FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Croatian: Najčešće su nuspojave lijeka Zoely (zabilježene u više od 1 na 10 korisnica) akne i promjene menstrualnog ciklusa (npr. izostanak menstruacije ili neredovite menstruacije).
English: The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Zoely nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Croatian: Zoely je kombinirana kontracepcijska pilula koja sadrži dvije djelatne tvari, nomegestrolacetat (progestogen) i estradiol (estrogen).
English: Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Croatian: Nomegestrolacetat dobiva se iz hormona koji se naziva progesteron, a koji također proizvode jajnici tijekom menstrualnog ciklusa.
English: A risk management plan has been developed to ensure that Zoely is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zoely.
English: Why has Zoely been approved?
Croatian: Zašto je lijek Zoely odobren?
English: What is Zoely used for?
Croatian: Za što se Zoely koristi?
English: How does Zoely work?
Croatian: Kako djeluje Zoely?
English: How is Zoely used?
Croatian: Kako se Zoely koristi?
English: What benefit has Zoely shown during the studies?
Croatian: Koje su koristi lijeka Zoely utvrđene u ispitivanjima?
English: The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Croatian: Sudionice ispitivanja jednu su godinu (13 menstrualnih ciklusa) uzimale ili lijek Zoely ili drugu kontracepcijsku pilulu koja sadrži drospirenon i etinilestradiol.
English: For the full list of all side effects reported with Zoely, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zoely potražite u uputi o lijeku.
English: How has Zoely been studied?
Croatian: Kako je lijek Zoely ispitivan?
English: Discussion of data available
Croatian: Rasprava o dostupnim podatcima
English: No guideline was given.
Croatian: Nisu pružene nikakve smjernice.
English: Member State EU/EEA
Croatian: Država članica EUa/EGP-a
English: Topical - on the back of the animal
Croatian: Topikalno - na leđa životinje
English: In case of insufficient space on the label:
Croatian: U slučaju nedostatnog prostora na naljepnici:
English: Do not contaminate watercourses with the product.
Croatian: Nemojte vodene tokove zagađivati tim proizvodima.
English: Commission Decision for this procedure
Croatian: Komisije o ovom postupku
English: Journal for Parasitology: Drugs Drug Resistance 2:134-53.
Croatian: International Journal for Parasitology: Drugs Drug Resistance 2:134-53.
English: The field study should fulfil the following criteria:
Croatian: Terensko ispitivanje treba ispunjavati sljedeće kriterije:
English: Low High
Croatian: Niska Visoka
English: Direct therapeutic benefits
Croatian: Izravna terapijska korist
English: • The duration of the study should be three consecutive years in order to consider seasonal and annual variations.
Croatian: • Ispitivanje treba provesti u razdoblju od tri uzastopne godine kako bi se uzele u obzir sezonske i godišnje promjene.
English: Additional benefits
Croatian: Dodatne koristi
English: de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Croatian: Avda. de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
English: However, the data provided for Tier B and C assessment do not comply with current standards.
Croatian: Međutim, podatci dostavljeni za procjene razina B i C ne udovoljavaju postojećim standardima.
English: Daphnia magna (reproduction)
Croatian: Daphnia magna (reprodukcija)
English: Nevertheless, the results of this study supported the conclusion on persistence from the first study.
Croatian: Ipak, rezultati ovog ispitivanja potkrijepili su zaključak o postojanosti iz prvog ispitivanja.
English: The following findings should be reported:
Croatian: Potrebno je prijaviti sljedeće rezultate:
English: Ireland Chanelle Pharmaceuticals Manufacturing Ltd.
Croatian: Chanelle Pharmaceuticals Manufacturing Ltd.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Upitajte svojeg veterinara ili ljekarnika kako odlagati lijekove koji vam više nisu potrebni.
English: Labelling:
Croatian: Označivanje:
English: • The study should be performed in one or more European geographical regions, representing worst case climatic and epidemiological conditions and adjacent to small water bodies.
Croatian: • Ispitivanje treba provesti u jednoj ili više zemljopisnih regija Europe s najgorim klimatskim i epidemiološkim uvjetima, u blizini malih vodnih tijela.
English: P. promelas (early life stages)
Croatian: P. promelas (rani životni stadiji)
English: The EC50 and the NOEC were established as >86.9 µg/l and 86.9 µg/l.
Croatian: Ustanovljeno je da su EC50 i NOEC > 86,9 µg/l i 86,9 µg/l.
English: However, toxicity to sediment-dwelling organisms is still very likely.
Croatian: Međutim, toksičnost za organizme koji žive u sedimentu još uvijek je vrlo vjerojatna.
English: Add, to all products:
Croatian: Za sve proizvode potrebno je dodati:
English: Germany CC-Pharma GmbH In den Feldern 2
Croatian: Njemačka CC-Pharma GmbH In den Feldern 2
English: The abovementioned data should be provided to the CVMP for assessment not later than 5 years after the Commission Decision on this referral procedure.
Croatian: CVMP-u treba dostaviti prethodno navedene podatke radi ocjenjivanja najkasnije pet godina nakon donošenja Odluke Komisije o ovom arbitražnom postupku.
English: 4.5 Special precautions for use
Croatian: 4.5. Posebne mjere opreza pri uporabi
English: Ireland Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
Croatian: Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
English: NOEC: the concentration in the study at which no effects are observed.
Croatian: NOEC: koncentracija u ispitivanju pri kojoj nisu zapaženi učinci.
English: Moxidectin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
Croatian: Moksidektin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
English: Concentration
Croatian: Koncentracija
English: Daphnia magna (acute)
Croatian: Daphnia magna (akutno)
English: Horse and Pony
Croatian: Konji i poniji
English: Not determined
Croatian: Nije utvrđeno
English: The aforementioned internal and external parasites are recognised as causing significant loss of production and negatively impacting on animal welfare.
Croatian: Prethodno navedeni unutarnji i vanjski paraziti poznati su kao uzročnici znatnih gubitaka u uzgoju te negativno utječu na dobrobit životinja.
English: • Moxidectin is inherently toxic to aquatic organisms including fish.
Croatian: • Moksidektin je inherentno toksičan za vodene organizme, uključujući ribe.
English: To mitigate this risk, all precautions for use and disposal must be adhered to.
Croatian: Kako bi se taj rizik ublažio, moraju se poštovati sve mjere opreza pri uporabi i odlaganju.
English: The Committee was also asked to recommend whether the marketing authorisations for the aforementioned veterinary medicinal products should be maintained, varied, suspended or withdrawn.
Croatian: Također je zatraženo da Odbor preporuči treba li odobrenja za stavljanje navedenih veterinarsko-medicinskih proizvoda u promet zadržati, izmijeniti, obustaviti ili opozvati.
English: Mineralisation (evolution of 14CO2) accounted for up to 5% of the applied radioactivity.
Croatian: Na mineralizaciju (stvaranje 14CO2) je otpadalo do 5 % primijenjene radioaktivnosti.
English: • Evidence of a trend i.e. increasing/decreasing concentrations or plateau.
Croatian: • dokaze o trendovima tj. o povećanju/smanjenju koncentracija ili platou (stabilno stanje).
English: • Concentrations of moxidectin in the different target matrices.
Croatian: • koncentracije moksidektina u različitim ciljnim medijima;
English: Co. Down, BT35 6JP
Croatian: Down BT35 6JP
English: When considering persistence under field conditions, the Committee acknowledged that degradation mechanisms exist and that a soil temperature of 12 °C might not be representative for all European regions.
Croatian: Pri razmatranju postojanosti u terenskim uvjetima, Odbor je potvrdio da mehanizmi razgradnje postoje te da temperatura tla od 12 °C možda nije reprezentativna za sve europske regije.
English: The CVMP considered that such warning is not in line with good agricultural practice and therefore should be deleted from the product information.
Croatian: CVMP je zaključio da takvo upozorenje nije u skladu s dobrom poljoprivrednom praksom te da ga stoga treba ukloniti iz informacija o VMP-u.
English: Environmental profile of alternatives
Croatian: Okolišni profil alternativa
English: As the mean recovery of moxidectin at the end of the study (63 days) was less than 50%, a value of 63 days is used as half-life value of moxidectin.
Croatian: Budući da je srednja vrijednost obnavljanja moksidektina na kraju ispitivanja (63 dana) bila manja od 50 %, vrijednost od 63 dana upotrebljava se kao vrijednost poluvijeka moksidektina.
English: Levels of radioactivity recovered in the organic soil extracts at the end of the study at day 63 ranged between 74-82%.
Croatian: Razine obnovljene radioaktivnosti u ekstraktima organskog tla 63. dana, na kraju ispitivanja, bile su u rasponu od 74 do 82 %.
English: Material balance, calculated as the percent of applied radioactivity, was maintained within guideline specification (90-110% of applied radioactivity) for all four soils.
Croatian: Materijalna ravnoteža, izračunana kao postotak primijenjene radioaktivnosti, održavana je unutar specifikacija smjernica za sve četiri vrste tla (90 - 110 % primijenjene radioaktivnosti).
English: On the other hand, there is evidence from literature (Prichard et al., 2012)18 that the resistance against avermectins and moxidectin is not always genetically identical, which implies that avermectin resistant parasite strains can be successfully treated with moxidectin.
Croatian: S druge strane, u literaturi postoje dokazi (Prichard et al., 2012.)18 da otpornost na avermektine i moksidektin nije uvijek genetski istovjetna, što ukazuje na to da se sojeve parazita koji su otporni na avermektine može uspješno tretirati moksidektinom.
English: Via Andrea Doria, 41 M 00192 Roma Italy
Croatian: Zoetis Italia S.r.l. Via Andrea Doria, 41 M 00192 Roma Italy
English: A terrestrial plant study with 12 weed species was also provided which was considered not relevant for the current assessment.
Croatian: Također je dostavljeno ispitivanje na kopnenim biljkama koje je uključivalo 12 vrsta korova, a koje se ne smatra relevantnim za ovu ocjenu.
English: Technical Assistance Document no. 4.12 Earthworm Subacute
Croatian: 4.12 Earthworm Subacute
English: Non-extractable residues accounted for 4-10% of the radioactivity applied to the soil.
Croatian: Na neekstrahirajuće ostatke otpadalo je od 4 do 10 % primijenjene radioaktivnosti u tlu.
English: Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.
Croatian: Liječenje treba provoditi samo kad je potrebno i treba se temeljiti na broju jajašaca u fecesu ili procjeni rizika od infestacije na razini životinje i/ili stada.
English: This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
Croatian: To znači da bi moksidektin, ako bi se dopustio njegov ulazak u vodna tijela, mogao imati ozbiljan i dugotrajan učinak na vodeni okoliš.
English: The bioconcentration factors were also determined as a function of lipid content of the fish following normalisation for a lipid content of 5%.
Croatian: Faktori biokoncentracije također su određeni kao funkcija sadržaja lipida u ribama nakon normiranja sadržaja lipida od 5 %.
English: Both studies were performed with Chironomus riparius exposed via spiked sediment.
Croatian: Oba ispitivanja provedena su na vrsti Chironomus riparius, izloženoj putem sedimenta u koji je dodana ispitivana tvar.
English: In conclusion, withdrawal of veterinary medicinal products containing moxidectin from the European market would limit the number of adequate therapeutic alternatives which is not considered desirable from a resistance perspective.
Croatian: Zaključno, povlačenjem veterinarsko-medicinskih proizvoda koji sadržavaju moksidektin s europskog tržišta ograničio bi se broj odgovarajućih mogućnosti za liječenje, što nije poželjno iz perspektive rezistencije.
English: In case of insufficient space on the label: SPECIAL WARNING(S), IF NECESSARY
Croatian: U slučaju nedostatnog prostora na naljepnici: POSEBNO(-A) UPOZORENJE(-A), AKO JE(SU) POTREBNO(-A)
English: Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.
Croatian: Ipak, u slučaju ponavljanja tretmana moksidektinom (kao i proizvodima istog razreda antihelmintika) preporučuje se da se životinje ne tretiraju svaki put na istom pašnjaku kako bi se omogućio oporavak faune prisutne u gnoju.
English: The CVMP considered that assessment of secondary poisoning can only be used as supportiveinformation but is not part of the PBT assessment.
Croatian: CVMP je zaključio da se procjena sekundarnog trovanja može upotrijebiti samo kao popratna informacija, ali da nije dio procjene svojstava PBT.
English: However, it has to be noted that the use of QSAR values as a substitute for experimental data for pharmaceuticals is not supported as no validated models are available for pharmaceuticals.
Croatian: Međutim, potrebno je napomenuti da se kod farmaceutskih proizvoda ne podupire uporaba vrijednosti dobivenih modelom QSAR umjesto pokusnih podataka jer nema provjerenih modela za farmaceutske proizvode.
English: The subsequent evaluation of data generated further to the fulfilment of these conditions should be undertaken by the CVMP due to the complexity of the data thus generated and in the interest of maintaining the harmonised EU approach achieved by this referral procedure.
Croatian: Naknadnu procjenu podatka koji su dodatno izrađeni radi ispunjavanja tih uvjeta treba provesti CVMP zbog složenosti podataka izrađenih na takav način te u cilju održavanja usklađenog pristupa EU-a postignutog ovim arbitražnim postupkom.
English: It was concluded that moxidectin degrades in soil with a dissipation half-life (DT50) of approximately 2 months and slowly mineralises.
Croatian: Zaključeno je da se moksidektin razgrađuje u tlu s vremenom poluraspada (DT50) od otprilike dva mjeseca te da se polako mineralizira.
English: A risk to the environment has been identified which can be partially mitigated by appropriate risk mitigation measures.
Croatian: Utvrđen je rizik za okoliš, koji se može djelomično ublažiti odgovarajućim mjerama za ublažavanje rizika.
English: The duration of the uptake (exposure) and depuration phases were 28 and 49 days, respectively.
Croatian: Faza apsorpcije i faza izlučivanja trajale su 28 odnosno 49 dana.
English: 6100 (horse, oral)
Croatian: 6100 (konji, peroralna primjena)
English: Detailed information on the field study design (protocol), including proposals for timelines for the provision of interim reports, should be submitted to the CVMP.
Croatian: CVMP-u treba dostaviti detaljne informacije o izvedbi terenskog ispitivanja (protokolu), uključujući prijedloge vremenskih rokova za podnošenje privremenih izvješća.
English: Residues in dung were toxic to dung flies for more than 7 days or for more than 28 days after treatment, depending on study duration, species and formulation.
Croatian: Ostatci u gnoju bili su toksični za jesenju kućnu muhu više od sedam dana ili više od 28 dana nakon tretiranja, ovisno o trajanju ispitivanja, vrsti i formulaciji.
English: That is, the marketing authorisation holders argued that mean land surface temperatures during spring/summer in predominant agricultural regions in Europe are likely to be higher leading to a faster degradation.
Croatian: To jest, nositelji odobrenja za stavljanje VMP-a u promet tvrdili su da je vjerojatno da će temperature površine tla tijekom proljeća i ljeta u pretežno poljoprivrednim regijama Europe biti više i rezultirati bržom razgradnjom.
English: The conditions imposed on the marketing authorisations are described in Annex IV.
Croatian: Uvjeti određeni za odobrenja za stavljanje VMP-a u promet opisani su Prilogu IV.
English: As no valid and reliable higher Tier studies were provided, the PNECs derived from the Tier A standard laboratory studies with spiked cattle manure are used for further risk assessment for all target species.
Croatian: Budući da nisu dostavljena valjana i pouzdana ispitivanja više razine, PNEC-ovi izvedeni iz standardnih laboratorijskih ispitivanja razine A s kravljim gnojem u koji je dodana ispitivana tvar upotrebljavaju se za daljnje procjene rizika za sve ciljne vrste.
English: In a second study with Raphidocelis subcapitata over 72 hours, no inhibition in the growth was noted at 86.9 µg/l, the highest concentration tested.
Croatian: U drugom ispitivanju na vrsti Raphidocelis subcapitata tijekom 72 sata nije primijećena inhibicija rasta na najvišoj ispitnoj koncentraciji od 86,9 µg/l.
English: As exposure of aquatic organism is unlikely to occur, the toxicity will be reduced significantly.
Croatian: S obzirom na malu vjerojatnost izloženosti vodenih organizama, toksičnost bi bila znatno manja.
English: Based on the [3H]-residues as [3H]-moxidectin in the test media, the bioconcentration factors for whole fish tissue were as follows:
Croatian: Na temelju ostataka [3H] kao [3H]-moksidektina u ispitnom mediju, faktori biokoncentracije za cjelokupno tkivo ribe jesu sljedeći:
English: However, when considering PBT status, the established criteria are based on evaluation of persistence at a soil temperature of 12 °C and this is accepted as mean European temperature.
Croatian: Međutim, pri razmatranju statusa s obzirom na svojstva PBT, uspostavljeni kriteriji temelje se na procjeni postojanosti pri temperaturi tla od 12 °C, što je prihvaćeno kao srednja vrijednost temperature u Europi.
English: So far, no criteria for bioaccumulation assessment in sediment or soil organisms have been established and the classification is based on the standard bioaccumulation study in fish.
Croatian: Dosad nisu ustanovljeni kriteriji za procjenu bioakumulacije u organizama koji žive u sedimentu ili tlu te se razvrstavanje temelji na standardnom ispitivanju bioakumulacije u riba.
English: The final study report should be submitted to the CVMP for assessment.
Croatian: CVMP-u treba dostaviti završno izvješće o ispitivanju radi ocjenjivanja.
English: The mean DT50 value was 104 days at 20 °C and 222 days normalised to 12 °C.
Croatian: Srednja vrijednost za DT50 iznosila je 104 dana pri 20 °C i 222 dana normalizirana na 12 °C.
English: If the study is conducted in one geographical region, the marketing authorisation holders should justify that this is truly the worst case.
Croatian: Ako se ispitivanje provede u jednoj zemljopisnoj regiji, nositelji odobrenja za stavljanje VMP-a u promet trebaju potvrditi da je zaista riječ o najgorem mogućem slučaju.
English: EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
Croatian: EC50: koncentracija koja rezultira s 50 % neželjenih učinaka na jedinkama vrste na kojoj je provedeno ispitivanje, tj. smrtnosti i subletalnih učinaka.
English: Germany Zoetis Deutschland GmbH Schellingstr.
Croatian: Njemačka Zoetis Deutschland GmbH Schellingstr.
English: PBT substances pose a hazard where the fate and behaviour in the environment and its toxicity in the long-term cannot be predicted.
Croatian: Tvari sa svojstvima PBT predstavljaju opasnost jer se njihova sudbina i ponašanje u okolišu te njihova dugoročna toksičnost ne mogu predvidjeti.
English: Therefore, on 22 October 2015, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses.
Croatian: Njemačka je stoga 22. listopada 2015. pokrenula arbitražni postupak u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadržavaju moksidektin za peroralnu, topikalnu ili supkutanu primjenu u goveda, ovaca i konja.
English: The following conditions should be fulfilled by all marketing authorisation holders: Conditions
Croatian: Svi nositelji odobrenja za stavljanje VMP-a u promet trebaju ispuniti sljedeće uvjete: Uvjeti
English: It can be concluded that there is a negligible risk for secondary poisoning from moxidectin.
Croatian: Može se zaključiti da je rizik od sekundarnog trovanja moksidektinom zanemariv.
English: The bioconcentration factor was also calculated as the ratio between uptake rate constant (k1) and depuration rate constant (k2).
Croatian: Faktor biokoncentracije također je izračunan kao omjer između konstante brzine apsorpcije (k 1) i konstante brzine izlučivanja (k 2).
English: In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:
Croatian: Konkretno, ispitivanjima akutne i kronične toksičnosti za alge, ljuskare i ribe pokazalo se da je moksidektin toksičan za te organizme te su utvrđene sljedeće krajnje točke:
English: In the second study no effects on D. magna survival and reproduction were seen at a concentration of 10 ng/l over the test period.
Croatian: U drugom ispitivanju nisu zamijećeni učinci na preživljavanje i reprodukciju vrste D. magna tijekom ispitnog razdoblja pri koncentraciji od 10 ng/l.
English: Horse
Croatian: Konji
English: Within 12 months of Commission Decision for this procedure
Croatian: U roku od 12 mjeseci od donošenja Odluke Komisije o ovom postupku
English: Within 60 months of
Croatian: U roku od 60 mjeseci od donošenja Odluke
English: Avermectins have a very similar broad spectrum of activity, but partly achieved through different mode of action on glutamate-gated chloride channel receptors in nematode and arthropod cells, and efflux pathways at molecular levels.
Croatian: Avermektini imaju vrlo sličan širok spektar djelovanja, no on se djelomično ostvaruje različitim načinom djelovanja na receptore glutamatnih kloridnih kanala u stanicama nematoda i artropoda te na mehanizme ispumpavanja na molekularnim razinama.
English: 0.025 (cattle, pour-on)
Croatian: 0,025 (goveda, polijevanje po koži)
English: Delete, where applicable, the following sentence: ‘Risk to dung fauna may be reduced by avoiding treatment that coincides with periods of local high activity of dung beetles.
Croatian: Potrebno je izbrisati sljedeću rečenicu gdje je to primjenjivo: „Rizik za faunu prisutnu u gnoju može se smanjiti izbjegavanjem primjene koja se podudara s razdobljima visoke lokalne aktivnosti balegara.”
English: • Indication for seasonal variation of the moxidectin concentrations due to different temperature, humidity, soil properties and, if applicable, for regional variation as well.
Croatian: • pokazatelje sezonskih razlika u koncentracijama moksidektina na osnovi različite temperature, vlage, svojstava tla te, ako je primjenjivo, regionalnih razlika;
English: Zoetis B.V.
Croatian: Nizozemska Zoetis B.V.