qanastek/EMEA-V3 huggingface dataset:
Therefore the Committee recommends maintaining the Marketing Authorisations for all veterinary medicinal products as referred to in Annex I and to vary the Marketing Authorisations in order to harmonise the indications and dosing regimens as described in the paragraph above.
Għall- valutazzjoni tal- esponiment, l- ekwazzjonijiet skond il- linja gwida tal- CVMP (Valutazzjoni tal - Impatt Ambjentali għall- Prodotti Mediċinali Veterinarji b' appoġġ għal- linji gwida GL6 u GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)) ntużaw ma 'parametri modifikati biex jirriflettu l- użu effettiv ta' toltrazuril.
This procedure will involve removing the following recommendations and indications for which no data were provided:
Madankollu, ġie nnutat li l - indikazzjonijiet, l- ispeċi u l- pożoloġija fl- SPCs ta 'wħud mill- prodotti awtorizzati kienu differenti u għalhekk dawn jeħtieġu li jiġu emendati skond l- indikazzjonijiet u l- preskrizzjoni tad- dożi użati fil - valutazzjoni tar- riskju ambjentali.
repeat treatment can be administered after 5 days if infection is severe; prevention and control of coccidiosis; use in pigeons.
Din il- proċedura se tinvolvi t- tneħħija tar- rakkomandazzjonijiet u l - indikazzjonijiet li ġejjin li għalihom ma ġiet ipprovduta l- ebda data: il- kura tista 'tiġi ripetuta wara ħamest ijiem jekk l- infezzjoni tkun severa; o il- prevenzjoni u l- kontroll tal- koċċidjożi; o l- użu fil- ħamiem. o
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
EMENDI GĦALL- ĠABRA FIL- QOSOR TAL- KARATTERISTIĊI TAL- PRODOTT
Amendments to be included in the relevant sections of the SPC:
Emendi li għandhom jiddaħħlu fis- sezzjonijiet rilevanti tal- SPC:
CLINICAL PARTICULARS Delete, where applicable, prevention and control of coccidiosis.
KARATTERISTIĊI KLINIĊI Ħassar, fejn applikabbli, prevenzjoni u kontroll tal- koċċidjożi.
Delete, where applicable, repeated treatment.
Ħassar, fejn applikabbli, kura ripetuta.
Delete, where applicable, pigeons.
Ħassar, fejn applikabbli, ħamiem.
London, 26 September 2008 EMEA/ 402698/ 2008
Londra, 26 ta ’ Settembru 2008 EMEA/ 402698/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU (CVMP)
OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR
OPINJONI WARA RIFERIMENT TAĦT L- ARTIKOLU 351
ALL AUTHORISED VETERINARY MEDICINAL PRODUCTS CONTAINING
GĦALL- PRODOTTI MEDIĊINALI VETERINARJI AWTORIZZATI KOLLHA LI FIHOM
TOLTRAZURIL INTENDED FOR USE IN POULTRY SPECIES
TOLTRAZURIL MAĦSUBA GĦALL- UŻU FI SPEĊI TA ’ TJUR
Toltrazuril is a triazinetrione derivative administered orally in the drinking water for the treatment of coccidiosis in chickens and turkeys.
Toltrazuril huwa derivattiv ta ’ triazinetrione li jingħata mill- ħalq fl- ilma tax- xorb għall- kura ta ’ kokkidijożi f ’ tiġieġ u dundjani.
The recommended dose and duration of treatment for chickens and turkeys is 7 mg/ kg bodyweight per day for two consecutive days.
Id- doża rakkomandata u t- tul tal- kura għal tiġieġ u dundjani hija 7 mg/ kg piż tal- ġisem kuljum għal jumejn konsekuttivi.
In practice this means that in intensive systems all the birds in one house will be treated even if not all exhibit signs of disease.
Fil- prattika dan ifisser li f’ sistemi intensivi, it - tjur kollha miżmumin f’ daqqa jiġu trattati anke jekk mhux kollha juru sinjali tal- marda.
Marketing Authorisations for veterinary medicinal products containing toltrazuril and intended for use in poultry species were previously granted to Bayer HealthCare and/ or Ceva Santé Animale in Austria, Belgium, Bulgaria, Cyprus, Czech republic, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, the Netherlands and the United Kingdom following national marketing authorisation procedures.
L- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għal prodotti mediċinali veterinarji li fihom toltrazuril u li huma maħsubin sabiex jintużaw fi speċi tat- tjur ingħataw preċedentement lil Bayer HealthCare u/ jew lil Ceva Santé Animale fl- Awstrija, il- Belġju, il- Bulgarija, Ċipru, ir- Repubblika Ċeka, Franza, il - Ġermanja, il- Greċja, l- Ungerija, l- Irlanda, l- Italja, il- Polonja, il- Portugall, ir- Rumanija, is- Slovakja, is - Slovenja, l- Olanda u r- Renju Unit wara proċeduri nazzjonali ta ’ awtorizzazzjoni għat- tqegħid fis- suq.
On 31 August 2007 a Community referral under Article 35 of Directive 2001/ 82/ EC, as amended, was initiated by Germany for the nationally authorised product Baycox 2.5% (solution for poultry).
Fil- 31 ta ’ Awwissu 2007, inbeda riferiment Komunitarju skont l- Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendata, mill- Ġermanja għall- prodott awtorizzat fuq livell nazzjonali, Baycox 2. 5% (soluzzjoni għat- tjur).
On 10 October 2007 the European Commission decided that the scope of the referral should include all authorised veterinary medicinal products containing toltrazuril (i. e. reference product and generics thereof) and intended for use in poultry species.
Fl- 10 ta ’ Ottubru 2007, il- Kummissjoni Ewropea ddeċidiet li l- ambitu tar- riferiment għandu jinkludi l - prodotti mediċinali veterinarji awtorizzati kollha li fihom toltrazuril (jiġifieri il- prodott ta ’ riferiment u l- ġeneriċi tiegħu) u maħsubin għall- użu fi speċi ta ’ tjur.
Germany referred the issue to CVMP due to concerns that toltrazuril may present a potential serious risk to the environment on the following grounds:
Il- Ġermanja rreferiet il- kwistjoni lis- CVMP minħabba tħassib li toltrazuril jista ’ jippreżenta riskju serju potenzjali għall- ambjent għar- raġunijiet li ġejjin:
An extended risk assessment on the basis of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines fully and clearly demonstrated that veterinary medicinal products containing toltrazuril and intended for use in poultry species must be expected to have impact on the environment.
Valutazzjoni tar- riskji estiża abbażi tal- linji gwida tal- Kooperazzjoni Internazzjoni dwar l - Armonizzazzjoni ta ’ Rekwiżiti Tekniċi għar- Reġistrazzjoni ta ’ Prodotti Mediċinali Veterinarji (VICH) uriet b’ mod ċar u sħiħ li l- prodotti mediċinali veterinarji li fihom toltrazuril u li huma maħsubin sabiex jintużaw fi speċi ta ’ tjur huma mistennija li jkollhom impatt fuq l- ambjent.
The arbitration procedure started on 11 October 2007 with the adoption of a list of questions to be put to the Marketing Authorisation Holders.
Il- proċedura ta ’ arbitraġġ bdiet fil- 11 ta ’ Ottubru 2007 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet li għandhom jiġu mistoqsijin lid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq.
The Rapporteur and Co-Rapporteur appointed were Mrs R.
Ir- Relatur u l- Ko - Relatur maħturin kienu s- Sinjura R.
Kearsley and Mr G.
Kearsley u s- Sur G.
Schefferlie respectively.
Schefferlie rispettivament.
The date set for submission of written responses by the Marketing Authorisation Holders was 14 January 2008.
Id- data li ġiet
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. stabbilita għas- sottomissjoni tat- tweġibiet bil- miktub mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq kienet l- 14 ta ’ Jannar 2008.
During its 11-13 December 2007 meeting, the CVMP agreed on a two month extension to the date for submission of responses to the list of questions following a request from Bayer HealthCare.
Matul il- laqgħa tiegħu tal- 11- 13 ta ’ Diċembru 2007, is- CVMP qabel fuq estensjoni ta ’ xahrejn għad - data għas- sottomissjoni tat- tweġibiet għal- lista ta ’ mistoqsijiet fuq talba ta ’ Bayer HealthCare.
Written explanations were provided by the Marketing Authorisation Holders on 18 March 2008.
Fit- 18 ta ’ Marzu 2008 ngħataw spjegazzjonijiet bil- miktub lid- Detenturi tal- Awtorizzazzjonijiet għat - Tqegħid fis- Suq.
The Marketing Authorisation Holders presented oral explanations to the CVMP on 18 June 2008.
Id- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ippreżentaw spjegi bil- fomm lis- CVMP fit- 18 ta ’ Ġunju 2008.
During its July 2008 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the assessment of the risk presented by toltrazuril and its major metabolite, toltrazuril sulfone, to terrestrial plants and to groundwater demonstrated that use of products containing toltrazuril is acceptable.
Matul il- laqgħa tiegħu ta ’ Lulju 2008, is- CVMP, fid- dawl tad- data ġenerali sottomessa u tad - diskussjoni xjentifika fi ħdan il- Kumitat, adotta opinjoni b’ kunsens li tikkonkludi li l- valutazzjoni tar - riskji ppreżentati minn toltrazuril u l- metabolit maġġuri tiegħu, toltrazuril sulfone, għal pjanti terrestri u għall- ilma ta ’ taħt l- art uriet li l- użu ta ’ prodotti li fihom toltrazuril huwa aċċettabbli.
The CVMP concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided that the product is used under the conditions agreed, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Is- CVMP ikkonkluda li l- awtorizzazzjonijiet għat- tqegħid fis- suq jistgħu jinżammu mingħajr twissijiet speċjali fil- punt 5. 3 (Karatteristiċi ambjentali) tal- SPC diment li l- prodott jintuża skont il- kundizzjonijiet miftehma, jiġifieri, doża ta ’ 7 mg/ kg piż tal- ġisem fuq jumejn konsekuttivi għall- kura ta ’ kokkidijożi f ’ tiġieġ u dundjani.
However, it was noted that the indications, species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Madankollu, ġie nnotat li l- indikazzjonijiet, l- ispeċi u l- pożoloġija fl- SPCs ta ’ uħud mill- prodotti awtorizzati kienu differenti u għaldaqstant, dawn ħtieġu li jiġu emendati sabiex jinġiebu konformi ma ’ l- indikazzjonijiet u r- reġimi ta ’ dożaġġ użati fil- valutazzjoni tar- riskji ambjentali.
Therefore the Committee recommended maintaining the Marketing Authorisations for all veterinary medicinal products containing toltrazuril intended for use in chickens and turkeys.
Għaldaqstant, il- Kumitat irrakkomanda li jinżammu l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għall - prodotti mediċinali veterinarji kollha li fihom toltrazuril maħsubin sabiex jintużaw f ’ tiġieġ u dundjani.
This pr ocedure will inv olve rem oving the following recommendations and indications for which no data were provided:
Il- Kumitat irrakkomanda wkoll li l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq relevanti għandhom jiġu varjati sabiex jiġu armonizzati l- indikazzjonijiet u r- reġimi ta ’ dożaġġ sabiex dawn jinġiebu konformi ma ’ dawk użati fil- valutazzjoni tar- riskji ambjentali.
repeat treatment can be administered after 5 days if infection is severe; prevention and control of coccidiosis; use in pigeons.
Din il- proċedura tinvolvi t - tneħħija tar- rakkomandazzjonijiet u tal- indikazzjonijiet li ġejjin li għalihom ma ġiet ipprovduta ebda data: jista ’ jingħata trattament ripetut wara 5 ijiem jekk l- infezzjoni tkun waħda severa; o il- prevenzjoni u l- kontroll tal- kokkidijożi; o l- użu fil- ħamiem. o
The list of product names concerned is given in Annex I.
Il- lista ta ’ l- ismijiet tal- prodotti konċernati hija pprovduta fl- Anness I.
The scientific conclusions are provided in Annex II, together with the amendments to the relevant sections of the Summary of Product Characteristics in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II flimkien ma ’ l- emendi għas- sezzjonijiet relevanti tas- Sommarju tal - Karatteristiċi tal- Prodott fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 26 September 2008.
L- opinjoni finali inqelbet f’ Deċiżjoni mill- Kummissjoni Ewropea fis- 26 ta ’ Settembru 2008.
EMEA/402698/2008-EN
EMEA/ 402698/ 2008- MT
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London, August 2008 EMEA/ 457286/ 2008
Londra, Awwissu 2008 EMEA/ 457286/ 2008
OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 35 GĦAL PRODOTTI MEDIĊINALI LI FIHOM IS- SUSTANZI ATTIVI TRIMETHOPRIM U SULFADIAZINE
On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/ 82/ EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Fil- 11 ta ’ Lulju tal- 2007, Franza ppreżentat lill- EMEA riferiment skont l- Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendata, dwar Pejst Orali għaż- Żwiemel Tribrissen (inkluż ismijiet assoċjati) u prodotti awtorizzati li għalihom dan il- prodott serva bħala prodott ta ’ referenza, li fihom trimethoprim u sulfadiazine bħala sustanzi attivi.
France considered that the dosing regime of the product is not correct.
Franza qieset li r- reġim tad- dożaġġ tal- prodott mhuwiex korrett.
It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Qieset li dan jista ’ jwassal għal nuqqas ta ’ effikaċja u jsaħħaħ l- iżvilupp tar- reżistenza fil- patoġeni fil- mira, li possibbilment jista ’ jwassal għal riskji għas- saħħa tal- bniedem fejn għandhom x’ jaqsmu batterji żoonotiċi.
The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Is- CVMP beda proċedura ta ’ riferiment waqt il- laqgħa tiegħu ta ’ bejn l- 10 u t- 12 ta ’ Lulju 2007.
The Marketing Authorisation Holders were requested in a list of questions to provide: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria. o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data. o The Periodic Safety Update Reports for at least the last 3 years. • Justification of the withdrawal period, in case the recommended dose should increase.
Id - Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq intalbu permezz ta ’ lista ta ’ mistoqsijiet jipprovdu: • Ġustifikazzjoni tad- doża rakkomandata għal kull waħda mill- indikazzjonijiet imsemmija b’ rabta mal- effikaċja u l- għażla potenzjali ta ’ batterji b’ reżistenza antimikrobika. o Parti I Sommarju tad- dokumentazzjoni, inkluż is- Sommarju tal- Karatteristiċi tal- Prodott, ir - rapporti esperti u l- kompożizzjoni kwantitattiva u kwalitattiva tal- prodott; o Jekk applikabbli, Parti IV Tagħrif dwar l- Effikaċja, inkluż tagħrif dwar il- farmakokinetika, il - farmakodinamika u d- dejta dwar ir- reżistenza antimikrobika. o Ir- Rapporti ta ’ Aġġornament Perjodiku dwar is- Sigurtà għal tal- anqas l- aħħar 3 snin. • Ġustifikazzjoni tal- perjodu ta ’ rtirar, f’ każ li d- doża rakkomandata jkollha tiżdied.
Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/ kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
Id- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq issottomettew tweġibiet bil- miktub, li jiddefendu d- doża awtorizzata ta ’ 1x30 mg/ kg piż korporali kuljum għall- indikazzjonijiet kollha iżda ssuġġerew li tista ’ tkun meħtieġa doża ogħla fil- każ ta ’ salmonellożi.
Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
La r- Rapporti ta ’ Aġġornament Perjodiku dwar is- Sigurtà tal- prodotti u lanqas il- letteratura ppreżentata ma inkludew rapporti ta ’ nuqqas ta ’ effikaċja fil- qasam.
Having assessed the responses, the CVMP concluded that:
Wara li vvaluta r- risposti, is- CVMP ikkonkluda li:
The efficacy of a dose of 1x30 mg/ kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
L- effikaċja ta ’ doża ta ’ 1x30 mg/ kg piż korporali kuljum li trid tiġi amministrata fuq perjodu massimu ta ’ 5 ijiem ġiet issostanzjata għall- indikazzjonijet kollha ħlief għas- salmonellożi.
There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Ma hemm l- ebda evidenza dokumentata ta ’ problemi relatati man- nuqqas ta ’ effikaċja jew ma ’ xi tibdil fis- sitwazzjoni ta ’ reżistenza tal- patoġeni fil- mira relevanti li kienu se jwasslu għal tħassib relatat mas- saħħa tal- annimali jew tal- bnedmin.
No dose could be established for the treatment of salmonellosis.
Ma setgħet tiġi stabbilita l- ebda doża għat- trattament tas- salmonellożi.
The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
L- użu tal- prodott m’ għandux ikun ibbażat fuq l- ittestjar għas- suxxettibilità u għandu jqis il- politiki antimikrobiċi uffiċjali u lokali.
The established withdrawal periods are safe and can be retained.
Il- perjodi ta ’ rtirar stabbiliti huma siguri u jistgħu jinżammu.
The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
Is- CVMP irrakkomanda l- varjazzjoni tal- Awtorizzazzjonijiet għat- Tqegħid fis- Suq tal- prodotti mediċinali veterinarji kkonċernati bi qbil mal- konklużjonijiet fejn applikabbli.
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
L- Opinjoni tas- CVMP ġiet adottata fit- 12 ta ’ Diċembru 2007 u d- Deċiżjoni tal- Kummissjoni sussegwenti fil- 11 ta ’ Marzu 2008.
EMEA/ 457286/ 2008-EN
EMEA/ 457286/ 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 'ANNIMAL, MNEJN JINGĦATA, U DETENTUR TA' L- AWTORIZZAZZJONI GĦALL - KUMMERĊJALIZZAZZJONI / APPLIKANT
1/ 16 Member State / Marketing Authorisation Number
1/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
Marketing Authorisation Holder
Detentur ta 'l - Awtorizzazzjoni tat- Tqegħid fis - Suq
Animal species
Speċi ta 'annimal
Netherlands NL 10351
L- Olanda NL 10351
Oral paste
Pejst orali
Active substances per gram:
Sustanzi attivi għal kull gramma:
horses
żwiemel
Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; Gastrointestinal infections
Infezzjonijiet fl- apparat respiratorju assoċjati ma 'Streptococcus spp. u Staphylococcus aureus;
One syringe is intended for 600
5 mg trimethoprim u 25 mg sulfadiazine għal kull kg ta 'piż tal- ġisem kuljum għal massimu ta' 5 ijiem.
Trimethoprim 66,7 mg Sulfadiazine 333,3 mg
Trimethoprim 66, 7 mg Sulfadiazine 333, 3 mg
associated with E.
infezzjonijiet gastrointestinali assoċjati ma' E.
Coli; Urogenital infections associated with beta-hemolytic streptococci; Wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus.
Coli; infezzjonijiet uroġenitali assoċjati ma 'streptokokki beta emolitiċi; infezzjonijiet f' feriti assoċjati ma' Streptococcus spp. u Staphylococcus aureus.
kg bodyweight and each syringe is subdivided into 12 markings.
Kull siringa hija maħsuba għal 600 kg piż tal- ġisem u kull siringa hija suddiviża fi 12- il marka.
The equivalent of one marking is sufficient to treat 50 kg of bodyweight.
L- ekwivalenti ta 'marka waħda hija biżżejjed sabiex jiġu ttrattati 50 kg ta' piż tal - ġisem.
Netherlands NL 10437
L- Olanda NL 10437
Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; Gastrointestinal infections associated with E. coli; Urogenital infections associated with beta-hemolytic streptococci; Wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus.
Infezzjonijiet fl- apparat respiratorju assoċjati ma 'Streptococcus spp. u Staphylococcus aureus;
5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
5 mg trimethoprim u 25 mg sulfadiazine għal kull kg ta 'piż tal- ġisem kuljum għal massimu ta' 5 ijiem.
One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings.
Kull siringa hija maħsuba għal 600 kg piż tal- ġisem u kull siringa hija subdiviża fi 12- il marka.
The equivalent of one marking is sufficient to treat 50 kg of bodyweight.
L- ekwivalenti ta 'marka waħda hija biżżejjed sabiex jiġu ttrattati 50 kg piż tal - ġisem.
Belgium 282IS20F7
Il- Belġju 282IS20F7
(Belgium)
(Il -
Tribrissen Oral Paste
Tribrissen Pejst Orali
Pro 100 g:
Pro 100 g:
Tribrissen Oral Paste is indicated for the treatment of horses with bacterial infections caused by sensitive bacteria, including: - gastro-intestinal infections - infections of respiratory tracts - infections of urogenital tracts
Tribrissen Pejst Orali huwa indikat għat- trattament ta '
The dose is 30 mg/ kg body weight per day.
Id- doża hija ta '30 mg/ kg piż tal- ġisem kuljum.
2/ 16 Member State / Marketing Authorisation Number
2/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
- wound infections and cellulitis - salmonellosis
żwiemel b' infezzjonijiet batteriċi kkawżati minn batterji sensittivi, inkluż: - infezzjonijiet gastrointestinali - infezzjonijiet fl- apparati respiratorji
paste for 50 kg body weight.
Kull unità fuq l- iskala tal- planġer tipprovdi pejst biżżejjed għal 50 kg piż tal- ġisem.
- as profylacticum for post- operative infections
- infezzjonijiet ta 'l- apparati uroġenitali - infezzjonijiet f' feriti u ċellulite - salmonellożi - bħala trattament profilattiku għal infezzjonijiet wara operazzjoni.
For horses, the following dosages can be applied according to the nature and seriousness of the ailment: − Gastro-intestinal infections:
Għaż- żwiemel, jistgħu jiġu applikati d- dożaġġi li ġejjin skond in- natura u l- gravità ta 'l- infezzjoni: − Infezzjonijiet gastrointestinali:
30 mg/ kg/ day over 2 applications of 15 mg/ kg body weight/ day or 1 application of 30 mg/ kg/ day, during minimal 5 days or until 2 days after the symptoms have disappeared. − Serious acute infections outside of the intestinal tracts (respiratory-urinal tracts): first an injection of Tribrissen 48% or Duoprim, followed by a daily administration of Tribrissen Oral Paste at 30mg/ kg/ day over 2 applications of 15 mg/ kg body weight/ day or 1 administrations of 30 mg/ kg/ day, during minimal 5 days or until 2 days after the symptoms have disappeared.
30 mg/ kg kuljum fuq 2 applikazzjonijiet ta '15 mg/ kg piż tal- ġisem kuljum jew applikazzjoni 1 ta' 30 mg/ kg kuljum, matul għallinqas 5 ijiem jew wara li jkunu għaddew jumejn mingħajr sintomi. − Infezzjonijiet akuti gravi barra mill- apparati intestinali (apparati respiratorji- urinarji): l - ewwel injezzjoni ta 'Tribrissen 48% jew Duoprim, segwita minn amministrazzjoni ta'
3/ 16 Member State / Marketing Authorisation Number
3/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
− Infections of the genital tracts.
Doża rrakkomandata Tribrissen Pejst Orali fi 30mg/ kg kuljum fuq 2 applikazzjonijiet ta '15 mg/ kg piż tal- ġisem kuljum jew amministrazzjoni 1 ta' 30 mg/ kg kuljum matul għallinqas 5 ijiem jew sakemm ikunu għaddew jumejn mingħajr sintomi. − Infezzjonijiet ta 'l - apparati ġenetali.
Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, an intra-uterine treatment will be administered with 10 ml Tribrissen 48%, diluted in an isotonic solution of 100 ml during 3 days. − Wound infections.
Wara trattament orali matul 5 ijiem jew wara li jkunu għaddew jumejn mingħajr sintomi, jingħata trattament fl - utru b' 10 ml Tribrissen 48%, maħlul f' soluzzjoni isotonika ta '100 ml matul 3 ijiem. − Infezzjonijiet minn feriti.
Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, a local treatment with Tribrissen Dispersible Powder will be administered.
Għat- trattament ta '
For the treatment of Salmonellosis, it is necessary to administer a double dose at 60 mg/ kg/ day.
Doża rrakkomandata salmonellożi, jeħtieġ li tingħata doża doppja, jiġifieri, 60 mg/ kg kuljum.
This dose needs to be administered in 2 times.
Din id- doża trid tingħata f' darbtejn.
The treatment must be given during 10 days.
It- trattament għandu jingħata fi żmien 10 ijiem.
Netherlands NL 5055
L- Olanda NL 5055
(Belgium)
(Il- Belġju)
Per 30 mg paste:
Għal kull 30 mg ta 'pejst:
Sulfadiazine 10 mg
Sulfadiazine 10
-- respiratory infections caused by Streptococcus spp., Staphylococcus aureus; - gastro-intestinal infections caused by E. coli;
Staphylococcus aureus;
5 days
massimu ta '5 ijiem
Trimethoprim 2 mg
mg Trimethoprim 2 mg
- urogenital infections caused by bèta-haemolytic streptococci; - wounds and abscesses by Streptococcus spp., Staphylococcus aureus.
- infezzjonijiet gastrointestinali kkawżati minn E. coli; - infezzjonijiet uroġenitali kkawżati minn streptokokki beta emolitiċi; - feriti u axxessi minn Streptococcus spp., Staphylococcus aureus.
Sweden 10893
L- Iżezja 10893
Schering- Plough A/ S (Denmark)
Schering- Plough A/ S (Id - Danimarka)
Sulfadiazine 333 mg Trimethoprim 67 mg
Sulfadiazine 333 mg Trimethoprim
Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Infezzjonijiet batteriċi, per eżempju feriti infettati, fl - apparat respiratorju, fl -
30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37.5 g paste (one tube) per os to a 500 kg horse 1- 2 times daily.
30 mg ta 'komponenti attivi kombinati għal kull kg ta' piż tal- ġisem minn darba għal darbtejn kuljum, li
Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for at least 2 days.
Doża rrakkomandata b' injezzjoni inizjali ta 'Tribrissen Injection, segwita minn pejst orali għal 5 ijiem jew sakemm ma jkunu dehru ebda sintomi għal mill- inqas jumejn.
Treated animals should have free access to water.
Annimali ttrattati għandu jkollhom aċċess liberu għall- ilma.
Iceland MTnr 880040
L- Iżlanda MTnr 880040
Schering Plough A/ S (Denmark)
Schering Plough A/ S (Id - Danimarka)
Sulfadiazine 333 mg/ g Trimethoprim 67 mg/ g
Sulfadiazine 333 mg/ g Trimethoprim 67 mg/ g
Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Infezzjonijiet batteriċi, per eżempju feriti infettati, fl - apparat respiratorju, fl - apparat GI jew fis- sistema uroġenitali.
30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37.5 g paste (one tube) per os to a 500 kg horse 1- 2 times daily.
30 mg ta 'kompoenti attivi kombinati għal kull kg ta' piż tal- ġisem minn darba għal darbtejn kuljum, li jikkorrispondu għal 37. 5 g pejst (tubu wieħed) mill- ħalq għal żiemel ta '500 kg minn darba għal darbtejn kuljum.
Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for
Preferibbilment, żwiemel għandhom jiġu ttrattati b' injezzjoni inizjali ta 'Tribrissen Injection, segwita minn pejst orali għal 5 ijiem jew sakemm ma jkunu dehru ebda sintomi għal mill- inqas jumejn.
UK Vm 00201/ 4064
Ir- Renju Unit Vm 00201/ 4064
Schering- Plough Limited (UK)
Schering- Plough Limited (ir- Renju Unit)
Active constituents %w/ w:
Komponenti attivi% w/ w:
The product is recommended for 30mg the treatment of bacterial diseases in horses including: - Alimentary tract infections.
Il- prodott huwa rakkomandat għat - trattament ta 'mard battriku fiż- żwiemel fosthom: - Infezzjonijiet fl- apparat
of combined active ingredients per kg bodyweight daily.
30 mg ta 'komponenti attivi kombinati għal kull kg ta' piż tal- ġisem kuljum.
This dose is provided by adjusting the screw-gauge on
6/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
Sulfadiazine 33.3 Trimethoprim
Detentur ta 'l - Awtorizzazzjoni tat- Tqegħid fis - Suq
- Upper and lower respiratory tract infections, including strangles.
Isem ivvintat tal - prodott
the plunger of the syringe according to the bodyweight of the horse.
Qawwa / Sustanza attiva (INN) Trimethoprim 6. 7
Each division on the
Speċi ta 'annimal
6.7
Indikazzjoni terapewtika: alimentari. - Infezzjonijiet fil- parti t' isfel jew ta 'fuq ta' l - apparat respiratorju, inkluża l- adenite taż - żwiemel (strangles). - Feriti infettati u ċellulite. - Salmonellożi. - Medikazzjoni antibatterika f' każijiet
- Infected wounds and cellulitis. plunger provides sufficient - Salmonellosis. paste to medicate 50 kg - Antibacterial medication in bodyweight.
Kull diviżjoni fuq il - planġer tipprovdi pejst biżżejjed biex tfejjaq 50 kg ta 'piż tal- ġisem.
Each syringe surgical cases where asepsis provides a daily dose for a 500 cannot be guaranteed. kg horse.
Kull siringa tipprovdi doża ta 'kuljum għal żiemel ta' 500 kg.
The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days.
Id- doża tista 'tingħata darba kuljum, jew id- doża ta' kuljum tista 'tkun diviża u amministrata f' intervalli ta' 12- il siegħa, għal 5 ijiem jew sakemm ikunu għaddew jumejn mingħajr sintomi, sa massimu ta '5 ijiem.
Ireland VPA 10277/ 41/ 1
L- Irlanda VPA 10277/ 41/ 1
Sulfadiazine 333 mg Trimethoprim 67 mg
Sulfadiazine 333 mg Trimethoprim 67 mg
The product is recommended for 30mg of combined active the treatment of bacterial diseases ingredients per kg bodyweight in horses including: daily.
Il- prodott huwa rakkomandat għat - trattament ta 'mard batteriku fiż- żwiemel fosthom: - Infezzjonijiet fl- apparat alimentari. - Infezzjonijiet fil- parti t' isfel jew ta' fuq ta 'l - apparat respiratorju, fostjhom l- adenite taż - żwiemel (strangles). - Feriti infettati u ċellulite. - Salmonellożi.
This dose is provided by - Alimentary tract infections. adjusting the screw-gauge on - Upper and lower respiratory the plunger of the syringe tract infections, including according to the bodyweight of strangles. the horse.
Din id- doża tingħata billi l - gauge tal- vit fuq il- planġer tas- siringa jiġi aġġustat skond il- piż tal- ġisem taż - żiemel.
Each division on the
Kull siringa tipprovdi doża ta 'kuljum għal żiemel ta' 500
6/ 16 Member State / Marketing Authorisation Number
7/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
Therapeutic indication:
Indikazzjoni terapewtika: - Medikazzjoni antibatterika f' każijiet
Recommended dose
Doża rrakkomandata kg.
Each syringe provides a daily dose for a 500 kg horse.
kirurġiċi fejn l- asepsi ma tistax tkun garantita.
The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days.
Id- doża tista 'tingħata darba kuljum, jew inkella d- doża ta' kuljum tista 'tinqasam u tingħata f' intervalli ta' 12- il siegħa, għal ħamest ijiem jew sakemm ikun għaddew jumejn mingħajr sintomi sa massimu ta '5 ijiem.
Preferably, horses should be treated initially with an initial injection of Tribrissen Injection 48% or Trivetrin Injection followed by daily administration of Tribrissen Oral Paste.
Preferibbilment, iż- żwiemel għandhom jiġu injettati b' injezzjoni inizjali ta 'Tribrissen Injection 48% jew b' Trivetrin Injection segwiti minn amministrazzjoni ta' kuljum ta 'Tribrissen Oral Paste.
60 mg of combined active ingredients per kg bodyweight per day.
Għat- trattament ta 'salmonellożi, jeħtieġ li jingħata d- doppju tar- rata tad- doża msemmija hawn fuq, jiġifieri, 60 mg tal - komponenti attivi kombinati għal kull kg ta' piż tal- ġisem kuljum.
This should be given as two equally divided doses per day.
Dan għandu jingħata bħala żewġ dożi diviżi ugwalment kuljum.
Treatment should be
It - trattament għandu jitkompla
7/ 16 Member State / Marketing Authorisation Number
8/ 18 Stat Membru / Numru ta 'l- Awtorizzazzjoni tal - Kummerċjalizzazzjoni
continued for at least ten days.
Doża rrakkomandata għal mill- inqas għaxart ijiem.
Denmark 18146
Id- Danimarka 18146
Trimethoprim 58 mg/ g Sulfadiazine 288,3 mg/ g
Trimethoprim 58 mg/ g Sulfadiazine 288, 3 mg/ g
Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide
Infezzjonijiet fiż- żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimethoprim + sulphonamide
The paste is presented in a syringe of plastic with the dose to treat 50 kg of horse.
Il- pejst huwa ppreżentat f' siringa tal- plastik bid- doża biex jiġi ttrattat żiemel ta '50 kg.
The daily dose is 30 mg combined active ingredients per kg body weight the equivalent to the contents of one syringe for a 500 kg horse
Id- doża ta 'kuljum hija 30 mg ta' komponenti attivi kombinati għal kull kg ta 'piż tal- ġisem ekwivalenti għall- kontenut ta' siringa waħda għal żiemel ta '500 kg
Ireland VPA 10999/ 23/ 1
L- Irlanda VPA 10999/ 23/ 1
Each 4.31g dose contains:
Kull doża ta '4. 31g fiha:
Trimethoprim 5.8 %w/ w Sulfadiazine 28.83 %w/ w
Trimethoprim 5. 8% piż/ piż Sulfadiazine 28. 83% w/ w
Norodine Equine Paste is indicated in the treatment of bacterial infections In horses caused by sensitive micro- organisms including: - Escherichia coli - Staphylococcus spp. - Streptococcus spp.
Norodine Equine Paste huwa indikat fit- trattament ta 'infezzjonijiet batteriċi fiż- żwiemel ikkawżati minn mikrorganiżmi sensittivi fosthom: - Escherichia coli - Staphylococcus spp. - Streptococcus spp.
The daily dose is 30 mg of combined actives per kg bodyweight by oral administration.
Id- doża ta 'kuljum hija 30 mg ta' komponenti attivi kombinati għal kull kg ta 'piż tal- ġisem permezz ta' amministrazzjoni mill- ħalq.
Treatment should be continued until 2 days after symptoms have resolved, up to a maximum of 5 days.
It- trattament għandu jitkompla wara li jkunu għaddew jumejn mingħajr sintomi, sa massimu ta '5 ijiem.
Norway 96-1182
In- Norveġja 96- 1182
Trimethoprim 58,00 mg, sulfadiazine 288,30 mg
Trimethoprim 58, 00 mg, sulfadiazine 288, 30 mg
The equivalent of one syringe is to treat 50 kg of body weight, from 50 kg to 500 kg.
L- ekwivalenti ta 'siringa waħda għandu jittratta 50 kg ta' piż tal- ġisem, minn 50 kg sa 500 kg.
The daily dose is 0.09 g oral paste (5 mg trimetoprim + 25 mg sulfadiazin) per kg body weight.
Dan huwa
This is equivalent to the contents of one syringe for a 500 kg horse.
Doża rrakkomandata ekwivalenti għall- kontenut ta 'siringa waħda ta' żiemel ta '500 kg.
Sweden 10966
L- Iżvezja 10966
1 g contain:
1 g fiha:
Sulfadiazine 288.3 mg
Sulfadiazine 288. 3 mg Trimethoprim 58. 0 mg
Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e. g. infections in the airways, GI-
Infezzjonijiet fiż- żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimetoprim + sulphonamide, eż. infezzjonijiet fil- passaġġi ta 'l- arja, fl- apparati GI, fl - apparat uroġenitali u f' feriti infettati.
The
45g/ żiemel ta '500 kg inkella 52g / 600kg (ugwali għal 30 mg/ kg tal- komponenti attivi kombinati) minn darba għal darbtejn kuljum.
treatment should continue in 5 days or until 2 days with no symptoms have passed.
It - trattament għandu jitkompla għal 5 ijiem jew wara li jkunu għaddew jumejn mingħajr sintomi.
The dosing-device is graded and each grade equals a dose for 50 kg bodyweight.
L- apparat tad- dosaġġ huwa gradat u kull grad huwa ugwali għal doża ta '50 kg piż tal- ġisem.
United Kingdom Vm 02000/ 4098
Ir- Renju Unit Vm 02000/ 4098
Each 45 g syringe contains:
Kull siringa ta '45 g fiha:
Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e. g. infections in the airways, GI-
Infezzjonijiet fiż- żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimetoprim + sulphonamide, eż. infezzjonijiet fil- passaġġi ta 'l- arja, fl- apparat GI, fl - apparat uroġenitali u f' feriti infettati.
Treatment
Id- doża ta 'kuljum hija 30 mg ta' komponenti attivi kombinati għal kull kg ta 'piż tal- ġisem permezz ta' amministrazzjoni mill- ħalq.
should be continued for up to 5 days or until 2 days after symptoms have resolved.
It- trattament għandu jitkompla sa 5 ijiem jew sa jumejn wara li s- sintomi jkunu għaddew.
Each syringe provides one daily dose for a 500 kg horse.
Kull siringa tagħti doża waħda ta 'kuljum għal żiemel ta' 500 kg.
Each division on the dial-a-dose plunger provides sufficient product to treat 50 kg of bodyweight.
Kull diviżjoni fuq il- planġer tat- tip 'dial- a- dose' tipprovdi prodott suffiċjenti biex jiġu ttrattati 50 kg tal- piż tal -
Trimethoprim 5.78%w/ w Sulfadiazine 28.89% w/ w
Sulfadiazine
horses
ikkawżati minn
Treatment of bacterial infections in horses caused by sensitive microorganisms including:
kombinati għal kull kg ta '
The product may be effective in alimentary tract infection such as diarrhoea; respiratory infections including pneumonia, pleurisy, strangles; wounds, septicaemia and general infections.
Il -
Each syringe contains one daily dose for a 500 kg horse.
fiha doża waħda ta 'kuljum għal żiemel ta' 500 kg.
Each division the dial-a-dose plunger provides sufficient medication to treat 50 kg of body weight.
Kull diviżjoni fuq il- planġer tat -
9/ 16 Member State / Marketing Authorisation Number
prodott jista 'jkun effikaċi f' infezzjoni fl- apparat alimentari bħal dijarrea;
Marketing Authorisation Holder
tip 'dial- a- dose' tipprovdi prodott suffiċjenti biex jiġu ttrattati 50 kg tal- piż tal -
Product invented name
infezzjonijiet respiratorji inkluż pulmonite, plewrite,
Pharmaceutical form
It- trattament għandu
Strength / Active substance (INN)
adenite taż- żwiemel (strangles); feriti, settiċemija u infezzjonijiet
Therapeutic indication:
jitkompla sa 5 ijiem jew sa jumejn wara li s- sintomi jkunu għaddew, sa massimu
Recommended dose
ġeneriċi.
up to a maximum of 5 days.
ta '5 ijiem.
Each 45g syringe contains:
Kull siringa ta '45g fiha:
The product is indicated in the treatment of bacterial infections in horses caused by sensitive micro-organisms including:
Il- prodott huwa indikat fit - trattament ta 'infezzjonijiet batteriċi fiż- żwiemel ikkawżati minn mikrorganiżmi sensittivi fosthom:
should be continued for up to 5 days or until 2 days after the symptoms have resolved.
It- trattament għandu jitkompla sa 5 ijiem jew sa jumejn wara li s- sintomi jkunu għaddew.
Each syringe provides one daily dose for a 500 kg horse.
għal żiemel ta '500 kg.
10/ 16 ANNEX II
12/ 18 ANNESS II
11/ 16 SCIENTIFIC CONCLUSIONS
13/ 18 KONKLUŻJONIJIET XJENTIFIĊI
On 11 July 2007, France presented to the EMEA a referral of TRIBRISSEN ORAL PASTE FOR HORSES (including associated names) and authorised products for which this product served as a reference product, under Article 35 of Directive 2001/ 82/ EC, as amended.
Fil- 11 ta 'Lulju ta' l- 2007, Franza ppreżentat lill- EMEA referenza ta 'TRIBRISSEN ORAL PASTE FOR HORSES (flimkien ma' ismijiet assoċjati) u prodotti awtorizzati li għalihom dan il- prodott serva bħala prodott ta 'referenza, skond l- Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendata.
France requested CVMP to consider the therapeutic scheme of these veterinary medicinal products and to indicate if the administration of the product once daily is considered appropriate in terms of efficacy and potential selection of antimicrobial resistant bacteria.
Franza tablet lis- CVMP sabiex jikkunsidra l- iskema terapewtika ta 'dawn il- prodotti mediċinali u biex jindika jekk l- għoti ta' dan il- prodott darba kuljum ikunx ikkunsidrat xieraq f' termini ta 'effikaċja u selezzjoni potenzjali ta' batterji reżistenti għall- prodotti antimikrobiċi.
France also requested CVMP to consider the consequences for the withdrawal period and ecotoxicity assessment in case the therapeutic scheme should be modified and the posology or the frequency of administration increased.
Franza tablet ukoll lis- CVMP jikkunsidra l- konsegwenzi tal- perjodu tat- tneħħija u l- valutazzjoni ta 'l- ekotossiċità u fil- każ li l - iskema terapewtika tkun modifikata u l- pożoloġija jew il- frekwenza ta' l- amministrazzjoni jiżdiedu.
France stated that these matters are of community interest because animal and human health concerns are at stake.
Franza stqarret li dawn il- materji huma ta 'interess għall- komunità għax jikkonċernaw is- saħħa ta' l - annimali u tal- bniedem.
CVMP decided not to review the ecotoxicity, as this was considered not applicable in the framework of the procedure.
Is- CVMP iddeċieda li ma jirrevedix l- ekotossiċità, għax dan ma kienx ikkunsidrat applikabbli fil- qafas tal- proċedura.
On 12 July 2007 CVMP sent a list of questions to all marketing authorisation holders.
Fit- 12 ta 'Lulju ta' l- 2007 s- CVMP bagħat lista ta 'mistoqsijiet lil dawk li għandhom l- awtorizzazzjoni għat- tqegħid fis- suq.
Responses were received by 16 October 2007.
It- tweġibiet intlaqgħu sas- 16 ta 'Ottubru ta' l- 2007.
The marketing authorisations for Tribrissen (Denmark), Tribrissen vet oraalipasta (Finland), Tribrissen vet Oralpasta til hest (Norway) were withdrawn during the referral procedure at the request of the marketing authorisation holder.
L- awtorizzazzjonijiet għat- tqegħid fis- suq għal Tribrissen (tad- Danimarka), Tribrissen vet oraalipasta (tal- Finlandja), Tribrissen vet Oralpasta til hest (tan- Norveġja) tneħħew matul il- proċedura ta 'referenza fuq talba tad- detentur ta' l- awtorizzazzjoni għat- tqegħid fis- suq.
Oriprim vet oral powder (Finland) was excluded from the scope of this referral procedure based on the fact that its pharmaceutical form is different from Tribrissen Oral Paste for Horses.
It- trab orali Oriprim vet (tal - Finlandja) ġie eskluż mill- ambitu ta 'din il- proċedura ta' referenza abbażi tal- fatt li l- għamla farmaċewtika tagħha hija differenti minn dik ta 'Tribrissen Oral Paste for Horses.
The aim of the assessment was to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
L- għan ta 'din il- valutazzjoni kien li jiġi stabbilit jekk l- awtorizzazzjonijiet għat- tqegħid fis- suq ta' prodotti mediċinali veterinarji inklużi fil- proċedura ta 'referenza għandhomx jinżammu, jiġu sospiżi, jinbidlu jew jiġu revokati skond ir- raġunijiet għar- riferiment.
Since the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/ 82/ EC, as amended.
Billi l- proċedura għandha x' taqsam ma 'varjetà ta' prodotti, il- valutazzjoni kienet limitata għal partijiet speċifiċi ta 'l- awtorizzazzjonijiet skond l- Artikolu 35( 2) tad- Direttiva 2001/ 82/ KE, kif emendata.
2.1 Questions put to the Marketing Authorisation Holder
2. 1 Mistoqsijiet magħmula lid- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq
CVMP requested the Marketing Authorisation Holder of each product:
Is- CVMP talab lid- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq għal kull prodott:
To provide for each country of the European Economic Area (EEA) where the product is authorised from the dossier submitted: a.
Jipprovdi għal kull pajjiż taż- Żona Ekonomika Ewropea (ŻEE) jekk il- prodott huwiex awtorizzat mill- fajl sottomess: a.
If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Parti I, Sommarju tal- fajl, inklużi s- Sommarju tal- Karatteristiċi tal- Prodott (SPC), ir- rapporti ta 'l- esperti u l- kompożizzjoni kwantitattiva u kwalitattiva tal- prodott; b. jekk ikun applikabbli, Parti IV, Tagħrif dwar l- Effikaċja, inkluż tagħrif dwar il - farmakoċinetika, il- farmakodinamika u d- dejta dwar ir- reżistenza antimikrobika.
Pivotal documents, including the SPC, should be presented in English.
Dokumenti ewlenin, inkluż l- SPC, għandhom jiġu ppreżentati bl- Ingliż.
3.
Jekk il- prodott ikun awtorizzat f' iktar minn Stat Membru wieħed, għandhom jitniżżlu d- differenzi li jeżistu bejn fajls differenti rigward it- tagħrif kif mitlub.
To provide the Periodic Safety Update Reports for the last 3 years.
Jipprovdi Rapporti Perjodiċi ta 'Aġġornamenti dwar is- Sigurtà għall- aħħar tliet snin.
To justify the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Jiġġustifika d- doża rakkomandata għal kull wieħed mill- indikazzjonijiet dikjarati b' rabta ma 'l - effikaċja u s- selezzjoni potenzjali ta' batterji reżistenti għall- antimikrobiċi.
To justify the withdrawal period, in case the recommended dose should increase.
Jiġġustifika l- perjodu ta 'tneħħija, fil- każ li d- dożi rakkomandati jkollha tiżdied.
12/ 16 2.2 Documentation provided
14/ 18 2. 2 Dokumentazzjoni pprovduta
For the submission of responses Schering-Plough Limited (UK) represented Schering-Plough NV/ SA (Belgium), Schering-Plough A/ S (Denmark), AST Beheer BV and AST Farma BV.
Għas- sottomissjoni tat- tweġibiet, Schering- Plough Limited (tar- Renju Unit) irrappreżentaw lil Schering- Plough NV/ SA (tal- Belġju), Schering- Plough A/ S (tad- Danimarka), AST Beheer BV u AST Farma BV.
Norbrook Laboratories Limited represented Scanvet Animal Health A/ S.
Norbrook Laboratories Limited irrappreżentaw lil Scanvet Animal Health A/ S.
Boehringer-Ingelheim Limited and Fort Dodge Animal Health responded separately.
Boehringer- Ingelheim Limited u Fort Dodge Animal Health irrispondew separatament.
CVMP received SPCs, a master reference dossier on residues and withdrawal periods, residue studies, efficacy data and periodic safety update reports, an expert statement on the efficacy including reference papers, pharmacokinetic data, antimicrobial resistance information and MIC/ resistance data.
Is- CVMP irċieva SPCs, dokument ta 'referenza ewlieni fuq ir- residwi u fuq il- perjodi ta' tneħħija, studji dwar ir- residwi u rapporti perjodiċi ta 'aġġornamenti dwar is- sigurtà, stqarrija minn esperti fuq l - effikaċja inklużi dokumenti ta' referenza, dejta farmakoċinetika, tagħrif dwar ir- reżistenza għall - antimikrobiċi u dejta dwar l- MIC / ir- reżistenza.
According to the PSURs, covering more than 3 years of use, safety is consistent with the details of the SPCs.
2. 3 Rapporti Perjodiċi ta 'Aġġornamenti dwar is- Sigurtà
There is no indication that necessitates a new safety assessment.
Ma hemmx indikazzjoni li minħabba fiha għandha ssir valutazzjoni ġdida tas- sigurtà.
The information provided does not cover the entire sales, but most products are included and the period covered by the PSURs is longer than requested.
It- tagħrif ipprovdut ma jkoprix il- bejgħ kollu, iżda ħafna mill- prodotti huma inklużi u l- perjodu kopert mill- PSURs huwa itwal minn dak mitlub.
According to the PSURs there are neither reports on lack of efficacy nor any other adverse reactions which would require change of the SPCs as regards safety instructions or the dose of 30 mg/ kg body weight (bw) per day.
Skond il- PSURs la hemm rapporti dwar in- nuqqas ta 'effikaċja u lanqas reazzjonijiet sekondarji oħra li minħabba fihom ikollhom jinbidlu l- SPCs fir- rigward ta' l- istruzzjonijiet tas- sigurtà jew id- doża ta '30 mg/ kg piż kuljum.
2.4 Antimicrobial resistance development and justification of recommended dose
2. 4 L- iżvilupp ta 'reżistenza għall- antimikrobiċi u l- ġustifikazzjoni tad- doża rakkomandata
On antimicrobial resistance development, no data are available that support the potential selection of resistant bacteria due to the use of TMP/ SDZ in horses.
Dwar l- iżvilupp ta 'reżistenza għall- antimikrobiċi, ma hemmx dejta dwar l- appoġġ għas- selezzjoni potenzjali ta' batterji reżistenti minħabba l- użu ta 'TMP/ SDZ fiż- żwiemel.
However, horses are treated individually and considered of relatively little importance as food producing species.
Madankollu, iż- żwiemel huma ttrattati individwalment u kkunsidrati ta 'importanza relattivament żgħira bħala speċi tal - produzzjoni alimentari.