FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint in Study M0631 was the proportion of subjects who required no platelet transfusion (i.e. achieved platelet count >50,000/µL) before the primary invasive procedure.
Slovenian: Primarni opazovani dogodek v študiji M0631 je bil delež bolnikov, ki pred primarnim invazivnim posegom niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl).
English: Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio.
Slovenian: Bolnike so randomizirali v razmerju 1:1 bodisi na 3 mg lusutrombopaga ali placebo.
English: Marketing Authorisation Holder Shionogi B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Shionogi B.V.
English: The primary endpoint in Study M0634 was the proportion of subjects who required no platelet transfusion (i.e. achieved platelet count >50,000/µL) before the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure.
Slovenian: Primarni opazovani dogodek v študiji M0634 je bil delež bolnikov, ki niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl) pred primarnim invazivnim posegom in nikakršnega rešilnega zdravljenja za krvavitev od randomizacije do vključno 7. dne po primarnem invazivnem posegu.
English: The proportion of subjects who required no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure was statistically significantly greater in the lusutrombopag group compared with placebo group for the individual study and pooled analyses (Table 2).
Slovenian: Delež bolnikov, ki niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl) pred primarnim invazivnim posegom in nikakršnega rešilnega zdravljenja za krvavitev od randomizacije do vključno 7. dne po primarnem invazivnem posegu, je bil statistično značilno večji v skupini z lusutrombopagom kot v skupini s placebom tako v posamični študiji kot v združenih analizah (preglednica 2).
English: Table 4 Proportion of responders Study M0631
Slovenian: Preglednica 4 Delež bolnikov, ki so se odzvali na zdravljenje Študija M0631
English: Phase 3 Study M0634
Slovenian: Študija 3. faze M0634
English: Lusutrombopag did not affect male or female fertility in rats at doses up to 176 and 252 times the human clinical exposures in adults based on AUC in males and females, respectively (see section 5.3).
Slovenian: Lusutrombopag ni vplival na plodnost pri samcih oziroma samicah podgan v odmerkih, ki povzročajo izpostavljenost, 176-krat oziroma 252-krat večjo od klinične izpostavljenosti odraslega človeka na podlagi AUC pri moških oziroma ženskah (glejte poglavje 5.3).
English: Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1.
Slovenian: Lusutrombopag je substrat P-gp in BCRP, ni pa substrat OATP1B1, OATP1B3 in OCT1.
English: There is limited information on the use of lusutrombopag in patients with severe (Child-Pugh class C) hepatic impairment (see section 5.1).
Slovenian: O uporabi lusutrombopaga pri bolnikih s hudo (razred C po Child-Pughu) okvaro jeter je na voljo malo podatkov (glejte poglavje 5.1).
English: [a] A responder was defined as a subject who achieved a platelet count of ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline.
Slovenian: Vrednost P [a] Bolnik, ki se je odzval na zdravljenje, je bil opredeljen kot bolnik, ki je dosegel število trombocitov ≥ 50.000/μl, z zvečanjem za ≥ 20.000/μl od izhodišča.
English: Red ferric oxide (E172)
Slovenian: Filmska obloga hipromeloza titanov dioksid trietilcitrat smukec rdeči železov oksid (E172)
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets
Slovenian: IME ZDRAVILA Mulpleo 3 mg filmsko obložene tablete
English: In the clinical drug-drug interaction study, co-administration of cyclosporine, a P-gp and BCRP dual inhibitor, increased the Cmax and AUCinf values of lusutrombopag by approximately 20% compared with lusutrombopag administration alone.
Slovenian: BCRP, zvečala vrednosti Cmax in AUCinf lusutrombopaga za približno 20 % v primerjavi z dajanjem samo lusutrombopaga.
English: No dosage adjustment is necessary in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: On the basis of the results, the no observed adverse effect level (NOAEL) was estimated to be near 4 mg/kg/day in the embryo-foetal development study in rats (23 times the human clinical exposures in adults based on AUC).
Slovenian: Na podlagi teh rezultatov so v študiji razvoja zarodka in ploda pri podganah ocenili, da je raven brez ugotovljenih neželenih učinkov (no observed adverse effect level - NOAEL) blizu 4 mg/kg/dan (23-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC).
English: Of the remaining subjects in the lusutrombopag group, 15, 8, and 11 subjects received study drug for 4, 5, and 6 days, respectively.
Slovenian: Od preostalih bolnikov v skupini z lusutrombopagom je 15 bolnikov prejemalo raziskovano zdravilo 4 dni, 8 bolnikov 5 dni, 11 bolnikov pa 6 dni.
English: Lusutrombopag did not affect male and female fertility and early embryo development in rats at doses up to 100 mg/kg/day (176 and 252 times respectively, the human clinical exposures in adults based on AUC).
Slovenian: Lusutrombopag ni vplival na plodnost samcev in samic in zgodnji razvoj zarodka pri podganah v odmerkih do 100 mg/kg/dan (176-krat oziroma 252-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC).
English: ➤ Get medical help immediately if you notice any of these.
Slovenian: ➤ Če opazite kaj od naštetega, nemudoma poiščite zdravniško pomoč.
English: Of the remaining subjects in the placebo group, 5, 4, and 4 subjects received study drug for 4, 5, and 6 days, respectively.
Slovenian: Od preostalih bolnikov v skupini s placebom je 5 bolnikov prejemalo raziskovano zdravilo 4 dni, 4 bolniki 5 dni, 4 bolniki pa 6 dni.
English: The mean (range) maximum platelet count in subjects without platelet transfusion in the lusutrombopag group in Studies M0631 and M0634 was 90,200 (59,000 to 145,000)/µL and 86,900 (25,000 to 219,000)/µL, respectively; and the median (range) time to reach the maximum platelet count was 14.0 (6 to 28) days and 12.0 (5 to 35) days, respectively, and platelet count is expected to decrease thereafter.
Slovenian: 86.900 (25.000 do 219.000)/µl; mediani (razpon) časa, v katerem je bilo doseženo največje število trombocitov, pa je bil 14,0 (6 do 28) dni oziroma 12,0 (5 do 35) dni, pričakuje pa se, da se po tistem število trombocitov zmanjšuje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Mulpleo in all subsets of the paediatric population for thrombocytopenia secondary to liver disease (see section 4.2 for information on paediatric use).
Slovenian: Mulpleo za vse podskupine pediatrične populacije za trombocitopenijo, ki je posledica bolezni jeter (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The efficacy and safety of lusutrombopag have not been established when administered in patients with a history of splenectomy.
Slovenian: Uporaba pri bolnikih z anamnezo splenektomije Učinkovitost in varnost lusutrombopaga nista bili ugotovljeni za dajanje bolnikom z anamnezo splenektomije.
English: Age, gender and race
Slovenian: Farmakokinetika pri podskupinah Starost, spol in rasa
English: The ranges of observed Cmax and AUC0-τ overlapped among the patients with Child-Pugh class A, B, and C. Cmax and AUC0-τ of all patients with Child-Pugh class C did not exceed the maximum values from Child-Pugh class A and class B. Due to the limited information available, lusutrombopag should not be used in Child-Pugh class C patients unless the expected benefit outweighs the expected risks.
Slovenian: Cmax in AUC0-τ vseh bolnikov razreda C po Child-Pughu niso presegli največjih vrednosti v razredu A
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Slovenian: Pri bolnikih z blago (razred A po Child-Pughu) do zmerno (razred B po Child-Pughu) okvaro jeter prilagajanje odmerka ni potrebno.
English: There is limited information on the use of lusutrombopag in patients with body weight <45 Kg. Platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Slovenian: Število trombocitov je treba določiti vsaj enkrat približno 5 dni po prvem odmerku, pozneje pa po potrebi.
English: The time course of platelet counts in lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion in Studies M0631 and M0634 is presented in Figure 1.
Slovenian: Časovni potek števila trombocitov pri bolnikih, zdravljenih z lusutrombopagom brez transfuzije trombocitov, in pri bolnikih, ki so prejemali placebo in transfuzijo trombocitov v študijah M0631 in M0634, kaže slika 1.
English: If you take more than you should
Slovenian: Če ste vzeli večji odmerek zdravila Mulpleo, kot bi smeli
English: No effects on foetal viability embryo-foetal development were noted in rabbits at doses up to 1000 mg/kg/day (161 times the human clinical exposures in adults based on AUC).
Slovenian: Opazili niso nikakršnega vpliva na sposobnost preživetja ploda ali na razvoj zarodka in ploda pri kuncih v odmerkih do 1000 mg/kg/dan (161-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC).
English: Table 3 Proportion of Subjects who required no platelet transfusion during the study (Day 1 through Day 35)
Slovenian: Delež bolnikov, pri katerih med študijo (od 1. do 35. dne) ni bila potrebna transfuzija trombocitov
English: Adverse reactions with 3 mg of lusutrombopag once daily for up to 7 days in randomised, doubleblind, placebo-controlled trials in thrombocytopenic patients with chronic liver disease undergoing an invasive procedure (M0626, M0631 and M0634; N=171) are listed in Table 1 by MedDRA System Organ Class.
Slovenian: V preglednici 1 so navedeni neželeni učinki lusutrombopaga po organskih sistemih po MedDRA v randomiziranih, dvojno slepih, s placebom kontroliranih preskušanjih pri trombocitopeničnih bolnikih s kronično boleznijo jeter, ki so jim naredili invaziven poseg, pri odmerku 3 mg lusutrombopaga enkrat na dan do 7 dni (M0626, M0631 in M0634; N=171).
English: Lusutrombopag does not stimulate platelet production in the species used for toxicological testing because of unique human TPO receptor specificity.
Slovenian: 5.3 Predklinični podatki o varnosti Lusutrombopag zaradi edinstveno človeške specifičnosti receptorja za TPO ne spodbuja nastajanja trombocitov pri živalskih vrstah, ki so jih uporabili za toksikološko testiranje.
English: Platelet count should be measured prior to the procedure.
Slovenian: Pred posegom je treba določiti število trombocitov.
English: Proportion of subjects who required no platelet transfusion during the study (Day 1 through Day 35) The proportion of subjects who required no platelet transfusion during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 3).
Slovenian: Delež bolnikov, pri katerih med študijo ni bila potrebna transfuzija trombocitov, je bil značilno večji v skupinah z lusutrombopagom tako v posamičnih študijah kot v združeni (študiji M0631 in M0634)
English: Film-coating
Slovenian: SPROŠČANJE SERIJ
English: Table 2 Proportion of subjects who required no platelet transfusion and no rescue therapy Study M0631
Slovenian: Preglednica 2 Delež bolnikov, ki ni potreboval niti transfuzije trombocitov niti rešilnega zdravljenja
English: Tel: +44 (0)20 3053 4190 contact@shionogi.eu
Slovenian: Shionogi B.V Tel: +44 (0)20 3053 4190 contact@shionogi.eu
English: Severe hepatic impairment
Slovenian: Bolezni živčevja glavobol
English: Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Slovenian: Pri bolnikih z anamnezo splenektomije, zdravljenih z lusutrombopagom, je treba skrbno spremljati število trombocitov.
English: if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline.
Slovenian: Če število trombocitov doseže ≥ 50.000/µl, ker se je zvečalo za 20.000/µl od izhodišča, je treba izvesti ustrezne ukrepe, na primer ukinitev lusutrombopaga.
English: Children and adolescents
Slovenian: Nosečnost in dojenje
English: Embryo-foetal development
Slovenian: Razvoj zarodka in ploda
English: The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
Slovenian: M0631 in M0634) skupini z lusutrombopagom je bilo značilno daljše kot pri placebu (preglednica 5).
English: Appropriate measures such as discontinuation of lusutrombopag should be taken, if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL
Slovenian: ≥ 50.000/µl, ker se je zvečalo za 20.000/µl od izhodišča, je treba izvesti ustrezne ukrepe, na primer ukinitev lusutrombopaga.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: Medicinal product subject to medical prescription.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom
English: ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Slovenian: Trajanje zvečanja števila trombocitov na ≥ 50.000/μl Trajanje zvečanja števila trombocitov na ≥ 50.000/μl v študijah M0631 in M0634 in v združeni (študiji
English: Overall
Slovenian: Skupaj
English: Treatment Group
Slovenian: Appelhof 13
English: BN
Slovenian: B.
English: Table 1 Adverse reactions System Organ Class
Slovenian: Preglednica 1 Neželeni učinki
English: Mulpleo contains sodium
Slovenian: Shranjevanje zdravila Mulpleo
English: There were no effects on pregnancy, parturition, lactation in F0 dams and postnatal development in F1 pups at doses up to 12.5 mg/kg/day (89 times the human clinical exposures in adults based on AUC).
Slovenian: Pri odmerkih do 12,5 mg/kg/dan (89-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC) ni bilo učinkov na brejost, porod, laktacijo pri F0 samicah in na poporodni razvoj pri F1 mladičih.
English: The patients were treated for 4 weeks.
Slovenian: Bolniki so zdravilo prejemali 4 tedne.
English: The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Slovenian: Priporočeni odmerek je ena tableta na dan v obdobju do 2 tednov, dokler se simptomi ne izboljšajo.
English: The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Slovenian: Odbor je zaključil, da se lahko bolniki s tem zdravilom varno zdravijo sami do 2 tedna.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Slovenian: Pojasnjuje, kako je Agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
English: The CHMP concluded that the medicine's effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients' symptoms cleared up in 2 weeks.
Slovenian: CHMP je zaključil, da so učinki zdravila že dobro znani, saj so zdravila, ki vsebujejo esomeprazol, odobrena za uporabo v državah EU že od leta 2000, in da so bile njegove kratkotrajne koristi prikazane v študijah, v katerih so simptomi pri večini bolnikov izginili v 2 tednih.
English: The full EPAR for Nexium Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nexium Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If symptoms persist after 2 weeks, the patient should see a doctor.
Slovenian: Če se simptomi po 2 tednih ne izboljšajo, naj se bolnik posvetuje z zdravnikom.
English: The main measure of effectiveness in both studies was the percentage of patients whose heartburn symptoms had completely cleared up at the end of the study.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bil odstotek bolnikov, pri katerih so simptomi zgage na koncu študije popolnoma izginili.
English: This is a summary of the European public assessment report (EPAR) for Nexium Control.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nexium Control.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nexium Control, veljavno po vsej Evropski uniji, odobrila dne 26. avgusta 2013.
English: It is available as tablets (20 mg) which are gastro-resistant (the contents pass through the stomach without being broken down until they reach the intestine).
Slovenian: Zdravilo je na voljo v obliki gastrorezistentnih tablet (20 mg) (vsebina preide skozi želodec, ne da bi se tableta razgradila, dokler ne pride v črevesje).
English: In both studies, most patients whose symptoms completely cleared up had already achieved this in the first 2 weeks, while patients whose symptoms did not completely clear up in 2 weeks showed little further improvement from continued treatment.
Slovenian: V obeh študijah je večina bolnikov, pri katerih so simptomi popolnoma izginili, to dosegla že v prvih 2 tednih, pri bolnikih, pri katerih simptomi niso izginili v 2 tednih, pa so zabeležili le minimalno dodatno izboljšanje pri nadaljevanju zdravljenja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Nexium Control večje od z njim povezanih tveganj, in priporočil, da se zdravilo odobri za uporabo v EU.
English: The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
Slovenian: Referenčno zdravilo je na voljo le na recept, zdravilo Nexium Control pa je namenjeno kratkotrajni uporabi brez recepta.
English: What measures are being taken to ensure the safe and effective use of Nexium Control?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nexium Control?
English: Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Slovenian: Zdravila Nexium Control se ne sme uporabljati sočasno z drugim zdravilom, ki se imenuje nelfinavir (uporablja se za zdravljenje okužbe s HIV).
English: A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Nexium Control je bil pripravljen načrt obvladovanja tveganj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nexium Control vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Nexium Control esomeprazole
Slovenian: Nexium Control esomeprazol
English: Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Slovenian: Zdravilo Nexium Control so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo 718 odraslih bolnikov s simptomi refluksa, vključno z zgago.
English: It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Slovenian: Zdravilo se uporablja za kratkotrajno zdravljenje simptomov refluksa (imenovanega tudi refluks kisline), npr. zgage in regurgitacije kisline, pri odraslih.
English: By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Slovenian: Esomeprazol z zaviranjem črpalk zmanjša izločanje kisline ter tako izboljša simptome refluksa kisline.
English: Other information about Nexium Control
Slovenian: Druge informacije o zdravilu Nexium Control
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Slovenian: Esomeprazol deluje tako, da zavira „protonske črpalke“, tj. beljakovine v specializiranih celicah stene želodca, ki črpajo kislino v želodec.
English: For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nexium Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Nexium Control, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Nexium Control, glejte navodilo za uporabo.
English: For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Nexium Control naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Nexium Control is a medicine that contains the active substance esomeprazole.
Slovenian: Nexium Control je zdravilo, ki vsebuje zdravilno učinkovino esomeprazol.
English: Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Slovenian: Zdravilo Nexium Control je podobno „referenčnemu zdravilu“ Nexium, ki je že odobreno za uporabo v Evropski uniji (EU) in vsebuje enako zdravilno učinkovito.
English: In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).
Slovenian: V prvi študiji so pri bolnikih, ki so prejemali 20 mg zdravila Nexium Control, simptomi zgage izginili pri približno 34 % (pri 41 od 121) bolnikov v primerjavi s približno 14 % bolnikov (17 od 124), ki so prejemali placebo.
English: What benefits of Nexium Control have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Nexium Control izkazalo v študijah?
English: What is Nexium Control and what is it used for?
Slovenian: Kaj je zdravilo Nexium Control in za kaj se uporablja?