FrancophonIA/ELRC3.0 huggingface dataset:
English: Single-dose pharmacokinetic parameters of Refixia are listed by age in Table 5.
Croatian: Farmakokinetički parametri jednokratne doze lijeka Refixia navedeni su po dobnim skupinama u Tablici 5. Refixia nije indicirana za primjenu u djece mlađe od 12 godina.
English: 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.
Croatian: ‘nefrotski sindrom' nakon velikih doza faktora IX u bolesnika s hemofilijom B s inhibitorima faktora IX i alergijskim reakcijama u povijesti bolesti.
English: Palpitations
Croatian: Tromboembolija
English: *recombinant human factor IX, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol (PEG).
Croatian: Chinese hamster ovary, CHO) tehnologijom rekombinantne DNK i kovalentno konjugiran s polietilenglikolom (PEG) od 40 kDa.
English: • Check the reconstituted solution.
Croatian: • Provjerite pripremljenu otopinu.
English: Dosing recommendations
Croatian: Preporuke za doziranje
English: The powder in the vial appears as a white to off-white powder.
Croatian: Prašak u bočici bijele je do bjelkaste boje.
English: No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of Refixia.
Croatian: U staničnoj kulturi, pročišćavanju, konjugiranju i formuliranju lijeka Refixia nisu upotrijebljeni aditivi humanog ili životinjskog porijekla.
English: Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator
Croatian: Dokazana je kemijska i fizikalna stabilnost pripremljene otopine tijekom 24 sata kad se čuva u hladnjaku (2°C-8°C) te tijekom 4 sata na sobnoj temperaturi (≤30°C).
English: After injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Croatian: Nakon injiciranja zbrinite štrcaljku s infuzijskim setom te bočicu s nastavkom za bočicu na siguran način.
English: Refixia 500 IU powder and solvent for solution for injection Refixia 1000 IU powder and solvent for solution for injection Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol
Croatian: Refixia 500 IU prašak i otapalo za otopinu za injekciju Refixia 1000 IU prašak i otapalo za otopinu za injekciju Refixia 2000 IU prašak i otapalo za otopinu za injekciju
English: Severe or life threatening haemorrhages.
Croatian: Teža krvarenja ili krvarenja opasna po život.
English: After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol.
Croatian: Nakon rekonstitucije, 1 ml lijeka Refixia sadrži približno 125 IU nonakog beta pegola.
English: Refixia is administered by intravenous bolus injection over several minutes after reconstitution of the powder for injection with the histidine solvent.
Croatian: Nakon rekonstitucije praška za injekciju s otopinom histidina koja služi kao otapalo, rekonstituirani lijek Refixia primijeniti intravenskom bolus injekcijom tijekom nekoliko minuta.
English: Table 4 Steady state pharmacokinetic parameters of Refixia (40 IU/kg) in adolescents and adults (geometric mean (CV%)) PK Parameter
Croatian: (40 IU/kg) u adolescenata i odraslih (geometrijska srednja vrijednost (CV%))
English: • Take the vial, the vial adapter and the prefilled syringe out of the carton.
Croatian: • Izvadite bočicu, nastavak za bočicu i napunjenu štrcaljku iz kutije.
English: Early haemarthrosis, muscle bleeding or oral bleeding.
Croatian: krvarenje u mišiću ili krvarenje u usnoj šupljini.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU
English: All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%).
Croatian: Lijek Refixia ima produljeni poluvijek u usporedbi s neizmijenjenim faktorom IX. Sva farmakokinetička ispitivanja lijeka Refixia provedena su u prethodno liječenih bolesnika s hemofilijom B (faktor IX ≤2%).
English: • rash, hives, weals or itching
Croatian: • osip, koprivnjača, urtike ili svrbež
English: Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Croatian: Tablica 6 Srednje vrijednosti najnižih koncentracija* lijeka Refixia (40 IU/kg) u stanju dinamičke ravnoteže
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom B (urođeni nedostatak faktora IX) u dobi od
English: After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Croatian: Nakon rekonstitucije, 1 ml lijeka Refixia sadrži približno 250 IU nonakog beta pegola.
English: Your doctor may need to treat you promptly for these reactions.
Croatian: Možda će Vam biti potrebna hitna liječnička pomoć.
English: Clearance = body weight adjusted clearance; Incremental recovery = incremental recovery 30 min post dosing, Volume of distribution = body weight adjusted volume of distribution at steady state.
Croatian: Volumen distribucije = volumen distribucije u stanju dinamičke ravnoteže prilagođen prema tjelesnoj težini.
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Croatian: • Preokrenite zaštitni pokrov i pričvrstite nastavak za bočicu na bočicu.
English: Refixia is now ready to inject into your vein.
Croatian: Injicirajte pripremljenu otopinu Refixia je sada spremna za injiciranje u venu.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu prijavljene interakcije lijekova koji sadrže humani koagulacijski faktor IX (rDNK) s drugim lijekovima.
English: Incremental Recovery (IR) (IU/ml per IU/kg)
Croatian: Prirast po jedinici doze (IR) (IU/ml po IU/kg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU
English: • Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Croatian: • Pritišćući potisni klip do kraja, nježno vrtite bočicu dok se sav prašak ne otopi.
English: Treatment with Refixia will be started by a doctor who is experienced in the care of patients with haemophilia B. Always use this medicine exactly as your doctor has told you.
Croatian: Liječenje lijekom Refixia započet će liječnik s iskustvom u liječenju bolesnika s hemofilijom B.
English: Hypersensitivity Anaphylaxis Inhibitors
Croatian: • neutralizirajuća protutijela (inhibitori).
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds.
Croatian: 40 IU/kg bile su blaga ili umjerena krvarenja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU
English: After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Croatian: Nakon rekonstitucije, 1 ml lijeka Refixia sadrži približno 500 IU nonakog beta pegola.
English: Allergic type hypersensitivity reactions are possible with Refixia.
Croatian: Kod primjene lijeka Refixia moguća je pojava reakcija preosjetljivosti alergijskog tipa.
English: • 1 plunger rod (placed under the syringe)
Croatian: • 1 napunjenu štrcaljku s otapalom • 1 potisni klip (nalazi se ispod štrcaljke)
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene potrebno je vizualno pregledati rekonstituirani lijek na prisutnost vidljivih čestica i promjenu boje.
English: The use of Refixia in children below 12 years is not indicated.
Croatian: Refixia nije indicirana za primjenu u djece mlađe od 12 godina.
English: Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to Refixia.
Croatian: U rijetkim slučajevima postoji rizik od pojave iznenadne i teške alergijske reakcije (npr. anafilaktičke reakcije) na lijek Refixia.
English: 18-65 years
Croatian: 18-65 godina N=20
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Croatian: Prašak i otapalo za otopinu za injekciju
English: • 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.
Croatian: štrcaljku s infuzijskim setom, bočicu s nastavkom za bočicu i drugi otpadni materijal, u skladu s uputama koje ste dobili od ljekarnika.
English: • Push the plunger rod to inject all the solvent into the vial.
Croatian: • Pritisnite potisni klip kako biste cjelokupno otapalo ubrizgali u bočicu.
English: This may become severe and could be life-threatening
Croatian: Mogu biti teške i opasne po život (anafilaktičke reakcije)
English: Record of use
Croatian: Evidencija primjene
English: Table 2 Treatment in surgery with Refixia
Croatian: Općenite preporuke navedene su u Tablici 2. Tablica 2 Liječenje lijekom Refixia kod kirurških zahvata Vrsta kirurškog zahvata
English: How to store Refixia
Croatian: Kako primjenjivati lijek Refixia
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Croatian: • Lagano povucite potisni klip prema dolje kako biste uvukli pripremljenu otopinu u štrcaljku.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use, after reconstitution
Croatian: NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: pH: 6.4.
Croatian: Otapalo je bistro i bezbojno. pH: 6,4.
English: Immune system disorders
Croatian: Klasifikacija organskih sustava
English: Uncommon Unknown Unknown
Croatian: Prethodno neliječeni bolesnici
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Croatian: Ako dotaknete bočne stranice ili navoj, može doći do prijenosa mikroorganizama s
English: Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product.
Croatian: 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.
English: The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Croatian: 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.
English: • Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Croatian: • Čvrsto navijte napunjenu štrcaljku na nastavak za bočicu dok ne osjetite otpor.
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Croatian: Unutar roka valjanosti lijek Refixia može se čuvati na temperaturi do 30°C tijekom jednokratnog razdoblja od najviše 6 mjeseci.
English: Mean residence time (MRT) (hours)
Croatian: (MRT) (sati)
English: Must not be returned to refrigerator after storage at room temperature Date removed from refrigerator: ____________ Store in the original package to protect from light
Croatian: Ne smije se vraćati u hladnjak nakon čuvanja na sobnoj temperaturi
English: Remove the protective cap from the vial adapter.
Croatian: Skinite zaštitni pokrov s nastavka za bočicu.
English: (anaphylactic reactions)
Croatian: (ispod zatvarača štrcaljke)
English: NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Croatian: Refixia 2000 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: • Keep the plunger rod pushed completely in.
Croatian: • Držite potisni klip pritisnutim do kraja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 500 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Croatian: Refixia 500 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 1000 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
English: NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Croatian: Refixia 1000 IU prašak i otapalo za otopinu za injekciju nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: 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.
Croatian: 40 kDa je otkriven imunohistokemijskim bojenjem u epitelnim stanicama koroidnog spleta mozga.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Refixia 2000 IU prašak za otopinu za injekciju nonakog beta pegol i.v.
English: 7-12 years
Croatian: 12 i više godina.
English: PK Parameter 0-6 years N=12
Croatian: 0-6 godina N=12
English: Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek Refixia primjenjuje se intravenski nakon rekonstitucije praška s otapalom koje dolazi u štrcaljki.
English: Pre-filled syringe with solvent
Croatian: Napunjena štrcaljka s otapalom Vrh štrcaljke
English: If you have to significantly increase your usage of Refixia to stop a bleed, talk to your doctor immediately.
Croatian: Odmah se obratite liječniku ako morate značajno povećati primjenu lijeka Refixia kako biste zaustavili krvarenje.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Croatian: U bolesnika s hemofilijom B koji imaju inhibitore faktora IX i alergijsku reakciju u anamnezi, nakon pokušaja indukcije imunološke tolerancije prijavljen je nefrotski sindrom.
English: • While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Croatian: lagano lupnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Croatian: Prašak: 500 IU nonakog beta pegola (pribl.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Croatian: Prašak: 1000 IU nonakog beta pegola (pribl.
English: 0-6 years
Croatian: 6.3 Rok valjanosti
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Croatian: 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.
English: (bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Croatian: - 1 potisni klip (polipropilen).
English: Vial adapter Protective cap
Croatian: 4.8 Nuspojave Sažetak sigurnosnog profila
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) • alergijske reakcije (preosjetljivost).
English: Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Croatian: Jedna bočica nominalno sadrži 2000 IU nonakog beta pegola*.
English: What Refixia is used for
Croatian: Za što se Refixia koristi
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/002
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/002
English: A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Croatian: Ukupno je 69 (98,6%) od 70
English: • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Croatian: Pripremite otopinu od praška i otapala • Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
English: Contents
Croatian: Sadržaj
English: • heart palpitations
Croatian: Srčani poremećaji palpitacije manje često
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/001
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/001
English: Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Croatian: Jedna bočica nominalno sadrži 1000 IU nonakog beta pegola*.
English: Degree of haemorrhage
Croatian: ROK VALJANOSTI Rok valjanosti
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/003
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/003
English: • hot flush.
Croatian: • osjećaj lupanja srca • navale vrućine.
English: Plastic cap
Croatian: Zaštitni pokrov
English: • feeling very tired.
Croatian: • osjećaj mučnine • osjećaj teškog umora.
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1193/001
English: Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Croatian: Jedna bočica nominalno sadrži 500 IU nonakog beta pegola*.
English: 1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe
Croatian: 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
English: 1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator
Croatian: 1 do 10 sterilnih cjevčica s do 2 aplikatora svaka + 1 štrcaljka po aplikatoru
English: Intraarticular use Pre-filled syringe (PP)
Croatian: Unaprijed napunjena štrcaljka
English: Member State EU/EEA
Croatian: Države članice EU/EEA
English: Milk: 72 hours
Croatian: Mlijeko: 72 sata
English: Assessment of the efficacy of the products for the other approved indications remains unchanged.
Croatian: Procjena djelotvornosti proizvoda za druge odobrene indikacije ostaje nepromijenjena.
English: Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika i rizik za okoliš nisu ispitani u ovom postupku procjene.
English: Meat and offal: 8 days
Croatian: Meso I iznutrice: 8 dana
English: S.P. Veterinaria, S.A. Ctra.
Croatian: S.P. Veterinaria, S.A.
English: According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
Croatian: U skladu s trenutnim informacijama o proizvodu za Dexadreson, liječenje se može ponoviti nakon 24-48 sati.
English: Kidney and liver were the tissues where the marker residue persisted longest.
Croatian: Bubrezi i jetra bili su tkiva gdje su se markeri rezidua najdulje zadržali.
English: Delete, where applicable, “in cases of shock in horses”.
Croatian: Izbrisati, gdje je primjenjivo, “u slučajevima šoka kod konja”.
English: Magna Drive, Magna Business Park Citywest Road
Croatian: Magna Drive, Magna Business Park
English: Further to this restriction the CVMP concluded that the single administration of the concerned products does not have an impact on their clinical efficacy.
Croatian: Nadalje uz ovo ograničenje CVMP je zaključio da pojedinačna primjena dotičnih proizvoda nema utjecaja na njihovu kliničku djelotvornost.
English: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Croatian: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona ŠPANJOLSKA
English: 192 07 Sollentuna SWEDEN
Croatian: 192 07 Sollentuna ŠVEDSKA
English: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Croatian: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCUSKA
English: D-85716 Unterschleißheim GERMANY
Croatian: D-85716 Unterschleißheim NJEMAČKA
English: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA
Croatian: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIJA
English: 88326 Aulendorf GERMANY
Croatian: 88326 Aulendorf NJEMAČKA
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Croatian: 4941 VX Raamsdonksveer NIZOZEMSKA
English: United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Croatian: Velika Britanija Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ VELIKA BRITANIJA
English: Not authorised for use in horses producing milk for human consumption.
Croatian: Nije za upotrebu kod konja čije je mlijeko namijenjeno za ljudsku upotrebu.
English: Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues.
Croatian: Stoga se smatralo prikladnim koristiti alternativnu metodu kako bi se utvrdila karencija za tkiva stoke.
English: All studies were conducted at a single dose of 0.06 mg/kg body weight.
Croatian: Sve su studije provedene pri pojedinačnoj dozi od 0,06 mg/kg tjelesne težine.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: Karencije za manje vrste konja mogu se temeljiti na usporedbi farmakokinetičkih podataka ukazujući da razgradnja tvari u konja nije sporija od one u stoke.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: The benefit-risk balance for the products concerned remains positive subject to amendments in the product information.
Croatian: Omjer dobrobiti i rizika dotičnog proizvoda ostaje pozitivan i podložan je promjenama u informacijama o proizvodu.