FrancophonIA/ELRC3.0 huggingface dataset:
English: France requested CVMP to consider the therapeutic scheme of these veterinary medicinal products and to indicate if the administration of the product once daily is considered appropriate in terms of efficacy and potential selection of antimicrobial resistant bacteria.
Danish: Frankrig anmodede Udvalget for Veterinærlægemidler (CVMP) om at overveje behandlingsskemaet for disse veterinærlægemidler og angive, om administration af produktet én gang daglig anses for passende med hensyn til effekt og potentiel selektion af antimikrobielt resistente bakterier.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJE OG ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: However, the data are not enough to clearly differentiate between the susceptibility of pathogens since no breakpoints are established for potentiated sulphonamides in equine infections.
Danish: Dataene er dog ikke tilstrækkelige til klart at skelne mellem patogenernes følsomhed, da der ikke er fastlagt breakpoints for potentierede sulfonamider i infektioner hos heste.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, the CVMP concludes that there is no documented evidence from the field of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Danish: Efter at have vurderet begrundelsen for indbringelsen og de svar, der er indgivet af indehaverne af markedsføringstilladelsen, konkluderer CVMP, at der ikke foreligger dokumentation vedrørende problemerne med manglende virkning eller en ændring i resistensforholdene i forbindelse med de relevante målpatogener, som giver anledning til bekymring for dyrs eller menneskers sundhed.
English: The marketing authorisations for Tribrissen (Denmark), Tribrissen vet oraalipasta (Finland), Tribrissen vet Oralpasta til hest (Norway) were withdrawn during the referral procedure at the request of the marketing authorisation holder.
Danish: Markedsføringstilladelserne for Tribrissen (Danmark), Tribrissen vet oraalipasta (Finland), Tribrissen vet Oralpasta til hest (Norge) blev trukket tilbage under indbringelsesproceduren efter anmodning fra indehaveren af markedsføringstilladelsen.
English: This dose needs to be administered in 2 times.
Danish: Denne dosis skal gives af to gange.
English: Some products include the recommendation to base treatment on susceptibility testing.
Danish: I forbindelse med visse produkter anbefales det, at behandlingen baseres på test for følsomhed.
English: Iceland MTnr 880040
Danish: Island MTnr 880040
English: Amendments to be included in the relevant sections of the SPC: 4.2.
Danish: De relevante afsnit i produktresuméet ændres i henhold til følgende: 4.2.
English: Oriprim vet oral powder (Finland) was excluded from the scope of this referral procedure based on the fact that its pharmaceutical form is different from Tribrissen Oral Paste for Horses.
Danish: Oriprim vet oral powder (Finland) var ikke omfattet af denne indbringelsesprocedure, fordi dets lægemiddelform er forskellig fra Tribrissen Oral Paste for Horses.
English: At most, it indicates that a daily dose of 2 X 30 mg/kg may be necessary when pathogens involved in the disease are less susceptible to TMP/SDZ.
Danish: Den viser højst, at en daglig dosis på 2 X 30 mg/kg kan være nødvendig, hvis patogenerne i forbindelse med lidelsen er mindre følsomme over for TMP/SDZ.
English: To justify the withdrawal period, in case the recommended dose should increase.
Danish: Begrundelse for tilbageholdelsestiden, hvis den anbefalede dosis øges.
English: A twice daily dosing of 15 mg/kg body weight is not recommended and should be deleted.
Danish: Indgivelse af to doser daglig af 15 mg/kg kropsvægt anbefales ikke og bør slettes.
English: Regarding the recommended dose, PK/PD-analysis is of limited value, considering that: - recent data on susceptibility and resistance of equine target pathogens are missing; - pharmacokinetic data do not allow proper comparison of the plasma concentration profiles in the horse over the dosing intervals and the entire treatment period depending on a once or twice daily dosing regimen.
Danish: Med hensyn til den anbefalede dosis er PK/PD-analysen af begrænset værdi, idet: - der mangler nylige data om følsomhed og resistens for målpatogener hos heste - de farmakokinetiske data ikke tillader tilstrækkelig sammenligning af plasmakoncentrationsprofilerne hos heste på tværs af doseringsintervallerne og hele behandlingsperioden ved en eller to daglige doseringer.
English: France also requested CVMP to consider the consequences for the withdrawal period and ecotoxicity assessment in case the therapeutic scheme should be modified and the posology or the frequency of administration increased.
Danish: Frankrig anmodede også CVMP om at overveje konsekvenserne for tilbageholdelsestiden og økotoksicitetsvurderingen ved ændring af behandlingsskemaet og forøgelse af doseringen eller hyppigheden af indgift.
English: To provide for each country of the European Economic Area (EEA) where the product is authorised from the dossier submitted: a. Part I Summary of the dossier, including the Summary of Product Characteristics (SPC), the expert reports and the quantitative and qualitative composition of the product; b. If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Danish: Indsendelse af følgende for hvert land i Det Europæiske Økonomiske Samarbejdsområde (EØS), hvor produktet er tilladt, fra det fremlagte dossier: a. resumé af dossier (del I), herunder produktresumé, ekspertudtalelser og den kvantitative og kvalitative sammensætning af produktet b. eventuelt oplysninger om effekt (del IV), herunder oplysninger om farmakokinetiske og farmakodynamiske egenskaber samt data om antimikrobiel resistens.
English: Considering the grounds for referral, assessment of the withdrawal period is only consequential to an increment of the recommended dose.
Danish: Baseret på begrundelsen for indbringelsen af sagen har vurderingen af tilbageholdelsestiden kun betydning ved en forøgelse af den anbefalede dosis.
English: Since no increase to the dose is recommended, no change to the withdrawal period is required.
Danish: Da der ikke anbefales en forøgelse af dosen, kræves der ingen ændring af tilbageholdelsestiden.
English: Moreover, there are no clinical studies in pathogens others than Salmonella employing a daily dose of 2 X 30 mg/kg body weight.
Danish: Der foreligger desuden ingen kliniske undersøgelser af andre patogener end Salmonella, som anvender en daglig dosis på 2 X 30 mg/kg kropsvægt.
English: Taking into account the results of the clinical studies, pharmacokinetic properties of TMP/SDZ and practical aspects of twice daily dosing, once daily dosing of 30mg/kg bw should be recommended.
Danish: På baggrund af resultaterne af de kliniske undersøgelser, de farmakokinetiske egenskaber af TMP/SDZ og de praktiske aspekter af dosering to gange daglig, bør en daglig dosis på 30 mg/kg kropsvægt anbefales.
English: One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings.
Danish: En sprøjte er beregnet til 600 kg kropsvægt, og hver sprøjte er inddelt i 12 markeringer.
English: CVMP received SPCs, a master reference dossier on residues and withdrawal periods, residue studies, efficacy data and periodic safety update reports, an expert statement on the efficacy including reference papers, pharmacokinetic data, antimicrobial resistance information and MIC/resistance data.
Danish: CVMP modtog produktresuméer, hovedreferencedossier om restkoncentrationer og tilbageholdelsestider, undersøgelser af restkoncentrationer, oplysninger om virkning og periodiske, opdaterede sikkerhedsindberetninger, en eksperterklæring vedrørende virkning, herunder referencedokumenter, farmakokinetiske data, oplysninger om antimikrobiel resistens og data om MIC/resistens.
English: The clinical studies presented for the treatment of salmonellosis, applying a daily dose of 2 X 30 mg/kg bw to be administered over 10 days are exceedingly poor (few animals, poor results).
Danish: De fremlagte kliniske undersøgelser vedrørende behandling af salmonellose, hvor en daglig dosis på 2 X 30 mg/kg kropsvægt indgives over 10 dage, er ekstremt ringe (få dyr, dårlige resultater).
English: − Infections of the genital tracts.
Danish: − Infektioner i kønsorganerne.
English: Indications for use, specifying the target species Delete, where applicable, salmonellosis from the indications.
Danish: Indikationer for brug med angivelse af tilsigtede dyrearter Slet i relevante tilfælde salmonellose fra indikationerne.
English: Therefore, it is not possible to recommend explicitly diseases or bacterial species for which the higher (2 X 30 mg/kg bw) or the lower dose (1 X 30 mg/kg bw) is appropriate.
Danish: Det er derfor ikke muligt udtrykkeligt at anbefale lidelser eller bakteriearter, som den højeste (2 X 30 mg/kg kropsvægt) eller den laveste dosis (1 X 30 mg/kg kropsvægt) er velegnet til.
English: Each division on the
Danish: Hver enhed på
English: It is noted that there are no reports (PSURs) on lack of efficacy or developing resistance following use of TMP/SDZ in horses.
Danish: Det bemærkes, at der ikke foreligger sikkerhedsindberetninger om manglende virkning eller udvikling af resistens efter brug af TMP/SDZ hos heste.
English: 45g/500 kg horse alternatively 52g / 600kg (equal to 30 mg/kg of the combined active substances) 1-2 times a day.
Danish: 45 g/500 kg hest alternativt 52 g/600 kg (svarende til 30 mg/kg kombinerede aktive stoffer) 1-2 gange daglig.
English: Netherlands NL 5055
Danish: Nederlandene NL 5055
English: On antimicrobial resistance development, no data are available that support the potential selection of resistant bacteria due to the use of TMP/SDZ in horses.
Danish: Der foreligger ingen data om udvikling af antimikrobiel resistens, som begrunder potentiel selektion af resistente bakterier på grund af brugen af TMP/SDZ hos heste.
English: The daily dose is 0.09 g oral paste (5 mg trimetoprim + 25 mg sulfadiazin) per kg body weight.
Danish: Den daglige dosis er 0,09 g oral pasta (5 mg trimethoprim + 25 mg sulfadiazin) pr. kg kropsvægt.
English: Where the product is authorised in more than one Member State, to detail differences that exist between dossiers with respect to the information as requested.
Danish: Detaljerede oplysninger om forskellene mellem dossierer med hensyn til de ønskede oplysninger, hvis produktet er tilladt i mere end én medlemsstat.
English: Since no increase to the dose is recommended, no change to the withdrawal period is anticipated.
Danish: Da det ikke anbefales at forøge dosen, forventes der ingen ændring af tilbageholdelsestiden.
English: − Wound infections.
Danish: − Sårinfektioner.
English: The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days.
Danish: Dosen kan gives én gang daglig, eller den daglige dosis kan opdeles og indgives med intervaller på 12 timer i fem dage eller indtil to dage efter, at symptomerne er forsvundet, i højst fem dage.
English: Each 4.31g dose contains:
Danish: Hver dosis på 4,31 g indeholder:
English: According to the PSURs, covering more than 3 years of use, safety is consistent with the details of the SPCs.
Danish: I henhold til de periodiske, opdaterede sikkerhedsindberetninger, som omhandler mere end tre års anvendelse, er sikkerheden i overensstemmelse med oplysningerne i produktresuméerne.
English: Recommended dose at least 2 days.
Danish: Anbefalet dosis symptomer i mindst to dage.
English: According to the PSURs there are neither reports on lack of efficacy nor any other adverse reactions which would require change of the SPCs as regards safety instructions or the dose of 30 mg/kg body weight (bw) per day.
Danish: I henhold til sikkerhedsindberetningerne foreligger der hverken indberetninger om manglende virkning eller andre bivirkninger, der ville kræve en ændring af sikkerhedsinstruktionerne i produktresuméerne eller dosen på 30 mg/kg kropsvægt pr. dag.
English: UK Vm 00201/4064
Danish: Det Forenede Kongerige Vm 00201/4064
English: Netherlands NL 10437
Danish: Nederlandene NL 10437
English: For the treatment of Salmonellosis, it is necessary to administer a double dose at 60 mg/kg/day.
Danish: Ved behandling af salmonellose skal der gives en dobbelt dosis på 60 mg/kg/dag.
English: The indication salmonellosis has therefore not been substantiated.
Danish: Der er derfor ingen begrundelse for indikationen salmonellose.
English: − Serious acute infections outside of the intestinal tracts (respiratory-urinal tracts): first an injection of Tribrissen 48% or Duoprim, followed by a daily administration of Tribrissen Oral Paste at 30mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 administrations of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.
Danish: − Alvorlige akutte infektioner uden for tarmkanalerne (luft- og urinveje): Først en injektion af Tribrissen 48 % eller Duoprim efterfulgt af en daglig indgivelse af Tribrissen Oral Paste på 30 mg/kg/dag med to doser a 15 mg/kg kropsvægt/dag eller en dosis på 30 mg/kg/dag i mindst fem dage eller indtil to dage efter, at symptomerne er forsvundet.
English: The
Danish: og
English: ScheringPlough Limited (UK)
Danish: Schering-Plough Limited (Det Forenede Kongerige)
English: Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, a local treatment with Tribrissen Dispersible Powder will be administered.
Danish: Ud over oral behandling i fem dage eller indtil to dage efter, at symptomerne er forsvundet, gives der en lokal behandling med Tribrissen
English: Preferably, horses should be treated initially with an initial injection of Tribrissen Injection 48% or Trivetrin Injection followed by daily administration of Tribrissen Oral Paste.
Danish: Heste skal helst indledningsvis behandles med en indledende injektion af Tribrissen Injection 48 % eller Trivetrin Injection efterfulgt af daglig indgivelse af Tribrissen Oral Paste.
English: The dose is reached by setting the drive screw on the plunger according to the weight of the horse.
Danish: Dosen opnås ved at indstille skruen på stemplet i overensstemmelse med hestens vægt.
English: and Staphylococcus aureus.
Danish: Staphylococcus aureus.
English: Netherlands NL 10351
Danish: Nederlandene NL 10351
English: This should be given as two equally divided doses per day.
Danish: Anbefalet dosis som to lige store doser pr. dag.
English: - Antibacterial medication in surgical cases where asepsis cannot be guaranteed.
Danish: Anbefalet dosis operation, hvor asepsis ikke kan garanteres.
English: Indication salmonellosis has not been substantiated.
Danish: Der er ingen begrundelse for indikationen salmonellose.
English: Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, an intra-uterine treatment will be administered with 10 ml Tribrissen 48%, diluted in an isotonic solution of 100 ml during 3 days.
Danish: Anbefalet dosis dage efter, at symptomerne er forsvundet, gives der en intrauterin behandling med 10 ml Tribrissen 48 % opløst i en isotonisk opløsning på 100 ml i tre dage.
English: Amounts to be administered and administration route Delete, where applicable, the dose of 2 X 15 mg/kg body weight per day.
Danish: Mængder, der skal indgives, og indgivelsesvej Slet i relevante tilfælde dosen på 2 X 15 mg/kg kropsvægt pr. dag.
English: It is noted that a daily dose of 2 X 15 mg/kg bw is recommended in several SPCs.
Danish: Det bemærkes, at en daglig dosis på 2 X 15 mg/kg kropsvægt anbefales i flere produktresuméer.
English: Kingdom Vm 00015/4028
Danish: Det Forenede Kongerige Vm 00015/4028
English: 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
Danish: 5 mg trimethoprim og 25 mg sulfadiazin pr. kg kropsvægt pr. dag i højst fem dage.
English: Kingdom Vm 02000/4098
Danish: Det Forenede Kongerige Vm 02000/4098
English: Boehringer-Ingelheim Limited and Fort Dodge Animal Health responded separately.
Danish: Norbrook Laboratories Limited repræsenterede Scanvet Animal Health A/S. Boehringer-Ingelheim Limited og Fort Dodge Animal Health svarede separat.
English: Therefore, the CVMP recommends maintaining the dose of 1 X 30 mg/kg body weight per day to be administered over a maximum period of 5 days.
Danish: CVMP anbefaler derfor, at dosen på 1 X 30 mg/kg kropsvægt pr. dag i maksimalt fem dage fastholdes.
English: The dose is 30 mg/kg body weight per day.
Danish: Dosen er 30 mg/kg kropsvægt pr. dag.
English: AST Farma BV Sultrisan Orale Paste voor paarden
Danish: Sultrisan Orale Paste voor paarden
English: This is equivalent to the contents of one syringe for a 500 kg horse.
Danish: Det svarer til indholdet af en sprøjte til en hest på 500 kg.
English: Corynebacterium equi Staphylococcus spp.
Danish: Escherichia coli Corynebacterium equi Staphylococcus spp.
English: For the treatment of salmonellosis, it is necessary to give double the above dose rate, i.e. 60 mg of combined active ingredients per kg bodyweight per day.
Danish: Til behandling af salmonellose skal den dobbelte dosis indgives, dvs. 60 mg kombinerede aktive stoffer pr. kg kropsvægt pr. dag.
English: This dose is provided by adjusting the screw-gauge on the plunger of the syringe according to the bodyweight of the horse.
Danish: Denne dosis opnås ved at indstille skruen på sprøjtens stempel i overensstemmelse med hestens vægt.
English: The equivalent of one syringe is to treat 50 kg of body weight, from 50 kg to 500 kg.
Danish: Indholdet af en sprøjte er tilstrækkelig til at behandle 50 kg kropsvægt, fra 50 kg til 500 kg.
English: In conclusion, considering the reasons and recommendations mentioned above, the dose of 1 X 30 mg/kg bw per day to be administered over a maximum period of 5 days has been substantiated.
Danish: På baggrund af ovennævnte begrundelser og anbefalinger konkluderes det, at dosen på 1 X 30 mg/kg kropsvægt pr. dag i maksimalt fem dage er dokumenteret.
English: 30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37.5 g paste (one tube) per os to a 500 kg horse 12 times daily.
Danish: 30 mg kombinerede aktive stoffer pr. kg kropsvægt 1-2 gange daglig, hvilket svarer til 37,5 g pasta (en tube) per os til en hest på 500 kg 1-2 gange daglig.
English: When sensitive organisms are present, the combination may be effective in treating alimentary tract infections including diarrhoea; respiratory tract infections including pneumonia, pleurisy and strangles; wounds; septicaemia and general infections.
Danish: Ved tilstedeværelse af sensitive organismer kan kombinationen være effektiv til behandling af infektioner i fordøjelseskanalen, f.eks. diaré, luftvejsinfektioner, herunder lungebetændelse, pleuritis og kværke, sår, septikæmi og generelle infektioner.
English: Schering Plough A/S (Denmark)
Danish: Schering Plough A/S (Danmark)
English: Include the following standard sentence: “Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies”.
Danish: Særlige forsigtighedsregler vedrørende brugen Medtag følgende standardsætning: "Brug af produktet skal baseres på test for følsomhed og være i overensstemmelse med officielle og lokale antimikrobielle politikker".
English: Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for at least 2 days.
Danish: Heste skal helst behandles med en indledende injektion af Tribrissen Injection efterfulgt af indgivelse af oral pasta i fem dage, eller indtil der ikke er observeret symptomer i mindst to dage.
English: It is recommended to implement the standard sentence “Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies” in section 4.5 of the SPC for all products.
Danish: Det anbefales at medtage standardsætningen "Brug af produktet skal baseres på test for følsomhed og være i overensstemmelse med officielle og lokale antimikrobielle politikker" i afsnit 4.5 i produktresuméet for alle produkter.
English: 1 g contains:
Danish: 1 g indeholder:
English: The paste is presented in a syringe of plastic with the dose to treat 50 kg of horse.
Danish: Pastaen findes i en plastsprøjte til behandling af 50 kg hest.
English: Each gram contains:
Danish: Hvert g indeholder:
English: Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for
Danish: Heste skal helst behandles med en indledende injektion af Tribrissen Injection efterfulgt af indgivelse af oral pasta i fem dage, eller indtil der ikke er observeret
English: It is recommended to implement the standard sentence “Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies” in section 4.5 of the relevant SPCs.
Danish: Det anbefales at medtage standardsætningen "Brug af produktet skal baseres på test for følsomhed og være i overensstemmelse med officielle og lokale antimikrobielle politikker" i afsnit 4.5 i alle relevante produktresuméer.
English: Product invented name
Danish: Lægemidlets særnavn
English: ScheringPlough A/S (Denmark)
Danish: Schering-Plough A/S (Danmark)
English: The daily dose is 30 mg combined active ingredients per kg body weight the equivalent to the contents of one syringe for a 500 kg horse
Danish: Den daglige dosis er 30 mg kombinerede aktive stoffer pr. kg kropsvægt, hvilket svarer til indholdet af en sprøjte til en hest på 500 kg.
English: The equivalent of one marking is sufficient to treat 50 kg of bodyweight.
Danish: Indholdet af en markering er tilstrækkeligt til at behandle 50 kg kropsvægt.
English: Each syringe contains one daily dose for a 500 kg horse.
Danish: Hver sprøjte indeholder en daglig dosis til en hest på 500 kg.
English: Each 45 g syringe contains:
Danish: Hver sprøjte med 45 g indeholder:
English: The dosing-device is graded and each grade equals a dose for 50 kg bodyweight.
Danish: Doseringsanordningen har en skala, hvor hver enhed svarer til en dosis til 50 kg kropsvægt.
English: Recommended dose continued for at least ten days.
Danish: Behandling skal fortsættes i mindst 10 dage.
English: The product may be effective in alimentary tract infection such as diarrhoea; respiratory infections including pneumonia, pleurisy, strangles; wounds, septicaemia and general infections.
Danish: Produktet kan være effektivt til behandling af infektioner i fordøjelseskanalen, f.eks. diaré, luftvejsinfektioner, herunder lungebetændelse, pleuritis og kværke,
English: Treatment should be continued until 2 days after symptoms have resolved, up to a maximum of 5 days.
Danish: Behandlingen skal fortsættes indtil to dage efter, at symptomerne er forsvundet, op til højst fem dage.
English: Sulfadiazine 33,34 g horses Tribrissen Oral Paste is indicated for the treatment of horses with bacterial infections caused by sensitive bacteria, including: - gastro-intestinal infections - infections of respiratory tracts - infections of urogenital tracts
Danish: Tribrissen Oral Paste er indiceret til behandling af heste med bakterieinfektioner forårsaget af følsomme bakterier, herunder: - gastrointestinale infektioner - luftvejsinfektioner - infektioner i urogenitalsystemet - sårinfektioner og cellulitis - salmonellose - som profylaktikum til post-operative infektioner
English: Trimethoprim 66,7 mg Sulfadiazine 333,3 mg horses Respiratory tract infections associated with Streptococcus spp.
Danish: Trimethoprim 66,7 mg Sulfadiazin 333,3 mg heste
English: Treatment should be
Danish: Denne dosis skal gives