FrancophonIA/ELRC3.0 huggingface dataset:
English: Under these conditions the ability to react may be decreased.
Danish: Under disse omstændigheder kan evnen til at reagere være nedsat.
English: Rare (0.01-0.1%)
Danish: Sjældne (0,01-0,1%)
English: Titanium dioxide (E 171)
Danish: Titaniumdioxid (E 171)
English: This medicine has the best effect when taken into empty stomach.
Danish: Dette lægemiddel har den bedste virkning, når det tages på tom mave.
English: Very Rare
Danish: Meget sjældne
English: Annex I).
Danish: (se bilag I).
English: Interaction with Other Medicinal Products and Other Forms of Interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion
English: The influence of this combined administration has not yet been investigated systemically.
Danish: Indflydelsen af denne kombinerede indgivelse er endnu ikke blevet systematisk undersøgt.
English: The lansoprazole dose should therefore be taken at least an hour prior or after.
Danish: Dosis af lansoprazol bør derfor tages mindst en time før eller efter.
English: After eight days of repeated administration the reduction is about 85%.
Danish: Efter otte dage med gentagen administration er reduktionen cirka 85%.
English: Aluminium/Aluminium blister (Alu/OPA/PVC/PE)
Danish: Aluminium/aluminium blisterpakning (Alu/OPA/PVC/PE)
English: The dose should be individually adjusted and the treatment should be continued for as long as necessary.
Danish: Dosis bør justeres individuelt, og behandlingen bør fortsætte så længe, det er nødvendigt.
English: Instructions for Use and Handling No special requirements.
Danish: Eventuelle instruktioner vedrørende anvendelse og håndtering Ingen særlige forholdsregler.
English: Caution is advised when combining the two drugs.
Danish: Der tilrådes forsigtighed, når man kombinerer de to lægemidler.
English: For reasons of theoretical considerations, enhanced interactions with other medicinal products must be expected as a precaution.
Danish: Af teoretiske betragningsgrunde må forstærkede interaktioner med andre lægemidler forventes som en forsigtighedsregel.
English: Consideration should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
Danish: Officielle lokale retningslinjer bør tages i betragtning (f.eks. nationale anbefalinger) med hensyn til bakterieresistens og den passende anvendelse og ordination af antibakterielle midler.
English: If the required daily dose exceeds 120 mg, it should be given in two divided doses.
Danish: Hvis den påkrævede daglige dosis overskrider 120 mg, bør den gives i to opdelte doser.
English: Lansoprazole is not recommended in children as safety and efficacy have not been established in this population.
Danish: Lansoprazol anbefales ikke til børn, da sikkerhed og virkning ikke er blevet fastslået hos denne population.
English: Intestinal metaplasia has been found in animal studies on rats.
Danish: Intestinal metaplasi er blevet fundet ved dyreundersøgelser hos rotter.
English: Note: This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for lansoprazole containing medicinal products.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 29 arbitreringssag vedrørende lægemidler indeholdende lansoprazol.
English: Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients (see “5.3 Preclinical safety data”).
Danish: På grund af begrænsede sikkerhedsdata for patienter på vedligeholdelsesbehandling i mere end 1 år, bør man regelmæssigt gennemgå behandlingen og en gennemgribende vurdering af fordele og risici bør regelmæssigt foretages hos disse patienter (se pkt.
English: The capsules may be emptied, but the contents may not be chewed or ground.
Danish: Kapslerne kan tømmes, men indholdet må ikke tygges eller stødes.
English: If visual disturbances occur during long-term use (>1 year), an ophthalmologist should be consulted.
Danish: Hvis der forekommer synsforstyrrelser under længerevarende brug (> 1 år), bør man rådføre sig med en oftalmolog.
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 oral dosis på 30 mg nedsætter basal sekretion med omkring 70%, og patientens symptomer lettes dermed, begyndende med den allerførste dosis.
English: Monitoring of the serum levels of other medicinal products taken during the 1-week eradication therapy is therefore recommended.
Danish: Monitorering af serumniveaue for andre lægemidler, der indtages under den 1 uge lange udryddelsesbehandling, anbefales derfor.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: fever, hyperhidrosis,
Danish: feber, hyperhidrose,
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.
Danish: Prækliniske data afslører ingen specielle farer for mennesker baseret på konventionelle undersøgelser over sikkerhedsfarmakologi, toksicitet ved gentagen dosering, toksicitet ved reproduktion eller genotoksicitet.
English: Common (>1%)
Danish: Almindelige (>1%) Ualmindelige
English: Gastro-resistant capsule, hard
Danish: Gastro-resistent kapsel, hård
English: DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN [Udfyldes nationalt]
English: Special Precautions for Storage Do not store above 25ºC.
Danish: Særlige opbevaringsforhold Opbevares ved under 25 ºC
English: bronchial constriction,
Danish: bronchiekonstriktion,
English: Effects on Ability to Drive and Use Machines
Danish: Virkninger på evnen til at føre motorkøretøj eller betrjene maskiner
English: Therefore, the use of lansoprazole during pregnancy is not recommended.
Danish: Brugen af lansoprzol under graviditet anbefales derfor ikke.
English: Reflux oesophagitis may not present as ulceration and/or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
Danish: Reflux øsofagitis fremstår måske ikke som ulceration og/eller visuel beskadigelse, hvorfor i visse tilfælde endoskopi alene ikke er tilstrækkelig.
English: However, in order to avoid treatment failure, local antibacterial resistance patterns and local guidelines should be considered.
Danish: For at undgå fejlslået behandling og lokale bakterieresistensmønstre bør lokale retningslinjer dog tages i betragtning.
English: This should be taken into account when driving or using machines.
Danish: Dette bør tages i betragtning ved kørsel eller betjening af maskiner (se pkt.
English: The plasma protein binding of lansoprazole is about 95%, but this has not been found to have a significant effect on other protein bound drugs.
Danish: Plasma proteinbindingen for lansoprazol er omkring 95%, men dette er ikke fundet at have en signifikant virkning på andre proteinbundne lægemidler.
English: Retinal atrophy occurred not until 18 months of treatment.
Danish: Retinal atrofi forekom ikke før 18 måneders behandling.
English: The effects of overdose of lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instructions for treatment cannot be given.
Danish: Overdosering Virkningerne ved overdosering med lansoprazol hos mennesker er ikke kendte (selvom den akutte toksicitet sandsynligvis er lav), og vejledninger for behandling kan derfor ikke gives.
English: Increase in cholesterol and triglyceride levels.
Danish: Underøgelser øgning i niveauerne for kolesterol og triglycerid.
English: Elderly: Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements.
Danish: Grundet forsinket elimination af lansoprazol hos de ældre, kan det være nødvendigt at indgive behandlingen i doser på 15 til 30 mg, justeret efter individuelle krav.
English: A rapid relief of symptoms is obtained by 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 lettelse af symptomer nås med 30 mg daglig, og de fleste patienter med duodenalulcus bliver raske inden for 2 uger, patienter med mavesår og reflux øsofagitis inden for 4 uger.
English: In patients receiving digoxin, the plasma levels should therefore be monitored and the dose of digoxin adjusted if necessary.
Danish: Hos patienter, der får digoxin, bør plasmaniveauerne derfor overvåges, og digoxindosis om nødvendigt justeres.
English: Mannitol Hypromellose Macrogol 6000 Talc
Danish: Hypromellose Macrogol 6000
English: Eradication of Helicobacter pylori:
Danish: Udryddelse af Helicobacter pylori:
English: There is no need to change the dose in patients with impaired renal function.
Danish: Der er intet behov for at ændre dosis hos patienter med nedsat nyrefunktion.
English: This concerns particularly such medicinal products also metabolized via the cytochrome P450 system.
Danish: Dette drejer sig især om sådanne lægemidler, der også metabliseres via cytochrom P450 systemet.
English: 15 mg once daily.
Danish: 15 mg én gang daglig.
English: A poor metaboliser would have more marked effects than an extensive metaboliser.
Danish: En dårlig metabolisator ville have mere udprægede virkninger end en omfattende metabolisator.
English: It has also been proven that eradication prevents ulcer recurrence without any maintenance antisecretory therapy.
Danish: Det er ligeledes blevet påvist, at eradikation forhindrer ulcusrecidiv uden sekretionshæmmende vedligeholdelsesbehandling.
English: mg twice daily was associated with eradication rates ranging from 71 to 94%, and ulcer healing rates were generally >80% in well designed studies.
Danish: 400 mg to gange dagligt var forbundet med eradikationsrater på mellem 71 og 94 % og rater for ulcusheling i veltilrettelagte undersøgelser i almindelighed på >80 %.
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 underkastet genetisk polymorfi og 2-6% af befolkningen, kaldet dårlige metabolikere (PM'er), er homozygote for en mutant CYP2C19 allele og mangler derfor et funktionelt CYP2C19 enzym.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige problemer som fruktose intolerance, glukose-galaktose malabsorption eller sukrase-isomaltase mangel bør ikke tage dette lægemiddel.
English: Triple therapy allows the eradication of H. pylori in more than 85% of cases in patients with peptic ulcer.
Danish: I en tredobbelt behandling er det muligt at udrydde H. pylori i over 85 % af tilfældene hos patienter med peptisk ulcus.
English: Member State Marketing Authorisation
Danish: Indehaver af markedsføringstilladelse
English: For lansoprazole no clinical data on exposed pregnancies are available.
Danish: Der foreligger for lansoprazol ingen kliniske data over eksponerede graviditeter.
English: Administration of lansoprazole may result in subtherapeutic concentrations of ketoconazol and itraconazol and the combination should be avoided.
Danish: Administration af lansoprazol kan resultere i subterapeutiske koncentrationer af ketoconazol og itraconazol, og kombinationen bør undgås.
English: • Zollinger-Ellison syndrome.
Danish: • Zollinger-Ellison syndrom.
English: Johnson syndrome and toxic epidermal necrolysis.
Danish: Johnson syndrom og toksisk epidermal nekrolyse.
English: Senses zaste disturbances and visual disturbances.
Danish: Sanser smagsforstyrrelser og synsforstyrrelser.
English: The dose may be increased up to 30 mg daily as necessary.
Danish: Dosis kan øges op til 30 mg daglig efter behov.
English: 3 years
Danish: Opbevaringstid 3 år
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development,
Danish: Dyreundersøgelser indikerer ingen direkte skadelig virkninger med hensyn til graviditet, embryonal/føtal udvikling, barsel eller postnatal udvikling.
English: impotence and angioedema.
Danish: impotens og angiødem.
English: Intake of food slows the absorption rate of lansoprazole and reduces its bioavailability (AUC) by about 25%.
Danish: Indtagelse af mad nedsætter absorptionshastigheden for lansoprazol og nedsætter biotilgængeligheden (AUC) med omkring 25%.
English: The effect may also be present if lansoprazole is combined with other drugs with pH dependent absorption.
Danish: Virkningen kan også være tilstede, hvis lansoprazol kombineres med andre lægemidler med pH-afhængig absorption.
English: The drug combination may result in increased carbamazepin concentrations as well as reduced lansoprazole concentrations.
Danish: Lægemiddelkombinationen kan resultere i øgede koncentrationer af carbamazepin såvel som nedsatte koncentrationer af lansoprazol.
English: The intake of food reduces the bioavailability of lansoprazole: it is recommended to take lansoprazole before the meal.
Danish: Indtagelsen af mad nedsætter lansoprazols biotilgængelighed: Det anbefales at tage lansoprazol inden måltidet.
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 virkningen gælder for både basal og stimuleret sekretion af mavesyre.
English: 7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 and 250 capsules
Danish: Lansoprazol 15 mg: 7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 og 250 kapsler
English: • Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography.
Danish: • Behandling af duodenalt og gastrisk ulcus bekræftet ved endoskopi eller røntgen.
English: The normal daily dose of 30 mg should not be exceeded in these patients, however.
Danish: Den normale daglige dosis på 30 mg bør imidlertid ikke overskrides hos disse patienter.
English: Patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
Danish: Patienter, der lider af gastro-duodenale ulcera, bør tage muligheden for infektion med H. pylori som en ætiologisk faktor i betragtning.
English: Zollinger-Ellison syndrome:
Danish: Zollinger-Ellison syndrom:
English: 2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 and 250 capsules
Danish: Lansoprazol 30 mg: 2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 og 250 kapsler
English: Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (Pgp) in vitro.
Danish: Lansoprazol er blevet set at hæmme transportproteinet P-glycoprotein (P-gp) in vitro.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03.
Danish: Farmakoterapeutisk klassifikation: protonpumpe-hæmmere, ACT-kode: A02BC03.
English: ANNEX III AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
Danish: BILAG III ÆNDRET PRODUKTRESUME FOR REFERENCE MEDLEMSLANDET
English: Preclinical Safety Data
Danish: Prækliniske sikkerhedsdata
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 en cirka 90% hæmning af mavesyresekretionen.
English: The possibility of malignant gastric tumour should be excluded before initiating treatment of gastric ulcer with lansoprazole, because lansoprazole can mask the symptoms and delay the diagnosis.
Danish: Muligheden for malign gastrisk tumor bør udelukkes, inden der indledes behandling af gastrisk ulcus med lansoprazol, da lansoprazol kan maskere symptomerne og forsinke diagnosen.
English: The following interactions between lansoprazole and one/two antibiotics used in eradication therapy have been found so far:
Danish: De følgende interaktioner mellem lansopranzol og visse antibiotika anvendt til udryddelsesbehandling er blevet fundet indtil nu:
English: Combinations of lansoprazole with one or two antibiotics produced equivalent eradication of H. pylori.
Danish: Kombinationer af lansoprazol med en eller to antibiotika medførte en tilsvarende eradikation af H. pylori.
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 breast feeding to the child and the benefit of lansoprazole therapy to the woman.
Danish: En beslutning om at fortsætte/afbryde amning eller fortsætte/afbryde behandling med lansoprazol bør foretages, idet fordelen ved amning for barnet og fordelen ved lansoprazolbehandling for kvinden bør tages i betragtning.
English: The concerns rose referred to discrepancies in comparison to the reference products on posology.
Danish: De spørgsmål, der blev rejst, vedrørte afvigelser med hensyn til dosering i forhold til referenceprodukterne.
English: Drugs associated with cytochrome P450
Danish: Lægemidler forbundet med cytochrom P450
English: It may not be excluded that lanzoprazole may affect transport via this protein giving rise to increased plasma concentrations of P-gp substrates such as digoxin.
Danish: Det kan ikke udelukkes, at lansoprazol kan påvirke tranport via dette protein og give anledning til øgede plasmakoncentrationer af P-gp substrater såsom digoxin.
English: hepatitis, icterus and interstitial nephritis.
Danish: hepatitis, ikterus og interstitiel nefritis.
English: If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Danish: Om nødvendigt anbefales gastrisk lavage, aktivt kul og symptomatisk behandling.
English: palpitation and chest pain.
Danish: palpitationer og brystsmerter.
English: Lansoprazole 30 mg combined with amoxicillin 1g, clarithromycin 250 or 500 mg, or metronidazole 400
Danish: Lansoprazol 30 mg kombineret med amoxicillin 1g, clarithromycin 250 eller 500 mg, eller metronidazol
English: Lansoprazole and associated names (see Annex I), 15 mg gastro-resistant capsule, hard Lansoprazole and associated names (see Annex I), 30 mg gastro-resistant capsule, hard
Danish: Lansopranzol og tilhørende navne (se Bilag I), 15 mg gastro-resistent kapsel, hård Lansopranzol og tilhørende navne (se Bilag I), 30 mg gastro-resistent kapsel, hård
English: Caution should be exercised when combining lansoprazole with drugs which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other drugs has not been extensively investigated.
Danish: Der bør udvises forsigtighed ved kombination af lansoprazol med lægemidler, der har et smalt terapeutisk indeks, da virkningen af lansoprazol på andre lægemidlers metabolisme ikke er blevet omfattende undersøgt.
English: Studies have shown that the dosage of phenytoin (CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
Danish: Undersøgelser har vist, at doseringen af fenytoin (CYP2C19 og CYP2C9 substrat) måske må nedsættes ved samtidig administration af lansoprazol.
English: • Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers..
Danish: • Udryddelse af Helicobacter pylori givet samtidig med passende antibiotikabehandling og forhindring af tilbagefald af peptiske ulcera hos patienter med H. Pylori forbundne ulcera.
English: Preliminary data suggest that lansoprazole-based eradication therapy is effective in children and the elderly.
Danish: at eradikationsbehandling baseret på lansoprazol er virksom hos børn og ældre.
English: Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Danish: Eksponering for lansoprazol øgede middel eksponering for tacrolimus med op til 81%.
English: (see section 4.8 Undesirable effects).
Danish: 4.8 ”Bivirkninger”).
English: Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme.
Danish: Der tilrådes derfor forsigtighed, når lansoprazol kombineres med lægemidler, der metaboliseres af dette enzym.
English: The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs).
Danish: Eksponeringen af lansoprazol er adskillige gange højere hos PM'er end hos ekstensive metabolikere (EM'er).
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den oprindelige emballage beskyttet mod fugt.
English: Increase bioaivalability and half-life of lansoprazole by 30 % each; increased plasma amoxicillin levels of a clarithromycin metabolite by 30 %
Danish: Øger biotilgængeligheden og halveringstiden for lansoprazol med 30 % hver; øgede plasmaniveauer af en clarithromycinmetabolit med 30 %
English: Results of studies on carcinogenic potential show that lansoprazole therapy is associated with Leydig cell hyperplasia and benign Leydig cell tumours in rats.
Danish: Resultater af undersøgelser af carcinogent potentiale viser, at behandling med lansoprazol er forbundet med Leydig cellehyperplasi og benign Leydig celletumorer hos rotter
English: Lansoprazole has a similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
Danish: Lansoprazol har samme virkningsmekanisme som omeprazol og begge øger gastrisk pH. Følgende udtalelse fremsættes analogt til omeprazol.
English: methacrylic acid ethyl acrylate copolymer, 1:1, dispersion 30 % Capsule shell:
Danish: Metakrylsyre - ethakrylat copolymer, 1:1, dispersion 30%
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 fremmes af tilstedeværelsen af mavesyre.
English: Fourteen-day, proton pump inhibitor-based triple therapy achieves better results than 7-day schedules.
Danish: I en 14 dage lang tredobbelt behandling baseret på en protonpumpehæmmer blev der opnået bedre resultater end i et 7 dage lang behandlingsprogram.
English: Increased plasma levels of a clarithromycin metabolite by 16 %; increased bioaivalability of lansoprazole by 19 % up to 32 %
Danish: Øgede plasmaniveauer af en clarithromycinmetabolit med 16 %; øget biotilgængelighed af lansoprazol med 19 % op til 32 %
English: In patients with moderately impaired hepatic function, the dose should be restricted to 15 mg daily.
Danish: Hos patienter med moderat nedsat levefuntion, bør dosis begrænses til 15 mg daglig.
English: Nervous system headache, dizziness restlessness, insomnia, drowsiness, depression, hallucination, confusion, vertigo and paresthesia, somnolence, tremor.
Danish: svimmelhed rastløshed, insomnia, døsighed, depression, hallucination, konfusion, vertigo og paræstesier, somnolens, tremor.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPON 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF LANSOPON 15 MG, 30 MG, GASTRO-RESISTENTE KAPSLER, HÅRDE (se bilag I)
English: Lansoprazol gives a 14% reduction in the plasma concentrations of theophyllin.
Danish: Lansoprazol giver en 14% reduktion i plasmakoncentrationerne af teofyllin.
English: 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
Danish: mg hæmmer pentagastrin-stimuleret mavesyresekretion med omkring 80%.
English: Since lansoprazole is activated in the parietal cells, its plasma concentration is not related to gastric acid inhibition.
Danish: Da lansoprazol aktiveres i parietalcellerne, er dets plasmakoncentration ikke relateret til hæmning af mavesyre.