FrancophonIA/ELRC3.0 huggingface dataset:
English: Available data support the use of lansoprazole-amoxicillin-clarithromycin as a first-line treatment.
Danish: De foreliggende data understøtter anvendelse af lansoprazol-amoxicillin-clarithromycin som førstevalgsbehandling.
English: Pancreatitis, candidiasis of oesophagus and glossitis.
Danish: Pancreatitis, candidiasis i øsofagus og glossitis.
English: It may not be excluded that lansoprazole 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 transport via dette protein og give anledning til øgede plasmakoncentrationer af P-gp substrater såsom digoxin.
English: To date, no clinically relevant interactions have been demonstrated between lansoprazole and diazepam.
Danish: Til dato er der ikke påvist klinisk relevante interaktioner mellem lansoprazol og diazepam.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i originalemballagen for at beskytte mod fugt.
English: The effect may also be present if lansoprazole is combined with other active substances with pH dependent absorption.
Danish: Virkningen kan også være tilstede,hvis lansoprazol kombineres med andre aktive substanser med pH-afhængig absorption.
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 or pharmacist.
Danish: Hvis nogen af bivirkningerne bliver alvorlige, eller hvis du bemærker nogen bivirkninger, der ikke er angivet i denne indlægsseddel, så fortæl det til din læge eller apotek.
English: Monitoring of the serum levels of other medicinal products taken during the 1-week eradication therapy is therefore recommended.
Danish: Monitorering af serumniveauerne for andre lægemidler taget unde den 1 uge lange udryddelsesbehandling anbefales derfor.
English: At dosages of more than 120 mg daily, the dose should be given in 2 divided doses (every 12 hours).
Danish: Ved doseringer på mere end 120 mg daglig, bør dosis gives som 2 opdelte doser (hver 12. time).
English: Increased plasma levels of a clarithromycin metabolite by 16 %; increased bioaivalability of lansoprazole by 19 % up to 32 %
Danish: Øgede plasmaniveauer af en clarithromycin metabolit med 16 %; øget biotilgænglighed for lansoprazol med 19 % op til 32 %
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 er koncentreret i parietalcellerne og bliver aktiv i deres syrlige miljø, hvorefter det reagerer med sulfydrylgruppen i H+/K+ATPase, hvilket medfører hæmning af enzymaktiviteten.
English: [to be completed nationally]
Danish: [udfyldes nationalt]
English: DATE OF FIRST AUTHRORISATION/RENEWAL OF AUTHORISATION [to be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN [udfyldes nationalt]
English: Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
Danish: Det er blevet set, at lansoprazol hæmmer transportproteinet P-glycoprotein (P-gp) in vitro.
English: − in the treatment of Zollinger-Ellison syndrome (ulcer formation in the stomach and duodenum, due to increased production of a hormone which secrets stomach acid, caused by a certain type of tumour).
Danish: − behandling af Zollinger-Ellison syndrom (ulcusdannelse i mavesækken og duodenum på grund af øget produktion af et hormon, der udskiller mavesyre, hvilket skyldes en bestemt type tumor).
English: Patients with severely impaired liver function should not take Lansoprazol-CT, nor should they be given combination therapy with clarithromycin.
Danish: Patienter med kraftig nedsat leverfunktion bør ikke tage Lansoprazol-CT, og de bør heller ikke få kombinationsbehandling med clarithromycin.
English: It is not known whether lansoprazole is excreted in human breast milk.
Danish: Det vides ikke, om lansoprazol udskilles i human brystmælk.
English: A single dose of lansoprazole has an inhibitory effect on gastric acid secretion lasting more than 24 hours.
Danish: En enkelt dosis lansoprazol har en hæmmende virkning på mavesyresekretionen, der varer mere end 24 timer.
English: Lansoprazole has 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, gælder følgende udtalelse analogt med omeprazol.
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: Studies have shown that the dose of phenytoin (a CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
Danish: Undersøgelser har vist, at dosis af fenytoin (et CYP2C19 og CYP2C9 substrat) måske må nedsættes, når det gives samtidig med lansoprazol.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver hyppighedsgruppering vises bivirkningerne i faldende avorlighed.
English: Agranulocytosis.
Danish: Agranulocytose.
English: Duodenal ulcer:
Danish: Duodenal ulcus:
English: Animal studies have shown excretion of lansoprazole in milk.
Danish: Dyreundersøgelser har vist udskillelse af lansoprazol i mælk.
English: Active substances associated with cytochrome P450
Danish: Aktive substanser forbundet med cytochrom P450
English: Intake of Lansoprazol-CT may mask the symptoms of a tumour and delay diagnosis of this condition
Danish: Indtagelse af Lansoprazol-CT kan maskere symptomerne på en tumor og forsinke diagnosen af denne tilstand.
English: If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Danish: Om nødvendigt anbefales maveudpumpning, aktivt kul og symptomatisk behandling.
English: Eradication of the Helicobacter pylori bacterium
Danish: Udryddelse af Helicobacter pylori bakterien
English: You should avoid breastfeeding while taking Lansoprazol-CT, as there has been insufficient experience with its use during lactation.
Danish: Du bør undgå at amme, mens du tager Lansoprazol-CT, da der er utilstrækkelig erfaring med dets brug under amning.
English: It is recommended that you take Lansoprazol-CT before meals, as simultaneous food intake reduces the availability of lansoprazole to the body.
Danish: Det anbefales, at du tager Lansoprazol-CT inden måltiderne, da samtidig fødeindtaelse nedsætter tilgængeligheden af lansoprazol til kroppen.
English: A single oral dose of 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
Danish: En enkelt oral dosis på 30 mg hæmmer pentagastrin-stimuleret mavesyresekretion med omkring 80%.
English: Gastro-resistant hard capsule (Gastro-resistant capsule) Hard gelatine capsules, with opaque yellow cap and body, containing pellets with enteric coating.
Danish: Gastro-resistent hård kapsel (gastro-resistent kapsel) Hårde gelatinekapsler med ugennemsigtig gul hætte og krop, indeholdende pellets med enterisk belægning.
English: Opaque white cap and body.
Danish: Ugennemsigtig hvid hætte og krop.
English: However, daily doses of up to 180 mg of lansoprazole have been administered in trials without significant undesirable effects.
Danish: Daglige doser på op til 180 mg lansoprazol er imidlertid blevet givet under afprøvninger uden signifikante bivirkninger.
English: Co-administered medicinal products
Danish: Samtidigt administrerede lægemidler
English: If lansoprazole, in combination with antibiotics, is used for eradication therapy of H. pylori, then also instructions for the use of these antibiotics should be followed.
Danish: Hvis lansoprazol, i kombination md antibiotika, anvendes til udryddelsesbehandling af H. pylori, bør brugsanvisningen for disse antibiotika også følges.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden anvendelsen.
English: However, awaiting confirmation as well as the results of the Maastricht 3-2005 Consensus Report, it is recommended that the dose should be 500 mg clarithromycin twice daily.
Danish: Mens der afventes en bekræftelse af resultaterne af rapporten Maastricht 3-2005 Consensus, anbefales der dog en dosis på 500 mg to gange dagligt.
English: Caution is advised when combining lansoprazole with active substances, which are metabolised by this enzyme.
Danish: Der tilrådes forsigtighed, når man kombinerer lansoprazol med aktive substanser, der metaboliseres af dette enzym.
English: The dose may be increased up to 30 mg daily as necessary.
Danish: Dosis kan øge op til 30 mg daglig efter behov.
English: LIST OF EXCIPIENTS Also contains sucrose (sugar).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også sukrose (sukker).
English: − as long-term treatment to prevent a recurrence of inflammation of the gullet due to reflux of stomach acid
Danish: − længerevarende behandling for at forhindre en gentagelse af inflammation i spiserøret på grund af refluks af mavesyre.
English: Clinically significant interactions of lansoprazole with diazepam have not been demonstrated.
Danish: Klinisk signifikante interaktioner af lansoprazol med diazepam er ikke blevet påvist.
English: Therapy of Helicobacter pylori infection is intended to be combined with concurrent administration of lansoprazole with two antibiotics.
Danish: Behandling af Helicobacter pylori infektion er beregnet til at blive kombineret med samtidig administration af lansoprazol med to antibiotika.
English: Use of Lansoprazol-CT is not recommended during pregnancy.
Danish: Brug af Lansoprazol-CT anbefales ikke under graviditet.
English: Dosages up to 180 mg have been administered.
Danish: Doseringer på op til 180 mg er blevet givet.
English: Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and bening Leydig cell tumours.
Danish: Intestinal metaplasi blev også observeret, ligesom Leydig cellehyperplasi og benigne Leydig celletumorer.
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 metabolisatorer (EM'er).
English: Lansoprazole should be used with caution in patients with hepatic dysfunction.
Danish: Lansoprazol bør anvendes med forsigtighed hos patienter med hepatisk dysfunktion.
English: Blood and lymphatic system disorders
Danish: Forstyrrelser i blod og lymfesystem
English: In case of clarithromycin resistance, or treatment failure, the combination of lansoprazole-amoxicillin metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazoleclarithromycin-metronidazole is advisable.
Danish: I tilfælde af resistens over for clarithromycin eller fejlslagen behandling kan der anvendes en kombination af lansoprazol-amoxicillin-metronidazol, og i tilfælde af allergi over for beta-lactam er det tilrådeligt at anvende en kombination af lansoprazol-clarithromycin-metronidazol.
English: Anaphylactic shock, impotence and general malaise
Danish: Anafylaktisk shock, impotens og almen utilpashed
English: Lansoprazol-CT is a medicine which reduces the amount of acid made by the stomach (selective proton pump inhibitor).
Danish: Lansoprazol-CT er en medicin, der nedsætter mængden af syre, der laves af maven (selektiv protonpumphæmmer).
English: Gastric ulcer:
Danish: Gastrisk ulcus:
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: Det hæmmer slutstadiet af dannelsen af mavesyre ved at hæmme aktiviteten af H+/K+ ATPase i mavens parietalceller.
English: Based on the results of animal studies, it is thought that lansoprazole crosses into the breast milk.
Danish: Baseret på resultaterne fra dreundersøgelser menes det, at lansoprazol krydser over i brystmælken.
English: For this reason, the plasma levels of patients being treated with digoxin should be monitored and a dose adjustment of digoxin made if necessary.
Danish: Af denne grund bør plasmaniveauerne hos patienter, der bliver behandlet med digoxin, overvåges og en dosisjustering af digoxin foretages om nødvendigt.
English: Lansoprazole may give rise to increased plasma concentrations of active substances metabolised by CYP3A4.
Danish: Lansoprazol kan anledning til øgede plasmakoncentrationer af aktive substanser, der metaboliseres af CYP3A4.
English: The paper newly published by Bago et al in Wiener Klinische Wochenschrift 2004, indicates that 250 mg twice daily may be as effective as 500 mg twice daily in eradicating H. pylori in patients with dyspepsia, even if numerically, eradication rates were somewhat lower.
Danish: i ”Wiener Klinische Wochenschrift 2004”, anføres det, at 250 mg to gange dagligt kan være lige så virksomt som 500 mg to gange dagligt til udryddelse af H. pylori hos patienter med dyspepsi, selv om eradikationsraterne var noget lavere.
English: Nervous system disorders
Danish: Forstrelser i nervesystemet
English: Combination treatment with clarithromycine should not be used in patients with impaired hepatic function.
Danish: Kombinationsbehandling med clarithromycin bør ikke anvendes til patienter med nedsat leverfunktion.
English: The effects of other active substances on lansoprazole
Danish: Virkningerne af andre aktive substanser på lansoprazol
English: Three metabolites have been identified in the plasma: the sulphone, 5-hydroxy lansoprazole and the sulphide.
Danish: Tre metabolitter er blevet identificeret i plasma: Sulfonen, 5-hydroxy lansoprazol og sulfiden.
English: This can lead to an increase in the number of natural bacteria present in the gastrointestinal tract.
Danish: Dette kan lede til en øgning af antallet af naturlige bakterier, der er tilstede i mave-tarmkanalen.
English: Hepatobiliary disorders
Danish: Hepatobiliære forstyrrelser
English: Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Danish: Lansoprazol eksponering øgede middeleksponeringen for tacrolimus med op til 81%.
English: Palpitation and chest pain.
Danish: Palpitation og brystsmerter.
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: Monitoring of the plasma levels of other medicines administered during simultaneous treatment with lansoprazole and antibiotics is therefore recommended.
Danish: Overvågning af plasmaniveauerne for andre lægemidler, der gives samtidig med behandling med lansoprazol og antibiotika, anbefales derfor.
English: The use of lansoprazole during pregnancy is not recommended.
Danish: 4.7 Anvendelsen af lansoprazol under graviditet anbefales ikke.
English: Helicobacter pylori eradication:
Danish: Udryddelse af Helicobacter pylori:
English: Theophylline (asthma medicine)
Danish: Theofyllin (astmamedicin)
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 monitoreres, og digoxindosis justeres om nødvendigt.
English: Eye disorders and changes in the sensation of taste Uncommon: disturbances in taste Rare:
Danish: Øjenforstyrrelser og ændringer i smagssansen Ualmindelig: Smagsforstyrrelser Sjælden:
English: Three metabolites have been identified in the urine: 5hydroxy sulphone, 5-hydroxy sulphide and 5-hydroxy lansoprazole.
Danish: Tre metabolitter er blevet identificeret i urinen: 5-hydroxysulfon, 5-hydroxysulfid og 5-hydroxylansoprazol.
English: DATE OF REVISION OF THE TEXT [to be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [udfyldes nationalt]
English: Using other medicines
Danish: Brug af andre lægemidler
English: Subsequent failures should be handled on caseby-case basis.
Danish: Flere på hinanden svigtende resultater håndteres fra tilfælde til tilfælde.
English: Second-line therapy with quadruple therapy using proton pump inhibitor combined with bismuth subcitrate (subsalicylate) and metronidazole, and tertacycline for a minimum of 7 days has been recommended.
Danish: Andetvalgsbehandlingen med firedobbelt behandling med en protonpumpe-hæmmer kombineret med vismutsubcitrat (subsalicylat) og metronidazol, og tertacyclin i mindst 7 dage er blevet anbefalet.
English: Caution is advised during co-treatment with carbamazepine (a CYP3A substrate) and lansoprazole.
Danish: Der tilrådes forsigtighed uder samtidig behandling med carbamazepin (et CYP3A substrat) og lansoprazol.
English: Lansoprazol-CT may not be used in children, as its safety and efficacy have not been established in this patient group.
Danish: Lansoprazol-CT må ikke anvendes til børn, da dets sikkerhed og virkning ikke er blevet fastslået hos denne patientgruppe.
English: Caution is urged if lansoprazole is combined with some potent medicines, as the influence of lansoprazole on other active substances has not yet been conclusively investigated.
Danish: Der manes til forsigtighed, hvis lansoprazol kombineres med nogen potente lægemidler, da påvirkningen af lansoprazol på andre aktive substanser endnu ikke er blevet endeligt undersøgt.
English: Dosages up to 180 mg daily are possible.
Danish: Doseringer på op til 180 mg daglig er mulige.
English: Lansoprazole is mainly metabolised in the liver.
Danish: Lansoprazol metaboliseres hovedsagelig i leveren.
English: The bioavailability of lansoprazole is not significantly changed in renal insufficiency.
Danish: Biotilgængeligheden for lansoprazol er ikke signifikant ændret ved nyreinsufficiens.
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 plamakoncentration ikke relateret til hæmning af mavesyre.
English: Fluvoxamine (a medicine for the treatment of depression), ketoconazole and itraconazole (medicines for the treatment of fungal infections), protease inhibitors (active substances used in the treatment of the AIDS virus) and macrolides (certain types of antibiotics) may markedly raise the concentration of lansoprazole in the blood and thus increase the effect of Lansoprazol-CT.
Danish: Fluvoxamin (et lægemiddel til behandling af depression), ketoconazol og itraconazole (lægemidler til behandling af svampeinfektioner), proteasehæmmere (aktive substanser anvendt til behandling af AIDS virus) og makrolider (visse typer antibiotika) kan mærkbart øge koncentrationen af lansoprazol i blodet og dermed øge virkningen af Lansoprazol-CT.
English: Daily dosages of greater than 120 mg should be administered in divided doses.
Danish: Daglige doseringer større end 120 mg bør gives som opdelte doser.
English: Eradication of H. pylori and peptic ulcer healing In order to standardise the treatment regimens for H. pylori eradication guidelines on the management of Helicobacter pylori infection were published by the European Helicobacter pylori Study Group.
Danish: Udryddelse af H. pyolori og heling af peptisk ulcus Med det formål at harmonisere behandlingerne til udryddelse af Helicobacter pylori blev der offentliggjort retningslinjer for behandling af Helicobacter pylori- infektion af European Helicobacter pylori Study Group.
English: The risk/benefit ratio of Lansoprazol CT-Arzneimittel 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Danish: Lansoprazol CT-Arzneimittel 15 mg, 30 mg udviser et gunstigt benefit/risk-forhold, forudsat at der indføjes passende oplysninger vedrørende eradikationsbehandlingen for H. pylori i produktresuméet.
English: nausea, vomiting, diarrhoea, stomach-ache, constipation, flatulence (sometimes accompanied by abdominal pain), upper abdominal pain.
Danish: Almindelig: Kvalme, opkastning, diaré, mavepine, forstoppelse, flatulense (nogle gange ledsaget af abdominalsmerter), smerter i øvre abdomen.
English: Very rare including isolated reports
Danish: Meget sjælden (<1/10000) inklusive isolerede rapporter
English: Caution should be exercised when combining lansoprazole with active substances which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other active substances has not been extensively investigated.
Danish: Der bør udvises forsigtighed, når man kombinerer lansoprazol med aktive substanser, der har et snævert terapeutisk indeks, da virkningen af lansoprazol på andre aktive substansers metabolisme ikke er blevet undersøgt i omfattende grad.
English: Lansoprazole gives a 14% reduction in the plasma concentrations of theophyllin.
Danish: Lansoprazol giver en 14% reduktion i plasmakoncentrationerne af teofyllin.
English: Thrombocytopenia, eosinophilia, pancytopenia, anemia and leucopenia.
Danish: Thrombocytopeni, eosinofili, pancytopeni, anæmi og leukopeni.
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 carcinogenicitetsundersøgelser på rotter frembragte lansoprazol dosis-relateret gastrisk ECL cellehyperplasi og ECL cellecarcinoider forbundet med hypergastrinæmi grundet hæmning af syresekretion.
English: skin bleeding (punctiform capillary bleeding and inflamed, mainly symmetrical skin bleeding), hair loss, excessive sweating, blood vessel inflammation with skin changes (erythema multiforme).
Danish: Hudblødning (punktformig kapillærblødning og inflammeret, hovedsagelig symmetrisk hudblødning), håtab, overdreven sveden, inflammation af lodkar med hudændringer (erythema multiforme).
English: This combination of medicines could cause a rise in carbamazepine concentrations and a decrease in lansoprazole concentrations.
Danish: Denne kombination af lægemdler kan medføre en stigning i carbamazepinkocentrationer og en sænkning i lansoprazolkoncentrationer.
English: Active substances, which inhibit CYP3A4 such as ketokonazole, itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole.
Danish: Aktive substanser, der hæmmer CYP3A4, såsom ketokonazol, itraconazol, proteasehæmmere, makrolider etc., kan mærkbart øge plasmakoncentrationerne af lansoprazol.
English: accumulation of water mainly in the legs (oedema) Disorders of the skeletal muscle, connective tissue and bones Rare:
Danish: Akkumulation af vand, hovedsagelig i benene (ødem) Forstyrrelser i skeletmuskulatur, bindevæv og knogler Sjælden:
English: Heart disorders Rare:
Danish: Hjerteforstyrrelser Sjælden:
English: The concerns rose referred to discrepancies in comparison to the reference products on posology of triple therapy for H. pylori eradication.
Danish: Spørgsmålene vedrørte afvigelser i forhold til referenceprodukterne med hensyn til doseringen i den tredobbelte behandling til udryddelse af H. pylori.
English: Skin and subcutaneous tissue disorders
Danish: Forstyrrelser i hud og subkutant væv
English: When making a decision as to whether breastfeeding or therapy with Lansoprazol-CT should be continued or discontinued, the benefits of breastfeeding for the child and the benefits of therapy with Lansoprazol-CT for the mother should be considered.
Danish: Når der skal tages beslutning om der skal fortsættes eller afbrydes med amning eller behandling med Lansoprazol-CT, bør fordelene ved amning for barnet og fordelene ved behandling med LansoprazolCT for moderen overvejes.
English: Lansoprazole reduces the acid content of the stomach.
Danish: Lansoprazol nedsætter syreindholdet i maven.
English: fungal infections of the gullet, inflammation of the pancreas, inflammation of the tongue.
Danish: Svampeinfektioner i spiserøret, inflammation af pancreas, inflammation af tungen.
English: Renal and urinary disorders
Danish: Renale og urinvejsmæssig e forstyrrelser