natgillin/translations-raw huggingface dataset:
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili (NSAID) (glejte poglavje 4.8).
Following oral administration in horses at the recommended dose of 1 tablet per horses, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 2.43 (± 2,17) hours.
Firokoksib se hitro absorbira po peroralnem dajanju v priporočenem odmerku po 1 tableto na konja, čas do maksimalne koncentracije (Tmax) je 2,43 (± 2,17) ur.
To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse's weight.
Za aplikacijo zdravila EQUIOXX v odmerku 0,1 mg firokoksiba/kg telesne mase, nastavite bat brizge na primeren razdelek odmerka, glede na telesno maso konja.
However, studies with laboratory animals have shown embryofoetotoxicity, malformations, delayed parturition and decreased pup survival.
Študije na laboratorijskih živalih pa so pokazale embriofetotoksičnost, malformacije, zakasnele porode in zmanjšano preživetje mladičev.
PACKAGE SIZE 1 syringe.
VELIKOST PAKIRANJA 1 brizga
TARGET SPECIES For horses
CILJNE ŽIVALSKE VRSTE Za konje
BATCH NUMBER Lot {number}
ŠTEVILKA SERIJE lot{številka}
- 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
- 1 kartonska škatla, ki vsebuje 60 tablet v 30 ml plastenki iz polietilena visoke gostote.
The incidence of oral/skin lesions increases with increasing dose.
Incidenca poškodb v ustih in na koži narašča z večanjem odmerka.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycerol formal
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Laktoza monohhidrat
White to off-white paste.
Bele do sivo bele barve.
0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
IC50) je 0,0369 - 0,12 μM, medtem pa je IC50 za COX-1 enaka 20,14 - 33,1 μM.
Muscle Fat
Mišice Maščoba Jetra Ledvice
Occasional lesions of the oral mucosa and of the skin around the mouth associated with salivation and labial and tongue oedema.
Pri zdravljenih živalih se občasno pojavijo poškodbe na ustni sluznici in na koži okrog ust, slinjenje in edem ustnic ter jezika.
TARGET SPECIES Horses (450-600 kg).
CILJNE ŽIVALSKE VRSTE Konji (450-600 kg).
Meat and offal: 26 days.
Meso in organi: 26 dni
Do not exceed the recommended dosage.
Ne prekoračite priporočenega odmerka.
Replace cap after use.
Po uporabi ponovno namestite pokrovček.
- 1 cardboard box containing 180 tablets in transparent PVC /aluminium foil blisters.
- 1 kartonska škatla, ki vsebuje 180 tablet v prozornih PVC/aluminijastih pretisnih omotih.
The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1 ml of the solution per 225 kg bodyweight) once daily by intravenous injection.
Priporočen odmerek je 0,09 mg firokoksiba /kg telesne mase intravensko enkrat dnevno (kar ustreza 1 ml raztopine na 225 kg telesne mase).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP
ADVERSE REACTIONS Mild injection site swellings associated with perivascular inflammation and pain.
Blage reakcije v obliki otekline in perivaskularnega vnetja in bolečina.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili (NSAID).
• EQUIOXX 20 mg/ml solution for injection for horses The excipients listed in section 6.1 of the SPC (Glycerol formal and Macrogol 400) are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
• EQUIOXX 20 mg/ml raztopina za injiciranje za konje Za pomožne snovi, navedene v poglavju 6.1 SPC (glicerol formal in makrogol 400) , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št.
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Lajšanje bolečine in vnetja povezanih z osteoartritisom in za zmanjšanje sočasnega šepanja pri konjih.
6.5 Nature and composition of immediate packaging Pre-filled oral syringe made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Že napolnjena brizga za peroralno uporabo iz polipropilena s polietilenskim pokrovčkom, gumijastim čepom za konico in polipropilenskim batom
Shelflife after first opening the container : 1 month.
Rok uporabnosti po prvem odpiranju vsebnika: 1 mesec
Mild reactions at the injection site characterised by swelling and associated with perivascular inflammation have been reported in clinical studies following administration of the product at the recommended dose.
Po dajanju zdravila v priporočenih odmerkih so bile med kliničnimi študijami na mestu injiciranja opažene blage reakcije v obliki otekline in perivaskularnega vnetja.
The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes - 1 carton box containing 14 syringes
Pakiranja peroralne paste: - Kartonska škatla z 1 brizgo - Kartonska škatla s 7 brizgami - Kartonska škatla s 14 brizgami
These lesions are mild and resolve without treatment.
Običajno so to manjše poškodbe, ki preidejo brez zdravljenja.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
NAČIN IN POT(I) UPORABE Peroralna uporaba.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 8.2 mg/g
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Firokoksib 8,2 mg/g
Do not use concomitantly with corticosteroids or other NSAIDs.
Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi priotivnetnimi zdravili.
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
Koncentracija firokoksiba, ki je potrebna, da se inhibira 50% encima COX-2 (t.j.
EXP {month/year} Once opened use within 3 months.
Odprto zdravilo uporabite znotraj 3 mesecev.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 57 mg
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Firokoksib 57 mg
Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
Slinjenje in edem ustnic ter jezika so bili občasni, povezani s poškodbami v ustih v kliničnih študijah.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 57 mg
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Firokoksib 57 mg
QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 8.2 mg/g
KOLIČINA ZDRAVILNE UČINKOVINE (UČINKOVIN) Firokoksib 8.2 mg/g
The safety of the veterinary medicinal product for use in breeding, pregnant or lactating horses has not been evaluated.
Varnost uporabe zdravila pri živalih v času razploda, med brejostjo in pri kobilah v laktaciji ni bila preučena.
The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Varnost uporabe zdravila pri vzrejnih, brejih kobilah ali pri kobilah v laktaciji ni bila preučena.
- 1 cardboard box containing 30 tablets in transparent PVC /aluminium foil blisters.
- 1 kartonska škatla, ki vsebuje 30 tablet v prozornih PVC/aluminijastih pretisnih omotih.
Administer 0.1 mg firocoxib per kg bodyweight, once daily.
0.1 mg firokoksiba na kg telesne mase, enkrat dnevno največ 14 dni.
Shelf-life after first opening the syringe: 3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX-2 je izoforma encima, za katerega se je izkazalo, da je induciran s pro-vnetnimi dražljaji, in za katerega se domneva, da je primarno odgovoren za sintezo prostanoidnih mediatorjev za bolečino, vnetje in vročino.
Pregnancy and lactation:
Uporaba v obdobju brejosti, laktacije:
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št. 470/2009.
MARKETING AUTHORISATION NUMBER EU/2/08/083/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/001
COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX-2 je izoformna oblika encima, ki je primarno odgovoren za sintezo prostanoidnih mediatorjev za bolečino, vnetje in vročino.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 20 mg/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Firokoksib 20mg/ml
EQUIOXX 57 mg chewable tablets for horses.
• EQUIOXX 57 mg žvečljive tablete za konje
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
IC50) je 0,0369 - 0,12 µM, medtem ko je IC50 za COX-1 20,14 - 33,1 µM.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Firocoxib 20 mg/ml
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Firokoksib 20mg/ml
Lactose monohydrate Microcrystalline cellulose Chartor hickory smoke flavour Hydroxypropyl cellulose Croscarmellose sodium
dinatrijev edetat, n-propil galat, tiodipropionska kislina
- carton containing 6 vials of 25 ml
Velikosti pakiranja: - škatlica z eno vialo s 25 ml - škatla s 6 vialami s 25 ml
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Firokoksib je nesteroidno protivnetno zdravilo (NSAID), ki selektivno zavira delovanje ciklooksigenaze-2 (COX-2) v sintezi prostaglandinov.
Therefore, do not use in breeding, pregnant or lactating animals.
Zdravila zato ne uporabljajte pri vzrejnih in brejih živalih ali živalih v laktaciji.
The injection vials are available in the following pack sizes: - carton containing one vial of 25 ml.
Žvečljive tablete so na voljo v naslednjih pakiranjih: - 1 kartonska škatla, ki vsebuje 10 tablet v pretisnih omotih.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Firocoxib 8.2 mg/g
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Firokoksib 8,2 mg/g
PACKAGE LEAFLET EQUIOXX 8.2 mg/g oral paste for horses
NAVODILO ZA UPORABO EQUIOXX 8.2 mg/g peroralna pasta za konje
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such medicinal products should therefore be observed.
Predhodno zdravljenje z drugimi protivnetnimi snovmi se lahko odraža v dodatnih ali povečanih neželenih učinkih, zato je potrebno upoštevati časovno obdobje, ko ne zdravimo s takimi zdravili.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/006-009
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/006-009
Do not use in breeding, pregnant or lactating animals.
Ne uporabljajte pri vzrejnih živalih, pri brejih živalih ali živalih v laktaciji.
Name and address of the manufacturer responsible for batch release:
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets firocoxib
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 57 mg žvečljive tablete
PACKAGE LEAFLET EQUIOXX 20 mg/ml solution for injection for horses
NAVODILO ZA UPORABO ZA: EQUIOXX 20 mg/ml raztopina za injiciranje za konje
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste .
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta Firokoksib
MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002-003
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/002-003
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Firokoksib je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino koksibov in deluje po mehanizmu selektivne inhibicije sinteze prostaglandinov, ki jo posreduje ciklooksigenaza-2 (COX-2).
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses Firocoxib
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta za konje Firokoksib
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection Firocoxib
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje Firokoksib
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 20 mg/ml
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Firokoksib 20 mg/ml
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets for horses firocoxib
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 57 mg žvečljive tablete za konje Firokoksib
EXP Once broached use within 1 month.
Odprto zdravilo uporabite znotraj 1 meseca.
PACKAGE LEAFLET EQUIOXX 57 mg chewable tablets for horses
NAVODILO ZA UPORABO EQUIOXX 57 mg žvečljive tablete za konje
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje za konje
Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there might be an increased risk of renal toxicity.
Izogibajte se sočasnemu dajanju zdravil, ki so potencialno toksična za ledvice, saj je v teh primerih povečana nevarnost toksičnosti za ledvice.
Withdrawal period: Meat and offal: 26 days.
Karenca: meso in notranji organi: 26 dni
6.5 Nature and composition of immediate packaging Multi-dose amber-coloured glass injection vials closed with rubber stopper and sealed with an aluminium crimped top.
Večodmerna viala jantarne barve z gumijastim pokrovčkom in aluminijasto zaporko.
Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM LyonCeva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France
EXPIRY DATE
Firokoksib Ekvidi
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Pri zdravljenih živalih se občasno pojavijo poškodbe (erozije /ulkusi) na ustni sluznici in na koži okrog ust.
Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Dajte eno tableto enkrat na dan konjem, ki tehtajo od 450 do 600 kg. Trajanje zdravljenja je odvisno od učinka, vendar naj ne bi preseglo 14 dni.
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses Firocoxib
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje za konje Firokoksib
Shelf life after first opening the immediate packaging: 1 month.
Rok uporabnosti po prvem odpiranju stične ovojnine: 1 mesec.
ADVICE ON CORRECT ADMINISTRATION Avoid the introduction of contamination during use.
NASVET O PRAVILNI UPORABI ZDRAVILA Držite se običajnih pravil asepse.
Yellow Iron Oxide (E172)
Mikrokristalna celuloza Chartor dimni hikori okus Hidroksipropilceluloza Natrijev karmelozat, premreženi Magnezijev stearat Karamelni sladkor (E150d) silicijev dioksid, koloidni, brezvodni Rumeni železov oksid (E172) Rdeči železov oksid (E172)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Syringe labelling
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta za konje
Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.
Ne dajajte sočasno z zdravili za uporabo v veterinarski medicini, ki so potencialno toksična za ledvice.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/083/002
EXPIRY DATE EXP {month/year} Once opened, use within 3 months
Odprto zdravilo uporabite znotraj 3 mesecev
For animal treatment only - To be supplied only on veterinary prescription.
Samo za živali - RpVet.
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose.
Pri živalih, zdravljenih s priporočenimi odmerki zdravila, se občasno pojavijo poškodbe (erozije /ulkusi) na ustni sluznici in na koži okrog ust.
The VICH GL 6 states that:
Smernica VICH GL 6 določa:
Evaluation of the environmental risk assessment
Vrednotenje ocene okoljevarstvenega tveganja
Therefore, in principle, a Phase II could exceptionally be requested.
Zato se načeloma lahko zahteva izjema s fazo II.
In view of the disagreement the issue was referred to CVMP.
Zaradi tega nestrinjanja je bila zadeva napotena na CVMP.
These situations are expected to be the exception rather than the rule and some evidence in support of the concern should be available.”
Pričakuje se, da so te okoliščine bolj izjema kot pravilo, zato morajo biti v podporo zadržkom razpoložljivi določeni dokazi.“
Furthermore, the scenarios for pig and poultry manure are not necessary comparable as breeding conditions, application and agricultural practises for handling of manure are often very different.
Poleg tega scenarija za prašičji in perutninski gnoj nista nujno primerljiva, saj so pogoji reje, uporaba zdravila in kmetijska praksa ravnanja z gnojem pogosto zelo različni.
The Phase II evaluation performed by the Applicant was based on:
Oceno faze II je predlagatelj opravil na podlagi:
La Ballastière 33500 Libourne FRANCE Bristol
La Ballastière 33500 Libourne FRANCIJA Bristol ZDRUŽENO KRALJESTVO
• The rearing and production methods are similar in poultry and pigs,
• metode vzreje in pridelave so pri perutnini in prašičih podobne,
During the decentralised procedure the disagreement between the Member States was on the adequacy of the data provided for the Phase II Environmental Risk Assessment.
Med decentraliziranim postopkom se je med državami članicami pojavilo nestrinjanje glede zadostnosti podatkov, predloženih za oceno okoljskega tveganja faze II.
This response was accepted by the reference Member State but rejected by some Concerned Member States on the basis that the reference to end point values from published summary of an assessment was not sufficient to substitute environmental risk assessment data.
Referenčna država članica je ta odgovor sprejela, določene zadevne države članice pa so ga zavrnile z utemeljitvijo, da s sklicem na vrednosti končne točke iz objavljenega povzetka ocene ni mogoče nadomestiti podatkov ocene okoljevarstvenega tveganja.
The information provided does not contain details on the design, conduct, analysis and results of the study allowing a full and independent assessment therefore does not allow for a Phase II evaluation according to the legal requirements and relevant guidelines3 in force.
Predloženi podatki ne vsebujejo podrobnosti o zasnovi, izvedbi, analizi in rezultatih študije, ki bi omogočile popolno in neodvisno oceno, zato ne omogočajo vrednotenja faze II po veljavnih pravnih zahtevah ter zadevnih smernicah.3
2.1 Assessment of Phase II data provided
2.1 Ocena predloženih podatkov faze II
It is indicated for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora sui.
Indicirano je za preprečevanje kliničnih znakov kokcidioze pri novoskotenih pujskih na kmetijah, kjer so bili v preteklosti potrjeni primeri kokcidioze zaradi Isospora sui.
2.1 Evaluation of Phase I and considerations on the need for a Phase II assessment
2.1 Vrednotenje faze I in utemeljevanje potrebe po oceni faze II
• argumentation for that the predicted environmental concentration (PEC) resulting from the use of the product in pigs is inferior to that, which arises from its use in poultry.
• argumenta, da je predvidena koncentracija v okolju (PKO), ki je posledica uporabe zdravila pri prašičih, manjša od koncentracije, do katere pride pri uporabi tega zdravila pri perutnini.
“Some VMPs that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their activity and use.
„Za določena zdravila za uporabo v veterinarski medicini bi se sicer ocena lahko ustavila v fazi I, vendar so morda potrebni dodatni okoljski podatki za obravnavo posebnih zadržkov, ki so povezani z njihovo aktivnostjo in uporabo.
Having considered the overall data submitted in writing and in the oral explanation the CVMP concluded after consulting with its Environmental Risk Assessment Working Party that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation.
CVMP je ob upoštevanju vseh podatkov, predloženih pisno in z ustnim pojasnilom, ter po posvetovanju s svojo delovno skupino za pripravo ocene okoljskega tveganja zaključil, da zadržki, ki so bili predstavljeni med decentraliziranim postopkom, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Frequency and route of administration species
Pogostost in pot uporabe zdravila vrsta
It is acknowledged that the main metabolite is probably the same for pigs and poultry for this compound and that the calculations in Phase I of the ERA take 100% of the dose into account (total residue approach) when environmental exposure is calculated.
Prizna se, da je poglavitni presnovek omenjene spojine verjetno enak pri prašičih in perutnini in da se pri izračunih okoljevarstvenega tveganja faze I, ko gre za okoljsko izpostavljenost, upošteva 100 % odmerka (pristop s celotnimi ostanki).
Potential variation in metabolism is therefore of little practical importance in the Phase I calculation of the PEC value.
Možne variacije v presnovi so zato pri izračunu vrednosti PKO faze I v praksi manjšega pomena.
The product is a generic of Baycox 5% oral solution.
Zdravilo je generična različica zdravila Baycox 5 % peroralna raztopina.
In addition to the question whether the provided data was sufficient for a Phase II assessment (see above) the Committee revisited the Phase I submitted with the application in order to reach an opinion on whether the marketing authorisation for the product could be granted or should be refused in accordance with Article 36 of Directive 2001/82/EC.
Odbor je poleg vprašanja, ali predloženi podatki zadostujejo za oceno faze II (glejte zgoraj), obravnaval tudi oceno faze I, ki je bila priložena vlogi za pridobitev dovoljenja za promet z zdravilom, da bi pripravil mnenje o odobritvi ali zavrnitvi dovoljenja za promet z zdravilom v skladu s členom 36 Direktive 2001/82/ES.
The current evidence is therefore not sufficient to justify a prevalence of particular concern and thereby to request a Phase II evaluation.
Predstavljeni dokazi torej ne zadostujejo za utemeljitev prevlade posebnega zadržka in s tem zahteve po oceni faze II.
Some concerned Member States raised potential concerns with the persistence of the main metabolite of toltrazuril, toltrazuril sulphone, and therefore the applicant was required to submit a Phase II.
Nekatere zadevne države članice so izrazile morebitne zadržke glede ohranjanja glavnega presnovka toltrazurila, tj. toltrazurilsulfona, in zato so od predlagatelja zahtevale predložitev ocene faze II.