FrancophonIA/ELRC3.0 huggingface dataset:
English: Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Croatian: U splenektomiranih bolesnika koji se liječe lusutrombopagom potrebno je pažljivo pratiti broj trombocita.
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).
Croatian: Nije bilo utjecaja na graviditet, parturiciju ili laktaciju u majki generacije F0 i postnatalni razvoj mladunčadi generacije F1 pri dozama do
English: 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)).
Croatian: < 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,
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets lusutrombopag
Croatian: Uputa o lijeku: Informacije za bolesnika Mulpleo 3 mg filmom obložene tablete lusutrombopag
English: Proportion of responders The proportion of subjects who met the responder criterion (defined as platelet count increase to
Croatian: P vrijednost [a] Ispitanik s terapijskim odgovorom definiran je kao ispitanik u kojeg je broj trombocita postigao vrijednost
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg lusutrombopag
Croatian: Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga
English: Film-coating
Croatian: Česte nuspojave
English: Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1.
Croatian: 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.
English: The patients were treated for 4 weeks.
Croatian: Bolesnici su liječeni 4 tjedna.
English: The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Croatian: Preporučena doza je jedna tableta po danu do 2 tjedna sve dok se simptomi ne povuku.
English: If symptoms persist after 2 weeks, the patient should see a doctor.
Croatian: Ako se simptomi nastave nakon 2 tjedna, bolesnik se mora obratiti liječniku.
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).
Croatian: Dostupne su kao tablete (20 mg) koje su želučano otporne (sadržaj prolazi kroz želudac bez razgradnje sve dok ne dođe u crijeva).
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.
Croatian: 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.
English: The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Croatian: Povjerenstvo je zaključilo da se bolesnici mogu sigurno liječiti ovim lijekom do 2 tjedna.
English: A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Nexium Control koristi što je sigurnije moguće.
English: This is a summary of the European public assessment report (EPAR) for Nexium Control.
Croatian: Ovo je sažetak Europskog javnog izvješća o ocjeni (EPAR) za Nexium Control.
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.
Croatian: Glavna mjera djelotvornosti u oba ispitivanja bio je postotak bolesnika čiji su simptomi žgaravice potpuno povukli na kraju ispitivanja.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Njime se objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te se navode uvjeti za njegovu primjenu.
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.
Croatian: 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.
English: Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Croatian: Nexium Control ne smiju se koristiti skupa s drugim lijekom zvanim nelfinavir (koji se koristi za liječenje infekcije HIV-om).
English: It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Croatian: Koristi se kod odraslih za kratkoročno liječenje simptoma refluksa (ponekad zvan i refluks kiseline), poput žgaravice i regurgitacije kiseline.
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.
Croatian: 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.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Croatian: Djeluje blokadom „protonskih crpki”, proteina koji se nalaze u specijaliziranim stanicama sluznice želuca koje pumpaju kiselinu u želudac.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Nexium Control vrijedi na prostoru Europske unije od 26. kolovoza 2013.
English: Nexium Control can be obtained without a prescription.
Croatian: Nexium Control može se nabaviti bez recepta.
English: Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Croatian: Nexium Control je sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) koji sadrži istu djelatnu tvar, zvanu Nexium.
English: Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Croatian: Nexium Control uspoređen je s placebom (slijepo liječenje) u dva glavna ispitivanja koja su uključivala 718 odraslih bolesnika sa simptomima refluksa uključujući žgaravicu.
English: 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).
Croatian: Glavobolja, bol u trbuhu, proljev i mučnina među najčešćim su nuspojavama s lijekom Nexium Control (koje se mogu javiti u 1 do 10 bolesnika).
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.
Croatian: 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.
English: The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
Croatian: Referentni lijek dostupan je samo uz recept, ali Nexium Control namijenjen je za kratkoročnu upotrebu bez recepta.
English: It is not intended to provide practical advice on how to use Nexium Control.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Nexium Control.
English: Other information about Nexium Control
Croatian: Druge informacije o lijeku Nexium Control
English: By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Croatian: Blokadom crpki esomeprazol reducira stvaranje kiseline i tako olakšava refluks kiseline.
English: What measures are being taken to ensure the safe and effective use of Nexium Control?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nexium Control?
English: Nexium Control esomeprazole
Croatian: Nexium Control esomeprazol
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.
Croatian: 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.
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).
Croatian: U prvom ispitivanju, oko 34 % bolesnika koji su uzimali 20 mg lijeka Nexium Control (41 od 121 bolesnika) više nije imalo simptome žgaravice u usporedbi s približno 14 % bolesnika koji su uzimali placebo (17 od 124).
English: In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
Croatian: U drugom ispitivanju, oko 42 % bolesnika koji su uzimali Nexium Control (47 od 113 bolesnika) više nije imalo simptome žgaravice, u usporedbi s 12 % bolesnika koji su uzimali placebo (14 od 118 bolesnika).
English: For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Nexium Control bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju s Nexium Control pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Croatian: Djelatna tvar u lijeku Nexium Control je esomeprazol, inhibitor protonske crpke.
English: Why is Nexium Control approved?
Croatian: Zašto je Nexium Control odobren?
English: What is Nexium Control and what is it used for?
Croatian: Što je Nexium Control i za što se koristi?
English: What are the risks associated with Nexium Control?
Croatian: Koji su rizici povezani s lijekom Nexium Control?
English: Nexium Control is a medicine that contains the active substance esomeprazole.
Croatian: Nexium Control je lijek koji sadrži djelatnu tvar esomeprazol.
English: For the full list of all side effects reported with Nexium Control, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s Nexium Control potražite u uputi o lijeku.
English: What benefits of Nexium Control have been shown in studies?
Croatian: Koje su koristi lijeka Nexium Control dokazane u ispitivanjima?
English: How does Nexium Control work?
Croatian: Kako djeluje Nexium Control?
English: How is Nexium Control used?
Croatian: Kako se Nexium Control koristi?
English: This combination is, therefore, not recommended.
Croatian: Stoga se ova kombinacija ne preporučuje.
English: Practically all the drug is eliminated within 6 days.
Croatian: Praktički sav lijek se eliminira unutar 6 dana.
English: HDPE bottle 3 years.
Croatian: HDPE boca 3 godine.
English: The volume of distribution is about 0.5 l/kg.
Croatian: Volumen distribucije je oko 0,5 l/kg.
English: This is a very rare reaction which can be serious if it occurs.
Croatian: Ovo je vrlo rijetka reakcija koja, ako se dogodi, može biti ozbiljna.
English: The following two side effects are important and will require immediate action.
Croatian: Sljedeće dvije nuspojave su važne i zahtijevaju trenutno djelovanje.
English: These changes are specific to small rodents and have not been observed in other animal species.
Croatian: Ove su promjene specifične za male glodavce i nisu primijećene u drugih životinjskih vrsta.
English: - Tell your doctor about all your medical conditions including allergies.
Croatian: - Obavijestite liječnika o svim Vašim zdravstvenim stanjima uključujući alergije.
English: Swallow the capsule with water.
Croatian: Kapsulu progutajte s vodom.
English: - You should always keep your alcohol intake to a minimum.
Croatian: - Uzimanje alkohola morate svesti na minimum.
English: They may raise your risk of having heart problems.
Croatian: Oni mogu povisiti Vaš rizik za razvoj srčanih problema.
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Croatian: Mehanizam ove interakcije (bilo da je farmakodinamička, farmakokinetička, ili oboje) još uvijek nije poznat.
English: If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Croatian: Ako Vas brine koliko alkohola smijete popiti dok uzimate ovaj lijek, raspravite to sa svojim liječnikom.
English: Always take Pravafenix exactly as your doctor has told you.
Croatian: Uvijek uzimajte Pravafenix točno onako kako Vam je rekao liječnik.
English: The clinical significance of this is not clear.
Croatian: Klinički značaj navedenog još nije jasan.
English: This is of no relevance to therapeutic use in man.
Croatian: Ovo nema važnosti za terapijsku primjenu u čovjeka.
English: In most people, there are no signs of cholesterol problems at first.
Croatian: U većine ljudi u početku nema znakova problema uzrokovanih kolesterolom.
English: What should I know about cholesterol and triglycerides?
Croatian: Što trebam znati o kolesterolu i trigliceridima?
English: - Children and adolescents (age below 18 years).
Croatian: - Djeca i adolescenti (u dobi ispod 18 godina)
English: Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant.
Croatian: Nemojte uzimati Pravafenix ako ste trudni, nastojite zatrudnjeti ili mislite da biste mogli biti trudni.
English: The increase in AUC
Croatian: Povećanje AUC
English: For any information over this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
English: - Tell your doctor if you drink large amounts of alcohol (if you drink more than the recommended daily amount; ask your doctor or pharmacist if you are unsure) or have ever had liver disease.
Croatian: - Obavijestite liječnika ako pijete velike količine alkohola (ako pijete više od preporučene dnevne količine; pitajte svog liječnika ili ljekarnika ako niste sigurni) ili ste nekad imali bolest jetre.
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Croatian: Ovo začepljenje može usporiti ili blokirati protok krvi do vitalnih organa kao što su srce i mozak.
English: If you are not sure about this, please follow your doctor's advice.
Croatian: Ako niste sigurni slijedite savjet liječnika.
English: ∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Croatian: ∞, AUCt, i Cmax iznosi 111,88%, 114,06%, odnosno 115,28%.
English: This is due to the fat content of the meal.
Croatian: Tome je razlog sadržaj masti u obroku.
English: - You are under 18 years old.
Croatian: - ako ste mlađi od 18 godina,
English: Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Croatian: Fenofibrična kiselina snažno se veže na albumine plazme (više od 99%).
English: Do not take Pravafenix if any of the above applies to you.
Croatian: Nemojte uzimati Pravafenix ako se bilo što od gore navedenog odnosi na Vas.
English: If you plan to become pregnant or become pregnant, inform your doctor immediately.
Croatian: Planirate li zatrudnjeti ili zatrudnite recite to odmah svom liječniku.
English: In clinical trials, over 1,566 patients received Pravafenix.
Croatian: U kliničkim ispitivanjima više od 1566 bolesnika primilo je Pravafenix.
English: The name of your medicine is Pravafenix.
Croatian: Naziv Vašeg lijeka je Pravafenix.
English: The risk of muscle breakdown is greater in certain patients.
Croatian: Rizik za pojavu razgradnje mišića veći je u nekih bolesnika.
English: Paediatric population (< 18 years old)
Croatian: Pedijatrijska populacija (< 18 godina)
English: - Fusidic acid: do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
Croatian: - fusidatnom kiselinom: nemojte uzimati fusidatnu kiselinu (lijek za bakterijske infekcije) dok uzimate ovaj lijek.
English: Biotransformation and elimination
Croatian: Biotransformacija i eliminacija Pravastatin
English: The recommended dose is one capsule per day.
Croatian: Preporučena doza je jedna kapsula na dan.
English: It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Croatian: Preporučuje se smanjivanje doze antikoagulansa za oko jednu trećinu na početku liječenja i zatim njena postupna prilagodba, ako je potrebna, prema INR-u (International Normalised Ratio).
English: It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Croatian: Važno je da kapsulu uzmete s hranom, jer inače neće djelovati jednako dobro ako je uzmete na prazan želudac.
English: What pravafenix is and what it is used for
Croatian: Što je pravafenix i za što se koristi
English: Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
Croatian: Maksimalne koncentracije u plazmi (Cmax) nastupju unutar 4 do 5 sati nakon peroralne primjene.
English: Polyamide-Aluminium-PVC/aluminium blister 2 years.
Croatian: Poliamid-aluminij-PVC/aluminij blister 2 godine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
Croatian: Datum prvog odobrenja: 14. travnja 2011.
English: Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Croatian: Terapija statinom može se ponovno započeti sedam dana nakon posljednje doze fusidatne kiseline.
English: Your total cholesterol is made up mainly of LDL and HDL cholesterol.
Croatian: Vaš ukupni kolesterol sastoji se uglavnom od LDL i HDL kolesterola.
English: Based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity on reproduction, there are no other risks for the patient than those expected due to the pharmacological mechanism of action.
Croatian: Temeljeno na konvencionalnim ispitivanjima sigurnosne farmakologije, toksičnosti ponovljenih doza i toksičnosti na reprodukciju smatra se da nema drugih rizika za bolesnika osim onih očekivanih zbog farmakološkog mehanizma djelovanja.
English: Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Croatian: Ispitivanja na miševima, štakorima i kunićima nisu otkrila bilo kakav teratogeni učinak.
English: In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Croatian: Obzirom na ovaj znatan prvi prolaz kroz jetru, koncentracije pravastatina u plazmi imaju samo ograničenu vrijednost za predviđanje njegovog učinka na snižavanje lipida.
English: On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
Croatian: U prosjeku 34% peroralno primijenjene doze se apsorbira s apsolutnom bioraspoloživosti od 17%.
English: The food effect increases with the fat content: the larger the lipid content the larger the bioavailability of fenofibrate.
Croatian: Učinak hrane se pojačava sa sadržajem masti: što je veći udio lipida to je veća bioraspoloživost fenofibrata.
English: HDL cholesterol levels are frequently increased.
Croatian: Razine HDL kolesterola često su povišene.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičnih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim Člankom 107c stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Croatian: Dok uzimate ovaj lijek liječnik će Vas pažljivo pratiti imate li šećernu bolest ili rizik za razvoj šećerne bolesti.
English: If you feel any of these symptoms you should stop taking Pravafenix and inform your doctor.
Croatian: Ako osjećate bilo koji od ovih simptoma morate odmah prekinuti uzimati Pravafenix i o tome obavijestiti liječnika.
English: If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so.
Croatian: Osjetite li bilo kakvu omaglicu, zamućen vid ili dvoslike tijekom liječenja, provjerite jeste li sposobni upravljati vozilima ili strojevima prije nego li to učinite.
English: The decreased in AUCt, AUC∞ and Cmax
Croatian: Smanjenje AUCt, AUC∞ i Cmax
English: Before treatment initiation
Croatian: Prije početka liječenja
English: Venothromboembolic events
Croatian: Venotromboembolijski događaji
English: See also below section “Taking Pravafenix with food and drink”.
Croatian: Vidjeti također dio u nastavku „Uzimanje Pravafenixa s hranom i pićem“.
English: 14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules
Croatian: 14 tvrdih kapsula 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula
English: About 50% of circulating pravastatin is bound to plasma proteins.
Croatian: Oko 50% cirkulirajućeg pravastatina veže se na proteine plazme.
English: Isolated cases of tendon disorders, sometimes complicated by rupture
Croatian: Izolirani slučajevi poremećaja tetiva, ponekad komplicirani rupturom
English: • Tingling and numbness (peripheral polyneuropathy).
Croatian: • Trnci i utrnulost (periferna polineuropatija).
English: Plasma concentrations are stable during continuous treatment in any given individual.
Croatian: Koncentracije u plazmi su stabilne tijekom kontinuirane primjene kod svakog pojedinca.
English: LDL and VLDL triglycerides are reduced.
Croatian: LDL i VLDL trigliceridi su sniženi.