FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Udfyldes nationalt]
English: Agopton is indicated for use in: - Treatment of heartburn and acid regurgitation
Danish: Agopton anvendes til behandling af: - Halsbrand og sure opstød.
English: Higher exposure to lansoprazole in comparison to adults has been seen in infants below the age of 2-3 months with doses of both 1.0 mg/kg and 0.5 mg/kg body weight given as a single dose.
Danish: Højere eksponering for lansoprazol sammenlignet med voksne er blevet set hos spædbørn yngre end 23 måneder med doser på både 1,0 mg/kg og 0,5 mg/kg kropsvægt administreret som en enkelt dosis.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Danish: 6.6 Instruktioner vedrørende håndtering og destruktion Ingen særlige forholdsregler.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Peroral anvendelse.
English: A rapid relief of symptoms is obtained by one oro-dispersible tablet (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 orodispersibel tablet (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: Netherlands Sanofi-Synthelabo B.V. / Aventis Pharma B.V. Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, The Netherlands
Danish: Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, Holland
English: Two pivotal studies for the support of the proposed indication in ulcer healing have been presented: Both of them were double-blind, positive-controlled, randomised, parallel group, multi-centre studies designed to evaluate the safety and efficacy of lansoprazole 15 mg and 30 mg o.d. in comparison to ranitidine 150 mg b.d.
Danish: Begge undersøgelser var dobbeltblinde, randomiserede multicenterundersøgelser med parallelgrupper og positiv kontrol designet til at vurdere sikkerheden og virkningen af lansoprazol 15 mg og 30 mg od sammenlignet med ranitidin 150 mg bid.
English: Belgium:
Danish: Belgien:
English: Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).
Danish: Lansoprazol skal anvendes med forsigtighed til patienter med moderat og svært nedsat leverfunktion (se pkt.
English: Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur (see section 4.8).
Danish: Bivirkninger som for eksempel svimmelhed, vertigo, synsforstyrrelser og somnolens kan forekomme (se pkt.
English: What Agopton is and what it is used for Before you take Agopton How to take Agopton Possible side effects How to store Agopton Further information
Danish: Hvad Agopton er, og hvad det anvendes til Hvad de skal gøre, før De begynder at anvende Agopton Hvordan De anvender Agopton.
English: The CHMP requested, the MAH to submit a full review of the paediatric data and to make an adequate proposal for the treatment of children in the relevant sections of the SPC The applicant answered the question on paediatric data with the filing of a complete paediatric data package.
Danish: CHMP anmodede om, at indehaveren af markedsføringstilladelsen forelagde en komplet gennemgang af de pædiatriske data og kom med et passende forslag til behandling af børn i de relevante afsnit i produktresuméet.
English: The recommended initial dose is 60 mg once daily.
Danish: Den anbefalede initialdosis er 60 mg én gang dagligt.
English: The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.
Danish: Såret heler normalt i løbet af 4 uger, men patienter, der ikke helbredes fuldstændigt i løbet af denne periode, kan blive behandlet med den samme dosis i yderligere 4 uger.
English: Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age > 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:
Danish: Profylakse af NSAID-associeret ulcus ventriculi og ulcus duodeni hos risikopatienter (som for eksempel alder > 65 eller ulcus ventriculi eller ulcus duodeni i anamnesen), der kræver forlænget NSAID-behandling:
English: • Symptomatic gastroesophageal reflux disease
Danish: • symptomatisk gastroøsofageal reflukssygdom
English: If you stop taking Agopton
Danish: Hvis De holder op med at tage Agopton
English: Austria:
Danish: Østrig:
English: Lansoprazole 30 mg combined with clarithromycin 250 or 500 mg and amoxicillin 1g, or clarithromycin 250 and metronidazole 400-500 mg twice daily was associated with eradication rates meeting the above described requirements.
Danish: Lansoprazol 30 mg kombineret med clarithromycin 250 mg eller 500 mg og amoxicillin 1 g eller kombineret med clarithromycin 250 mg og metronidazol 400-500 mg to gange dagligt blev forbundet med eradikationsrater, der lå over de ovenfor beskrevne krav.
English: Drugs which inhibit CYP2C19
Danish: Lægemidler, der hæmmer CYP2C19
English: The studies presented by the MAH demonstrated efficacy of lansoprazole in the treatment and prevention of gastric ulceration associated with continued intake of NSAIDs.
Danish: Undersøgelserne, der blev fremlagt af indehaveren af markedsføringstilladelsen, påviste, at lansoprazol er effektivt til behandling og forebyggelse af gastrisk ulceration, der er forbundet med indtag af NSAID'er.
English: Possible side effects 5.
Danish: Hvilke mulige bivirkninger Agopton har 5.
English: Nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence, dry mouth or throat
Danish: Kvalme, diarré, abdominalsmerter, obstipation, opkastning, flatulens, mund- og halstørhed
English: Please follow your doctor's instructions for taking your medicine.
Danish: Følg altid lægens anvisninger til fulde.
English: Hepatitis, jaundice
Danish: Hepatitis, icterus
English: Effect on gastric acid secretion:
Danish: Effekt på mavesyresekretion:
English: Sweden:
Danish: Sverige:
English: Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening.
Danish: Behandling af infektion med Helicobacter pylori: Den normale dosis er 1 kapsel (30 mg) kombineret med to forskellige antibiotika om morgenen og 1 kapsel (30 mg) kombineret med to forskellige antibiotika om aftenen.
English: Musculoskeletal and connective tissue disorders
Danish: Muskuloskeletale-, bindevævs- og knoglelidelser
English: Greece:
Danish: Grækenland:
English: • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers
Danish: • eradikation af Helicobacter pylori (H. pylori) i kombination med passende antibiotika til behandling af H. pylori-relaterede ulcera
English: Prophylaxis of reflux oesophagitis: 15 mg once daily.
Danish: Profylakse af refluksøsofagitis: 15 mg én gang dagligt.
English: The following side effects are common (occur in more than 1 in 100 patients): - headache, dizziness - diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat - skin rash, itching - changes in liver function test values - tiredness.
Danish: Følgende bivirkninger er almindelige (forekommer hos flere end 1 ud af 100 patienter): - hovedpine, svimmelhed - diarré, forstoppelse, mavesmerter, en følelse af at være syg, opkastninger, luft i maven, tørhed eller ondt i mund eller hals - hududslæt, kløe - ændringer i resultater af leverfunktionsprøver - træthed.
English: OPIREN Frash
Danish: OPIREN Flas
English: The objective of this trial was to compare the efficacy /safety or lansoprazole 15/30mg to placebo in the prevention of duodenal ulcers in those with a history of duodenal, or gastric ulcer disease in those with a history of gasric ulcers.
Danish: Formålet med denne undersøgelse var at sammenligne virkningen af og sikkerheden ved lansoprazol 15/30 mg med placebo i forbindelse med forebyggelse af duodenale ulcera hos patienter, der tidligere havde haft duodenale ulcera, eller i forbindelse med forebyggelse af gastriske ulcera hos patienter, der tidligere havde haft gastriske ulcera.
English: The recommended dose is 30 mg of Agopton twice daily for 7 days in combination with one of the following: clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily
Danish: Den anbefalede dosis er 30 mg Agopton to gange dagligt i 7 dage kombineret med en af følgende: 250-500 mg clarithromycin to gange dagligt + 1 g amoxicillin to gange dagligt 250 mg clarithromycin to gange dagligt + 400-500 mg metronidazol to gange dagligt.
English: In patients not fully healed the treatment may be continued for another four weeks.
Danish: Patienter, der ikke helbredes fuldstændigt, kan fortsætte med behandlingen i yderligere 4 uger.
English: For the best results from your medicines you should take Agopton at least 30 minutes before food.
Danish: Hvordan man anvender Agopton sammen med mad og drikkevarer De bør tage Agopton mindst 30 minutter før indtagelse af mad for at opnå de bedste resultater af lægemidlet.
English: - Remove the plunger of the syringe (at least 5 ml syringe for the 15 mg tablet and 10 ml syringe for the 30 mg tablet) - Put the tablet into the barrel - Put the plunger back onto the syringe - For the 15 mg tablet: Draw 4 ml tap water into the syringe - For the 30 mg tablet: Draw 10 ml tap water into the syringe - Invert the syringe and draw an additional 1 ml of air into it - Shake the syringe gently for 10-20 seconds until the tablet is dispersed - The contents can be emptied directly into the mouth - Refill the syringe with 2-5 ml of tap water to flush the remnants out of the syringe into the mouth
Danish: - Ved 30 mg tabletter: Hæld 10 ml vand fra hanen i sprøjten - Vend sprøjten, og træk yderligere 1 ml luft ind i den - Ryst sprøjten forsigtigt i 10-20 sekunder, indtil tabletten er opløst - Indholdet kan sprøjtes direkte ind i munden - Hæld derefter 2-5 ml vand fra hanen i sprøjten for at skylle den sidste medicin ud i munden.
English: How to store Agopton 6.
Danish: Hvordan De opbevarer Agopton 6.
English: Increase in liver enzyme levels
Danish: Stigning i leverenzymniveauer
English: Alternatively, the tablet can be swallowed whole with a drink of water.
Danish: Tabletten kan også sluges hel sammen med vand.
English: For the complete wording of section 4.5 please see attched SPC.
Danish: Den nøjagtige ordlyd af punkt 4.5 fremgår af produktresuméet.
English: 6.5 Nature and contents of container Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Lansoprazole is a specific inhibitor of the parietal cell proton pump.
Danish: Lansoprazol er en specifik hæmmer af protonpumpen i parietalcellen.
English: GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: For lansoprazole no clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data vedrørende eksponering for lansoprazol under graviditet.
English: Iceland:
Danish: Island:
English: Agopton contains sucrose.
Danish: Agopton indeholder saccharose.
English: Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg oro-dispersible tablet in combination with two different antibiotics in the morning and one 30 mg oro-dispersible tablet in combination with two different antibiotics in the evening.
Danish: Behandling af infektion med Helicobacter pylori: Den normale dosis er 1 orodispersibel tablet (30 mg) kombineret med to forskellige antibiotika om morgenen og 1 orodispersibel tablet (30 mg) kombineret med to forskellige antibiotika om aftenen.
English: Spain:
Danish: Spanien:
English: The plasma protein binding is 97%.
Danish: Plasmaproteinbindingen er
English: Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules every day to start with, then depending on how you respond to Agopton the dose that your doctor decides is best for you.
Danish: Zollinger-Ellisons syndrom: Den normale dosis er 2 kapsler (30 mg) hver dag til at begynde med, og derefter afgør lægen, hvilken dosis der er passende for Dem, afhængigt af hvordan De responderer på Agopton.
English: The recommended dose is 30 mg once daily for 2 weeks.
Danish: Den anbefalede dosis er 30 mg én gang dagligt i 2 uger.
English: In patients who continue to take NSAID medication healing is delayed.
Danish: Helingen forsinkes hos patienter, der fortsat tager NSAID'er.
English: <As Agopton contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.>
Danish: <Da Agopton indeholder lactose, bør lægemidlet ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase Deficiency) eller glucose-/galactosemalabsorption.>
English: This is reflected in the SPC.
Danish: Dette er afspejlet i produktresuméet.
English: Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined.
Danish: Anvendelse af et regimen, der omfatter lansoprazol 30 mg to gange dagligt, amoxicillin 1 g to gange dagligt og metronidazol 400-500 mg to gange dagligt, er også blevet undersøgt.
English: The recommended dose is 30 mg once daily for 4 weeks.
Danish: Den anbefalede dosis er 30 mg én gang dagligt i 4 uger.
English: Impaired hepatic or renal function:
Danish: Nedsat lever- eller nyrefunktion:
English: United Kingdom
Danish: Storbritannien:
English: Zollinger-Ellison syndrome: The usual dose is two 30 mg oro-dispersible tablet every day to start with, then depending on how you respond to Agopton the dose that your doctor decides is best for you.
Danish: Zollinger-Ellisons syndrom: Den normale dosis er 2 orodispersible tabletter (30 mg) hver dag til at begynde med, og derefter afgør lægen, hvilken dosis der er passende for Dem, afhængigt af hvordan De responderer på Agopton.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, herunder også håndkøbsmedicin, skal De fortælle det til Deres læge.
English: Each 30 mg oro-dispersible tablet contains 30 mg of lactose and 9.0 mg of aspartame For a full list of excipients, see section 6.1.
Danish: Hver 30 mg orodispersibel tablet indeholder 30 mg lactose og 9,0 mg aspartam
English: Therefore, the use of lansoprazole during pregnancy is not recommended.
Danish: Lansoprazol må ikke anvendes til gravide.
English: Symptomatic gastro-oesophageal reflux disease:
Danish: Symptomatisk gastroøsofageal reflukssygdom:
English: BAMALITE Frash, OPIREN Frash
Danish: BAMALITE Flas, OPIREN Flas
English: <For countries with OTC use and prescription use>
Danish: <Til lande, hvor medicinen fås i håndkøb og på recept>
English: FURTHER INFORMATION What Agopton contains - The active substance is lansoprazole - The other ingredients are [To be completed nationally]
Danish: YDERLIGERE OPLYSNINGER Hvad Agopton indeholder - Det aktive stof er lansoprazol.
English: For the prevention of NSAID associated ulceration, one pivotal study was presented.
Danish: Der blev fremlagt en hovedundersøgelse vedrørende forebyggelse af NSAID-relateret ulceration.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
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: • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section
Danish: • profylakse af NSAID-relaterede gastriske og duodenale ulcera hos risikopatienter (se punkt 4.2),
English: When reconstituted in water the granules give a pink suspension with a strawberry flavour.
Danish: Granulaterne giver en lyserød opløsning med jordbærsmag, når de opløses i vand.
English: Directions for re-constituting suspension from sachets:
Danish: Anvisninger til opløsning af pakkernes indhold:
English: 4.2) requiring continued therapy
Danish: der kræver fortsat behandling
English: When reconstituted in water Agopton is a pink suspension with a strawberry flavour.
Danish: Agopton giver en lyserød opløsning med jordbærsmag, når det opløses i vand.
English: Your doctor may also prescribe Agopton for the following indications: - Treatment of duodenal and stomach ulcer - Treatment of inflammation in your oesophagus (reflux oesophagitis) - Prevention of reflux oesophagitis
Danish: Lægen kan også ordinere Agopton ved: - Duodenalsår og mavesår - Betændelsestilstand i spiserøret (refluksøsofagitis) - Forebyggelse af refluksøsofagitis
English: Do not crush or chew
Danish: Må ikke knuses eller tygges.
English: Denmark:
Danish: Danmark:
English: Do not take Agopton: - if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Agopton - if you are taking a medicine containing the active substance atazanavir (used in the treatment of
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT ANVENDE AGOPTON De bør ikke anvende Agopton: - Hvis De er allergisk (overfølsom) over for lansoprazol eller et af de øvrige indholdsstoffer i
English: Before you take Agopton 3.
Danish: Hvad de skal gøre, før De begynder at anvende Agopton 3.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each oro-dispersible tablet contains 15 mg of lansoprazole Each oro-dispersible tablet contains 30 mg of lansoprazole Excipient(s): Each 15 mg oro-dispersible tablet contains 15 mg of lactose and 4.5 mg of aspartame
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver orodispersibel tablet indeholder 15 mg lansoprazol Hver orodispersibel tablet indeholder 30 mg lansoprazol Hjælpestof(fer):
English: Each 30 mg capsule contains 59.8 mg of sucrose For a full list of excipients, see section 6.1.
Danish: Hver 30 mg kapsel indeholder 59,8 mg saccharose.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
English: Your doctor may prescribe Agopton for the following indications: - Treatment of duodenal and stomach ulcer - Treatment of inflammation in your oesophagus (reflux oesophagitis) - Prevention of reflux oesophagitis - Treatment of heartburn and acid regurgitation - Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy - Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID
Danish: Lægen kan ordinere Agopton ved: - Duodenalsår og mavesår - Betændelsestilstand i spiserøret (refluksøsofagitis) - Forebyggelse af refluksøsofagitis - Halsbrand og sure opstød - Infektioner, der er forårsaget af bakterien Helicobacter pylori, når midlet kombineres med antibiotisk behandling - Behandling eller forebyggelse af duodenalsår eller mavesår hos patienter, der kræver samtidig behandling med NSAID'er (NSAID'er er midler, der anvendes mod smerter eller betændelsestilstande) - Behandling af Zollinger-Ellisons syndrom (kronisk dannelse af store mængder mavesyre).
English: The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs).
Danish: Eksponeringen for lansoprazol er flere gange højere hos personer, der har en ringe metaboliseringsevne, end hos personer, som har en god metaboliseringsevne.
English: CYP2C19 poor metabolisers
Danish: Personer med nedsat CYP2C19-metabolisme
English: HOW TO STORE AGOPTON
Danish: HVORDAN DE OPBEVARER AGOPTON
English: Treatment of gastric ulcer:
Danish: Behandling af ulcus ventriculi:
English: Blood and lymphatic system disorders
Danish: Lidelser i blod og lymfe
English: In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.
Danish: Patienter, der ikke helbredes fuldstændigt i løbet af denne periode, vil blive behandlet med den samme dosis i yderligere 2 uger.
English: Agopton 30 mg: <colour> oro-dispersible tablet.
Danish: Agopton 30 mg: <farve> orodispersibel tablet.
English: Agopton and associated names (see Annex I) 15 mg capsules Agopton and associated names (see Annex I) 30 mg capsules
Danish: Agopton og tilknyttede navne (se Bilag I) enterokapsler 15 mg Agopton og tilknyttede navne (se Bilag I) enterokapsler 30 mg
English: • Mixing the content of the “opened capsules” with food Studies have been performed investigating the effect of mixing the granules of lansoprazole with food.
Danish: • Sammenblanding af indholdet af de "åbnede kapsler" med fødevarer
English: Agopton and associated names (see Annex I) 15 mg oro-dispersible tablets Agopton and associated names (see Annex I) 30 mg oro-dispersible tablets [See Annex I - To be completed nationally]
Danish: Agopton og tilknyttede navne (se Bilag I) orodispersible tabletter 15 mg Agopton og tilknyttede navne (se Bilag I) orodispersible tabletter 30 mg [Se Bilag I - Udfyldes nationalt]
English: Agopton 15 mg: <colour> oro-dispersible tablet.
Danish: Agopton 15 mg: <farve> orodispersibel tablet.
English: Agopton 30 mg: <colour> capsules.
Danish: Agopton 30 mg: <farve> enterokapsler.
English: Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks
Danish: Behandling af ulcus duodeni: 1 kapsel (30 mg) hver dag i 2 uger.
English: treatment (NSAID treatment is used against pain or inflammation) - Treatment of Zollinger-Ellison syndrome.
Danish: - Behandling eller forebyggelse af duodenalsår eller mavesår hos patienter, der kræver samtidig behandling med NSAID'er (NSAID'er er midler, der anvendes mod smerter eller betændelsestilstande) - Behandling af Zollinger-Ellisons syndrom (kronisk dannelse af store mængder mavesyre).
English: HOW TO TAKE AGOPTON
Danish: HVORDAN DE ANVENDER AGOPTON
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Agopton and associated names 30 mg gastro-resistant granules for oral suspension [See Annex 1- To be completed nationally] Lansoprazole
Danish: INDLÆGSSEDDEL: OPLYSNINGER TIL BRUGEREN Agopton og tilknyttede navne enterogranulater 30 mg til peroral opløsning [Se Bilag I - Udfyldes nationalt] Lansoprazol
English: Agopton 15 mg: <colour> capsules.
Danish: Agopton 15 mg: <farve> enterokapsler.
English: Pharmacokinetics in hepatic insufficiency
Danish: Farmakokinetik ved nedsat leverfunktion
English: Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks.
Danish: Behandling af halsbrand og sure opstød: 1 kapsel (15 mg eller 30 mg) hver dag i 4 uger.
English: If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before taking this medicine.
Danish: Få vejledning hos lægen eller apoteket, før De tager nogen form for medicin, hvis De er gravid, ammer eller har mistanke om, at De er gravid.
English: In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.
Danish: Patienter, der ikke helbredes fuldstændigt i løbet af denne periode, vil blive behandlet med den samme dosis i yderligere 4 uger.
English: • Prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions, and prevention of the associated symptoms, in patients who require continued NSAID treatment
Danish: • Profylakse af NSAID-relaterede gastriske ulcera, duodenale ulcera og gastroduodenale erosioner samt forebyggelse af de tilknyttede symptomer hos patienter, der kræver fortsat NSAID-behandling