FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + doxylamine succinate + caffeine + codeine
Italian: Regno Unito Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Regno Unito paracetamolo + doxylamine succinate + caffeina + codeina
English: AUROBINDO PHARMA LIMITED Ares Block, Odyssey Business Park, West End Road, South Ruislip HA4 6QD,
Italian: Regno Unito AUROBINDO PHARMA LIMITED Ares Block, Odyssey Business
English: Paracetamol/Codeinefosf aat 500/10 PCH, tabletten 500 mg/10 mg
Italian: Paracetamolo/Codeinafo sfaat 500/10 PCH, tabletten 500 mg/10 mg
English: Paracetamol, codeine +caffeine
Italian: Paracetamolo, codeina +caffeina
English: Codeine
Italian: Codeina
English: Kodein/Paracetamol
Italian: Codeina/Paracetamolo Citodon
English: 500 mg/20 mg tablet
Italian: 500 mg/20 mg compressa
English: Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/10 mg Zäpfchen suppository rectal use
Italian: Codeine fosfato emiidrato paracetamolo talvosilen 500 mg/10 mg Zäpfchen supposta uso rettale
English: Paracetamol/codeinefosf aat Apotex 500/10 mg, tabletten
Italian: Paracetamolo/codeinafos faat Apotex 500/10 mg, tabletten
English: 15mg + 500mg Coated tablet
Italian: 15mg + 500mg Compressa rivestita
English: 400 mg and 30 mg film-coated tablet oral use
Italian: 400 mg and 30 mg compressa rivestita con film
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom codeine phosphate+paracetamo l
Italian: Industrial Estate, Wrexham LL13 9UF, Regno Unito codeina fosfato+ paracetamolo
English: SOLPADEINE TABLET 500mg/8mg/30mg tablet
Italian: SOLPADEINE TABLET 500mg/8mg/30mg compressa
English: Codeine phosphate Tablets 60mg BP
Italian: Codeina fosfato Tablets 60mg BP
English: Acidum acetylsalicylicum + Codeini phosphas
Italian: Acido acetilsalicilico + Codeina fosfato
English: 500mg/50mg/30mg effervescent tablet
Italian: 500mg/50mg/30mg compressa effervescente
English: 500mg + 12.8mg + 30mg effervescent tablet
Italian: 500mg + 12.8mg + 30mg compressa effervescente
English: Praha 10,
Italian: 3WE,
English: Paracetamol/codeinefosf aat Apotex 500/20 mg, tabletten
Italian: Paracetamolo/codeinafos faat Apotex 500/20 mg, tabletten
English: Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg
Italian: Paracetamolo 500mg Codeina fosfato Emiidrata 8mg Caffeina 30mg
English: 500mg + 30mg film-coated tablet oral use
Italian: 500mg + 30mg compressa rivestita con film
English: 20 mg + 500 mg tablet
Italian: 20 mg + 500 mg compressa
English: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
Italian: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg compressa effervescente
English: Paracetamol Caffeine
Italian: paracetamolo+ caffeina
English: Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable effervescent tablet
Italian: Paracetamolo/Codeina CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable compressa effervescente
English: 200mg +12.8mg coated tablet
Italian: 200mg + 12,8mg compressa
English: Codipar effervescent tablets 15mg/500mg
Italian: Codipar compressa effervescentes 15mg/500mg
English: hard capsule
Italian: Paracodol Capsules capsula
English: Codeini phosphas sesquihydricus + paracetamolum
Italian: Codeina fosfato sesquihydricus + paracetamolo
English: 200 mg/ 12.8 mg film-coated tablet oral use
Italian: 200 mg/ 12.8 mg compressa rivestita con film
English: Codeine + paracetamol
Italian: Codeina + paracetamolo
English: 500 mg and 30 mg tablet
Italian: 500 mg and 30 mg compressa
English: 500 mg/30 mg coated tablet
Italian: 500 mg/30 mg compressa rivestita
English: Cox Codeine Phosphate Tablets BP 15mg
Italian: Cox Codeina fosfato Tablets BP 15mg
English: Co-codamol 500 mg/8 mg tablets effervescent tablet
Italian: Co-codamol 500 mg/8 mg tablets compressa effervescente
English: 15mg + 500mg capsule, hard Oral use
Italian: 15mg + 500mg Capsula rigida Uso orale
English: Codeini phosphas hemihydricus + paracetamolu + coffeinum
Italian: Codeina fosfato hemihydricus + paracetamolo + caffeina
English: Sterwin Meds Cocodamol 8/500 effervescent tablets
Italian: Sterwin Meds Cocodamol 8/500 compressa effervescentes
English: Codeine phosphate
Italian: Codeina fosfato
English: Codeine phosphate 60 mg tablets
Italian: Codeina fosfato 60 mg tablets
English: Codeine phosphate+paracetamo l
Italian: Codeinaa fosfato+paracetamolo
English: 500 mg+8 mg+30 mg effervescent tablet
Italian: 500 mg+8 mg+30 mg compressa effervescente
English: PANADOL ULTRA RAPIDE 8 mg + 500 mg + 30 mg effervescent tablet
Italian: PANADOL ULTRA RAPIDE 8 mg + 500 mg + 30 mg
English: Codeine phosphate hemihydrate + ibuprofen
Italian: Codeina fosfato emiidrata + ibuprofene
English: Codeine phosphate + paracetamol + doxylamine succinate + caffeine
Italian: Codeina fosfato + paracetamolo + dossilamine succinato + caffeina
English: Solpadol 500 mg/30 mg Effervescent Tablets effervescent tablet
Italian: Solpadol 500 mg/30 mg Compressa effervescentes compressa effervescente
English: Paracetamol/Codeine PARACETAMOL CODEINE SANDOZ 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA SANDOZ 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol and codeine phosphate
Italian: Paracetamolo and codeina fosfato
English: Paracetamol/Codeine PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA CRISTERS 500 mg/30 mg, comprimé effervescent sécable
English: 30mg + 500 mg effervescent tablet
Italian: 30mg + 500 mg compressa effervescente
English: Algocod effervescent tablet
Italian: Algocod compressa effervescente
English: 120 mg and 12 mg / 5 ml oral solution oral use
Italian: 120 mg and 12 mg / 5 ml
English: Paracetamol Codeine Phosphate Caffeine
Italian: Paracetamolo Codeina fosfato Caffeina
English: Codeine phosphate + caffeine + paracetamol + doxylamine succinated
Italian: Codeina fosfato + caffeina + paracetamolo + dossilamine succinato
English: 15mg + 500mg effervescent tablet
Italian: 15mg + 500mg compressa effervescente
English: Site Apollo,
Italian: Hampden Park,
English: Codeine phosphate 60mg tablets
Italian: Codeina fosfato 60mg tablets
English: 500 mg and 30 mg effervescent tablet
Italian: 500 mg and 30 mg compressa effervescente
English: 500mg + 30mg tablet
Italian: 500mg + 30mg compressa
English: 500 mg and 30 mg film-coated tablet oral use
Italian: 500 mg and 30 mg compressa rivestita con film
English: Acetylsalicylic acid + Codeine phosphate hemihydrate + Caffeine
Italian: Acido acetilsalicilico + Codeina fosfato emiidrata + Caffeina
English: 15mg + 500mg tablet
Italian: 15mg + 500mg compressa
English: SW1V 2SA United Kingdom paracetamol + codeine Solpadeine Max Tablets 500mg + 12.8mg film-coated tablet oral use
Italian: Solpadeine Max Tablets 500mg + 12.8mg compressa rivestita con film
English: Mercury Pharms Cocodamola effervescent tablets 30mg/500mg
Italian: Mercury Pharms Cocodamola compressa effervescentes 30mg/500mg
English: Codalvonil effervescent tablet
Italian: Codalvonil compressa effervescente
English: Codeine Phosphate Tablets BP 60mg
Italian: Codeina fosfato Tablets BP 60mg
English: Paracetamol, Codeine Phosphate Hemihydrate, Caffeine
Italian: Paracetamolo, Codeina fosfato Emiidrata, Caffeina
English: 500 mg/8 mg/30 mg effervescent tablet
Italian: 500 mg/8 mg/30 mg compressa effervescente
English: Acetylsalicylic acid, codeine phosphate hemihydrate and caffeine
Italian: Acido acetilsalicilico, codeina fosfato emiidrata and caffeina
English: Codeine phosphate Paracetamol
Italian: Codeine fosfato emiidrato paracetamolo talvosilen
English: Romania paracetamol, cafeină anhidră, fosfat de codeină hemihidrat
Italian: Romania paracetamolo , codeina fosfato emiidrato ,caffeina anidra
English: Algocod powder for oral solution
Italian: Polvere per soluzione orale
English: Codeine phosphate + paracetamol + caffeine
Italian: Codeina fosfato + paracetamolo + caffeina
English: Paracetamol/Codeine PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA TEVA 500 mg/30 mg, comprimé effervescent sécable
English: 89150 Laichingen Germany codeinphosphathemihydrat paracetamol
Italian: 89150 Laichingen Germania
English: Paracetamol/Codeine PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA MYLAN 500 mg/30 mg, comprimé effervescent sécable
English: 500mg 8mg 30mg effervescent tablet
Italian: 500mg, 8mg 30mg compressa effervescente
English: Codeine phosphate codeine phosphate tablets BP 60mg
Italian: Codeina fosfato codeina fosfato tablets BP 60mg
English: Codeini phosphas hemihydricus + paracetamolum
Italian: Codeina fosfato hemihydricus + paracetamolo
English: Codeine phosphate tablets BP 30mg
Italian: Codeina fosfato tablets BP 30mg
English: 500mg/8mg/30mg effervescent tablet
Italian: 500mg/8mg/30mg Compressa effervescente
English: 30mg + 500mg effervescent tablet
Italian: 30mg + 500mg compressa effervescente
English: 500 mg/30 mg effervescent tablet
Italian: 500 mg/30 mg compressa effervescente
English: Citodon suppository rectal use
Italian: Codeina/Paracetamolo Citodon supposta uso rettale
English: Paracetamolum + Codeini phosphas + Coffeinum
Italian: Paracetamolo + Codeina fosfato+ caffeina
English: Paracetamol/Codeine PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA ARROW 500 mg/30 mg, comprimé effervescent sécable
English: Ireland codeine phosphate+paracetamo l
Italian: Irlanda codeina fosfato+paracetamolo
English: Ibuprofen/Codeine Phosphate Hemihydrate
Italian: Ibuprofen/Codeina fosfato Emiidrata
English: Codeine phosphate codeine phosphate tablets BP 30mg
Italian: Codeina fosfato codeina fosfato tablets BP 30mg
English: Paracetamol and anhidrous codeine phosphate
Italian: Paracetamolo , codeina fosfato anidra
English: Codeine phosphate tablets BP 15mg
Italian: Codeina fosfato Tablets BP 15mg
English: Codeine Phosphate Tablets BP 15mg
Italian: Codeina fosfato tablets BP 15mg
English: Paracetamol/Codeine PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA EG 500 mg/30 mg, comprimé effervescent sécable
English: 500mg + 30mg effervescent tablet
Italian: 500mg + 30mg compressa effervescente
English: Slovak Republic
Italian: Slovacchia
English: 30mg + 500mg tablet
Italian: 30mg + 500mg compressa
English: 500mg + 8mg + 30mg effervescent tablet
Italian: 500mg + 8mg + 30mg compressa effervescente
English: 200mg +12,8 mg film-coated tablet oral use
Italian: 200mg +12,8 mg compressa rivestita con film
English: 30mg + 500 mg capsule, hard oral use
Italian: 30mg + 500 mg Capsula rigida uso orale
English: Paracetamol+ Caffeine+ Codeine phosphate hemihydrate
Italian: Paracetamolo+ Caffeina+ Codeina fosfato emiidrata
English: paracetamol + codeine Pharmachem CoCodamol Tablets 8/500
Italian: Pharmachem CoCodamol Tablets 8/500
English: 8mg + 500mg + 30mg effervescent tablet
Italian: 8mg +500mg + 30mg compressa effervescente
English: 200mg +12.8mg film-coated tablet Oral use
Italian: 200mg +12.8mg compressa rivestita con film
English: Paracetamol/Codeine PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA ALMUS 500 mg/30 mg, comprimé effervescent sécable
English: Codeine phosphate 30 mg tablets
Italian: Codeina fosfato 30 mg tablets
English: 500 mg/8 mg/30 mg tablet
Italian: 500 mg/ 8 mg/ 30 mg
English: Codeine phosphate codeine phosphate tablets BP 15mg
Italian: Codeina fosfato codeina fosfato tablets BP 15mg
English: 500mg/8mg/30mg tablet
Italian: 500mg/8mg/30mg compressa
English: Codeine phosphate 30mg tablets
Italian: Codeina fosfato 30mg tablets
English: Paracetamol/Codeine PARACETAMOL CODEINE SANOFI-AVENTIS
Italian: Paracetamolo/Codeina PARACETAMOLO CODEINA SANOFI
English: 6,33 mg/ 5 ml oral solution oral use
Italian: 6,33 mg/ 5 ml
English: Ibuprofen and codeine phosphate hemihydrate
Italian: Ibuprofen and codeina fosfato emiidrata
English: 30mg film-coated tablet oral use
Italian: 30mg compressa rivestita con film
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom
Italian: Regno Unito WOCKHARDT UK LIMITED Ash Road North, Wrexhan
English: Paracetamol/ Codeine phosphate
Italian: Paracetamolo/codeina fosfato
English: Paracetamol/codeine phosphate
Italian: Paracetamolo/ Codeina fosfato
English: 30mg + 500 mg tablet
Italian: 30mg + 500 mg compressa
English: KG
Italian: 6GT
English: 200 mg and 10 mg /1 ml oral solution oral use
Italian: 200 mg and 10 mg /1 ml
English: Codeine phosphate hemihydrate + caffeine + paracetamol
Italian: Codeina fosfato emiidrata + caffeina + paracetamolo
English: 30 mg + 500 mg tablet
Italian: 30 mg +500 mg compressa
English: 30 mg +500 mg tablet
Italian: 30 mg + 500 mg compressa
English: Ibuprofen Codeine Phosphate Hemihydrate
Italian: Ibuprofen Codeina fosfato Emiidrata
English: 500mg/8mg/30mg soluble tablet
Italian: 500mg/8mg/30mg Compressa solubile
English: Paracetamol+ Codeine phosphate hemihydrate
Italian: Paracetamolo+ Codeina fosfato emiidrata
English: Germany codeinphosphathemihydrat paracetamol talvosilen-Saft
Italian: Codeine fosfato emiidrato paracetamolo talvosilen-Saft
English: 500 mg/8 mg/30 mg soluble tablet
Italian: 500 mg/8 mg/30 mg Compressa solubile
English: Germany codeinphosphathemihydrat acetylsalicylsäure
Italian: Codeine fosfato emiidrato caffeina paracetamolo acido acetilsalicilico
English: Codeine phosphate+paracetamo l + caffeine
Italian: Codeina fosfato+paracetamolo + caffeina
English: 1 cartridge and 1 pen
Italian: 1 cartuccia e 1 penna
English: 3 cartridges
Italian: 3 cartucce
English: MA (EU) number (Invented) name
Italian: Numero AIC (UE)
English: Route of Administration
Italian: Via di somministrazione Confezionamen to primario
English: 1 cartridge
Italian: 1 cartuccia
English: Immediate Packaging
Italian: Numero di unità posologiche
English: This approach offers the highest degree of consumer protection
Italian: Questo approccio garantisce la massima protezione dei consumatori.
English: The responses were submitted on 17 June 2004.
Italian: Le risposte sono state trasmesse il 17 giugno 2004.
English: Porte Salvo Portugal
Italian: Porte Salvo Portogallo
English: 2.2 Calculation of withdrawal periods
Italian: 2.2 Calcolo dei periodi di sospensione
English: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS
Italian: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS Spagna
English: 2900 AA CAPELLE AAN DEN IJSSEL The Netherlands
Italian: 2900 AA CAPELLE AAN DEN IJSSEL Paesi Bassi
English: Conclusions and recommendations
Italian: Conclusioni e raccomandazioni
English: 2.1 Residue depletion studies
Italian: 2.1 Studi della deplezione dei residui
English: The remaining 4 sheep (group 1) served as untreated controls.
Italian: Le rimanenti 4 pecore (gruppo 1) sono state utilizzate come gruppo di controllo non trattato.
English: 00330 Helsinki Finland
Italian: 00330 Helsinki Finlandia
English: For the referral procedure, the representative of the Marketing Authorisation Holder presented three studies.
Italian: Per la procedura di deferimento il rappresentante del titolare dell'autorizzazione all'immissione in commercio ha trasmesso tre studi.
English: Withdrawal period (meat and milk)
Italian: Tempo di sospensione (carne e latte)
English: Group 3 animals were sacrificed at day 35 after treatment.
Italian: Gli animali del gruppo 3 sono stati sacrificati il giorno 35 successivo al trattamento.
English: 45 days
Italian: 45 giorni
English: The grounds for the appeal were submitted to the EMEA on 8 November 2004.
Italian: Le basi per l'appello sono state presentate all'EMEA il giorno 8 Novembre 2004.
English: The product has been authorised in the EU Member States and EEA/EFTA States listed in Annex I as an injectable solution for intramuscular and/or subcutaneous administration.
Italian: Il prodotto è stato autorizzato negli Stati membri dell'Unione europea e nei paesi del SEE/EFTA elencati nell'allegato I come soluzione iniettabile per via intramuscolare e/o sottocutanea.
English: Therefore, the recommendation of a 70-day withdrawal period applies to both doses.
Italian: Pertanto, la raccomandazione di un periodo di sospensione di 70 giorni va applicata a entrambi i dosaggi.
English: 183 25 Täby Sweden
Italian: 183 25 Täby Svezia
English: Strength Pharmaceutical form
Italian: Forma farmaceutica
English: Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT England
Italian: Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT Inghilterra
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES, ICELAND AND NORWAY
Italian: ELENCO DEI NOMI, DELLE FORME FARMACEUTICHE, DEI DOSAGGI, DELLE VIE DI SOMMINISTRAZIONE, DELLE SPECIE ANIMALI E DEI TITOLARI DELLE AUTORIZZAZIONI ALL'IMMISSIONE IN COMMERCIO NEGLI STATI MEMBRI INTERESSATI, IN ISLANDA E IN NORVEGIA
English: Frequency Recommended dose
Italian: Specie animale Frequenza Dose raccomandata
English: In fat, residues were below 8 μg/kg at all remaining time-points.
Italian: Nel grasso i residui erano inferiori a 8 μg/kg in tutti i restanti punti temporali.
English: The third study was a re-analysis of injection site tissue from the second study due to the high variability of the results obtained.
Italian: Il terzo studio consisteva in una nuova analisi del tessuto prelevato dal sito dell'iniezione nel corso del secondo studio, in considerazione dell'elevata variabilità dei risultati ottenuti.
English: Introduction and Background
Italian: Introduzione e antefatti
English: The withdrawal periods set for edible tissues of ovine species by the different Member States diverge significantly, from 35 to 70 days.
Italian: I periodi di sospensione fissati dai vari Stati membri per i tessuti commestibili degli ovini divergono in maniera considerevole, da 35 a 70 giorni.
English: 18 2650 Hvidovre Denmark
Italian: 18 2650 Hvidovre Danimarca
English: With respect to doramectin administered subcutaneously the studies reviewed did not provide reliable data from which a valid calculation could be made.
Italian: Per quanto riguarda la doramectina somministrata per via sottocutanea gli studi riesaminati non hanno messo a disposizione dati affidabili su cui fondare un calcolo valido.
English: The CVMP had previously assessed doramectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Italian: Il CVMP aveva precedentemente valutato la doramectina per la determinazione dei limiti massimi di residui (MRL) in conformità con il regolamento n. 2377/90/CEE del Consiglio.
English: Neither the second nor third studies are suitable for the determination of a withdrawal period following subcutaneous administration.
Italian: Né il secondo né il terzo studio sono adatti per la determinazione del periodo di sospensione dopo un'iniezione sottocutanea.
English: A withdrawal period of 182 days was calculated, but in the opinion of the CVMP this approach is not sustainable as there are no actual time point slaughter studies to confirm this prediction and extrapolation from the concentration of residues found in the samples at the injection site to predict an adequate withdrawal period is difficult.
Italian: È stato calcolato un periodo di sospensione di 182 giorni, ma nel parere del CVMP questo approccio non è sostenibile, poiché non esistono studi effettuati al momento effettivo della macellazione che confermino questa previsione e l'estrapolazione del dato dalla concentrazione di residui trovata nei campioni prelevati nel sito di iniezione per prevedere un periodo di sospensione adeguato è alquanto difficile.
English: Doramectin was included in Annex I of Council Regulation (EEC) No 2377/90 and the following maximum residue limits were established for ovine species:
Italian: La doramectina è stata inclusa nell'allegato I del regolamento (CEE) n. 2377/90 del Consiglio, fissando per gli ovini i seguenti limiti massimi di residui:
English: Lagoas Park Edifício 10
Italian: Lagoas Park
English: Pfizer Italia SRL Via Valbondione 113 00188 Roma
Italian: Pfizer Italia SRL Via Valbondione 113 00188 Roma Italia
English: In the group 2 animals given two doses, the injection sites contained the highest residues followed by liver and fat.
Italian: Negli animali del gruppo 2 a cui erano state somministrate due dosi di farmaco, la più alta quantità di residui era contenuta nel sito di iniezione, seguito da fegato e grasso.
English: The CVMP working paper on injection site residues (III/5933/94-EN) recommends that the injection site and its residues be treated as “normal” muscle where one of the target tissues is muscle.
Italian: Il documento di lavoro del CVMP sulle concentrazioni di residui nel sito di iniezione (III/5933/94EN) raccomanda che il sito di iniezione stesso e i suoi residui siano trattati come muscolo “normale” nel caso in cui uno dei tessuti bersaglio sia un muscolo.
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 16 February 2004.
Italian: Le questioni sottoposte al parere del CVMP riguardavano i periodi di sospensione e sono state rese note ai titolari dell'autorizzazione all'immissione in commercio il 16 febbraio 2004.
English: Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period
Italian: Tempo di sospensione per il latte: 60 giorni per giovenche, renne e animali durante il periodo asciutto
English: Comparison of the data from groups 2 and 3 indicated that administration of the second dose did not affect the depletion profile in edible tissue at withdrawal times around 35 days.
Italian: Il confronto dei dati ottenuti con gli animali dei gruppi 2 e 3 indicava che la somministrazione della seconda dose non interferiva con il profilo della deplezione nei tessuti commestibili in caso di sospensione fissata a circa 35 giorni.
English: Denmark Pfizer Aps Lautrupvang 8
Italian: Danimarca Pfizer ApS Lautrupvang 8
English: Pfizer Corp. Austria Seidengasse 33-35 1071 Wien
Italian: Pfizer Corp. Austria Seidengasse 33 -35 1071 Wienna Austria
English: A further 2 animals served as untreated controls.
Italian: Come controllo sono stati utilizzati altri 2 animali.
English: The CVMP during its meeting of 10-12 February 2004 initiated a referral procedure under Article 34 of Council Directive 2001/82/EC for Dectomax injectable solution products containing doramectin.
Italian: Nel corso della riunione del 10-12 febbraio 2004 il CVMP ha avviato una procedura di deferimento ai sensi dell'articolo 34 della direttiva 2001/82/CE per i prodotti medicinali Dectomax in soluzione iniettabile contenenti doramectina.
English: At all other time-points doramectin concentrations in liver, kidney and skeletal muscle were at or below the limit of quantification.
Italian: In tutti gli altri punti temporali le concentrazioni di doramectina in fegato, rene e muscolo scheletrico erano uguali o inferiori al limite di quantificazione.
English: Dectomax injectable solution contains doramectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle, sheep, pigs and reindeer, excluding lactating animals producing milk for human consumption.
Italian: La soluzione iniettabile Dectomax contiene il principio attivo doramectina, un composto semisintetico della famiglia dell'avermectina, usato come antiparassitario contro i parassiti interni ed esterni di bovini, ovini, suini e renne, a esclusione degli animali in lattazione che producono latte destinato al consumo umano.
English: The withdrawal period should be based on residue depletion to below the MRL at the injection site.
Italian: Il periodo di sospensione deve essere calcolato sulla deplezione dei residui a valori inferiori all'MRL in corrispondenza del sito di iniezione.