FrancophonIA/ELRC3.0 huggingface dataset:
English: The data from the 2 pivotal studies as well as supportive data from the open-label extension study and the comparative study with omeprazole and misoprostol, support the indication: “Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment”.
Danish: Dataene fra de to hovedundersøgelser samt understøttende data fra den åbne, udvidede undersøgelse og den komparative undersøgelse med omeprazol og misoprostol understøtter indikationen "behandling af NSAID-relaterede godartede gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID-behandling".
English: Data concerning the indications “relief of symptoms” and “healing of gastroduodenal erosions” are scarce and are not sufficient for approval of these indications.
Danish: Der findes meget få data vedrørende indikationerne "lindring af symptomer" og "heling af gastroduodenale erosioner", og de er ikke tilstrækkelige til godkendelse af disse indikationer.
English: It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach.
Danish: Den hæmmer den sidste fase af mavesyreproduktionen ved at hæmme aktiviteten af H+/K+-ATPase i mavens parietalceller.
English: The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%.
Danish: Lansoprazols clearance reduceres hos ældre patienter med en øget elimineringshalveringstid på cirka 50 % til 100 %.
English: This is reflected in the SPC under section 4.2 and 5.2.
Danish: Dette er afspejlet i produktresuméet under punkt 4.2 og 5.2.
English: What Agopton contains
Danish: Hvad Agopton indeholder
English: For healing of gastric ulcers, both the 15 and 30 mg dose were statistically superior to the ranitidine at both 4 and 8 weeks.
Danish: Til heling af gastriske ulcera var både doserne på 15 mg og 30 mg lansoprazol statistisk langt bedre end behandling med ranitidin efter både 4 og 8 uger.
English: The exposure of lansoprazole is doubled in patients with mild hepatic impairment and much more increased in patients with moderate and severe hepatic impairment.
Danish: Eksponeringen for lansoprazol fordobles hos patienter med mildt nedsat leverfunktion og øges langt mere hos patienter med moderat og svært nedsat leverfunktion.
English: Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.
Danish: Der blev fremlagt to randomiserede, dobbeltblinde hovedundersøgelser med parallelgrupper og fem understøttende undersøgelser til vurdering af effekten af lansoprazol til behandling af symptomatisk gastroøsofageal reflukssygdom.
English: The dose may be increased up to 30 mg daily as necessary.
Danish: Dosis kan øges op til 30 mg dagligt efter behov.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: SÆRLIGE ADVARSLER OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: If the treatment fails the dose 30 mg once daily should be used.
Danish: Hvis behandlingen ikke virker, skal der anvendes en dosis på 30 mg dagligt.
English: Effects of lansoprazole on other drugs
Danish: Lansoprazols effekt på andre lægemidler
English: Animal studies have shown excretion of lansoprazole in milk.
Danish: Dyreforsøg har vist, at lansoprazol udskilles i mælk.
English: Petechiae, purpura, hair loss, erythema multiforme, photosensitivity
Danish: Petekkier, purpura, hårtab, erythema multiforme, lysfølsomhed
English: Further issues: it was requested to present a harmonised SPC for all other relevant sections Quality aspects do not form part of the current arbitration procedure.
Danish: Andre spørgsmål: Der blev anmodet om udarbejdelse af et harmoniseret produktresumé i forbindelse med alle andre relevante afsnit.
English: Interstitial nephritis
Danish: Interstitiel nefritis
English: Zollinger-Ellison syndrome:
Danish: Zollinger-Ellisons syndrom:
English: Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract.
Danish: Nedsat ventrikelaciditet på grund af lansoprazol kan forventes at øge forekomsten af bakterier, der normalt er til stede i gastrointestinalkanalen.
English: Pharmacokinetics in paediatric patients
Danish: Farmakokinetik hos pædiatriske patienter
English: Restlessness, vertigo, paresthesia, somnolence, tremor
Danish: Rastløshed, vertigo, paræstesi, somnolens, tremor
English: The plasma concentrations of lansoprazole increase up to 4-fold.
Danish: Plasmakoncentrationerne af lansoprazol øges op til 4 gange.
English: H. pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with Agopton and amoxicillin or metronidazole.
Danish: Eradikation af H. pylori på op til 90 % opnås, når clarithromycin kombineres med Agopton og amoxicillin eller metronidazol.
English: Lansoprazole is extensively metabolised by the liver and the metabolites are excreted by both the renal and biliary route.
Danish: Lansoprazol metaboliseres i vid udstrækning af leveren, og metabolitterne udskilles både via nyrerne og galdevejene.
English: The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19.
Danish: Lansoprazols biotransformation katalyseres hovedsageligt af enzymet CYP2C19.
English: The contents of one sachet should be reconstituted by stirring into 30 ml (two tablespoons) of tap water, and swallowed immediately.
Danish: Indholdet af én pakke opløses i 30 ml (to teskefulde) vand fra hanen og synkes med det samme.
English: The MAH proposed to include preliminary data in paediatric patients in the SPC.
Danish: Indehaveren af markedsføringstilladelsen foreslog at inkludere foreløbige data fra pædiatriske patienter i produktresuméet.
English: It is not known whether lansoprazole is excreted in human breast milk.
Danish: Det vides ikke, om lansoprazol udskilles i modermælk.
English: This is also reflected in the SPC for lansoprazole.
Danish: Dette fremgår også af produktresuméet for lansoprazol.
English: No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.
Danish: Ingen klinisk signifikante interaktioner af lansoprazol med ikke-steroide antiinflammatoriske farmaka er blevet påvist.
English: The H. pylori eradication results obtained when clarithromycin is combined with either amoxicillin or metronidazole give rates of up to 90%, when used in combination with Agopton.
Danish: Eradikationen af H. pylori, når clarithromycin administreres i kombination med enten amoxicillin eller metronidazol, giver rater på op til 90 %, når disse stoffer anvendes i kombination med Agopton.
English: Theophylline:
Danish: Theophyllin:
English: 6.6 Special precautions for disposal and other handling No special requirements for disposal.
Danish: 6.6 Instruktioner vedrørende håndtering og destruktion Ingen særlige forholdsregler ved bortskaffelse.
English: Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2).
Danish: Enterokapslerne kan også åbnes og granulaterne blandes med 40 ml æblejuice til administration via en nasogastrisk sonde (se pkt.
English: Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and benign Leydig cell tumours.
Danish: Der blev også observeret intestinal metaplasi samt hyperplasi i Leydigceller og godartede tumorer i Leydig-celler.
English: A study shows that the plasma concentrations of lansoprazole increase up to 4-fold.
Danish: Et forsøg viser, at plasmakoncentrationerne af lansoprazol øges op til 4 gange.
English: The submitted data on the use of maintenance antisecretory therapy to prevent duodenal ulcer recurrence predates the use of such eradication therapy.s.
Danish: De forelagte data vedrørende antisekretorisk vedligeholdelsesbehandling for at forebygge tilbagefald af duodenale ulcera ligger forud for anvendelsen af eradikationsterapi.
English: Gastric acid is central in the pathogenesis of gastroduodenal ulcers and acid inhibition has been shown to effectively heal NSAID-associated ulcers.
Danish: Mavesyre spiller en central rolle i patogenesen af gastroduodenale ulcera, og syrehæmning har vist sig effektivt til at hele NSAID-relaterede ulcera.
English: Sucralfate/Antacids:
Danish: Sukralfat/antacider:
English: In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion.
Danish: I to carcinogenicitetsforsøg med rotter fremkaldte lansoprazol dosisrelateret gastrisk ECLcellehyperplasi og ECL-cellecarcinoider, der blev forbundet med hypergastrinæmi på grund af hæmningen af syresekretion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING & SACHET CARTON & SACHET
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE & PAKKERNE KARTON & PAKKE
English: <As Agopton contains sucrose, patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.>
Danish: <Da Agopton indeholder saccharose, må patienter med sjældne arvelige problemer med fructoseintolerans, glucose-galactosemalabsorption eller sucrase-isomaltase-insufficiens ikke anvende dette lægemiddel.>
English: Agopton contains aspartame.
Danish: Agopton indeholder aspartam.
English: If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.
Danish: Hvis De oplever en infektion med symptomer som for eksempel feber og alvorlig svækkelse af Deres almene tilstand eller feber med lokale symptomer på infektion som for eksempel ondt i hals/svælg/mund eller vandladningsproblemer, skal De omgående søge læge.
English: However, prophylactic treatment should be recommended only for patients at high risk, see SPC for detailed proposal.
Danish: Profylaktisk behandling bør dog kun anbefales til højrisikopatienter - yderligere oplysninger om dette forslag findes i produktresuméet.
English: The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).
Danish: Den forebyggende behandling af peptisk ulceration hos patienter, der kræver fortsat NSAIDbehandling, skal begrænses til højrisikopatienter (f.eks. tidligere gastrointestinal blødning, perforation eller ulcus, fremskreden alder, samtidig brug af medicin, der er kendt for at øge sandsynligheden for bivirkninger i den øvre gastrointestinalkanal [f.eks. kortikosteroider eller antikoagulantia], tilstedeværelse af en alvorlig faktor for komorbiditet eller forlænget brug af de maksimalt anbefalede doser af NSAID).
English: In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.
Danish: Som ved andre behandlinger af ulcus skal muligheden for malign gastrisk tumor udelukkes, inden behandling af ulcus ventriculi med lansoprazol påbegyndes, idet lansoprazol kan skjule symptomerne og forsinke diagnosen.
English: Also contains sucrose.
Danish: Indeholder også saccharose.
English: Equivalent AUC has also been shown for granules suspended in apple juice administered through a naso-gastric tube.
Danish: Samme AUC er også påvist for granulater, der er blandet med æblejuice og administreret via en nasogastrisk sonde.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Danish: Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge.
English: The time to first recurrence of duodenal ulcer was significantly longer for lansoprazole patients compared to placebo.
Danish: Det første tilbagefald af duodenal ulcer forekom væsentligt senere hos patienter, der fik lansoprazol, end hos patienter, der fik placebo.
English: The data regarding healing of duodenal ulcers in one of the pivotal studies is limited (few patients) but support efficacy of both doses of lansoprazole 15 and 30 mg o.d.
Danish: I et af hovedundersøgelserne foreligger der begrænsede data (få patienter) i forbindelse med heling af duodenale ulcera, men de understøtter virkningen af begge doser lansoprazol (15 mg og 30 mg od).
English: The following side effects are uncommon (occur in less than 1 in 100 patients): - depression - joint or muscle pain - fluid retention or swelling - changes in blood cell counts.
Danish: Følgende bivirkninger er ikke almindelige (forekommer hos færre end 1 ud af 100 patienter): - depression - smerter i muskler eller led - væskeophobning eller hævelser - ændringer i antallet af blodceller.
English: For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration.
Danish: Til patienter, der har svært ved at synke medicinen, anbefales det på grundlag af forsøg og klinisk praksis, at enterokapslerne åbnes, og granulaterne blandes med lidt vand eller æble-/tomatjuice eller drysses ud over en lille smule flydende mad (f.eks. yoghurt eller æblemos) for at gøre administrationen lettere.
English: Luxembourg Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgium
Danish: Luxembourg Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgien
English: • Dosage and dosing schedule of symptomatic gastroesophageal reflux disease.
Danish: • Dosis og doseringsplan i forbindelse med symptomatisk gastroøsofageal reflukssygdom.
English: If you take more Agopton than prescribed
Danish: Hvis De tager mere Agopton end De bør
English: As lansoprazole is rapidly inactivated by gastric acid, it is administered orally in enteric-coated form(s) for systemic absorption.
Danish: Eftersom lansoprazol hurtigt inaktiveres af mavesyre, administreres det peroralt som enterogranulat for at opnå systemisk absorption.
English: Empty the granules from one sachet into the glass.
Danish: Hæld granulaterne fra en pakke i glasset.
English: If this happens skip the missed dose and take the remaining capsules as normal.
Danish: Hvis dette er tilfældet, skal De springe den glemte dosis over og tage de resterende kapsler på normal vis.
English: Studies have shown that oro-dispersible tablets dispersed in a small amount of water and given via syringe directly into the mouth or administered via naso-gastric tube result in equivalent AUC compared to the usual mode of admnisistration.
Danish: Det er påvist i forsøg, at orodispersible tabletter opløst i en smule vand og administreret direkte i munden ved hjælp af en sprøjte eller via en nasogastrisk sonde giver stort set samme AUC som den almindelige administrationsmetode.
English: Thrombocytopenia, eosinophilia, leucopenia
Danish: Trompocytopeni, eosinofili, leukopeni
English: Metabolism and elimination
Danish: Biotransformation og elimination:
English: The second study examined the use of lansoprazole in the maintenance of healed ulcer (prevention of relapse) of duodenal or gastric ulcer disease resistant H2 blockers.
Danish: Den anden undersøgelse så nærmere på anvendelsen af lansoprazol som vedligeholdelsesbehandling af helede gastriske ulcera eller duodenale ulcera (forebyggelse af tilbagefald), der var resistente mod H2blokkere.
English: It was demonstrated that the total lansoprazole exposure is many-fold increased in patients with severe hepatic impairment.
Danish: Det blev påvist, at den samlede lansoprazoleksponering mangedobles hos patienter med svær nedsat leverfunktion.
English: No data regarding of the use of lanzoprazole during preganancy and lactation has been provided.
Danish: Der foreligger ingen data vedrørende brug af lansoprazol under graviditet og amning.
English: After preparing the suspension or mixture, the drug should be administered immediately.
Danish: Lægemidlet skal administreres omgående, efter at suspensionen eller blandingen er lavet.
English: The tablet rapidly disperses in the mouth, releasing gastro-resistant microgranules which are swallowed with the patient's saliva.
Danish: Tabletten opløses i munden og frigiver enteromikrogranulater, som sluges sammen med patientens spyt.
English: Belgium Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgium
Danish: Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgien
English: Lansoprazole is not significantly eliminated by haemodialysis.
Danish: Lansoprazol elimineres ikke signifikant ved hæmodialyse.
English: A single oral dose of lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
Danish: En enkelt peroral dosis på 30 mg lansoprazol hæmmer den pentagastrin-stimulerede mavesyresekretion med cirka 80 %.
English: The objective of one study was to compare the efficacy and safety of lansoprazole 15mg qd with placebo in preventing the recurrence of duodenal ulceration in patients with a history of recently healed duodenal ulcer.
Danish: Formålet med den ene undersøgelse var at sammenligne virkningen af og sikkerheden ved lansoprazol 15 mg qd med placebo i forbindelse med forebyggelse af tilbagefald af duodenal ulceration hos patienter, der for nylig var blevet behandlet for duodenale ulcera.
English: <Prescription>
Danish: <Receptpligtig medicin>
English: Do not take a double dose to make up for a forgotten oro-dispersible tablet.
Danish: De må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: The active ingredient in Agopton is lansoprazole, which is a proton pump inhibitor.
Danish: Det aktive indholdsstof i Agopton er lansoprazol, der er en protonpumpehæmmer.
English: It has a corresponding effect on the basal secretion of gastric acid.
Danish: Der opnås en tilsvarende effekt på den basale sekretion af mavesyre.
English: The recommended dose is 15 mg or 30 mg daily.
Danish: Den anbefalede dosis er 15 mg eller 30 mg dagligt.
English: Add 30 ml (two tablespoons) of tap water to a glass.
Danish: Hæld 30 ml (to teskefulde) vand fra hanen i et glas.
English: Visual disturbances.
Danish: Synsforstyrrelser
English: The evaluation of the pharmacokinetics in children aged 1 -17 years of age showed a similar exposure as compared to adults with doses of 15 mg for those below 30 kg of weight and 30 mg for those above.
Danish: Evalueringen af farmakokinetikken hos børn i alderen 1-17 år viste en lignende eksponering sammenlignet med voksne, når der blev givet doser på 15 mg til personer, som vejede under 30 kg, og 30 mg til personer over 30 kg.
English: The evaluation of the pharmacokinetics in children aged 10 weeks and above showed similar exposures in comparison to healthy adult volunteers receiving a 30 mg dose either with a body weight or body surface based dosing for babies.
Danish: Evalueringen af farmakokinetikken hos børn i alderen 10 uger og opefter viste eksponeringer af samme størrelsesorden som hos raske voksne frivillige, der fik en dosis på 30 mg med enten en kropsvægt- eller kropsoverfladebaseret dosis for spædbørn.
English: If your doctor has given you Agopton in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully.
Danish: Hvis lægen har ordineret Agopton sammen med anden medicin, der anvendes til behandling af infektion med Helicobacter pylori (antibiotika), eller sammen med betændelsesdæmpende medicin til behandling af smerter eller gigt, skal De læse indlægssedlerne til disse præparater omhyggeligt.
English: Gastro-resistant granules for oral suspension
Danish: Enterogranulat til oral opløsning
English: <For countries with prescription use only>
Danish: <Til lande, hvor medicinen kun fås på recept>
English: In mouse carcinogenicity studies dose-related gastric ECL cell hyperplasia developed as well as liver tumours and adenoma of rete testis.
Danish: I carcinogenicitetsforsøg med mus blev der udviklet dosisrelateret gastrisk hyperplasi i ECL-celler samt levertumorer og adenom i rete testis.
English: If this happens skip the missed dose and take the remaining oro-dispersible tablets as normal.
Danish: Hvis dette er tilfældet, skal De springe den glemte dosis over og tage de resterende tabletter på normal vis.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose sachet contains 30 mg of lansoprazole Excipient(s): Each single dose sachet contains 25.248 g of sucrose and 24.64 g of mannitol.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enkeltdosispakke indeholder 30 mg lansoprazol Hjælpestof(fer): Hver enkeltdosispakke indeholder 25,248 g saccharose og 24,64 g mannitol.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, Labelling and Package Leaflet is set out in Annex III of the CHMP Opinion for Agopton and associated names (see Annex I of the opinion).
Danish: har CHMP anbefalet, at markedsføringstilladelserne for Agopton og tilknyttede navne (se bilag I til CHMP's udtalelse) ændres.
English: The recommended combinations of antibiotics are: - 30 mg Agopton together with 250-500 mg clarithromycin and 1000 mg amoxicillin - 30 mg Agopton together with 250 mg clarithromycin and 400-500 mg metronidazole
Danish: De anbefalede kombinationer af antibiotika er: - 30 mg Agopton sammen med 250-500 mg clarithromycin og 1000 mg amoxicillin - 30 mg Agopton sammen med 250 mg clarithromycin og 400-500 mg metronidazol.
English: for 9 days on the pharmacokinetics of phenytoin after a 250 mg i.v.
Danish: Indvirkningen af lansoprazol 60 mg qd i 9 dage på phenytoins farmakokinetik efter en intravenøs dosis på 250 mg blev undersøgt.
English: 30 mg once daily for four weeks.
Danish: 30 mg én gang dagligt i 4 uger.
English: Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Agopton.
Danish: Bivirkninger som for eksempel svimmelhed, vertigo, træthed og synsforstyrrelser kan opstå ved brug af Agopton.
English: • Treatment of duodenal and gastric ulcer
Danish: • behandling af duodenale ulcera og gastriske ulcera
English: Member State Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af markedsføringstilladelsen Lægemidlets navn Styrke
English: Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines.
Danish: En af de faktorer, der kan nedsætte Deres evne til at udføre disse ting sikkert, er brug af medicin på grund af dens effekt eller bivirkninger.
English: If you forget to take Agopton
Danish: Hvis De glemmer at tage Agopton
English: A rapid relief of symptoms is obtained by one capsule (30 mg) daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks.
Danish: En hurtig symptomlindring opnås med én kapsel (30 mg) dagligt, og de fleste patienter med ulcus duodeni kommer sig i løbet af 2 uger, mens patienter med ulcus ventriculi og refluksøsofagitis kommer sig i løbet af 4 uger.
English: Treatment of duodenal ulcer:
Danish: Behandling af ulcus duodeni:
English: Each capsule contains <white to pale brownish white entericcoated granules>.
Danish: Hver kapsel indeholder <hvide til lysebrune enterogranulater>.