FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment.
Croatian: Nuspojave su obično bile blage do umjerene i uglavnom su se javljale tijekom prvog tjedna liječenja.
English: It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth.
Croatian: Dostupan je u obliku tableta (od 200 mg, 400 mg, 600 mg i 800 mg) i suspenzije koje se uzimaju na usta.
English: This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
Croatian: Tako se smanjuje aktivnost živčanih stanica u mozgu, što rezultira smanjenjem intenziteta i broja napadaja.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Croatian: Sekundarna generalizacija događa se kad se pretjerana aktivnost proširi na cijeli mozak.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Croatian: To je vrsta epilepsije kod koje pretjerana električna aktivnost u jednoj polutki mozga uzrokuje simptome kao što su iznenadni trzaji jednog dijela tijela, smetnje sluha, njuha ili vida, utrnulost ili iznenadni osjećaj straha.
English: It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).
Croatian: Ne smije se primjenjivati u osoba s atrioventrikularnim blokom drugog ili trećeg stupnja (poremećajem prijenosa električnih impulsa u srcu).
English: What measures are being taken to ensure the safe and effective use of Zebinix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zebinix?
English: This compared with 25% of patients (10 out of 40) on placebo.
Croatian: Usporedbe radi, to je bio slučaj u 25 % bolesnika (10 od 40) koji su primili placebo.
English: In children weighing less than 60 kg, the starting dose is 10 mg per kg body weight once a day.
Croatian: U djece koja teže manje od 60 kg, početna doza iznosi 10 mg po kilogramu tjelesne težine jednom dnevno.
English: A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used.
Croatian: U drugom ispitivanju koje je obuhvatilo djecu u dobi od 2 do 18 godina nije pronađena razlika između lijeka Zebinix i placeba, što je obrazloženo činjenicom da su primjenjivane niže doze.
English: In one study involving 123 children aged 6 to 16 years, Zebinix over 12 weeks halved the number of seizures in 51% of patients (42 out of 83).
Croatian: U jednom ispitivanju kojim je bilo obuhvaćeno 123 djece u dobi od 6 do 16 godina, Zebinix je tijekom 12 tjedana upola smanjio broj napadaja u 51 % bolesnika (42 od 83).
English: For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells.
Croatian: Da bi električni impulsi mogli putovati duž živaca, natrij mora brzo prodrijeti u živčane stanice.
English: Zebinix was effective, although slightly less than carbamazepine, at reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months compared with 76% of patients taking carbamazepine (300 out of 397 patients).
Croatian: Lijek Zebinix bio je učinkovit, iako nešto manje od karbamazepina, u smanjenju broja napadaja nakon šestomjesečnog liječenja: 71 % bolesnika (276 od 388 bolesnika) koji su primali Zebinix i nisu se prijevremeno povukli iz ispitivanja nisu imali napadaje nakon 6 mjeseci, u usporedbi sa 76 % bolesnika (300 od 397 bolesnika) koji su uzimali karbamazepin.
English: Other information about Zebinix
Croatian: Ostale informacije o lijeku Zebinix
English: Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation.
Croatian: Zebinix se može primjenjivati i u adolescenata i djece starije od 6 godina, u kombinaciji s postojećim terapijama, za liječenje parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje.
English: An overview of Zebinix and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zebinix i zašto je odobren u EU-u
English: Side effects reported with Zebinix are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zebinix pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zebinix 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 Zebinix nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: All of the patients also received other epilepsy medicines.
Croatian: Svi bolesnici primali su i druge lijekove protiv epilepsije.
English: The dose is then increased after one or two weeks to 20 mg/kg per day and then to 30 mg/kg per day, based on the patient's response.
Croatian: Nakon jednoga ili dva tjedna doza se povećava na 20 mg/kg dnevno i zatim na 30 mg/kg dnevno, ovisno o odgovoru bolesnika.
English: In these studies, all the children also received other epilepsy medicines.
Croatian: U tim ispitivanjima sva su djeca primala i druge lijekove protiv epilepsije.
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Croatian: Smatra se da eslikarbazepin djeluje tako da blokira „natrijeve kanale ovisne o naponu”, čime se sprečava ulazak natrija u živčane stanice.
English: Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Croatian: Zebinix se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na eslikarbazepinacetat, bilo koji drugi sastojak lijeka ili druge derivate karboksamida (lijekove čija je struktura slična eslikarbazepinacetatu, kao što su karbamazepin ili okskarbazepin).
English: For children and adults who use Zebinix in combination with other medicines the maximum dose is 1,200 mg once a day.
Croatian: U djece i odraslih koji primaju Zebinix u kombinaciji s drugim lijekovima, maksimalna doza iznosi 1 200 mg jednom dnevno.
English: What is Zebinix and what is it used for?
Croatian: Što je Zebinix i za što se koristi?
English: The European Medicines Agency decided that Zebinix's benefits are greater than its risks and that it be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Zebinix nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The effects of Zebinix were also studied in children with partial-onset seizures.
Croatian: Učinci lijeka Zebinix ispitivani su i u djece s parcijalnim napadajima.
English: For adults, the most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), headache and nausea.
Croatian: Najčešće nuspojave lijeka Zebinix u odraslih bolesnika (uočene u više od 1 na 10 bolesnika) jesu vrtoglavica, somnolencija (pospanost), glavobolja i mučnina.
English: In clinical trials, around half of the patients treated with Zebinix experienced side effects.
Croatian: U kliničkim ispitivanjima kod gotovo polovice bolesnika koji su liječeni lijekom Zebinix pojavile su se nuspojave.
English: As for all medicines, data on the use of Zebinix are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zebinix kontinuirano se prate.
English: Zebinix (eslicarbazepine acetate)
Croatian: Zebinix (eslikarbazepinacetat)
English: What are the risks associated with Zebinix?
Croatian: Koji su rizici povezani s lijekom Zebinix?
English: Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Croatian: Zebinix je lijek protiv epilepsije koji se primjenjuje u liječenju odraslih osoba s parcijalnim napadajima (epileptičnim napadajima) sa sekundarnom generalizacijom ili bez nje.
English: For adults and children weighing 60 kg or more, treatment is started at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks.
Croatian: U odraslih i djece koji teže 60 kg ili više, liječenje počinje dozom od 400 mg jednom dnevno koja se, nakon jednog ili dva tjedna, povećava na uobičajenu dozu od 800 mg jednom dnevno.
English: The active substance in Zebinix, eslicarbazepine acetate, is converted into eslicarbazepine in the body.
Croatian: Djelatna tvar u lijeku Zebinix, eslikarbazepinacetat, u tijelu se pretvara u eslikarbazepin.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix 800 mg and Zebinix 1,200 mg respectively, compared with 11.7 per month in those taking placebo.
Croatian: Tijekom 12 tjedana primjene lijeka taj broj se smanjio na 9,8 u bolesnika koji su uzimali Zebinix u dozi od 800 mg i na 9,0 u onih koji su uzimali Zebinix u dozi od 1 200 mg, a u onih koji su uzimali placebo smanjio se na 11,7 napadaja mjesečno.
English: Zebinix can only be obtained with a prescription.
Croatian: Zebinix se izdaje samo na liječnički recept.
English: Looking at the results of the three studies taken together, Zebinix 800 mg and 1,200 mg were more effective than placebo at reducing the number of seizures, when used as add-on to other epilepsy medicines.
Croatian: Ukupni rezultati triju ispitivanja pokazuju da je Zebinix u dozama od 800 mg i 1 200 mg djelotvorniji od placeba u smanjenju broja napadaja kada se primjenjivao kao dodatak drugim lijekovima protiv epilepsije.
English: Severe skin reactions, including Stevens-Johnson syndrome, have also been reported with Zebinix.
Croatian: Prilikom primjene lijeka Zebinix zabilježene su i teške kožne reakcije, uključujući Stevens-Johnsonov sindrom.
English: Three main studies compared Zebinix with placebo (a dummy treatment) in 1,050 adults with partialonset seizures that were not controlled by other medicines.
Croatian: U trima glavnim ispitivanjima lijek Zebinix uspoređen je s placebom (prividno liječenje) na 1 050 odraslih osoba s parcijalnim napadajima koji nisu kontrolirani drugim lijekovima.
English: Zebinix received a marketing authorisation valid throughout the EU on 21 April 2009.
Croatian: Lijek Zebinix dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 25. travnja
English: For more information about using Zebinix, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Zebinix pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Zebinix should not be used in patients with severe kidney problems and the dose should be adjusted in moderately impaired kidney function.
Croatian: Zebinix se ne smije primjenjivati u bolesnika koji imaju ozbiljne probleme s bubrezima, a u slučaju umjereno oslabljene bubrežne funkcije dozu treba prilagoditi.
English: Another study compared Zebinix taken on its own with another epilepsy medicine, carbamazepine, in 815 newly diagnosed adults.
Croatian: U drugom ispitivanju lijek Zebinix kao monoterapija uspoređen je s drugim lijekom protiv epilepsije, tj. karbamazepinom, u 815 novodijagnosticiranih odraslih bolesnika.
English: For adults who take Zebinix on its own, a dose up to 1,600 mg may be used.
Croatian: U odraslih osoba koje primaju Zebinix kao monoterapiju, može se primjenjivati doza od najviše 1 600 mg.
English: Why is Zebinix authorised?
Croatian: Zašto je lijek Zebinix odobren?
English: Zebinix can be taken on its own, in newly diagnosed epilepsy, or can be added to existing antiepileptic medicines.
Croatian: Kod novodijagnosticirane epilepsije Zebinix se može primjenjivati samostalno ili kao dodatak postojećim lijekovima protiv epilepsije.
English: What benefit of Zebinix have been shown in studies?
Croatian: Koje su koristi lijeka Zebinix dokazane u ispitivanjima?
English: How does Zebinix work?
Croatian: Kako djeluje Zebinix?
English: How is Zebinix used?
Croatian: Kako se Zebinix koristi?
English: For the full list of side effects and restrictions with Zebinix, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Zebinix potražite u uputi o lijeku.
English: Zebinix contains the active substance eslicarbazepine acetate.
Croatian: Zebinix sadrži djelatnu tvar eslikarbazepinacetat.
English: This is considered as one treatment cycle.
Croatian: To se smatra jednim ciklusom liječenja.
English: Your doctor should monitor you carefully.
Croatian: Liječnik Vas mora pažljivo nadzirati.
English: This information supplements the sections 3 and 5 for the user.
Croatian: Ove informacije dopuna su dijelovima 3. i 5. za korisnika.
English: These effects were fully reversible within 8-18 weeks after the last injection.
Croatian: Ti su se učinci u potpunosti povukli unutar 8-18 tjedana nakon posljednje injekcije.
English: • You will usually be given an infusion once every 2 weeks.
Croatian: • Obično ćete infuziju primati jedanput svaka 2 tjedna.
English: These animals also lost normal menstrual cycling.
Croatian: U tih je životinja također izostao normalan menstrualni ciklus.
English: • in your eye, since it may severely damage it.
Croatian: • u oko, jer ga može teško oštetiti.
English: • for at least 6 months after the last dose of treatment.
Croatian: • najmanje 6 mjeseci nakon posljednje doze u sklopu liječenja.
English: • changes in the colour of the skin.
Croatian: • promjene boje kože.
English: Invasive dental procedures are also an identified risk factor.
Croatian: Invazivni stomatološki zahvati također su identificirani faktor rizika.
English: Men and women who can father or have children should use effective contraception:
Croatian: Muškarci i žene koji mogu imati djecu moraju koristiti učinkovitu kontracepciju:
English: Date of first authorisation: 01 February 2013 Date of latest renewal: 21 September 2017
Croatian: Datum posljednje obnove odobrenja: 21. rujna 2017.
English: The infusion sets should be made of one of the following materials:
Croatian: Setovi za infuziju moraju biti načinjeni od jednog od sljedećih materijala:
English: Talk to your doctor for advice if you plan to have or father a child.
Croatian: Obratite se svom liječniku za savjet ako planirate imati dijete.
English: It is important that you read the entire content of this procedure prior to the preparation of infusion solution.
Croatian: Važno je da pročitate cijeli sadržaj ovoga postupka prije pripreme otopine za infuziju.
English: You may need to go to the hospital for treatment.
Croatian: Možda ćete se morati liječiti u bolnici.
English: This medicine is not for children or adolescents under the age of 18 years because the safety and benefit of using ZALTRAP in children and adolescents have not been shown.
Croatian: Ovaj lijek nije namijenjen za djecu niti adolescente mlađe od 18 godina jer nisu utvrđene sigurnost i korist primjene lijeka ZALTRAP u djece i adolescenata.
English: You should not use ZALTRAP during pregnancy unless you and your doctor decide that the benefit for you is greater than any possible risk to you or your unborn baby.
Croatian: ZALTRAP ne smijete koristiti u trudnoći, osim ako liječnik ne odluči da je korist za Vas veća od mogućih rizika za Vas ili Vaše nerođeno dijete.
English: • Your doctor will decide how often you will be given the medicine and if you need a change in the dose.
Croatian: • Liječnik će odrediti kako često ćete primati lijek i treba li mijenjati dozu.
English: You may need to read it again, or provide it to future healthcare providers.
Croatian: Možda ćete je trebati ponovno pročitati ili dati zdravstvenim djelatnicima koji Vas u budućnosti budu liječili.
English: If you are a woman that could become pregnant you should use effective contraception (see “Contraception” section below for details on male and female contraception).
Croatian: Ako ste žena koja bi mogla zatrudnjeti, morate koristiti učinkovitu kontracepciju (vidjeti dio “Kontracepcija” u nastavku za pojedinosti o kontracepciji u muškaraca i žena).
English: Your doctor will temporarily stop the treatment before and after surgery.
Croatian: Liječnik će privremeno prekinuti liječenje prije i nakon operacije.
English: How much and how often you will receive treatment
Croatian: Koliko lijeka ćete primiti i kako često
English: The treatment cycle is repeated every 2 weeks.
Croatian: Ciklus liječenja ponavlja se svaka 2 tjedna.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima niti otapalima, osim onih navedenih u dijelu 6.6.
English: • The recommended dose is 4 mg for each kilogram of your body weight.
Croatian: • Preporučena doza je 4 mg po svakom kilogramu tjelesne težine.
English: The tumour needs nutrients and oxygen from blood in order to grow.
Croatian: Tumoru trebaju hranjive tvari i kisik iz krvi da bi mogao rasti.
English: It is therefore also important to tell your doctor, pharmacist or nurse if you have other heart problems since high blood pressure could make these worse.
Croatian: Stoga je važno da obavijestite liječnika, ljekarnika ili medicinsku sestru ako imate nekih drugih srčanih tegoba, jer ih visok krvni tlak može pogoršati.
English: • The drip (infusion) lasts for about 1 hour.
Croatian: • Kapanje u venu (infuzija) traje približno 1 sat.
English: Grades ≥3
Croatian: Stupnjevi ≥ 3
English: What you need to know before you are given ZALTRAP
Croatian: Što morate znati prije nego počnete primati ZALTRAP
English: • Compromised wound healing requiring medical intervention
Croatian: • otežanog zacjeljivanja rana koje zahtijeva medicinsku intervenciju
English: Your doctor will decide the correct dose for you.
Croatian: Liječnik će odrediti točnu dozu lijeka za Vas.
English: ZALTRAP must not be injected into the eye, since it may severely damage it.
Croatian: ZALTRAP se ne smije injicirati u oko jer ga može teško oštetiti.
English: Your doctor will decide the appropriate doses for these other chemotherapy medicines.
Croatian: Liječnik će odrediti odgovarajuće doze tih kemoterapijskih lijekova.
English: • The active substance is aflibercept.
Croatian: • Djelatna tvar je aflibercept.
English: • inflammation inside the nose and upper part of the throat
Croatian: • upala u nosu i gornjem dijelu grla
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the assay.
Croatian: Podaci o imunogenosti uvelike ovise o osjetljivosti i specifičnosti testa.
English: This may include medicines obtained without a prescription or herbal medicines.
Croatian: To uključuje i one lijekove koje ste nabavili bez recepta ili biljne lijekove.
English: It is given by a drip (infusion) into one of your veins (‘intra-venous').
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: • you have high blood pressure.
Croatian: • ako imate povišen krvni tlak.
English: This medicine may harm your unborn baby since it may stop new blood vessels from forming.
Croatian: Ovaj lijek može naškoditi nerođenu djetetu jer može zaustaviti stvaranje novih krvnih žila.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznate (učestalost se ne može se procijeniti na temelju dosupnih podataka)
English: The infusion should be temporarily suspended until the reaction resolves.
Croatian: Infuziju treba privremeno prekinuti dok se reakcija ne povuče.
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Odmah se obratite svom liječniku ako se pojavi neka od sljedećih ozbiljnih nuspojava - možda će Vam biti potrebno hitno liječenje:
English: During treatment, your doctor will perform a number of tests to monitor the function of your body and how the medicine is working.
Croatian: Liječnik će za vrijeme liječenja provoditi niz pretraga kojima će kontrolirati funkcioniranje Vašeg tijela i pratiti kako lijek djeluje.
English: The use of granulocyte colony-stimulating factor (G-CSF) may be considered.
Croatian: Može se razmotriti primjena stimulirajućeg faktora kolonije granulocita (G-CSF).
English: • your level of everyday activities is limited or worsens on treatment.
Croatian: • ako Vam je provođenje svakodnevnih aktivnosti ograničeno ili smanjeno za vrijeme liječenja.
English: Irinotecan dose should be reduced by 15-20 %.
Croatian: Treba smanjiti dozu irinotekana za 15-20%.
English: Sometimes, depending on where this happens, you may get an unusual discharge at that place.
Croatian: Ovisno o tome gdje nastanu, ponekad se na tom mjestu može pojaviti neobičan iscjedak.
English: They may also prescribe a medicine called ‘G-CSF' to help prevent complications if your white blood cell count is too low.
Croatian: Također će možda propisati lijek koji se naziva ‘G-CSF', a pomaže spriječiti nastanak komplikacija u slučaju premalog broja bijelih krvnih stanica.
English: PlGF and VEGF-B bind only to VEGFR-1, which is also present on the surface of leucocytes.
Croatian: PlGF i VEGF-B vežu se samo za VEGFR-1, koji se nalazi i na površini leukocita.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojeno dijete.
English: This may include swelling of the feet or whole body and may be related to kidney disease.
Croatian: Može uključivati oticanje stopala ili cijelog tijela, a može biti povezano s bubrežnom bolešću.
English: PFS (based on tumour assessment by the IRC): Significance threshold is set to 0.0001
Croatian: b PFS (na temelju procjene tumora od strane neovisnog ocjenjivačkog povjerenstva): prag značajnosti iznosi 0,0001
English: Cases of overdose should be managed by appropriate supportive measures particularly with regard to monitoring and treatment of hypertension and proteinuria.
Croatian: Slučajeve predoziranja treba zbrinuti uvođenjem odgovarajućih suportivnih mjera, osobito kad je u pitanju praćenje i liječenje hipertenzije i proteinurije.
English: If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you cannot use these medicines.
Croatian: Ako niste sigurni, pitajte liječnika, ljekarnika ili medicinsku sestru postoji li razlog zašto ne možete uzimati te lijekove.
English: These data are exploratory and the statistical interaction test was non-significant (lack of evidence for heterogeneity in treatment effect between the RAS wild-type and RAS mutant subgroups).
Croatian: Ti su podaci eksplorativni, a test statističke interakcije nije bio značajan (manjak dokaza za heterogenost učinka liječenja između podskupina RAS divljeg tipa i RAS mutiranog tipa).
English: Elderly (≥ 65 years of age) may be more likely to experience adverse reactions.
Croatian: U starijih osoba (≥ 65 godina) može postojati veća vjerojatnost nuspojava.
English: By blocking the growth of blood vessels, ZALTRAP helps to stop or slow down the growth of the tumour.
Croatian: Blokirajući rast krvnih žila, ZALTRAP pomaže zaustaviti ili usporiti rast tumora.
English: Linear clearance observed in the dose range of 2 to 9 mg/kg is likely due to non saturable biological mechanisms of elimination such as protein catabolism.
Croatian: Linearni klirens primijećen u rasponu doza od 2 do 9 mg/kg vjerojatno je posljedica nezasićenih bioloških mehanizama eliminacije, poput proteinskog katabolizma.
English: There are no data from the use of aflibercept in pregnant women.
Croatian: Nema podataka o primjeni aflibercepta u trudnica.