FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller hjælpestoffer, som ikke anses for at være omfattet af forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: The treatment should be combined with environmental control.
Danish: Behandlingen bør kombineres med kontrol af omgivelserne.
English: The overall average Tmax is 2.5 ± 3.1 hours, Cmax is 237 ± 154 ng/ml and AUCt is 989 ± 234 ng∙h/ml.
Danish: Den totale gennemsnitlige Tmax er 2,5 ± 3,1 timer, Cmax er 237 ± 154 ng/ml, og AUCt er 989 ± 234 ng∙h/ml.
English: Food mixed with the veterinary medicinal product should be replaced if not consumed within 24 hours.
Danish: Foder, der er iblandet dette veterinærlægemiddel, skal udskiftes, hvis det ikke er indtaget i løbet af 24 timer.
English: Marketing authorisation holder: Le Vet B.V.
Danish: Indehaver af markedsføringstilladelsen: Le Vet B.V.
English: Bodyweight (kg) of horse
Danish: Hestens kropsvægt (kg)
English: Corticoids/ Glucocorticoids
Danish: Kortikoider /glukokortikoider
English: Therefore horses should be monitored frequently during the treatment period.
Danish: Derfor skal heste monitoreres regelmæssigt under behandlingsperioden.
English: Because corticosteroids can reduce the immunoresponse to vaccination, prednisolone should not be used in combination with vaccines or within two weeks after vaccination.
Danish: Da kortikosteroider kan nedsætte immunresponsen på vaccination, bør prednisolon ikke anvendes i kombination med vacciner eller inden for to uger efter vaccination.
English: It is recommended to wear gloves and a protective mask during handling and administration of the product.
Danish: Det anbefales at bruge handsker og beskyttelsesmaske under håndtering og administration af lægemidlet.
English: Pharmacotherapeutic group: corticosteroid for systemic use, glucocorticoid.
Danish: Farmakoterapeutisk gruppe: kortikosteroider til systemisk brug, glukokortikoider.
English: Very rarely urticaria has been observed.
Danish: Urticaria er observeret meget sjældent.
English: Shelf life after incorporation into meal or pelleted feed: 24 hours
Danish: Opbevaringstid efter opblanding i foder eller foderpiller: 24 timer
English: Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
Danish: Ved mellemlang til lang behandlingstid bør doseringen derfor holdes på det laveste niveau, der er nødvendigt til kontrol af symptomer.
English: Multiple dosing does not result in plasma accumulation of prednisolone.
Danish: Gentagen dosering medfører ikke akkumulering af prednisolon i plasma.
English: Corticosteroids suppress the immunologic response by inhibition of dilatation of capillaries, migration and function of leucocytes and phagocytosis.
Danish: Kortikosteroider undertrykker immunresponsen ved at hæmme dilatation af kapillærerne, migration og funktion af leukocytter samt fagocytose.
English: Due to the risk of foetal malformation, the veterinary medicinal product must not be administered by pregnant women.
Danish: På grund af risiko for fostermisdannelser må veterinærlægemidlet ikke indgives af gravide kvinder.
English: Affected horses are susceptible to inhaled antigens and other pro-inflammatory agents, including fungal spores and dust-derived endotoxin.
Danish: De berørte heste er følsomme over for inhalerede antigener og andre proinflammatoriske agenser, herunder svampesporer og endotoksiner fra støv.
English: White to off-white powder containing 33.3 mg/g of prednisolone.
Danish: Hvidt til off-white pulver, der indeholder 33,3 mg prednisolon/g.
English: Glucocorticoids have an effect on metabolism by increasing gluconeogenesis.
Danish: Glukokortikoider indvirker på metabolismen ved at øge glukoneogenesen.
English: Equal amounts of prednisolone, prednisone, 20βdihydroprednisolone and 20β-dihydroprednisone are found in urine.
Danish: I urinen findes lige store mængder af prednisolon, prednison, 20βdihydroprednisolon og 20β-dihydroprednison.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Sachets are for single use and should be disposed after use/opening.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Brevene er til engangsbrug og skal bortskaffes efter brug/åbning.
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid under- and overdosing.
Danish: For at sikre korrekt dosis bør kropsvægten bestemmes så nøjagtigt som muligt for at undgå under- eller overdosering.
English: Muscle Fat
Danish: Muskel Fedt Lever Nyre
English: Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone.
Danish: Behandling med prednisolon bør kun iværksættes, når tilfredsstillende lindring af kliniske symptomer ikke er opnået eller ikke forventes opnået ved kontrol af omgivelserne alene.
English: Manufacturer responsible for batch release: LelyPharma B.V.
Danish: Fremstiller ansvarlig for batchfrigivelse: LelyPharma B.V.
English: Where medical treatment of horses with RAO is required, glucocorticoids are effective in controlling clinical signs and decreasing neutrophilia in airways.
Danish: Til heste med behandlingskrævende recidiverende luftvejsobstruktion er glukokortikoider effektive til at kontrollere kliniske tegn og reducere neutrofili i luftvejene.
English: Administration in late pregnancy is likely to cause abortion or early parturition in ruminants and may have a similar effect in other species.
Danish: Indgivelse sent i drægtighedsperioden kan let medføre abort eller tidlig kælvning hos drøvtyggere og kan have tilsvarende virkning også hos andre arter.
English: Other gastrointestinal symptoms that have been very rarely observed are colic and anorexia.
Danish: Andre gastrointestinale symptomer som er blevet observeret meget sjældent er kolik og anoreksi.
English: Meat and offal: 10 days.
Danish: Kød og indmad: 10 dage.
English: Shelf-life after first opening of the container: 4 weeks.
Danish: Holdbarhed efter første åbning af emballagen: 4 uger.
English: Treatment with prednisolone may not sufficiently restore respiratory function in all cases, and in each individual case the use of medicinal products with more rapid onset of action may need to be considered.
Danish: Behandling med prednisolon medfører ikke altid sufficient genopretning af respirationsfunktionen, og i det enkelte tilfælde kan det være nødvendigt at overveje et hurtigere virkende lægemiddel.
English: Excessive sweating has been very rarely observed.
Danish: Overdreven svedproduktion er observeret meget sjældent.
English: Because of the pharmacological properties of prednisolone, use with caution when the veterinary medicinal product is used in animals with a weakened immune system.
Danish: På grund af prednisolons farmakologiske egenskaber bør veterinærlægemidlet anvendes med forsigtighed til dyr med svækket immunsystem.
English: Once opened, use within 4 weeks.
Danish: Skal anvendes indenfor 4 uger efter åbning.
English: Do not use in viral infections in which the virus particles circulate in the bloodstream or in cases of systemic fungal infections.
Danish: Bør ikke anvendes i tilfælde af virusinfektioner, hvor viruspartiklerne cirkulerer i blodbanen, eller ved svampeinfektioner, der har bredt sig i kroppen.
English: Withdrawal period: Meat and offal: 10 days.
Danish: Tilbageholdelsestid: Kød og indmad: 10 dage.
English: Partial metabolism of prednisolone to the biologically inert substance prednisone takes place.
Danish: Prednisolon metaboliseres delvis til det biologisk inaktive prednison.
English: Do not use in animals suffering from gastrointestinal ulcers.
Danish: Bør ikke anvendes til dyr med gastrointestinalt ulcus.
English: The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.
Danish: Anvendelse af dette veterinærlægemiddel sammen med ikke-steroide antiinflammatoriske lægemidler kan forværre gastrointestinal ulceration.
English: Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections.
Danish: Bør ikke anvendes i tilfælde af virale infektioner i det viræmiske stadium eller ved systemiske mykoser.
English: Pharmacologically active substance
Danish: Farmakologisk aktivt stof
English: The risk of hypokalaemia may be increased if prednisolone is administered together with potassium depleting diuretics.
Danish: Risikoen for hypokaliæmi kan øges, hvis prednisolon administreres sammen med kaliumdepleterende diuretika.
English: This can be a part of possible iatrogenic hyperadrenocorticism (Cushings disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness and wastage and osteoporosis may result.
Danish: Dette kan være en del af en mulig iatrogen hyperadrenokorticisme (Cushings sygdom) med betydelige ændringer i fedtstof-, kulhydrat-, proteinog mineralstofskiftet, f.eks. omfordeling af kropsfedt, stigning i kropsvægt, muskelsvaghed, sarkopeni og osteoporose.
English: Whilst single high doses of corticosteroids are generally well tolerated, they may induce severe sideeffects in long term use.
Danish: Høje enkeltdoser af kortikosteroider tolereres sædvanligvis godt, men langtidsanvendelse kan forårsage svære bivirkninger.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: 3421 TV Oudewater THE NETHERLANDS
Danish: 3421 TV Oudewater Holland
English: Administration of prednisolone may induce hypokalaemia and hence increase the risk of toxicity from cardiac glycosides.
Danish: Indgivelse of prednisolon kan medføre hypokaliæmi og dermed øget risiko for toksicitet af kardiale glykosider.
English: Overdose (symptoms, emergency procedures, antidotes) Short-term administration of even large doses is unlikely to cause serious harmful systemic effects.
Danish: Overdosering (symptomer, nødforanstaltninger, modgift) Det er usandsynligt at korttidsbehandling af selv store doser forårsager alvorlige, skadelige systemiske effekter.
English: Using the measuring spoon the following dosing table applies:
Danish: Ved brug af måleskeen anvendes følgende doseringstabel:
English: In order to prevent dust formation, do not shake the veterinary medicinal product.
Danish: For at undgå støvdannelse må veterinærlægemidlet ikke omrystes.
English: 100 mg prednisolone 300 mg prednisolone 600 mg prednisolone
Danish: 100 mg prednisolon 300 mg prednisolon 600 mg prednisolon
English: An increase of alkaline phosphatase by glucocorticoids is very rarely observed and could be related to enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.
Danish: En stigning i alkalisk fosfatase forårsaget af glukokortikoider ses meget sjældent og kan være forbundet med forstørret lever (hepatomegali) og forhøjede serum-leverenzymer.
English: Prednisolone is an intermediate acting corticosteroid having about 4 times the anti-inflammatory activity and about 0.8 times the sodium-retaining effect of cortisol.
Danish: Dets antiinflammatoriske virkning er ca. 4 gange virkningen af kortisol, mens dets natriumretentionsvirkning er 0,8 gange virkningen af kortisol.
English: Very rarely, neurological signs such as ataxia, recumbency, head tilting, restlessness or incoordination have been observed after use of the product.
Danish: Der er meget sjældent set neurologiske symptomer som ataksi, ude af stand til at rejse sig, hovedtiltning, rastløshed eller koordinationssvigt efter anvendelse af lægemidlet.
English: Do not use during pregnancy.
Danish: Bør ikke anvendes under drægtighed.
English: ul.Klimczaka 1, 02-797 Warszawa, Polska
Danish: 02-797 Warszawa
English: Corticoid administration is to induce an improvement in clinical signs rather than a cure.
Danish: Formålet med anvendelse af kortikoider er symptomatisk bedring fremfor helbredelse.
English: Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals.
Danish: Indgivelse tidligt i drægtighedsperioden har medført fostermisdannelser hos laboratoriedyr.
English: Short-term administration of even large doses is unlikely to cause serious harmful systemic effects.
Danish: Det er usandsynligt at korttidsbehandling med selv store doser forårsager alvorlige, skadelige systemiske effekter.
English: Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations.
Danish: Efter ophør af behandlingen kan der opstå tegn på binyrebarkinsufficiens rækkende til binyrebarkatrofi, hvilket kan gøre dyret ud af stand til at klare situationer med stress.
English: Using the jar and measuring spoon the following dosing table applies:
Danish: Ved brug af beholderen og måleskeen anvendes følgende doseringstabel:
English: The significant dose related cortisol suppression very commonly noticed during therapy is a result of effective doses suppressing the hypothalamo-pituitreal adrenal axis.
Danish: Den betydelige dosisrelaterede suppression af kortisol, der ses meget almindeligt under behandlingen, skyldes, at effektive doser undertrykker hypothalamus-hypofyse-binyreaksen.
English: Not authorised for use in mares producing milk for human consumption.
Danish: Må ikke anvendes til hopper, hvis mælk er bestemt til menneskeføde.
English: Use of corticosteroids in horses has been reported to induce laminitis (see section 4.6).
Danish: Anvendelse af kortikosteroider hos heste er indberettet at fremkalde laminitis (se pkt.
English: To ensure administration of the correct dose, body weight should be determined as accurately as possible to avoid under- or overdosing.
Danish: For at sikre administration af korrekt dosis og undgå under- eller overdosering bør kropsvægten bestemmes så nøjagtigt som muligt.
English: Lactose monohydrate Anise aroma powder Silica colloidal hydrated.
Danish: Lactosemonohydrat Anisaroma, pulver Silica, kolloid, hydreret.
English: Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Lechner Ödön fasor 6.
Danish: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Lechner Ödön fasor 6.
English: Do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or osteoporosis.
Danish: Bør ikke anvendes til dyr med diabetes mellitus, nyreinsufficiens, hjerteinsufficiens, hyperadrenokorticisme eller osteoporose.
English: Interaction with other medicinal products and other forms of interaction The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.
Danish: Interaktion med andre lægemidler og andre former for interaktion Anvendelse af dette veterinærlægemiddel sammen med ikke-steroide antiinflammatoriske lægemidler kan forværre sår i mave-tarmkanalen.
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: People with known hypersensitivity to corticosteroids or any of the excipients must not be in contact with the veterinary medicinal product.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Personer med kendt overfølsomhed over for kortikosteroider eller over for et eller flere af hjælpestofferne skal undgå kontakt med veterinærlægemidlet.
English: PACKAGE SIZE
Danish: Pakningsstørrelse
English: Jar with measuring spoon (1 spoon = 4.6 g powder) Number of spoons
Danish: Beholder med måleske (1 skefuld = 4,6 g pulver) Antal skefulde
English: However, chronic usage of corticosteroids may lead to serious adverse effects (please see section 4.6).
Danish: Imidlertid kan kronisk anvendelse af kortikosteroider lede til alvorlige bivirkninger (se pkt.
English: Very rarely, laminitis has been observed after use of the product.
Danish: Der er meget sjældent set forfangenhed efter anvendelse af dette lægemiddel.
English: However, chronic usage of corticosteroids may lead to serious adverse effects (please see section Adverse reactions).
Danish: Imidlertid kan kronisk anvendelse af binyrebarkhormoner lede til alvorlige bivirkninger (se afsnittet ”Bivirkninger”).
English: 8203 AA Lelystad
Danish: Zuiveringsweg 42 8203 AA Lelystad Nederlandene
English: Marker residue
Danish: KARTON - Beholder
English: Gastrointestinal ulceration has been very rarely reported and gastrointestinal ulceration may be exacerbated by steroids in animals given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma (see section Contraindications).
Danish: Der er meget sjældent rapporteret gastrointestinal ulceration, og gastrointestinal ulceration kan forværres af steroider hos dyr, der får ikke-steroide antiinflammatoriske lægemidler, og hos dyr med rygmarvstraumer (se pkt.
English: Cardboard box containing 20 pentalaminate sachets (inner coating LDPE) of 3 g (containing 100 mg prednisolone), or 10 sachets of 9 g (containing 300 mg prednisolone) or 18 g (containing 600 mg prednisolone) of oral powder.
Danish: Karton med 20 breve af pentalaminat (indvendigt foret med LDPE) á 3 g (indeholdende 100 mg prednisolon), eller 10 breve á 9 g (indeholdende 300 mg prednisolon) eller 18 g (indeholdende 600 mg prednisolon) oralt pulver.
English: België/Belgique/Belgien Boehringer Ingelheim Animal Health Belgium SA Avenue Ariane/Arianelaan 16
Danish: België/Belgique/Belgien Boehringer Ingelheim Animal Health Belgium SA
English: Jar with 180 g or 504 g oral powder.
Danish: Beholder med 180 g eller 504 g oralt pulver.1 g indeholder:
English: THE NETHERLANDS
Danish: Holland
English: Cardboard box containing 20 pentalaminate sachets (inner coating LDPE) of 3 g (containing 100 mg prednisolone), or 10 sachets of 9 g (200 mg) or 18 g (300 mg) of oral powder.
Danish: Karton med 20 breve af pentalaminat (indvendigt foret med LDPE) á 3 g (indeholdende 100 mg prednisolon), eller 10 breve á 9 g (300 mg) eller 18 g (600 mg) oralt pulver.
English: Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, kortikosteroider eller over for et eller flere af hjælpestofferne.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (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) - Ualmindelige (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: The frequency of adverse reactions is defined using the following convention: - 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: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere 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: Equisolon 100 mg oral powder for horses Equisolon 300 mg oral powder for horses Equisolon 600 mg oral powder for horses
Danish: Equisolon, oralt pulver, 100 mg, til heste Equisolon, oralt pulver, 300 mg, til heste Equisolon, oralt pulver, 600 mg, til heste
English: Active substance: prednisolone
Danish: Terapeutisk klassifikation prednisolon prednisolon Equidae
English: Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.
Danish: Kombineret med kontrol af omgivelserne, lindring af inflammatoriske og kliniske parametre knyttet til recidiverende luftvejsobstruktion hos heste.
English: Equisolon 100 mg oral powder for horses Equisolon 300 mg oral powder for horses Equisolon 600 mg oral powder for horses prednisolone
Danish: Equisolon, oralt pulver, 100 mg, til heste Equisolon, oralt pulver, 300 mg, til heste Equisolon, oralt pulver, 600 mg, til heste prednisolon
English: Cardboard box containing one HDPE (white) jar with LDPE tear band lid containing 180 gram or 504 gram of oral powder and one polystyrene (colourless) measuring spoon (measuring 4.6 grams of oral powder).
Danish: Karton med en beholder (hvid) af HDPE med låg med afrivningsbånd af LDPE indeholdende 180 g eller 504 g oralt pulver og en (farveløs) måleske af polystyren (opmåler 4,6 g oralt pulver).
English: 300 mg prednisolone per 9 g sachet 600 mg prednisolone per 18 g sachet
Danish: 100 mg prednisolon pr. brev á 3 g 300 mg prednisolon pr. brev á 9 g 600 mg prednisolon pr. brev á 18 g
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Holdbarhed efter første åbning af emballagen: 4 uger.
English: Do not use in animals suffering from corneal ulcers.
Danish: Bør ikke anvendes til dyr med kornealsår.
English: Luxembourg/Luxemburg Boehringer Ingelheim Animal Health Belgium SA Avenue Ariane/Arianelaan 16
Danish: Luxembourg/Luxemburg Boehringer Ingelheim Animal Health Belgium SA
English: 33.3 mg
Danish: prednisolon 33,3 mg/g
English: The safety of the veterinary medicinal product during pregnancy has not been established in horses, and the product is contraindicated for use in pregnant horses (please see section Contraindications).
Danish: Sikkerheden af veterinærlægemidlet er ikke fastlagt for heste ved drægtighed og lægemidlet må ikke anvendes til drægtige hopper (se afsnittet “Kontraindikationer”).
English: A single dose of 1 mg prednisolone/kg body weight per day corresponds to 3 g powder per 100 kg body weight (see dosing table below).
Danish: En enkelt dosis på 1 mg prednisolon/kg kropsvægt pr. dag svarende til 3 g pulver pr. 100 kg kropsvægt(se doseringstabel herunder).
English: A single dose of 1 mg prednisolone/kg body weight per day corresponds to 100 mg prednisolone in a 3 g sachet per 100 kg body weight (see dosing table below).
Danish: En enkelt dosis på 1 mg prednisolon/kg kropsvægt pr. dag svarer til 100 mg prednisolon i et brev á 3 g pr. 100 kg kropsvægt (se doseringstabel herunder).
English: 600 mg prednisolone (18 g sachet )
Danish: 600 mg prednisolon (brev á 18 g)