FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to:
Slovenian: Na podlagi dokumentacije, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ter znanstvene razprave v okviru Odbora je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Agopton in z njim povezana imena ugodno za uporabo v zvezi z:
English: Lansoprazole has not been marketed for use in children or adolescents in the EU.
Slovenian: Lansoprazol v EU nima dovoljenja za promet za uporabo pri otrocih ali mladostnikih.
English: Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
Slovenian: Bolnike z zmerno do hudo boleznijo jeter je treba redno nadzorovati, priporoča pa se 50-odstotno zmanjšanje dnevnega odmerka (glejte poglavji 4.4 in 5.2).
English: Due to the fact that Agopton and associated names (lansoprazole) does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union as a result of divergent national decisions, a harmonisation of the SPC for Agopton and associated names, throughout Europe has become necessary.
Slovenian: Z ozirom na dejstvo, da zdravilo Agopton in z njim povezana imena (lansoprazol) v različnih državah članicah EU nima istega Povzetka glavnih značilnosti zdravila (SPC), kar je posledica razhajajočih se nacionalnih odločitev, je prišlo do potrebe po uskladitvi SPC za zdravilo Agopton in z njim povezana imena po celotni Evropi.
English: The overall relief of the primary symptoms (epigastric pain and heartburn) were assessed.
Slovenian: Ocenjeno je bilo splošno lajšanje primarnih simptomov (epigastrična bolečina in zgaga).
English: The recommended dose should be 15-30 mg o.d. with recommendations regarding further investigation, should the patient not respond within 4 weeks.
Slovenian: Priporočeni odmerek naj bo 15 do 30 mg enkrat dnevno, s priporočilom za nadaljnje preiskave, če se bolnik ne odzove v roku 4 tednov.
English: Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, France
Slovenian: Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, Francija
English: Increase in liver enzyme levels
Slovenian: Zvišane ravni jetrnih encimov
English: Directions for re-constituting suspension from sachets:
Slovenian: Navodila za rekonstitucijo suspenzije iz vrečic:
English: 46 quai de la Papee 75601 Paris Cedex 12, France
Slovenian: 46 quai de la Papee 75601 Paris Cedex 12, Francija
English: Higher exposure for lansoprazole was also seen in newborns and babies up to an age of approx. 10 weeks.
Slovenian: Višja izpostavljenost lansoprazolu je bila opažena tudi pri novorojenčkih in dojenčkih starosti do približno 10 tednov.
English: The contents of one sachet should be reconstituted by stirring into 30 ml (two tablespoons) of tap water, and swallowed immediately.
Slovenian: Vsebino ene vrečice je treba rekonstituirati tako, da jo vmešate v 30 ml (dve žlici) vode in takoj pogoltnete.
English: However, the pharmacokinetic and pharmacodynamic data as well as clinical data for the use of lansoprazole in children are available in the literature.
Slovenian: Vendar pa so v literaturi na voljo farmakokinetični in farmakodinamični podatki, kakor tudi klinični podatki za uporabo lansoprazola pri otrocih.
English: Capsules should be swallowed whole with liquid.
Slovenian: Kapsule je treba pogoltniti cele, s tekočino.
English: The CHMP agrees that no information regarding the lansoprazole effects on phenytoin or carbamazepine is needed in the SPC.
Slovenian: CHMP se strinja, da v SPC ni potrebno navesti nobene informacije v zvezi z vplivom lansoprazola na fenitoin ali karbamazepín.
English: Steven-Johnson syndrome, toxic epidermal necrolysis
Slovenian: Steven-Johnsonov sindrom, toksična epidermalna nekroliza
English: The following side effects are very rare (occur in less than 1 in 10000 patients): - severe hypersensitivity reactions including shock.
Slovenian: Naslednji neželeni učinki so zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000): - hude preobčutljivostne reakcije, vključno s šokom.
English: No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.
Slovenian: Klinično pomembnih interakcij med lansoprazolom in nesteroidnimi antirevmatiki niso ugotovili, vendar formalnih študij interakcij niso opravili.
English: However, at 4 weeks, the efficacy of the 15 mg dose was less than for the comparator at 8 weeks.
Slovenian: Vendar pa je bila učinkovitost 15 mg odmerka pri 4 tednih manjša od učinkovitosti primerjalnega zdravila pri 8 tednih.
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.
Slovenian: CYP2C19 je izpostavljen genetskemu polimorfizmu in 2-6 % populacije, t. i. bolniki s počasno presnovo (PM - Poor Metaboliser) so homozigoti za mutantni alel CYP2C19 in zato nimajo funkcionalnega encima CYP2C19.
English: It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.
Slovenian: Utegne pa biti primeren za tiste, ki v okviru eradikacijskega zdravljenja ne morejo jemati klaritromicina, če so lokalne stopnje rezistence na metronidazol nizke.
English: In conclusion, the efficacy data are considered too weak to support a paediatric indication of oesophagitis in children and adolescents.
Slovenian: Tako so podatki glede učinkovitosti ocenjeni kot prešibki, da bi podpirali pediatrično indikacijo za ezofagitis pri otrocih in mladostnikih.
English: Caution is advised when combining the two drugs.
Slovenian: Pri kombiniranju teh dveh zdravil se priporoča previdnost.
English: If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Slovenian: Če se simptomi ne ublažijo v 4 tednih zdravljenja z odmerkom 30 mg na dan, se priporočajo nadaljnje preiskave.
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.
Slovenian: Če ste noseči, dojite ali če obstaja verjetnost, da ste noseči, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom.
English: Insomnia, hallucination, confusion
Slovenian: Insomnija, halucinacije, konfuznost
English: Hepatitis, jaundice
Slovenian: Hepatitis, zlatenica
English: Different disease concepts for “symptomatic gastroesophageal reflux disease” and other “functional diseases” e.g. “dyspepsia”, are established throughout Europe and reflected in different labelling.
Slovenian: Po Evropi so uveljavljena različna tolmačenja za »simptomatsko gastroezofagealno refluksno bolezen« in druge »funkcionalne bolezni«, npr. dispepsijo«, kar se odraža v različnem označevanju.
English: - very rarely Agopton may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
Slovenian: - Zdravilo Agopton lahko zelo redko povzroči zmanjšanje števila belih krvničk, kar lahko zmanjša odpornost na okužbe.
English: When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days) and appropriate use of antibacterial agents.
Slovenian: Pri iskanju ustreznega kombiniranega zdravljenja je treba upoštevati uradne lokalne smernice glede bakterijske rezistence, trajanja zdravljenja (najpogosteje 7 dni, vendar včasih 14 dni) in ustrezne uporabe antibiotikov.
English: The proportion remaining healed at 12 months in evaluable patients was 39% on placebo vs. 84 % on lansoprazole15 mg maintenance.
Slovenian: Delež ocenjevanih bolnikov, ki so ostali zdravi po 12 mesecih, je znašal 39 % pri placebu v primerjavi s 84 % za lansoprazol 15 mg kot vzdrževalno zdravljenje.
English: Effects of other drugs on lansoprazole
Slovenian: Učinki drugih zdravil na lansoprazol
English: John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH UK
Slovenian: John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Velika Britanija
English: • Dosage recommendation for the eradication of H. pylori differences: inclusion of specific recommendations on the antibiotics to be used
Slovenian: • Razlike v priporočilu za odmerjanje za eradikacijo H. pylori: Vključitev specifičnih priporočil za antibiotike, ki se naj uporabljajo
English: However, higher values for exposure will be expected in children below 1 year of age with the pharmaceutical forms that are commercially available.
Slovenian: Vendar pa se pri otrocih, starih manj kot eno leto, ob uporabi komercialno dosegljivih farmacevtskih oblik pričakujejo višje vrednosti izpostavljenosti.
English: Germany (referring Member State) identified the following issues, each affecting several sections of the SPC.
Slovenian: Nemčija (referenčna država članica) je opredelila v nadaljevanju naštete vidike, od katerih se vsak tiče več poglavij Povzetka glavnih značilnosti zdravila (SPC).
English: However the trial design and the results of the studies were not adequate to recommend the use of lansoprazole in for the treatment of oesophagitis in children.
Slovenian: Vendar pa zasnova raziskav in rezultati niso bili ustrezni, da bi bilo mogoče priporočiti uporabo lansoprazola za zdravljenje ezofagitisa pri otrocih.
English: 15 mg once daily.
Slovenian: 15 mg enkrat na dan.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni: Irska:
English: In the case of suspected overdose the patient should be monitored.
Slovenian: Če se sumi na preveliko odmerjanje, mora biti bolnik pod nadzorom.
English: Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
Slovenian: Zdravnik bo morda opravil ali pa je opravil dodatno preiskavo, imenovano endoskopija, da bi ugotovil, katero bolezen imate ali izključil možnost raka ali oboje.
English: As short-term antisecretory treatment combined with eradication therapy is known to be associated with significantly improved healing rates over antisecretory treatment alone, testing for and eradication of H. pylori would be considered mandatory.
Slovenian: Glede na to, da je znano, da je kratkoročno antisekretorno zdravljenje v kombinaciji z eradikacijskim zdravljenjem povezano s pomembno izboljšanimi stopnjami celjenja v primerjavi z zgolj antisekretornim zdravljenjem, bi morala biti testiranje za H. pylori in eradikacija obvezna.
English: The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%.
Slovenian: Očistek lansoprazola se pri starejših osebah zmanjša, razpolovni čas izločanja pa poveča za približno 50 do 100 %.
English: Important information about some of the ingredients of Agopton
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Agopton
English: Therefore, the use of lansoprazole during pregnancy is not recommended.
Slovenian: Uporaba lansoprazola med nosečnostjo torej ni priporočena.
English: If you are taking Agopton twice a day, you should have the first dose in the morning and the second dose in the evening.
Slovenian: Če zdravilo Agopton jemljete dvakrat na dan, vzemite prvi odmerek zjutraj, drugega pa zvečer.
English: Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements.
Slovenian: Zaradi zmanjšanega očistka lansoprazola pri starejših bo morda treba prilagoditi odmerek glede na potrebe vsakega bolnika posebej.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Slovenian: Študije na živalih ne nakazujejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: Lower eradication rates were seen using this combination than in regimens involving clarithromycin.
Slovenian: Pri tej kombinaciji so opazili nižjo stopnjo eradikacije kot pri režimih s klaritromicinom.
English: Sub-optimal results were obtained for children 1-11 years of age and pharmacodynamic as well as the efficacy results make dosing recommendations difficult.
Slovenian: Pri otrocih, starih od 1 do 11 let, so bili doseženi podoptimalni rezultati, farmakodinamika in rezultati glede učinkovitosti pa povzročajo težave pri izdelavi priporočil za odmerjanje.
English: This effect remains after adjustment for a range of covariates.
Slovenian: Učinek se ohrani tudi po popravku različnih kovariat.
English: Like all medicines, Agopton can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Agopton neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose.
Slovenian: Lansoprazol zmanjša koncentracijo teofilina v plazmi, kar lahko zmanjša pričakovani klinični učinek odmerka.
English: Intake of food slows the absorption rate of lansoprazole and reduces the bioavailabilty by about 50%.
Slovenian: Vnos hrane upočasni absorpcijo lansoprazola in zmanjša biološko uporabnost za približno 50 %.
English: Cyanamid of Great Briain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, UK
Slovenian: Cyanamid of Great Britain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, Velika Britanija
English: The Maastricht Consensus states 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.
Slovenian: V skladu z dogovorom s konference v Maastrichtu morajo biti režimi zdravljenja za eradikacijo bakterije H. pylori enostavni, bolniki jih morajo dobro prenašati ter dosegati morajo stopnjo eradikacije preko 80 % na osnovi namena zdravljenja (intention to treat).
English: If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.
Slovenian: Če se lansoprazol uporablja v kombinaciji z antibiotiki pri eradikaciji bakterije H. pylori, je treba upoštevati tudi navodila za uporabo teh antibiotikov.
English: Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.
Slovenian: Zato je treba v primeru hude ali perzistentne driske ali obojega pretehtati možnost prekinitve zdravljenja.
English: Effects of lansoprazole on other drugs
Slovenian: Učinki lansoprazola na druga zdravila
English: Therefore the 15 mg dose cannot be recommended for healing of NSAID-associated gastric ulcers.
Slovenian: Posledično 15 mg odmerka ni mogoče priporočiti za celjenje razjed želodca, povezanih z jemanjem NSAID.
English: Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Slovenian: Izpostavljenost lansoprazolu je povečala povprečno izpostavljenost takrolimusu do 81 %.
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.
Slovenian: Lansoprazol je koncentriran v parietalnih celicah in se aktivira v njihovem kislem okolju, kjer reagira s sulfidrilno skupino H+/K+ATPaze, kar povzroči zaviranje encimske aktivnosti.
English: • 4.6 Pregnancy and lactation
Slovenian: • 4.6 Nosečnost in dojenje
English: A study with 14C labelled lansoprazole indicated that approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the faeces.
Slovenian: Študija z lansoprazolom, označenim s 14C, je pokazala, da se približno ena tretjina uporabljenega označenega lansoprazola izloči z urinom, dve tretjini pa z blatom.
English: Netherlands Sanofi-Synthelabo B.V. / Aventis Pharma B.V. Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, The Netherlands
Slovenian: / Aventis Pharma B.V.Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, Nizozemska
English: If you have any further questions on the use of this product, ask your doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
English: Due to a marked reduction in atazanavir trough concentrations observed during concomitant use of omeprazole, use of PPIs is contraindicated in the SPC for Rayataz (atazanavir).
Slovenian: Z ozirom na izkazano zmanjšanje koncentracije atazanavirja, opaženo ob sočasni uporabi omeprazola, je uporaba ZPČ kontraindicirana v SPC za Reyataz (atazanavir).
English: Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2).
Slovenian: Kapsule se lahko odprejo in zrnca premešajo s 40 ml jabolčnega soka za uporabo z nazogastrično cevko (glejte poglavje 5.2).
English: For patients requiring 15 mg lansoprazole daily, either Agopton 15 mg capsules or Agopton 15 mg oro-dispersible tablets should be used.
Slovenian: Pri bolnikih, ki potrebujejo odmerek 15 mg lansoprazola na dan, je treba uporabiti zdravilo Agopton 15 mg kapsule ali Agopton 15 mg orodisperzibilne tablete.
English: Ketoconazole and itraconazole:
Slovenian: Ketokonazol in itrakonazol:
English: If the treatment fails the dose 30 mg once daily should be used.
Slovenian: Če zdravljenje ni uspešno, je treba uporabiti odmerek 30 mg enkrat na dan.
English: There was no baseline stratification for H. pylori status, reflecting clinical practice at the time.
Slovenian: Izhodiščne stratifikacije za status glede H. pylori, ki bi odražala klinično prakso v danem trenutku, ni bilo.
English: The dose of Agopton depends on your condition.
Slovenian: Odmerek zdravila Agopton je odvisen od vaše bolezni.
English: Your doctor may have prescribed Agopton for another indication or with a dose different from that which is written in this information leaflet.
Slovenian: Zdravnik vam lahko zdravilo Agopton predpiše za druge indikacije ali pa vam predpiše odmerek, ki se razlikuje od odmerka, navedenega v navodilu za uporabo.
English: Three studies were submitted addressing the pharmacokinetics in lansoprazole in patients with different levels of (mild, moderate and severe) liver impairment
Slovenian: Predložene so bile tri raziskave, ki so obravnavale farmakokinetiko lansoprazola pri bolnikih z različnimi stopnjami (blagimi, zmernimi in resnimi) okvar jeter.
English: Data concerning the indications “relief of symptoms” and “healing of gastroduodenal erosions” are scarce and are not sufficient for approval of these indications.
Slovenian: Podatki, zadevajoči indikaciji »lajšanje simptomov« in »celjenje erozij v želodcu in dvanajstniku« so skromni in ne zadoščajo za odobritev teh indikacij.
English: Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Slovenian: Aspartam je vir fenilalanina, ki lahko škoduje osebam s fenilketonurijo.
English: Petechiae, purpura, hair loss, erythema multiforme, photosensitivity
Slovenian: Petehije, purpura, izguba las, multiformni eritem, občutljivost za svetlobo
English: Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Slovenian: Induktorji encimov, ki vplivajo na CYP2C19 in CYP3A4, kot sta rifampicin in šentjanževka (Hypericum perforatum), lahko precej zmanjšajo koncentracijo lansoprazola v plazmi.
English: Peak plasma levels were not increased in the elderly.
Slovenian: Največje koncentracije v plazmi pri starejših niso bile povečane.
English: Pharmacokinetics in elderly patients
Slovenian: Farmakokinetika pri starejših bolnikih
English: Fever, hyperhidrosis, angioedema, anorexia, impotence
Slovenian: Zvišana telesna temperatura, hiperhidroza, angioedem, anoreksija, impotenca
English: If your symptoms are not relieved within 4 weeks, please contact your doctor.
Slovenian: Če se simptomi v 4 tednih ne ublažijo, obvestite zdravnika.
English: If you experience side effects like these you should take caution as your ability to react may be decreased.
Slovenian: Če imate podobne neželene učinke, morate biti previdni, ker lahko zmanjšajo možnost odzivanja
English: Pharmacokinetics in hepatic insufficiency
Slovenian: Farmakokinetika pri jetrni insuficienci
English: The tablet rapidly dissolves in the mouth, releasing microgranules which you should swallow without chewing.
Slovenian: Tableta se hitro raztopi v ustih, pri čemer se sprostijo mikrozrnca, ki jih morate pogoltniti brez žvečenja.
English: Further issues: it was requested to present a harmonised SPC for all other relevant sections Quality aspects do not form part of the current arbitration procedure.
Slovenian: Nadaljnji vidiki: zahtevano je bilo, da se predstavi harmonizirani SPC za vsa ostala zadevna poglavja.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da nekaterih sladkorjev ne prenašate, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: These are:
Slovenian: Ti vidiki so:
English: Studies have shown that granules from opened capsules give equivalent AUC as the intact capsule if the granules are suspended in a small amount of orange juice, apple juice, or tomato juice mixed with a tablespoon of apple or pear puree or sprinkled on a tablespoon of yoghurt, pudding or cottage cheese.
Slovenian: Študije so pokazale, da je vrednost AUC pri uporabi zrnc iz odprtih kapsul enaka kot pri neodprtih kapsulah, če so zrnca suspendirana v majhni količini pomarančnega, jabolčnega ali paradižnikovega soka, zmešanega z žlico jabolčnega ali hruškovega pireja, ali če so posute na žlico jogurta, pudinga ali skute.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Eradication of Helicobacter pylori:
Slovenian: Eradikacija bakterije Helicobacter pylori:
English: Increase in cholesterol and triglyceride levels, hyponatremia
Slovenian: Zvišane ravni holesterola in trigliceridov, hiponatriemija
English: This is reflected in section 4.2, 4.4 and 5.2 of the SPC.
Slovenian: To je razvidno iz poglavij 4.2, 4.4 in 5.2 SPC.
English: The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”.
Slovenian: Podatki ne podpirajo ne indikacije »preprečevanje simptomov« ne »profilaksa erozij v želodcu in dvanajstniku«.
English: The MAH proposed to include preliminary data in paediatric patients in the SPC.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal vključitev predhodnih podatkov o uporabi pri pediatričnih bolnikih v SPC.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03
Slovenian: Farmakoterapevtska skupina: Zaviralci protonske črpalke, oznaka ATC: A02BC03.
English: The data regarding healing of duodenal ulcers in one of the pivotal studies is limited (few patients) but support efficacy of both doses of lansoprazole 15 and 30 mg o.d.
Slovenian: Podatki v zvezi s celjenjem razjed dvanajstnika so pri eni osrednji raziskavi omejeni (malo bolnikov), vendar podpirajo tezo o učinkovitosti obeh odmerkov lansoprazola 15 in 30 mg enkrat dnevno.