra indehaveren af markedsføringstilladelsen er acceptable.
English: However, daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects.
Danish: Der er dog under forsøg givet daglige doser på op til 180 mg lansoprazol peroralt og op til 90 mg lansoprazol intravenøst uden signifikante bivirkninger.