FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the safety findings and possible mechanism of action, the experts of the ad hoc experts group were of the view that a causal association between Esmya and severe liver injury is plausible.
Croatian: Na temelju nalaza o sigurnoj primjeni lijeka i mogućeg mehanizma djelovanja, stručnjaci ad hoc stručne skupine bili su mišljenja da je uzročna povezanost između lijeka Esmya i teškog oštećenja jetre vjerodostojna.
English: • The PRAC reviewed the totality of the data regarding the risk for liver injury with Esmya provided by the marketing authorisation holder and National Competent Authorities on cases of liver injury and liver transplantation reported since the initial marketing authorisation of the product.
Croatian: • PRAC je razmotrio sve podatke s obzirom na rizik od oštećenja jetre uz primjenu lijeka Esmya koje su dostavili nositelj odobrenja za stavljanje lijeka u promet i nacionalna nadležna tijela o slučajevima oštećenja jetre i transplantaciji jetre zabilježenima nakon inicijalnog odobrenja za stavljanje lijeka u promet.
English: In order to ensure that decisions on the initiation and continuation of the treatment are made by physicians who are familiar with diagnosis of uterine fibrosis, the PRAC also recommends that the initiation and supervision of treatment with Esmya should be restricted to physicians experienced in the diagnosis and treatment of uterine fibroids.
Croatian: Kako bi se osiguralo da odluke o započinjanju i nastavku liječenja donose liječnici koji su upoznati s dijagnozom mioma maternice, PRAC također preporučuje da se početak i nadzor liječenja lijekom Esmya ograniči na liječnike iskusne u postavljanju dijagnoze i liječenju mioma maternice.
English: Balancing this to the benefits of Esmya treatment of moderate to severe symptoms of uterine fibroids, the PRAC concluded that the indicated population should be restricted for safety reasons.
Croatian: Dovodeći to u ravnotežu s koristima od primjene lijeka Esmya za liječenje umjerenih do teških simptoma mioma maternice, PRAC je zaključio da indiciranu populaciju treba ograničiti iz sigurnosnih razloga.
English: In addition, in order to analyse data on risk of liver injury related with Esmya and on effectiveness of risk minimisation measures, observational studies should be performed.
Croatian: Osim toga, kako bi se analizirali podatci o riziku od oštećenja jetre povezanom s primjenom lijeka Esmya te o učinkovitosti mjera za smanjenje rizika, potrebno je provesti promatračka ispitivanja.
English: In post marketing settings, all of the reported cases lack information hampering causality assessment, and causal relationship with Esmya and serious hepatic injury is therefore not firmly established.
Croatian: U praćenju lijeka nakon stavljanja u promet, za sve zabilježene slučajeve nedostaju podatci što otežava procjenu uzročnosti, tako da uzročna povezanost između lijeka Esmya i ozbiljnog oštećenja jetre nije neosporno utvrđena.
English: The temporary measure recommended by the PRAC in February 2018, to not treat any new patients is superseded by these new recommendations.
Croatian: Ove nove preporuke nadilaze privremenu mjeru o neliječenju novih bolesnica, koju je PRAC preporučio u veljači 2018.
English: • The PRAC recommended that intermittent treatment of moderate to severe symptoms of uterine fibroids with Esmya should be restricted to adult women of reproductive age who are not eligible for surgery.
Croatian: • PRAC je preporučio da privremeno liječenje umjerenih do teških simptoma mioma maternice lijekom Esmya treba ograničiti na odrasle žene reproduktivne dobi koje nisu prikladne za kirurški zahvat.
English: Therefore, liver function tests should be performed before starting treatment with Esmya, monthly during the first two courses of treatment as well as two to four weeks after the discontinuation of the treatment.
Croatian: Stoga je pretrage funkcije jetre potrebno provesti prije početka liječenja lijekom Esmya, provoditi ih jednom mjesečno tijekom prva dva ciklusa liječenja te dva do četiri tjedna nakon prestanka liječenja.
English: The PRAC also recommended that the initiation and supervision of treatment with Esmya should be restricted to physicians experienced in the diagnosis and treatment of uterine fibroids.
Croatian: PRAC je također preporučio da se započinjanje i nadzor liječenja lijekom Esmya ograniči na liječnike s iskustvom u postavljanju dijagnoze i liječenju mioma maternice.
English: and assuming that all such cases are due to Esmya, regardless of causality, the peak time to onset of liver injury is around 140 days and the vast majority of the reported potential drug induced liver injuries occurring between 1 and 8 months (2 treatment cycles including 2 months pause).
Croatian: Na temelju slučajeva potencijalnog oštećenja jetre zabilježenih nakon stavljanja lijeka Esmya u promet te uz pretpostavku da su svi ti slučajevi nastali zbog primjene lijeka Esmya, bez obzira na uzročnu povezanost, vršno vrijeme do početka oštećenja jetre iznosi oko 140 dana, a najveći broj prijavljenih oštećenja jetre potencijalno nastalih uslijed primjene lijeka pojavi se u razdoblju između jednog i osam mjeseci (dva ciklusa liječenja i dva mjeseca stanke u liječenju).
English: In order to exclude patients that would be potentially more susceptible to hepatic insult from the treatment with Esmya, the product should be contraindicated in patients with underlying hepatic disorder.
Croatian: Kako bi se isključile bolesnice koje bi mogle biti osjetljivije na hepatični inzult zbog liječenja lijekom Esmya, lijek treba biti kontraindiciran u bolesnica s podležećim poremećajem funkcije jetre.
English: In addition, the PRAC recommended the performance of liver function tests before starting each treatment course with Esmya, during treatment as well as two to four weeks after the discontinuation of treatment.
Croatian: Osim toga, PRAC je preporučio provedbu pretraga funkcije jetre prije početka svakog ciklusa liječenja lijekom Esmya, tijekom liječenja te dva do četiri tjedna nakon prestanka liječenja.
English: Furthermore, measures to minimise a risk for liver injury should be implemented.
Croatian: Nadalje, potrebno je uvesti mjere minimizacije rizika od oštećenja jetre.
English: • The PRAC further concluded that Esmya should be contraindicated in patients with underlying hepatic disorder.
Croatian: • PRAC je nadalje zaključio da lijek Esmya treba biti kontraindiciran u bolesnica s podležećim poremećajem funkcije jetre.
English: The PRAC considers that in vitro studies should be performed by the MAH, in order to better characterize the mechanistic profile of DILI as associated with Esmya.
Croatian: PRAC smatra da nositelj odobrenja treba provesti in vitro ispitivanja kako bi se dobila bolja karakterizacija mehanicističkog profila DILI povezanog s lijekom Esmya.
English: It was noted that no signal of hepatic toxicity was identified from non-clinical or clinical studies on Esmya.
Croatian: Opaženo je da u nekliničkim i kliničkim ispitivanjima lijeka Esmya nisu ustanovljeni signali toksičnosti za jetru.
English: PRAC considered all the data submitted by the MAH, as well as data provided by the National Competent Authorities including follow-up information on cases of liver transplantation.
Croatian: PRAC je razmotrio sve podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet te podatke koje su dostavila nacionalna nadležna tijela uključujući informacije dobivene praćenjem slučajeva transplantacije jetre.
English: In view of the above, the Committee considers that the benefit-risk balance of Esmya (ulipristal acetate) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
Croatian: S obzirom na sve prethodno navedeno, Odbor je zaključio da omjer koristi i rizika lijeka Esmya (ulipristal acetat) ostaje povoljan pod uvjetom da se u informacije o lijeku uvedu dogovorene izmjene i provedu dodatne mjere za smanjenje rizika.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Croatian: Esmya (ulipristal acetat, 5 mg) lijek je odobren centraliziranim postupkom, a indiciran je za prijeoperacijsko liječenje, kao i povremeno liječenje umjerenih do teških simptoma mioma maternice u odraslih žena reproduktivne dobi.
English: In addition, other cases of hepatic injury were also reported post marketing for Esmya.
Croatian: Osim toga, zabilježeni su i drugi slučajevi oštećenja jetre nakon stavljanja lijeka Esmya u promet.
English: PRAC considered that it should be clarified in in the wording of the indication that in line with the current posology Esmya is to be used for a single treatment course in pre-operative setting.
Croatian: PRAC smatra da je u tekstu indikacije potrebno razjasniti kako prema trenutačno važećem doziranju, lijek Esmya treba primjenjivati kao jedan ciklus liječenja u situaciji prije kirurškog zahvata.
English: Although the general characteristics of Esmya do not support it to be a typical DILI causing agent, based on the current review, and taking experts views into consideration, the PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Croatian: Drug-Induced Liver Injury, DILI), na temelju sadašnje analize te uzimajući u obzir mišljenje stručnjaka, PRAC je zaključio da Esmya (ulipristal acetat) može uključivati rizik za ozbiljno oštećenje jetre.
English: In conclusion, the PRAC considered that the benefit-risk balance of Esmya remained favourable subject to the amendments of the terms of the marketing authorisations.
Croatian: Kao zaključak, PRAC smatra da je omjer koristi i rizika za lijek Esmya povoljan uz predložene izmjene uvjeta davanja odobrenja za stavljanje lijeka u promet.
English: It is also clarified that Esmya can be used as one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Croatian: Također je objašnjeno da se lijek Esmya može primjenjivati kao jedan ciklus prijeoperacijskog liječenja umjerenih do teških simptoma mioma maternice u odraslih žena reproduktivne dobi.
English: Uterine fibroids are the most common female pelvic tumour.
Croatian: Miomi maternice najčešći su tumori zdjelice u žena.
English: The marketing authorisation of Esmya was extended to include the therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Croatian: Odobrenje za stavljanje u promet lijeka Esmya prošireno je tako da uključuje terapijske indikacije za povremeno liječenje umjerenih do teških simptoma mioma maternice u odraslih žena reproduktivne dobi.
English: Three cases of serious liver injury leading to a hepatic transplantation were reported between the marketing authorisation of Esmya (ulipristal acetate) and November 2017.
Croatian: Od datuma izdavanja odobrenja za stavljanje u promet lijeka Esmya (ulipristal acetat) do studenoga 2017. zabilježena su tri slučaja ozbiljnog oštećenja jetre koja su dovela do transplantacije jetre.
English: No information on hepatic events was at that time included in the Product Information of Esmya.
Croatian: U tadašnjim informacijama o lijeku Esmya nije bilo podataka o štetnim događajima povezanima s jetrom.
English: The pre-operative treatment may be considered of least benefit as it reflects a situation when surgery is planned; however reductions in myoma size as well as reductions in blood loss and anaemia are considered of clinical significance.
Croatian: Prijeoperacijsko liječenje može se smatrati najmanje korisnim jer se provodi u situaciji kada je planiran kirurški zahvat.
English: The results from three main studies are as follows:
Croatian: Rezultati triju glavnih ispitivanja jesu sljedeći:
English: Emtriva emtricitabine
Croatian: Emtriva emtricitabin
English: This summary was last updated in 11-2016.
Croatian: Sažetak je posljednji put ažuriran u 11. 2016.
English: This difference was maintained after 48 weeks of treatment (73% and 56%).
Croatian: Ta se razlika održala i nakon 48 tjedana liječenja (73 % i 56 %).
English: Skin discoloration was very common in children.
Croatian: Promjena boje kože bila je vrlo učestala u djece.
English: The full EPAR for Emtriva 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 lijek Emtriva 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 Emtriva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Emtriva?
English: What is Emtriva and what is it used for?
Croatian: Što je Emtriva i za što se koristi?
English: The usual dose of oral solution is 6 mg per kilogram body weight once a day, up to a maximum of 240 mg (24 ml).
Croatian: Uobičajena doza oralne otopine iznosi 6 mg po kilogramu tjelesne težine jedanput na dan, najviše 240 mg (24 ml).
English: The oral solution is for patients who weigh less than 33 kg, and those who cannot swallow the capsules.
Croatian: Oralna otopina namijenjena je bolesnicima tjelesne težine manje od 33 kg i onima koji ne mogu gutati kapsule.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva on 24 October 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Emtriva u promet koje vrijedi na prostoru Europske unije od 24. listopada 2003.
English: Emtriva is available as capsules (200 mg) and as a solution (10 mg/ml) to be taken by mouth.
Croatian: Lijek Emtriva dostupan je u obliku kapsula (200 mg) i kao otopina (10 mg/ml) koja se primjenjuje kroz usta.
English: This is a summary of the European public assessment report (EPAR) for Emtriva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Emtriva.
English: Similar results on effectiveness were seen in two studies involving 120 children and adolescents taking Emtriva in combination with other antiviral medicines.
Croatian: Slični rezultati djelotvornosti zabilježeni su u dvjema studijama provedenima na 120 djece i adolescenata koji su uzimali lijek Emtriva u kombinaciji s drugim antivirusnim lijekovima.
English: It blocks the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Croatian: On onemogućuje djelovanje reverzne transkriptaze, enzima koji proizvodi virus i koji omogućuje virusu da se množi u stanicama koje je zarazio.
English: The usual dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more.
Croatian: Uobičajena doza lijeka Emtriva jest jedna kapsula jedanput na dan za bolesnike s tjelesnom težinom od 33 kg i više.
English: Emtriva is an antiviral medicine for treating adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Emtriva je antivirusni lijek koji se upotrebljava za liječenje odraslih i djece zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Croatian: Djelatna tvar lijeka Emtriva, emtricitabin, jest nukleozidni inhibitor reverzne transkriptaze (NRTI).
English: It is not intended to provide practical advice on how to use Emtriva.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Emtriva.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtriva 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 Emtriva nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What is the risk associated with Emtriva?
Croatian: Koji su rizici povezani s lijekom Emtriva?
English: The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
Croatian: Najčešće su nuspojave lijeka Emtriva (zabilježene u više od 1 na 10 bolesnika) glavobolja, proljev, mučnina (osjećaj slabosti) i povišene razine kreatin kinaze u krvi (enzima koji se nalazi u mišićima).
English: In this study after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ml, and slightly fewer had viral loads below 50 copies/ml.
Croatian: U tom su ispitivanju nakon 48 tjedana virusna opterećenja u otprilike dvije trećine bolesnika iznosila manje od 400 kopija/ml, a neznatno manji broj bolesnika imao je virusna opterećenja manja od 50 kopija/ml.
English: Emtriva should only be started by a doctor experienced in managing HIV infections.
Croatian: Liječenje lijekom Emtriva treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: Emtriva does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijekom Emtriva ne liječi se infekcija HIV-om ni AIDS, no njegovom primjenom može se obuzdati narušavanje imunosnog sustava i izbjeći razvoj infekcija i bolesti povezanih s AIDS-om.
English: The Committee recommended that it be given marketing authorisation.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Emtriva u promet.
English: • In another study in 468 previously untreated patients, Emtriva was as effective as lamivudine (both taken in combination with stavudine and either efavirenz or nevirapine).
Croatian: • U drugom ispitivanju na 468 prethodno neliječenih bolesnika Emtriva je imala jednak učinak kao lamivudin (oba lijeka primjenjivala su se u kombinaciji sa stavudinom i ili efavirenzom ili nevirapinom).
English: Why is Emtriva approved?
Croatian: Zašto je lijek Emtriva odobren?
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Croatian: Bolesnicima koji su prethodno uzimali lijekove za liječenje HIV-a i nisu odgovorili na to liječenje liječnici smiju propisivati lijek Emtriva tek nakon što provjere koje je antivirusne lijekove bolesnik prethodno uzimao i vjerojatnost odgovora virusa na nove antivirusne lijekove koji bi se mogli propisati.
English: For more information about treatment with Emtriva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Emtriva pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Lijek Emtriva, kad se uzima u kombinaciji s drugim antivirusnim lijekovima, smanjuje količinu HIV-a u krvi i održava je na niskoj razini.
English: What benefits of Emtriva have been shown in studies?
Croatian: Koje su koristi lijeka Emtriva dokazane u ispitivanjima?
English: Other information about Emtriva:
Croatian: Ostale informacije o lijeku Emtriva
English: Emtriva is used in combination with other antiviral medicines and contains the active substance emtricitabine.
Croatian: Emtriva se primjenjuje u kombinaciji s drugim antivirusnim lijekovima i sadržava djelatnu tvar emtricitabin.
English: Studies have shown that Emtriva, in combination with other antiviral medicines, reduces viral loads in HIV-infected patients and compares well with other medicines used in combination.
Croatian: Ispitivanja su pokazala da lijek Emtriva u kombinaciji s drugim antivirusnim lijekovima smanjuje virusna opterećenja u bolesnika zaraženih HIV-om i ima dobre rezultate u usporedbi s drugim lijekovima koji se kombinirano primjenjuju.
English: • In a third study in 459 patients who had been taking three antiviral medicines (including lamivudine), the number of patients switching from lamivudine to Emtriva who had viral loads below 400 copies/ml after 48 weeks was similar to the number of those who continued taking lamivudine (73% and 82%, respectively).
Croatian: • U trećem ispitivanju na 459 bolesnika koji su bili uzimali tri antivirusna lijeka (uključujući lamivudin) broj bolesnika koji su zamijenili lamivudin lijekom Emtriva i koji su imali virusno opterećenje manje od 400 kopija/ml (73 %) nakon 48 tjedana bio je sličan broju onih koji su nastavili uzimati lamivudin (82 %).
English: The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
Croatian: Odbor je uočio da se ova terapijska indikacija temelji na ispitivanjima provedenima na bolesnicima koji prethodno nisu bili podvrgnuti liječenju zaraze HIV-om,ili u kojih je HIV pod uspješnom kontrolom s pomoću antivirusnih lijekova te da nema slučajeva primjene lijeka Emtriva u bolesnika u kojih se prethodno liječenje zaraze HIV-om pokazalo neuspješnim.
English: • In a study of 571 previously untreated adults, more patients taking Emtriva (in combination with didanosine and efavirenz) had viral loads below 50 copies/ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
Croatian: • u ispitivanju na 571 prethodno neliječenom odraslom bolesniku, u više bolesnika koji su uzimali lijek Emtriva (u kombinaciji s didanozinom i efavirenzom) virusno opterećenje iznosilo je manje od 50 kopija/ml nakon 24 tjedna liječenja (81 %) nego u bolesnika koji su uzimali stavudin (70 %).
English: The dose may need to be adjusted in patients who have problems with their kidneys.
Croatian: Bolesnicima koji imaju problema s bubrezima možda će biti potrebno prilagoditi dozu.
English: For practical information about using Emtriva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Emtriva bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: How is Emtriva used?
Croatian: Kako se Emtriva koristi?
English: How does Emtriva work?
Croatian: Kako djeluje Emtriva?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva's benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Emtriva nadmašuju s njim povezane rizike u liječenju odraslih i djece zaraženih virusom HIV-1 u kombinaciji s drugim antiretrovirusnim lijekovima te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Content (concentration)
Croatian: (koncentracija)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: (Zaštićeno) ime Doza
English: Pack size
Croatian: Sadržaj
English: This does not affect the health or performance of the animal.
Croatian: To ne utječe na zdravlje i učinak životinje.
English: The vaccine is given into the neck at the front of the shoulder.
Croatian: Cjepivo se daje u vrat na prednjem dijelu ramena.
English: In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly.
Croatian: Ako životinje u budućnosti budu izložene aktivnom virusu, imunosni sustav moći će brže reagirati.