qanastek/EMEA-V3 huggingface dataset:
In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Fiż- żewġ speċi, il- prodott jingħata fil- muskolu b’ rata ta ’ 15 mg amoxicillin/ kg piż tal- ġisem (ekwivalenti għal 1 ml ta ’ Suramox 15% LA/ 10 kg piż tal- ġisem) darbtejn b’ 48 siegħa bejn kull doża.
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S. A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product.
Awtorizzazzjoni għat- tqegħid fis- suq għal Suramox 15% LA kienet ingħatat preċedentement lil Virbac S. A. fi Franza fis- 6 ta ’ Lulju 2004 abbażi ta ’ applikazzjoni mqassra li fiha Duphamox LA kien imsemmi bħala prodott mediċinali ta’ riferiment.
The withdrawal periods established for Suramox 15% LA were 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Il- perjodi ta ’ irtirar iffissati għal Suramox 15% LA kienu ta ’ 58 jum fl- ifrat għall- laħam u l- ġewwieni u 35 jum f’ majjali għall- laħam u l- ġewwieni.
The withdrawal period for milk was 2.5 days.
Il- perjodu ta ’ rtirar għall- ħalib kien ta ’ jumejn u nofs (2. 5 jiem).
A mutual recognition procedure was started on 28 April 2005.
Fit- 28 ta ’ April 2005 nbdiet proċedura ta ’ rikonoxximent reċiproku.
The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
L- Istat Membru ta ’ Riferiment kien Franza u l- Istati Membri Konċernati kienu l- Belġju, ir- Repubblika Ċeka, il- Ġermanja, l- Italja, Spanja u r- Renju Unit.
The product was accepted by the Czech Republic, Italy and Spain.
Il- prodott ġie aċċettat mir- Repubblika Ċeka, mill- Italja u minn Spanja.
Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Tqajjem tħassib mill- Belġju, il- Ġermanja u r- Renju Unit minħabba n- nuqqas ta ’ adegwatezza tal- perjodi ta ’ rtirar u l - applikazzjonijiet ġew irtirati minn dawn il- pajjiżi.
Belgium referred the issue to the EMEA on 28 July 2005.
Il- Belġju rrefera l- kwistjoni lill- EMEA fit- 28 ta ’ Lulju 2005.
The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
L- għan tar- riferiment kien li jintlaħaq qbil dwar jekk il- perjodi ta ’ rtirar proposti ta ’ 58 jum għall - ifrat u 35 jum għall- majjali kinux ġew iffissati b’ mod adegwat.
The arbitration procedure started on 8 September 2005 with the adoption of a list of questions.
Il- proċedura ta ’ arbitraġġ bdiet fit- 8 ta ’ Settembru 2005 permezz ta ’ l- adozzjoni ta ’ lista ta ’ mistoqsijiet.
J.
Ir- rapporteur kien is- Sur J.
Schefferlie and the co-rapporteur was Prof.
Schefferlie u l- ko- rapporteur kien il- Prof.
The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) sussegwentement ippreżenta spjegazzjonijiet bil- miktub lill- Kumitat fis- 16 ta ’ Jannar 2006.
During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Matul il- laqgħa tiegħu ta ’ Mejju 2006, is- CVMP, fid- dawl tad- data ġenerali ppreżentata u fid- dawl tad - diskussjoni xjentifika fi ħdan il- Kumitat, adotta b’ kunsens opinjoni li tirrakkomanda s- sospensjoni ta ’ l - awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA u Stabox 15% LA, għallifrat u l- majjali.
The reasons being the following:
Ir- raġunijiet huma dawn li ġejjin:
1 Article 35 of Directive 2001/82/EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendata 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
ma kienx possibbli li jiġi ffissat perjodu ta ’ rtirar għallifrat u l- majjali abbażi tad- data disponibbli;
the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
il- perjodi ta ’ rtirar iffissati fil- preżent għallifrat u l- majjali mhumiex adegwati biex jiżguraw li r - residwi ma jaqbżux l- MRLs (limiti massimi ta ’ residwi);
On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
il- perjodi ta ’ rtirar awtorizzati fil- preżent mhumiex adegwati sabiex jiżguraw li l- oġġetti ta ’ l - ikel miksubin mill- annimali ttrattati ma fihomx residwi li jistgħu jikkostitwixxu periklu għas - saħħa tal- konsumatur.
During its June 2006 meeting, the CVMP appointed Dr.
Fl- 1 ta ’ Ġunju 2006, l- MAH innotifika lill- EMEA bl- intenzjoni tiegħu li jitlob l- eżami mill- ġdid ta ’ l - opinjoni tas- CVMP skond l- Artikolu 36( 4). 2 Matul il- laqgħa tiegħu ta ’ Ġunju 2006, is- CVMP ħatar lil Dr.
Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Breathnach bħala rapporteur għall- valutazzjoni tar- raġunijiet għat- talba ta ’ eżami mill- ġdid ta ’ l - opinjoni.
The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Ir- raġunijiet dettaljati għat- talba ġew ippreżentati lill- EMEA fit- 18 ta ’ Lulju 2006 u l - proċedura ta ’ valutazzjoni għall- eżami mill- ġdid bdiet fid- 19 ta ’ Lulju 2006.
On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Fit- 13 ta ’ Settembru 2006, is- CVMP ikkunsidra r- raġunijiet dettaljati ta ’ l- eżami mill- ġdid ta ’ l- opinjoni u kkonferma l- opinjoni preċedenti tiegħu li tgħid li l- awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA għandhom jiġu sospiżi.
The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Ir- raġunijiet għas- sospensjoni kienu l- istess bħal dawk identifikati fil- laqgħa tas- CVMP ta ’ Mejju 2006.
On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
Fil- 25 ta ’ Ottubru 2006, il- Kummissjoni Ewropea ppreżentat abbozz ta ’ deċiżjoni lill- Kumitat Permanenti dwar il- Prodotti Mediċinali Veterinarji għall- adozzjoni bi proċedura bil- miktub.
During the written procedure a request was received from France for a scientific assessment of new studies made available by the Marketing Authorisation Holder.
Matul il - proċedura bil- miktub, waslet talba mingħand Franza għal valutazzjoni xjentifika ta ’ studji ġodda li d - Detentur għall- Awtorizzazzjoni għat- Tqegħid fis- Suq għamel disponibbli.
On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Fl- 14 ta ’ Novembru 2006, il- Kummissjoni Ewropea ssospendiet il- proċedura bil- miktub u fis- 16 ta ’ Novembru 2006, talbet lis- CVMP sabiex jikkunsidra l- istudji ġodda dwar ir- residwi fil- valutazzjoni tar - riferiment u sabiex jirrevedi kif xieraq l- opinjoni tat- 13 ta ’ Settembru 2006.
The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ippreżenta l- istudji l- ġodda dwar ir- residwi lis - CVMP fid- 9 ta ’ Jannar 2007 u fit- 13 ta ’ Marzu 2007 ppreżenta spjegazzjonijiet bil- fomm lill- Kumitat.
On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
Fl- 14 ta ’ Marzu 2007 s- CVMP, wara li kien ikkunsidra l- istudji l- ġodda tar- residwi, ikkonkluda li ma kienx possibbli li jiġi ffissat perjodu ta ’ rtirar għal Suramox 15% LA u Stabox 15% LA, għall- laħam u l - ġewwieni ta ’ l- ifrat u l- majjali u għalhekk irrakkomanda b’ kunsens is- sospensjoni ta ’ l - awtorizzazzjonijiet għat- tqegħid fis- suq għall- prodotti msemmija hawn fuq.
On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Fit- 13 ta ’ Ġunju 2007, il- Kummissjoni Ewropea adottat Deċiżjoni tal- Kummissjoni li ssospendiet l - awtorizzazzjonijiet nazzjonali għat- tqegħid fis- suq għal Suramox 15% LA u Stabox 15% LA, iżda li tipprovdi l- opportunità għal reviżjoni tad- deċiżjoni wara opinjoni ġdida mis- CVMP abbażi tal - valutazzjoni ta ’ studji ġodda dwar it- tnaqqis ta ’ residwi.
The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- suq ippreżenta aktar studji ġodda ta ’ residwi lis - CVMP fl- 14 ta ’ April 2008.
The procedure for evaluation of the new data started on 15 April 2008.
Il- proċedura għall- valutazzjoni tad- data ġdida bdiet fil- 15 ta ’ April 2008.
Kearsley and the co-rapporteur was Prof.
Ir- rapporteur kienet is- Sinjura R. Kearsley u l- ko- rapporteur kien il- Prof.
During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA.
Matul il- laqgħa tiegħu ta ’ Ġunju 2008, is- CVMP ikkunsidra l- istudji ġodda dwar ir- residwi ppreżentati fir- rigward ta ’ Suramox 15% LA u kkonkluda li l- perjodi ta ’ rtirar issa jistgħu jiġu ffissati għall - ifrat kif ukoll għall- majjali għal Suramox 15% LA u Stabox 15% LA.
Therefore, the Committee adopted by consensus an opinion recommending the lifting of the suspension of the marketing authorisations for the above-mentioned product.
Għalhekk, il- Kumitat adotta b’ kunsens opinjoni li tirrakkomanda t- tneħħija tas- sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq għall - prodott imsemmi hawn fuq.
Furthermore, the Committee recommends varying the marketing authorisations of the veterinary medicinal products referred to in Annex I in accordance with the Summary of Product Characteristics (SPC) as set out in Annex III.
Barra minn hekk, il- Kumitat irrakkomanda li jiġu varjati l- awtorizzazzjonijiet għat- tqegħid fis- suq ta ’ prodotti mediċinali veterinarji msemmija fl- Anness I skond is- Sommarju tal- Karatteristiċi tal- Prodott (SPC) kif imniżżel fl- Anness III.
2 Article 36(4) of Directive 2001/82/EC, as amended
2 Artikolu 36( 4) tad- Direttiva 2001/ 82/ KE, kif emendata
The list of product names concerned is given in Annex I.
EMEA/ 301122/ 2007- MT Il- lista ta 'ismijiet tal- prodotti kkonċernati hija mniżżla fl- Anness I.
The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
Il- konklużjonijiet xjentifiċi pprovduti fl- Anness II, flimkien ma ’ l- SPC fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 5 September 2008.
L- opinjoni finali nqalbet f' Deċiżjoni mill- Kummissjoni Ewropea fil- 5 ta ’ Settembru 2008.
EMEA/344321/2008-EN
EMEA/ 301122/ 2007- MT
Page 3/3
Paġna 3/ 3
London, 24 July 2007 EMEA/ 301122/ 2007
Londra, 24 ta ’ Lulju 2007 EMEA/ 301122/ 2007
OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15% LA and its associated name Stabox 15% LA International Non-Proprietary Name (INN):
OPINJONI WARA RIFERIMENT TAĦT L- ARTIKOLU 351 GĦAL Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA Denominazzjoni Komuni Internazzjonali (DKI):
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Suramox 15% LA huwa sospensjoni li tiġi injettata li fiha amoxicillin, li huwa antibijotiku beta - lactam, li jappartieni għall- grupp ta ’ peniċillini.
The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Il- prodott jintuża għall- kura ta ’ infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fil- frat u għall- kura ta ’ infezzjonijiet respiratorji dovuti għal Pasteurella multocida fil- majjali.
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Fiż- żewġ speċi, il- prodott jingħata ġo muskolu b’ rata ta ’ doża ta ’ 15 mg amoxicillin/ kg piż korporali (ekwivalenti għal 1 ml ta ’ Suramox 15% LA/ 10 kg piż korporali) darbtejn f’ intervall ta ’ 48 siegħa.
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S. A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Awtorizzazzjoni għat- Tqegħid fis- Suq għal Suramox 15% LA kienet ingħatat preċedentament lil Virbac S. A. fi Franza fis- 6 ta ’ Lulju 2004 abbażi ta ’ applikazzjoni imqassra għal Duphamox LA, bħala prodott mediċinali ta ’ referenza, b’ perjodu ta ’ irtirar ta ’ 58 jum fil- frat għall- laħam u l- intern u 35 jum f’ majjali għall- laħam u l- intern.
The withdrawal period for milk was 2.5 days.
Il- perjodu ta ’ irtirar għall- ħalib kien ta ’ jumejn u nofs (2. 5 jiem).
A mutual recognition procedure was started on 28 April 2005.
Fit- 28 ta ’ April 2005 inbdiet proċedura ta ’ rikonoxximent reċiproku.
The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain, and the United Kingdom.
L- Istat Membru ta ’ Referenza kien Franza u l- Istati Membri Konċernati kienu l- Belġju, ir- Repubblika Ċeka, il- Ġermanja, l- Italja, Spanja u r- Renju Unit.
Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Tqajjem tħassib mill- Belġju, il- Ġermanja u r- Renju Unit minħabba n- nuqqas ta ’ adegwatezza tal- perjodi ta ’ rtirar u l- applikazzjonijiet ġew irtirati minn dawn il- pajjiżi.
Belgium referred the reason for disagreement to the EMEA on 28 July 2005.
Il- Belġju rrefera r- raġuni għan- nuqqas ta ’ ftehim lill- EMEA fit- 28 ta ’ Lulju 2005.
The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
L- iskop tar- riferiment kien li jsir qbil fuq jekk il- perjodi proposti ta ’ rtirar ta ’ 58 jum għall- frat u 35 jum għall- majjali kinux ġew iffissati b’ mod adegwat.
The arbitration procedure started on 8 September 2005 with the adoption of list of questions.
Il- proċedura ta ’ arbitraġġ inbdiet fit- 8 ta ’ Settembru 2005 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The Marketing Authorisation Holder (MAH) provided written explanations on 16 January 2006.
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) ta spjegazzjonijiet bil- miktub fis- 16 ta ’ Jannar 2006.
At the request of the MAH the evaluation procedure was suspended on 15 March 2006 in order to allow for the MAH to prepare for the provision of oral explanations.
Fuq talba tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, il- proċedura ta ’ valutazzjoni ġiet sospiża fil- 15 ta ’ Marzu 2006 sabiex id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ikun jista ’ jħejji għall- għoti ta ’ spjegazzjonijiet bil- fomm.
The oral explanations were presented on 17 May 2006 by the MAH to the Committee.
L- ispjegazzjonijiet bil- fomm ġew ippreżentati fis- 17 ta ’ Mejju 2006 mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq lill- Kumitat.
1 Article 35 of Directive 2001/ 82/ EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendat 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged marketing authorisations for Suramox 15% LA and the associated invented name Stabox 15% LA, for cattle and pigs.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Matul il- laqgħa tiegħu ta ’ Mejju 2006, il- CVMP, fid- dawl tat- tagħrif ġenerali ppreżentat u fid- dawl tad- diskussjoni xjentifika fi ħdan il- Kumitat, adotta b’ kunsensus, opinjoni li tirrakkomanda s - sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA u l- isem ivvintat assoċjat Stabox 15% LA, għall- frat u l- majjali.
it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
ma kienx possibbli li jiġi ffissat perjodu ta ’ rtirar għall- frat u l- majjali abbażi tat- tagħrif disponibbli;
the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
il- perjodi ta ’ rtirar iffissati fil- preżent għall- frat u l- majjali mhumiex adegwati biex jiżguraw li r- residwi ma jaqbżux l- MRLs (limiti massimi ta ’ residwi);
the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer.
il- perjodi ta ’ rtirar awtorizzati fil- preżent mhumiex adegwati sabiex jiżguraw li l- oġġetti ta ’ l- ikel miksubin mill- annimal ikkurati ma fihomx residwi li jistgħu jikkostitwixxu perikolu għas- saħħa tal- konsumatur.
On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Fl- 1 ta ’ Ġunju 2006, ir- rappreżentant tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq innotifika lill- EMEA bl- intenzjoni tiegħu li jitlob l- eżami mill- ġdid ta ’ l- opinjoni tal- CVMP skond l - Artikolu 36( 4) 2.
During their June 2006 meeting, the CVMP appointed Dr.
Matul il- laqgħa tiegħu ta ’ Ġunju 2006, il- CVMP ħatar lil Dr.
Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Breathnach bħala rapporteur għall- valutazzjoni tar- raġunijiet għat- talba ta ’ eżami mill- ġdid ta ’ l- opinjoni.
The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Ir- raġunijiet dettaljati għat- talba ġew ippreżentanti lill- EMEA fit- 18 ta ’ Lulju 2006 u l- proċedura ta ’ valutazzjoni għall- eżami mill- ġdid bdiet fid- 19 ta ’ Lulju 2006.
On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Fit- 13 ta ’ Settembru 2006, il- CVMP ikkunsidra r- raġunijiet dettaljati ta ’ l- eżami mill- ġdid ta ’ l - opinjoni u kkonferma l- opinjoni preċedenti tiegħu li tgħid li l- awtorizzazzjoni għat- tqegħid fis- suq għal Suramox 15% LA għandha tiġi sospiża.
The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Ir- raġunijiet għas- sospensjoni kienu l- istess bħal dawk identifikati fil- laqgħa tal- CVMP ta ’ Mejju 2006.
During the written procedure a request was received from the France for new studies made available by the Marketing Authorisation Holder to be scientifically assessed.
Matul il - proċedura bil- miktub, waslet talba mingħand Franza sabiex jiġu vvalutati b’ mod xjentifiku studji ġodda li d- Detentur għall- Awtorizzazzjoni għat- Tqegħid fis- Suq għamel disponibbli.
On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP, to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Fl- 14 ta ’ Novembru 2006, il- Kummissjoni Ewropea ssospendiet il- proċedura bil- miktub u fis- 16 ta ’ Novembru 2006, talbet lill- CVMP, sabiex jikkunsidra l- istudji ġodda dwar ir- residwi fil- valutazzjoni tar- riferiment u sabiex jirrevedi bix- xieraq l- opinjoni tat- 13 ta ’ Settembru 2006.
The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq issottometta l- istudji l- ġodda dwar ir- residwi lill- CVMP fid- 9 ta ’ Jannar u fit- 13 ta ’ Marzu 2007 ta spjegazzjonijiet bil- fomm lill- Kumitat inkluż preżentazzjoni ta ’ studju ġdid dwar ir- residwi fil- majjali u kalkolazzjoni u proposta ġdida għal perjodu ta ’ rtirar għal majjali.
During its March 2007 meeting, the CVMP, c onsidered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Matul il- laqgħa tiegħu ta ’ Marzu 2007, il- CVMP, ikkunsidra l- istudji ġodda dwar ir- residwi ppreżentati fir- rigward ta ’ Suramox 15% LA u kkonkluda li t- tagħrif ġdid ma ppermettix li jiġu iffissati perjodi ta ’ rtirar għal tessuti li jittieklu fil- frat u fil- majjali.
The reas ons being the following:
Għalhekk, il- Kumitat adotta b’ konsensus opinjoni riveduta li tikkonferma r- rakkomandazzjoni preċedenti għas- sospensjoni ta ’ l - awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA u l- isem ivvintat assoċjat, Stabox 15% LA.
in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point;
Ir- raġunijiet huma dawn li ġejjin: o fil- frat, il- konċentrazzjonijiet tar- residwi fis- sit ta ’ l- injezzjoni kienu għadhom ogħla mill- MRL fil- ħin ta ’ l- aħħar qatla; o fil- majjali, il- konċentrazzjonijiet tar- residwi fis- sit ta ’ l- injezzjoni kienu għadhom ogħla mill - MRL fil- ħin ta ’ l- aħħar qatla.
in pigs, residue concentrations at the injection site were still above the MRL at the last slaughter time point.
Il- lista ta ’ l- ismijiet tal- prodotti konċernati hija mogħtija fl- Anness 1.
The list of product names concerned is given in Annex I.
Il- konklużjonijiet xjentifiċi huma mogħtija fl- Anness II.
The scientific conclusions are provided in Annex II.
L- opinjoni finali nqalbet f’ Deċiżjoni mill- Kummissjoni Ewropea fit- 13 ta ’ Ġunju 2007.
The final opinion was converted into a Decision by the European Commission on 13 June 2007.
2 L- Artikolu 36( 4) tad- Direttiva 2001/ 82/ KE, kif emendat
2 Article 36(4) of Directive 2001/82/EC, as amended
Paġna 2/ 2
EN 1/ 8 Member
MT 1/ 8
Invented
Detentur ta ’ l -
Animal species
Qawwa
Frequency and
Speċi ta ’
Recommended dose
Frekwenza u
Withdrawal period
Doża rakkomandata
Authorisation
Perjodu ta ’ rtirar
name
Membru
form
Awtorizzazzjoni
route of
inventat
(meat and milk)
farmaċewtika
Holder
annimal
administration
mnejn jingħata
Czech Republic
(laħam u ħalib)
Two intramuscular injections at 48 hours interval
Żewġ injezzjonijiet ġol- muskoli b’ intervall ta ’
1 Marketing Authorisation pending 2 Reference Member State for the Mutual recognition Procedure
1 Awtorizzazzjoni għat- Tqegħid fis- Suq pendenti 2 Stat Membru ta ’ Riferenza għall- Proċedura ta ’ Rikonoxximent Reċiproku
EN
MT
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦAS- SOSPENSJONI TA ’ L- AWTORIZZAZZJONIJIET GĦAT- TQEGĦID FIS- SUQ
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
MT 3/ 8 KONKLUŻJONIJIET XJENTIFIĊI SOMMARJU ĠENERALI TAL- VALUTAZZJONI XJENTIFIKA TA ’ SURAMOX 15% LA3 1.
Introduction Suramox 15% LA contains amoxicillin which is a beta lactam antibiotic belonging to the group of penicillins.
Introduzzjoni Suramox 15% LA fih amoxicillin li huwa antibijotiku tat- tip beta lactam fil- kategorija tal- peniċillini.
Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Qabel, amoxicillin kien evalwat mis- CVMP flimkien ma ’ peniċillini oħra, sabiex ikunu stabbiliti l - limiti massimi tar- residwi (MRLs).
However an ADI for penicillins was not established.
Madankollu ma ġiex stabbilit ADI għall- peniċillini.
Benzylpenicillin was considered by the Joint FAO/ WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Benzylpenicillin kien ikkonsidrat fil- Kumitat Espert Konġunt tal- FAO/ WHO dwar l- Addittivi ta ’ l - Ikel (JECFA) fis- 36 laqgħa tiegħu fl- 1990.
Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed.
Il- Kumitat studja diversi każi fil- bniedem ta ’ reazzjonijiet allerġiċi wara t- teħid ta ’ ikel li jkun fih residwi tal- peniċillina.
Reports of further cases, which were not available to JECFA, had also been reported in the published literature.
Fil- letteratura pubblikata kienu rappurtati wkoll każi oħra li ma kinux disponibbli għall- JECFA.
It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious.
Deher ċar li r- residwi tal- peniċillina kkawżaw reazzjonijiet allerġiċi fil- konsumaturi u li wħud minn dawn ir- reazzjonijiet kienu serji.
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/ WHO Expert Committee on Food Additives (JECFA).
Is- CVMP addotta l- istess metodu bħall- JEFCA biex jiffissa l- limiti massimi tar- residwi (MRLs) għall - peniċillini.
Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person.
Billi kien jaf b’ każi ta ’ reazzjonijiet allerġiċi b’ dożi baxxi ħafna, il- JECFA rrakkommanda li l- konsum ta ’ benzylpenicillin mill- ikel kuljum kellu jinżamm baxx kemm jista ’ jkun fil- prattika, u dejjem inqas minn 30 µg tal- mediċina oriġinali f’ kull persuna.
The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Is- CVMP iffissa MRLs b’ mod li l - konsum mill- konsumatur mill- prodotti kollha ta ’ l- ikel ma jaqbiżx dan il- livell ta ’ 30 µg.
Thus, the MRLs established by the CVMP for benzylpenicillin were 50 µg/ kg for edible tissues.
Għalhekk, l - MRLs iffissati mis- CVMP għal benzylpenicillin kienu 50 µg/ kg għal tessuti li jittieklu.
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/ 90, in accordance with the following table:
Skond dan ir- raġunament is- CVMP ppropona MRLs għal amoxicillin u peniċillini oħra, u amoxicillin iddaħħal fl- Anness I tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90, skond it- tabella ta ’ hawn taħt:
Pharmacologically
Is- sustanza
Marker
Ir- residwu
Animal
L- ispeċi ta ’ l -
Target
It- tessut
Other
Dispożizzjoniji
residue
markatur
tissue
studjat
provisions
et oħra
All food producing species
L- ispeċi kollha li jipproduċu l - ikel
Muscle Fat Liver Kidney Milk
Il- muskolu Ix- xaħam Il- fwied Il- kliewi Il- ħalib
Assessment of residue depletion studies initially submitted For the referral procedure, the MAH presented one residue study in cattle and one in pigs.
Il- valutazzjoni ta ’ studji tat- tnaqqis tar- residwi sottomessi fil- bidu Għall- proċedura tar- riferiment, il- MAH ippreżenta studju wieħed ta ’ residwu fuq l- ifrat u wieħed fuq il- majjali.
184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/ kg bw (1 ml per 10 kg).
Fl- ifrat, għaxart irġiel u għaxar nisa (jiżnu 184 ± 24 kg) ingħataw injezzjonijiet ta ’ Suramox 15% LA fil- muskolu b’ doża ta ’ 15 mg/ kg toqol (millilitru għal kull 10 kg).
The first injection was given in the muscles of the left side of the neck, the second injection was given 48 hours later in the right side of the neck.
L- ewwel injezzjoni ngħatat fil - muskoli fin- naħa tax- xellug tal- għonq, it- tieni injezzjoni ngħatat 48 siegħa wara fin- naħa tal- lemin tal - għonq.
Injection volumes ranged from 15.0 to 25.9 ml.
Il- volumi ta ’ l- injezzjoni varjaw bejn 15. 0 u 25. 9 ml.
Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection.
Gruppi ta ’ 4 annimali (2 irġiel u 2 nisa) inqatlu wara ġurnata, sebat ijiem, 14- il jum, 21 jum u 36 jum wara l- aħħar injezzjoni.
At slaughter, the left (first) injection site was taken for local tolerance assessment.
Mal- qatla, is- sît ta ’ l- ewwel injezzjoni (tax- xellug) intuża għall- valutazzjoni tat- tolleranza lokali.
In addition, samples were taken from muscle (mixed sample of hindquarter/ forequarter muscle), fat (mixed sample of perirenal/ omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Barra minn hekk, ittieħdu kampjuni mill- muskolu (taħlita ta ’ muskolu min- naħa ta ’ quddiem u ta ’ wara), mix- xaħam (taħlita ta ’ xaħam mill- kirxa u minn madwar il- kliewi), il- fwied sħiħ, iż- żewġt ikliewi u s- sît tat- tieni injezzjoni (tan- naħa tal- lemin) (madwar 10 ċm dijametru u 6 ċm fond).
These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed).
Dawn il- kampjuni tkessħu, ġew omoġenizzati u nħażnu f’ temperatura ta ’ - 80 °C sakemm ġew analizzati bejn 4 u 6 xhur wara (l - istabbilità tal- ħażna ġiet ikkonfermata).
All samples were analysed for amoxicillin concentrations using an HPLC-UV method with a claimed limit of quantification of 25 µg/ kg for all tissues.
Il- kampjuni kollha ġew analizzati biex tkun stabbilita l - konċentrazzjoni ta ’ amoxicillin bl- użu ta ’ HPLC- UV b’ limitu ta ’ kwantifikazzjoni dikjarat ta ’ 25 µg/ kg għat- tessuti kollha.
3 Or variations of that name as referred to in Annex I
3 Jew varjazzjonijiet ta ’ dak l- isem kif imsemmi fl- Anness I ta ’
EN
MT 1651 µg/ kg fil- 14- il jum u inqas mil- limitu ta ’ kwantifikazzjoni ta ’ 472 µg/ kg fil- 21 jum u inqas
The injection sites contained the highest residue concentrations followed by kidney.
mil- limitu ta ’ kwantifikazzjoni ta ’ 162 µg/ kg fis- 36 jum.
In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/ kg bw (1 ml per 10 kg).
Fil- majjali, għaxart irġiel u għaxar nisa (jiżnu 42 ± 7 kg) ingħataw żewġ injezzjonijiet ta ’ Suramox 15% LA fil- muskolu b’ doża ta ’ 15 mg/ kg toqol (millilitru għal kull 10 kg).
The first injection was given in the muscles of the left side of the neck, the second injection was given 48 hours later in the right side of the neck.
L- ewwel injezzjoni ngħatat fil- muskoli fin- naħa tax- xellug tal- għonq, it- tieni injezzjoni ngħatat 48 siegħa wara fin- naħa tal- lemin tal- għonq.
Injection volumes ranged from 2.88 to 5.52 ml.
Il- volumi ta ’ l- injezzjoni varjaw bejn 2. 88 u 5. 52 ml.
Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection.
Gruppi ta ’ 4 annimali (2 irġiel u 2 nisa) inqatlu wara ġurnata, sebat ijiem, 14- il jum, 21 jum u 27 jum wara l- aħħar injezzjoni.
In addition, samples were taken from muscle (mixed sample of hindquarter/ forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Barra minn hekk, ittieħdu kampjuni mill- muskolu (taħlita ta ’ muskolu min- naħa ta ’ quddiem u ta ’ wara), mix - xaħam u l- ġilda fil- proporzjonijiet naturali, il- fwied sħiħ, iż- żewġt ikliewi u mis- sît tat- tieni injezzjoni (tan- naħa tal- lemin) (madwar 10 ċm dijametru u 6 ċm fond).
These samples were chilled, homogenized and stored at -80°C until analysis 4 to 6 months later; the storage stability was confirmed.
Dawn il- kampjuni tkessħu, ġew omoġenizzati u nħażnu f’ temperatura ta ’ - 80 °C sakemm ġew analizzati bejn 4 u 6 xhur wara (l - istabbilità tal- ħażna ġiet ikkonfermata).
All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/ kg for all tissues.
Il- kampjuni kollha ġew analizzati biex tkun stabbilita l - konċentrazzjoni ta ’ amoxicillin bl- użu ta ’ l- HPLC- UV (bi fluworoxxenza- HPLC għall- fwied) b’ limitu ta ’ kwantifikazzjoni ta ’ 25 µg/ kg għat- tessuti kollha.
The injection sites contained the highest residue concentrations followed by kidney.
Is- siti ta ’ l- injezzjoni kien fihom l- ogħla konċentrazzjoni ta ’ residwi segwiti mill- kliewi.
However, the residue depletion profile in kidney indicated a non-regular profile.
Madankollu l- profil ta ’ eliminazzjoni tar- residwi mill- kliewi kien irregolari.
In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/ kg at day 1, 358 to 5429 µg/ kg at day 7, 182 to 2816 µg/ kg at day 14, below the limit of quantification to 211 µg/ kg at day 21 and below the limit of quantification to 38 µg/ kg at day 27.
Fis- siti ta ’ l- injezzjoni, il - konċentrazzjonijiet ta ’ amoxicillin kienu ta ’ bejn 14209 u 109535 µg/ kg fl- ewwel jum, bejn 358 u 5429 fis- 7 jum, bejn 182 u 2816 µg/ kg fl- 14- il jum, inqas mil- limitu ta ’ kwantifikazzjoni ta ’ 211 µg/ kg fil- 21 jum u inqas mil- limitu ta ’ kwantifikazzjoni ta ’ 38 µg/ kg fis- 27 jum.
In kidney, amoxicillin concentrations were 5446 to 9896 µg/ kg at day 1, 45 to 811 µg/ kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/ kg at day 21 and below the limit of quantification to 62 µg/ kg at day 27.
Fil- kliewi, il - konċentrazzjonijiet ta ’ amoxicillin kienu bejn 5446 u 9896 µg/ kg fl- ewwel jum, bejn 45 u 811 µg/ kg fis- 7 jum, inqas mil- limitu ta ’ kwantifikazzjoni fl- 14- il jum, inqas mil- limitu ta ’ kwantifikazzjoni ta ’ 180 µg/ kg fil- 21 jum u inqas mil- limitu ta ’ kwantifikazzjoni ta ’ 62 µg/ kg fis- 27 jum.
2.1 Calculation of withdrawal periods for Suramox 15% LA The MAH initially provided residue data in cattle and pigs using the product under consideration at the recommended dose treatment.
2. 1 Kalkoli tal- perjodi ta ’ rtirar għal Suramox 15% LA Fil- bidu, il- MAH ipprovda data tar- residwi fl- ifrat u l- majjali bl- użu tal- prodott studjat fid- dożi tat - trattament rakkomandati.
The data generated from these studies however, did not allow, at that stage, to establish withdrawal periods for cattle or pigs with the desired level of reliability.
Madankollu id- data ġenerata minn dawn l- istudji ma tippermettix, f’ dan l - istadju, li jiġu stabbiliti l- perjodi ta ’ rtirar għall- ifrat u l- majjali sal- livell ta ’ l- affidabilità mixtieq.
For cattle the injection site was the withdrawal time determining tissue and the residue concentrations of amoxicillin in the injection sites were still above the MRL at the last slaughter time point.
Għall- ifrat, is- sît ta ’ l- injezzjoni kien it- tessut li jistabbilixxi l- ħin ta ’ tneħħija, u l- konċentrazzjonijiet tar- residwi ta ’ amoxicillin xorta kienu ogħla mill- MRL fl- annimali li nqatlu fl- aħħar jum.
Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “ Note for guidance:
Mad- data pprovduta, la seta ’ jiġi applikat il- metodu statistiku (estrapolazzjoni kbira) u lanqas dak alternattiv (valuri ogħla mill- MRL fl- aħħar punt ta ’ ħin il- qatla), u allura l- perjodu ta ’ rtirar ma setax jiġi stabbilit skond in - “ Nota għall- gwida:
Approach towards harmonisation of withdrawal periods ” (EMEA/ CVMP/ 036/ 95-FINAL).
Metodu lejn l- armonizzazzjoni tal- perjodi ta ’ rtirar ” (EMEA/ CVMP/ 036/ 95- FINAL).
In addition the data were derived from animals weighting approximately 200 kg and receiving only one injection per dose administration, which are not necessarily representative of heavier animals requiring multiple injections.
Barra minn hekk id- data inkisbet minn annimali li jiżnu madwar 200 kg u li rċevew injezzjoni waħda biss ta ’ kull doża amministrata, u dawn mhux bilfors huma rappreżentattivi ta ’ annimali itqal li jeħtieġilhom iktar minn injezzjoni waħda.
In addition the analytical method for the determination of the residues was not sufficiently validated.
Barra minn hekk il - metodu analitiku għad- determinazzjoni tar- residwi ma kienx validitat biżżejjed.
For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues.
Għall- majjali li jiżnu bejn 40 u 50 kg, seta ’ jiġi derivat perjodu ta ’ rtirar ta ’ 35 jum ibbażat fuq ir - residwi fis- sît ta ’ l- injezzjoni.
However, the residues in kidney showed an irregular depletion profile and concentrations above the MRL were still observed at the last slaughter time point.
Madankollu, ir- residwi fil- kliewi wrew profil irregolari ta ’ eliminazzjoni u konċentrazzjonijiet ogħla mill- MRL fl- annimali li nqatlu fl- aħħar jum.
Therefore kidney was considered the tissue determining the withdrawal period.
Għalhekk il- kliewi kienu kkunsidrati bħala t- tessut li jiddetermina l- perjodu ta ’ rtirar.
The data available did not allow establishing a reliable withdrawal period based on residues in kidney by either the statistical or the alternative method.
Bid- data disponibbli, il- perjodu ta ’ rtirar bbażat fuq ir- residwi fil- kliewi ma setax jiġi stabbilit b’ mod affidabbli, la bil- metodu statistiku u lanqas bil- metodu alternattiv.
Re-examination of the opinion In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
L - istħarriġ mill- ġdid ta ’ l- opinjoni Fir- raġunijiet dettaljati ta ’ l - istħarriġ mill- ġdid ta ’ l- opinjoni, il- MAH argumenta li tlieta mit- tmien kampjuni tal- kliewi b’ konċentrazzjonijiet ta ’ amoxicillin ogħla mill- MRL fil- 21 u fis- 27 jum wara l - aħħar amministrazzjoni kellhom jiġu ikkunsidrati bħala artefatt minħabba l- profil mhux normali ta ’ l - eliminazzjoni kinetika tar- residwi.
EN 5/ 8 Whilst the finding of amoxicillin concentrations above the MRL at two time points following the apparent clear result at 14 days could be an artefact, it could equally be argued that it was the results at 14 days that proved unreliable.
Filwaqt li s- sejba ta ’ konċentrazzjonijiet ta ’ amoxicillin ogħla mill- MRL f’ żewġ punti ta ’ żmien wara r- riżultat apparentament ċar fl- 14- il jum tista ’ tkun artefatt, jista ’ bl- istess saħħa jiġi argumentat li kienu r- riżultati miksuba fl- 14- il jum li ma kienux affidabbli.
Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘ positive’ samples found.
Wara li kkunsidra li l- istudju kien konformi mal- GLP, is- CVMP ma jistax jinjora dawn ir- riżultati, l- aktar billi b’ kollox instabu tliet kampjuni pożittivi.
The MAH further argued that the method used was probably not robust enough and cited a recent publication that mentions the need for deproteinization steps to improve method recovery.
MT 5/ 8 Il- MAH argumenta wkoll li l- metodu li ntuża x’ aktarx ma kienx b’ saħħtu biżżejjed u semma ’ pubblikazzjoni riċenti li ssemmi l- ħtieġa li jittieħdu passi ta ’ deproteinizzazzjoni biex jittejjeb il - metodu ta ’ l- irkupru.
Assuming the MAH has a valid scientific point, and thus the method should have included an additional clean-up step to improve recovery, the weakness of this argument was that all sample results could therefore be understated.
Jekk wieħed jassumi li l- MAH għandu punt xjentifiku validu, u allura l - metodu kellu jinkludi pass ieħor ta ’ tindif biex jitjieb l- irkupru, id- dgħufija ta ’ dan l- argument kienet li r- riżultati kollha tal- kampjuni setgħu għalhekk jiġi sottovalutati.
Furthermore, the method provided was validated over a range using fortified samples.
Barra minn hekk, il - metodu pprovdut kien validitat f’ medda sħiħa ta ’ kampjuni msaħħa.
As the validation data fell within accepted specifications, the CVMP could not agree that it was appropriate to simply dismiss the findings above the MRL as artefacts.
Billi d- data ta ’ validazzjoni kienet aċċettabbli, is- CVMP ma setax jaqbel li kien xieraq li r- riżultati ogħla mill- MRL kellhom jitwarrbu billi jitqiesu bħala artefatti.
The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated.
Fl- aħħar, il- MAH argumenta li l- metodu fluworimetriku li ntuża kien kapaċi juri l- preżenza ta ’ residwi ta ’ prodotti tad- degradazzjoni ta ’ amoxicillin, u allura, il- konċentrazzjonijiet irrapportati setgħu ġew stmati b’ valur ikbar minn dak reali.
As a validated method was used with appropriate controls, the CVMP did not consider it appropriate to invalidate the method whilst arguing for its validity for all other results.
Billi ntuża metodu vvaliditat b’ kontrolli xierqa, is- CVMP ma kkunsidrax xieraq li jqis il- metodu bħala invalidu waqt li argumenta favur il- validità tiegħu għar- riżultati l- oħra kollha.
Assessment of new data further to the request for re-consideration by the European Commission One new GLP-study in cattle and two complementary GLP-residue studies in pigs were submitted during the procedure for the reconsideration of the opinion.
Il- valutazzjoni ta ’ data ġdida fid- dawl tat- talba mill- Kummissjoni Ewropea għall - konsiderazzjoni mill- ġdid Matul il- proċedura għall- konsiderazzjoni mill- ġdid ta ’ l- opinjoni, ġie sottomess studju ġdid konformi mal- GLP għall- ifrat kif ukoll żewġ studji kumplimentari tar- residwi għall- majjali.
Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox.
Sittax- il fart inqatlu sebat ijiem, 14- il jum, 46 jum u 57 jum wara t- trattament b’ Suramox.
Residues in muscle, fat, liver and kidney were below the MRL at all time points.
Ir - residwi fil- muskoli, fix- xaħam, fil- fwied u fil- kliewi kienu inqas mill- MRL fil- punti taż- żmien kollha.
Residues in the injection sites were high and still up to 5 times above the muscle MRL at the latest time point.
Ir- residwi fis- siti ta ’ l- injezzjoni kienu għoljin u sa ħames darbiet ogħla mill- MRL fil - muskoli fl- annimali li nqatlu fl- aħħar punt ta ’ żmien.
Sixteen pigs were slaughtered at 7, 14, 21 and 27 days after treatment with Suramox.
Sittax- il majjal inqatlu sebat ijiem, 14- il jum, 21 jum u 27 jum wara t- trattament b’ Suramox.
Residues in muscle, fat and liver were below the MRL at all time points.
Ir - residwi fil- muskoli, fix- xaħam, fil- fwied u fil- kliewi kienu inqas mill- MRL fil- punti taż- żmien kollha.
Residues in kidney ranged from below the limit of quantification to 150 µg/ kg at 7 days and were below the limit of quantification at later time points.
Ir- residwi fil- kliewi varjaw minn inqas mill- limitu tal- kwantifikazzjoni għal 150 µg/ kg wara sebat ijiem u kienu inqas mill- limitu tal- kwantifikazzjoni fil- punti taż- żmien ta ’ wara.
Residues at the injection sites were high and still up to 5 times above the muscle MRL at the latest time point.
Ir - residwi fis- siti ta ’ l- injezzjoni kienu għoljin u iktar minn ħames darbiet ogħla mill- MRL tal - muskoli fl- annimali li nqatlu fl- aħħar punt ta ’ żmien.
In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox.
Fi studju kumplimentari, inqatlu tmien majjali 30 u 36 jum wara t- trattament b’ Suramox.
Only residues at the injection sites were investigated.
Ġew investigati biss residwi fis- siti ta ’ l- injezzjoni.
The results reported indicated residue values below the muscle MRL at all time points except for 1 animal at the last time point, which had a concentration of 6 times above the muscle MRL.
Ir- riżultati rrappurtati indikaw valuri tar- residwi inqas mill- MRL fil- muskoli fil- punti taż- żmien kollha ħlief għal annimal wieħed fl- aħħar punt taż- żmien, li kellu konċentrazzjoni sitt darbiet ogħla mill- MRL fil- muskoli.
For one animal the result at 30 days was not reported.
Għal annimal wieħed, ir- riżultat wara 30 jum ma ġiex irrappurtat.
Establishment of the withdrawal period following consideration of all residue studies for pigs and cattle available With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method.
L- iffissar tal- perjodi ta ’ rtirar wara l- konsiderazzjoni ta ’ l- istudji tar- residwi kollha disponibbli għall- majjali u l- ifrat Bis- sottomissjoni ta ’ l- istudju l- ġdid tar- residwi għall- ifrat, il- MAH ippropona perjodu ta ’ rtirar ta ’ 96 jum ibbażat fuq il- metodu statistiku.
When providing oral explanations to the Committee concerning the new data submitted the MAH agreed however that withdrawal periods for cattle could not be set on the basis of the data available.
Meta ta spjegazzjonijiet bil- fomm lill- Kumitat dwar id- data l- ġdida sottomessa, il- MAH madankollu qabel li l- perjodi ta ’ rtirar għall- ifrat ma setgħux jiġu iffissati abbażi tad- data disponibbli.
The CVMP concluded that the statistical method could not be used based on the data of the new study provided.
Is- CVMP ikkonkluda li l- metodu statistiku ma setax jiġi bbażat fuq id- data mill- istudju l- ġdid ipprovdut.
An alternative method could not be used because at the last time point residue concentrations at the injection site were up to 5 times the MRL for muscle.
Ma setax jintuża metodu alternattiv għax fl- aħħar punt taż- żmien, il - konċentrazzjonijiet tar- residwi fis- siti ta ’ l- injezzjoni kienu sa ħames darbiet ogħla mill- MRL għall- muskoli.
With the submission of the new residue studies for pigs the MAH proposed a withdrawal period of 38 days based on the two studies provided.
Bis- sottomissjoni ta ’ l- istudji l- ġodda tar- residwi għall- majjali, il- MAH ippropona perjodu ta ’ rtirar ta ’ 38 jum ibbażat fuq iż- żewġ studji pprovduti.
EN 6/ 8 The CVMP noted that the MAH excluded two observations as being outliers when calculating the withdrawal period.
Is- CVMP innota li l- MAH eskluda żewġ osservazzjonijiet bħala outliers għall- kalkolu tal- perjodu ta ’ rtirar.
The CVMP concluded that this was not scientifically justified.
Is- CVMP ikkonkluda li dan ma kienx ġustifikat xjentifikament.
The statistical nor the alternative method could be used as at the last time point residues at the injection site were up to 6 times the MRL for muscle.
La seta ’ jintuża l - metodu statistiku u lanqas il- metodu alternattiv billi fl- aħħar punt taż- żmien, ir- residwi fis- siti ta ’ l- injezzjoni kienu sa sitt darbiet ogħla mill- MRL għall- muskoli.