FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the side effects of Zubrin?
Danish: Hvilke bivirkninger har Zubrin?
English: Zubrin is used in dogs to reduce inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Danish: Zubrin anvendes til at mindske betændelse og lindre smerter ved akutte og kroniske sygdomme i muskler og knogler hos hunde.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Zubrin are greater than any risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Zubrin should be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) har fundet, at fordelene ved Zubrin er større end risiciene til behandling af smerter i muskler eller led hos hunde.
English: How does Zubrin work?
Danish: Hvordan virker Zubrin?
English: This effect is transient.
Danish: Denne effekt er forbigående.
English: The CVMP can accept:
Danish: CVMP kan acceptere:
English: 15 to 21 days
Danish: 15 til 21 dage
English: The elimination half-life was 22 hours.
Danish: Halveringstiden var 22 timer.
English: Applicable to both species:
Danish: Gælder for begge dyrearter:
English: However, marketing authorisations were also granted via two separate Mutual Recognition Procedures with Italy and Ireland as the Reference Member States.
Danish: Der blev imidlertid også udstedt markedsføringstilladelser via to separate gensidige anerkendelsesprocedurer med Italien og Irland som referencemedlemsstater.
English: Do not eat, drink or smoke when handling this product.
Danish: Der må ikke spises, drikkes eller ryges under håndtering af produktet.
English: The majority of the marketing authorisations have been approved via national procedures.
Danish: Størstedelen af markedsføringstilladelserne er blevet godkendt via nationale procedurer.
English: ATCvet code: QJ01FA91.
Danish: ATCvet-kode: QJ01FA91.
English: See the environmental properties section.
Danish: Se afsnittet om miljøoplysninger.
English: It would give warning that there could be other components (such as other cereals) that could produce the same effect, since the reason for this loss of activity has not been explained in the submission and remained unknown.
Danish: Dette advarer om, at andre komponenter (f.eks. andre kortsorter) muligvis ville kunne frembringe samme effekt, da årsagen til dette fald i aktivitet ikke forklares i ansøgningen og forblev ukendt.
English: Lung concentrations increased rapidly between days 2 and 4 but no significant changes were obtained following four days of dosing.
Danish: Lungekoncentrationer øgedes hurtigt mellem dag 2 og 4, men ingen signifikante ændringer blev opnået efter 4 dages dosering.
English: 2800 Lyngby Denmark
Danish: 2800 Lyngby Danmark
English: Prevention and treatment of respiratory disease
Danish: Forebyggelse og behandling af luftvejsinfektioner
English: • The description of the nature and composition of immediate packaging should be harmonised.
Danish: • Beskrivelsen af arten og sammensætningen af den indre emballage harmoniseres.
English: The main sections of disharmony of the existing SPCs (non exhaustive) are:
Danish: De områder, der især er uenighed om i de eksisterende produktresuméer, er (ikke udtømmende):
English: CVMP can also accept the proposed dose in both pigs and rabbits as these are in accordance with those used in the experimental and field studies.
Danish: CVMP kan endvidere acceptere den foreslåede dosis for både svin og kaniner, da disse er i overensstemmelse med dem, der er anvendt i forsøgs- og feltundersøgelser.
English: The CVMP recommends that further changes to the SPC proposed by the Marketing Authorisation Holders are made:
Danish: CVMP anbefaler, at der foretages yderligere ændringer af det produktresumé, der foreslås af indehaverne af markedsføringstilladelsen:
English: Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigt, læber og øjne eller vejrtrækningsbesvær er mere alvorlige symptomer, som kræver øjeblikkelig lægehjælp.
English: - Do not handle the product if you are allergic to ingredients in the product.
Danish: - Undgå at håndtere lægemidlet, hvis du er allergisk over for dets indholdsstoffer.
English: In very rare cases, feed intake may decrease (including feed refusal) in animals receiving medicated feed.
Danish: Fødeindtagelse kan i meget sjældne tilfælde aftage (inklusive nægtelse af fødeindtagelse) hos dyr, som modtager medicineret foder.
English: The uptake of medicated feed depends on the clinical condition of the animals.
Danish: Indtagelsen af medicineret foder afhænger af dyrenes kliniske tilstand.
English: • The inclusion rate in feed established at the tables (4.9) would differ on each product strength;
Danish: • Opblandingsmængden i foder, som fastsat i tabellerne (4.9), ville variere afhængig af produktstyrke.
English: Tilmicosin degrades/declines slowly in the soil.
Danish: Tilmicosin nedbrydes/aftager langsomt i jorden.
English: The primary route of environmental exposure is from manure applied to agricultural land as fertilizer.
Danish: Den primære miljøeksponering er fra gødning, som anvendes til landbrugsjord som gødningsstof.
English: Biotransformation: Several metabolites are formed, the predominant one being identified as T1.
Danish: Biologisk omdannelse: Der dannes adskillige metabolitter, hvoraf den hyppigst forekommende identificeredes som T1.
English: Use the following formula:
Danish: Brug følgende beregning:
English: Read the package leaflet on reverse of the bag before use.
Danish: Læs indlægssedlen på bagsiden af posen inden brug.
English: However the bulk of tilmicosin is excreted unchanged.
Danish: Hovedparten af tilmicosin udskilles uændret.
English: Where the indications in rabbits are restricted to respiratory infections, the CVMP can accept this claim.
Danish: Når indikationerne for kaniner er begrænset til luftvejsinfektioner, kan CVMP acceptere denne påstand.
English: In particular its activity has been demonstrated against the following micro-organism:
Danish: Veterinærlægemidlets aktivitet er blevet påvist at være særligt effektiv over for følgende mikroorganismer:
English: It is also distributed in the liver and kidney tissues.
Danish: Det distribueres også i lever- og nyrevævet.
English: The Marketing Authorisation Holders' proposal to harmonise the withdrawal period for both species, on the basis of the pivotal residue studies presented can be accepted:
Danish: Forslagene fra indehaverne af markedsføringstilladelserne om at harmonisere tilbageholdelsestiden for begge arter på grundlag af de fremlagte pivotale restkoncentrationsundersøgelser kan accepteres.
English: MANUFACTURER'S BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER Parti
English: Rabbits: 4 days
Danish: Kaniner: 4 dage
English: 4.2 Indications for Use, Specifying the Target Species: in some Member States the product is indicated for rabbits and in others not.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til: I visse medlemsstater er lægemidlet indiceret til kaniner, i andre er det ikke.
English: In relation to ‘shelf life after incorporation into meal or pelleted feed', CVMP cannot accept the Marketing Authorisation Holders' proposal “ 3 months, except for medicated feed containing 30% wheat in which case the validity is reduced to 1 month”.
Danish: Hvad angår "Opbevaringstid efter opblanding i fodermel eller foderpiller", kan CVMP ikke acceptere forslaget fra indehaverne af markedsføringstilladelserne om "3 måneder, bortset fra medicineret foder indeholdende 30 % hvede, i hvilket tilfælde gyldighedsperioden reduceres til 1 måned".
English: 4.11 Withdrawal period(s): for pigs the withdrawal period granted for the product varies among the Member States from 7 to 21 days before slaughter
Danish: 4.11 Tilbageholdelsestid: Tilbageholdelsestiden for svin i forbindelse med lægemidlet varierer fra medlemsstat til medlemsstat fra 7 til 21 dage før slagtning.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Danish: Der foreligger videnskabelig dokumentation, som viser, at makrolider virker synergistisk med værtens immunsystem.
English: • Contraindications: include a new statement in relation to the hypersensitivity to tilmicosin;
Danish: • Kontraindikationer: Der medtages en ny erklæring om overfølsomhed over for tilmicosin.
English: Soya-bean oil (as stated in the Ph.Eur)
Danish: Sojaolie (som angivet i Den Europæiske Farmakopé)
English: SPECIAL STORAGE CONDITIONS Store in a dry place.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares tørt.
English: When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Danish: Ved iblanding af veterinærlægemidlet og håndtering af det medicinerede foder bør man undgå direkte kontakt med øjne, hud og slimhinder.
English: It is noted in relation to the list of excipients, that the difference in formulations of the different product strengths should be resolved by the use of separate SPCs per product strength;
Danish: Det bemærkes i forbindelse med listen over hjælpestoffer, at forskellen i formuleringerne for de forskellige produktstyrker afhjælpes ved, at der anvendes et separat produktresumé for hver produktstyrke.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATE
Danish: LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, DYREART, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATEN
English: In relation to the pathogens involved the microorganism Haemophilus parasuis should be removed.
Danish: I forbindelse med de involverede patogener skal mikroorganismen Haemophilus parasuis fjernes.
English: Not to be incorporated into feeds containing Bentonite.
Danish: Må ikke blandes med foder, som indeholder bentonit.
English: 4.9 Amount to be administered and administered route: the recommended amount to be administered and the treatment duration vary amount the Member States.
Danish: 4.9 Dosering og indgivelsesvej: Den anbefalede dosering og behandlingens varighed varierer fra medlemsstat til medlemsstat.
English: WITHDRAWAL PERIOD Pigs: 21 days
Danish: TILBAGEHOLDELSESTID Svin: 21 dage
English: Pigs: 21 days Rabbits: 4 days
Danish: Svin: 21 dage Kaniner: 4 dage
English: As to where the SPC in Austria and Italy include indications that cover enteric disease caused by Clostridia, CVMP concludes that no data have been provided in support of this claim.
Danish: Hvad angår de østrigske og italienske produktresuméer, der indeholder indikationer, som dækker tarmsygdomme forårsaget af klostridier, konkluderer CVMP, at der ikke er fremlagt data til understøttelse af denne påstand.
English: Besides, temperature in the pelleting conditions have not exceeded 75 ºC;
Danish: Temperaturen ved foderpelleteringsforholdene har i øvrigt ikke oversteget 75 ºC.
English: The CVMP has assessed for the preventive use a pilot study, four dose determination studies and 12 field trial reports.
Danish: CVMP har i forbindelse med den forebyggende anvendelse vurderet en pilotundersøgelse, fire dosisfastsættelsesundersøgelser og data fra 12 feltundersøgelser.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Antibakterielt stof til systemisk brug, makrolider.
English: Tilmicosin plasma concentrations decreased to 0.1 µg/ml within 2 hours and to 0.02 µg/ml after 8 hours.
Danish: Koncentrationen af tilmicosin i plasma aftog til 0,1 µg/ml efter 2 timer og til 0,02 µg/ml efter 8 timer.
English: • The shelf life after first opening of the immediate packaging should be added;
Danish: • Opbevaringstiden efter første åbning af den indre emballage tilføjes.
English: Although tilmicosin appears to have an acceptable stability through 3 months at 25 ºC in meal type feeds, in pelleted feeds the behaviour is not the same.
Danish: Selv om tilmicosin synes at have en acceptabel stabilitet i 3 måneder ved 25 ºC i fodermel, opfører det sig anderledes i foderpiller.
English: To ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed before incorporation into the finished feed.
Danish: For at sikre grundig opblanding af produktet bør det først blandes med en passende mængde foder forinden sammenblanding med det færdige foder.
English: Kg Premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x premix strength (g/kg)
Danish: Kg premix/ton foder = Dosishastighed (mg/kg kropsvægt) x kropsvægt (kg) Daglig foderoptagelse (kg) x styrke af premix (g/kg)
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of overdose have been seen in pigs fed a ration containing levels of tilmicosin up to 80 mg/kg bodyweight (equivalent to 2000 ppm in the feed or ten times the recommended dose) for 15 days.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Ingen symptomer på overdosering er blevet set hos svin, der fik en ration, som indeholdt tilmicosinniveauer op til 80 mg/kg kropsvægt (svarende til 2000 ppm i foder eller ti gange den anbefalede dosis) i 15 dage.
English: The sudden decline in potency after one month at 25 ºC for tilmicosin in pelleted feeds with levels of wheat higher than 30% is troubling.
Danish: Det pludselige fald i styrke efter 1 måned ved 25 ºC for tilmicosin i foderpiller med et hvedeindhold på mere end 30 % er foruroligende.
English: Having considered the grounds for referral and the response provided by the Marketing Authorisation Holders, the CVMP concludes that the benefit/risk balance of the products is positive for use in both pigs and rabbits subject to the recommended changes of Summary of the Product Characteristics and product information (Annex III).
Danish: Efter at have overvejet begrundelsen for indbringelsen og det svar, der blev givet af indehaverne af markedsføringstilladelsen, konkluderer CVMP, at lægemidlets benefit/risk-forhold er positivt til anvendelse til både svin og kaniner under forudsætning af de anbefalede ændringer i produktresuméet og produktinformationen (bilag I).
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Danish: Indehaverne af markedsføringstilladelsen fremsendte på CVMP's anmodning: - en udtømmende liste over forskellene mellem produktresuméerne for det lægemiddel, der er tilladt i medlemsstaterne - et forslag til harmoniseret produktinformation (produktresumé, etikettering og indlægsseddel), hvori der tages hensyn til den seneste vejledning - de tilgængelige relevante data, der underbygger denne foreslåede harmoniserede produktinformation.
English: • The reference to rice hulls should be removed from the SPC.
Danish: • Henvisningen til risbælge fjernes fra produktresuméet.
English: Pulmotil VET Premix for medicated feeding stuff is currently registered in 19 EU Member States with three different strengths (40g, 100g and 200g per kg) available.
Danish: Pulmotil Vet. premix til foderlægemiddel er på nuværende tidspunkt registreret i 19 EUmedlemsstater og fås i tre forskellige styrker (40 g, 100 g og 200 g pr. kg).
English: - If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning.
Danish: - Ved udvikling af symptomer efter eksponering, såsom hududslæt, søg straks læge og vis lægen denne advarsel.
English: In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Danish: Koncentrationen af tilmicosin skal justeres i overensstemmelse hermed for at opnå den korrekte dosering.
English: • Modify the special precautions to be taken by the person administering the veterinary medicinal product to animals;
Danish: • De særlige forsigtighedsregler for personer, som indgiver veterinærlægemidlet til dyr, ændres.
English: • Indication for pigs: delete the microorganism Haemophilus parasuis;
Danish: • Indikationer for svin: Mikroorganismen Haemophilus parasuis slettes.
English: 2 kg, 5 kg and 10 kg 200g/kg: 1 kg and 10 kg
Danish: 2 kg, 5 kg og 10 kg 200 g/kg: 1 kg og 10 kg
English: - The efficacy against infections caused by Haemophilus parasuis in pigs has not been substantiated; - Contraindications should include a statement in relation to the hypersensitivity to tilmicosin; - Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended; - The special precautions to be taken by the person administering the veterinary medicinal product to animals need modification; - Information should be provided on pre-mixing before pelleting and pelleting temperature; - The inclusion rate in feed established would differ for each product strength; - The reference to rice hulls should be removed; - The shelf life after first opening of the immediate packaging should be added; - The proven shelf life after incorporation into meal or pelleted feed is 1 month; - The description of the nature and composition of immediate packaging should be harmonised; - The complete SPC should be harmonised in the framework of this referral procedure,
Danish: - effekten imod infektioner forårsaget af Haemophilus parasuis er ikke dokumenteret, - kontraindikationerne bør omfatte en erklæring om overfølsomhed over for tilmicosin, - da forekomsten af bakteriers resistens over for tilmicosin sandsynligvis varierer (tidsmæssigt og geografisk), anbefales det, at der foretages bakteriologiske prøver og følsomhedsbestemmelse, - de særlige forsigtighedsregler for personer, som indgiver veterinærlægemidlet til dyr, bør ændres, - der skal medtages oplysninger om forblanding før pelletering og pelleteringstemperatur, - den fastsatte opblandingsmængde i foder ville være forskellig for hver produktstyrke, - henvisningen til risbælge skal fjernes, - opbevaringstiden efter første åbning af den indre emballage skal angives, - den påviste opbevaringstid efter opblanding i fodermel eller foderpiller er på 1 måned, - beskrivelsen af arten og sammensætningen af den indre emballage skal harmoniseres, - det komplette produktresumé skal harmoniseres inden for rammerne af denne indbringelsesprocedure,
English: Shelf life after first opening the immediate packaging: 3 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 3 måneder.
English: This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine and avian origin.
Danish: Dets antibakterielle virkning retter sig hovedsagligt mod grampositive mikroorganismer med aktivitet over for visse gramnegative mikroorganismer og mycoplasma-organismer af bovin, ovin, porcin og aviær oprindelse.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de nationale krav.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PULMOTIL VET PREMIX
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF PULMOTIL VET. PREMIX
English: Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Danish: Heste, som får foderlægemiddel med tilmicosin, kan udvise tegn på toksicitet i form af apati, anoreksi, reduceret foderforbrug, tynd afføring, kolik, maveudspiling og død.
English: Maximum concentrations were reached in 30 minutes, being the Cmax obtained of 0.35 µg/ml.
Danish: De højeste koncentrationer blev nået på 30 minutter, med en spidskoncentration på 0,35 µg/ml.
English: For the treatment use, the field trial reports included in the two European Clinical Field Trials Programme (9 field trial in the first phase and 10 field trial in the second phase) and two additional field trial reports were assessed.
Danish: Til behandlingsformål blev der foretaget en vurdering af dataene fra feltundersøgelserne i de to europæiske programmer for kliniske feltundersøgelser (ni fase I-feltundersøgelser og 10 fase II-feltundersøgelser) samt dataene fra to øvrige feltundersøgelser.
English: Rabbits were approved as target species only in Austria, Belgium, Italy and Luxembourg for Pulmotil 200 Vet premix.
Danish: Kaniner blev kun godkendt som målart for Pulmotil 200 Vet. premix i Østrig, Belgien, Italien og Luxembourg.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {For national implementation}
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN {Til national gennemførelse}
English: Quantifiable levels of tilmicosin were found in lung tissue with the maximum concentration (1.43±1.13 µg/ml) being recorded on day 10 of medication.
Danish: Kvantificerbare niveauer af tilmicosin blev fundet i lungevæv med den højeste koncentration (1,43 ± 1,13 µg/ml) registreret på dag 10 af medicinering.
English: Rabbits: Pasteurella multocida, Staphylococcus aureus and Bordetella bronchoseptica
Danish: Kaniner: Pasteurella multocida, Staphylococcus aureus og Bordetella bronchoseptica
English: Horses or other Equidae, must not be allowed access to feeds containing tilmicosin.
Danish: Heste eller andre dyr af hestefamilien må ikke have adgang til foder, som indeholder tilmicosin.
English: 2 kg, 5 kg and 10 kg 100 g/kg Premix:
Danish: 2 kg, 5 kg og 10 kg 100 g/kg premix:
English: Shelf life of the veterinary medicinal product as packaged for sale: the proposed 2 years is acceptable.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: forslaget om 2 år er acceptabelt.
English: • Two sentences should be added in point 4.9: in accordance with the information provided, it has been observed that before incorporation into the finished feed, it was performed a previous mix with a suitable amount of feed.
Danish: 4.9: Det er i overensstemmelse med de fremsendte oplysninger blevet observeret, at der før opblanding med det færdige foder blev foretaget en forudgående blanding med en passende mængde foder.
English: This product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C.
Danish: Lægemidlet kan pelleteres ved at benytte et prækonditioneringstrin i den minimale tidsperiode ved en temperatur, som ikke må overstige 75 °C.
English: - To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143.
Danish: - Anvend overtrækstøj, sikkerhedsbriller og tætte handsker samt enten en halvmaske-respirator til engangsbrug, som overholder europæisk standard EN149, eller en respirator til gentagen brug,
English: This referral was related to the divergent national decisions taking by member states in relation with the SPC of the products Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated name, raised by Belgium.
Danish: Denne indbringelse vedrører divergerende nationale beslutninger truffet i medlemsstaterne i forbindelse med produktresuméet for lægemidlerne Pulmotil 40 Vet. premix, Pulmotil 100 Vet. premix, Pulmotil 200 Vet. premix og tilknyttede navne og er rejst af Belgien.