FrancophonIA/ELRC3.0 huggingface dataset:
English: Direct-acting antivirals work by blocking the action of proteins which are essential for making new hepatitis C viruses.
Croatian: Antivirusni lijekovi s izravnim djelovanjem blokiraju djelovanje bjelančevina ključnih za stvaranje novih virusa hepatitisa C.
English: • All patients should be screened for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
Croatian: • Sve je bolesnike potrebno testirati na hepatitis B prije nego što započnu liječenje antivirusnim lijekovima s izravnim djelovanjem na hepatitis C; bolesnike koji su istodobno zaraženi hepatitisom B i C mora se potom pratiti i liječiti u skladu s važećim kliničkim smjernicama.
English: • Further studies are needed to evaluate the risk of recurring or newly diagnosed hepatocellular carcinoma in patients treated with direct-acting antivirals.
Croatian: • Potrebno je provesti dodatna ispitivanja za procjenu rizika od vraćanja ili pojave novodijagnosticiranog hepatocelularnog karcinoma u bolesnika liječenih antivirusnim lijekovima s izravnim djelovanjem.
English: On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.
Croatian: Europska agencija za lijekove (EMA) potvrdila je 15. prosinca 2016. svoju preporuku o testiranju svih bolesnika na hepatitis B prije nego što započnu liječenje antivirusnim lijekovima s izravnim djelovanjem na hepatitis C.
English: These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Croatian: Tim mjerama pokušava se smanjiti rizik od ponovne aktivacije hepatitisa B tijekom liječenja antivirusnim lijekovima s izravnim djelovanjem.
English: In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with directacting antivirals.
Croatian: daljnja ispitivanja rizika za pojavu novog raka jetre u bolesnika s kroničnim hepatitisom C i cirozom (ožiljci na jetri) koji se liječe antivirusnim lijekovima s izravnim djelovanjem.
English: Speak to your doctor if you have any question or concern regarding your treatment.
Croatian: • Obavijestite liječnika ako ste bili zaraženi, ili ste sada zaraženi hepatitisom B. Ako imate bilo kakvih pitanja ili nedoumica u vezi sa svojim liječenjem, obratite se liječniku.
English: • You will be tested for hepatitis B before starting treatment with direct-acting antivirals to check if you might be at risk of hepatitis B reactivation.
Croatian: • Prije nego što započnete liječenje antivirusnim lijekovima s izravnim djelovanjem, testirat ćete se na hepatitis B kako bi se provjerilo postoji li rizik od ponovne aktivacije hepatitisa B.
English: • If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again.
Croatian: • Ako ste zaraženi i virusom hepatitisa B, antivirusni lijekovi s izravnim djelovanjem na hepatitis C mogu uzrokovati ponovnu aktivaciju hepatitisa B.
English: The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.
Croatian: Smatra se da je reaktivacija hepatitisa B posljedica brzog smanjenja količine virusa hepatitisa C uzrokovanog liječenjem (poznato je da koinfekcija suprimira virus hepatitisa B) i nedostatka djelovanja antivirusnih lijekova s izravnim djelovanjem na virus hepatitisa B.
English: 1 Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Croatian: 1 Nakon početka pregleda na području EU-a odobrena su još dva antivirusna lijeka s izravnim djelovanjem: Epclusa (sofosbuvir/velpatasvir) i Zepatier (elbasvir/grazoprevir).
English: • Hepatitis B re-activation is thought to be caused by the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of antihepatitis B activity of direct-acting antivirals.
Croatian: • Smatra se da je ponovna aktivacija hepatitisa B posljedica brzog smanjenja količine virusa hepatitisa C uzrokovanog liječenjem (poznato je da koinfekcija suprimira virus hepatitisa B) i nedostatka djelovanja antivirusnih lijekova s izravnim djelovanjem na hepatitis B.
English: Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Croatian: Nakon početka pregleda na području EU-a odobrena su još dva antivirusna lijeka s izravnim djelovanjem: Epclusa (sofosbuvir/velpatasvir) i Zepatier (elbasvir/grazoprevir).
English: It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.
Croatian: Razmatrani su slučajevi2 u kojima su se u bolesnika liječenih antivirusnim lijekovima s izravnim djelovanje na hepatitis C vratili pokazatelji i simptomi prethodno neaktivne infekcije hepatitisa B (reaktivacija).
English: • Cases of hepatitis B re-activation (with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with direct-acting antivirals.
Croatian: • U bolesnika istodobno zaraženih virusom hepatitisa B i C liječenih antivirusnim lijekovima s izravnim djelovanjem, zabilježeni su slučajevi reaktivacije hepatitisa B (s teškim posljedicama).
English: Description and strength
Croatian: Opis i jačina
English: If you have any questions about your treatment, contact your doctor, pharmacist or nurse.
Croatian: Ako imate bilo kakvih pitanja o liječenju, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: More information on Exjade, including its indications in full, can be found on the Agency's website: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Exjade, uključujući cjelovite indikacije, nalazi se na internetskim stranicama Agencije: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
English: 31 March 2016 EMA/174254/2016
Croatian: EMA/174254/2016
English: Measures to avoid medication errors with Exjade
Croatian: Mjere za izbjegavanje medikacijskih pogrešaka u pogledu lijeka Exjade
English: Not to be chewed or swallowed whole
Croatian: Ne smije se žvakati niti cijela progutati
English: How to take tablets
Croatian: Kako uzimati tablete
English: Dispersed in water, orange juice or apple juice.
Croatian: Suspendiranu u čaši vode ili narančina ili jabučnog soka.
English: It has important information about your treatment and how to take the medicine.
Croatian: One sadrže važne informacije o liječenju i načinu uzimanja lijeka.
English: The doctor will tell you how much of the new tablet you need to take.
Croatian: Liječnik će vam reći koliku dozu nove tablete trebate uzimati.
English: Once daily, must be taken on an empty stomach, at least 30 minutes before food
Croatian: Jedanput dnevno, moraju se uzimati na prazan želudac, najmanje 30 minuta prije obroka
English: Educational material to raise awareness of dose variation between different types of tablets
Croatian: Edukativni materijal za podizanje svijesti o razlici u dozama između različitih vrsta tableta
English: Swallowed whole with some water or crushed and sprinkled on soft food (e.g. yogurt or apple sauce)
Croatian: Progutati cijelu s malo vode ili zdrobiti i posipati po mekoj hrani (npr. jogurt ili jabučna kaša)
English: When to take tablets
Croatian: Kada uzimati tablete
English: This helps to correct iron overload and prevent the extra iron from damaging organs such as the heart and liver.
Croatian: To pomaže pri korigiranju preopterećenja željezom i sprečava da višak željeza ošteti organe, poput srca ili jetre.
English: Once daily, may be taken on an empty stomach or with a light meal
Croatian: Jedanput dnevno, mogu se uzimati na prazan želudac ili uz lagani obrok
English: The dose depends on your weight, the amount of iron in your blood, how well your liver and kidneys work and the amount of blood transfusions you receive.
Croatian: Doza ovisi o vašoj težini, količini željeza u vašoj krvi, radu jetre i bubrega te količini transfuzija krvi koje primate.
English: • The summary of product characteristics and the educational materials on the use of Exjade should be followed because they give important information on its use.
Croatian: • Potrebno se pridržavati sažetka opisa svojstava lijeka i edukativnih materijala o primjeni lijeka Exjade jer sadrže važne informacije o njegovoj primjeni.
English: • Your doctor will have worked out the dose of Exjade you need.
Croatian: • Vaš će vam liječnik odrediti dozu lijeka Exjade koja vam je potrebna.
English: Exjade contains the active substance deferasirox which is an ‘iron chelator'.
Croatian: Exjade sadrži djelatnu tvar deferasiroks koja je „kelator željeza”.
English: • You will be given a handbook with information on the two types of tablets and how to take them.
Croatian: • Dobit ćete priručnik s informacijama o dvjema vrstama tableta te o načinu njihova uzimanja.
English: This means that it attaches to iron in the body to form a ‘chelate' that can be excreted by the body, mainly in the stool.
Croatian: To znači da se vezuje za željezo u tijelu i stvara „kelat” koji se može izlučiti iz tijela, uglavnom kroz stolicu.
English: • Read the package leaflet and other information you have been given with your tablets.
Croatian: • Pročitajte uputu o lijeku i ostale informacije koje ste dobili s tabletama.
English: Round, white tablets containing 125 mg, 250 mg and 500 mg (all white)
Croatian: Okrugle, bijele tablete od 125 mg, 250 mg i 500 mg (sve bijele)
English: • Whereas the dispersible tablets have to be taken on an empty stomach 30 minutes before food, the film-coated tablets can be taken on an empty stomach or with a light meal.
Croatian: • Dok se tablete za oralnu suspenziju moraju uzimati na prazan želudac 30 minuta prije jela, filmom obložene tablete mogu se uzimati na prazan želudac ili uz lagani obrok.
English: Does not contain lactose
Croatian: Ne sadrži laktozu
English: The two types of tablets can be easily distinguished by their shape, and the design of the outer cartons and blisters.
Croatian: Dvije vrste tableta mogu se jednostavno razlikovati prema obliku te dizajnu vanjske kutije i blistera.
English: Film-coated tablets containing 90, 180 and 360 mg are equivalent to dispersible tablets containing 125, 250 and 500 mg, respectively.
Croatian: Filmom obložene tablete od 90, 180 i 360 mg odgovaraju tabletama za oralnu suspenziju od 125, 250 i 500 mg.
English: Excipient: lactose
Croatian: Pomoćna tvar: laktoza
English: • Exjade film-coated tablets have been introduced.
Croatian: • Uvedene su filmom obložene tablete lijeka Exjade.
English: • The following table describes the differences between the two formulations: Film-coated tablets
Croatian: • U sljedećoj tablici opisane su razlike između dviju formulacija:
English: • The dispersible tablets and the new film-coated tablets are to be taken once a day, preferably at the same time each day.
Croatian: • Tablete za oralnu suspenziju i nove filmom obložene tablete moraju se uzimati jedanput na dan, po mogućnosti u isto vrijeme svakog dana.
English: Oval, blue tablets containing 90 mg (light blue), 180 mg (medium blue) and 360 mg (dark blue)
Croatian: Ovalne, plave tablete od 90 mg (svijetloplava), 180 mg (srednje plava) i 360 mg (tamnoplava)
English: If you are switching from dispersible tablets to the new film-coated tablets, you will need a smaller dose.
Croatian: Ako prelazite s tableta za oralnu suspenziju na nove filmom obložene tablete, bit će vam potrebna manja doza.
English: The education material will advise that the doses for the two types of Exjade tablets are different.
Croatian: Edukativni će materijal upozoravati na to da se doze za navedene dvije vrste tableta lijeka Exjade razlikuju.
English: • To avoid errors, prescriptions for Exjade must specify the type of formulation (dispersible tablets or film-coated tablets), the prescribed dose in mg/kg/day, and the calculated dose per day with the strength of film-coated or dispersible tablets.
Croatian: • Kako bi se izbjegle pogreške, na liječničkim receptima za lijek Exjade mora biti navedena vrsta formulacije (tablete za oralnu suspenziju ili filmom obložene tablete), propisana doza u mg/kg/dan te izračunana dnevna doza s navedenom jačinom filmom obloženih tableta ili tableta za oralnu suspenziju.
English: Contains lactose
Croatian: Sadrži laktozu
English: Healthcare professionals will be notified of the planned date for removing the dispersible tablets from the market.
Croatian: Zdravstveni radnici bit će obaviješteni o planiranom datumu uklanjanja tableta za oralnu suspenziju s tržišta.
English: • Exjade dispersible tablets will not be available in the future.
Croatian: • Tablete Exjade za oralnu suspenziju ubuduće neće biti dostupne.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in patients with beta thalassemia or other blood disorders in which patients do not have enough normal haemoglobin in the blood.
Croatian: Exjade je lijek koji se koristi za liječenje kroničnog preopterećenja željezom (prekomjerna količina željeza u krvi) u bolesnika s beta-talasemijom ili drugim poremećajima krvi kod kojih bolesnici nemaju normalne vrijednosti hemoglobina u krvi.
English: • Bioavailability of film-coated tablets is higher than of the dispersible tablets and the strength of film-coated tablets is correspondingly lower.
Croatian: • Bioraspoloživost filmom obloženih tableta veća je nego kod tableta za oralnu suspenziju, a jačina filmom obloženih tableta odgovarajuće je slabija.
English: Exjade is a medicine used to remove excessive iron from the blood of patients with beta thalassemia or other blood disorders which result in excessive iron in the blood.
Croatian: Exjade je lijek koji se upotrebljava za uklanjanje prekomjerne količine željeza iz krvi bolesnika s beta-talasemijom ili drugim poremećajima krvi koji za posljedicu imaju prekomjernu količinu željeza u krvi.
English: Both types of tablets will be available for some time, which will allow doctors to switch patients from dispersible tablets to film-coated tablets.
Croatian: Obje vrste tableta bit će dostupne određeno vrijeme, što će liječnicima omogućiti da bolesnike prebace s tableta za oralnu suspenziju na filmom obložene tablete.
English: Dispersible tablets (to be discontinued)
Croatian: Filmom obložene tablete Tablete za oralnu suspenziju (koje će se povući iz prometa)
English: The patient may receive too little or too much of the medicine if the dose is not correct when changing from one type of tablet to another.
Croatian: Pri prelasku s jedne vrste tableta na drugu, bolesnik bi mogao dobiti premalo ili previše lijeka ako doza nije ispravna.
English: • Both types of tablets will be available for a limited period to allow doctors to switch patients from the dispersible tablets to the film-coated tablets.
Croatian: • Obje vrste tableta bit će dostupne određeno vrijeme kako bi se liječnicima omogućilo dovoljno vremena da prebace bolesnike s tableta za oralnu suspenziju na filmom obložene tablete.
English: After this time, Exjade dispersible tablets will no longer be marketed.
Croatian: Nakon toga tablete Exjade za oralnu suspenziju neće se više stavljati na tržište.
English: • Exjade (deferasirox) is now available as film-coated tablets in addition to the already authorised dispersible tablets.
Croatian: • Osim u obliku odobrenih tableta za oralnu suspenziju, lijek Exjade (deferasiroks) sada je dostupan i u obliku filmom obloženih tableta.
English: A smaller dose is needed of the new film-coated tablets compared to that of the dispersible tablet.
Croatian: U usporedbi s tabletama za oralnu suspenziju, potrebna je manja doza novih filmom obloženih tableta.
English: Educational material will be given to patients and healthcare professionals using Exjade (deferasirox), following the introduction of a film-coated tablet to the already authorised dispersible tablet.
Croatian: Nakon uvođenja filmom obloženih tableta uz već odobrene tablete za oralnu suspenziju, bolesnici koji koriste lijek Exjade (deferasiroks) i zdravstveni djelatnici dobit će edukativni materijal.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela država članica ili referentne države članice ukoliko je to primjenjivo, osigurat će da nositelj odobrenja ispuni sljedeće uvjete:
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Croatian: Prilog IV Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Its use during the first three months of pregnancy is not recommended.
Croatian: Ne preporučuje se korištenje tijekom prva tri mjeseca trudnoće.
English: It must not be used in women who are more than three months pregnant.
Croatian: Ne smije se upotrebljavati kod žena koje su trudne dulje od tri mjeseca.
English: Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel.
Croatian: Irbesartan je pojedinačno odobren u Europskoj uniji (EU) od 1997. pod nazivima Karvea i Aprovel.
English: Other information about CoAprovel
Croatian: Druge informacije o lijeku CoAprovel
English: The full EPAR for CoAprovel 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 CoAprovel može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel on 15 October 1998.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za CoAprovel vrijedi na prostoru Europske unije od 15. listopada 1998.
English: CoAprovel irbesartan / hydrochlorothiazide
Croatian: CoAprovel irbesartan/hidroklorotiazid
English: For more information about treatment with CoAprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom CoAprovel pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: Glavna mjera učinkovitosti bilo je smanjenje dijastoličkog krvnog tlaka (krvni tlak izmjeren između dva otkucaja srca).
English: This is a summary of the European public assessment report (EPAR) for CoAprovel.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za CoAprovel.
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Irbesartan je „antagonist receptora angiotenzina II”, što znači da blokira rad hormona angiotenzina II u tijelu.
English: CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Croatian: CoAprovel je bio učinkovitiji od placeba (liječenje bez djelatne tvari) i od samog hidroklorotiazida u smanjenju dijastoličkog krvnog tlaka.
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel.
Croatian: Ispitivanja lijekova Karvea/Aprovel korištenih uz hidroklorotiazid u obliku odvojenih tableta korištena su za podržavanje uporabe lijeka CoAprovel.
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokiranjem receptora na koja se angiotenzin II inače veže irbesartan sprječava učinak hormona i omogućuje širenje krvnih žila.
English: It can be used with hydrochlorothiazide to treat hypertension.
Croatian: Može se koristiti uz hidroklorotiazid za liječenje hipertenzije.
English: Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels.
Croatian: Potreban je oprez prilikom primjene lijeka CoAprovel s drugim lijekovima koji utječu na razinu kalija u krvi.
English: It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Croatian: Djeluje na način da povećava izlučivanje mokraće, a time smanjuje količinu tekućine u krvi i snižava krvni tlak.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Croatian: Kombinacija ovih dviju djelatnih tvari ima zbrojni učinak tako što snižava krvni tlak više nego svaki lijek pojedinačno.
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Croatian: Hidroklorotiazid je diuretik, što je druga vrsta liječenja hipertenzije.
English: The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Croatian: Doza lijeka CoAprovel koja se koristi ovisi o dozi irbesartana ili hidroklorotiazida koju je bolesnik uzimao prije.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for CoAprovel.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi preporučilo njegovo odobrenje za stavljanje u promet te uključuje preporuke Povjerenstva o uvjetima za primjenu lijeka CoAprovel.
English: What is the risk associated with CoAprovel?
Croatian: Koji su rizici povezani s lijekom CoAprovel?
English: CoAprovel may be added to some other treatments for hypertension.
Croatian: CoAprovel se može dodati nekim drugim načinima liječenja hipertenzije.
English: The full list of these medicines is given in the Package Leaflet.
Croatian: Cijeli popis ovih lijekova navodi se u uputi o lijeku.
English: Why has CoAprovel been approved?
Croatian: Zašto je CoAprovel odobren?
English: CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Croatian: CoAprovel se ne smije upotrebljavati kod osoba koje su preosjetljive (alergične) na irbesartan, hidroklorotiazid, sulfonamide ili neku od drugih sastavnica.
English: What benefit has CoAprovel shown during the studies?
Croatian: Koje koristi lijeka CoAprovel su dokazane u ispitivanjima?
English: Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Croatian: Povećavanje doze na 300 mg irbesartana i 25 mg hidroklorotiazida moglo bi dodatno smanjiti krvni tlak.
English: The CHMP decided that CoAprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka CoAprovel nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za stavljanje u promet.
English: What is CoAprovel?
Croatian: Što je CoAprovel?