FrancophonIA/ELRC3.0 huggingface dataset:
English: • However, other findings4-7 do not provide evidence of an association between testosterone and cardiovascular events, and data from a multinational observational registry study (RHYME) looking at prostate health outcomes in men treated with testosterone for over 2 years also indicate cardiovascular events within the anticipated range.
Croatian: • No, ostali nalazi4-7 ne pružaju dovoljno dokaza o vezi između testosterona i kardiovaskularnog događaja, a podaci iz opservacijskih ispitivanja multinacionalnih registara (RHYME) koji navode ishode vezane uz zdravlje prostate u muškaraca liječenih testosteronom tijekom razdoblja od 2 godine također navode kardiovaskularne događaje unutar očekivanog raspona.
English: The changes to the product information for testosterone medicines are based on a PRAC review of data available from clinical trials, observational studies, meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Croatian: Izmjene informacija o lijeku za lijekove koji sadrže testosteron temelje se na PRAC-ovu pregledu podataka dostupnih iz kliničkih ispitivanja, opservacijskih ispitivanja, meta analiza, podataka prikupljenih nakon stavljanja lijeka u promet i dodatnih objavljenih podataka o kardiovaskularnim rizicima povezanima s terapijom testosteronom.
English: In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function.
Croatian: U muškaraca s hipogonadizmom razine testosterona su abnormalno niske, što utječe na normalni spolni razvoj i funkciju.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih standarda za sigurnu primjenu na razini EU-a za lijekove odobrene nacionalnim postupcima.
English: • Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently.
Croatian: • Iako pojedina ispitivanja potvrđuju povišeni rizik od kardiovaskularnih događaja u muškaraca liječenih testosteronom, dokazi u literaturi ne potvrđuju to konzistentno.
English: • Caution is also advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure.
Croatian: • Oprez se savjetuje i pri primjeni u bolesnika s postojećom hipertenzijom jer testosteron može uzrokovati povišenje krvnog tlaka.
English: • The product information will also be amended to make it clear that these medicines should only be given to men in whom both signs and symptoms and laboratory tests confirm abnormally low levels of testosterone.
Croatian: • Informacije o lijeku treba također izmijeniti kako bi bilo jasno da se ovi lijekovi trebaju primjenjivati samo u muškaraca u kojih znakovi i simptomi te laboratorijski testovi potvrđuju abnormalno niske koncentracije testosterona.
English: The CMDh position follows a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines.
Croatian: Mišljenje CMDh-a doneseno je nakon pregleda Odbora za ocjenu rizika na području farmakovigilancije (PRAC) pri EMA-i koji je razmotrio rizik od ozbiljnih problema koji utječu na srce i cirkulaciju, posebice infarkt miokarda, u muškaraca liječenih ovim lijekovima.
English: • The cardiovascular safety of testosterone medicines will continue to be monitored and the findings of ongoing studies will be reflected in the next regular benefit-risk assessments when available.
Croatian: • Kardiovaskularna sigurnost lijekova koji sadrže testosteron i dalje će se pratiti, a nalazi ispitivanja u tijeku bit će prikazani u sljedećoj redovitoj ocjeni omjera koristi i rizika kada postanu dostupni.
English: • There is not much information on the use of testosterone medicines in men over 65 years of age.
Croatian: • Nema mnogo dostupnih informacija o primjeni lijekova koji sadrže testosteron u muškaraca starijih od 65 godina.
English: • Relevant safety and efficacy data in patients with age-related hypogonadism and established physiological reference values in older patients are lacking, and further studies are needed.
Croatian: • Nedostaju relevantni podaci vezani uz sigurnu primjenu i djelotvornost u bolesnika s hipogonadizmom povezanim s godinama, a nisu utvrđene ni fiziološke referentne vrijednosti za starije bolesnike, te su potrebna daljnja ispitivanja.
English: The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it.
Croatian: Pregled je započet zato što su pojedina novija ispitivanja navodila povećanje broja srčanih problema u muškaraca koji su koristili testosteron u odnosu na muškarce koji ga nisu koristili.
English: However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines.
Croatian: No, informacije o lijeku trebaju biti ažurirane kako bi bile u skladu s najnovijim dostupnim dokazima o sigurnoj primjeni, te sadržavale upozorenja da se manjak testosterona treba potvrditi znakovima i simptomima te laboratorijskim testovima prije primjene terapije ovim lijekovima u muškaraca.
English: • Testosterone is a hormone responsible for normal sexual development and function in men.
Croatian: • Testosteron je hormon odgovoran za normalni spolni razvoj i spolnu funkciju muškaraca.
English: • Some recent studies have suggested that using testosterone may increase a man's risk of heart attacks or other serious effects on the heart and circulation.
Croatian: • Pojedina novija ispitivanja ukazuju da bi primjena testosterona mogla povećati rizik u muškaraca od infarkta miokarda ili drugih ozbiljnih nuspojava vezanih za srce i cirkulaciju.
English: • There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age.
Croatian: • Postoji ograničeno iskustvo o sigurnosti i djelotvornosti primjene testosterona u bolesnika starijih od 65 godina.
English: The CMDh has endorsed the PRAC recommendations by consensus and they will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Croatian: CMDh je konsenzusom potvrdio preporuke PRAC-a, te će one sada biti izravno primijenjene u skladu s usuglašenim rasporedom u državama članicama u kojima je lijek odobren.
English: It should be borne in mind that physiological testosterone levels decrease somewhat with age, though there is no current consensus on appropriate age-specific testosterone reference values, and use to boost these levels in healthy older men is not an authorised use in the EU.
Croatian: Treba imati na umu da se fiziološke razine testosterona smanjuju s godinama, no trenutno ne postoji konsenzus u pogledu referentne vrijednosti testosterona koje bi bile primjerene za specifičnu dob, a primjena lijeka za podizanje ovih razina u zdravih starijih muškaraca nije odobrena primjena u EU-u.
English: Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men.
Croatian: Lijekovi koji sadrže testosteron djeluju zamjenjujući testosteron koji nedostaje, pomažući pri uspostavi normalnih koncentracija testosterona kako bi se osigurao normalan spolni razvoj i funkcija u muškaraca.
English: The use of testosterone in healthy older men is not an authorised use in the EU.
Croatian: Primjena testosterona u zdravih starijih muškaraca nije odobrena primjena u EU-u.
English: In particular, concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease.1-3
Croatian: Zabrinutost je posebice prisutna u pogledu mogućeg povećanog rizika od kardiovaskularnih događaja, i to infarkta miokarda, u muškaraca liječenih testosteronom te onih s već postojećom srčanom bolesti.1-3
English: Medicines containing testosterone are licensed in the EU to treat men with abnormally low levels of the hormone (hypogonadism).
Croatian: Lijekovi koji sadrže testosteron odobreni su za primjenu u EU-u za liječenje muškaraca s abnormalno niskim koncentracijama hormona (hipogonadizam).
English: Testosterone-containing medicines are used to replace testosterone in men with hypogonadism.
Croatian: Lijekovi koji sadrže testosteron koriste se kao zamjena za testosteron u muškaraca s hipogonadizmom.
English: • Some recent studies have shown an increased risk of cardiovascular events in men treated with testosterone.
Croatian: • Pojedina novija ispitivanja potvrđuju povišeni rizik od kardiovaskularnih događaja u muškaraca liječenih testosteronom.
English: The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests.
Croatian: U informacijama o lijeku treba jasno navesti da se testosteron treba primjenjivati samo u slučajevima kada su potvrđene abnormalno niske razine hormona, i to znakovima, simptomima i odgovarajućim laboratorijskim testovima.
English: The level of testosterone falls naturally with age and testosterone-containing medicines are not approved in the EU for use to boost testosterone levels in healthy older men.
Croatian: Koncentracija testosterona prirodno se snižava s godinama, te lijekovi koji sadrže testosteron nisu odobreni u EU-u za podizanje razina testosterona u zdravih starijih muškaraca.
English: The benefit-risk balance of these medicines has been reviewed following recent published evidence pointing to an increased risk of cardiovascular events, particularly myocardial infarction, in men treated with testosterone.
Croatian: Omjer koristi i rizika tih lijekova pregledan je nakon nedavno objavljenih dokaza koji su istaknuli povišeni rizik od kardiovaskularnih događaja, posebice infarkta miokarda, u muškaraca liječenih testosteronom.
English: Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorised use of the medicine in the EU.
Croatian: Razine testosterona prirodno se snižavaju tijekom godina, no ponovna uspostava tih razina u zdravih starijih muškaraca ne smatra se odobrenom primjenom ovog lijeka u EU-u.
English: Xu L, Freeman G, Cowling BJ, et al. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
Croatian: Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
English: Corona G, Maseroli E, Rastrelli G, et al. Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
Croatian: Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
English: It follows concerns over reports about side effects of these medicines on the heart.
Croatian: Postupak je pokrenut nakon što je iskazana zabrinutost vezana uz prijavljene nuspojave pri primjeni tih lijekova na srce.
English: As the CMDh position was adopted by consensus, it will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Croatian: Mišljenje CMDh-a doneseno je konsenzusom, a bit će izravno primijenjeno u skladu s usuglašenim rasporedom za lijekove odobrene nacionalnim postupcima na razini EU-a.
English: Vigen R, O'Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.
Croatian: Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.
English: Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism.
Croatian: Lijekovi koji sadrže testosteron odobreni su u EU-u za liječenje hipogonadizma u muškaraca.
English: The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them.
Croatian: Utvrđeno je da su dokazi vezani uz rizik od srčanih problema nekonzistentni: pojedina ispitivanja ukazuju na povišeni rizik, dok druga nisu potvrdila taj rizik.
English: Baillargeon J, Urban RJ, Kuo Y-F, et al. Risk of myocardial infarction in older men receiving testosterone therapy.
Croatian: Risk of myocardial infarction in older men receiving testosterone therapy.
English: It is used in the following types of cancer:
Croatian: Koristi se kod sljedećih tipova karcinoma:
English: The full EPAR for Docetaxel Teva 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) nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Croatian: Održavanjem kostura očuvanim stanice se ne mogu dijeliti i naposljetku umiru.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Croatian: • karcinoma glave i vrata u bolesnika čiji je karcinom lokalno uznapredovao (karcinom koji je narastao, ali se nije raširio).
English: Docetaxel Teva is given as a one-hour infusion every three weeks.
Croatian: Docetaxel Teva daje se kao jednosatna infuzija svaka tri tjedna.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Croatian: Doza, trajanje liječenja i lijekovi koji se koriste ovise o vrsti karcinoma koji se liječi.
English: Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3.)
Croatian: Docetaxel Teva koristi se samo kad je broj neutrofila (razina vrste leukocita) normalan (najmanje 1 500 stanica/mm3.)
English: This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Croatian: To znači da je Docetaxel Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Taxotere.
English: Docetaxel Teva can be used on its own after other treatments have failed.
Croatian: Docetaxel Teva može se koristiti sam nakon što su sve druge terapije zatajile.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Croatian: • karcinoma prostate kada karcinom ne odgovara na hormonsko liječenje.
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Croatian: Docetaxel blokira stadije diobe stanica pri čemu se unutarnji „kostur” rastavlja kako bi se omogućilo dijeljenje stanica.
English: • breast cancer.
Croatian: • karcinom dojke.
English: Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Croatian: Budući da je Docetaxel Teva generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Docetaxel Teva pročitajte u uputi lijeka (također dio EPARa), odnosno obratite se svom liječniku ili ljekarniku.
English: Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.
Croatian: Docetaxel Teva treba koristiti na odjelima specijaliziranim za kemoterapiju (lijekovi za liječenje karcinoma) i smije se davati samo pod nadzorom liječnika kvalificiranog za uporabu kemoterapije.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Docetaxel Teva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Docetaxel Teva vrijedi na prostoru Europske unije od 26. siječnja 2010.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Croatian: Može se također koristiti s drugim lijekovima protiv karcinoma (doksorubicin, ciklofosfamid, trastuzumab ili kapecitabin) u bolesnika koji još nisu primili nikakvo liječenje za svoj karcinom ili nakon što su druge terapije zatajile, ovisno o vrsti i stadiju karcinoma dojke koji se liječi;
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion.
Croatian: Deksmetazon (protuupalni lijek) također treba davati bolesnicima počevši na dan prije infuzije lijeka Docetaxel Teva.
English: Docetaxel Teva is a ‘generic medicine'.
Croatian: Docetaxel Teva je „generički lijek”.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Croatian: Docetaxel također zahvaća stanice koje nisu kancerozne poput krvnih stanica što uzrokuje nuspojave.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil.
Croatian: Docetaxel Teva koristi se s cisplatinom i 5-fluorouracilom.
English: What benefit and risk of Docetaxel Teva?
Croatian: Koje su koristi i rizici lijeka Docetaxel Teva?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) zaključilo je kako je, u skladu s preduvjetima EU-a, potvrđeno kako Docetaxel Teva posjeduje usporedivu kvalitetu s lijekom Taxotere.
English: Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel.
Croatian: Budući da je Docetaxel Teva generički lijek, proizvođač je dostavio podatke o docetakselu iz objavljenje literature.
English: Other information about Docetaxel Teva
Croatian: Ostale informacije o lijeku Docetaxel Teva
English: The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Croatian: Djelatna tvar u lijeku Docetaxel Teva, docetaksel pripada skupini lijekova protiv karcinoma poznatih kao taksani.
English: Docetaxel Teva docetaxel
Croatian: Docetaxel Teva docetaksel
English: It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
Croatian: Također se može koristiti s cisplatinom (drugim lijekom protiv karcinoma) u bolesnika koji još nisu primili nikakvu terapiju protiv karcinoma;
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Croatian: Docetaxel Teva koristi se s cisplatinom i 5-fluorouracilom (drugim lijekovima protiv karcinoma);
English: • non-small cell lung cancer.
Croatian: • nemalih stanica karcinoma pluća.
English: No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Docetaksel Teva generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Taxotere.
English: In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.
Croatian: Pored toga, tvrtka je prikazala ispitivanja da bi pokazala da je otopina lijeka Docetaxel Teva usporedive kvalitete kao i Taxotere.
English: It contains the active substance docetaxel.
Croatian: Sadrži djelatnu tvar docetaksel.
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 Docetaxel Teva.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek Docetaxel Teva da bi preporučilo njegovo odobrenje za stavljanje u promet te uvjete za njegovu primjenu.
English: What is Docetaxel Teva?
Croatian: Što je Docetaxel Teva?
English: Docetaxel Teva is an anticancer medicine.
Croatian: Docetaxel Teva je lijek protiv karcinoma.
English: Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
Croatian: Docetaxel Teva koristi se s prednizonom ili prednizolonom (lijekovima protiv upale);
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Croatian: • adenokarcinoma želudca kod bolesnika koji još nisu primili terapiju za svoj karcinom.
English: Why has Docetaxel Teva been approved?
Croatian: Zašto je lijek Docetaxel Teva odobren?
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Taxotere.
English: The Committee recommended that Docetaxel Teva be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Docetaxel Teva.
English: Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein.
Croatian: Docetaxel Teva je dostupan kao tekućina za pripravu otopine za infuziju (drip) u venu.
English: What is Docetaxel Teva used for?
Croatian: Za što se Docetaxel Teva koristi?
English: How is Docetaxel Teva used?
Croatian: Kako se Docetaxel Teva koristi?
English: How has Docetaxel Teva been studied?
Croatian: Kako je Docetaxel Teva ispitivan?
English: How does Docetaxel Teva work?
Croatian: Kako djeluje Docetaxel Teva?
English: • If you are over 65.
Croatian: • Ako ste stariji od 65 godina.
English: Once you start taking Stribild, look out for:
Croatian: Kad jednom počnete uzimati Stribild, pazite na:
English: • other allergic reactions
Croatian: • druge alergijske reakcije
English: 3 These are drugs within class where similar interactions could be predicted.
Croatian: 3 To su lijekovi iz klase u kojoj se mogu predvidjeti slične interakcije.
English: If you take more Stribild than you should
Croatian: Ako uzmete više Stribilda nego što ste trebali
English: • Tell your doctor immediately if you become pregnant, think you may be pregnant or are planning to have a baby.
Croatian: • Odmah obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: • Use effective contraception while taking Stribild.
Croatian: • Koristite učinkovitu kontracepciju dok uzimate Stribild.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}>.