natgillin/translations-raw huggingface dataset:
The principal toxicity findings associated with lusutrombopag administration included prolongation of PT and APTT (rats), increased activities of plasma ALT and AST (rats and dogs), adrenal toxicity (rats and dogs), skin and forestomach lesions (rats) and renal toxicity (rats). 
PT-a i APTT-a (štakori), povećanu aktivnost ALT-a i AST-a u plazmi (štakori i psi), adrenalnu toksičnost (štakori i psi), lezije kože i predželuca (štakori) i bubrežnu toksičnost (štakori).
Figure 1 Time course profiles of platelet count in the Phase 3 studies in thrombocytopenic patients with chronic liver disease (lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion) Phase 3 Study M0631 
Slika 1 Profil broja trombocita tijekom vremena u ispitivanjima faze 3 u trombocitopeničnih bolesnika s kroničnom bolešću jetre (ispitanici liječeni lusutrombopagom bez transfuzije trombocita i ispitanici koji su primali placebo s transfuzijom trombocita) Faza 3 ispitivanja M0631
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). 
Lusutrombopag nije utjecao na plodnost mužjaka ili ženki štakora pri dozama s izloženošću do 176 odnosno 252 puta višom od kliničke izloženosti odraslih osoba na temelju AUC-a u muškaraca i žena (vidjeti dio 5.3).
NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Shionogi
There is limited information on the use of lusutrombopag in patients with severe (Child-Pugh class C) hepatic impairment (see section 5.1). 
Ograničene su informacije o primjeni lusutrombopaga u bolesnika s teškim (Child-Pugh stadij C) oštećenjem funkcije jetre (vidjeti dio 5.1).
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. 
Mjera primarnog ishoda u ispitivanju M0634 bila je udio ispitanika kojima nije bila potrebna transfuzija trombocita (tj. postignut broj trombocita bio je > 50 000/µl) prije primarnog invazivnog postupka, a hitna terapija zbog krvarenja nije im bila potrebna od trenutka randomizacije do 7 dana nakon primarnog invazivnog postupka.
A subject was considered a nonresponder if the subject met the responder criterion only after platelet transfusion. 
Ispitanikom u kojeg nije bilo terapijskog odgovora smatrao se ispitanik koji je zadovoljio kriterij za terapijski odgovor tek nakon transfuzije trombocita.
➤ Get medical help immediately if you notice any of these. 
➤Ako opazite bilo koji od ovih znakova, odmah potražite liječničku pomoć.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3 mg of lusutrombopag. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga.
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). 
Trajanje povećanja broja trombocita na ≥ 50 000/µl u ispitivanjima M0631 i M0634 i objedinjenoj skupini (ispitivanja M0631 i M0634) liječenoj lusutrombopagom bilo je značajno dulje nego ono uz placebo (tablica 5).
No dosage adjustment is necessary in patients with renal impairment (see section 5.2). 
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
On Day 5 to Day 7, the platelet count was measured before administration of study drug. 
Broj trombocita izmjeren je između 5. i 7. dana prije primjene ispitivanog lijeka.
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). 
Na temelju ovih rezultata, razina pri kojoj nisu opaženi štetni učinci (engl. no observed adverse effect level, NOAEL) u ispitivanju embriofetalnog razvoja u štakora procijenjena je na oko 4 mg/kg na dan (izloženost 23 puta viša od kliničke izloženosti odraslih osoba na temelju
P value [a] Proportion of subjects who required no platelet transfusion during the study (i.e., from Day 1 through Day 35). 
P vrijednost [a] Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja (tj. od 1. do 35. dana).
Marketing Authorisation Holder Shionogi B.V. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Shionogi B.V.
Of the remaining subjects in the placebo group, 5, 4, and 4 subjects received study drug for 4, 5, and 6 days, respectively. 
Od preostalih ispitanika u skupini koja je primala placebo, 5 ispitanika primalo je ispitivani lijek 4 dana, 4 ispitanika tijekom 5, a 4 tijekom 6 dana.
Table 3 Proportion of Subjects who required no platelet transfusion during the study (Day 1 through Day 35) 
Tablica 3 Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja (od 1. do 35. dana)
Duration of the increase in platelet count to ≥ 50,000/μL 
Trajanje povećanja broja trombocita na ≥ 50 000/μl
Kingsfordweg 151, 1043GR Amsterdam The Netherlands 
1043GR Amsterdam
In patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy the risk for thrombosis or thromboembolism may increase. 
Rizik od tromboze i tromboembolije može biti povećan u bolesnika s trombozom ili tromboembolijom, s anamnezom tromboze ili tromboembolije, bez hepatopetalnog protoka kroz glavno stablo portalne vene ili u bolesnika s kongenitalnom koagulopatijom.
A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of renal function on the pharmacokinetics of lusutrombopag. 
Analiza populacijske farmakokinetike na temelju koncentracije lusutrombopaga u plazmi u kliničkim ispitivanjima lusutrombopaga nije pokazala kinički značajan učinak funkcije bubrega na farmakokinetiku lusutrombopaga.
Mulpleo contains sodium 
Mulpleo sadrži natrij
Of the remaining subjects in the lusutrombopag group, 15, 8, and 11 subjects received study drug for 4, 5, and 6 days, respectively. 
Od preostalih ispitanika u skupini liječenoj lusutrombopagom, 15 ispitanika primalo je ispitivani lijek 4 dana, 8 ispitanika tijekom 5, a 11 tijekom 6 dana.
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). 
Nisu opaženi nikakvi učinci na vijabilnost fetusa ili embriofetalni razvoj kunića pri dozama do 1000 mg/kg na dan (izloženost 161 puta viša od kliničke izloženosti odraslih osoba na temelju AUC-a).
Adverse reaction - Common 
Nuspojava - često
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). 
Lusutrombopag nije utjecao na plodnost mužjaka i ženki i rani embrionalni razvoj štakora pri dozama do 100 mg/kg na dan (izloženost 176 odnosno 252 puta viša od kliničke izloženosti odraslih osoba na temelju AUC-a).
Study M0631 
Ispitivanje M0631 Ispitivanje M0634
Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use. 
U kliničkoj primjeni nisu zabilježene interakcije lijekova putem inhibicije i indukcije bilo kojeg enzima
Use in patients with a history of splenectomy 
Primjena u splenektomiranih bolesnika
Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts. 
Bez obzira na broj trombocita, potreban je oprez zbog mogućih tromboembolijskih događaja nakon invazivnih postupaka, kao i nakon liječenja.
Each film-coated tablet contains 3 mg lusutrombopag. 
Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga.
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. 
Promjene broja trombocita tijekom vremena u ispitanika liječenih lusutrombopagom bez transfuzije trombocita i ispitanika koji su primali placebo s transfuzijom trombocita u ispitivanjima M0631 i M0634 prikazane su na slici 1.
Red ferric oxide (E172) 
Film-ovojnica hipromeloza titanijev dioksid trietilcitrat talk crveni željezov oksid (E172)
Repeated toxicity 
Ponavljanje liječenja
Proportion of subjects [a] 75.5% 12.5% 64.8% 29.0% 68.2% 23.9% (number of subjects) 
59 000 do 145 000)/µl odnosno 86 900 (od 25 000 do 219 000)/µl.
Lusutrombopag acts on the haematopoietic stem cells and on the transmembrane domain of human TPO receptors expressed in megakaryocytes, to stimulate the megakaryocyte to proliferate and differentiate via the similar signal transduction pathway for up-regulating production used by endogenous TPO, thus leading to thrombocytopoiesis. 
čime potiče megakariocite na proliferaciju i diferencijaciju putem signalnog transdukcijskog puta za povećanje njihovog stvaranja sličnog onome kakvim se koristi endogeni TPO te tako dovodi do trombocitopoeze.
NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets 
NAZIV LIJEKA Mulpleo 3 mg filmom obložene tablete
High dose (10 mg/kg/day) and long-term treatment (8 weeks) of lusutrombopag has a potential risk of fibrosis in the bone marrow via human TPO receptor based on the results of study in TPOR-Ki/Shi mice with chimeric human transmembrane domain TPO receptor knocked-in to the mouse TPO receptor. 
Na temelju rezultata ispitivanja u miševa tipa TPOR-Ki/Shi s kimeričnom ljudskom transmembranskom domenom TPO-receptora ubačenom (engl. knocked-in) u mišji TPO receptor, kod visoke doze (10 mg/kg na dan) i dugotrajnog liječenja (8 tjedana) lusutrombopagom postoji potencijalni rizik od fibroze koštane srži posredovane ljudskim TPO receptorom.
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. 
Potrebno je odrediti broj trombocita barem jedanput približno 5 dana nakon prve doze, a poslije po potrebi.
Table 2 Proportion of subjects who required no platelet transfusion and no rescue therapy Study M0631 
Tablica 2 Udio ispitanika kojima nije bila potrebna ni transfuzija trombocita ni hitna terapija
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. 
U svih bolesnika s Child-Pugh stadijem C vrijednosti Cmax i AUC0-τ nisu premašile maksimalne vrijednosti kod Child-Pugh stadija A i stadija B.
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. 
Medijan (raspon) vremena do postizanja maksimalnog broja trombocita bio je 14,0 (od 6 do 28) dana te 12,0 (od 5 do 35) dana, a nakon toga se očekivalo smanjenje broja trombocita.
Platelet count should be measured prior to the procedure. 
Prije postupka mora se odrediti broj trombocita.
➤ Check with your doctor if this applies to you before you take Mulpleo 
➤ Prije nego što uzmete lijek Mulpleo provjerite sa svojim liječnikom vrijedi li ovo za Vas.
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). 
Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja bio je značajno veći i u skupinama liječenima lusutrombopagom u pojedinačnim ispitivanjima i u objedinjenoj skupini (ispitivanja M0631 i M0634) liječenoj lusutrombopagom u usporedbi s placebom (tablica 3).
Environmental risk assessment studies have shown that lusutrombopag has the potential to be very persistent, very bioaccumulative and toxic to the environment. 
Procjena rizika za okoliš (ERA) Ispitivanja procjene rizika za okoliš pokazala su da lusutrombopag može biti vrlo postojan,
Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio. 
Ispitanici su bili randomizirani u omjeru 1:1 u skupinu koja je primala lusutrombopag u dozi od 3 mg i skupinu koja je primala placebo.
if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline. 
≥ 50 000/μl uz povećanje za ≥ 20 000/μl od početne vrijednosti.
EU/1/18/1348 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1348
≥ 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). 
Udio ispitanika s terapijskim odgovorom Udio ispitanika koji su tijekom ispitivanja zadovoljili kriterij za terapijski odgovor (definiran kao povećanje broja trombocita na ≥ 50 000/μl uz povećanje za ≥ 20 000/μl od početne vrijednosti) bio je značajno veći i u skupinama liječenima lusutrombopagom u pojedinačnim ispitivanjima i u objedinjenoj (ispitivanja M0631 i M0634) skupini liječenoj lusutrombopagom u usporedbi s placebom (tablica 4).
In the phase 2b study one patient had portal vein thrombosis reported as a treatment-emergent adverse event (TEAE) in the lusutrombopag 2 mg and 4 mg groups. 
U skupinama liječenima lusutrombopagom u dozi od 2 mg i 4 mg u ispitivanju faze 2b, jedan je bolesnik imao trombozu portalne vene zabilježenu kao štetan događaj nastao tijekom liječenja (engl. treatment-emergent adverse event, TEAE).
How to store Mulpleo 
Moguće nuspojave Kako čuvati Mulpleo
Mild and moderate hepatic impairment (mild, Child-Pugh class A; moderate, Child-Pugh class B) is expected to have little effect on the pharmacokinetics of lusutrombopag. 
Child-Pugh stadij B) utjecati na farmakokinetiku lusutrombopaga.
Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag. 
U splenektomiranih bolesnika koji se liječe lusutrombopagom potrebno je pažljivo pratiti broj trombocita.
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). 
Nije bilo utjecaja na graviditet, parturiciju ili laktaciju u majki generacije F0 i postnatalni razvoj mladunčadi generacije F1 pri dozama do
Two Phase 3, randomised, double-blind, placebo-controlled studies were conducted to evaluate lusutrombopag versus placebo in thrombocytopenic (platelet count < 50,000/µL) subjects with chronic liver disease (Child-Pugh class A and B), undergoing elective invasive procedures (excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection) in Japan (M0631 (L-PLUS 1)) and multiple countries (M0634 (L-PLUS 2)). 
< 50 000/µl) s kroničnom bolešću jetre (Child-Pugh stadij A i B) u kojih su se provodili elektivni invazivni postupci (isključujući laparatomiju, torakotomiju, kraniotomiju, otvorenu operaciju srca,
NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets lusutrombopag 
Uputa o lijeku: Informacije za bolesnika Mulpleo 3 mg filmom obložene tablete lusutrombopag
Proportion of responders The proportion of subjects who met the responder criterion (defined as platelet count increase to 
P vrijednost [a] Ispitanik s terapijskim odgovorom definiran je kao ispitanik u kojeg je broj trombocita postigao vrijednost
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg lusutrombopag 
Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga
Film-coating 
Česte nuspojave
Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Inhibitori P-glikoproteina i proteina rezistencije raka dojke Lusutrombopag je supstrat P-glikoproteina (P-gp) i proteina rezistencije raka dojke (BCRP), ali nije supstrat prijenosnika OATP1B1, OATP1B3 i OCT1.
The patients were treated for 4 weeks. 
Bolesnici su liječeni 4 tjedna.
The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved. 
Preporučena doza je jedna tableta po danu do 2 tjedna sve dok se simptomi ne povuku.
If symptoms persist after 2 weeks, the patient should see a doctor. 
Ako se simptomi nastave nakon 2 tjedna, bolesnik se mora obratiti liječniku.
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). 
Dostupne su kao tablete (20 mg) koje su želučano otporne (sadržaj prolazi kroz želudac bez razgradnje sve dok ne dođe u crijeva).
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. 
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Nexium Control može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks. 
Povjerenstvo je zaključilo da se bolesnici mogu sigurno liječiti ovim lijekom do 2 tjedna.
A risk management plan has been developed to ensure that Nexium Control is used as safely as possible. 
Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Nexium Control koristi što je sigurnije moguće.
This is a summary of the European public assessment report (EPAR) for Nexium Control. 
Ovo je sažetak Europskog javnog izvješća o ocjeni (EPAR) za Nexium Control.
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. 
Glavna mjera djelotvornosti u oba ispitivanja bio je postotak bolesnika čiji su simptomi žgaravice potpuno povukli na kraju ispitivanja.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. 
Njime se objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te se navode uvjeti za njegovu primjenu.
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. 
CHMP je zaključio da su učinci lijekova već utvrđeni jer su lijekovi koji sadrže esomeprazol odobreni u EU-a od 2000. godine i da su njihove kratkoročne dobrobiti dokazane u ispitivanjima na bolesnicima čiji su se simptomi povukli u 2 tjedna.
Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection). 
Nexium Control ne smiju se koristiti skupa s drugim lijekom zvanim nelfinavir (koji se koristi za liječenje infekcije HIV-om).
It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation. 
Koristi se kod odraslih za kratkoročno liječenje simptoma refluksa (ponekad zvan i refluks kiseline), poput žgaravice i regurgitacije kiseline.
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. 
U oba ispitivanja većina bolesnika čiji su se simptomi potpuno povukli već su postigli to u prva dva tjedna dok su bolesnici čiji se simptomi nisu potpuno povukli u 2 tjedna imali slabo poboljšanje od nastavka liječenja.
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach. 
Djeluje blokadom „protonskih crpki”, proteina koji se nalaze u specijaliziranim stanicama sluznice želuca koje pumpaju kiselinu u želudac.
The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013. 
Europska komisija izdala je odobrenje za stavljanje u promet koje za Nexium Control vrijedi na prostoru Europske unije od 26. kolovoza 2013.
Nexium Control can be obtained without a prescription. 
Nexium Control može se nabaviti bez recepta.
Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium. 
Nexium Control je sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) koji sadrži istu djelatnu tvar, zvanu Nexium.
Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn. 
Nexium Control uspoređen je s placebom (slijepo liječenje) u dva glavna ispitivanja koja su uključivala 718 odraslih bolesnika sa simptomima refluksa uključujući žgaravicu.
Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients). 
Glavobolja, bol u trbuhu, proljev i mučnina među najčešćim su nuspojavama s lijekom Nexium Control (koje se mogu javiti u 1 do 10 bolesnika).
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. 
Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Nexium Control nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription. 
Referentni lijek dostupan je samo uz recept, ali Nexium Control namijenjen je za kratkoročnu upotrebu bez recepta.
It is not intended to provide practical advice on how to use Nexium Control. 
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Nexium Control.
Other information about Nexium Control 
Druge informacije o lijeku Nexium Control
By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux. 
Blokadom crpki esomeprazol reducira stvaranje kiseline i tako olakšava refluks kiseline.
What measures are being taken to ensure the safe and effective use of Nexium Control? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nexium Control?
Nexium Control esomeprazole 
Nexium Control esomeprazol
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. 
Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Nexium Control uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.