qanastek/EMEA-V3 huggingface dataset:
From the original residue depletion study in pigs, the CVMP concluded that the kidney was the limiting tissue for the establishment of a withdrawal period.
MT 6/ 8 Mill- istudju oriġinali ta ’ l- eliminazzjoni tar- residwi fil- majjali, is- CVMP ikkonkluda li l- kliewi kienu t- tessut kruċjali biex ikunu stabbiliti l- perjodi ta ’ rtirar.
However, taking into account also the two new residue depletion studies in pigs, the CVMP concludes that the totality of the data indicates that the residue depletion at the injection site will determine the withdrawal period.
Madankollu, meta wieħed jikkonsidra wkoll iż- żewġ studji ġodda dwar l- eliminazzjoni tar- residwi fil- majjali, is- CVMP ikkonkluda li d- data kollha tindika li l- eliminazzjoni tar- residwu fis- sît ta ’ l- injezzjoni jiddetermina l- perjodu ta ’ l- eleminazzjoni.
Therefore withdrawal periods for cattle and pigs could not be recommended.
Għalhekk il- perjodi ta ’ rtirar għall- ifrat u l- majjali ma setgħux jiġu rakkomandati.
EN 7/ 8 GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
MT 7/ 8 RAĠUNIJIET GĦAS- SOSPENSJONI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Billi:
- the CVMP considered the referral made under Article 35 of Directive 2001/ 82/ EC in the interest of
- is- CVMP ikkonsidra r- riferenza magħmula skond l- Artikolu 35 tad- Direttiva 2001/ 82/ KE fl -
the Community regarding consumer safety for national marketing authorisations for Suramox 15% LA or variations of that name as referred to in Annex I;
interess tal- Komunità dwar is- sigurtà tal- konsumatur għal awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA jew varjazzjonijiet ta ’ dak l- isem kif imsemmi fl- Anness I;
- the CVMP assessed the information provided by the Marketing Authorisation Holder in response
- is- CVMP studja t- tagħrif mogħti mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq bi
- the CVMP considered that based on the residue depletion data provided concerning the depletion
tweġiba għal- lista ta ’ mistoqsijiet maqbula mis- CVMP, l- argumentazzjoni pprovduta mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq b’ appoġġ għat- talba għall- istħarriġ mill- ġdid ta ’ l - opinjoni u ta ’ data ġdida dwar ir- residwi pprovduta mid- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq matul il- konsiderazzjoni mill- ġdid ta ’ l- opinjoni mitluba mill- Kummissjoni Ewropea;
of residues of amoxicillin when administered by injection it was not possible to establish a withdrawal period for cattle and pigs as:
- is- CVMP ikkonsidra li skond id- data ta ’ l- eliminazzjoni tar- residwi pprovduta dwar l- eliminazzjoni
o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations in kidneys were still above the MRL at the last slaughter time point;
tar- residwi ta ’ amoxicillin meta mogħti b’ injezzjoni ma kienx possibbli li jkun iffissat perjodu ta ’ rtirar għall- ifrat u l- majjali billi: o fl- ifrat, il- konċentrazzjonijiet fis- sît ta ’ l- injezzjoni xorta kienu ogħla mill- MRL fiż- żmien meta l- aħħar sar il- qtil; o fil- majjali, il- konċentrazzjonijiet tar- residwi fil- kliewi xorta kienu ogħla mill- MRL fiż- żmien meta l- aħħar sar il- qtil;
- the CVMP, having considered the data provided concluded that the currently established
- Is- CVMP, wara li kkonsidra d- data pprovduta ikkonkluda li l- perjodi ta ’ rtirar attwalment iffissati
withdrawal periods for cattle and pigs are inadequate to ensure that foodstuffs obtained from the treated animals do not contain residues which might constitute a health hazard to the consumer; the CVMP recommends the suspension of the marketing authorisations for Suramox 15% LA or variations of that name as referred in Annex I, presented as injectable suspension for pigs and cattle.
għall- ifrat u l- majjali mhumiex adekwati biex ikun żgurat li l- prodotti ta ’ l- ikel miksuba minn annimali li jkunu ngħataw trattament, ma jkunx fihom residwi li jkunu jistgħu jikkostitwixxu periklu għas- saħħa tal- konsumatur; is- CVMP jirrakkomanda s- sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA jew varjazzjonijiet ta ’ dak l- isem kif imsemmi fl- Anness I, ippreżentat bħala soluzzjoni għall - injezzjoni għall- majjali u l- ifrat.
In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary.
Sabiex jikkonsidra t- tneħħija tas- sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq ikunu meħtieġa data dwar l- eliminazzjoni tar- residwi wara intervalli itwal sabiex ikunu jistgħu jiġu iffissati l- perjodi ta ’ rtirar għal- laħam u l- ġewwieni ta ’ l- ifrat u l- majjali.
In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.
Sabiex tkun żgurata konklużjoni armonizzata dwar l- iffissar ta ’ perjodi ta ’ rtirar, huwa rakkomandabbli ħafna li kwalunkwe studju ġdid dwar l- eliminazzjoni tar- residwi intiż għat- tneħħija tas- sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq jiġi sottomess lis- CVMP għall - valutazzjoni.
EN 8/ 8
MT 8/ 8
London, June 2008 EMEA/ 532233/ 2007- Rev.1
Londra, Ġunju 2008 EMEA/ 532233/ 2007 - Rev. 1
OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN ERY
OPINJONI DWAR REFERENZA SKOND L- ARTIKOLU 40 GĦAL SUVAXYN ERY
France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/ 82/ EC, as amended, in relation to Suvaxyn Ery.
Fil- 11 ta ’ Lulju 2006, Franza nnotifikat lill- EMEA b’ Referenza skond l- Artikolu 40 tad- Direttiva tal - Kunsill 2001/ 82/ KE, kif emendata, fir- rigward ta ’ Suvaxyn Ery.
Suvaxyn Ery is indicated for the active immunisation of pigs (gilts and sows) to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Suvaxyn Ery huwa indikat għat- tilqim attiv fil- ħnieżer (ħnieżer nisa li għadhom ma kellhomx għalla [gilts] u ħnieżer nisa) biex inaqqas is- sinjali kliniċi ikkawżati minn infezzjonijiet ta ’ Erysipelothrix rhusiopathiae, serotip 2 u serotip 1.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Ir- referenza tindirizza l- kwistjoni li fl- opinjoni ta ’ Franza, l- ekwivalenza bejn il- lott tal- vaċċin ta ’ referenza għat- test tal- qawwa tal- lott ta ’ erysipelas ivvalidat fid- dossier oriġinali u l- lottijiet tal- vaċċin ta ’ referenza l- ġodda ma ntwerietx għal dawn iż- żewġ lottijiet u li konsegwentement is- CVMP kien jeħtieġ jikkunsidra jekk għandux ivarja, jirtira jew jissospendi l- awtorizzazzjoni għat- tqegħid fis- suq.
The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) beda l- proċedura ta ’ referenza fid - 19 ta ’ Lulju 2006.
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Is- CVMP ikkonkluda li, abbażi tad- dejta kollha disponibbli, ma kien hemm ebda tħassib fir- rigward tas- sigurtà jew l- effikaċja għall- prodott.
However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Madankollu, kien importanti li jiġi żgurat li l- limiti ta ’ suċċess tat- test tal- qawwa ma jitbegħdux mill- oriġinali.
In addition, a more robust test for potency should be applied to the product in the future.
Barra minn hekk, test għall- qawwa iktar b’ saħħtu għandu jiġi applikat għall- prodott fil- futur.
The CVMP, therefore, recommended a variation of the Marketing Authorisation.
Għaldaqstant, is- CVMP irrakkomanda varjazzjoni ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- Suq.
The Marketing Authorisation(s) should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
L - Awtorizzazzjoni( jiet) Għat- Tqegħid Fis- Suq għandhom ivarjaw sabiex inaqqsu l- varjabbiltà tat- test tal- qawwa seroloġika fil- ġrieden permezz ta ’ miżuri xierqa bħas- sostituzzjoni ta ’ l- użu ta ’ tilqima ta ’ referenza fit- test tal- qawwa seroloġika fil- ġrieden bl- użu ta ’ serum ta ’ referenza.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 19 April 2007.
L- Opinjoni tas- CVMP ġiet adottata fis- 17 ta ’ Jannar u d- Deċiżjoni tal- Kummissjoni sussegwenti ġiet adottata fid- 19 ta ’ April 2007.
London, June 2008 EMEA/ 532267/ 2007- Rev.1
Londra, Ġunju 2008 EMEA/ 532267/ 2007 - Rev. 1
OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN PARVO/ E
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 40 GĦAL SUVAXYN PARVO/ E
France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/ 82/ EC, as amended, in relation to Suvaxyn Parvo/ E.
Fil- 11 ta ’ Lulju 2006, Franza nnotifikat lill- EMEA b’ Referenza skond l- Artikolu 40 tad- Direttiva tal - Kunsill 2001/ 82/ KE, kif emendata, fir- rigward ta ’ Suvaxyn Parvo/ E.
Suvaxyn Parvo/ E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Suvaxyn Parvo/ E huwa indikat għat- tilqim attiv fil- ħnieżer (ħnieżer nisa li għadhom ma kellhomx għalla [gilts] u ħnieżer nisa) biex jimpedixxi d- disturbi riproduttivi kkawżati minn parvovirus tal - qżieqeż u biex inaqqas is- sinjali kliniċi kkawżati minn infezzjonijiet ta ’ Erysipelothrix rhusiopathiae, serotip 2 u serotip 1.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Ir- referenza tindirizza l- kwistjoni li fl- opinjoni ta ’ Franza, l- ekwivalenza bejn il- lott tal- vaċċin ta ’ referenza għat- test tal- qawwa tal- lott ta ’ erysipelas ivvalidat fid- dossier oriġinali u l- lottijiet tal- vaċċin ta ’ referenza l- ġodda ma ntwerietx għal dawn iż- żewġ lottijiet u li konsegwentement is- CVMP ħtieġ li jikkunsidra jekk għandux ivarja, jirtira jew jissospendi l- awtorizzazzjoni għat- tqegħid fis- suq.
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Is- CVMP ikkonkluda li, abbażi tad- dejta kollha disponibbli, ma kien hemm ebda tħassib fir- rigward tas- sigurtà u l- effikaċja għall- prodott.
In addition, a more robust test for potency should be applied to the product in the future.
Barra minn hekk, test tal- qawwa iktar b’ saħħtu għandu jiġi applikat għall- prodott fil- futur.
The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Għaldaqstant, is- CVMP irrakkomanda li l- Awtorizzazzjoni Għat- Tqegħid Fis- Suq għandha tkun varjata biex tnaqqas il- varjabbiltà tat- test tal- qawwa seroloġika fil- ġrieden b’ miżuri xierqa bħas - sostituzzjoni ta ’ l- użu ta ’ vaċċin ta ’ referenza fit- test tal- qawwa seroloġika fil- ġrieden bl- użu ta ’ serum ta ’ referenza.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007. ---------------------------------------------------------------------------
L- Opinjoni tal- CVMP ġiet adottata fis- 17 ta ’ Jannar 2007 u d- Deċiżjoni tal- Kummissjoni sussegwenti fis- 17 ta ’ April 2007. ---------------------------------------------------------------------------
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TAL- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI TA 'ANNIMALI, MNEJN JINGĦATAW, DETENTURI TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL - ISTATI MEMBRI
EMEA/ CVMP/ 345752/ 2008-EN
EMEA/ CVMP/ 345752/ 2008- MT
16 July 2008
16 ta 'Lulju 2008
Marketing Authorisation Holder,
Detentur tal- Awtorizzazzjoni għat - Għamla
Pharmaceutical
Stat Membru
State
Isem ivvintat
Invented name
Tqegħid fis- Suq,
Company Name and Address
Speċi ta 'annimal
Animal species
Farmaċewtika
form
Qawwa
Strength
Isem u
Indications
Indirizz tal- Kumpanija
Chickens and turkeys
Tiġieġ u dundjani
25 mg/ ml Lösung zum Bayer Austria Ges. m. b. H Chickens and turkeys Oral solution 25 mg/ ml
25 mg/ ml Lösung Bayer Austria Ges. m. b. H Tiġieġ u dundjani Soluzzjoni orali 25 mg/ ml
Treatment of
Kura tal -
Herbststraße 6-10 1160 Wien Austria
Herbststraße 6- 10 1160 Wien L- Awstrija
coccidiosis
koċċidjożi
Bayer SA-NV Health Care Animal Health Louizalaan 143 Avenue Louise 1050 Brussel Belgium
Bayer SA- NV Health Care Animal Health Louizalaan 143 Avenue Louise 1050 Brussel Il- Belġju
Treatment of coccidiosis
Kura tal - koċċidjożi
Ceva Sante Animale La Balastriere 33501 Libourne Cedex France
Ceva Sante Animale La Balastriere 33501 Libourne Cedex Franza
Broilers, breeders, pullets and turkeys
Brojlers, riprodutturi, għewietaq u dundjani
Prevention and treatment of coccidiosis
Prevenzjoni u kura tal - koċċidjożi
Broilers and turkeys
Brojlers u dundjani
Litvinovska 609/ 3 190 21 Praha 9 Czech Republic
Litvinovska 609/ 3 190 21 Praha 9 Ir- Repubblika Ċeka
BAYER SANTE 13 rue Jean Jaures 92807 PUTEAUX France
BAYER SANTE 13 rue Jean Jaures 92807 PUTEAUX Franza
Chickens: broilers, pullets and breeders
Tiġieġ: brojlers, għewietaq u riprodutturi
Alkotás u.50 1123 Budapest Hungary
Alkotás u. 50 1123 Budapest L- Ungerija
Baycox 2.5% Solution
Baycox 2. 5% solution
Bayer Ltd Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland
Bayer Ltd Animal Health Division The Atrium Blackthorn Road Dublin 18 L- Irlanda
Chickens
Tiġieġ
Treatment and control of coccidiosis
Kura u kontroll tal- koċċidjożi
Viale Certosa, 130 20156 Milano Italia
Viale Certosa, 130 20156 Milano L- Italja
Cevazuril1
L- Italja
Via Colleoni, 15 Agrate Brianza Italia
Via Colleoni, 15 Agrate Brianza L- Italja
1 The marketing authorisation is suspended on 12 June 2007
1 L- awtorizzazzjoni għat- tqegħid fis- suq ġiet sospiża fit- 12 ta 'Ġunju 2007
Member
Stat Membru
Marketing Authorisation Holder,
Isem ivvintat
Pharmaceutical
Tqegħid fis- Suq,
State
Speċi ta 'annimal
Invented name
Farmaċewtika
Company Name and Address
Qawwa
Animal species
Indikazzjonijiet
form
Isem u
Broilers, breeders, turkeys and pigeons
Brojlers, riprodutturi, dundjani u ħamiem
Chickens and turkeys: treatment of coccidiosis
Tiġieġ u dundjani: kura tal- koċċidjożi
Pigeons:
Ħamiem:
Treatment and prevention of coccidiosis
Kura u prevenzjoni tal - koċċidjożi
Bayer Portugal S. A Rua Da Quinta do Pinheiro, N. º 5 2794-003 Carnaxide Portugal
Bayer Portugal S. A Rua Da Quinta do Pinheiro, N. º 5 2794- 003 Carnaxide Il- Portugall
Bayer d. o. o., Bravnič arjeva 13, 1000 Ljubljana Slovenia
Bayer d. o. o., Bravničarjeva 13, 1000 Ljubljana Is- Slovenja
Marketing Authorisation Holder,
Detentur tal- Awtorizzazzjoni għat - Għamla Stat Membru
Strength
Indikazzjonijiet
Indications
Isem u
The Netherlands
Indirizz tal- Kumpanija
Bayer BV HealthCare Animal Health Postbus 80 3640 AB Mijdrecht Energieweg 1 3641 RT MIJDRECHT The Netherlands
Bayer BV HealthCare Animal Health Postbus 80 3640 AB Mijdrecht Energieweg 1 3641 RT MIJDRECHT L- Olanda
The Netherlands
Ir- Renju Unit
Baycox oplossing 2.5%
Baycox 2. 5% oral solution
Bayer Plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom
Bayer Plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Ir- Renju Unit
Broilers and broiler breeders
Brojlers u brojlers riprodutturi
SUMMARY OF PRODUCT CHARACTERISTICS
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDA TAL - ĠABRA FIL- QOSOR TAL- KARATTERISTIĊI TAL- PRODOTT
EMEA/ CVMP/ 345752/ 2008-EN SCIENTIFIC CONCLUSIONS
EMEA/ CVMP/ 345752/ 2008- MT KONKLUŻJONIJIET XJENTIFIĊI
Introduction and background Toltrazuril is administered orally in the drinking water for the treatment of coccidiosis.
Toltrazuril jingħata oralment fl- ilma tax- xorb għall- kura tal- koċċidjożi (coccidiosis).
In practice this means that in intensive systems all the birds in one house will be treated even though not all are exhibiting signs of disease.
Fil- prattika dan ifisser li f' sistemi intensivi, it- tjur kollha f' gallinar wieħed jiġu ttrattati anke jekk mhux kollha jkunu qegħdin juru sinjali tal- marda.
In some Member States (Bulgaria, France and Romania) indications include the prevention of coccidiosis.
F' xi Stati Membri (il- Bulgarija, Franza u r- Rumanija) l- indikazzjonijiet jinkludu l- prevenzjoni tal- koċċidjożi.
In Ireland indications include the control of coccidiosis.
Fl- Irlanda l- indikazzjonijiet jinkludu l- kontroll tal- koċċidjożi.
The dose and duration of treatment in all Member States for chickens and turkeys is 7 mg/ kg bodyweight per day for two consecutive days.
Id- doża u t- tul tal- kura fl- Istati Membri kollha għat- tiġieġ u d- dundjani hija 7 mg/ kg tal- piż tal- ġisem kuljum għal jumejn konsekuttivi.
However, in some Member States (Czech Republic, Hungary, Italy, The Netherlands, Portugal and the United Kingdom) administration can be repeated after five days in the face of severe challenge.
Madankollu, f' xi Stati Membri (ir- Repubblika Ċeka, l- Ungerija, l - Italja, l- Olanda, il- Portugall u r- Renju Unit) l- amministrazzjoni tista 'tiġi ripetuta wara ħamest ijiem fil- każ ta' sitwazzjoni kritika.
In Poland the product is authorised in pigeons for treatment and prevention of coccidiosis at a dose of 20 mg/ kg bodyweight per day for three consecutive days.
Fil- Polonja, il- prodott huwa awtorizzat fil- ħamiem, għall- kura u l - prevenzjoni tal- koċċidjożi f' doża ta '20 mg/ kg tal- piż tal- ġisem kuljum għal tlett ijiem konsekuttivi.
1.1 Concerns raised by Germany Germany considered that the authorisation of Baycox 2.5% solution may present a potential serious risk to the environment on the following grounds:
1. 1 Tħassib imqajjem mill- Ġermanja Il- Ġermanja qieset li l- awtorizzazzjoni ta 'Baycox 2. 5% solution tista' tippreżenta riskju serju potenzjali għall- ambjent għal dawn ir- raġunijiet:
Non-acceptable risk to higher plants There is evidence of a non-acceptable risk for plants when manure obtained from Baycox 2.5% treated poultry are applied to agricultural land.
Hemm evidenza ta 'riskju mhux aċċettabbli għall- pjanti meta demel miksub minn tjur ikkurati b' Baycox 2. 5% jiġi applikat fuq art agrikola.
Contamination of groundwater with organohalogens, list I of the European Directive 80/ 68/ EEC Toltrazuril sulfone (Ponazuril) the major metabolite of toltrazuril, may reach groundwater after spreading of Baycox 2.5% contaminated poultry manure on agricultural land (PECgroundwater > 0.1 µg/ l).
Toltrazuril sulfone (Ponazuril) il- prodott metaboliku ewlieni ta 'toltrazuril, jista' jilħaq l- ilma tal- pjan wara li d- demel mit- tjur ittrattati b' Baycox 2. 5% jitferrex fuq art agrikola (PECilma tal- pjan > 0. 1 µg/ l).
Toltrazuril and its major metabolite toltrazuril sulfone are organohalogens, included in list I of the European Groundwater Directive 80/ 68/ EEC.
Toltrazuril u l- prodott metaboliku ewlieni tiegħu toltrazuril sulfone huma organoaloġeni, inklużi fil - lista I tad- Direttiva Ewropea tal- Ilma ta 'taħt l- Art (ilma tal- pjan) 80/ 68/ KEE.
List I substances must be prevented from entering to groundwater.
Is- sustanzi tal- Lista I m' għandhomx jitħallew jidħlu fl- ilma tal- pjan.
Questions to the CVMP:
Mistoqsijiet lis- CVMP:
1) Is it a serious risk for the environment if one trophic level of the terrestrial ecosystem, i. e. plants, is affected by the use of Baycox 2.5%?
1) Huwa riskju serju għall- ambjent jekk livell trofiku wieħed tal- ekosistema terrestri, jiġifieri l - pjanti, jintlaqat mill- użu ta 'Baycox 2. 5%?
If so, which are the appropriate risk mitigation measures to reduce the risk to the environment to an acceptable level?
Jekk iva, liema huma l- miżuri għat- taffija tar- riskju x- xierqa biex jitnaqqas ir- riskju ambjentali għal livell aċċettabbli?
2) Is it acceptable that the active ingredient of Baycox 2.5%, toltrazuril, may enter groundwater after application to target animals although the active substance is listed in the EU Groundwater Directive 80/ 68/ EEC?
2) Huwa aċċettabbli li s- sustanza attiva ta 'Baycox 2. 5%, toltrazuril, tista' tidħol fl- ilma tal- pjan wara l- applikazzjoni fuq annimali fil- mira anke jekk is- sustanza attiva hija elenkata fid - Direttiva tal- UE għall- Ilma ta 'taħt l- Art (ilma tal- pjan) 80/ 68/ KEE?
1.2 Information made available to the CVMP Responses to the CVMP list of questions containing the three points considered by the CVMP (as listed in the opinion) were received from Bayer HealthCare AH (Baycox) and Ceva Santé Animale (Cevazuril).
1. 2 Tagħrif magħmul disponibbli lis- CVMP It- tweġibiet għal- lista ta 'mistoqsijiet tas- CVMP li jinkludu t- tliet punti kkunsidrati mis- CVMP (kif elenkati fl- opinjoni) intlaqgħu minn Bayer HealthCare AH (Baycox) u Ceva Santé Animale (Cevazuril).
The data submitted by the Marketing Authorisation Holders was only for chickens and turkeys.
Id- data sottomessa mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq irrigwardat biss it- tiġieġ u d- dundjani.
EMEA/ CVMP/ 345752/ 2008-EN 2.
EMEA/ CVMP/ 345752/ 2008- MT 2.
Critical evaluation
Valutazzjoni Kritika
The products under consideration contain the active substance toltrazuril and are indicated for use in poultry for the treatment of coccidiosis.
Il- prodotti kkunsidrati fihom is- sustanza attiva toltrazuril u huma indikati għall- użu fit- tjur għall- kura tal- koċċidjożi.
The group of products was referred to CVMP as it was considered that there was the potential for unacceptable risks to terrestrial plants and to groundwater.
Il- grupp ta 'prodotti ġie riferut lis- CVMP għax kien ikkunsidrat li hemm il- potenzjal għal riskji mhux aċċettabbli għall- pjanti terrestri u għall- ilma tal- pjan.
In both chickens and turkeys, toltrazuril is administered orally in the drinking water at a dose of 7 mg/ kg bodyweight per day for two consecutive days.
Kemm fit- tiġieġ kif ukoll fid- dundjani, toltrazuril jiġi amministrat oralment fl- ilma tax- xorb f' doża ta '7 mg/ kg ta ‘ piż tal- ġisem kuljum għal jumejn konsekuttivi.
In some Member States this administration can be repeated after five days in the face of severe challenge.
F' xi Stati Membri din l- amministrazzjoni tista 'tiġi ripetuta wara ħamest ijiem fid- dawl ta' sitwazzjoni severa.
The information provided stressed the importance of the product for use in cases where coccidiostats and vaccination had failed, given the limited availability of other treatments (amprolium, sulphonamides) and the need to rotate these treatments in order to avoid/ postpone the development of resistance.
It- tagħrif ipprovdut saħaq fuq l - importanza tal- prodott għall- użu f' każijiet fejn koċċidjostatiċi u tilqim rriżultaw ineffikaċi, meta wieħed iqis id- disponibilità limitata ta 'kura oħra (amprolium, sulfonamidi) u l- ħtieġa li wieħed jagħmel rotazzjoni bejn dawn it- trattamenti biex jevita/ jittardja l- iżvilupp ta' reżistenza.
It was also indicated that in practice repeat treatment with the product is never used as it is unnecessary.
Huwa indikat ukoll li fil- prattika, il- kura ripetuta bil- prodott ma tintuża qatt għax mhijiex meħtieġa.
In chickens the product is used in broilers and pullets destined to become laying birds.
Fit- tiġieġ, il- prodott jintuża fil- brojlers u fl- għewietaq destinati biex isiru tajr li jbid.
Broilers are treated after 14 days of age and usually no earlier than 18-19 days due to the epidemiology of the disease.
Il- brojlers jiġu kkurati wara l- eta ta ’ 14- il jum u ġeneralment mhux qabel 18- 19- il jum minħabba l- epidemjoloġija tal - marda.
Because of the length of the withdrawal period, in some countries broilers are treated rarely.
Minħabba t- tul tal- perjodi ta 'rtirar, f' xi pajjiżi, il- brojlers jiġu kkurati rarament.
In pullets the product can be used after two weeks of age and before the animals come into lay.
Fl- għewietaq, il- prodott jista 'jintuża wara li jkunu għalqu ġimagħtejn u qabel ma l- annimali jkunu waslu biex ibidu.
The use of the product in both types of chicken is infrequent as coccidiosis is mainly controlled by good hygiene and coccidiostats or vaccines.
L- użu tal- prodott fiż- żewġ tipi ta 'tiġieġ mhuwiex frekwenti għaliex il- koċċidjożi ġeneralment tiġi kkontrollata b' iġjene tajba u koċċidjostatiċi jew tilqim.
In turkeys the product is used in animals of 5-6 weeks of age.
Fid- dundjani, il- prodott jintuża f' annimali ta '5 - 6 ġimgħat.
In summary the pattern of use is of a product which is not routinely used in either chickens or turkeys, but is used in the face of an outbreak of coccidiosis.
Fil- qosor il- prodott ma jistax jintuża b' rutina la fit- tiġieġ u lanqas fid- dundjani, iżda jintuża meta tfaqqa 'l- koċċidjożi.
The main use is in pullets with broilers being treated rarely.
L- użu ewlieni huwa fl- għewietaq; il- brojlers jiġu kkurati rarament.
It is highly unlikely that in normal use more than one or two cycles of broilers would be treated in any one year.
Huwa improbabbli ħafna li fl- użu normali jiġi kkurat iktar minn ċiklu wieħed jew tnejn ta 'brojlers f' sena waħda.
In the estimation of exposure the information provided indicates that it is not necessary to calculate a plateau concentration for toltrazuril sulfone as this will not be attained in practice.
Fl- istima tal - esponiment, it- tagħrif ipprovdut jindika li ma hemmx bżonn li tiġi kkalkolata l- konċentrazzjoni ta 'plateau għal toltrazuril sulfone għaliex fil- prattika, din ma tintlaħaqx.
Information provided on the way chicken litter is processed and handled in practice indicates that houses are cleaned after the crop of birds has been removed.
It- tagħrif ipprovdut dwar il- mod kif jiġi pproċessat u ġestit il- mifrex għall- ħmieġ tat- tiġieġ fil- prattika jindika li l- gallinari jitnaddfu wara li jkunu tneħħew it- tjur imrobbija.
Litter from the house may be spread onto land as organic manure, but it is very rarely spread onto grassland because of the possibility of the ammonia ‘ burning’ the grass and the possibility that grazing animals will pick up disease organisms from the litter.
Il- mifrex tal- ħmieġ mill- gallinar jista 'jitferrex fuq art bħala demel organiku, iżda huwa rari ħafna li jitferrex f' art bil- ħaxix minħabba l - possibbiltà li l- ammonja' taħraq 'il- ħaxix u l- possibbiltà li l- annimali li jkunu qegħdin jirgħu jidħlu f' kuntatt mal- organiżmi tal- mard mill- iskart.
Manure from chicken farms is also collected for transport and sale, in which case manure from treated birds is likely to be mixed with litter from untreated birds.
Id- demel mill- irziezet tat- tiġieġ jinġabar ukoll għall- ġarr u għall- bejgħ, f' liema każ ikun probabbli li d- demel minn tjur ikkurati jitħallat mal- mifrex tal- ħmieġ tat- tjur mhux ikkurati.
Broiler chicken litter is also taken for incineration to produce power (about 40% in The Netherlands).
Il- mifrex tal- ħmieġ tal- brojlers ukoll jittieħed għall- inċinerazzjoni għall - produzzjoni tal- enerġija (madwar 40% fl- Olanda).
This information further reduces the chances of litter from treated birds being repeatedly spread onto the same land year after year.
Dan it- tagħrif ikompli jnaqqas il- possibbiltajiet li l - mifrex tal- ħmieġ tat- tjur ikkurati jitferrex ripetutament fuq l- istess art sena wara l- oħra.
EMEA/ CVMP/ 345752/ 2008-EN 2.1 Risk to terrestrial plants
EMEA/ CVMP/ 345752/ 2008- MT 2. 1 Riskju għall- pjanti terrestri
After administration of toltrazuril to the target animal the dose is excreted as a mixture of parent compound and a major metabolite toltrazuril sulfone.
Wara l- amministrazzjoni ta 'toltrazuril lill- animal fil- mira, id- doża titneħħa bħala taħlita tal- kompost oriġinali u l- prodott metaboliku ewlieni, toltrazuril sulfone.
In the soil toltrazuril is rapidly degraded (DT50 7.5 days) to toltrazuril sulfone.
Fil- ħamrija toltrazuril jiġi degradat malajr (DT50 7. 5 ijiem) f' toltrazuril sulfone.
Toltrazuril sulfone has been shown to be very persistent in soil (DT50 472 days), however it should be noted that there is a high degree of variability in the data (range 87-3285 days) which creates some uncertainty when estimating plateau values.
Intwera li toltrazuril sulfone huwa persistenti ħafna fil- ħamrija (DT50 472 jum), madankollu għandu jiġi nnotat li hemm livell għoli ta 'varjabilità fid- data (bejn 87 u 3285 jum) li toħloq xi ftit tal - inċertezza fl- istima tal- valuri ta' plateau.
Toltrazuril sulfone is slightly mobile in soil (mean Koc 616.5).
Toltrazuril sulfone huwa xi ftit mobbli fil- ħamrija (Koc medju 616. 5).
It has been shown to be toxic to terrestrial plants with greater effects on plant growth compared with plant emergence.
Intweriet t- tossiċità tiegħu għal pjanti terrestri b' effetti ikbar fuq it- tkabbir tal- pjanti meta mqabbel ma 'meta l- pjanti jfellsu.
The PNEC for growth effects on terrestrial plants is 45 µg/ kg determined from the NOEC of 0.45 mg/ kg for P. trivialis and an assessment factor of 10.
Il- PNEC għall- effetti tat- tkabbir fuq il- pjanti terrestri huwa ta '45 µg/ kg determinat mill- NOEC ta' 0. 45 mg/ kg għal P. trivialis u b' fattur tal- valutazzjoni ta '10.
In this evaluation a considerable number of plant species have been tested and it has been possible to use a sensitivity distribution to calculate an HC5 of 150 µg/ kg (the HC5 is the hazardous concentration below which 95% of plant species will not be affected).
F' din l- valutazzjoni ġew ittestjati għadd konsiderevoli ta 'speċijiet ta' pjanti u kien possibbli li wieħed juża distribuzzjoni tas- sensittività biex jikkalkula HC5 ta '150 µg/ kg (HC5 hija l- konċentrazzjoni perikoluża li taħtha, 95% tal- ispeċijiet tal- pjanti ma jintlaqtux).
When toltrazuril products for poultry are used as intended, the properties of toltrazuril sulfone suggest that there may be a potential for adverse effects being manifest in terrestrial plants when manure from treated birds is spread onto land and a potential for the compound to leach into groundwater at concentrations which may present an unacceptable risk for the environment.
Meta l- prodotti għat- tjur abbażi ta 'toltrazuril jintużaw kif maħsub, il- karatteristiċi ta' toltrazuril sulfone jindikaw li jeżisti potenzjal li effetti sekondarji jiġu mmanifestati fi pjanti terrestri meta d - demel minn tjur ikkurati jitferrex fuq l- art u potenzjal li l- kompost jitnixxa fl- ilma tal- pjan f' konċentrazzjonijiet li jistgħu jippreżentaw riskju mhux aċċettabbli għall- ambjent.
The exposure of soil to toltrazuril sulfone has been determined using acceptable equations.
L- esponiment tal- ħamrija għal toltrazuril sulfone ġie ddeterminat bl- użu ta 'ekwazzjonijiet aċċettabbli.
The input parameters were those agreed in the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)) with the exception of bodyweight, which for broilers and turkeys was age specific, and nitrogen production per place per year, which for broilers (0.34 kg N/ place/ year) and turkeys (1.23 kg N/ place/ year) was higher than the value in the guideline as it was agreed that birds with coccidiosis would have a lower feed conversion efficiency and excrete more nitrogen than healthy birds.
Il- parametri li ddaħħlu kienu dawk li sar qbil fuqhom fil- linja gwida tas- CVMP (Valutazzjoni tal - Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b' appoġġ għal- linji gwida tal- VICH GL6 u GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)) bl- eċċezzjoni tal- piż tal- ġisem, li għall- brojlers u għad - dundjani kien speċifiku għall- età, u l- produzzjoni tan- nitroġenu għal kull post kull sena, li għall - brojlers (0. 34 kg N/ post/ sena) u għad- dundjani (1. 23 kg N/ post/ sena) kien ogħla mill- valur stabbilit fil- linja gwida għax kien hemm qbil li tjur bil- koċċidjożi jkollhom effikaċja tal- konverżjoni tal- ikel iktar baxxa u jneħħu iktar nitroġenu fil- ħmieġ milli tjur b' saħħithom.
This approach is justified and accepted by the CVMP.
Din l- istrateġija hija ġġustifikata u aċċettata mis- CVMP.
In order to assess the risk for plants the PECsoil initial for both grassland and arable land was compared with the PNEC for plants of 45 µg/ kg.
Għall- valutazzjoni tar- riskju għall- pjanti, tqabbel l- PECħamrija inizjali għall- art bil- ħaxix kif ukoll għar - raba '(arable land) mal- PNEC għall- pjanti ta' 45 µg/ kg.
Only for broilers treated for 9 cycles per year and only when litter is spread on grassland could there be an unacceptable risk for plants (Risk Quotient (RQ) value > 1).
Jista 'jkun hemm riskju mhux aċċettabbli għall- pjanti (valur tal- Kwozjent tar- Riskju (RQ) > 1) biss għall- brojlers ikkurati għal 9 ċikli kull sena u biss meta l- mifrex tal- ħmieġ jitferrex fuq art bil- ħaxix.
For broiler breeders, pullets and turkeys the RQ was < 1 in all cases.
L- RQ irriżulta < 1 fil- każijiet kollha għar - riprodutturi ta 'brojlers, għewietaq u dundjani.
Target group
Grupp fil -
Cycles per
Ċikli kull
PECsoil initial (µg/ kg)
PECħamrija inizjali (µg/ kg)
RQ value
Valur RQ
Application
Rata tal -
year
mira
Grass
sena
Arable Grass Arable
Raba 'Art bil -
rate (g/ ha)
Applikazzjoni (g/ ha)
Broilers 21d (0.95 kg)
Brojlers 21 jum (0. 95 kg)
Broilers 28d (1.3 kg)
Brojlers 28 jum (1. 3 kg)
Broiler breeders
Riprodutturi ta 'brojlers
8.4
0. 2
2.1 0.2 0.05
0. 05
Pullets Turkeys 6 weeks (2.75 kg)
Għewietaq Dundjani 6 ġimgħat (2. 75 kg)
However, as can be seen from the PEC values in the above table there is not an unacceptable risk for 95% of plant species when the PECs are compared with the HC5 value of 150 µg/ kg.
Madankollu, kif jista 'jidher mill- valuri tal- PEC fit- tabella ta' hawn fuq, mhemmx riskju mhux aċċettabbli għal 95% tal- ispeċijiet tal- pjanti meta l- PECs jitqabblu mal- valur HC5 ta '150 µg/ kg.
Comparison of the data for plants with the PECsoil initial value is considered to be justified on the basis of the information provided on the use of the product.
It - tqabbil tad- data għal pjanti bil- valur PECħamrija inizjali jitqies ġustifikabbli abbażi tat- tagħrif ipprovdut fuq l- użu tal- prodott.
It is highly unlikely that litter from a house of treated birds will be repeatedly spread onto the same area of land year after year for the following reasons: • treatment is limited to treatment of outbreaks of coccidiosis;
Huwa improbabbli ħafna li l- mifrex tal- ħmieġ minn gallinar tat- tjur ikkurati jitferrex ripetutament fl- istess żona ta 'art sena wara l- oħra minħabba r- raġunijiet li ġejjin:
• litter is likely to be diluted, because much of it is collected and sold for use off the farm.
• il- kura hija limitata għal kura meta tfaqqa 'l- koċċidjożi;
• in many broiler production facilities there are only 6-7 cycles per year
• huwa probabbli li l- mifrex tal- ħmieġ jiġi dilwit, għaliex ħafna minnu jinġabar u jinbiegħ għall- użu barra mill- azjenda tat- trobbija tal- bhejjem.
It should also be noted that if, for example, broiler litter was spread onto land once every three years the PECsoil-initial value would increase by 25% (maximum 146 µg/ kg) meaning RQ values remain below 1 compared with the HC5.
Irid jiġi nnutat ukoll li jekk, pereżempju, il- mifrex tal- ħmieġ ta 'brojler jinfirex fl- art darba kull tliet snin, il- valur tal- PECħamrija inizjali jiżdied b' 25% (massimu 146 µg/ kg) li jfisser li l- valuri RQ jibqgħu inqas minn 1 meta mqabbla mal- HC5.
It was therefore concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Għalhekk ġie konkluż li l- awtorizzazzjonijiet għat- tqegħid fis- suq jistgħu jinżammu mingħajr twissijiet speċjali fil- punt 5. 3 (Karatteristiċi ambjentali) tal- SPC sakemm il- prodott jintuża kif indikat mid- Detenturi tal- Awtorizzazzjonijiet għat- Tqegħid fis- Suq fit- tweġibiet għall- mistoqsijiet mill - Kumitat, jiġifieri doża ta '7 mg/ kg tal- piż tal- ġisem f' jumejn konsekuttivi għall- kura tal- koċċidjożi fit - tiġieġ u d- dundjani.
However, there are changes required to the SPCs of some of the authorised products to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Madankollu, hemm bżonn li jsiru xi tibdiliet fl- SPCs ta 'wħud mill- prodotti awtorizzati biex dawn jinġiebu konformi mal- indikazzjonijiet u l- preskrizzjonijiet ta' dożi użati fil - valutazzjoni tar- riskju ambjentali.
2.2 Risk to groundwater Concerning the potential entry of toltrazuril sulfone into groundwater the following points extracted from the Groundwater Directive 80/ 68/ EEC are considered pertinent:
2. 2 Riskju għall- ilma tal- pjan Dwar id- dħul potenzjali ta 'toltrazuril sulfone fl- Ilma ta' taħt l- Art, dawn il- punti mislutin mid - Direttiva Ewropea għall- Ilma ta 'taħt l- Art 80/ 68/ KEE huma meqjusa pertinenti:
• the purpose of the Directive is to prevent the pollution of groundwater by substances belonging to the families and groups of substances in lists I or II,
• l- iskop tad- Direttiva huwa l- prevenzjoni tat- tniġġis tal- ilma ta 'taħt l- art (ilma tal- pjan) minn sustanzi li jagħmlu parti mill- familji u gruppi ta' sustanzi fil- listi I jew II,
• "indirect discharge" means the introduction into groundwater of substances in lists I or II after percolation through the ground or subsoil (this is the route of exposure to toltrazuril sulfone),
• "skarikar indirett" tfisser introduzzjoni ta 'sustanzi fl- ilma ta' taħt l- art fil- listi I jew II wara li joskulaw minn ġo l- art jew mis- saff ħamrija ta 'taħt il- wiċċ (din hija r- rotta tal- esponiment għal toltrazuril sulfone),
• pollution of groundwater is considered any entry of a substance into groundwater which will endanger human health or water supplies, harm living resources and the aquatic ecosystem or interfere with other legitimate uses of water,
• it- tniġġis tal- ilma ta 'taħt l- art jitqies bħala kull dħul ta' sustanzi fl- ilma ta 'taħt l- art li jipperikola s - saħħa tal- bniedem jew il- provvisti tal- ilma, jagħmel ħsara lir- riżorsi ħajjin u lill- ekosistema akkwatika jew jinterferixxu ma' kull xorta ta 'użu leġittimu ieħor ta' l- ilma.
• Member States shall take the necessary steps to prevent the introduction into groundwater of substances in list I,
• l- Istati Membri għandhom jieħdu l- passi meħtieġa sabiex jipprevjenu l- introduzzjoni fl- ilma tal - pjan tas- sustanzi elenkati fil- lista I,
In essence the provisions of Directive 80/ 68/ EEC are now covered by the Water Framework Directive and the new Groundwater Directive and are essentially unchanged.
• id- Direttiva ma tapplikax għal skarikar li l- awtorità kompetenti ta 'l- Istat Membru kkonċernat issib li fih is- sustanzi mniżżla fil- listi I jew II fi kwantità u f' konċentrazzjoni li tant hi żgħira li ma toħloq ebda periklu, la fil- preżent u lanqas fil- futur, ta' deterjorament fil- kwalità tal- ilma ta 'taħt l - art li jkun qiegħed jirċivihom.
The trigger value of 0.1 µg/ l that is used in some assessment frameworks as a surrogate zero for pollutants in groundwater is not mentioned in the Groundwater Directive (80/ 68/ EEC) and is specific for pesticides and biocides in the replacement Groundwater Directive.
Il- valur ta 'referenza ta' 0. 1 µg/ l li jintuża f' xi oqfsa tal- valutazzjoni bħala żero alternattiv għas - sustanzi li jniġġsu l- ilma tal- pjan mhuwiex imsemmi fid- Direttiva tal- Ilma ta 'taħt l- Art (80/ 68/ KEE) u huwa speċifiku għall- pestiċidi u l- bijoċidi fid- Direttiva tal- Ilma ta' taħt l- Art li qiegħda tissostitwixxi l- oriġinal.
According to the ground water directive any decision to prevent substances from entering the groundwater is to be based on an exposure based risk assessment.
Skont id- Direttiva tal- Ilma ta 'taħt l- Art kull deċiżjoni li tipprevjeni sustanzi milli jidħlu fl- ilma tal - pjan hija bbażata fuq il- valutazzjoni tar- riskju bbażata fuq l- esponiment.
Based on the highest application rate of toltrazuril sulfone to soil of 87.8 g/ ha the PECgroundwater has been calculated using the FOCUS PEARL (v3.3) model.
Abbażi tal- ogħla perċentwal ta 'applikazzjoni ta' toltrazuril sulfone għall- ħamrija ta '87. 8 g/ ha, il - PECilma tal- pjan ġie kkalkulat bl- użu tal- mudell FOCUS PEARL (v3. 3).
All parameters in the model were in line with those considered acceptable in the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)).
Il- parametri kollha fil- mudell kienu skont dawk meqjusa aċċettabbli fil- linja gwida tal- CVMP (Valutazzjoni tal- Impatt Ambjentali għall- Prodotti Mediċinali Veterinarji b' appoġġ għal- linji gwida tal- VICH GL6 u GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)).
The model used a sensitive scenario for groundwater and assumed a worst case scenario of annual application of litter from treated birds to the soil.
Il- mudell uża xenarju sensittiv għall- ilma tal- pjan u ipotizza każ estrem ta 'applikazzjoni annwali lill- ħamrija tal- mifrex tal- ħmieġ li ġej minn tjur ikkurat.
The PECgroundwater for this sensitive scenario was 1.1 µg/ l.
Il- PECilma tal - pjan għal dan ix- xenarju sensittiv kien 1. 1 µg/ l.
Toltrazuril sulfone has a low toxicity to aquatic organisms with the lowest relevant PNEC being 24 µg/ l (Daphnia).
Toltrazuril sulfone għandu tossiċità baxxa għal organiżmi akkwatiċi bl- inqas PNEC rilevanti jkun 24 µg/ l (Daphnia).
Comparison of the PEC and PNEC indicates that the risk to any biota in groundwater is acceptable.
It- tqabbil bejn il- PEC u l- PNEC jindika li r- riskju għal kwalunkwe bijota fl- ilma tal- pjan huwa aċċettabbli.
Groundwater is also used as a source of drinking water.
L- ilma tal- pjan jintuża wkoll bħala sors ta 'ilma tax- xorb.
To assess the risk to human health consideration was given to the consumer safety evaluation with regards to residues of toltrazuril in food products of animal origin.
Biex ikun ivvalutat ir- riskju għas- saħħa tal - bniedem, ingħatat konsiderazzjoni għall- valutazzjoni tas- sigurtà tal- konsumatur fir- rigward tal preżenza ta 'residwi ta' toltrazuril fil- prodotti tal- ikel li joriġinaw minn annimali.
120 µg/ person.
L- ADI stabbilita għal toltrazuril hija 2 µg/ kg tal- piż tal- ġisem, jiġifieri 120 µg/ persuna.
Based on a consumption of 2 l of drinking water per person per day the concentration of toltrazuril sulfone potentially present in groundwater would use up 1.8% of the ADI.
Abbażi ta 'konsum ta' 2 l ilma tax - xorb kull persuna kuljum, il- konċentrazzjoni ta 'toltrazuril sulfone potenzjalment preżenti fl- ilma tal - pjan mistennija tirrappreżenta sa 1. 8% tal- ADI.
This proportion is compatible with the theoretical maximum daily intake of toltrazuril sulfone in other foodstuffs, as calculated when establishing MRLs for toltrazuril.
Il- proporzjon huwa konformi mad- dħul massimu teoriku ta 'kuljum ta' toltrazuril sulfone fi prodotti tal- ikel oħrajn, kif ikkalkulat meta ġew stabbiliti l - MRLs għal toltrazuril.
It is concluded from the above evaluation that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Mill- valutazzjoni ta 'hawn fuq wieħed jista' jasal għall- konklużjoni li l- awtorizzazzjonijiet għat - tqegħid fis- suq jistgħu jinżammu mingħajr twissijiet speċjali fil- punt 5. 3 (Karatteristiċi ambjentali) tal- SPC sakemm il- prodott jintuża kif indikat mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq fit- tweġibiet għall- mistoqsijiet mill- Kumitat, jiġifieri doża ta '7 mg/ kg tal- piż tal- ġisem għal jumejn konsekuttivi għall- kura tal- koċċidjożi fit- tiġieġ u d- dundjani.
However, as no data were provided for use in other avian species apart from chickens and turkeys, or for the administration of repeated treatment or for preventive treatment, all the calculations were based on use of the products for a single course of treatment in chickens and turkeys.
Madankollu, billi ma ġiet prodotta l - ebda data għall- użu fi speċijiet avjarji oħra ħlief it- tiġieġ u d- dundjani, jew għall- amministrazzjoni ta 'kura ripetuta jew preventiva, il- kalkoli kollha kienu bbażati fuq l- użu tal- prodotti għal kors wieħed ta' kura fit- tiġieġ u d- dundjani.
It should be noted that a second course of treatment is not considered necessary as reported by Marketing Authorisation Holders.
Għandu jiġi nnutat li ma jitqiesx neċessarju li jingħata kors ieħor ta 'kura kif rappurtat mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq.
The indication for prevention and control of coccidiosis and mention of repeated treatment should be removed from those SPCs which currently include it.
L- indikazzjoni għall - prevenzjoni u l- kontroll tal- koċċidjożi u r- riferiment għal kura ripetuta għandhom jitneħħew minn dawk l- SPCs li bħalissa jinkluduhom.
The dose recommended for pigeons (20 mg/ kg for 3 days) is about 4 times higher than the dose recommended for chickens and turkeys (7 mg/ kg bw for 2 consecutive days).
Id- doża rakkomandata għall- ħamiem (20 mg/ kg għal tlett ijiem) hija madwar 4 darbiet ogħla mid- doża rakkomandata għat- tiġieġ u d- dundjani (7 mg/ kg tal- piż tal - ġisem għal jumejn konsekuttivi).
As no data generated from use in pigeons was provided for the environmental risk assessment it was not possible to conclude on the risk for the environment taking into account the higher dose for pigeons.
Billi ma ġiet ipprovduta l- ebda data ġġenerata mill- użu fil- ħamiem għall- valutazzjoni tar- riskju ambjentali ma kienx possibbli li ssir konklużjoni fuq ir- riskju ambjentali meta wieħed iqis id- dożi ogħla għall- ħamiem.
EMEA/ CVMP/ 345752/ 2008-EN
EMEA/ CVMP/ 345752/ 2008- MT 3.
The assessment of the risk presented by toltrazuril sulfone to terrestrial plants and to groundwater demonstrated that the use of products containing toltrazuril is acceptable and the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Is- CVMP wara li qies id- data pprovduta u d- diskussjoni xjentifika fi ħdan il- Kumitat ikkonkluda li wara l- amministrazzjoni ta 'prodotti li jkun fihom toltrazuril lill- annimal fil- mira, id- doża titneħħa mill- ġisem bħala taħlita tal- kompost oriġinali u l- prodott metaboliku ewlieni toltrazuril sulfone.
However, it was noted that the indications, species and posology in the SPCs of some of the authorised products were different and these therefore need to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Għal dawn ir- raġunijiet il - mira ewlenija tal- valutazzjoni tar- riskju hija fuq toltrazuril sulfone.