FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Enbrel used for?
Danish: Hvad anvendes Enbrel til?
English: Etanercept is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) that makes them able to produce etanercept.
Danish: Det fremstilles af celler, som har modtaget et gen (DNA), der sætter dem i stand til at producere etanercept.
English: adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment.
Danish: patienter i alderen 2-17 år, der har polyarthritis (positiv eller negativ rheumatoidfaktor) og udvidet oligoarthritis, og som ikke har reageret tilstrækkeligt på eller ikke kan få methotrexat unge i alderen 12-17 år, der har arthritis psoriatica (en sygdom, der giver røde skællende pletter på huden og betændelse i leddene), og som ikke har reageret tilstrækkeligt på eller ikke kan få methotrexat unge i alderen 12-17 år, der har enthesitis-relateret arthritis, og som ikke har reageret tilstrækkeligt på eller ikke kan få standardbehandling
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults who have not responded adequately to other treatments;
Danish: • svær ankyloserende spondylitis (en sygdom, der medfører inflammation af leddene i rygsøjlen) hos voksne, der ikke har reageret tilstrækkeligt på anden behandling
English: Overall, in the studies of rheumatoid arthritis, about two-thirds of the patients receiving Enbrel had a reduction in symptoms of 20% or more after three months.
Danish: Som samlet resultat af alle undersøgelserne ved rheumatoid arthritis bevirkede Enbrel en symptomlettelse på 20 % eller mere hos omkring to tredjedele af patienterne efter tre måneder.
English: How has Enbrel been studied?
Danish: Hvordan blev Enbrel undersøgt?
English: It is available as vials containing a powder that is made up into a solution for injection, and as prefilled syringes and pens containing a solution for injection.
Danish: Det leveres i hætteglas, der indeholder et pulver, som skal opløses inden injektion, og som fyldte sprøjter, der indeholder en injektionsvæske (opløsning).
English: How is Enbrel used?
Danish: Hvordan anvendes Enbrel?
English: In the fourth study, Enbrel was compared with methotrexate in 632 patients who had not taken methotrexate before.
Danish: I den fjerde undersøgelse blev Enbrel sammenlignet med methotrexat hos 632 patienter,
English: How does Enbrel work?
Danish: Hvordan virker Enbrel?
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Chiesi España, S.A. Plaça d'Europa, 41-43, Planta 10, 08908 L'Hospitalet de Llobregat, Barcelona, España
Danish: Chiesi España, S.A. Plaça d'Europa, 41-43, Planta 10, 08908 L'Hospitalet de Llobregat,
English: 63, Ag. Dimitriou Str., GR 174 56 Alimos, Greece
Danish: Grækenland UCB A.E. 63, Ag. Dimitriou Str., GR 174 56 Alimos, Greece
English: Chiesi Pharmaceuticals GmBH Gonzagagasse 16/6 Vienna A-1010 Austria
Danish: Romænien Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna
English: Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, Cheshire SK8 3GY, UK
Danish: Stobritannien Chiesi Limited, Cheadle Royal Business Park, Highfield,
English: Belgium Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122
Danish: via Palermo 26/A ,
English: Luxembourg Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122
Danish: Luxembourg Chiesi Farmaceutici S.p.A.
English: These measures should help to protect the environment.
Danish: Disse forholdsregler tages for at beskytte miljøet.
English: Date of first authorisation: 20 June 2007 Date of last renewal: 22 May 2012
Danish: Dato for første markedsføringstilladelse: 20. juni 2007 Dato for seneste ændring: 22. maj 2012
English: Food increases the bioavailability from 80 % to 90 %.
Danish: Foder øger biotilgængeligheden til 80-90 %.
English: Steady-state conditions are reached by day 2.
Danish: Steady-state forhold indtræder på dag 2.
English: For a full list of excipients, see section 6.1.
Danish: For udførlig liste over hjælpestoffer, se afsnit 6.1.
English: ADVICE ON CORRECT ADMINISTRATION
Danish: VEJLEDNING VEDRØRENDE KORREKT ADMINISTRATION
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt indhold:
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIGE ADVARSELER, HVIS NØDVENDIGT
English: D-73614 Schorndorf Germany
Danish: D-73614 Schorndorf Tyskland
English: Pharmacotherapeutic group: Aldosterone antagonist.
Danish: Farmakoterapeutisk gruppe: Aldosteron-antagonist.
English: Ceva Santé Animale ensures that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Danish: Ceva Santé Animal skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i part I i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og under markedsføringen af veterinærlægemidlet.
English: Très le Bois 22600 Loudéac France
Danish: Très le Bois 22600 Loudéac Frankrig
English: 5 to 10 kg 10 to 15 kg 15 to 20 kg 20 to 30 kg 30 to 40 kg 40 to 50 kg 50 to 60 kg
Danish: 5 til 10 kg 10 til 15 kg 15 til 20 kg 20 til 30 kg 30 til 40 kg 40 til 50 kg 50 til 60 kg
English: This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
Danish: Dette menes at være forårsaget af en aktivering af feedbackmekanismer uden deraf følgende kliniske 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: Detaljeret information om dette veterinærlægemiddel er tilgængelig på hjemmesiden for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/.
English: Do not use in animals used for, or intended for use in breeding.
Danish: Bør ikke anvendes til dyr, der anvendes eller påtænkes anvendt til avl.
English: The tablet can either be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding.
Danish: Tabletten kan enten iblandes en lille mængde foder, der gives før resten af hundens foder, eller indgives direkte i munden efter fodring.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Danish: Detaljeret information vedrørende dette produkt er tilgængelig på European Medicines Agency (EMEA)´s hjemmeside http://www.emea.europa.eu
English: OTHER INFORMATION Pack size:
Danish: ØVRIG INFORMATION Pakningsstørrelser:
English: Tel: + 33 (0) 5 57 55 40 40 Fax : + 33 (0) 5 57 55 41 98
Danish: Fax: + 33 (0) 5 57 55 41 98
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Danish: Observerer du andre alvorlige bivirkninger, som ikke er nævnt i denne indlægsseddel, bedes du kontakte dyrlægen.
English: For animal treatment only.
Danish: Kun til behandling af dyr.
English: After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels from 32 % to 49 % of the administered dose.
Danish: Efter oral administration af spironolakton til hunde, er det vist, at de tre metabolitter når et niveau på 32 til 49 % af den administrerede dosis.
English: Spironolactone is a natriuretic drug (historically described as a soft diuretic).
Danish: Spironolakton er et natriuretisk lægemiddel (historisk beskrevet som et svagt diuretikum).
English: The tablets contain beef flavouring to improve palatability, and a study conducted in healthy dogs showed that they were voluntarily and fully consumed 75% of the time.
Danish: Tabletterne indeholder oksekødsmag for at forbedre palatibiliteten, og afprøvning på raske hunde har vist, at tabletterne blev indtaget frivilligt og fuldstændigt i 75 % af tilfældene.
English: Do not use after the expiry date which is stated on the carton after EXP.
Danish: Bør ikke anvendes efter udløbsdatoen, der er angivet på æsken efter ”EXP”.
English: EXP: {month/year}
Danish: EXP: {Måned/år}
English: Do not use during pregnancy and lactation, laboratory studies in species (rat, mouse, rabbit and monkey) have shown evidence of developmental toxicity.
Danish: Bør ikke anvendes til drægtige og lakterende dyr, da der hos laboratoriedyr (rotte, mus, kanin og abe) er observeret tegn på udviklingsrelateret toksicitet.
English: Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Danish: Spironolakton nedsætter eliminationen af digoxin og hæver derved plasmakoncentrationen af digoxin.
English: Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Danish: Bør ikke anvendes til dyr, der lider af hypoadrenokorticisme, hyperkalæmi eller hyponatriæmi.
English: As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Danish: Da det terapeutiske indeks for digoxin er meget snævert, er det tilrådeligt at monitorere hunde, der både modtager digoxin og spironolaktone, meget nøje.
English: 30 tablets 180 tablets
Danish: 30 tabletter 180 tabletter
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Danish: Ceva Santé Animale 10, avenue de la Ballastière 33500 Libourne Frankrig
English: Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
Danish: Efter oral adminstrering af 2 til 4 mg/kg øges absorptionen lineært indenfor måleområdet.
English: Beef flavouring Mannitol
Danish: Oksekødssmag Mannitol
English: Lot: {number}
Danish: Lot : {nummer}
English: After oral administration of radiolabelled spironolactone to the dog, 70 % of the dose is recovered in faeces and 20 % in the urine.
Danish: Efter oral administration af radioaktivt mærket spironolakton til hunde blev 70 % af dosis genfundet i fæces og 20 % i urinen.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: ORDENE “KUN TIL DYR” OG RESTRIKTIONER OMKRING LEVERING OG ANVENDELSE
English: Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.
Danish: Selvom den præcise virkningsmekanisme endnu ikke er veldefineret, fremmer aldosteron fibrose af myokardiet, myokardiel og vaskulær remodellering og endothelial dysfunktion.
English: In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
Danish: I eksperimentelle modeller hos hunde er det vist, at langtidsbehandling med en aldosteron-antagonist forebygger progressiv dysfunktion af venstre ventrikel og mindsker remodelleringen af venstre ventrikel hos hunde med kronisk hjerteinsufficiens.
English: Administer 2 mg/kg of body weight of spironolactone once daily.
Danish: Administrer 2 mg spironolakton pr. kg legemsvægt én gang dagligt.
English: Polyamide/aluminium/polyvinyl chloride//aluminium blisters containing 10 tablets.
Danish: Polyamid/aluminium/polyvinylklorid/aluminium-blistre indholdende 10 tabletter Pakningsstørrelser:
English: Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
Danish: Spironolakton kan forårsage både induktion og inhibition af cytokrom P450-enzymer og kan derfor afficere metabolismen af andre lægemidler, der metaboliseres på samme måde.
English: May cause skin sensitisation: people with known hypersensitivity to spironolactone should avoid contact with the veterinary medicinal product.
Danish: Sensibilisering af hud kan forekomme: personer der er overfølsomme over for spironolaktoner, bør undgå kontakt med veterinærlægemidlet.
English: Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
Danish: Hunde, der behandles med spironolakton og NSAID sideløbende, bør sikres korrekt væskeoptagelse.
English: Sodium laurilsulfate Microcrystalline cellulose Povidone
Danish: Natriumlaurylsulfat Mikrokrystallinsk cellulose Povidon
English: Do not use after the expiry date which is stated on the carton and blister label after EXP.
Danish: Bør ikke anvendes efter udløbsdatoen, der er angivet på æsken og blisterpakningen efter ”EXP”.
English: Cardboard box containing 3 or 18 blisters of 10 tablets.
Danish: Kartonæske indeholdende 3 eller 18 bilstre à 10 tabletter.
English: In case of an accidental massive ingestion by the dog, there is no specific antidote or treatment.
Danish: I tilfælde af en hunds utilsigtede massive indtagelse er der ingen specifik antidot eller behandling.
English: In a clinical study investigating the survival time in dogs with congestive heart failure, there was a 65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in combination with standard therapy compared to dogs treated with standard therapy alone.
Danish: I en klinisk undersøgelse af overlevelsestiden hos hunde med kongestiv hjerteinsufficiens, fandtes en 65 % reduktion i relativ risiko for dødsfald efter 15 måneder hos hunde behandlet med spironolakton i kombination med standardbehandling i forhold til hunde, som kun blev behandlet med standardbehandling (dødsfald blev defineret som naturlig død eller aflivning pga. hjertesvigt).
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Danish: ORDENE “KUN TIL DYR”
English: Furosemide and pimobendan have been used together with Spironolactone Ceva in dogs with heart failure without any clinical evidence of adverse reactions.
Danish: Furosomid og pimobendan er hos hunde med hjerteinsufficiens blevet anvendt sammen med Spironolactone Ceva uden nogen kliniske tegn på bivirkninger.
English: Plasma clearance of canrenone is 1.45±0.39 l/h/kg and 7α-thiomethyl-spironolactone is 0.89±0.44 l/h/kg.
Danish: Plasmaclearance for canrenon er 1,45±0,39 l/time/kg og for 7α-thiomethyl-spironolakton 0,89±0,44 l/time/kg.
English: It is therefore recommended to induce vomiting, gastric lavage (depending on risk assessment) and monitor electrolytes.
Danish: Det anbefales i så tilfælde at inducere vomitus samt at foretage lavage af ventriklen (afhængig af risikovurdering).
English: For animal treatment only - to be supplied only on veterinary prescription.
Danish: Kun til behandling af dyr - udleveres kun efter dyrlægens ordination
English: EXP: {month/year} Partially used tablets to be used within 7 days.
Danish: EXP: {måned/år} Rester af delvist brugte tabletter skal anvendes inden for 7 dage.
English: Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7αthiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
Danish: Spironolakton metaboliseres hurtigt og fuldstændigt i leveren til dets aktive metabolitter, 7αthiomethyl-spironolakton og canrenon, der er de primære metabolitter hos hunden.
English: However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.
Danish: Hos hunde med renal svækkelse anbefales regelmæssig monitorering af renalfunktion og serumkalium, da der kan være en øget risiko for hyperkaliæmi.
English: The veterinary medicinal product should be administered with food.
Danish: Veterinærlægemidlet bør indgives sammen med foder.
English: Symptomatic treatment, e.g., fluid therapy, should be provided.
Danish: Symptomatisk behandling som f.eks. væsketerapi bør indledes.
English: Partially used tablets should be stored in the original blister and used within 7 days.
Danish: Rester af delte tabletter bør opbevares i den originale blisterpakning og anvendes inden for 7 dage.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: ANNEX III MÆRKNING OG INDLÆGSSEDDEL.
English: Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dysfunction).
Danish: Bør ikke anvendes sammen med nonsteroide antiflammatoriske stoffer (NSAID) til hunde med renal insufficiens eller renal dysfunktion
English: After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dosedependent adverse effects were noted (see section 4.6).
Danish: Efter administration af op til 10 gange den anbefalede dosis (20 mg/kg) til raske hunde, observeredes dosis-afhængige bivirkninger.
English: The mean volumes of distribution (Vss) of 7α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres, respectively.
Danish: Det gennemsnitlige distributionsvolumen for 7α-thiomethyl-spironolakton og canrenon er henholdsvis ca.153 liter og 177 liter.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLINGSTILLADELSE ANSVARLIG FOR BATCH RELEASE
English: Spironolactone.
Danish: Spironolakton.
English: There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.
Danish: Ved høje doseringer kan der forekomme en dosisrelateret hypertrofi af den adrenale zona glomerulosa.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Søg læge i tilfælde at utilsigtet indtagelse og vis indlægsseddel og mærkning til lægen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINIMUMS OPLYSNINGER TIL BLISTRE ELLER MÆRKATER
English: C. STATEMENT OF THE MRLs
Danish: C. ANGIVELSE AF MRL-værdier.
English: CLINICAL PARTICULARS 4.1 Target species
Danish: KLINISKE OPLYSNINGER 4.1 Dyrearter
English: Ceva Santé Animale Z.I.
Danish: Fremstiller for batch release: Ceva Santé Animale Z.I.
English: The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Danish: Administration af enten deoxycorticosteron eller NSAID sammen med spironolaktone kan føre til en moderat reduktion af den spironolaktons natriuretiske effekt (reduktion af natriumudskillelse i urinen).
English: Bottle containing 30 tablets packed in a cardboard box.
Danish: Glas indeholdende 30 tabletter pakket i en kartonæske.
English: Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and Angiotensin Converting Enzyme (ACE) inhibitors.
Danish: Nyrefunktion og serumkaliumniveau bør evalueres før indledning af kombineret behandling med spironolakton og hæmmere af angiotensin-konverterende-enzym (ACE-inhibitorer).
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVER AF MARKEDFØRINGSTILLADELSE OG INDEHAVER AF FREMSTILLINGSTILLADELSE ANSVARLIG FOR BATCH RELEASE.
English: Veterinary medicinal product subject to prescription.
Danish: Receptpligtigt veterinærlægemiddel.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: Do not use during pregnancy or lactation.
Danish: Bør ikke anvendes i forbindelse med drægtighed og laktation.
English: When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “aldosterone escape”.
Danish: Spironolakton kan, ved anvendelse i kombination med ACE-hæmmere, modvirke effekten af “ aldosteron escape”.
English: Blister - 10 mg tablets, 40 mg tablets and 80 mg tablets
Danish: Blistre - 10 mg tabletter, 40 mg tabletter og 80 mg tabletter
English: The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure.
Danish: Den renale effekt af spironolakton og dets metabolitter fører til et fald i ekstracellulærvolumen og deraf følgende nedsættelse af preload og tryk i venstre forkammer.
English: A slight increase in aldosterone blood levels may be observed in animals on treatment.
Danish: Hos dyr i behandling kan en let forøgelse af aldosteronniveauet i blodet observeres.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Spørg dyrlægen hvordan rester af medicinen bortskaffes efter ophør med behandling.
English: In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.
Danish: I nyrerne inhiberer spironolakton den aldosteron-inducerede natriumretention, hvilket fører til en øget udskillelse af natrium og dermed følgelig vand, samt retention af kalium.
English: Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers…etc) may potentially lead to hyperkalaemia (see section 4.5).
Danish: Samtidig administration af spironolakton og ACE-hæmmere eller andre kaliumbesparende lægemidler (som angiotensionreceptorblokkere, ß-blokkere, calciumkanalblokkere, etc.) kan potentielt føre til hyperkaliæmi.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Danish: ORDENE “OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Danish: Til anvendelse i kombination med standard-behandling (omfattende vanddrivende behandling om nødvendigt) til behandling af kongestiv hjerteinsufficiens forårsaget af valvulært tilbageløb hos hunde.
English: As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the veterinary medicinal product to growing dogs.
Danish: Da spironolakton har en antiandrogen effekt (virker mod hanlige kønshormoner) anbefales det ikke at anvende veterinærlægemidlet til hunde i vækst.
English: In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Danish: I det cardio-vaskulære system, forebygger spironolakton de nedbrydende effekter af aldosteron.
English: Spironolactone and its active metabolites (including 7α-thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.
Danish: Spironolakton og dets aktive metabolitter (inklusiv 7α-thiomethyl-spironolaktone og canrenon) fungerer som en specifik antagonist i forhold til aldosteron, og udøver deres effekt ved kompetitiv binding til mineralokortikoid-receptor, lokaliseret i nyrer, hjerte og blodkar.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, der administrerer veterinærlægemidlet
English: A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.
Danish: Der kan observeres reversibel atrofi (reduktion af størrelse) af prostata hos intakte handyr.