FrancophonIA/ELRC3.0 huggingface dataset:
English: It was to be used if the ALL did not improve with standard treatment or if it had come back after such treatment.
Croatian: Lijek se trebao primjenjivati u slučajevima kada se standardnim liječenjem nije postiglo poboljšanje ALL-a ili se bolest vratila nakon takvog liječenja.
English: The CHMP was concerned that the medicine contains a different type of asparaginase to that used in clinical studies and that the data provided were not sufficient to show how the medicine behaved in the body or how well it worked compared with other asparaginase medicines.
Croatian: CHMP je izrazio zabrinutost zbog toga što lijek sadrži različitu vrstu asparaginaze od one koja je korištena u kliničkim ispitivanjima te zbog toga što dostavljeni podatci nisu dostatni za dokazivanje načina na koji lijek djeluje u tijelu ili koliko je djelotvoran u usporedbi s drugim lijekovima koji sadrže asparaginazu.
English: Withdrawal of the marketing authorisation application for Graspa (L-asparaginase)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Graspa (L-asparaginaza)
English: Asparagine is an amino acid produced by healthy cells in the body.
Croatian: Asparagin je aminokiselina koju u tijelu proizvode zdrave stanice.
English: Graspa is a cancer medicine that contains the active substance L-asparaginase that has been enclosed in red blood cells.
Croatian: Graspa je lijek protiv raka koji sadrži djelatnu tvar L-asparaginazu koja se nalazi u crvenim krvnim stanicama.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the data provided were not sufficient to conclude on Graspa's benefit and risk.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da dostavljeni podatci nisu dostatni za donošenje zaključka o koristima i rizicima liječenja lijekom Graspa.
English: In Graspa, L-asparaginase is enclosed in red blood cells because it was expected that this would allow the enzyme to work while protecting it from being broken down in blood and from antibodies that may attach to it and stop it from working.
Croatian: L-asparaginaza u lijeku Graspa nalazi se u crvenim krvnim stanicama jer se očekivalo da će to omogućiti djelovanje enzima i istodobno zaštititi enzim od razgradnje u krvi te od protutijela koja bi se mogla vezati za enzim i onemogućiti njegovo djelovanje.
English: Withdrawal of the marketing authorisation application for Graspa (L-asparaginase) EMA/431413/2018
Croatian: asparaginaza) EMA/431413/2018
English: Graspa was intended to be given by infusion (drip) into a vein.
Croatian: Lijek Graspa trebao se primjenjivati intravenskom infuzijom (drip).
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Graspa za liječenje bolesnika s ALL-om.
English: Giving the enzyme L-asparaginase destroys asparagine in the blood and deprives the leukaemia cells of this amino acid, causing them to die.
Croatian: Primjenom enzima L-asparaginaza uništava se asparagin u krvi te se leukemijskim stanicama onemogućava pristup toj aminokiselini, što uzrokuje njihovo odumiranje.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Graspa did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je, zbog izostanka potvrde o učinkovitosti, smatrao kako koristi od lijeka Graspa ne nadmašuju s njim povezane rizike.
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 October 2006 for ALL.
Croatian: Graspa je uvršten na popis lijekova za rijetke bolesti dana 27. listopada 2006. za akutnu limfoblastičnu leukemiju.
English: This summary was last updated in October 2014.
Croatian: Sažetak je posljednji put ažuriran u listopadu 2014.
English: Mucosal disease is usually fatal.
Croatian: Bolest sluznice je najčešće smrtonosna.
English: Other information about Bovela:
Croatian: Ostale informacije o VMP-u Bovela:
English: Protection starts three weeks after vaccination and lasts for one year.
Croatian: Imunizacija započinje tri tjedna nakon cijepljenja i traje godinu dana.
English: The withdrawal period for Bovela for cattle is zero days.
Croatian: Razdoblje karencije za Bovela za goveda iznosi nula dana.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju „učeći“ imunosni sustav (prirodnu obranu tijela) kako da se štiti protiv bolesti.
English: It is available as a lyophilisate (freeze dried powder) and solvent for injection.
Croatian: Dostupno je kao liofilizat (zamrznuti osušeni prah) i otopina za injekciju.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za VMP Bovela dana 22/12/2014.
English: The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.
Croatian: Najčešće nuspojave (mogu se javiti u više od 1 na 100 goveda) su povećanje u tjelesnoj temperaturi (unutar normalnog raspona) u roku od četiri sata od cijepljenja, što spontano nestaje nakon 24 sata.
English: The vaccine is given to cattle as a single injection into the muscle.
Croatian: Cjepivo se primjenjuje u goveda kao jedna injekcija u mišić.
English: Bovela contains two BVDV strains (or types) modified by deletion of parts of two genes so that they can no longer cause disease.
Croatian: Bovela sadrži dva soja BVDV-a (ili vrste) modificirana brisanjem dijela dva gena tako da ne mogu više uzrokovati bolest.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in cattle.
Croatian: Djelotvornost cjepiva prvo je ispitana nizom laboratorijskih ispitivanja u goveda.
English: The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje u broju trajno inficirane novorođene teladi kako je utvrđeno identifikacijskim testovima specifičnima za virus.
English: The effectiveness of Bovela was further investigated in the field in eight dairy cattle herds of which five of them had a history of BVD or persistent infection at the beginning of the study.
Croatian: Djelotvornost cjepiva Bovela dalje je ispitana na terenu u osam stada mliječnih goveda, od kojih je pet imalo povijest BVD-a ili perzistentnu infekciju na početku ispitivanja.
English: In the field study 98.5% of vaccinated cattle sampled (range 269-274 animals) developed antibodies to both BVD virus types.
Croatian: U terenskom ispitivanju 98,5% od cijepljenje stoke koje su uzorkovane (raspon 269-274 životinja) razvilo je protutijela na oba tipa BVD virusa.
English: Why has Bovela been approved?
Croatian: Zašto je VMP Bovela odobren?
English: However a severe form of BVD can occur, when cattle have a high temperature and bloody diarrhoea.
Croatian: No ozbiljni oblici BVD-a mogu nastupiti, ako stoka ima visoku temperaturu i krvavi proljev.
English: The purpose of the studies was to establish how long it took for cattle to be fully protected, the length of time protection against BVD lasts, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine in calves.
Croatian: Svrha ispitivanja je bilo utvrditi koliko je dugo potrebno da se goveda u potpunosti zaštite, trajanje razdoblja imunizacije protiv BVD-a kao i utjecaj materinjih protutijela (prenose se s majki) na djelotvornost cjepiva u teladi.
English: In the group vaccinated with Bovela five out of 1,216 (0.4%) newborn calves were persistently infected with the virus, whereas in the group given the dummy injection there were ten persistently infected newborn calves out of 1,183 born (0.8%).
Croatian: U grupi koja je cijepljena cjepivom Bovela pet od 1 216 (0,4%) novorođene teladi bilo je trajno inficirano virusom, pri čemu je u grupi koja je primila lažnu injekciju bilo deset trajno zaražene novorođene teladi od 1 183 teladi (0,8%).
English: What is the risk associated with Bovela?
Croatian: Koji su rizici povezani s VMP-om Bovela?
English: Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus (BVDV-1 and BVDV-2).
Croatian: Bovela je veterinarsko cjepivo koje sadrži dva tipa modificiranog živog virusa proljeva goveda (BVD) (BVDV-1 i BVDV-2).
English: However, for the vaccinated group the period of infection was either before vaccination or before the start of protection.
Croatian: No, za cijepljenu skupinu, razdoblje infekcije je bilo ili prije cijepljenja ili prije početka imunizacije.
English: To prevent the birth of a PI calf the vaccine should be given at least three weeks before insemination/mating.
Croatian: Da bi se spriječilo rođenje trajno inficiranog teleta, cjepivo treba primijeniti najmanje tri tjedna prije oplodnje/parenja.
English: What is Bovela used for?
Croatian: Za što se Bovela koristi?
English: What is Bovela?
Croatian: Što je Bovela?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi lijeka Bovela nadmašuju rizike za odobrenu indikaciju i preporučio je da se za VMP Bovela odobrenje za stavljanje VMP-a u promet.
English: In non-pregnant animals the infection is generally mild, with signs affecting the airways such as cough, and reduced milk yield.
Croatian: U negravidnih životinja, infekcija je općenito blaga, s znakovima koji utječu na zračne putove poput kašlja i smanjenje proizvodnje mlijeka.
English: Bovine viral diarrhoea vaccine (modified live)
Croatian: Cjepivo protiv virusnog proljeva goveda (modificirano živo)
English: They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth.
Croatian: Može doći do progresije bolesti sluznice što je drugi oblik bolesti BVD-a sa čirevima i mjehurićima na njuški i unutar usta.
English: PI animals tend never to reach their productive potential, have reduced fertility and are more susceptible to other diseases.
Croatian: Trajno inficirane životinje sklone su tome da ne postižu svoj produktivan potencijal, imaju smanjenu plodnost i podložnije su drugim bolestima.
English: Approximately half of the cattle were vaccinated with Bovela and the rest received a dummy injection.
Croatian: Otprilike polovica goveda cijepljena je cjepivom Bovela, a ostatak je primio lažno liječenje.
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept nalazi se na etiketi/vanjskom pakiranju.
English: Bovela is a vaccine.
Croatian: Bovela je cjepivo.
English: In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI).
Croatian: U gravidnih krava, infekcija BVD-om može uzrokovati pobačaje ili rezultirati teljenjem teladi koja je trajno inficirana (PI).
English: When Bovela is given to cattle the animals' immune system recognises the virus strains as ‘foreign' and makes antibodies against them.
Croatian: Ako se Bovela primjenjuje u goveda imunosni sustav životinje prepoznaje sojeve virusa kao „strane“ te proizvodi protutijela protiv njih.
English: In the future, if the animals are exposed to the virus the immune system will be able to respond more quickly.
Croatian: Ubuduće, imunosni će sustav moći brže reagirati ako je životinja izložena virusu.
English: How does Bovela work?
Croatian: Kako djeluje Bovela?
English: What benefit has Bovela shown during the studies?
Croatian: Koje su koristi VMP-a Bovela utvrđene u ispitivanjima?
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjiciranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP-u ili etiketu.
English: PI animals are a constant source of BVD virus, infecting other cattle in the herd.
Croatian: Trajno inficirane životinje kontinuirani su izvor virusa BVD-a, te inficiraju ostala goveda u stadu.
English: In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
Croatian: U laboratorijskim ispitivanjima, cjepivo Bovela spriječilo je trajno inficiranje u 100% teladi dok su životinje koje nisu primile cjepivo otelile do 100% trajno inficirane teladi.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda (VMP).
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 or milk used for human consumption.
Croatian: Karencija je razdoblje koje treba proći od primjene VMP-a do klanja životinja i konzumacije mesa u ljudskoj prehrani ili mlijeka u ljudskoj prehrani.
English: This will help protect the cattle against BVD infections.
Croatian: Ova protutijela pomažu u zaštiti goveda od infekcija BVD-om.
English: Bovela is used to protect cattle against BVD viral infection.
Croatian: Bovela se koristi za imunizaciju stoke protiv virusne infekcije BVD-om.
English: How has Bovela been studied?
Croatian: Kako je VMP Bovela ispitivan?
English: EMA/296074/2014 EMEA/V/C/003679
Croatian: EMA/296074/2014 EMEA/H/C/003679
English: The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100% and for parainfluenza virus 73 to 97%.
Croatian: Postotak pasa sa zaštitnim razinama protutijela za parvovirus bio je u rasponu od 73 do 100 %, a za virus parainfluence 73 do 97 %.
English: Responses in puppies were lower than in adult dogs in some cases, because of antibodies inherited from their mothers since maternal antibodies may block the immune response to vaccination.
Croatian: Odgovori u štenaca bili su niži nego u odraslih pasa u nekim slučajevima jer su oni naslijedili protutijela od svojih majki budući da majčinska protutijela mogu onemogućiti imunosni odgovor na cijepljenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi on 4 July 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za cjepivo Versican Plus DHPPi dana 7. srpnja 2014.
English: Versican Plus DHPPi is used to protect dogs against:
Croatian: Versican Plus DHPPi koristi se za zaštitu pasa od:
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Croatian: Najčešća nuspojava (uočena kod više od 1 na 100 pasa) kod primjene cjepiva Versican Plus DHPPi je kratkotrajna oteklina do 5 cm koja se može javiti na mjestu injekcije nakon cijepljenja.
English: The effectiveness of Versican Plus DHPPi was initially investigated in a field study involving 129 dogs.
Croatian: Djelotvornost cjepiva Versican Plus DHPPi ispitana je u terenskom ispitivanju koje je obuhvatilo 129 pasa.
English: The vaccine is given to puppies from six weeks of age as an injection under the skin which is repeated three to four weeks later.
Croatian: Cjepivo se daje štencima u dobi od šest tjedana u obliku potkožne injekcije, što se ponavlja tri do četiri tjedna kasnije.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi exceed the risks for the approved indications and recommended that Versican Plus DHPPi be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva DHPPi nadmašuju rizike za odobrene indikacije i preporučio izdavanje odobrenja za stavljanje cjepiva Versican Plus DHPPi u promet.
English: When Versican Plus DHPPi is given to dogs, the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Croatian: Kada se Versican Plus DHPPi/L4 daje psima, imunosni sustav životinje prepoznaje viruse kao „strana tijela” i proizvodi protutijela protiv njih.
English: The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against distemper, adenovirus, parvovirosis and kennel cough in addition to other diseases to demonstrate effectiveness of Versican Plus DHPPi.
Croatian: Terensko ispitivanje uključivalo je veće kombinacije cjepiva Versican Plus DHPPi/L4 i Versican Plus DHPPi/L4R koji su također namijenjeni zaštiti od štenećaka, adenovirusa, parvovirusa i kašlja čopora, kao i drugih bolesti, kako bi se dokazala djelotvornost cjepiva Versican Plus DHPPi.
English: Versican Plus DHPPi is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2.
Croatian: Versican Plus DHPPi je veterinarsko cjepivo koje sadrži živi, atenuirani (oslabljeni) virus štenećaka, pseći adenovirus tipa 2, pseći parvovirus tipa 2b i virus pseće parainfluence tipa 2.
English: Versican Plus DHPPi is a vaccine.
Croatian: Versican Plus DHPPi je cjepivo.
English: The field study showed that vaccination with Versican Plus DHPPi resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Croatian: Terensko ispitivanje pokazalo je da cijepljenje cjepivom Versican Plus DHPPi stvara razine protutijela koje su dostatne za zaštitu od virusa štenećaka i psećeg adenovirusa u svih pasa.
English: Versican Plus DHPPi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.
Croatian: Versican Plus DHPPi dostupan je u obliku liofilizata (peleta zamrznutih sušenjem) s otapalom za injekciju.
English: This will help protect them against distemper, adenovirus liver infection, parvovirosis and kennel cough.
Croatian: To će pomoći u njihovoj zaštiti od štenećaka, infekcije jetre adenovirusom, infekcije parvovirusom i „kašlja čopora” (zaraznog traheobronhitisa).
English: What is the risk associated with Versican Plus DHPPi?
Croatian: Koji su rizici povezani s cjepivom Versican Plus DHPPi?
English: Why has Versican Plus DHPPi been approved?
Croatian: Zašto je Versican Plus DHPPi odobren?
English: • canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough.
Croatian: • virusa pseće parainfluence i psećeg adenovirusa tipa 2 koji uzrokuju zarazni traheobronhitis (kašalj čopora).
English: Other information about Versican Plus DHPPi:
Croatian: Ostale informacije o cjepivu Versican Plus DHPPi:
English: What is Versican Plus DHPPi?
Croatian: Što je Versican Plus DHPPi?
English: What is Versican Plus DHPPi used for?
Croatian: Za što se Versican Plus DHPPi koristi?
English: For revaccination, a single dose of Versican Plus DHPPi is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Croatian: Za docjepljivanje protiv štenećaka, psećeg adenovirusa (tipa 1 i 2) i parvovirusa potrebna je jedna doza cjepiva Versican Plus DHPPi svake tri godine.
English: What benefit has Versican Plus DHPPi shown during the studies?
Croatian: Koje su koristi cjepiva Versican Plus DHPPi utvrđene u ispitivanjima?
English: Canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)
Croatian: Cjepivo protiv štenećaka, psećeg adenovirusa, psećeg parvovirusa i pseće parainfluence (živo atenuirano)
English: Annual revaccination is required for protection against canine parainfluenza virus.
Croatian: Kao zaštita od virusa pseće parainfluence potrebno je docjepljivanje jednom godišnje.
English: How has Versican Plus DHPPi been studied?
Croatian: Kako je Versican Plus DHPPi ispitivan?
English: How does Versican Plus DHPPi work?
Croatian: Kao djeluje Versican Plus DHPPi?
English: List of antiretrovirals: abacavir; abacavir, dolutegravir, lamivudine; abacavir; abacavir, lamivudine, zidovudine; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabine, tenofovir alafenamide; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabine, tenofovir alafenamide; didanosine; dolutegravir; dolutegravir, rilpivirine; efavirenz ; efavirenz, emtricitabine, tenofovir disoproxil; elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil; emtricitabine; emtricitabine, rilpivirine, tenofovir alafenamide; emtricitabine, rilpivirine, tenofovir disoproxil; emtricitabine, tenofovir alafenamide; emtricitabine, tenofovir disoproxil; enfuvirtide; etravirine; fosamprenavir; indinavir; lamivudine; lamivudine, tenofovir; lamivudine, zidovudine; lopinavir, ritonavir; maraviroc; nevirapine; raltegravir; rilpivirine; ritonavir; saquinavir; stavudine; tenofovir disoproxil; tipranavir; zidovudine
Croatian: Popis antiretrovirusnih lijekova: abakavir; abakavir, dolutegravir, lamivudin; abakavir; abakavir, lamivudin, zidovudin; atazanavir; atazanavir, kobicistat; biktegravir, emtricitabin, tenofoviralafenamid; darunavir; darunavir, kobicistat; darunavir, kobicistat, emtricitabin, tenofoviralafenamid; didanozin; dolutegravir; dolutegravir, rilpivirin; efavirenz ; efavirenz, emtricitabin, tenofovirdizoproksil; elvitegravir, kobicistat, emtricitabin, tenofoviralafenamid; elvitegravir, kobicistat, emtricitabin, tenofovirdizoproksil; emtricitabin; emtricitabin, rilpivirin, tenofoviralafenamid; emtricitabin, rilpivirin, tenofovirdizoproksil; emtricitabin, tenofoviralafenamid; emtricitabin, tenofovirdizoproksil; enfuvirtid; etravirin; fosamprenavir; indinavir; lamivudin; lamivudin, tenofovir; lamivudin, zidovudin; lopinavir, ritonavir; maravirok; nevirapin; raltegravir; rilpivirin; ritonavir; sakvinavir; stavudin; tenofovirdizoproksil; tipranavir; zidovudin
English: Antiretrovirals - Autoimmune hepatitis (EPITT no 18956)
Croatian: Antiretrovirusni lijekovi - Autoimuni hepatitis (EPITT br. 18956)
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Obično su takve reakcije zapažene unutar prvih nekoliko tjedana ili mjeseci liječenja CART-om.
English: Adopted at the 9-12 July 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a održanoj od 9. do 12. srpnja 2018.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/414649/2018
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/496952/2018
English: Human normal immunoglobulin for intravenous administration (IVIg) - Lupus-like syndrome and related terms (EPITT no 19098)
Croatian: Ljudski normalni imunoglobulin za intravensku primjenu (i.v.Ig)- Sindrom nalik lupusu i povezani pojmovi (EPITT br. 19098)