FrancophonIA/ELRC3.0 huggingface dataset:
English: H. For products listed in Annex I for which lactating cows have already been approved as target species
Danish: H. For produkter, der er opført i bilag I, og for hvilke lakterende køer allerede er godkendt som måldyreart
English: They do not relate to the same applied posology.
Danish: De refererer ikke til samme anvendte dosering.
English: Milk samples were collected up to 90 hours after the last administration.
Danish: Der blev taget mælkeprøver op til 90 timer efter sidste administration.
English: Therefore, the withdrawal periods cannot be extrapolated to higher injection volumes than those applied in the studies.
Danish: Tilbageholdelsestiderne kan derfor ikke ekstrapoleres til større injektionsvolumener end dem, der er anvendt i undersøgelserne.
English: In both studies, calves of maximum 1.5 months, presumably nonruminating, were involved.
Danish: I begge undersøgelser indgik kalve på højst 1,5 måneder, antagelig ikke-drøvtyggende.
English: For the target species pigs, three studies were identified from which a sufficiently reliable withdrawal period could be drawn.
Danish: For måldyrearten grise blev der fundet tre undersøgelser, hvoraf der kunne udledes en tilstrækkelig pålidelig tilbageholdelsestid.
English: No antimicrobial active residues could be detected in any milk sample collected, which is indicative of an overall very rapid depletion.
Danish: Der kunne ikke detekteres antimikrobielt aktive rester i nogen af de indsamlede mælkeprøver, hvilket tyder på en generelt meget hurtig depletion.
English: The 192 days withdrawal period was established in ruminating animals; however the Committee considers that it is applicable also to non-ruminating calves.
Danish: Tilbageholdelsestiden 192 dage er fastlagt hos drøvtyggende dyr; udvalget finder imidlertid, at den også kan anvendes på ikke-drøvtyggende kalve.
English: The enrolled animals were 6-7 month old ruminating calves.
Danish: De inkluderede dyr var 6-7 måneder gamle drøvtyggende kalve.
English: Furthermore, data available in Belgium for comparable products clearly indicate that residue levels can be above the maximum residue limits (MRLs) at the proposed withdrawal periods.
Danish: Desuden viser de i Belgien foreliggende data for sammenlignelige produkter klart, at restkoncentrationerne kan være over maksimalværdierne (MRL-værdierne) ved de foreslåede tilbageholdelsestider.
English: Poligono Industrial Vallecas 28031 Madrid Spain
Danish: Poligono Industrial Vallecas 28031 Madrid
English: CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne France
Danish: Frankrig CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Danish: Gentamicin er et antibiotikum af aminoglykosidtypen, der er indiceret til behandling af en række bakterielle infektioner.
English: The study is considered by the MAH as a pilot study and involves only 8 animals.
Danish: Undersøgelsen anses af markedsføringstilladelsesindehaveren for en pilotundersøgelse og omfatter kun 8 dyr.
English: IM, SC (only dogs)
Danish: IM, SC (kun hunde)
English: PROPHARMA VET d.o.o.
Danish: Kroatien PROPHARMA VET d.o.o.
English: The withdrawal periods are, respectively, 44, 66 and 146 days.
Danish: Tilbageholdelsestiderne er hhv. 44, 66 og 146 dage.
English: The approved withdrawal period of 146 days was derived using the alternative method with a safety span of 30%, and can be considered as safe for the consumer.
Danish: Den godkendte tilbageholdelsestid på 146 dage blev udledt ved hjælp af den alternative metode med en sikkerhedsmargin på 30 % og kan anses for at være risikofri for forbrugeren.
English: Calves and piglets up to one month old
Danish: kalve og smågrise op til én måned gamle
English: It is the responsibility of each National Competent Authority to apply the recommendations of this opinion based on the recommended maximum dose as per the approved SPC, and to take action in case the recommendations in the product information cannot be properly interpreted.
Danish: Det påhviler hver nationale kompetente myndighed at anvende anbefalingerne i denne udtalelse på grundlag af den anbefalede maksimale dosis svarende til det godkendte produktresumé og at gribe ind, hvis anbefalingerne i produktinformationen ikke kan fortolkes hensigtsmæssigt.
English: Only two animals per slaughter time were involved (14 hours, 7 days, 14 days, 28 days).
Danish: Der blev kun anvendt to dyr pr. slagtetidspunkt (14 timer, 7 dage, 14 dage og 28 dage).
English: PASTEUR - Filiala Filipesti SRL
Danish: Rumænien PASTEUR - Filiala Filipesti SRL
English: The enrolled animals were non-ruminating calves of approximately 3 months, reported to have been fed solid feed during the study.
Danish: De inkluderede dyr var ikkedrøvtyggende kalve på ca. 3 måneder, som blev angivet at have fået fast foder under undersøgelsen.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsveje og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: Using the alternative method, applied to data in kidney, and with a 10% safety margin, leads to a withdrawal period of 139 days.
Danish: Ved hjælp af den alternative metode, anvendt på dataene for nyre med en sikkerhedsmargin på 10 %, fås en tilbageholdelsestid på 139 dage.
English: Krka - Farma d.o.o.
Danish: Kroatien Krka - Farma d.o.o.
English: Overall the data from this study were not considered adequate for the purpose of deriving a milk withdrawal period.
Danish: Data fra denne undersøgelse blev overordnet ikke anset for tilstrækkelige til at udlede en tilbageholdelsestid for mælk.
English: Moreover the residue depletion period is long for gentamicin, and will in most cases cover a period where animals will at least partly, be ruminating.
Danish: Desuden er depletionsperioden for restkoncentrationer af gentamicin lang og vil som regel omfatte en periode, hvor dyrene i det mindste delvis er drøvtyggende.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics
Danish: Videnskabelige konklusioner og begrundelser for ændringen af produktresuméet
English: However, in the context of this referral procedure, where products are already authorised and where limited residue depletion data are available, use of this pragmatic approach was considered to be an acceptable way to maintain the availability of medicinal products while ensuring consumer safety.
Danish: Ved denne indbringelsesprocedure, hvor produkterne allerede er godkendt, og hvor der foreligger begrænsede restkoncentrationsdata, anses en sådan pragmatisk tilgang imidlertid for acceptabel for at opretholde lægemidlernes tilgængelighed og samtidig varetage forbrugersikkerheden.
English: It is not appropriate to pool the residue data in order to calculate an overall withdrawal period for all products as different dosing regimens were applied in the studies.
Danish: Det er ikke hensigtsmæssigt at poole restkoncentrationsdataene for at beregne en overordnet tilbageholdelsestid for alle produkterne, da der er anvendt forskellige dosisregimer i undersøgelserne.
English: Intramuscular or intravenous use:
Danish: Intramuskulær eller intravenøs anvendelse:
English: No complete validation data are available.
Danish: Der foreligger ikke fuldstændige valideringsdata.
English: 1ere Avenue 2065 MLID 06516 Carros Cedex France
Danish: Frankrig VIRBAC 1ere Avenue 2065 MLID 06516 Carros Cedex France
English: 1, it was not possible for Belgium to confirm that the withdrawal periods of 95 days for cattle and 60 days for pigs are safe.
Danish: 1 fastslå, at tilbageholdelsestiderne på 95 dage for kvæg og 60 dage for grise er risikofri.
English: No full report is available for the study with Genta-kel 5%, while the study with Gentaveto-5 was provided as a full report.
Danish: Undersøgelsen med Genta-kel 5 % forelå ikke som fuldstændig rapport, hvorimod undersøgelsen med Gentaveto-5 blev fremlagt som en fuldstændig rapport.
English: Therefore, on 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs.
Danish: Den 8. januar 2016 indledte Belgien derfor en procedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, til kvæg og grise.
English: In addition the period over which depletion takes place is very long, and all products concerned by this referral are aqueous solutions.
Danish: Den periode, hvori depletionen finder sted, er desuden meget lang, og alle produkter omfattet af denne indbringelse er vandige opløsninger.
English: Calves (up to 13 weeks of age)
Danish: kalve (indtil 13 uger gamle)
English: 19 300 Aspropyrgos mailbox 26
Danish: Rumænien Alapis SA 19 300 Aspropyrgos mailbox 26
English: LABIANA LIFE SCIENCES, S.A.
Danish: Spanien LABIANA LIFE SCIENCES, S.A.
English: Taking a pragmatic approach intended to preserve product availability in lactating cows while ensuring consumer safety, it is considered appropriate to apply to the maximum milk withdrawal period currently authorised, i.e., 7 days, to all products that have lactating cows as an indicated species.
Danish: Med en pragmatisk tilgang, der har som mål at bevare tilgængeligheden af produkter til lakterende køer og samtidig varetage forbrugernes sikkerhed, er det hensigtsmæssigt at anvende den maksimale aktuelt godkendte tilbageholdelsestid for mælk, dvs. 7 dage, for alle produkter indiceret til lakterende køer.
English: A validated HPLC-MS/MS analytical method was used.
Danish: Der blev anvendt en valideret HPLC-MS/MS-analysemetode.
English: In addition, for the injection site, one concentration was still slightly above the MRL at day 49.
Danish: Desuden var én koncentration på injektionsstedet stadig lidt over maksimalgrænseværdien på dag 49.
English: For that reason it is not possible to use the study to demonstrate a safe withdrawal period, despite the fact that no residues above the sensitivity limit of 100 µg/kg were detected.
Danish: Af undersøgelsen kan der derfor ikke fastlægges en risikofri tilbageholdelsestid, skønt der ikke blev påvist restkoncentrationer over følsomhedsgrænsen på 100 µg/kg.
English: Withdrawal periods for pigs
Danish: Tilbageholdelsestider for grise
English: On day 112 after the last injection, the last time point, all concentrations were below the MRL.
Danish: På dag 112 efter sidste injektion, der var sidste målepunkt, var alle koncentrationer under maksimalgrænseværdien.
English: It is noted that the dose used in the relevant study (50 mg gentamicin base per kg bw) appears to cover all of the currently recommended dosing regimens.
Danish: Det bemærkes, at den dosis, der er anvendt i den pågældende undersøgelse (50 mg gentamicinbase/kg kropsvægt) synes at dække alle de aktuelt anbefalede dosisregimer.
English: The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended amendments in the product information (see Annex III).
Danish: Det overordnede benefit/risk-forhold for produkterne i denne procedure blev anset for at være positivt forudsat at der foretages de anbefalede ændringer af produktinformationen (se bilag III).
English: Vetoquinol SA Magny-Vernois 70200 Lure France
Danish: Frankrig Vetoquinol SA Magny-Vernois 70200 Lure
English: It can be considered that this worst case withdrawal period sufficiently covers possible effects arising from differences in product composition.
Danish: Denne værste tilfælde tilbageholdelsestid kan antages at dække de mulige virkninger af forskelle i produktsammensætning tilstrækkeligt.
English: The same rationale used as a basis for the withdrawal periods for products containing gentamicin as the sole active substance may also be applied to gentamicin in combination with trimethoprim and sulfadimethoxine.
Danish: Samme rationale, der er grundlag for tilbageholdelsestiderne for produkter indeholdende gentamicin som eneste aktive stof, kan også anvendes på gentamicin i kombination med trimetoprim og sulfadimethoxin.
English: That study in piglets is GLP-compliant; the design is in accordance with current standards.
Danish: Denne undersøgelse i smågrise er GLPoverensstemmende; designet svarer til gældende standarder.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs.
Danish: Udvalget for Lægemidler til Dyr (CVMP) blev anmodet om at gennemgå alle foreliggende data vedrørende depletion af restkoncentrationer og anbefale tilbageholdelsestider for kvæg (kød og mælk) og for grise.
English: The study was conducted in ruminating cattle (350-380 kg).
Danish: Undersøgelsen blev udført hos drøvtyggende kvæg (350-380 kg).
English: The intention is to address those products concerned by this procedure for which the maximum recommended dose is high and for which no withdrawal period can be set in a conventional manner based on residue data.
Danish: Hensigten er at tage de produkter i proceduren op, for hvilke den anbefalede maksimale dosis er høj, og for hvilke der ikke kan fastlægges en tilbageholdelsestid på den konventionelle måde på grundlag af restkoncentrationsdata.
English: Belgium also noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pigs meat and offal from 28 days to 150 days.
Danish: Belgien konstaterede også, at der i EU gælder forskellige godkendte tilbageholdelsestider for kvæg og grise for veterinærlægemidler, der indeholder gentamicin og dispenseres som injektionsvæske, opløsning, f.eks. kød og indmad fra kvæg: fra 28 dage til 210 dage, mælk fra kvæg: 2 til 7 dage, idet det for nogle af produkterne angives "må ikke anvendes hos køer, hvis mælk er bestemt til konsum", samt kød og indmad fra grise: 28 dage til 150 dage.
English: Some of the concerned products may be used in older animals than those used in the studies, leading to higher total injection volumes, which may entail a slowest depletion rate due to the decreased surface/volume ratio of the injection site bolus.
Danish: Nogle af de omfattede produkter kan blive anvendt i dyr, der er ældre end dyrene i undersøgelserne, hvilket kan medføre en langsom depletionsrate pga. det mindskede overflade/volumen-forhold for bolus på injektionsstedet.
English: Otherwise, it can be regarded as meeting current standards, although muscle (other than injection site) and fat were not analysed; this can be accepted as these tissues are recognised as not limiting with regard to gentamicin residue depletion.
Danish: Ellers kan den anses for at opfylde gældende standarder, skønt der ikke blev analyseret muskel (bortset fra injektionsstedet) eller fedt; dette kan accepteres, da disse væv anses for ikke-begrænsende hvad angår depletionen af restkoncentrationer af gentamicin.
English: The study is not provided as a full report, but rather as a summary.
Danish: Undersøgelsen foreligger ikke som fuldstændig rapport, men snarere som sammenfatning.
English: WPnew = WPold + {log2(Dnew/Dold) x T1/2(final phase)}
Danish: Tilbageholdelsestidny = Tilbageholdelsestidgammel + {log2(Dny/Dgammel) x T1/2(slutfase)}
English: Therefore, Belgium considered that consumer safety is not ensured by the withdrawal periods set for the reference product Genta 100 mg/ml (marketing authorisation holder (MAH): CP-Pharma) and consequently, for its generic product Emdogent 100 (applicant: Emdoka).
Danish: Belgien fandt derfor, at forbrugernes sikkerhed ikke er garanteret med de tilbageholdelsestider, der er fastsat for referenceproduktet Genta 100 mg/ml (markedsføringstilladelsesindehaver: CP-Pharma) og dermed heller ikke for det tilsvarende generiske product Emdogent 100 (ansøger: Emdoka).
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
Danish: Bulgarien Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
English: It is considered that the intravenous route is unlikely to lead to higher residue levels in comparison to the intramuscular route and consequently the withdrawal periods derived based on subcutaneous administration can also be recommended for intravenous administration.
Danish: Den intravenøse administrationsvej anses ikke for at være tilbøjelig til at frembringe større restkoncentrationer end den intramuskulære, hvorfor tilbageholdelsestider baseret på subkutan administration også kan anbefales for intravenøs administration.
English: The withdrawal periods for cattle (meat and milk) and pigs should be amended as recommended to provide assurance for consumer safety.
Danish: Tilbageholdelsestiderne for kød og mælk fra kvæg og for grise bør af hensyn til forbrugersikkerheden ændres som anbefalet.
English: Indeed, the concerned products are for parenteral injection and therefore the impact of digestive physiology is likely limited.
Danish: De omfattede produkter er da også bestemt til parenteral anvendelse, hvorfor fordøjelsessystemets fysiologi forventes at have begrænset betydning.
English: The analytical method used liquid-liquid chromatography with fluorometric detection but data demonstrating the validity of the method were not available; only 3 of the 4 recommended gentamicin marker residue components were monitored.
Danish: Den anvendte analysemetode var væske-væske kromatografi med fluorimetrisk detektion, men der var ingen data til påvisning af metodens validitet; kun 3 af de anbefalede 4 restmarkører for gentamicin blev overvåget.
English: It is acknowledged that there are some uncertainties in the data with respect to the terminal half-life and dose linearity of the depletion kinetics, both being conditions, that have to be fulfilled for a correct use of the extrapolation.
Danish: Det vedgås, at der er visse usikkerheder i dataene hvad angår depletionskinetikkens terminale halveringstid og dosislinearitet, idet begge betingelser skal være opfyldt, for at det vil være korrekt at anvende ekstrapolationen.
English: The study involved calves of less than 1 month of age.
Danish: Undersøgelsen omfattede kalve mindre end 1 måned gamle.
English: A warning sentence should be added to the product information to advise that any repeated course of treatment during the withdrawal period must be avoided.
Danish: Der bør tilføjes en advarsel i produktinformationen om, at det skal undgås at gentage behandlingsforløbet under tilbageholdelsestiden.
English: This is confirmed to some extent by the rapid depletion observed with Forticine Solution 1% (MAH: Vetoquinol), also conducted in young calves fed with milk replacer.
Danish: Dette bekræftes i nogen grad af den hurtige depletion, der ses med Forticine Solution 1 % (markedsføringstilladelsesindehaver: Vetoquinol), for hvilket undersøgelsen ligeledes er udført hos unge kalve, som får mælkeerstatning.
English: Indeed, given the especially long persistence of gentamicin in tissues, which is not the case for the other substances in combination products, in view of the withdrawal periods generally approved for products containing trimethoprim and sulphonamides, there is no reason to expect any long-term effect on residues due to interaction.
Danish: På baggrund af gentamicins særligt lange persistens i vævene modsat de øvrige stoffer i kombinationsprodukterne er der i betragtning af de generelt godkendte tilbageholdelsestider for produkter indeholdende trimetoprim og sulfonamider ikke grund til at forvente interaktionsbetinget langtidsvirkning på restkoncentrationerne.
English: However, in view of the residues above the MRL in liver at day 89, and given that no full study report is available and no analytical method validation report is available, it is not possible to derive a withdrawal period from the study.
Danish: På baggrund af, at restkoncentrationerne var over maksimalgrænseværdierne i leveren på dag 89, og at der ikke foreligger en fuldstændig undersøgelsesrapport eller en valideringsrapport over analysemetoden, kan der imidlertid ikke udledes en tilbageholdelsestid af undersøgelsen.
English: Following a marketing authorisation application to the Belgian Federal Agency for Medicines and Health Product, under Article 13(1) of Directive 2001/82/EC as amended, i.e., a generic application, it appeared that no product-specific residue data were generated in support of the cattle and pigs' meat and offal withdrawal periods for the reference product Genta 100 mg/ml, as authorised in Germany.
Danish: Efter en ansøgning om markedsføringstilladelse til det belgiske Federal Agency for Medicines and Health Products i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, som ændret, dvs. en generisk ansøgning, fremgik det, at der ikke var genereret produktspecifikke restkoncentrationsdata til dokumentation af tilbageholdelsestiderne for kød og indmad fra kvæg og grise for referenceproduktet Genta 100 mg/ml, som er godkendt i Tyskland.
English: No withdrawal period can be drawn from the study since residues above the MRL were detected in all tissues for which adequate data were available at the last time point i.e., 89 days after the last administration.
Danish: Der kan ikke udledes en tilbageholdelsestid af undersøgelsen, da der blev detekteret restkoncentrationer over maksimalgrænseværdien i alle de væv, for hvilke der forelå tilstrækkelige data ved sidste prøvetagningspunkt, dvs. 89 dage efter sidste administration.
English: Based on the information made available to the CVMP it appears that there are several products for which unclear dosing instructions are given in the product information.
Danish: Af oplysningerne, der er stillet til rådighed for CVMP, fremgår, at der gives usikre doseringsanvisninger i produktinformationen for flere af produkterne.
English: Aspropyrgos Attikis 19300 Greece
Danish: Grækenland PROVET SA Aspropyrgos Attikis 19300 Greece
English: 08017 Barcelona Spain
Danish: 08017 Barcelona
English: No full study report and analytical method validation report are available.
Danish: Der foreligger ikke en fuldstændig undersøgelsesrapport eller en valideringsrapport for analysemetoden.
English: Where: WPnew is the withdrawal period for the product for which a withdrawal period is to be derived; WPold is the withdrawal period for the product from which extrapolation is proposed; Dnew is the dose of the product for which a withdrawal period is to be derived; Dold is the dose of the product from which extrapolation is proposed; T1/2(final phase) is the terminal half-life.
Danish: Hvor: Tilbageholdelsestidny er tilbageholdelsestiden for det produkt, for hvilket der skal udledes en tilbageholdelsestid; Tilbageholdelsestidgammel er tilbageholdelsestiden for det produkt, der ekstrapoleres fra; Dnyer den dosis af produktet, der skal udledes en tilbageholdelsestid for; Dgammel er den dosis af produktet, der ekstrapoleres fra; T1/2 (slutfase) er den terminale halveringstid.
English: It can be considered that this withdrawal period is sufficient to cover differences in product composition that could have an impact on the residue depletion pattern.
Danish: Denne tilbageholdelsestid kan anses for tilstrækkelig til at omfatte forskelle i produktsammensætning med mulig indvirkning på depletionsmønsteret for restkoncentrationerne.
English: Residue concentrations in milk were determined 12, 24, 36, 48, 60, 72, 84 and 96 hours after the last administration.
Danish: Restkoncentrationerne i mælk blev bestemt 12, 24, 36, 48, 60, 72, 84 og 96 timer efter sidste administration.