FrancophonIA/ELRC3.0 huggingface dataset:
English: - 1 cardboard box containing 10 tablets in transparent PVC /aluminium foil blisters.
Maltese: - Kaxxa tal-kartun li fiha 10 pilloli fi blisters tal-PVC trasparenti/fojl tal-aluminju.
English: TARGET SPECIES Horses (450-600 kg).
Maltese: HUWA INDIKAT IL-PRODOTT Żwiemel (450 - 600 kg).
English: The 57 mg chewable tablets are available in the following pack sizes:
Maltese: Il-pilloli li jintmagħdu ta' 57 mg jinstabu fid-daqsijiet tal-pakkett li ġejjin:
English: Magnesium stearate
Maltese: Speċje talannimal
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 20 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Firocoxib 20 mg/ml
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompattibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Administer 0.1 mg firocoxib per kg bodyweight, once daily.
Maltese: Amministra 0.1 mg firocoxib għal kull kg ta' piż tal-ġisem darba kuljum.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Maltese: Il-Firocoxib hija mediċina anti-infjammatorja mhux sterojdi (NSAID) li taġixxi b'inibizzjoni selettiva ta' cyclooxygenase-2 (COX-2) - sintesi medjata tal-prostaglandin.
English: Disodium EDTA, n-propyl gallate, and thiodipropionic acid, are used to stabilize the glycerol formal and therefore are not considered as excipients in the context of MRLs.
Maltese: Disodium EDTA, n-propyl gallate, u thiodipropionic acid, jintużaw biex jistabbilizzaw il-glycerol formal u għaldaqstant mhumiex ikkunsidrati bħala ingredjenti mhux attivi fil-kuntest tal-MRLs.
English: - 1 cardboard box containing 30 tablets in transparent PVC /aluminium foil blisters.
Maltese: - Kaxxa tal-kartun li fiha 30 pillola fi blisters tal-PVC trasparenti/fojl tal-aluminju.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Maltese: Il-Firocoxib hija mediċina anti-infjammatorja mhux sterojdi (NSAID) li tappartjeni għall-grupp Coxib, li taġixxi b'inibizzjoni selettiva ta' cyclooxygenase-2 (COX-2) - sintesi medjata tal-prostaglandin.
English: “In “in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
Maltese: Fil-provi in-vitro tad-demm sħiħ taż-żiemel, il-firocoxib juri selettività ta' 222 sa' 643 darba għal COX-2 fuq COX-1.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity.
Maltese: Evita l-użu f'annimali deidrati, hypovolaemic jew hypotensive, peress li jista' jkun hemm riskju potenzjali ta' żieda ta' tossiċità fil-kliewi.
English: The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes - 1 carton box containing 14 syringes
Maltese: Il-paste tal-ħalq jinstab fid-daqsijiet tal-pakketti li ġejjin: - kaxxa tal-kartun li fiha siringa - kaxxa tal-kartun li fiha 7 siringi - kaxxa tal-kartun li fiha 14-il siringa
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection Firocoxib
Maltese: VETERINARJU EQUIOXX soluzzjoni ta' 20mg/ml għal injezzjoni Firocoxib
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycerol formal
Maltese: 6.1 Lista ta' ingredjenti mhux attivi
English: If clinical signs occur, treatment should be discontinued and symptomatic treatment initiated.
Maltese: Jekk ikun hemm sinjali kliniċi, il-kura għandha titwaqqaf u tinbeda kura sintomatika.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 8.2 mg/g
Maltese: TAS-SUSTANZA(I) / ATTIVA(I) Firocoxib 8.2mg/g
English: EQUIOXX 8.2 mg/g Oral Paste may be used for continuation of treatment at a dosage of 0.1 mg firocoxib per kg bodyweight once daily.
Maltese: Il-paste tal-ħalq EQUIOXX 8.2mg/g jista' jintuża għall-kumplament tal-kura b'doża ta' 0.1 mg firocoxib għal kull kg ta' piż tal-ġisem darba kuljum.
English: Titanium dioxide (E 171)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed.
Maltese: F'dożi għolja u kura fit-tul (tliet darbiet iżjed mid-doża rakkomandata għal 42 jum konsekuttiv u 2.5 drabi iżjed mid-doża rakkomandata għal 92 jum konsekuttiv amministrata darba kuljum) leżjonijiet ħfief sa moderati fil-kliewi ġew osservati.
English: • EQUIOXX 20 mg/ml solution for injection for horses The excipients listed in section 6.1 of the SPC (Glycerol formal and Macrogol 400) are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: L-ingredjenti mhux attivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor (Glycerol formal u Macrogol 400) huma ingredjenti aċċettati li dwarhom it-Tabella I tal-anness tar-Regolament tal-Kummissjoni (UE) n.
English: Thiodipropionic acid
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses Firocoxib
Maltese: VETERINARJU EQUIOXX 8.2 mg/g paste għall-ħalq għaż-żwiemel Firocoxib
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of the solution contains:
Maltese: U KWANTITATTIVA Millitru tas-soluzzjoni fih:
English: The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1ml of the solution per 225 kg bodyweight) once daily by intravenous injection.
Maltese: Id-doża rakkomandata hija ta' 0.09 mg firocoxib għal kull kg ta' piż tal-ġisem (ekwivalenti għal ml tas-soluzzjoni għal 225 kg ta' piż tal-ġisem) darba kuljum b'injezzjoni fil-vina.
English: ADVERSE REACTIONS
Maltese: KONTRAINDIKAZZJONIJET
English: Withdrawal period : Meat and offal: 26 days.
Maltese: Żmien ta' tiżmim: Laħam u ġewwieni: 26 ġurnata.
English: Chewable tablets.
Maltese: DAQS TAL-PAKKETT Siringa.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/006-009
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/083/006-009
English: • EQUIOXX 8.2 mg/g oral paste for horses
Maltese: • EQUIOXX 8.2mg/g paste tal-ħalq għaż-żwiemel
English: Brown, round, convex, scored tablets.
Maltese: Pilloli ta' kulur kannella, tondi, konvessi u mmarkati b'linja.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Maltese: Iscyclooxygenase huwa responsabbli biex jifforma l-prostaglandin.
English: Silica, colloidal anhydrous
Maltese: Titanium dioxide (E 171) Glycerol triacetate Silica, colloidal anhydrous Magnesium carbonate, tqil Macrogol 300
English: For safe and effective use, this product should only be administered to horses in the weight range 450-600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.
Maltese: Għal żwiemel li jiżnu taħt l-450 kg jew 'il fuq minn 600 kg, u fejn il-firocoxib huwa dak magħżul għall-kura, l-użu ta' formulazzjonijiet oħra li fihom il-firocoxib li jippermettu dożaġġ preċiż huwa rakkomandat.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAL-MANIFATTURA RESPONSABBLI
English: Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses weighing between 450 kg and 600 kg bodyweight.
Maltese: Biex itaffi l-uġigħ u l-infjammazzjoni assoċjati mal-ostjoartrite u biex inaqqas it-zappip assoċjat fi żwiemel li għandhom bejn 450 kg u 600 kg piż tal-ġisem.
English: Do not store above 30 °C.
Maltese: Taħżinx 'il fuq minn 30° C.
English: The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
Maltese: Il-konċentrazzjoni tal-firocoxib neċessarja biex tinibixxi 50% tal-enżima COX-2 (jigifieri lIC50) hija ta' 0.0369 sa 0.
English: Marketing authorisation holder : Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ : Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu fil-vina.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002-003
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/083/002-003
English: - carton containing 6 vials of 25 ml
Maltese: - kaxxa li fiha fjal ta' 25 ml - kaxxa li fiha 6 fjali ta' 25 ml
English: Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring.
Maltese: L-użu flimkien ma' molekuli li jaġixxu fuq il-flussu tal-kliewi (bħal dijuretiċi) għandu jsir taħt monitoraġġ kliniku.
English: Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver.
Maltese: Il-Firocoxib huwa metabolizzat l-aktar bil-dealkilazzjoni u glukoronidazzjoni fil-fwied.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets firocoxib
Maltese: VETERINARJU EQUIOXX 57 mg pillolI li jintmagħdu Firocoxib
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste .
Maltese: VETERINARJU EQUIOXX 8.2 mg/g paste tal-ħalq.
English: To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse's weight.
Maltese: U METODU TA' AMMINISTRAZZJONI 0.1 mg firocoxib għal kull kg ta' piż tal-ġisem, darba kuljum sa 14-il ġurnata.
English: • EQUIOXX 57 mg chewable tablets for horses The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: • EQUIOXX pilloli li jintmagħdu ta' 57 mg għaż-żwiemel L-ingredjenti mhux attivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma ingredjenti aċċettati li dwarhom it-Tabella I tal-anness tar-Regolament tal-Kummissjoni (UE) n.
English: PHARMACEUTICAL FORM Oral paste.
Maltese: GĦAMLA FARMAĊEWTIKA Paste tal-ħalq.
English: Muscle Fat
Maltese: Muskolu Xaham Fwied Kilwa
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Firocoxib 8.2 mg/g
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OHRA Firocoxib 8.2 mg/g
English: Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Maltese: Xxxxx to insert in right place
English: Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Maltese: Amministra pillola waħda kuljum għal żwiemel li jiżnu 450-600 kg ta' piż tal-ġisem.
English: PACKAGE LEAFLET EQUIOXX 8.2 mg/g oral paste for horses
Maltese: FIL-PAKKETT EQUIOXX 8.2 mg/g paste tal-ħalq għaż-żwiemel
English: 6.5 Nature and composition of immediate packaging Pre-filled oral syringe made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Maltese: Siringa tal-ħalq mimlija għal-lest tal-polypropylene, bl-għatu tal-polyethylene, rod tip tal-gomma, u plunger rod tal-polypropylene.
English: Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France
English: Elimination is principally in the excreta (primarily the urine), with some biliary excretion also observed.
Maltese: L-eliminazzjoni hija prinċipalment fl-ekskreta (primarjament fl-urina), u ġiet osservata wkoll xi ekskreta fil-bile.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Firocoxib 57 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OHRA Firocoxib 57 mg
English: If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm xi effetti mhux mixtieqa, l-kura għandha titwaqqaf u għandu jittieħed parir tat-tabib veterinarju.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 7.32 g of oral paste
Maltese: PIZ, VOLUM JEW NUMRU TA' DOŻI 7.32 g ta' paste għall-ħalq.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.
Maltese: L-użu flimkien ma' prodotti mediċinali veterinarji li huma potenzjalment nefrotossiċi għandu jiġi evitat.
English: Excipients:
Maltese: DIKJARAZZJONI
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Disposal: read package leaflet.
Maltese: Paste ta' kulur abjad sa' abjad maħmuġ.
English: 4.11 Withdrawal period(s)
Maltese: (ara sezzjoni 4.8).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Maltese: Aħsel idejk wara li tuża l-prodott veterinarju mediċinali.
English: PACKAGE LEAFLET EQUIOXX 20 mg/ml solution for injection for horses
Maltese: FIL-PAKKETT EQUIOXX soluzzjoni ta' 20mg/ml għal injezzjoni għaż-żwiemel
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/083/002
English: Mild reactions at the injection site characterised by swelling and associated with perivascular inflammation have been reported in clinical studies following administration of the product at the recommended dose.
Maltese: Reazzjonijiet ħfief fil-post tal-injezzjoni karatterizzati b'nefħa u assoċjati ma' infjammazzjoni perivaskolari ġew irraportati fi studji kliniċi wara l-amministrazzjoni tal-prodott fid-doża rakkomandata.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/083/001
English: PACKAGE LEAFLET EQUIOXX 57 mg chewable tablets for horses
Maltese: FIL-PAKKETT EQUIOXX 57 mg pilloli li jintmagħdu għaż-żwiemel
English: France.
Maltese: Xejn.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses
Maltese: VETERINARJU EQUIOXX soluzzjoni ta' 20mg/ml għal injezzjoni għaż-żwiemel.
English: Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 3.9 (± 4.4) hours.
Maltese: Wara l-amministrazzjoni mill-ħalq liż-żwiemel fid-doża rakkomandata ta' 0.1mg għal kull kg ta' piż tal-ġisem, il-firocoxib jiġi assorbit malajr u l-ħin għall-konċentrazzjoni massimali (Tmax) huwa ta' 3.9 (± 4.4) sigħat.
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Maltese: COX-2 hija l-isoforma tal-enżima li huwa maħsub li hija primarjament responsabbli għas-sintesi talmedjaturi prostanojdi tal-uġigħ, infjammazzjoni u d-deni.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Tużax flimkien ma' kortikosterojdi jew mediċini oħra anti-infjammatorji mhux sterojdi (NSAID)
English: Disposal: read the package leaflet
Maltese: KONDIZZJONIJIET OĦRA U REKWIŻITI
English: La Ballastière 33500 Libourne FRANCE Bristol
Maltese: Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE Bristol UK
English: The VICH GL 6 states that:
Maltese: Il-VICH GL 6 tgħid li:
English: The product is a generic of Baycox 5% oral solution.
Maltese: Il-prodott huwa ġeneriku ta' Baycox 5% soluzzjoni orali.
English: I
Maltese: II
English: 3 CVMP/VICH GL6: Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: Environmental impact assessments for veterinary medicinal products (VMPs) - Phase II (CVMP/VICH/790/03-FINAL) and Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005- Rev.1)
Maltese: 3 CVMP/VICH GL6: Valutazzjoni tal-impatt ambjentali (EIAS) għal prodotti mediċinali veterinarji - Fażi I (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: Valutazzjonijiet tal-impatt ambjentali għal prodotti mediċinali veterinarji (VMPs) - Fażi
English: La Ballastière
Maltese: II pprovduta
English: • The rearing and production methods are similar in poultry and pigs,
Maltese: • Il-metodi tat-tkabbir u tal-produzzjoni huma simili fit-tjur u fil-majjali,
English: • The metabolism of toltrazuril was considered as qualitatively similar in poultry and in pigs Therefore the Applicant considered that the conclusions from the CVMP referral for poultry could be extrapolated to piglets.
Maltese: • Il-metaboliżmu ta' toltrazuril tqies li huwa kwalitattivament simili fit-tjur u fil-majjali Għaldaqstant, l-Applikant qies li l-konklużjonijiet mir-referenza tas-CVMP għat-tjur jistgħu jiġu estrapolati għall-ħnienes.
English: PECsoil for piglets was
Maltese: Oral para lechones
English: The CVMP has, however, previously concluded that toltrazuril and toltrazuril sulphone do not pose an unacceptable risk at environmental concentrations exceeding the concentrations predicted as a result of normal use of Cevazuril 50mg/ml oral suspension for piglets.
Maltese: Madankollu, is-CVMP ikkonkluda preċedentament li toltrazuril u toltrazuril sulphone mhumiex ta' riskju mhux aċċettabbli f'konċentrazzjonijiet ambjentali li jaqbżu l-konċentrazzjonijiet imbassra bħala riżultat tal-użu normali ta' Cevazuril 50mg/ml sospensjoni orali għall-ħnienes.
English: Marketing Authorisation granted
Maltese: TAL-PRODOTT MEDIĊINALI
English: • the conclusions from the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and;
Maltese: • il-konklużjonijiet mill-proċedura ta' referenza skont l-Artikolu 35 tad-Direttiva 2001/82/KE dwar il-prodotti mediċinali veterinarji li fihom toltrazuril intenzjonati sabiex jintużaw fi speċi ta' tjur fir-rigward tal-valutazzjoni tar-riskju ambjentali u;
English: The environmental risk assessment of the product in accordance to the VICH GL 6 (Environmental Impact Assessment for veterinary medicinal products- Phase I, CVMP/VICH/592/98-Final) concluded that the PECsoil for piglets was 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Maltese: Il-valutazzjoni tar-riskju ambjentali tal-prodott skont VICH GL 6 (Valutazzjoni tal-Impatt Ambjentali għal prodotti mediċinali veterinarji- Fażi I, CVMP/VICH/592/98-Finali) ikkonkluda li l-PECħamrija għall-majjali kien 12 µg/kg, li huwa ferm inqas mill-valur ta' azzjonar għal valutazzjoni ta' Fażi
English: Some evidence from the public domain indicates that the main metabolite and degradation product in soil of toltrazuril - toltrazuril sulphone - is persistent, phytotoxic and mobile with the potential to leach to groundwater.
Maltese: Xi evidenza mill-qasam pubbliku tindika li l-prodott metabolit u ta' degradazzjoni ewlieni fil-ħamrija ta' toltrazuril - toltrazuril sulphone - huwa persistenti, fitotossiku u mobbli bil-potenzjal li jgħaddi għall-ilma ta' taħt l-art.
English: 2.1 Assessment of Phase II data provided
Maltese: 2.1 Valutazzjoni tad-dejta ta' Fażi
English: In response to the questions raised in the decentralised procedure the Applicant referred to the CVMP conclusions reached during the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and argued that:
Maltese: Bi tweġiba għall-mistoqsijiet imqajjma fil-proċedura deċentralizzata, l-Applikant irrefera għallkonklużjonijiet tas-CVMP milħuqa matul il-proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE dwar il-prodotti mediċinali veterinarji li fihom toltrazuril intenzjonati sabiex jintużaw fi speċi ta' tjur fir-rigward tal-valutazzjoni tar-riskju ambjentali u argumenta li;
English: The recommended dose is a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight, on day 3-5 of life.
Maltese: Id-doża rakkomandata f'doża orali singola ta' 20 mg toltrazuril/kg piż tal-ġisem tikkorrespondi għal 0.4 ml sospensjoni orali għal kull kg piż tal-ġisem, f'jum 3-5 tal-ħajja.
English: It is acknowledged that the main metabolite is probably the same for pigs and poultry for this compound and that the calculations in Phase I of the ERA take 100% of the dose into account (total residue approach) when environmental exposure is calculated.
Maltese: Huwa rikonoxxut li l-metabolit prinċipali huwa probabbilment l-istess għall-majjali u għat-tjur għal dan il-kompost u li l-kalkolazzjonijiet fil-Fażi I tal-ERA iqisu 100% tad-doża (approċċ ta' residwu totali) meta jiġi kkalkolat l-esponiment ambjentali.
English: CEVAZURIL 50 mg/ml oral suspension for piglets is a suspension for oral administration, which contains 50 mg toltrazuril/ml as an active substance.
Maltese: CEVAZURIL 50 mg/ml sospensjoni orali għall-ħnienes huwa sospensjoni għal għoti mill-ħalq, li fiha 50 mg toltrazuril/ml bħala sustanza attiva.
English: Denmark Ceva Santé Animale Z.I.
Maltese: Id-Danimarka Ceva Santé Animale Z.I. La Ballastière
English: Having considered the overall data submitted in writing and in the oral explanation the CVMP concluded after consulting with its Environmental Risk Assessment Working Party that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation.
Maltese: Wara li kkunsidra d-dejta ġenerali sottomessa bil-miktub u fl-ispjegazzjoni orali, is-CVMP ikkonkluda wara li kkonsulta mal-Parti ta' Ħidma tal-Valutazzjoni tar-Riskju Ambjentali li l-oġġezzjonijiet imqajma matul il-proċedura deċentralizzata ma għandhomx jimpedixxu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: It is indicated for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora sui.
Maltese: Huwa indikat għall-prevenzjoni ta' sinjali kliniċi ta' kokkidijożi fi ħnienes li jkunu għadhom kif twieldu f'irziezet bi storja kkonfermata ta' kokkidożi kkawżata minn Isospora sui.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: VETERINARJU, SPEĊI TA' ANNIMAL, MNEJN JINGĦATA, APPLIKANT/DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: Hungary Ceva Santé Animale Z.I.
Maltese: L-Ungerija Ceva Santé Animale Z.I. La Ballastière
English: Belgium Ceva Santé Animale Z.I.
Maltese: Il-Bulgarija Ceva Santé Animale Z.I. La Ballastière
English: Evaluation of the environmental risk assessment
Maltese: Evalwazzjoni tal-valutazzjoni tar-riskju ambjentali
English: 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Maltese: Din il-Fażi I tikkonkludi li PECħamrija għall-ħnienes kien 12 µg/kg, li huwa ferm inqas mill-valur ta' azzjonar għal valutazzjoni ta' Fażi
English: Luxembourg Ceva Santé Animale Z.I.
Maltese: Is-Slovakkja Ceva Santé Animale Z.I. La Ballastière
English: In view of the disagreement the issue was referred to CVMP.
Maltese: III tal-Opinjoni tas-CVMP.
English: Germany Ceva Santé Animale Z.I.
Maltese: Ir-Rumanija Ceva Santé Animale Z.I. La Ballastière