natgillin/translations-raw huggingface dataset:
No clinically relevant difference in ulcer prevention between the 15 and 30 mg dose of lansoprazole could be demonstrated.
Le pri maloštevilnih bolnikih se je razvila razjeda dvanajstnika.
Only a small minority of patients developed duodenal ulcers The studies presented by the MAH demonstrated efficacy of lansoprazole in the treatment and prevention of gastric ulceration associated with continued intake of NSAIDs.
Raziskave, ki jo je predstavil imetnik dovoljenja za promet z zdravilom, so dokazale učinkovitost lansoprazola pri zdravljenju in preprečevanju razjed na želodcu, povezanih z nadaljnjim jemanjem NSAID.
The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”. • Symptomatic gastroesophageal reflux disease (4.1 and 4.2) Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.
Predloženi sta bili dve osrednji randomizirani, dvojno slepi raziskavi z vzporednima skupinama ter 5 podpornih raziskav, katerih cilj je bil ovrednotiti učinkovitost lansoprazola pri zdravljenju simptomatske gastroezofagealne refluksne bolezni.
The submitted data for the indication “symptomatic gastroesophageal reflux disease” support this the indication.
Predloženi podatki za indikacijo » simptomatska gastroezofagealna refluksna bolezen « podpirajo to indikacijo.
Different disease concepts for “symptomatic gastroesophageal reflux disease” and other “functional diseases” e.g. “dyspepsia”, are established throughout Europe and reflected in different labelling.
Po Evropi so uveljavljena različna tolmačenja za » simptomatsko gastroezofagealno refluksno bolezen « in druge » funkcionalne bolezni «, npr. dispepsijo «, kar se odraža v različnem označevanju.
It was agreed that the indication should only mention “symptomatic gastroesophageal reflux disease”.
Dogovorjeno je bilo, naj indikacija omenja zgolj » simptomatsko gastroezofagealno refluksno bolezen «.
Posology and methods of administration • Eradication of Helicobacter pylori Eradication of H. pylori has been shown to be a definitive cure for duodenum ulcer and most gastric ulcers.
9 Eradikacija bakterije H. pylori se je izkazala kot metoda za dokončno ozdravitev razjed dvanajstnika in večine razjed želodca.
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.
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).
Lansoprazole 30 mg combined with clarithromycin 250 or 500 mg and amoxicillin 1g, or clarithromycin 250 and metronidazole 400-500 mg twice daily was associated with eradication rates meeting the above described requirements.
Lansoprazol 30 mg v kombinaciji s klaritromicinom 250 ali 500 mg in amoksicilinom 1g, ali klaritromicinom 250 in metronidazolom 400- 500 mg dvakrat dnevno je izkazal stopnje eradikacije, ki izpolnjujejo zgoraj navedene zahteve.
The use of a regimen including lansoprazole 30mg twice daily, amoxicillin 1g twice daily and metronidazole 400-500mg twice daily has also been examined.
Obravnavan je bil tudi režim, vključujoč lansoprazol 30 mg dvakrat dnevno, amoksicilin 1g dvakrat dnevno in metronidazol 400- 500 mg dvakrat dnevno.
4.1 Therapeutic indications • Eradication and prevention of relapse of gastric ulcer and duodenal Two studies to support the indication prevention of duodenal ulcers were provided.
Predloženi sta bili dve raziskavi v podporo indikaciji za preprečevanje razjed dvanajstnika.
84% on lansoprazole15 mg maintenance.
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.
The objective of this trial was to compare the efficacy /safety or lansoprazole 15/30mg to placebo in the prevention of duodenal ulcers in those with a history of duodenal, or gastric ulcer disease in those with a history of gasric ulcers.
Cilj te raziskave je bil primerjati učinkovitost/ varnost lansoprazola 15/ 30 mg s placebom pri preprečevanju razjed dvanajstnika pri bolnikih s predhodno ulkusno boleznijo dvanajstnika oz. preprečevanje razjed želodca pri bolnikih s predhodno ulkusno boleznijo želodca.
4.2 Posology and methods of administration • Food interaction The MAH has provided three bioequivalence studies as background documentation on the effect of food intake on the bioavailability of lansoprazole.
4. 2 Odmerjanje in način uporabe
The AUC was reduced by about 50%.
AUC se je zmanjšal za približno 50%.
A restriction regarding food intake is necessary, since effects of food consumption on the pharmacokinetic profile has been observed.
10 Z ozirom na opažen vpliv uživanja hrane na farmakokinetični profil je omejitev glede uživanja hrane potrebna.
It can be expected that normally under fasting conditions gastric emptying of a formulation has taken place 30 minutes post-dose.
To je razvidno v SPC.
This is reflected in the SPC. • Mixing the content of the “opened capsules” with food Studies have been performed investigating the effect of mixing the granules of lansoprazole with food.
Izvedene so bile raziskave, ki so preučevale vpliv mešanja zrnc lansoprazola s hrano.
The factor that would influence the bioavailability the most would be if the granules were mixed with a vehicle of pH > 7.
Dejavnik, ki bi najbolj vplival na biološko uporabnost, bi nastopil, če bi bila zrnca zmešana z vehiklom s pH > 7.
This is reflected in the SPC under section 4.2 and 5.2.
To je razvidno iz poglavij 4. 2 in 5. 2 SPC.
4.2 Posology (in special populations) • Use in children A statement indicating the experience with the medicinal product in children is required under section 4.2 of the SPC.
V poglavju 4. 2 SPC je potrebna navedba glede izkušenj z uporabo zdravila pri otrocih.
10 The evaluation of the pharmacokinetics in children aged 10 weeks and above showed similar exposures in comparison to healthy adult volunteers receiving a 30 mg dose either with a body weight or body surface based dosing for babies.
Vlagatelj je na vprašanje glede pediatričnih podatkov odgovoril z izdelavo celovitega sklopa pediatričnih podatkov.
However, higher values for exposure will be expected in children below 1 year of age with the pharmaceutical forms that are commercially available.
Vrednotenje farmakokinetike pri otrocih, starih 10 tednov in več, je pokazalo podobne izpostavljenosti v primerjavi z zdravimi odraslimi prostovoljci, prejemajočimi 30 mg odmerek, ob odmerjanju za dojenčke na podlagi telesne teže ali telesne površine.
Higher exposure for lansoprazole was also seen in newborns and babies up to an age of approx.
Vendar pa se pri otrocih, starih manj kot eno leto, ob uporabi komercialno dosegljivih farmacevtskih oblik pričakujejo višje vrednosti izpostavljenosti.
10 weeks.
Višja izpostavljenost lansoprazolu je bila opažena tudi pri novorojenčkih in dojenčkih starosti do približno 10 tednov.
This is reflected in the SPC under 4.2.
To je razvidno iz poglavij 4. 2 SPC.
The pharmacokinetic data of children and adolescents are summarised under section 5.2. • Liver impairment Three studies were submitted addressing the pharmacokinetics in lansoprazole in patients with different levels of (mild, moderate and severe) liver impairment It was demonstrated that the total lansoprazole exposure is many-fold increased in patients with severe hepatic impairment.
Farmakokinetični podatki za otroke in mladostnike so povzeti v poglavju 5. 2.
The usually recommended dose in patients with normal hepatic function is 30 mg q.d.
Pokazano je bilo, da je skupna izpostavljenost lansoprazolu pri bolnikih z resnimi okvarami jeter večkratno povečana.
Unless the applicant can show convincing data on satisfactory safety with the exposures obtained, it is recommended that a dose reduction of 50% is made.
Razen če lahko vlagatelj pokaže prepričljive podatke o zadovoljivi varnosti pri doseženih izpostavljenostih, je priporočljivo upoštevati 50% zmanjšanje odmerka.
Further reductions are not practically possible and data may not allow simulations of PK/PD regarding the increase the dose-interval.
Nadaljnja zmanjšanja praktično niso možna in podatki morda ne dopuščajo simulacije farmakokinetike/ farmakodinamike v zvezi s povečanjem odmernega intervala.
This is reflected in section 4.2, 4.4 and 5.2 of the SPC. • 4.3 Contraindication 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).
• 4. 3 Kontraindikacije Z ozirom na izkazano zmanjšanje koncentracije atazanavirja, opaženo ob sočasni uporabi omeprazola, je uporaba ZPČ kontraindicirana v SPC za Reyataz (atazanavir).
This is also reflected in the SPC for lansoprazole. • 4.5 Interaction with other medicinal products and other forms of interaction One study of the interaction with phenytoin has been submitted.
To je razvidno tudi iz SPC za lansoprazol.
The effect of lansoprazole 60 mg q.d. for 9 days on the pharmacokinetics of phenytoin after a 250 mg i.v. dose was investigated.
Preučevali so vpliv lansoprazola 60 mg enkrat dnevno v obdobju 9 dni na farmakokinetiko fenitoina po 250 mg intravenozno.
For the complete wording of section 4.5 please see attched SPC. • 4.6 Pregnancy and lactation No data regarding of the use of lanzoprazole during preganancy and lactation has been provided.
O uporabi lanzoprazola med nosečnostjo in dojenjem niso bili predloženi nikakršni podatki.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne nakazujejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj.
Therefore, the use of lansoprazole during pregnancy is not recommended.
Uporaba lansoprazola med nosečnostjo ni priporočljiva.
The divergences identified at the start of the referral have been resolved.
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:
GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS LABELLING AND PACKAGE LEAFLET Whereas, • the scope of the referral was the harmonisation of the Summary of Products Characteristics, • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, Labelling and Package Leaflet is set out in Annex III of the CHMP Opinion for Agopton and associated names (see Annex I of the opinion).
• zdravljenjem razjede dvanajstnika in želodca • zdravljenjem refluksnega ezofagitisa • profilakso refluksnega ezofagitisa • eradikacijo Helicobacter pylori (H. pylori) pri sočasni terapiji z ustreznimi antibiotiki za zdravljenje razjed, povezanih s H. pylori • zdravljenjem benignih razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih, ki potrebujejo nadaljnje zdravljenje z NSAID • profilakso razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih s povečanim tveganjem (glej poglavje 4. 2), ki potrebujejo nadaljnje zdravljenje • simptomatsko gastroezofagealno refluksno boleznijo • Zollinger- Ellisonovim sindromom
12 ANNEX III
12 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
• Namen napotitve je bil usklajevanje Povzetkov glavnih značilnosti zdravila,
The text was valid at that time.
• Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, ki jih je predlagalo podjetje, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v okviru odbora,
Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
je CHMP priporočil dopolnitev dovoljenja za promet z zdravilom, za katerega so Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo podani v Dodatku III Mnenja CHMP za zdravilo Agopton in z njim povezana imena (glejte Dodatek I mnenja).
13 SUMMARY OF PRODUCT CHARACTERISTICS
13 DODATEK III
[See Annex I - To be completed nationally]
[Glejte Dodatek I – Izpolni država članica]
Each capsule contains 15 mg of lansoprazole Each capsule contains 30 mg of lansoprazole
Vsaka kapsula vsebuje 15 mg lansoprazola Vsaka kapsula vsebuje 30 mg lansoprazola
Each 15 mg capsule contains 29.9 mg of sucrose Each 30 mg capsule contains 59 .8 mg of sucrose
Vsaka 30- miligramska kapsula vsebuje 59, 8 mg saharoze.
Agopton 15 mg: < colour > capsules.
Agopton 15 mg: < barva > kapsule.
Each capsule contains < white to pale brownish white enteric- coated granules >.
Vsaka kapsula vsebuje < bela do bledo rjavo bela zrnca z gastrorezistentno oblogo >.
Agopton 30 mg: < colour > capsules.
Agopton 30 mg: < barva > kapsule.
• Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome.
• Zdravljenje razjede dvanajstnika in želodca. • Zdravljenje refluksnega ezofagitisa. • Profilaksa refluksnega ezofagitisa. • Eradikacija bakterije Helicobacter pylori (H. pylori) pri sočasnem zdravljenju z ustreznimi antibiotiki za zdravljenje razjed, povezanih s H. pylori. • Zdravljenje benignih razjed dvanajstnika in želodca, povezanih z nesteroidnimi protivnetnimi zdravili (NSAID), pri bolnikih, pri katerih je potrebno neprekinjeno zdravljenje z NSAID. • Profilaksa razjed dvanajstnika in želodca, povezanih z NSAID, pri bolnikih, pri katerih obstaja tveganje (glejte poglavje 4. 2) in pri katerih je potrebno neprekinjeno zdravljenje z NSAID. • Simptomatska bolezen gastroezofagealnega refluksa. • Zollinger- Ellisonov sindrom.
For optimal effect, Agopton should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.
Takrat ga je treba jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer.
Agopton should be taken at least 30 minutes before food (see section 5.2).
Zdravilo Agopton je treba jemati vsaj 30 minut pred obrokom (glejte poglavje 5. 2).
15 For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration.
Za bolnike, ki imajo težave s požiranjem, so študije in klinična praksa pokazale, da se za lažjo uporabo kapsule lahko odprejo in zrnca premešajo z malo vode ali jabolčnega/ paradižnikovega soka ali pa se 16 potresejo na majhno količino mehke hrane (npr. jogurt, jabolčni pire).
Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2).
Kapsule se lahko odprejo in zrnca premešajo s 40 ml jabolčnega soka za uporabo z nazogastrično cevko (glejte poglavje 5. 2).
Treatment of duodenal ulcer:
Zdravljenje razjede dvanajstnika:
Treatment of gastric ulcer:
Zdravljenje razjede želodca:
Prophylaxis of reflux oesophagitis:
Profilaksa refluksnega ezofagitisa:
The dose may be increased up to 30 mg daily as necessary.
Odmerek se po potrebi lahko poveča na 30 mg na dan.
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.
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.
The recommended dose is 30 mg of Agopton twice daily for 7 days in combination with one of the following: clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily
Priporočeni odmerek je 30 mg zdravila Agopton dvakrat na dan 7 dni v eni izmed naslednjih kombinacij: klaritromicin 250– 500 mg dvakrat na dan + amoksicilin 1 g dvakrat na dan; klaritromicin 250 mg dvakrat na dan + metronidazol 400– 500 mg dvakrat na dan.
H. pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with Agopton and amoxicillin or metronidazole.
Pri uporabi kombinacije klaritromicina z zdravilom Agopton in amoksicilinom ali metronidazolom se doseže do 90- odstotna eradikacija bakterije H. pylori.
Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined.
Proučili so tudi režim, ki vključuje 30 mg lansoprazola dvakrat na dan, 1 g amoksicilina dvakrat na dan in 400– 500 mg metronidazola dvakrat na dan.
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.
Kadar je lokalna stopnja rezistence na metronidazol majhna, je lahko ta kombinacija primerna za osebe, ki pri eradikacijskem zdravljenju ne morejo jemati klaritromicina.
Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age > 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:
Profilaksa razjed dvanajstnika in želodca, povezanih z NSAID, pri bolnikih, pri katerih obstaja tveganje (kot je starost > 65 let ali razjeda dvanajstnika in želodca v anamnezi) in pri katerih je potrebno neprekinjeno zdravljenje z NSAID:
16 Symptomatic gastro-oesophageal reflux disease:
Simptomatska bolezen gastroezofagealnega refluksa:
Zollinger-Ellison syndrome:
17 Zollinger- Ellisonov sindrom:
The recommended initial dose is 60 mg once daily.
Priporočeni začetni odmerek je 60 mg enkrat na dan.
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).
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).
The use of Agopton is not recommended in children as clinical data are limited (see also section 5.2).
Klinični podatki so omejeni, zato uporaba zdravila Agopton pri otrocih ni priporočena (glejte tudi poglavje 5. 2).
Lansoprazole should not be administered with atazanavir (see section 4.5).
Lansoprazol se ne sme uporabljati skupaj z atazanavirom (glejte poglavje 4. 5).
Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).
Pri bolnikih z zmerno do hudo jetrno okvaro je treba lansoprazol uporabljati previdno (glejte poglavji 4. 2 in 5. 2).
17 Very rarely cases of colitis have been reported in patients taking lansoprazole.
Pri bolnikih, ki jemljejo lansoprazol, so zelo redko poročali o primerih kolitisa.
The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).
18 perforacija ali razjeda v prebavilih, starost, sočasna uporaba zdravil, ki povečajo verjetnost neželenih učinkov v zgornjih prebavilih [npr. kortikosteroidi ali antikoagulanti], prisotnost resnega dejavnika komorbidnosti ali dolgotrajna uporaba največjih priporočenih odmerkov nesteroidnih antirevmatikov).
< As Agopton contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. >
< Zdravilo Agopton vsebuje saharozo, zato bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali pomanjkanjem saharoza- izomaltaze ne smejo jemati tega zdravila. >
Medicinal products with pH dependent absorption Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavailability.
Zdravila, katerih absorpcija je odvisna od pH Lansoprazol lahko ovira absorpcijo zdravil, pri katerih je vrednost pH v želodcu ključna za biološko uporabnost.
A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
Študija je pokazala, da je sočasna uporaba lansoprazola (60 mg enkrat na dan) in atazanavira 400 mg pri zdravih prostovoljcih povzročila pomembno zmanjšanje izpostavljenosti atazanaviru (približno 90 - odstotno zmanjšanje vrednosti AUC in Cmax).
Lansoprazole should not be co-administered with atazanavir (see section 4.3).
Lansoprazol se ne sme uporabljati skupaj z atazanavirom (glejte poglavje 4. 3).
Medicinal products metabolised by P450 enzymes Lansoprazole may increase plasma concentrations of drugs that are metabolised by CYP3A4.
Zdravila, ki jih presnavljajo encimi P450 Lansoprazol lahko poveča koncentracije zdravil, ki jih presnavlja CYP3A4, v plazmi.
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P- gp substrate).
Sočasna uporaba z lansoprazolom poveča koncentracijo takrolimusa (substrat encimov CYP3A in P - gp) v plazmi.
Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Izpostavljenost lansoprazolu je povečala povprečno izpostavljenost takrolimusu do 81%.
Medicinal products transported by P-glycoprotein Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
Zdravila, ki jih transportira P- glikoprotein Opazili so, da lansoprazol in vitro zavira transportno beljakovino P- glikoprotein (P- gp).
18 Effects of other drugs on lansoprazole
Učinki drugih zdravil na lansoprazol
Drugs which inhibit CYP2C19 Fluvoxamine:
Zdravila, ki zavirajo CYP2C19 Fluvoksamin:
A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine.
19 Pri uporabi kombinacije lansoprazola in fluvoksamina, ki zavira CYP2C19, je treba pretehtati možnost zmanjšanja odmerka lansoprazola.
Drugs which induces CYP2C19 and CYP3A4 Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Zdravila, ki inducirajo delovanje CYP2C19 in CYP3A4 Induktorji encimov, ki vplivajo na CYP2C19 in CYP3A4, kot sta rifampicin in šentjanževka (Hypericum perforatum), lahko precej zmanjšajo koncentracijo lansoprazola v plazmi.
Others Sucralfate/Antacids:
Druga zdravila Sukralfat, antacidi:
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj.