FrancophonIA/ELRC3.0 huggingface dataset:
English: Solutions in milk and reconstituted milk replacer should be prepared immediately before use.
Croatian: Otopine u mlijeku ili rekonstituiranom zamjenskom mlijeku potrebno je pripremiti neposredno prije upotrebe.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan tekućeg mjeseca.
English: In all trials, the animals were examined to confirm the diagnosis prior of to the initiation of treatment.
Croatian: U svim ispitivanjima životinje su pregledane radi potvrđivanja dijagnoze prije početka liječenja.
English: Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.
Croatian: Pri svakoj primjeni u iznimnim okolnostima s obzirom na zdravlje i dobrobiti životinja potrebno je imati u vidu posljedice za javno zdravlje.
English: Eli Lilly Italia SpA Via A. Gramsci,
Croatian: Eli Lilly Italia SpA Via A.
English: Following the CVMP opinion of 5 October 2017 on this referral procedure, the marketing authorisation holders requested a re-examination of the CVMP opinion.
Croatian: Nakon što je CVMP 5. listopada 2017. donio mišljenje o ovom postupku upućivanja, nositelji odobrenja zatražili su ponovnu procjenu mišljenja CVMP-a.
English: Whenever possible, susceptibility testing and serotyping of bacterial isolates were carried out.
Croatian: Kad god je bilo moguće, provedena su ispitivanja osjetljivosti i serotipizacija bakterijskih izolata.
English: Germany Lilly Deutschland GmbH
Croatian: Njemačka Lilly Deutschland GmbH
English: The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Croatian: Potencijalni rizik od razvoja otpornosti, koji može utjecati na djelotvornost lijeka te ukupno zdravlje životinja i ljudi, ograničen je:
English: National control programmes should be followed where available.‘
Croatian: Potrebno je pridržavati se nacionalnih kontrolnih programa ako postoje.”
English: Furthermore, the European Commission shall adopt delegated acts concerning amendments to the list referred.
Croatian: Nadalje, Europska komisija donosi delegirane akte radi izmjene tog popisa.
English: The amount of product (mg) to be incorporated per 1 l of water or milk should be established according to the following formula:
Croatian: Točnu količinu proizvoda (mg) za primjenu u litri pitke vode ili mlijeku treba izračunati prema sljedećoj formuli:
English: Surviving calves in the untreated control group failed to gain weight in the twelve days period whereas the survivors in the treated groups showed significant increases in average daily weight gain.
Croatian: Preživjela telad u neliječenoj kontrolnoj skupini nije dobila na težini u razdoblju od 12 dana, dok je u preživjelih životinja u liječenim skupinama došlo do znatnog porasta prosječnog dnevnog povećanja težine.
English: Possible intoxications can be recognised by the following symptoms: soft faeces, diarrhoea, vomiting (weight loss, anorexia, and similar), renal impairment and effects on the central nervous system (reduced activity, loss of reflexes, convulsions, etc.).
Croatian: Moguća trovanja mogu se prepoznati po sljedećim simptomima: meki izmet, proljev, povraćanje (gubitak težine, anoreksija i slično), oštećenje bubrega i utjecaj na središnji živčani sustav (smanjena aktivnost, gubitak refleksa, grčevi itd.).
English: IU 2 x 106 IU
Croatian: 2 x 106 IU
English: In case of skin contact, wash thoroughly with soap and water.
Croatian: U slučaju kontakta s kožom područje temeljito isperite sapunom i vodom.
English: Treatment should be based on prior confirmation of the Salmonella serovars involved or at least the availability of epidemiological data confirming the presence of this serovar.
Croatian: Liječenje treba temeljiti na prethodnoj potvrdi postojanja serovara Salmonella ili barem na dostupnosti epidemioloških podataka koji potvrđuju prisutnost tog serovara.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Croatian: Službena, nacionalna i regionalna antimikrobna pravila potrebno je uzeti u obzir prilikom primjene VMP.
English: However, no storage conditions are provided for these stability studies and it is therefore not clear if they have been conducted at 25 °C/60% RH in accordance with the requirements of the ‘Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1)'15.
Croatian: Međutim, za te studije o stabilnosti nisu dostavljeni podatci o uvjetima čuvanja i stoga nije jasno jesu li one provedene pri 25 °C / 60% RH u skladu sa zahtjevima iz dokumenta „Smjernice o ispitivanju stabilnosti postojećih djelatnih tvari i povezanih završnih proizvoda (EMEA/CVMP/846/99-Rev.1)”15.
English: This product may cause irritation or sensitisation after skin or eye contact or inhalation.
Croatian: Ovaj proizvod može izazvati iritaciju ili preosjetljivost u dodiru s kožom ili očima ili prilikom udisanja.
English: On 24 June 2016 Spain submitted a referral notification in accordance with Article 34 of Directive 2001/82/EC to the European Medicines Agency (the Agency) for Girolan and its associated name Apralan.
Croatian: Španjolska je 24. lipnja 2016. podnijela Europskoj agenciji za lijekove (Agencija) obavijest o upućivanju u skladu s člankom 34. Direktive 2001/82/EZ za Girolan i njegovo pridruženo ime Apralan.
English: With regard to Salmonella, a series of twenty-seven further experiments were conducted in calves, 15 of which therapeutic and 12 prophylactic.
Croatian: U pogledu bakterije Salmonella proveden je niz od 27 dodatnih pokusa na teladi, 15 terapeutskih i 12 profilaktičkih.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the veterinary medicinal product Girolan.
Croatian: Ova procjena koristi i rizika provedena je u kontekstu članka 34.Direktive 2001/82/EZ koja u sadašnjem postupku ima svrhu postići usklađenost uvjeta odobrenja za VMP Girolan unutar EU-a.
English: To be completed nationally.
Croatian: Ispuniti na nacionalnoj razini.
English: In this respect, it is to be noted that colibacillosis in chickens is essentially a systemic infection, involving a variety of organs, and its main entry route is the respiratory system.
Croatian: U tom je pogledu potrebno napomenuti da je kolibaciloza u pilića u biti sustavna infekcija koja zahvaća razne organe i čiji je glavni put ulaza dišni sustav.
English: Thus the data provided includes a sufficient number of batches in each of the container types for the full duration of the proposed shelf life.
Croatian: Stoga dostavljeni podatci obuhvaćaju dovoljan broj serija u svakoj od vrsta spremnika za ukupno trajanje predloženog roka valjanosti.
English: A pivotal recently-conducted clinical field trial was provided.
Croatian: Dostavljeno je glavno kliničko terensko ispitivanje koje je nedavno provedeno.
English: National control programmes should be followed where available.
Croatian: Nacionalne programe kontrole potrebno je slijediti tamo gdje je to moguće.
English: Elanco Valquímica, S.A.
Croatian: Španjolska Elanco Valquímica, S.A.
English: These were conducted in Greece, Italy and Jordan, and involved 27-29 days old broilers from commercial farms with natural E. coli infection.
Croatian: Ta su ispitivanja provedena u Grčkoj, Italiji i Jordanu te su obuhvaćala tovne piliće s komercijalnih farmi u dobi od 27 - 29 dana s prirodnom infekcijom bakterijom E. coli.
English: Whilst it is not clear if the stability data was generated under controlled conditions or not, given the lack of significant change in active substance content and the fact that the product historically had a shelf life of 3 years, the data is considered adequate to support a 2 year shelf life for the finished product as proposed by the MAH.
Croatian: Iako nije jasno jesu li podatci o stabilnosti izrađeni u kontroliranim uvjetima, a s obzirom na to da ne postoji znatna promjena sadržaja djelatne tvari i da je proizvod, povijesno gledano, imao rok valjanosti od 3 godine, podatci se smatraju prikladnima kako bi se potkrijepio rok valjanosti od 2 godine za završni proizvod, kako je predložio nositelj odobrenja.
English: All the bacteria isolated from treated and untreated animals were sensitive to 16 μg/ml or less of apramycin.
Croatian: Sve bakterije izolirane iz liječenih i neliječenih životinja bile su osjetljive na 16 μg/ml ili manje apramicina.
English: Do not use during pregnancy.
Croatian: Ne primjenjivati tijekom graviditeta.
English: Since the dosing regimens recommended by the CVMP have not been increased, and the indications have not been extended with regard to those approved in most summaries of product characteristics, the assessment of target animal safety and user safety did not present new issues.
Croatian: Budući da režimi doziranja koje je CVMP predložio nisu povećani, a indikacije nisu proširene u odnosu na indikacije odobrene u većini sažetaka opisa svojstava VMP-a, procjena sigurnosti ciljanih vrsta životinja i sigurnosti potrošača nije upućivala na nova sigurnosna pitanja.
English: However, recent publications in the scientific literature indicate that the disease is present in cattle in Europe, e.g. in Ireland (O´Leary, 20145) and the UK (Henderson and Mason, 20176).
Croatian: Međutim, u najnovijim publikacijama u području znanstvene literature navodi se da je ta bolest prisutna u goveda u Europi, npr. u Irskoj (O´Leary, 2014.5) i Ujedinjenoj Kraljevini (Henderson i Mason, 2017.6).
English: The treatment period was initiated two weeks after weaning, when the signs of colibacillosis were clearly established.
Croatian: Razdoblje liječenja započelo je dva tjedna nakon odbijanja, kada su jasno utvrđeni znakovi kolibaciloze.
English: Some studies pointed out resistance percentages of 38% (MIC data) or even higher for disk diffusion (up to
Croatian: U nekim je studijama istaknuto da otpornost iznosi 38% (podatci o MIK-u) ili čak više za difuziju diska (do 82,1%).
English: Medicated water should be the only source of drinking.
Croatian: Voda koja sadržava VMP životinji treba biti jedini izvor pića.
English: The testing timepoints for these batches are not all in accordance with current guidelines but in all cases, data is provided for at last 5 time-points over the course of the stability study and trending of data is therefore possible.
Croatian: Nisu sve ispitne vremenske točke za te serije usklađene s trenutačnim smjernicama, no u svim su slučajevima dostavljeni podatci za barem 5 vremenskih točaka tijekom trajanja studije o stabilnosti i stoga je moguće pratiti kretanje podataka.
English: Once opened, use within 28 days.
Croatian: Jednom otvoren upotrijebiti unutar 28 dana.
English: All studies have been performed with the maximal dose proposed in the product information.
Croatian: Sve studije provedene su uz primjenu maksimalne doze predložene u informacijama o VMP-u.
English: The main animal species to be listed are all species of domestic poultry and wild species of mainly Anseriformes and Galliformes.
Croatian: Glavne vrste životinja koje je potrebno uvrstiti na popis jesu sve vrste domaće peradi i divlje vrste uglavnom iz redova guščarica (Anseriformes) i kokoški (Galliformes).
English: In the detailed grounds for re-examination the MAH requested a shelf life of 24 months based on stability data provided during the referral.
Croatian: U detaljnom obrazloženju za ponovnu procjenu nositelj odobrenja zahtijevao je rok valjanosti od 24 mjeseca na temelju podataka o stabilnosti dostavljenih tijekom postupka upućivanja.
English: Very little metabolism of apramycin takes place in the animal.
Croatian: Svinje: Vrlo se malo metabolizma apramicina zbiva u životinji.
English: Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7
Croatian: Farmacêuticos, Lda Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7
English: This evaluation focuses on issues with regard to the harmonisation that may change the benefit-risk balance.
Croatian: Ova procjena usredotočena je na pitanja usklađivanja koja mogu promijeniti omjer koristi i rizika.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte veterinara kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Resistance developed by chromosomal resistance is minimal for most of the aminoglycosides.
Croatian: Otpornost razvijena kromosomskom rezistencijom minimalna je kod većine aminoglikozida.
English: Zoonotic Salmonella is listed in this Regulation.
Croatian: Zoonotska bakterija Salmonella uvrštena je u tu Uredbu.
English: However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Croatian: Međutim, kako režimi doziranja i indikacije nisu prošireni, izloženost okoliša djelatnoj tvari nije povećana.
English: The risks associated with use of Girolan are those generally attributed to antimicrobials which are used in food-producing animals, i.e. development of antimicrobial resistance in target bacteria, dissemination of resistant bacteria/resistance factors etc.
Croatian: Rizici povezani s primjenom Girolana jesu oni koji se općenito pripisuju antimikrobnim lijekovima koji se primjenjuju u životinja namijenjenih za proizvodnju hrane, tj. razvoj antimikrobne otpornosti u ciljanoj bakteriji, širenje otporne bakterije / faktora otpornosti itd.
English: According to Regulation (EC) No 1177/200610, antimicrobials should not be used as part of national control programs of Salmonella due to public health risks associated with development, selection and spread of resistance.
Croatian: U skladu s Uredbom (EZ) br. 1177/200610, antimikrobni lijekovi ne bi se trebali upotrebljavati u okviru nacionalnih programa kontrole za bakteriju Salmonella zbog rizika za javno zdravlje povezanih s razvojem, selekcijom i širenjem otpornosti.
English: Having reviewed the relevant information submitted during the initial assessment procedure and the detailed grounds for re-examination put forward by the MAH, the Committee concluded that the previous CVMP opinion should be revised as follows:
Croatian: Nakon preispitivanja relevantnih informacija dostavljenih tijekom postupka prvotne procjene i iznesenih detaljnih obrazloženja za ponovnu procjenu koje je iznio nositelj odobrenja, Odbor je zaključio da je prethodno mišljenje CVMP-a potrebno revidirati kako slijedi:
English: INN Strength
Croatian: INN Jačina
English: Although these risks have not been unequivocally assessed, the possibility of impact on human health through cross-resistance to gantamicin and other substances of the aminoglycoside group is a reality.
Croatian: Iako ti rizici nisu bili nedvosmisleno procijenjeni, postoji stvarna mogućnost utjecaja na ljudsko zdravlje zbog unakrsne otpornosti na gantamicin i druge tvari iz skupine aminoglikozida.
English: These enzymes confer different cross-resistance against other aminoglycosides.
Croatian: Ti enzimi pružaju različitu križnu otpornost protiv drugih aminoglikozida.
English: Several residues depletion studies in the different target species were made available, which were variable in terms of reliability of the data, study design and reporting, and subsequently their outcomes.
Croatian: Na raspolaganje je stavljeno nekoliko ispitivanja o izlučivanju rezidua za različite ciljane vrste, koja su bila varijabilna u pogledu pouzdanosti podataka, dizajna studije i izvješćivanja o njoj te stoga i u pogledu rezultata.
English: Although it is acknowledged that Salmonella Dublin is an uncommon cause of salmonellosis in man, infection can be severe.
Croatian: Iako je potvrđeno da je bakterija Salmonella Dublin rijedak uzrok salmoneloze u ljudi, infekcija može biti ozbiljna.
English: This was not considered acceptable, as the active substance strength should be expressed in IU/g product, since the assay is determined by means of a microbiological method.
Croatian: To se nije smatralo prihvatljivim jer bi se jačina djelatne tvari trebala izražavati u međunarodnim jedinicama (IU/g) proizvoda s obzirom na to da se ispitivanje utvrđuje mikrobiološkom metodom.
English: In addition use of apramycin was considered preferable to the potential use of more critical antimicrobials such as fluoroquinolones.
Croatian: Osim toga, primjena apramicina smatrala se poželjnom u odnosu na potencijalnu uporabu antimikrobnih lijekova od ključne važnosti, kao što su fluorokinoloni.
English: Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product.
Croatian: Pribor za osobnu zaštitu, koji se sastoji od rukavica, maske, zaštitnih naočala i zaštitne odjeće,
English: The presence of the disease in the herd must be established before the product is used.
Croatian: Prisutnost bolesti u stadu/skupini mora se utvrditi prije primjene proizvoda.
English: This was also not considered acceptable, as dosing by product weight was considered the most appropriate in terms of reproducibility of the dose and therefore any reference to the measuring device was deleted from the product information.
Croatian: Ni to se nije smatralo prihvatljivim jer se doziranje prema težini proizvoda smatralo najprikladnijim s obzirom na ponovljivost doze i stoga su u informacijama o VMP-u izbrisani svi navodi o uređaju za mjerenje.
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Croatian: Otpornost može biti izravan razlog za zabrinutost kada utječe na zoonotske patogene kao što su bakterije Campylobacter i Enterococcus, a može se horizontalno prenijeti na ljudske patogene putem mobilnih genetskih elemenata.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on this matter and to harmonise the product information for Girolan and its associated name Apralan (thereafter called Girolan).
Croatian: Od Odbora za veterinarsko-medicinske proizvode (CVMP) zatraženo je da iznese svoje mišljenje o tom pitanju te da uskladi informacije o VMP-u za Girolan i njegovo pridruženo ime Apralan (dalje u tekstu „Girolan”).
English: Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
Croatian: Svinje: svinje su dobile dozu do devet puta višu od preporučene razine upotrebe u svojoj pitkoj vodi u razdoblju od 28 dana bez neželjene reakcije.
English: Resistance mechanisms: Different aminoglycoside 3-N acetyltransferase enzymes (AAC-3) have been related with resistance to apramycin.
Croatian: Mehanizmi rezistencije: Različiti aminoglikozidni enzimi 3-N acetiltransferaze (AAC-3) povezani su s otpornošću na apramicin.
English: European Control programmes of Salmonella in poultry in Europe have been focused on Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow and Salmonella Infantis, as the five most frequent serovars in human salmonellosis (Regulation (EC) No 2160/20039).
Croatian: Europski kontrolni programi za bakteriju Salmonella u peradi u Europi usmjereni su na bakterije Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow i Salmonella Infantis, pet najčešćih serovara u pogledu salmoneloze u ljudi (Uredba (EU) br. 2160/20039).
English: These data are consistent with the published literature.
Croatian: Ti su podatci u skladu s objavljenom literaturom.
English: Additional data provided from 2014 indicate that Salmonella Dublin was mostly susceptible to apramycin (96.5% of isolates susceptible to all antimicrobials in the panel, including apramycin).
Croatian: Dodatni podatci pruženi od 2014. pokazuju da je bakterija Salmonella Dublin uglavnom osjetljiva na apramicin (96,5% izolata osjetljivo je na sve antimikrobne lijekove s popisa, uključujući apramicin).
English: • The harmonised product information of Girolan contains the necessary information to ensure the safe and effective use of the product.
Croatian: • usklađivanjem informacija o VMP-u Girolan koje sadržavaju podatke koji su potrebni kako bi se zajamčila njegova sigurna i učinkovita primjena.
English: Apramycin sulfate 333 mg/ml equivalent to apramycin 230 mg/ml
Croatian: Apramicin-sulfat 333 mg/ml ekvivalentan 230 mg/ml apramicina
English: Therefore, the CVMP considered it justified to retain the indication for Salmonella Dublin for Girolan.
Croatian: Stoga je CVMP smatrao opravdanim zadržati indikaciju za bakteriju Salmonella Dublin za Girolan.
English: No recent data about susceptibility of Salmonella Gallinarum or Salmonella Pullorum isolates obtained in clinical cases in Europe were available as salmonellosis caused by these serovars has not been detected in Europe since 2007.
Croatian: Noviji podatci o osjetljivosti izolata bakterija Salmonella Gallinarum i Salmonella Pullorum dobiveni na osnovi kliničkih slučajeva u Europi nisu bili dostupni jer slučajevi salmoneloze prouzročene tim serovarima nisu utvrđeni u Europi od 2007.
English: The weight of the animals should be determined as accurately as possible to avoid underdose.
Croatian: Tjelesnu masu životinja treba odrediti što preciznije kako bi se osiguralo točno doziranje.
English: Furthermore, taking into account the data provided and in line with the ‘Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01)1', the shelf life period of the veterinary medicinal product as packaged for sale, which was 3 years, was reduced to 18 months.
Croatian: Nadalje, uzimajući u obzir dostavljene podatke te u skladu s dokumentom „Napomena za smjernice o početku roka valjanosti konačnog doznog oblika (EMEA/CVMP/453/01)1”, razdoblje roka valjanosti veterinarsko-medicinskog proizvoda pakiranog za prodaju, koje je iznosilo 3 godine, skraćeno je na 18 mjeseci.
English: From the study it could be concluded that Salmonella Pullorum infections could be controlled with apramycin.
Croatian: Iz studije bi se moglo zaključiti da bi se infekcije bakterijom Salmonella Pullorum mogle kontrolirati apramicinom.
English: No accelerated data have been provided during the referral procedure.
Croatian: Tijekom postupka upućivanja nisu dostavljeni pospješeni podatci.
English: Dosing 10 kg pigs with 14C apramycin resulted in approximately 83% being recovered from the faeces, and 4% from the urine, as 14C apramycin.
Croatian: Doziranje 10 kg svinja 14C apramicinom rezultiralo je s otprilike 83 % proizvoda dobivenog iz izmeta te 4 % iz urina, u obliku 14C apramicina.
English: These data are consistent with the information available in published literature.
Croatian: Ti su podatci u skladu s informacijama koje su dostupne u objavljenoj literaturi.
English: Apramycin sulfate
Croatian: Apramicinsulfat
English: This lack of storage precautions for the product is based on historical data, and was already approved in the individual Member States prior to the referral.
Croatian: To nepostojanje mjera opreza u pogledu čuvanja VMP-a temelji se na povijesnim podatcima te je već bilo dopušteno u pojedinim državama članicama prije postupka upućivanja.
English: Salmonella is one of the most frequent microorganisms causing foodborne zoonoses outbreaks and cases in Europe in humans (EFSA and ECDC, 20164).
Croatian: Bakterija Salmonella jedan je od najčešćih mikroorganizama koji uzrokuju epidemije i slučajeve zoonoza koje se prenose hranom u ljudi u Europi (EFSA i ECDC, 2016.4).
English: PACKAGE SIZE 50 sachets
Croatian: VELIČINA PAKOVANJA 50 vrećica
English: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954
Croatian: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954 14 World Health Organization (2017).
English: Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Croatian: Rizici za korisnike smatraju se malim, a u informacije o VMP-u uvrštene su odgovarajuće informacije kako bi se zajamčila sigurnost primjene za korisnike.