FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC was requested to give a recommendation on whether the indication of medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol combined with an oestrogen (ethinylestradiol or estradiol) should be restricted and/or any other regulatory measure(s) taken.
Croatian: Od PRAC-a je zatraženo da donese preporuku o tome treba li se indikacija lijekova koji sadrže klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ili nomegestrol kombiniranih s estrogenom (etinilestradiolom ili estradiolom) ograničiti i/ili je(su) potrebna(e) druga(e) regulatorna(e) mjera(e).
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors (overweight, smoking, hypertension, increasing age etc.), in patients after major surgery with prolonged immobilisation and patients with history or hereditary predisposition of venous thrombosis.
Croatian: Ovi lijekovi moraju posebice biti kontraindicirani u bolesnika s višestrukim faktorima rizika (prekomjerna težina, pušenje, hipertenzija, starost, itd.), u bolesnika nakon većeg kirurškog zahvata s kasnijom imobilizacijom i u bolesnika s anamnezom ili nasljednom predispozicijom venske tromboze.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Croatian: Slijedom navedenog PRAC je zaključio da omjer koristi i rizika za lijekove Evra, Ioa i Zoely u indikaciji kontracepcije ostaje povoljan, što je predmetom usuglašenih uvjeta, ograničenja, upozorenja, drugih izmjena u informacijama o lijeku i dodatnih mjera minimiziranja rizika.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Croatian: Uzimajući u obzir prethodno navedeno, PRAC je zaključio da omjer koristi i rizika lijekova Evra, Ioa i Zoely u indikaciji kontracepcije ostaje povoljan, no predmetom je uključivanja usuglašenih ograničenja, upozorenja i drugih izmjena u informacijama o proizvodu.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety of the combined hormonal contraceptive containing medicinal products, in particular with regards to the risk of thromboembolism.
Croatian: • je PRAC pregledao sve dostupne podatke iz kliničkih ispitivanja, farmakoepidemioloških ispitivanja, objavljene literature, iskustva nakon stavljanja lijeka u promet, uključujući odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet putem pisanih i oralnih pojašnjenja kao i stavove ad hoc stručne skupine o djelotvornosti i sigurnosti KHKova, posebice s obzirom na rizik od tromboembolije.
English: Checking personal and family history of VTE before prescribing combined CHC medicinal products is, therefore, recommended in the product information of the products.
Croatian: Stoga je u informacijama o proizvodu za ove lijekove navedena preporuka da se provjeri postoji li u osobnoj ili obiteljskoj anamnezi povijest VTE-a prije propisivanja kombiniranih KHK-ova.
English: It contains a strain called GM 199.
Croatian: Sadrži soj naziva GM 199.
English: This summary was last updated in February 2014.
Croatian: Sažetak je posljednji put dopunjen u veljači 2014.
English: Other information about Parvoduk:
Croatian: Druge informacije o Parvoduk:
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Croatian: Koje su mjere opreznosti za osobu koja lijek daje ili dolazi u kontakt sa životinjom?
English: This was considered acceptable, given the laboratory data and taking into account that the Muscovy duck is a minor species.
Croatian: Ovo se smatra prihvatljivim s obzirom na laboratorijske podatke i uzimajući u obzir da je mošusna patka manja vrsta.
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 brani protiv bolesti.
English: No side effects have been reported to date.
Croatian: Do danas nema prijavljenih nuspojava.
English: No field studies were conducted.
Croatian: Nisu provedena terenska ispitivanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Parvoduk on 11/04/2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Parvoduk dana 11.04.2014.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Croatian: Cilj mu je objasniti kako procjena, koju Povjerenstvo za veterinarske lijekove (CVMP) provodi na temelju zaprimljene dokumentacije, dovodi do preporuka o uvjetima korištenja.
English: The effectiveness of Parvoduk was investigated in laboratory studies.
Croatian: Djelotvornost cjepiva Parvoduk ispitana je u laboratorijskim ispitivanjima.
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 Povjerenstva za veterinarske lijekove (CVMP), pročitajte znanstvenu raspravu (isto je dio Europskoga javnog izvješća o procjeni lijeka (EPAR)).
English: What is the risk associated with Parvoduk?
Croatian: Koji je rizik povezan s Parvoduk?
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovaj dokument je sažetak Europskoga javnog izvješća o procjeni lijeka.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Parvoduk exceed the risks for the approved indication and recommended that Parvoduk be given a marketing authorisation.
Croatian: Povjerenstvo za veterinarske lijekove (CVMP) zaključio je da koristi od lijeka Parvoduk nadmašuju rizike za odobrene indikacije i preporučio je izdavanje odobrenja za stavljanje VMP-a Parvoduk u promet.
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 liječnički recept možete naći na oznaci/vanjskom dijelu pakiranja.
English: Although the weakened virus in Parvoduk has not been shown to pass between birds or to cause disease, all the ducklings in a flock should be vaccinated to reduce the risk of this happening.
Croatian: Iako nije dokazano da se oslabljeni virus u cjepivu Parvoduk prenosi između ptica ili da uzrokuje bolesti, svi pačići u jatu trebaju biti cijepljeni kako bi se smanjio rizik da se to dogodi.
English: Growth after exposure to Muscovy duck parvovirus or goose parvovirus was improved in vaccinated ducklings by 70% and 110%, respectively.
Croatian: Rast nakon izlaganja parvovirusu mošusne patke ili parvovirusu guske poboljšao se u cijepljenih pačića za 70% odnosno 110%.
English: The vaccine is given to day-old ducklings as an injection under the skin, repeated after 16 days.
Croatian: Cjepivo se daje pačićima u dobi od jednog dana kao supkutana injekcija, te se ponavlja nakon 16 dana.
English: In the future, if the animals are exposed to Muscovy duck parvovirus, the immune system will be able to respond more quickly.
Croatian: U buduće ako se životinje izlože parvovirusu mošusne patke, imunosni sustav će moći brže odgovoriti.
English: Parvoduk is available as a suspension and diluent for injection.
Croatian: Parvoduk je dostupan kao suspenzija i otapalo za suspenziju za injekciju.
English: The laboratory studies showed that, two weeks after vaccination, Parvoduk prevented deaths in the ducklings and reduced damage to organs.
Croatian: Laboratorijska su ispitivanja pokazala da je dva tjedna nakon cijepljenja Parvoduk spriječio smrti u pačića i smanjio oštećenje organa.
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 eggs or milk used for human consumption.
Croatian: Karencija je razdoblje koje treba proći od primjene lijeka do klanja životinje prije nego što se meso može koristiti u prehrani ljudi ili jaja ili mlijeko mogu koristiti u prehrani ljudi.
English: Parvoduk is a vaccine.
Croatian: Parvoduk je cjepivo.
English: The withdrawal period for Parvoduk is zero days.
Croatian: Parvoduk je nula dana.
English: The measure of effectiveness was reduction in death rates, stunting of growth, feather abnormalities and damage to organs seen at post-mortem.
Croatian: Mjera djelotvornosti bilo je smanjenje u stopama smrtnosti, prestanku rasta, abnormalnostima perja i oštećenju organa uočeno post-mortem.
English: Why has Parvoduk been approved?
Croatian: Zašto je Parvoduk odobren?
English: Week-old ducklings show a range of signs including death and muscle weakness whilst older ducklings display stunted growth, nervous symptoms and feather abnormalities.
Croatian: Tjedan dana stari pačići pokazuju raspon znakova, uključujući smrt i slabost mišića, dok se u starijih pačića manifestirao prestanak rasta, nervozni simptomi i abnormalnosti u perju.
English: The Muscovy duck parvovirus in Parvoduk is alive but it has been attenuated (weakened) so that it does not cause disease.
Croatian: Parvovirus mošusne patke u lijeku Parvoduk je živ, no atenuiran (oslabljen) tako da ne uzrokuje bolest.
English: What is Parvoduk?
Croatian: Što je Parvoduk?
English: Because goose parvovirus is very similar to Muscovy duck parvovirus, the immune response also provides protection if the animal is exposed to goose parvovirus.
Croatian: Budući da je parvovirus guske vrlo sličan parvovirusu mošusne patke, imunosni odgovor pruža dodatnu zaštitu, ako je životinja izložena parvovirusu guske.
English: In addition it was shown that Parvoduk remains effective until the ducklings are aged six weeks, which means that the ducklings are protected during the period when they are at risk of Muscovy duck parvovirosis and Derzsy's disease.
Croatian: Nadalje, dokazano je da Parvoduk ostaje djelotvoran sve do starosti pačića od šest tjedana, što znači da su pačići zaštićeni tijekom razdoblja kada su izloženi parvovirozi mošusne patke i Derzsy bolesti.
English: What is Parvoduk used for?
Croatian: Za što se Parvoduk koristi?
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika nalazi se u modulu znanstvenog zaključka ovog EPAR-a.
English: When Parvoduk is given to Muscovy ducks the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Croatian: Nakon što mošusne patke prime cjepivo Parvoduk imunosni sustav životinje prepoznaje viruse kao „strano tijelo” i proizvodi protutijela protiv njih.
English: Two further studies were carried out to investigate the effects of Parvoduk in ducklings who had inherited protective antibodies against Muscovy duck parvovirus or goose parvovirus from their mother.
Croatian: Dva daljnja ispitivanja provedena su kako bi se istražilo djelovanje cjepiva Parvoduk u pačića koji su imali naslijeđena zaštitna protutijela protiv parvovirusa mošusne patke ili parvovirusa guske od svojih majki.
English: Parvoduk is a veterinary vaccine that contains live attenuated (weakened) Muscovy duck parvovirus.
Croatian: Parvoduk je veterinarsko cjepivo koje sadrži atenuirani (oslabljeni) parvovirus mošusne patke.
English: Derzsy's disease is a similar infection caused by the closely related virus, goose parvovirus.
Croatian: Derzsy bolest je bolest slična infekciji uzrokovana usko povezanim virusom, parvovirusom guske.
English: What benefit has Parvoduk shown during the studies?
Croatian: Koje je koristi Parvoduk potvrdio tijekom ispitivanja?
English: Muscovy duck parvovirus (live attenuated)
Croatian: Parvovirus mošusne patke (živi atenuirani)
English: One-day-old ducklings were given a single injection of Parvoduk and then exposed two weeks later to either Muscovy duck parvovirus or goose parvovirus.
Croatian: Jedan dan stari pačići primili su jednu injekciju lijeka Parvoduk, a zatim su izloženi nakon dva tjedna parvovirusu mošusne patke ili parvovirusu guske.
English: How has Parvoduk been studied?
Croatian: Kako se Parvoduk ispitivao?
English: Muscovy duck parvovirosis is an infectious disease caused by Muscovy duck parvovirus.
Croatian: Parvoviroza mošusne patke je infektivna bolest koju uzrokuje parvovirus mošusne patke.
English: Parvoduk is used to protect Muscovy ducks against Muscovy duck parvovirosis and Derzsy's disease.
Croatian: Parvoduk se koristi za aktivnu imunizaciju mošusnih pataka protiv parvoviroze mošusne patke i Derzsy bolesti.
English: The further study showed that Parvoduk vaccination of ducklings was not counteracted by protective antibodies from their mother.
Croatian: Daljnje je ispitivanje pokazalo da zaštitna protutijela u majkama pačića nisu djelovala protivno cijepljenju cjepivom Parvoduk.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: The recommended dose is one tablet a day, taken with food.
Croatian: Preporučena doza je jedna tableta na dan koja se uzima s hranom.
English: This summary was last updated in 01/2018.
Croatian: Sažetak je posljednji put ažuriran u 01. 2018.
English: Genvoya contains four active substances.
Croatian: Genvoya sadrži četiri djelatne tvari.
English: The CHMP also considered that combining the medicines in a single tablet simplifies treatment.
Croatian: CHMP također smatra da spajanje lijekova u jednu tabletu pojednostavljuje liječenje.
English: The full EPAR for Genvoya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Genvoya nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Genvoya
Croatian: Ostale informacije o lijeku Genvoya
English: The main measure of effectiveness was based on the reduction of the amount of HIV-1 in the blood.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na smanjenju količine virusa HIV-1 u krvi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Genvoya on 19 November 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Genvoya u promet koje vrijedi na prostoru Europske unije od 19. studenoga 2015.
English: This is a summary of the European public assessment report (EPAR) for Genvoya.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Genvoya.
English: What measures are being taken to ensure the safe and effective use of Genvoya?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Genvoya?
English: Genvoya must not be taken with certain other medicines because of the possibility of harmful interactions.
Croatian: Genvoya se ne smije uzimati s određenim lijekovima zbog opasnosti od štetne interakcije.
English: This reduces the virus's ability to replicate and slows down the spread of infection.
Croatian: Na taj se način smanjuje mogućnost virusa da se razmnožava i usporava se širenje infekcije.
English: Genvoya's side effects were similar to those of the individual medicines.
Croatian: Nuspojave lijeka Genvoya bile su slične onima pojedinačnih lijekova.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Genvoya's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Genvoya nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Further data indicated that Genvoya can be used safely in children as young as 6 years of age.
Croatian: Dodatni podatci upućivali su na to da se lijek Genvoya može sigurno primjenjivati u djece u dobi od samo 6 godina.
English: The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 of HIV-1 RNA copies/ml.
Croatian: Smatralo se da je infekcija odgovorila na liječenje ako je virusno opterećenje u krvi bolesnika iznosilo manje od 50 HIV-1 RNK kopija/ml.
English: Genvoya does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Genvoya ne liječi infekciju virusom HIV-1 ni AIDS, no može odgoditi oštećenje imunološkog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: The most common side effect with Genvoya (which may affect more than 1 in 10 people) is nausea (feeling sick).
Croatian: Najčešća nuspojava lijeka Genvoya (može se javiti u više od 1 na 10 osoba) jest mučnina (osjećaj slabosti).
English: After 48 weeks around 90% of patients treated with both Genvoya (800 of 866 patients) and the comparator (784 of 867 patients) had responded to treatment.
Croatian: Nakon 48 tjedana oko 90 % bolesnika koji su primali lijek Genvoya (800 od 866 bolesnika) i usporednik (784 od 867 bolesnika) odgovorilo je na liječenje.
English: What is Genvoya and what is it used for?
Croatian: Što je Genvoya i za što se koristi?
English: In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya.
Croatian: U studiji potpore bolesnici liječeni djelotvornom terapijom protiv HIV-a nastavili su s istom terapijom ili su prešli na lijek Genvoya.
English: It is not intended to provide practical advice on how to use Genvoya.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Genvoya.
English: This boosts elvitegravir's antiviral effect.
Croatian: Time se potencira antivirusno djelovanje elvitegravira.
English: It is used in adults and adolescents aged over 12 years whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.
Croatian: Indiciran je za liječenje odraslih osoba i adolescenata starijih od 12 godina kod kojih se očekuje da bolest neće biti otporna ni na koju antivirusnu tvar u lijeku Genvoya.
English: By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.
Croatian: Blokirajući reverznu transkriptazu Genvoya smanjuje količinu virusa HIV-1 u krvi i održava je na niskoj razini.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Genvoya 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 Genvoya nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: This study also involved 23 children aged 8 to 11 years weighing at least 25 kg, and showed that after 48 weeks of treatment with Genvoya the viral load was reduced to less than 50 copies/ml in all patients.
Croatian: Tim je ispitivanjem također bilo obuhvaćeno 23 djece u dobi između 8 i 11 godina, koja su težila najmanje 25 kg, te se njime pokazalo da je nakon 48 tjedana liječenja lijekom Genvoya virusno opterećenje u svih bolesnika smanjeno na manje od 50 kopija/ml.
English: Genvoya is available as tablets, each containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Croatian: Lijek Genvoya dostupan je u obliku tableta koje sadržavaju 150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i 10 mg tenofoviralafenamida.
English: Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Genvoya je antivirusni lijek koji se primjenjuje za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: By blocking an enzyme called integrase, elvitegravir stops the virus's genetic material from integrating into the genetic material of the cells it has infected.
Croatian: Blokirajući enzim naziva integraza elvitegravir sprječava integraciju genetskog materijala virusa u genetski materijal zaraženih stanica.
English: After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.
Croatian: Nakon 48 tjedana virusno opterećenje od manje od 50 kopija/ml uočeno je u 97 % (932 od 959) bolesnika koji su prešli na lijek Genvoya te 93 % (444 od 477) bolesnika koji su nastavili s uobičajenom terapijom.
English: What are the risks associated with Genvoya?
Croatian: Koji su rizici povezani s lijekom Genvoya?
English: Other side effects include abnormal dreams, dizziness, feeling tired, and diarrhoea.
Croatian: Ostale nuspojave uključuju abnormalne snove, omaglicu, umor i proljev.
English: Cobicistat increases the level of elvitegravir by slowing its breakdown.
Croatian: Kobicistat povećava koncentraciju elvitegravira tako što usporava njegovu razgradnju.
English: Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: Tenofoviralafenamid je „prolijek” tenofovira, što znači da se u tijelu pretvara u djelatnu tvar tenofovir.
English: For more information about treatment with Genvoya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Genvoya pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Elvitegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Croatian: Elvitegravir je vrsta antivirusne tvari koja se naziva „inhibitor integraze”.
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Croatian: Tenofovir i emtricitabin povezane su antivirusne tvari koje se nazivaju inhibitorima reverzne transkriptaze.
English: Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously.
Croatian: Lijek Genvoya ispitan je u dvama glavnim ispitivanjima koja su obuhvatila 1 733 odrasla bolesnika zaražena virusom HIV-1 koji prethodno nisu bili liječeni.
English: Genvoya elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Croatian: Genvoya elvitegravir / kobicistat / emtricitabin / tenofoviralafenamid
English: Why is Genvoya approved?
Croatian: Zašto je lijek Genvoya odobren?
English: They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Croatian: Inhibiraju djelovanje reverzne transkriptaze, virusnog enzima koji omogućuje replikaciju virusa HIV-1 u zaraženim stanicama.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Croatian: Genvoya se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.