FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection
Croatian: NAZIV GOTOVOG LIJEKA OPTISON 0,19 mg/ml disperzija za injekciju
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima Nisu provedena ispitivanja učinka lijeka na sposobnost upravljanja vozilima i rada na strojevima.
English: Paediatric population Efficacy and safety in patients below 18 years has not been studied.
Croatian: Djelotvornost i sigurnost primjene kod bolesnika mlađih od 18 godina nije ispitana.
English: In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Croatian: Primjena ljudskog albumina općenito je povezana s prolaznim poremećajem okusa, mučninom, crvenilom uz osjećaj vrućine, osipom, glavoboljom, povraćanjem, zimicom i vrućicom.
English: Undesirable Effects
Croatian: Nema poznatih učinaka.
English: As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it will also give enhanced echo signals in the left heart cavities.
Croatian: Budući da se sastoji od mikrosfera koje su stabilne i dovoljno male za transpulmonalni prolaz,
English: The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ml.
Croatian: mikrona i koncentraciju od 5-8 x 108 mikrosfera/ml.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: 10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: Anaphylactic reactions have been associated with the administration of human albumin products.
Croatian: Anafilaktičke reakcije povezane su s primjenom lijekova koji sadrže ljudski albumin.
English: In general the administration of human albumin has been associated with transient (non lasting) altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Croatian: Primjena ljudskog albumina općenito je povezana s prolaznim (kratkotrajnim) poremećajem okusa, mučninom, crvenilom uz osjećaj vrućine, osipom, glavoboljom, povraćanjem, zimicom i vrućicom.
English: Package leaflet: Information for the user OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres
Croatian: Uputa o lijeku: Informacija za korisnika OPTISON 0,19 mg/ml disperzija za injekciju mikrosfere s perflutrenom
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for injection should be injected at a rate of 1 ml/s to optimise the effect of the contrast agent.
Croatian: Odmah nakon ubrizgavanja lijeka OPTISON, mora se ubrizgati 10 ml otopine natrijeva klorida (9 mg/ml) za injekcije ili 50 mg/ml otopine glukoze za injekcije brzinom od 1 ml/s kako bi se optimizirao učinak kontrastnog sredstva.
English: What OPTISON contains - The active substance is perflutren-containing microspheres of heat treated human albumin 58 x 108/ml, suspended in human albumin solution 1%.
Croatian: - Djelatne tvari su 5-8 x 108/ml mikrosfere toplinski obrađenog ljudskog albumina s perflutrenom, suspendirane u 1% otopini ljudskog albumina.
English: Concentration: Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.54.5 µm.
Croatian: Koncentracija: 5-8 x 108/ml mikrosfera s perflutrenom, srednjeg promjera u rasponu 2,5 - 4,5 µm.
English: Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe.
Croatian: Iz tog razloga, prije uvlačenja suspenzije u štrcaljku za ubrizgavanje, probušite bočicu sterilnim probadačem ili sterilnom 18 G iglom.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Croatian: Manje česte nuspojave (pogađaju 1 do 10 na 1000 korisnika):
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s.
Croatian: Odmah nakon ubrizgavanja lijeka OPTISON morate ubrizgati 10 ml 0,9% (9 mg/ml) otopine natrijeva klorida za injekcije ili 5% (50 mg/ml ) otopinu glukoze za injekcije pri brzini ubrizgavanja od 1 ml/s.
English: When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and visualisation of wall motion and blood flow within the heart.
Croatian: Farmakoterapijska skupina: Ultrazvučno kontrastno sredstvo, ATK oznaka: V08D A01 Kada se koristi zajedno s dijagnostičkim ultrazvukom, OPTISON omogućuje opacifikaciju srčanih komora, poboljšanje obrisa endokardijalnog ruba, poboljšan Doppler signal i vizualizaciju kretanja srčane stijenke i protoka krvi unutar srca.
English: s r.o.
Croatian: M.G.P. spol. s r.o.
English: Therefore, caution should be exercised when OPTISON is administered to nursing women.
Croatian: Zato je potreban oprez u slučaju primjene lijeka OPTISON kod dojilja.
English: The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml.
Croatian: Lijek je dostupan u pakovanju od 1 bočice od 3 ml ili 5 bočica od 3 ml.
English: Common Rare
Croatian: Manje često
English: • Headache
Croatian: • Omaglica
English: No such finding was observed in the rat embryotoxicity study.
Croatian: U embriotoksikološkom ispitivanju na štakorima takvi učinci nisu primijećeni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains: Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, equivalent to 0.19 mg perflutren gas per ml.
Croatian: I KVANTITATIVNI SASTAV DJELATNIH TVARI 1 ml sadrži: 5 - 8 x 108 mikrosfera s perflutrenom, srednjeg raspona promjera 2,5 - 4,5 µm, što odgovara 0,19 mg perflutren plina po ml.
English: Ventricular tachycardia
Croatian: Ventrikularna tahikardija
English: 4.7 Effects on the ability to drive and use machines
Croatian: Upravljanje vozilima i strojevima
English: Warm sensation Chest pain
Croatian: • Osjećaj topline • Mučnina
English: MARKETING AUTHORISATION HOLDER GE Healthcare AS
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET GE Healthcare AS
English: PHARMACEUTICAL FORM AND CONTENTS 1 x 3 ml 5 x 3 ml METHOD AND ROUTE(S) OF ADMINISTRATION Ultrasound contrast medium.
Croatian: OBLIK I SADRŽAJ 1 x 3 ml
English: spol.
Croatian: Tel.
English: Talk to your doctor before using OPTISON - if you have any known allergies - if you have a severe heart, lung, kidney or liver disease.
Croatian: - ako imate dokazanih alergija, - ako imate tešku bolest srca, pluća, bubrega ili jetre.
English: See the package leaflet for further information.
Croatian: Daljnje informacije pročitajte u Uputi o lijeku.
English: Visual disturbances
Croatian: Smetnje vida
English: Via Galeno 36
Croatian: GE Healthcare S.r.l. Via Galeno 36
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: • Flushing (redness)
Croatian: • Parestezija (trnci)
English: Discard any unused portion.
Croatian: Neiskorišteni lijek zbrinuti.
English: OTHER GE Healthcare
Croatian: DRUGO GE Healthcare
English: In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Croatian: (npr. ozljedu stanica endotela, rupturu kapilara) pri interakciji s ultrazvučnim snopom.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS, Nycoveien 1, 0485 Oslo, Norway 12.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET GE Healthcare AS, Nycoveien 1, 0485 Oslo, Norveška 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/98/065/001 EU/1/98/065/002 13. BROJ SERIJE Serijski broj
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres Intravenous use METHOD OF ADMINISTRATION
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA NAZIV GOTOVOG LIJEKA OPTISON 0,19 mg/ml disperzija za injekciju mikrosfere s perflutrenom KVALITATIVNI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 May 1998
Croatian: DATUM PRVOG ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET/ DATUM OBNOVE ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČAVANJE I UPUTA O LIJEKU
English: Common side effects (affects 1 to 10 users in 100):
Croatian: Česte nuspojave (pogađaju 1 do 10 na 100 korisnika): • Dizgeusija (poremećaj okusa)
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Croatian: I SAŽETAK OPISA SVOJSTAVA LIJEKA
English: trgovina d.o.o.
Croatian: Biomedis M.B. trgovina d.o.o. Slokanova 12
English: 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari ljudski albumin natrijev klorid
English: The European reference product is Zanil which has been authorised for decades in several Member States of the European Union.
Croatian: Europski referentni proizvod je Zanil koji već desetljećima ima odobrenje za stavljanje u promet u nekoliko država članica Europske unije.
English: This is considered to represent a pragmatic approach, appropriate in the case of this referral.
Croatian: Takav se pristup smatra pragmatičnim te je prikladan u slučaju ovog arbitražnog postupka.
English: When the products are administered at the recommended doses, the available data supported:
Croatian: Kada se lijekovi primjenjuju u preporučenim dozama, dostupni podatci ukazuju na sljedeće:
English: Residues on day 21 were considered to be outliers and were excluded from the analysis.
Croatian: Rezidui na 21. dan smatraju se izuzetnima i isključeni su iz analize.
English: Milk: 108 hours (4.5 days).
Croatian: Mlijeko: 108 sati (4,5 dana).
English: These withdrawal periods are considered adequate to ensure consumer safety.
Croatian: Ta razdoblja karencije smatraju se primjerenima da bi omogućila sigurnost potrošača.
English: Tissue samples were analysed using a HPLC-MS/MS analytical method.
Croatian: Uzorci tkiva analizirani su pomoću analitičke metode HPLC-MS/MS.
English: This half-life was calculated to be approximately 1.1 days based on the pivotal cattle study (reported above).
Croatian: Računa se da taj poluvijek iznosi približno 1,1 dan na temelju glavnog ispitivanja na govedima (prethodno navedeno).
English: Both the immature and mature flukes are harmful to the target species.
Croatian: I zreli i nezreli metilji štetni su za ciljane vrste.
English: Norbrook Laboratories Limited
Croatian: Norbrook Laboratories Limited Station Works
English: Where cattle, sheep and/or goats have already been approved as target species the wording below relating to the relevant species should be used:
Croatian: Ako su goveda, ovce i/ili koze već odobrene kao ciljana vrsta, za relevantne vrste potrebno je koristiti tekst u nastavku:
English: Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Croatian: Fasciola hepatica (uobičajeni naziv: veliki metilj) uzročnik je fascioloze, jedne od ekonomski najvažnijih bolesti crijevnih parazita u stoke diljem svijeta.
English: Recalculated fat data (at 2, 4 and 7 days after administration) were analysed using the EMA statistical software (WT 1.4).
Croatian: Ponovno izračunati podatci za masnoće (2., 4. i 7. dan nakon primjene) analizirani su pomoću statističkog softvera EMA-e (WT 1.4).
English: In the first study, a group of cows with very low milk yield was used (11 to 14 L/day) whereas in the second study, the lowest milk yield was 16.8 L/day/animal.
Croatian: Prvim ispitivanjem obuhvaćena je skupina krava s vrlo niskim prinosom mlijeka (11 do 14 l/dnevno), dok je u drugom ispitivanju najniži prinos mlijeka krava iznosio 16,8 l/dnevno po životinji.
English: This was also the case when the raw data were corrected to take account of single batch accuracy data (which was seen to deviate considerably from the inter-day accuracy).
Croatian: Isto se dogodilo kada su sirovi podatci ispravljeni kako bi se uvažili podatci temeljeni na točnosti jednog skupa (koji se uvelike razlikuju od podataka temeljeni na točnosti tijekom cijelog dana).
English: 4.11 Withdrawal period(s) Cattle:
Croatian: 4.11 Razdoblje(a) karencije Goveda:
English: For example for cattle meat and offal the approved withdrawal periods ranged from 10 days to 28 days; for cattle milk from zero hours to 108 hours; for sheep meat and offal from 14 days to 28 days; for sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days.
Croatian: Na primjer, za meso i iznutrice goveda odobreno razdoblje karencije bilo je od 10 do 28 dana, za mlijeko goveda od nula do 108 sati; za meso i iznutrice ovaca od 14 do 28 dana; za ovčje mlijeko od „ne koristiti u ovaca koje proizvode mlijeko za ljudsku potrošnju” do 7 dana.
English: Merial Italia S.p.A. Viale Luigi Bodio, 37/b 20158 Milano Italy
Croatian: Viale Luigi Bodio, 37/b 20158 Milano Italy
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicants/marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačine veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene, podnositelja zahtjeva / nositelja odobrenja za stavljanje VMP-a u promet u državama članicama
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Croatian: Oksiklozanid je antihelmintik salicilanilid koji se koristi za liječenje fascioloze kod goveda, ovaca i koza, kao i za uklanjanje gravidnih članaka trakavica (Moniezia spp).
English: Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Road Dublin 24
Croatian: Magna Drive Magna Business Park Citywest Road Dublin 24
English: It was acknowledged that extrapolation from one major species to another is not discussed in current CVMP guidelines, that no species-specific half-life for sheep fat is available and that the half-life in cattle fat was calculated on the basis of a limited number of data points.
Croatian: Utvrđeno je da ekstrapolacija jedne velike vrste u drugu nije navedena u trenutačnim smjernicama CVMP-a, da nisu dostupni podatci o poluvijeku za masnoću ovaca te da je poluvijek u masnoći goveda izračunat na temelju ograničenog broja podataka.
English: Assumptions of log-linearity, homogeneity of variances and normality of residuals were confirmed and a withdrawal period of 12.78 days, was calculated.
Croatian: Pretpostavke o linearnosti zapisa, homogenosti varijanti i normalnosti rezidua potvrđene su te je izračunata karencija od 12,78 dana.
English: The CVMP considered this figure to represent a worst case scenario as it was derived from a group of animals that included low yielding cows, and that consequently the addition of a safety span was not necessary.
Croatian: CVMP smatra da ta brojka predstavlja najgori mogući scenarij jer je dobivena ispitivanjem skupine životinja koja je obuhvaćala krave te da zbog toga nije potrebno uvoditi dodatni sigurnosni faktor.
English: Because the dose increase between cattle and sheep/goat is less than double, one half-life (i.e. approximately 1 day) should be added to the withdrawal period for cattle meat and offal (13 days) to compensate for the difference in dose.
Croatian: Budući da je povećanje doza između goveda i ovaca/koza manja od dvostruke, treba dodati jedan poluvijek (tj. približno 1 dan) u razdoblje karencije za meso i iznutrice goveda (13 dana) radi nadomještanja razlike u dozi.
English: However all the fat samples from the four treated animals and one of the control animals sacrificed on day 21 had detectable levels of oxyclozanide, with higher values than in the fat samples from days 5, 10 and 15.
Croatian: Međutim, svi uzorci masnoće četiriju liječenih životinja i jedne iz kontrolne skupine koje su zaklane 21. dana pokazivali su značajne razine oksiklozanida, pri čemu su vrijednosti bile više od onih u uzorcima masnoće iz 5., 10. i 15. dana.
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for Zanil and associated names, and generic products thereof have not been assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljane životinje, sigurnost korisnika, rizik za okoliš i otpornost na parazite nije procijenjena u ovom arbitražnom postupku za Zanil i pridružena imena te njegove generičke lijekove.
English: While the efficacy of the products in cattle, sheep and goats has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and control of fasciolosis caused by adult flukes (Fasciola spp.).
Croatian: Budući da djelotvornost lijeka u goveda, ovaca i koza nije posebno procijenjena u okviru ovog arbitražnog postupka, lijekovi koji se procjenjuju smatraju se djelotvornima u liječenju i upravljanju fascioloze uzrokovane odraslim metiljima (Fasciola spp.).
English: None of the cows in the medium or high milk yield groups had any samples with residue levels above the MRL (10 μg/kg).
Croatian: Nijedna krava iz skupine sa srednjim ili visokim prinosom mlijeka nije imala uzorke s razinom rezidua koja je bila veća od najveće dopuštene količine rezidua (10 μg/kg).
English: The 25 cows included in the study were at different stages of lactation with low to high milk yield.
Croatian: 25 krava koje su obuhvaćene ispitivanjem bile su u različitim fazama laktacije, pri čemu je količina dobivenog mlijeka varirala od visoke do niske.
English: The control of liver fluke is achieved primarily by treatment with veterinary medicinal products containing flukicidal substances and is also assisted by appropriate husbandry measures (e.g. not grazing low-lying pastures or wet pastures near ponds and streams).
Croatian: Kontrola velikih metilja postiže se prvenstveno liječenjem veterinarsko-medicinskim proizvodima koji sadržavaju flukicidalna sredstva, a pomaže joj i primjena odgovarajućih mjera uzgoja (npr. izbjegavanje ispaše na niskim pašnjacima ili mokrim pašnjacima blizu jezera i rijeka).
English: A withdrawal period of 14 days is also supported by the fact that the same figure can be reached by extrapolating from the withdrawal period recommended for cattle, taking the half-life of oxyclozanide in fat into consideration.
Croatian: Razdoblje karencije od 14 dana također je utvrđeno na temelju činjenice da se ista brojka može dobiti ekstrapolacijom razdoblja karencije koje se preporučuje za goveda, pri čemu se uzima u obzir poluvijek oksiklozanida u masnoći.
English: Therefore, the Committee considered that based on the results of this study, a safe withdrawal period of 13 days for cattle meat and offal can be recommended.
Croatian: Stoga je Odbor smatrao da je na temelju rezultata ovog ispitivanja moguće preporučiti sigurno razdoblje karencije od 13 dana za meso i iznutrice goveda.
English: Whilst these veterinary medicinal products (the reference product Zanil and its generics Chanil/Rumenil) are oral suspensions, bioequivalent and should have similar withdrawal periods the two residue depletion studies led to substantially different withdrawal periods.
Croatian: Dok su ti veterinarsko-medicinski proizvodi (referentni proizvod Zanil i njegovi generički lijekovi Chanil/Rumenil) oralne suspenzije, bioekvivalentni su te bi trebali imati slično razdoblje karencije, dva ispitivanja o izlučivanju rezidua pokazala su znatno drugačija razdoblja karencije.
English: The first time point at which all milk residues were below the MRL was 108 hours.
Croatian: Prva vremenska točka u kojoj su svi rezidui u mlijeku bili manji od najveće dopuštene količine rezidua bila je 108 sati.
English: The second study was conducted in 2013 with a generic product containing oxyclozanide 34 mg/ml (marketed under the names Chanil 34 mg/ml oral suspension for cattle and Rumenil 34 mg/ml oral suspension for cattle).
Croatian: Drugo ispitivanje provedeno je 2013. na generičkom lijeku koji je sadržavao oksiklozanid 34 mg/ml (na tržištu je bio dostupan pod nazivima Chanil 34 mg/ml oralna suspenzija za stoku i Rumenil 34 mg/ml oralna suspenzija za stoku).
English: Residues levels were also below the MRLs (and limit of quantification) in liver, kidney and muscle on day 21.
Croatian: Količine rezidua bile su manje od najveće dopuštene količine rezidua (i ograničenja kvantifikacije) u jetri, bubrezima i mišićima 21. dana.
English: • a cattle milk withdrawal period of 108 hours (4.5 days),
Croatian: • razdoblje karencije za mlijeko goveda iznosi 108 sati (4,5 dana),
English: In the low milk yield group, 3 of 9 cows had residue levels above the MRL.
Croatian: U skupini krava s niskim prinosom mlijeka, 3 od 9 krava imalo je razinu rezidua veću od najveće dopuštene količine rezidua.
English: Before performing the statistical analysis, the CVMP corrected the raw oxyclozanide residue concentrations reported in the study with the single-batch accuracy instead of inter-day accuracy evaluated in the validation study, because these single-batch accuracies deviate considerably from the inter-day accuracy.
Croatian: Prije provedbe statističke analize, CVMP ispravio je koncentraciju rezidua sirovog oksiklozanida koja je prijavljena u ispitivanju na temelju točnosti koja se temelji na jednom skupu umjesto točnosti koja se temelji na cijelom danu koja je procijenjena u ispitivanju valjanosti jer točnosti koje se temelje na jednom skupu uvelike odstupaju od točnosti koja se temelji na cijelom danu.
English: The veterinary medicinal products Zanil and associated names, and generic products thereof are oral suspensions containing 34 mg oxyclozanide per ml.
Croatian: Veterinarsko-medicinski proizvod Zanil i pridružena imena te njegovi generički lijekovi oralne su suspenzije koje sadržavaju 34 mg oksiklozanida po ml.
English: Meat and offal: 13 days.
Croatian: Meso i iznutrice: 13 dana.
English: Based on the available residue depletion data, the CVMP considered that oxyclozanide residue levels are higher in cows with a low milk yield and that the daily milk yield has more influence on milk residue levels than the animals' body weights.
Croatian: Na temelju dostupnih podataka o izlučivanju rezidua, CVMP smatra da su razine rezidua oksiklozanida više u krava s niskim prinosom mlijeka te da dnevni prinos mlijeka ima veći utjecaj na razine rezidua u mlijeku nego tjelesna masa životinje.
English: Taking into account that Zanil is administered orally and assuming that bioequivalence between Zanil and its generic products is accepted, France considered that it is in the interest of consumer safety to review the adequacy of the withdrawal periods for cattle, sheep and goats and referred the matter to the Committee for Medicinal Products for Veterinary Use (CVMP).
Croatian: Uzimajući u obzir da se Zanil primjenjuje peroralno i pod pretpostavkom da je bioekvivalentnost između Zanila i njegovih generičkih lijekova prihvaćena, Francuska je smatrala da radi sigurnosti potrošača važno pregledati prikladnost karencije za goveda, ovaca i koza te je uputila predmet Odboru za veterinarsko-medicinske proizvode (CVMP).
English: Meat and offal: 14 days.
Croatian: Meso i iznutrice: 14 dana.
English: Therefore, based on the pharmacokinetic similarities between sheep and other ruminants the withdrawal period of 14 days recommended for sheep meat and offal can also be applied for goat meat and offal.
Croatian: Stoga, na temelju farmakokinetičkih sličnosti između ovaca i drugih preživača, preporučeno razdoblje karencije od 14 dana za meso i iznutrice ovaca može se primijeniti i na meso i iznutrice koza.