natgillin/translations-raw huggingface dataset:
Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid
Vehikel: histidin, voda za injekcije, natrijev hidroksid in klorovodikova kislina.
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).
1000 i.e. ali 2000 i.e. praška v viali, 4 ml vehikla v napolnjeni injekcijski brizgi, potisni bat in nastavek za vialo - velikost pakiranja je 1 pakiranje).
• Turn over the protective cap, and snap the vial adapter onto the vial.
• Obrnite zaščitno zaporko in nastavek za vialo namestite na vialo.
Instructions on how to use Refixia
Navodila za uporabo zdravila Refixia
• Remove the protective paper from the vial adapter.
• Z nastavka za vialo odstranite zaščitni papir.
Store the reconstituted product in the vial.
Rekonstituirano zdravilo shranjujte v viali.
Must not be returned to refrigerator after storage at room temperature Date removed from refrigerator: ____________ Store in the original package to protect from light
Datum odvzema zdravila iz hladilnika: ____________ Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
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
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje
Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature.
Datum odvzema zdravila Refixia iz hladilnika in začetek shranjevanja pri sobni temperaturi zabeležite na škatlo.
STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),
Prašek: 2000 i.e. nonakog beta pegola (približno 500 i.e./ml po rekonstituciji),
If you cannot use the reconstituted Refixia solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
Če raztopine zdravila Refixia ne morete uporabiti takoj po rekonstituciji, jo morate porabiti v 4 urah, če jo shranjujete pri sobni temperaturi (do 30 °C), in v 24 urah, če jo shranjujete v hladilniku
(2°C - 8°C) and 4 hours stored at room temperature (≤ 30°C).
(2 °C - 8 °C).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e.
After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol.
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 125 i.e. nonakog beta pegola.
STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Prašek: 500 i.e. nonakog beta pegola (približno 125 i.e./ml po rekonstituciji),
• shortness of breath or wheezing
• sopeče ali piskajoče dihanje
In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients.
V namenskem kirurškem preskušanju so z analizo učinkovitosti zajeli 13 večjih kirurških posegov,
Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery.
V prvem tednu po kirurškem posegu je treba presoditi o aplikaciji dveh odmerkov po 40 i.e./kg (z 1-3 dnevnim vmesnim presledkom).
Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. nonakog beta pegola*.
All patients assessed in the steady state pharmacokinetic session had factor IX activity levels above 0.24 IU/ml at 168 hours post dosing with a weekly dose of 40 IU/kg.
Pri uporabi tedenskega odmerka 40 i.e./kg je bila raven aktivnosti faktorja IX 168 ur po odmerku pri vseh bolnikih, ovrednotenih v stanju dinamičnega ravnovesja, večja od 0,24 i.e./ml.
Keep reconstituted Refixia solution out of direct light.
Rekonstituirano raztopino zdravila Refixia shranjujte zaščiteno pred svetlobo.
Talk to your doctor immediately if your bleeding does not stop as expected or if you have to significantly increase your usage of Refixia in order to stop a bleed.
Če se krvavitev ne ustavi po pričakovanjih ali če ste za zaustavitev krvavitve morali znatno povečati uporabo zdravila Refixia, se nemudoma posvetujte z zdravnikom.
Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Če uporaba kromogenega testa ali primernega enostopenjskega testa strjevanja krvi lokalno ni na voljo, priporočamo uporabo referenčnega laboratorija.
18-65 years
18-65 let N=20
How to use Refixia
Način uporabe zdravila Refixia
• Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
• Potisni bat potegnite rahlo navzdol, da boste rekonstituirano raztopino izvlekli v injekcijsko brizgo.
Dose and duration of the substitution therapy depend on the location and severity of the bleeding, see Table 1 for dosing guidance in bleeding episodes.
Odmerek in trajanje nadomestnega zdravljenja sta odvisna od mesta in resnosti krvavitve.
STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Prašek: 1000 i.e. nonakog beta pegola (približno 250 i.e./ml po rekonstituciji),
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Pri bolnikih s hemofilijo B z zaviralci faktorja IX in predhodno alergijsko reakcijo so po poskusu indukcije imunske tolerance poročali o nefrotskem sindromu.
not use the pre-filled syringe.
raztopine ne uporabljajte.
After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 250 i.e. nonakog beta pegola.
• feeling sick (nausea)
• slabost (navzea)
• allergic reactions (hypersensitivity).
• alergijske reakcije (preobčutljivost); te lahko postanejo hude in so lahko smrtno nevarne
Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Preglednica 6: Srednje najmanjše koncentracije* zdravila Refixia (40 i.e./kg) v stanju dinamičnega ravnovesja
Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. nonakog beta pegola*.
If you touch the spike on the vial adapter, germs from your fingers can be transferred.
Če se konice nastavka za vialo dotaknete s prsti, jo lahko kontaminirate z mikrobi.
Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds.
Blage in zmerne krvavitve so zdravili z zdravilom Refixia v odmerku 40 i.e./kg.
Your doctor may need to treat you promptly for these reactions.
V primeru pojava takih reakcij bo zdravnik morda moral nemudoma uvesti ustrezno zdravljenje.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Refixia nima vpliva na sposobnost vožnje in upravljanja strojev.
Mean steady state factor IX trough levels above 15% were observed for all age groups, see section 5.2 for details.
Pri vseh starostnih skupinah je povprečna najmanjša koncentracija faktorja IX v stanju dinamičnega ravnovesja znašala nad 15 %.
After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 500 i.e. nonakog beta pegola.
If you notice particles or discolouration, do not use it. Use a new package instead.
Če opazite kakršne koli delce ali spremembo barve, rekonstituirane raztopine ne uporabljajte.
Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. nonakog beta pegola*.
• heart palpitations
• vročinski oblivi
What Refixia is used for
Za kaj uporabljamo zdravilo Refixia
If a chromogenic assay is not available, it is recommended to use a one-stage clotting assay with an aPTT reagent (e.g. Cephascreen) qualified for use with Refixia.
Če kromogeni test ni na voljo, priporočamo uporabo enostopenjskega testa strjevanja krvi z aPTT
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Prašek natrijev klorid histidin saharoza polisorbat 80 manitol natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
Due date
Razpolovni čas
How to store Refixia
Shranjevanje zdravila Refixia
NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use, after reconstitution
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
What Refixia is
Kaj vsebuje zdravilo Refixia
• 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