natgillin/translations-raw huggingface dataset:
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.
Treatment of Zollinger-Ellison syndrome
Zdravljenje Zollinger-Ellisonovega sindroma
Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and bening Leydig cell tumours.
Opazili so intestinalno metaplazijo, hiperplazijo Leydigovih celic in benigne tumorje Leydigovih celic.
Clinically significant interactions of lansoprazole with diazepam have not been demonstrated.
Klinično pomembnih interakcij med lansoprazolom in diazepamom niso opazili.
Palpitation and chest pain.
Palpitacije in bolečine v prsnem košu.
- Before treatment with Lansoprazol-CT - the diagnosis of ulcers of the duodenum or stomach and inflammation of the gullet due to reflux of stomach acid should be confirmed by gastroscopy or other appropriate diagnostic measures (e.g. X-ray with contrast media) - a stomach ulcer with Lansoprazol-CT, the possibility of a malignant stomach tumour should be excluded.
- Pred zdravljenjem z zdravilom Lansoprazol-CT - diagnozo razjed dvanajstnika ali želodca in vnetje požiralnika zaradi refluksa želodčne kisline je treba potrditi z gastroskopijo ali drugo ustrezno diagnostično metodo (npr. rentgenskim slikanjem s kontrastnim sredstvom) - pred zdravljenjem želodčne razjede z zdravilom Lansoprazol-CT je treba izključiti možnost obstoja malignega tumorja na želodcu.
The enzyme CYP3A4 also contributes to the metabolism.
K presnovi prispeva tudi encim CYP3A4.
Therapy of Helicobacter pylori infection is intended to be combined with concurrent administration of lansoprazole with two antibiotics.
Zdravljenje okužbe z bakterijo Helicobacter pylori poteka kot kombinirano zdravljenje z lansoprazolom in dvema antibiotikoma.
Patients with severely impaired liver function should not take Lansoprazol-CT, nor should they be given combination therapy with clarithromycin.
Bolniki s hudo okvaro delovanja jeter ne smejo jemati zdravila Lansoprazol-CT niti ne smejo biti podvrženi kombiniranemu zdravljenju s klaritromicinom.
Angioedema, bronchial constriction, fever.
Angioedem, bronhialna konstrikcija, povišana telesna temperatura.
Three metabolites 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.
Tacrolimus (medicine used to prevent rejection of a transplant) Simultaneous use of lansoprazole causes a rise in the plasma concentrations of tacrolimus.
Takrolimus (zdravilo za preprečevanje zavračanja presadkov) Sočasna uporaba lansoprazola povzroči povečanje koncentracij takrolimusa v plazmi.
For lansoprazole no clinical data on exposed pregnancies are available.
Za lansoprazol ni kliničnih podatkov o uporabi med nosečnostjo.
Interstitial nephritis.
Intersticijski nefritis
Gelatin, Titanium dioxide (E171), Quinoline yellow (E104)
Želatina, titanov dioksid (E171), kinolinsko rumeno (E104)
If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Če je potrebno zdravljenje, se priporoča izpiranje želodca, uporaba aktivnega oglja in simptomatsko zdravljenje.
In mouse carcinogenicity studies dose-related gastric ECL cell hyperplasia developed as well as liver tumours and adenoma of rete testis.
V študijah karcinogenosti pri miših so se razvili od odmerka odvisna hiperplazija želodčnih celic ECL, tumorji na jetrih in adenom mrežja testisa.
The recommended adult oral starting dose is 60 mg once a day.
Priporočeni začetni odmerek za odrasle je 60 mg enkrat dnevno.
Monitoring of the serum levels of other medicinal products taken during the 1-week eradication therapy is therefore recommended.
Zato se priporoča nadzorovanje serumske koncentracije drugih zdravil, ki se uporabljajo v enotedenskem eradikacijskem zdravljenju.
In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion.
V dveh študijah karcinogenosti na podganah je lansoprazol povzročil od odmerka odvisno hiperplazijo želodčnih celic ECL in karcinoide celic ECL, povezane s hipergastrinemijo zaradi zaviranja izločanja kisline.
WHAT Lansoprazol-CT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Lansoprazol-CT IN ZA KAJ GA UPORABLJAMO
For a full list of excipients, see section 6.1.
Vsebuje tudi saharozo (sladkor) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole.
Zaradi pomanjkanja podatkov, bolnikov s hudo okvaro delovanja jeter ne smemo zdraviti z lansoprazolom.
dryness of the throat or mouth, loss of appetite.
Občasni: suho grlo ali usta, izguba teka.
Methacrylic Acid-Ethyl Acrylate Copolymer, 1:1, Dispersion 30%
Kopolimer metilakrilne kisline in etilakrilata (1:1, 30-odstotna disperzija)
To date, no clinically relevant interactions have been demonstrated between lansoprazole and diazepam.
Klinično pomembnih interakcij med lansoprazolom in diazepamom še niso odkrili.
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).
Second-line therapy with quadruple therapy using proton pump inhibitor combined with bismuth subcitrate (subsalicylate) and metronidazole, and tertacycline for a minimum of 7 days has been recommended.
Kot zdravljenje druge izbire je bilo priporočeno štiritirno zdravljenje z uporabo zaviralca protonske črpalke v kombinaciji z bizmut subcitratom (subsalicilat), metronidazolom in tetraciklinom, ki traja vsaj sedem dni.
Decreased gastric acidity due to lansoprazole increases gastric counts of bacteria normally present in the gastrointestinal tract.
Zmanjšana kislost v želodcu zaradi lansoprazola poveča število bakterij, ki so normalno prisotne v prebavilih.
Active substances, which inhibit CYP2C19 may increase the plasma concentration of lansoprazole.
Zdravilne učinkovine, ki zavirajo CYP2C19, lahko povečajo koncentracijo lansoprazola v plazmi.
allergic shock, impotence, feeling unwell.
Zelo redki: alergijski šok, impotenca, slabo počutje.
Lansoprazol-CT may not be used in children, as its safety and efficacy have not been established in this patient group.
Otroci ne smejo uporabljati zdravila Lansoprazol-CT, ker v tej skupini bolnikov njegova varnost in učinkovitost nista bili potrjeni.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Fluvoxamine (a medicine for the treatment of depression), ketoconazole and itraconazole (medicines for the treatment of fungal infections), protease inhibitors (active substances used in the treatment of the AIDS virus) and macrolides (certain types of antibiotics) may markedly raise the concentration of lansoprazole in the blood and thus increase the effect of Lansoprazol-CT.
Fluvoksamine (zdravilo za zdravljenje depresije), ketokonazol in itrakonazol (zdravili za zdravljenje glivičnih okužb), zaviralci proteaze (zdravilne učinkovine za zdravljenje okužbe z virusom AIDS) in makrolidi (vrsta antibiotikov) lahko znatno povečajo koncentracijo lansoprazola v krvi tako povečajo učinek zdravila Lansoprazol-CT.
Effects of lansoprazole on other active substances
Učinek lansoprazola na druge zdravilne učinkovine
inflammation of the kidneys (interstitial nephritis) Blood and lymphatic system disorders Rare:
vnetje ledvic (intersticijski nefritis) Bolezni krvi in limfatičnega sistema Redki:
Dosages up to 180 mg have been administered.
Uporabili so domerke do 180 mg.
Treatment with Lansoprazol-CT therefore leads to a slightly increased risk of infections in the gastrointestinal tract, such as with salmonella and Campylobacter.
Zdravljenje z zdravilom Lansoprazol-CT zato nekoliko poveča tveganje okužb prebavil, kot so okužbe s salmonelo in bakterijo Campylobacter.
Interactions have been observed when lansoprazole was combined with certain antibiotics such as clarithromycin and amoxicillin and in a combination of all three medicines.
Pri kombinaciji lansoprazola z nekaterimi antibiotiki, kot sta klaritromicin in amoksicilin, ter pri kombinaciji vseh treh zdravil, so opazili interakcije.
Please read the package leaflet of the antibacterial agents for further information.
Za dodatne informacije preberite navodila, priložena antibakterijskim učinkovinam.
Monitoring of the plasma levels of other medicines administered during simultaneous treatment with lansoprazole and antibiotics is therefore recommended.
Zato se priporoča nadzorovanje ravni drugih zdravil, ki se uporabljajo sočasno z lansoprazolom, v plazmi.
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 %.
Caution is advised during co-treatment with carbamazepine (a CYP3A substrate) and lansoprazole.
Med sočasnim zdravljenjem s karbamazepinom (substratom encima CYP3A) in lansoprazolom se priporoča previdnost.
In case of clarithromycin resistance, or treatment failure, the combination of lansoprazole-amoxicillin metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazoleclarithromycin-metronidazole is advisable.
V primeru odpornosti proti klaritromicinu ali kadar je zdravljenje neuspešno, je priporočljiva uporaba kombinacije lansoprazol-amoksicilin-metronidazol.
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").
Decelerates uptake of amoxicillin lansoprazole + metronidazole
Upočasnjen privzem amoksicilina lansoprazol + metronidazol
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 tritirnem zdravljenju za eradikacijo H.pylori.
Caution should be exercised when combining lansoprazole with active substances which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other active substances has not been extensively investigated.
Pri kombiniranju lansoprazola in zdravilnih učinkovin z ozkim terapevtskim indeksom je treba biti previden, ker učinek lansoprazola na presnovo drugih zdravilnih učinkovin še ni bil temeljito raziskan.
headache, dizziness
glavobol, vrtoglavica
Warfarin (medicine used to prevent blood clotting) At the beginning or end of lansoprazole therapy in patients who are already receiving warfarin therapy, caution is urged and more frequent monitoring is recommended.
Varfarin (zdravilo za preprečevanje strjevanja krvi) Ob začetku in koncu zdravljenja z lansoprazolom je treba biti pri bolnikih, ki že prejemajo varfarin, zelo previden, priporoča pa se tudi pogostejše nadziranje koncentracije varfarina.
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 zadostuje odmerek 250 mg, kljub temu da je priporočen odmerek 500 g. 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.
maplike rash on the mucous membranes/skin (Stevens-Johnson syndrome), severe skin damage (toxic epidermal necrolysis).
Zelo redki: izpuščaj v obliki zemljevida na sluznici/koži (Stevens-Johnsonov sindrom), hude okvare kože (toksična epidermalna nekroliza).
Ketoconazole and itraconazole (medicines for the treatment of fungal infections) The combination of lansoprazole and ketoconazole or itraconazole should be avoided, as the reduction in stomach acid caused by intake of Lansoprazol-CT may impair the absorption of the other medicines into the blood, thus leading to an underdose.
Ketokonazol in itrakonazol (zdravili za zdravljenje glivičnih okužb) Kombinaciji lansoprazola in ketokonazola ali itrakonazola se je treba izogibati, ker zmanjšanje količine želodčne kisline pri jemanju zdravila Lansoprazol-CT lahko poslabša absorpcijo drugih zdravil v kri in tako povzroči zmanjšanje odmerka.
Very rare including isolated reports
vključno s posameznimi primeri
The possibility of malignant gastric tumour should be excluded before initiating treatment of gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.
Pred začetkom zdravljenja razjede želodca z lansoprazolom je treba izključiti možnost malignega tumorja želodca, ker lahko lansoprazol zakrije simptome in prepreči pravočasno diagnosticiranje.
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate).
Sočasna uporaba z lansoprazolom poveča koncentracijo takrolimusa (substrat encimov CYP3A in Pgp) v plazmi.
Eradication of the Helicobacter pylori bacterium
Eradikacija bakterije Helicobacter pylori
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15 mg or 30 mg lansoprazole.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka kapsula vsebuje 15 ali 30 mg lansoprazola.
Skin and connective tissue disorders Common:
Bolezni kože in vezivnega tkiva Pogosti:
• metronidazole, 400 mg (tinidazole, 500 mg) twice daily, + clarithromycin, 250 mg twice daily;
• metronidazol, 400 mg (tinidazol, 500 mg) dvakrat dnevno, + klaritromicin, 250 mg dvakrat dnevno
Antacids and sucralfate may reduce the bioavailability of lansoprazole.
Antacidi in sukralfat lahko zmanjšajo biološko uporabnost lansoprazola.
INSTRUCTIONS ON USE Acid repressive gastrointestinal-therapeutic
NAVODILA ZA UPORABO Gastrointestinalno zdravilo za zaviranje izločanja kisline
Thrombocytopenia, eosinophilia, pancytopenia, anemia and leucopenia.
Trombocitopenija, eozinofilija, pancitopenija, anemij in levkopenija.
Since lansoprazole is activated in the parietal cells, its plasma concentration is not related to gastric acid inhibition.
Lansoprazol se aktivira v parietalnih celicah, zato njegova koncentracija ni odvisna od zaviranja izločanja želodčne kisline.
Agranulocytosis.
Agranulocitoza.
The effect of clarithromycin on lansoprazole is increased if the patient is a so-called slow metaboliser.
Učinek klaritromicina na lansoprazol se pri tako imenovanih počasnih presnavljalcih poveča.
Lansoprazole may give rise to increased plasma concentrations of active substances metabolised by CYP3A4.
Lansoprazol lahko poveča plazemsko koncentracijo zdravilnih učunkovin, ki jih presnavlja CYP3A4.
What Lansoprazol-CT looks like and contents of the pack
Izgled zdravila Lansoprazol-CT in vsebina pakiranja
You should avoid breastfeeding while taking Lansoprazol-CT, as there has been insufficient experience with its use during lactation.
Med jemanjem zdravila Lansoprazol-CT se morate izogibati dojenju, ker so izkušnje z njegovo uporabo med dojenjem omejene.
− to remove the bacterium Helicobacter pylori together with suitable antibiotics in the treatment of ulcers in the stomach or duodenum (eradication therapy) and to prevent the recurrence of ulcers in patients with Helicobacter pylori-related ulcers in the stomach and intestines
− skupaj z ustreznimi antibiotiki za odstranjevanje bakterije Helicobacter pylori pri zdravljenju razjed v želodcu in dvanajstniku (eradikacijsko zdravljenje) in za preprečevanje ponovitve razjed pri bolnikih z razjedami v želodcu in črevesu, povezanimi z bakterijo Helicobacter 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.
Z namenom da bi standardizirali sheme zdravljenj za eradikacijo bakterije H.pylori, je Evropsko združenje za raziskave Helicobacter pylori objavilo smernice o obvladovanju okužbe z Helicobacter pylori.
Depression, hallucination, confusion, insomnia, somnolence, drowsiness, vertigo, tremor and paresthesia, restlessness.
Depresija, halucinacije, zmedenost, insomnija, zaspanost, dremavost, vrtoglavica, tremor in parestezija, nemir.
Lansoprazole reduces the acid content of the stomach.
Lansoprazol zmanjša količino kisline v želodcu.
However, daily doses of up to 180 mg of lansoprazole have been administered in trials without significant undesirable effects.
V preskušanjih so brez bistvenih neželenih učinkov uporabili odmerke do 180 mg lansoprazola dnevno.
[to be completed nationally]
[Podatke je treba dopolniti v posameznih državah]
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
Pri oceni neželenih učinkov so upoštevani naslednji podatki o njihovi pogostosti: Zelo pogosti več kot 1 oseba na 10 bolnikov
fever, narrowing of the airways, swelling of tissue (angioedema).
povišana telesna temperatura, ožanje dihalnih poti, otekanje tkiva (angioedem).
For those therapeutic indications in which a daily dose exceeding 15 mg lansoprazole is specified, gastro-resistant hard capsules containing 30 mg of medically active ingredient are also available.
Za indikacije, pri katerih so določeni odmerki, večji od 15 mg lansoprazola dnevno, so na voljo tudi gastrorezistentne trde kapsule, ki vsebujejo 30 mg zdravilne učinkovine.
HOW TO STORE Lansoprazol-CT Do not store above 30°C.
SHRANJEVANJE ZDRAVILA Lansoprazol-CT Shranjujte pri temperaturi do 30 °C.
Fluvoxamine, an inhibitor of CYP2C19, increased the plasma concentrations of lansoprazole up to 4fold.
Zaviralec CYP2C19, fluvoksamin, je povečal koncentracijo lansoprazola v plazmi do 4-krat.
• amoxicillin, 1000 mg twice daily, + clarithomycin, 500 mg twice daily (advisable when metronidazole resistance is likely);
• amoksicilin, 1000 mg dvakrat dnevno, + klaritromicin, 500 mg dvakrat dnevno (priporočeno, kadar je verjetna odpornost na metronidazol);
Lansoprazole gives a 14% reduction in the plasma concentrations of theophyllin.
Lansoprazol zmanjša koncentracijo teofilina v plazmi za 14 %.
Active substances associated with cytochrome P450
Zdravilne učinkovine, povezane s citokromom P450
Active substances, which inhibit CYP3A4
Zdravilne učinkovine, ki zavirajo CYP3A4
At the beginning or end of simultaneous use of Lansoprazol-CT, plasma tacrolimus concentrations should be monitored.
Na začetku in koncu sočasne uporabe zdravila Lansoprazol-CT je treba nadzorovati koncentracijo takrolimusa v plazmi.
Dosage in patients with impaired kidney or liver function No dose adjustment is necessary in patients with impaired kidney function.
Odmerjanje pri bolnikih z okvarjenim delovanjem ledvic ali jeter Pri bolnikih z okvaro delovanja ledvic prilagoditev odmerka ni potrebna.
Lansoprazole is a specific inhibitor of the parietal cell proton pump.
Lansoprazol je specifični zaviralec protonske črpalke parietalnih celic.
restlessness, drowsiness, sleep disturbances, light-headedness, depression, hallucinations, confusion, dizziness, trembling, discomfort.
nemir, dremavost, motnje spanja, omotica, depresija, halucinacije, zmedenost, vrtoglavica, tresenje, neprijeten občutek.
For those therapeutic indications in which a daily dose of 15 mg lansoprazole is specified, gastroresistant hard capsules containing 15 mg of medically active ingredient are also available.
Za indikacije, pri katerih so določeni odmerki 15 mg lansoprazola dnevno, so na voljo tudi gastrorezistentne trde kapsule, ki vsebujejo 15 mg zdravilne učinkovine.
− to treat inflammation of the gullet caused by reflux of stomach acid into the gullet (reflux oesophagitis)
− za zdravljenje vnetja požiralnika, ki ga povzroča refluks želodčne kisline v požiralnik (refluksni ezofagitis)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL CTARZNEIMITTEL 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LANSOPRAZOL CT-ARZNEIMITTEL 15 MG, 30 MG, GASTROREZISTENTNE KAPSULE, TRDE (glejte Dodatek I)
INFORMATION IN BRAILLE < Lansoprazol-CT 30 mg > [to be completed nationally]
PODATKI V BRAILLOVI PISAVI Lansoprazol-CT 30 mg [Podatke je treba dopolniti v posameznih državah]
First line therapy should be with triple therapy using a proton pump inhibitor or ranitidine bismuth citrate, combined with clarithromycin (500 mg twice daily) and amoxicillin (1 g twice daily) or metronidazole (500 twice daily).
Shema zdravljenja prve izbire mora biti tritirna, v njej pa je treba uporabiti ali zaviralec protonske črpalke ali ranitidin bizmut citrat v kombinaciji s klaritromicinom (500 g dvakrat dnevno) in amoksicilinom (1 g dvakrat dnevno) ali metronidazolom (500 dvakrat dnevno).
nausea, vomiting, diarrhoea, stomach-ache, constipation, flatulence (sometimes accompanied by abdominal pain), upper abdominal pain.
slabost, bruhanje, driska, bolečine v želodcu, zaprtje, vetrovi (včasih jih spremljajo bolečine v trebuhu), bolečine v zgornjem delu trebuha.
Not yet investigated lansoprazole + clarithromycin + amoxicillin
Še ni raziskano lansoprazol + klaritromicin + amoksicilin
INFORMATION IN BRAILLE < Lansoprazol-CT 15 mg > [to be completed nationally]
PODATKI V BRAILLOVI PISAVI Lansoprazol-CT 15 mg [Podatke je treba dopolniti v posameznih državah]
A daily dose of 30 mg lansoprazole should not, however, be exceeded.
Vendar odmerkov, večjih od 30 mg lansoprazola dnevno, ne smete preseči.
Eye disorders and changes in the sensation of taste Uncommon: disturbances in taste Rare:
bolečine v mišicah in sklepih Očesne bolezni in spremembe pri okušanju Občasni: motnje okušanja Redki:
Helicobacter pylori eradication:
Eradikacija bakterije Helicobacter pylori:
Active substances metabolised by CYP3A4
Zdravilne učinkovine, ki jih presnavlja CYP3A4
changes in liver enzyme values.
Občasni: spremembe ravni jetrnih encimov.
increased cholesterol and blood lipid values.
Preiskave Zelo redki: povečane vrednosti holesterola in lipidov v krvi.
Increase in liver enzyme levels.
Povečanje ravni jetrnih encimov
Caution is advised when combining lansoprazole with active substances, which are metabolised by this enzyme.
Pri kombiniranju lansoprazola z zdravilnimi učinkovinami, ki jih presnavlja ta encim, je priporočena previdnost.
Titanium dioxide (E171) Quinoline yellow (E104) - only 15 mg capsules
Kinolinsko rumeno (E104) - le v 15-miligramskih kapsulah
Rare less than 1 in 1,000, but more than 1 in 10,000 treated patients
Redki manj kot 1 bolnik od 1.000, vendar več kot 1 od 10.000
Patients with renal or hepatic impairment:
Bolniki z okvaro ledvic in jeter:
A single dose of lansoprazole has an inhibitory effect on gastric acid secretion lasting more than 24 hours.
Enkratni odmerek lansoprazola zavira izločanje želodčne kisline za več kot 24 ur.
30 mg + 500 mg 3 times/day for 5 days
30 mg +500 mg 3-krat/dan, 5 dni
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 AbZPharma and associated names (see Annex I).
je CHMP za Lansoprazol CT-Arzneimittel 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.
30 mg + 1000 mg 3 times/day for 5 days
30 mg + 1000 mg 3krat/dan, 5 dni