FrancophonIA/ELRC3.0 huggingface dataset:
English: Germany codeinphosphathemihydrat paracetamol talvosilen 250 mg/5 mg Zäpfchen suppository rectal use
Slovenian: 1 - 3 81479 München Nemčija kodeinijev fosfat hemihidrat paracetamol talvosilen 250 mg/5 mg Zäpfchen svečka rektalna uporaba
English: Germany Merck Serono GmbH Alsfelder Str. 17
Slovenian: Merck Serono GmbH Alsfelder Str. 17 64289 Darmstadt Nemčija kodeinijev fosfat hemihidrat paracetamol
English: Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Slovenian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Nemčija kodeinijev fosfat hemihidrat paracetamol
English: 500 mg+8 mg+30 mg effervescent tablet
Slovenian: 500 mg+8 mg+30 mg šumeča tableta peroralna uporaba
English: 500mg + 8mg + 30mg capsule, hard Oral use
Slovenian: 500mg + 8mg + 30mg kapsula, trda
English: Paracetamol Codeine Phosphate Caffeine
Slovenian: Paracetamol kodeinijev fosfat hemihidrat kofein
English: Paracetamol+ caffeine+ codeine phosphate hemihydrate
Slovenian: Paracetamol+ Kofein + Kodeinijev fosfat hemihidrat
English: Paracetamol+ Caffeine+ Codeine phosphate hemihydrate
Slovenian: Paracetamol+ kofein+ kodeinijev fosfat hemihidrat
English: 500mg +8mg + 30mg tablet for oral solution
Slovenian: 500mg +8mg + 30mg tableta za peroralno raztopino
English: 200mg +12.8mg coated tablet
Slovenian: 200mg +12.8mg filmsko obložena tableta
English: 8mg +500mg + 30mg effervescent tablet
Slovenian: 8mg + 500mg + 30mg tableta za peroralno raztopino
English: Paracetamolum + Codeini phosphas + Coffeinum
Slovenian: Paracetamol + kodeinijev fosfat + kofein
English: Co-codamol 8/500 mg tablets effervescent tablet
Slovenian: Co-codamol 8/500 mg tablets šumeča tableta peroralna uporaba
English: 30mg + 500mg capsule, hard oral use
Slovenian: 30mg + 500mg kapsula, trda
English: Paracetamol, codeine phosphate and caffeine
Slovenian: Paracetamol kodeinijev fosfat in kofein
English: Paracetamolum + Coffeinum + Codeini phosphas
Slovenian: Paracetamol + kofein + kodeinijev fosfat
English: 500mg/50mg/30mg effervescent tablet
Slovenian: 500mg/50mg/30mg šumeča tableta peroralna uporaba
English: 120 mg and 12 mg / 5 ml oral solution oral use
Slovenian: 120 mg and 12 mg / 5 ml peroralna raztopina
English: 30mg + 500 mg capsule, hard oral use
Slovenian: 30mg + 500 mg kapsula, trda
English: 6,33 mg/ 5 ml oral solution oral use
Slovenian: 6,33 mg/ 5 ml peroralna raztopina
English: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
Slovenian: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg šumeča tableta t peroralna uporaba
English: Hämeenlinna 13500 Finland paracetamol, codeine,
Slovenian: Finska paracetamol, kodein,
English: Paracetamol and codeine phosphate hemihydrate
Slovenian: Paracetamol in kodeinijev fosfat hemihidrat
English: Paracetamol Codeine Phosphate hemihydrate
Slovenian: Paracetamol kodeinijev fosfat hemihidrat
English: Ibuprofen Codeine Phosphate Hemihydrate
Slovenian: Ibuprofen kodeinijev fosfat hemihidrat
English: Ibuprofen Codeine phosphate hemihydrate
Slovenian: Ibuprofen Kodeinijev fosfat hemihidrat
English: 500mg + 30mg film-coated tablet oral use
Slovenian: 500mg + 30mg filmsko obložena tableta
English: 30 mg + 500 mg tablet
Slovenian: 30 mg +500 mg tableta
English: 30 mg +500 mg tablet
Slovenian: 30 mg + 500 mg tableta
English: Paracetamol Codeine Phosphate
Slovenian: Paracetamol kodeinijev fosfat
English: Paracetamol Codeine phosphate
Slovenian: Paracetamol Kodeinijev fosfat
English: 30mg + 500 mg tablet
Slovenian: 30mg + 500 mg tableta
English: Paracetamol/codeine phosphate
Slovenian: Paracetamol/ Kodeinijev fosfat
English: Paracetamol/ Codeine phosphate
Slovenian: Paracetamol/ kodeinijev fosfat
English: Sweden codeine phosphate hemihydrate/ paracetamol
Slovenian: 167 14 Bromma Švedska kodeinijev fosfat hemihidrat / paracetamol
English: Paracetamol and codeine phosphate
Slovenian: Paracetamol in kodeinijev fosfat
English: Co-codamol 500 mg/8 mg tablets effervescent tablet
Slovenian: Co-codamol 500 mg/8 mg tablets šumeča tableta peroralna uporaba
English: 500mg + 30mg + 8mg effervescent tablet
Slovenian: 500mg + 30mg + 8mg šumeča tableta peroralna uporaba
English: Einsteinova 24
Slovenian: Darwinweg 20
English: Paracetamol/Codeine/C affeine
Slovenian: Paracetamol/kodein/kof ein
English: Acetylsalicylic acid + Codeine phosphate hemihydrate + Caffeine
Slovenian: Carnaxide Portugalska acetilsalicilna kislina + kodeinijev fosfat hemihidrat + kofein
English: 1300 Wavre
Slovenian: Hämeenlinna 13500
English: 200mg +12,8 mg film-coated tablet oral use
Slovenian: 200mg +12,8 mg filmsko obložena tableta
English: Codiene phosphate
Slovenian: Kodeinijev fosfat
English: 8mg + 500mg + 30mg soluble tablet
Slovenian: 8mg +500mg + 30mg šumeča tableta PERORALNA UPORABA
English: Strength Pharmaceutical Form
Slovenian: Farmacevtsk a oblika
English: 1 cartridge and 1 pen
Slovenian: 1 vložek in 1 peresnik
English: 3 cartridges
Slovenian: 3 vložki
English: 1 cartridge
Slovenian: 1 vložek
English: This approach offers the highest degree of consumer protection
Slovenian: Ta pristop nudi največjo stopnjo varnosti za potrošnika.
English: The responses were submitted on 17 June 2004.
Slovenian: Odgovori so bili poslani dne 17. junija 2004.
English: Porte Salvo Portugal
Slovenian: Porte Salvo Portugalska
English: Conclusions and recommendations
Slovenian: Zaključki in priporočila
English: 2900 AA CAPELLE AAN DEN IJSSEL The Netherlands
Slovenian: 2900 AA CAPELLE AAN DEN IJSSEL Nizozemska
English: Introduction and Background
Slovenian: Uvod in ozadje
English: 00330 Helsinki Finland
Slovenian: 00330 Helsinki Finska
English: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS
Slovenian: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS Španija
English: 183 25 Täby Sweden
Slovenian: 183 25 Täby Švedska
English: For the referral procedure, the representative of the Marketing Authorisation Holder presented three studies.
Slovenian: V okviru postopka obravnave je predstavnik Imetnika dovoljenja za promet z zdravilom predložil tri študije.
English: Group 3 animals were sacrificed at day 35 after treatment.
Slovenian: Živali iz skupine 3 so bili žrtvovane 35. dan po terapiji.
English: The remaining 4 sheep (group 1) served as untreated controls.
Slovenian: Ostale štiri ovce (skupina 1) so služile kot kontrolna skupina.
English: 45 days
Slovenian: 45 dni
English: Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT England
Slovenian: Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT Anglija
English: 2.1 Residue depletion studies
Slovenian: 2.1 Študije o odstranjevanju zaostankov
English: 11633 PagratiAthina
Slovenian: 11633 PagratiAtene
English: 23/25 Ave du docteur Lannelongue 75014 Paris France
Slovenian: 23/25 Ave du docteur Lannelongue 75014 Pariz Francija
English: Therefore, the recommendation of a 70-day withdrawal period applies to both doses.
Slovenian: Zato priporočilo o 70-dnevni karenci velja za oba odmerka.
English: 18 2650 Hvidovre Denmark
Slovenian: 18 2650 Hvidovre Danska
English: The grounds for the appeal were submitted to the EMEA on 8 November 2004.
Slovenian: Podlaga za ta namen je bila oddana na EMEA dne 8. septembra 2004.
English: A further 2 animals served as untreated controls.
Slovenian: Novi dve živali sta služili kot kontroli.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES, ICELAND AND NORWAY
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, NAČINA UPORABE, ŽIVALSKIH VRST IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V ZADEVNIH DRŽAVAH ČLANICAH, ISLANDIJI IN NA NORVEŠKEM
English: Lagoas Park Edifício 10
Slovenian: Lagoas Park
English: Pfizer Ltd, Sandwich, Kent, CT13 9NJ, UK
Slovenian: Pfizer Ltd, Sandwich, Kent, CT13 9NJ Velika Britanija
English: Sheep; repeated if signs of P.ovis infection do not disappear in 14 days
Slovenian: enkratni odmerek, ki ga ponovimo, če znaki infekcije s P.ovis ne izginejo v 14 dneh
English: Pfizer Italia SRL Via Valbondione 113 00188 Roma
Slovenian: Pfizer Italia SRL Via Valbondione 113 00188 Rim Italija
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 16 February 2004.
Slovenian: 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.
English: In fat, residues were below 8 μg/kg at all remaining time-points.
Slovenian: V maščevju so bili zaostanki v vseh preostalih časovnih točkah nižji od 8 μg/kg.
English: 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.
Slovenian: 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.
English: Doramectin was included in Annex I of Council Regulation (EEC) No 2377/90 and the following maximum residue limits were established for ovine species:
Slovenian: 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:
English: Frequency Recommended dose
Slovenian: Priporočen odmerek
English: 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.
Slovenian: 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.
English: Only where muscle is not a target tissue and hence there is no MRL for muscle should an ADI approach be considered.
Slovenian: V primerih, ko mišica ni tarčno tkivo in posledično ni znan MRL, je potrebno upoštevati pristop s toksikološkim parametrom ADI.
English: Member State
Slovenian: Država članica
English: With respect to doramectin administered subcutaneously the studies reviewed did not provide reliable data from which a valid calculation could be made.
Slovenian: Pregledane študije o subkutani uporabi doramektina ne vsebujejo zanesljivih podatkov, na podlagi katerih bi lahko naredili veljaven izračun.
English: In the second study twenty sheep were injected subcutaneously with
Slovenian: V drugi študiji je dvajset ovc subkutano prejelo s
English: Pfizer Corp. Austria Seidengasse 33-35 1071 Wien
Slovenian: Pfizer Corp. Austria Seidengasse 33-35 1071 Dunaj Avstrija
English: 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.
Slovenian: 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.
English: Neither the second nor third studies are suitable for the determination of a withdrawal period following subcutaneous administration.
Slovenian: Niti druga niti tretja študija nista primerni za določitev karence po subkutani uporabi zdravila.
English: 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.
Slovenian: 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.
English: Dextomax 1 % Solution for injection
Slovenian: Dextomax 1 % Raztopina za injiciranje
English: Luxembourg Pfizer Animal Health Rue Laid Burniat 1
Slovenian: Luksemburg Pfizer Animal Health Rue Laid Burniat 1
English: Withdrawal period (meat and milk)
Slovenian: Karenca (meso in mleko)
English: Groups of 4 sheep (2 male, 2 female) were sacrificed at 14, 35, 42, 49 and 56 days after treatment.
Slovenian: Skupine štirih ovc (dve ženskega in dve moškega spola) so bile žrtvovane po 14, 35, 42, 49 in 56 dneh po terapiji.
English: Box 52 0508 Oslo, Norway
Slovenian: 0508 Oslo Norveška
English: Cattle and sheep
Slovenian: govedo in ovce:
English: 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.
Slovenian: 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.
English: On 17 September 2004, an intention to appeal against the opinion was submitted to the EMEA by the representative of the Marketing Authorisation Holders.
Slovenian: Imetniki dovoljenj za promet so dne 17. septembra 2004 na EMEA oddali namen pritožiti se zoper temu priporočilu.
English: In the group 2 animals given two doses, the injection sites contained the highest residues followed by liver and fat.
Slovenian: 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.
English: At all other time-points doramectin concentrations in liver, kidney and skeletal muscle were at or below the limit of quantification.
Slovenian: V vseh preostalih časovnih točkah (čas odvzema vzorcev) so bile koncentracije doramektina v jetrih, ledvicah in skeletni mišici na meji kvantifikacije oziroma pod njo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Laboratórios Pfizer, Lda
Slovenian: Portugalska Laboratórios Pfizer, Lda
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Injection site residues ranged from 67.3 to 144 μg/kg at this single time-point.
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 3H -radiolabelled doramectin at a dose level of 300 μg/kg.
Slovenian: 3H (radioaktivno) označen doramektin v odmerku
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Cattle
Slovenian: govedo
English: Pigs: 77 days
Slovenian: Prašiči: 77 dni
English: Box 501
Slovenian: Pfizer AB Box 501
English: Pigs: 56 days
Slovenian: Prašiči: 56 dni
English: 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.
Slovenian: 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.
English: Belgique
Slovenian: Belgija
English: 300 g/kg bw Cattle:
Slovenian: 300 g/kg telesne teže govedo:
English: Pigs: 49 days
Slovenian: Prašiči: 49 dni
English: The CVMP had previously assessed doramectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Slovenian: CVMP je že predhodno, v skladu z Uredbo Sveta 2377/90, ocenil doramektin s stališča odobritve najvišje dovoljene količine zaostankov (maximum residue limits, MRLs).
English: Dectomax 10 mg/ml Injection Cattle and sheep Not for use in cattle producing milk for human consumption.
Slovenian: Dectomax 10 mg/ml injekcija govedo in ovce Ni namenjeno uporabi pri govedu, ki proizvaja mleko za prehrano ljudi.
English: Pigs
Slovenian: prašiči:
English: 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.
Slovenian: 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.
English: Cattle:
Slovenian: govedo:
English: The third study was a re-analysis of injection site tissue from the second study due to the high variability of the results obtained.
Slovenian: Zaradi velike variabilnosti teh rezultatov so v okviru tretje študije ponovno analizirali tkiva z mestom vbrizga zdravila, ki so jih pridobili v drugi študiji.
English: Cattle: 42 days Sheep: 35 days Pigs: 37 days
Slovenian: Govedo: 42 dni Ovce: 35 dni Prašiči: 37 dni
English: Dectomax Injectable Solution for Cattle and Sheep
Slovenian: Dectomax Raztopina za injiciranje za govedo in ovce
English: Not to be used later than 60 days prior to expected calving.
Slovenian: Uporaba v času 60 dni pred predvideno otelitvijo ni dovoljena.
English: The withdrawal period should be based on residue depletion to below the MRL at the injection site.
Slovenian: Karenca bi morala biti določena na podlagi izčistka zaostankov oz. v vrednostih, ki so pod MRL v tkivih z mestom vbrizga.
English: 2.2 Calculation of withdrawal periods
Slovenian: 2.2 Izračun karence
English: 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).
Slovenian: 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).
English: Four sheep (group 3) were given a single intramuscular injection of doramectin at a dose of 300 μg/kg bw on study day 0.
Slovenian: Štiri ovce (skupina 3) so prvi dan študije (dan 0) prejele eno intramuskularno injekcijo doramektina v odmerku 300 μg/kg telesne teže.
English: Pfizer Animal Health B.V.
Slovenian: Nizozemska Pfizer Animal Health B.V.