natgillin/translations-raw huggingface dataset:
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Prašak i otapalo za otopinu za injekciju
• After injection, safely dispose of all unused Refixia solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
štrcaljku s infuzijskim setom, bočicu s nastavkom za bočicu i drugi otpadni materijal, u skladu s uputama koje ste dobili od ljekarnika.
• Push the plunger rod to inject all the solvent into the vial.
• Pritisnite potisni klip kako biste cjelokupno otapalo ubrizgali u bočicu.
This may become severe and could be life-threatening
Mogu biti teške i opasne po život (anafilaktičke reakcije)
Record of use
Evidencija primjene
Table 2 Treatment in surgery with Refixia
Općenite preporuke navedene su u Tablici 2. Tablica 2 Liječenje lijekom Refixia kod kirurških zahvata Vrsta kirurškog zahvata
How to store Refixia
Kako primjenjivati lijek Refixia
• Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
• Lagano povucite potisni klip prema dolje kako biste uvukli pripremljenu otopinu u štrcaljku.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use, after reconstitution
NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
pH: 6.4.
Otapalo je bistro i bezbojno. pH: 6,4.
Immune system disorders
Klasifikacija organskih sustava
Uncommon Unknown Unknown
Prethodno neliječeni bolesnici
If you touch the sides or the thread, germs from your fingers can be transferred.
Ako dotaknete bočne stranice ili navoj, može doći do prijenosa mikroorganizama s
Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product.
Refixia sadrži djelatnu tvar nonakog beta pegol, a to je dugodjelujući rekombinantni koagulacijski faktor IX. Faktor IX je protein koji se prirodno nalazi u krvi i pomaže zaustaviti krvarenja.
The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Nakon aktivacije lijeka Refixia, cijepa se aktivacijski peptid uključujući polietilenglikolnu skupinu od 40 kDa, ostavljajući nativnu aktiviranu molekulu faktora IX. Primarna sekvenca aminokiselina u rFIX iz lijeka Refixia identična je alelnom obliku Ala148 humanog faktora IX dobivenog iz plazme.
• Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
• Čvrsto navijte napunjenu štrcaljku na nastavak za bočicu dok ne osjetite otpor.
During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Unutar roka valjanosti lijek Refixia može se čuvati na temperaturi do 30°C tijekom jednokratnog razdoblja od najviše 6 mjeseci.
Mean residence time (MRT) (hours)
(MRT) (sati)
Must not be returned to refrigerator after storage at room temperature Date removed from refrigerator: ____________ Store in the original package to protect from light
Ne smije se vraćati u hladnjak nakon čuvanja na sobnoj temperaturi
Remove the protective cap from the vial adapter.
Skinite zaštitni pokrov s nastavka za bočicu.
(anaphylactic reactions)
(ispod zatvarača štrcaljke)
NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Refixia 2000 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
• Keep the plunger rod pushed completely in.
• Držite potisni klip pritisnutim do kraja.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 500 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Refixia 500 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 1000 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Refixia 1000 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
In repeat dose toxicity studies in rats and monkeys, 40 kDa polyethylene-glycol (PEG) was detected by immunohistochemical staining in epithelial cells of choroid plexus in the brain.
40 kDa je otkriven imunohistokemijskim bojenjem u epitelnim stanicama koroidnog spleta mozga.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 2000 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
7-12 years
12 i više godina.
PK Parameter 0-6 years N=12
0-6 godina N=12
Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek Refixia primjenjuje se intravenski nakon rekonstitucije praška s otapalom koje dolazi u štrcaljki.
Pre-filled syringe with solvent
Napunjena štrcaljka s otapalom Vrh štrcaljke
If you have to significantly increase your usage of Refixia to stop a bleed, talk to your doctor immediately.
Odmah se obratite liječniku ako morate značajno povećati primjenu lijeka Refixia kako biste zaustavili krvarenje.
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
U bolesnika s hemofilijom B koji imaju inhibitore faktora IX i alergijsku reakciju u anamnezi, nakon pokušaja indukcije imunološke tolerancije prijavljen je nefrotski sindrom.
• While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
lagano lupnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Prašak: 500 IU nonakog beta pegola (pribl.
STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Prašak: 1000 IU nonakog beta pegola (pribl.
0-6 years
6.3 Rok valjanosti
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
U bolesnika s hemofilijom B mogu se razviti neutralizirajuća protutijela (inhibitori) na faktor IX. Ako se takvi inhibitori razviju, stanje se manifestira kao nedovoljan klinički odgovor.
(bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
- 1 potisni klip (polipropilen).
Vial adapter Protective cap
4.8 Nuspojave Sažetak sigurnosnog profila
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) • alergijske reakcije (preosjetljivost).
Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Jedna bočica nominalno sadrži 2000 IU nonakog beta pegola*.
What Refixia is used for
Za što se Refixia koristi
MARKETING AUTHORISATION NUMBER EU/1/17/1193/002
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/002
A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Ukupno je 69 (98,6%) od 70
• Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Pripremite otopinu od praška i otapala • Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
• heart palpitations
Srčani poremećaji palpitacije manje često
MARKETING AUTHORISATION NUMBER EU/1/17/1193/001
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/001
Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Jedna bočica nominalno sadrži 1000 IU nonakog beta pegola*.
Degree of haemorrhage
ROK VALJANOSTI Rok valjanosti
MARKETING AUTHORISATION NUMBER EU/1/17/1193/003
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/003
• hot flush.
• osjećaj lupanja srca • navale vrućine.
Plastic cap
Zaštitni pokrov
• feeling very tired.
• osjećaj mučnine • osjećaj teškog umora.
MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/001
Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Jedna bočica nominalno sadrži 500 IU nonakog beta pegola*.
1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe
1 do 10 sterilnih cjevčica, svaka s 1 unaprijed napunjenom štrcaljkom + 1 kanila za umetanje ili 1 cjevčica s filtrom za svaku unaprijed napunjenu štrcaljku
1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator
1 do 10 sterilnih cjevčica s do 2 aplikatora svaka + 1 štrcaljka po aplikatoru
Intraarticular use Pre-filled syringe (PP)
Unaprijed napunjena štrcaljka
Member State EU/EEA
Države članice EU/EEA
Milk: 72 hours
Mlijeko: 72 sata
Assessment of the efficacy of the products for the other approved indications remains unchanged.
Procjena djelotvornosti proizvoda za druge odobrene indikacije ostaje nepromijenjena.
Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure.
Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika i rizik za okoliš nisu ispitani u ovom postupku procjene.
Meat and offal: 8 days
Meso I iznutrice: 8 dana
S.P. Veterinaria, S.A. Ctra.
S.P. Veterinaria, S.A.
According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
U skladu s trenutnim informacijama o proizvodu za Dexadreson, liječenje se može ponoviti nakon 24-48 sati.
Kidney and liver were the tissues where the marker residue persisted longest.
Bubrezi i jetra bili su tkiva gdje su se markeri rezidua najdulje zadržali.
Delete, where applicable, “in cases of shock in horses”.
Izbrisati, gdje je primjenjivo, “u slučajevima šoka kod konja”.
Further to this restriction the CVMP concluded that the single administration of the concerned products does not have an impact on their clinical efficacy.
Nadalje uz ovo ograničenje CVMP je zaključio da pojedinačna primjena dotičnih proizvoda nema utjecaja na njihovu kliničku djelotvornost.
Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona ŠPANJOLSKA
192 07 Sollentuna SWEDEN
192 07 Sollentuna ŠVEDSKA
Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCUSKA
D-85716 Unterschleißheim GERMANY
D-85716 Unterschleißheim NJEMAČKA
Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA
Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIJA
88326 Aulendorf GERMANY
88326 Aulendorf NJEMAČKA
4941 VX Raamsdonksveer THE NETHERLANDS
4941 VX Raamsdonksveer NIZOZEMSKA
United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Velika Britanija Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ VELIKA BRITANIJA
Not authorised for use in horses producing milk for human consumption.
Nije za upotrebu kod konja čije je mlijeko namijenjeno za ljudsku upotrebu.
Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues.
Stoga se smatralo prikladnim koristiti alternativnu metodu kako bi se utvrdila karencija za tkiva stoke.
All studies were conducted at a single dose of 0.06 mg/kg body weight.
Sve su studije provedene pri pojedinačnoj dozi od 0,06 mg/kg tjelesne težine.
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.
Njemačka je uočila da Dexadreson 2 mg/ml i njegova pridružena imena imaju različite karencije u stoke (meso i mlijeko) i konja (meso) koje su utvrdile države članice širom EU/EGP.
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.
Predani su rezultati tri studije razgradnje rezidua kod stoke s tim da su se dvije studije odnosile na razgradnju rezidua u tkivu stoke, a jedna studija na razgradnju rezidua u mlijeku.
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.
Karencije za manje vrste konja mogu se temeljiti na usporedbi farmakokinetičkih podataka ukazujući da razgradnja tvari u konja nije sporija od one u stoke.
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.
Jedna od studija o razgradnji rezidua u tkivu stoke nije provedena tijekom dovoljno dugog razdoblja i stoga se nije smatrala prikladnom da bi se na temelju njenih rezultata zaključilo o valjanoj karenciji mesa i iznutrice stoke.
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.
Njemačka prikazala Agenciji obavijest o procjeni u skladu s člankom 35 Direktive 2001/82/EK za Dexadreson 2 mg/ml i pridružena imena i njegove generičke proizvode.
The benefit-risk balance for the products concerned remains positive subject to amendments in the product information.
Omjer dobrobiti i rizika dotičnog proizvoda ostaje pozitivan i podložan je promjenama u informacijama o proizvodu.
Therefore the CVMP considered that the indication for treatment of shock in horses should be removed from the product information;
CVMP je stoga smatrao da je potrebno ukloniti indikaciju za liječenje šoka u konja iz informacija o proizvodu;
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.
Kao posljedica toga, Njemačka je smatrala da je u interesu potrošača da procijeni adekvatnost karencije za meso stoke i konja te za mlijeko stoke.
5830 AB Boxmeer THE NETHERLANDS
5830 AB Boxmeer NIZOZEMSKA
Conclusions on the benefit-risk balance
Zaključci o omjeru dobrobiti i rizika
Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Deksametazon je sintetski glukokortikoid dugog djelovanja koji se djeluje protuupalno, protualergijski i glukoneogenetski kod primjene na poljoprivrednim i domaćim životinjama.
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 se studija smatrala valjanom no, podaci dobiveni iz nje nisu omogućavali upotrebu statističkog pristupa za određivanje karencija u skladu s CVMP napomenom za smjernicu: pristup prema harmonizaciji karencija (EMEA/CVMP/036/95)2 jer statistički kriteriji za analizu linearne regresije nisu ispunjeni.
Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses.
Izbrisati, gdje je primjenjivo, sve reference za ponovan tretman kod goveda i konja i tretman u slučavevima šoka kod konja .
3 CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
3 CVMP napomena za smjernice za određivanje karencije u mlijeku (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
No residue depletion or pharmacokinetic data are available for the much higher dosages recommended for the treatment of shock in horses.
Nisu dostupni podaci o razgradnji rezidua ili farmakokinetici za puno više preporučene doze za liječenje šoka u konja.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Popis imena, farmaceutskog oblika, jačine VMP, ciljnih vrsta, nositelja odobrenja država članica
Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I)
Ukupni sažetak znanstvene procjene za Dexadreson 2 mg/ml i pridruženi nazivi te njegove generičke proizvode (vidjeti prilog I)
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.
Veterinarsko-medicinski proizvod Dexadreson 2 mg/ml i njegovi pridruženi nazivi i generički proizvodi otopine su za injekciju koje sadrže 2 mg deksametazona po ml.
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: Studije za procjenu metabolizma i kinetike rezidua veterinarskih lijekova u životinja koje služe kao hrana: ispitivanja razgradnje markera rezidua za utvrđivanje karencije (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP napomena za smjernice: pristup prema harmonizaciji karencija (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf do karencije od 8 dana za liječenje pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
No residue depletion data are available in horses for the single or repeat dose treatment.
Nisu dostupni podaci o razgradnji rezidua kod konja za liječenje jednom dozom ili ponovljenim dozama.
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.
Stoga nijedno ispitivanje nije provedeno pri maksimalnoj namjeravanoj dozi kako to zahtijeva VICH GL48: Studije za procjenu metabolizma i kinetike rezidua veterinarskih lijekova u životinja koje služe kao hrana: studije razgradnje markera rezidua (EMA/CVMP/VICH/463199/2009)1 i sigurna karencija u tkivu stoke i mlijeku mogu se podesiti samo za pojedinačno liječenje.
The marketing authorisation holders agreed to remove the advice on repeat dose treatment in horses from the product information.
Nositelji odobrenja slažu se da treba ukloniti savjet o liječenju ponovljenom dozom u konja iz informacija o proizvodu.
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.
Ispitivanja razgradnje rezidua u mlijeku smatrano je prihvatljivim ali preporučena metoda za izračun karencije u mlijeku u skladu s napomenom CVMP za smjernice za određivanje karencija u mlijeku (EMEA/CVMP/473/98)3 - metoda mjerenja do sigurne koncentracije (TTSC) - ne može se koristiti zbog nedostatnog broja životinja uključenih u ispitivanje.
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.
Nije moguće odrediti sigurne karencije za te doze te je CVMP smatrao da se indikacija šoka može povući iz informacija o proizvodu za Dexadreson i njegove generičke proizvode ako je to primjenjivo.
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.
U nedostatku podataka o razgradnji rezidua pri maksimalnoj namjeravanoj dozi te nadalje u vezi prethodno izraženih razloga za zabrinutost, nositelji odobrenja za stavljanje lijeka u promet dogovorili su se da uklone savjet o ponovljenom doziranju nakon 24-48 sati u stoke iz informacija o proizvodu.
Animal species
Ciljne vrste
DOSAGES FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
Cattle:
Govedo:
Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS
Wim de Körverstraat 35 5831, AN Boxmeer NIZOZEMSKA
• 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 temelju podataka o razgradnji rezidua u stoke i farmakokinetičkih podataka u konja koje su podnijeli nositelji odobrenja za Dexadreson 2 mg/ml i njegove pridružene nazive te generičke proizvode, CVMP je smatrao da su karencije od 8 dana za meso stoke i iznutrice, 72 sata za mlijeko stoke i 8 dana za konjsko meso i iznutrice sigurne;
Annex III
ANEKS III
Annex II
Prilog II
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.
S obzirom na nema podataka o razgradnji rezidua s preporučenim liječenje ponovljenom dozom u stoke i konja, CVMP je zaključio da savjet o liječenju ponovljenom dozom u stoke i konja treba ukloniti iz informacija o proizvodu.
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.
Stoga je primijenjen sigurnosni raspon od 20% na promatrano razdoblje od 60 sati što je uzrokovalo karenciju od 72 sata, tj. 3 dana u mlijeku krava liječenih pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
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.
Ista karencija za jestiva tkiva može se primijeniti na stoku i konje za isti režim doziranja što je uzrokovali karenciju za konjsko meso i iznutrice od 8 dana za liječenje pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
Benefit-Risk Assessment
Procjena omjera dobrobiti i rizika
United Kingdom Eurovet Animal Health B.V. Handelsweg 25
Velika Britanija Eurovet Animal Health B.V.