FrancophonIA/ELRC3.0 huggingface dataset:
English: In chicken an acute overdose will not occur because the birds will be reluctant to drink the strongly concentrated drinking water (too bitter taste if above 2 litres Methoxasol-T per 1000 litre drinking water).
Danish: Hos kyllinger vil der ikke opstå akut overdosering, fordi fuglene vil tøve med at drikke det stærkt koncentrerede drikkevand (smagen er for bitter, hvis der er mere end 2 liter Methoxasol pr. 1000 liter drikkevand).
English: Therefore water intake should be monitored, especially in broilers.
Danish: Derfor skal vandindtagelsen overvåges nøje især for slagtekyllinger.
English: Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae.
Danish: Luftvejsinfektioner forårsaget af Pasteurella multocida, Actinobacillus pleuropneumoniae.
English: Within 48 hours after the last medication trimethoprim, sulfamethoxazole and their metabolites are undetectable in urine and faeces.
Danish: I løbet af 48 timer efter den sidste indgivelse kan trimethoprim, sulfamethoxazol og disses metabolitter ikke længere detekteres i urin og fæces.
English: Within 2 days following treatment residue concentrations of trimethoprim and sulphamethoxazole were below the MRL in all edible tissues, with the exception of skin.
Danish: Inden for to dage efter behandlingen var restkoncentrationerne af trimethoprim og sulfamethoxazol under MRL-værdien i alt spiseligt væv bortset fra skindet.
English: The Cmax of sulfamethoxazole in chickens is approximately 9.0 µg/g, whereas that of trimethoprim is 0.12 µg/g.
Danish: Cmax for sulfamethoxazol i kyllinger er cirka 9,0 µg/g, mens værdien for trimethoprim er 0,12 µg/g.
English: The 1000 ml bottle is closed with a tamper-proof LDPE screw-cap.
Danish: Flasken med 1000 ml er lukket med et pillesikkert LDPE-skruelåg.
English: To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in pigs, except for the treatment and prevention of swine respiratory disease associated with A. pleuropneumoniae sensitive to trimethoprim and sulphamethoxazole.
Danish: Feltdata, der underbygger produktets anvendelse og tilstrækkeligheden af den anbefalede dosis for hver af de påberåbte indikationer hos svin, dog bortset fra behandling og forebyggelse af luftvejssygdomme hos svin forårsaget af trimethoprim-sulphamethoxazolfølsomme stammer af A. pleuropneumoniae.
English: Excipients: N-methyl-pyrrolidone
Danish: N-methyl-pyrrolidon
English: Therefore the use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm or from recent previous experience on the farm.
Danish: Derfor skal anvendelsen af produktet baseres på en kultur af mikroorganismer fra dyr, der er døde på gården og disse organismers følsomhed, eller på aktuelle, tidligere erfaringer på gården.
English: For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole.
Danish: Til behandling af infektioner forårsaget af organismer, der er følsomme for kombinationen af trimethoprim og sulfamethoxasol.
English: Questions put to the Marketing Authorisation Holder
Danish: Oplysninger, som indehaveren af markedsføringstilladelsen blev anmodet om
English: The 5000 ml can is closed with a tamper-proof HDPE screw-cap.
Danish: Dunken med 5000 ml er lukket med et pillesikkert HDPE-skruelåg.
English: Hens:
Danish: Høns:
English: The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay.
Danish: Lægemidlets sikkerhed under drægtighed, laktation eller æglægning er ikke fastlagt.
English: In an old study in broilers with a dose of 38.5mg /kg bwt depletion in skin and plasma demonstrated that the residues were below the MRL by 4 days.
Danish: I en gammel undersøgelse hos fjerkræ med en dosis på 38,5 mg /kg kropsvægt blev restkoncentrationen fundet at være under MRL-værdien efter fire dage.
English: Bronchial infections caused by Pasteurella multocida.
Danish: Luftvejsinfektioner forårsaget af Pasteurella multocida.
English: Urogenital infections caused by Escherichia coli
Danish: Urogenitale infektioner forårsaget af Escherichia coli
English: The MAH proposed a withdrawal period of 5 days in pigs and 6 days in broilers.
Danish: Indehaveren af markedsføringstilladelsen har ansøgt om en tilbageholdelsestid på fem dage for svin og seks dage for fjerkræ.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Polyarthritis caused by susceptible Escherichia coli.
Danish: Polyarthritis forårsaget af følsomme Escherichia coli.
English: Pigs:20.8 mg sulfamethoxasole + 4.2 mg trimethoprim per kg body weight per day for 3-4 days.
Danish: Svin:20,8 mg sulfamethoxasol + 4,2 mg trimethoprim pr. kg legemsvægt pr. dag i 3-4 dage.
English: PHARMACEUTICAL FORM Solution for oral administration.
Danish: LÆGEMIDDELFORM Opløsning til oral indgivelse.
English: The CVMP recommends the following changes to the SPC proposed by the MAH:
Danish: CVMP anbefaler følgende ændringer i det af indehaveren af markedsføringstilladelsen foreslåede produktresumé:
English: Pigs: 24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1,000 kg of body weight per day.
Danish: Svin: 24 mg af forbindelsen af de aktive stoffer pr. kg legemsvægt eller 200 ml af lægemidlet pr. 1 000 kg legemsvægt pr. dag.
English: Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1,000 kg of body weight per day.
Danish: Fjerkræ: 33 mg af forbindelsen af de aktive stoffer pr. kg legemsvægt eller 275 ml af lægemidlet pr. 1 000 kg legemsvægt pr. dag.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol, oral solution for pigs and broilers.
Danish: VETERINÆRLÆGEMIDLETS NAVN Metoxasol-T, oral opløsning til svin og slagtekyllinger.
English: N-methyl-pyrrolidone For a full list of excipients, see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Pigs and broilers.
Danish: Svin og slagtekyllinger.
English: For the treatment of pigs and nonegg-laying chickens suffering from infectious diseases of the respiratory system caused by bacteria sensitive to sulfa-Methoxasole and trimethoprim, (e.g. porcine A. pleuropneumoniae and gallinaceous E. coli) and for prophylactic use.
Danish: Til behandling af svin og ikkeæglæggende kyllinger med infektionssygdomme i luftvejene forårsaget af bakterier, der er følsomme for sulfa-Methoxasol og trimethoprim, (f.eks. A. pleuropneumoniae hos svin og E. coli hos fjerkræ) og til profylaktisk anvendelse.
English: For the treatment of respiratory tract infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers).
Danish: Til behandling af luftvejsinfektioner, urogenitale, gastrointestinale infektioner og hudinfektioner forårsaget af patogener, som er følsomme for trimethoprim og sulfamethoxasol, hos svin og fjerkræ (slagtekyllinger).
English: The Netherlands Eurovet Animal Health
Danish: Nederlandene Eurovet Animal Health Handelsweg 25
English: Use during pregnancy and lactation The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Danish: Anvendelse under drægtighed og laktation Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Protein binding for TMP and SMX is not very high.
Danish: Proteinbindingen af trimethoprim og sulfamethoxazol er ikke særligt høj.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years After first opening the remaining shelf life is 12 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år.
English: Methoxasol-T Solution for oral administration
Danish: Methoxasol-T Opløsning til oral indgivelse.
English: Non-egg-laying chickens:
Danish: Slagtekyllinger:
English: Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for trimethoprim / sulfamethoxazole bacteriological sampling and susceptibility testing are recommended.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr På grund af sandsynligheden for forskelle (tid, geografisk) i forekomsten af bakterier, der er resistente over for trimethoprim/sulfamethoxazol, anbefales det at udtage bakterieprøver og analysere dem for følsomhed.
English: TARGET SPECIES Pigs and broilers
Danish: DYREARTER Svin og slagtekyllinger
English: SPC harmonisation
Danish: Harmonisering af produktresuméerne
English: Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria
Danish: Terapeutisk behandling af infektioner forårsaget af bakterier, der er følsomme for trimethoprim og sulfamethoxasol
English: Where the indications in both pigs and broilers are restricted to respiratory infections, the CVMP can accept this claim.
Danish: CVMP kan godtage indikationerne, når disse både hos svin og fjerkræ begrænses til luftvejsinfektioner.
English: Infections of the respiratory tract caused by Escherichia coli, Salmonella spp., Pasteurella multocida.
Danish: Luftvejsinfektioner forårsaget af Escherichia coli, Salmonella spp., Pasteurella multocida.
English: Box 179 5530 AD Bladel The Netherlands
Danish: 5530 AD Bladel Nederlandene
English: In the event of accidental ingestion, seek medical advice.
Danish: Søg læge i tilfælde af utilsigtet indtagelse.
English: Oral, via the drinking water Pigs: 2.5-5 mg trimethoprim and 12.5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days
Danish: Oral indgivelse via drikkevandet Svin: 2,5-5 mg trimethoprim og 12,5-25 mg sulfamethoxasol pr. kg legemsvægt pr. dag i 3-5 dage.
English: Infections of the digestive system caused by Salmonella spp.
Danish: Infektioner i fordøjelsessystemet forårsaget af Salmonella spp.
English: Eurovet Animal Health
Danish: Eurovet Animal Health Handelsweg 25
English: Holder
Danish: Propylenglykol
English: During preparation and administration of the medicated drinking water, skin contact with the drug should be avoided.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Det skal undgås, at lægemidlet kommer i kontakt med huden under klargøring og indgivelse af det medicintilsatte drikkevand.
English: As to where the SPC´s in The Netherlands, Austria and Poland, Methoxasol-T include indications that cover urogenital, gastrointestinal and skin infections, CVMP concludes that no data have been provided supporting these claims.
Danish: CHMP konkluderer, at der ikke er forelagt data, der giver belæg for de i produktresumeerne i Nederlandene, Østrig og Polen påberåbte indikationer urogenitale og gastrointestinale infektioner samt hudinfektioner.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol-T oral solution for pigs and broilers
Danish: VETERINÆRLÆGEMIDLETS NAVN Methoxasol-T, oral opløsning, til svin og slagtekyllinger
English: Sulfamethoxazole
Danish: Natriumhydroxid
English: Broilers:27.5 mg sulfamethoxasole + 5.5 mg trimethoprim per kg body weight per day for 3-4 days.
Danish: Slagtekyllinger:27,5 mg sulfamethoxasol + 5,5 mg trimethoprim pr. kg legemsvægt pr. dag i 3-4 dage.
English: PHARMACEUTICAL FORM Oral solution.
Danish: LÆGEMIDDELFORM Oral opløsning
English: Intestinal infections caused by Escherichia coli and Salmonella spp.
Danish: Tarminfektioner forårsaget af Escherichia coli og Salmonella spp.
English: Infections of the digestive system caused by Escherichia coli, Salmonella spp.
Danish: Infektioner i fordøjelsessystemet forårsaget af Escherichia coli, Salmonella spp.
English: Broilers: 33 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 750 L drinking water, for 3-4 days.
Danish: Slagtekyllinger: 33 mg/kg legemsvægt, svarende til cirka 1 liter af lægemidlet i 750 l drikkevand i 3-4 dage.
English: SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares utilgængeligt for børn Må ikke nedfryses
English: Pigs: Treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Danish: Svin: Til behandling og forebyggelse af infektioner i luftvejene forårsaget af Actinobacillus pleuropneumoniae, der er følsomme for trimethoprim og sulfamethoxazol, i besætninger hvor sygdommen er blevet diagnosticeret.
English: Infections of the urinary system caused by Escherichia coli.
Danish: Unrinvejsinfektioner forårsaget af Escherichia coli.
English: Broilers: Treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Danish: Slagtekyllinger: Til behandling og forebyggelse af infektioner i luftvejene forårsaget af Escherichia coli, der er følsomme for trimethoprim og sulfamethoxazol, i flokke hvor sygdommen er blevet diagnosticeret.
English: Authorisation
Danish: Overdosering
English: Pigs: 24 mg/kg b.w., equivalent to 1 litre of the drug in 500 L drinking water, for 3-4 days Hens: 33 mg/kg b.w., equivalent to 1 litre of the drug in 750 L drinking water, for 3-4 days
Danish: Svin: 24 mg/kg legemsvægt svarende til 1 liter af lægemidlet i 500 liter drikkevand i 3-4 dage.
English: Bronchial infections caused by Escherichia coli, Salmonella spp.
Danish: Ikke-æglæggende kyllinger: Luftvejsinfektioner forårsaget af Escherichia coli, Salmonella spp.
English: Methoxasol is intended for oral administration with drinking water: Pigs: 25 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 500 L drinking water, for 3-4 days.
Danish: Svin: 25 mg/kg legemsvægt, svarende til cirka 1 liter af lægemidlet i 500 l drikkevand i 3-4 dage.
English: The reconstitution time may be up to 5 minutes.
Danish: Rekonstitutionstiden kan være op til 5 minutter.
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal indsendes:
English: Dry powder: 4 years
Danish: Tørt pulver: 4 år
English: Do not give this medicine to children under 18 years of age.
Danish: Giv ikke denne medicin til børn under 18 år.
English: • Changes in hearing.
Danish: • Ændringer i hørelsen.
English: Date of first authorisation: 19 February 2015 Date of latest authorisation:
Danish: Dato for første autorisation: 19. februar 2015 Dato for seneste fornyelse:
English: The frequency cannot be estimated from the available data.
Danish: Hyppigheden kan ikke vurderes ud fra tilgængelige data.
English: 1 Source: DAL-MS-01.
Danish: 1 Kilde: DAL-MS-01.
English: • If you have or have had kidney problems.
Danish: • Hvis du har eller har haft nyreproblemer.
English: Patients up to 93 years of age have been included in clinical studies.
Danish: Patienter op til 93 år har deltaget i kliniske studier.
English: Using antibiotics may sometimes allow a new and different infection to develop.
Danish: Brug af antibiotika kan nogle gange forårsage, at der udvikles en ny og anderledes infektion.
English: These may all be signs of a hypersensitivity reaction and may be life-threatening.
Danish: Dette kan alt sammen være tegn på en overfølsomhedsreaktion og kan være livstruende.
English: The frequency is not known.
Danish: Hyppigheden er ukendt.
English: Adverse reactions are classified according to System Organ Class and frequency.
Danish: Bivirkningerne er kategoriseret efter systemorganklasse og frekvens.
English: Long-term carcinogenicity studies have not been conducted.
Danish: Langvarige karcinogenicitetsstudier er ikke blevet gennemført.
English: The total in-use stability from reconstitution to administration should not exceed 48 hours.
Danish: Den samlede i-brug-tid fra rekonstitution til administration bør ikke overstige 48 timer.
English: No dose adjustment is recommended based on gender.
Danish: Der anbefales ikke dosisjustering på baggrund af køn.
English: These patients must never be treated with medicinal products that suppress the peristalsis.
Danish: Disse patienter må aldrig behandles med lægemidler, som hæmmer peristaltikken.
English: Ask your doctor for advice before breast-feeding your baby.
Danish: Spørg din læge til råds, før du ammer din baby.
English: If this happens tell your doctor and they will decide what to do.
Danish: Hvis dette sker, skal du tale med din læge, som vil beslutte, hvad der skal ske.
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Danish: Antibiotikabehandling kan fremme overvækst af ikke-følsomme mikroorganismer.
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Danish: Grænseværdier for mindste hæmmende koncentration (MIC) fastslået af European Committee on Antimicrobial Susceptibility Testing (EUCAST) er følgende:
English: Metabolites have not been observed in significant amounts in human plasma.
Danish: Der er ikke fundet metabolitter i signifikante mængder i humant plasma.
English: Co. Louth, A91 P9KD, Ireland
Danish: Co. Louth, A91 P9KD, Irland
English: These may be signs of an infection of the bowel.
Danish: Dette kan være et tegn på en tarminfektion.
English: Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:
Danish: Kontakt straks din læge, hvis du får nogle af disse symptomer - du kan have brug for hurtig lægehjælp:
English: Take care with driving and using machines after you have been given this medicine.
Danish: Udvis forsigtighed med bilkørsel eller betjening af maskiner, efter du har fået dette lægemiddel.
English: This severe reaction has been reported as a rare side effect.
Danish: Denne alvorlige reaktion har været rapporteret som en sjælden bivirkning.
English: • If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
Danish: • Hvis du lider af diarré, eller hvis du tidligere har fået diarré ved behandling med antibiotika.
English: Treatment of overdose with dalbavancin should consist of observation and general supportive measures.
Danish: Behandling af overdosering med dalbavancin bør bestå af observation og generelle undersstøttende foranstaltninger.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S.
Danish: • Streptococcus anginosus gruppe (heriblandt S. anginosus, S. intermedius og S.
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • If you are allergic to other antibiotics such as vancomycin or teicoplanin.
Danish: • Hvis du er allergisk over for andre antibotika som vancomycin eller teiroplanin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, så det er stort set ”natrium-frit”.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Danish: Afbrydelse af eller langsommere infusion kan medvirke til, at disse reaktioner ophører.
English: This has been reported as a side effect with a similar medicine.
Danish: Dette er blevet rapporteret som en bivirkning for et lignende lægemiddel.
English: Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: Tal med din læge, før du får dette lægemiddel, hvis du er gravid, tror du er gravid eller overvejer at få et barn.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis lægemidlet ikke anvendes øjeblikkeligt, er opbevaringstider og -forhold forud for anvendelse på brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 til 8 °C, medmindre rekonstitution/fortynding er sket under kontrollerede og validerede aseptiske forhold.
English: Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin.
Danish: Dalbavancin er reversibelt bundet til humane plasmaproteiner, primært til albumin.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer vedrørende korrekt brug af antibiotika bør følges.
English: Approximately 20 % of the administered dose was excreted in faeces.
Danish: Omkring 20 % af den administrerede dosis blev udskilt i fæces.
English: Clostridioides (formerly Clostridium) difficile-associated diarrhoea
Danish: Clostridioides (tidligere Clostridium) difficile-associeret diarré
English: Clearance and volume of distribution at steady state are comparable between healthy subjects and patients with infections.
Danish: Clearance og fordelingsvolumen ved steady state er sammenlignelige mellem raske personer og patienter med infektioner.
English: Xydalba will be given to you by a doctor or nurse.
Danish: Du vil få Xydalba af en læge eller sygeplejerske.
English: This medicine does not require any special storage conditions if kept unopened in the original container.
Danish: Dette lægemiddel kræver ikke særlige opbevaringsforhold, hvis det opbevares uåbnet i den originale emballage.
English: Xydalba works by killing certain bacteria, which can cause serious infections.
Danish: Xydalba virker ved at dræbe bestemte bakterier, som forårsager alvorlige infektioner.
English: In this situation, you should not take medicines that stop or slow bowel movement.
Danish: I denne situation må du ikke tage medicin, som stopper eller reducerer tarmbevægelserne.
English: Xydalba is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus.
Danish: Xydalba anbefales ikke under graviditet, medmindre den potentielle forventede fordel klart retfærdiggør den potentielle risiko for fosteret.
English: There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart).
Danish: Der er begrænsede data for dalbavancins sikkerhed og virkning, når det administreres i mere end to doser (med en uges mellemrum).
English: Reproductive toxicity studies in rats and rabbits showed no evidence of a teratogenic effect.
Danish: Studier af reproduktionstoksicitet hos rotter og kaniner viste ingen tegn på teratogen effekt.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der optræder superinfektion under behandlingen, skal de nødvendige foranstaltninger tages.
English: In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered.
Danish: I sådan tilfælde skal det overvejes at afbryde behandlingen med dalbavancin og iværksætte understøttende foranstaltninger sammen med administration af specifik behandling for Clostridioides (tidligere Clostridium) difficile.
English: The mean terminal elimination half-life (t1/2) was 372 (range 333 to 405) hours.
Danish: Den gennemsnitlige terminale eliminationshalveringstid (t1/2) var 372 (333-405) timer.
English: The safety profile of dalbavancin in the subjects aged between 12 and 16 years in this study was consistent with the safety profile observed in adults treated with dalbavancin.
Danish: Dalbavancins sikkerhedsprofil hos personer mellem 12 og 16 år var i dette studie konsistent med sikkerhedsprofilen observeret hos voksne behandlet med dalbavancin.