FrancophonIA/ELRC3.0 huggingface dataset:
English: The animals treated showed significant improvements in clinical endpoints such as diarrhoea score, feed conversion efficiency, average daily gain, and bacterial shedding was completely stopped (not examined in all studies).
Danish: De behandlede dyr udviste signifikant bedring med hensyn til kliniske endepunkter som diarré-score, foderomsætningseffektivitet og gennemsnitlig daglig tilvækst, og bakteriespredningen blev standset helt (ikke vurderet i alle undersøgelser).
English: Dose-related reductions in mortality, average lung lesion area and A. pleuropneumoniae re-isolation but no complete clinical cure were observed at lower doses (20 mg).
Danish: Der sås dosisrelaterede reduktioner i mortalitet, gennemsnitligt lungelæsionsområde og A. pleuropneumoniae-reisolering, men der sås ikke fuldstændig helbredelse ved den laveste dosis (20 mg).
English: antibacterial for systemic use / Pleuromutilins / tiamulin
Danish: antibakterielle midler til systemisk brug / pleuromutiliner / tiamulin
English: Increased MICs against B. hyodysenteriae isolates in different European Member States give rise for concern as there are only limited antimicrobials left for the treatment of swine dysentery.
Danish: Øgede MIC'er over for B. hyodysenteriae-isolater i flere EU-medlemsstater giver anledning til bekymring, da der kun er begrænsede antimikrobielle stoffer tilbage til behandling af svinedysenteri.
English: Remove contaminated feed as soon as possible and replace with feed not containing the tiamulinincompatible ionophores.
Danish: Kontamineret foder fjernes så hurtigt som muligt og erstattes af foder, som ikke indeholder ionophor-præparater, der er inkompatible med tiamulin.
English: Appropriate guidance has been included in the product information to mitigate the risk.
Danish: Relevant vejledning er tilføjet i produktinformationen for at mindske risikoen.
English: 2370 Arendonk Belgium
Danish: Hoge Mauw 900 2370 Arendonk Belgien
English: Tiamulin hydrogen fumarate is considered to have an adequate therapeutic index in the pig and a minimum lethal dose has not been established.
Danish: Tiamulinhydrogenfumarat anses for at have et tilstrækkeligt højt terapeutisk indeks hos svin, og en mindste dødelig dosis er ikke fastlagt.
English: Tiamulin hydrogen fumarate is well absorbed in chickens (70-95%) after oral administration and reaches peak concentrations in 2-4 hours (Tmax 2.85 hours).
Danish: Tiamulinhydrogenfumarat absorberes godt hos kyllinger (70-95 %) efter peroral administration og når maksimale koncentrationer inden for 2-4 timer (Tmax 2,85 timer).
English: administered in the drinking water gave a mycoplasmacidal effect at MIC90, reduced lung lesions and eliminated the organism in some cases.
Danish: Doserne i den høje ende administreret i drikkevandet gav en anti-mykoplasmatisk effekt ved MIC90, reducerede lungelæsioner og eliminerede organismen i nogle tilfælde.
English: Choi, and J.B. Lee.
Danish: Choi, and J.B.
English: Due to the irritant properties, it is also recommended to wear a dust mask to minimise inhalation exposure.
Danish: På grund af produktets lokalirriterende egenskaber tilrådes det også at anvende støvmaske for at mindske inhalering af støv.
English: On 25 August 2015 Germany submitted a referral notification in accordance with Article 34(1) of Directive 2001/82/EC, to the CVMP/European Medicines Agency for Denagard 45% and its associated names (thereafter called Denagard 45%).
Danish: Den 25. august 2015 indsendte Tyskland en indbringelsesanmeldelse til CVMP/Det Europæiske Lægemiddelagentur vedrørende Denagard 45% og relaterede navne (i det følgende benævnt Denagard 45%), jf. artikel 34, stk. 1, i direktiv 2001/82/EF.
English: Denagard 45% is also effective in the treatment of Pleuropneumonia caused by A. pleuropneumoniae in pigs.
Danish: Denagard 45% er også effektivt til behandling af pleuropneumoni forårsaget af A. pleuropneumoniae hos grise.
English: At 0, 24, 36 and 48 hours after the last treatment, animals were necropsied and the entire liver was analysed for 8-α-hydroxymutilin based on a GC analytical method.
Danish: 0, 24, 36 og 48 timer efter den sidste behandling blev dyrene slagtet og hele leveren analyseret for 8-α-hydroxymutilin ved hjælp af en GC-analysemetode.
English: Regarding poultry, there is a relatively high therapeutic index with tiamulin hydrogen fumarate and the likelihood of an overdose is considered remote especially as water intake and hence tiamulin hydrogen fumarate intake is reduced if abnormally high concentrations are given.
Danish: Hos fjerkræ har tiamulinhydrogenfumarat et relativt højt terapeutisk indeks, og sandsynligheden for en overdosis anses for lav, især da vandindtaget og dermed indtaget af tiamulinhydrogenfumarat er reduceret, hvis der indgives abnormt høje koncentrationer.
English: It can be as little as two times the MIC for Brachyspira hyodysenteriae and Actinobacillus pleuropneumoniae but as high as 50100 times the bacteriostatic level for Staphylococcus aureus.
Danish: Koncentrationen kan være så lille som to gange MIC for Brachyspira hyodysenteriae og Actinobacillus pleuropneumoniae, men så høj som 50-100 gange det bakteriostatiske niveau for Staphylococcus aureus.
English: From each individual pig, specimens from liver and muscle were collected and analysed for 8-α-hydroxymutilin using a validated LCMS-MS analytical method.
Danish: Fra den enkelte gris blev der taget lever- og muskelprøver, som blev analyseret for 8-α-hydroxymutilin ved brug af en valideret LCMS-MS-analysemetode.
English: The tiamulin MIC data determined for the available EU Lawsonia strains are all below the estimated ileal tiamulin contents of 0.63 μg/ml.
Danish: De MIC-data for tiamulin, der er fastsat for de tilgængelige Lawsoniastammer i EU, ligger alle under den estimerede tiamulin-koncentration i ileum på 0,63 μg/ml.
English: The single mode susceptibility pattern suggested that there has been little resistance development to date.
Danish: Det enstrengede følsomhedsmønster taler for, at der til dato kun er udviklet begrænset resistens.
English: The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.
Danish: Foderet bør fjernes og erstattes med frisk foder, der ikke indeholder coccidiosemidlerne monensin, salinomycin eller narasin.
English: Pre-formed foil bag of 1112 g and 5000 g
Danish: Præformet foliesæk på 1112 g og 5000 g
English: In order to avoid interactions between the ionophores and tiamulin, the veterinarian and farmer should check that the feed label does not state that it contains salinomycin, monensin and narasin.
Danish: For at undgå interaktioner mellem ionophor-præparater og tiamulin bør dyrlægen og landmanden kontrollere, at etiketten på foderet ikke angiver, at det indeholder salinomycin, monensin og narasin.
English: ALUMINIUM LAMINATE BAG
Danish: POSE AF ALUMINIUMSLAMINAT
English: Do not use in cases of hypersensitivity to the active substance or to the excipient.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for hjælpestoffet.
English: Clinical case reports did suggest that M. synoviae was treated effectively in a French study, and Hungarian and UK studies showed that M. meleagridis was also effectively treated causing reductions in clinical signs, airsacculitis and sinusitis.
Danish: I henhold til kliniske caserapporter blev M. synoviae behandlet effektivt i en fransk undersøgelse, og undersøgelser fra Ungarn og Det Forenede Kongerige viste, at M. meleagridis også blev effektivt behandlet med reduktion af kliniske tegn, luftsækbetændelse og bihulebetændelse.
English: Pregnancy and lactation: Can be used in pigs during pregnancy and lactation.
Danish: Drægtighed og diegivning: Kan anvendes til grise under drægtighed og diegivning.
English: A. COMBINED LABEL-LEAFLET
Danish: A. KOMBINERET ETIKET OG INDLÆGSSEDDEL
English: 6.2 Major incompatibilities
Danish: 6.2 Uforligeligheder
English: Overall, the benefit-risk balance of Denagard 45% is considered positive subject to the recommended changes in the product information (see Annex III).
Danish: Overordnet set vurderes benefit/risk-forholdet for Denagard 45% at være positivt under forudsætning af, at de anbefalede ændringer indføres i produktinformationen (se bilag III).
English: If signs of intoxication do occur promptly remove the medicated water and replace with fresh water.
Danish: Hvis tegnene på forgiftning opstår pludseligt, skal det medicinerede vand fjernes og erstattes af frisk vand.
English: The indications in turkeys were supported by in vitro susceptibility data from the same three studies as in chickens and limited susceptibility data on M. meleagridis, a limited number of artificial infection and field studies, and a number of case reports published in the late 1970s and early 1980s.
Danish: Indikationerne hos kalkuner blev understøttet af in vitro-følsomhedsdata fra de samme 3 undersøgelser som for kyllinger, begrænsede følsomhedsdata om M. meleagridis, et begrænset antal undersøgelser med kunstig infektion og feltundersøgelser samt en række case-rapporter fra sidst i 1970'erne og først i 1980'erne.
English: At higher doses (40 mg) no deaths, significantly reduced lung lesion scores, as well as no A. pleuropneumoniae re-isolation, indicating a strong bactericidal effect, were observed.
Danish: Ved den højeste dosis (40 mg) sås ingen dødsfald, signifikant reducerede scorer for lungelæsioner samt ingen A. pleuropneumoniae-reisolering, hvilket peger på en stærk bakteriedræbende effekt.
English: The liver residue data were subjected to log-linear regression using the WT1.4 calculation program and the resulting withdrawal period was 42 hours, rounded up to two days.
Danish: Dataene om restkoncentrationer i leveren blev underkastet log-lineær regression ved brug af WT1.4-programmet, hvorefter tilbageholdelsestiden blev fastsat til 42 timer, rundet op til 2 dage.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE - KOMBINERET ETIKET OG INDLÆGSSEDDEL
English: (equivalent to tiamulin 365 mg/g) Excipients:
Danish: (svarende til tiamulin 365 mg/g) Hjælpestoffer:
English: Groups of birds were sacrified at 0 hours, 8 hours, 1 day, 2 days, 3 days and 5 days after withdrawal of treatment and samples from muscle (mixed samples from breast and leg), liver, skin and underlying subcutaneous fat were taken for residue analysis.
Danish: Grupper af fjerkræ blevet slagtet 0 timer, 8 timer, 1 dag, 2 dage, 3 dage og 5 dage efter seponering af behandlingen, og der blevet taget prøver fra muskler (blandede bryst- og lårprøver), lever, skind og subkutant fedt til analyse af restkoncentrationer.
English: DATE OF REVISION OF THE TEXT To be completed nationally.
Danish: DATO FOR ÆNDRING AF TEKSTEN Udfyldes nationalt.
English: In case of accidental spillage into the eyes, the open eyes should be flushed with water.
Danish: I tilfælde af kontakt med øjnene ved hændeligt uheld bør det åbne øje skylles med vand.
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Nine older artificial infection studies and three old field studies were presented to support the indication ‘treatment and metaphylaxis of Chronic Respiratory Disease caused by M. gallisepticum'.
Danish: 9 tidlige undersøgelser med kunstig infektion og 3 tidlige feltundersøgelser blev fremlagt til understøttelse af indikationen "behandling og metafylakse af kronisk luftvejssygdom (CRD) forårsaget af M. gallisepticum".
English: Strength Pharmaceutical form
Danish: INN-navn Styrke Lægemiddelform
English: 9 CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf dose was in excess of the indicated dose (25 mg tiamulin hydrogen fumarate).
Danish: 9 CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
English: In pigs appropriate GLP-compliant study data were provided to derive withdrawal periods for edible tissues for two different dosage regimens.
Danish: Hvad angår grise, blev der fremlagt relevante data fra GLP-undersøgelser for 2 forskellige doseringsregimer for at fastsætte tilbageholdelsestiden for spiseligt væv.
English: Administered for five days these doses caused significant improvements in clinical endpoints (e.g. feed conversion efficiency, average daily gain, diarrhoea score) and pathological signs though complete elimination of L. intracellularis could not be achieved.
Danish: Ved administration i 5 dage gav disse doser en signifikant bedring med hensyn til kliniske endepunkter (f.eks. foderomsætningseffektivitet, gennemsnitlig tilvækst, diarré-score) og patologiske tegn, selv om komplet elimination af L. intracellularis ikke kunne opnås.
English: At 250 ppm tiamulin hydrogen fumarate administered for three days significant improvements in clinical endpoints, pathological signs and elimination of M. gallisepticum were shown.
Danish: Ved 250 ppm tiamulinhydrogenfumarat administreret i 3 dage sås signifikant bedring med hensyn til kliniske endepunkter, patologiske tegn og elimination af M. gallisepticum.
English: Shelf life after dilution or reconstitution according to directions: The solution remains stable for 24 hours.
Danish: Efter fortynding eller rekonstituering ifølge anvisning: Opløsningen er stabil i 24 timer.
English: The susceptibility of B. pilosicoli towards tiamulin was investigated in three studies.
Danish: B. pilosicolis følsomhed over for tiamulin blev vurderet i 3 undersøgelser.
English: It appears to be concentration-dependent with 500 mg tiamulin hydrogen fumarate (equivalent to 1.11 g of product) in 4 litres of water reducing intake by approximately 10% and 500 mg tiamulin hydrogen fumarate (equivalent to 1.11 g of product) in 2 litres of water by 15% in chickens.
Danish: Det synes at være afhængigt af koncentrationen, hvor 500 mg tiamulinhydrogenfumarat (svarende til 1,11 g af produktet) i 4 liter vand reducerer vandindtaget med ca. 10 %, og 500 mg tiamulinhydrogenfumarat (svarende til 1,11 g af produktet) i 2 liter vand reducerer vandindtaget med 15 % hos kyllinger.
English: It appears to inhibit microbial protein production by producing biochemically inactive initiation complexes, which prevent elongation of the polypeptide chain.
Danish: Tiamulin synes at hæmme den mikrobielle proteinproduktion ved at producere biokemiske inaktive initieringskomplekser, som forhindrer forlængelse af polypeptidkæden.
English: Tiamulin MICs are high against A. pleuropneumoniae.
Danish: Tiamulins MIC-værdier over for A. pleuropneumoniae er høje.
English: In order to obtain the correct dosage, the concentration of tiamulin has to be adjusted accordingly.
Danish: Koncentrationen af tiamulin skal justeres i overensstemmelse hermed for at få den korrekte dosering.
English: In case of accidental ingestion, seek medical advice immediately and show the label to the physician.
Danish: I tilfælde af indgift ved hændeligt uheld skal der straks søges lægehjælp, og etiketten bør vises til lægen.
English: A withdrawal period of 4 days was calculated based on residue concentrations in liver tissues using the WT1.4 calculation program and setting values below limit of quantification (LOQ) at ½ LOQ according to the CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95)9.
Danish: Der blev fastsat en tilbageholdelsestid på 4 dage ud fra restkoncentrationerne i levervævet beregnet ved brug af WT1.4-programmet og indstillingsværdier på ½ LOQ (kvantificeringsgrænse) i overensstemmelse med CVMP's vejledning "Approach towards harmonisation of withdrawal periods" (metode til harmonisering af tilbageholdelsestider) (EMEA/CVMP/036/95)9.
English: Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin.
Danish: Dyr må ikke få præparater, der indeholder monensin, narasin eller salinomycin, under og i mindst 7 dage før og 7 dage efter behandling med tiamulin.
English: Field exposure to tiamulin at around the proposed dose rate of 25 mg/kg body weight yielded a 100% microbiological response.
Danish: Felteksponering for tiamulin ved en dosis tæt på den anførte dosis på 25 mg/kg legemsvægt gav et mikrobiologisk respons på 100 %.
English: Although VICH guideline GL48 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) recommends sampling eggs until at least 12 days after the end of treatment, data from two other studies (one of which measured tiamulin-like activity using a microbiological method and the other of which measured total radioactive residues) indicate that tiamulin levels in eggs peak immediately after the end of treatment and consequently there is no concern that increased tiamulin levels in eggs will occur at time points beyond those measured in the pivotal residue depletion study.
Danish: Selv om VICH-retningslinje GL48 "Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods" (EMA/CVMP/VICH/463199/2009) anbefaler at vente med indsamling af æg til tidligst 12 dage efter behandlingsafslutning, indikerer data fra 2 andre undersøgelser (hvor den ene målte tiamulin-lignende aktivitet ved brug af en mikrobiologisk metode, og hvor den anden målte samlede radioaktive restkoncentrationer), at tiamulin-koncentrationen i æg topper umiddelbart efter behandlingsafslutning.
English: For five French isolates of M. meleagridis the MIC ranged from 0.03 - 0.06 µg/ml.
Danish: For 5 franske isolater af M. meleagridis lå MIC på 0,03-0,06 µg/ml.
English: The situation is transient and recovery normally occurs within 35 days following withdrawal of tiamulin treatment.
Danish: Situationen er forbigående, og bedring ses for det meste inden for 3-5 dage efter, at tiamulinbehandlingen er stoppet.
English: No specific artificial challenge studies were available.
Danish: Der forelå ingen undersøgelser med kunstig infektion.
English: Lee, H.R. Yeh, A. Kim, J.Y.
Danish: 6 Yeh, J.Y., J.H. Lee, H.R. Yeh, A. Kim, J.Y.
English: As long as combined use with these ionophores is avoided, especially in broilers, Denagard 45% has proven to be safe and effective in the treatment of airsacculitis, synovitis and sinusitis caused by M. gallisepticum, M. synoviae and/or M meleagridis in chickens and turkeys.
Danish: Når blot samtidig anvendelse af disse ionoforer undgås, navnlig hos slagtekyllinger, er det påvist, at Denagard 45% er sikkert og effektivt til behandling af luftsækbetændelse, synovitis og bihulebetændelse forårsaget af M. gallisepticum, M. synoviae og/eller M. meleagridis hos kyllinger og kalkuner.
English: Water intake may be depressed during the administration of tiamulin in birds.
Danish: Vandindtaget kan være nedsat under administration af tiamulin til fugle.
English: Aluminium foil sachets of 55.6 g and 111.2 g
Danish: Poser af aluminiumsfolie på 55,6 g og 111,2 g
English: If an interaction does occur, stop tiamulin medication immediately and replace with fresh drinking water.
Danish: Hvis der forekommer en interaktion, standses lægemidlet tiamulin straks, og det erstattes af frisk drikkevand.
English: Serum protein binding is approximately 30%.
Danish: Binding til serumprotein er ca. 30 %.
English: Shelf life after first opening the immediate packaging: 3 months Shelf life after dilution or reconstitution according to directions: The solution remains stable for 24 hours.
Danish: Efter første åbning af den indre emballage: 3 måneder Efter fortynding eller rekonstituering ifølge anvisning: Opløsningen er stabil i 24 timer.
English: This suggests that reduced sensitivity of individual Lawsonia strains can occur but as there have been no reported adverse events in the EU regarding treatment of ileitis failures it suggests that such reduced sensitivity has not developed extensively in the EU.
Danish: Da der imidlertid ikke er indberettet nogen uønskede hændelser i EU i forbindelse med ileitis-behandlingssvigt, ser det ud til, at en sådan reduceret følsomhed ikke har spredt sig så meget i EU.
English: If you notice any side effects, even those not already listed in this label, or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel, eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Do not use in pigs and birds that could receive products containing monensin, narasin or salinomycin during or for at least seven days before or after treatment with tiamulin.
Danish: Bør ikke anvendes til svin og fugle, der kan få præparater, der indeholder monensin, narasin eller salinomycin, under og i mindst 7 dage før og 7 dage efter behandlingen med tiamulin.
English: Use in drinking water or in feed
Danish: Anvendelse i drikkevand eller foder
English: The product has been shown to be efficacious in the treatment of Swine Dysentery caused by B. hyodysenteriae, Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli and Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis.
Danish: Det er påvist, at produktet er effektivt til behandling af svinedysenteri forårsaget af B. hyodysenteriae, porcin kolonspirokætose (kolitis/tyktarmsbetændelse) forårsaget af B. pilosicoli og porcin proliferativ enteropati (ileitis/tyndtarmsbetændelse) forårsaget af L. intracellularis.
English: In chicken a GLP-compliant residue depletion study in laying hens was conducted.
Danish: Med hensyn til kyllinger er der udført en GLP-undersøgelse af restkoncentrationerne hos læggehøns.
English: For any information about this veterinary medicinal product, please contact the marketing authorisation holder.
Danish: Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette veterinærlægemiddel.
English: Corresponding wordings is added in the product information.
Danish: En beskrivelse af dette er indført i produktinformationen.
English: Doses as low as 10 mg tiamulin hydrogen fumarate/kg body weight by gavage gave excellent microbiological results when used for prevention/metaphylaxis but much higher doses were required for treatment.
Danish: Doser på helt ned til 10 mg sondeadministreret tiamulinhydrogenfumarat/kg legemsvægt gav fremragende mikrobiologiske resultater med henblik på forebyggelse/metafylakse, men langt højere doser var påkrævet til behandling.
English: Further studies showed a 95% lesion reduction for prevention and 74% during treatment at around the proposed dose of 40 mg tiamulin hydrogen fumarate/kg body weight given in the drinking water.
Danish: Yderligere undersøgelser viser en læsionsreduktion på 95 % ved forebyggelse og en læsionsreduktion på 74 % ved behandling med en dosis tæt på den anførte dosis på 40 mg tiamulinhydrogenfumarat/kg legemsvægt administreret i drikkevandet.