FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited experience to date with the use of lansoprazole in pregnant women has produced no evidence of any side effects on the unborn child or on the pregnancy itself.
Danish: Begrænset erfaring til dato med brugen af lansoprazol til gravide kvinder har ikke frembragt noget bevis for nogen bivirkninger for det ufødte barn eller for selve graviditeten.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.
Danish: Non-kliniske data afslører ikke nogen særlig fare for mennesker baseret på konventionelle undersøgelser afsikkerhedfarmakologi, gentagen dosis toksicitet, toksicitet ved reproduktion eller genotoksicitet.
English: If you have the impression that the effect of Lansoprazol-CT is too strong or too weak, please talk to your doctor.
Danish: Hvis du har indtryk af, at virkningen af Lansoprazol-CT er for kraftig eller for svag, så snak med din læge.
English: 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 15-30 mg, justeret efter individuelle krav.
English: The capsules are swallowed whole with liquid.
Danish: Kapslerne synkes hele med væske.
English: These metabolites have no significant effect on acid secretion.
Danish: Disse metabolitter har ingen signifikant virkning på syresekretionen.
English: Colitis, stomatitis and black tongue.
Danish: Colitis, stomatitis og sort tunge.
English: The following undesirable effects have been observed during treatment with lansoprazole with the following frequencies: Common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000) including isolated reports.
Danish: Følgende bivirkninger er blevet observeret under behandling med lansoprazol med følgende hyppigheder: Almindelig (>1/100, <1/10), ualmindelig (>1/1,000, <1/100), sjælden (>1/10,000, <1/1,000), meget sjælden (<1/10,000) inklusive isolerede rapporter.
English: The stomach ulcer usually heals within 4 weeks.
Danish: Mavesår heler sædvanligvis op inden for 4 uger.
English: - Keep this leaflet.
Danish: - Gem denne indlægssddel.
English: Lansoprazol-CT should be taken on an empty stomach (before meals).
Danish: Lansoprazol-CT bør tages på en tom mave (inden måltiderne).
English: Do not use Lansoprazol-CT after the expiry date which is stated on the carton and the blister.
Danish: Anvend ikke Lansoprazol-CT efter udløbsdatoen, der er angivet på æsken og blisterpakningen.
English: Lansoprazol-CT has minor or moderate influence on the ability to drive and use machines.
Danish: Lansoprazol-CT har mindre eller moderat indvirken på evnen til at køre og betjene maskiner.
English: If you take too low a dose, if you take your medicine irregularly or if you stop your treatment prematurely, this may endanger the success of your treatment or may cause relapses which are more difficult to treat.
Danish: Hvis du tager for lav en dosis, hvis du tager din medicin uregelmæssigt, eller hvis du stopper di behanling for tidligt, kan dette sætte den heldige gennemførelse af din behandling på spil eller kan medføre tilbagefald, der er vanskeligere at behandle.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL FREMGÅ PÅ YDEREMBALLAGEN OG DEN UMIDDELBARE EMBALLAGE
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: Virkningerne ved overdosering med lansoprazol hos mennesker kendes ikke (selvom den akutte tokcisitet sandsynligvis er lav), og der kan derfor ikke gives vejledning om behandling.
English: An interval of at least 1 hour before or after should be allowed between administration of lansoprazole and antacids and sucralfate.
Danish: Et interval på mindst 1 time før og efter bør der være mellem administration af lansoprazol og antacider og sukralfat.
English: Like all medicines, Lansoprazol-CT can cause side effects, although not everybody gets them.
Danish: Som alle lægemidler kan Lansoprazol-CT medføre bivikninger, selvom ikke alle får dem.
English: The elimination half-life of lansoprazole is 1.0-2.0 hours.
Danish: Eliminationshalveringstiden for lansoprazol er 1,0-2,0 timer.
English: If you forget to take Lansoprazol-CT Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du glemmer at tage Lansoprazol-CT Lad være med at tage en dobbelt dosis for at erstatte en glemt dosis.
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 reducerer basal sekretion med omkring 70%, og patientens symptomer bliver dermed lettet startende fra den allerførste dosis.
English: However, in order to avoid treatment failure, local antibacterial resistance patterns and local guidelines should be considered.
Danish: For at undgå fejlslagen behandling bør lokale bakterieresistensmønstre og retningslinjer dog tages i betragtning.
English: - The active substance is lansoprazol.
Danish: - Den aktive substans er lansoprazol.
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 active substances.
Danish: Plasma proteinbindingen for lansoprazol er omkring 95%, men dette er ikke fundet at have en signifikant virkning på andre proteinbundne aktive substanser.
English: The capsules may be opened but the minitablets inside may not be chewed or crushed.
Danish: Kapslerne kan åbnes, men minitabletterne indeni må ikke tygges eller knuses.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis du har nogen yderligere spørgsmål om anvendelsen af dette produkt, så spørg din læge eller apoteket.
English: The following interactions between lansoprazole and one/two antibiotics used in eradication therapy have been found so far:
Danish: Følgende interaktioner mellem lansoprazol og et/to antibiotika anvendt ved udryddelsesbehandling er hidtil blevet fundet:
English: After 18 months of treatment retinal atrophy was observed.
Danish: Efter 18 måneders behandling blev der observeret retinal atrofi.
English: 4.1 Therapeutical indications
Danish: 4.1 Terapeutiske indikationer
English: This concerns particularly such medicinal products also metabolized via the cytochrome P450 system.
Danish: Dette drejer sig især om sådanne lægemidler, der også metaboliseres via cytochrom P450 systemet.
English: Reflux oesophagitis may not present, as ulceration and/or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
Danish: Refluks øsofagitis udviser måske ikke som ulceration og/eller visuel beskadigelse, hvorfor endoskopi alene i visse tilfælde ikke er tilstrækkeligt.
English: Please consult your doctor before taking Lansoprazol-CT if you know that you are intolerant to certain sugars.
Danish: Snak med din læge, inden du tager Lansoprazol-CT, hvis du ved, at du er intolerant overfor visse sukkerstoffer.
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 symptomerne opnås ved 30 mg daglig, og de fleste patienter med duodenal ulcus bliver raske inden for 2 uger, patienter med gastrisk ulcus og refluks øsofagitis inden for 4 uger.
English: Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.
Danish: Dosis bør justeres efter den individuelle patients behov og bør fortsættes så længe, det er klinisk indikeret.
English: For lansoprazole no clinical data on exposed pregnancies are available.
Danish: For lansoprazol findes der ingen kliniske data tilgængelige om eksponerede graviditeter.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for den aktive substans eller over for nogen af hjælpestofferne.
English: Caution is advised if the two medicines are administered in combination.
Danish: Der tilrådes forsigtighed, hvis de to lægemidler gives i kombination.
English: Children: Lansoprazole is not recommended for use in children due to insufficient data on safety and efficacy.
Danish: Børn: Lansoprazol anbefales ikke til brug hos børn grundet utilstrækkelige data om sikkerhed og effektivitet.
English: Lansoprazol CT-Arzneimittel 15 mg, 30 mg, gastro-resistant capsules, hard were referred for arbitration according to Article 29 of Council Directive 2001/83/EC, as amended, following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
Danish: Lansoprazol CT-Arzneimittel 15 mg, 30 mg, gastro-resistente kapsler, hårde, blev indbragt til voldgiftsafgørelse i henhold til artikel 29 i Rådets direktiv 2001/83/EF, med senere ændringer, efter at Tyskland havde givet udtryk for betænkeligheder under en procedure om gensidig anerkendelse med Finland som referencemedlemsstat.
English: The effect of clarithromycin on lansoprazole is increased if the patient is a so-called slow metaboliser.
Danish: Virkningen af clarithromycin på lansoprazol er øget, hvis patienten er en såkaldt langsom metabolisaor.
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 undergivet genetisk polymorfisme, og 2-6 % af populationen, kaldet dårlige metabolisatorer (PM'er), er homozygote for en mutant CYP2C19 allele og mangler derfor et funktionelt CYP2C19 enzym.
English: Do not take Lansoprazol-CT - if you are allergic (hypersensitive) to Lansoprazol or any of the other ingredients of
Danish: Lad være med at tage Lansoprazol-CT - hvis du er allergisk (overfølsom) overfor Lansoprazol eller nogen af de andre ingredienser i
English: If bismuth is not available, PPI-based triple therapies should be used.
Danish: Hvis vismut ikke er tilgængeligt, skal der anvendes PPI-baserede tredobbelte behandlinger.
English: This can reduce your responsiveness when driving a vehicle or operating machinery.
Danish: Dette kan nedsætte din reaktionsevne, når du kører bil eler betjener maskineri.
English: The Maastricht Consensus stated that treatment regimens for eradication of H. pylori should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis.
Danish: I anbefalingen ”The Maastricht Consensus” hedder det, at behandlingerne til udryddelse af H. pylori skal være enkle, godt tolererede og opnå en eradikationsrate på over 80 % beregnet efter ”intention-to-treat-princippet”.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedregler vedrørende brugen
English: Interactions have been observed when lansoprazole was combined with certain antibiotics such as clarithromycin and amoxicillin and in a combination of all three medicines.
Danish: Interaktioner er blevet observeret, når lansoprazol blev kombineret med visse antibiotika såsom clarithromycin og amoxicillin og i en kombination af alle tre lægemidler.
English: Dry mouth or throat and anorexia.
Danish: Tørhed i mund eller hals og anorexi.
English: Caution is advised when combining the two active substances.
Danish: Der tilrådes forsigtighed, når de to aktive substanser kombineres.
English: The effect of simultaneous administration of lansoprazole and various antibiotics (particularly clarithromycin) has not been systematically investigated.
Danish: Virkningen af samtidig administration af lansoprazol og forskellige antibiotika (især clarithromycin) er ikike blevet systematisk undersøgt.
English: Effects of lansoprazole on other active substances
Danish: Virkninger af lansoprazol på andre aktive substanser
English: In elderly patients, a dose adjustment may be necessary due to the slower elimination of lansoprazole.
Danish: Hos ældre patienter kan det være nødvendigt med en justering af dosis grundet den langsommere udskillelse af lansoprazol.
English: Manufacturer:
Danish: Producent:
English: The dosage should be adjusted on an individual patient basis and continued for as long as required under specialist medical supervision.
Danish: Dosis bør justeres på en individuel patientbasis og fortsætte så længe som nødvendigt under medicinsk overvågning af en specialist.
English: The enzyme CYP3A4 also contributes to the metabolism.
Danish: Enzymet CYP3A4 medvirker også til metabolismen.
English: This result in sub-therapeutic concentrations of ketokonazole and itrakonazole and the combination should be avoided.
Danish: Dette resulterer i sub-terapeutiske koncentrationer af ketokonazol og itrakonazol, og kombinationen bør undgås.
English: Since this product contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Da dette product indeholder sukrose, bør patienter med sjældne arvelige problemer som intolerance over for fruktose, glukose-galaktose malabsorption eller sukrase-isomaltase insufficiens ikke tage dette lægemiddel.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: If visual disturbances occur during long-term use (>1 year), intake of the medicine should immediately be stopped and an ophthalmologist should be consulted.
Danish: Hvis der forekommer synsforstyrrelser under langtidsbrugen (>1 år), bør indtagelse af lægemidlet straks ophøre, og en oftalmolog bør rådspørges.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel er sidst godkendt den {MM/ÅÅÅÅ}
English: Erythema multiforme, Petechia, hair loss, hyperhidrosis and purpura .
Danish: Erythema multiforme, Petechia, hårtab, hyperhidrosis og purpura .
English: Stevens-Johnson syndrome and toxic epidermal necrolysis.
Danish: Stevens-Johnson syndrome og toksisk epidermal nekrolyse.
English: Please read the package leaflet of the antibacterial agents for further information.
Danish: Læs indlægssedlen for de antibakterielle midler for yderligere oplysninger.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03.
Danish: Farmakoterapeutisk gruppe: Protonpumpehæmmere, ATC-kode: A02BC03.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt igennem inden du begynder at anvende dette lægemiddel.
English: If you take more Lansoprazol-CT than you should you should always consult a doctor.
Danish: Hvis du tager mere Lansoprazol-CT end du skulle Du bør altid tale med en læge.
English: changes in the blood count with a reduction in the blood platelet count, an increase in the number of certain white blood corpuscles (eosinophilia), a reduced production of all blood cells, anaemia or a reduction in the number of all white blood corpuscles.
Danish: Ændringer i blodtælling med en reduktion i blodpladetællingen, en øgning i antallet af visse hvide blodlegemer (eosinofili), en nedsat produktion af alle blodceller, anæmi eller en reduktion i antallet af hvide blodlegemer.
English: Patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
Danish: Hos patienter, der lider af gastro-duodenale ulcera, bør muligheden for H. pylori infektion som en ætiologisk faktor overvejes.
English: A poor metaboliser would have more marked effects than an extensive metaboliser.
Danish: En dårlig metabolisator vil have mere udprægede virkninger end en ekstensiv metabolisator.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Hvis du har yderligere spørgsmål, så henvend dig til din læge eller apotek.
English: Taking Lansoprazol-CT with food and drink:
Danish: Indtagelse af Lansoprazol-CT med mad og drikke:
English: Capsule content:
Danish: Kapslens indhold:
English: For reasons of theoretical considerations, enhanced interactions with other medicinal products must be expected as a precaution.
Danish: Teoretisk betragtet må der forventes øgede interaktioner med andre lægemidler som en forsigtighedsregel.
English: Daily doses of 180 mg were tolerated without any marked side effects.
Danish: Daglig doser på 180 mg blev tolereret uden nogen mærkbare bivirkninger.
English: There has been no experience with the effects of lansoprazole overdose in humans.
Danish: Der findes ikke nogen erfaring med virkningerne ved en lansoprazol overdosering hos mennesker.
English: * The effects of clarithromycine on the pharmacokinetics of lansoprazole are likely to be dependent on the patient's CYP2C19 genotype.
Danish: * Virkningerne af clarithromycin på farmakokinetikken for lansoprazol er sandsynligvis afhængig af patientens CYP2C19 genotype.
English: The effect of the following medicines or drug groups may be influenced by Lansoprazol-CT if they are used at the same time:
Danish: Virkningen af følgende lægemidler eller lægemddelgrupper kan blive påvirket af Lansoprazol-CT, hvis de anvendes på samme tid.
English: Angioedema, bronchial constriction, fever.
Danish: Angioødem, bronchial konstriktion, feber.
English: Important information about some of the ingredients of Lansoprazol-CT This medicine contains sucrose.
Danish: Vigtige oplysninger om nogen af indholdsstofferne i Lansoprazol-CT Dette lægemiddel indeholder sukrose.
English: In this leaflet:
Danish: I denne indlægsseddel:
English: severe reduction in certain white blood corpuscles (agranulocytosis).
Danish: Meget sjælden: Kraftig reduktion i visse hvide blodlegemer (agranulocytose).
English: Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole.
Danish: På grund af mangel på data hos patienter med kraftig nedsat leverfunktion, bør disse patienter ikke behandles med lansoprazol.
English: As lansoprazole is mainly broken down by certain enzymes in the liver, interactions with other medicines that are broken down by the same enzymes are possible.
Danish: Da lansoprazol hovedsageli nedbrydes af visse enzymer i leveren, er interaktioner med andre lægemidler, der bliver nedbrudt af de samme enzymer, mulige.
English: POSSIBLE SIDE EFFECTS
Danish: MULIGE BIVIRKNINGER
English: The effect of Lansoprazol-CT may be influenced by the following medicines or drug groups:
Danish: Virkningen af Lansoprazol-CT kan blive påvirket af følgende lægemidler eller lægemiddelgrupper.
English: Ketoconazole and itraconazole
Danish: Ketoconazol og itraconazol
English: PHARMACEUTICAL FORM Gastro-resistant hard capsule.
Danish: LÆGEMIDDELFORM Gastro-resistent hard kapsel.
English: Intake of food slows the absorption rate of lansoprazole and reduces its bioavailability (AUC) by about 25%.
Danish: Indtagelse a mad nedsætter absorptionhastigheden for lansoprazol og nedsætter biotilgængeligheden (AUC) med omkring 25%.
English: The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means.
Danish: Diagnosen af gastroduodenale ulcera og refluks øsofagitis bør bekræftes ved endoskopi eller andre passende diagnostiske tiltag.
English: Increase in cholesterol and triglyceride levels.
Danish: Øgning i cholesterolog triglyceridniveauer.
English: Sugar spheres (sucrose and maize starch), Sodium laurilsulphate, Meglumine, Mannitol, Hypromellose, Macrogol, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic AcidEthyl Acrylate Copolymer (1:1), Dispersion 30%
Danish: Sukkerkugler (sukrose og majsstivelse), natriumlaurylsulfat, meglumin, mannitol, hypromellose, macrogol, talkum, polysorbat 80, titaniumdioxid (E171), metakrylsyreethylakrylat copolymer (1:1), Dispersion 30%
English: The inhibition is dose dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Danish: Hæmninger er dosisafhængig og reversibel, og virkningen gælder både basal og stimuleret sekretion af mavesyre.
English: As lansoprazole is metabolised via a drug metabolising enzyme system associated with cytochrome P450 (CYP2C19 and CYP3A4), interactions with active substances metabolised via the same enzyme system are possible.
Danish: Da lansoprazol bliver metaboliseret via et lægemiddelmetaboliserende enzymsystem forbundet med cytochrom P450 (CYP2C19 og CYP3A4), er interaktioner med aktive substanser, der metaboliseres via det samme enzymsystem, mulige.
English: In patients with cirrhosis the AUC of lansoprazole is significantly increased and the elimination half-life is prolonged, but no signs of accumulation of lansoprazole have been detected.
Danish: Hos patienter med skrumpelever er AUC for lansoprazol signifikant øget, og eliminationshalveringstiden er forlænget, men der er ikke fundet nogen tegn på akkumulering af lansoprazol.
English: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH [to be completed nationally]
Danish: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH [udfyldes nationalt]
English: The intake of food reduces the bioavailability of lansoprazole: it is recommended to take lansoprazole before the meal.
Danish: Indtagelsen af føde nedsætter biotilgængeligheden af lansoprazol: det anbefales at tage lansoprazol inden måltidet.
English: The following frequency data are used in the evaluation of side effects: Very common more than 1 in 10 persons treated Common less than 1 in 10, but more than 1 in 100 treated patients
Danish: De følgende data over hyppighed anvendes til evalueringen af bivirkninger: Meget almindelig mere end 1 ud af 10 behandlede personer Almindelig mindre end 1 ud af 10, men mere end 1 ud af 100 behandlede patienter
English: Treatment of Zollinger-Ellison syndrome
Danish: Behandling af Zollinger-Ellison syndrome
English: 7 Gastro-resistant hard capsules 14 Gastro-resistant hard capsules 28 Gastro-resistant hard capsules 56 Gastro-resistant hard capsules 98 Gastro-resistant hard capsules
Danish: 7 gastro-resistente hårde kapsler 14 gastro-resistente hårde kapsler 28 gastro-resistente hårde kapsler 56 gastro-resistente hårde kapsler 98 gastro-resistente hårde kapsler
English: The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19.
Danish: Lansoprazols metabolisme katalyseres hovedsagelig af enzymet CYP2C19.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.8 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
English: Increase bioaivalability and half-life of lansoprazole by 30 % each; increased plasma levels of a clarithromycin metabolite by 30 %
Danish: Øger biotilgængeligheden og halveringstiden for lansoprazol med hver 30 %; øgede plasmaniveauer af en clarithromycin metabolit med 30 %
English: [see Annex I - to be completed nationally]
Danish: [se Bilag I - udfyldes nationalt]
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: Endocrine disorders
Danish: Endokrine forstyrrelse
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 omkring 90% hæmning af mavesyresekretion.
English: − to treat ulcers in the duodenum and stomach (diagnosed through gastroscopy or X-ray)
Danish: − at behandle sår i duodenum og mavesækken (diagnosticeret gennem gastroskopi eller røntgen).