FrancophonIA/ELRC3.0 huggingface dataset:
English: Paracetamol/codeinefosf aat Apotex 500/10 mg, tabletten
Swedish: Paracetamol/kodeinfosf aat Apotex 500/10 mg, tablettten
English: Paracetamol/Codeinefosf aat 500/10 PCH, tabletten 500 mg/10 mg
Swedish: Paracetamol/Kodeinfosf aat 500/10 PCH, tablettten 500 mg/10 mg
English: M & A Pharmachem Limited, Allenby Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL,
Swedish: Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5
English: Paracetamol/codeinefosf aat Apotex 500/20 mg, tabletten
Swedish: Paracetamol/kodeinfosf aat Apotex 500/20 mg, tablettten
English: Acetylsalicylic acid, codeine phosphate hemihydrate and ascorbic acid
Swedish: Acetylsalicylsyra, kodeinfosfathemihy drat och askorbinsyra
English: Germany codeinphosphathemihydrat paracetamol talvosilen-Saft
Swedish: Tyskland kodeinfosfathemi hydrat paracetamol talvosilen-Saft
English: 500 mg, 10 mg and 30 mg film-coated tablet oral use
Swedish: 500 mg, 10 mg and 30 mg filmdragerad tablett
English: 500mg + 30mg tablet
Swedish: 500mg + 30mg tablett
English: paracetamol + codeine M&A Pharmachem CoCodamol Tablets 60/500
Swedish: Storbritannien paracetamol + kodein M&A Pharmachem CoCodamol Tabletts
English: AUROBINDO PHARMA LIMITED Ares Block, Odyssey Business Park, West End Road, South Ruislip HA4 6QD,
Swedish: Storbritannien AUROBINDO PHARMA LIMITED Ares Block, Odyssey Business
English: Codeine phosphate/ Paracetamol
Swedish: Kodeinfosfat/ Paracetamol
English: Ibuprofen Codeine phosphate
Swedish: Ibuprofen Kodeinfosfat
English: 500mg + 8mg + 6.25mg coated tablet
Swedish: 500mg + 8mg + 6.25mg dragerad tablett oral användning
English: 6.1% w/v
Swedish: 6.1% w/v injektionsvätska, lösning intramuskulär
English: 20 mg + 500 mg tablet
Swedish: 20 mg + 500 mg tablett
English: 500mg/8mg/30mg tablet
Swedish: 500mg/8mg/30mg tablett
English: Mercury Pharms Cocodamol Tablets 30mg/500mg
Swedish: Mercury Pharms Cocodamol Tabletts 30mg/500mg
English: Paracetamol 450 mg Codeine Phosphate Hemihydrate 10 mg Doxylamine succinate 5 mg
Swedish: Paracetamol 450 mg Kodeinfosfathemihyd rat 10 mg
English: Germany codeinphosphathemihydrat coffein paracetamol
Swedish: Tyskland kodeinfosfathemi hydrat koffein paracetamol
English: Waymade codeine phosphate tablets 15mg
Swedish: Waymade kodeinfosfattabletts 15mg
English: Codeine phosphate Tablets 60mg BP
Swedish: Kodein phosphate Tabletts 60mg BP
English: 500mg/8mg/30mg soluble tablets
Swedish: 500mg/8mg/30mg soluble tabletts
English: 500mg + 12.8mg + 30mg effervescent tablet
Swedish: 500mg + 12.8mg + 30mg brustablett
English: 8mg + 500mg + 30mg soluble tablet
Swedish: 8mg + 500mg + 30mg löslig tablett
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + doxylamine succinate + caffeine + codeine
Swedish: Storbritannien Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien paracetamol + doxylaminsuccinat + koffein + kodein
English: Great West Road 980 Brentford TW8 9GS United Kingdom
Swedish: Great West Road 980
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + diphenhydramine hydrochloride + caffeine + codeine
Swedish: Storbritannien Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien paracetamol + difenhydraminhydr oklorid + koffein + kodein
English: SW1V 2SA United Kingdom ibuprofen +codeine
Swedish: Storbritannien ibuprofen +kodein
English: Codeine phosphate+paracetamo l + caffeine
Swedish: Kodeinfosfat +paracetamo l + koffein
English: Codeine Phosphate Tablets BP 15mg
Swedish: Kodein Phosphate Tabletts BP 15mg
English: Paracetamol Codeine Phosphate Buclizine Hydrochloride
Swedish: Paracetamol Kodeinfosfat Buklizinhydroklorid
English: 500 mg and 30 mg tablet
Swedish: 500 mg and 30 mg tablett
English: Ibuprofen/Codeine Phosphate Hemihydrate
Swedish: Ibuprofen/ Kodeinfosfathemihydrat
English: Codeine phosphate + paracetamol
Swedish: Kodeinfosfat+ paracetamol
English: Paracetamol and codeine phospate
Swedish: Paracetamol och kodein phosphate
English: Germany codeinphosphathemihydrat paracetamol
Swedish: Tyskland kodeinfosfathemi hydrat paracetamol
English: Codeine phosphate + paracetamol + caffeine
Swedish: Kodeinfosfat+ paracetamol + koffein
English: Cupanol Co-codamol effervescent tablet
Swedish: Cupanol Co-codamol brustablett
English: Paracetamol+ Codeine phosphate hemihydrate
Swedish: Paracetamol+ Kodeinfosfathemihydrat
English: Co-Codamol 500 mg/8 mg tablets
Swedish: Co-Codamol 500 mg/8 mg tabletts
English: 30mg + 500mg capsule, hard oral use
Swedish: 30mg + 500mg kapsel, hård oral användning
English: Codeine phosphate tablets BP 30mg
Swedish: Kodein Phosphate Tabletts BP 30mg
English: Ibuprofen and codeine phosphate hemihydrate
Swedish: Ibuprofen och kodeinfosfathemihydrat
English: Paracetamol/ Codeine phosphate
Swedish: Paracetamol/Kodein phosphate
English: 500 mg/8 mg/30 mg tablet
Swedish: 500 mg/8 mg/30 mg tablett
English: Codeine Phosphate Tablets BP 60mg
Swedish: Kodein Phosphate Tabletts BP 60mg
English: 500 mg/8 mg/30 mg hard capsule
Swedish: 500 mg/8 mg/30 mg kapsel, hård
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Tablets tablet for oral solution
Swedish: Berkshire RG14 1JA, Storbritannien paracetamol + kodein Paracodol Tabletts tablett for oral lösning
English: Germany codeinphosphathemihydrat paracetamol talvosilen capsule
Swedish: Tyskland kodeinfosfathemi hydrat paracetamol talvosilen kapsel
English: 400 mg and 30 mg film-coated tablet oral use
Swedish: 400 mg and 30 mg filmdragerad tablett
English: Codeine phosphate 60mg tablets
Swedish: Kodein phosphate 60mg tabletts
English: Paracetamol/Codeine PARACETAMOL CODEINE SANDOZ 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN SANDOZ 500 mg/30 mg, comprimé effervescent sécable
English: 30mg + 500 mg capsule, hard oral use
Swedish: 30mg + 500 mg kapsel, hård oral användning
English: Paracetamolum + Codeini phosphas
Swedish: Paracetamol + Kodeinfosfat
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Co-Codamol Disp tablet for oral solution
Swedish: Berkshire RG14 1JA, Storbritannien paracetamol + kodein Co-Codamol Disp tablett for oral lösning
English: Pinex Forte effervescent tablet
Swedish: Pinex Forte brustablett
English: Caffeine 30 mg film-coated tablet oral use
Swedish: Koffein 30 mg filmdragerad tablett
English: Paracetamolum INN/Codeini Phosphas Hemihydricus
Swedish: Paracetamol INN/Kodeinfosfathemi hydrat
English: 200 mg/ 12.8 mg film-coated tablet oral use
Swedish: 200 mg/ 12.8 mg filmdragerad tablett
English: Site Apollo,
Swedish: Hampden Park,
English: Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable effervescent tablet
Swedish: Paracetamol/Kodein CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable brustablett
English: Dafalgan codeine film-coated tablet oral use
Swedish: Dafalgan kodein filmdragerad tablett
English: Migraleve Yellow film-coated tablet oral use
Swedish: Migraleve Yellow filmdragerad tablett
English: Codeine phosphate hemihydrate + caffeine + paracetamol
Swedish: Kodeinfosfathemihydrat + koffein + paracetamol
English: 500mg + 8mg + 30mg film-coated tablet oral use
Swedish: 500mg + 8mg + 30mg filmdragerad tablett
English: 30,6 mg + 500 mg film-coated tablet oral use
Swedish: 30,6 mg + 500 mg filmdragerad tablett
English: Paracetamol/Codeine PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol/Codeine PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN TEVA 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol/Codeine PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN CRISTERS 500 mg/30 mg, comprimé effervescent sécable
English: 500 mg + 10 mg effervescent tablet
Swedish: 500 mg + 10 mg brustablett
English: Germany codeinphosphathemihydrat paracetamol talvosilen forte
Swedish: Tyskland kodeinfosfathemi hydrat paracetamol talvosilen forte
English: Paracetamol Codeine Phosphate Hemihydrate Caffeine
Swedish: Paracetamol Kodeinfosfathemihy drat Koffein
English: Paracetamol + codeine phosphate hemihydrate+ caffeine
Swedish: Paracetamol + kodeinfosfathemihydra t+ koffein
English: Codeine phosphate 15 mg tablets
Swedish: Kodeinfosfat15 mg tabletts
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Capsules capsule
Swedish: Berkshire RG14 1JA, Storbritannien paracetamol + kodein Paracodol Capsules kapsel
English: 500mg/50mg/30mg effervescent tablet
Swedish: 500mg/50mg/30mg brustablett
English: Paracetamol/Codeine PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN MYLAN 500 mg/30 mg, comprimé effervescent sécable
English: 30mg + 500mg tablet
Swedish: 30mg + 500mg tablett
English: Paracetamol/Codeine PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN ARROW 500 mg/30 mg, comprimé effervescent sécable
English: 500mg 8mg 30mg effervescent tablet
Swedish: 500mg 8mg 30mg brustablett
English: 25 mg film-coated tablet oral use
Swedish: 25 mg filmdragerad tablett
English: 500 mg and 30 mg film-coated tablet oral use
Swedish: 500 mg/30 mg dragerad tablett oral användning
English: Codeine Phosphate 30mg Tablets
Swedish: Kodein phosphate 30mg tabletts
English: Codeine phosphate 30mg tablets
Swedish: Kodein Phosphate 30mg Tabletts
English: 200mg + 12,8mg film-coated tablet oral use
Swedish: 200mg +12.8mg dragerad tablett oral användning
English: Paracetamol/Codeine PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN ALMUS 500 mg/30 mg, comprimé effervescent sécable
English: 500 mg+8 mg+30 mg effervescent tablet
Swedish: 500 mg+8 mg+30 mg brustablett
English: Germany codeinphosphathemihydrat
Swedish: Tyskland kodeinfosfathemi hydrat
English: KG
Swedish: 2SA
English: 500 mg/30 mg coated tablet
Swedish: 500 mg/30 mg tablett
English: 9GS Brentford United Kingdom codeine + paracetamol + caffeine
Swedish: Storbritannien kodein + paracetamol + koffein
English: 500mg + 30mg film-coated tablet oral use
Swedish: 15mg + 500mg dragerad tablett Oral användning
English: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
Swedish: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg brustablett
English: Dafalgan codéine effervescent tablet
Swedish: Dafalgan codéine brustablett
English: Paracetamol, codeine phosphate and caffeine
Swedish: Paracetamol, kodeinfosfatand koffein
English: Paracetamolum + Coffeinum + Codeini phosphas
Swedish: Paracetamol + Koffein + Kodeinfosfat
English: Paracetamol/Codeine PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Swedish: Paracetamol/Kodein PARACETAMOL KODEIN EG 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol+ caffeine+ codeine phosphate hemihydrate
Swedish: Paracetamol+ Koffein+ Kodeinfosfathemihydrat
English: Paracetamol+ Caffeine+ Codeine phosphate hemihydrate
Swedish: Paracetamol+ koffein+ kodeinfosfathemihydrat
English: 500mg + 30mg + 8mg effervescent tablet
Swedish: 500mg + 30mg + 8mg brustablett
English: Paracetamol, codeine phosphate hemihydrate
Swedish: Paracetamol, kodeinfosfathemihydrat
English: ABBOTT
Swedish: brustablett
English: Codeine phosphate hemihydrate + paracetamol
Swedish: Kodeinfosfathemihy drat + paracetamol
English: RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ibuprofen, fosfat de codeină hemihidrat
Swedish: Berkshire SL1 3UH, Storbritannien ibuprofen, kodeinfosfathemihydrat
English: Co-codamol 8/500 mg tablets effervescent tablet
Swedish: Co-codamol 8/500 mg tabletts brustablett
English: Codeini phosphas hemihydricus + paracetamolum
Swedish: Kodeinfosfathemi hydrat + paracetamol
English: Sterwin Meds Cocodamol 30/500 effervescent tablets 30mg/500mg
Swedish: Sterwin Meds Cocodamol 30/500 effervescent tabletts
English: 200mg +12.8mg coated tablet
Swedish: 200mg +12.8mg filmdragerad tablett
English: Aspirin/Codeine phosphate hemihydrate
Swedish: Storbritannien aspirin + kodein phosphate
English: 500mg + 8mg + 30mg effervescent tablet
Swedish: 500mg + 8mg + 30mg brustablett
English: Codeini phosphas hemihydricus + paracetamolum + coffeinum
Swedish: Kodeinfosfathemi hydrat + paracetamol + koffein
English: ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovenia paracetamol, propifenazonă , cafeină , fosfat de codeină sesquihidrat
Swedish: Črnuče, Slovenien paracetamol, propifenazo , koffein, kodeinfosfatseskvihydrat
English: Ibuprofen Codeine phosphate hemihydrate
Swedish: Ibuprofen Kodeinfosfathemihydrat
English: Migraleve Pink Tablets: Paracetamol, codeine phosphate, buclizine hydrochloride
Swedish: Paracetamol, kodeinfosfat, buklizinhydroklorid
English: paracetamol + codeine Pharmachem CoCodamol Tablets 8/500
Swedish: Storbritannien paracetamol + kodein Pharmachem CoCodamol Tabletts
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom
Swedish: Storbritannien WOCKHARDT UK LIMITED Ash Road North, Wrexhan
English: LABORATORIOS ERN, S.A. Pedro IV, 499 08022 Barcelona Spain
Swedish: Spanien LABORATORIOS ERN, S.A. Pedro IV, 499
English: Paracetamol/Codeine/C affeine
Swedish: Paracetamol/Kodein/koff ein
English: TW8
Swedish: 3FR
English: Codeine phosphate + caffeine + paracetamol + doxylamine succinated
Swedish: Kodeinfosfat+ koffein + paracetamol doxylaminsuci nat
English: 30 mg + 500 mg tablet
Swedish: 30 mg +500 mg tablett
English: 30 mg +500 mg tablet
Swedish: 30 mg + 500 mg tablett
English: 30mg + 500 mg tablet
Swedish: 30mg + 500 mg tablett
English: Sweden codeine phosphate hemihydrate/ paracetamol
Swedish: 167 14 Bromma Sverige kodeinfosfathemih ydrat/ paracetamol
English: 500 mg/ 8 mg/ 30 mg capsule, hard oral use
Swedish: 500 mg/ 8 mg/ 30 mg kapsel, hård
English: Co-codamol 500 mg/8 mg tablets effervescent tablet
Swedish: Co-codamol 500 mg/8 mg tabletts brustablett
English: Paracetamol Codeine Phosphate hemihydrate
Swedish: Paracetamol Kodeinfosfathemihy drat
English: 8mg + 500mg + 30mg effervescent tablet
Swedish: 8mg + 500mg + 30mg brustablett
English: Paracetamol Codeine phosphate
Swedish: Paracetamol Kodeinfosfat
English: 15mg + 500mg effervescent tablet
Swedish: 15mg + 500mg brustablett
English: 500 mg, 8 mg, 30 mg effervescent tablet
Swedish: 500mg, 8mg 50mg brustablett
English: Content (concentration)
Swedish: Innehåll (koncentration)
English: 1 cartridge and 1 pen
Swedish: 1 cylinderampull och 1 penna
English: Strength Pharmaceutical Form
Swedish: Läkemedelsform Administrering ssätt
English: Pack size
Swedish: Innerförpack ning
English: 3 cartridges
Swedish: 3 cylinderampuller
English: 1 cartridge
Swedish: MTnr
English: This approach offers the highest degree of consumer protection
Swedish: Denna strategi ger det bästa skyddet för konsumenterna.
English: The responses were submitted on 17 June 2004.
Swedish: Svaren inkom den 17 juni 2004.
English: Conclusions and recommendations
Swedish: Slutsatser och rekommendationer
English: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS
Swedish: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS Spanien
English: Strength Pharmaceutical form
Swedish: Namn Styrka Farmaceutisk form
English: 2900 AA CAPELLE AAN DEN IJSSEL The Netherlands
Swedish: 2900 AA CAPELLE AAN DEN IJSSEL Nederländerna
English: The grounds for the appeal were submitted to the EMEA on 8 November 2004.
Swedish: Grunderna för överklagandet inlämnades till EMEA den 8 november 2004.
English: Therefore, the recommendation of a 70-day withdrawal period applies to both doses.
Swedish: Rekommendationen om en karenstid på 70 dagar gäller därför båda doserna.
English: 00330 Helsinki Finland
Swedish: 00330 Helsingfors Finland
English: Introduction and Background
Swedish: Inledning och bakgrund
English: 183 25 Täby Sweden
Swedish: 183 25 Täby Sverige
English: Group 3 animals were sacrificed at day 35 after treatment.
Swedish: Djuren i grupp 3 slaktades dag 35 efter behandlingen.
English: 45 days
Swedish: 45 dagar
English: 76139 Karlsruhe Germany
Swedish: 76139 Karlsruhe Tyskland
English: 23/25 Ave du docteur Lannelongue 75014 Paris France
Swedish: 23/25 Ave du docteur Lannelongue 75014 Paris Frankrike
English: 2.1 Residue depletion studies
Swedish: 2.1 Restmängdsstudier
English: The remaining 4 sheep (group 1) served as untreated controls.
Swedish: De återstående 4 fåren (grupp 1) fungerade som kontrollgrupp och fick inte någon behandling.
English: Neither the second nor third studies are suitable for the determination of a withdrawal period following subcutaneous administration.
Swedish: Varken den andra eller den tredje studien lämpar sig för att fastställa en karenstid efter subkutan administrering.
English: Pfizer Ltd, Sandwich, Kent, CT13 9NJ, UK
Swedish: Pfizer Ltd, Sandwich, Kent, CT13 9NJ, Storbritannien
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.
Swedish: Den tredje studien utgjordes av en ny analys av vävnad från injektionsställen från den andra studien på grund av de stora skillnaderna i de erhållna resultaten.
English: In fat, residues were below 8 μg/kg at all remaining time-points.
Swedish: I fett låg restmängderna under 8 µg/kg vid alla återstående tidpunkter.
English: 18 2650 Hvidovre Denmark
Swedish: 18 2650 Hvidovre Danmark
English: For the referral procedure, the representative of the Marketing Authorisation Holder presented three studies.
Swedish: Företrädaren för innehavaren av godkännandet för försäljning presenterade tre studier för hänskjutningsförfarandet.
English: 2.2 Calculation of withdrawal periods
Swedish: 2.2 Beräkning av karenstider
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 16 February 2004.
Swedish: Frågorna gällde karenstiderna och lämnades till innehavarna av godkännande för försäljning den 16 februari 2004.
English: Withdrawal period (meat and milk)
Swedish: Karenstid (kött och mjölk)
English: Pfizer Italia SRL Via Valbondione 113 00188 Roma
Swedish: Pfizer Italia SRL Via Valbondione 113 00188 Rom Italien
English: Frequency Recommended dose
Swedish: Frekvens Rekommenderad dos
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:
Swedish: Doramektin togs med i bilaga I till rådets förordning (EEG) nr 2377/90 och följande högsta tillåtna restmängder fastställdes för får:
English: The CVMP had previously assessed doramectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Swedish: CVMP hade tidigare utvärderat doramektin för att fastställa högsta tillåtna restmängder (MRL) i enlighet med rådets förordning 2377/90.
English: In the group 2 animals given two doses, the injection sites contained the highest residues followed by liver and fat.
Swedish: I grupp 2, djur som fått två doser, återfanns de högsta restmängderna på injektionsställena följt av lever och fett.
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
Swedish: LÄKEMEDLENS NAMN, LÄKEMEDELSFORMER, STYRKOR, ADMINISTRERINGSSÄTT, INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING, FÖRPACKNINGAR OCH FÖRPACKNINGSSTORLEKAR I MEDLEMSSTATERNA, ISLAND OCH NORGE
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.
Swedish: I EU:s medlemsstater och i de EES/EFTA-stater som anges i bilaga I har produkten godkänts som injektionsvätska för intramuskulär eller subkutan administrering.
English: Pfizer Corp. Austria Seidengasse 33-35 1071 Wien
Swedish: Pfizer Corp. Austria Seidengasse 33-35 1071 Wien Österrike
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.
Swedish: En karenstid på 182 dagar beräknades, men CVMP anser inte att detta är ett hållbart tillvägagångssätt eftersom det inte finns några studier från tidpunkterna för slakt som kan bekräfta denna prediktion och det är svårt att extrapolera en lämplig karenstid från de koncentrationer av restmängder som påträffats i proverna från injektionsstället.
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.
Swedish: Jämförelse av data från grupperna 2 och 3 indikerade att administrering av en andra dos inte påverkade restmängdens profil i köttvävnader vid karenstider på omkring 35 dagar.
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.
Swedish: Vid sitt sammanträde den 10-12 februari 2004 inledde CVMP ett hänskjutningsförfarande enligt artikel 34 i rådets direktiv 2001/82/EG för Dectomax injektionsvätska innehållande doramektin.
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.
Swedish: I CVMP:s arbetsdokument om restmängder på injektionsställen (III/5933/94-EN) rekommenderas att injektionsstället och restmängderna däri skall behandlas som ”normala” muskler där en av målvävnaderna består av muskler.
English: At all other time-points doramectin concentrations in liver, kidney and skeletal muscle were at or below the limit of quantification.
Swedish: Vid alla andra tidpunkter låg koncentrationerna av doramektin i lever, njure och skelettmuskulatur på eller under kvantifieringsgränsen.
English: Box 52 0508 Oslo, Norway
Swedish: 0508 Oslo, Norge
English: Denmark Pfizer Aps Lautrupvang 8
Swedish: Danmark Pfizer Aps Lautrupvang 8
English: Not to be used later than 60 days prior to expected calving.
Swedish: Skall inte användas senare än 60 dagar före förväntad kalvning.
English: A simplified approach to the residues at the injection site is not possible as residues were above the MRL of 20 μg/kg in most of the samples taken at the last period in which the animals were slaughtered (56 days).
Swedish: Det är inte möjligt att behandla restmängderna på injektionsstället på ett förenklat sätt eftersom de översteg MRL på 20 µg/kg i de flesta av de provexemplar som togs under den sista perioden innan djuren slaktades (56 dagar).
English: With respect to the subcutaneous use in ovine species, the Committee recommended that no withdrawal period could be set and references to this route of administration should be removed from the product literature.
Swedish: Med avseende på den subkutana användningen hos får-arter, rekommenderade kommitteen att ingen karenstid kunde fastställas och att referenser till denna administreringsväg skulle tas bort från produktinformationen.
English: Following extensive re-homogenisation of the remaining injection site tissue (38-204 g) four 2.5 g sub-samples were analysed per animal for doramectin determination.
Swedish: Efter omfattande re-homogenisering av återstående vävnader från injektionsställen (38-204 g) analyserades fyra delprover på 2,5 g per djur för bestämning av doramektin.