natgillin/translations-raw huggingface dataset:
Paracetamolum + Codeini phosphas
Paracetamol + Kodeinijev fosfat
500mg 8mg 30mg effervescent tablet
500mg 8mg 30mg šumeča tableta peroralna uporaba
Bene Arzneimittel GmbH
Madžarska Bene Arzneimittel GmbH
Codeine phosphate hemihydrate
Kodeinijev fosfat hemihidrat
Tipperary, Ireland
Tipperary, Irska kodeinijev fosfat
12489 Berlin
20144 Milano Italija
ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovenia paracetamol, propifenazonă , cafeină , fosfat de codeină sesquihidrat
Črnuče, Slovenija paracetamol, propifenazon , kofein , kodeinijev fosfat seskvihidrat
500mg + 8mg + 30mg film-coated tablet oral use
500mg + 8mg + 30mg filmsko obložena tableta
Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable effervescent tablet
Paracetamol/Kodein CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable šumeča tableta peroralna uporaba
Paracetamol+ Codeine phosphate hemihydrate
Paracetamol+ Kodeinijev fosfat hemihidrat
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ibuprofen, fosfat de codeină hemihidrat
Berkshire SL1 3UH, Velika Britanija ibuprofen, kodeinijev fosfat hemihidrat
15mg + 500mg Coated tablet
15mg + 500mg Obložena tableta Peroralna uporaba
Codeine phosphate + paracetamol + caffeine
Kodeinijev fosfat hemihidrat + paracetamol + kofein
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Tablets tablet for oral solution
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Velika Britanija paracetamol + kodein Paracodol Tablets tableta za peroralno razotpino
Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg suppository rectal use
1 - 3 81479 München Nemčija kodeinijev fosfat hemihidrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg svečka rektalna uporaba
Codeine phosphate hemihydrate + paracetamol
Kodeinijev fosfat hemihidrat + paracetamol
Ireland codeine phosphate+paracetamo l
Irska kodeinijev fosfat + paracetamol
500 mg + 10 mg effervescent tablet
500 mg + 10 mg šumeča tableta peroralna uporaba
Paracetamol Codeine Phosphate Hyoscine Hydrobromide Anhydrous caffeine
Paracetamol, Kodeinijev fosfat hioscinijev bromid kofein, brezvodni
Paracetamol/Codeine PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Paracetamol/Kodein PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Paracetamol + codeine phosphate hemihydrate+ caffeine
Paracetamol + kodeinijev fosfat hemihidrat + kofein
500mg + 12.8mg + 30mg effervescent tablet
500mg + 12.8mg + 30mg šumeča tableta peroralna uporaba
Paracetamol/ Codein phosphate hemihydrate
Paracetamol/ Kodeinijev fosfat hemihidrat
Paracetamol Codeine phosphate hemihydrate Doxylamine succinate Caffeine
Paracetamol kodeinijev fosfat doksilaminijev sukcinat Kofein
Dafalgan codéine film-coated tablet oral use
Dafalgan codéine filmsko obložena tableta
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Co-Codamol Disp tablet for oral solution
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Velika Britanija paracetamol + kodein Co-Codamol Disp tableta za peroralno razotpino
Paracetamol, codeine phosphate hemihydrate
Paracetamol, Kodeinijev fosfat hemihidrat
Pinex Forte effervescent tablet
Pinex Forte šumeča tableta peroralna uporaba
Ibuprofen Codeine phosphate
Ibuprofen kodeinijev fosfat
500 mg and 30 mg film-coated tablet oral use
500 mg and 30 mg filmsko obložena tableta
Carnaxide Portugal
Romunija kodein
Germany codeinphosphathemihydrat paracetamol talvosilen 250 mg/5 mg Zäpfchen suppository rectal use
1 - 3 81479 München Nemčija kodeinijev fosfat hemihidrat paracetamol talvosilen 250 mg/5 mg Zäpfchen svečka rektalna uporaba
Germany Merck Serono GmbH Alsfelder Str. 17
Merck Serono GmbH Alsfelder Str. 17 64289 Darmstadt Nemčija kodeinijev fosfat hemihidrat paracetamol
Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Nemčija kodeinijev fosfat hemihidrat paracetamol
500 mg+8 mg+30 mg effervescent tablet
500 mg+8 mg+30 mg šumeča tableta peroralna uporaba
500mg + 8mg + 30mg capsule, hard Oral use
500mg + 8mg + 30mg kapsula, trda
Paracetamol Codeine Phosphate Caffeine
Paracetamol kodeinijev fosfat hemihidrat kofein
Paracetamol+ caffeine+ codeine phosphate hemihydrate
Paracetamol+ Kofein + Kodeinijev fosfat hemihidrat
Paracetamol+ Caffeine+ Codeine phosphate hemihydrate
Paracetamol+ kofein+ kodeinijev fosfat hemihidrat
500mg +8mg + 30mg tablet for oral solution
500mg +8mg + 30mg tableta za peroralno raztopino
200mg +12.8mg coated tablet
200mg +12.8mg filmsko obložena tableta
8mg +500mg + 30mg effervescent tablet
8mg + 500mg + 30mg tableta za peroralno raztopino
Paracetamolum + Codeini phosphas + Coffeinum
Paracetamol + kodeinijev fosfat + kofein
Co-codamol 8/500 mg tablets effervescent tablet
Co-codamol 8/500 mg tablets šumeča tableta peroralna uporaba
30mg + 500mg capsule, hard oral use
30mg + 500mg kapsula, trda
Paracetamol, codeine phosphate and caffeine
Paracetamol kodeinijev fosfat in kofein
Paracetamolum + Coffeinum + Codeini phosphas
Paracetamol + kofein + kodeinijev fosfat
500mg/50mg/30mg effervescent tablet
500mg/50mg/30mg šumeča tableta peroralna uporaba
120 mg and 12 mg / 5 ml oral solution oral use
120 mg and 12 mg / 5 ml peroralna raztopina
30mg + 500 mg capsule, hard oral use
30mg + 500 mg kapsula, trda
6,33 mg/ 5 ml oral solution oral use
6,33 mg/ 5 ml peroralna raztopina
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg šumeča tableta t peroralna uporaba
Hämeenlinna 13500 Finland paracetamol, codeine,
Finska paracetamol, kodein,
Paracetamol and codeine phosphate hemihydrate
Paracetamol in kodeinijev fosfat hemihidrat
Paracetamol Codeine Phosphate hemihydrate
Paracetamol kodeinijev fosfat hemihidrat
Ibuprofen Codeine Phosphate Hemihydrate
Ibuprofen kodeinijev fosfat hemihidrat
Ibuprofen Codeine phosphate hemihydrate
Ibuprofen Kodeinijev fosfat hemihidrat
500mg + 30mg film-coated tablet oral use
500mg + 30mg filmsko obložena tableta
Paracetamol Codeine Phosphate
Paracetamol kodeinijev fosfat
Paracetamol Codeine phosphate
Paracetamol Kodeinijev fosfat
Paracetamol/codeine phosphate
Paracetamol/ Kodeinijev fosfat
Paracetamol/ Codeine phosphate
Paracetamol/ kodeinijev fosfat
Sweden codeine phosphate hemihydrate/ paracetamol
167 14 Bromma Švedska kodeinijev fosfat hemihidrat / paracetamol
Paracetamol and codeine phosphate
Paracetamol in kodeinijev fosfat
Co-codamol 500 mg/8 mg tablets effervescent tablet
Co-codamol 500 mg/8 mg tablets šumeča tableta peroralna uporaba
500mg + 30mg + 8mg effervescent tablet
500mg + 30mg + 8mg šumeča tableta peroralna uporaba
Paracetamol/Codeine/C affeine
Paracetamol/kodein/kof ein
Acetylsalicylic acid + Codeine phosphate hemihydrate + Caffeine
Carnaxide Portugalska acetilsalicilna kislina + kodeinijev fosfat hemihidrat + kofein
1300 Wavre
Hämeenlinna 13500
200mg +12,8 mg film-coated tablet oral use
200mg +12,8 mg filmsko obložena tableta
Codiene phosphate
Kodeinijev fosfat
8mg + 500mg + 30mg soluble tablet
8mg +500mg + 30mg šumeča tableta PERORALNA UPORABA
Strength Pharmaceutical Form
Farmacevtsk a oblika
1 cartridge and 1 pen
1 vložek in 1 peresnik
3 cartridges
3 vložki
1 cartridge
1 vložek
This approach offers the highest degree of consumer protection
Ta pristop nudi največjo stopnjo varnosti za potrošnika.
The responses were submitted on 17 June 2004.
Odgovori so bili poslani dne 17. junija 2004.
Porte Salvo Portugal
Porte Salvo Portugalska
Conclusions and recommendations
Zaključki in priporočila
2900 AA CAPELLE AAN DEN IJSSEL The Netherlands
2900 AA CAPELLE AAN DEN IJSSEL Nizozemska
Introduction and Background
Uvod in ozadje
Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS
Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS Španija
183 25 Täby Sweden
183 25 Täby Švedska
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.
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.
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