FrancophonIA/ELRC3.0 huggingface dataset:
English: In all patients the cancer did not respond to a previous treatment or had come back.
Croatian: Ni u jednog bolesnika rak nije reagirao na prethodno liječenje ili se vratio.
English: The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Croatian: Liječnik može prekinuti ili okončati terapiju, odnosno smanjiti dozu ako bolesnik razvije određene ozbiljne nuspojave.
English: Further information on Poteligeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Poteligeo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Poteligeo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Poteligeo?
English: The medicine is given as an infusion (drip) into a vein lasting at least 1 hour.
Croatian: Lijek se primjenjuje intravenskom infuzijom (drip) u trajanju od najmanje jednog sata.
English: Why is Poteligeo authorised in the EU?
Croatian: Zašto je Poteligeo odobren u EU-u?
English: What are the risks associated with Poteligeo?
Croatian: Koji su rizici povezani s lijekom Poteligeo?
English: Patients should be monitored during and after the infusion for certain side effects related to the infusion.
Croatian: Bolesnike je potrebno pratiti tijekom i nakon infuzije radi određenih nuspojava povezanih s infuzijom.
English: Poteligeo can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of cancer and in a place where equipment for resuscitation is available in case of rare and severe allergic reaction to the medicine.
Croatian: Poteligeo se može dobiti samo na liječnički recept te liječenje mora nadgledati liječnik s iskustvom u liječenju raka, na mjestu na kojem je dostupna oprema za oživljavanje u slučaju rijetke i ozbiljne alergijske reakcije na lijek.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: In this study, patients receiving Poteligeo lived for around 8 months without their disease getting worse compared with 3 months for patients on vorinostat.
Croatian: U tom su ispitivanju bolesnici koji su primali lijek Poteligeo živjeli oko osam mjeseci bez pogoršanja bolesti u usporedbi s tri mjeseca u bolesnika koji su primali vorinostat.
English: Side effects reported with Poteligeo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Poteligeo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Croatian: Kako bi se smanjili rizici, bolesnicima je moguće dati druge lijekove kao što su antipiretici (lijekovi za snižavanje vrućice) i antihistaminici (za liječenje alergijskih reakcija) prije ili tijekom liječenja lijekom Poteligeo.
English: The most commonly reported serious reactions are pneumonia (infection of the lungs), fever, infusion-related reactions and cellulitis (inflammation of the deep skin tissue).
Croatian: Najčešće prijavljene ozbiljne nuspojave su upala pluća (infekcija pluća), vrućica, rekreacije povezane s infuzijom i celulitis (upala dubokog potkožnog tkiva).
English: The European Medicines Agency therefore decided that Poteligeo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Poteligeo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: By attaching to CCR4, mogamulizumab stimulates the body's immune system to attack the cancer cells, helping to control the disease.
Croatian: Vezanjem na CCR4, mogamulizumab stimulira imunosni sustav organizma da napada stanice raka te pomaže u kontroli bolesti.
English: What is Poteligeo and what is it used for?
Croatian: Što je Poteligeo i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Poteligeo 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 Poteligeo nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It is used in patients who have received previous treatment by mouth or injection.
Croatian: Upotrebljava se u bolesnika koji su prethodno liječenje primili peroralno ili injekcijom.
English: As for all medicines, data on the use of Poteligeo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Poteligeo kontinuirano se prate.
English: An overview of Poteligeo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Poteligeo i zašto je odobren u EU-u
English: For more information about using Poteligeo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Poteligeo pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Poteligeo was shown to be more effective than a comparator medicine, vorinostat, in a study of 372 adults with either mycosis fungoides or Sezary syndrome.
Croatian: Lijek Poteligeo pokazao se djelotvornijim od usporednog lijeka, vorinostata, u ispitivanju 372 odrasle osobe s limfomom mycosis fungoides ili Sézaryevim sindromom.
English: The active substance in Poteligeo, mogamulizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a receptor (target) called CCR4.
Croatian: Djelatna tvar lijeka Poteligeo, mogalizumab, monoklonsko je protutijelo (vrsta bjelančevine) koje je osmišljeno da se veže na receptor (cilj) koji se naziva CCR4.
English: Poteligeo is a cancer medicine used to treat mycosis fungoides and Sezary syndrome - two cancers of blood cells that affect mainly the skin.
Croatian: Poteligeo je lijek protiv raka koji se primjenjuje za liječenje limfoma mycosis fungoides i Sézaryeva sindroma - dvije vrste raka krvnih stanica koje uglavnom utječu na kožu.
English: The side effects seen with Poteligeo are considered manageable and most of them are mild or moderate.
Croatian: Smatra se da se nuspojavama opaženima pri primjeni lijeka Poteligeo može upravljati te da su većinom su blage ili umjerene.
English: CCR4 is found on the surface of white blood cells, including the cancerous cells in mycosis fungoides or Sezary syndrome.
Croatian: CCR4 nalazi se na površini leukocita, uključujući rakom zahvaćene stanice u limfomu mycosis fungoides i Sézaryevu sindromu.
English: The most common side effects with Poteligeo (seen in more than 1 patient in 10) are infusion-related reactions and rash.
Croatian: Najčešće su nuspojave lijeka Poteligeo (uočene u više od 1 na 10 bolesnika) rekreacije povezane s infuzijom i osip.
English: Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 October 2016.
Croatian: Limfom mycosis fungoides i Sézaryev sindrom pripadaju skupini rijetkih oblika raka (kožni limfomi T stanica) te je lijek Poteligeo odobren kao lijek za rijetku bolest 14. listopada 2016.
English: Poteligeo is effective at prolonging the time patients with mycosis fungoides or Sezary syndrome live without their disease getting worse.
Croatian: Poteligeo je djelotvoran u produljenu vremena tijekom kojeg bolesnici s limfomom mycosis fungoides i Sézaryevim sindromom žive bez pogoršanja bolesti.
English: What benefits of Poteligeo have been shown in studies?
Croatian: Koje su koristi od lijeka Poteligeo utvrđene u ispitivanjima?
English: Poteligeo contains the active substance mogamulizumab.
Croatian: Lijek Poteligeo sadržava djelatnu tvar mogamulizumab.
English: For the full list of side effects and restrictions with Poteligeo, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Poteligeo potražite u uputi o lijeku.
English: Other information about Poteligeo
Croatian: Ostale informacije o lijeku Poteligeo
English: How is Poteligeo used?
Croatian: Kako se Poteligeo primjenjuje?
English: How does Poteligeo work?
Croatian: Kako djeluje lijek Poteligeo?
English: This may take up to 5 weeks.
Croatian: To može trajati i do 5 tjedana.
English: This may help these women to become pregnant.
Croatian: To može pomoći tim ženama da zatrudne.
English: Pergoveris must not be used in women who have:
Croatian: Pergoveris se ne smije koristiti u žena koje imaju:
English: This summary was last updated in 03-2017.
Croatian: Sažetak je posljednji put ažuriran: 03. 2017.
English: The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Pergoveris nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle.
Croatian: Primjena manje doze od preporučene početne doze možda neće biti dovoljna za stimuliranje razvoja folikula.
English: The medicine can only be obtained with a prescription.
Croatian: Lijek se izdaje samo na recept.
English: • bleeding from the genital region whose cause is unknown,
Croatian: • ginekološka krvarenja čiji uzrok nije poznat;
English: If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Croatian: Ako je potrebno, doza folitropina alfa može se povećati tako da se doda kao zasebni lijek, pri čemu treba proći 7 do 14 dana između svakog povećanja doze.
English: The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice.
Croatian: Prva injekcija mora se dati pod nadzorom liječnika s iskustvom u liječenju problema neplodnosti, ali pacijentica si može sama davati injekcije ako želi, uz uvjet da je odgovarajuće podučena te da ima pristup stručnom savjetovanju.
English: The company also carried out bioequivalence studies to establish whether the combined injection produced the same levels of the active substances in the body as the two medicines given separately.
Croatian: Tvrtka je provela i ispitivanja bioekvivalencije da bi se utvrdilo je li kombinirana injekcija dovela do stvaranja jednakih razina djelatnih tvari u tijelu kao i dva lijeka primijenjena odvojeno.
English: It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant.
Croatian: Također se ne smije primjenjivati u žena s malformacijama spolnih organa ili fibroidnim tumorima maternice koji im mogu onemogućiti da zatrudne.
English: The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response.
Croatian: Preporučena početna doza je 150 međunarodnih jedinica (IU) folitropina alfa i 75 IU lutropina alfa jednom dnevno, ali dozu treba prilagoditi odgovoru pacijentice na lijek.
English: • cancer of the ovary, womb or breast.
Croatian: • rak jajnika, maternice ili dojke.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Pergoveris na snazi u Europskoj uniji od 25. lipnja 2007.
English: Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause).
Croatian: Pergoveris se ne smije primjenjivati kad se ne može postići korist, kao npr. u žena s primarnim zatajenjem jajnika (kad jajnici prestanu funkcionirati prije menopauze).
English: Other information about Pergoveris
Croatian: Ostale informacije o lijeku Pergoveris
English: What measures are being taken to ensure the safe and effective use of Pergoveris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pergoveris?
English: In the body, FSH stimulates the production of eggs, and LH stimulates their release.
Croatian: FSH u tijelu stimulira proizvodnju jajnih stanica, a LH stimulira njihovo otpuštanje.
English: Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris.
Croatian: Stoga je tvrtka predstavila informacije iz ispitivanja provedenih tijekom razvoja lijeka Luveris kako bi se poduprla primjena lijeka Pergoveris.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Pergoveris nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems.
Croatian: Liječenje može prouzročiti prekomjernu stimulaciju jajnika (poznato kao sindrom hiperstimulacije jajnika (OHSS)), što može dovesti do ozbiljnih medicinskih problema.
English: This is a summary of the European public assessment report (EPAR) for Pergoveris.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Pergoveris.
English: The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection).
Croatian: Najčešće nuspojave zabilježene pri primjeni lijeka Pergoveris (koje su zabilježene u više od 1 na 10 osoba) su glavobolja, ciste na jajnicima i reakcije na mjestu injiciranja (npr. bol, svrbež, crvenilo, modrice, oticanje ili iritacija na mjestu injiciranja).
English: What is Pergoveris and what is it used for?
Croatian: Što je Pergoveris i za što se koristi?
English: • enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease and is of unknown origin,
Croatian: • povećane jajnike ili cistu na jajniku koja nije nastala zbog bolesti policističnih jajnika te je nepoznatog podrijetla;
English: Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels.
Croatian: Pergoveris se ubrizgava pod kožu jednom dnevno dok pacijentica ne razvije odgovarajući folikul, prema ocjeni na temelju ultrazvučnih snimki i mjerenja razina estrogena u krvi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pergoveris 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 Pergoveris nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Pergoveris.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pergoveris.
English: Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Croatian: Tromboembolija (ugrušci u krvnim žilama) mogu se pojaviti vrlo rijetko, obično u vezi s teškim oblikom sindroma OHSS.
English: Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris.
Croatian: Obje djelatne tvari već su odobrene u Europskoj uniji (EU-u), folitropin alfa kao GONAL-f i lutropin alfa kao Luveris.
English: Why is Pergoveris approved?
Croatian: Zašto je lijek Pergoveris odobren?
English: For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Pergoveris pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with Pergoveris?
Croatian: Koji su rizici povezani s lijekom Pergoveris?
English: Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH).
Croatian: Lijek Pergoveris namijenjen je odraslim ženama koje imaju nisku razinu dvaju hormona koji stimuliraju jajnike - hormona za stimulaciju folikula (FSH) i luteinizirajućega hormona (LH).
English: For further information see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: EPAR summary for the public follitropin alfa / lutropin alfa
Croatian: EPAR, sažetak za javnost folitropin alfa / lutropin alfa
English: Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Croatian: Pergoveris je lijek za plodnost koji se primjenjuje u žena za stimuliranje razvoja folikula, struktura u jajnicima koje sadržavaju jajnu stanicu.
English: • tumours of the hypothalamus or pituitary gland,
Croatian: • tumor hipotalamusa ili hipofize;
English: Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection.
Croatian: Lijek Pergoveris dostupan je u obliku otopine za injekciju u napunjenoj brizgalici ili u obliku praška i otapala za otopinu za injekciju.
English: Mild or moderate OHSS is common, while severe OHSS is uncommon.
Croatian: Blagi ili umjereni oblik sindroma OHSS čest je, ali teški oblik sindroma OHSS manje je čest.
English: For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pergoveris bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH.
Croatian: Djelatne tvari u lijeku Pergoveris, folitropin alfa i lutropin alfa, preslike su prirodnih hormona FSH i LH.
English: By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG).
Croatian: Pergoveris nadomješta hormone koji nedostaju i omogućuje ženama s nedostatkom hormona FSH i LH razvoj folikula koji će otpustiti jajnu stanicu nakon injekcije hormona „humani korionski gonadotropin” (hCG).
English: What benefits of Pergoveris have been shown in studies?
Croatian: Koje su koristi lijeka Pergoveris dokazane u ispitivanjima?
English: These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately.
Croatian: Ta su ispitivanja potvrdila da je lijek Pergoveris doveo do stvaranja sličnih razina folitropina alfa i lutropina alfa u tijelu kao i pri odvojenoj primjeni dvaju lijekova.
English: How is Pergoveris used?
Croatian: Kako se Pergoveris koristi?
English: For the full list of all side effects and restrictions with Pergoveris, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Pergoveris potražite u uputi o lijeku.
English: In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles.
Croatian: Kombinacija folitropina alfa i lutropina alfa u tim ispitivanjima u jednakim dozama kao u lijeku Pergoveris dovela je do stvaranja aktivnih folikula.
English: The medicine contains the active substances follitropin alfa and lutropin alfa.
Croatian: Lijek sadrži djelatne tvari folitropin alfa i lutropin alfa.
English: How does Pergoveris work?
Croatian: Kako djeluje Pergoveris?
English: Whereas
Croatian: Budući da
English: Annex IV
Croatian: Dodatak IV
English: The European Commission requested the Agency to give its opinion on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Croatian: Europska komisija zatražila je od Agencije da iznese svoje mišljenje o tome treba li se odobrenje za stavljanje u promet ovih lijekova zadržati, izmijeniti, suspendirati ili povući.
English: Risk minimisation measures
Croatian: Mjere smanjivanja rizika
English: Treatment should be discontinued if the symptoms of angina do not improve within 3 months.
Croatian: Liječenje treba prekinuti ako se simptomi angine ne poboljšaju u roku od 3 mjeseca.
English: • Reinforcement of the recommendation not to exceed the authorised posology.
Croatian: • naglašavanje preporuke da se ne premašuje odobreno doziranje.
English: No significant differences were also observed in any of the secondary endpoints.
Croatian: Značajne razlike nisu uočene u niti jednoj sekundarnoj završnoj točci.
English: After three to four weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response.
Croatian: Nakon tri do četiri tjedna liječenja, doza se može povećati na 7,5 mg dva puta na dan ovisno o terapijskom odgovoru.
English: The individual components of the endpoint were not significantly increased.
Croatian: Pojedine komponente završne točke nisu se značajno povećale.
English: • The PRAC considered Procoralan and Corlentor (ivabradine) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Croatian: • je PRAC razmotrio lijekove Procoralan i Corlentor (ivabradin) u postupku u skladu sa člankom 20. Uredbe (EZ) br. 726/2004, pokrenutim od strane Europske komisije.
English: As the absolute risk is based on 69 events, the possibilities for further analysis to identify the contributing risk factors are limited.
Croatian: Budući da se apsolutan rizik temelji na 69 događaja, ograničene su mogućnosti daljnje analize za identifikaciju čimbenika koji doprinose riziku.
English: This highlights the need to comply with the currently authorized posology.
Croatian: Ovime se naglašava potreba za postupanje u skladu s trenutno odobrenim doziranjem.
English: Ivabradine was also associated with a significantly higher risk of bradycardia.
Croatian: Ivabradin je također povezan sa značajno povišenim rizikom od bradikardije.
English: Additional clarifications were also introduced in the DHPC.
Croatian: Dodatna pojašnjenja su također uvrštena u DHPC.
English: The Product Information for Corlentor and Procoralan was revised to include the following:
Croatian: Informacije za lijekove Corlentor i Procoralan revidirane su kako bi uključivale sljedeće:
English: Background information
Croatian: Pozadinske informacije
English: Grounds for the recommendation
Croatian: Razlozi za preporuku
English: Other factors could not be directly related to a higher CV risk.
Croatian: Ostali čimbenici ne mogu se izravno povezati s povišenim rizikom od CV-a.
English: The frequency of atrium fibrillation (AF) was higher than currently described in the product information.
Croatian: Učestalost fibrilacije atrijuma (AF) bila je veća od trenutno opisane u informacijama o lijeku.