FrancophonIA/ELRC3.0 huggingface dataset:
English: Clarithromycin, metronidazole, tinidazole and amoxicillin are widely used in Europe for eradication of H. Pylori, however the prevalence of antimicrobial resistance in H. pylori shows regional variability and alternative antibiotics based on local resistance rates may improve eradication rates.
Slovenian: V Evropi se za eradikacijo H. pylori pogosto uporabljajo klaritromicin, metronidazol, tinidazol in amoksicilin, vendar se pogostnost odpornosti H. pylori proti antibiotikom razlikuje med območji, zato lahko stopnje eradikacije izboljšamo z alternativnimi antibiotiki.
English: The trials showed that pantoprazole is superior to ranitidine and comparable to omeprazole in ulcer healing while the meta-analysis suggests that first-line drug therapy for patients diagnosed with gastric ulcer should preferably be PPI, rather than a H2 antagonist.
Slovenian: V preskušanjih so dokazali, da je pantoprazol boljši od ranitidina za ozdravitev razjede in primerljiv z omeprazolom, metaanaliza pa kaže, da bi moralo biti zdravilo prve izbire za bolnike z diagnozo želodčnega ulkusa prednostno zaviralec protonske črpalke in ne antagonistov H2.
English: For the prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs, a summary of three clinical trials was provided, showing superiority of pantoprazole versus placebo and misoprostol and similar effectiveness to omeprazole.
Slovenian: Za preprečevanje razjed na želodcu in dvanajstniku, povzročenih z neselektivnimi nesteroidnimi protivnetnimi zdravili, je bil predložen povzetek treh kliničnih preskušanj, ki kažejo superiornost pantoprazola v primerjavi s placebom in misoprostolom ter podobno učinkovitost kot omeprazol.
English: Antibiotic resistance is a major cause of treatment failure and as the prevalence of resistance in H. pylori shows regional variation, alternative antibiotics based on local resistance rates may improve eradication rates.
Slovenian: Odpornost proti antibiotikom je poglaviten vzrok neuspešnega zdravljenja, ker pa pogostnost odpornosti H. pylori krajevno variira, lahko stopnje eradikacije izboljšamo z alternativnimi antibiotiki na podlagi krajevnih stopenj odpornosti.
English: For the treatment of mild reflux disease and associated symptoms, several studies in adult patients with mild GERD have shown pantoprazole to be superior to placebo and ranitidine for the relief from the key GERD symptoms (heartburn, acid regurgitation, pain on swallowing) and healing of lesions and comparable to omeprazole and lansoprazole regarding the rate of symptom relief and healing in patients with mild GERD.
Slovenian: Za zdravljenje blage refluksne bolezni in povezanih simptomov so v več študijah pri odraslih bolnikih z blagim GERB dokazali, da je pantoprazol boljši od placeba in ranitidina za lajšanje ključnih simptomov GERB (zgage, kislinske regurgitacije, bolečine pri požiranju) in zdravljenja lezij ter primerljiv z omeprazolom in lansoprazolom glede hitrosti lajšanja simptomov ter ozdravitve bolnikov z blagim GERB.
English: Pantoprazole was shown to be equally effective to the other PPIs in terms of antisecretory potency.
Slovenian: Dokazali so, da je pantoprazol z vidika jakosti antisekretornega delovanja enako učinkovit kot drugi zaviralci protonske črpalke.
English: Tablet characterisation, excipient compliance with the requirements of the Ph. Eur, specifications for dissolution, tests on colorants, stress and impurities, certificates of analysis of the reference substances and packaging and containers are considered generally acceptable.
Slovenian: Na splošno so se opis tablet, skladnost pomožnih snovi z zahtevami Evropske farmakopeje, specifikacije raztapljanja, preskušanja na barvila, stres in nečistoče, analizni certifikati referenčnih snovi ter ovojnina in vsebniki šteli za sprejemljive.
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: - obseg napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: Warnings related to long term treatment and for prevention of gastroduodenal ulcers induced by NSAIDs were added, and the statement on hepatically impaired patients was maintained.
Slovenian: Dodana so bila opozorila v zvezi z dolgotrajnim zdravljenjem in preprečevanjem razjed na želodcu in dvanajstniku zaradi nesteroidnih protivnetnih zdravil, ohranjena pa je bila izjava v zvezi z bolniki z okvarjenim delovanjem jeter.
English: • Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Slovenian: • Zollinger-Ellisonov sindrom in druga stanja s patološko povečanim izločanjem želodčne kisline.
English: Regarding duodenal ulcer, data from several randomized trials was provided, comparing pantoprazole with ranitidine.
Slovenian: V zvezi z razjedo na dvanajstniku so bili predloženi podatki iz več randomiziranih preskušanj, v katerih so primerjali pantoprazol in ranitidin.
English: The association between NSAIDs and the presence of upper gastrointestinal (GI) complications is considered well established and evidence that acid aggravates NSAID-induced injury provides a rationale for minimizing such damage by acid suppression.
Slovenian: Povezava med nesteroidnimi protivnetnimi zdravili in prisotnostjo zapletov v zgornjih prebavilih se šteje za dobro poznano, zato so dokazi, da kislina poslabša poškodbe, ki jih inducirajo nesteroidna protivnetna zdravila, osnova za čim večje zmanjšanje takih poškodb s supresijo kisline.
English: Finally, for the Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions, data from two studies comparing the efficacy of pantoprazole in reducing gastric acid secretion in 11 ZES patients who previously had received omeprazole and lansoprazole was provided.
Slovenian: Na koncu pa so bili za Zollinger-Ellisonov sindrom (ZES) in druga stanja s patološko povečanim izločanjem želodčne kisline predloženi podatki iz dveh študij, v katerih so primerjali učinkovitost zmanjševanja izločanja želodčne kisline s pantoprazolom pri bolnikih z ZES, ki so prej prejemali omeprazol in lansoprazol.
English: Regarding hypersensitivity and concomitant use with atazanavir, the comments provided for the 20 mg tablet dose apply.
Slovenian: V zvezi s preobčutljivostjo in sočasno uporabo z atazanavirjem veljajo opombe, uporabljene za odmerek 20 mg tablete.
English: The CHMP also stated that a daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment.
Slovenian: CHMP je navedel tudi, da se pri bolnikih s hudo okvarjenim delovanjem ledvic ne sme preseči dnevni odmerek 20 mg pantoprazola.
English: Numerous studies have demonstrated that PPIs are both efficacious and well tolerated in patients with hypersecretory conditions; consequently, they are currently the anti-secretory agents of choice to control gastric acid hypersecretion.
Slovenian: V številnih študijah so dokazali, da so zaviralci protonske črpalke učinkoviti in jih bolniki s stanji s patološko povečanim izločanjem želodčne kisline dobro prenašajo, zato se trenutno uporabljajo kot antisekretorna sredstva zdravila izbire za obvladovanje hipersekrecije želodčne kisline.
English: formulation, a text with detailed information on the reconstitution of the solution and on the special precautions was adopted.
Slovenian: s podrobnimi informacijami o rekonstituciji raztopine ter o posebnih previdnostnih ukrepih.
English: Co-administration of atazanavir with proton pump inhibitors is not recommended and if the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended while high doses of proton pump inhibitors should be avoided.
Slovenian: Če pa se kombinacija atazanavirja z zaviralcem protonske črpalke šteje za neizogibno, je priporočljivo skrbno klinično spremljanje, izogniti pa se je treba visokim odmerkom zaviralcev protonske črpalke.
English: The dossier for the Drug Substance was harmonised and the CHMP noted the Ph. Eur.
Slovenian: Dokumentacija za zdravilno učinkovino je bila usklajena, CHMP pa je upošteval monografijo Evropske farmakopeje.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Protium formulations.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo za to poglavje, ki velja za vse formulacije zdravila Protium.
English: The MAH discussed the concomitant use of PPIs and clopidogrel, noting a trend towards a potential clinical interaction between PPIs and clopidogrel.
Slovenian: Imetnik dovoljenja za promet z zdravilom je razpravljal o sočasni uporabi zaviralcev protonske črpalke in ugotovil trend proti možni klinični interakciji med zaviralci protonske črpalke in klopidogrelom.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Protium and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom Protium in z njim povezanih imen (glejte Dodatek I), za katere so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo navedeni v Dodatku III. Priporočeni pogoji dovoljenja za promet z zdravilom so navedeni v Dodatku IV.
English: The relapse of erosive oesophagitis in subjects with GERD was shown to be dramatically decreased by PPI treatment and reflux symptoms were also better controlled with maintenance-dose PPI therapy than with placebo.
Slovenian: Ponovitve erozivnega ezofagitisa pri preiskovancih z GERB so se dokazano bistveno zmanjšale po zdravljenju z zaviralcem protonske črpalke, simptomi refluksa so bili tudi bolje obvladovani z vzdrževalnim odmerkom zaviralca protonske črpalke kot s placebom.
English: Indications proposed for pantoprazole 40 mg i.v.
Slovenian: Indikacije, predlagane za pantoprazol 40 mg i.v.
English: Regarding elderly patients, and patients with mild hepatic impairment, no dose adjustment is necessary.
Slovenian: Pri starostnikih in bolnikih z blago okvarjenim delovanjem jeter odmerka ni treba prilagajati.
English: justify use in the treatment of moderate and severe reflux oesophagitis, duodenal ulcer, gastric ulcer and ZES and other pathological hypersecretory conditions.
Slovenian: upravičijo uporabo za zdravljenje zmernega in hudega refluksnega ezofagitisa, razjede na dvanajstniku in želodcu ter ZES ter drugih stanj s patološko povečanim izločanjem želodčne kisline.
English: Apart from a single case report which indicated a slight burden for the infant, further clinical experience is missing.
Slovenian: Ni drugih kliničnih izkušenj kot poročilo o posameznem primeru, ki kaže majhno breme za dojenčka.
English: Abundant data supports treating patients with oesophageal GERD syndromes with antisecretory drugs and there is ample evidence that, as a drug class, PPIs are more effective in these patients than H2 receptor antagonist.
Slovenian: Poleg tega obstaja veliko podatkov, da so zaviralci protonske črpalke kot skupina zdravil pri teh bolnikih učinkovitejši od antagonistov receptorja H2.
English: Indications proposed for pantoprazole 20 mg gastro-resistant tablets:
Slovenian: Indikacije, predlagane za pantoprazol 20 mg gastrorezistentne tablete:
English: Currently, ulcers related to H. Pylori infection can be healed and prevented from recurring and in NSAIDs naïve patients with H. Pylori infection, pantoprazole is better than placebo in preventing peptic ulcer and upper gastrointestinal bleeding at six months.
Slovenian: Pri bolnikih, predhodno nezdravljenih z nesteroidnimi protivnetnimi zdravili, ki so okuženi s H. pylori pa je pantoprazol boljši od placebo z vidika preprečevanja peptične razjede in krvavitev v zgornjih prebavilih po šestih mesecih.
English: Indications proposed for pantoprazole 40 mg gastro-resistant tablets:
Slovenian: Indikacije, predlagane za pantoprazol 40 mg gastrorezistentne tablete:
English: For the pantoprazole 40 mg tablet formulation, the CHMP noted the MAH proposal and adopted a harmonised text.
Slovenian: V zvezi s formulacijo pantoprazol 40 mg tablete je CHMP upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo.
English: For the pantoprazole 20 mg tablets, the CHMP noted the MAH proposal and adopted a harmonised text.
Slovenian: V zvezi s tabletami pantoprazol 20 mg je CHMP upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo.
English: For duodenal ulcer, gastric ulcer, moderate and severe reflux oesophagitis, open-label studies have shown that pantoprazole 40 mg/d, p.o. is comparably effective and safe to pantoprazole 40 mg/d, i.v.
Slovenian: Za razjedo na dvanajstniku in želodcu, zmeren in hud refluksni ezofagitis so nerandomizirane študije pokazale, da ima pantoprazol 40 mg/dan p.o. za zdravljenje refluksnega ezofagitisa primerljivo učinkovitost in varnost kot pantoprazol 40 mg/dan i.v.
English: 20 mg gastro-resistant tablets
Slovenian: 20 mg gastrorezistentne tablete
English: The dose, schedule and duration of treatment are in line with the clinical practices.
Slovenian: Priporočilo o jemanju tablet je bilo usklajeno z 20-miligramsko formulacijo.. Odmerek, shema in trajanje zdravljenja so v skladu s kliničnimi praksami.
English: 40 mg gastro-resistant tablets
Slovenian: 40 mg gastrorezistentne tablete
English: and even up to 320 mg/d, p.o. for years in single patients and 240 mg i.v.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel številne študije, ki kažejo dobro prenašanje odmerkov 120 mg/dan p.o. in tudi do 320 mg/dan p.o. več let zapored pri posameznih bolnikih ter 240 mg i.v.
English: (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4)
Slovenian: • preprečevanje razjed na dvanajstniku in želodcu, povzročenih z neselektivnimi nesteroidnimi protivnetnimi zdravili, pri bolnikih s tveganjem in potrebo po neprekinjenem zdravljenju z nesteroidnimi protivnetnimi zdravili (glejte poglavje 4.4).
English: formulation, the CHMP noted the MAH proposal and adopted a harmonised text, in particular regarding hypersensitivity to the active substance or to any of the excipients.
Slovenian: V zvezi s formulacijo pantoprazola 40 mg tablete je CHMP upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo, in sicer glede preobčutljivosti za zdravilno učinkovino ali katerokoli pomožno snov.
English: However, the epidemiological studies were considered to be conflicting and heterogeneous and the clinical PD/PK
Slovenian: Vendar so se epidemiološke študije štele za nasprotujoče in heterogene, klinične študije farmakodinamike in farmakokinetike pa niso dokazale posebnega vpliva na protitrombocitni učinek klopidogrela na pantoprazol, kar je dobro.
English: bid for up to 6 days was efficacious and safe for controlling gastric acid.
Slovenian: dvakrat dnevno za največ 6 dni učinkovito in varno obvladujemo želodčno kislino.
English: The CHMP did not consider it justified to contraindicate pantoprazole 20 mg in hepatically impaired patients.
Slovenian: Kontraindikacije 20-miligramskega pantoprazola pri bolnikih z okvarjenim delovanjem jeter CHMP ne šteje za utemeljeno.
English: The CHMP noted the MAH proposal for this section.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom glede tega poglavja.
English: • Reflux oesophagitis
Slovenian: • refluksni ezofagitis,
English: The CHMP noted the MAH proposal.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom.
English: Warnings related to prevention of gastroduodenal ulcers induced by NSAIDs were added.
Slovenian: Dodana so bila opozorila v zvezi s preprečevanjem razjed na želodcu in dvanajstniku zaradi nesteroidnih protivnetnih zdravil.
English: in the healing of reflux oesophagitis, and that 40 mg pantoprazole p.o. and i.v.
Slovenian: in da sta formulaciji 40 mg pantoprazola p.o. in i.v.
English: In conclusion, the harmonisation procedure led to the adoption by the CHMP of a harmonised set of Product Informations for the three Protium formulations included in the scope and the CHMP was of the opinion that the benefit/risk ratio of Protium and associated names is considered to be favourable.
Slovenian: V postopku usklajevanja je na koncu CHMP uskladil sklop navodil za uporabo za tri formulacije zdravila Protium, ki so zajeta v tem postopku.
English: This summary was last updated in June 2007.
Slovenian: Povzetek je bil nazadnje posodobljen junija 2007.
English: Treatment continued for up to 15 months.
Slovenian: Zdravljenje je trajalo do 15 mesecev.
English: However, this is reversible.
Slovenian: Vendar pa je to reverzibilen pojav.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom PRILACTONE, veljavno po vsej Evropski uniji, odobrila družbi CEVA SANTE ANIMALE dne 20. junija 2007.
English: Other information about PRILACTONE:
Slovenian: Druge informacije o zdravilu PRILACTONE:
English: PRILACTONE tablets contain the active substance spironolactone (10 mg, 40 mg or 80 mg).
Slovenian: Tablete zdravila PRILACTONE vsebujejo zdravilno učinkovino spironolakton (10 mg, 40 mg ali 80 mg).
English: The dose to use is 2 mg per kilogram of the dog's body weight.
Slovenian: Pri tem se uporabi odmerek, ki znaša 2 mg na kilogram telesne mase psa.
English: When the heart valves are faulty, the heart is not able to pump blood as efficiently as before.
Slovenian: Če so srčne zaklopke okvarjene, srce ne more črpati krvi tako učinkovito kot pred tem.
English: The tablets are scored to make them easier to break if smaller doses are needed.
Slovenian: Tablete imajo zareze, tako da jih je lažje prelomiti, če so potrebni manjši odmerki.
English: PRILACTONE is given to the dog once daily, with food (either mixed in the food, or immediately after feeding).
Slovenian: Zdravilo PRILACTONE se psu daje enkrat dnevno skupaj s hrano (primešano v hrano ali neposredno po hranjenju).
English: PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘clinical studies‘).
Slovenian: Zdravilo PRILACTONE so raziskovali v laboratoriju, kakor tudi v treh študijah pri psih z boleznimi srčnih zaklopk, ki so jih zdravili v različnih veterinarskih praksah ali klinikah po Evropi („klinične študije“).
English: What benefit has PRILACTONE shown during the studies?
Slovenian: Kakšne koristi je zdravilo PRILACTONE izkazalo med študijami?
English: What is the risk associated with PRILACTONE?
Slovenian: Kakšna tveganja so povezana z zdravilom PRILACTONE?
English: The appropriate number of tablets, half tablets or quarter tablets to give according to the dog's size is given in the Package Leaflet.
Slovenian: Ustrezno število tablet, polovičk tablet ali četrtink tablet, ki jih morate psu dati glede njegovo velikost, je podano v Navodilu za uporabo.
English: For the same reasons, PRILACTONE tablets should not be used in growing dogs.
Slovenian: Zaradi istih razlogov tablet zdravila PRILACTONE ne smete dajati rastočim psom.
English: It is accepted there are also other ways in which spironolactone works on the heart and blood vessels in congestive heart failure (although these mechanisms of action have not yet been fully demonstrated in dogs).
Slovenian: Znano je, da pri kongestivni odpovedi srca spironolakton deluje na srce in krvne žile tudi na druge načine (čeprav teh mehanizmov delovanja pri psih še niso popolnoma dokazali).
English: In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/kg with food.
Slovenian: V teh kliničnih študijah so lastniki svojim psom dajali bodisi tablete zdravila PRILACTONE ali pa placebo (tablete brez zdravilne učinkovine) enkrat dnevno v odmerku 2 mg/kg skupaj s hrano.
English: PRILACTONE is used in combination with ‘standard therapy' (other heart medicines, including diuretic support where necessary).
Slovenian: Zdravilo PRILACTONE se uporablja v kombinaciji s „standardnim zdravljenjem“ (drugimi zdravili za srce, vključno z diuretično podporo, če je ta potrebna).
English: As a result, blood can accumulate in the veins and fluid can leak out into the tissues, leading to the heart being unable to deliver oxygen-rich blood to the body adequately.
Slovenian: Posledično se lahko začne v venah zbirati kri, tekočina pa lahko začne uhajati v tkiva, kar pripelje do tega, da srce telesa ne more več zadostno oskrbovati s krvjo, ki je bogata s kisikom.
English: Anyone handling PRILACTONE should wash their hands afterwards.
Slovenian: Vsaka oseba, ki pride v stik z zdravilom PRILACTONE, si mora po uporabi umiti roke.
English: They should also not be given to animals with high blood potassium levels (hyperkalaemia) or low blood sodium levels (hyponatraemia), or to animals with hypoadrenocorticism (a disease that results from the reduction in corticosteroid secretion from the adrenal gland).
Slovenian: Zdravila prav tako ne smete dajati živalim z visoko koncentracijo kalija v krvi (hiperkaliemija) ali nizko koncentracijo natrija v krvi (hiponatriemija) oziroma živalim s hipoadrenokorticizmom (boleznijo, ki je posledica zmanjšanega izločanja kortikosteroidov iz nadledvične žleze).
English: Why has PRILACTONE been approved?
Slovenian: Zakaj je bilo zdravilo PRILACTONE odobreno?
English: Information on the prescription status of this product may be found on the outer package.
Slovenian: Podatki o predpisovanju tega zdravila so na zunanji ovojnini zdravila.
English: PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals.
Slovenian: Tablet zdravila PRILACTONE ne smete uporabljati pri psih, ki so namenjeni za rejo, saj je bilo dokazano, da lahko spironolakton poškoduje mladiče ali mlade laboratorijske živali.
English: As spironolactone is broken down in the liver, the tablets should be used with caution in dogs with liver disease.
Slovenian: Ker se spironolakton razgrajuje v jetrih, morate tablete uporabljati previdno pri psih z boleznijo jeter.
English: PRILACTONE tablets were given with food because this results in more of the active substance being absorbed from the tablets.
Slovenian: Tablete zdravila PRILACTONE so dajali skupaj s hrano zato, ker se tako iz tablet absorbira večja količina zdravilne učinkovine.
English: PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Tablet zdravila PRILACTONE ne smete dajati psom s slabo delujočimi ledvicami, ki prejemajo zdravila, znana kot nesteroidna protivnetna zdravila (NSAID).
English: PRILACTONE is used to treat dogs that have congestive heart failure because of faulty heart valves.
Slovenian: Zdravilo PRILACTONE se uporablja za zdravljenje psov s kongestivno odpovedjo srca zaradi okvarjenih srčnih zaklopk.
English: The active substance in PRILACTONE, spironolactone, blocks the actions of a hormone called aldosterone in the kidneys, heart and blood vessels.
Slovenian: Zdravilna učinkovina zdravila PRILACTONE, spironolakton, blokira učinkovanje hormona, imenovanega aldosteron, v ledvicah, srcu in krvnih žilah.
English: For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PRILACTONE, in seznam medsebojnih delovanj z drugimi zdravili glejte Navodilo za uporabo.