FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
Croatian: Cjepivo sadrži oociste vrste Eimeria koje su oslabljene kako ne bi mogle uzrokovati bolest.
English: Why is Evalon approved?
Croatian: Zašto je Evalon odobren?
English: What is Evalon and what is it used for?
Croatian: Što je Evalon i za što se koristi?
English: Coccidiosis is a disease of the gut which results in reduced growth, severe diarrhoea, reduced egg production and a high death rate.
Croatian: Kokcidioza je bolest crijeva koja rezultira smanjenim rastom, teškim proljevom, smanjenom proizvodnjom jaja i visokom stopom smrtnosti.
English: The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Croatian: Otapalo cjepiva sadrži adjuvans montanid IMS radi pojačavanja imunosnog odgovora.
English: When Evalon is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Croatian: Kada se Evalon daje pilićima, imunosni sustav životinje prepoznaje oociste parazita Eimeria kao „strano tijelo” i stvara obrambeni mehanizam protiv njih.
English: Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Croatian: Zaražene ptice izlučuju spore bolesti (oociste) u izmetu kojima se može širiti infekcija.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Evalon's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Evalon nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Evalon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Evalon.
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Croatian: Cjepivo sadrži žive atenuirane (oslabljene) oociste parazita Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix i Eimeria tenella.
English: Evalon is a veterinary vaccine to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Croatian: Evalon je veterinarsko cjepivo za zaštitu pilića od kokcidioze koju uzrokuju paraziti kokcidije Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix i Eimeria tenella.
English: It is not intended to provide practical advice on how to use Evalon.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Evalon.
English: What are the risks associated with Evalon?
Croatian: Koji su rizici povezani s VMP-om Evalon?
English: Other information about Evalon?
Croatian: Ostale informacije o VMP-u Evalon?
English: In a field study involving 4 farms, shedding of oocysts in the faeces was reduced within 3 weeks of vaccination both in Evalon vaccinated chicks and those vaccinated with another vaccine against Eimeria.
Croatian: U terenskom ispitivanju kojim su obuhvaćene četiri farme izlučivanje oocista u izmet smanjeno je u roku od tri tjedna nakon cijepljenja, i kod pilića cijepljenih Evalonom i kod pilića cijepljenih drugim cjepivom protiv parazita Eimeria.
English: The vaccine is given to one-day-old chicks by coarse spray vaccination.
Croatian: Cjepivo se daje pilićima starima 1 dan raspršivanjem velikih kapljica.
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o VMP.
English: There are no known side effects with Evalon.
Croatian: Nema poznatih nuspojava u primjeni VMP-a Evalon.
English: Evalon avian coccidiosis vaccine (live)
Croatian: Evalon cjepivo (živo) protiv kokcidioze peradi
English: How does Evalon work?
Croatian: Kako djeluje Evalon?
English: How is Evalon used?
Croatian: Kako se Evalon koristi?
English: For practical information about using Evalon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Evalon vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evalon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Evalon nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For more information about treatment with Evalon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Evalon vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of Evalon have been shown in studies?
Croatian: Koje su koristi VMP-a Evalon utvrđene u ispitivanjima?
English: The European Commission granted a marketing authorisation valid throughout the EU for Evalon on
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Evalon na snazi u Europskoj uniji od 18/04/2016.
English: The results with Evalon and the comparator vaccine were similar for 3 out 4 farms; on 1 farm Evalon vaccinated chickens showed better protection than those given the comparator.
Croatian: Rezultati cijepljenja Evalonom i usporednim cjepivom bili su slični na trima od četiriju farmi.
English: MA (EU) Numbers (Invented) name Strength
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET (EU)
English: Immediate Packaging Pack size blister (PVC/PVDC-Alu); wallet blister (PVC/PVDC-AluAlu); carton
Croatian: Kroz usta blister (PVC/PVDC/Alu); kutija
English: Route of Administration
Croatian: Farmaceutski oblik Put primjene
English: It is given once a day by slow infusion lasting about one hour.
Croatian: Lijek se daje jedanput dnevno putem polagane infuzije u trajanju od oko jedan sat.
English: In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the patient's height and weight).
Croatian: U bolesnika u dobi od 12 mjeseci do 17 godina, doza ovisi o tjelesnoj površini bolesnika (koja se izračunava na osnovi visine i težine bolesnika).
English: The full EPAR and risk management plan summary for Caspofungin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Caspofungin Accord nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, treatment begins with a 70mg starting dose, followed by a daily dose of 50 mg, or of 70 mg if the patient weighs more than 80 kg. A lower dose is given to adults who have moderate problems with their liver.
Croatian: U odraslih, liječenje počinje početnom dozom od 70 mg, a nastavlja se dnevnom dozom od 50 mg ili 70 mg ako bolesnik ima više od 80 kg.
English: This means that Caspofungin Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cancidas.
Croatian: To znači da je Caspofungin Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Cancidas.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je Caspofungin Accord usporediv s lijekom Cancidas.
English: Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children with:
Croatian: Caspofungin Accord je antifungalni lijek koji se koristi za liječenje odraslih, adolescenata i djece s:
English: • invasive candidiasis (a type of fungal infection due to Candida);
Croatian: • invazivnom kandidijazom (vrstom gljivične infekcije koju uzrokuje gljivica Candida);
English: Because Caspofungin Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Caspofungin Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Fungal cells treated with Caspofungin Accord have incomplete or defective cell walls, making them fragile, unable to grow and causing their death.
Croatian: Stanice gljivice liječene lijekom Caspofungin Accord imaju nepotpuno razvijene ili oštećene stanične stjenke što ih čini krhkima, onemogućava njihov rast i uzrokuje njihovo umiranje.
English: • invasive aspergillosis (another type of fungal infection due to Aspergillus) when the infection does not respond to or the patient does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Croatian: • invazivnom aspergilozom (drugom vrstom gljivične infekcije koju uzrokuje gljivica Aspergillus) u slučaju izostanka odgovora na liječenje ili u slučaju kada bolesnik ne podnosi amfotericin B ili itrakonazol (druge antifungalne lijekove);
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to survive and grow.
Croatian: Djeluje tako da ometa stvaranje sastavnice stanice gljivice koja se naziva „polisaharid glukan”, i potrebna je za opstanak i rast gljivice.
English: Caspofungin Accord is a ‘generic medicine'.
Croatian: Caspofungin Accord je „generički lijek”.
English: Caspofungin Accord caspofungin
Croatian: Caspofungin Accord kaspofungin
English: The company provided data from the published literature on caspofungin.
Croatian: Tvrtka je pružila podatke o kaspofunginu iz objavljene literature.
English: Caspofungin Accord should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Croatian: U djece mlađe od 12 mjeseci, Caspofungin Accord treba koristiti s oprezom jer lijek nije u dovoljnoj mjeri ispitan za tu dobnu skupinu.
English: It is not intended to provide practical advice on how to use Caspofungin Accord.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Caspofungin Accord.
English: The Committee recommended that Caspofungin Accord be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za primjenu lijeka Caspofungin Accord u EU-u.
English: Caspofungin Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Croatian: Caspofungin Accord se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju invazivnih gljivičnih infekcija.
English: No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Caspofungin Accord generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i Cancidas.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Caspofungin Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka i uputu o lijeku za Caspofungin Accord uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: A risk management plan has been developed to ensure that Caspofungin Accord is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Caspofungin Accord.
English: What measures are being taken to ensure the safe and effective use of Caspofungin Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Caspofungin Accord?
English: This is a summary of the European public assessment report (EPAR) for Caspofungin Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Caspofungin Accord.
English: Other information about Caspofungin Accord
Croatian: Ostale informacije o lijeku Caspofungin Accord
English: Caspofungin Accord must be made up into a concentrated solution and then diluted before use, using a diluent that does not contain glucose.
Croatian: Od lijeka Caspofungin Accord mora se napraviti koncentrirana otopina koju je potrebno razrijediti prije uporabe uz pomoć sredstva koje ne sadrži glukozu.
English: The active substance in Caspofungin Accord, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Croatian: Djelatna tvar u lijeku Caspofungin Accord, kaspofungin, pripada skupini antifungalnih lijekova poznatih pod nazivom „ehinokandini”.
English: What are the benefits and risks of Caspofungin Accord?
Croatian: Koje su koristi i rizici lijeka Caspofungin Accord?
English: What is Caspofungin Accord and what is it used for?
Croatian: Što je Caspofungin Accord i za što se koristi?
English: For more information about treatment with Caspofungin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Caspofungin Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: It contains the active substance caspofungin.
Croatian: Sadrži djelatnu tvar kaspofungin.
English: The list of fungi against which Caspofungin Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis gljivica protiv kojih je Caspofungin Accord aktivan dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile
Croatian: • sumnjom na gljivične infekcije (uzrokovane gljivicama kao što su Candida ili Aspergillus) u slučaju kada je bolesnik febrilan (ima groznicu) i ima neutropeniju (nisku razinu bijelih krvnih stanica).
English: Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Caspofungin Accord je prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: For practical information about using Caspofungin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Caspofungin Accord pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Cancidas, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Cancidas.
English: Why is Caspofungin Accord approved?
Croatian: Zašto je Caspofungin Accord odobren?
English: How does Caspofungin Accord work?
Croatian: Kako djeluje Caspofungin Accord?
English: How is Caspofungin Accord used?
Croatian: Kako se Caspofungin Accord koristi?
English: How has Caspofungin Accord been studied?
Croatian: Kako je Caspofungin Accord ispitivan?
English: This is of particular concern, as these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
Croatian: Ovo je razlog za posebnu zabrinutost budući da su ovi bolesnici i bolesnici s oštećenjem funkcije bubrega već posebno skloni razvijanju hiperkalemije.
English: RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Croatian: Lijekovi koji djeluju na RAS uključuju inhibitore enzima, koji konvertiraju angiotenzin (inhibitore ACE-a) poput benazeprila, kaptoprila, cilazaprila, delaprila, enalaprila, fosinoprila, imidaprila, lisinoprila, moeksiprila, perindoprila, kvinaprila, ramiprila, spiraprial, trandolaprila i zofenoprila), blokatore receptora angiotenzina (ARB-ovi) poput kandesartana, telmisartana, valsartana, irbesartana, eprosartana, olmesartana, losartana i azilsartana, te izravne inhibitori renina, poput aliskirena.
English: In particular, a number of trials in heart failure patients have shown that the addition of a second RAS-acting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Croatian: Posebice, niz ispitivanja provedenih kod bolesnika sa srčanom insuficijencijom pokazala su da dodavanje drugog lijeka koji djeluje na RAS može smanjiti stopu prijema u bolnicu uslijed srčane insuficijencije u bolesnika sa srčanom insuficijencijom, što se smatra značajnom kliničkom završnom točkom.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Croatian: Uzimajući u obzir nove dostupne dokaze iz znanstvene literature i ozbiljnost identificiranih razloga za zabrinutost za sigurnu primjenu, Talijanska agencija za lijekove (AIFA) odlučila je pokrenuti pregled sukladno članku 31. Direktive Vijeća 2001/83/EZ dana 17. travnja 2013., upućujući predmet Povjerenstvu za ocjenu rizika na području farmakovigilancije (PRAC) i tražeći od PRAC-a da izda preporuku o omjeru koristi i rizika dualne terapije inhibicije RAS-a putem kombinirane primjene inhibitora ACE-a, ARB-ova ili aliskirena, te je li potrebno poduzeti bilo kakve regulatorne mjere u vezi s odobrenjima za stavljanje u promet lijeka uključenog u ovaj postupak.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Croatian: PRAC je također bio mišljenja da su kontraindikacije temeljene na podacima ispitivanja ALTITUDE5 u vezi s istovremenom primjenom inhibitora ACE-a ili ARB-ova s proizvodima koji sadrže aliskiren u bolesnika s dijabetesom melitusom ili oštećenjem bubrega (stopa glomerularne filtracije (GFR) < 60 ml/min/1.73 m2) potvrđenim dodatnim pregledom podataka te da se također treba uvrstiti u informacije o proizvodu za ARB-ove i inhibitore ACE-a.
English: In particular, the publication of a metaanalysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Croatian: Posebice, objava meta analize provedene od strane Makani et al1 koja je obuhvatila više od 68.000 bolesnika dala je povoda za zabrinutost da kombiniranje nekoliko lijekova koji djeluju na RAS može biti povezano s povišenim rizikom od hiperkalemije, preosjetljivosti i zatajenja bubrega, u usporedbi s jednokratnom primjenom jednog lijeka koji djeluje na RAS.
English: In addition, the metaanalysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Croatian: Nadalje, meta analiza ukazuje da primjena višestrukih lijekova koji djeluju na RAS može imati više koristi od primjene jednog lijeka koji djeluje na RAS u smislu smanjivanja ukupne smrtnosti.
English: However, new data has emerged in the past years, raising doubts over the efficacy and identifying safety concerns associated with dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren.
Croatian: No, pojavili su se novi podaci u prošlosti koji pobuđuju sumnju u djelotvornost te identificiraju razloge za zabrinutost za sigurnu primjenu povezane s dualnom terapijom inhibicije RAS-a pomoću kombinirane primjene inhibitora ACE, ARB-ova ili aliskirena.
English: Annex I Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Croatian: Znanstveni zaključci, razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje znanstvenih razloga za razlike u odnosu na preporuku PRAC-a
English: BMJ.
Croatian: Dodatak I
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and
Croatian: PRAC je mišljenja da postoje značajni dokazi iz velikih kliničkih ispitivanja i meta analiza koje definitivno demonstriraju da je dualna terapija inhibicije RAS-a putem kombinirane primjene inhibitora ACE-a, ARB-ova ili aliskirena povezana s povišenim rizikom od nuspojava, uključujući hipotenziju, hiperkalemiju i zatajenje bubrega u usporedbi s monoterapijom,
English: renal failure compared to monotherapy, in particular in patients with diabetic nephropathy.
Croatian: posebice u bolesnika s dijabetičkom nefropatijom.
English: What is PREZISTA?
Croatian: Što je PREZISTA?
English: In some patients additional factor VIII was given.
Croatian: Kod nekih je bolesnika primjenjen dodatni faktor VIII.
English: This ingredient may cause allergic reactions (sometimes delayed).
Croatian: Ovaj sastojak može uzrokovati alergijske reakcije (ponekad odgođene).
English: What PREZISTA is and what it is used for
Croatian: Što je PREZISTA i za što se koristi
English: PREZISTA with food and drink See section 3 ‘How to take PREZISTA.'
Croatian: PREZISTA s hranom i pićem Vidjeti dio 3 „Kako uzimati lijek PREZISTA“.
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Croatian: HIV IP darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
English: Avoid exposure to excessive heat.
Croatian: Ne izlagati prekomjernoj toplini.
English: These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:'
Croatian: Navedeni su gore pod naslovom „Nemojte kombinirati lijek PREZISTA ni s jednim od sljedećih lijekova“.
English: based upon non dose normalised values
Croatian: na temelju normaliziranih vrijednosti neovisnih o dozi
English: PREZISTA oral suspension is available in packs of one bottle.
Croatian: PREZISTA oralna suspenzija dostupna je u pakiranjima od jedne bočice.
English: There are some medicines that you must not combine with PREZISTA.
Croatian: Postoje neki lijekovi koje ne smijete kombinirati s lijekom PREZISTA.