FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of Activyl Tick Plus against fleas and ticks was investigated in laboratory studies and in three field studies.
Croatian: Učinkovitost VMP-a Activyl Tick Plus protiv buha i krpelja ispitana je u laboratorijskim ispitivanjima i u trima terenskim ispitivanjima.
English: The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas and ticks that may be found on the skin or in the fur of animals.
Croatian: Djelatne tvari u VMP-u Activyl Tick Plus, indoksakarb i permetrin, pripadaju ektoparaziticidima, koji ubijaju nametnike kao što su buhe i krpelji koji se mogu naći na koži ili u dlaci životinja.
English: Together, the active form of indoxacarb and permethrin interfere with the parasites' nervous system, causing paralysis and death.
Croatian: Djelatne tvari indoksakarb i permetrin zajedničkim djelovanjem ometaju živčani sustav nametnika, što uzrokuje paralizu i smrt.
English: An overview of Activyl Tick Plus and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Activyl Tick Plus i zašto je odobren u EU-u
English: The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue.
Croatian: Primjenom VMP-a Activyl Tick Plus može doći do pojave privremenog masnog izgleda ili nakupljanja dlake na mjestu nanošenja ili suhog bijelog ostatka.
English: The effectiveness of Activyl Tick Plus against sand flies was shown in two laboratory studies.
Croatian: Učinkovitost VMP-a Activyl Tick Plus protiv pješčanih mušica utvrđena je u dvama laboratorijskim ispitivanjima.
English: What are the risks associated with Activyl Tick Plus?
Croatian: Koji su rizici povezani s VMP-om Activyl Tick Plus?
English: Activyl Tick Plus is a veterinary medicine used in dogs to treat flea and tick infestations.
Croatian: Activyl Tick Plus je veterinarsko-medicinski proizvod (VMP) koji se koristi u pasa za suzbijanje infestacija buhama i krpeljima.
English: After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form).
Croatian: Nakon primjene VMP-a buhe i krpelji progutaju indoksakarb i permetrin (indoksakarb se u njihovim crijevima pretvara u djelatni oblik).
English: In one study, Activyl Tick Plus showed repellant activity of above 95% at 1 day after treatment, falling to 92% at 3 weeks after treatment.
Croatian: VMP Activyl Tick Plus u jednom je ispitivanju pokazao odbijajuće djelovanje veće od 95 % jedan dan nakon primjene, da bi se tri tjedna nakon primjene ono smanjilo na 92 %.
English: Why is Activyl Tick Plus authorised in the EU?
Croatian: Zašto je VMP Activyl Tick Plus odobren u EU-u?
English: If adverse reactions occur, medical advice should be sought and the package leaflet shown to the doctor.
Croatian: U slučaju nuspojava potrebno je odmah zatražiti liječnički savjet te pokazati liječniku uputu o VMP-u.
English: For more information about using Activyl Tick Plus, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Activyl Tick Plus pročitajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: In the other study, Activyl Tick Plus showed repellant activity of 98% at 2 days after treatment falling to 86% at 3 weeks.
Croatian: U drugom je ispitivanju VMP Activyl Tick Plus pokazao odbijajuće djelovanje od 98 % dva dana nakon primjene, da bi se tri tjedna nakon primjene ono smanjilo na
English: The medicine, available as a spot-on solution, is given as a single application to the dog's skin.
Croatian: VMP je dostupan u obliku otopine za nakapavanje, a primjenjuje se jednokratnim nanošenjem na kožu psa.
English: The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals.
Croatian: Učinkovitost se mjerila utvrđivanjem broja buha i krpelja u dvotjednim razmacima.
English: Permethrin also acts as a repellent and so helps prevent sand flies from settling and taking a blood meal.
Croatian: Permetrin djeluje i kao repelent te sprječava pješčane mušice da dođu na tijelo i nahrane se krvlju.
English: How is Activyl Tick Plus used?
Croatian: Kako se Activyl Tick Plus koristi?
English: What benefits of Activyl Tick Plus have been shown in studies?
Croatian: Koje su koristi VMP-a Activyl Tick Plus utvrđene u ispitivanjima?
English: Activyl Tick Plus contains the active substances indoxacarb and permethrin.
Croatian: Activyl Tick Plus sadržava djelatne tvari indoksakarb i permetrin.
English: Protective gloves should be worn when handling or applying Activyl Tick Plus to dogs.
Croatian: Prilikom rukovanja VMP-om Activyl Tick Plus ili njegove primjene u pasa moraju se nositi zaštitne rukavice.
English: No changes were introduced.
Croatian: Nisu uvedene izmjene.
English: The European and Asian development plans have been conducted independently in the two different populations.
Croatian: Europski i azijski planovi za razvoj provedeni su nezavisno u dvije različite populacije.
English: The results of this PASS are awaited in Q1 2015.
Croatian: Rezultati ovog PASS-a očekuju se u 1. tromjesečju 2015.
English: These doses were therefore used in all the major controlled trials.
Croatian: Te su doze stoga korištene u svim glavnim kontroliranim ispitivanjima.
English: Labelling The labelling was reviewed during this procedure.
Croatian: Tijekom ovog postupka pregledano je označivanje.
English: However, strong uncertainties regarding this preventive effect do not allow any recommendation and cannot support such an indication.
Croatian: No, velike nesigurnosti u vezi s ovim preventivnim djelovanjem ne dopuštaju davanje bilo kakvih preporuka i ne mogu podržati tu indikaciju.
English: Be careful to avoid nitrate tolerance (Class IIb, level of evidence C).
Croatian: Pripazite da izbjegavate toleranciju nitrata (klasa II.b, razina dokaza C).
English: However this was based on limited evidence via literature10 (Ekanayaka, 2014).
Croatian: No, ovo je temeljeno na ograničenom dokazu iz literature10 (Ekanayaka, 2014.).
English: In general, it can be stated, that the treatment should be conducted with the lowest effective dose.
Croatian: Načelno, može se reći da se terapija treba provesti s najmanjom djelotvornom dozom.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Croatian: Odjeljak 4.5. - Interakcije s drugim lijekovima i drugi oblici interakcija
English: Ikorel and Dancor medicinal products are registered and marketed in the following EU Members States: Austria, Denmark, France, Ireland, the Netherlands, Portugal and United Kingdom.
Croatian: Lijekovi Ikorel i Dancor registrirani su i stavljeni u promet u sljedećim državama članicama EU-a: Austriji, Danskoj, Francuskoj, Irskoj, Nizozemskoj, Portugalu i Ujedinjenoj Kraljevini.
English: Therefore, a contra-indication is not considered justified, however a warning statement is requested by the CHMP.
Croatian: Stoga se kontraindikacija ne smatra opravdanom, no izjavu o upozorenju zatražio je CHMP.
English: <Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Croatian: <Zaštićeno ime> ne preporuča se u pedijatrijskih bolesnika budući da njegova sigurnost i djelotvornost nisu utvrđeni u ovoj grupi bolesnika.
English: There were no major discrepancies between the existing wordings in the different SmPCs.
Croatian: Nisu postojale veće razlike između postojećeg teksta u različitim SmPC-ovima.
English: Therefore the 20 mg daily dose could not be generalised.
Croatian: Stoga se dnevna doza od 20 mg ne može generalizirati.
English: In addition, this study is limited by the enrolled population with low revascularisation.
Croatian: Uz to, ovo je ispitivanje ograničeno upisanom populacijom s niskom revaskularizacijom.
English: The reduction in preload was proportionally more important than that of the afterload.
Croatian: Smanjenje preopterećenja bilo je proporcionalno značajnije od onog u naknadnom opterećenju.
English: The CHMP noted that the daily dose in Asiatic patients is below the one defined in European patients.
Croatian: CHMP je zaključio da je dnevna doza za azijske bolesnike manja od one definirane za europske bolesnike.
English: Therefore, the CHMP is of opinion that this indication is not supported due to lack of appropriate data.
Croatian: Stoga CHMP smatra da ta indikacija nije podržana uslijed nedostatka odgovarajućih podataka.
English: The results of the IONA study were summarised following the same wording for both groups of products.
Croatian: Rezultati ispitivanja IONA sažeti su, a koristi se isti tekst za obje grupe proizvoda.
English: The information/education to gain a knowledge that allows this diagnosis is the best risk minimisation measure identified so far.
Croatian: Informiranje/educiranje radi stjecanja znanja koje omogućuje ovu dijagnozu najbolja je mjera smanjivanja rizika koja je do sada utvrđena.
English: Case Rep. BMJ, 2014, Mar 10.
Croatian: BMJ, 2014, Mar 10.
English: Hyperkalaemia occurs infrequently with NSAIDs.
Croatian: Hiperkalemija nastupa rijetko s NSAID-ovima.
English: Postural hypotension was observed, although only after the first administration, whether it was 40 or 60 mg.
Croatian: Uočena je posturalna hipotenzija, iako samo nakon prve primjene, bez obzira na to da li se radilo o dozi od 40 ili 60 mg.
English: Furthermore, the secondary endpoint, the composite of cardiovascular death and MI, does not reach statistical significance and thus confirms the weakness and irrelevancy of the primary endpoint.
Croatian: Osim toga, sekundarna završna točka, kombinacija kardiovaskularne smrti i IM-a, ne postiže statistički značaj te stoga potvrđuje slabost i nerelevantnost primarne završne točke.
English: The statistically significant superiority of a single 5 mg dose over placebo was not considered as relevant evidence for efficacy after repeated dosing, as it was an acute administration only, and this was not the objective of the study.
Croatian: Statistički značajna superiornost jedne doze od 5 mg u odnosu na placebo nije se smatrala relevantnim dokazom djelotvornosti nakon ponovljenog doziranja jer je to bila samo akutna primjena, a to nije bio cilj ispitivanja.
English: The step of a retrospective assessment as part of the pharmacovigilance plan is a pre-requisite for a thorough understanding of the factors leading to the development of ulcerations.
Croatian: Korak retrospektivne ocjene kao dijela farmakovigilancijskog plana jest preduvjet za temeljno razumijevanje čimbenika koji uzrokuju razvoj ulceracija.
English: While the IONA study does not provide adequate support for a prevention indication, the totality of the data, including IONA, provide good support for the new symptomatic indication proposed above.
Croatian: Iako ispitivanje IONA ne pruža primjerenu podršku za indikaciju prevencije, sveukupni podaci, uključujući i ispitivanje IONA, pružaju dobru podlogu za novu simptomatičku indikaciju koja je prethodno predložena.
English: The CHMP was therefore of the view that the indication of cardiovascular prevention was not further supported.
Croatian: CHMP je stoga smatrao da indikacija kardiovaskularne prevencije više nije podržana.
English: However, the 5 mg dose although active in Japanese patients has shown to induce modest haemodynamic changes.
Croatian: No, iako je doza od 5 mg djelovala, u japanskih bolesnika, utvrđene su skromne hemodinamske promjene.
English: Consequently, as none of the performed studies show efficacy at doses lower than 20 mg b.i.d., and as the toxicity is dose dependant and appears at 20 mg b.i.d., the indication should be restricted to second line treatment as recommended in section 4.1 for safety reasons.
Croatian: Posljedično, budući da niti jedno provedeno ispitivanje nije pokazalo djelotvornost u dozi manjoj od 20 mg b.i.d. te budući da je toksičnost ovisna o dozi i pojavljuje se pri 20 mg b.i.d., indikaciju treba ograničiti na drugu liniju terapije kako je preporučeno u odjeljku 4.1. iz sigurnosnih razloga.
English: The number of patients treated by nicorandil per dosage is unavailable; it is thus unknown whether a dose reduction would allow a reduction in ulceration without lack of efficacy.
Croatian: Broj bolesnika liječenih nikorandilom po doziranju nije dostupan; stoga nije poznato bi li smanjenje doze omogućilo smanjenje ulceracije bez gubitka djelotvornosti.
English: The main objective criterion of efficacy was exercise capacity reported in terms of time to onset of angina, total exercise duration and time to 1 mm ST segment depression.
Croatian: Glavni objektivni kriterij djelotvornosti bio je kapacitet vježbanja prijavljen u smislu vremena potrebnog da nastupi angina, ukupnog trajanja vježbanja i vremena potrebnog do depresije 1 mm ST segmenta.
English: Efficacy in the clinical programme was based on the measurement of anginal attack rates on exercise tests.
Croatian: Djelotvornost u kliničkom programu temeljena je na mjerenju broja antianginalnih napadaja tijekom testova vježbanja.
English: The CHMP therefore requested the MAHs to include a statement mentioning that nicorandil should be used with caution in such a population.
Croatian: Stoga je CHMP zatražio od nositelja odobrenja da uključe izjavu u kojoj se spominje da se nikorandil treba koristiti oprezno u takvoj populaciji.
English: Event counts were presented by the different daily doses in the previous Periodic Safety Update Report for nicorandil (reporting period 01-March-2010 to 28- February
Croatian: Brojevi događaja dostavljeni su prema različitim dnevnim dozama u prethodnom Periodičnom ažuriranom izvještaju o sigurnoj primjeni za nikorandil (razdoblje podnošenja izvještaja od 01. ožujka 2010. do 28. veljače 2013.).
English: This risk of ulcerations was mainly established based on safety reports received in association with the marketed product.
Croatian: Opisani rizik od ulceracija bio je uglavnom utvrđen na temelju izvještaja o sigurnoj primjeni zaprimljenih u vezi s proizvodom stavljenim u promet.
English: Nicorandil 20 mg was more effective in reducing resting systolic blood pressure (SBP) and increasing total exercise work load (55% vs 94%).
Croatian: Nikorandil 20 mg bio je djelotvorniji u smanjivanju sistoličkog krvnog tlaka u mirovanju (SBP) i povećavanju ukupnog radnog opterećenja tijekom vježbanja (55 % u odnosu na 94 %).
English: Hereafter it is summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Croatian: U nastavku teksta ukratko su navedene točke koje su raspravljane radi usklađivanja različitih dijelova SmPC-a.
English: The effect on venous capacitance was less than with nitrates.
Croatian: Učinak na kapacitivnost vena bio je manji nego u slučaju nitrata.
English: They are also available in the EU under other trade names: Adancor, Angicor and Nicorandil Zentiva.
Croatian: Oba su lijeka također dostupna u EU-u pod sljedećim trgovačkim nazivima: Adancor, Angicor i Nicorandil Zentiva.
English: Pre-referral meetings between the EMA and marketing authorisation holders (MAHs) were held.
Croatian: Održani su sastanci prije upućivanja između EMA-e i nositelja odobrenja za stavljanje lijeka u promet (nositelja odobrenja).
English: It is more likely to occur in patients with specific risk factors such as those receiving potassium supplements or potassium-sparing diuretics.
Croatian: Vjerojatnije je da će nastupiti u bolesnika sa specifičnim faktorima rizika poput onih koji primaju dodatke natrija ili dijuretike koji štede natrij.
English: According to the risk management plan assessed separately in a worksharing procedure9, a DHPC emphasising the risk of ulceration is already planned to be disseminated in all member states.
Croatian: Sukladno planu upravljanja rizikom koji je ocijenjen zasebno u postupku podjele rada9,, već je planirana distribucija DHPC-a u kojem se naglašava rizik od ulceracije u svim državama članicama.
English: The CHMP considers that the DHPC should also inform about the main modifications of the product information following the outcome of this harmonisation procedure; this should be decided at national level by each competent authority, if deemed necessary.
Croatian: CHMP je zaključio da DHPC treba također sadržavati obavijest o glavnim izmjenama informacija o lijeku nakon ishoda ovog postupka usklađivanja; o tome trebaju odlučiti nadležna tijela na nacionalnoj razini, ako se smatra neophodnim.
English: As specified in the current ICH guidance on ”Ethnic factors in the acceptability of foreign clinical data” dated 1998 evaluation of the pharmacokinetics and pharmacodynamics and their comparability in the three major racial groups most relevant to the ICH regions (Asian, Black, Caucasian) is critical to the registration of medicines in the ICH regions.
Croatian: Kako je specificirano u aktualnim smjernicama ICH-a o „etničkim čimbenicima prihvatljivosti inozemnih kliničkih podataka" izdanim 1998., ocjena farmakokinetike i farmakodinamike te njihova usporedivost u tri glavne rasne skupine najvažnija je za područja ICH-a (azijati, crnci, bijelci) odlučujuća je za registraciju lijekova u područjima ICH-a.
English: • the summary of products characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee;
Croatian: • su sažetak opisa svojstava lijeka, označivanje i uputa o lijeku koje je predložio nositelj odobrenja ocijenjeni na temelju dostavljene dokumentacije i znanstvene rasprave unutar Odbora;
English: Furthermore, the reduction of enddiastolic pressure and wall tension decreases the extravascular component of vascular resistance.
Croatian: Nadalje, smanjenje završnog dijastoličkog tlaka i napetosti stijenke smanjuje ekstravaskularnu komponentu vaskularnog otpora.
English: For consistency the MAHs should provide a common DHPC, if required by the national authority.
Croatian: Za potrebe dosljednosti, nositelji odobrenja trebaju dostaviti zajednički DHPC, ako to zatraži nacionalno tijelo.
English: Nicorandil may induce hyperkalaemia.
Croatian: Nikorandil može inducirati hiperkalemiju.
English: Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
Croatian: Oprez se savjetuje pri primjeni nikorandila u kombinaciji s drugim lijekovima koji mogu povećati koncentracije natrija (vidjeti odjeljke 4.4. i 4.8.).
English: This section of the SmPC has been harmonised to include the relevant available information.
Croatian: Ovaj odjeljak SmPC-a usklađen je uključivanjem relevantnih dostupnih informacija.
English: This section was clarified by indicating that the tablets should not be removed from the blister strip until intake (with cross references to the sections 4.4 and 6.4) as they are affected by humidity and mentioning of the absence of effect with food intake.
Croatian: Ovaj odjeljak je pojašnjen napomenom da se tabele ne smiju ukloniti iz blister traka sve do unosa (s unakrsnom referencom na odjeljke 4.4. i 6.4.) budući da na njih utječe vlaga, te navođenjem izostanka djelovanja s unosom hrane.
English: The anti-ischemic activity of nicorandil seems to be comparable to that of diltiazem, nifedipine, nitrates and propranolol.
Croatian: Čini se da je antiishemijsko djelovanje nikorandila usporedivo s onim diltiazema, nifedipina, nitrata i propranolola.
English: No dose recommendation is proposed for prevention of CHD events and the product information was adapted accordingly.
Croatian: Za prevenciju CHD događaja nema prijedloga preporučene doze, a informacija o lijeku prilagođena je na odgovarajući način.
English: In addition one of the following was also in force: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55mm, age ≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease.
Croatian: Nadalje, postojalo je također nešto od sljedećeg: hipertrofija lijevog ventrikula na EKG-u, frakcija odbacivanja lijevog ventrikula ≤45% ili završna dijastolička dimenzija od >55mm, starost ≥65, dijabetes, hipertenzija, periferna vaskularna bolest ili cerebrovaskularna bolest.
English: However, the important identified risk of ulceration (gastrointestinal (GI), skin, mucosal, genital and ocular) and perforations, fistula and abscesses has been recognized and monitored since 1997.
Croatian: No, prepoznata je važnost utvrđenog rizika od ulceracije (gastrointestinalne, kožne, na sluznici, genitalne i okularne) i perforacije, fistula i apcesa i oni se prate od 1997.
English: Others studies did not enrol patients with stable angina and thus are not relevant to evaluate its efficacy for the treatment of angina.
Croatian: Druga ispitivanja nisu obuhvatila bolesnike sa stabilnom anginom, te stoga nisu relevantna za ocjenu njegove djelotvornosti u liječenju angine.
English: The half-life of 6 to 8 hours permits twice daily dosage, and total-daily dosages between 10 and 40 mg have been effective in patients with chronic stable angina.
Croatian: Poluvijek od 6 do 8 sati dopušta doziranje dva puta dnevno, a ukupne dnevne doze između 10 i 40 mg djelovale su u bolesnika s kroničnom stabilnom anginom.
English: In addition, two hemodynamic studies (SG 002 and EMD 034) studied hemodynamic effects of single oral doses of nicorandil (40 mg, 60 mg, 80 mg) in a total of 21 pharmacodynamically evaluable patients with severe heart failure (N.Y.H.A.
Croatian: Nadalje, dva hemodinamska ispitivanja (SG 002 i EMD 034) ispitala su hemodinamska djelovanja jedne oralne doze nikorandila (40 mg, 60 mg, 80 mg) u ukupno 21 farmakodinamički ocjenjiva bolesnika s ozbiljnim zatajenjem srca (N.Y.H.A. klasa III. i IV.).
English: • If CCB monotherapy or combination therapy (CCB with beta-blocker) is unsuccessful, substitute the CCB with a long-acting nitrate or nicorandil.
Croatian: • Ako monoterapija CCB-om ili kombinacijska terapija (CCB-om s beta blokerima) nije uspješna, zamijenite CCB dugodjelujućim nitratom ili nikorandilom.
English: However, the primary endpoint is weak as it includes the criterion “reduction of hospitalisation” which is subjective criteria for cardiovascular prevention in patient with coronary heart disease (CHD) patients with angina.
Croatian: No, primarna završna točka je slaba budući da uključuje kriterij "smanjenja hospitalizacije" koji je subjektivan kriterij za kardiovaskularnu prevenciju u bolesnika s koronarnom bolesti srca (CHD-om) s anginom.
English: It appears that most cases, beside GI ulcerations, were reported at a higher dose than 20 mg/day.
Croatian: Čini se da je većina slučajeva, uz gastrointestinalne ulceracije, prijavljena pri dozi većoj od 20 mg na dan.
English: Prevention of cardiovascular events in patients with stable coronary heart disease (CHD)
Croatian: Prevencija kardiovaskularnih događaja u bolesnika sa stabilnom koronarnom bolesti srca (CHD)
English: The SG 002 study was an open label non-controlled study and EMD 034 study was a double-blind randomized cross over study.
Croatian: Ispitivanje SG 002 bilo je otvoreno nekontrolirano ispitivanje, a EMD 034 ispitivanje bilo je dvostruko slijepo randomizirano prijelazno ispitivanje.
English: Furthermore Japanese studies with double blind randomised controlled design have used higher single doses, i.e., 10 or 30 mg nicorandil.
Croatian: Nadalje, u japanskim ispitivanjima s dvostrukim slijepim randomiziranim kontroliranim dizajnom koristile su se veće pojedinačne doze, odnosno 10 ili 30 mg nikorandila.
English: Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (GMP).
Croatian: Zbog svog dijela nitrata, nikorandil otpušta također vaskularne glatke mišiće, posebice u venskom sustavu putem povećanja intrastaničnog cikličkog guanozin monofosfata (GMP-a).