FrancophonIA/ELRC3.0 huggingface dataset:
English: It must especially not be mixed with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Danish: Det må især ikke blandes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, fordi det er blevet påvist, at chlorid nedsætter opløseligheden af methylthioniniumchlorid.
English: If diluted in glucose 50 mg/ml (5%) solution for injection, methylthioninium chloride must be used with caution in patients with hyperglycaemia or diabetes mellitus, as these conditions may be exacerbated by the glucose solution.
Danish: Hvis methylthioniniumchlorid opløses i glukose 50 mg/ml (5 %) injektionsvæske, opløsning, skal det anvendes med forsigtighed hos patienter med hyperglycæmi eller diabetes mellitus, da disse lidelser kan forværres af glukoseopløsningen.
English: Avoid concomitant use of methylthioninium chloride with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (see section 4.5).
Danish: Undgå samtidig brug af methylthioniniumchlorid og selektive serotoningenoptagelseshæmmere (SSRI), serotonin- og noradrenalingenoptagelseshæmmere (SNRI) og monoaminooxidasehæmmere (se pkt.
English: Special care must be taken with Methylthioninium chloride Proveblue: - in newborns and infants 3 months old or younger, lower doses are recommended (see section 3 of this package leaflet).
Danish: Vær ekstra forsigtig med Methylthioniniumchlorid Proveblue: - Hos nyfødte og børn under 3 måneder anbefales lavere doser (jf. pkt.
English: Solution for injection (injection) Clear dark blue solution with a pH value between 3.0 and 4.5 Osmolality is usually between 10 and 15 mOsm/kg.
Danish: Injektionsvæske, opløsning (injektionsvæske) Klar mørkeblå opløsning med en pH-værdi på mellem 3,0 og 4,5.
English: Reproductive Toxicology
Danish: Reproduktionstoksicitet
English: Individuals with methaemoglobinaemia
Danish: Personer med methæmoglobinæmi
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om Methylthioniniumchlorid Proveblue på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Chromaturia (blue-green)
Danish: Farvet urin (blågrøn)
English: A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range.
Danish: En ny dosis (1 til 2 mg/kg legemsvægt, dvs. 0,2-0,4 ml/kg legemsvægt) kan indgives en time efter den første dosis i tilfælde af vedvarende eller tilbagevendende symptomer, eller hvis methæmoglobinniveauet forbliver væsentligt højere end det normale kliniske niveau.
English: Methylthioninium chloride Proveblue is not an in vitro inducer of CYP2B6 and CYP3A4.
Danish: Methylthioniniumchlorid Proveblue inducerer ikke CYP2B6 og CYP3A4 in vitro.
English: Warnings and precautions Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue - if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed - if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3 of this package leaflet) - if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3)
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Methylthioniniumchlorid Proveblue - Hvis du har en moderat til svær nyrelidelse; lavere doser (< 1 mg/kg) kan være nødvendige - Hvis din blodlidelse er forårsaget af det kemiske stof anilin, som findes i farvestoffer; lavere doser kan være nødvendige, og den samlede kumulative dosis bør ikke overskride 4 mg/kg (jf. pkt.
English: Methylthioninium chloride Proveblue is for administration by a healthcare professional.
Danish: Methylthioniniumchlorid Proveblue skal indgives af en kvalificeret sundhedsfaglig person.
English: It must not be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Danish: Må ikke fortyndes med natriumchlorid 9 mg/ml (0.9%) injektionsvæske, opløsning, fordi det er blevet påvist, at chlorid nedsætter opløseligheden af methylthioniniumchlorid.
English: A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range (see section 4.4 for important safety information).
Danish: En ny dosis (0,3 til 0,5 mg pr. kg legemsvægt, dvs. 0,06-0,1 ml pr. kg legemsvægt) kan indgives en time efter den første dosis i tilfælde af vedvarende eller tilbagevendende symptomer, eller hvis methæmoglobinniveauet forbliver væsentligt højere end det normale kliniske niveau (se vigtige sikkerhedsoplysninger i pkt.
English: Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters.
Danish: Methylthioniniumchlorid kan forårsage en lysfølsomhedsreaktion i huden (reaktion, der minder om solskoldning) ved udsættelse for stærke lyskilder, såsom lysbehandling, lys på operationsstuer og pulsoximetre.
English: Methylthioninium chloride is an in vitro inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5.
Danish: In vitro hæmmer methylthioniniumchlorid CYP2A1, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/5.
English: Haemoglobin decreased
Danish: Hæmoglobin faldet
English: 5 ampoules of 2 ml 20 ampoules of 2 ml 10 mg/2 ml
Danish: 50 mg/10 ml 5 ampuller à 2 ml 20 ampuller à 2 ml 10 mg/2 ml
English: If you have any doubts about whether this medicine should be given to you, consult your doctor.
Danish: Tal med din læge, hvis du er i tvivl om, hvorvidt lægemidlet bør gives til dig.
English: What Methylthioninium chloride Proveblue looks like and contents of the pack Methylthioninium chloride Proveblue is a clear dark blue solution for injection (injection) and is supplied in clear glass ampoules.
Danish: Methylthioniniumchlorid Proveblue er en klar mørkeblå injektionsvæske, opløsning og leveres i klare glasampuller.
English: If any of the above applies to you, please consult your doctor.
Danish: Fortæl det til din læge, hvis noget af ovenstående gælder for dig.
English: Methylthioninium chloride may cause a cutaneous photosensitivity reaction when exposed to strong light sources, such as phototherapy, those found in operating theatres or locally from illuminating devices such as pulse oximeters.
Danish: Methylthioniniumchlorid kan forårsage en kutan fotosensitivitetsreaktion ved eksponering for stærke lyskilder, såsom lysbehandling, lys på operationsstuer eller lokalt fra lysenheder såsom pulsoximetre.
English: 22 rue Marc Donadille, 13013 Marseille, France
Danish: 22 rue Marc Donadille, 13013 Marseille, Frankrig
English: Serotonin Syndrome with concomitant use of serotonergic drugs (see section 4.4 and section 4.5).
Danish: Serotoninsyndrom ved samtidig brug af serotonerge lægemidler (se pkt.
English: No evidence of carcinogenic activity was observed in female rats.
Danish: Der blev ikke observeret tegn på karcinogenicitet i hunrotter.
English: After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues.
Danish: Efter intravenøs indgivelse optages Methylthioniniumchlorid Proveblue hurtigt i vævene.
English: What you need to know before you are given Methylthioninium chloride Proveblue
Danish: Det skal du vide, før du begynder at få Methylthioniniumchlorid Proveblue
English: Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride.
Danish: 2 spædbørn døde efter indgivelse af 20 mg/kg methylthioniniumchlorid.
English: Intravenous use only
Danish: Kun til intravenøs anvendelse
English: How to store Methylthioninium chloride Proveblue
Danish: Sådan gives Methylthioniniumchlorid Proveblue
English: When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening.
Danish: Hvis methylthioniniumchlorid anvendes sammen med disse lægemidler, kan det forårsage serotoninsyndrom, som kan være livstruende.Sådanne lægemidler omfatter:
English: Faeces discoloration (blue-green)
Danish: Misfarvning af afføring (blågrøn)
English: There is no experience in patients with severe hepatic impairment.
Danish: Nedsat leverfunktion Der er ingen erfaring med behandling af patienter med svært nedsat leverfunktion.
English: AMPOULE
Danish: AMPUL
English: Use immediately on opening.
Danish: Anvendes umiddelbart efter anbrud.
English: A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case of persistence or recurrence of symptoms.
Danish: Der kan gives endnu en dosis (0,3-0,5 mg/kg legemsvægt, dvs. 0,06-0,1 ml/kg) efter en time, hvis symptomerne varer ved eller dukker op igen.
English: You must not be given Methylthioninium chloride Proveblue: - if you are allergic to methylthioninium chloride or other thiazine dyes - if your body does not produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase) - if your body does not produce enough of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase - if your blood disorder has been caused by nitrite during treatment of cyanide poisoning - if your blood disorder has been caused by chlorate poisoning.
Danish: - Hvis din krop ikke producerer nok af enzymet G6PD (glukose-6-phosphatdehydrogenase) - Hvis din krop ikke producerer nok af enzymet NADPH (nicotinamidadenindinucleotidphosphat)
English: This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children.
Danish: Dette lægemiddel kan fortyndes i 50 ml glukose 50 mg/ml (5 %) injektionsvæske, opløsning for at undgå lokale smerter, navnlig hos børn.
English: Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, France
Danish: PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, Frankrig
English: PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, France
Danish: Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, Frankrig
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride Each 2 ml ampoule contains 10 mg methylthioninium chloride
Danish: Hver 10 ml-ampul indeholder 50 mg methylthioniniumchlorid Hver 2 ml-ampul indeholder 10 mg methylthioniniumchlorid.
English: Some evidence of carcinogenic activity of methylthioniniul chloride has been shown in male mice and male rats.
Danish: Der foreligger en vis evidens for methylthioniniulchlorids karcinogene aktivitet i hanmus og hanrotter.
English: An equivocal evidence of carcinogenic activity was observed in female mice.
Danish: Der blev observeret usikre tegn på karcinogenicitet i hunmus.
English: Methylthioninium chloride Proveblue is an in vitro inhibitor of P-gp.
Danish: Methylthioniniumchlorid Proveblue hæmmer P-gp in vitro.
English: Such medicines include:
Danish: Oversigt over indlægssedlen:
English: Methylthioninium chloride is an in vitro inducer of CYP1A2.
Danish: In vitro inducerer methylthioniniumchlorid CYP1A2.
English: Methylthioninium chloride Proveblue has been observed to stain tissues selectively.
Danish: Det er blevet observeret, at Methylthioniniumchlorid Proveblue farver vævene selektivt.
English: Each box contains a tray with 20 ampoules of 2 ml.
Danish: Hver æske indeholder en bakke med 20 ampuller à 2 ml.
English: The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.
Danish: Den anbefalede dosis er 0,3 til 0,5 mg pr. kg legemsvægt, dvs. 0,06-0,1 ml/kg over et tidsrum på 5 minutter.
English: Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Danish: Methylthioniniumchlorid Proveblue er hypotonisk og kan fortyndes i 50 ml glukose 50 mg/ml (5 %) injektionsvæske, opløsning for at undgå lokale smerter, navnlig i den pædiatriske population.
English: Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Danish: Methylthioniniumchlorid Proveblue kan fortyndes i en 50 ml glukose 50 mg/ml (5 %) injektionsvæske, opløsning for at undgå lokale smerter, navnlig i den pædiatriske population.
English: Infants 3 months old or younger
Danish: Spædbørn på 3 måneder eller derunder
English: The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg body weight, given over a period of 5 minutes.
Danish: Den normale dosis er 1 til 2 mg pr. kg legemsvægt, dvs. 0,2-0,4 ml pr. kg legemsvægt administreret over et tidsrum på 5 minutter.
English: What Methylthioninium chloride Proveblue is and what it is used for What you need to know before you are given Methylthioninium chloride Proveblue How Methylthioninium chloride Proveblue is given Possible side effects
Danish: Det skal du vide, før du begynder at få Methylthioniniumchlorid Proveblue Sådan gives Methylthioniniumchlorid Proveblue Bivirkninger
English: Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.
Danish: Hver æske indeholder en bakke med 5 eller 20 ampuller à 2 ml.
English: Each ml of solution contains 5 mg methylthioninium chloride.
Danish: Hver ml opløsning indeholder 5 mg methylthioniniumchlorid.
English: Each box contains a tray with 5 ampoules of 10 ml.
Danish: Hver æske indeholder en bakke med 5 ampuller à 10 ml.
English: The recommended dose is 0.3-0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg body weight, given over a period of 5 minutes.
Danish: Den anbefalede dosis er 0,3 til 0,5 mg pr. kg legemsvægt, dvs. 0,06-0,1 ml pr. kg legemsvægt administreret over et tidsrum på 5 minutter.
English: Each box contains a tray with 5 ampoules of 2 ml.
Danish: Hver æske indeholder en bakke med 5 ampuller à 2 ml.
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection methylthioninium chloride
Danish: Methylthioniniumchlorid Proveblue 5 mg/ml injektionsvæske, opløsning methylthioniniumchlorid
English: Each 2 ml ampoule contains 10 mg methylthioninium chloride.
Danish: Hver 2 ml ampul indeholder 10 mg methylthioniniumchlorid.
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Danish: Hver 10 ml-ampul indeholder 50 mg methylthioniniumchlorid.
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Danish: Methylthioniniumchlorid Proveblue 5 mg/ml injektionsvæske, opløsning.
English: The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes.
Danish: Den normale dosis er 1 til 2 mg pr. kg legemsvægt, dvs. 0,2-0,4 ml pr. kg administreret over et tidsrum på 5 minutter.
English: • Monoamine oxidase inhibitors
Danish: • monoaminooxidasehæmmere.
English: Cardiac arrhythmia
Danish: Brystsmerter
English: Please refer to section 4.4 for important safety information.
Danish: For yderligere vigtige sikkerhedsoplysninger, se pkt.
English: Aphasia
Danish: Paræstesi
English: Dizziness
Danish: Afasi
English: The responses were submitted on 25 November 2003.
Danish: Besvarelserne blev forelagt den 25. november 2003.
English: B-1070 Bruxelles Belgium
Danish: B-1070 Bruxelles Belgien
English: E-08014 Barcelona Spain
Danish: E-08014 Barcelona Spanien
English: I-20090 Assago (MI) Italy
Danish: I-20090 Assago (MI) Italien
English: Residue concentrations in this study showed a large variation.
Danish: Restkoncentrationerne i denne undersøgelse viste store udsving.
English: AMSTELVEEN The Netherlands
Danish: AMSTELVEEN Nederlandene
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 28 July 2003.
Danish: De anførte spørgsmål vedrørte tilbageholdelsestiden og blev forelagt indehaverne af markedsføringstilladelsen den 28. juli 2003.
English: For 3 studies the data allowed the use of the statistical approach.
Danish: For tre undersøgelser gjorde de anførte data det muligt at anvende den statistiske metode.
English: The product has been authorised in the European Union (all Member States except Greece) and in Norway as a pour on solution for topical use.
Danish: Produktet er blevet tilladt i Den Europæiske Union (alle medlemsstater undtagen Grækenland) og i Norge som en pouron-opløsning til lokal påføring.
English: 2.2 Calculation of withdrawal periods
Danish: 2.2 Beregning af tilbageholdelsestiden
English: 29 av Tony Garnier F-69007 Lyon France
Danish: 29 av Tony Garnier F-69007 Lyon Frankrig
English: Muscle: 50 µg/kg Fat: 250 µg/kg Liver: 1500 µg/kg Kidney: 300 µg/kg Milk: 20 µg/kg
Danish: Muskel: 50 µg/kg Fedt: 250 µg/kg Lever: 1500 µg/kg Nyre: 300 µg/kg Mælk: 20 µg/kg
English: All studies were conducted according to GLP-guidelines and using the formulation as marketed in all relevant Member States and Norway in the correct dosage.
Danish: Alle undersøgelser var udført i overensstemmelse med GLP-retningslinjerne og under anvendelse af den lægemiddelform, der var markedsført i alle berørte medlemsstater og Norge, med en korrekt dosering.
English: 2.1 Residue depletion studies
Danish: 2.1 Undersøgelse af depletering af restkoncentrationer
English: Box 327
Danish: P.O. Box 327
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY
Danish: BILAG I LISTE OVER NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJE, DYREARTER OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE OG NORGE
English: The CVMP had previously assessed eprinomectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Danish: CVMP havde tidligere evalueret eprinomectin med henblik på fastsættelsen af maksimalgrænseværdierne for restkoncentrationer (MRL) i overensstemmelse med Rådets forordning 2377/90.
English: Eprinomectin was included in Annex I of Council Regulation 2377/90 and the following maximum residue limits were established for bovine species:
Danish: Eprinomectin blev indføjet i bilag I til Rådets forordning 2377/90, og maksimalgrænseværdierne for restkoncentrationer i kvæg blev fastsat til følgende:
English: All four studies were considered relevant to be used in the establishment for the determination of the withdrawal period.
Danish: Alle fire undersøgelser blev anset for at være relevante for fastsættelsen af tilbageholdelsestiden.
English: UK-Essex CM19 5TG United Kingdom
Danish: UK-Essex CM19 5TG Det Forenede Kongerige
English: For the 4th study, the statistical method could not be used due to large variation in the data set.
Danish: Det var ikke muligt at anvende den statistiske metode på den fjerde undersøgelse som følge af de store udsving i de anvendte data.
English: Eprinex pour-on products contain eprinomectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle including lactating cows.
Danish: Eprinex pour-on-produkterne indeholder eprinomectin, som er et halvsyntetisk avermectin til behandling af interne og eksterne parasitter hos kvæg, herunder lakterende køer.
English: Therefore, the CVMP recommended that all marketing authorisations pour-on solutions containing eprinomectin for topical use in bovine species known as Eprinex or variations of that name as referred to in Annex I a withdrawal period for meat and offal of 15 days is set.
Danish: Derfor anbefalede CVMP, at der for markedsføringstilladelser for pour-on-opløsninger, der indeholder eprinomectin til lokal behandling af kvæg under betegnelsen Eprinex eller varianter af dette navn som angivet i bilag I, fastsættes en tilbageholdelsestid for kød og indvolde på 15 døgn.
English: On 18 June 2003 Germany requested the CVMP to give an opinion under Article 34 of Council Directive 2001/82/EC concerning the divergent decisions taken by the competent national authorities regarding the withdrawal periods for meat and offal when granting the marketing authorisations for Eprinex pour on products.
Danish: Den 18. juni 2003 anmodede Tyskland CVMP om at afgive en udtalelse, jf. artikel 34 i Rådets direktiv 2001/82/EF, om de kompetente nationale myndigheders afvigende afgørelser vedrørende tilbageholdelsestiden for kød og indmad i forbindelse med udstedelsen af markedsføringstilladelserne for Eprinex pour-on-produkterne.
English: The alternative approach yields a withdrawal period of 14 days plus a safety margin, based on depletion from liver, fat and muscle for the 4th study.
Danish: Den alternative metode gav en tilbageholdelsestid på 14 døgn plus en sikkerhedsmargin baseret på depleteringen i lever, fedt og muskel for den fjerde undersøgelse.
English: The withdrawal period was calculated using either the statistical approach or the alternative approach, as appropriate according to the CVMP note for guidance approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Danish: Den blev beregnet ved hjælp af en statistisk metode eller en alternativ metode afhængigt af omstændighederne i overensstemmelse med CVMP's notat med retningslinjer for harmonisering af tilbageholdelsestiden (EMEA/CVMP/036/95).
English: The withdrawal period for milk of zero days as established in all the relevant Member States and Norway is unaffected.
Danish: Tilbageholdelsestiden for mælk på nul døgn i alle berørte medlemsstater og Norge forbliver uændret.
English: Based on the results of the four different residue depletion studies conducted in adult cattle as well in calves, the longest calculated withdrawal period in meat and offal is 15 days (by statistical approach) or 14 days plus a safety margin (by alternative approach).
Danish: Resultaterne af de fire forskellige undersøgelser af depleteringen af restkoncentrationer i voksent kvæg og i kalve viser, at den længste beregnede tilbageholdelsestid for kød og indmad er 15 døgn (med den statistiske metode) eller 14 døgn plus en sikkerhedsmargin (med den alternative metode).
English: Merial GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany
Danish: Merial GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Tyskland
English: This approach yields 7 days plus a safety margin for the 1st study, 10 days plus a safety margin for the 2nd study, and 0.5 days plus a safety margin for the 3rd.
Danish: Denne metode gav syv døgn plus en sikkerhedsmargin for den første undersøgelse, 10 døgn plus en sikkerhedsmargin for den anden undersøgelse og het halvt døgn plus en sikkerhedsmargin for den tredje.
English: The withdrawal period calculated was 15 days for 2 of the studies and 3 days for the 3rd one, based on depletion from liver.
Danish: Tilbageholdelsestiden blev beregnet til 15 dage for to undersøgelser og til tre dage for den tredje baseret på depleteringen i lever.
English: Overall, a withdrawal period of 15 days is considered appropriate to ensure depletion of residues below the MRLs.
Danish: Generelt mentes en tilbageholdelsestid på 15 døgn at give en passende sikkerhed for at nedbringe restkoncentrationen under MRL.
English: The CVMP during its meeting of 23 July 2003 decided to start a referral procedure under Article 34 of Council Directive 2001/82/EC for the Eprinex pour-on products containing eprinomectin.
Danish: På mødet den 23. juli 2003 vedtog CVMP at indlede en henvisningsprocedure i overensstemmelse med artikel 34 i Rådets direktiv 2001/82/EF for Eprinex pour-on-produkter indeholdende eprinomectin.
English: The withdrawal period for milk was consistently set as 0 days.
Danish: Tilbageholdelsestiden for mælk er overalt fastsat til nul døgn.