natgillin/translations-raw huggingface dataset:
1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link results was submitted and study methods were poorly reported (no study protocols, no raw data, no statistical analysis). 
1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no.
Czech Republic MIKROP ČEBÍN a.s. Čebín 416 
MIKROP ČEBÍN a.s.
Regarding the potential for risk reduction when complying with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to limit direct entry to water courses, but would not affect the zinc reaching water surface by leaching and run-off processes. 
U pogledu mogućnosti smanjenja rizika ako postoji usklađenost s lokalnim ili nacionalnim pravilima za najmanju udaljenost od otvorene vode na kojoj bi gnojivo smjelo biti rasprostranjeno, CVMP smatra da bi to bilo primjenjivo samo na granice izravnog ulaženja u vodene tokove, ali ne bi utjecalo na dospijevanje cinka do površine vode kroz ispiranje i otjecanje.
According to recently published data, zinc used in animal farming might promote the spread of antibiotic resistance due to co-resistance. 
Prema novijim objavljenim podatcima, cink koji se koristi na farmama životinja može poticati širenje rezistencije na antibiotike zbog korezistencije.
MEDITEK Zn 500 mg/g premix pro medikaci krmiva 
Zn 500 mg/g premix pro medikaci krmiva
33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land. 
Stoga CVMP smatra da će prethodno preporučene mjere za smanjenje rizika u okviru postupka prema članku 33. stavku 3. Direktive 2001/82 za Gutal (EMEA/V/A/108), samo odgoditi rizike utvrđene za sve dijelove okoliša ako se gnojivo svinja liječenih veterinarsko-medicinskim proizvodom koji sadrži cinkov oksid nanosi na zemlju.
13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15. 
14 Arche Consulting Soil PNEC calculator - link 15 ECHA, 2014.
Considering the use of these products, current EU rules and Good Agricultural Practice on manure spreading, how the target animals are kept and how manure is managed, the suggested risk mitigation measures (dilution of manure and distance to surface waters), although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were recommended for the referral procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate either the imminent and future environmental risks identified from the risk assessment, but will just delay the total zinc accumulation in the environment (i.e. the time when the PEC will exceed the PNECs). 
S obzirom na upotrebu tih proizvoda, sadašnja pravila i dobra poljoprivredna praksa za primjenu gnojiva EU-a, kako se drže ciljane životinje te kako se barata gnojivom, navedene mjere za smanjenje rizika (razrjeđenje gnojiva i udaljenost od površinskih voda), iako su u skladu sa smjernicom CVMP/VICH (CVMP/VICH/790/03) i preporučene su za postupak arbitraže prema članku 33(4) Direktive 2001/82 za Gutal (EMEA/V/A/108) kako bi se smanjila
• the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated; 
• CVMP smatra da je dokazana djelotvornost veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za sprječavanje proljeva u prasadi nakon razdoblja prestanka sisanja;
Although during the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure, and despite being in line with the criteria set out by the CVMP reflection paper on risk mitigation measures23, it may prove difficult to enact in reality; not only in instances where there may not be the possibility to apply 
Iako se tijekom prethodno spomenutog postupka arbitraže za Gutal kao moguća mjera za smanjenje rizika smatrala mogućnost da se gnojivo ne nanosi na istu površinu zemlje tijekom uzastopnih godina kako bi se usporila akumulacija cinka, te unatoč tome što je u skladu s kriterijima navedenim u mišljenju CVMP-a o mjerama za smanjenje rizika23, to se može pokazati teško provedivim u stvarnosti, ne samo u slučajevima gdje možda ne postoji mogućnost nanošenja obrađenog gnojiva na različite površine zemlje, nego i zbog trgovine gnojivom između država članica i mogućnosti da se na osjetljive tipove tla nanosi gnojivo s visokim koncentracijama cinkova oksida.
However, while the marketing authorisation holder claims a lower exposure and annual load from their products compared to other zinc oxide veterinary medicines, they have not submitted data supporting a quantitative risk assessment, and have not considered that, while their conclusion on a limited environmental release of zinc oxide was estimated from the use of these products on 3-4 week old piglets (7-8 kg), the claim for their products is for pigs up to 40 kg/bw, and treating heavier pigs would also increase the environmental load. 
Nadalje, nositelj odobrenja za stavljanje u promet nije uzeo u obzir da su njihovi zaključci o ograničenom ispuštanju cinkova oksida bili procijenjeni na temelju upotrebe tih proizvoda u prasadi od 3 - 4 tjedna (7 - 8 kg), dok se zahtjev povezan s njihovim proizvodima odnosi na svinje do 40 kg tjelesne težine, a liječenje težih svinja povećalo bi i opterećenje za okoliš.
On 1 February 2016, the Netherlands and France presented to the European Medicines Agency a referral notification in accordance with Article 35 of Directive 2001/82/EC for veterinary medicinal products containing zinc oxide to be administered orally to food producing species, due to concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide. 
Nizozemska i Francuska podnijele su Europskoj agenciji za lijekove obavijest o arbitražnom postupku u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže cinkov oksid, a namijenjeni su za peroralnu primjenu u vrsta životinja od kojih se proizvodi hrana.
Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching surface water and drinking water by leaching and run-off processes. 
S obzirom na mjere smanjenja rizika koje bi bile usklađene s lokalnim ili nacionalnim propisima za najmanju udaljenost od otvorene vode na kojoj bi gnojivo smjelo biti rasprostranjeno, CVMP smatra da bi to bilo primjenjivo samo za sprječavanje izravnog ulaženja u vodene tokove, ali ne bi utjecalo na ulaženje cinka u površinske vode i pitku vodu kroz procese ispiranja i otjecanja.
Zinc oxide Sulfaguanidin um 
Cinkov oksid Sulfagvanidin
10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no. EMEA/V/A/106) - link 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link combination. 
10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no.
Johansen M., Jørgensen L and Schultz M.S., 2007. 
Johansen M., Jørgensen L and Schultz M.S., 2007. Effect of zinc and organic acids on diarrhoea in the weaner period.
Whereas 
Stoga, u
The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)14 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity. 
12 European Union Risk Assessment Report (EU RAR) on zinc (2010) - link 13 Metal bioavailability assessment tool (M-BAT) - link proveden je primjenom kalkulatora Excel alata za PNEC tla (razvila ga je tvrtka Arche Consulting)14 u koji su ugrađeni parametri relevantni za određivanje bioraspoloživosti cinka u tlu poput pH, organskog udjela i udjela gline, te kapaciteta izmjene kationa.
Zinc oxide 492 mg/g 
Cinkov oksid 492 mg/g Premiks
Sulfaguanidine and zinc oxide combination 
Kombinacija sulfagvanidina i cinkova oksida
Combination of zinc oxide and colistin or sulfaguanidine Based on the data presented, the combinations of zinc oxide, recommended for the prevention of unspecific diarrhoea during the post-weaning period, with any antimicrobial substance recommended for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), are not justified. 
Na temelju navedenih podataka, kombinacije cinkova oksida preporučene za sprječavanje nespecifičnog proljeva u razdoblju nakon prestanka sisanja i bilo koje antimikrobne tvari preporučene za liječenje i metafilaksu proljeva izazvanog ciljanim patogenom/patogenima nisu opravdane.
The percentage of piglets with diarrhoea was significantly influenced by the administration of zinc in feed. 
Primjena cinka u hrani značajno je utjecala na postotak prasadi s proljevom.
Consequently, the CVMP considers that the environmental risk assessment provided during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108) is scientifically sound and should be used in the benefit-risk evaluation for products containing zinc oxide to be administered orally to food producing species. 
Stoga CVMP smatra da je procjena rizika za okoliš navedena u arbitražnom postupku prema članku 33. stavku 4. Direktive 2001/82/EZ za Gutal (EMEA/V/A/108) znanstveno opravdana i treba se upotrijebiti
23 CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link treated manure to different areas of land, but also because of the trade on manure between Member States and possibility for manure containing high concentrations of zinc oxide being used in susceptible soil types. 
11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link u procjeni koristi i rizika za proizvode koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja namijenjenih za proizvodnju hrane.
Zinc oxide 600 mg/g 
Cinkov oksid 600 mg/g Premiks
Zinc oxide 622 mg/g 
Cinkov oksid 622 mg/g Premiks
Supporting field studies on zinc accumulation in soils were not available during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108). 
U postupku arbitraže prema članku 33(4) Direktive 2001/82/EZ za Gutal (EMEA/V/A/108) potporna terenska ispitivanja akumulacije cinka u tlu nisu bila dostupna.
Date of first authorisation: 15/01/2015 Date of last renewal: 
Datum prvog odobrenja: 15/01/2015 Datum posljednjeg produljenja odobrenja:
The absolute bioavailability is 88%. 
Apsolutna bioraspoloživost bila je 88%.
ATC vet code: QP54AB51. 
ATCvet broj: QP54AB51.
- Wash hands after use. 
- Operite ruke nakon rukovanja s proizvodom.
The terminal plasma half-life is approximately 2 weeks in dogs. 
Terminalno vrijeme poluraspada u plazmi je otprilike 2 tjedna u pasa.
If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon. 
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
For oral use. 
Za peroralnu uporabu.
Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity. 
Stoga, istovremeno liječenje s ostalim P-gp supstratima može uzrokovati pojačanu toksičnost.
In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian. 
U nedostatku dostupnih podataka, liječenje štenaca s manje od 8 tjedana starosti i pasa s manje od 2 kg tjelesne težine treba se temeljiti na procjeni odnosa koristi i rizika odgovornog veterinara.
Number and strength of tablet to be administered 
Broj i jačina tableta koje treba primijeniti
For dogs above 60 kg appropriate combinations of chewable tablets should be used. 
Za pse iznad 60 kg tjelesne težine, treba koristiti odgovarajuće kombinacije žvakaćih tableta.
Bodyweight (kg) of dog 
Tjelesna težina psa (kg)
No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose. 
Nepovoljne reakcije nisu zabilježene kod zdravih štenaca u dobi od 8 tjedana nakon 6 primjena doze do 5 puta veće od maksimalne doze.
The veterinary medicinal product should be administered in accordance with the following table: 
Veterinarsko-medicinski proizvod treba se primijeniti u skladu prema sljedećoj tabeli:
Use only according to the benefit-risk assessment by the responsible veterinarian. 
Koristite samo prema procjeni odnosa koristi-rizika od strane odgovornog veterinara.
- In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician. 
Ako se dogodi slučajna ingestija, naročito ako se radi o djetetu, odmah potražite savjet liječnika i pokažite mu uputu ili etiketu ovog proizvoda.
Ask your veterinary surgeon how to dispose of medicines no longer required. 
Pitajte vašeg veterinara kako odlagati veterinarsko-medicinske proizvode koji više nisu potrebni.
Treatment should continue until 1 month after the last exposure to mosquitoes. 
Liječenje treba nastaviti do mjesec dana nakon zadnjeg mogućeg izlaganja komarcima.
These occurrences were generally self-limiting and of short duration. 
navedene nuspojave uglavnom su prolazile same od sebe i kratko bi trajale.
The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu). 
Veterinarskomedicinski proizvod pojedinačno pakiran u termoformirane lamelirane PVC blistere s papirno-aluminijskom podlogom (Aclar/PVC/Alu).
4 Chemin du Calquet 31000 Toulouse FRANCE 
4 Chemin du Calquet 31000 Toulouse FRANCUSKA
Milbemycin oxime: 
Milbemicin oksim:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Svaki neiskorišteni veterinarsko-medicinski proizvod ili otpadni materijal koji potječe od njega treba zbrinuti u skladu s lokalnim propisima.
It is a fermentation product of Streptomyces milbemycinicus. 
Radi se o produktu fermentacije Streptomyces milbemycinicus.
Further monthly administrations of the product may be required based on clinical assessment and skin scrapings. 
Dodatne mjesečne primjene proizvoda moguće je preporučiti na temelju kliničkog pregleda i pretrage strugotina kože.
Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. 
Afoksolaner ubija buhe prije početka produkcije jajašaca i na taj način sprečava kontaminaciju domaćinstva.
Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class. 
Rezistencija parazita na neku određenu grupu paraziticida može se razviti kao posljedica česte i ponavljane primjene proizvoda određene grupe.
If the dog does not accept the tablets directly, they may be administered with food. 
Ako pas ne prihvati tabletu izravno, mogu se primjenjivati s hranom.
To establish a treatment routine, it is recommended that the same day or date be used each month. 
Kako bi uspostavili rutinu liječenja preporuča se aplicirati proizvod u istom danu u mjesecu tijekom određenog broja mjeseci.
The treatment schedule should be based on veterinary diagnosis and on the local epidemiological situation. 
Raspored liječenja: Raspored liječenja treba se temeljiti na veterinarskoj dijagnozi i na lokalnoj epidemiološkoj situaciji.
Soy protein fines Beef braised flavouring Povidone (E1201) Macrogol 400 
Pirjana aroma govedine Povidon (E1201)
It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). 
Može se koristiti kao dio strategije liječenja u smislu kontrole alergijskog dermatitisa uzrokovanog buhama (FAD).
4 Chemin du Calquet, 31000 Toulouse, 
4 Chemin du Calquet, 31000 Toulouse, FRANCUSKA
The tablets are chewable and palatable to most dogs. 
Tablete za žvakanje ukusne su za većinu pasa.
The absolute bioavailability is 81% and 65% for the A3 and A4 forms, respectively. 
Apsolutna bioraspoloživost je 81% i 65% za A3 i
Milbemycin oxime contains two major components, A3 and A4 (ratio of 20:80 for A3:A4). 
Milbemicin oksim sadržidvije glavne komponente, A3 i A4 (u međusobnom odnosu 20:80 za A3:A4).
Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. 
Produžena hiperekscitacija uzrokovana afoksolanerom ima za posljedicu nekontroliranu aktivnost središnjeg živčanog sustava i smrt insekata ili akarida.
Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations. 
Farmakoterapijska skupina: antiparazitski proizvod, endektocid, milbemicin kombinacije.
This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites. 
Na ovaj način dolazi do hiperpolarizacije neuromuskularne membrane i posljedične paralize i smrti parazita.
The mean maximum concentration (Cmax) is 1822 ± 165 ng/ml in plasma found 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose. 
Srednja maksimalna koncentracija (Cmax) je 1822 ± 165 ng/ml u plazmi 2-4 sata (Tmax) nakon 2,5 mg/kg doze afoksolanera.
Both forms have low systemic clearance (75 ± 22 ml/h/kg for the A3 form and 41 ± 12 ml/h/kg for the A4 form). 
Oba oblika imaju niski sustavni klirens (75 ± 22 ml/h/kg za A3 oblik i 41 ± 12 ml/h/kg za A4 oblik).
The veterinary medicinal product should be administered at a dose of 2.50-5.36 mg/kg of afoxolaner and 0.50-1.07 mg/kg of milbemycin oxime in accordance with the following table: 
Veterinarsko-medicinski proizvod treba se primijeniti u dozi od 2,50-5,36 mg/kg afoksolanera i 0,50-1,07 mg/kg milbemicin oksima u skladu prema slijedećoj tabeli:
NEXGARD SPECTRA is not indicated for removal of microfilariae from positive dogs. 
SPECTRA se ne koristi za uklanjanje mikrofilarija iz organizma pozitivnih pasa.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 
Zadržavanje učinkovitosti makrolidnih laktona je od kritične važnosti za kontrolu parazita Dirofilaria immitis.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. 
Nemojte koristiti nakon isteka roka valjanosti koji je naveden na pakovanju nakon EXP.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. 
Neškodljivost veterinarsko medicinskog proizvoda nije ispitana tijekom graviditeta i laktacije ili u rasplodnih pasa.
Special warnings for each species: 
Posebna upozorenja za svaku ciljnu vrstu:
Therefore, the use of this product should be adapted to each individual case based on local information relating to disease status, including current susceptibility of the target parasites to the active substances in this product, in order to limit the possibility of a future selection for resistance. 
Stoga korištenje ovog proizvoda treba biti prilagođeno individualnom slučaju na osnovi informacija vezanih uz status i prisutnost neke bolesti, uključujući osjetljivost ciljanog parazita na djelatne tvari iz ovog proizvoda, kako bi se ograničila mogućnost selekcije u smislu rezistencije.
The terminal half-lives and maximum concentrations (Cmax) following oral administration are 1.6 ± 0.4 days and 42 ± 11 ng/ml for the A3 form, 3.3 ± 1.4 days and 246 ±71 ng/ml for the A4 form. 
Terminalno vrijeme poluraspada i maksimalne koncentracije (Cmax) nakon oralne primjene su 1,6 ± 0,4 dana i 42 ± 11 ng/ml za A3 oblik, 3,3 ± 1,4 dana i 246 ±71 ng/ml za A4 oblik.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 
Rok valjanosti kad je zapakiran za prodaju: 2 godine.
Therefore, the product should be administered at regular monthly intervals during the time of the year when mosquitoes are present, starting in the month after the first expected exposure to them. 
Stoga proizvod treba primijeniti u redovitim mjesečnim intervalima tijekom dijela godine kad su komarci prisutni, s početkom u mjesecu nakon prvog mogućeg izlaganja komarcima.
Further treatments may be indicated throughout the flea and/or tick season. 
Daljnje liječenje može biti indicirano tijekom sezone krpelja i buha.
NEXGARD SPECTRA kills Dirofilaria immitis larvae up to one month after their transmission by mosquitoes, therefore the product should be administered at regular monthly intervals during the time of the year when vectors are present, starting in the month after the first expected exposure to mosquitoes. 
NEXGARD SPECTRA ubija Dirofilaria immitis larve tijekom mjesec dana nakon transmisije preko vektora komarca te se zato proizvod treba primijeniti u redovitim mjesečnim intervalima tijekom dijela godine kad su vektori prisutni, s početkom u mjesecu nakon prvog mogućeg izlaganja komarcima.
Milbemycin oxime is a substrate for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones. 
Milbemicin oksim je supstrat za P-glikoprotein (P-gp) te stoga može imati interakciju s drugim P-gp supstratima (na primjer digoksin, doksorubicin) ili s drugim makrocikličkim laktonima.
Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance. 
Stoga, korištenje ovog proizvoda treba biti temeljeno na procijeni individualnog slučaja i na epidemiološkim informacijama s obzirom na izloženost ciljane skupine životinja kako bi se ograničila mogućnost selekcije u smislu rezistencije.
To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment. 
Kako bi se smanjio rizik rezistencije kroz selekciju preporučamo da se psa testira na postojanje antigena u cirkulaciji i na prisutnost mikrofilarija u krvi prije sezonske primjene preventivne zaštite.
NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes. 
NEXGARD SPECTRA ubija larve Dirofilaria immitis (larve srčanog crva) tijekom mjesec dana nakon transmisije preko komarca.
Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. 
Milbemicin oksim je antiparazitski endektocid koji spada u grupu makrocikličkih laktona.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity in males and females. 
Laboratorijski pokusi na štakorima i kunićima nisu dali dokaz teratogenog učinka, ili bilo kakvog nepovoljnog učinka na reproduktivnu sposobnost mužjaka i ženki.
- This product may cause gastrointestinal disturbances if ingested. 
- Ovaj proizvod može uzrokovati gastrointestinalne smetnje u slučaju ingestije.