qanastek/EMEA-V3 huggingface dataset:
The applicant was requested to provide the following information:
L- applikant kien mitlub li jipprovdi t- tagħrif li ġej:
A copy of the dossier of Equibactin vet.
Kopja tal- fajl tal- Pejst Orali għaż- Żwiemel Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v).
(333 mg/ g + 67 mg/ g) u kwalunkwe dejta supplimentari miżjuda miegħu, sa jum 60 tal- proċedura ta ’ referenza f' CMD( v).
In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet.
Fid- dawl tat- tħassib imqajjem minn Franza, li tkun indikata u ssostanzjata fejn ikun hemm bżonn kwalunkwe differenza bejn Pejst Orali għaż- Żwiemel Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products.
(333 mg/ g + 67 mg/ g) u l - prodott ta ’ referenza Pejst Orali Tribrissen (awtorizzat fl- Olanda) li tista ’ tiġġustifika konklużjonijiet differenti fuq is- sigurtà jew l- effikaċja għaż- żewġ prodotti.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
F’ reazzjoni għal mistoqsija nru 1, l- applikant ipprovda kopja tal- fajl oriġinali kif sottomess bħala sostenn ta ’ l- applikazzjoni ta ’ proċedura deċentralizzata, u kwalunkwe dejta supplimentari sottomessa waqt il- proċedura ddeċentralizzata f’ reazzjoni għall- istima ta ’ fażi I u fażi II u l- proċedura ta ’ referenza f’ CMD( v) minn hemm ’ il quddiem.
Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/ 4064 in the UK).
Fl- istudju GLP ta ’ bijoekwivalenza ta ’ doża waħda fiż- żwiemel, magħmul skond linji gwidi xierqa, Pejst Orali għaż- Żwiemel Equibactin vet. intwera li huwa bijoekwivalenti għall- prodotti ta ’ referenza Tribrissen (REG NL 5055 fl- Olanda) u Tribissen (Vm 0201/ 4064 fir- Renju Unit).
The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992.
Il- prodott ta ’ referenza oriġinali "Pejst Orali Tribrissen" kien awtorizzat fl- Olanda fl- 1992.
Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product, and can claim the same indications for use and the same precautionary warnings to ensure safe use for the product as for the reference product Tribrissen Oral Paste.
Taħt dawn il- kondizzjonijiet l- applikant huwa eżenti milli jissottometti aktar dejta preklinika jew klinika fuq l- effikaċja tal- prodott propost, u jista ’ jafferma l- istess indikazzjonijiet għal użu u l- istess twissijiet ta ’ prekawzjoni biex ikun żgurat użu sikur għall- prodott bħalma huma għall- prodott ta ’ referenza Pejst Orali Tribrissen.
In response to question 2, the applicant pointed out that there are no differences at all that would justify different conclusions on the safety and efficacy for the two products.
F’ reazzjoni għal mistoqsija nru 2, l- applikant wera li żgur ma hemm l- ebda differenza li tiġġustafika konklużjonijiet differenti fuq is- sigurtà u l- effikaċja għaż- żewġ prodotti.
Moreover, there are only
Barra dan, hemm biss l -
Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055).
4/ 7 analoġiji ta ’ Pejst Orali għaż- Żwiemel Equibactin vet. mal- prodott ta ’ referenza Pejst Orali Tribrissen (awtorizzat fl- Olanda taħt REG NL 5055) li jaffermaw l- istess sigurtà u effikaċja.
Oral Paste and Tribrissen oral paste for trimethoprim as well as for sulfadiazine, the products are regarded to be essentially similar.
Fuq il- bażi tal- kompożizzjoni fir- rigward tas- sustanzi attivi, Trimethoprim u Sulfadiazine, l- istess għamla farmaċewtika, u bijoekwivalenza bejn Pejst Orali Equibactin vet. u Pejst Orali Tribrissen għal trimethoprim kif ukoll għal sulfadiazine, il- prodotti jitqiesu li huma essenzjalment simili.
Oral Paste.
Konsegwentement, il- konklużjonijiet għall- effikaċja u s- sigurtà għal prodott ta ’ referenza, pejst orali Tribrissen, jistgħu jiġu estiżi għal prodott ġeneriku, Pejst Orali Equibactin vet.
Oral Paste, in accordance with the outcome of referral procedure EMEA/ V/ 023 under Article 35 of Directive 2001/ 82/ EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
L- applikant qabel li jissottometti talba għal varjazzjoni ta ’ Pejst Orali Equibactin vet., f’ konformità ma 'l- eżitu tal- proċedura ta ’ referenza EMEA/ V/ 023 skond l- Artikolu 35 tad- Direttiva 2001/ 82/ KE kif emendat, għal prodott mediċinali ta ’ referenza Pejst Orali Tribrissen awtorizzat fl- Olanda.
Equibactin vet Oral Paste proved to be essentially similar to the reference product, Tribrissen Oral Paste.
Pejst Orali Equibactin vet. wera li huwa essenzjalment simili għal prodott ta ’ referenza, Pejst Orali Tribrissen.
Consequently, the same conclusions on efficacy and safety apply to both products.
Konsegwentement, l- istess konklużjonijiet fuq l- effikaċja u s- sigurtà japplikaw għaż- żewġ prodotti.
Oral Paste.
L- oġġezzjonijiet imqajma minn Franza m’ għandhomx jimpedixxu l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq għal Pejst Orali Equibactin vet..
Oral Paste in accordance with the outcome of referral procedure EMEA/ V/ 023 under Article 35 of Directive 2001/ 82/ EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Huwa rakkomandat li Pejst Orali Equibactin vet. ivarja f’ konformità ma 'l- eżiti ta ’ proċedura ta ’ referenza EMEA/ V/ 023 skond l- Artikolu 35 ta ’ Direttiva 2001/ 82/ KE kif emendat, għall- prodott mediċinali ta ’ referenza Pejst Orali Tribrissen awtorizzat fl- Olanda.
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France) at day 210 of the decentralised procedure.
6/ 7 Is- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif validi huma l- verżjonijiet li sar qbil fuqhom mill- Istat Membru ta ’ Referenza u mill- Istati Membri Konċernati (għajr Franza) fil - jum 210 tal- proċedura deċentralizzata.
London, June 2008 EMEA/ 532271/ 2007 – Rev.1
Londra, Ġunju 2008 EMEA/ 532271/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIMECTIN 12MG/ G ORAL GEL FOR HORSES
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 33( 4) GĦAL EQUIMECTIN 12MG/ G ĠEL ORALI GĦAŻ- ŻWIEMEL
Equimectin 12mg/ g oral gel for horses contains ivermectin.
Equimectin 12mg/ g ġel orali għaż- żwiemel fih ivermectin.
The product is indicated for the treatment of endo- and ectoparasitic infections in horses, particularly gastrointestinal nematodes, dermal nematodes, lung nematodes and bots.
Il- prodott huwa indikat għall- kura ta ’ infezzjonijiet endo - u ektoparassitiċi fiż- żwiemel, b’ mod partikolari nematodi gastrointestinali, nematodi tal- ġilda, nematodi tal- pulmun u parassiti taż- żwiemel.
A Mutual Recognition Procedure (MRP) was started based on the Marketing Authorisation granted by the Netherlands with fourteen Concerned Member States.
Inbdiet Proċedura ta ’ Rikonoxximent Reċiproku (MRP) abbażi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq mogħtija mill- Olanda b’ erbatax- il Stat Membru Konċernat.
The Member States who raised concerns regarding the potential risk to animal health were Belgium, Denmark, France, Germany, Ireland, Italy, Portugal and Spain.
L- Istati Membri li qajmu tħassib fir- rigward tar- riskju potenzjali għas- saħħa ta ’ l- annimal kienu l - Belġju, id- Danimarka, Franza, il- Ġermanja, l- Irlanda, l- Italja, il- Portugall u Spanja.
The ground for the referral was the substantiation of the bioavailability/ bioequivalence of Equimectin in comparison to Eqvalan.
Ir- raġuni għar- referenza kienet il- prova tal- verità tal- bijodisponibilità/ bijoekwivalenza ta ’ Equimectin meta mqabbel ma ’ Eqvalan.
The CVMP during its meeting of May 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended.
Matul il- laqgħa tiegħu ta ’ Mejju 2006, is- CVMP beda proċedura ta ’ referenza skond l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE kif emendata.
The Marketing Authorisation Holder was requested to substantiate the bioavailability/ bioequivalence of the product, justifying the efficacy of the product.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq intalab jagħti prova tal- bijodisponibilità/ bijoekwivalenza tal- prodott, filwaqt li jiġġustifika l- effikaċja tal- prodott.
The documentation submitted with this application consisted of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Id- dokumentazzjoni ppreżentata ma ’ din l- applikazzjoni kienet tikkonsisti f’ litteratura li tirreferi għall - użu tal- prodott oriġinatur Eqvalan, studju farmakokinetiku komparattiv li juża Equimectin u Eqvalan, u studju kliniku supplimentari fuq il- post.
During the referral procedure, it was established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/ CVMP/ 016/ 00-corr- FINAL); however, from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Matul il- proċedura ta ’ referenza, ġie stabbilit li l- istudju ta ’ bijoekwivalenza ppreżentat ma kienx adegwat biex juri l- bijoekwivalenza (kif definita fil- gwida attwali EMEA/ CVMP/ 016/ 00- corr - FINALI); madankollu, mit- tagħrif farmakokinetiku komparattiv, huwa possibbli li l- prodott tal- prova jkun sistemikament inqas bijodisponibbli mill- prodott ta ’ referenza.
Therefore, the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Għalhekk, ir- relevanza tat- tagħrif biblijografiku fir- rigward ta ’ Eqvalan għall- prodott tal - prova ma tistax tiġi kkonfermata.
The residue data provided was inadequate and the withdrawal period is therefore inadequately supported.
It- tagħrif residwu pprovdut ma kienx adegwat u l- perjodu ta ’ l- irtirar huwa għalhekk mhux appoġġat b’ mod adegwat.
The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin, bioequivalence with the reference product had not been shown.
Il- Kumitat, wara li kkunsidra l- kwistjoni, ikkonkluda li abbażi tat- tagħrif disponibbli għal Equimectin, il- bijoekwivalenza mal- prodott ta ’ referenza ma ntwerietx.
The efficacy of the product for the treatment of endo- and ectoparasitic infections has not been demonstrated.
L- effikaċja tal- prodott għall- kura ta ’ infezzjonijiet endo - u ektoparassitiċi ma ntwerietx.
The amended indication for the treatment of gastrointestinal endoparasitic infections in horses had not been demonstrated by the data provided.
L- indikazzjoni emendata għall- kura ta ’ infezzjonijiet endoparassitiċi gastrointestinali fiż- żwiemel ma ntwerietx bit- tagħrif ipprovdut.
The CVMP recommended the refusal of the granting of the Marketing Authorisation and the suspension of the Marketing Authorisation for Equimectin where appropriate.
Il- CVMP irrakkomanda r- rifjut ta ’ l- għoti ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u s- sospensjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għal Equimectin fejn xieraq.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 2 April 2007.
L- Opinjoni tas- CVMP ġiet adottata fis- 17 ta ’ Jannar 2007 u d- Deċiżjoni tal- Kummissjoni sussegwenti ġiet adottata fit- 2 ta ’ April 2007.
EMEA/ 532271/ 2007 – Rev.1
EMEA/ 532271/ 2007 – Rev. 1- MT
London, August 2008 EMEA/ 458933/ 2008
Londra, Awwissu 2008 EMEA/ 458933/ 2008
OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 34 GĦAL METHOXASOL- T
On 8 September 2006, Germany presented to the EMEA a referral under Article 34 of Directive 2001/ 82/ EC, as amended, concerning Methoxasol-T (including associated names), containing trimethoprim and sulfamethoxazole as active ingredient.
Fit- 8 ta ’ Settembru 2006, il- Ġermanja ppreżentat lill- EMEA riferiment skont l- Artikolu 34 tad - Direttiva 2001/ 82/ KE, kif emendata, dwar Methoxasol- T (inkluż l- ismijiet assoċjati), li fih trimethoprim u sulfamethoxazole bħala sustanzi attivi.
Methoxasol-T was authorised through a national procedure in The Netherlands in 1999, but a marketing authorisation was refused in Germany in 2001.
Methoxasol- T ġie awtorizzat permezz ta ’ proċedura nazzjonali fl- Olanda fl- 1999, iżda l - awtorizzazzjoni għat- tqegħid fis- suq ġiet rifjutata fil- Ġermanja fl- 2001.
Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk to the target animals.
Il- Ġermanja qieset li l - effikaċja ta ’ Methoxasol- T kif proposta mill- applikant ma ġietx ġustifikata adegwatament, u dan wassal għal riskju potenzjali serju għall- annimali fil- mira.
An intended application for a marketing authorisation of a generic triggered Germany to submit the referral regarding the divergent decisions taken on Methoxasol-T.
Applikazzjoni intiża għall- awtorizzazzjoni għat- tqegħid fis- suq ta ’ prodott ġeneriku qanqlet lill - Ġermanja tissottometti riferiment dwar id- deċiżjonijiet diverġenti meħudin dwar Methoxasol- T.
The CVMP started the referral procedure during its meeting of 12-14 September 2006.
Is- CVMP beda l- proċedura ta ’ riferiment waqt il- laqgħa tiegħu ta ’ bejn it- 12 u l- 14 ta ’ Settembru 2006.
The Marketing Authorisation Holder was requested:
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq intalab:
To provide the relevant parts of the dossier of each Member State where an application has been submitted and to detail the differences between the dossiers.
Jipprovdi l- partijiet relevanti tad- dokumentazzjoni ta ’ kull Stat Membru fejn ġiet sottomessa applikazzjoni u jniżżel fid- dettall id- differenzi bejn id- diversi dokumentazzjoni.
To justify compliance of the dossier with respect to the requirements for obtaining a marketing authorisation (Annex I of Directive 2001/ 82/ EC, as amended).
Jiġġustifika l- konformità tad- dokumentazzjoni b’ rabta mar- rekwiżiti għall- ksib ta ’ awtorizzazzjoni għat- tqegħid fis- suq (Anness I tad- Direttiva 2001/ 82/ KE, kif emendata).
To consider in particular the issues mentioned in the referral notification as the grounds for refusing an authorisation in Germany.
Jikkunsidra b’ mod partikolari, il- kwistjonijiet imsemmija fin- notifika ta ’ riferiment bħala r - raġunijiet għar- rifjut tal- awtorizzazzjoni fil- Ġermanja.
To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in pigs and poultry.
Jiġġustifika b’ dejta minn fuq il- post (field data), l- użu tal- prodott u l- adegwatezza tad- doża rakkomandata għal kull waħda mill- indikazzjonijiet imsemmija għall- ħnieżer u t- tjur.
For poultry comment was required on the current use of the product, in particular on the dose used or prescribed under field conditions.
Għat- tjur kien hemm bżonn ta ’ kumment fuq l- użu kurrenti tal- prodott, b’ mod partikolari fuq id- doża użata jew preskritta għall il- kundizzjonijiet fuq il- post.
To propose and justify with data a suitable shelf life for the product, including an in-use shelf life where relevant.
Jipproponi u jiġġustifika b’ dejta d- data sa meta jista ’ jintuża l- prodott, inkluż kemm jista ’ jdum jintuża minn meta jinfetaħ fejn relevanti.
To propose and justify a harmonised text of the Summary of Product Characteristics (SPC), including posology and method of administration as well as withdrawal periods for pigs and poultry.
Jipproponi u jiġġustifika test armonizzat tas- Sommarju tal- Karatteristiċi tal- Prodott (SPC), inkluż il- pożoloġija u l- metodu tal- għoti kif ukoll il- perjodi ta ’ rtirar għall- ħnieżer u t- tjur.
The Marketing Authorisation Holder submitted written responses, defending the indications, recommended dose and shelf life, and proposing a harmonised SPC text.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq issottometta tweġibiet bil- miktub, biex jiddefendi l- indikazzjonijiet, id- doża rakkomandata u d- data sa meta jista ’ jintuża l- prodott, u ippropona test tal- SPC armonizzat.
On the basis of the data provided, the CVMP agreed on the following harmonised indications for use: • Pigs: treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Abbażi tad- dejta pprovduta, is- CVMP qabel fuq l- indikazzjonijiet armonizzati tal- użu li ġejjin: • Ħnieżer: it- trattament u l- prevenzjoni ta ’ infezzjonjiet respiratorji ikkawżati minn Actinobacillus pleuropneumoniae suxxettibbli għal trimethoprim u sulfamethoxazole fejn il- mard ikun ġie dijanjostikat fil- merħla.
Reproduction is authorised provided the source is acknowledged. • Broilers: treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Reproduction is authorised provided the source is acknowledged. • Brojlers: it- trattament u l- prevenzjoni ta ’ infezzjonjiet respiratorji ikkawżati minn Escherichia coli suxxettibbli għal trimethoprim u sulfamethoxazole fejn il- mard ikun ġie dijanjostikat fil - merħla.
The CVMP recommended in relation to the pharmacokinetic properties described that the inclusion of environmental effects should be deleted.
Is- CVMP irrakkomanda, li l- karatteristiċi farmakokinetiċi deskritti fl- inklużjoni tal- effetti ambjentali m’ għandhomx jitħassru.
The CVMP also recommended that the use of the product should be based on culture and sensitivity testing of micro-organisms from diseased cases on farm or from recent previous experience on the farm, as resistance against potentiated sulphonamides may vary.
Is- CVMP irrakkomanda wkoll li l- użu tal- prodott għandu jkun ibbażat fuq l - ittestjar tal- kultura u tas- sensittività ta ’ mikroorganiżmi minn każijiet b’ mard f’ razzett jew minn esperjenza preċedenti fuq ir- razzett, billi r- reżistenza kontra s- sulphonamides potenzjati tista ’ tvarja.
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concluded that the benefit/ risk balance of the product is positive for use in both pigs and broilers subject to recommended changes to the Summary of Product Characteristics and product information, and that the concerns raised by Germany should not prevent the granting of a marketing authorisation.
Wara li qies ir- raġunijiet għar- riferiment u t- tweġibiet ipprovduti mid- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, is- CVMP ikkonkluda li l- bilanċ bejn il- benefiċċju u r- riskju tal- prodott huwa pożittiv għall- użu kemm fil- ħnieżer kif ukoll fil- brojlers soġġett għat- tibdil rakkomandat fis- Sommarju tal- Karatteristiċi tal- Prodott, u li t- tħassib imressaq mill- Ġermanja m’ għandux jipprevjeni l- għoti tal - awtorizzazzjoni għat- tqegħid fis- suq.
The CVMP Opinion was adopted on 11 October 2007 and the subsequent Commission Decision on 11 January 2008.
L- Opinjoni tas- CVMP ġiet adottata fil- 11 ta ’ Ottubru 2007 u d- Deċiżjoni sussegwenti tal - Kummissjoni fil- 11 ta ’ Jannar 2008.
EMEA/ 458933/ 2008-EN
EMEA/ 458933/ 2008- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, SPEĊI TA ’ ANNIMALI, KIF JINGĦATA, U SID TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
1/ 19 Member State
1/ 20 Stat Membru
Applicant or Marketing Authorisation Holder
Applikant jew Sid ta ’ l - Awtorizzazzjoni għat- Tqegħid fis - Suq
Product invented name
Isem inventat tal- prodott
Recommended dose Frequency and route of administration
Doża rakkomandata Frekwenza u kif jingħata
Eurovet Animal Health Handelsweg 25 P. O.
Eurovet Animal Health Handelsweg 25,
Solution for oral administration
Soluzjoni għall - amministrazzjoni orali
Trimethoprim 20 mg/ ml Sulfamethoxazole 100 mg/ ml N-Methyl-2-
Trimethoprim 20 mg/ ml Sulfamethoxazole
Bronchial infections caused by Pasteurella multocida.
Ħnieżer Infezzjonijiet fil- Bronki kkawżati minn Pasteurella multocida
Intestinal infections caused by Escherichia coli and Salmonella spp.
Orali, permezz ta ’ l- ilma tax- xorb Ħnieżer 2. 5- 5 mg trimethoprim u 12. 5- 25mg sulfamethoxasole għal
Urogenital infections caused by Escherichia coli Non-egg-laying chickens:
Infezzjonijiet intestinali kkawżati minn Escherichia coli u Salmonella spp.
Bronchial infections caused by Escherichia coli, Salmonella spp. and Pasteurella spp.
Infezzjonijiet uroġenitali kkawżati minn Escherichia coli
Oral, via the drinking water Pigs:
kull kilo ta ’ piż tal- ġisem kull jum għal bejn 3- 5 ijiem Tiġieġ:
2.5-5 mg trimethoprim and 12.5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens:
5- 12 mg trimethoprim u 25 - 58 mg sulfamethoxasole għal kull
5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days
kilo ta ’ piż tal- ġisem kull jum għal bejn 3- 5 ijiem
Box 179
Eurovet Animal Health
As for The As for The Netherlands Netherlands
Bħal ta ’ l- Olanda Bħal ta ’ l- Olanda
Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria
Trattament terapewtiku ta ’ infezzjonijiet ikkawżati minn batterji li huma
Oral, via the drinking water Methoxasol-T should be administered daily in drinking water
Orali, permezz ta ’ l- ilma tax- xorb
5530 AD Bladel The Netherlands
Box 179, 5530 AD Bladel
Pigs:20.8 mg sulfamethoxasole + 4.2 mg trimethoprim per kg body weight per day for 3-4 days.
suxxetibbli għal trimethoprim u sulfamethoxasole
Pasteurella haemolytica, salmonella Broilers:27.5 mg sulfamethoxasole
Methaxosol- T għandu jingħata kull jum ma ’ l- ilma tax- xorb għal perjodu ta ’ bejn 3 u 4 ijiem:
cholerasuis, Salmonella thyphimurium, Streptococcus spp., Staphylococcus aureus, Staphylococcus spp.
Ħnieżer Pasteurella multocida, Actinobacillus pleuropneumoniae, Staphylococcus hyicus, E / coli, Haemophilus spp, Pasteurella haemolytica, salmonella
+ 5.5 mg trimethoprim per kg body weight per day for 3-4 days.
Ħnieżer20. 8mg sulfamethoxasole + 4. 2mg trimethoprim għal kull kilogramm ta ’ piż tal- ġisem kull jum għal bejn 3- 4 ijiem.
Broilers:
cholerasuis, Salmonella thyphimurium, sulfamethoxasole + 5. 5 mg trimethoprim għal kull kilogramm Streptococcus spp., Staphylococcus ta ’ piż tal- ġisem kull jum għal bejn aureus, Staphylococcus spp 3- 4 ijiem.
Staphylococcus aureus, Salmonella enteritidis, E. coli.
Tiġieġ imkabbar għal- laħam Staphylococcus aureus, Salmonella enteritidis, E. coli.
2/ 19 Member State
2/ 20 Stat Membru
Eurovet Animal Health Handelsweg 25 P. O.
Eurovet Animal Health Handelsweg 25, P. O.
Box 179 5530 AD Bladel The Netherlands
Box 179, 5530 AD Bladel L- Olanda
Methoxasol – Lösung für Schweine und Hühner
Methoxasol - Lösung für Schweine und Hühner (Soluzzjonijiet għall- Ħnieżer u t- Tiġieġ)
As for The As for The Netherlands Netherlands
Bħal ta ’ l- Olanda
For the treatment of respiratory tract As for Germany infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers).
Għat- trattament ta ’ infezzjonijiet fis - sistema respiratorja, infezzjonijiet fil - ġilda, gastrointestinali u uroġenitali kkawżati minn patoġeni li huma sensittivi għal trimethoprim u sulfamethoxasole fil- ħnieżer u t- tjur (imkabbra għal- laħam).
Eurovet Animal Health Handelsweg 25 P. O.
Handelsweg 25, P. O.
Methoxasol
Ħnieżer:
As for The As for The Netherlands Netherlands
Infezzjonijiet fis- sistema respiratorja kkawżati minn Pasteurella multocida, Antinobacillus pleuropneumonaie.
Pigs:
24mg/ kilogramm ta ’ piż tal- ġisem, ekwivalenti għal litru ta ’ mediċina f’ 500 litru ilma tax- xorb, għal bejn 3 u 4 ijiem Tiġieġ:
Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae.
33 mg/ kilogramm ta ’ piż tal - ġisem, ekwivalenti għal litru ta ’
Infections of the digestive system caused by Escherichia coli, Salmonella spp.
Infezzjonijiet fis- sistema diġestiva kkawżati minn escherichia coli, Salmonella spp.
Infections of the urinary system caused by Escherichia coli.
Infezzjonijiet tas- sistema urinarja kkawżati minn Escherichia coli.
Hens:
Tiġieġ:
Infections of the respiratory tract caused by Escherichia coli, Salmonella spp., Pasteurella multocida.
Infezzjonijiet fis- sistema respiratorja kkawżati minn Escherichia coli, Salmonella spp., Pasteurella multocida.
Infections of the digestive system caused by Salmonella spp.
Infezzjonijiet fis- sistema diġestiva kkawżati minn Salmonella spp.
Polyarthritis caused by susceptible Escherichia coli.
Polyarthritis ikkawżat minn Escherichia coli.
33 mg/ kg b. w., equivalent to 1 litre of the drug in 750 L drinking water, for 3-4 days
mediċina f’ 750 litru ilma tax- xorb, għal bejn 3 u 4 ijiem
3/ 19 Member State
4/ 20 Stat Membru
Hungary and Lithuania
L- Ungerija u l- Litwanja
As for The Netherlands
Bħal ta ’ l- Olanda Bħal ta ’ l- Olanda
For the treatment of pigs and non- egg-laying chickens suffering from infectious diseases of the respiratory system caused by bacteria sensitive to sulfa-Methoxasole and trimethoprim, (e. g. porcine A. pleuropneumoniae and gallinaceous E. coli) and for prophylactic use.
Għat- trattament ta ’ ħnieżer u tiġieġ li ma jbidux bajd li jkunu jsofru minn mard fis- sistema respiratorja li jkun jittieħed u li jkun ikkawżat minn batterju li huwa sensittiv għal sulfa - Methoxasole u trimethoprim (eż porcine A. pleuropneumoniae i gallinaceous E. coli) u għall- użu profilattiku.
Oral, via the drinking water Pigs:
Orali, permezz ta ’ l- ilma tax- xorb Ħnieżer:
24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1,000 kg of body weight per day.
24 mg ta ’ kompost ta ’ ingredjent attiv għal kull kilogramm ta ’ piż tal- ġisem jew 200 ml tal - mediċina għal kull 1, 000 kilo ta ’ piż tal- ġisem kull jum.
Poultry:
Tjur:
33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1,000 kg of body weight per day.
33 mg ta ’ kompost ta ’ ingredjent attiv għal kull kilogramma ta ’ piż tal- ġisem jew 275 ml tal - mediċina għal kull 1, 000 kilo ta ’ piż tal- ġisem kull jum.
4/ 19 ANNEX II
5/ 20 ANNESS II
5/ 19 SCIENTIFIC CONCLUSIONS
6/ 20 KONKLUŻJONIJIET XJENTIFIĊI
Methoxasol-T was authorised through a national procedure in the Netherlands in 1999 but a marketing authorisation was refused in Germany in 2001.
Methoxasol- T kien awtorizzat permezz ta ’ proċedura nazzjonali fl- Olanda fl- 1999 iżda awtorizzazzjoni għat- tqegħid fis- suq kienet irrifjutata fil- Ġermanja fl- 2001.
Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk for the target animals.
Il- Ġermanja ikkunsidrat li l- effikaċja ta ’ Methoxasol- T kif proposta mill- applikant ma kinitx adegwatament iġġustifikata, għaldaqstant kienet tirriżulta f’ riskju potenzjali serju għall- annimali fil- mira.
As to where Methoxasol-T is also authorised in Austria, Poland, Hungary, and Lithuania, these marketing authorisations have been included in the scope of the procedure.
Għal imkejjen fejn Methoxasol- T huwa awtorizzat ukoll fl- Awstrija, il- Polonja, l- Ungerija, u l- Litwanja, dawn l - awtorizzazzjonijiet għat- tqegħid fis- suq ġew inklużi fl- iskop tal- proċedura.
No member states, other than Germany, have reported the refusal of a marketing authorisation.
L- ebda Stat Membru, għajr il- Ġermanja, ma irrapportaw ir- rifjut ta ’ awtorizzazzjoni għat- tqegħid fis- suq.
Questions put to the Marketing Authorisation Holder
Mistoqsijiet magħmula lid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
To provide the dossier submitted upon application for a marketing authorisation, for each Member State mentioned above (including Germany) and, if applicable, for any other Member State or country of the European Economic Area (EEA): a.
Biex jipprovdi d- dossier ippreżentat ma ’ l- applikazzjoni għat- tqegħid fis- suq, għal kull Stat Membru msemmi hawn fuq (inkluża l- Ġermanja) u, jekk applikabbli, għal kwalunkwe Stat Membru ieħor jew pajjiż taż- Żona Ekonomika Ewropea (EEA): a.
Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; b.
Parti I Sommarju tad- dossier, inkluż is- Sommarju tal- Karatteristiċi tal- Prodott, ir- rapporti ta ’ l - esperti u l- kompożizzjoni kwantitattiva u kwalitattiva tal- prodott; b.
Part IV Preclinical and clinical information.
Parti IV Tagħrif ta ’ qabel l- użu kliniku u kliniku.
As many documents as possible, and at least the SPCs, should be presented in English.
Kemm jista ’ jkun dokumenti, u ta ’ l- anqas l- SPCs, għandhom jiġu ippreżentati bl- Ingliż.
To provide information on any addition, deletion or change made to the information as requested under point 1, after the initial application.
Biex jipprovdi tagħrif fuq kwalunkwe żieda, tħassir jew bidla magħmula lit- tagħrif kif mitlub taħt punt 1, wara l- applikazzjoni inizjali.
To detail differences that exist between the dossiers with respect to the information as requested under point 1 and 2.
Biex jagħti fid- dettall id- differenzi li jeżistu bejn id- dossiers fir- rigward tat- tagħrif kif mitlub taħt punt 1 jew 2.
To justify compliance of the dossier, as it exists in each Member State or EEA country, with respect to the requirements of Annex I of Directive 2001/ 82/ EC, as amended.
Biex jiġġustifika l- konformità tad- dossier, kif jeżisti f’ kull Stat Membru jew pajjiż taż- ŻEE, fir - rigward tal- ħtiġijiet ta ’ l- Anness I tad- Direttiva 2001/ 82/ KE, kif emendata.
To consider in particular the issues to which reference is made in the Annex to the referral notification from Germany as to the grounds for refusing an authorisation.
Biex partikolarment jikkunsidra l- argumenti, li r- referenza għalihom hija magħmula fl- Anness għan- notifikazzjoni ta ’ riferenza mill- Ġermanja bħala r- raġunijiet għar- rifjut ta ’ l- awtorizzazzjoni.
To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in pigs, except for the treatment and prevention of swine respiratory disease associated with A. pleuropneumoniae sensitive to trimethoprim and sulphamethoxazole.
Biex jiġġustifika d- dejta tal- kamp, l- użu tal- prodott u s- suffiċjenza tad- doża irrikkmandata għal kull waħda mill- indikazzjonijiet affermati fil- ħnieżer, ħlief għall- kura u l- prevenzjoni ta ’ marda respiratorja tal- ħnieżer assoċjata ma ’ A. pleuropneumoniae sensittiv għal trimethoprim u sulphamethoxazole.
To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in poultry.
Biex jiġġustifika d- dejta tal- kamp, l- użu tal- prodott u s- suffiċjenza tad- doża irrikkmandata għal kull waħda mill- indikazzjonijiet affermati fit- tjur.
Comment is required on the current use of the product in poultry and in particular on the dose used or prescribed by veterinary surgeons under field conditions.
Huwa meħtieġ kumment fuq l- użu kurrenti tal - prodott fit- tjur u b’ mod partikolari fuq id- doża użata jew miktuba f’ riċetta mill- kirurgi veterinarji taħt il- kundizzjonijiet tal- kamp.
To propose and justify with data a suitable shelf life for the product, including an in-use shelf life where relevant.
Biex jipproponi u jiġġustifika b’ dejta, it- tul ta ’ żmien ta ’ ħażna adegwata għall- prodott, inkluż it- tul ta ’ żmien tal- ħażna waqt l- użu fejn relevanti.
To propose and justify a harmonised SPC text, including posology and method of administration as well as withdrawal periods for pigs and poultry.
Biex jipproponi u jiġġustifika test ta ’ l- SPC armonizzat, inklużi l- pożoloġija u l- metodu ta ’ l - amministrazzjoni kif ukoll perijodi ta ’ irtirar għall- ħnieżer u t- tjur.
Differences between dossiers
Differenzi bejn l- inkartamenti
The dossier submitted to the Netherlands was only bibliographic.
Id- dossier sottomess lill- Olanda kien biblijografiku biss.
The dossier sent to Germany including the answers to the list of questions and to Poland, Hungary and Lithuania was almost the same, but with additional experimental clinical studies.
Id- dossier mibgħut lill- Ġermanja inklużi t - tweġibiet għal- lista ta ’ mistoqsijiet u lill- Polonja, l- Ungerija u l- Litwanja kienu kważi l- istess, iżda bi studji kliniċi esperimentali addizzjonali.
Austria received a dossier similar to the original sent to Germany.
L- Awstrija irċeviet dossier simili għal dak oriġinali mibgħut lill- Ġermanja.
It can be concluded that the dossiers on which the Member States took their decisions were largely similar but not identical.
Jista ’ jiġi konkluż li d- dossiers fuq liema l- Istati Membri ħadu d- deċiżjonijiet kienu fil- parti l- kbira simili iżda mhux identiċi.
The physical product manufactured for sale in the various markets appears to be identical.
Il- prodott fiżiku immanifatturat għal bejgħ fis- swieq diversi jidher li huwa identiku.
1.3.
7/ 20 1. 3.
Efficacy in pigs
Effikaċja fil- ħnieżer
The CVMP has assessed a pilot study, a main experimental study, 2 field trial reports as well as other efficacy, pharmacokinetics and tolerance data submitted by the marketing authorisation holder.
Is- CVMP ivvaluta studju pilota, studju esperimentali ewlieni, 2 rapporti ta ’ provi tal- kamp kif ukoll dejta oħra ta ’ effikaċja, farmakokinetika u tolleranza sottomessi mid- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
6/ 19 The CVMP accepts that a claim for efficacy at a dose of 25mg/ kg for 4 days for the treatment of respiratory infections in pigs has been demonstrated.
Is- CVMP aċċetta li intweriet affermazzjoni għal effikaċja f’ doża ta ’ 25mg/ kg għal 4 ijiem għat - trattament ta ’ infezzjonijiet respiratorji fil- ħnieżer.
The CVMP agrees that as long as the treatment is directed against respiratory infections in pigs, it is not necessary to perform additional field studies to demonstrate efficacy against other organisms with similar MIC levels as A. pleuropleumonia.
Is- CVMP jaqbel li sakemm il- kura hija diretta kontra infezzjonijiet respiratorji fil- ħnieżer, m’ hemmx bżonn li jsiru studji tal- kamp addizzjonali biex tintwera l- effikaċja kontra organiżmi oħra b’ livelli MIC simili bħal ta ’ A. pleuropleumonia.
However, for the use of the product confirmation of the presence of a specific infection and confirmation of a bacteriological cure is required.
Madankollu, għall- użu tal- prodott jeħtieġ li jkun hemm konferma tal- preżenza ta ’ infezzjoni speċifika u konferma ta ’ kura batterjoloġika.
As to where the SPC´s in The Netherlands, Austria and Poland, Methoxasol-T include indications that cover urogenital, gastrointestinal and skin infections, CVMP concludes that no data have been provided supporting these claims.
Fir- rigward ta ’ fejn l- SPC’ s fl- Olanda, l- Awstrija u l- Polonja, (Methoxasol- T) inkludew indikazzjonijiet li jkopru infezzjonijiet uroġenitali, gastrointestinali u tal- ġilda, is- CVMP ikkonkluda li l- ebda dejta ma ġiet ipprovduta li twieżen dawn l- affermazzjonijiet.
On the basis of further additional MIC data from various publications (including two 2004 published papers showing susceptibility of various isolates from pig respiratory samples from Denmark) and from resistance monitoring by the BVL in Germany in 2006, the CVMP can accept the proposed revision of the indication:
Fuq il- bażi ta ’ aktar dejta MIC addizzjonali minn pubblikazzjonijiet diversi (inklużi żewġ karti ippubblikati fl- 2004 li juru s- suxxettibbiltà ta ’ diversi iżolati minn kampjuni respiratorji tal- ħnieżer fid- Danimarka) u minn sorveljanza ta ’ reżistenza mill- BVL fil- Ġermanja fl- 2006, is- CVMP ma jistax jaċċetta r- reviżjoni proposta ta ’ l- indikazzjoni:
Pigs:
Ħnieżer:
Treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Il- kura u l- prevenzjoni ta ’ infezzjonijiet respiratorji ikkaġunati minn Actinobacillus pleuropneumoniae suxxettibbli għal trimethoprim u sulfamethoxazole fejn il- marda ġiet dijanjotizzata fil- merħla.
Resistance against potentiated sulphonamides may vary.
Ir- reżistenza kontra sulfonamidi potenzjati tista ’ tvarja.
Therefore the use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm or from recent previous experience on the farm.
Għaldaqstant, l- użu tal- prodott għandu jkun ibbażat fuq kultura u sensittività ta ’ mikro- organiżmi minn każijiet morda fir- razzett jew minn esperjenza ta ’ qabel, riċenti fir- razzett.
Efficacy in broilers
Effikaċja fil- brojlers
The CVMP has assessed an experimental study on clinical efficacy of Methoxasol-T for treatment of a respiratory infection caused by E. coli in chickens, as well as bibliographic and pharmacovigilance data provided by the marketing authorisation holder.
Is- CVMP ivvaluta studju esperimentali fuq l- effikaċja klinika ta ’ Methoxasol- T għall- kura ta ’ infezzjoni respiratorja ikkaġunata minn E. coli fit- tiġieġ, kif ukoll dejta biblijografika u ta ’ farmakoviġilanza ipprovduta mid- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
In respect of the benefit/ risk balance for target species poultry, the CVMP concludes that: • notwithstanding the fact that a definitive clinical field study using the recommended dosage of the product has not been provided, taking into account the pre-clinical studies, the artificial infection model, the history of use and the other pertinent information provided, the various risk management steps now set out in the proposed SPC and noting the fact that the indications for use are restricted, the benefit / risk balance is positive; • the availability of an authorised veterinary medicinal product containing active substances other than fluoroquinolones might be regarded an indirect benefit and not directly relevant to the scope of this referral procedure (as efficacy must be shown for each product independently); • the conditions of use as proposed in the SPC preclude use in laying birds and restrict use of the product based on culture and sensitivity testing of micro-organisms from diseased farms.
• minkejja l- fatt li studju kliniku definittiv bl- użu tad- dożaġġ irrikmandat tal- prodott ma ġiex ipprovdut, filwaqt li ġew ikkunsidarti l- istudji ta ’ qabel l- użu kliniku, il- mudell ta ’ infezzjoni artifiċjali, l- istorja ta ’ l- użu u tagħrif ieħor pertinenti ipprovdut, id- diversi passi ta ’ maniġment ta ’ riskju maħruġa issa fl- SPC proposta u bl- osservanza tal- fatt li l- indikazzjonijiet għall- użu huma limitati, il- bilanċ benefiċċju/ riskju huwa wieħed pożittiv; • id- disponibbiltà ta ’ prodott mediċinali veterinarju awtorizzat li fih sustanzi attivi għajr fluoroquinolones (florokwinoloni) tista ’ tiġi ikkunsidrata benefiċċju indirett u mhux direttament relevanti għall- iskop ta ’ din il- proċedura ta ’ referenza (peress li l- effikaċja trid tintwera għal kull prodott b’ mod indipendenti); • il- kundizzjonijiet ta ’ l- użu kif proposti fl- SPC jipprekludu użu f’ għasafar li jbidu u jillimitaw l - użu tal- prodott abbażi ta ’ l- ittestjar ta ’ kultura u sensittività ta ’ mikro- organiżmi minn irziezet morda.
The CVMP can accept the proposed revision of the indication:
Is- CVMP jista ’ jaċċetta r- reviżjoni proposta ta ’ l- indikazzjoni:
Broilers:
Brojlers:
Treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Kura u prevenzjoni ta ’ infezzjonijiet respiratorji ikkaġunati minn Escherichia coli suxxettibbli għal trimethoprim u sulfamethoxazole fejn il- marda ġiet dijanjotizzata fil- qatgħa ta ’ l - għasafar.
Resistance against potentiated sulphonamides may vary.
Reżistenza kontra sulfonamidi potenzjati tista ’ tvarja.
Therefore the use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm or from recent previous experience on the farm.
Għaldaqstant l- użu tal- prodott għandu jiġi ibbażat fuq kultura u sensittività ta ’ mikro- organiżmi minn każijiet morda fir- razzett jew minn esperjenza ta ’ qabel riċenti fir- razzett.
1.5.
8/ 20 1. 5.
Shelf life
Tul ta ’ żmien ta ’ ħażna
The Marketing Authorisation Holder presented 3 studies on shelf life and in-use shelf life.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ippreżenta 3 studji fuq it- tul ta ’ żmien ta ’ ħażna u t- tul ta ’ żmien ta ’ ħażna waqt l- użu.
Based on these studies a 36 months shelf life for Methoxasol-T is claimed.
Abbażi ta ’ dawn l- istudji, perjodi ta ’ ħażna ta ’ 36 xahar huwa affermat għal Methoxasol- T.
Since no freezing studies have been performed the SPC must contain the note:
Peress li ma saru l- ebda studji fuq l- iffriżar, l- SPC irid ikollu n - nota:
7/ 19 The results of the in-use stability testing of the product after 15 months storage at 25°C/ 60% RH and in-use of 12 months after opening showed acceptable stability.
Ir- riżultati ta ’ l- ittestjar ta ’ l- istabbilità waqt l- użu wara ħażna ta ’ 15- il xahar f’ 25°C/ 60% RH u waqt l - użu ta ’ 12- il xahar wara li jiġi miftuħ urew stabbilità aċċettabbli.
Finally a 24 hours in-use shelf-life is demonstrated for concentrated and therapeutic solutions of the product Methoxasol-T.
Fl- aħħarnett, tul ta ’ żmien ta ’ ħażna waqt l- użu ta ’ 24l siegħa jintwera għal soluzzjonijiet ikkonċentrati u terapewtiċi tal- prodott Methoxosol- T.
SPC harmonisation
Armonizzazzjoni ta ’ l- SPC
The Marketing Authorisation Holder has proposed a new harmonised SPC.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ippropona SPC armonizzata ġdida.
Where the indications in both pigs and broilers are restricted to respiratory infections, the CVMP can accept this claim.
Is- CVMP jista ’ jaċċetta din l- affermazzjoni, fejn l- indikazzjonijiet kemm fil- ħnieżer u kemm fil - brojlers huma ristretti għal infezzjonijiet respiratorji.
The CVMP can also accept the dose as these are in accordance with those used in the experimental and field studies.
Is- CVMP jista ’ wkoll jaċċetta d- dożi għaliex dawn huma konformi ma ’ dawk użati fi studji esperimentali u fil- kamp.
The withdrawal period for Methoxasol-T varied between EU countries, pigs 3-5 days and non-laying hens 6- 10 days.
Il- perijodu ta ’ irtirar għal Methoxasol- T varja bejn pajjiżi ta ’ l- UE, ħnieżer 3- 5 ijiem u tiġieġ li ma jbiedux 6- 10 ijiem.
The MAH proposed a withdrawal period of 5 days in pigs and 6 days in broilers.
Il- MAH ippropona perijodu ta ’ irtirar ta ’ 5 ijiem fil- ħnieżer u 6 ijiem fil- brojlers.
Based on a residue study in pigs a 3 days withdrawal period was recommended.
Perijodu ta ’ irtirar ta ’ 3 ijiem kien irrikkmandat abbażi ta ’ studju ta ’ residwi fil- ħnieżer.
No statistical approach was followed because both TMP and SMX concentrations in muscle, liver, kidney and fat + skin were below limit of quantification at the first sampling point 2 days after cessation of Methoxasol- T medication.
L- ebda avviċinament statistiku ma kien segwit peress li kemm konċentrazzjonijiet ta ’ TMP u ta ’ SMX fil - muskolu, fwied, kilwa u xaħam + ġilda ma kienu taħt limitu ta ’ kwantifikazzjoni fil- punt ta ’ l- ewwel teħid ta ’ kampjuni jumejn wara t- twaqqif ta ’ medikazzjoni Methoxasol - T.
Thus it appears that 5 days is acceptable for pigs.
Għalhekk jidher li 5 ijiem huma aċċettabbli għal ħnieżer.
In an old study in broilers with a dose of 38.5mg / kg bwt depletion in skin and plasma demonstrated that the residues were below the MRL by 4 days.
Fi studju antik fil- brojlers b’ doża ta ’ 38. 5mg / kg piż tal- ġisem (bwt) fil- ġilda u fil- plażma wera li r - reżidwi kienu taħt l- MRL sa 4 ijiem.
A residue depletion study in broilers was conducted following use of Methoxasol-T at a dose of 70mg/ kg/ day for 5 days.
Wara l- użu ta ’ Methoxasol- T f’ doża ta ’ 70mg/ kg/ kuljum għal 5 ijiem sar studju ta ’ żvujtar tar- reżidwu fil- brojlers sar.
The residues were rapidly depleted.
Ir- residwi kienu żvujtati rapidament.
The data show that skin was a marker tissue and sulfamethoxazole the marker residue.
Id- dejta turi li l- ġilda kienet marker tat- tessuti u sulfamethoxazole l- marker tar- residwu.
Within 2 days following treatment residue concentrations of trimethoprim and sulphamethoxazole were below the MRL in all edible tissues, with the exception of skin.
Fi żmien jumejn wara l- kura, il- konċentrazzjonijiet tar- residwi ta ’ trimethoprim u sulphamethoxazole kienu taħt l- MRL fit - tessuti li jittieklu kollha, bl- eċċezzjoni tal- ġilda.
A GLP study on pharmacokinetics following water medication of 35 mg TMP/ SMX per kg per day was carried out.
Sar studju GLP fuq il- farmakokinetika wara medikazzjoni bl- ilma ta ’ 35 mg TMP/ SMX kull kg kuljum.
Plasma elimination of both TMP and suphamethoxazole in broilers is more rapid than in pigs (TMP t½: < 1 h in broilers vs 2.5 h in pigs; SMX t½:
Eliminazzjoni mill- plażma kemm ta ’ TMP u kemm ta ’ suphamethoxazole fil- brojlers hija aktar rapida milli fil- ħnieżer (TMP t½: < 1 h fil- brojlers vs 2. 5 h fil- ħnieżer; SMX t½:
1.7 h in broilers vs 2.3 h in pigs).
1. 7 h fil- brojlers vs 2. 3 h fil- ħnieżer).
Since there is no high tissue accumulation for any of the compounds it is expected that the depletion in broiler tissues is as rapid as the depletion in pigs.
Peress li ma hemm l- ebda akkumulazzjoni għolja fit- tessuti għal kwalunkwe mit- taħlitiet huwa mistenni li l- iżvujtar fit- tessuti tal- brojlers kien rapidu daqs l- iżvujtar fil- ħnieżer.
Consequently, the proposed withdrawal of 6 days in broilers is on the safe side.
Konsegwentement, l- irtirar propost ta ’ 6 ijiem fil - brojlers huwa fis- sikur.
The CVMP recommends the following changes to the SPC proposed by the MAH:
Is- CVMP jirrikmanda t- tibdil li ġej fl- SPC propost mill- MAH:
SPC guideline states:
4. 3 Kontra- indikazzjonijiet Din is- sezzjoni hija strettament riżervata għall- kontra- indikazzjonijiet relatati mas- sigurtà ta ’ l - annimali ikkurati.
The contraindication for laying birds should be deleted.
Il- linja gwida ta ’ l- SPC tgħid: “ Sitwazzjonijiet, li jseħħu minn sett ta ’ ċirkostanzi fejn il- prodotti mediċinali veterinarji ma jistgħux jintużaw għal raġunijiet ta ’ sigurtà ta ’ l- annimali fil - mira, jiġifieri kontra- indikazzjonijiet assoluti, huma s- suġġett ta ’ din is- sezzjoni. ” Il - kontraindikazzjoni għal għasafar li jbidu għandha titħassar.
4.11 Withdrawal period The sentence "Not permitted for use in laying birds..." should be changed to "Not authorised for use in laying birds..." in accordance with the SPC guideline.
4. 11 Perijodu ta ’ irtirar Is- sentenza “ Mhux permess għal użu f’ għasafar li jbidu … ” għandha tinbidel għal “ Mhux awtorizzat għal użu f’ għasafar li jbidu … ” b’ mod konformi mal- linja gwida ta ’ l- SPC.
5.1:
9/ 20 5. 1:
Delete MIC data
Ħassar dejta MIC
5.2: protein binding for TMP and SMX is not high (TMP 50, SMX 60), but the overall proposal of the MAH can be accepted.
5. 2: l- irbit mal- proteini għal TMP u SMX mhuwiex għoli (TMP 50, SMX 60), iżda l- proposta totali tal- MAH tista ’ tiġi aċċettata.
Conclusion
Konklużjoni