FrancophonIA/ELRC3.0 huggingface dataset:
English: Different indications and dosages are currently recommended, but zinc oxide is mainly used in the feed at a dosage of 100 mg per kg body weight per day for 14 consecutive days, which equates to 2500 ppm zinc in feed.
Croatian: Trenutačno se preporučuju različite indikacije i doze, ali cinkov oksid uglavnom se koristi u hrani u dozi od 100 mg po kg tjelesne težine na dan tijekom 14 uzastopnih dana, što odgovara količini od 2500 ppm cinka u hrani.
English: The European Commission issued a decision on 26 June 2017 and Member States may defer the withdrawal of the marketing authorisations for up to five years from this date, if they consider that immediate action may have adverse impact in their territory given the lack of availability of alternatives and the change required in pig farming practices.
Croatian: Prema odluci Europske komisije od 26. lipnja 2017., države članice mogu odgoditi povlačenje odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet do pet godina od navedenog datuma ako smatraju da bi povlačenje bez odgode moglo imati štetan učinak na njihovu području uzimajući u obzir nepostojanje alternativa i promjene potrebne u dosadašnjoj praksi uzgoja svinja.
English: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link
Croatian: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no.
English: In May 2015, following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets1, the CVMP identified a risk to the environment due to accumulation of zinc.
Croatian: U svibnju 2015., nakon arbitražnog postupka (EMEA/V/A/108) prema članku 33. stavku 4. Direktive 2001/82/EZ za Gutal 1000 g/kg premiks za ljekovitu hranu za praščiće1, CVMP je utvrdio rizik za okoliš zbog akumulacije cinka.
English: The CVMP considered that there is some uncertainty associated with the calculated risks for some environmental compartments and recommended various risk mitigation measures, which were anticipated to reduce the accumulation of zinc in the environment.
Croatian: CVMP smatra da postoji određena nesigurnost povezana s izračunatim rizicima za neke dijelove okoliša i preporučene različite mjere za ublažavanje rizika za koje se predviđalo da će smanjiti akumulacija cinka u okolišu.
English: The CVMP acknowledged that there is a risk of co-selection for resistance (the selection of multiple antimicrobial resistance genes by an antimicrobial) associated with the use of zinc oxide but that, at the present time, such risk is not quantifiable.
Croatian: CVMP prihvaća da postoji rizik od koselekcije s obzirom na rezistenciju (selekcija gena s višestrukom antimikrobnom rezistencijom) povezan s primjenom cinkova oksida, ali u ovom trenutku taj se rizik ne može kvantificirati.
English: Veterinary medicinal products containing zinc oxide are used for the treatment and/or prevention and control of post-weaning diarrhoea in piglets.
Croatian: Veterinarsko-medicinski proizvodi koji sadrže cinkov oksid namijenjeni su za liječenje i/ili sprječavanje i kontrolu proljeva u praščića nakon odbijanja.
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicinal products containing zinc oxide to be administered orally to food-producing species.
Croatian: Europska agencija za lijekove (Agencija) završila je 16. ožujka 2017. ocjenu sigurnosti i učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane.
English: Questions and answers on veterinary medicinal products containing zinc oxide to be administered orally to food-producing species EMA/394961/2017
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane EMA/478878/2017
English: The applicants and marketing authorisation holders concerned by the referral procedure submitted proprietary data and scientific references on efficacy, antimicrobial resistance and environmental risk.
Croatian: Podnositelj zahtjeva i nositelji odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet na koje se ovaj arbitražni postupak odnosi dostavili su vlasničke podatke i znanstvene referencije o djelotvornosti, antimikrobnoj rezistenciji i riziku za okoliš.
English: Effective measures to manage the accumulation of zinc in the environment were not identified and, as a result, the CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Croatian: Učinkovite mjere kojima bi se riješilo pitanje akumulacije cinka u okolišu nisu utvrđene te je, posljedično tomu, CVMP preporučio odbijanje odobrenja za stavljanje u promet i povlačenje postojećih odobrenja za veterinarsko-medicinske proizvode koji sadrže cinkov oksid.
English: Why were orally-administered veterinary medicinal products containing zinc oxide reviewed?
Croatian: Zašto su ocjenjivani veterinarsko-medicinski proizvodi za peroralnu primjenu koji sadrže cinkov oksid?
English: Questions and answers on veterinary medicinal products containing zinc oxide to be administered orally to food-producing species
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane
English: The CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Croatian: CVMP je preporučio da se odbije izdavanje odobrenja za stavljanje u promet te da se povuku sadašnja odobrenja za stavljanje u promet veterinarskomedicinskih proizvoda koji sadrže cinkov oksid.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Croatian: Na temelju procjene trenutačno dostupnih podataka, CVMP je zaključio da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u svinja negativan jer koristi cinkova oksida za sprječavanje proljeva u svinja ne premašuju rizike za okoliš.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u svinja negativan jer koristi cinkova oksida za sprječavanje proljeva u svinja ne premašuju rizike za okoliš.
English: Nevertheless, in February 2016, due to remaining concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide, the Netherlands and France initiated a referral procedure under Article 35 of Directive 2001/82/EC for all orally-administered veterinary medicinal products containing zinc oxide and requested the CVMP to review all available data and to evaluate the overall benefit-risk balance of the products concerned.
Croatian: Štoviše u veljači 2016. zbog preostalih zabrinutosti povezanih s rizikom za okoliš i mogućom povećanom prevalencijom bakterija otpornih na antibiotike zbog primjene proizvoda koji sadrže cinkov oksid, Nizozemska i Francuska pokrenule su arbitražni postupak prema članku 35.
English: Oral use bottle (HDPE)
Croatian: Peroralna primjena Boca (HDPE)
English: MA (EU) Number
Croatian: Broj EU odobrenja (Novoizumljen o) ime
English: This overview was last updated in September 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 9. 2018.
English: Afoxolaner kills parasites by causing an over-stimulation of their nervous system.
Croatian: Afoksolaner ubija parazite uzrokujući prekomjernu stimulaciju njihova živčanog sustava.
English: Further information on NexGard can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
Croatian: Više informacija o VMP-u NexGard nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
English: NexGard kills fleas within 8 hours and ticks within 48 hours.
Croatian: NexGard ubija buhe unutar 8 sati, a krpelje unutar 48 sati.
English: This results in uncontrolled activity of the nervous system and the paralysis and
Croatian: To rezultira nekontroliranim djelovanjem živčanog sustava i paralizom te smrću
English: NexGard (afoxolaner) EMA/783550/2013
Croatian: NexGard (afoksolaner) EMA/783550/2013
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter).
Croatian: Blokira normalno kretanje nabijenih čestica klorida (iona) u živčanim stanicama i iz njih, posebno onih povezanih s gama-aminobutričnom kiselinom (GABA), tvari koja prenosi poruke između živaca (neurotransmiteri).
English: NexGard received a marketing authorisation valid throughout the EU on 11 February 2014.
Croatian: VMP NexGard dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 11. veljače 2014.
English: This means that it kills parasites that live on or in the skin or in the fur of animals, such as fleas, ticks and mites.
Croatian: To znači da ubija parazite koji žive na koži ili u krznu životinja, poput buha, krpelja i grinja.
English: The effectiveness of NexGard was investigated in both laboratory and field studies.
Croatian: Djelotvornost VMP-a NexGard ispitana je i u laboratorijskim i u terenskim ispitivanjima.
English: In order for the active substance to have an effect, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Croatian: Kako bi ih se izložilo djelatnoj tvari, buhe i krpelji moraju biti pričvršćeni na kožu i početi se hraniti krvlju životinje.
English: NexGard (afoxolaner)
Croatian: NexGard (afoksolaner)
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Croatian: Terapiju treba ponoviti u mjesečnim intervalima tijekom sezone buha ili krpelja, mjesečno kod demodikoze sve dok je se uspješno ne izliječi (što se potvrđuje dvama negativnima strugotinama kože u razmaku od mjesec dana) i jednom mjesečno tijekom dva mjeseca kod sarkoptoze ili duže ako terapija nije uspješna, što se utvrđuje kliničkim znakovima i strugotinama kože.
English: Other information about NexGard
Croatian: Ostale informacije o VMP-u NexGard
English: The European Medicines Agency decided that NexGard's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a NexGard nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: Why is NexGard authorised in the EU?
Croatian: Zašto je NexGard odobren u EU-u?
English: What is NexGard and what is it used for?
Croatian: Što je NexGard i za što se primjenjuje?
English: NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as a spoton medicine containing pyriprole (another medicine against fleas and ticks).
Croatian: NexGard je smanjio broj buha i krpelja za najmanje 98 % i bio je barem jednako djelotvoran kao VMP za nakapavanje na kožu koji sadržava piriprol (drugi VMP protiv buha i krpelja).
English: NexGard reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Croatian: NexGard smanjio je broj živih grinja za 97 % 56 dana nakon početka terapije te za 98 % 84 dana nakon početka terapije.
English: NexGard is given as a tablet of the appropriate strength for the dog's bodyweight.
Croatian: NexGard se daje kao tableta odgovarajuće jačine prema tjelesnoj težini pasa.
English: NexGard reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Croatian: NexGard smanjio je broj živih grinja za 96% 28 dana nakon početka terapije te za 100% 56 dana nakon početka terapije.
English: The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide'.
Croatian: Djelatna tvar u VMP-u NexGard, afoksolaner, djeluje kao „ektoparaziticid”.
English: An overview of NexGard and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u NexGard i zašto je odobren u EU-u
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Croatian: U terenskom ispitivanju EU-a koje je obuhvatilo 146 pasa s infestacijama buha ili krpelja, jedan tretman VMP-om NexGard bio je djelotvoran u liječenju infestacija buha i krpelja u pasa do 30 dana nakon terapije.
English: NexGard is a medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Croatian: NexGard je VMP koji se primjenjuje za liječenje infestacija buhama i krpeljima, kao i demodikoze i sarkoptoze (infestacija kože koje uzrokuju dvije različite vrste grinja) u pasa.
English: What are the risks associated with NexGard?
Croatian: Koji su rizici povezani s VMP-om NexGard?
English: death of fleas, ticks and mites.
Croatian: buha, krpelja i grinja.
English: How does NexGard work?
Croatian: Kako djeluje NexGard?
English: For more information about using NexGard, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Više informacija o primjeni VMP-a NexGard pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with NexGard.
Croatian: Drugo terensko ispitivanje EU-a uključivalo je 31 psa s demodikozom koja je tretirana tri puta u mjesečnim intervalima VMP-om NexGard.
English: NexGard is available as chewable tablets in four different strengths for use in dogs of different weights.
Croatian: VMP NexGard dostupan je u obliku tableta za žvakanje u četiri različite jačine za primjenu u pasa različite tjelesne težine.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with NexGard.
Croatian: Treće terensko ispitivanje EU-a obuhvatilo je 38 pasa sa sarkoptozom koja je tretirana VMP-om NexGard jednom mjesečno tijekom dva mjeseca.
English: What benefits of NexGard have been shown in studies?
Croatian: Koje su koristi od VMP-a NexGard utvrđene u ispitivanjima?
English: NexGard contains the active substance afoxolaner.
Croatian: VMP NexGard sadržava djelatnu tvar afoksolaner.
English: These patients should be monitored closely.
Croatian: Te se bolesnike mora pozorno nadzirati.
English: YES NO
Croatian: DA NE
English: OTHER SPECIAL WARNINGS, IF NECESSARY
Croatian: DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
English: > 3 hours to ≤ 7 days
Croatian: > 3 sata do ≤ 7 dana
English: The company will start to include the pre-infusion check list in packs packed at the packaging site as soon as possible but at the latest on 15 November 2012.
Croatian: Proizvođač će predinfuzijski kontrolni upitnik početi umetati u pakiranja u procesu pakiranja na mjestu pakiranja što je prije moguće, a najkasnije 15. studenog 2012.
English: (see sections 4.4 Hypotension, Congestive Heart Failure).
Croatian: (Vidjeti dijelove 4.4 Hipotenzija, Kongestivno zatajenje srca).
English: • Bradycardia
Croatian: • bradikardija
English: In the remaining patients, electrical cardioversion can be recommended.
Croatian: Za preostale se bolesnike može preporučiti električna kardioverzija.
English: Other diseases and conditions not studied
Croatian: Ostale bolesti i stanja koja nisu ispitivana
English: Step 2: Dilution of concentrate
Croatian: 2.korak: Razrjeđivanje koncentrata
English: Does the patient have a systolic blood pressure < 100 mm Hg?
Croatian: Ima li bolesnik sistolički krvni tlak < 100 mm Hg?
English: By 90 minutes after the start of infusion, this difference was reduced to 8.1 msec.
Croatian: Devedeset minuta nakon početka infuzije ta se razlika smanjila na 8,1 ms.
English: • pain in your mouth or throat
Croatian: • bol u Vašim ustima ili grlu
English: ACT III BRINAVESS Placebo P-Value† BRINAVESS Placebo P-Value†
Croatian: BRINAVESS Placebo P-vrijednost† BRINAVESS Placebo P-vrijednost†
English: Studies in animal have shown malformations after repeated oral exposure (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su malformacije nakon ponovljene peroralne izloženosti (vidjeti dio 5.3).
English: If you are not sure, talk to your doctor before you use this medicine.
Croatian: Ako niste sigurni, obratite se liječniku prije nego primite ovaj lijek.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stanovišta lijek se mora odmah primijeniti.
English: The free fraction of vernakalant in human serum is 53-63 % at concentration range of 1-5 μg/ml.
Croatian: Slobodni dio vernakalanta u ljudskom serumu iznosi 53-63 % u rasponu koncentracija od 1-5 μg/ml.
English: Cumulative doses above 565 mg have not been evaluated.
Croatian: Kumulativne doze iznad 565 mg nisu ispitivane.
English: Your doctor may decide to stop the infusion if he observes any of the following abnormal changes of:
Croatian: Liječnik može odlučiti prekinuti infuziju ako primijeti bilo koju od sljedećih nepravilnosti u:
English: Vernakalant is extensively and rapidly distributed in the body, with a volume of distribution of approximately 2 l/kg.
Croatian: Vernakalant se opsežno i brzo raspodjeljuje u tijelu, uz volumen distribucije od približno 2 l/kg.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100).
English: Geodis Logistics Netherlands B.V. Columbusweg 16
Croatian: Geodis Logistics Netherlands B.V.
English: Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Croatian: Kriteriji za odabir bolesnika, uključujući kontraindikacije, posebna upozorenja i mjere opreza pri uporabi te informacije o populacijama bolesnika s ograničenim podacima iz kliničkih ispitivanja.
English: • the electrical activity of your heart (uncommon)
Croatian: • električnoj aktivnosti srca (manje često)
English: There are no clinical data on repeat doses after the initial and second infusions.
Croatian: Nema kliničkih podataka o ponovljenoj primjeni nakon početne i druge infuzije.
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 06 September 2015
Croatian: Datum posljednje obnove odobrenja: 1. rujna 2015.
English: Variations of colour within this range do not affect potency.
Croatian: Nijanse boje unutar ovog raspona ne utječu na potentnost lijeka.
English: Very common: Dysgeusia
Croatian: Vrlo često: disgeuzija
English: If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.
Croatian: Ako se pojave takvi znakovi, sa ili bez simptomatske hipotenzije ili bradikardije, infuzija se mora odmah prekinuti.
English: When giving BRINAVESS, follow these instructions:
Croatian: Kod primjene lijeka BRINAVESS slijedite ove upute:
English: Appropriate measures to manage and minimize the risks, including the need for close monitoring during and after administration of BRINAVESS.
Croatian: Odgovarajuće mjere za upravljanje rizicima i minimalizaciju rizika, uključujući i potrebu pozornog nadziranja bolesnika tijekom i nakon primjene lijeka BRINAVESS.
English: • your blood pressure (such as a very low blood pressure causing a serious heart condition)
Croatian: • krvnom tlaku (kao što je veoma nizak krvni tlak koji uzrokuje ozbiljne srčane tegobe) (manje često)
English: BRINAVESS must NOT be given to any patients with a “YES” response below:
Croatian: BRINAVESS se NE SMIJE dati bolesniku kod kojega je odgovor na bilo koje od sljedećih pitanja “DA”:
English: The Cmax and AUC were dose proportional between 0.5 mg/kg and 5 mg/kg.
Croatian: Cmax i AUC bili su proporcionalni dozi između doza od 0,5 mg/kg i 5 mg/kg.
English: Does the patient have severe aortic stenosis?
Croatian: Ima li bolesnik tešku stenozu aorte?
English: Detailed information on warnings and precautions relating to side effects that could occur are presented in section 4.
Croatian: Detaljne informacije o upozorenjima i mjerama opreza povezanima s nuspojavama koje bi se mogle javiti navedene su u dijelu 4.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti pojedinačne i ponovljenih doza te genotoksičnosti.
English: If you have very low blood pressure or slow heart rate or certain changes in your ECG while using this medicine, your doctor will stop your treatment.
Croatian: Ako budete imali vrlo nizak tlak ili usporen rad srca ili određene promjene na EKG-u dok primate ovaj lijek, liječnik će prekinuti liječenje.
English: Hypotension typically occurs early, either during the infusion or early after the end of the infusion, and can usually be corrected by standard supportive measures.
Croatian: Hipotenzija se u pravilu javlja rano, ili tijekom ili ubrzo nakon završetka infuzije, i obično se može korigirati uobičajenim suportivnim mjerama.
English: These reactions occurred around the time of infusion, were transient and were rarely treatment limiting.
Croatian: Te su se nuspojave javile otprilike u vrijeme primjene infuzije, bili su prolazne naravi i rijetko su ograničavale liječenje.
English: Uncommon: Pain in extremity
Croatian: Manje često: bol u ekstremitetima
English: Pharmacodynamics effects
Croatian: Farmakodinamički učinci
English: Elderly (≥ 65 years): No dose adjustment necessary.
Croatian: Starije osobe (≥ 65 godina):
English: You must not use BRINAVESS if any of the above apply to you.
Croatian: Ne smijete primiti BRINAVESS ako se nešto od navedenog odnosi na Vas.
English: There was no meaningful difference when stratifying the analysis by therapeutic indication (i.e. non-surgery and post-cardiac surgery patients).
Croatian: Nije bilo značajne razlike stratifikacijom analize prema terapijskoj indikaciji (tj. u bolesnika koji nisu operirani i u bolesnika nakon kirurškog zahvata na srcu).
English: Cases of serious hypotension have been reported during and immediately following vernakalant infusion.
Croatian: Prijavljeni su slučajevi ozbiljne hipotenzije tijekom i neposredno nakon infuzije vernakalanta.
English: Uncommonly, cases of severe hypotension have been observed.
Croatian: Manje često opaženi su slučajevi teške hipotenzije.