natgillin/translations-raw huggingface dataset:
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL ABZ- PHARMA 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I) Lansoprazol AbZ-Pharma 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.
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LANSOPRAZOL ABZ- PHARMA 15 MG, 30 MG, GASTROREZISTENTNE KAPSULE, TRDE (glejte Dodatek I) Zdravilo Lansoprazol AbZ- Pharma 15- mg, 30- mg gastrorezistentne kapsule, trde, je bilo napoteno na arbitražni postopek v skladu s členom 29 Direktive Sveta 2001/ 83/ ES, kakor je bila spremenjena, zaradi zadržkov, ki jih je predložila Nemčija v okviru postopka medsebojnega priznavanja s Finsko, ki je bila referenčna država članica.
The concerns rose referred to discrepancies in comparison to the reference products on posology of triple therapy for H. pylori eradication.
Zadržki so bili predloženi zaradi neskladnosti pri primerjavi z referenčnimi zdravili v zvezi z odmerjanjem v tritirni terapiji za eradikacijo H. pylori.
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.
Eradikacija H. pylori in zdravljenje želodčne razjede Z namenom, da bi standardizirali terapevtske sheme za eradikacijo bakterije H. pylori, je Evropsko združenje za raziskave Helicobacter pylori objavilo smernice o obvladovanju okužbe z Helicobacter pylori.
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.
Pylori, ki se jih dobro prenaša in katerih odstotek uspešnosti doseže več kot 80% na osnovi namere za zdravljenje.
Standard dose proton pump inhibitor, twice daily, and: • metronidazole, 400 mg (tinidazole, 500 mg) twice daily, + clarithromycin, 250 mg twice daily; • amoxicillin, 1000 mg twice daily, + clarithomycin, 500 mg twice daily (advisable when metronidazole resistance is likely); • amoxicillin, 500 mg three times daily, + metronidazole, 400 mg three times daily (advisable when clarithomycin resistance is likely) Since then new data became available that necessitated an update of the original guidelines in order to provide practical management guidelines that would be acceptable across clinical practice, both in primary care and the specialist level.
Sheme zdravljenja, ki so ustrezale gornjim merilom, so bile naslednje: standardni odmerek zaviralca protonske črpalke, dvakrat dnevno, ter: • metronidazol, 400 mg (tinidazol, 500 mg) dvakrat dnevno, + klaritromicin, 250 mg dvakrat dnevno • amoksicilin, 1000 mg dvakrat dnevno, + klaritromicin, 500 mg dvakrat dnevno (priporočeno, kadar je možna odpornost na metronidazol); • amoksicilin, 500 mg trikrat dnevno, + metronidazol, 400 mg trikrat dnevno (priporočeno, kadar je verjetna odpornost na klaritromicin); Od takrat so bili na razpolago dani novi podatki zaradi katerih je bilo potrebno smernice posodobiti, da bi tako zagotovili praktična priporočila za obvladovanje, ki bi bila sprejemljiva po vsej klinični praksi, tako v osnovnem zdravstvu kot na specialistični ravni.
The updated guidelines were established during the Maastricht 2- 2000 Consensus meeting.
Posodobljene smernice so bile vzpostavljene na 2. konsenz konferenci v Maastrichu 2000.
Subsequent failures should be handled on case- by-case basis.
Vsak primer nadaljnjega neuspešnega zdravljenja je treba obravnavati posebej.
Reduction of the clarithromycin dose in the clarithromycin-metronidazole combination is supported by clinical data as well as the Maastricht Consensus Report, stating that 250 mg dose is sufficient even if the recommended dose is 500 mg.
Zmanjšanje odmerka klaritromicina v kombinaciji klaritromicin- metronidazol podpirajo tako klinični podatki kot poročilo o konsenzu iz Maastrichta, ki navaja, da odmerek 250 mg zadostuje, kljub temu da je priporočen odmerek 500 g.
The reduction of clarithromycin to 250 mg in the triple combination therapy with amoxicillin 1000 mg, however, is not supported by the Maastricht 2-2000 Consensus Report.
Vendar pa poročilo z 2. konsenz konference v Maastrichtu ne podpira zmanjšanja odmerka klaritromicina na 250 mg v tritirnem zdravljenju, kjer je odmerek amoksiklicina 1000 mg.
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.
V članku, ki so ga v reviji Wiener Klinische Wochenschrift 2004 objavili Bago et al, je navedeno, da je lahko pri bolnikih z dispepsijo za eradikacijo H. pylori odmerek 250 mg dvakrat dnevno ravno tako učinkovit kot 500 mg dvakrat dnevno, čeprav so bile številčno stopnje eradikacije nekaj nižje.
4 metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazole- clarithromycin-metronidazole is advisable.
4 Razmerje med koristmi/ tveganji
The risk/ benefit ratio of Lansoprazol AbZ-Pharma 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Razmerje med tveganji in koristmi za zdravilo Lansoprazol AbZ- Pharma 15 mg, 30 mg velja za ugodno pod pogojem, da se ustrezni podatki v zvezi z zdravljenjem za eradikacijo H. pylori vključijo v Povzetek glavnih značilnosti zdravila.
Whereas, The scope of the referral was to agree on a harmonised dosing schedule for triple therapy for eradication therapy for H. pylori The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lansoprazol AbZ- Pharma and associated names (see Annex I).
Ker je bil namen napotitve uskladiti shemo odmerjanja pri tritirni terapiji za zdravljenje za eradikacijo H. pylori. so bili Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki jih je predlagal vlagatelj, ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora, je CHMP za Lansoprazol AbZ- Pharma in povezana imena (glejte Dodatek I), za katere so Povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo opredeljeni v Dodatku III, priporočil odobritev dovoljenj za promet.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA OZNAČEVANJE IN NAVODILO ZA UPORABO
< Lansoprazol AbZ and associated names (see Annex I) 15 mg, gastro-resistant capsules, hard > < Lansoprazol AbZ and associated names (see Annex I) 30 mg, gastro-resistant capsules, hard >
< Lansoprazol - AbZ in povezana imena (glejte Dodatek I) 15 mg gastrorezistentne trde kapsule > < Lansoprazol - AbZ in povezana imena (glejte Dodatek I) 30 mg gastrorezistentne trde kapsule >
[see Annex I – to be completed nationally]
[Glejte Dodatek I – podatke je treba dopolniti v posameznih državah]
Each capsule contains 15 mg or 30 mg lansoprazole.
Vsaka kapsula vsebuje 15 ali 30 mg lansoprazola.
For a full list of excipients, see section 6.1.
Vsebuje tudi saharozo (sladkor) Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Gastro-resistant hard capsule.
Gastrorezistentna trda kapsula
4.1 Therapeutical indications
4. 1 Terapevtske indikacije
- Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography
- Zdravljenje endoskopsko ali radiografsko potrjenih razjed dvanajstnika in želodca.
- Treatment of reflux oesophagitis
- Zdravljenje refluksnega ezofagitisa.
- Long-term prophylaxis of reflux oesophagitis
- Dolgotrajna profilaksa refluksnega ezofagitisa.
- Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy and
- Eradikacija Helicobacter pylori pri sočasnem zdravljenju z ustreznimi antibiotiki in preprečevanje
prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers
ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori.
- Zollinger-Ellison Syndrome
- Zollinger- Ellisonov sindrom.
Duodenal ulcer:
Razjeda dvanajstnika:
Gastric ulcer:
Razjeda želodca:
Long-term prophylaxis of reflux oesophagitis:
Dolgotrajna profilaksa refluksnega ezofagitisa:
8 Helicobacter pylori eradication:
8 Eradikacija bakterije Helicobacter pylori:
The recommended dose is 30 mg lansoprazole 2 times daily for one week in combination with one of the following three combinations: a) amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily, b) clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily, c) amoxicillin 1 g twice daily + metronidazole 400-500 mg twice daily.
a) amoksicilin, 1 g, dvakrat dnevno + klaritromicin, 500 mg, dvakrat dnevno b) klaritromicin, 250 mg, dvakrat dnevno + metronidazol, 400- 500 mg, dvakrat dnevno c) amoksicilin, 1 g, dvakrat dnevno + metronidazol, 400- 500 mg, dvakrat dnevno
Consideration should be given to official local guidance (e. g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
Bodite pozorni na uradne smernice (npr. državna priporočila) glede bakterijske rezistence in ustrezne uporabe ter predpisovanja protibakterijskih sredstev.
Zollinger-Ellison Syndrome:
Zollinger- Ellisonov sindrom:
However the normal daily dose of 30 mg should not be exceeded.
Prilagoditev odmerka pri bolnikih z okvarjenim delovanjem ledvic ni potrebna, vendar odmerkov, večjih od 30 mg dnevno ne smete preseči.
Lansoprazole is not recommended for use in children due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti, uporaba lansoprazola pri otrocih ni priporočljiva.
The capsules may be emptied, but the contents may not be chewed or ground. Concomitantly taken food slows down and reduces the absorption of lansoprazole.
Kapsule se lahko izpraznijo, vendar se njihove vsebine ne sme žvečiti ali zdrobiti.
This medicine has the best effect when taken into empty stomach.
Sočasno uživanje hrane upočasni in zmanjša absorpcijo lansoprazola.
Reflux oesophagitis may not present, as ulceration and/ or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
Refluksni ezofagitis morda ni prisoten v obliki razjede in/ ali vidne poškodbe, zato v nekaterih primerih endoskopija ni zadostna.
(See Section 4.2 Posology and Method of Administration)
(Glejte poglavje 4. 2 Odmerjanje in način uporabe)
9 Lansoprazole has similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
9 analogiji z omeprazolom.
If visual disturbances occur during long-term use (> 1 year), intake of the medicine should immediately be stopped and an ophthalmologist should be consulted.
Če se pri dolgotrajni uporabi (> 1 leto) pojavijo motnje vida, je treba jemanje zdravila nemudoma prekiniti in se posvetovati z okulistom.
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.
Zdravilo vsebuje saharozo, zato bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali pomanjkanjem saharoza- izomaltaze ne smejo jemati tega zdravila.
Active substances associated with cytochrome P450 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.
Zdravilne učinkovine, povezane s citokromom P450 Lansoprazol se presnavlja z encimskim sistemom, povezanim s citokromom P450 (CYP2C19 in CYP3A4), zato so mogoče interakcije z zdravilnimi učinkovinami, ki jih presnavlja isti encimski sistem.
Active substances, which inhibit CYP2C19 Active substances, which inhibit CYP2C19 may increase the plasma concentration of lansoprazole.
Zdravilne učinkovine, ki zavirajo CYP2C19 Zdravilne učinkovine, ki zavirajo CYP2C19, lahko povečajo koncentracijo lansoprazola v plazmi.
Fluvoxamine, an inhibitor of CYP2C19, increased the plasma concentrations of lansoprazole up to 4- fold.
Zaviralec CYP2C19, fluvoksamin, je povečal koncentracijo lansoprazola v plazmi do 4- krat.
Active substances, which inhibit CYP3A4 Active substances, which inhibit CYP3A4 such as ketokonazole, itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole.
Zdravilne učinkovine, ki zavirajo CYP3A4 Zdravilne učinkovine, ki zavirajo CYP3A4, kot so ketokonazol, itrakonazol, zaviralci proteaz, makrolidi itn., lahko bistveno povečajo koncentracijo lansoprazola v plazmi.
Active substances metabolised by CYP3A4 Lansoprazole may give rise to increased plasma concentrations of active substances metabolised by CYP3A4.
Zdravilne učinkovine, ki jih presnavlja CYP3A4 Lansoprazol lahko poveča plazemsko koncentracijo zdravilnih učunkovin, ki jih presnavlja CYP3A4.
10 Tacrolimus Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P- gp substrate).
Takrolimus Sočasna uporaba z lansoprazolom poveča koncentracijo takrolimusa (substrat encimov CYP3A in P – gp) v plazmi.
Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lansoprazole is initiated or ended.
Ob začetku in koncu sočasnega zdravljenja z lansoprazolom se priporoča nadzorovanje koncentracije
Carbamazepine Caution is advised during co-treatment with carbamazepine (a CYP3A substrate) and lansoprazole.
Karbamazepin Med sočasnim zdravljenjem s karbamazepinom (substratom encima CYP3A) in lansoprazolom se priporoča previdnost.
The drug combination may result in increased carbamazepine concentrations as well as reduced lansoprazole concentrations.
Ta kombinacija zdravil lahko povzroči povečanje koncentracije karbamazepina in zmanjšanje koncentracije lansoprazola.
Phenytoin Studies have shown that the dose of phenytoin (a CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
Fenitoin Študije so pokazale, da je morda treba zmanjšati odmerek fenitoina (substrata encimov CYP2C19 in CYP2C9), kadar se uporablja skupaj z lansoprazolom.
Theophyllin Lansoprazole gives a 14% reduction in the plasma concentrations of theophyllin.
Teofilin Lansoprazol zmanjša koncentracijo teofilina v plazmi za 14%.
Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
Opazili so, da lansoprazol in vitro zavira transportno beljakovino P- glikoprotein (P- gp).
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.
Ni mogoče izključiti možnosti, da lansoprazol morda vpliva na transport prek te beljakovine in posledično poveča plazemske koncentracije substratov P- gp, kot je digoksin.
30 mg + 500 mg 3 times/ day for 5 days
30 mg +500 mg 3- krat/ dan, 5 dni
11 lansoprazole + amoxicillin lansoprazole + metronidazole
lansoprazol + amoksicilin lansoprazol + metronidazol
lansoprazole + clarithromycin + amoxicillin
lansoprazol + klaritromicin + amoksicilin
Increase bioaivalability and half-life of lansoprazole by 30% each; increased plasma levels of a clarithromycin metabolite by 30%
Povečana biološka razpoložljivost in razpolovni čas lansoprazola za 30%; povečana plazemska koncentracija presnovka klaritromicina za 30%
* The effects of clarithromycine on the pharmacokinetics of lansoprazole are likely to be dependent on the patient’ s CYP2C19 genotype.
11 * Učinki klaritromicina na farmakokinetiko lansoprazola so verjetno odvisni od bolnikovega genotipa CYP2C19.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ fetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with lansoprazole should be made taking into account the benefit of breast-feeding to the child and the benefit of lansoprazole therapy to the woman.
Pri odločitvi, ali nadaljevati ali prekiniti dojenje oziroma ali nadaljevati ali prekiniti zdravljenje z lansoprazolom, je treba upoštevati korist dojenja za otroka in korist zdravljenja z lansoprazolom za žensko.
Lansoprazol AbZ has minor or moderate influence on the ability to drive and use machines.
Lansopazol - AbZ ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
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.
Pri zdravljenju z lansoprazolom so opazili naslednje neželene učinke z naslednjo pogostostjo: pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000) vključno s posameznimi primeri.
Common (1/ 100, < 1/ 10)
Pogosti (1/ 100, < 1/ 10)
Uncommon (> 1/ 1000, < 1/ 100)
Občasni (> 1/ 1. 000, < 1/ 100)
Rare (> 1/ 10000, < 1/ 1000)
Redki (> 1/ 10. 000, < 1/ 1. 000)
Very rare (< 1/ 10000) including isolated reports
(< 1/ 10. 000) vključno s posameznimi primeri
Vomiting, nausea, Dry mouth or diarrhea, stomach throat and ache, constipation, anorexia. flatulence and dyspepsia.
Bruhanje, navzea, Suha usta in driska, bolečine v grlo ter trebuhu, zaprtje, anoreksija. flatulenca in dispepsija.
Skin and subcutaneous tissue disorders
Bolezni kože in Ekcem, urtikarija podkožja in srbenje.
Eczema, urticaria and itching.
multiformni eritem, petehija, izguba las, hiperhidroza in purpura.
Erythema multiforme, Petechia, hair loss, hyperhidrosis and purpura.
Depresija, halucinacije, zmedenost, insomnija, zaspanost, dremavost, vrtoglavica, tremor in parestezija, nemir.
Stevens-Johnson syndrome and toxic epidermal necrolysis.
Stevens- Johnsonov sindrom in toksična epidermalna nekroliza.
Nervous system disorders
Bolezni hepatobiliarneg a sistema
Headache and dizziness.
Povečanje ravni jetrnih encimov
Depression, hallucination, confusion, insomnia, somnolence, drowsiness, vertigo, tremor and paresthesia, restlessness.
Hepatitis in ikterus
Hepatobiliary disorders Renal and urinary disorders
Bolezni sečil
Increase in liver enzyme levels.
Intersticijski nefritis
Hepatitis and icterus Interstitial nephritis.
Bolezni krvi in limfatičnega sistema
Blood and lymphatic system disorders Cardiac disorders Vascular disorders
Trombocitopenija, eozinofilija, pancitopenija, anemij in levkopenija.
Palpitation and chest pain.
Agranulocitoza.
Peripheral edema.
Srčne bolezni
Agranulocytosis.
Palpitacije in bolečine v prsnem košu.
Musculoskeletal and connective tissue disorders
Žilne bolezni Bolezni mišično - skeletnega sistema in vezivnega tkiva
Muscle and joint pain.
Periferni edem Bolečine v mišicah in sklepih
Taste disturbances.
Motnje okušanja
Visual disturbances.
Motnje vida
General disorders
Angioedem, bronhialna Anafilaktični šok, Splošne motnje Preiskave
Angioedema, bronchial Anaphylactic shock, constriction, fever. impotence and general malaise
konstrikcija, povišana telesna temperatura.
Increase in cholesterol and triglyceride levels.
impotenca in splošno slabo počutje Povečanje ravni holesterola in trigliceridov.
Possible symptoms of lansoprazole overdose can be expected to be similar with adverse drug reactions listed in section 4.8.
Pričakovati je, da bodo morebitni znaki prevelikega odmerjanja lansoprazola podobni neželenim učinkom, navedenim v poglavju 4. 8.
Proton pump inhibitors, ATC code:
Zaviralci protonske črpalke, ATC oznaka:
It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/ K+ ATPase of the parietal cells in the stomach.
Z zaviranjem aktivnosti H+/ K+ ATPaze parietalnih celic želodca zavira končno stopnjo tvorbe želodčne kisline.
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.
Lansoprazol je koncentriran v parietalnih celicah in se aktivira v njihovem kislem okolju, kjer reagira s sulfhidrilno skupino H+/ K+ATPaze, kar povzroči zaviranje encimske aktivnosti.
A single oral dose of 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
En 30- miligramski peroralni odmerek zavre izločanje želodčne kisline spodbujene s pentagastrinom za približno 80%.
After eight days of repeated administration the reduction is about 85%.
Po osmih dneh ponavljajoče se uporabe je zmanjšanje približno 85%.
Bioavailability after a single dose of 30 mg and after repeated daily administration is 80-90%.
Biološka uporabnost po enkratnem 30- miligramskem odmerku in po ponavljajoči se dnevni uporabi je 80– 90%.
Intake of food slows the absorption rate of lansoprazole and reduces its bioavailability (AUC) by about 25%.
Uživanje hrane upočasni absorpcijo lansoprazola in zmanjša biološko uporabnost (AUC) za približno 25%.
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.
Vezava lansoprazola na beljakovine v plazmi je približno 95 -%, vendar to ne vpliva na druge zdravilne učinkovine, ki se vežejo na beljakovine v plazmi.
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.
CYP2C19 je izpostavljen genetskemu polimorfizmu in 2– 6% populacije, t. i. slabi presnavljalci (PM – "Poor Metaboliser"), so homozigoti za mutantni alel CYP2C19, in zato nimajo funkcionalnega encima CYP2C19.
The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs).
Pri PM je izpostavljenost lansoprazolu nekajkrat večja kot pri dobrih presnavljalcih (EM – "Extensive Metaboliser").
The elimination half-life of lansoprazole is 1.0-2.0 hours.
Razpolovni čas izločanja lansoprazola je 1, 0 do 2, 0 uri.
14 have been identified in the plasma: the sulphone, 5-hydroxy lansoprazole and the sulphide.
V plazmi so odkrili tri presnovke: sulfon, 5- hidroksilansoprazol in sulfid.
Three metabolites have been identified in the urine:
V urinu so odkrili 14 tri presnovke:
5- hydroxy sulphone, 5-hydroxy sulphide and 5-hydroxy lansoprazole.
5- hidroksisulfon, 5- hidroksisulfid in 5- hidroksilansoprazol.
Sugar spheres(sucrose and maize starch) Sodium laurilsulphate Meglumine Mannitol Hypromellose Macrogol Talc Polysorbate 80 Titanium dioxide (E171) Methacrylic Acid-Ethyl Acrylate Copolymer, 1:1, Dispersion 30%
Kroglice iz sladkorja (saharoza in koruzni škrob) Natrijev lavrilsulfat Meglumin Manitol Hipromeloza Makrogol Smukec Polisorbat 80 Titanov dioksid (E 171) Kopolimer metilakrilne kisline in etilakrilata (1: 1, 30- odstotna disperzija)
Gelatin Titanium dioxide (E171) Quinoline yellow (E104) – only 15 mg capsules
Želatina Titanov dioksid (E 171) Kinolinsko rumeno (E104) – le v 15- miligramskih kapsulah
Al/ Al (OPA/ Al/ PVC/ /PVC/ Al/ PET) blister
Al/ Al (OPA/ Al/ PVC // PVC/ Al/ PET) pretisni omot
7, 10, 10x1, 14, 14x1, 20, 28, 28x1, 30, 30x1, 56, 56x1, 60, 98, 98x1, 100 and 100x1 capsules
7, 10, 10x1, 14, 14x1, 20, 28, 28x1, 30, 30x1, 56, 56x1, 60, 98, 98x1, 100 in 100x1 kapsula