FrancophonIA/ELRC3.0 huggingface dataset:
English: As a validated method was used with appropriate controls, the CVMP did not consider it appropriate to invalidate the method whilst arguing for its validity for all other results.
Danish: Eftersom der er anvendt en valideret metode med passende kontrolprøver, finder CVMP det ikke på sin plads at underkende metoden og samtidig gøre gældende, at den er valid for alle andre resultater.
English: Suramox 15% LA contains amoxicillin which is a beta lactam antibiotic belonging to the group of penicillins.
Danish: Suramox 15% LA indeholder amoxicillin, der er et β-lactamantibiotikum tilhørende penicillingruppen.
English: These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed).
Danish: Prøverne blev afkølet, homogeniseret og opbevaret ved -80 °C, indtil de analyseredes 4 til 6 måneder senere (opbevaringsstabiliteten er verificeret).
English: The CVMP noted that the MAH excluded two observations as being outliers when calculating the withdrawal period.
Danish: CVMP konstaterede, at indehaveren af markedsføringstilladelsen udelukkede to observationer som afvigende ved beregning af tilbageholdelsesperioden.
English: The data generated from these studies however, did not allow, at that stage, to establish withdrawal periods for cattle or pigs with the desired level of reliability.
Danish: Resultaterne af disse undersøgelser giver imidlertid ikke på dette trin mulighed for at fastsætte tilbageholdelsestider for kvæg eller svin med den nødvendige sikkerhed.
English: The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated.
Danish: Indehaveren af markedsføringstilladelsen fremførte endelig, at den anvendte fluorimetriske metode kan detektere restkoncentrationer af nedbrydningsprodukter af amoxicillin, og at de fundne koncentrationer derfor kan være overvurderet.
English: France2
Danish: Frankrig2
English: In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary.
Danish: For at en ophævelse af suspenderingen af markedsføringstilladelsen kan komme på tale, skal der forelægges restkoncentrationsdata for senere slagtetidspunkter, som gør det muligt at fastsætte tilbageholdelsestider for kød og indmad fra både kvæg og svin.
English: Assuming the MAH has a valid scientific point, and thus the method should have included an additional clean-up step to improve recovery, the weakness of this argument was that all sample results could therefore be understated.
Danish: Hvis det antages, at indehaveren af markedsføringstilladelsen peger på noget videnskabeligt holdbart, og et metoden altså burde have omfattet et ekstra oprensningstrin for at forbedre genfindingen, består argumentets svaghed i, at alle prøveresultaterne dermed skulle være for lave.
English: The MAH initially provided residue data in cattle and pigs using the product under consideration at the recommended dose treatment.
Danish: Indehaveren af markedsføringstilladelsen forelagde oprindeligt restkoncentrationsdata fra undersøgelser i kvæg og svin, hvor produktet er anvendt i den anbefalede dosering.
English: With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method.
Danish: Ved forelæggelsen af den nye restkoncentrationsundersøgelser for kvæg foreslog indehaveren af markedsføringstilladelsen en tilbageholdelsesperiode på 96 dage, baseret på den statistiske metode.
English: However, the residue depletion profile in kidney indicated a non-regular profile.
Danish: Forløbet af restkoncentrationen i nyrerne tydede imidlertid på en irregulær depletionsprofil.
English: Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “Note for guidance: Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95-FINAL).
Danish: Der kunne derfor ikke fastsættes en tilbageholdelsestid som foreskrevet i "Note for guidance: Approach towards harmonisation of withdrawal periods" (EMEA/CVMP/036/95-FINAL).
English: Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox.
Danish: 16 stykker kvæg blev slagtet 7, 14, 46 og 57 dage efter behandling med Suramox.
English: From the original residue depletion study in pigs, the CVMP concluded that the kidney was the limiting tissue for the establishment of a withdrawal period.
Danish: Af den oprindelige restkoncentrationsundersøgelse i svin konkluderede CVMP, at nyren var det bestemmende væv for fastsættelse af tilbageholdelsestiden.
English: Residues in kidney ranged from below the limit of quantification to 150 µg/kg at 7 days and were below the limit of quantification at later time points.
Danish: Efter 7 dage lå restkoncentrationerne i nyre fra under kvantificeringsgrænsen op til 150 µg/kg, og var under kvantificeringsgrænsen på senere slagtetidspunkter.
English: Furthermore, the method provided was validated over a range using fortified samples.
Danish: Desuden blev den anvendte metode valideret inden for et interval med anvendelse af berigede prøver.
English: With the submission of the new residue studies for pigs the MAH proposed a withdrawal period of 38 days based on the two studies provided.
Danish: Ved forelæggelsen af den nye restkoncentrationsundersøgelser for svin foreslog indehaveren af markedsføringstilladelsen en tilbageholdelsestid på 38 dage, baseret på de to forelagte undersøgelser.
English: Thus, the MRLs established by the CVMP for benzylpenicillin were 50 µg/kg for edible tissues.
Danish: CVMP fastlagde på denne måde en MRL-værdi for benzylpenicillin på 50 µg/kg for spiseligt væv.
English: One new GLP-study in cattle and two complementary GLP-residue studies in pigs were submitted during the procedure for the reconsideration of the opinion.
Danish: Til proceduren om fornyet overvejelse af udtalelsen blev der forelagt én ny GLP-undersøgelse i kvæg og to supplerende GLP-restkoncentrationsundersøgelser i svin.
English: Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection.
Danish: Grupper på fire dyr (to handyr og to hundyr) blev slagtet 1, 7, 14, 21 og 36 dage efter den sidste injektion.
English: For the referral procedure, the MAH presented one residue study in cattle and one in pigs.
Danish: Til indbringelsesproceduren fremlagde indehaveren af markedsføringstilladelsen en restkoncentrationsundersøgelse i kvæg og en i svin.
English: However, taking into account also the two new residue depletion studies in pigs, the CVMP concludes that the totality of the data indicates that the residue depletion at the injection site will determine the withdrawal period.
Danish: CVMP konkluderer imidlertid på baggrund af de to nye restkoncentrationsundersøgelser i svin, at de foreliggende oplysninger tilsammen viser, at depletionen af restkoncentrationer på injektionsstedet er bestemmende for fastsættelse af tilbageholdelsestiden.
English: When providing oral explanations to the Committee concerning the new data submitted the MAH agreed however that withdrawal periods for cattle could not be set on the basis of the data available.
Danish: Ved afgivelsen af mundtlige redegørelser til udvalget vedrørende de forelagte nye oplysninger tilsluttede indehaveren af markedsføringstilladelsen sig imidlertid, at de foreliggende oplysninger ikke gjorde det muligt at fastsætte tilbageholdelsestider for kvæg.
English: Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection.
Danish: Grupper på fire dyr (to handyr og to hundyr) blev slagtet 1, 7, 14, 21 og 27 dage efter den sidste injektion.
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), fat (mixed sample of perirenal/omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Danish: Desuden udtoges prøver af muskel (blandede prøver af muskel fra bagfjerding/forfjerding), fedt (blandet prøve af perirenalt fedt/net), hele leveren, begge nyrer og det højre (sidste) injektionssted (prøvens diameter ca. 10 cm, dybde ca. 6 cm).
English: Sixteen pigs were slaughtered at 7, 14, 21 and 27 days after treatment with Suramox.
Danish: 16 svin blev slagtet 7, 14, 21 og 27 dage efter behandling med Suramox.
English: All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/kg for all tissues.
Danish: I alle prøver blev indholdet af amoxicillin bestemt med en HPLC-UV metode (HPLC-fluorescens til lever) med en angiven kvantificeringsgrænse på 25 µg/kg for alle væv.
English: Pharmaceutical form
Danish: Særnavn Lægemiddelform Styrke
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Danish: Desuden udtoges prøver af muskelvæv (blandet prøve af muskel fra skinke/forende), fedt (blandet prøve af hud + fedt i naturligt forhold), hele leveren, begge nyrer og det højre (sidste) injektionssted (prøvens diameter ca. 10 cm, dybde ca. 6 cm).
English: The results reported indicated residue values below the muscle MRL at all time points except for 1 animal at the last time point, which had a concentration of 6 times above the muscle MRL. For one animal the result at 30 days was not reported.
Danish: Resultaterne viste restkoncentrationsværdier under MRL-værdien for muskel på alle tidspunkter bortset fra 1 dyr på det seneste slagtetidspunkt, hvor koncentrationen var 6 gange over MRL-værdien for muskel.
English: In cattle ten male and ten female (body weight: 184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Danish: I undersøgelsen i kvæg fik ti handyr og ti hundyr (legemsvægt: 184 ± 24 kg) to intramuskulære injektioner med Suramox 15% LA i en dosis på 15 mg/kg legemsvægt (1 ml pr. 10 kg).
English: All samples were analysed for amoxicillin concentrations using an HPLC-UV method with a claimed limit of quantification of 25 µg/kg for all tissues.
Danish: I alle prøver blev indholdet af amoxicillin bestemt med en HPLC-UV-metode med en angiven kvantificeringsgrænse på 25 µg/kg for alle væv.
English: In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Danish: I undersøgelsen i svin blev ti handyr og ti hundyr (legemsvægt 42 ± 7 kg) indgivet to intramuskulære injektioner med Suramox 15% LA i en dosis på 15 mg/kg legemsvægt (1 ml pr. 10 kg).
English: For cattle the injection site was the withdrawal time determining tissue and the residue concentrations of amoxicillin in the injection sites were still above the MRL at the last slaughter time point.
Danish: For kvæg var injektionsstedet det bestemmende væv for fastsættelse af tilbageholdelsestiden, og restkoncentrationen af amoxicillin på injektionsstedet var stadig over MRL-værdien på tidspunktet for sidste slagtning.
English: The statistical nor the alternative method could be used as at the last time point residues at the injection site were up to 6 times the MRL for muscle.
Danish: Hverken den statistiske eller den alternative metode kan anvendes, da restkoncentrationerne på injektionsstedet var indtil 6 gange MRL-værdien for muskel på det sidste slagtetidspunkt.
English: Therefore kidney was considered the tissue determining the withdrawal period.
Danish: Nyrerne anses derfor for at være det bestemmende organ for fastsættelsen af tilbageholdelsestiden.
English: - the CVMP considered that based on the residue depletion data provided concerning the depletion of residues of amoxicillin when administered by injection it was not possible to establish a withdrawal period for cattle and pigs as:
Danish: - efter at have gennemgået de forelagte restkoncentrationsdata for amoxicillin indgivet ved injektion fandt CVMP at der ikke kan fastsættes en tilbageholdelsestid for kvæg og svin, idet:
English: Residues in muscle, fat, liver and kidney were below the MRL at all time points.
Danish: Restkoncentrationerne i muskel, fedt, lever og nyre var under MRL-værdien på alle tidspunkter.
English: Residues in muscle, fat and liver were below the MRL at all time points.
Danish: Restkoncentrationerne i muskel, fedt og lever var under MRL-værdien på alle tidspunkter.
English: However, the residues in kidney showed an irregular depletion profile and concentrations above the MRL were still observed at the last slaughter time point.
Danish: Nyrerne udviste imidlertid en irregulær depletionsprofil, og restkoncentrationer over MRL-værdien forekom stadig ved sidste slagtetidspunkt.
English: In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/kg at day 1, 358 to 5429 µg/kg at day 7, 182 to 2816 µg/kg at day 14, below the limit of quantification to 211 µg/kg at day 21 and below the limit of quantification to 38 µg/kg at day 27.
Danish: På injektionsstedet var koncentrationen af amoxicillin 14 209 til 109 535 µg/kg på dag 1, 358 til 5 429 µg/kg på dag 7, 182 til 2 816 µg/kg på dag 14, under kvantificeringsgrænsen til 211 µg/kg på dag 21 og under kvantificeringsgrænsen til 38 µg/kg på dag 27.
English: In the injection sites, the amoxicillin concentrations were 5822 to 149831 µg/kg at day 1, below the limit of quantification to 21724 µg/kg at day 7, below the limit of quantification to 1651 µg/kg at day 14, below the limit of quantification to 472 µg/kg at day 21 and below the limit of quantification to 162 µg/kg at day 36.
Danish: På injektionsstedet var koncentrationen af amoxicillin 5 822 til 149 831 µg/kg på dag 1, under kvantificeringsgrænsen til 21 724 µg/kg på dag 7, under kvantificeringsgrænsen til 1 651 µg/kg på dag 14, under kvantificeringsgrænsen til 472 µg/kg på dag 21 og under kvantificeringsgrænsen til 162 µg/kg på dag 36.
English: In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.
Danish: For at sikre en harmoniseret fastsættelse af tilbageholdelsestiderne anbefales det at eventuelle nye restkoncentrationsundersøgelser,
English: The data available did not allow establishing a reliable withdrawal period based on residues in kidney by either the statistical or the alternative method.
Danish: De foreliggende restkoncentrationsdata for nyrerne giver hverken med den statistiske eller den alternative metode mulighed for at fastsætte en sikker tilbageholdelsestid.
English: o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations in kidneys were still above the MRL at the last slaughter time point;
Danish: o restkoncentrationen på injektionsstedet i kvæg stadig var over MRL-værdien ved det sidste slagtetidspunkt o restkoncentrationen i nyrerne i svin stadig var over MRL-værdien ved det sidste slagtetidspunkt
English: In kidney, amoxicillin concentrations were 5446 to 9896 µg/kg at day 1, 45 to 811 µg/kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/kg at day 21 and below the limit of quantification to 62 µg/kg at day 27.
Danish: I nyrerne var koncentrationen af amoxicillin 5 446 til 9 896 µg/kg på dag 1, 45 til 811 µg/kg på dag 7, under kvantificeringsgrænsen på dag 14, under kvantificeringsgrænsen til 180 µg/kg på dag 21 og under kvantificeringsgrænsen til 62 µg/kg på dag
English: An alternative method could not be used because at the last time point residue concentrations at the injection site were up to 5 times the MRL for muscle.
Danish: Der kan ikke anvendes en alternativ metode, da restkoncentrationerne på injektionsstedet var indtil 5 gange MRL-værdien for muskel på det sidste slagtetidspunkt.
English: Marketing Authorisation Holder
Danish: Indehaveren af markedsføringstilla delsen
English: The injection sites contained the highest residue concentrations followed by kidney.
Danish: Den højeste restkoncentration fandtes i væv fra injektionsstedet, efterfulgt af nyrerne.
English: Residues in the injection sites were high and still up to 5 times above the muscle MRL at the latest time point.
Danish: Restkoncentrationerne ved injektionsstederne var høje og stadig op til 5 gange over MRL-værdien for muskel på det sidste slagtetidspunkt.
English: Suramox 15% LA
Danish: Suramox 15% LA Injektionsvæske, suspension
English: MRLs
Danish: MRLværdi
English: Two intramuscular injections at 48 hours interval
Danish: 150 mg/ml Kvæg, svin To intramuskulære injektioner med 48 timers mellemrum
English: Stabox 15% LA
Danish: Stabox 15% LA Injektionsvæske, suspension
English: This summary was last updated on 14/01/2010.
Danish: Dette sammendrag blev sidst ajourført den 14/01/2010.
English: This protects the pigs against the disease.
Danish: Derved er svinene beskyttet mod sygdommen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RESPIPORC FLU3 to IDT Biologika GmbH on 14/01/2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for RESPIPORC FLU3 til IDT Biologika GmbH den 14/01/2010.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RESPIPORC FLU3 EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) RESPIPORC FLU3 EPAR - sammendrag for offentligheden
English: Sometimes, a slight increase in the rectal temperature might occur after vaccination.
Danish: Af og til kan rektaltemperaturen stige let efter vaccinationen.
English: A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days.
Danish: Der kan forekomme en mindre hævelse på injektionsstedet efter vaccinationen hos et mindre antal grise, men det forsvinder i løbet af 2 dage.
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Danish: Når et svin vaccineres, opfatter immunsystemet de dræbte vira som "fremmede" og producerer antistoffer mod dem.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Danish: Uforsætlig injektion/selvinjektion forventes kun at medføre en mindre reaktion på injektionsstedet
English: RESPIPORC FLU3 is a vaccine.
Danish: RESPIPORC FLU3 er en vaccine.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Danish: Når immunsystemet efterfølgende udsættes for viraene igen, vil det være i stand til hurtigere at danne antistoffer mod dem.
English: RESPIPORC FLU3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Danish: RESPIPORC FLU3 er en vaccine, der indeholder 3 forskellige stammer af svineinfluenzavirus A, som er blevet inaktiveret (dræbt).
English: RESPIPORC FLU3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness.
Danish: RESPIPORC FLU3 indeholder små mængder af en modificeret og herefter dræbt form at svineinfluenza, som forårsager læsioner og sygdom.
English: RESPIPORC FLU3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
Danish: RESPIPORC FLU3 anvendes også til at vaccinere drægtige søer efter deres første immunisering ved at give dem en dosis 14 dage før faring, så der er en tilstrækkelig mængde af antistoffer i søernes mælk til at beskytte pattegrisene mod svineinfluenza i mindst 33 dage efter fødslen.
English: The effectiveness of RESPIPORC FLU3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Danish: Virkningen af RESPIPORC FLU3 blev undersøgt hos dyr, som var 56 dage gamle og derover, og hos søer før og under drægtighedsperioden, og disse undersøgelser dokumenterer, at vaccinen beskytter mod svineinfluenza.
English: Other information about RESPIPORC FLU3:
Danish: Andre oplysninger om RESPIPORC FLU3:
English: RESPIPORC FLU3 is a suspension for injection.
Danish: RESPIPORC FLU3 er en injektionsvæske, suspension.
English: Use of the RESPIPORC FLU3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Danish: Anvendelsen af RESPIPORC FLU3 til grise begrænser kliniske tegn og mængden af virus i lungerne efter infektion, der skyldes svineinfluenzavirus A.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RESPIPORC FLU3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that RESPIPORC FLU3 be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved RESPIPORC FLU3 er større end risiciene med hensyn til vaccination af grise, der er 56 dage og derover, herunder drægtige søer, mod svineinfluenza, der er forårsaget af undertyperne H1N1, H3N2 og H1N2, og at den er i stand til at begrænse kliniske tegn og mængden af virus i lungerne efter infektionen.
English: RESPIPORC FLU3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Danish: RESPIPORC FLU3 anvendes til at vaccinere grise, herunder drægtige søer, som er over 56 dage gamle, mod svineinfluenza, dels for at hjælpe dem klinisk set og dels for at mindske indholdet af virus i lungerne.
English: What is the risk associated with RESPIPORC FLU3?
Danish: Hvilken risiko er der forbundet med RESPIPORC FLU3?
English: What is RESPIPORC FLU3?
Danish: Hvad er RESPIPORC FLU3?
English: How has RESPIPORC FLU3 been studied?
Danish: Hvordan blev RESPIPORC FLU3 undersøgt?
English: What benefit has RESPIPORC FLU3 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved RESPIPORC FLU3?
English: How does RESPIPORC FLU3 work?
Danish: Hvordan virker RESPIPORC FLU3?
English: What is RESPIPORC FLU3 used for?
Danish: Hvad anvendes RESPIPORC FLU3 til?
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: ANNEX BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: The data to be collected shall be agreed with the CHMP.
Danish: Data, der skal indsamles, skal aftales med CHMP.
English: • The need for regular pregnancy tests
Danish: • Nødvendigheden af regelmæssige graviditetstest
English: • Information about Tracleer
Danish: • Information om Tracleer
English: • That pregnant women must not take Tracleer
Danish: • At gravide kvinder ikke må tage Tracleer
English: Details of the operation of the surveillance programme/registry shall be agreed with the National Competent Authorities in each Member State.
Danish: Detaljer vedrørende styringen af overvågningsprogrammet/-registeret skal aftales med den kompetente, nationale myndighed i hvert medlemsland.
English: • That hormonal contraceptives on their own are not effective
Danish: • At hormonale præventionsmidler alene ikke er effektive