natgillin/translations-raw huggingface dataset:
100 mg of Doxycycline base as hyclate Excipients:
100 mg doksiciklinijevega hiklata
Semoline q. s.
Pomožne snovi:
Premix for medicated feeding stuff Doxyprex is presented as yellow granules.
Zdravilo Doxyprex je na voljo v obliki rumenih granul.
Pigs (after weaning)
Prašiči (po odstavitvi).
Special precautions for use
4. 5 Posebni previdnostni ukrepi
Special precautions for use in animals Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Upoštevati je treba uradne in lokalne antimikrobne politike.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid handling the product if hypersensitivity to tetracyclines exists.
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Izogibajte se uporabi zdravila, če obstaja preobčutljivost za tetracikline.
10/ 21 Care should be taken to avoid contact with the product during its incorporation to the feed as well as during the administration of the medicated feed to the animals.
10/ 21 Izogibajte se stiku z zdravilom med njegovim vmešavanjem v krmno mešanico in med dajanjem zdravilne krmne mešanice živalim.
It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
Priporočeno je, da uporabljate masko brez smukca (skladno s predpisom EN140FFP1), rokavice, delavno obleko in odobrena zaščitna očala.
Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet.
Če so v krmi velike količine Ca, Fe, Mg ali Al, se lahko zniža absorpcija doksiciklina.
Do not administer together with antacids, kaolin and iron preparations.
Zdravila ne dajajte skupaj s sredstvi proti želodčni kislini ali skupaj s kaolinom in preparati z železom.
Amounts to be administered and administration route
4. 9 Odmerjanje in pot uporabe
The recommended dose is 10 mg of doxycycline/ kg of body weight/ day (equivalent to 1 g of Doxyprex/ 10 kg of b. w.) for 7 consecutive days.
Priporočeni odmerek je 10 mg doksiciklina/ kg telesne teže/ dan (kar je enako 1 g zdravila Doxyprex/ 10 kg telesne teže) 7 zaporednih dni.
For pigs with a daily consumption of 40 g of feed/ kg b. w. / day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/ Ton.
Pri prašičih z dnevnim vnosom 40 g krmne mešanice/ kg telesne teže/ dan ta odmerek ustreza 250 mg doksiciklina na kg krmne mešanice, kar pomeni, da je razmerje za mešanje 2, 5 kg/ tono.
1 mg Doxyprex/ kg feed = 10 mg doxycycline/ kg b. w. x 10 x bodyweight (kg)/ Daily feed intake (kg)
1 mg Doxyprex/ kg krmne mešanice = 10 mg doksiciklina/ kg telesne teže x 10 x telesna teža (kg) / dnevni vnos krmne mešanice (kg)
35 kg body weight) Complete feed for fattening pigs up to approx.
Začetna krmna mešanica za pujske I (popolna krmna mešanica do približno 20 kg telesne teže) Začetna krmna mešanica za pujske II (popolna krmna mešanica do približno 35 kg telesne teže) Popolna krmna mešanica za rejenje prašičev do približno 50 kg telesne teže Popolna krmna mešanica za rejenje prašičev s telesno težo približno 50 kg Popolna krmna mešanica za rejenje prašičev s telesno težo približno 35 kg
50 kg body weight Complete feed for fattening pigs of approx.
11/ 21 Za vmešavanje zdravila v krmno mešanico je treba uporabiti mešalnik s horizontalnim trakom.
Pelleting
Potem se lahko zdravilna krmna mešanica granulira.
11/ 21 conditions involve preconditioning ingredients with steam at 55-65ºC and 10% moisture.
Pogoji za peletiranje vključujejo vnaprej določene sestavine s paro pri 55– 65 °C in 10- odstotno vlago.
No symptoms of intolerance to the speciality have been detected in the studies conducted in which a medicated feed with 600 ppm (2.4 times the recommended dose) was administered to the 20-30 kg animals during twice the recommended period.
V raziskavah, pri katerih so 600 ppm (2, 4- kratna količina priporočenega odmerka) dajali 20– 30 - kilogramskim živalim v obdobju, ki je bilo dvakrat daljše od priporočenega trajanja zdravljenja, niso opazili slabega prenašanja tega zdravila.
Meat and offal:
Meso in drobovje:
Antibacterials for systemic use.
Antibakterijska sredstva za sistemsko uporabo.
Tetracyclines, ATCvet code:
Tetraciklini, oznaka ATC vet:
Doxycycline is a semi-synthetic tetracycline derived from oxytetracycline that acts on the 30S ribosomal bacterial subunit in a reversible union, by blocking the binding of aminoacyl-tRNA (transference RNA) to the mRNA/ ribosome complex, avoiding the addition of new amino acids to the growing peptide chain and interfering therefore on the protein synthesis.
Doksiciklin je polsintetični tetraciklin, pridobljen iz oksitetraciklina, ki deluje na ribosomsko bakterijsko podenoto 30S v reverzni zvezi tako, da blokira vezavo aminoacil- tRNA (prenašalne RNA) na kompleks mRNA/ ribosom, pri čemer se izogiba dodajanju novih aminokislin na rastočo peptidno verigo in tako vpliva na beljakovinsko sintezo.
It is active against:
Deluje proti:
Pasteurella multocida and Bordetella bronchiseptica
Pasteurella multocida in Bordetella bronchiseptica
“ In Spain during 2001, the in vitro sensitivity to doxycycline has been determined against porcine strains of Pasteurella multocida and Bordetella bronchiseptica resulting in MIC90 values of 0.795µg/ ml and 0.053µg/ ml respectively .”
» Leta 2001 so v Španiji določili in vitro občutljivost doksiciklina proti prašičjim sevom bakterij Pasteurella multocida in Bordetella bronchiseptica, pri čemer sta bili vrednosti MIC90 0, 795 µg/ ml oziroma 0, 053 µg/ ml. «
According to the Clinical and Laboratory Standard (CLSI) regulation, organisms other than streptococci with MIC values ≤ 4 µg/ ml are considered sensitive, at 8 µg/ ml intermediate and with MIC values ≥ 16 resistant to doxycycline.
Glede na predpis Inštituta za klinične in laboratorijske standarde (CLSI) so organizmi (razen streptokokov) z vrednostmi MIC ≤ 4 µg/ ml občutljivi, 8 µg/ ml srednje občutljivi in ≥ 16 µg/ ml odporni na doksiciklin.
The other mechanism is evidenced by a reduction in the affinity of the ribosome for the Tetracycline-Mg2+ complex due to mutations in the chromosome.
Drug mehanizem se kaže z zmanjšanjem afinitete ribosoma za kompleks tetraciklin- Mg2+, ki ga povzročijo mutacije v kromosomu.
Pharmacokinetic particulars
5. 2 Farmakokinetični podatki
After oral administration, in most species values higher than 70% are reached.
Po peroralni uporabi se pri večini vrst dosežejo vrednosti, večje od 70%.
Food can slightly modify oral bioavailability of doxycycline.
12/ 21 Hrana lahko nekoliko spremeni peroralno biološko razpoložljivost doksiciklina.
Doxycycline is widely distributed throughout the organism due to its physico-chemical characteristics, provided that is highly lipid-soluble.
Doksiciklin se zaradi fizikalno- kemičnih lastnosti obširno porazdeli v organizmu, pri čemer mora biti zelo topen v lipidih.
Concentrations
Koncentriran je v jetrih, ledvicah, kosteh in črevesu; v slednjem je koncentriran zaradi enterohepatičnega obtoka.
12/ 21 that reaches in lung are always higher than in plasma.
Koncentracije, ki dosežejo pljuča, so vedno večje kot v plazmi.
Binding to plasmatic proteins is about 90-92%.
Vezava na plazemske beljakovine je približno 90– 92%.
A 40% of the drug is metabolised and largely excreted in faeces (bile and intestinal route), mostly as conjugates microbiologically inactive.
40% zdravila se presnavlja in pretežno izloča z blatom (žolč in črevo), večinoma v obliki mikrobiološko neaktivnih konjugatov.
Pigs (after weaning) Oral bioavailability of doxycycline ranges between 50-60% values.
Prašiči (po odstavitvi) Peroralna razpoložljivost doksiciklina je med 50– 60% vrednosti.
Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Po absorpciji se zdravilo v zelo velikem odstotku (93%) veže na plazemske beljakovine.
Provided its lipophilic properties doxycycline is easily distributed in animal tissues, showing volumes of distribution of 0.53 l/ kg.
Zaradi svojih lipofilnih lastnosti se doksicilin zlahka razporedi v tkivih živali, pri čemer je volumen razporeditve 0, 53 l/ kg.
Its excretion is carried out through the intestinal mucous and in a lower extent, through bile excretion, resulting in plasmatic clearance values of 1.7 ml/ min/ kg.
Njegovo izločanje poteka prek črevesne membrane in v manjši meri prek žolča, pri čemer je vrednost plazemskega očistka 1, 7 ml/ min/ kg.
Following single dose administration, Cmax was 1.70 µg/ ml with a Tmax of 6 hours.
Po prekinitvi jemanja zdravila je razpolovni čas v končni fazi 6 ur.
Administration of the product according to the recommended posology results in a maximum plasmatic concentration at steady of 2.0 ± 0.4 µg/ ml.
Večinoma se izloči prek tankega črevesa, kar je prednost v primerjavi z drugimi tetraciklini, saj se ne kopiči v organizmu, kadar je ledvično delovanje oslabljeno, ker to ni njegova glavna pot izločanja.
Liquid sorbitol, non-crystallising Liquid paraffin Semolinea (declared on labelling as carrier)
Tekoči sorbitol, nekristalizirajoči Tekoči parafin Pšenični zdrob (na oznakah naveden kot nosilec)
Shelf-life after first opening the immediate packaging:
Rok uporabnosti po prvem odpiranju stične ovojnine:
3 months.
3 meseci.
Shelf-life after incorporation into pelleted feed:
Rok uporabnosti po vključitvi v peletirano krmo:
Containers of 1 kg, 5 kg, 20 kg and 25 kg.
Vsebniki po 1, 5, 20 in 25 kg.
Industrial Veterinaria, S. A.
A.
Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain Tel: +34 934 706 270 Fax: +34 933 727 556 e-mail: invesa@invesagroup. com
Esmeralda, 19 E- 08950 Esplugues de Llobregat (Barcelona), Španija Tel.: +34 934 706 270 Faks: +34 933 727 556 e- pošta: invesa@ invesagroup. com
MARKETING AUTHORISATION NUMBER(S)/ MRP PROCEDURE NUMBER
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET / ŠTEVILKA MEDSEBOJNIM PRIZNAVANJEM (MRP)
{< DD/MM/YYYY >}
{< DD/ MM/ LLLL >}
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
14/ 21 LABELLING AND PACKAGE INSERT
14/ 21 OZNAČEVANJE IN NAVODILO ZA UPORABO
15/ 21 PACKAGE LEAFLET
15/ 21 NAVODILO ZA UPORABO
Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain
Esmeralda, 19 E- 08950 Esplugues de Llobregat (Barcelona), Španija
Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Zdravilo Doxyprex je na voljo v obliki rumenih granul, ki vsebujejo po 100 mg doksiciklinskega hiklata na gram izdelka.
INDICATION(S)
INDIKACIJA( E)
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT( I) IN NAČIN UPORABE ZDRAVILA
In feed use The recommended dose is 10 mg of doxycycline/ kg of body weight/ day (equivalent to 1 g of Doxyprex/ 10 kg of b. w.) for 7 consecutive days.
Uporaba v krmi Priporočeni odmerek je 10 mg doksiciklina/ kg telesne teže/ dan (kar je enako 1 g zdravila Doxyprex/ 10 kg telesne teže) 7 zaporednih dni.
For pigs with a daily consumption of 40 g of feed/ kg
Pri prašičih z dnevnim vnosom 40 g krmne mešanice/ kg telesne
16/ 21 b. w. / day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/ Ton..
16/ 21 teže/ dan ta odmerek ustreza 250 mg doksiciklina na kg krmne mešanice, kar pomeni, da je razmerje za mešanje 2, 5 kg/ tono.
The following calculation can be used to calculate dosage:
Za izračun odmerka lahko uporabite naslednjo enačbo:
1 mg Doxyprex/ kg feed = 10 mg doxycycline/ kg b. w. x 10 x bodyweight (kg)/ Daily feed intake (kg)
1 mg zdravila Doxyprex/ kg krmne mešanice = 10 mg doksiciklina/ kg telesne teže x 10 x telesna teža (kg) / dnevni vnos krmne mešanice (kg)
35 kg body weight) Complete feed for fattening pigs up to approx.
Začetna krmna mešanica za pujske I (popolna krmna mešanica do približno 20 kg telesne teže) Začetna krmna mešanica za pujske II (popolna krmna mešanica do približno 35 kg telesne teže) Popolna krmna mešanica za rejenje prašičev do približno 50 kg telesne teže Popolna krmna mešanica za rejenje prašičev s telesno težo približno 50 kg Popolna krmna mešanica za rejenje prašičev s telesno težo približno 35 kg Za vmešavanje zdravila v krmno mešanico je treba uporabiti mešalnik s horizontalnim trakom.
50 kg body weight Complete feed for fattening pigs of approx.
Priporočeno je, da se najprej en del zdravila Doxyprex vmeša v en del krmne mešanice, potem se doda preostala krmna mešanica in dobro premeša.
35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Potem se lahko zdravilna krmna mešanica granulira.
It is recommended that one part of Doxyprex is first mixed into one part of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Pogoji za peletiranje vključujejo vnaprej določene sestavine s paro pri 55– 65 °C in 10- odstotno vlago.
Medicated feed may then be granulated.
Pred granuliranjem moka ne sme preseči temperature 55 °C.
10.
KARENCA
EXP {month/ year} Do not use after the expiry date.
EXP {mesec/ leto} Ne uporabljajte po izteku roka uporabnosti.
SPECIAL WARNING(S)
POSEBNO( A) OPOZORILO( A)
Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Zaradi različne dovzetnosti bakterij za doksiciklin mora uporaba tega zdravila temeljiti na bakteriološkem vzorčenju in testiranju občutljivosti ali nedavnih izkušnjah na kmetiji.
Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet.
Če je v krmi velika količina Ca, Fe, Mg ali Al, se lahko zniža absorpcija doksiciklina.
Do not administer in conjunction with bactericidal antibiotics like beta-lactames.
Zdravila ne dajajte skupaj s sredstvi proti želodčni kislini ali skupaj s kaolinom in preparati z železom.
Do not administer with oxidant substances.
Zdravila ne dajajte v kombinaciji z baktericidnimi antibiotiki, kakršni so betalaktami.
17/ 21 The uptake of medicated feed by animals can be altered as a consequence of illness.
17/ 21 Zdravila ne dajajte sočasno z oksidanti.
In case of insufficient feed intake, animals should be treated parenterally.
Pri živalih se lahko kot posledica bolezni spremeni vnos zdravilne krvne mešanice s krmo.
Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention It is not recommended its use in pregnant animals and during lactation periods.
Uporaba ni priporočljiva v obdobju brejosti in med laktacijo.
PACKAGE SIZE 1 kg 5 kg 20 kg 25 kg
VELIKOST PAKIRANJA 1 kg 5 kg 20 kg 25 kg
18/ 21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ONTHE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
{NATURE/ TYPE}
VRSTA/ TIP
Premix for medicated feeding stuff
Predmešanica za zdravilno krmno mešanico.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT( I) UPORABE
In feed use
Uporaba v krmi.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO » SAMO ZA ŽIVALI « IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO » ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM «
London, June 2008 EMEA/ 532206/ 2007- Rev.1
London, junij 2008 EMEA/ 532206/ 2007 - Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOXYPREX 100mg PREMIX
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO DOXYPREX 100 mg PREMIX
Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg bags containing 100 mg/ g doxycycline base as hyclate.
Zdravilo Doxyprex 100 mg je na voljo v 5 kg, 20 kg in 25 kg vrečah in vsebuje 100 mg/ g doksiciklina v obliki hiklata.
Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Nemčija se ni strinjala z odobritvijo dovoljenja za promet, zato je bila zadeva napotena na Ukslajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v veterinarski medicini (CMD( v)) in nato na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended, for Doxyprex 100 mg premix.
CVMP je med svojim zasedanjem 21. in 22. junija 2006 pričel napotitveni postopek v skladu s členom 33( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena, za zdravilo Doxyprex 100 mg Premix.
The applicant provided a justification for submission of this application on a “ well-established use” basis.
Predlagatelj je svojo vlogo utemeljil na podlago „ dobro uveljavljene uporabe “.
Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/ kg once daily for 5 days are stated as having been authorised since 1985.
Navedel je, da so v EU predmešanice na podlagi doksiciklina za prašiče v priporočljivih odmerkih 10 mg/ kg enkrat dnevno do 5 dni odobrene od leta 1985.
Annex I of Directive 2001/ 82/ EC as amended by directive 2004/ 28/ EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
V Prilogi I Direktive 2001/ 82/ ES, kakor je bila spremenjena z Direktivo 2004/ 28/ EC, je navedeno, da so postmarketinške izkušnje z drugimi zdravili, ki vsebujejo enake sestavine, posebnega pomena, zato morajo predlagatelji temu nameniti posebno pozornost.
The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/ g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/ risk analysis has been demonstrated and no potential serious risk has been identified.
CVMP je priporočil odobritev dovoljenja za promet z zdravilom Doxyprex 100 mg/ g Premix za predmešanico za pripravo zdravilne krmne mešanice za prašiče za naslednjo indikacijo, ker je bilo v analizi ugotovljeno pozitivno razmerje med koristmi in tveganji, hkrati pa ni bilo dokazano nobeno možno resno tveganje.
“ For the treatment and prevention of porcine respiratory disease, caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd .”
„ Za zdravljenje in preprečevanje bolezni dihal pri prašičih, ki jo povzročata na doksiciklin občutljivi bakteriji Pasteurella multocida in Bordetella bronchiseptica, če je bila bolezen diagnosticirana v čredi. “
EMEA/ 532206/ 2007- Rev.1
EMEA/ 532206/ 2007 - Rev. 1- SL
London, 18 February 2008 EMEA/ 48261/ 2008
London, 18. februar 2008 EMEA/ 48261/ 2008
Ivermectin
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 331 ZA Ecomectin 18, 7 mg/ g peroralno pasto za konje in z njim povezana imena Mednarodno nelastniško ime (INN): ivermektin
Ecomectin 18.7 mg/ g Oral Paste for Horses is a white homogenous paste containing ivermectin.
Zdravilo Ecomectin 18, 7 mg/ g peroralna pasta za konje je bela homogena pasta, ki vsebuje ivermektin.
Ivermectin is a member of the macrocyclic lactone class of endectocides.
Ivermektin sodi v skupino makrocikličnih laktonov v okviru endektocidov.
Ecomectin 18.7 mg/ g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains):
Zdravilo Ecomectin 18, 7 mg/ g peroralna pasta za konje je namenjeno za uporabo pri konjih za zdravljenje okužb z nematodi ali artropodi, ki jih povzročajo Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, mali strongilidi (vključno s sevi, odpornimi na benzimidazol):
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids:
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., askaridi:
Parascaris equorum, Pinworms:
Parascaris equorum, podančice:
Oxyuris equim, Neck threadworms:
Oxyuris equim, nitasti zajedavci iz rodu Onchocerca:
Onchocerca spp, Stomach bots:
Onchocerca spp, trebušni zolji:
A marketing authorisation for Ecomectin 18.7 mg/ g Oral Paste for Horses was previously granted to Eco Animal Health Ltd in Ireland on 10 November 2006.
Dovoljenje za promet za zdravilo Ecomectin 18, 7 mg/ g peroralna pasta za konje je bilo predhodno podeljeno podjetju Eco Animal Health Ltd na Irskem dne 10. novembra 2006.
A mutual recognition procedure was started on 1 February 2007.
Postopek medsebojnega priznavanja se je začel 1. februarja 2007.
The Reference Member State was Ireland and the Concerned Member States were Belgium, Cyprus, Czech Republic, Germany, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
Referenčna država članica je bila Irska, zadevne države članice pa Belgija, Ciper, Češka, Nemčija, Danska, Grčija, Španija, Finska, Francija, Madžarska, Italija, Nizozemska, Norveška, Portugalska, Švedska in Združeno kraljestvo.
The product was accepted by the Belgium, Cyprus, Czech Republic, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
Izdelek so sprejele Belgija, Ciper, Češka, Danska, Grčija, Španija, Finska, Francija, Madžarska, Italija, Nizozemska, Norveška, Portugalska, Švedska in Združeno kraljestvo.
Concerns were raised by Germany regarding that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Nemčija je izrazile pomisleke, da bi utegnilo to zdravilo za uporabo v veterinarski medicini pomeniti potencialno resno tveganje za javno zdravje, in sicer na naslednji podlagi:
No adequate data for Tier B were provided by the applicant to assess the long-term effects on dung fauna organisms caused by the use of the product.
med stopnjo A faze II ocenjevanja tveganja je bilo ugotovljeno tveganje za okolje v zvezi z o organizmi, prisotnimi v gnoju; predlagatelj ni predložil ustreznih podatkov za stopnjo B, ki bi omogočali oceno dolgoročnih o učinkov uporabe zdravila na organizme, prisotne v gnoju.
On 4 July 2007, Ireland notified EMEA that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/ g Oral Paste for Horses and its associated names.
Irska je dne 4. julija 2007 obvestila Evropsko agencijo za zdravila, da Koordinacijska skupina za postopek medsebojnega priznavanja in decentralizirane postopke za zdravila v veterinarski medicini (CMD( v)) ni uspela doseči sporazuma glede peroralne paste za konje Ecomectin 18, 7 mg/ g in z njim povezana imena.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to the CVMP.
V skladu s členom 33( 4) Direktive Sveta 2001/ 82/ ES, kakor je bila spremenjena, je bila zadeva napotena na CVMP.
The scope of the referral was to whether the environmental risk detected during the risk assessment Phase II Tier A for dung fauna organisms would present a potential serious risk to public health.
Predmet napotitve je zadeval vprašanje, ali bi tveganje za okolje v zvezi z organizmi, prisotnimi v gnoju, ugotovljeno med stopnjo A faze II ocenjevanja tveganja, pomenilo potencialno resno tveganje za javno zdravje.
The arbitration procedure started on 11 July 2007 with the adoption of list of questions.
Arbitražni postopek se je začel 11. julija 2007 s sprejetjem seznama vprašanj.
The rapporteur was Dr.
Poročevalec je bil dr.
Urbain and the co-rapporteur was Prof.
Urbain, soporočevalec pa prof.
The Marketing Authorisation Holder provided written explanations on 12 September 2007.
Imetnik dovoljenja za promet z zdravilom je posredoval pisno razlago 12. septembra 2007.