FrancophonIA/ELRC3.0 huggingface dataset:
English: Chicken (broilers, replacement chickens, broiler breeders), rabbit
Croatian: Pilići (brojleri, zamjenski pilići, uzgojni brojleri), kunići
English: Calves, lambs, kids, piglets, poultry, dogs, cats
Croatian: Goveda, janjad, mlado, praščići, perad, psi, mačke
English: Pigs, calves, lambs, kids, poultry (chicken and turkey)
Croatian: Svinje, goveda, janjad, mlado, perad (pilići i purani)
English: enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
Croatian: ENROFLOKSACYN A 10%, enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
English: Chickens (broilers, replacement chickens, broiler breeders) and turkeys
Croatian: Perad (brojleri, zamjenski pilići, uzgojni brojleri) i purani
English: Chickens, turkeys and rabbits
Croatian: Pilići, purani i kunići
English: Broiler chicken, non-ruminating calves and pigs
Croatian: Brojler pilići, telad hranjena formulom i svinje
English: Belgium Vetpharma Animal Health S.L.,
Croatian: Slovačka Vetpharma Animal Health S.L.,
English: Solution for oral use
Croatian: Otopina za peroralnu uporabu
English: Virbac
Croatian: Perad
English: Entecavir Accord is taken once a day.
Croatian: Entekavir Accord uzima se jednom dnevno.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Croatian: Može se razmotriti i primjena u djece u dobi od 2 do 18 godina, ali samo u one s kompenziranom bolešću jetre.
English: The full EPAR for Entecavir Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Entekavir Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Croatian: Kada se liječenje smatra primjerenim u djece, doza ovisi o njihovoj tjelesnoj težini.
English: The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Croatian: Doza od 0,5 mg može se uzimati s hranom ili bez nje, ali doza od 1 mg mora se uzeti najmanje 2 sata prije ili 2 sata nakon obroka.
English: This means that Entecavir Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
Croatian: To znači da Entekavir Accord sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Baraclude.
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Croatian: Dnevna doza od 1 mg primjenjuje se i u odraslih bolesnika s dekompenziranom bolešću jetre te se prestanak liječenja u ovih bolesnika ne preporučuje.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Croatian: Entekavir zaustavlja virus u stvaranju DNK-a te sprječava njegovo razmnožavanje i širenje.
English: Entecavir Accord can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Croatian: Entekavir Accord izdaje se samo na liječnički recept i dostupan je u obliku tableta (od 0,5 mg i 1 mg).
English: What measures are being taken to ensure the safe and effective use of Entecavir Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Entekavir Accord?
English: It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
Croatian: Primjenjuje se u odraslih sa znakovima kontinuiranog oštećenja jetre (poput upale i fibroze) u slučaju kada jetra još uvijek ispravno radi (kompenzirana bolest jetre) te kada jetra više ne radi ispravno (dekompenzirana bolest jetre).
English: Entecavir Accord is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Croatian: Entekavir Accord je lijek koji se koristi za liječenje kroničnog (dugotrajnog) hepatitisa B (infektivne bolesti jetre koju uzrokuje virus hepatitisa B).
English: As for every medicine, the company provided studies on the quality of Entecavir Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Entekavir Accord.
English: Treatment with Entecavir Accord should be started by a doctor with experience in the management of chronic hepatitis B.
Croatian: Liječenje lijekom Entekavir Accord treba započeti liječnik s iskustvom u liječenju kroničnog hepatitisa B.
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Croatian: Bolesnici koji nisu prethodno liječeni analogom nukleozida primaju dozu od 0,5 mg, a oni prethodno liječeni lamivudinom u kojih infekcija više ne odgovara na ovaj lijek primaju dozu od 1 mg.
English: This is a summary of the European public assessment report (EPAR) for Entecavir Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Entekavir Accord.
English: Because Entecavir Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Entekavir Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What is Entecavir Accord and what is it used for?
Croatian: Što je Entekavir Accord i za što se koristi?
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Accord.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim primjenama već su provedena za referentni lijek Baraclude te ih ne treba ponavljati za lijek Entekavir Accord.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Accord has been shown to have comparable quality and to be bioequivalent to Baraclude.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, za lijek Entekavir Accord dokazana usporediva kakvoća i bioekvivalencija s lijekom Baraclude.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Accord have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Entekavir Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir may be available for children weighing less than 32.6 kg. For further information, see the package leaflet.
Croatian: Djeci tjelesne težine 32,6 kg i veće mogu se davati tablete od 0,5 mg, a za djecu tjelesne težine manje od 32,6 kg može biti dostupna oralna otopina entekavira.
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Accord (a nucleoside analogue, such as lamivudine).
Croatian: Doza u odraslih bolesnika s kompenziranom bolešću jetre ovisi o tome je li bolesnik prethodno liječen lijekom iz iste skupine kao Entekavir Accord (analogom nukleozida, poput lamivudina).
English: Entecavir Accord entecavir
Croatian: Entekavir Accord entekavir
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Croatian: Entekavir sprječava djelovanje virusnog enzima, DNK polimeraze, koji sudjeluje u stvaranju virusnog DNK-a.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je provela i ispitivanje kojim je potvrđeno da je lijek „bioekvivalentan” referentnom lijeku.
English: Other information about Entecavir Accord
Croatian: Ostale informacije o lijeku Entekavir Accord
English: For more information about treatment with Entecavir Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Entekavir Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The Agency recommended that Entecavir Accord be approved for use in the EU.
Croatian: Agencija je preporučila davanje odobrenja za stavljanje lijeka Entekavir Accord u promet u EU-u.
English: The active substance in Entecavir Accord, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Croatian: Djelatna tvar lijeka Entekavir Accord, entekavir, jest antivirotik koji pripada razredu analoga nukleozida.
English: Entecavir Accord contains the active substance entecavir and is a ‘generic medicine'.
Croatian: Entekavir Accord sadržava djelatnu tvar entekavir te je „generički lijek”.
English: It is not intended to provide practical advice on how to use Entecavir Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Entekavir Accord.
English: For practical information about using Entecavir Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Entekavir Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: What are the benefits and risks of Entecavir Accord?
Croatian: Koje su koristi i rizici lijeka Entekavir Accord?
English: Therefore, the Agency's view was that, as for Baraclude, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje utvrđeni rizik, kao i za lijek Baraclude.
English: Why is Entecavir Accord approved?
Croatian: Zašto je lijek Entekavir Accord odobren?
English: How has Entecavir Accord been studied?
Croatian: Kako je Entekavir Accord ispitivan?
English: How is Entecavir Accord used?
Croatian: Kako se Entekavir Accord koristi?
English: Exelon can be used with food, drink and alcohol.
Croatian: Exelon se može koristiti uz hranu, piće i alkohol.
English: If you find you have forgotten to take your dose of Exelon, wait and take the next dose at the usual time.
Croatian: Ako primijetite da ste zaboravili uzeti svoju dozu Exelona, pričekajte i uzmite iduću dozu u uobičajeno vrijeme.
English: Can you wear your Exelon transdermal patch when you are bathing, swimming, or in the sun?
Croatian: Možete li nositi Exelon transdermalni flaster dok se kupate, plivate ili boravite na suncu?
English: Date of first authorisation: 12 May 1998 Date of latest renewal: 20 May 2008
Croatian: Datum posljednje obnove odobrenja: 20. svibnja 2008.
English: If you accidentally take more Exelon than you should, inform your doctor.
Croatian: Ako slučajno uzmete više Exelona nego biste trebali, obavijestite svog liječnika.
English: Always use Exelon transdermal patches exactly as your doctor has told you.
Croatian: Uvijek uzmite Exelon transdermale flastere točno onako kako Vam je rekao liječnik.
English: Medicinal product matrix:
Croatian: Matriks s lijekom:
English: Your doctor will tell you which Exelon transdermal patch is most suitable for you.
Croatian: Liječnik će Vam reći koji je Exelon transdermalni flaster najprikladniji za Vas.
English: Other medicines and Exelon
Croatian: Drugi lijekovi i Exelon
English: Your doctor will tell you what dose of Exelon to take.
Croatian: Liječnik će Vam reći koju dozu Exelona trebate uzimati.
English: For patients starting treatment for the first time and for patients restarting Exelon after treatment interruption, please begin with the second picture.
Croatian: Za bolesnike koji po prvi put počinju liječenje i za bolesnike koji ponovno počinju primjenjivati Exelon nakon prekida liječenja, počnite od druge slike.
English: - Blister of clear PVC tray with blue lidding foil with 14 capsules.
Croatian: - Blister od prozirne PVC podloge i plave pokrovne folije s 14 kapsula.
English: If you stop using Exelon Tell your doctor or pharmacist if you stop using the patch.
Croatian: Ako prestanete uzimati Exelon Obratite se svom liječniku ili ljekarniku ako prestanete koristiti flaster.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Exelon patch is marketed, all physicians who are expected to prescribe Exelon patch are provided with an information pack containing the following elements:
Croatian: Nositelj odobrenja dužan je osigurati da nakon razgovora i usuglašavanja s nacionalnim nadležnim tijekom u svakoj državi članici u kojoj se Exelon flaster nalazi na tržištu, svi liječnici za koje se očekuje da će propisivati Exelon flaster imaju informacijski paket koji sadrži sljedeće elemente:
English: However, Exelon may be used in this patient population and close monitoring is necessary.
Croatian: Međutim, Exelon se može koristiti u ovoj populaciji bolesnika te je nužno pažljivo praćenje.
English: If you take more Exelon than you should
Croatian: Ako uzmete više Exelona nego što ste trebali
English: Talk to your doctor before taking Exelon: - if you have, or have ever had, irregular or slow heartbeat.
Croatian: Obratite se svom liječniku prije nego uzmete Exelon: - ako imate ili ste imali nepravilne ili spore otkucaje srca.
English: Gently pull at one edge of the patch to remove it slowly from the skin.
Croatian: Lagano povucite jedan kraj flastera kako biste ga polako skinuli s kože.
English: Exelon patches are thin, opaque, plastic patches that stick to the skin.
Croatian: Exelon flasteri su tanki, neprozirni, plastični flasteri koji se lijepe na kožu.
English: If you have not taken Exelon for more than three days, do not take the next dose until you have talked to your doctor.
Croatian: Ako niste uzeli Exelon više od tri dana, nemojte uzimati sljedeću dozu dok se niste posavjetovali sa svojim liječnikom.
English: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Exelon transdermal patches in a Japanese study.
Croatian: Bio je ocijenjen kao težak u ≤2,2% bolesnika u tim ispitivanjima te u ≤3,7% bolesnika liječenih Exelon transdermalnim flasterima u jednom japanskom ispitivanju.
English: Misuse of the medicinal product and dosing errors with Exelon transdermal patch have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death (see section 4.9).
Croatian: Neodgovarajuća primjena lijeka i pogreške u doziranju s Exelon transdermalnim flasterom imale su za posljedicu ozbiljne nuspojave; neki su slučajevi zahtijevali hospitalizaciju, a rijetko imali i smrtni ishod (vidjeti dio 4.9).
English: Exelon contains sodium benzoate
Croatian: Exelon sadrži natrijev benzoat
English: Contact with the eyes should be avoided after handling Exelon transdermal patches (see section 5.3).
Croatian: Potrebno je izbjegavati kontakt s očima nakon rukovanja Exelon transdermalnim flasterima (vidjeti dio 5.3).
English: In other cases, Exelon has been discontinued (see section 4.8).
Croatian: U ostalim je slučajevima prekinuta primjena Exelona (vidjeti dio 4.8).
English: If this applies to you, tell your doctor and do not take Exelon.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i nemojte uzimati Exelon.
English: • The previous day's patch must be removed before applying a new one every day (see section 4.9).
Croatian: • Flaster od prethodnog dana mora se ukloniti prije primjene novog flastera svakog dana (vidjeti dio
English: Exelon transdermal patches may cause fainting or severe confusion.
Croatian: Exelon transdermalni flasteri mogu uzrokovati nesvjesticu ili jaku smetenost.
English: The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Exelon transdermal patches.
Croatian: Incidencija kožnih reakcija na mjestu primjene koje su dovele do prekida terapije bila je ≤2,3% u bolesnika liječenih Exelon transdermalnim flasterima.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji je opisan u Modulu 1.8.2
English: Exelon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Croatian: Exelon može uzrokovati omaglicu i pospanost, pogotovo na početku liječenja ili prilikom povećanja doze.
English: Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Croatian: Neki ljudi koji su slučajno uzeli previše Exelona su osjećali mučninu, povraćali, imali proljev, visoki krvni tlak i halucinacije.
English: This may indicate a potential for Exelon transdermal patches to induce mild erythema in patients.
Croatian: To može upućivati na mogućnost da Exelon transdermalni flasteri uzrokuju blagi eritem u bolesnika.
English: 42 transdermal patches.
Croatian: 42 transdermalna flastera.
English: Exelon is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Croatian: Exelon se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika s blagom do umjerenom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: • Uneven heartbeat and poor control of movements Other side effects seen with Exelon transdermal patches and which may occur with the hard capsules:
Croatian: • Nepravilni otkucaji srca i slaba kontrola pokreta Ostale nuspojave zabilježene s Exelon transdermalnim flasterima a koje se mogu pojaviti s tvrdim kapsulama:
English: When observed in patients treated with Exelon transdermal patches, skin irritation was mostly slight or mild in severity.
Croatian: Kada je bio uočen u bolesnika liječenih Exelon transdermalnim flasterima, nadražaj kože bio je uglavnom neznatan ili blag po težini.
English: If this applies to you, tell your doctor and do not apply Exelon transdermal patches.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i ne koristite Exelon transdermalne flastere.
English: Patients and their caregivers must be instructed on important administration instructions for Exelon transdermal patch (see section 4.2).
Croatian: Bolesnici i njihovi njegovatelji moraju dobiti važne upute o primjeni Exelon transdermalnog flastera (vidjeti dio 4.2).
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Exelon in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Croatian: Tablica 3 navodi broj i postotak bolesnika iz specifičnog kliničkog ispitivanja u trajanju od 24 tjedna, provedenog Exelonom u bolesnika s demencijom povezanom s Parkinsonovom bolešću, pri čemu su nuspojave, koje bi mogle odražavati pogoršanje simptoma parkinsonizma, bile unaprijed definirane.
English: Do not use Exelon - if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Exelon - ako ste alergični na rivastigmin (djelatna tvar u Exelonu) ili neki drugi sastojak ovog lijeka
English: By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Croatian: Blokiranjem tih enzima Exelon omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove bolesti.
English: Absorption of rivastigmine from Exelon transdermal patches is slow.
Croatian: Absorpcija rivastigmina iz Exelon transdermalnih flastera je spora.
English: Otherwise your doctor will restart your treatment on Exelon 4.6 mg/24 h.
Croatian: U suprotnom, liječnik će ponovno započeti Vaše liječenje Exelonom 4,6 mg/24 h.
English: What Exelon is and what it is used for What you need to know before you take Exelon How to take Exelon
Croatian: Što je Exelon i za što se koristi Što morate znati prije nego počnete uzimati Exelon Kako uzimati Exelon
English: If you have to undergo surgery whilst taking Exelon, tell your doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.
Croatian: Ako se, tijekom primjene Exelona, morate podvrgnuti operaciji, obavijestite liječnika prije nego što Vam primjeni bilo koji anestetik, jer Exelon može tijekom anestezije pojačati učinke nekih mišićnih relaksansa.
English: Exelon should not be given at the same time as other medicines with similar effects to Exelon.
Croatian: Exelon se ne smije davati istodobno s drugim lijekovima sa sličnim djelovanjem Exelonu.
English: Multipack: 60 (2 packs of 30) transdermal patches Multipack: 90 (3 packs of 30) transdermal patches Multipack: 84 (2 packs of 42) transdermal patches
Croatian: Višestruko pakiranje: 60 (2 pakiranja od 30) transdermalnih flastera Višestruko pakiranje: 90 (3 pakiranja od 30) transdermalnih flastera Višestruko pakiranje: 84 (2 pakiranja od 42) transdermalna flastera
English: One of the excipients in Exelon oral solution is sodium benzoate.
Croatian: Jedna od pomoćnih tvari u Exelon oralnoj otopini je i natrijev benzoat.
English: Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with Exelon transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Croatian: Tablica 1 prikazuje nuspojave zabilježene u 1670 bolesnika s Alzheimerovom demencijom liječenih u randomiziranim, dvostruko slijepim, placebom i aktivno kontroliranim kliničkim ispitivanjima s Exelon transdermalnim flasterom u trajanju od 24-48 tjedana te iz podataka nakon stavljanja lijeka u promet.
English: If you forget to take Exelon
Croatian: Ako ste zaboravili uzeti Exelon
English: Exelon 2 mg/ml [folding box only]
Croatian: Exelon 2 mg/ml [samo kutija]
English: When and for how long to apply your Exelon transdermal patch
Croatian: Kada i koliko dugo koristiti Exelon transdermalni flaster
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with Exelon transdermal patches.
Croatian: Dob nije imala utjecaja na izloženost rivastigminu u bolesnika s Alzheimerovom bolešću liječenih Exelon transdermalnim flasterima.
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Exelon 4.6 mg/24 h transdermal patches, 0.77 for Exelon 9.5 mg/24 h transdermal patches and 0.72 for Exelon 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Croatian: Indeks fluktuacije (FI), mjera relativne razlike između vršne i najniže koncentracije ((Cmax-Cmin)/Cavg), bio je 0,58 za Exelon 4,6 mg/24 h transdermalne flastere, 0,77 za Exelon 9,5 mg/24 h transdermalne flastere i 0,72 za Exelon 13,3 mg/24 h transdermalne flastere, čime se potvrđuje puno manja fluktuacija između najniže i vršne koncentracije nego kod oralne formulacije (FI = 3,96 (6 mg/dan) i 4,15 (12 mg/dan)).