FrancophonIA/ELRC3.0 huggingface dataset:
English: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20.
English: Less than 1% of the parent compound is found in urine.
Croatian: U urinu se pojavljuje manje od 1% ishodišnog spoja.
English: Poor metabolisers
Croatian: Spori metabolizatori
English: Elderly patients (≥65 years old) The metabolism of esomeprazole is not significantly changed in elderly patients (71-80 years of age).
Croatian: Starije osobe (≥ 65 godina) Metabolizam esomeprazola nije značajno drugačiji u starijih ispitanika (71-80 godina).
English: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, supstituirane benzimidazole ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravan ili neizravan štetni učinak na reprodukciju (vidjeti dio 5.3).
English: Therapeutic monitoring of digoxin should then be reinforced.
Croatian: U tom slučaju treba pojačati nadzor nad terapijskim učincima digoksina.
English: No specific antidote is known.
Croatian: Nije poznat specifičan protulijek.
English: There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
Croatian: Teški oblici mjehurića i krvarenja mogu se pojaviti i na usnama, očima, ustima, nosu i genitalijama.
English: If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Croatian: Ako se simptomi ne ublaže unutar 2 tjedna kontinuiranog liječenja, bolesnika treba uputiti da se obrati liječniku.
English: The clinical importance and the mechanisms behind these reported interactions are not always known.
Croatian: Nisu uvijek poznati klinički značaj i mehanizmi u podlozi ovih interakcija.
English: Psychiatric disorders insomnia agitation, confusion, depression aggression, hallucinations
Croatian: Psihijatrijski poremećaji nesanica agitacija, konfuzija, depresija agresivnost, halucinacije
English: However, caution should be exercised when esomeprazole is given at high doses in elderly patients.
Croatian: Međutim, neophodan je oprez kod primjene visokih doza esomeprazola u starijih bolesnika.
English: If you have persistent or longstanding, frequently recurring symptoms even after treatment with this medicine, you should contact your doctor.
Croatian: Ako imate uporne ili dugotrajne simptome koji se često javljaju čak i nakon liječenja ovim lijekom, obratite se liječniku.
English: • Aggression
Croatian: • agresivnost
English: • You begin to vomit food or blood, which may appear as dark coffee grounds in your vomit.
Croatian: • Ako počnete povraćati hranu ili krv, povraćanje krvi može izgledati kao talog crne kave u povraćenu sadržaju.
English: • Enlarged breasts in men.
Croatian: • povećanje dojki u muškaraca.
English: Since the kidney is responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the parent compound, the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function.
Croatian: Budući da su bubrezi odgovorni za izlučivanje metabolita esomeprazola, ali ne i za eliminaciju ishodišnog spoja, ne očekuje se promjena u metabolizmu esomeprazola u bolesnika s oštećenom bubrežnom funkcijom.
English: Once complete relief of symptoms has occurred, treatment should be discontinued.
Croatian: Kada se simptomi u potpunosti povuku, liječenje se mora prekinuti.
English: Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao ljekarnik.
English: Do not use if you are allergic to esomeprazole or any of the other ingredients of this medicine.
Croatian: Nemojte uzimati ako ste alergični na esomeprazol ili neki drugi sastojak ovog lijeka.
English: Elderly patients (≥65 years old) Dose adjustment is not required in elderly patients.
Croatian: Starije osobe (≥ 65 godina) Nije potrebno prilagođavati dozu u starijih bolesnika.
English: Nexium Control contains sugar spheres, which contain sucrose, a type of sugar.
Croatian: Nexium Control sadrži šećerne kuglice, koje sadrže saharozu, jednu vrstu šećera.
English: Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical studies (and also from post-marketing use).
Croatian: Glavobolja, bol u abdomenu, proljev i mučnina neke su od najčešće prijavljenih nuspojava u kliničkim ispitivanjima (i nakon stavljanja lijeka u promet).
English: An interaction is observed between clopidogrel and esomeprazole.
Croatian: Primijećena je interakcija između klopidogrela i esomeprazola.
English: You should not use this medicine during breast-feeding.
Croatian: Ne smijete uzimati ovaj lijek tijekom dojenja.
English: However, patients with severe liver impairment should be advised by a doctor before taking Nexium Control (see sections 4.4 and 5.2).
Croatian: Bolesnici s teškim oštećenjem jetre moraju se posavjetovati s liječnikom prije uzimanja lijeka Nexium Control (vidjeti dijelove 4.4 i 5.2).
English: Metabolism and nutrition disorders peripheral oedema hyponatraemia hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia; hypomagnesaemia may also result in hypokalaemia
Croatian: Poremećaji metabolizma i prehrane periferni edem hiponatrijemija hipomagnezijemija; teška hipomagnezijemija može biti povezana s hipokalcijemijom; hipomagnezijemija također može dovesti do hipokalijemije
English: The clinical relevance of this interaction is uncertain.
Croatian: Nije utvrđen klinički značaj te interakcije.
English: • Do not take more than this recommended dose of one capsule (20 mg) a day, even if you don't feel an improvement immediately.
Croatian: • Nemojte uzeti više od preporučene doze od jedne kapsule (20 mg) na dan, čak ni ako odmah ne osjetite poboljšanje.
English: Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated (see section 4.3 and 4.4).
Croatian: S obzirom na slične farmakodinamičke učinke i farmakokinetička svojstva omeprazola i esomeprazola, istodobna primjena esomeprazola i atazanavira se ne preporučuje, a istodobna primjena esomeprazola i nelfinavira je kontraindicirana (vidjeti dijelove 4.3 i 4.4).
English: Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).
Croatian: Zbog ograničenog iskustva u bolesnika s teškom bubrežnom insuficijencijom, preporučuje se oprez u liječenju tih bolesnika (vidjeti dio 5.2).
English: Tell your doctor immediately before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease.
Croatian: Odmah obavijestite svog liječnika ako prije ili nakon uzimanja ovog lijeka primijetite neki od sljedećih simptoma, koji mogu biti znak neke druge, ozbiljnije bolesti.
English: • Do not take more than this recommended dose of one tablet (20 mg) a day, even if you don't feel an improvement immediately.
Croatian: • Nemojte uzeti više od preporučene doze od jedne tablete (20 mg) na dan, čak ni ako odmah ne osjetite poboljšanje.
English: Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure.
Croatian: Povećanje doze atazanavira na 400 mg nije kompenziralo učinak omeprazola na izloženost atazanaviru.
English: • You can take your capsule at any time of the day either with food or on an empty stomach.
Croatian: Uzimanje ovog lijeka • Kapsulu možete uzeti u bilo koje doba dana, s hranom ili na prazan želudac.
English: • You get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Nexium Control.
Croatian: • Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije moguće, jer ćete možda morati prekinuti liječenje lijekom Nexium Control.
English: Pharmacotherapeutic group: Drugs for acid related disorders, proton pump inhibitors, ATC code: A02BC05.
Croatian: Farmakoterapijska skupina: Lijekovi za poremećaje kiselosti, inhibitori protonske pumpe, ATK oznaka: A02BC05.
English: This medicinal product contains sugar spheres (sucrose).
Croatian: Ovaj lijek sadrži šećerne kuglice (saharozu).
English: • If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na esomeprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • The recommended dose is one tablet a day.
Croatian: • Preporučena doza je jedna tableta na dan.
English: • Blood problems such as a reduced number of white blood cells or platelets.
Croatian: • problemi s krvnom slikom, kao što je smanjen broj bijelih krvnih stanica ili krvnih pločica.
English: The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma.
Croatian: Ostatak ovisi o drugoj specifičnoj izoformi, CYP3A4, odgovornoj za stvaranje esomeprazolsulfona, glavnog metabolita u plazmi.
English: The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole.
Croatian: Blago produljeni QTc-interval primijećen nakon primjene samog cisaprida nije se dodatno produljio kad je cisaprid primijenjen u kombinaciji s esomeprazolom.
English: Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Croatian: Bolesnici stariji od 55 godina, koji svakodnevno uzimaju bezreceptne lijekove za indigestiju ili žgaravicu, moraju o tome obavijestiti svog ljekarnika ili liječnika.
English: The capsules should be swallowed whole.
Croatian: Kapsule treba progutati cijele.
English: You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
Croatian: Osobito je važno da obavijestite liječnika ili ljekarnika ako uzimate klopidogrel (koristi se za sprječavanje nastanka krvnih ugrušaka).
English: • If you are suffering from any of the side effects detailed in Section 4 which require medical attention.
Croatian: • Ako imate bilo koju od nuspojava opisanih u dijelu 4. koja zahtijeva liječničku intervenciju.
English: Approximately 2.9±1.5% of the population lack a functional CYP2C19 enzyme and are called poor metabolisers.
Croatian: Približno 2,9±1,5% populacije nema funkcionalan enzim CYP2C19 te ih se naziva sporim metabolizatorima.
English: • The recommended dose is one capsule a day.
Croatian: • Preporučena doza je jedna kapsula na dan.
English: Do not take this medicine with other medicines that limit the amount of acid produced in your stomach such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an H2 antagonist (e.g. ranitidine or famotidine).
Croatian: Nemojte uzimati ovaj lijek s drugim lijekovima koji smanjuju stvaranje kiseline u želucu poput inhibitora protonske pumpe (npr. pantoprazola, lanzoprazola, rabeprazola ili omeprazola) ili antagonista H2 receptora (npr. ranitidina ili famotidina).
English: The symptoms described in connection with 280 mg esomeprazole were gastrointestinal symptoms and weakness.
Croatian: Simptomi opisani kod primjene doze od 280 mg bili su gastrointestinalni simptomi i slabost.
English: The capsule has a yellow centre band, and contains yellow and purple enteric coated pellets.
Croatian: Kapsula ima žutu prugu na sredini te sadrži žute i ljubičaste pelete sa želučanootpornom ovojnicom.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of esomeprazole.
Croatian: Umjerena količina podataka o primjeni u trudnica (između 300-1000 ishoda trudnoće) pokazuje da esomeprazol ne uzrokuje malformacije niti feto/neonatalnu toksičnost.
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium Control.
Croatian: Ako nastupe lezije, posebice na suncem izloženim područjima kože, te ako su popraćene artralgijom, bolesnik treba odmah potražiti medicinsku pomoć, a zdravstveni radnik treba razmotriti prekid liječenja lijekom Nexium Control.
English: Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H
Croatian: Esomeprazol je slaba lužina koja se koncentrira i pretvara u aktivni oblik u izrazito kiselom okruženju sekretornih kanalića unutar parijetalnih stanica gdje inhibira djelovanje H
English: Other medicines and Nexium Control
Croatian: Drugi lijekovi i Nexium Control
English: They work by reducing the amount of acid that your stomach produces.
Croatian: Djeluju tako da smanjuju količinu kiseline koja se stvara u želucu.
English: The median time to first resolution of night-time heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) and approaching significance in the other (p=0.069).
Croatian: Medijan vremena do prvog povlačenja noćne žgaravice iznosio je 1 dan što je statistički značajno u usporedbi s placebom u jednom ispitivanju (p=0,048) te se značajno približava u drugom (p=0,069).
English: Esomeprazole is 97% plasma protein bound.
Croatian: Za proteine u plazmi veže se 97% esomeprazola.
English: If affected, you should not drive or use machines.
Croatian: Ako do toga dođe, ne smijete upravljati vozilima niti raditi sa strojevima.
English: Symptoms associated with acid reflux (such as heartburn and acid regurgitation) were evaluated retrospectively over a 24 hour period.
Croatian: Simptomi povezani s refluksom želučane kiseline (poput žgaravice i regurgitacije kiseline) ocijenjeni su retrospektivno tijekom razdoblja od 24 sata.
English: Almost 80% of an oral dose of esomeprazole is excreted as metabolites in the urine, the remainder in the faeces.
Croatian: Gotovo 80% peroralne doze esomeprazola izlučuje se u urinu u obliku metabolita, a ostatak fecesom.
English: However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
Croatian: Međutim, prilagodbu doze treba razmotriti u bolesnika s teškim oštećenjem jetre i u slučajevima kada je indicirano dugotrajno liječenje.
English: The capsules must not be chewed, crushed or opened.
Croatian: Kapsule se ne smiju žvakati, drobiti niti otvarati.
English: If affected, patients should not drive or use machines.
Croatian: Ako do toga dođe, bolesnici ne smiju upravljati vozilima niti raditi sa strojevima.
English: It is important for you to give information about your medicine at this time.
Croatian: Važno je da u tom trenutku liječnika obavijestite o lijekovima koje uzimate.
English: Both the Rand S-isomer of omeprazole have similar pharmacodynamic activity.
Croatian: Oba izomera omeprazola, R-izomer i S-izomer, imaju sličnu farmakodinamičku aktivnost.
English: If you notice any of the following serious side effects, stop taking Nexium Control and contact a doctor immediately:
Croatian: Ako primijetite bilo koju od navedenih ozbiljnih nuspojava, prestanite uzimati Nexium Control i odmah se obratite svom liječniku:
English: • You can take your tablet at any time of the day either with food or on an empty stomach.
Croatian: Uzimanje ovog lijeka • Tabletu možete uzeti u bilo koje doba dana, s hranom ili na prazan želudac.
English: There is very limited experience to date with deliberate overdose.
Croatian: Dosadašnje iskustvo s namjernim predoziranjem je vrlo oskudno.
English: • You have had a stomach ulcer or stomach surgery in the past.
Croatian: • Ako ste u prošlosti imali želučani čir ili operaciju želuca.
English: Esomeprazole 20 mg should not be exceeded.
Croatian: Ne smije se prekoračiti doza esomeprazola od 20 mg.
English: Alternative method of taking this medicine
Croatian: Drugi način uzimanja ovoga lijeka
English: Absorption of esomeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose.
Croatian: Apsorpcija esomeprazola je brza, a vršne koncentracije u plazmi postižu se približno 1-2 sata nakon primjene.
English: This time and dose-dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by esomeprazole and/or its sulphone metabolite.
Croatian: Ova ovisnost o vremenu i dozi nastaje zbog smanjenog metabolizma prvog prolaza i sistemskog klirensa, što je vjerojatno uzrokovano inhibicijom enzima CYPC19 esomeprazolom i/ili njegovim sulfonskim metabolitom.
English: The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight.
Croatian: Prividni volumen raspodjele u stanju dinamičke ravnoteže u zdravih ispitanika iznosi otprilike 0,22 l/kg tjelesne težine.
English: • They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Croatian: • ako primaju kontinuirano simptomatsko liječenje za indigestiju ili žgaravicu tijekom 4 tjedna ili dulje.
English: Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of acid secretion and exposure has been shown.
Croatian: Kad se AUC koristio kao zamjenski pokazatelj koncentracije u plazmi, pokazalo se da postoji veza između inhibicije lučenja kiseline i izloženosti lijeku.
English: Nexium Control is available in pack sizes of 7 and 14 gastro-resistant tablets in blisters.
Croatian: Nexium Control dostupan je u pakiranjima od 7 i 14 želučanootpornih tableta u blisterima.
English: The absolute bioavailability is 64% after a single dose of 40 mg and increases to 89% after repeated once-daily administration.
Croatian: Apsolutna bioraspoloživost nakon jedne doze od 40 mg iznosi 64%, a povećava se na 89% nakon višekratne primjene jedanput na dan.
English: • Increased liver enzymes shown in blood tests that check how the liver is working.
Croatian: • povišene vrijednosti jetrenih enzima prikazane u krvnim nalazima koji pokazuju jetrenu funkciju
English: • Rash, possibly with pain in the joints.
Croatian: • osip, moguće praćen boli u zglobovima.
English: If you have very low levels of magnesium, you may also have low levels of calcium and/or potassium in your blood.
Croatian: možda su Vam niske i razine kalcija i/ili kalija u krvi
English: In vivo conversion to the R-isomer is negligible.
Croatian: Pretvaranje u R-izomer in vivo je zanemarivo.
English: The following adverse reactions have been identified or suspected in the clinical studies programme for esomeprazole and post-marketing.
Croatian: Sljedeće su nuspojave utvrđene ili se na njih posumnjalo u programu kliničkih ispitivanja esomeprazola te nakon stavljanja lijeka u promet.
English: Alternatively, the tablet can be dispersed in half a glass of non-carbonated water.
Croatian: Alternativno se tableta može otopiti u pola čaše negazirane vode.
English: Tell your doctor or pharmacist if you are taking any of the following medicines: • Ketoconazole and itraconazole (used to treat infections caused by a fungus)
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova: • Ketokonazol i itrakonazol (koriste se za liječenje gljivičnih infekcija)
English: In case of clopidogrel, a prodrug which is transformed into its active metabolite via CYP2C19, the plasma concentrations of the active metabolite may be decreased.
Croatian: U slučaju klopidogrela, predlijeka koji se pretvara u aktivni metabolit posredstvom CYP2C19, koncentracije aktivnog metabolita u plazmi mogu biti snižene.
English: • You are due to have an endoscopy or a urea breath test.
Croatian: • Ako trebate napraviti endoskopiju ili urea izdisajni test.
English: - If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole,
Croatian: • ako ste alergični na lijekove koji sadrže druge inhibitore protonske pumpe (npr. pantoprazol,
English: Esomeprazole is completely metabolised by the cytochrome P450 system (CYP).
Croatian: Esomeprazol se u potpunosti metabolizira sustavom citokroma P450 (CYP).
English: What Nexium Control is and what it is used for
Croatian: Što je Nexium Control i za što se koristi
English: Yellow iron oxide (E172)
Croatian: Pruga želatina žuti željezov oksid (E172)
English: There is no relevant use of Nexium Control in the paediatric population below 18 years of age for the indication of “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”.
Croatian: Nema relevantne primjene lijeka Nexium Control u pedijatrijskoj populaciji (ispod 18 godina starosti) za indikaciju „kratkotrajnog liječenja simptoma refluksa (npr. žgaravice i regurgitacije želučane kiseline)“.
English: It is a specific inhibitor of the acid pump in the parietal cell.
Croatian: Specifični je inhibitor protonske pumpe u parijetalnim stanicama.
English: Indigo carmine (E132) Erythrosine (E127) Allura red AC (E129)
Croatian: Ovojnica kapsule želatina bojilo Indigo carmine (E132) bojilo Erythrosine (E127) bojilo Allura red AC (E129)
English: The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing.
Croatian: Poluvrijeme eliminacije iz plazme iznosi oko 1,3 sata nakon višekratne primjene jedanput na dan.
English: To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Croatian: Kako bi se izbjegla ova interferencija, liječenje lijekom Nexium Control 20 mg želučanootporne tablete potrebno je prekinuti najmanje pet dana prije mjerenja CgA (vidjeti dio 5.1).
English: Talk to your pharmacist or doctor if:
Croatian: Obavijestite ljekarnika ili liječnika:
English: • They have jaundice or severe liver disease.
Croatian: • ako imaju žuticu ili tešku bolest jetre.
English: You may take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or combinations of these) if needed.
Croatian: Po potrebi možete ovaj lijek uzeti s antacidima (npr. magaldratom, alginatnom kiselinom, natrijevim bikarbonatom, aluminijevim hidroksidom, magnezijevim karbonatom ili kombinacijom navedenih lijekova).
English: Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two out of ten subjects).
Croatian: Istodobna primjena omeprazola (20 mg na dan) i digoksina u zdravih ispitanika povećala je bioraspoloživost digoksina za 10% (do 30% u dva od deset ispitanika).
English: If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
Croatian: Ako se procijeni da je kombinacija atazanavira s inhibitorom protonske pumpe neizbježna, preporučuje se strogi klinički nadzor i povećanje doze atazanavira na 400 mg uz 100 mg ritonavira.
English: dry mouth stomatitis, gastrointestinal candidiasis microscopic colitis
Croatian: suha usta stomatitis, kandidijaza u gastrointestinalnom traktu mikroskopski kolitis
English: Corresponding proportions for esomeprazole 40 mg were 97%, 92%, and 56%.
Croatian: Za esomeprazol u dozi od 40 mg odgovarajući udjeli bili su 97%, 92% odnosno 56%.