natgillin/translations-raw huggingface dataset:
In patients not fully healed within this time, the medication should be continued at the same dose for another two weeks.
Pri bolnikih, ki se ne pozdravijo v tem asu, je treba zdravljenje z istim odmerkom nadaljevati še dva tedna. č
The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication should be continued at the same dose for another 4 weeks.
Razjeda se ponavadi zaceli v 4 tednih, vendar je treba pri bolnikih, ki se ne pozdravijo v tem asu, zdravljenje podaljšati z istim odmerkom za č 4 tedne.
In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.
Pri bolnikih, ki se ne pozdravijo v tem asu, se sme zdravljenje z istim odmerkom nadaljevati še 4 tedne. č
7 Eradication of Helicobacter pylori:
7 Eradikacija Helicobacter pylori:
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.
30 mg lansoprazola dvakrat dnevno v trajanju enega tedna v kombinaciji z eno od treh navedenih kombinacij: a) amoksicilin 1 g dvakrat dnevno + klaritromicin 500 mg dvakrat dnevno, b) klaritromicin 250 mg dvakrat dnevno + metronidazol 400– 500 mg dvakrat dnevno, b) 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 antibakterijskih sredstev.
The recommended initial dose is 60 mg once daily.
Priporočeni začetni odmerek je 60 mg enkrat dnevno.
If the required daily dose exceeds 120 mg, it should be given in two divided doses.
Č
Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole (see section 4.4 “ Special warnings and precautions for use”).
Zaradi pomanjkanja podatkov, bolnikov s hudo okvaro delovanja jeter ne smemo zdraviti z lansoprazolom (glejte poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).
Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements.
Zaradi podaljšanega izločanja lansoprazola, bo pri starejših osebah morda treba zdravljenje razdeliti v odmerke po 15– 30 mg, glede na potrebe posameznika.
Special Warning and Precautions for Use
4. 4 Posebna opozorila in previdnostni ukrepi
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)
Lansoprazole has a similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
Oba povečata pH v želodcu.
Decreased gastric acidity due to lansoprazole
Naslednja izjava temelji na analogiji z omeprazolom.
8 increases gastric counts of bacteria normally present in the gastrointestinal tract.
8 normalno prisotne v prebavilih.
Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients (see “ 5.3 Preclinical safety data”).
Zaradi omejenih podatkov o varnosti bolnikov na vzdrževalnem zdravljenju, ki traja dlje kot eno leto, je treba redno ocenjevati zdravljenje in opraviti temeljito oceno tveganja in koristi (glejte 5. 3 Predklinični podatki o varnosti).
If visual disturbances occur during long-term use (> 1 year), an ophthalmologist should be consulted.
Č
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redkimi podedovanimi težavami z netoleranco za fruktozo, okvarjeno absorpcijo glukoze in galaktoze ali pomanjkanjem sukraze- izomaltaze ne smejo jemati tega zdravila.
Interaction with Other Medicinal Products and Other Forms of Interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Drugs associated with cytochrome P450 As lansoprazole is metabolised via a drug metabolising enzyme system associated with cytochrome P450 (CYP2C19 and CYP3A4), interactions with drugs metabolised via the same enzyme system are possible.
Zdravila, povezana s citokromom P450 Lansoprazol presnavlja encimski sistem, povezan s citokromom P450 (CYP2C19 in CYP3A4), zato so mogoče interakcije z zdravili, ki jih presnavlja isti encimski sistem.
Drugs which inhibits CYP2C19 Drugs which inhibit CYP2C19 may increase the plasma concentration of lansoprazole.
Zdravila, ki zavirajo CYP2C19 Zdravila, 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.
Drugs which inhibits CYP3A4 Drugs which inhibit CYP3A4 such as ketokonazole, itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole.
Zdravila, ki zavirajo CYP3A4 Zdravila, ki zavirajo CYP3A4, kot so ketokonazol, itrakonazol, zaviralci proteaz, makrolidi itn., lahko bistveno povečajo koncentracijo lansoprazola v plazmi.
Ketoconazole and itraconazole The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid.
Ketokonazol in itrakonazol Prisotnost želodčne kisline poveča absorpcijo ketokonazola in itrakonazola iz prebavil.
The effect may also be present if lansoprazole is combined with other drugs with pH dependent absorption.
Ta učinek je lahko prisoten tudi, e lansoprazol kombiniramo z č drugimi zdravili, katerih absorpcija je odvisna od pH.
Digoxin Coadminitration of lansoprazole and digoxin may lead to increased digoxin plasma levels.
Digoksin Sočasna uporaba lansoprazola in digoksina lahko poveča ravni digoksina v plazmi.
Drugs metabolised by CYP3A4 Lansoprazole may give rise to increased plasma concentrations of drugs metabolised by CYP3A4.
Zdravila, ki jih presnavlja CYP3A4 Lansoprazol lahko poveča plazemsko koncentracijo zdravil, ki jih presnavlja CYP3A4.
Tacrolimus Coadministration 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.
Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Uporaba lansoprazola lahko poveča povprečno izpostavljenost takrolimusu za do 81%.
9 Carbamazepine Caution is adviced during cotreatment with carbamazepin (a CYP3A substrate) and lansoprazole.
9 Med sočasnim zdravljenjem s karbamazepinom (substratom encima CYP3A) in lansoprazolom se priporoča previdnost.
Phenytoin Studies have shown that the dosage of phenytoin (CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
Fenitoin Študije so pokazale, da je morda treba zmanjšati odmerjanje fenitoina (substrata encimov CYP2C19 in CYP2C9), kadar se uporablja skupaj z lansoprazolom.
Warfarin Caution and increased monitoring frequency is advised when initiating or ending lansoprazole co- treatment in patients treated with warfarin.
Varfarin Ob začetku in koncu sočasnega zdravljenja z lansoprazolom in varfarinom se priporočata previdnost in pogostejši nadzor.
Theophyllin Lansoprazol 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 (Pgp) in vitro.
Opazili so, da lansoprazol in vitro zavira transportno beljakovino P- glikoprotein (Pgp).
It may not be excluded that lanzoprazole 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.
The following interactions between lansoprazole and one/ two antibiotics used in eradication therapy have been found so far:
Do sedaj so odkrili naslednje interakcije med lansoprazolom in enim/ dvema antibiotikoma, ki se uporabljajo v eradikacijskem zdravljenju:
Effect*
Učinek *
30 mg + 500 mg 3 times/ day for 5 days
30 mg + 500 mg 3- krat/ dan, 5 dni
Increased plasma levels of a clarithromycin metabolite by 16%; increased bioaivalability of lansoprazole by 19% up to 32%
Povečane plazemske koncentracije presnovka klaritromicina za 16%; povečana biološka razpoložljivost lansoprazola za 19% do 32%
lansoprazole + amoxicillin lansoprazole + metronidazole
lansoprazol + amoksicilin lansoprazol + metronidazol
30 mg + 1000 mg 3 times/ day for 5 days Not yet investigated
30 mg + 1000 mg 3 - krat/ dan, 5 dni Še ni raziskano
Decelerates uptake of amoxicillin
Upočasnjen privzem amoksicilina
lansoprazole + clarithromycin +
lansoprazol + klaritromicin +
Increase bioaivalability and half-life of lansoprazole by 30% each; increased plasma
Povečana biološka razpoložljivost in razpolovni as lansoprazola za 30%; povečana č
10 amoxicillin
10 Uživanje hrane zmanjša biološko razpoložljivost lansoprazola: lansoprazol je priporočeno vzeti pred obrokom.
Pregnancy and Lactation
4. 6 Nosečnost in dojenje
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 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.
Effects on Ability to Drive and Use Machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Adverse drug reactions such as dizziness and fatigue may occur (see section 4.8 undesirable effects).
Lahko se pojavijo neželene reakcije na zdravilo, kot sta vrtoglavica in utrujenost (glejte poglavje 4. 8 Neželeni učinki).
(see section 4.8 Undesirable effects).
(glejte poglavje 4. 8 Neželeni učinki).
Undesirable Effects
4. 8 Neželeni učinki
Common (> 1%)
Pogosti (> 1%)
Uncommon (0.1-1%)
Občasni (0, 1- 1%)
Rare (0.01-0.1%)
Redki (0, 01– 0, 1%)
Very Rare (< 0.01%)
Zelo redki (< 0, 01%)
nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence and dyspepsia.
navzeja, driska, bolečine v trebuhu, zaprtje, bruhanje, vetrovi in dispepsija.
dry mouth or throat, glossitis, candidiasis of oesophagus, pancreatitis
suha usta ali žrelo, glositis, kandidiaza ezofagusa, pankreatitis
colitis, stomatitis and black tongue.
kolitis, stomatitis in rn č jezik.
Skin and hair
Koža in lasje
eczema, urticaria and itching.
ekcem, urtikarija in srbenje.
petechia, purpura, hair loss, erythema multiforme, stevens- Johnson syndrome and toxic epidermal necrolysis.
petehija, purpura, izguba las, multiformni eritem, Stevens- Johnsonov sindrom in toksična epidermalna nekroliza.
restlessness, insomnia, drowsiness, depression, hallucination, confusion, vertigo and paresthesia, somnolence, tremor.
nemir, insomnija, dremavost, depresija, halucinacije, zmedenost, vrtoglavica in parestezija, zaspanost, tremor.
Increase in liver enzyme levels.
hepatitis, ikterus in intersticijski nefritis.
hepatitis, icterus and interstitial nephritis.
periferni edem, palpitacije in bolečine v prsnem košu.
thrombocytopenia, eosinophilia, pancytopenia and agranulocytosis, anemia, leucopenia.
Č
Cardiovascular
utila
peripheral edema, palpitation and chest pain.
motnje okusa in vida.
muscle and joint pain
Bolezni endokrinega sistema
zaste disturbances and visual disturbances.
ginekomastija, galaktoreja.
fatigue.
utrujenost.
fever, hyperhidrosis, bronchial constriction, impotence and angioedema.
povečana telesna temperatura, hiperhidroza, bronhialna konstrikcija, impotenca in angioedem.
The effects of overdose of lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instructions for treatment cannot be given.
Učinki prevelikega odmerjanja lansoprazola pri loveku niso znani (čeprav je akutna toksičnost verjetno č majhna), zato ni mogoče dati navodil za zdravljenje.
Please refer to section 4.8.
V preskušanjih so brez bistvenih neželenih učinkov uporabili odmerke do 180 mg lansoprazola dnevno.
Lansoprazole is not significantly eliminated by haemodialysis.
Možni simptomi prevelikega odmerjanja lansoprazola so v poglavju 4. 8 Neželeni učinki.
If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
S hemodializo se ne odstrani pomembna količina lansoprazola. e je potrebno zdravljenje, se priporoča Č izpiranje želodca, uporaba aktivnega oglja in simptomatsko zdravljenje.
Pharmacodynamic Properties
5. 1 Farmakodinamične lastnosti
Proton pump inhibitors, ATC code:
Zaviralci protonske rpalke, oznaka ATC:
A02BC03.
A02BC03. č
Lansoprazole is a gastric proton pump inhibitor.
Lansoprazol je zaviralec protonske rpalke v želodcu.
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 č celic želodca zavira končno stopnjo tvorbe želodčne kisline.
The inhibition is dose- dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Zaviranje je odvisno od odmerka in reverzibilno, učinkuje pa na bazalno in tudi stimulirano izločanje 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 sulfidrilno skupino H+/ K+ATPaze, kar povzroči zaviranje encimske aktivnosti.
Lansoprazole is a specific inhibitor of the parietal cell proton pump.
Lansoprazol je specifični zaviralec protonske rpalke parietalnih celic.
A single oral dose of lansoprazole 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
En 30- miligramski peroralni č odmerek lansoprazola zavre izločanje želodčne kisline, ki ga spodbuja pentagastrin, za približno 80%.
A single oral dose of 30 mg reduces basal secretion by about 70%, and the patients' symptoms are consequently relieved starting from the very first dose.
En 30- miligramski peroralni odmerek zmanjša bazalno izločanje za približno 70%, posledično pa se že od prvega odmerka ublažijo simptomi pri bolnikih.
A rapid relief of symptoms
Po osmih dneh ponavljajoče se uporabe je zmanjšanje približno 85- odstotno.
12 is obtained by 30 mg daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks.
Hitro lajšanje simptomov dosežemo z odmerkom 30 mg dnevno, večina bolnikov z razjedo dvanajstnika okreva v 2 tednih, bolniki z razjedo želodca in refluksnim ezofagitisom pa v 4 tednih.
Pharmacokinetic Properties
5. 2 Farmakokinetične lastnosti
Absorption from the duodenum is rapid and plasma peak concentration is achieved within 1.5-2.0 hours.
Absorpcija iz dvanajstnika je hitra in največja koncentracija v plazmi se doseže v 1, 5– 2, 0 urah.
Bioavailability after a single dose of 30 mg and after repeated daily administration is 80-90%.
Biološka razpoložljivost 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 razpoložljivost (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 drugs.
Vezava lansoprazola na beljakovine v plazmi je približno 95- odstotna, vendar to ne vpliva na druga zdravila, ki se vežejo na beljakovine v plazmi.
Metabolism and elimination:
12 Presnova in izločanje:
The enzyme CYUP3A4 also contributes to the metabolism.
K presnovi prispeva tudi encim CYUP3A4.
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 as izločanja lansoprazola je 1, 0 do 2, 0 uri.
There is no change in half-life during treatment.
spreminja.
Three metabolites have been identified in the plasma: the sulphone, 5-hydroxy lansoprazole and the sulphide.
V plazmi so odkrili tri presnovke: sulfon, 5- hidroksi lansoprazol in sulfid.
About 15-50% of the metabolites are secreted in the urine and the remainder in the faeces.
Približno 15– 50% presnovkov se izloči z urinom, preostanek pa z blatom.
Three metabolites have been identified in the urine:
V urinu so odkrili tri presnovke:
5-hydroxy sulphone, 5- hydroxy sulphide and 5-hydroxy lansoprazole.
5- hidroksi sulfon, 5- hidroksi sulfid in 5- hidroksi lansoprazol.
In patients with cirrhosis the AUC of lansoprazole is significantly increased and the elimination half-life is prolonged, but no signs of accumulation of lansoprazole have been detected.
Pri bolnikih s cirozo je vrednost AUC lansoprazola bistveno povečana, razpolovni as izločanja je podaljšan, vendar znakov č kopičenja lansoprazola niso odkrili.
Preclinical Safety Data
5. 3 Predklinični podatki o varnosti
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.
Predklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
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 and retinal atrophy.
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 in atrofijo mrežnice.
PHARMACEUTICAL PARTICULARS
FARMACEVTSKE PODATKI
List of Excipients
6. 1 Seznam pomožnih snovi
Sugar spheres (sucrose and maize starch) Sodium laurilsulphate Meglumine Mannitol Hypromellose Macrogol 6000 Talc Polysorbate 80 Titanium dioxide (E 171) methacrylic acid ethyl acrylate copolymer, 1:1, dispersion 30%
Kroglice iz sladkorja (saharoza in koruzni škrob) Natrijev lavrilsulfat Meglumin Manitol Hipromeloza Makrogol 6000 Smukec Polisorbat 80 Titanov dioksid (E 171) kopolimer metilakrilne kisline in etilakrilata (1: 1, 30- odstotna disperzija)
Gelatin Titanium dioxide (E 171)
Želatina Titanov dioksid (E 171)
In addition for Lansoprazole 15 mg:
13 Pri zdravilu Lansoprazol 15 mg tudi:
Quinoline yellow (E 104)
Kinolinsko rumeno (E 104)
Special Precautions for Storage
6. 4 Posebna navodila za shranjevanje
Do not store above 25ºC.
Zdravilo shranjujte pri temperaturi do 25 °C.
Nature and Contents of Container
6. 5 Vrsta ovojnine in vsebina
Aluminium/ Aluminium blister (Alu/ OPA/ PVC/ PE)
Pretisni omot iz aluminija/ aluminija (Alu/ OPA/ PVC/ PE)
6.6.
7.
Instructions for Use and Handling
[Podatke je treba dopolniti v posameznih državah]
No special requirements.
ŠTEVILKA DOVOLJENJA ZA PROMET
14 7.
14 9.
DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
21 February 2006 EMEA/ CHMP/ 373083/ 2005
21/ 02/ 06 EMEA/ CHMP/ 373083/ 2005
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary Name (INN):
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29( 2) 1 ZA Lansoprazol AbZ- Pharma 15 mg in 30 mg Mednarodno nelastniško ime (INN):
Lansoprazol AbZ-Pharma (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Lansoprazol AbZ- Pharma (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega ezofagitisa, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger- Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori.
A Marketing Authorisation for Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Dovoljenje za promet z zdravilom Lansoprazol AbZ- Pharma (15 mg in 30 mg) je bilo prvotno dodeljeno družbi ratiopharm GmbH s Finske 7. novembra 2003.
During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Lansoprazol AbZ-Pharma.
Na sestanku v septembru 2005 je CHMP glede na vse predložene podatke ter znanstvene razprave znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol AbZ- Pharma ugodno.
Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “ Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Odbor za zdravila za uporabo v humani medicini je izrazil strinjanje s spremembami v razdelku 4. 2 (Odmerjanje in način uporabe) Povzetka glavnih značilnosti zdravila, ki navajajo natančna priporočila glede odmerjanja za antibiotike v skladu s “ Točkami, ki jih je treba upoštevati pri pisanju besedila za eradikacijsko zdravljenje Helicobacter pylori v izbranih poglavjih Povzetka glavnih značilnosti zdravila ”, in 15. septembra 2005 sprejel pozitivno mnenje.
The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 21/ 02/ 06.