FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall the applicant considered that the new data from the aforementioned studies added significant support to the classification as non-prescription product as they provided both effect and relevance to the assessment.
Slovenian: Na splošno je predlagatelj menil, da ti novi podatki iz prej omenjenih študij zaradi svojega pomena in učinka na oceno pomembno podpirajo razvrstitev v skupino zdravil, ki se izdajajo brez recepta.
English: Relief of leading GORD symptoms and other GI symptoms
Slovenian: Olajšanje glavnih simptomov GERB in drugih gastrointestinalnih simptomov
English: The justification of the applicant was based on 6 ‘non-published' studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309).
Slovenian: Študije so bile predložene kot podpora vlogi (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 in BY1023/VMG309).
English: In the non-prescription product setting, the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14, making this study of limited value in the non-prescription context.
Slovenian: V primeru izdajanja zdravila brez recepta bi se bolnik, če se do 14. dneva simptomi ne bi izboljšali, sam napotil k zdravniku, zaradi česar ima ta študija omejeno vrednost za zdravila, ki se izdajajo brez recepta.
English: • Risk and consequences of incorrect use
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: With reference to Article 74a of Directive 2001/83/EC, as amended, the applicant requested one year data exclusivity for the data submitted for the change of the classification of the medicinal product
Slovenian: V skladu s členom 74(a) Direktive 2001/83/ES, kakor je bila spremenjena, je predlagatelj zahteval enoletno izključno pravico do uporabe podatkov, ki so bili predloženi za spremembo razvrstitve zdravila iz skupine zdravil, ki se izdajajo le na recept, v skupino zdravil, ki se izdajajo brez recepta.
English: Time to first symptom relief of GORDrelated symptoms in GORD Stage 0
Slovenian: Čas do prvega olajšanja z GERB povezanih simptomov pri GERB stopnje 0
English: Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Slovenian: Poleg tega je običajni začetni odmerek omeprazola za refluksno bolezen 20 mg; 10 mg omeprazola ni terapevtsko enakovrednih 20 mg pantoprazola.
English: Both PPIs were comparably effective; pantoprazole was noninferior to esomeprazole
Slovenian: Oba zaviralca protonske črpalke sta primerljivo učinkovita; pantoprazol ni dosegal slabših rezultatov od esomeprazola
English: Assessment of GI symptoms at day 14 and
Slovenian: Ocena gastrointestinalnih simptomov na 14. in 28. dan
English: The usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Slovenian: Običajni začetni odmerek omeprazola pri refluksni bolezni je 20 mg; 10 mg omeprazola ni terapevtsko enakovrednih 20 mg pantoprazola.
English: Endoscopic healing of GORD Stage I after 8 weeks, Improvement of GORD symptoms after 2 and 4 weeks
Slovenian: Endoskopsko zdravljenje GERB stopnje I po 8 tednih, izboljšanje simptomov GERB po 2 in 4 tednih
English: The CHMP reviewed the clinical data submitted, taking into account the provisions of Article 74a of Directive 2001/83/EC, as amended, in support of the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
Slovenian: CHMP je ob upoštevanju določb člena 74(a) Direktive 2001/83/ES, kakor je bila spremenjena, pregledal predložene klinične podatke, ki podpirajo razvrstitev zdravila CONTROLOC Control 20 mg gastrorezistentne tablete v skupino „zdravil, ki se izdajajo brez recepta“.
English: Symptom relief at 2 and 4 weeks of treatment
Slovenian: Olajšanje simptomov v 2. in 4. tednu zdravljenja
English: Pantoprazole was effective and well tolerated
Slovenian: Pantoprazol je bil učinkovit in bolniki so ga dobro prenašali
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg after one and two weeks or treatment.
Slovenian: V študiji so primerjali učinkovitost omeprazola 10 mg in pantoprazola 20 mg po enem in po dveh tednih zdravljenja.
English: Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320).
Slovenian: Poleg tega so v drugih študijah primerjali učinkovitost pantoprazola z drugimi zaviralci protonske črpalke (z lansoprazolom, esomeprazolom) in ugotovili, da ni dosegal slabših rezultatov od teh zdravil pri lajšanju simptomov zgage in regurgitacije kisline (študiji VMG305 in M3-320).
English: Overall treatment duration without consultation of a doctor is limited to 4 weeks; if no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Slovenian: Če ne pride do olajšanja simptomov v 2 tednih neprekinjenega zdravljenja, je treba bolnika napotiti na posvet k zdravniku.
English: Leading symptom relief after 2 weeks of treatment
Slovenian: Olajšanje glavnega simptoma po 2 tednih zdravljenja
English: Relief of GORD-related symptoms after 14 and 28 days
Slovenian: Olajšanje z GERB povezanih simptomov po 14 in 28 dneh
English: The approved indication is:
Slovenian: Navodilo vsebuje:
English: Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms.
Slovenian: Pantoprazol je bil pri zdravljenju glavnih simptomov gastroezofagealne refluksne bolezni učinkovitejši od ranitidina.
English: Medicinal Product
Slovenian: FARMACEVTSKI PODATKI
English: were given.
Slovenian: Navodilo je bilo odobreno
English: 2 weeks 521 Both PPIs were comparably effective; pantoprazole was noninferior to omeprazole, nonsignificant primary endpoint
Slovenian: 2 tedna 521 Oba zaviralca protonske črpalke sta primerljivo učinkovita; pantoprazol ni dosegal slabših rezultatov od
English: CSR = Clinical Study Report, N = Number of Patients, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Placebo, Ran = Ranitidine, bid =twice daily
Slovenian: Pantoprazol in omeprazol sta bila primerljivo učinkovita CSR = poročilo klinične študije (Clinical Study Report), Št. (ITT) = število bolnikov, ki so jih nameravali zdraviti (Intent To Treat), Eso = esomeprazol, Lan = lansoprazol, Niz = nizatidin, Ome = omeprazol, Pan = pantoprazol, Pla = placebo, Ran = ranitidin
English: Pantoprazole was significantly more effective than placebo
Slovenian: Pantoprazol je bil bistveno učinkovitejši od placeba
English: GCP
Slovenian: EXP
English: Treatments
Slovenian: ZDRAVILA
English: Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment
Slovenian: Endoskopsko zdravljenje GERB stopnje II/III po 4 in 8 tednih zdravljenja
English: - Marketing authorisation number:
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: Comments
Slovenian: Pripombe
English: The CHMP noted that in the majority of the studies patients were included based on endoscopic examination rather than symptoms alone.
Slovenian: Diagnoza GERB v teh študijah je temeljila na endoskopski oceni, z izjemo ene študije, v katero so bili vključeni bolniki zgolj na osnovi simptomov.
English: GERD stage I
Slovenian: GERB stopnje
English: Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment
Slovenian: Olajšanje zgage pri GERB stopnji I po 1 in 2 tednih zdravljenja
English: In this study the efficacy of 20 mg pantoprazole was compared to 10 mg omeprazole at day 28 in patients with reflux oesophagitis.
Slovenian: V tej študiji so primerjali učinkovitost 20 mg pantoprazola z 10 mg omeprazola na 28. dan pri bolnikih z refluksnim ezofagitisom.
English: Pantoprazole and omeprazole were similarly effective
Slovenian: 346 Pantoprazol in omeprazol sta bila podobno učinkovita
English: There are potential interactions with anticoagulants and with drugs, which bioavailability is pH dependent such as atanazavir.
Slovenian: Zdravilo CONTROLOC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka razpoložljivost je odvisna od želodčnega pH (npr. ketokonazol).
English: Relief of typical GORD symptoms
Slovenian: Olajšanje značilnih simptomov GERB
English: “Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.”
Slovenian: Kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
English: This study compared the efficacy and tolerability of pantoprazole 20 mg, 40 mg, or 80 mg in healing of oesophagitis and freedom from GORD symptoms.
Slovenian: V tej študiji so primerjali učinkovitost in prenašanje pantoprazola 20 mg, 40 mg ali 80 mg pri zdravljenju ezofagitisa in odsotnosti simptomov gastroezofagealnega refluksa.
English: There are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine.
Slovenian: Bolniki ne smejo jemati pantoprazola kot preventivno zdravilo.
English: It is extensively metabolised in the liver.
Slovenian: Pantoprazol se skoraj izključno presnavlja v jetrih.
English: Pan 20, Ran 300 once daily
Slovenian: Pan 20, Ran 300 enkrat dnevno
English: Pan 20, 40, Niz 150 bid weeks
Slovenian: Pan 20, 40, Niz 150 dvakrat dnevno tednov
English: 2.5 Pharmacovigilance
Slovenian: 5.2 Farmakokinetične lastnosti
English: Pan 20, Ran 300 once daily weeks
Slovenian: Pan 20, Ran 300 enkrat dnevno tednov
English: This study compared the efficacy of 20 mg pantoprazole once daily with 150 mg twice daily ranitidine in healing of oesophagitis and freedom from GORD symptoms after treatment.
Slovenian: V tej študiji so primerjali učinkovitost 20 mg pantoprazola enkrat dnevno s 150 mg ranitidina dvakrat dnevno pri zdravljenju ezofagitisa in odsotnosti simptomov gastroezofagealne refluksne bolezni po zdravljenju.
English: Pantozol 20 mg gastro-resistant tablets
Slovenian: CONTROLOC Control 20 mg gastrorezistentne tablete pantoprazol
English: 2.4 Clinical aspects
Slovenian: 4.1 Terapevtske indikacije
English: Results for the relief of acid regurgitation showed similar results.
Slovenian: Pri popolnem izboljšanju simptomov regurgitacije kisline so zabeležili podobne rezultate kot pri zgagi.
English: Relief of GORD symptoms after 2 weeks of treatment
Slovenian: Olajšanje simptomov GERB po 2 tednih zdravljenja
English: Clinical studies in elderly patients and in patients with liver or kidney disease did not identify any concerns.
Slovenian: Pri starejših bolnikih in pri tistih z okvarjeno ledvično ali jetrno funkcijo ni treba prilagajati odmerka.
English: The main serum metabolite is formed by demethylation at the 4-position of the pyridine ring, followed by conjugation with sulphate.
Slovenian: Glavni presnovek v serumu in v urinu je desmetilpantoprazol, ki je konjugiran s sulfatom.
English: Pantoprazole was superior to placebo
Slovenian: Pantoprazol je dosegal boljše rezultate od placeba
English: Time to freedom from key GORD symptoms
Slovenian: Čas do odsotnosti glavnih simptomov GERB
English: 344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms
Slovenian: 4 tedne 344 Pantoprazol je pri lajšanju simptomov GERB dosegal boljše rezultate od ranitidina
English: The absolute bioavailability of pantoprazole in healthy subjects is 77% and does not change at multiple dosing.
Slovenian: Absolutna biološka razpoložljivost tablete znaša približno 77%.
English: Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate).
Slovenian: Vsaka tableta vsebuje 20 mg pantoprazola (v obliki natrijevega seskvihidrata).
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy.
Slovenian: V tej študiji so primerjali učinkovitost omeprazola 10 mg in prantoprazola 20 mg na 28. dan pri bolnikih brez ezofagitisa, ugotovljenega z endoskopijo.
English: Diarrhoea Headache Nausea / Vomiting Abdominal distension and bloating Abdominal pain and discomfort Constipation Dizziness Liver enzymes increased (transaminases, γ-GT) Rash / Exanthema / Eruption Pruritus Sleep disorders Dry mouth Asthenia, fatigue and malaise Hyperlipidaemias and lipid increases Disturbances in vision / Blurred vision Hypersensitivity (incl.
Slovenian: - Občasni neželeni učinki: glavobol, vrtoglavica, driska, občutek slabosti, bruhanje, napihnjenost in vetrovi, zaprtje, suha usta, bolečina in neugodje v območju trebuha, izpuščaj na koži ali koprivnica, srbenje, občutek slabosti, izčrpanost ali splošno slabo počutje, motnje spanja, povišanje jetrnih encimov v krvni preiskavi.
English: Relief of heartburn in GORD Stage 0/I at day 14
Slovenian: Olajšanje zgage pri GERB stopnje 0/I na 14. dan
English: Enrolment
Slovenian: Absorpcija
English: Relief of heartburn in GORD Stage 0/I at day 28
Slovenian: Olajšanje zgage pri GERB stopnje 0/I na 28. dan
English: Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment
Slovenian: Olajšanje simptomov pri GERB stopnje 0/I po 4 tednih zdravljenja
English: • Clinical studies in special populations
Slovenian: Posebne skupine bolnikov
English: The PSUR submission schedule for CONTROLOC Control 20 mg gastro-resistant tablets should follow the PSUR submission schedule of the reference medicinal product.
Slovenian: Redno dopolnjeno poročilo o varnosti zdravila (PSUR) Urnik oddaje rednih dopolnjenih poročil o varnosti zdravila CONTROLOC Control 20 mg gastrorezistentne tablete sledi urniku oddaje rednih dopolnjenih poročil o varnosti referenčnega zdravila.
English: Clinical safety
Slovenian: KLINIČNI PODATKI
English: • Manufacture
Slovenian: A. OZNAČEVANJE
English: The excipients used in the formulation of the finished product are well known excipients used for preparation of tablets such as sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate (present in tablet core), hypromellose, povidone K25, titanium dioxide, yellow iron oxide, methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate (present in film-coating, including enteric coating and undercoating), shellac, red iron oxide, black iron oxide, yellow iron oxide, soya lecithin, titanium dioxide and antifoam DC 1510 (present in printing ink).
Slovenian: - Obloga: hipromeloza, povidon, titanov dioksid (E 171), rumeni železov oksid (E 172), propilenglikol, kopolimer metakrilne kisline in etilakrilata, natrijev lavrilsulfat, polisorbat 80, trietilcitrat.
English: European Medicines Agency Evaluation of Medicines for Human Use
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: ASSESSMENT REPORT FOR CONTROLOC Control
Slovenian: Shranjevanje zdravila CONTROLOC Control Dodatne informacije
English: This was considered acceptable.
Slovenian: Navedba smiselno ni potrebna.
English: Numbers analysed
Slovenian: ŠTEVILKA SERIJE
English: Relief of key symptoms in GORD after 28 days
Slovenian: Olajšanje glavnih simptomov GERB po 28 dneh
English: Pantoprazole was significantly more effective than ranitidine
Slovenian: Pantoprazol je bil bistveno učinkovitejši od ranitidina
English: Relief of key symptoms in GORD after 14 days
Slovenian: Olajšanje glavnih simptomov GERB po 14 dneh
English: It acts by inhibiting the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Slovenian: Pantoprazol je substituiran benzimidazol, ki zavira izločanje klorovodikove kisline v želodcu, s specifičnim delovanjem na protonsko črpalko parietalnih celic .
English: Relief of GORD
Slovenian: Olajšanje zgage pri
English: Relief of heartburn in GORD Stage 0
Slovenian: Olajšanje zgage pri GERB stopnje 0
English: Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Slovenian: Objavljene študije kažejo, da pantoprazol ni dosegal slabših rezultatov od drugih zaviralcev protonske črpalke (študiji VGM305 in M3
English: Randomisation
Slovenian: Dojenje
English: from prescription to non-prescription.
Slovenian: Zdravilo je na voljo brez recepta.
English: Pharmacokinetics
Slovenian: Sistrem farmakovigilance
English: Published studies suggest noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Slovenian: Objavljene študije nakazujejo, da pantoprazol ni dosegal slabših rezultatov od drugih zaviralcev protonske črpalke (študiji VGM305 in M3
English: The most frequent adverse events (≥5%) included diarrhoea, headache, and nausea.
Slovenian: Najpogosteje zabeležena neželena učinka sta driska in glavobol, oba se pojavita pri približno 1% bolnikov.
English: symptoms after 7 and 28 days of
Slovenian: Olajšanje simptomov GERB po 7 in 28 dneh zdravljenja
English: Table 1 Overview of the design of the main studies Study Design
Slovenian: DODATEK I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Placebo
Slovenian: Batch
English: It inhibits basal and stimulated acid secretion in animals and man via the covalent binding H+/K+ ATP-ase, also known as the “gastric proton pump” located in the secretory membrane of the parietal cell.
Slovenian: Pantoprazol se pretvori v svojo aktivno obliko, ciklični sulfenamid, v kislem okolju parietalnih celic, kjer zavira H+,K+ ATPazni encim, to je končno stopnjo v tvorbi klorovodikove kisline v želodcu.
English: Comparator
Slovenian: dimetikon
English: In these studies between 57 and 78% of patients reported relief from heartburn at day 7 and 73-83% at day 14.
Slovenian: V teh študijah je v skupini s pantoprazolom delež bolnikov s popolnim izboljšanjem zgage po 7 dneh znašal med 54,0% in 80,6%.
English: 1.2 Steps taken for the assessment of the product
Slovenian: 4.2 Odmerjanje in način uporabe
English: 2.7 Data exclusivity
Slovenian: 6.2 Inkompatibilnosti
English: Endoscopic healing of GORD Stage I after 8 weeks of treatment
Slovenian: Endoskopsko zdravljenje GERB stopnje I po 8 tednih zdravljenja
English: Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet).
Slovenian: Zdravilo CONTROLOC Control se dobi v Alu/Alu pretisnih omotih s ali brez kartonske opore.
English: The application concerns the supply as non-prescription medicine.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je brez recepta.
English: Number of patients with this adverse drug reaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Baseline data
Slovenian: PODATKI V BRAILLOVI PISAVI
English: - Date of authorisation: - Marketing authorisation granted by:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: Pantoprazole was superior to ranitidine
Slovenian: Pantoprazol je dosegal boljše rezultate od ranitidina
English: Sample size
Slovenian: Okvara ledvic
English: Overall, the low incidence rate of adverse events during the post-marketing period is reassuring.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: However, this is not considered representative for the general population.
Slovenian: Možno tveganje za ljudi ni znano.
English: Table 5 Relief rate of acid eructation in study BGI022
Slovenian: Farmakoterapevtska skupina: zaviralci protonske črpalke, oznaka ATC: A02BC02
English: Pan 20, Ran 150 bid weeks
Slovenian: Pan 20, Ran 150 dvakrat dnevno tednov
English: The assay, identification and related substances are determined by an in-house HPLC method.
Slovenian: Opozorila in druge pomožne snovi so navedene v navodilu za uporabo.
English: CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance.
Slovenian: Zdravilo CONTROLOC Control vsebuje zdravilno učinkovino pantoprazol, ki blokira »črpalko«, ki proizvaja želodčno kislino.
English: Results of 17 randomized controlled clinical studies (i.e. two pivotal and 15 supportive studies), in which pantoprazole 20mg was investigated with regard to relief of reflux symptoms as a primary or secondary endpoint, have been presented.
Slovenian: V retrospektivni analizi 17 študij na 5960 bolnikih z gastroezofagealno refluksno boleznijo (GERB), ki so jih zdravili z monoterapijo 20 mg pantoprazola, so s standardizirano metodologijo ocenjevali simptome, povezane z refluksom kisline, npr. zgago in regurgitacijo kisline.
English: The results also show an early onset of the clinical effect, with rates of complete relief of heartburn between 54.0% and 80.6% achieved after 7 days of treatment with pantoprazole 20 mg. A further improvement in the symptom relief rates was observed after 14 days and 28 days of treatment, respectively.
Slovenian: Po 7 dneh je delež bolnikov s popolnim izboljšanjem simptomov regurgitacije kisline znašal med 61,5% in 84,4%, po 14 dneh med 67,7% in 90,4% ter po 28 dneh med 75,2% in 94,5%.
English: Endoscopic healing of GORD Stage I after 4 weeks of treatment
Slovenian: Endoskopsko zdravljenje GERB stopnje I po 4 tednih zdravljenja
English: • Adverse events
Slovenian: • DRUGI POGOJI
English: Endoscopic healing of GORD Stage II/III
Slovenian: Endoskopsko zdravljenje GERB stopnje I
English: Patients with conditions for whom a nonprescription use of pantoprazole would not be appropriate, like patients with current erosive lesions of the upper gastrointestinal tract (e.g. reflux esophagitis stage I-V, erosive gastritis, were excluded.
Slovenian: Odmerka pantoprazola ni potrebno zmanjšati pri bolnikih z okvarjeno ledvično funkcijo (vključno z bolniki na dializi, ki odstrani samo zanemarljive količine pantoprazola).
English: 1.1 Submission of the dossier
Slovenian: 6.1 Seznam pomožnih snovi
English: Appropriate compatibility studies of the active substance with different excipients have been performed.
Slovenian: Medsebojnega delovanja z drugimi snovmi, ki se presnavljajo z istim encimskim sistemom, ni mogoče izključiti.
English: From the safety database all the adverse reactions reported in clinical trials and post-marketing have been included in the Summary of Product Characteristics.
Slovenian: Neželeni učinki pantoprazola v kliničnih študijah in poročilih o post-marketinših izkušnjah Pogostnost Organski sistemi
English: Concomitant intake of food has no influence on the bioavailability of pantoprazole.
Slovenian: Sočasen vnos hrane ni imel vpliva na biološko razpoložljivost (AUC ali Cmax), povečal pa je variabilnost v časovnem zamiku (tlag).
English: The success rate was similar in patients treated for more than 17 days and in patients treated between 11 and 17 days in the pantoprazole group, while the success rate was slightly lower with longer treatment in the ranitidine group.
Slovenian: Bolniki utegnejo opaziti zmanjšanje simptomov po približno enem dnevu zdravljenja s pantoprazolom, včasih pa ga je potrebno jemati 7 dni za dosego popolnega nadzora nad zgago.
English: Endoscopic healing of GORD Stage I after 4 weeks
Slovenian: Endoskopsko zdravljenje GERB stopnje I po 4 tednih
English: Since the elimination half-life in these patients is still shorter than the dosing interval of 24 hours, no accumulation of pantoprazole was observed following multiple dosing.
Slovenian: Čeprav ima glavni presnovek daljši razpolovni čas (2-3 ure), je izločanje še vedno hitro in zato ne pride do akumulacije.
English: 2.8 Overall conclusions, risk/benefit assessment and recommendation
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: The claimed indication at time of application read as follows: “Treatment of reflux symptoms (e.g. heartburn, acid regurgitation)”
Slovenian: Zdravilo CONTROLOC Control se uporablja za kratkotrajno zdravljenje znakov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.