natgillin/translations-raw huggingface dataset:
For the referral procedure, the representative of the Marketing Authorisation Holder presented three studies. 
V okviru postopka obravnave je predstavnik Imetnika dovoljenja za promet z zdravilom predložil tri študije.
Group 3 animals were sacrificed at day 35 after treatment. 
Živali iz skupine 3 so bili žrtvovane 35. dan po terapiji.
The remaining 4 sheep (group 1) served as untreated controls. 
Ostale štiri ovce (skupina 1) so služile kot kontrolna skupina.
45 days 
45 dni
Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT England 
Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT Anglija
2.1 Residue depletion studies 
2.1 Študije o odstranjevanju zaostankov
11633 PagratiAthina 
11633 PagratiAtene
23/25 Ave du docteur Lannelongue 75014 Paris France 
23/25 Ave du docteur Lannelongue 75014 Pariz Francija
Therefore, the recommendation of a 70-day withdrawal period applies to both doses. 
Zato priporočilo o 70-dnevni karenci velja za oba odmerka.
18 2650 Hvidovre Denmark 
18 2650 Hvidovre Danska
The grounds for the appeal were submitted to the EMEA on 8 November 2004. 
Podlaga za ta namen je bila oddana na EMEA dne 8. septembra 2004.
A further 2 animals served as untreated controls. 
Novi dve živali sta služili kot kontroli.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES, ICELAND AND NORWAY 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, NAČINA UPORABE, ŽIVALSKIH VRST IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V ZADEVNIH DRŽAVAH ČLANICAH, ISLANDIJI IN NA NORVEŠKEM
Pfizer Ltd, Sandwich, Kent, CT13 9NJ, UK 
Pfizer Ltd, Sandwich, Kent, CT13 9NJ Velika Britanija
Sheep; repeated if signs of P.ovis infection do not disappear in 14 days 
enkratni odmerek, ki ga ponovimo, če znaki infekcije s P.ovis ne izginejo v 14 dneh
Pfizer Italia SRL Via Valbondione 113 00188 Roma 
Pfizer Italia SRL Via Valbondione 113 00188 Rim Italija
The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 16 February 2004. 
Vprašanja, ki so se pojavila na sestanku in so se nanašala na karence, so bila predana Imetnikom dovoljenj za promet z zdravilom dne 16. februarja 2004.
In fat, residues were below 8 μg/kg at all remaining time-points. 
V maščevju so bili zaostanki v vseh preostalih časovnih točkah nižji od 8 μg/kg.
Although, a lower dose of 200 g/kg bw is also indicated in a number of Member States as well as the higher dose of 300 g/kg bw, no residues data was provided for this lower dose. 
Čeprav je v številnih državah članicah, skupaj z večjim odmerkom 300 g/kg telesne teže, predpisan tudi nižji odmerek v vrednosti 200 g/kg telesne teže, niso znani nobeni podatki o zaostankih po uporabi teh nižjih odmerkov.
Doramectin was included in Annex I of Council Regulation (EEC) No 2377/90 and the following maximum residue limits were established for ovine species: 
Doramektin je bil vključen v Dodatek I Uredbe Sveta (EGS) št. 2377/90; odobrene so bile naslednje najvišje dovoljene količine zaostankov (maximum residue limits, MRLs) za ovčje vrste:
Frequency Recommended dose 
Priporočen odmerek
The CVMP during its meeting of 10-12 February 2004 initiated a referral procedure under Article 34 of Council Directive 2001/82/EC for Dectomax injectable solution products containing doramectin. 
Odbor CVMP je na sestanku od 10. do 12. februarja 2004 pričel s postopkom obravnave v skladu s 34. členom Direktive Sveta 2001/82/ES za zdravilo Dectomax v obliki raztopin za injiciranje, ki vsebujejo učinkovino doramektin.
Only where muscle is not a target tissue and hence there is no MRL for muscle should an ADI approach be considered. 
V primerih, ko mišica ni tarčno tkivo in posledično ni znan MRL, je potrebno upoštevati pristop s toksikološkim parametrom ADI.
With respect to doramectin administered subcutaneously the studies reviewed did not provide reliable data from which a valid calculation could be made. 
Pregledane študije o subkutani uporabi doramektina ne vsebujejo zanesljivih podatkov, na podlagi katerih bi lahko naredili veljaven izračun.
In the second study twenty sheep were injected subcutaneously with 
V drugi študiji je dvajset ovc subkutano prejelo s
Pfizer Corp. Austria Seidengasse 33-35 1071 Wien 
Pfizer Corp. Austria Seidengasse 33-35 1071 Dunaj Avstrija
Comparison of the data from groups 2 and 3 indicated that administration of the second dose did not affect the depletion profile in edible tissue at withdrawal times around 35 days. 
Primerjava podatkov iz skupin 2 in 3 je pokazala, da uporaba drugega odmerka ni vplivala na profil izčistka v užitnih tkivih pri karenci (čakalni dobi) okrog 35 dni.
Neither the second nor third studies are suitable for the determination of a withdrawal period following subcutaneous administration. 
Niti druga niti tretja študija nista primerni za določitev karence po subkutani uporabi zdravila.
The CVMP working paper on injection site residues (III/5933/94-EN) recommends that the injection site and its residues be treated as “normal” muscle where one of the target tissues is muscle. 
Delovno gradivo CVMP-ja o zaostankih v tkivih z mestom vbrizga (III/5933/94-EN) priporoča, da se tkivo z mestom vbrizga skupaj z njegovimi zaostanki obravnava kot “normalno” mišico v primerih, ko je eno izmed tarčnih tkiv mišica.
Dextomax 1 % Solution for injection 
Dextomax 1 % Raztopina za injiciranje
Withdrawal period (meat and milk) 
Karenca (meso in mleko)
Groups of 4 sheep (2 male, 2 female) were sacrificed at 14, 35, 42, 49 and 56 days after treatment. 
Skupine štirih ovc (dve ženskega in dve moškega spola) so bile žrtvovane po 14, 35, 42, 49 in 56 dneh po terapiji.
Box 52 0508 Oslo, Norway 
0508 Oslo Norveška
Cattle and sheep 
govedo in ovce:
Following extensive re-homogenisation of the remaining injection site tissue (38-204 g) four 2.5 g sub-samples were analysed per animal for doramectin determination. 
Po obsežni ponovni homogenizaciji ostankov tkiv z mestom vbrizga (38-204 g) so za vsako žival analizirali štiri podvzorce z maso 2,5 g z namenom določitve zaostanka doramektina.
On 17 September 2004, an intention to appeal against the opinion was submitted to the EMEA by the representative of the Marketing Authorisation Holders. 
Imetniki dovoljenj za promet so dne 17. septembra 2004 na EMEA oddali namen pritožiti se zoper temu priporočilu.
In the group 2 animals given two doses, the injection sites contained the highest residues followed by liver and fat. 
Tkiva z mestom vbrizga v živalih iz skupine 2 (le-te so prejele dva odmerka) so vsebovala največji zaostanek, sledila so jim jetra in maščevje.
At all other time-points doramectin concentrations in liver, kidney and skeletal muscle were at or below the limit of quantification. 
V vseh preostalih časovnih točkah (čas odvzema vzorcev) so bile koncentracije doramektina v jetrih, ledvicah in skeletni mišici na meji kvantifikacije oziroma pod njo.
A withdrawal period of 182 days was calculated, but in the opinion of the CVMP this approach is not sustainable as there are no actual time point slaughter studies to confirm this prediction and extrapolation from the concentration of residues found in the samples at the injection site to predict an adequate withdrawal period is difficult. 
Izračunana je bila sicer karenca 182 dni, toda po mnenju CVMP ta pristop ne vzdrži, saj niso bile narejene nobene dejanske študije zakolov v določenih časovnih točkah, ki bi potrdile to predpostavko.
In first study, thirty-two sheep (group 2) received an intramuscular injection of doramectin at a dose of 300 μg/kg bw on 2 occasions, 7 days apart. 
V prvi študiji je dvaintrideset ovc (skupina 2) prejelo intramuskularno injekcijo doramektina v odmerku 300 μg/kg telesne teže in sicer dvakrat v razmaku 7 dni.
Dectomax injectable solution contains doramectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle, sheep, pigs and reindeer, excluding lactating animals producing milk for human consumption. 
Raztopina za injiciranje Dectomax vsebuje učinkovino doramektin, ki je spojina polsinteznega izvora iz družine avermektinov, namenjeno zdravljenju infekcij z internimi ter eksternimi paraziti pri govedu, ovcah, prašičih in severni jelenjadi, z izjemo živali, ki proizvajajo mleko za prehrano ljudi.
Laboratórios Pfizer, Lda 
Portugalska Laboratórios Pfizer, Lda
The Committee, having considered the matter as set out in the appended Referral Assessment Report, recommends that the withdrawal period for injectable solutions containing doramectin for intramuscular use in ovine species should be 70 days for meat and offal. 
Odbor, po preučitvi zadeve, kot je predstavljena v priloženem poročilu o oceni, priporoča, da bi morala karenca za raztopine za injiciranje, ki vsebujejo doramektin, namenjene intramuskularni uporabi v ovčjih vrstah, znašati 70 dni za meso in drobovino.
Withdrawal periods were based on statistical calculations of injection site residues relative to the muscle MRL as recommended in the CVMP working paper on injection site residues (III/5933//94EN). 
Izračun karence je temeljil na statističnih izračunih zaostankov v tkivih z mestom vbrizga glede na MRL v mišicah in sicer v skladu s priporočili delovnega gradiva CVMP o zaostankih v tkivih z mestom vbrizga (III/5933//94-EN).
On 7 September 2004, the CVMP adopted an opinion recommending that the withdrawal period for injectable solutions containing doramectin for intramuscular use in ovine species should be 70 days for meat and offal. 
Dne 7. septembra 2004 je CVMP sprejela mnenje, ki priporoča , da bi morala karenca za raztopine za injiciranje, ki vsebujejo doramektin, namenjene intramuskularni uporabi v ovčjih vrstah, znašati 70 dni za meso in drobovino.
Injection site residues ranged from 67.3 to 144 μg/kg at this single time-point. 
Zaostanki v tkivu na mestu vbrizga so se gibali v intervalu od 67,3 do 144 μg/kg na tej časovni točki (to je, po 35 dneh).
The tissue samples were homogenised and the concentration of doramectin in a single sub-sample was determined using a validated HPLC analytical method (limit of detection 0.5 μg/kg, limit of quantification 2.5 μg/kg). 
Vzorci tkiv so bili homogenizirani, koncentracija doramektina v podvzorcu je bila določena z uporabo validiranega analitičnega postopka s HPLC (meja detekcije 0,5 μg/kg, meja kvantifikacije 2,5 μg/kg).
200 g/kg bw (sc, im) Pigs: 300 μg/kg bw Small pigs < 16 kg: < 4 kg: 0,1 ml 5-7 kg: 0,2 ml 8-10 kg: 0,3 ml 11-13 kg: 0,4 ml 14-16 kg: 0,5 ml 
prašiči: 300 μg/kg telesne teže majhni prašiči < 16 kg: < 4 kg: 0,1 ml 5-7 kg: 0,2 ml 8-10 kg: 0,3 ml 11-13 kg: 0,4 ml 14-16 kg: 0,5 ml
The CVMP established a toxicological ADI of 0.5 µg/kg bw (30 µg/person) for doramectin, based on the NOEL of 0.1 mg/kg bw/day for mydriasis observed in a 3-month toxicity study in beagle dogs and applying a safety factor of 200. 
CVMP je odobril toksikološki parameter ADI (accepted daily intake - najvišji dovoljen dnevni vnos) v vrednosti 0,5 µg/kg telesne teže (30 µg/osebo) za učinkovino doramektin in sicer na podlagi parametra NOEL (no observed effect level - odmerek brez opaznega učinka) v vrednosti 0,1 mg/kg telesne teže/dan za midriazo, določenega v trimesečni toksikološki študiji, izvedeni na vohunskih psih ter z uporabo faktorja varnosti v vrednosti 200.
For the first study, statistical calculation of the withdrawal period for injection site tissue following intramuscular injection in accordance with EMEA/CVMP/036/95-FINAL gives a period of 70 days (rounded to whole weeks). 
Za prvo študijo je statistični izračun, narejen v skladu z EMEA/CVMP/036/95-FINAL pokazal, da znaša karenca za tkiva z mestom vbrizga po intramuskularnem injiciranju 70 dni (zaokroženo na cele tedne).
On 27 January 2004 the United Kingdom requested the CVMP to give an opinion under Article 34 of Council Directive 2001/82/EC concerning the divergent decisions taken by the concerned competent national authorities regarding the withdrawal periods for meat and offal when granting the marketing authorisations for Dectomax injectable products for use in ovine species. 
Dne 27. januarja 2004 je Velika Britanija zahtevala od CVMP, da v skladu s 34. členom Direktive Sveta 2001/82/ES poda mnenje glede razlikujočih si odločitev pristojnih nacionalnih odborov o karenci za meso in drobovino.
3H -radiolabelled doramectin at a dose level of 300 μg/kg. 
3H (radioaktivno) označen doramektin v odmerku
A simplified approach to the residues at the injection site is not possible as residues were above the MRL of 20 μg/kg in most of the samples taken at the last period in which the animals were slaughtered (56 days). 
Poenostavljen pristop k zaostankom v tkivih z mestom vbrizga ni mogoč, saj so bili zaostanki v večini vzorcev, pridobljenih v zakolu 56 dni po terapiji, nad MRL vrednostjo 20 μg/kg.
Group 2 animals were sacrificed (2 males and 2 females at each time point) at 7, 14, 21, 28, 35, 42, 49 and 56 days after the second treatment. 
Živali is skupine 2 (dve živali moškega in dve ženskega spola) so bile žrtvovane po 7, 14, 21, 28, 35, 42, 49 in 56 dneh, šteto od dneva, ko je bil uporabljen drugi odmerek.
Cattle 
govedo
Pigs: 77 days 
Prašiči: 77 dni
Pigs: 56 days 
Prašiči: 56 dni
In the group 3 animals that received a single dose, mean residues were all below 10 μg/kg in liver (2.56 to 7.72 μg/kg), kidney (less than 2.5 to 2.58 μg/kg), fat (less than 2.5 to 17.4 μg/kg) and skeletal muscle (less than 2.5 to 4.89) after 35 days. 
V živalih iz skupine 3, ki so prejela le enkratni odmerek, so bila povprečja vseh zaostankov nižja od 10 μg/kg in sicer v jetrih (2,56 do 7,72 μg/kg), v ledvicah (manj kot 2,5 do 2,58 μg/kg), v maščevju (manj kot 2,5 to 17,4 μg/kg) in v skeletni mišici (manj kot 2,5 do 4,89) po 35 dneh.
300 g/kg bw Cattle: 
300 g/kg telesne teže govedo:
Pigs: 49 days 
Prašiči: 49 dni
The CVMP had previously assessed doramectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90. 
CVMP je že predhodno, v skladu z Uredbo Sveta 2377/90, ocenil doramektin s stališča odobritve najvišje dovoljene količine zaostankov (maximum residue limits, MRLs).
Dectomax 10 mg/ml Injection Cattle and sheep Not for use in cattle producing milk for human consumption. 
Dectomax 10 mg/ml injekcija govedo in ovce Ni namenjeno uporabi pri govedu, ki proizvaja mleko za prehrano ljudi.
Pigs 
prašiči:
In the injection sites, the doramectin concentrations were 709 to 5731 μg/kg at 7 days, 326 to 4144 μg/kg at 14 days, 96.3 to 1381 μg/kg at 21 days, 40.1 to 754 μg/kg at 28 days, 4.88 to 119 μg/kg at 35 days, 24.4 to 185 μg/kg at 42 days, less than 2.5 to 94.3 at 49 days and less than 2.5 to 31.5 μg/kg at 56 days. 
V tkivih z mestom vbrizga zdravila so bile koncentracije doramektina 709 do 5731 μg/kg po 7 dneh, 326 do 4144 μg/kg po 14 dneh, 96,3 do 1381 μg/kg po 21 dneh, 40,1 to 754 μg/kg po 28 dneh, 4,88 to 119 μg/kg po 35 dneh, 24,4 do 185 μg/kg po 42 dneh, manj kot 2,5 do 94,3 po 49 dneh in manj kot 2,5 do 31,5 μg/kg po 56 dneh.
Cattle: 
govedo:
The third study was a re-analysis of injection site tissue from the second study due to the high variability of the results obtained. 
Zaradi velike variabilnosti teh rezultatov so v okviru tretje študije ponovno analizirali tkiva z mestom vbrizga zdravila, ki so jih pridobili v drugi študiji.
Cattle: 42 days Sheep: 35 days Pigs: 37 days 
Govedo: 42 dni Ovce: 35 dni Prašiči: 37 dni
Dectomax Injectable Solution for Cattle and Sheep 
Dectomax Raztopina za injiciranje za govedo in ovce
Not to be used later than 60 days prior to expected calving. 
Uporaba v času 60 dni pred predvideno otelitvijo ni dovoljena.
The withdrawal period should be based on residue depletion to below the MRL at the injection site. 
Karenca bi morala biti določena na podlagi izčistka zaostankov oz. v vrednostih, ki so pod MRL v tkivih z mestom vbrizga.
2.2 Calculation of withdrawal periods 
2.2 Izračun karence
Highest concentrations of doramectin in liver, kidney, muscle and fat were found at 14 days (mean values were: liver, 38.8 + 14.5 μg/kg; kidney, 12.3 + 7.4 μg/kg; skeletal muscle, 9.8 + 4.6 μg/kg and fat, 62.2 + 25.6 μg/kg). 
Najvišje koncentracije doramektina v jetrih, ledvicah, mišicah in maščevju so bile določene v vzorcih, ki so bili odvzeti 14 dni po terapiji (povprečne vrednosti so bile: jetra, 38,8 + 14,5 μg/kg; ledvica, 12,3 + 7,4 μg/kg; skeletna mišica, 9,8 + 4,6 μg/kg in maščevje, 62,2 + 25,6 μg/kg).
Four sheep (group 3) were given a single intramuscular injection of doramectin at a dose of 300 μg/kg bw on study day 0. 
Štiri ovce (skupina 3) so prvi dan študije (dan 0) prejele eno intramuskularno injekcijo doramektina v odmerku 300 μg/kg telesne teže.
Pfizer Animal Health B.V. 
Nizozemska Pfizer Animal Health B.V.
Not for use in dairy cows. 
Ni namenjeno uporabi pri kravah molznicah.
Meat: Cattle, sheep: 60 days 
Meso: govedo, ovce: 60 dni
Product trade name 
Imetnik dovoljenja za promet z zdravilom
Sheep: 35 days. 
Ovce: 35 dni.
The concentration of doramectin in the various tissues was determined in duplicate tissue samples (injection site quadruplicate) using a validated HPLC procedure (limit of detection 0.5 μg/kg, limit of quantification 2.5 μg/kg (5 μg/kg in fat). 
Koncentracije doramektina v različnih tkivih so bile določene z validiranim postopkom s HPLC v dveh ponovitvah (duplikatih) za vse tkivne vzorce, razen za vzorec tkiva z mestom vbrizga, ki je bil analiziran v štirih ponovitvah (meja detekcije 0,5 μg/kg, meja kvantifikacije 2,5 μg/kg (5 μg/kg v maščevju).
Cattle and reindeer: 42 days Swine: 49 days 
Govedo in severna jelenjad: 42 dni svinje: 49 dni
At sacrifice the liver, kidneys, the injection site, samples of fat and skeletal muscle were taken from each animal. 
Po zakolu so iz vsake žrtvovane živali vzeli jetra, ledvici, tkivo z mestom vbrizga, vzorce maščevja in skeletno mišico.
Sheep: Not to be used in dairy ewes, for at least 70 days before giving birth, if the milk is going to be used for human consumption 
Ovce: Uporaba pri brejih ovcah molznicah v času najmanj 70 dni pred jagnjitvijo, ni dovoljena v primeru, da gre za mleko, namenjeno prehrani ljudi.
Cattle esp. bullocks, Not for use in lactating cows producing milk for human consumption, even in the resting period 
Govedo, zlasti voli.Ni namenjeno uporabi pri kravah molznicah, ki proizvajajo mleko za prehrano ljudi, in sicer niti v mirujočem obdobju.
76139 Karlsruhe Germany 
Pfizer GmbH Pfizerstrasse 1 76139 Karlsruhe Nemčija
Sheep: 70 days 
Ovce: 70 dni
Sheep: 56 days 
Ovce: 56 dni
Concentrations of doramectin in injection site tissue were very variable and the mean value remained above the MRL at all sacrifice times (629 + 829 μg/kg at 14 days, 108 + 101 μg/kg at 35 days, 25.5 + 42.4 μg/kg at 42 days, 103 + 101 μg/kg at 49 days and 112 + 106 μg/kg at 56 days). 
Koncentracije doramektina v tkivih z mestom vbrizga so bile zelo različne; povprečna vrednost je bila nad vrednostjo MRL v vseh časovnih točkah (629 + 829 μg/kg po 14 dneh, 108 + 101 μg/kg po 35 dneh, 25,5 + 42,4 μg/kg po 42 dneh , 103 + 101 μg/kg po 49 dneh in 112 + 106 μg/kg po 56 dneh).
On the basis of the data that were available, no withdrawal period could be set for the subcutaneous injection of doramectin and references to administration by this route should be removed from the product literature. 
Na podlagi podatkov, ki so bili na voljo, ni bilo mogoče določiti karence po subkutanem injiciranju doramektina.
Dectomax 10 mg/ml Solution for injection 
Dectomax 10 mg/ml Raztopina za injiciranje ovce govedo
Sheep: Not for use in dairy ewes producing milk for human consumption. 
ovce: Ni namenjeno uporabi v ovcah molznicah, ki proizvajajo mleko za prehrano ljudi.
The product has been authorised in the EU Member States and EEA/EFTA States listed in Annex I as an injectable solution for intramuscular and/or subcutaneous administration. 
Zdravilo v obliki raztopine za injiciranje za intramuskularno in/ali subkutano uporabo ima dovoljenje za promet v državah članicah Evropske unije (EU) in v državah članicah EGP/EFTA, ki so navedene v Dodatku I. Karence, določene za užitna tkiva ovčjih živalskih vrst, se med posameznimi državami članicami pomembno razlikujejo; gibljejo se med 35 in 70 dnevi.
Cattle, sheep and pigs Use not permitted in animals producing milk for human use 
govedo, ovce in prašiči Uporaba pri živalih, ki proizvajajo mleko za prehrano ljudi, ni dovoljena.
DK 2750 Ballerup 
Pfizer Aps Lautrupvang 8 2750 Ballerup Danska
Cattle: 42 days Sheep: 60 days 
Govedo: 42 dni Ovce: 60 dni
Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period 
V suhi dobi je karenca za mleko telic, severne jelenjadi in drugih živali 60 dni.
Sheep: 35 days 
Ovce: 35 dni
Muscle: 20 µg/kg 
mišice: 20 µg/kg maščevje: 100 µg/kg jetra: 50 µg/kg ledvica: 30 µg/kg
Sheep: 35 days (im), 56 days (sc) 
), 56 dni (s.c.)
Cattle: 42 days Sheep: 40 days 
Meso: govedo: 42 dni ovce: 40 dni
Meat: Cattle: 49 days 
Govedo: 49 dni
Cattle: Not for use in the last 60 days before calving. 
Govedo: Ni namenjeno uporabi v času 60 dni pred otelitvijo.
300 g/kg bw (im) 
300 g/kg telesne teže (i.m.)
Sheep: Not for use in the last 70 days before lambing. 
Ovce: Ni namenjeno uporabi v času 70 dni pred jagnjitvijo.
200 g/kg bw (sc) Pigs: 
200 g/kg telesne teže (s.c.) prašiči
Cattle and reindeer: 200 g/kg bw Sheep: 
govedo in severna jelenjad: 200 g/kg telesne teže ovce:
Sheep: 45 days (im); 60 days (sc) Reindeer: 42 days Milk: 
); 60 dni (s.c.) Severnega jelena: 42 dni Mleko:
Sheep: Do not use in dairy sheep, including pregnant ewes within 50 days of lambing 
Ovce: uporaba pri ovcah molznicah, vključujoč breje ovce samice v času 50 dni pred jagnjitvijo, ni dovoljena.
Not for use in sheep producing milk for human consumption 
Ni namenjeno uporabi pri ovcah, ki proizvajajo mleko za prehrano ljudi.
Fat: 100 µg/kg 
300 μg/kg.
Cattle and sheep No treatment of animals producing milk for human consumption 
Raztopina za injiciranje za govedo in ovce govedo in ovce Ni namenjeno zdravljenju živali, ki proizvajajo mleko za prehrano ljudi
Cattle and sheep: 200 g / kg bw Pigs: 
govedo in severna jelenjad: 200 g / kg telesne teže svinje:
200 μg/kg bw (sc only) Sheep: 
200 μg/kg telesne teže (samo s.c.) ovce:
200 g/kg bw (sc) Sheep: 
200 g/kg telesne teže (s.c.) ovce:
300 μg/kg bw 
300 μg/kg telesne teže
200 μg/kg bw (sc) Sheep: 
200 μg/kg telesne teže (s.c.) ovce:
Cattle: Forbidden in lactating cows, not to be administered 60 days before calving. 
Govedo: Prepovedana uporaba pri kravah molznicah in v času 60 dni pred otelitvijo.
Sheep: Forbidden in lactating sheep, not to be administered 70 days before lambing 
Ovce: Prepovedana uporaba v ovcah molznicah in v času 70 dni pred jagnjitvijo.
Despite the extensive re-homogenisation and increased number of sub-samples the results remained highly variable with mean values exceeding the MRL at all time-points (1866.8 + 1725.9 μg/kg at 14 days, 267 + 283.1 μg/kg at 35 days, 81.8 + 60.1 μg/kg at 42 days, 261.4 + 302.6 μg/kg at 49 days and 82.8 + 66.4 μg/kg at 56 days). 
14 dneh, 267 + 283,1 μg/kg po 35 dneh, 81,8 + 60,1 μg/kg po 42 dneh, 261,4 + 302,6 μg/kg po 49 dneh in 82,8 + 66,4 μg/kg po 56 dneh).
Sheep and cattle Not permitted for use in lactating ewes or cows used to produce milk for human consumption 
Raztopina za injiciranje ovce in govedo Uporaba pri ovcah ali kravah molznicah, ki proizvajajo mleko za prehrano ljudi, ni dovoljena ovce:
200 μg/kg bw (sc or im) 
200 μg/kg telesne teže (s.c. ali i.m.)
300 g/kg bw (sc or im) 
300 g/kg telesne teže (s.c. ali i.m.)
Pigs: Meat: 49 days Milk: 
Meso: ovce: 35 dni govedo: 42 dni prašiči: 49 dni mleko:
Cattle: 200 g/kg bw Sheep: 300 g/kg bw 
Raztopina za injiciranje govedo in ovce govedo: 200 g/kg telesne teže ovce: 300 g/kg telesne teže meso: govedo: 63 dni ovce: 63 dni
Cattle: 42 days Sheep: 35 days Milk: 
Meso: govedo: 42 dni ovce: 35 dni (i.m.
Cattle, sheep, (reindeer) 
Dectomax vet govedo, ovce, (severna jelenjad)
Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving. 
Govedo: uporaba pri kravah molznicah v suhi dobi, vključno z brejimi telicami, v času 60 dni pred otelitvijo ni dovoljena.
200 g/kg bw (sc or im) 
200 g/kg telesne teže (s.c. ali i.m.)