natgillin/translations-raw huggingface dataset:
• omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (medicines for reducing stomach acid);
• omeprazol, esomeprazol, dekslansoprazol, lansoprazol, pantoprazol, rabeprazol (zdravila za zmanjšanje želodčne kisline);
Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Tenofovir in emtricitabin sta povezani protivirusni sredstvi, imenovani zaviralca reverzne transkriptaze.
This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant, and the same levels of emtricitabine and tenofovir alafenamide as Genvoya.
Ta študija je pokazala, da zdravilo Odefsey tvori enake ravni rilpivirina v telesu kot zdravilo Edurant in enake ravni emtricitabina in alafenamidtenofovirata kot zdravilo Genvoya.
Rilpivirine is an antiviral agent called non-nucleoside reverse transcriptase inhibitor.
Rilpivirin je protivirusno sredstvo, imenovano nenukleozidni zaviralec reverzne transkriptaze.
• St John's wort (a herbal preparation used for depression and anxiety).
• šentjanževka (pripravek rastlinskega izvora proti depresiji in tesnobi).
How does Odefsey work?
Kako zdravilo Odefsey deluje?
Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide.
Zdravilo Odefsey vsebuje zdravilne učinkovine emtricitabin, rilpivirin in alafenamidtenofovirat.
How is Odefsey used?
Kako se zdravilo Odefsey uporablja?
100 g 1 bottle
50 g 10 stekleničk
Invented name
Številka EU Izmišljen ime
Safety was comparable between the groups.
Varnost je bila primerljiva med skupinami.
In total 692 patients were enrolled.
Skupno je bilo vključenih 692 bolnikov.
An indication that includes relief of symptoms in this population, however, is not sufficiently supported.
Toda indikacija, ki vključuje lajšanje simptomov v tej populaciji, ni zadostno podprta.
Interaction with Other Medicinal Products and Other Forms of Interaction
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
dry mouth or throat,
suha usta ali grlo,
All three have a very limited potential for drug interactions at the CYP level (Unge and Andersson 1997).
Vsi trije imajo zelo omejen potencial za interakcijo z drugimi zdravili na ravni CYP (Unge in Andersson 1997).
petechia, purpura,
petehija, purpura,
Overall rate of healing according to Sakitas classification was 95%.
Celokupna stopnja celjenja po klasifikaciji Sakitas je bila 95 %.
Relief of symptoms is obtained rapidly.
Simptomi se hitro odpravijo.
The primary endpoint was recurrence of symptomatic and complicated ulcers during the 8 weeks.
Poglavitna končna točka je bila ponovitev simptomatskih in zapletenih razjed v 8 tednih.
The Summary of Products Characteristic proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
je bil Povzetek glavnih značilnosti zdravila, ki ga je predlagal vlagatelj, ovrednoten na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
4.1 Therapeutic Indications
KLINIČNI PODATKI 4.1 Terapevtske indikacije
Endoscopy was also performed at week 8.
V 8. tednu je bila opravljena tudi endoskopija.
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.
The limited data as regards lansoprazole support this.
Omejena količina podatkov v zvezi z lansoprazolom podpira to trditev.
Lansoprazol HEXAL 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.
Zdravilo Lansoprazol HEXAL, 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.
3 years
Rok uporabnosti 3 leta
At 4 weeks, the corresponding healing rates were 30%, 47% and 57%.
Po 4 tednih so bile stopnje celjenja v naštetih skupinah bolnikov 30 %, 47 % in 57 %.
Benefit/Risk considerations
Obravnavanje razmerja med koristmi in tveganji
pancreatitis colitis, stomatitis and black tongue
pankreatitis kolitis, stomatitis in črn jezik.
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 warning 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).
Rare (0.01-0.1%) Very Rare
Zelo redki (< 0,01
If lansoprazole, in combination with antibiotics, is used for eradication therapy of H.-pylori, then also instructions for the use of these antibiotics should be followed.
Če se lansoprazol uporablja v kombinaciji z antibiotiki pri eradikaciji bakterije H. pylori, je treba upoštevati tudi navodila za uporabo teh antibiotikov.
If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Če se simptomi ne odpravijo v 4 tednih zdravljenja z odmerkom 30 mg dnevno, se priporočajo nadaljnje preiskave.
Compared with placebo, lansoprazole only reduced the need for antacids in one of the studies but significant difference with regard to symptoms was not shown.
V eni izmed raziskav je lansoprazol v primerjavi s placebom zmanjšal le potrebo po antacidih, ni pa bila dokazana bistvena razlika pri simptomih.
Patients in the lansoprazole groups had significantly less abdominal pain compared with patients in the misoprostol group.
Bolniki v skupinah z lansoprazolom so imeli znatno manj trebušnih bolečin v primerjavi z bolniki v skupini z misoprostolom.
Ulcer status was determined by endoscopy at week 4, 8, and 12.
Status razjede so določali endoskopsko v 4., 8. in 12.
Effects of lansoprazole on other drugs
Učinek lansoprazola na druga zdravila
Therefore, the benefit-risk profile of Lansoprazol HEXAL 15 mg, 30 mg in the proposed indications can be considered favourable.
Zato lahko razmerje med koristmi in tveganji za zdravilo Lansoprazol HEXAL 15 mg, 30 mg, za predlagane indikacije velja kot ugodno.
Instructions for Use and Handling
Navodila za pripravo in ravnanje z zdravilom
The following interactions between lansoprazole and certain antibiotics used in eradication therapy have been found so far:
Do sedaj so odkrili naslednje interakcije med lansoprazolom in nekaterimi antibiotiki, ki se uporabljajo v eradikacijskem zdravljenju: Sočasno uporabljeno zdravilo
The cumulative incidence of symptomatic and complicated GD ulcers at week 8 was 4.5% in the lansoprazole group and 42.9% in the no treatment group (P=0.0025).
Kumulativna incidenca simptomatskih in zapletenih želodčnih razjed je bila v 8. tednu 4,5 % v skupini z lansoprazolom in 42,9 % v skupini brez zdravljenja (P=0,0025).
Antacid use was significantly less among patients in the lansoprazole groups compared with patients in the misoprostol and placebo groups.
Uporaba antacidov je bila znatno manjša pri bolnikih v skupinah z lansoprazolom v primerjavi z bolniki v skupinah z misoprostolom in placebom.
Senses taste disturbances and visual disturbances.
Čutila motnje okusa in vida.
For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should be considered.
Pri bolnikih z razjedami, ki se težko zacelijo, ali tveganjem zanje bo morda potrebno daljše zdravljenje in/ali večji odmerki.
Clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs or diazepam have not been demonstrated.
Klinično pomembnih interakcij med lansoprazolom in nesteroidnimi protivnetnimi zdravili ali diazepamom niso ugotovili.
If the treatment fails the dose 30 mg once daily should be used.
Če zdravljenje ni uspešno, je treba uporabiti odmerek 30 mg enkrat dnevno.
Several clinical trials as well as extensive clinical experience has not indicated that there exist interactions when lansoprazole is given together with NSAIDs.
Več kliničnih preskušanj ter obsežne klinične izkušnje niso odkrile obstoja interakcij med lansoprazolom in NSAID pri njunem sočasnem jemanju.
Healing was assessed endoscopically at 4 and 8 weeks.
Celjenje so ocenjevali endoskopsko po 4 ali 8 tednih.
Three published papers on the clinical evidence for prevention of NSAID related ulcers are submitted.
Predloženi so bili trije objavljeni članki s kliničnimi dokazi o preprečevanju razjed, povezanih z
The SPC of the reference product in Germany does not contain the indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds.
Povzetek glavnih značilnosti referenčnega zdravila v Nemčiji ne vsebuje indikacij, povezanih s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID), ter zdravljenja in preprečevanja razjed dvanajstnika in želodca, ki jih povzročajo te snovi.
The lack of formal interaction studies with NSAIDs has to be adequately reflected in the SPC.
Pomanjkanje formalnih raziskav interakcije z NSAID se mora primerno odražati v Povzetku glavnih značilnosti zdravila.
Blood thrombocytopenia, eosinophilia, pancytopenia and agranulocytosis, anemia, leucopenia.
Kri trombocitopenija, eozinofilija, pancitopenija in agranulocitoza agranulocitoza, anemija,
Lansoprazole and associated names (see Annex I), 15 mg gastro-resistant capsule, hard Lansoprazole and associated names (see Annex I), 30 mg gastro-resistant capsule, hard
Lansoprazol in povezana imena (glejte Dodatek I), 15-mg gastrorezistentne kapsule, trde Lansoprazol in povezana imena (glejte Dodatek I), 30-mg gastrorezistentne kapsule, trde
Primary endpoint was the recurrence of ulcer complications.
Poglavitna končna točka je bila ponovitev zapletov razjede.
Nature and Contents of Container
Vrsta ovojnine in vsebina
At week 4 the healing rates were 44% and 51% for the 15 mg and 30 mg dose, respectively.
V 4. tednu so bile stopnje celjenja 44 % za 15-mg odmerek in 51 % za 30-mg odmerek.
In patients who continue to take NSAID medication healing is delayed.
Pri bolnikih, ki nadaljujejo z jemanjem NSAID, je celjenje zakasnjeno.
Special Warning and Precautions for Use The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means.
Diagnozo razjede želodca ali dvanajstnika in refluksnega ezofagitisa je treba potrditi z endoskopijo ali drugo ustrezno diagnostično metodo.
In a study published as an abstract (Goldstein et al), the healing rates were 64% and 76% for the 15 mg and 30 mg dose, respectively, at week 8.
V raziskavi, ki so jo objavili kot izvleček (Goldstein et al), so bile v 8. tednu stopnje celjenja 64 % za 15-mg odmerek in 76 % za 30-mg odmerek.
There is scarce data concerning healing rates for duodenal ulcers but duodenal ulcers are known in general to heal better than gastric ulcers following acid suppression.
Podatkov o hitrostih celjenja razjed dvanajstnika je malo, vendar je za razjede dvanajstnika znano, da se po zaviranju kisline na splošno celijo bolje kot želodčne razjede.
Patients with duodenal ulcers (n=3) were treated for 6 weeks and patients with gastric ulcers (n=42) or multiple ulcers (n=5) for 8 weeks.
(n=3) so zdravili 6 tednov, bolnike z želodčnimi razjedami (n=42) ali multiplimi razjedami (n=5) pa 8
Lai et al studied 123 patients with ulcer complications relating to the use of low dose aspirin and who were infected by H. pylori.
Lai et al so preučili 123 bolnikov z zapleti razjed, povezanimi z jemanjem majhnih odmerkov aspirina, in ki so bili okuženi s H. pylori.
Agrawal et al conducted a double-blind RCT in 353 patients with gastric ulcer and who continued to receive stable doses of NSAIDs.
Agrawal et al so opravili dvojno slepo randomizirano klinično preskušanje pri 353 bolnikih z razjedo želodca, ki so še naprej prejemali stabilne odmerke NSAID.
The scope of the referral was to agree on a Summary of Products Characteristics in view of the indication.
Ker je bil namen napotitve uskladiti Povzetek glavnih značilnosti zdravila glede indikacije,
In patients receiving NSAIDs with H. pylori infection gastric ulcer healing with an antisecretory agent was significantly enhanced (70% vs 61%, P<0.05).
Pri bolnikih z okužbo s H. pylori, ki so prejemali NSAID, je bilo celjenje želodčne razjede s sredstvom za preprečevanje izločanja znatno izboljšano (70 % v primerjavi z 61 %,
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).
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 o varnosti Predklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
Adverse drug reactions such as dizziness and fatigue may occur (see section 4.8 undesirable effects).
Vpliv na sposobnost vožnje in upravljanja s stroji Lahko se pojavijo neželene reakcije na zdravilo, kot sta vrtoglavica in utrujenost (glejte poglavje 4.8
After successful healing of the ulcers and eradication of H. pylori, patients were randomized to treatment with lansoprazole 30 mg or placebo in addition to aspirin 100 mg daily for 12 months.
Po uspešnem zaceljenju razjed in eradikaciji H. pylori, so bolnike za 12 mesecev naključno razporedili v skupini, ki sta se zdravili z lansoprazolom 30 mg ali placebom z dodatkom aspirina 100 mg dnevno.
Lai et al studied 43 patients who presented with peptic ulcer and were found to be infected with H. pylori while receiving NSAIDs.
Lai et al so preučili 43 bolnikov, ki so imeli peptično razjedo in so bili okuženi s H. pylori ter so prejemali NSAID.
[See Annex I - to be completed nationally]
[Glejte Dodatek I - podatke je treba dopolniti v posameznih državah] 2.
The recommended dose is 15 mg or 30 mg once daily.
Priporočeni odmerek je 15 mg ali 30 mg enkrat dnevno.
The proton pump inhibitors, omeprazole, lansoprazole and pantoprazole are all mainly metabolized by the cytochrome P450 isoform CYP2C19.
Zaviralci protonske črpalke (omeprazol, lansoprazol in pantoprazol) se v glavnem presnavljajo z izoobliko CYP2C19 citokroma P450.
Graham et al conducted a prospective; double blind RCT
Graham et al so opravili prospektivno dvojno slepo randomizirano klinično preskušanje pri 537
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL HEXAL 15 MG, 30 MG GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LANSOPRAZOL HEXAL 15 MG, 30 MG, GASTROREZISTENTNE KAPSULE, TRDE (glejte Dodatek I)
DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION [To be completed nationally]
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Podatke je treba dopolniti v posameznih državah] 10.
Administration of lansoprazole may result in subtherapeutic concentrations of ketoconazol and itraconazol and the combination should be avoided.
Odmerjanje lansoprazola lahko zmanjša koncentracijo ketokonazola in itrakonazola pod terapevtsko raven, zato se je treba kombinaciji teh zdravil izogibati.
Opaque, yellow hard gelatine capsule, containing pellets with enteric coating.
Neprosojne, rumene, trde želatinaste kapsule, ki vsebujejo pelete z enterično oblogo.
Musculoskeletal and connective tissue disorders muscle and joint pain
Bolezni mišično skeletnega sistema in vezivnega tkiva bolečine v mišicah in sklepih
Metabolism and elimination: The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19.
Presnova in odstranjevanje iz telesa: Presnovo lansoprazola katalizira predvsem encim CYP2C19.
Opaque, white hard gelatine capsule, containing pellets with enteric coating.
Neprosojne, bele, trde želatinaste kapsule, ki vsebujejo pelete z enterično oblogo.
For duodenal ulcers (n=46), the healing rates were between 81%-93% at week 8 in the 3 treatment groups.
Stopnje celjenja razjed dvanajstnika (n=46) so bile v naštetih 3 skupinah bolnikov med 81 % in 93 %.
30 mg once daily for four weeks.
30 mg enkrat dnevno v trajanju 4 tednov.
[To be completed nationally] 4.
[Podatke je treba dopolniti v posameznih državah] 7.
Simple healing rates (independent of H. pylori status) were at 8 weeks, 66%, 74% and 50% in the lansoprazole 15 mg, 30 mg and ranitidine groups, respectively; P<0.001).
Enostavne stopnje celjenja (neodvisne od H. pylori statusa) so bile po 8 tednih 66 % za skupino z lansoprazolom 15 mg, 74 % za skupino z lansoprazolom 30 mg in 50 % za skupino z ranitidinom (P<0,001).
Johnson syndrome and toxic epidermal necrolysis.
multiformni eritem, Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
Campell et al evaluated the effect of pre-treatment of Helicobacter pylori (H. pylori) infection on gastric ulcer healing rates in patients receiving NSAIDs and antisecretory medication in pooled analyses of two identical double-blind RCT comparing lansoprazole with ranitidine.
Campell et al so v analizi združenih podatkov dveh identičnih dvojno slepih randomiziranih kliničnih preskušanj, kjer so primerjali lansoprazol in ranitidin, ovrednotili učinek predhodnega zdravljenja okužbe s Helicobacter pylori (H. pylori) na stopnje celjenja želodčnih razjed pri bolnikih, ki so prejemali NSAID in zdravila, ki zavirajo izločanje.
81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine, lansoprazole 15 mg, and lansoprazole 30 mg, respectively (P<0.05 for ranitidine vs. both lansoprazole doses).
Po 8 tednih so celjenje opazili pri 61 (53 %) od 115 bolnikov, ki so prejemali ranitidin, 81 (69 %) od 118 bolnikov, ki so prejemali lansoprazol 15 mg in pri 85 (73 %) od 117 bolnikov, ki so prejemali 30 mg (P<0,05 za ranitidin v primerjavi z obema odmerkoma lansoprazola).
the CHMP has recommended the granting of the Marketing Authorisations with amendments of the Summary of Product Characteristics as set out in Annex III for Lansoprazol HEXAL and associated names (see Annex I).
je CHMP za Lansoprazol in povezana imena (glejte Dodatek I) priporočil odobritev dovoljenj za promet z dopolnili Povzetka glavnih značilnosti zdravila, kakor je opredeljeno v Dodatku III.
Patients were randomized to receive placebo, misoprostol or lansoprazole 15 mg or 30 mg for 12 weeks.
Bolnike so za 12 tednov naključno razporedili v skupine, ki so prejemale placebo, misoprostol ali lansoprazol 15 mg ali 30 mg.
In patients not fully healed the treatment may be continued for another four weeks.
Pri bolnikih, ki ne okrevajo povsem, se zdravljenje lahko podaljša še za štiri tedne.
During follow-up, 9/61 patient (14.8%) in the placebo group had recurrence of ulcer complications compared with 1/62 patients
Med sledenjem je pri 9 od 61 bolnikov (14,8 %) v skupini s placebom prišlo do ponovitve zapletov razjede v primerjavi z 1 od 62 bolnikov (1,6 %) v skupini z lansoprazolom (P=0,008).
Patients were randomized to treatment with either ranitidine 150 mg twice daily or lansoprazole, 15 mg or 30 mg once daily for 8 weeks.
Bolnike so za 8 tednov naključno razporedili v skupine, ki so se zdravile z ranitidinom 150 mg dvakrat dnevno ali lansoprazolom 15 mg ali 30 mg enkrat dnevno.
among 537 patients without H. pylori infection who were long-term users of NSAIDs with a history of endoscopically documented gastric ulcer.
bolnikih brez okužbe s H. pylori, ki so dolgotrajno jemali NSAID in so imeli endoskopsko dokazano želodčno razjedo.
By week 12, the percentages of gastric ulcer-free patients were 51%, 93%, 80% and 82% for the placebo, misoprostol, lansoprazole 15 mg and lansoprazole 30 mg group, respectively.
Do 12. tedna je bilo brez želodčne razjede 51 % bolnikov v skupini s placebom, 93 % bolnikov v skupini s misoprostolom, 80 % bolnikov v skupini z lansoprazolom 15 mg in 82 % bolnikov v skupini z lansoprazolom 30 mg.
Interaction with NSAIDs has not been suggested.
Interakcije z NSAID niso omenjene.
Formal interaction studies with lansoprazole and NSAIDs have not been conducted.
Formalnih študij z lansoprazolom in NSAID niso opravili.
MARKETING AUTHORISATION NUMBER [To be completed nationally]
ŠTEVILKA DOVOLJENJA ZA PROMET [Podatke je treba dopolniti v posameznih državah] 9.
In patients with moderately impaired hepatic function, the dose should be restricted to 15 mg daily.
Pri bolnikih z zmerno okvarjenim delovanjem jeter odmerek ne sme preseči 15 mg dnevno.
Titanium dioxide (E 171) In addition for Lansoprazole 15 mg: Quinoline yellow (E 104) [To be completed nationally] 6.2.
Kinolinsko rumeno (E 104) [Podatke je treba dopolniti v posameznih državah] 6.2.
Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme.
Pri kombiniranju lansoprazola z zdravili, ki jih presnavlja ta encim, je treba biti previden.
Gastric acid is central in the pathogenesis of gastroduodenal ulcers and acid inhibition has been shown to effectively heal NSAID induced ulcers.
Želodčna kislina je osrednji dejavnik pri patogenezi razjed želodca ali dvanajstnika, hkrati pa je bilo dokazano, da zaviranje izločanja kisline učinkovito zaceli razjede, ki so bile povzročene z NSAID.
Incompatibilities Not applicable
Inkompatibilnosti
In mildly impaired patients, the dose should not exceed 30 mg.
Pri bolnikih z blago okvarjenim delovanjem jeter odmerek ne sme preseči 30 mg.
Pharmacokinetic Properties
Farmakodinamične lastnosti
hepatitis, icterus and interstitial nephritis.
Povečanje ravni jetrnih encimov hepatitis, ikterus in intersticialni nefritis.
Matsukawa et al evaluated in an uncontrolled study the efficacy of lansoprazole 15 mg and 30
Matsukawa et al so v nekontrolirani raziskavi ovrednotili učinkovitost lansoprazola 15 mg in 30 mg pri 47 bolnikih z razjedami želodca ali dvanajstnika, ki so bile povzročene z NSAID.
Absorption and distribution: Lansoprazole is rapidly inactivated by gastric acid and lansoprazole is consequently administered as enteric coated granules in gelatin capsules.
Želodčna kislina hitro inaktivira lansoprazol, ki se zato daje v obliki granul z enterično oblogo v želatinastih kapsulah.
• Treatment of benign gastric and duodenal ulcers associated with the use of anti-inflammatory analgesics in patients requiring continued anti-inflammatory analgesic treatment.
• Zdravljenje benignih razjed dvanajstnika in želodca, povezanih z uporabo protivnetnih analgetikov pri bolnikih, pri katerih je potrebno neprekinjeno zdravljenje s protivnetnimi analgetiki.
Posology and Method of Administration
Odmerjanje in način uporabe
The bibliographic data submitted by the applicant show that in patients who continue to receive NSAID medication, lansoprazole is more effective in healing gastric ulcers than H2-receptor antagonist and the healing rates are acceptable although somewhat lower than reported for omeprazole.
NSAID, lansoprazol učinkovitejši pri celjenju želodčnih razjed kot zaviralec receptorjev H2 ter da so hitrosti celjenja sprejemljive, čeprav nekoliko manjše od hitrosti, ki se navaja za omeprazol.
Care should be exercised in the administration of lansoprazole in patients with mildly to moderately impaired hepatic function.
Pri uporabi lansoprazola pri bolnikih z blago do zmerno okvarjenim delovanjem jeter je treba biti previden.
The bibliographic data submitted provide evidence to support the indications:
Bibliografski podatki, ki jih je predložil vlagatelj, kažejo, da je pri bolnikih, ki še naprej jemljejo
D-83607 Holzkirchen Lansohexal 30 mg - Hartkapseln 30 mg
D-83607 Holzkirchen Lansohexal 30 mg - Hartkapseln 30 mg Gastrorezistentna kapsula, trda Peroralna uporaba
drowsiness, depression,
depresija,
Lansohexal 15 mg - Hartkapseln 15 mg
Lansohexal 15 mg - Hartkapseln 15 mg Gastrorezistentna kapsula, trda Peroralna uporaba
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
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