natgillin/translations-raw huggingface dataset:
The Czech Republic, Spain and Portugal referred the reasons for disagreement to the EMEA on 30 November 2006.
Češka republika, Španija in Portugalska so svoje razloge za nesoglasje podale agenciji EMEA dne 30. novembra 2006.
Frits Lekkerkerker and Co-Rapporteur was Dr.
Frits Lekkerkerker, soporočevalec pa dr.
During their 18 – 21 June 2007 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 Lansoprazole and associated names, that the objections raised by the Czech Republic, Spain and Portugal should not prevent the granting of a Marketing Authorisation and that the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Med zasedanjem, ki je potekalo od 18. do 21. junija 2007, je bil odbor CHMP zaradi vseh predloženih podatkov in znanstvene razprave v odboru mnenja, da je razmerje med koristmi in tveganji za zdravilo Lansoprazole in z njim povezana imena ugodno, tako da zadržki Češke republike, Španije in Portugalske ne morejo preprečiti podelitve dovoljenja za promet z zdravilom, in da so trenutno veljavni Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo končne različice, ki so bile sprejete med postopkom skupine za usklajevanje.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH Država članica
Industrieweg 23, P. O.
Peroralna uporaba
Belgium
15 mg
Jozef Nellenslei 10 – B-2100 Deurne Belgium
Gastrorezistentna Peroralna uporaba trda kapsula
Gastro-resistant capsule, hard
Gastrorezistentna Peroralna uporaba trda kapsula
Oral use
Češka
Dráž ní 7, 627 00 Brno Czech Republic
Gastrorezistentna Peroralna uporaba trda kapsula
Lansoprazol - TEVA 30 mg 30 mg
Lansoprazol- TEVA® 15 mg magensaftresistente Hartkapseln
Lansoprazol TEVA 15 mg 15 mg enterokapsler
Lansoprazol TEVA
Denmark
Gastrorezistentna Peroralna uporaba
Box 217, 3640 AE Mijdrecht The Netherlands
Box 217, 15 mg enterokapsler
Lansoprazol TEVA 30 mg 30 mg enterokapsler
trda kapsula
Gastro-resistant capsule, hard
3640 AE Mijdrecht Lansoprazol TEVA The Netherlands 30 mg enterokapsler
Gastro-resistant
Gastrorezistentna Peroralna uporaba trda kapsula
Oral use
Finska
capsule, hard
Gastrorezistentna Peroralna uporaba trda kapsula
France
The Netherlands
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
Lansoprazol Teva, 30 mg enterokapseli, kova
Lansoprazole TEVA 15 mg 15 mg microgranules gastro résistantes en gélule
30 mg
Oral use
Francija
Hungary
Gastrorezistentna Peroralna uporaba trda kapsula
Lansoprazole TEVA 30 mg 30 mg Gastro-resistant Capsules
Lansoprazole TEVA 15 mg Gastro - resistant Capsules
3 The Netherlands
The Netherlands,
Gastro-resistant
Lansoprazole TEVA 30 mg Gastro - resistant Capsules
maagsapresistente capsule
Gastrorezistentna Peroralna uporaba trda kapsula
capsule, hard
Nizozemska
Lansoprazol 30 mg PCH, 30 mg maagsapresistente capsule
Lansoprazol 15 mg PCH, maagsapresistente capsule
Lansoprazole 30 mg 30 mg Gastro-resistant Capsules
Lansoprazol 30 mg PCH, maagsapresistente capsule
Industrieweg 23, P. O.
Teva Pharma B. V., Industrieweg 23, P. O.
enterokapseler, harde
Lansoprazol TEVA 15 mg enterokapseler, harde
Norway
3
Lansoprazol TEVA 30 mg 30 mg enterokapseler, harde
Lansoprazol TEVA 30 mg enterokapseler, harde
Plater 53, 00-113 Warsaw Poland
Plater 53, 00- 113 Warsaw
LansoTEVA 15 mg 15 mg kapsulka dojelitowa twarda
LansoTEVA 15 mg kapsulka dojelitowa twarda
Teva Pharmaceuticals Polska Sp. z o. o.
LansoTEVA 30 mg kapsulka dojelitowa twarda
E.
30 mg
Plater 53, 00-113 Warsaw Poland
Gastrorezistentna Peroralna uporaba trda kapsula
LansoTEVA 30 mg 30 mg kapsulka dojelitowa twarda
Lansoprazol TEVA 15 mg Cápsula gastro- resistente
Slovak Republic
Švedska
Dráž ní 7, 627 00 Brno Czech Republic
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg
Lansoprazol - TEVA 15 mg 15 mg
Lansoprazol TEVA 15 mg enterokapslar, hårda
Lansoprazol - TEVA 30 mg 30 mg
Lansoprazol - TEVA 15 mg
Oral use
Lansoprazol - TEVA 30 mg
Sweden
30 mg
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
Gastrorezistentna Peroralna uporaba trda kapsula
Lansoprazol TEVA 15 mg 15 mg enterokapslar, hårda
TEVA UK Limited Brampton Road, Hampden Park,
Gastro-resistant capsule, hard
TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22
Oral use
Lansoprazole 15 mg Gastro- resistant Capsules
Sweden
15 mg
Lansoprazol TEVA 30 mg 30 mg enterokapslar, hårda
Eastbourne, East Sussex, BN22 9AG United Kingdom
Oral use
4 DODATEK II
Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro- oesophageal reflux disease and associated conditions.
Lansoprazol je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed v dvanajstniku in benignih razjed v želodcu, za zdravljenje gastroezofagealne refluksne bolezni in s tem povezanih bolezenskih stanj.
On 30 November 2006, the application has been referred and submitted for arbitration according to Article 29 of Directive 2001/ 83/ EC, as amended.
30. novembra 2006 je bila vloga predana in predložena v presojo skladno s členom 29 Direktive 2001/ 83/ EC, s spremembami.
The RMS approved the product on the basis of the results of the fasted study showed unequivocal equivalence as shown by the 90% confidence intervals (CI) for the AUC and Cmax which were within the conventional 80-125% bioequivalence range.
Referenčna država članica je zdravilo odobrila na osnovi rezultatov študije, v kateri so bolniki zdravilo jemali na tešče, in pri kateri se je pokazala nedvoumna enakovrednost, kar se izkazuje z 90% intervalom zaupanja (CI) za površino pod krivuljo (AUC) in Cmaks, ki sta se nahajali znotraj običajnega 80 do 125 - odstotnega območja biološke enakovrednosti.
78– 110%) were outside the conventional limits they comply with the wider 75-133% criterion.
78 do 110%), nahajale zunaj običajnih meja, pa izpolnjujejo zahteve širšega merila, ki se nahaja v območju od 75 do 133%.
It was considered that this wider criterion can be applied in this case because of the extremely high intra-subject variability (70- 82%) under fed conditions shown in this study.
Prisotno je bilo mnenje, da se zaradi izredno velike variabilnosti znotraj posameznih bolnikov (70 do 82%), ki se je v tej študiji pokazala v razmerah, ko so bolniki zdravilo jemali na poln želodec, v tem primeru lahko uporabi to širše merilo.
The results were also considered acceptable on clinical grounds as lansoprazole’ s efficacy is largely independent of dose at this therapeutic dose range.
Poleg tega so rezultate obravnavali kot sprejemljive na kliničnih temeljih, saj je v tem razponu terapevtskih odmerkov učinkovitost lansoprazola v veliki meri neodvisna od odmerka.
The results of these fed studies demonstrate that Lansoprazole’ s bioavailability is not only markedly reduced when taken with food, but that its absorption, in the presence of food, can be very erratic.
Rezultati teh študij pri bolnikih, ki so zdravilo jemali na poln želodec, kažejo, da biološka razpoložljivost zdravila Lansoprazola, kadar se ga jemlje skupaj s hrano, ni samo znatno manjša, temveč da je v prisotnosti hrane lahko zelo neurejena.
It also has a flat dose/ response curve i. e. its efficacy is largely independent of the dose.
Poleg tega je pri njem krivulja odmerek/ odziv izravnana, to pomeni, da je njegova učinkovitost v veliki meri neodvisna od odmerka.
The CHMP has recommended the granting of the Marketing Authorisation(s).
6 CHMP je priporočil odobritev dovoljenja za promet z zdravilom( i).
SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
8 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
8 Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol HEXAL 15 mg and 30 mg International Non-Proprietary Name (INN):
MNENJE V ZVEZI Z NAPOTITVIJO IZ LENA 29( 2) 1 ZA Lansoprazol Hexal 15 mg in 30 mg Mednarodno nelastniško ime (INN):
Lansoprazol HEXAL (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 Hexal (lansoprazol) je zaviralec protonske rpalke, ki zavira izločanje želodčne kisline in č se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega vnetja požiralnika, 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 peptične razjede pri bolnikih z razjedami, povezanimi s H. pylori.
A Marketing Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to Hexal AG in Finland on 7 November 2003.
Dovoljenje za promet z zdravilom Lansoprazol Hexal (15 mg in 30 mg) je bilo prvotno dodeljeno družbi Hexal AG iz Finske 7. novembra 2003.
The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Danska, Nemčija, in Švedska.
Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Nemčija je 15. decembra 2004 Evropski agenciji za zdravila podala razloge za nesoglasje. č
Significant differences in comparison to the reference product have been identified with regard to the indications’ section of the SPCs.
V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v zvezi z razdelkom o indikacijah v Povzetku glavnih značilnosti zdravila.
During its June 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 HEXAL.
Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol Hexal ugodno.
1 Article 29(2) of Directive 2001/ 83/ EC, as amended.
1 len 29( 2) Direktive 2001/ 83/ ES, kot je bila spremenjena.
Lansohexal 15 mg - Hartkapseln
Lansohexal 15 mg - Hartkapseln 15 mg Lansohexal 30 mg - Hartkapseln 30 mg
Gastro-resistant capsule, hard
Gastrorezistentna kapsula, trda Gastrorezistentna kapsula, trda
Gastro-resistant capsule, hard
Peroralna uporaba Peroralna uporaba
Lansoprazol HEXAL
Lansoprazol HEXAL 15 mg
15 mg
Gastrorezistentna kapsula, trda
Gastro-resistant capsule, hard
Peroralna uporaba
Oral use
-
Lansoprazol HEXAL
Lansoprazol HEXAL 30 mg
Lansohexal 15 mg Hartkapseln
Lansohexal 15 mg - Hartkapseln 15 mg Lansohexal 30 mg - Hartkapseln 30 mg
Lansoprazol HEXAL
Lansoprazol HEXAL 15mg 15 mg Lansoprazol HEXAL 30 mg 30 mg
Oral use
Švedska
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 lenom 29 Direktive Sveta 2001/ 83/ ES, kakor je bila spremenjena, zaradi č zadržkov, ki jih je predložila Nemčija v okviru postopka medsebojnega priznavanja s Finsko, ki je bila referenčna država lanica.
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 č indikacij, povezanih s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID), ter zdravljenja in preprečevanja razjed dvanajstnika in želodca, ki jih povzročajo te snovi.
After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 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).
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%.
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%.
Matsukawa et al evaluated in an uncontrolled study the efficacy of lansoprazole 15 mg and 30 mg in 47 patients with NSAID induced gastroduodenal ulcers.
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.
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.
Bolnike z razjedami dvanajstnika (n=3) so zdravili 6 tednov, bolnike z želodčnimi razjedami (n=42) ali multiplimi razjedami (n=5) pa 8 tednov.
Overall rate of healing according to Sakitas classification was 95%.
Celokupna stopnja celjenja po klasifikaciji Sakitas je bila 95%.
The rate of S2-healing (good healing) was 35%.
Celokupna stopnja celjenja S2 (dobro zaceljenje) je bila 35%.
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).
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%, P < 0, 05).
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.
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.
The proton pump inhibitors, omeprazole, lansoprazole and pantoprazole are all mainly metabolized by the cytochrome P450 isoform CYP2C19.
Zaviralci protonske rpalke (omeprazol, lansoprazol in pantoprazol) se v glavnem presnavljajo z č izoobliko CYP2C19 citokroma P450.
Three published papers on the clinical evidence for prevention of NSAID related ulcers are submitted.
4 Predloženi so bili trije objavljeni lanki s kliničnimi dokazi o preprečevanju razjed, povezanih z č NSAID.
During follow-up, 9/ 61 patient (14.8%) in the placebo group had recurrence of ulcer complications compared with 1/ 62 patients (1.6%) in the lansoprazole group (P=0.008).
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).
Graham et al conducted a prospective; double blind RCT 4 among 537 patients without H. pylori infection who were long-term users of NSAIDs with a history of endoscopically documented gastric ulcer.
Graham et al so opravili prospektivno dvojno slepo randomizirano klinično preskušanje pri 537 bolnikih brez okužbe s H. pylori, ki so dolgotrajno jemali NSAID in so imeli endoskopsko dokazano želodčno razjedo.
Ulcer status was determined by endoscopy at week 4, 8, and 12.
Status razjede so določali endoskopsko v 4., 8. in 12. tednu.
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.
Patients received eradication treatment followed by lansoprazole 30 mg for 4 weeks.
Bolniki so bili podvrženi eradikacijskemu zdravljenju, emur je sledilo 4- tedensko jemanje lansoprazola č 30 mg.
Patients with healed ulcers and H. pylori eradicated then received naproxen 750 mg daily and were randomized to receive either lansoprazole 30 mg or no treatment for 8 weeks.
Bolniki z zaceljenimi razjedami in odstranjeno H. pylori so nato dnevno prejemali naproksen 750 mg in bili za 8 tednov naključno razporejeni v skupino, ki je prejemala lansoprazol 30 mg ali skupino brez zdravljenja.
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).
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.
Bibliografski podatki, ki jih je predložil vlagatelj, kažejo, da je pri bolnikih, ki še naprej jemljejo NSAID, lansoprazol učinkovitejši pri celjenju želodčnih razjed kot zaviralec receptorjev H2 ter da so hitrosti celjenja sprejemljive, eprav nekoliko manjše od hitrosti, ki se navaja za omeprazol.
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 č hitrostih celjenja razjed dvanajstnika je malo, vendar je za razjede dvanajstnika znano, da se po zaviranju kisline na splošno celijo bolje kot želodčne razjede.
No formal interaction studies with lansoprazole and NSAIDs have been performed.
Formalnih raziskav interakcije med lansoprazolom in NSAID niso opravili.
Furthermore, interaction studies performed with omeprazole and several NSAIDs have not shown any interaction.
Poleg tega tudi raziskave interakcij med omeprazolom in NSAID niso pokazale takšnih učinkov.
The bibliographic data submitted provide evidence to support the indications: • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID-treatment” • Prophylaxis of NSAID-associated benign gastric and duodenal ulcers patients at risk requiring continuous NSAID-treatment”.
Predloženi bibliografski podatki vsebujejo dokaze, ki podpirajo indikacije: • Zdravljenje benignih razjed dvanajstnika in želodca, povezanih z NSAID pri bolnikih, pri katerih je potrebno neprekinjeno zdravljenje z NSAID • Zdravljenje benignih razjed dvanajstnika in želodca, povezanih z NSAID, pri bolnikih, pri katerih obstaja tveganje, da bo potrebno neprekinjeno zdravljenje z NSAID.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas, The scope of the referral was to agree on a Summary of Products Characteristics in view of the indication.
RAZLOGI ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA Ker je bil namen napotitve uskladiti Povzetek glavnih značilnosti zdravila glede indikacije,
The Summary of Products Characteristic 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 with amendments of the Summary of Product Characteristics as set out in Annex III for Lansoprazol HEXAL and associated names (see Annex I).
5 je bil Povzetek glavnih značilnosti zdravila, ki ga je predlagal vlagatelj, ovrednoten na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora, 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.
5 ANNEX III
6 DODATEK III
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
[See Annex I - to be completed nationally]
[Glejte Dodatek I – podatke je treba dopolniti v posameznih državah]
• Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography. • Treatment of reflux oesophagitis. • Long-term prophylaxis of reflux oesophagitis. • Zollinger-Ellison syndrome. • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID-treatment • Prophylaxis of NSAID-associated gastric and duodenal ulcer in patients at risk requiring continuous NSAID-treatment
• Zdravljenje endoskopsko ali radiografsko potrjenih razjed dvanajstnika in želodca. • Zdravljenje refluksnega ezofagitisa. • Dolgotrajna profilaksa refluksnega ezofagitisa. • Zollinger- Ellisonov sindrom. • Zdravljenje benignih razjed dvanajstnika in želodca, povezanih z nesteroidnimi protivnetnimi zdravili (NSAID) pri bolnikih, pri katerih je potrebno neprekinjeno zdravljenje z NSAID • Profilaksa razjed dvanajstnika in želodca, povezanih z NSAID pri bolnikih, pri katerih obstaja tveganje, da bo potrebno neprekinjeno zdravljenje z NSAID
7 Treatment of reflux oesophagitis:
Zdravljenje refluksnega ezofagitisa:
The recommended dose of lansoprazole is 30 mg once daily for 4 weeks.
8 Priporočeni odmerek lansoprazola je 30 mg enkrat dnevno v trajanju 4 tednov.
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.
Prophylaxis of NSAID-associated gastric and duodenal ulcers in patients requiring continuous NSAID- treatment:
Profilaksa benignih razjed dvanajstnika in želodca, povezanih z NSAID, pri bolnikih, pri katerih je potrebno neprekinjeno zdravljenje z NSAID:
If the treatment fails the dose 30 mg once daily should be used.
Č
If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Morda bo potrebno prilagajanje odmerka posamezniku. e se simptomi ne odpravijo v 4 tednih zdravljenja z Č odmerkom 30 mg dnevno, se priporočajo nadaljnje preiskave.