FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency noted that the immune system's response to Synflorix was comparable to its response to another vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
Croatian: Europska agencija za lijekove napomenula je da je odgovor imunosnog sustava na lijek Synflorix bio usporediv odgovoru komparatorskog cjepiva, koje je također odobreno za zaštitu djece od bakterije S. pneumoniae na razini EU-a.
English: It is recommended that a booster dose is given at least 2 months after the second dose, during the child's second year of life.
Croatian: Preporuča se davanje treće doze kao doze docjepljivanja najmanje dva mjeseca nakon druge doze, tijekom druge godine života djeteta.
English: The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months.
Croatian: Djeca su u ovom ispitivanju primila Synflorix ili komparatorsko cjepivo koje nije bilo djelotvorno protiv bakterije S. pneumoniae te su praćena prosječno 30 mjeseci.
English: Why is Synflorix approved?
Croatian: Zašto je lijek Synflorix odobren?
English: For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Synflorix bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Based on a comparison of the immune response of Synflorix with the investigational vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.
Croatian: Na temelju usporedbe imunološkog odgovora lijeka Synflorix s ispitivanim cjepivom korištenim u ispitivanju, očekuje se da će Synflorix pružiti sličnu zaštitu od akutne upale srednjeg uha uzrokovane bakterijom S. pneumoniae.
English: Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae.
Croatian: Synflorix je ocijenjen u velikom ispitivanju koje je obuhvatilo više od 30 000 dojenčadi u dobi mlađoj od 7 mjeseci koji su primili Synflorix ili komparatorsko cjepivo koje nije bilo djelotvorno protiv bakterije S. pneumoniae.
English: Another main study looked at whether Synflorix prevents acute otitis media.
Croatian: Drugo glavno ispitivanje provedeno je s ciljem utvrđivanja može li cjepivo Synflorix spriječiti akutni otitis media (akutnu upalu srednjeg uha).
English: The study compared the immunogenicity of Synflorix with that of another vaccine that is authorised in the EU to protect children against S. pneumoniae infection, and which contains seven of the ten polysaccharides in Synflorix.
Croatian: U ispitivanju je provedena usporedba imunogenosti lijeka Synflorix s imunogenosti drugog cjepiva odobrenog u EU-u za zaštitu djece od infekcije uzrokovane bakterijom S. pneumoniae, koje sadrži sedam od deset polisaharida koji se nalaze u sastavu lijeka Synflorix.
English: • Premature babies (born between 27 and 36 weeks gestation) are given a course of three doses with an interval of at least one month between each dose, with the first dose given at 2 months of age.
Croatian: • Prijevremeno rođena djeca (rođena između 27. i 36. tjedna gestacije) primaju tri doze u intervalima od najmanje mjesec dana između svake doze, pri čemu se prva doza daje u dobi od dva mjeseca.
English: What benefits of Synflorix have been shown in studies?
Croatian: Koje su koristi lijeka Synflorix dokazane u ispitivanjima?
English: How does Synflorix work?
Croatian: Kako djeluje Synflorix?
English: How is Synflorix used?
Croatian: Kako se Synflorix koristi?
English: • Children aged between 12 months and 5 years are given a course of two doses with an interval of at least 2 months between them.
Croatian: • Djeca u dobi između 12 mjeseci i pet godina primaju dvije doze u intervalima od najmanje dva mjeseca između doza.
English: • Infants aged between 6 weeks and 6 months are given a course of three doses with an interval of at least one month between each dose, with the first dose usually given at 2 months of age.
Croatian: • Dojenčad u dobi između šest tjedana i šest mjeseci prima tri doze u intervalu od najmanje mjesec dana između svake doze, pri čemu se prva doza najčešće daje u dobi od dva mjeseca.
English: A fourth (‘booster') dose is recommended at least 6 months after the third dose, preferably when the child is between 12 and 15 months of age.
Croatian: Preporuča se davanje četvrte doze kao doze docjepljivanja najmanje šest mjeseci nakon treće doze, po mogućnosti u dobi djeteta između 12 i 15 mjeseci.
English: It is recommended that a booster dose be given at least 6 months after the third dose.
Croatian: Preporuča se davanje četvrte doze kao doze docjepljivanja najmanje šest mjeseci nakon treće doze.
English: For the full list of side effects with Synflorix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Synflorix potražite u uputi o lijeku.
English: • Infants aged between 7 and 11 months are given a course of two doses with an interval of at least one month between them.
Croatian: • Dojenčad u dobi između sedam i 11 mjeseci prima dvije doze u intervalu od najmanje mjesec dana između doza.
English: Determination of specific conditions
Croatian: Određivanje posebnih uvjeta
English: However, these effects have only been observed during early treatment.
Croatian: Međutim, ti su učinci opaženi samo tijekom ranog liječenja.
English: The margin of safety for the target animals at the dose stated above is relatively small but acceptable.
Croatian: Granica sigurnosti za ciljne životinje pri gore navedenoj dozi relativno je mala, ali prihvatljiva.
English: No synergy was demonstrated and the potential antagonism was not tested.
Croatian: Nije se dokazala sinergija, a potencijalni antagonizam nije bio testiran.
English: CVMP overall conclusions after re-examination
Croatian: Ukupni zaključci CVMP-a nakon ponovne procjene
English: This linear extrapolation is questionable, since the processes involved are not linear.
Croatian: Ta je linearna ekstrapolacija upitna, budući da uključeni procesi nisu linearni.
English: Antimicrobial resistance
Croatian: Antimikrobna rezistencija
English: The margin of safety can be considered as lower than 3 times the recommended dose.
Croatian: Granicom sigurnosti može se smatrati doza koja je za više od 3 puta niža od preporučene.
English: Risks of (co-)selection of resistant bacteria
Croatian: Rizici od (ko)selekcije rezistentne bakterije
English: The fact that LAMRSA CC398 has currently a low impact on human populations does not negate the public health concerns.
Croatian: Činjenica da LA-MRSA CC398 trenutačno ima mali utjecaj na ljudsku populaciju ne negira zabrinutost za opće javno zdravlje.
English: Every active substance in a fixed combination should be indicated for use at the moment of treatment and administered in the correct dose.'
Croatian: Svaka djelatna tvar u fiksnoj kombinaciji mora biti indicirana za upotrebu u trenutku liječenja i primijenjena u točnoj dozi.”
English: The CVMP has calculated PECsoils when taking into account the two approaches noted above, separately.
Croatian: CVMP je izračunao PECtla kada se uzmu u obzir dva gore spomenuta pristupa odvojeno.
English: Vol. 23, no. 6, pp. 949-958, 1994.
Croatian: 6, pp. 949-958, 1994.
English: Reduction of global use of antibiotics
Croatian: Smanjenje opće upotrebe antibiotika
English: The administration period was 14 or 21 days immediately after weaning.
Croatian: Razdoblje primjene bilo je 14 ili 21 dan neposredno nakon prestanka sisanja.
English: However, more studies are required to fill remaining data gaps in this area and to confirm these effects.
Croatian: Ipak, potrebno je više ispitivanja kako bi se popunile praznine u tom području i potvrdili ti učinci.
English: It appears that one-week of administration is not sufficiently efficacious and a duration longer than 14 days is not justified either.
Croatian: Čini se da primjena od jednog tjedna nije dovoljno djelotvorna, a ni trajanje dulje od 14 dana također nije opravdano.
English: In sandy soils, PNECs were exceeded in 66% of all cases.
Croatian: U pjeskovitim tlima, PNEC-ovi su bili premašeni u 66 % svih slučajeva.
English: This restricts the focus to the findings of Poulsen (1995), and Holm (1990)27.
Croatian: To ograničava područje nalaza koje navode Poulsen (1995.), i Holm (1990.)27.
English: The bioavailable fraction of zinc in soils is small (<1%).
Croatian: Bioraspoloživa frakcija cinka u tlu je mala (<1 %).
English: In the absence of relevant diagnostic data it was not possible to identify the pathogens involved.
Croatian: U odsutnosti relevantnih dijagnostičkih podataka nije bilo moguće identificirati uključene patogene.
English: The Committee also considers that variability in soil characteristics (i.e. soil types) causes variation in zinc fate and behaviour.
Croatian: Odbor također smatra da varijabilnost u karakteristikama tla (tj. vrste tla) uzrokuje varijaciju u sudbini i ponašanju cinka.
English: Acta Agric. Scand.
Croatian: Acta Agric.
English: Duration of the protective effect The duration of the protective effect was investigated only in one study (Johansen et al. (2007), in which the follow-up period was approximately 41 days.
Croatian: Trajanje zaštitnog učinka Trajanje zaštitnog učinka istraživano je samo u jednom ispitivanju (Johansen et al. (2007.) u kojem je razdoblje praćenja bilo približno 41 dan.
English: The marketing authorisation holders' grounds for the re-examination were submitted before 6 February
Croatian: Razlozi nositelja odobrenja za stavljanje u promet za ponovnu procjenu podneseni su prije 6. veljače
English: However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface waters given that bioavailability considerations were harder to take into account.
Croatian: Međutim, uočeno je da je razina nesigurnosti u karakterizaciji rizika za sediment znatno viša nego za tlo ili površinske vode, s obzirom na to da je pitanje bioraspoloživosti bilo teže uzeti u obzir.
English: The specific action (on some pathogens) or unspecific action (local action on the digestive tract) is thus not yet fully elucidated.
Croatian: Specifično djelovanje (na neke patogene) ili nespecifično djelovanje (lokalno djelovanje na probavni sustav) stoga još nije potpuno razjašnjeno.
English: At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Croatian: Trenutačno je nejasno što predstavlja razumno najgori scenarij izloženosti za stopu primjene gnojiva.
English: It should be noted that the CVMP is a scientific Committee and that while it operates within the framework of the Union legislation regulating veterinary medicinal products, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Croatian: Valja zamijetiti da je CVMP znanstveni odbor te da s obzirom na to da djeluje unutar zakonodavstva Unije koja regulira veterinarsko-medicinske proizvode, ne može raspravljati o vrijednostima proceduralnih i pravnih aspekata administrativnih postupaka utemeljenih na zakonodavstvu.
English: Additionally the marketing authorisation holders consider that an ad hoc expert group together EFSA could help to address the environmental risks from a broader point of view.
Croatian: Osim toga, nositelji odobrenja za stavljanje u promet smatraju da bi jedna ad hoc ekspertna skupina zajedno s EFSA-om mogla pomoći u rješavanju rizika za okoliš iz šire perspektive.
English: Shorter or longer treatment durations were considered not supported by sufficient data.
Croatian: Smatra se da kraća ili dulja trajanja liječenja nisu potkrijepljena s dovoljno podataka.
English: Diarrhoea was observed only during the first two weeks after weaning.
Croatian: Proljev je opažen samo tijekom prva dva tjedna nakon prestanka sisanja.
English: 101, Ap. 47 sector 6, Bucharest Romania
Croatian: 2 Intrarea Vagonetului, Bl. 101, Ap. 47 sector 6, Bucharest Romania
English: Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona Spain
Croatian: Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona
English: This is not only applicable on farms where dilution of manure is not possible, but also for farms that are able to dilute manure.
Croatian: To nije primjenjivo samo za farme na kojima razrjeđivanje gnojiva nije moguće, nego i za farme na kojima se gnojivo može razrjeđivati.
English: • The aetiology of the observed diarrhoea was not established in most of studies submitted.
Croatian: • Etiologija opaženog proljeva nije bila utvrđena u većini dostavljenih ispitivanja.
English: Therefore, in the absence of more data, it is not possible to further characterise the risk posed to both public and animal health.
Croatian: Stoga, u nedostatku većeg broja podataka, nije moguće daljnje karakterizirati rizik koji predstavlja za zdravlje ljudi i životinja.
English: The marketing authorisation holders informed the EMA that they had not received the official notification of the inclusion of their products (Pigzin and ZincoTec) in this Article 35 referral procedure.
Croatian: Nositelji odobrenja za stavljanje u promet obavijestili su EMA-u da nisu primili službenu obavijest o uključivanju njihovih proizvoda (Pigzin i ZincoTec) u ovaj arbitražni postupak prema članku 35.
English: The efficacy in piglets weaned later is not documented neither in less intensive breeding conditions.
Croatian: Djelotvornost u prasadi odviknute od sisanja kasnije nije dokumentirana ni u manje intenzivnim uvjetima uzgoja.
English: To conclude on this point, the marketing authorisation holders did not provide any additional data that will change the original CVMP conclusion with regard to efficacy.
Croatian: Kao zaključak u tom smislu, nositelji odobrenja za stavljanje u promet nisu dostavili nikakve dodatne podatke koji bi promijenio prvobitni zaključak CVMP-a u pogledu djelotvornosti.
English: Contamination of soil and water systems by heavy metals, such as zinc, is currently difficult to remedy with existing technologies.
Croatian: Kontaminaciju sustava tla i vode teškim metalima, kao što je cink, trenutačno je teško ukloniti postojećim tehnologijama.
English: Therefore the information submitted by those marketing authorisation holders at the stage of reexamination was taken into consideration in order to safeguard their rights.
Croatian: Stoga su podatci koje su dostavili ti nositelji odobrenja za stavljanje u promet uzeti u obzir u fazi ponovne procjene, kako bi se zaštitila njihova prava.
English: 1998 - link
Croatian: FEDNA. 1998 - link
English: Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Croatian: Posljedično, utvrđen je čimbenik „starenja” 3, a koristi se za izračun PNEC-ova specifičnih za lokaciju.
English: Colistin alone is sufficiently effective for the metaphylaxis and treatment of gastrointestinal infections caused by non-invasive E. coli (see procedure EMEA/V/A/106)10.
Croatian: Kolistin primjenjivan sam dovoljno je učinkovit za metafilaksu i liječenje gastrointestinalnih infekcija prouzročenih neinvazivnom E. coli (vidjeti postupak EMEA/V/A/106)10.
English: Fixed combination products cannot be justified for reasons of compensating inadequate diagnosis.
Croatian: Lijekovi s fiksnom kombinacijom ne mogu se opravdati kako bi se kompenzirala neodgovarajuća dijagnoza.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene, podnositelja zahtjeva za odobrenje i nositelja odobrenja za stavljanje u promet u državama članicama
English: However, the importance of these findings to animal and public health remains unclear due to gaps in the available knowledge.
Croatian: Međutim, važnost tih nalaza za zdravlje životinja i ljudi ostaje nerazjašnjeno, jer su dostupna saznanja nepotpuna.
English: It is still difficult at present time to define the situations in which the zinc oxide containing products will be beneficial or not beneficial.
Croatian: Još uvijek je zasad teško definirati situacije u kojima će proizvodi koji sadrže cinkov oksid biti ili neće biti korisni.
English: No dose determination study or justification of the selected dose is given, neither confirmatory data supporting an optimal duration of administration of 14 days.
Croatian: Nije prikazano ni jedno ispitivanje s određivanjem doze ili opravdanjem izabrane doze, ni s podatcima koji bi potvrdili optimalno trajanje primjene od 14 dana.
English: 664 23 Čebín
Croatian: 664 23 Čebín Czech Republic
English: Significant reduction of diarrhoea (p<0.02) was observed in animals treated with high zinc diets, although significant differences were not observed between both treatment periods.
Croatian: Značajno smanjenje proljeva (p<0,02) opaženo je u životinja liječenih prehranom s velikom količinom cinka, iako između oba razdoblja liječenja nisu bile opažene značajne razlike.
English: 08028 Barcelona Spain
Croatian: 08028 Barcelona
English: It has to be noted that the PNECs used in this study is adapted to Danish situations and may be lower (more worst-case) in other parts of Europe with different soil types.
Croatian: Valja napomenuti da su PNEC-ovi upotrijebljeni u ovom ispitivanju prilagođeni situaciji u Danskoj i da u drugim dijelovima Europe oni mogu biti niži (teži slučaj) zbog drugačijih tipova tla.
English: And when using the bioavailability correction, then:
Croatian: Kada se koristi pristup korekcije bioraspoloživosti:
English: DSM Nutritional Products (UK) Ltd. and Provimi Ltd.
Croatian: DSM Nutritional Products (UK) Ltd. i Provimi Ltd.
English: D-48308 Senden-Bösensell Germany aniMedica Enteroxid N Zinc oxide Colistin sulfate
Croatian: D-48308 Senden-Bösensell Germany aniMedica Enteroxid N Cinkov oksid Kolistin sulfat
English: There is also the possibility for manure containing high concentrations of zinc oxide being applied to susceptible soil types.
Croatian: Postoji također mogućnost da gnojivo koje sadrži visoke koncentracije cinkova oksida bude primijenjeno na osjetljive tipove tla.
English: This duration of treatment differs from all other products containing zinc oxide (i.e. 14 consecutive days).
Croatian: Ovo trajanje liječenja razlikuje se od svih ostalih proizvoda koji sadrže cinkov oksid (tj. 14 uzastopnih dana).
English: The information provided indicates that there are errors and these are more pronounced for the sediment compartment and at low loadings.
Croatian: Dostavljene informacije ukazuju da postoje pogreške, a one su izraženije za sediment te kod malih opterećenja.
English: However, after the cessation of zinc oxide supplementation at day 14, acids were added in the feed and consequently the effects of each component could not be evaluated during the follow-up period.
Croatian: Međutim, nakon prestanka dodavanja cinkova oksida 14. dana, u hranu su dodane kiseline, pa se posljedično tomu, učinci svake komponente nisu mogli procijeniti tijekom razdoblja praćenja.
English: Some of the grounds for re-examination raised by the marketing authorisation holders related to considerations of a procedural and legal nature.
Croatian: Neki od razloga za ponovnu procjenu, koje su potaknuli nositelji odobrenja za stavljanje u promet, odnosili su se na pitanja proceduralne i pravne prirode.
English: As zinc is a metal, general assumptions that are usually made about degradation are not applicable; therefore, once critical concentrations are exceeded, the risk will be difficult to remedy.
Croatian: Budući da je cink metal, uobičajene opće pretpostavke o razlaganju nisu primjenjive; stoga, kad se jednom kritična koncentracija premaši, rizik će biti teško ukloniti.
English: Given that the VICH and CVMP guidelines16,17,18 on the Phase II environmental risk assessment of veterinary medicinal products are not primarily developed for inorganic molecules, many of the assumptions and exposure models described in the guidelines are unsuitable for a substance such as zinc.
Croatian: Budući da smjernice VICH i CVMP 16,17,18 o procjeni rizika za okoliš faze II za veterinarsko-medicinske proizvode nisu razvijene prvenstveno za anorganske molekule, mnoge pretpostavke i modeli izloženosti opisani u smjernicama nisu prikladne za tvar kao što je cink.
English: It has to be noted that bioavailability was not considered but the PNECs used in this study were higher (less worst-case) than those reported in the EU RAR and that the annual application of manure was based on 140 kg/N/ha/year which is less worst-case than the European limit for sensitive soils of 170 kg/N/ha/year.
Croatian: Treba napomenuti da se bioraspoloživost nije razmatrala, ali su vrijednosti PNEC upotrijebljene u ovom ispitivanju bile više (manje loš scenarij) od onih navedenih u EU RAR-u, a godišnja primjena gnojiva temeljila se na 140 kg/N/ha godišnje što je slučaj manje loš nego europsko ograničenje za osjetljiva tla od 170 kg/N/ha godišnje.
English: AVS is produced by bacteria in anoxic sediments.
Croatian: AVS proizvodi bakterija u anoksičnim sedimentima.
English: Hollis G. Use of Growth Promotants in Swine Feeding Programs.
Croatian: Use of Growth Promotants in Swine Feeding Programs.
English: Also, according to Mateos et al., 19987 zinc supplement should not be prolonged further than the weaning period.
Croatian: Također, prema Mateosu et al., 1998.7 cink kao dodatak ne smije se davati dulje od razdoblja odvikavanja od sisanja.
English: The marketing authorisation holder also chose to include bioavailability aspects in soil by calculating PNECbioavailable for 19 European soils by means of the Arche Soil PNEC calculator.
Croatian: Nositelj odobrenja za stavljanje u promet također je odlučio uključiti aspekte bioraspoloživosti u tlu izračunom PNECbioraspoloživi za 19 europskih tla pomoću kalkulatora Arche Soil PNEC.
English: Risk management or mitigation measures
Croatian: Mjere za upravljanje rizikom ili za smanjivanje rizika
English: For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Croatian: Za sedimentne sustave, budući da je izračunata predviđena koncentracija u okolišu za sediment (PEC) (EU RAR, 2010,), utvrđene su značajne promjene u načinu na koji se određuje koncentracija u sedimentu.
English: The marketing authorisation holder Huvepharma, however, did provide robust summaries of the additional peer-reviewed studies used in the effect assessment, that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Croatian: Međutim, nositelj odobrenja za stavljanje u promet, tvrtka Huvepharma, dostavila je detaljne sažetke dodatnih recenziranih ispitivanja upotrijebljenih u procjeni učinaka, koji nisu bili uključeni u EU RAR (2010.), uključujući zaključak o pouzdanosti i valjanosti svakog ispitivanja.
English: Considering that the recommended duration of colistin administration in pigs is seven days the concomitant administration of zinc oxide included in the product will also be for seven days.
Croatian: Uzimajući u obzir da je preporučeno trajanje primjene kolistina u svinja sedam dana, istovremena primjena cinkova oksida uključenog u proizvod trajat će također sedam dana.
English: To manage the risks and determine adequate risk mitigation measures, the marketing authorisation holders suggest adding a number of statements on the product information regarding the mixing and/or spreading of manure to land.
Croatian: Kako bi se upravljalo rizicima i odredile odgovarajuće mjere za smanjenje rizika, nositelji odobrenja za stavljanje u promet predlažu da se u informacije o proizvodu doda nekoliko rečenica o miješanju ili prostiranju gnojiva na tlo.