natgillin/translations-raw huggingface dataset:
• Take the vial, the vial adapter and the prefilled syringe out of the carton. 
• Iz škatle vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo.
PK Parameter 0-6 years N=12 
0-6 let N=12
NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX) 
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol 
IME ZDRAVILA IN POT(I) UPORABE Refixia 2000 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
There is a rare risk of developing a specific kidney disorder called “nephrotic syndrome” following high doses of factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions. 
Pri bolnikih s hemofilijo B, ki imajo zaviralce faktorja IX in so že doživeli pojav alergijske reakcije, pri uporabi velikih odmerkov faktorja IX obstaja majhno tveganje za razvoj posebne bolezni ledvic, imenovane “nefrotski sindrom”.
NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX) 
Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
Reconstitute the powder with the solvent 
Rekonstitucija praška z vehiklom
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol 
IME ZDRAVILA IN POT(I) UPORABE Refixia 1000 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
PHARMACOLOGICAL PROPERTIES 
Farmakokinetični parameter
Table 1 Treatment of bleeding episodes with Refixia 
Preglednica 1: Zdravljenje krvavitev z zdravilom Refixia Stopnja krvavitve Priporočeni odmerek zdravila Refixia v i.e./kg
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol 
IME ZDRAVILA IN POT(I) UPORABE Refixia 500 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
If you touch the sides or the thread, germs from your fingers can be transferred. 
Če se ga dotaknete ob straneh ali na mestu za pritrditev, ga lahko kontaminirate z mikrobi.
Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator 
Dokazano je bilo, da je zdravilo med uporabo kemijsko in fizikalno stabilno 24 ur, če se ga shranjuje v hladilniku (2 °C - 8 °C), in 4 ure, če se ga shranjuje pri sobni temperaturi (≤ 30 °C).
Syringe tip (under syringe cap) Scale 
Napolnjena injekcijska brizga z vehiklom konica brizge (pod zaporko brizge) skala batni zamašek zaporka brizge
Pivotal trial 
Ključno preskušanje
Thread 
Viala
Vial with Refixia powder 
OVOJNINAH Napolnjena injekcijska brizga
MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1193/001
Hypersensitivity Anaphylaxis Inhibitors 
Bolezni imunskega sistema preobčutljivost anafilaksija zaviralci občasni neznana neznana
Fifty-four of the patients across all age-groups were treated with a weekly prophylactic dose of 40 IU/kg where 23 (43%) of these patients had no bleeding episodes. 
S tedenskim profilaktičnim odmerkom 40 i.e./kg se je zdravilo 54 bolnikov iz vseh starostnih skupin.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Refixia 
IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo Refixia Raztopina histidina
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place under controlled and validated aseptic conditions. 
Zdravila se običajno ne sme shranjevati dlje kot 4 ure pri sobni temperaturi (≤ 30 °C) ali 24 ur v hladilniku
Contents 
SERIJ
• rash, hives, weals or itching 
• kožni izpuščaj, koprivnica ali srbenje
MARKETING AUTHORISATION NUMBER EU/1/17/1193/002 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1193/002
0-6 years 
6.3 Rok uporabnosti
Clearance CL (ml/hour/kg) 
(ml/ura/kg)
Polysorbate 80 
Večji kirurški posegi 80
In case of self-administration or administration by caregiver appropriate training is needed. 
Če bo zdravilo uporabljal bolnik sam ali mu ga bo aplicirala oseba, ki skrbi zanj, je treba bolnika oziroma osebo o tem ustrezno poučiti.
For treatment of bleeds in paediatrics, the overall success rate (defined as excellent or good) was 93% (39 out of 42 bleeds), where 36 (86 %) of the bleeds were resolved with 1 injection, and 5 (12%) of the bleeds were resolved with 2 injections of Refixia. 
Pri zdravljenju krvavitev pri otrocih je delež celokupne uspešnosti (opredeljene kot odlična ali dobra) znašal 93 % (39 od 42 krvavitev).
SPECIAL STORAGE CONDITIONS 
Srednji čas zadrževanja
On-demand treatment 
Zdravljenje po potrebi
MARKETING AUTHORISATION NUMBER EU/1/17/1193/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1193/003
Contents of the pack and other information What Refixia contains 
Shranjevanje zdravila Refixia Vsebina pakiranja in dodatne informacije
Leave the plunger rod untouched in the carton. 
Potisnega bata se ne dotikajte ob straneh ali na mestu za pritrditev.
PHARMACEUTICAL FORM Powder and solvent for solution for injection. 
FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Prašek je bel do skoraj bel.
1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe 
1 do 10 sterilnih tub, vsaka z 1 napolnjeno injekcijsko brizgo + 1 vstavljena kanila ali 1 filtrirna ročica za vsako napolnjeno injekcijsko brizgo
1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator 
1 do 10 sterilnih tub, vsaka z do dvema aplikatorjema + ena injekcijska brizga za vsak aplikator
MA (EU) Number Invented name 
Izmišljeno ime
Intraarticular use Pre-filled syringe (PP) 
Pot uporabe Stična ovojnina Vsebina Velikost pakiranja
Intraarticular use Applicator (PU) 
Št. (EU) dovoljenja za promet
Immediate Packaging 
Aplikator
Milk: 72 hours 
Mleko: 72 ur
Member State EU/EEA 
Država članica EU / EGP
Meat and offal: 8 days 
Meso in organi: 8 dni
Assessment of the efficacy of the products for the other approved indications remains unchanged. 
Ocena učinkovitosti zdravil za druge odobrene indikacije ostaja nespremenjena.
Not authorised for use in horses producing milk for human consumption. 
Ni dovoljeno za uporabo pri konjih, ki dajejo mleko za humano potrošnjo.
4.2 Indications for use, specifying the target species 
4.2 Indikacije za uporabo z navedbo ciljnih živalskih vrst
Further to this restriction the CVMP concluded that the single administration of the concerned products does not have an impact on their clinical efficacy. 
Poleg te omejitve je CVMP zaključil, da enkratno dajanje zadevnih zdravil ne vpliva na njihovo klinično učinkovitost.
Therefore, on 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Dexadreson 2 mg/ml and associated names, and generic products thereof. 
Nemčija je zato 22. avgusta 2012 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila.
According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours. 
V skladu s trenutnimi informacijami o zdravilu Dexadreson se lahko zdravljenje ponovi po 24 do 48 urah.
Kidney and liver were the tissues where the marker residue persisted longest. 
Ledvice in jetra so bila tkiva, v katerih se je ostanek označevalca ohranil najdlje.
Cattle, horses 
Govedo, konji
Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN 
Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona ŠPANIJA
Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTUGAL 
Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTUGALSKA
Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE 
Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCIJA
88326 Aulendorf GERMANY 
88326 Aulendorf NEMČIJA
D-85716 Unterschleißheim GERMANY 
D-85716 Unterschleißheim NEMČIJA
Three residue depletion studies in cattle have been provided, two studies on residue depletion in cattle tissues and one study on residue depletion in milk. 
Predložene so bile tri študije izločanja ostankov pri govedu, dve študiji izločanja ostankov pri tkivih goveda in ena študija izločanja ostankov pri mleku.
United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM 
Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ ZDRUŽENO KRALJESTVO
All studies were conducted at a single dose of 0.06 mg/kg body weight. 
Vse študije so bile izvedene pri enkratnem odmerku 0,06 mg/kg telesne mase.
Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA 
Intervet GmbH Siemensstraße 107 AT-1210 Wien AVSTRIJA
Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses. 
Kjer je smiselno, zbrisati vse reference za ponovitev zdravljenja pri govedu in konjih in zdravljenje v primerih šoka pri konjih.
Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure. 
V tem napotitvenem postopku kakovost, varnost zdravila za ciljne živalske vrste, varnost zdravila za uporabnika in okoljska tveganja niso bili obravnavani.
The benefit-risk balance for the products concerned remains positive subject to amendments in the product information. 
Razmerje med tveganji in koristmi za zadevna zdravila ostaja ugodno, če se upošteva spremembe v informacijah o zdravilu.
Therefore the CVMP considered that the indication for treatment of shock in horses should be removed from the product information; 
CVMP je zato menil, da je treba indikacijo zdravljenja šoka pri konjih iz informacij o zdravilu odstraniti;
Withdrawal periods for the minor species horse can be based on comparison of pharmacokinetic data, indicating that depletion of the substance in horses is not slower than in cattle. 
Karence za manj pomembne vrste konjev se lahko določi s primerjavo farmakokinetičnih podatkov, kar označuje, da izločanje snovi pri konjih ni počasnejše kot pri govedu.
One of the studies on residue depletion in cattle tissues was not conducted over a sufficiently long period of time and was therefore not considered suitable to derive a valid withdrawal periods in cattle meat and offal. 
Ena od študij izločanja ostankov pri tkivih goveda ni potekala dovolj dolgo, zato je bila ocenjena kot neustrezna za izpeljevanje veljavnih karenc pri mesu in drobovini goveda.
Consequently Germany considered that it is in the interest of consumer safety to evaluate the adequacy of the meat withdrawal periods in cattle and horses and the milk withdrawal periods in cattle. 
Nemčija je menila, da je v interesu varnosti potrošnikov, da se oceni ustreznost karenc za meso pri govedu in konjih ter karenc za mleko pri govedu.
Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Dexadreson 2 mg/ml in povezanih imen ter njegovih generičnih zdravil (glejte Prilogo I)
Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues. 
Zato so menili, da je ustrezno uporabiti alternativni način za določitev karence za tkiva goveda.
Germany noted that Dexadreson 2 mg/ml and its associated names has different withdrawal periods in cattle (meat and milk) and horses (meat) established by the Member States across the EU/EEA. 
Nemčija je zabeležila, da imajo zdravilo Dexadreson 2 mg/ml in povezana imena drugačne karence pri govedu (meso in mleko) in konjih (meso), kot so jih določile države članice po celotni EU/EGP.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States 
Seznam imen, farmacevtske oblike, jakosti zdravil za uporabo v veterinarski medicine, živalske vrste, imetniki dovoljenja za promet z zdravilom v državah članicah
No residue depletion data are available in horses for the single or repeat dose treatment. 
Na voljo niso nobeni podatki o izločanju ostankov pri konjih za zdravljenje z enkratnim ali ponovnim odmerkom.
The other study was considered valid, however, the data set obtained from it did not allow the use of the statistical approach for the determination of withdrawal periods in accordance with the CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)2 as statistical criteria for the linear regression analysis were not fulfilled. 
Druga študija je bila ocenjena kot veljavna, vendar z njo pridobljeni podatki niso omogočali uporabe statističnega pristopa za določanje karenc v skladu z navodili odbora CVMP: pristop k usklajevanju karenc (EMEA/CVMP/036/95)2, ker statistična merila za linearno regresijsko analizo niso bila izpolnjena.
Delete, where applicable, “in cases of shock in horses”. 
Zbrisati “v primerih šoka pri konjih”, kjer je to smiselno.
The marketing authorisation holders agreed to remove the advice on repeat dose treatment in horses from the product information. 
Imetniki dovoljenj za promet z zdravili so se strinjali z umikom nasveta o zdravljenju s ponovnim odmerkom pri konjih iz informacij o zdravilu.
VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf below the MRL values in kidney and liver. 
VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf kar povzroči 8-dnevno karenco za zdravljenje z enkratnim odmerkom 0,06 mg deksametazona na kg telesne mase.
Strength Pharmaceutical form 
Generično ime Jakost Farmacevtska oblika
The residue depletion study in milk was considered acceptable, but the recommended method for the calculation of a milk withdrawal period according to the CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)3 - the Time to safe concentration (TTSC) methodcannot be used due to the insufficient number of animals included in the study. 
Študijo izločanja ostankov za mleko so ocenili kot sprejemljivo, vendar priporočenega načina za izračun karence za mleko v skladu z navodili CVMP za določitev karenc za mleko (EMEA/CVMP/473/98)3 - s pristopom časa do varne koncentracije (TTSC) - ni mogoče uporabiti zaradi nezadostnega števila živali, vključenih v študijo.
Therefore, none of the studies was conducted at the maximum intended dose as requested in VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)1 and safe withdrawal periods in cattle tissues and milk can only be set for single treatment. 
Zato nobena od študij ni bila izvedena pri največjem predvidenem odmerku, kot je bilo zahtevano v VICH GL48: Študije za oceno presnove in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: študije izločanja ostankov označevalca za izračun karenc zdravil (EMA/CVMP/VICH/463199/2009)1, in varne karence pri tkivih goveda in mleku se lahko določijo samo za enkratno zdravljenje.
• the CVMP considered that the overall benefit-risk balance is positive for Dexadreson 2 mg/ml and associated names, and generic products thereof subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for Dexadreson 2 mg/ml and associated names, and generic products thereof (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III. 
• CVMP je menil, da je celokupno razmerje med tveganji in koristmi za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila pozitivno, če se upoštevajo spremembe v informacijah o zdravilu; je CVMP priporočil spremembe dovoljenj za promet z zdravilom Dexadreson 2 mg/ml in povezanimi imeni ter njegovimi generičnimi zdravili (glejte prilogo I), da se dopolni povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v skladu s priporočenimi spremembami v informacijah o zdravilu, navedenih v prilogi III.
No safe withdrawal period for these dosages can be set and the CVMP considered that the shock indication should be withdrawn from the product information of Dexadreson and its generic products, where applicable. 
Določiti ni mogoče nobene varne karence za te odmerke in CVMP je menil, da je treba indikacijo šoka izključiti iz informacij o zdravilu Dexadreson in njegovih generičnih zdravilih, kjer je primerno.
DOSAGES FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
In the absence of residue depletion data at the maximum intended dose and further to the concerns expressed above, the marketing authorisation holders agreed to remove the advice on repeat dose treatment after 24-48 hours in cattle from the product information. 
Zaradi odsotnosti podatkov o izločanju ostankov pri največjem predvidenem odmerku in zgoraj navedenih zadržkov so se imetniki dovoljenj za promet z zdravili strinjali, da se iz informacij o zdravilu odstrani nasvet o zdravljenju s ponovnim odmerkom po 24 do 48 urah pri govedu.
Therefore a 20% safety span was applied to the observed period of 60 hours, resulting in a withdrawal period of 72 hours, i.e. 3 days, in milk from cows treated at a single dose of 0.06 mg dexamethasone per kg body weight. 
Zato je bil za opazovano obdobje 60 ur uporabljen 20-odstotni varnostni razpon, kar je povzročilo 72-urno karenco, tj. 3 dni, za mleko krav, zdravljenih z enkratnim odmerkom 0,06 mg deksametazona na kg telesne mase.
Applicant/marketing authorisation holder 
Imetnik dovoljenja za promet z zdravilom
• In the absence of residue depletion or pharmacokinetic data for the higher dosages recommended for the indication concerning treatment of shock in horses, no safe withdrawal period for these dosages can be set for Dexadreson 2 mg/ml and associated names, and generic products thereof. 
• zaradi odsotnosti podatkov o izločanju ostankov in farmakokinetičnih podatkov za višje odmerke, priporočene za indikacijo zdravljenja šoka pri konjih, za te odmerke ni mogoče določiti nobene varne karence za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila.
As there were no residue depletion data with the recommended repeat dose treatment in cattle and horses, the CVMP concluded that the advice on repeat dose treatment in cattle and horses should be removed from the product information. 
Ker niso bili predloženi nobeni podatki o izločanju ostankov pri zdravljenju s priporočenim ponovnim odmerkom pri govedu in konjih, je CVMP zaključil, da je treba nasvet o zdravljenju s ponovnim odmerkom pri govedu in konjih izbrisati iz informacij o zdravilu.
• In the absence of residue depletion or pharmacokinetic data following a repeat treatment in cattle and horses for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that the advice on repeat dose treatment after 24-48 hours in cattle and horses should be removed from the product information; 
• zaradi odsotnosti podatkov o izločanju ostankov in farmakokinetičnih podatkov po ponovnem zdravljenju pri govedu in konjih za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila je CVMP menil, da je treba nasvet o zdravljenju s ponovnim odmerkom po 24 do 48 urah pri govedu in konjih iz informacij o zdravilu odstraniti;
The same withdrawal period for edible tissues may be applied for cattle and horses for the same dosing regimen, resulting in a withdrawal period for horse meat and offal of 8 days for the single dose treatment of 0.06 mg dexamethasone per kg body weight. 
Za govedo in konje se lahko uporabi enaka karenca za užitna tkiva za enak režim odmerjanja, kar povzroči karenco za konjsko meso in drobovino 8 dni za zdravljenje z enkratnim odmerkom 0,06 mg deksametazona na kg telesne mase.
Residue depletion data was made available and supported a cattle meat and offal withdrawal period of 8 days and a cattle milk withdrawal period of 72 hours, as well as a horse meat and offal withdrawal period of 8 days following a single injection at the recommended dose of 0.06 mg dexamethasone per kg body weight. 
Podatki o izločanju ostankov so bili predloženi in so podpirali 8-dnevno karenco za goveje meso in drobovino, 72-urno karenco za goveje mleko ter 8-dnevno karenco za konjsko meso in drobovino po enkratnem injiciranju pri priporočenem odmerku 0,06 mg deksametazona na kg telesne mase.
As there were no data available to support safe withdrawal periods for horse meat and offal following administration of high dosages in case of treatment of shock, the CVMP concluded that the shock indication in horses should be removed from the product information for Dexadreson and its generic products, where applicable. 
Ker niso bili predloženi nobeni podatki v podporo varnih karenc za konjsko meso in drobovino po dajanju visokih odmerkov v primeru zdravljenja šoka, je CVMP zaključil, da je treba indikacijo šoka odstraniti iz informacij o zdravilu Dexadreson in njegovih generičnih zdravilih, kjer je primerno.
• On the basis of the residue depletion data in cattle and the pharmacokinetic data in horses submitted by the marketing authorisation holders for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that withdrawal periods of 8 days for cattle meat and offal, 72 hours for cattle milk and 8 days for horse meat and offal were safe; 
• na podlagi podatkov o izločanju ostankov pri govedu in farmakokinetičnih podatkov pri konjih, ki so jih predložili imetniki dovoljenj za promet z zdravilom Dexadreson 2 mg/ml in povezanimi imeni ter njegovimi generičnimi zdravili, je CVMP menil, da so varne 8-dnevna karenca za goveje meso in drobovino, 72-urna karenca za goveje mleko in 8-dnevna karenca za konjsko meso in drobovino;
Six days after administration the residue concentrations were 
Šest dni po dajanju so bile koncentracije ostankov pod vrednostmi MRL v ledvicah in jetrih.
Cattle, pigs, dogs and cats 
Govedo, prašiči, psi in mačke
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet 
Spremembe v določenih poglavjih povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
Cattle, horses, goat, pigs, dogs and cats 
Govedo, konji, koze, prašiči, psi in mačke
The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products are solutions for injection which contain 2 mg dexamethasone per ml. 
Zdravilo za uporabo v veterinarski medicini Dexadreson 2 mg/ml in povezana imena ter generična zdravila so raztopine za injiciranje, ki vsebujejo 2 mg deksametazona na ml. Deksametazon je dolgo delujoči sintetični glukokortikoid, ki se uporablja proti vnetjem, alergijam in kot glukoneogena snov za dajanje kmetijskim in domačim živalim.