natgillin/translations-raw huggingface dataset:
The provided meta-analyses and controlled clinical studies support the efficacy of the proposed H. Pylori eradication combinations but with wide divergences between member states. 
Predložene metaanalize in kontrolirane klinične študije podpirajo učinkovitost predlaganih kombinacij za eradikacijo H. pylori, vendar z velikimi razlikami med državami članicami.
The experience in children is limited and therefore Protium i.v. 
Izkušenj pri otrocih je malo, zato se zdravilo Protium i.v.
It was considered that patients under long-term treatment should be kept under regular surveillance, especially when exceeding a treatment period of 1 year. 
Šteje se, da je treba bolnike na dolgotrajnem zdravljenju redno nadzorovati, zlasti če je zdravljenje daljše od enega leta.
40 mg powder for solution for injection is not recommended in patients below 18 years of age until further data become available. 
40 mg prašek za raztopino za injiciranje ne priporoča za bolnike, mlajše od 18 let, dokler ne bo na voljo več podatkov.
Because the MAH presented a study performed to provide information regarding the effects of pantoprazole on the ability to drive and use machines, Section 4.7 now states that “adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). 
Ker je imetnik dovoljenja za promet z zdravilom predložil študijo, ki je bila opravljena za pridobitev informacij o učinkih pantoprazola na sposobnost vožnje in upravljanja s stroji, je sedaj v poglavju 4.7 zapisano: „ lahko se pojavijo neželeni učinki zdravila, kot so omotica in motnje vida (glejte poglavje 4.8).
Although one multi-centre study indicates that the use of PPIs during the first trimester of pregnancy is not associated with an increased teratogenic risk, clinical experience is limited during pregnancy. 
Čeprav ena multicentrična študija kaže, da uporaba zaviralcev protonske črpalke v prvem tromesečju nosečnosti ni povezana z zvišanim teratogenim tveganjem, je kliničnih izkušenj med nosečnostjo malo.
When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required. 
Ko se doseže ublažitev simptomov, se lahko ponovitve simptomov obvladujejo s shemo v odmerku 20 mg enkrat dnevno po potrebi.
• Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers 
• eradikacija Helicobacter pylori (H. pylori) v kombinaciji z ustreznim antibiotičnim zdravljenjem pri bolnikih z razjedami, ki so povezane s H. pylori,
- the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- povzetek glavnih značilnosti zdravil, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ocenjeni na podlagi predložene dokumentacije in strokovne razprave v Odboru;
Protium was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended. 
Zdravilo Protium je bilo dano na seznam za usklajevanje povzetkov glavnih značilnosti zdravil, ki ga je pripravila Koordinacijska skupina o medsebojnih in decentraliziranih postopkih - zdravila za uporabo v humani medicini (CMD(h)) v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
The CHMP considered the general information of drug substance to be acceptable. 
CHMP je menil, da so splošne informacije o zdravilni učinkovini sprejemljive.
Instructions that the tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water was harmonised. 
Usklajena so bila navodila, da se tablete ne smejo žvečiti ali zdrobiti in da se pogoltnejo cele z vodo eno uro pred obrokom.
The dosage of pantoprazole may need to be reduced in patients with severe hepatic impairment, and liver enzymes should be monitored regularly during treatment with pantoprazole. 
Odmerjanje pantoprazola je morda treba zmanjšati pri bolnikih s hudo okvarjenim delovanjem jeter, jetrne encime pa je treba med zdravljenjem s pantoprazolom redno spremljati.
The CHMP noted that all the indications have been previously fully justified and adopted three harmonised therapeutic indications for the 40 mg intravenous formulation. 
CHMP je izpostavil, da so bile vse indikacije predhodno popolnoma utemeljene, in sprejel tri usklajene terapevtske indikacije za 40-miligramsko intravensko formulacijo.
The MAH submitted the module 2.3 for pantoprazole gastro-resistant tablets 20 and 40mg dated March 2009 and for pantoprazole powder for solution for injection dated December 2008 as well as the module 3 for pantoprazole gastro-resistant tablets 20 and 40mg and for pantoprazole powder for solution for injection dated April 2009. 
Imetnik dovoljenja za promet z zdravilom je marca 2009 predložil modul 2.3 za pantoprazol gastrorezistentne tablete 20 in 40 mg, za pantoprazol prašek za raztopino za injiciranje decembra 2008 ter modul 3 za pantoprazol gastrorezistentne tablete 20 in 40 mg in za pantoprazol prašek za raztopino za injiciranje aprila 2009.
The CHMP agreed that on demand treatment is an appropriate option for symptomatic gastro-oesophageal reflux disease. 
CHMP se je strinjal, da je zdravljenje po potrebi primerna možnost za simptomatsko gastroezofagealno refluksno bolezen.
The specific mention of levonorgestrel and ethinyl oestradiol is justified as a general extrapolation to the whole group of oral contraceptives cannot be made. 
Posebna omemba levonorgestrela in etinilestradiola je utemeljena, saj splošna ekstrapolacija na celotno skupino peroralnih kontracepcijskih sredstev ni možna.
It was noted that concomitant intake of food had no influence on AUC and maximum serum concentration but that the variability of the lag-time will be increased. 
Ugotovljeno je bilo, da sočasen vnos hrane ni imel vpliva na AUC ali največjo koncentracijo v serumu, vendar pa je podaljšal zakasnitev.
Since efficacy of low dose (20 mg) pantoprazole in triple therapy for the eradication of H. pylori has not been investigated, the use of Protium is considered contraindicated and the dose needed to eradicate this infection (40 mg twice daily) cannot be administrated to these patients. 
Ker učinkovitost majhnega odmerka (20 mg) pantoprazola v tritirni terapiji za eradikacijo H. pylori ni bila raziskana, se uporaba zdravila Protium šteje za kontraindicirano, tem bolnikom pa se ne sme dajati odmerka, potrebnega za eradikacijo te okužbe (40 mg dvakrat dnevno).
In summary, the CHMP adopted the following sets of indications for Protium and associated names: 
Če povzamemo, CHMP je sprejel naslednje sklope indikacij za zdravilo Protium in z njim povezana imena:
The CHMP adopted a harmonised text for all sections under Section 5. 
CHMP je sprejel usklajeno besedilo za vse razdelke v poglavju 5.
Protium should not be used in combination treatment for eradication of H. pylori in patients with impaired renal function or moderate to severe hepatic dysfunction since currently no data is available on the efficacy and safety in combination treatment for these patients. 
Zdravilo Protium se ne sme uporabljati v kombiniranem zdravljenju za eradikacijo H. pylori pri bolnikih z okvarjenim delovanjem ledvic ali zmerno do hudo jetrno disfunkcijo, ker trenutno ni razpoložljivih podatkov o učinkovitosti in varnosti pri teh bolnikih v kombiniranem zdravljenju.
In line with the assessment of the 20 mg gastro-resistant tablets, Protium is not recommended in children below 12 years. 
V skladu z vrednotenjem 20-miligramskih gastrorezistentnih tablet se zdravilo Protium ne priporoča za otroke, mlajše od 12 let.
No marketing authorisations exist for Pantoprazole i.v., powder for solution for injection, in Bulgaria, Estonia, Latvia and Lithuania. 
Pantoprazol i.v., prašek za raztopino za injiciranje, nima dovoljenja za promet v Bolgariji, Estoniji, Latviji in Litvi.
• Symptomatic gastro-oesophageal reflux disease 
• simptomatska gastroezofagealna refluksna bolezen,
Section 4.3 - Contraindications 
Razdelek 4.3 - Kontraindikacije
Under Section 6.6, for the i.v. 
Sprejeto je bilo besedilo za poglavje 6.6 za formulacijo i.v.
• For long-term management and prevention of relapse in reflux oesophagitis 
• dolgotrajno obvladovanje in preprečevanje ponovitve refluksnega ezofagitisa,
Finally, the dossier for the Drug Product (powder for solution for injection) was harmonised. 
Na koncu je bila usklajena dokumentacija za zdravilo (prašek za raztopino za injiciranje).
Similarly, the dossier for the Drug Product (gastro-resistant tablets) was harmonised. 
Podobno je bila usklajena dokumentacija za zdravilo (gastrorezistentne tablete).
In general, the elucidation of structure, the batch testing, the specifications and the stability tests were considered acceptable. 
Na splošno so se opis strukture, preskušanje serij, specifikacije in preskusi stabilnosti šteli za sprejemljive.
Superiority of pantoprazole over ranitidine and comparable healing rates after two and four weeks of treatment with omeprazole were demonstrated. 
Dokazali so superiornost pantoprazola nad ranitidinom ter primerljive stopnje ozdravitve po dveh in štirih tednih zdravljenja z omeprazolom.
Regarding special populations, the CHMP noted that for patients with hepatic impairment, specific information related to monitoring liver enzymes and discontinuation of treatment in severe liver impairment is available and concluded that a daily dose of 20 mg pantoprazole should not be exceeded. 
V zvezi s posebnimi populacijami je CHMP ugotovil, da so za bolnike z okvarjenim delovanjem jeter na voljo posebne informacije glede spremljanja jetrnih encimov in prekinitve zdravljenja v primeru hudo okvarjenega delovanja jeter, ter zaključil, da se dnevni odmerek 20 mg pantoprazola ne sme preseči.
For patients with hepatic impairment, only a maximum of 20 mg daily is recommended although the proposed posology of 40 mg on alternate days can not be supported as the lack of efficacy data has not been addressed. 
Za bolnike z okvarjenim delovanjem jeter se priporoča le zgornja omejitev 20 mg dnevno, saj predlaganega odmerjanja 40 mg vsak drugi dan ni možno podpreti, ker ni podatkov o učinkovitosti.
In particular, a description of the metabolic pathway which adequately reflects what is known about pantoprazole metabolism and a text on antibiotics interactions were adopted. 
Sprejet je bil opis presnovne poti, ki zadostno odraža poznavanje o presnovi pantoprazola, ter besedilo o medsebojnem delovanju z antibiotiki.
The general text of frequencies classification, and the adverse reaction obtained from postmarketing experience were clarified, and the frequency of a number of events was revised. 
Splošno besedilo o razvrstitvi pogostnosti in opis neželene reakcije iz obdobja trženja zdravila sta bila preoblikovana v jasnejšo obliko, popravljena pa je bila pogostnost številnih reakcij.
The statement on a possible increase in gastrointestinal infections is supported by a case-control study comparing 6,414 patients with an episode of gastroenteritis (GE) with a healthy control group of 50,000 and showing that the use of PPIs is associated with an increased risk of bacterial GE, regardless of the treatment duration. 
Izjavo o možnem povečanju okužb prebavil podpira študija primerov in kontrol, v kateri so primerjali 6 414 bolnikov z epizodo gastroenteritisa in kontrolno skupino 50 000 zdravih preiskovancev in dokazali, da je uporaba zaviralcev protonske črpalke povezana s povečanim tveganjem bakterijskega gastroenteritisa ne glede na trajanje zdravljenja.
Regarding on-demand treatment, data shows that pantoprazole at a daily dose of 20 mg for 4 weeks is effective and safe in the treatment of mild GERD and its associated symptoms and that an extension of treatment duration to 8 weeks resulted in an increase in cumulative healing rates. 
V zvezi z zdravljenjem po potrebi podatki kažejo, da je pantoprazol pri dnevnem odmerku 20 mg v obdobju štirih tednov učinkovit in varen za zdravljenje blage GERB in z njo povezanih simptomov ter da je podaljšanje trajanja zdravljenja na osem tednov povečalo kumulativne stopnje ozdravitve.
In particular, the text on the general pharmacokinetics, the bioavailability, the characteristics in patients/special groups of subjects and the characteristics in patients/special groups of subjects and in children was harmonized. 
Usklajeno je bilo besedilo o splošni farmakokinetiki, biološki razpoložljivosti, značilnostih pri bolnikih/posebnih skupinah preiskovancev in značilnostih pri bolnikih/posebnih skupinah preiskovancev in pri otrocih.
The safety in long-term treatment was discussed and the data collected since the original licensing of the product is re-assuring for long-term safety. 
Odbor je obravnaval varnost pri dolgotrajnem zdravljenju in ugotovil, da so podatki, ki so bili zbrani od prvotne odobritve zdravila, pomirjujoči.
This was supported by several guidelines recommending the use of PPIs in GERD regardless of severity. 
To podpira več smernic, v katerih se priporoča uporaba zaviralcev protonske črpalke za GERB ne glede na resnost bolezni.
Specifically for 20 mg tablets, a statement was inserted recommending that patients under long treatments should be kept under regular surveillance, especially when exceeding a treatment period of 1 year. 
Samo za 20-miligramske tablete je bila vstavljena izjava s priporočilom, da je treba bolnike na dolgotrajnem zdravljenju skrbno spremljati, zlasti če je zdravljenje daljše od enega leta.
In the case of non-erosive disease, PPI treatment also proved a reasonable strategy in symptoms control but the role of daily maintenance therapy is less clear than the “on demand” use. 
V primeru neerozivne bolezni so dokazali, da je zdravljenje z zaviralcem protonske črpalke primerna strategija za obvladovanje simptomov, vendar pa je vloga dnevnega vzdrževalnega zdravljenja manj jasna kot uporaba „po potrebi“.
In all other EU countries and Norway pantoprazole 20 mg and 40 mg, gastro-resistant tablets, are registered. 
V vseh drugih članicah EU in na Norveškem so registrirane gastrorezistentne tablete z 20 mg in 40 mg pantoprazola.
The literature shows that this interaction exists and is related to changes in gastric pH that can lead to a reduction in the bioavailability of atazanavir and other HIV medications whose absorption is pHdependent. 
V literaturi je dokazano, da to medsebojno delovanje obstaja in je povezano s spremembami pH v želodcu, ki lahko povzročijo zmanjšanje biološke razpoložljivosti atazanavirja in drugih zdravil za zdravljenje okužbe z virusom HIV, katerih absorpcija je odvisna od pH.
Expert opinions are unanimous in recommending twicedaily dosing of PPIs to improve symptom relief in patients with an oesophageal GERD syndrome with an unsatisfactory response to once daily treatment. 
Strokovnjaki soglasno priporočajo dvakrat dnevno odmerjanje zaviralcev protonske črpalke, da se izboljša lajšanje simptomov pri bolnikih z ezofagealnim sindromom GERB in nezadovoljivim odzivom na zdravljenje enkrat dnevno.
40 mg powder for solution for injection 
40 mg prašek za raztopino za injiciranje
Doubling the PPI dose further increased the risk of GE, with Campylobacter and Salmonella the most frequently responsible. 
Podvojitev odmerka zaviralcev protonske črpalke dodatno poveča tveganje gastroenteritisa, največkrat zaradi kampilobaktrov in salmonel.
The CHMP also noted that the published literature on the concomitant use of PPIs and clopidogrel suggests that clopidogrel may be less effective in patients receiving PPIs and requested the MAH to discuss this potential interaction. 
CHMP je izpostavil tudi, da objavljena literatura o sočasni uporabi zaviralcev protonske črpalke in klopidogrela kaže, da je morda klopidogrel manj učinkovit pri bolnikih, ki prejemajo zaviralce protonske črpalke, ter imetnika dovoljenja za promet z zdravilom prosil za razpravljanje o tej možni interakciji.
The pharmaceutical development, the description of the manufacturers and their activities, the packaging and containers, the excipients used, the release specifications, the lower assay limit in drug product shelf-life specifications, the inclusion of related substances, the peak purity test, the reference standards of the drug substance and related substances and the stability of the drug product are considered generally acceptable. 
Na splošno so se farmacevtski razvoj, opis izdelovalcev in njihovih dejavnosti, ovojnina in vsebniki, uporabljene pomožne snovi, specifikacije sproščanja, spodnja mejna vrednost preskušanja v specifikacijah roka uporabnosti zdravila, vsebnost sorodnih snovi, preskus največje čistoče, referenčni standardi za zdravilno učinkovino in sorodne snovi ter stabilnost zdravila šteli za sprejemljive.
The CHMP considered that the proven clinical efficacy of pantoprazole 40 mg p.o. and the documented equivalence of pantoprazole 40 mg p.o. and pantoprazole 40 mg i.v. 
CHMP je menil, da dokazana klinična učinkovitost pantoprazola 40 mg p.o. in dokumentirana enakovrednost pantoprazola 40 mg p.o. in pantoprazola 40 mg i.v.
Specifically for the 40 mg tablets, information regarding patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions was included and the statement "Diagnosis of reflux oesophagitis should be confirmed by endoscopy" was removed as this is no longer the clinical practice. 
Samo za 20-miligramske tablete je bila vstavljena informacija glede bolnikov s Zollinger-Ellisonovim sindromom in drugimi stanji s patološko povečanim izločanjem želodčne kisline, izbrisana pa je bila izjava „Diagnozo refluksnega ezofagitisa je treba potrditi z endoskopijo“, saj to ni več klinična praksa.
For gastric ulcer, data from two clinical trials and one meta-analysis was provided. 
Za razjedo na želodcu so bili predloženi podatki iz dveh kliničnih preskušanj in ene metaanalize.
The CHMP is of the opinion that a commitment to address these concerns is sufficient, and to reduce administrative work, a common time of 1 year after the issue of the EC decision is proposed for all response documents to be handed in as a single data package (see Annex IV). 
Zaradi zmanjšanja administrativnega dela se predlaga običajno obdobje 1 leta po izdaji odločitve Evropske komisije za predložitev vseh odgovorov v obliki enega podatkovnega paketa (glejte Dodatek IV).
Protium (pantoprazole) is a proton-pump inhibitor and is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (oesophagus). 
Zdravilo Protium (pantoprazol) je zaviralec protonske črpalke in se uporablja za zdravljenje gastroezofagealne refluksne bolezni (GERB), stanja pri katerem povratni tok kisline iz želodca povzroča zgago in poškodbe požiralnika (ezofagusa).
The dose and schedule for the indications is appropriate, based on the available data with pantoprazole 40 mg p.o. and the pharmacodynamic and therapeutic equivalence of pantoprazole 40 mg i.v. 
Odmerek in shema za indikacije sta primerna in temeljita na razpoložljivih podatkih, pridobljenih s pantoprazolom 40 mg p.o., ter na farmakodinamični in terapevtski enakovrednosti pantoprazola 40 mg i.v.
The CHMP adopted four harmonised therapeutic indications for the 40 mg gastro-resistant tablets. 
CHMP je sprejel štiri usklajene terapevtske indikacije za 40-miligramske gastrorezistentne tablete.
In conclusion, based on the data provided by the MAH and the existing clinical evidence, the proposed indications are considered appropriate; however, the CHMP proposed a new wording for the moderate and severe reflux oesophagitis, taking into account the current classification of gastroesophageal reflux disease. 
Na podlagi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, in obstoječih kliničnih dokazov se torej predlagane indikacije štejejo za primerne, vendar je CHMP predlagal novo besedilo za zmeren do hud refluksni ezofagitis, pri čemer je upošteval trenutno razvrstitev gastroezofagealne refluksne bolezni.
For the combination with two appropriate antibiotics for the eradication of H. pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism, there is a vast knowledge about the eradication of H. Pylori and the role of PPIs. 
O kombiniranju z dvema antibiotikoma, primernima za eradikacijo H. pylori, pri bolniki s peptičnimi razjedami za zmanjšanje ponovitev razjed dvanajstnika in želodca, ki jih povzroča ta mikroorganizem, je veliko znanja o eradikaciji H. pylori in vlogi zaviralcev protonske črpalke.
A randomized, dose-finding study showed statistically significant differences between 20 mg and 40 mg, thus indicating that pantoprazole at a daily dose of 40 mg is the recommended efficacious and safe dosage. 
V randomizirani študiji z namenom določanja odmerka so dokazali statistično pomembne razlike med odmerkoma 20 mg in 40 mg, kar pomeni, da je dnevni odmerek 40 mg pantoprazola priporočeni, učinkovit in varen odmerek.
The CHMP noted the submitted randomized clinical trials results demonstrating that pantoprazole is therapeutically superior to placebo and to ranitidine in patients with moderate and severe reflux oesophagitis and equivalent in healing rates after 4/8 weeks and/or symptom relief after 2/4 weeks of treatment with omeprazole, esomeprazole and lansoprazole. 
CHMP je upošteval predložena randomizirana klinična preskušanja, ki dokazujejo, da je pantoprazol terapevtsko boljši od placeba in ranitidina pri bolnikih z zmernim do hudim refluksnim ezofagitisom ter enakovreden z vidika stopenj ozdravitve po 4/8 tednih in/ali lajšanju simptomov po 2/4 tednih zdravljenja z omeprazolom, esomeprazolom in lansoprazolom.
In conclusion, based on the data provided by the MAH and the existing clinical evidence the CHMP adopted three harmonised therapeutic indications for the 20 mg gastro-resistant tablets. 
Na podlagi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, in obstoječih kliničnih dokazov je torej CHMP sprejel tri usklajene terapevtske indikacije za 20-miligramske gastrorezistentne tablete.
formulations are equivalent in their ability to suppress gastric acid output. 
enakovredni glede zmožnosti zaviranja izločanja želodčne kisline.
No dose adjustment is considered necessary for patients with renal impairment and elderly patients as the primary route of elimination for pantoprazole is hepatic, thus elimination of pantoprazole is minimally affected by renal dysfunction and the slight increase in AUC and Cmax in elderly compared with younger volunteers is not considered clinically relevant. 
Za bolnike z okvarjenim delovanjem ledvic in starostnike pa se prilagajanje odmerka ne šteje za potrebnega, saj je primarna pot eliminacije pantoprazola prek jeter, zato ledvična disfunkcija minimalno vpliva na eliminacijo pantoprazola, manjše povečanje AUC in Cmax pri starostnikih v primerjavi z mlajšimi prostovoljci pa se ne šteje za klinično pomembnega.
For patients with impaired renal function, no dose adjustment is necessary as the primary route of elimination of pantoprazole is hepatic; therefore, elimination is minimally affected by renal dysfunction. 
Za bolnike z okvarjenim delovanjem ledvic ni potrebno prilagajanje odmerka, saj je primarna pot eliminacije pantoprazola prek jeter, zato ledvična disfunkcija minimalno vpliva na eliminacijo.
The inclusion of the substances diclofenac, naproxen, and piroxicam is justified by their recommended co-prescription according to the NSAID related ulcer prevention indication and are mentioned separately. 
Vključitev snovi diklofenak, naproksen in piroksikam je utemeljena, ker je sočasna uporaba priporočena pri indikaciji preprečevanja z nesteroidnimi protivnetnimi zdravili povzročene razjede, zato so omenjeni ločeno.