FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT 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
Estonian: RAVIMPREPARAADI NIMETUS Refixia 500 RÜ süstelahuse pulber ja lahusti Refixia 1000 RÜ süstelahuse pulber ja lahusti Refixia 2000 RÜ süstelahuse pulber ja lahusti
English: Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Estonian: Refixia't manustatakse intravenoosselt pärast pulbri kokkusegamist süstlas oleva lahustiga.
English: Degree of haemorrhage
Estonian: Kummist punnkork
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Estonian: RAVIMVORM JA PAKENDI SUURUS Süstelahuse pulber ja lahusti
English: Incremental Recovery (IR) (IU/ml per IU/kg)
Estonian: Täiendav taastumine (Incremental Recovery, IR) (RÜ/ml RÜ/kg kohta)
English: How to store Refixia
Estonian: Kuidas Refixia't säilitada
English: Overall haemostatic efficacy
Estonian: Üldine hemostaatiline efektiivsus
English: If you touch the spike on the vial adapter, germs from your fingers can be transferred.
Estonian: Kui puudutate viaali adaptril olevat naastu, võivad mikroobid teie sõrmedelt sinna üle kanduda.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Refixia
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Refixia lahusti
English: If the plastic cap is loose or missing, do not use the vial.
Estonian: Ärge kasutage viaali, kui plastkork puudub või on purunenud.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 1000 RÜ
English: Remove the protective cap from the vial adapter.
Estonian: Eemaldage viaali adaptrilt kaitsepakend.
English: Recommended dose IU/kg body weight
Estonian: Soovituslik annus ühikutes RÜ / kehakaalu kg kohta
English: DATE OF REVISION OF THE TEXT
Estonian: Kasutamise protokollimine
English: • The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid.
Estonian: • Steriliseeritud lahusti koostisosad on histidiin, süstevesi, naatriumhüdroksiid ja vesinikkloriidhape.
English: Plastic cap
Estonian: Plastkork
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
Estonian: Refixia 500 RÜ süstelahuse pulber ja lahusti Refixia 1000 RÜ süstelahuse pulber ja lahusti Refixia 2000 RÜ süstelahuse pulber ja lahusti beetanonakogpegool (nonacogum beta pegolum)
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Estonian: TOIMEAINE SISALDUS Pulber: 500 RÜ beetanonakogpegooli (ligikaudu 125 RÜ/ml pärast manustamiskõlblikuks muutmist)
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Estonian: Võib hoida toatemperatuuril ≤30 °C ühe kuni kuuekuulise perioodi jooksul.
English: After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab 1 ml Refixia't ligikaudu 125 RÜ beetanonakogpegooli.
English: Each vial of Refixia contains nominally 500 IU, 1000 IU or 2000 IU nonacog beta pegol corresponding to approximately 125 IU/ml, 250 IU/ml or 500 IU/ml respectively after reconstitution with histidine solvent.
Estonian: mis pärast histidiinlahustiga manustamiskõlblikuks muutmist vastab ligikaudu kontsentratsioonidele 125 RÜ/ml, 250 RÜ/ml või 500 RÜ/ml.
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Estonian: Eelnevalt ravitud noorukite (12…18aastaste) ja täiskasvanud patsientide vahel ei märgatud erinevusi Refixia ohutusprofiilis.
English: Record of use
Estonian: KASUTUSJUHEND
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Estonian: Kõlblikkusaja jooksul võib ravimit Refixia hoida temperatuuril kuni 30 °C ühe kuni kuuekuulise perioodi jooksul.
English: On-demand treatment
Estonian: Vajaduspõhine ravi
English: Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Estonian: Tabel 6 Refixia keskmised madalaimad tasemed* (40 RÜ/kg) stabiilses olekus 0…6 aastat
English: The long-term safety of Refixia in children below 12 years has not yet been established.
Estonian: Puuduvad pikaaegsed ohutusandmed Refixia kasutamise kohta noorematel kui 12 aastastel lastel.
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
Estonian: Veritsuse ravi ja profülaktika B-hemofiilia (kaasasündinud IX hüübefaktori puudulikkus) patsientidel alates vanusest 12 aastat.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 2000 RÜ
English: Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid
Estonian: Lahusti: histidiin, süstevesi, naatriumhüdroksiid, vesinikkloriidhape
English: Recommended dose IU/kg of Refixia
Estonian: Refixia soovituslik annus ühikutes RÜ/kg
English: 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.
Estonian: Ravimit võib säilitada kuni 4 tundi toatemperatuuril (≤ 30 °C) või kuni 24 tundi külmkapis (2 °C…8 °C), välja arvatud juhul, kui manustamiskõlblikuks muutmine on toimunud kontrollitud ja valideeritud aseptilistes tingimustes..
English: After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab 1 ml Refixia't ligikaudu 250 RÜ beetanonakogpegooli.
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Estonian: Refixia on puhastatud rekombinantne inimese IX hüübimisfaktor (rFIX), mille külge on konjugeeritud 40 kDa polüetüleenglükool (PEG).
English: Histidine solution
Estonian: Histidiinilahus
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Estonian: RAVIMPREPARAADI NIMETUS Refixia 500 RÜ süstelahuse pulber ja lahusti Nonacogum beta pegolum (rekombinantne IX hüübimisfaktor)
English: Half-life (t1/2) (hours) Incremental Recovery (IR) (IU/ml per IU/kg)
Estonian: Poolväärtusaeg (t1/2) (tundi) Täiendav taastumine (Incremental Recovery, IR) (RÜ/ml RÜ/kg kohta) Kõveraalune pindala (AUC)0-168 h (RÜ*tundi/ml)
English: NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Estonian: RAVIMPREPARAADI NIMETUS Refixia 2000 RÜ süstelahuse pulber ja lahusti Nonacogum beta pegolum (rekombinantne IX hüübimisfaktor)
English: Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Estonian: Refixia 2000 RÜ süstelahuse pulber ja lahusti Üks viaal sisaldab nominaalkogusena 2000 RÜ beetanonakogpegooli*.
English: Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product.
Estonian: Refixia toimeaine on beetanonakogpegool ja on pikatoimeline rekombinantset IX hüübimisfaktorit sisaldav ravimpreparaat.
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Estonian: Ärge kasutage viaali adaptrit, kui selle kaitsepaber ei ole korralikult kinnitunud või on purunenud.
English: After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab 1 ml Refixia't ligikaudu 500 RÜ beetanonakogpegooli.
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Estonian: • Tõmmake kolvivart kergelt tagasi, et lahus täidaks süstla.
English: Refixia is given as an injection into a vein.
Estonian: Refixia süstitakse veeni.
English: Do not use solutions that are cloudy or have deposits.
Estonian: Ärge kasutage hägust või sadet sisaldavat lahust.
English: Nausea
Estonian: Keermestik
English: Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Estonian: Refixia 500 RÜ süstelahuse pulber ja lahusti Üks viaal sisaldab nominaalkogusena 500 RÜ beetanonakogpegooli*.
English: How Refixia is given
Estonian: Kuidas Refixia't manustatakse
English: • Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Estonian: Selleks keerake kolvivars kellaosuti suunas eeltäidetud süstla sees oleva kolvi sisse, kuni tunnete takistust.
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Estonian: • Tõstke kaitsepakend üles ja kinnitage viaali adapter viaali külge.
English: • Keep the plunger rod pushed completely in.
Estonian: • Hoidke kolvivars lõpuni sissesurutuna.
English: For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Estonian: Ravimpreparaadi manustamiskõlblikuks muutmise juhiseid vt pakendi infolehelt.
English: Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Estonian: Refixia 1000 RÜ süstelahuse pulber ja lahusti Üks viaal sisaldab nominaalkogusena 1000 RÜ beetanonakogpegooli*.
English: Pre-operative dose.
Estonian: Operatsioonieelne annus.
English: *Pruritus includes the terms pruritus and ear pruritus **Injection site reactions include injection site pain, infusion site pain, injection site swelling, injection site erythema and injection site rash.
Estonian: ** Süstekoha reaktsioonid hõlmavad süstekoha valu, infusioonikoha valu, süstekoha turset, süstekoha erüteemi ja süstekoha löövet.
English: Solvent
Estonian: Iiveldus
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Estonian: Pulber: 1000 RÜ beetanonakogpegooli (ligikaudu 250 RÜ/ml pärast manustamiskõlblikuks muutmist)
English: Before injection it must be reconstituted with the solvent supplied in the syringe.
Estonian: Enne süstimist tuleb see lahustada süstlas olevas lahustis.Lahustiks on histidiinilahus.
English: Factor IX activity 168 h post dosing (IU/ml)
Estonian: IX faktori aktiivsus 168 h
English: Each pack contains: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger
Estonian: - 1 (I tüüpi) klaasist viaal pulbri ja klorobutüülkummist punnkorgiga - 1 steriilne viaali adapter lahuse valmistamiseks
English: Pre-filled syringe with solvent
Estonian: Eeltäidetud süstal lahustiga
English: The average molecular weight of Refixia is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa.
Estonian: Refixia keskmine molekulmass on ligikaudu 98 kDa, millest valguosa moodustab 56 kDa. Refixia aktiveerumisel lõigatakse aktiveeruv peptiid koos 40 kDa polüetüleenglükooliga molekuli küljest ära, misjärel jääb alles natiivne aktiveeritud IX faktori molekul.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),
Estonian: TOIMEAINE SISALDUS Pulber: 2000 RÜ beetanonakogpegooli (ligikaudu 500 RÜ/ml pärast manustamiskõlblikuks muutmist)
English: • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Estonian: • Hoidke eeltäidetud süstalt kergelt kaldu,
English: Non-clinical data reveal no concern for humans based on conventional safety pharmacology and repeated dose toxicity studies in rats and monkeys.
Estonian: Farmakoloogilise ohutuse ja kroonilise toksilisuse mittekliinilised uuringud ei ole näidanud inimesi kahjustada võivat toimet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Refixia 2000 RÜ süstelahuse pulber Nonacogum beta pegolum i.v.
English: Please record the beginning of storage at room temperature on the product carton.
Estonian: Toatemperatuuril säilitamise algus tuleks märkida ravimi välispakendile.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Refixia 1000 RÜ süstelahuse pulber Nonacogum beta pegolum i.v.
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.
Estonian: Pärast IX faktori suurte annuste manustamist B-hemofiiliaga patsientidele, kelle organismis esinevad IX faktori inhibiitorid ja kellel on anamneesis allergilised reaktsioonid, on harvaesinev oht teatud neeruhaiguse (nimega „nefrootiline sündroom“) tekkeks.
English: After reconstitution
Estonian: Lai tagumine ots
English: • heart palpitations
Estonian: • pitsitustunne rinnus
English: Gastrointestinal disorders
Estonian: Refixia kasutusjuhend
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Refixia 500 RÜ süstelahuse pulber Nonacogum beta pegolum i.v.
English: Attach the vial adapter
Estonian: Viaali adaptri kinnitamine
English: 2000 IU powder in a vial and 4 ml solvent in a pre-filled syringe, a plunger rod with a vial adapter - pack size of 1).
Estonian: • Refixia on saadaval süstelahuse pulbri ja lahustina (kas 500 RÜ, 1000 RÜ või 2000 RÜ pulbrit viaalis ning 4 ml lahustit eeltäidetud süstlas koos kolvivarre ja viaali adaptriga.
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/002
Estonian: MÜÜGILOA NUMBER EU/1/17/1193/002
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/003
Estonian: MÜÜGILOA NUMBER EU/1/17/1193/003
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
Estonian: MÜÜGILOA NUMBRID EU/1/17/1193/001
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.
Estonian: Refixia-ravi tuleb alustada B-hemofiilia ravis kogenud arsti järelevalve all.
English: Due date
Estonian: Tähtaeg
English: (bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Estonian: - 1 histidiinilahustiga (4 ml) eeltäidetud polüpropüleenist süstal , millel on bromobutüülkummist kolb ja bromobutüülkummist kaitsekork - 1 kolvivars (polüpropüleen).
English: 18-65 years
Estonian: 18…65 aastat N = 20
English: • Push the plunger rod to inject all the solvent into the vial.
Estonian: • Kolvivart vajutades süstige kogu lahusti viaali.
English: Intraarticular use Applicator (PU)
Estonian: Intraartikulaarne Aplikaator (PU)
English: 1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe
Estonian: 1-10 steriilset toru ja à 1 eeltäidetud süstal + 1 püsikanüül või 1 varrega filter eeltäidetud süstla kohta
English: Intraarticular use Pre-filled syringe (PP)
Estonian: Intraartikulaarne Eeltäidetud süstal (PP)
English: 1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator
Estonian: 1-10 steriilset toru ja à kuni 2 aplikaatorit + 1 süstal aplikaatori kohta
English: MA (EU) Number Invented name
Estonian: Väljamõeldud nimetus
English: Member State EU/EEA
Estonian: Liikmesriik EL/EEA
English: Milk: 72 hours
Estonian: Piimale: 72 tundi.
English: Assessment of the efficacy of the products for the other approved indications remains unchanged.
Estonian: Ravimite efektiivsuse hinnang teistel heakskiidetud näidustustel jäi endiseks.
English: 192 07 Sollentuna SWEDEN
Estonian: 192 07 Sollentuna ROOTSI
English: Magna Drive, Magna Business Park Citywest Road
Estonian: 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.
Estonian: Selle piirangu suhtes järeldas veterinaarravimite komitee, et asjaomaste ravimite ühekordne manustamine ei mõjuta nende kliinilist efektiivsust.
English: Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTUGAL
Estonian: Rua Agualva dos Açores n. 16 2735-557 Agualva-Cacém, PORTUGAL
English: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Estonian: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona HISPAANIA
English: United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Estonian: Ühendkuningriik Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ ÜHENDKUNINGRIIK
English: 88326 Aulendorf GERMANY
Estonian: 88326 Aulendorf SAKSAMAA
English: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Estonian: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex PRANTSUSMAA
English: Meat and offal: 8 days
Estonian: Lihale ja söödavatele kudedele: 8 päeva.
English: According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
Estonian: Dexadresoni praeguse ravimiteabe kohaselt tohib ravi korrata 24-48 tunni pärast.
English: D-85716 Unterschleißheim GERMANY
Estonian: D-85716 Unterschleißheim SAKSAMAA
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Estonian: 4941 VX Raamsdonksveer HOLLAND
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Estonian: Veterinaarravimite nimetuste, ravimvormide, tugevuse, loomaliikide, müügiloa hoidjate loetelu liikmesriikides
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.
Estonian: 22. augustil 2012 tegi Saksamaa seetõttu Euroopa Ravimiametile (EMA) direktiivi 2001/82/EÜ artikli 35 alusel esildise ravimi Dexadreson 2 mg/ml ja sarnaste nimetuste ning nende geneeriliste ravimite kohta.
English: All studies were conducted at a single dose of 0.06 mg/kg body weight.
Estonian: Kõik uuringud toimusid ühekordse annusega 0,06 mg kehamassi kg kohta.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Estonian: Deksametasoon on pika toimeajaga sünteetiline glükokortikoid, mida kasutatakse põletikuvastase, antiallergilise ja glükoneogeneetilise ainena manustamiseks põllumajandus- ja koduloomadele.
English: Delete, where applicable, “in cases of shock in horses”.
Estonian: Asjakohastel juhtudel kustutada “ hobuste šoki korral ”.
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.
Estonian: Üks veisekudede ravimijääkide vähenemise uuring ei kestnud piisavalt kaua, mistõttu ei peetud seda sobivaks veiseliha ja veiste söödavate kudede nõuetekohaste keeluaegade määramiseks.
English: Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses.
Estonian: Asjakohastel juhtudel kustutada kõik viited hobuste ja veiste korduvale ravile ning ravile hobuste šoki korral.
English: 5830 AB Boxmeer THE NETHERLANDS
Estonian: 5830 AB Boxmeer HOLLAND
English: Cattle, horses
Estonian: Süstelahus Veised, hobused
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.
Estonian: Esitati kolme veistel toimunud ravimijääkide vähenemise uuringu, kolme veisekudedega toimunud ravimijääkide vähenemise uuringu ja ühe ravimijääkide piimas vähenemise uuringu andmed.
English: Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure.
Estonian: Esildismenetluses ei hinnatud kvaliteeti, sihtloomade ohutust, kasutajate ohutust ega keskkonnariske.
English: Horses:
Estonian: Hobune:
English: Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I)
Estonian: Ravimi Dexadreson 2 mg/ml ja sarnaste nimetuste ning nende geneeriliste ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: 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.
Estonian: 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 tulemusel määrati keeluajaks 8 ööpäeva ravi korral ühekordse annusega 0,06 mg deksametasooni kg kehamassi kohta.
English: No residue depletion data are available in horses for the single or repeat dose treatment.
Estonian: Hobuste kohta puuduvad ravimijääkide vähenemise andmed nii ühekordse kui ka korduva raviannuse korral.
English: 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.
Estonian: Veterinaarravim Dexadreson 2 mg/ml ja sarnased nimetused ning nende geneerilised ravimid on süstelahused, mis sisaldavad 2 mg/ml deksametasooni.
English: Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues.
Estonian: Nii peeti asjakohaseks määrata veisekudede keeluaeg alternatiivmeetodil.
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.
Estonian: Hobuse kui vähelevinud liigi keeluajad saab määrata farmakokineetika andmete võrdlemisel, millest nähtub, et aine ei elimineeru hobuse organismist aeglasemalt kui veise organismist.
English: 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.
Estonian: Ravimijääkide vähenemise andmete puudumisel maksimaalse ettenähtud annuse korral ja seoses eespool väljendatud kahtlustega nõustusid müügiloa hoidjad kustutama ravimiteabest nõuande manustada veistele 24-48 tunni pärast teine annus.
English: No residue depletion or pharmacokinetic data are available for the much higher dosages recommended for the treatment of shock in horses.
Estonian: Puuduvad ravimijääkide vähenemise või farmakokineetika andmed palju suuremate annuste kohta, mida soovitatakse hobuste šokiraviks.
English: Applicant/marketing authorisation holder
Estonian: Müügiloa hoidja