FrancophonIA/ELRC3.0 huggingface dataset:
English: EPAR summary for the public
Croatian: EPAR sažetak za javnost
English: This summary was last updated in May 2014.
Croatian: Sažetak je posljednji put dopunjen u svibnju 2014.
English: In the control group more than 80% of pigs showed specific skin lesions.
Croatian: U kontrolnoj grupi više od 80% praščića pokazalo je specifične kožne lezije.
English: It contains a bacterial strain called R32E11.
Croatian: Sadrži soj bakterije naziva R32E11.
English: Other information about Eryseng:
Croatian: Druge informacije o Eryseng:
English: A single injection is given two to three weeks before each mating so approximately every six months.
Croatian: Jedna se injekcija primjenjuje dva do tri tjedna prije svakog parenja, i tako otprilike svakih šest mjeseci.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eryseng on 4 July 2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Eryseng od 04. srpnja 2014.
English: The onset of immunity was shown to be three weeks.
Croatian: Dokazano je da imunost nastupa nakon tri tjedna.
English: This will help protect them against swine erysipelas.
Croatian: Ovo pomaže pri njihovoj zaštiti od svinjske erizipele.
English: Eryseng is available as a suspension for injection.
Croatian: Eryseng je dostupan kao suspenzija za injekciju.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Eryseng exceed the risks for the approved indication and recommended that Eryseng be given a marketing authorisation.
Croatian: Odbor za veterinarsko- medicinske proizvode (CVMP) zaključio je da koristi lijeka Eryseng nadmašuju rizike za odobrene indikacije i preporučilo je izdavanje odobrenja za stavljanje u promet Eryseng.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka Odbora za veterinarsko- medicinske proizvode (CVMP), pročitajte znanstvenu raspravu (ista je dio Europskoga javnog izvješća o procjeni veterinarskomedicinskog proizvoda (EPAR)).
English: The measure of effectiveness was the percentage of vaccinated pigs free from specific (diamond shaped) skin lesions at the challenge site.
Croatian: Mjera djelotvornosti bio je postotak cijepljenih svinja u kojih se nisu pojavile specifične (dijamantnog oblika) kožne lezije u mjestu testiranja.
English: Eryseng contains an adjuvant (aluminium hydroxide, DEAE-dextran and ginseng) to enhance the immune response.
Croatian: Eryseng sadrži adjuvans (aluminijev hidroksid, DEAE-dekstran i ginseng) kako bi se pojačao imunosni odgovor.
English: The vaccine is given to pigs from six months of age as an injection into the neck muscles, repeated after three to four weeks.
Croatian: Cjepivo se primjenjuje u svinja u dobi od šest mjeseci u obliku injekcije u vratni mišić i ponavlja se nakon tri do četiri tjedna.
English: The duration of protection was confirmed to be six months.
Croatian: Dokazano je trajanje imunizacije od šest mjeseci.
English: In the future, if the animals are exposed to Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Croatian: Ubuduće ako se životinje izlože ovim bakterijama Erysipelothrix rhusiopathiae, imunosni sustav će brže stvarati protutijela.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Croatian: Karencija je razdoblje nakon primjene lijeka i prije nego što se životinja može zaklati, a meso koristiti za prehranu ljudi.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nuspojava nakon slučajnog samoinjiciranja odmah potražite medicinski savjet i liječniku pokažite uputu o VMP ili oznaku.
English: Eryseng is a veterinary vaccine that contains inactivated (killed) Erysipelothrix rhusiopathiae bacteria.
Croatian: Eryseng je veterinarsko cjepivo koje sadrži inaktiviranu (ubijenu) bakteriju Erysipelothrix rhusiopathiae.
English: Swine erysipelas vaccine (inactivated)
Croatian: Cjepivo protiv erizipele u svinja (inaktivirano)
English: In a laboratory study involving 40 pigs, 30 pigs were vaccinated with two doses, separated by three weeks, while a control group of 10 pigs received placebo (dummy treatment).
Croatian: U laboratorijskom ispitivanju koje je obuhvatilo 40 svinja, 30 svinja je cijepljeno s dvije doze, u razmaku od tri tjedna, dok je kontrolna grupa od 10 svinja primila placebo (lažno liječenje).
English: Eryseng is a bacterial vaccine.
Croatian: Eryseng je bakterijsko cjepivo.
English: When Eryseng is given to pigs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Croatian: Nakon što se Eryseng primjeni u svinja, imunosni sustav životinje prepoznaje bakterije kao „strane” i proizvodi protutijela protiv virusa.
English: The most common side effect (seen in more than 1 in 10 pigs) with Eryseng is mild to moderate inflammation at the injection site, which typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Croatian: Najčešće nuspojave (kod više od 1 na 10 svinja) lijeka Erysengi su blaga do umjerena upala u mjestu injekcije, što se najčešće ukloni u roku od četiri dana no u pojedinim slučajevima može biti prisutno i do 12 dana nakon cijepljenja.
English: A second laboratory study involved 15 gilts (female pigs that have not yet had piglets) which were vaccinated according to the basic vaccination schedule with a booster dose six months later.
Croatian: Drugo laboratorijsko ispitivanje obuhvatilo je 15 nazimica (ženskih svinja koje još nisu imale praščića) koje su cijepljene u skladu s osnovnim rasporedom cijepljenja s booster dozom nakon šest mjeseci.
English: What is the risk associated with Eryseng?
Croatian: Koji su rizici povezani s Eryseng?
English: The withdrawal period for Eryseng is zero days.
Croatian: Karencija za lijek Eryseng iznosi nula dana.
English: Why has Eryseng been approved?
Croatian: Zašto je Eryseng odobren?
English: What is Eryseng?
Croatian: Što je Eryseng?
English: The first laboratory study showed 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions.
Croatian: Prvo laboratorijsko ispitivanje pokazalo je da je 90% (27 od 30) cijepljenih praščića bilo zaštićeno protiv serotipa 1 bakterije Erysipelothrix rhusiopathiae, što znači da nisu imali specifičnih kožnih lezija dok je 93% (28 od 30) cijepljenih praščića bilo zaštićeno protiv serotipa 2 bakterije Erysipelothrix rhusiopathiae, što znači da nisu imali specifičnih kožnih lezija.
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Croatian: Praščići su testirani nakon šest mjeseci injekcijom bakterije Erysipelothrix rhusiopathiae serotipovima 1 i 2, a mjera djelotvornosti bio je postotak praščića zaštićenih cjepivom.
English: What is Eryseng used for?
Croatian: Za što se Eryseng koristi?
English: The second laboratory study showed 93% (14 out of 15) of pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2.
Croatian: Drugo laboratorijsko ispitivanje pokazalo je da je 93% (14 od 15) praščića bilo zaštićeno od testa serotipovima 1 i 2 bakterije Erysipelothrix rhusiopathiae.
English: All pigs were challenged 22 days after the second vaccination dose with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2.
Croatian: Sve su svinje podvrgnute testu 22 dana nakon druge doze cjepiva tako što su primile serotipove 1 i 2 bakterije Erysipelothrix rhusiopathiae.
English: How does Eryseng work?
Croatian: Na koji način Eryseng djeluje?
English: What benefit has Eryseng shown during the studies?
Croatian: Koje koristi VMP-a Eryseng su utvrđene tijekom ispitivanja?
English: How has Eryseng been studied?
Croatian: Kako se Eryseng ispitivao?
English: Eryseng is used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae bacteria of specific types called serotype 1 and serotype 2.
Croatian: Eryseng se koristi za imunizaciju mužjaka i ženki svinja protiv svinjske erizipele uzrokovane bakterijom Erysipelothrix rhusiopathiae specifičnih tipova naziva serotip 1 i serotip 2. Svinjska erizipela je bakterijska bolest svinja koja je karakterizirana iznenadnom smrti, groznicom povezanom s dijamantnim kožnim lezijama, artritisom i pobačajem u gravidnih krmača.
English: 60 months.
Croatian: 60 mjeseci
English: de los Reyes 1
Croatian: Avda. de los Reyes 1
English: • You may lose hair (alopecia).
Croatian: • Mogli biste izgubiti kosu (alopecija).
English: Caution should be taken in such situations.
Croatian: U takvim slučajevima potreban je oprez.
English: • You may:
Croatian: • Možda ćete:
English: Otherwise treatment must be delayed for up to 3 weeks until the criteria are met.
Croatian: U suprotnom liječenje se mora odgoditi do 3 tjedna dok se ne ispune kriteriji.
English: Date of latest renewal: 03 August 2012
Croatian: Datum posljednje obnove odobrenja: 3. kolovoza 2012.
English: Your doctor will tell you how long your treatment lasts.
Croatian: Liječnik će Vam reći koliko će dugo trajati liječenje.
English: Appropriate aseptic techniques must be used.
Croatian: Potrebno je upotrebljavati odgovarajuće aseptičke tehnike.
English: You should seek medical attention immediately if any of the following conditions appear:
Croatian: Morate odmah potražiti liječničku pomoć ako se pojavi bilo koje od sljedećih stanja:
English: - if you will receive yellow fever vaccine.
Croatian: - ako ćete primiti cjepivo protiv žute groznice.
English: You should not work with this medicine if you are pregnant.
Croatian: Ne smijete rukovati ovim lijekom ako ste trudni.
English: No specific studies in older people have been performed.
Croatian: Nisu provedena posebna ispitivanja u starijih osoba.
English: Do not drive or use any tools or machines if you are experiencing any of these side effects.
Croatian: Nemojte voziti ni koristiti ikakve alate ili strojeve ako osjećate bilo koju od ovih nuspojava.
English: The length of your whole treatment period will depend on your progress and how well you feel.
Croatian: Trajanje cijelog razdoblja liječenja ovisit će o napretku liječenja i o tome kako se osjećate.
English: Renal elimination of unchanged trabectedin in humans is low (less than 1%).
Croatian: Bubrežna eliminacija nepromijenjenog trabektedina u ljudi je niska (manje od 1 %).
English: • If you have an allergic reaction (hypersensitivity).
Croatian: • ako imate alergijsku reakciju (preosjetljivost).
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Croatian: Genetičko savjetovanje preporučuje se i bolesnicima koji žele imati djecu nakon terapije.
English: Long-term carcinogenicity studies have not been performed.
Croatian: Nisu provedena dugoročna ispitivanja karcinogenosti.
English: Some of the symptoms or signs of extravasation may not be visible until several hours after it occurred.
Croatian: Neki od navedenih simptoma ili znakova ekstravazacije mogu postati vidljivi tek nekoliko sati nakon njezina nastanka.
English: Patients who experience any of these adverse reactions during therapy must not drive or operate machines.
Croatian: Bolesnici koji primijete bilo koju od tih nuspojava tijekom terapije ne smiju voziti niti upravljati strojevima.
English: Store in a refrigerator (2ºC - 8ºC).
Croatian: Čuvati u hladnjaku (2ºC - 8ºC).
English: If you are not sure what the side effects below are, you should ask your doctor to explain them to you in more detail.
Croatian: Ako niste sigurni što znače dolje navedene nuspojave, morate zamoliti svog liječnika da Vam ih iscrpnije objasni.
English: CLS can be idiopathic (Clarkson's disease) or secondary to various conditions and treatments.
Croatian: CLS može biti idiopatski (Clarksonova bolest) ili sekundarni, kod različih stanja i liječenja.
English: Overall 20% of the 1,164 patients in the integrated safety analysis of monotherapy clinical trials were over 65 years.
Croatian: Ukupno 20 % od 1164 bolesnika u integriranim analizama sigurnosti monoterapije u kliničkim ispitivanjima bilo je starije od 65 godina.
English: Overall Response Rate (ORR)
Croatian: Ukupna stopa odgovora (ORR)
English: The terminal half-life is long (population value of the terminal elimination phase: 180-hr).
Croatian: Terminalni poluvijek je dug (populacijska vrijednost terminalne faze eliminacije: 180 sati).
English: Trabectedin can have genotoxic effects.
Croatian: Trabektedin može imati genotoksične učinke.
English: Maximum fetal tissue radioactivity concentration was similar to that in maternal plasma or blood.
Croatian: Maksimalna koncentracija radioaktivnosti u fetalnom tkivu bila je slična onoj u plazmi ili krvi majke.
English: The secondary endpoints included objective response analysed using the RECIST and Choi criteria.
Croatian: Sekundarni ishodi uključivali su objektivni odgovor analiziran pomoću RECIST i Choi kriterija.
English: It is possible for it to take a few days before the full extent of tissue damage is visible.
Croatian: Može proći nekoliko dana prije nego postane vidljiv potpuni opseg oštećenja tkiva.
English: If this occurs, active supportive therapy should be started immediately.
Croatian: U tom slučaju mora se odmah započeti s aktivnim potpornim liječenjem.
English: Additional anti-emetics may be administered as needed.
Croatian: Prema potrebi mogu se primijeniti dodatni antiemetici.
English: • You could have an allergic reaction.
Croatian: • Možete imati alergijsku reakciju.
English: Pharmacotherapeutic group: Antineoplastic agent, ATC code: L01CX01.
Croatian: Farmakoterapijska skupina: antineoplastici, ATK oznaka: L01CX01.
English: • You may have a reaction at the site of injection.
Croatian: • Možete imati reakciju na mjestu injiciranja.
English: Independent radiology review, measurable disease *
Croatian: Nezavisna radiološka procjena, mjerljiva bolest *
English: If pregnancy occurs during treatment the possibility of genetic counselling should be considered.
Croatian: U slučaju trudnoće tijekom liječenja, mora se razmotriti mogućnost genetičkog savjetovanja.
English: Allergic Reactions
Croatian: Alergijske reakcije
English: The excretion of trabectedin in milk has not been studied in animals.
Croatian: . Izlučivanje trabektedina u mlijeko nije ispitano na životinjama.
English: Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regimen.
Croatian: Dodatni podaci o djelotvornosti dostupni su iz 3 ispitivanja, iz faze II, na pojedinačnim skupinama sa sličnim populacijama koje su liječene istim režimom.
English: Forty patients were fully evaluable for response.
Croatian: Kod četrdeset bolesnika odgovor na terapiju procijenjen je u potpunosti.
English: In some patients, a compartment syndrome can occur.
Croatian: U nekih bolesnika može se pojaviti i sindrom odjeljka.
English: Septic shock
Croatian: Septički šok
English: Trabectedin is genotoxic both in vitro and in vivo.
Croatian: Trabektedin je genotoksičan i in vitro i in vivo.
English: Instructions for use - preparation, handling and disposal
Croatian: Upute za uporabu - priprema, rukovanje i odlaganje
English: What Yondelis contains:
Croatian: Što Yondelis sadrži:
English: No relevant differences in the safety profile were seen in this patient population.
Croatian: U toj populaciji bolesnica nisu uočene relevantne razlike u sigurnosnom profilu.
English: The median time to reach the peak values was 5 days for both AST and ALT.
Croatian: Medijan vremena do dostizanja vršnih vrijednosti bio je 5 dana i za AST i za ALT.
English: Once a dose has been reduced because of toxicity, dose escalation in the subsequent cycles is not recommended.
Croatian: Kada se jednom doza smanji zbog toksičnosti, ne preporučuje se povećavanje doze u sljedećim ciklusima.
English: These signs could be indicative of the inability of the liver to perform its normal function.
Croatian: Navedeni znakovi mogu upućivati na nesposobnost jetre u izvršavanju normalnih funkcija.
English: Other P450 enzymes may contribute to metabolism.
Croatian: Drugi enzimi P450 mogu pridonijeti metabolizmu.
English: The infusion is given to you every 3 weeks, although occasionally your doctor may recommend dose delays to ensure that you receive the most appropriate dose of Yondelis.
Croatian: Infuzija se primjenjuje svaka 3 tjedna, iako Vaš liječnik može povremeno preporučiti odgodu doze da bi se osigurao unos najbolje odgovarajuće doze Yondelisa.
English: • Your doctor will order regular blood tests to detect any abnormalities in the blood.
Croatian: • Vaš liječnik će vas uputiti na krvne pretrage da bi se otkrile bilo kakve abnormalnosti u krvi.
English: Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
Croatian: Reverzibilna akutna povećanja aspartat aminotransferaze (AST) i alanin aminotransferaze (ALT) zabilježena su u većine bolesnika.
English: Fax: +34 91 846 60 01
Croatian: Faks: +34 91 846 60 01
English: Neutropenia is the most common haematological toxicity.
Croatian: Neutropenija je najčešća hematološka toksičnost.
English: Most of the values had decreased to grade 1 or resolved by day 14-15 (see section 4.4).
Croatian: Većina se vrijednosti smanjila na 1. stupanj ili se normalizirala do 14.-15. dana (vidjeti dio 4.4).
English: The same criteria as above must be met prior to re-treatment.
Croatian: Isti uvjeti kao gore navedeni moraju biti ispunjeni prije ponovnog početka liječenja.
English: Considering the nature of the compound (cytotoxic and mutagenic), it is likely to affect the reproductive capacity.
Croatian: Uzimajući u obzir prirodu tvari (citotoksičnost i mutagenost), vjerojatno je da će utjecati na reproduktivnu sposobnost.
English: Treatment continued whilst clinical benefit was noted.
Croatian: Liječenje se nastavljalo sve dok ga je pratila klinička dobit.
English: Information on in-use stability of the reconstituted and diluted solutions is included in the section for medical and healthcare professionals.
Croatian: Informacije o stabilnosti pripremljenih i razrijeđenih otopina nalaze se u dijelu za liječnike i zdravstvene radnike.
English: Creatinine clearance must be monitored prior to and during treatment.
Croatian: Klirens kreatinina se mora pratiti prije i tijekom liječenja.
English: Do not use this medicine if you notice visible particles after the reconstitution or dilution of the medicine.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive čestice nakon pripreme ili razrjeđivanja lijeka.
English: Therefore, dose adjustments based uniquely on age criteria are not routinely recommended.
Croatian: Stoga, rutinske prilagodbe doze koje se temelje isključivo na kriteriju dobi se ne preporučuju.
English: No statistically significant differences were found between treatment arms in global measures of Quality of Life.
Croatian: Nisu pronađene statistički značajne razlike između skupina za liječenje u općim mjerenjima kvalitete života.
English: AST/ALT increases:
Croatian: Povišene razine AST-a/ALT-a:
English: Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Croatian: Lijekovi koji sadržavaju statine (za snižavanje razine kolesterola i sprječavanje kardiovaskularne bolesti) su primjerice lijekovi koji mogu prouzročiti oštećenje mišića.
English: Electrocardiogram (ECG) investigations
Croatian: Ispitivanja elektrokardiograma (EKG)
English: No sufficient clinical data on exposed pregnancies are available.
Croatian: Nije dostupno dovoljno kliničkih podataka o izlaganju tijekom trudnoće.
English: • You could also feel pain in your muscles (myalgia).
Croatian: • Možda ćete također osjetiti bol u mišićima (mialgija).
English: Therefore you must stop breast-feeding before you start your treatment and you must not begin breast-feeding again until your doctor has confirmed that it is safe to do so.
Croatian: Stoga morate prestati dojiti prije početka liječenja i ne smijete ponovno početi dojiti sve dok liječnik ne potvrdi da je nastavak dojenja bezopasan.
English: Withdraw the appropriate amount of reconstituted solution from the vial.
Croatian: Izvucite odgovarajuću količinu rekonstituirane otopine iz bočice.
English: • You may experience headache and sleeping problems.
Croatian: • Možete osjetiti glavobolju i probleme sa snom.
English: The same dose should be given for all cycles provided that no grade 3-4 toxicities are seen and that the patient fulfils the re-treatment criteria.
Croatian: Istu dozu se mora dati u svim ciklusima pod uvjetom da nisu uočene toksičnosti 3-4. stupnja te da bolesnik ispunjava kriterije za ponovni početak liječenja.
English: • be more prone to infections.
Croatian: • biti skloniji infekcijama.
English: Every time you are given Yondelis for the treatment of soft tissue sarcoma, it will take about 24 hours for all of the solution to enter your blood.
Croatian: Svaki put kada primite Yondelis za liječenje sarkoma mekog tkiva, bit će potrebno otprilike 24 sata da sva otopina uđe u krvotok.
English: • feel pain in your back and joints
Croatian: • imati bol u leđima i zglobovima
English: Calculate the required volume as follows:
Croatian: Izračunajte potrebni volumen na sljedeći način:
English: Treatment with Yondelis should be discontinued until the patient fully recovers.
Croatian: Liječenje Yondelisom se mora prekinuti dok se bolesnik potpuno ne oporavi.
English: A total of 76 Japanese patients were enrolled in the study, among which 73 patients were included in the final analysis set.
Croatian: japanskih bolesnika, od kojih su 73 bila uključena u set završne analize.
English: Therefore, CPK should be closely monitored whenever a patient may be experiencing any of these toxicities or muscle weakness or muscle pain.
Croatian: Stoga, CPK se mora pomno nadzirati kad god bolesnik osjeti bilo koju od ovih reakcija toksičnosti ili slabost mišića ili bol u mišićima.
English: No studies on the effects of the ability to drive and to use machines have been performed.
Croatian: Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: Gamma-glutamyltransferase increased
Croatian: Povišena gama glutamiltransferaza
English: If any of the following events occur at any time between cycles, the dose must be reduced one level, according to table 1 below, for subsequent cycles:
Croatian: Ako se dogodi bilo koji od sljedećih događaja u bilo koje vrijeme između ciklusa, doza za sljedeće cikluse se mora smanjiti za jednu razinu, prema niže navedenoj Tablici 1:
English: However, the incidences of clinical complications related to haematological toxicity such as severe infections or bleeding, or those leading to death or treatment termination, were similar in both subpopulations.
Croatian: Međutim, incidencija kliničkih komplikacija koje su povezane s hematološkom toksičnošću kao što su teške infekcije ili krvarenje, ili onih koje prouzročuju smrt ili prekid liječenja, bile su slične u objema podpopulacijama.
English: Mortality in the presence of hepatic injury occurred in less than 1% of patients in both regimens.
Croatian: Smrtnost u prisutnosti oštećenja jetre u oba režima se dogodila u manje od 1 % bolesnika.
English: The required volume should be calculated as follows:
Croatian: Potrebni volumen treba računati na sljedeći način:
English: Extravasation should be managed by local standard practice.
Croatian: Ekstravazacija se mora sanirati u skladu s lokalnom standardnom praksom.