FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not possible to conclude at present whether these findings could be extrapolated to altrenogest.
Croatian: Za sada nije moguće zaključiti mogu li se ovi nalazi ekstrapolirati na altrenogest.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from France.
Croatian: Uzimajući u obzir predane podatke, povjerenstvo je zaključilo na sljedeći način o problemima istaknutim u obavijesti zaprimljenoj od strane Francuske.
English: Assessment of the data submitted
Croatian: Procjena predanih podataka
English: Both values are less than the trigger value of 100 µg/kg.
Croatian: Obje vrijednosti su manje od vrijednosti okidanja od 100 µg/kg.
English: Quality, target animal safety, user safety and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Croatian: Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika i rezidue nisu ispitivane u ovom postupku procjene, a referentna država članica nije priopćila nijedan razlog za zabrinutost.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Croatian: Popis imenom, farmaceutski oblik, jačina veterinarskog lijeka, životinjske vrste, put primjene, podnositelj zahtjeva u državama članicama
English: Animal species
Croatian: Ciljna vrsta životinja
English: For DT50 soil a conservative approach of 10 days was used, based on reported half-lives of different hormones.
Croatian: Za DT50 tlokorišten je konzervativan pristup od 10 dana, na temelju prijavljenih poluživota različitih hormona.
English: This indicates potential adverse effects of steroid hormones in the environment.
Croatian: To ukazuje na moguće štetne učinke steroidnih hormona za okoliš.
English: No further risk mitigation measures were considered than the ones proposed in the decentralised procedure.
Croatian: Nisu razmatrane ostale mjere smanjenja rizika, drugačije od onih predloženih u decentraliziranom postupku.
English: In parallel of the QSAR calculation, the applicant has considered the worst case where altrenogest is not metabolised at all.
Croatian: Usporedno s izračunima QSAR-a, podnositelj zahtjeva smatrao je najgorim slučajem onaj u kojem altrenogest nije uopće metaboliziran.
English: Lastly, an expert report was provided which discusses the need for altrenogest-containing products in pig farming.
Croatian: Naposljetku, predano je stručno izvješće koje raspravlja potrebu za proizvodima koji sadrže altrenogest na farmama svinja.
English: The calculated values for altrenogest were 13.5 (in the case of 80% metabolism) and 2.7 (in the case of 0% metabolism) times lower than the total gestagen excretion by pigs.
Croatian: Izračunate vrijednosti za altrenogest bile su 13,5 (u slučaju 80 %-tnog metabolizma) i 2,7 (u slučaju 0 %-tnog metabolizma) puta niže od ukupne ekskrecije gestagena od strane svinja.
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Croatian: Nisu potrebne daljnje mjere upravljanja rizikom ili smanjenje rizika kao posljedica ovog postupka procjene.
English: Effect data with altrenogest are not available in the public domain.
Croatian: Podaci o učinku altrenogesta na okoliš nisu dostupni za javnost.
English: Surface water for altrenogest was modelled using FOCUS simulation models, using the two scenarios (open and closed models) with 0% and 80% metabolism each.
Croatian: Površinska voda za altrenogest modelirana je upotrebom modela stimulacije FOCUS s dva scenarija (otvoreni i zatvoreni modeli) svaki s 0 i 80 % metabolizma.
English: These scenarios led to a PECsurfacewater ranging from 0.641 ng/l (for a closed system with 80% metabolism) up to 8.98 ng/l (for an open system with 0% metabolism).
Croatian: Ti scenariji doveli su vrijednosti PECza površinske vode u rasponu od 0,641 ng/l (za zatvoreni sustav s 80 %-tnim metabolizmom) do 8,98 ng/l (za otvoreni sustav s 0 %-tnim metabolizmom).
English: Efficacy was not assessed in this referral procedure.
Croatian: U ovom postupku procjene nije procijenjena djelotvornost.
English: The environmental risk assessment will be reviewed within the Article 35 referral.
Croatian: Procjena rizika za okoliš bit će pregledana u sklopu procjene za članak 35.
English: The applicant used Quantitative structure-activity relationship models (QSAR models) to calculate excretion levels of altrenogest and compared them with the measured total gestagen excretion by pigs reported in public literature.
Croatian: Podnositelj zahtjeva koristio je modele odnosa kvantitativne strukture i aktivnosti (QSAR modeli) za izračuna razina altrenogesta te ih usporedio s izmjerenim ukupnim vrijednostima ekskrecije gestagena od svinja koje je zabilježeno u javnoj literaturi.
English: The referenced ‘however clause' is a provision in the introduction section of VICH GL6 which states “Phase I also identifies VMPs that require a more extensive EIA under Phase II.
Croatian: Navedena „klauzula ipak” je uredba u uvodu poglavlja VICH GL6 koja tvrdi „Faza I također identificira veterinarsko-medicinske proizvode koji zahtijevaju intenzivniji EIA pod fazom II.
English: The two studies with the most sensitive results display effects in amphibians and fish already at the lowest test concentration of 1.3 and 0.8 ng/l, respectively.
Croatian: Dva ispitivanja s najosjetljivijim rezultatima prikazuju učinke kod vodozemaca i riba već pri najnižoj koncentraciji od 1,3 i 0,8 ng/l.
English: 1 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf order to assess the potential risk of Suifertil 4 mg/ml Oral Solution for Pigs to the environment.
Croatian: 1 VICH GL6: Smjernice o procjeni utjecaja na okoliš (EIAs) za veterinarsko-medicinske proizvode - Faza I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf ipak” te da oblikovanu Fazu II procjene rizika za okoliš treba predati kako bi se procijenio mogući rizik od Suifertila 4 mg/ml oralne otopine za svinje za okoliš.
English: A class referral under Article 35 of Directive 2001/82/EC has been initiated in April 2013 for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, the scope of which also includes Suifertil.
Croatian: Klasa procjene u skladu s člankom 35. Direktive 2001/82/EZ započela je u travnju 2013. godine za sve veterinarsko-medicinske proizvode koji sadrže altrenogest i koji se peroralno daju svinjama i konjima, a čiji djelokrug također uključuje i Suifertil.
English: Application of the ‘however clause' or can the ERA stop at Phase I
Croatian: 2.1. Primjena „klauzule ipak” ili može li ERA stati u Fazi
English: Using the total residue approach for intensively reared animals the PECsoil for pigs was determined to be 3.01 μg/kg and refining by means of FOCUS models led to values of 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems.
Croatian: Upotrebom pristupa ukupnih rezidua za intenzivno gojene životinje PECtla za svinje određena je kao 3,01 µg/kg i fino podešena putem FOCUS modela dovela je do vrijednosti od 0,93 µg/kg za otvorene sustave i 0,36 µg/kg za zatvorene sustave.
English: Germany expressed concerns regarding a potential serious risk for the environment as the active ingredient is a steroid hormone and data from publicly available literature show a high risk to aquatic organisms arising from other steroids with a similar molecular structure at environmental concentrations far below the trigger value in nanogram range.
Croatian: Njemačka je izrazila zabrinutost glede mogućeg ozbiljnog rizika za okoliš s obzirom na to da je djelatna tvar steroidni hormon, a javno dostupni podaci pokazuju visoki rizik za vodene organizme koji proizlazi iz drugih steroida sa sličnom molekularnom strukturom pri koncentracijama u okolišu puno nižim od vrijednosti okidanja u rasponu nanograma.
English: The Phase I environmental risk assessment (ERA) conducted by the applicant for Suifertil indicated a predicted environmental concentration (PEC) in soil below the value of 100 µg active substance per kg soil which triggers a Phase II ERA, therefore no further assessment was carried out.
Croatian: Faza I procjena rizika za okoliš (ERA) koju je proveo podnositelj zahtjeva za Suifertil ukazala je na predviđenu koncentraciju u okolišu (PEC) u zemlji ispod vrijednosti od 100 µg djelatne tvari po kg tla koja okida fazu II ERA-e pa stoga nije provedena daljnja procjena.
English: Annex III
Croatian: Aneks III
English: It is included in veterinary medicinal products currently authorised in the European Union for gilts and mares for zootechnical purposes (oestrus synchronisation).
Croatian: Uključen je u veterinarsko-medicinske proizvode koji su trenutačno odobreni u Europskoj uniji za nazimice i kobile za zootehničke svrhe (sinkronizacija estrusa).
English: The applicant provided a Phase I ERA, in which PECsoil initial for the active ingredient was calculated to be 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems, which is considered plausible and acceptable.
Croatian: Podnositelj zahtjeva predao je ERA Faze I u kojem je početni PECtla za djelatnu tvar izračunat na 0,93 µg/kg za otvorene sustave i 0,36 µg/kg za zatvorene sustave što se smatra vjerojatnim i prihvatljivim.
English: Altrenogest is a synthetic steroidal hormone, an orally active (pro)gestagen.
Croatian: Altrenogest je sintetski steroidni hormon, peroralno aktivan (pro)gestagen.
English: Altrenogest is a synthetic steroidal hormone, an orally active progestogen.
Croatian: Altrenogest je sintetički steroidni hormon, peroralno aktivni progesteron.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III of the CVMP opinion.
Croatian: Stoga je CVMP preporučio izdavanje odobrenja za stavljanje Suifertil 4 mg/ml oralne otopine za svinje u promet, čiji su sažetak opisa svojstava, označavanje i uputa priloženi u Prilogu III. mišljenja CVMP-a.
English: Within the ongoing Article 35 referral for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, further ecotoxicity and environmental fate data are expected to be submitted.
Croatian: Unutar tekuće procjene u skladu s člankom 35. svi veterinarsko-medicinski proizvodi koji sadrže altrenogest koji se daju peroralno svinjama i konjima, očekuje se predavanje daljnjih podataka o ekotoksičnosti i sudbini u okolišu.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Suifertil 4 mg/ml Oral Solution for Pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Croatian: Ova procjena u skladu s člankom 33. stavkom 4. Direktive 2001/82/EZ provedena je zbog zabrinutosti da podnositelj zahtjeva nije na zadovoljavajući način dokazao sigurnost za okoliš Suifertila 4 mg/ml oralne otopine za svinje zbog nedostatka glavnih podataka bez kojih nije moguće zaključiti je li proizvod siguran za okoliš ili ne.
English: Studies in the published literature on effects of several hormones other than altrenogest on aquatic organisms indicate adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Croatian: Ispitivanja u objavljenoj literaturi o učincima nekoliko hormona različitih od altrenogesta na vodene organizme ukazuju na štetne učinke pri koncentracijama ispod vrijednosti okidanja od 100 µg/kg tla.
English: The applicant argued that the environmental load of altrenogest is comparable to other hormones measured and provided public available literature regarding effect concentrations of different hormones in the low ng/l range, but none with altrenogest.
Croatian: Podnositelj zahtjeva naveo je da je opterećenje okoliša atrenogestom usporedivo s izmjerenim hormonima te je predao javnosti dostupnu literaturu u vezi učinka koncentracija različitih hormona u niskom rasponu ng/l ali nijedan s altrenogestom.
English: The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in gilts and mares for synchronisation of oestrus.
Croatian: Djelatna je tvar uključena u veterinarskomedicinske proizvode koji su trenutačno odobreni u nekoliko država Europske unije za upotrebu na krmačama nazimicama i kod kobila za sinkronizaciju estrusa.
English: Germany considered that the data provided are inadequate to conclude that altrenogest will not pose a risk to the environment and that a tailored Phase II ERA based on the so called ‘however clause' of VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I1 is necessary.
Croatian: Njemačka je smatrala da predani podaci ne odgovaraju zaključku da altrenogest neće predstavljati rizik za okoliš i da se oblikovana faza II ERA-e temelji na tzv. „klauzuli ipak” smjernica VICH GL6: Potrebna je smjernica o procjeni utjecaja na okoliš (EIAs) za veterinarsko-medicinske proizvode- Faza I1. Nadalje, Njemačka je smatrala da nedostaju odgovarajuće mjere smanjenja rizika (RMM) u sažetku opisa svojstava lijeka kao posljedica identificiranog neprihvatljivog rizika za vodene organizme.
English: As there is no product specific concern identified for Suifertil 4 mg/ml Oral Solution for Pigs that is different from the other, already authorised altrenogest containing veterinary medicinal products, it is considered appropriate to await the outcome of the ongoing Article 35 referral before any different conclusions regarding the environmental risk assessment or specific measures would be envisaged for Suifertil 4 mg/ml Oral Solution for Pigs.
Croatian: S obzirom na to da nije identificirana zabrinutost specifična za proizvod za Suifertil 4 mg/ml oralnu otopinu za svinje koja je različita od drugih, već odobrenih veterinarsko-medicinskih proizvoda koji sadrže altrenogest, smatra se odgovarajućim pričekati ishod tekuće procjene u skladu s člankom 35. prije bilo kojeg drugog zaključka u svezi procjene rizika za okoliš ili će biti potrebno opisati specifične mjere za Suifertil 4 mg/ml oralnu otopinu za svinje.
English: It is considered appropriate to await the outcome of the ongoing Article 35 referral before any specific measures would be envisaged for Suifertil 4 mg/ml Oral Solution for Pigs.
Croatian: Smatra se odgovarajućim pričekati ishod tekućeg članka 35. procjene prije predlaganja bilo kakvih specifičnih mjera za Suifertil 4 mg/ml oralnu otopinu za svinje.
English: Therefore, a NOEC could not be derived in these studies.
Croatian: Stoga u ovim ispitivanjima nije bilo moguće izvesti NOEC.
English: Based on the currently available data, and in anticipation of a more in-depth assessment of the environmental risk assessment under an ongoing Article 35 referral, the benefit-risk ratio is considered positive for Suifertil 4 mg/ml Oral Solution for Pigs at present.
Croatian: Na temelju trenutačno dostupnih podataka te u iščekivanju dublje procjene rizika za okoliš pod tekućom procjenom iz članka 35. omjer dobrobiti i rizika zasada se smatra pozitivnom za Suifertil 4 mg/ml oralnu otopinu za svinje.
English: Consequently, the applicant concluded that the ERA can stop at Phase I. Additionally, the applicant provided a scientific justification why the ‘however clause' of VICH GL6 should not be invoked.
Croatian: Osim toga, nositelj odobrenja predao je znanstveno objašnjenje zašto se „klauzula ipak” VICH GL6 ne smije prizivati.
English: This is a generic application according to Art. 13(1) of Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Croatian: To je generički zahtjev u skladu s člankom 13. stavkom 1. Direktive 2001/82/EZ i njezinih izmjena i odnosi se na referentni lijek Regumate uljnu otopinu 4 mg/ml.
English: The submitted published literature on effect studies for three other hormones, the gestagens levonorgestrel, drosperinone and progestrerone, is indicating adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Croatian: Predana objavljena literatura u ispitivanjima učinka na okoliš za druga tri hormona, gestagene levonorgestrel, drosperinon i progestrenon ukazuju na štetne učinke pri koncentracijama daleko nižim ispod vrijednosti okidanja od 100 µg/kg tla.
English: The concerns expressed by the objecting CMS in respect to the risk to aquatic organisms do not relate specifically to the product Suifertil 4 mg/ml Oral Solution for Pigs, but equally to all relevant veterinary medicinal products containing the active substance altrenogest.
Croatian: Te su zabrinutosti izražene protivljenjem države članice s obzirom na to da se rizik za vodene organizme ne odnosi posebno na proizvod Suifertil 4 mg/ml oralnu otopinu za svinje već jednako na sve odgovarajuće veterinarsko-medicinske proizvode koji sadrže djelatnu tvar altrenogest.
English: In this procedure, the Committee was asked to consider whether in the case of Suifertil 4 mg/ml Oral Solution for Pigs, containing as the active substance a synthetic hormone (altrenogest), the ‘however clause' should be applied and a tailored Phase II environmental risk assessment should be provided in
Croatian: U ovom postupku od povjerenstva se tražilo da razmotri treba li u slučaju Suifertila 4 mg/ml oralne otopine za svinje koja kao djelatnu tvar sadrži sintetski hormon (altrenogest)primjenjivati „klauzulu
English: Some VMPs that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their activity and use.”
Croatian: I mogu zahtijevati dodatne informacije o okolišu posebice u vezi s njihovom aktivnošću i upotrebom.
English: Annex II
Croatian: Aneks II
English: Within this referral the submission of further ecotoxicity and environmental fate data are expected.
Croatian: Očekuje se predaja daljnjih podataka o ekotoksičnosti i sigurnosti za okoliš unutar ove procjene.
English: The applicant submitted an application for a decentralised procedure for Suifertil 4 mg/ml Oral Solution for Pigs.
Croatian: Podnositelj zahtjeva predao je zahtjev za decentralizirani postupak za Suifertil 4 mg/ml oralnu otopinu za svinje.
English: The application in question, submitted via the decentralised procedure, is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Croatian: Dotični zahtjev, predan decentraliziranim postupkom generički je zahtjev u skladu s člankom 13. stavkom 1. Direktive 2011/82/EZ i njezinim izmjenama, s referentnim veterinarsko-medicinskim proizvodom Regumate uljna otopina 4 mg/ml.
English: A Phase I environmental risk assessment in compliance with the relevant guidelines was provided, which showed that the PECsoil value for pigs does not exceed the VICH threshold of 100 μg/kg.
Croatian: Faza I procjene rizika za okoliš vrijednost PECtlo za svinje ne premašuje graničnu vrijednost VICH od 100 µg/kg.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs and associated names
Croatian: Znanstveni zaključci i razlozi za davanje odobrenja za stavljanje lijeka Suifertil 4 mg/ml oralne otopine za svinje u promet i pridruženi nazivi
English: Applicant
Croatian: Podnositelj
English: The proposed indication for Suifertil 4 mg/ml Oral Solution for Pigs is to synchronise oestrus in sexually mature gilts.
Croatian: Predložena indikacija za Suifertil 4 mg/ml oralnu otopinu za svinje je sinkronizacija estrusa u spolno zrelih nazimica.
English: In order to address the concerns raised by the referral, the applicant provided a Phase I ERA, references from public literature and a scientific justification why the ERA can stop at Phase I and the ‘however clause' should not be invoked.
Croatian: I ERA-e iz javne literature i znanstveno opravdanje zašto ERA ne može stati na Fazi
English: Suifertil 4 mg/ml Oral Solution for Pigs is intended for synchronisation of oestrus in sexually mature pigs.
Croatian: Suifertil 4 mg/ml oralna otopina za svinje namijenjena je sinkronizaciji estrusa u spolno zrelih svinja.
English: Suifertil 4 mg/ml Oral Solution for Pigs contains altrenogest as an active ingredient.
Croatian: Suifertil 4 mg/ml oralna otopina za svinje sadrži altrenogest kao djelatnu tvar.
English: Evaluation of the benefit-risk balance
Croatian: Procjena omjera dobrobiti i rizika
English: Overall summary of the scientific evaluation of Suifertil 4 mg/ml Oral Solution for Pigs
Croatian: Ukupni sažetak znanstvene procjene za Suifertil 4 mg/ml oralne otopine za svinje
English: Benefit-risk assessment
Croatian: Procjena dobrobiti i rizika
English: Grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs
Croatian: Razlozi za davanje odobrenja za stavljanje Suifertil 4 mg/ml oralne otopine za svinje u promet
English: INN
Croatian: I
English: Pharmaceutical form
Croatian: Farmaceuts ki oblik
English: PRIMARY ANALYSIS
Croatian: PRIMARNA ANALIZA
English: • Fever: if you have a temperature of 38 °C or greater.
Croatian: • vrućica: ako imate temperaturu od 38 °C ili višu.
English: Also, you need to be particularly careful if you are taking any of the following:
Croatian: Također, trebate biti posebno oprezni ako uzimate neki od ovih lijekova:
English: • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Croatian: • mučnina: ako izgubite apetit, a količina hrane koju svakodnevno konzumirate znatno je manja nego inače.
English: Date of latest renewal: 16 June 2017
Croatian: Datum posljednje obnove odobrenja: 16. lipnja 2017
English: • Take the tablets in the morning and evening as prescribed by your doctor.
Croatian: - Tablete uzimajte ujutro i navečer, kako Vam je to propisao liječnik.
English: • if you have a history of eye problems as you may need extra monitoring of your eyes,
Croatian: • ako ste ranije imali očnih tegoba jer će vam možda biti potrebna dodatna kontrola očiju,
English: • Vomiting: if you vomit more than once in a 24-hour time period.
Croatian: • povraćanje: ako povratite više od jednom u 24 sata.
English: (neuropathy),
Croatian: (neuropatija),
English: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Croatian: Nedostatak DPD-a je rijetko stanje prisutno od rođenja, koje obično nije povezano sa zdravstvenim problemima osim ako ne primate određene lijekove.
English: Median time to event (days)
Croatian: Medijan vremena do pojave događaja (dani)
English: taste changes
Croatian: promjene u okusu
English: STOP taking Capecitabine medac immediately and contact your doctor if any of these symptoms occur:
Croatian: PRESTANITE odmah uzimati Kapecitabin medac i obratite se liječniku ako se pojave neki od ovih simptoma:
English: • unusual bleeding from the vagina
Croatian: • neuobičajeno krvarenje iz vagine
English: Rare/Very rare (Post-marketing experience)
Croatian: Rijetko/vrlo rijetko (iskustvo nakon stavljanja lijeka u promet)
English: • bruising or reaction at the injection site (caused by medicines given by injection at the same time)
Croatian: • stvaranje modrica ili reakcije na mjestu injekcije (uzrokovane lijekovima koji se daju injekcijom u isto vrijeme)
English: About 3 % of the administered dose is excreted in urine unchanged.
Croatian: Oko 3 % primijenjene doze izluči urinom u nepromijenjenom obliku.
English: • if you have a severe skin reaction.
Croatian: • ako imate tešku kožnu reakciju.
English: Other side-effects seen in this setting are the following:
Croatian: Druge nuspojave uočene u ovom okruženju su sljedeće:
English: • hiccups, change in voice
Croatian: • štucavica, promjene u glasu