FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and as a result the cancer cells die.
Croatian: Stoga se nakon inhibiranja bjelančevina PARP oštećeni DNK u stanicama raka ne može popraviti, što uzrokuje odumiranje stanica raka.
English: An overview of Talzenna and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Talzenna i zašto je odobren u EU-u
English: As for all medicines, data on the use of Talzenna are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Talzenna kontinuirano se prate.
English: The side effects with Talzenna were generally well-tolerated and when needed, manageable with dose modifications, and/or standard supportive medical therapy.
Croatian: Nuspojave lijeka Talzenna općenito se dobro podnose i kada je to potrebno, mogu se kontrolirati izmjenom doze i/ili standardnom potpornom medicinskom terapijom.
English: Talzenna can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Talzenna se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Why is Talzenna authorised in the EU?
Croatian: Zašto je lijek Talzenna odobren u EU-u?
English: The active substance in Talzenna, talazoparib, blocks the action of enzymes called human poly-ADP ribose polymerase (PARP), which are proteins that help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Croatian: Djelatna tvar lijeka Talzenna, talazoparib, inhibira djelovanje enzima naziva humana poli -ADP riboza polimeraza (PARP), bjelančevina koje pomažu u popravljanju oštećenja DNK u stanicama (u normalnim stanicama i u stanicama raka) tijekom diobe stanica.
English: For more information about using Talzenna, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Talzenna pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.
Croatian: Talzenna je lijek protiv raka koji se koristi kao monoterapija za liječenje određene vrste raka dojke (HER2-negativan s mutiranim BRCA genom) koji se proširio izvan izvorišta, u bolesnika koji su liječeni lijekovima koji su prestali djelovati ili ako ti lijekovi nisu prikladni.
English: The most common side effects with Talzenna (which may affect more than 1 in 4 people) are tiredness, anaemia (low red blood cell counts which can cause tiredness and pale skin), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low blood levels of platelets), and headache.
Croatian: Najčešće nuspojave lijeka Talzenna (koje se mogu javiti u više od 1 na 4 osobe) jesu umor, anemija (nizak broj crvenih krvnih zrnaca koji može uzrokovati umor i blijedu kožu), mučnina (slabost), neutropenija (nizak broj neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcija), trombocitopenija (niske razine trombocita) i glavobolja.
English: The most common severe side effects (which may affect more than 1 in 10 people) which led to changes in the dose of Talzenna are anaemia, neutropenia and thrombocytopenia.
Croatian: Najčešće teške nuspojave lijeka Talzenna (koje se mogu javiti u više od 1 na 10 osoba) koje su uzrokovale promjene u doziranju lijeka Talzenna jesu anemija, neutropenija i trombocitopenija.
English: Generally the outcome is poor for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Croatian: Općenito su loši izgledi za bolesnice s HER2-negativnim rakom dojke s mutiranim BRCA genom čiji se rak proširio.
English: Talzenna can increase the time these patients live without their disease getting worse.
Croatian: Terapija lijekom Talzenna može produljiti razdoblje života tijekom kojeg bolesnice žive bez pogoršanja bolesti.
English: Talzenna was shown to be effective at increasing the time patients live without their disease getting worse in one main study involving 431 patients with HER2-negative breast cancer with BRCA mutations whose cancer had spread.
Croatian: Lijek Talzenna pokazao se učinkovitim u produljenju razdoblja tijekom kojeg su bolesnice živjele bez pogoršanja bolesti u jednom glavnom ispitivanju koje je obuhvatilo 431 bolesnicu s HER2-negativnim rakom dojke s mutiranim BRCA genom čiji se rak proširio.
English: What benefits of Talzenna have been shown in studies?
Croatian: Koje su koristi od lijeka Talzenna utvrđene u ispitivanjima?
English: How does Talzenna work?
Croatian: Kako djeluje Talzenna?
English: How is Talzenna used?
Croatian: Kako se Talzenna primjenjuje?
English: The dose may be reduced or treatment interrupted if certain side effects develop.
Croatian: Ako dođe do određenih nuspojava, dozu treba smanjiti ili prekinuti liječenje.
English: For the full list of side effects and restrictions with Talzenna, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Talzenna potražite u uputi o lijeku.
English: Further information on Fasenra can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/fasenra.
Croatian: Više informacija o lijeku Fasenra dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/Human/EPAR/fasenra.
English: Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.
Croatian: Lijek Fasenra treba davati sve dok bolesnik od njega ima koristi, a liječnici trebaju najmanje jednom godišnje ponovno procijeniti treba li liječenje nastaviti.
English: Fasenra received a marketing authorisation valid throughout the EU on 8 January 2018.
Croatian: Lijek Fasenra dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 8. siječnja 2018.
English: The recommended dose is 30 mg injected under the skin of the thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards.
Croatian: Preporučena doza je 30 mg i daje se injekcijom pod kožu bedra ili trbuha svaka četiri tjedna za prve tri doze, te svakih osam tjedana nakon toga.
English: What is Fasenra and what is it used for?
Croatian: Što je Fasenra i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Fasenra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fasenra?
English: If the injection is given by a doctor or carer, it can also be given under the skin of the upper arm.
Croatian: Ako injekciju daju liječnik ili njegovatelj, može se dati i pod kožu nadlaktice.
English: The European Medicines Agency therefore decided that Fasenra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Fasenra nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u EU-u.
English: Side effects reported with Fasenra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Fasenra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Among patients with the highest number of blood eosinophils before treatment, the number of severe flareups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).
Croatian: Među bolesnicima s najvećim brojem eozinofila u krvi prije liječenja, broj teških razbuktavanja godišnje bio je 0,66 u bolesnika liječenih lijekom Fasenra (koji su ga primali svaka četiri tjedna za prve tri doze i svakih osam tjedana nakon toga), u usporedbi s 1,14 u bolesnika koji su primali placebo (prividno liječenje).
English: A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.
Croatian: U trećem ispitivanju, koje je obuhvaćalo 220 bolesnika, utvrđeno je da se u više bolesnika koji su primali lijek Fasenra stanje popravilo u tolikoj mjeri da su mogli smanjiti svoju dozu kortikosteroida za prosječno 75 % u usporedbi s 25 % u onih koji su primali placebo.
English: It can only be obtained with a prescription and treatment should be started by doctors with experience in the diagnosis and treatment of severe asthma.
Croatian: Lijek se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju teške astme.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fasenra 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 Fasenra nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Fasenra?
Croatian: Koji su rizici povezani s lijekom Fasenra?
English: As for all medicines, data on the use of Fasenra are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Fasenra kontinuirano se prate.
English: The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat).
Croatian: Najčešće nuspojave lijeka Fasenra (koje se mogu javiti u najviše 1 na 10 osoba) jesu glavobolja i faringitis (grlobolja).
English: An overview of Fasenra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Fasenra i zašto je odobren u EU-u
English: Other information about Fasenra
Croatian: Ostale informacije o lijeku Fasenra
English: For more information about using Fasenra, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Fasenra pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Why is Fasenra authorised in the EU?
Croatian: Zašto je lijek Fasenra odobren u EU-u?
English: Fasenra contains the active substance benralizumab.
Croatian: Fasenra sadržava djelatnu tvar benralizumab.
English: Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment.
Croatian: Utvrđeno je da je lijek Fasenra učinkovitiji od placeba u smanjivanju broja razbuktavanja astme i potrebi za liječenjem kortikosteroidima.
English: Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists.
Croatian: Utvrđeno je da Fasenra smanjuje broj pogoršanja (razbuktavanja) astme tijekom liječenja u dvama glavnim ispitivanjima koja su obuhvatila ukupno 2 511 bolesnika s eozinofilnom astmom koja se nije mogla na odgovarajući način kontrolirati kombinacijom visokih doza inhalacijskih kortikosteroida i dugodjelujućim beta-agonistima.
English: The medicine is well tolerated with few side effects.
Croatian: Lijek se dobro podnosi i ima malo nuspojava.
English: Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma.
Croatian: Fasenra je lijek protiv astme koji se koristi za liječenje odraslih osoba s posebnom vrstom astme zvanom eozinofilna astma.
English: It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists.
Croatian: Koristi se kao dodatna terapija u odraslih osoba s teškom astmom koja se ne može na odgovarajući način kontrolirati kombinacijom visokih doza inhalacijskih kortikosteroida i lijekovima naziva dugodjelujući beta-agonisti.
English: The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils.
Croatian: Djelatna tvar u lijeku Fasenra, benralizumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno vezivanju na receptore (ciljna mjesta) naziva interleukin-5 receptori na
English: Fasenra is available as a solution for injection in pre-filled syringes and pre-filled pens.
Croatian: Lijek Fasenra dostupan je kao otopina za injekciju u napunjenim štrcaljkama ili brizgalicama.
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Croatian: Simptomi eozinofilne astme povezani su s prevelikim brojem bijelih krvnih stanica zvanih eozinofili u krvi te u sluzi u plućima.
English: If agreed with the treating doctor, patients already using Fasenra and with no history of severe allergic reactions, or their carers, can inject Fasenra themselves after proper training, including on how to watch out for signs and symptoms of allergic reactions.
Croatian: Bolesnici koji već uzimaju lijek Fasenra i koji nisu prethodno imali teške alergijske reakcije, ili njihovi njegovatelji, mogu u dogovoru s liječnikom nakon odgovarajuće obuke, koja podrazumijeva i praćenje znakova i simptoma alergijskih reakcija, samostalno ubrizgavati lijek Fasenra.
English: What benefits of Fasenra have been shown in studies?
Croatian: Koje su koristi od lijeka Fasenra utvrđene u ispitivanjima?
English: Fasenra activates the immune system (the body's natural defences) to kill the eosinophils in the blood and lungs.
Croatian: Vezivanjem na interleukin-5 receptore lijek Fasenra aktivira imunosni sustav (prirodnu obranu tijela) da uništava eozinofile u krvi i plućima.
English: How does Fasenra work?
Croatian: Kako djeluje Fasenra?
English: For the full list of side effects and restrictions of Fasenra, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Fasenra potražite u uputi o lijeku.
English: How is Fasenra used?
Croatian: Kako se Fasenra primjenjuje?
English: When should I seek advice or help?
Croatian: Kada trebate potražiti savjet ili pomoć?
English: Why do you get these symptoms?
Croatian: Zašto dobivate ove simptome?
English: • Eat slowly and eat smaller portions.
Croatian: • Jedite polako i manje porcije.
English: Do not use any other liquids.
Croatian: Nemojte koristiti nikakvu drugu tekućinu.
English: If you forget to take a dose, take it as soon as you remember it, on the same day.
Croatian: Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite, istoga dana.
English: <www.xxx.xxx>
Croatian: <www.xxx.xx>
English: Do not exceed this dose.
Croatian: Nemojte prekoračiti ovu dozu.
English: Always stir the mixture just before drinking it.
Croatian: Uvijek promiješajte mješavinu neposredno prije nego što je popijete.
English: • Avoid fizzy drinks, coffee, chocolate and alcohol.
Croatian: • Izbjegavajte gazirana pića, kavu, čokoladu i alkohol.
English: Children and adolescents This medicine should not be used by children and adolescents under 18 years of age.
Croatian: Ovaj lijek se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: The liquid with the pellets should be drunk immediately or within 30 minutes.
Croatian: Tekućinu s peletama treba popiti odmah ili unutar 30 minuta.
English: This is because this medicine can affect the way some medicines work and some medicines can have an effect on it.
Croatian: To je zato što ovaj lijek može utjecati na djelovanje nekih lijekova, a neki drugi lijekovi mogu utjecati na njega.
English: It is important not to damage the pellets.
Croatian: Važno je ne oštetiti pelete.
English: Treatment should be symptomatic and general supportive measures should be utilised.
Croatian: Liječenje treba biti simptomatsko i treba primijeniti opće suportivne mjere.
English: • Stir until the tablet breaks up (the mixture will not be clear) then drink the mixture straight away or within 30 minutes.
Croatian: • Miješajte dok se tableta ne razgradi (mješavina neće biti bistra), a zatim mješavinu popijte odmah ili unutar 30 minuta.
English: Aluminium blister.
Croatian: Aluminijski blister.
English: • Try to lose weight.
Croatian: • Pokušajte smanjiti tjelesnu težinu.
English: Do not take this medicine if any of the above apply to you.
Croatian: Nemojte uzimati ovaj lijek ako se nešto od gore navedenoga odnosi na Vas.
English: • Increased sweating.
Croatian: • pojačano znojenje.
English: In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.
Croatian: Osim toga, sigurnosni profil sličan je za različite formulacije, indikacije za liječenje, dobne skupine i populacije bolesnika.
English: FURTHER HELPFUL INFORMATION
Croatian: DODATNE KORISNE INFORMACIJE
English: However, the maximum levels of inhibition of (ADP induced) platelet aggregation in these subjects were the same in both groups.
Croatian: Međutim, maksimalne razine inhibicije agregacije trombocita (potaknute ADP-om) u tih ispitanika bile su jednake u obje skupine.
English: • Seeing, feeling or hearing things that are not there (hallucinations)
Croatian: • osoba vidi, osjeća ili čuje stvari koje nisu prisutne (halucinacije)
English: The majority of these rated the importance of this change to be Important to Extremely Important in performing their activities of daily living (79 - 86% at week 2).
Croatian: Većina njih ocijenila je tu promjenu važnom ili iznimno važnom za obavljanje njihovih svakodnevnih aktivnosti (79-86% u 2. tjednu).
English: Digoxin toxicity has been rarely reported.
Croatian: Rijetko je prijavljena toksičnost digoksina.
English: • Taste changes.
Croatian: • promjene okusa
English: The water should be stirred until the tablet disintegrates.
Croatian: Vodu treba miješati dok se tableta ne raspadne.
English: • Stop smoking.
Croatian: • Prestanite pušiti.
English: One tablet daily Lasts 24 hours
Croatian: Jedna tableta dnevno Traje 24 sata
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 25 June 2018
Croatian: Datum posljednje obnove odobrenja: 25. lipnja 2018.
English: • Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime.
Croatian: • Jedite zdraviju hranu i pokušajte izbjegavati začinjenu i masnu hranu te obilne obroke prije spavanja.
English: Non-clinical data reveal no particular hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti te reproduktivne i razvojne toksičnosti.
English: The duration of treatment is up to 2 weeks.
Croatian: Liječenje traje najviše 2 tjedna.
English: Take one capsule once a day.
Croatian: Uzmite jednu kapsulu jedanput na dan.
English: Take one tablet once a day.
Croatian: Uzmite jednu tabletu jedanput na dan.
English: Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking lots of alcohol.
Croatian: Žgaravica može biti posljedica prekomjernog jedenja, jedenja masne hrane, prebrzog jedenja i konzumacije velike količine alkohola.
English: • You are due to have a specific blood test (Chromogranin A).
Croatian: • Ako trebate napraviti posebne krvne pretrage (kromogranin A).
English: • The treatment length is up to 14 days.
Croatian: • Liječenje traje najviše 14 dana.
English: There is insufficient information on the effects of esomeprazole in newborns/infants.
Croatian: Nema dovoljno podataka o učincima esomeprazola na novorođenčad/dojenčad.
English: Your doctor may adjust your dose of Nexium Control if you also have severe liver problems and are treated for a long period of time.
Croatian: Vaš liječnik može prilagoditi Vašu dozu lijeka Nexium Control ukoliko također imate teške probleme s jetrom i ako se liječite duže vrijeme.
English: • Medicines that are used to thin your blood, such as warfarin.
Croatian: • Lijekove koji se koriste za razrjeđivanje krvi, poput varfarina.
English: General Patients should be instructed to consult a doctor if:
Croatian: Općenito Bolesnike treba uputiti da se obrate liječniku:
English: • Generally feeling unwell and lacking energy.
Croatian: • opća slabost i nedostatak energije
English: • You have ever had a skin reaction after treatment with a medicine similar to Nexium Control that reduces stomach acid.
Croatian: • Ako ste ikad imali kožnu reakciju nakon liječenja s lijekom sličnim lijeku Nexium Control koji smanjuje želučanu kiselinu.
English: This could be a sign of a serious condition with your heart.
Croatian: Ovo može biti znak ozbiljnih srčanih tegoba.
English: • Hair loss (alopecia).
Croatian: • gubitak kose (alopecija)
English: May take 2-3 days for full effect.
Croatian: Možda će biti potrebna 2-3 dana za puni učinak.
English: The solid pieces contain the medicine - do not chew or crush them.
Croatian: Kruti komadići sadrže lijek - nemojte ih žvakati niti drobiti.
English: What are the symptoms of heartburn?
Croatian: Koji su simptomi žgaravice?
English: If any of the above apply to you (or you are not sure), talk to your doctor straight away.
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), odmah se obratite svom liječniku.
English: Medicinal products with pH dependent absorption
Croatian: Lijekovi čija apsorpcija ovisi o pH
English: The reactions are classified according to MedDRA frequency convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema MedDRA klasifikaciji i kategorijama učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italy.
Croatian: Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italija.
English: Combination with other medicinal products
Croatian: Kombinacija s drugim lijekovima
English: Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.
Croatian: Bolesnici se moraju posavjetovati s liječnikom prije nego uzmu ovaj lijek ako trebaju napraviti endoskopiju ili urea izdisajni test.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek.
English: It belongs to a group of medicines called ‘proton pump inhibitors'.
Croatian: On pripada skupini lijekova koji se zovu „inhibitori protonske pumpe“.
English: • Low levels of magnesium in the blood.
Croatian: • niske razine magnezija u krvi.
English: This could be ‘Stevens-Johnson syndrome' or ‘toxic epidermal necrolysis', seen very rarely.
Croatian: To može biti ‘Stevens-Johnsonov sindrom' ili ‘toksična epidermalna nekroliza', nuspojave koje se javljaju vrlo rijetko.
English: • When your reflux symptoms have completely gone you should stop taking this medicine.
Croatian: • Kada Vam simptomi refluksa u potpunosti nestanu, prestanite uzimati ovaj lijek.