FrancophonIA/ELRC3.0 huggingface dataset:
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, 7-αthiomethyl-spironolakton og canrenon, der er de primære metabolitter hos hunden.
English: The tablets should be administered with food, either mixed with a small amount of food offered to the dog just prior to the main meal, or with the meal itself.
Danish: Tabletterne bør administreres med foder enten iblandet en lille mængde foder, der gives før resten af hundens foder, eller direkte i selve foderet.
English: Benazepril and benazeprilat are rapidly distributed, mainly in liver and kidney.
Danish: Benazepril og benazeprilat fordeles hurtigt hovedsageligt i lever og nyrer.
English: 30 tablets 90 tablets
Danish: 30 tabletter 90 tabletter
English: Do not use during pregnancy and lactation (see section "Pregnancy and lactation ").
Danish: Bør ikke anvendes i forbindelse med drægtighed og laktation (se afsnit ”Anvendelse under drægtighed og laktation”)
English: Benazepril hydrochloride (HCl)
Danish: Benazepril hydroklorid (HCl)
English: The systemic bioavailability of benazepril is incomplete due to incomplete absorption and first pass metabolism.
Danish: Den systemiske biotilgængelighed er ufuldstændig pga. ufuldstændig absorption og førstepassagemetabolisme.
English: Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child during pregnancy in humans.
Danish: Gravide skal være særligt opmærksomme på at undgå utilsigtet indtagelse, da ACE-hæmmere hos mennesker har vist sig at kunne påvirke fosteret under graviditeten.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Danish: Kontakt Deres dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: There is no significant difference in the pharmacokinetics of benazeprilat when benazepril (as hydrochloride) is administered to fed or fasted dogs.
Danish: Der er ingen signifikant forskel i farmakokinetikken af benazepril, uanset om benazepril (som hydroklorid) administreres med foder eller til fastende hunde.
English: The product should be used with caution in dogs with hepatic dysfunction because it may alter the extensive biotransformation of spironolactone in liver.
Danish: Produktet bør anvendes med forsigtighed hos hunde med leverdysfunktion, da denne lidelse kan ændre den ekstensive, hepatiske biotransformation af spironolakton.
English: Spironolactone and its active metabolites (including 7-α-thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone by binding competitively to mineralocorticoid receptors located in the kidneys, heart and blood vessels.
Danish: Spironolakton og dets aktive metabolitter (inklusiv 7-α-thiomethyl-spironolakton og canrenon) fungerer som en specifik antagonist i forhold til aldosteron, og udøver deres effekt ved kompetitiv binding til mineralokortikoid-receptorer, lokaliseret i nyrer, hjerte og blodkar.).
English: The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of benazepril dose is required in cases of renal insufficiency
Danish: Benazeprilats plasmaclearance påvirkes ikke hos hunde med nedsat nyrefunktion, og derfor er det ikke nødvendigt at justere benazepril-dosisen i tilfælde af nyreinsufficiens.
English: Accidental ingestion, particularly by children, may lead to adverse events such as drowsiness, nausea and vomiting and diarrhoea, and skin rashes.
Danish: Utilsigtet indtagelse, særligt af børn, kan medføre bivirkninger som f.eks. døsighed, kvalme, opkastning og diarré, samt hududslæt.
English: Due to the antiandrogenic effect of spironolactone, it is not recommended to administer the veterinary medicinal product to growing dogs.
Danish: Da spironolakton har en antiandrogen effekt, bør veterinær lægemidlet ikke anvendes til hunde i vækst.
English: Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Danish: Bør ikke anvendes i tilfælde af nedsat hjerteoutput pga. aortastenose eller pulmonær stenose.
English: EU/2/12/142/001(1 x 30 tablets, 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tablets, 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tablets, 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tablets, 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tablets, 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tablets, 10 mg/80 mg)
Danish: EU/2/12/142/001 (1 x 30 tabletter, 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tabletter, 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tabletter, 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tabletter, 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tabletter, 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tabletter, 10 mg/80 mg)
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: However, aldosterone release is not fully controlled by ACE Inhibitors because Angiotensin-II is also produced by non-ACE pathways such as chymase (phenomenon known as “aldosterone breakthrough”).
Danish: Aldosteronfrigørelsen er dog ikke fuldt kontrolleret af ACE-hæmmerne, fordi angiotensin II også produceres af ikke-ACE-ruter som chymase (fænomenet kendes som “aldosterongennembrud").
English: The mean volumes of distribution of 7-α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Danish: Det gennemsnitlige distributionsvolumen for 7-α-thiomethyl-spironolakton og canrenon er henholdsvis ca.153 liter og 177 liter.
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: Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Danish: Indehaver af markedsføringstilladelsen: Ceva Santé Animale 10, avenue de la Ballastière 33500 Libourne
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) -Almindelige (mere end 1 men mindre end 10 dyr ud af 100 behandlede dyr) -Ikke almindelige (mere end 1 men mindre end 10 dyr ud af 1000 behandlede dyr) -Sjældne (mere end 1 men mindre end 10 dyr ud af 10.000 behandlede dyr) -Meget sjælden (mindre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: EXP {month/year} Once opened, use within 6 months.
Danish: EXP {måneder/år} Anvendes inden 6 måneder efter anbrud/åbning
English: Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Danish: Bør ikke anvendes til dyr, der lider af hypoadrenokorticisme, hyperkaliæmi eller hyponatriæmi.
English: INDICATION
Danish: INDIKATIONER
English: The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is unstable at assay.
Danish: Farmakokinetikken for spironolakton er baseret på dennes metabolitter, da spironolakton selv er meget ustabil ved prøvetagning.
English: After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly and decline quickly as the drug is partially metabolized by liver enzymes to benazeprilat.
Danish: Efter oral administration af benazepril opnås maksimalkoncentration hurtigt og falder hastig, da lægemidlet via leverenzymer delvis metaboliseres til benazeprilat.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
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 af utilsigtet indtagelse og vis indlægssedlen eller etiketten til lægen.
English: Benazeprilat is excreted via the biliary and the urinary route in dogs.
Danish: Benazepril udskilles hos hunde via biliær og urinær ekskretion.
English: Shelf-life after first opening the bottle: 6 months.
Danish: Holdbarhed efter flaskens anbrud: 6 måneder
English: The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially distributed to the gastro-intestinal tract, kidney, liver and adrenal glands.
Danish: Den gennemsnitlige opholdstid (MRT) for metabolitterne spænder fra 9-14 timer, og de distribueres fortrinsvis til mavetarmkanal, nyrer, lever og binyrer.
English: As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and a combination of benazepril hydrochloride and spironolactone.
Danish: Da det terapeutiske indeks for digoksin er meget snævert, er det tilrådeligt meget nøje at monitorere hunde, der både behandles med digoksin og en kombination af benazepril hydroklorid og spironolakton.
English: Strength and number of tablets to be administered: Cardalis 2.5 mg/20 mg chewable tablets
Danish: Styrke og antallet af tabletter, der skal administreres: Cardalis 2,5 mg/20 mg tyggetabletter
English: For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support, as appropriate).
Danish: Til behandling af kongestiv hjerteinsufficiens forårsaget af kronisk degenerativ valvulær sygdom hos hunde (i kombination med diuretika efter behov).
English: Dogs
Danish: Hund
English: As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and a combination of benazepril (hydrochloride) and spironolactone.
Danish: Da det terapeutiske indeks for digoksin er meget snævert, er det tilrådeligt meget nøje at monitorere hunde, der både behandles med digoksin og en kombination af benazepril (hydroklorid) og spironolakton.
English: Benazepril and benazeprilat are extensively bound to plasma proteins, and in tissues are found mainly in the liver and kidney.
Danish: Benazepril og benazeprilat er i stort omfang bundet til plasmaproteiner - forekomsten i væv er især i lever og nyre.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo into its active metabolite, benazeprilat.
Danish: Benazepril HCl er et pro-drug, der hydrolyseres in vivo til dets aktive metabolit benazeprilat.
English: Clinical studies investigating the survival time demonstrated that the fixed combination increased the life expectancy in dogs with congestive heart failure with a 89% reduction in the relative risk of cardiac mortality assessed in dogs treated with spironolactone in combination with benazepril (hydrochloride) compared to dogs treated with benazepril (hydrochloride) alone (mortality was classified as death or euthanasia due to heart failure).
Danish: Kliniske studier, der omhandlede overlevelsestid, har vist, at den faste kombination forøgede overlevelsesforventningen hos hunde med kongestiv hjerteinsufficiens med en 89 % reduktion i den relative risiko for kardial dødelighed vurderet i hunde behandlet med spironolakton i kombination med benazepril (hydroklorid) sammenlignet med hunde behandlet med benazepril (hydroklorid) alene (dødelighed klassificeredes som død eller euthanasi pga. hjerteinsufficiens).
English: Clinical studies investigating the survival time demonstrated that the fixed combination increased the life expectancy in dogs with congestive heart failure with a 89% reduction in the relative risk of cardiac mortality assessed in dogs treated with spironolactone in combination with benazepril (as the hydrochloride) compared to dogs treated with benazepril (as hydrochloride) alone (mortality was classified as death or euthanasia due to heart failure).
Danish: Kliniske studier, der omhandlede overlevelsestid, har vist, at den faste kombination forøgede overlevelsesforventningen hos hunde med kongestiv hjerteinsufficiens med en 89 % reduktion i den relative risiko for kardial dødelighed vurderet i hunde behandlet med spironolakton i kombination med benazepril (som hydroklorid) sammenlignet med hunde behandlet med benazepril (som hydroklorid) alene (dødelighed klassificeredes som død eller euthanasi pga. hjerteinsufficiens).
English: Spironolactone
Danish: Spironolakton
English: The tablets contain beef flavouring to improve palatability, and in a field study conducted in dogs with chronic degenerative valvular disease the tablets were voluntarily and fully consumed 92% of the time when offered either with or without food.
Danish: I et feltstudium udført hos hunde med kronisk valvulær degenerativ sygdom blev tabletterne frivilligt og fuldstændigt indtaget i 92% af tilfældene, uanset om de blev tilbudt med foder eller ej.
English: People with known hypersensitivity to spironolactone or benazepril should avoid contact with the product.
Danish: Personer, der er overfølsomme over for benazepril eller spironolakton, bør undgå kontakt med veterinærlægemidlet.
English: PHARMACOLOGICAL PROPERTIES
Danish: FARMAKOLOGISK EGENSKABER
English: After multiple oral doses of 0.25 mg benazepril hydrochloride per kg (with 2 mg spironolactone per kg) for 7 consecutive days, a peak benazeprilat concentration (Cmax of 52.4 ng/ml) is achieved with a Tmax of 1.4 h.
Danish: Efter adskillige orale doser på 0,25 mg benazepril hydroklorid pr. kg (med 2 mg spironolakton pr. kg) i 7 på hinanden følgende dage opnåedes en maksimal benazeprilat-koncentration (Cmax = 52,4 ng/ml) med en Tmax på 1,4 time.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 1 bottle of 30 tablets
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med et glas à 30 tabletter
English: Kidney function and serum potassium levels should be evaluated before initiating the treatment with benazepril and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Danish: Nyrefunktion og serumkaliumniveau bør evalueres før indledning af kombineret behandling med benazepril og spironolakton især hos hunde, der måtte lide af hypoadrenokorticisme, hyperkaliæmi eller hypernatriæmi.
English: A dose related but moderate compensatory physiological hypertrophy of zona glomerulosa of the adrenal glands was also observed at doses of 3 times and greater of the recommended dose.
Danish: Dosisafhængig men moderat kompensatorisk, fysiologisk hypertrofi af binyrenes zona glomerulosa blev også observeret ved doser, der var 3 gange højere end den anbefalede.
English: A dose related but moderate compensatory physiological hypertrophy of the zona glomerulosa of the adrenal glands was also observed at doses of 3 times and greater of the recommended dose.
Danish: Dosisafhængig men moderat kompensatorisk, fysiologisk hypertrofi af binyrernes zona glomerulosa blev også observeret ved doser, der var 3 gange højere end den anbefalede.
English: The tablets are packed bottles of 30 tablets or 90 tablets, and each bottle is presented in an outer cardboard box.
Danish: Tabletterne er pakket i kartonæsker, som indeholder et glas à 30 tabletter eller et glas à 90 tabletter.
English: Pharmacodynamic properties
Danish: Farmakodynamiske egenskaber
English: Do not use in case of hypersensitivity to Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for angiotensin-konverterende enzym ACEhæmmere eller nogen af tilsætningsstofferne.
English: Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination.
Danish: I modsætning til i human medicin, er der i kliniske undersøgelser med denne kombinationsbehandling hos hunde ikke observeret øget forekomst af hyperkaliæmi.
English: Aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction, although the precise mechanism of action is not yet clearly defined.
Danish: Selvom den præcise virkningsmekanisme endnu ikke er veldefineret, fremmer aldosteron fibrose af myokardiet, myokardial og vaskulær remodellering og endotelial dysfunktion.
English: Kidney function and serum potassium levels should be evaluated before initiating the treatment with benazepril (hydrochloride) and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Danish: Nyrefunktion og serumkaliumniveau bør evalueres før indledning af kombineret behandling med benazepril (hydroklorid) og spironolakton især hos hunde, der måtte lide af hypoadrenokorticisme, hyperkaliæmi eller hypernatriæmi.
English: Repeated administration of benazepril leads to slight bioaccumulation of benazeprilat, steady state being achieved within few days.
Danish: Gentagen administration af benazepril fører til moderat bioakkumulering af benazeprilat.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: Fremstiller ansvarlig for batchfrigivelse:
English: 80 mg The tablets are brown coloured, palatable, oblong shaped with a score line and chewable.
Danish: Tyggetabletterne er brune, aflange, smagskorrigerede og med delekærv.
English: The plasma clearances of canrenone and 7-αthiomethyl-spironolactone are 1.5 l/h/kg bw and 0.9 l/h/kg bw respectively.
Danish: Plasmaclearance for canrenon og 7-αthiomethyl-spironolakton er hhv. 1,5 l/time/kg lgm.
English: Bottle of 90 tablets
Danish: Glas à 90 tabletter
English: Furosemide has been used together with this combination of benazepril hydrochloride and spironolactone in dogs with heart failure without any clinical evidence of adverse interactions.
Danish: Furosemid er hos hunde med hjerteinsufficiens blevet anvendt sammen med benazepril hydroklorid og spironolakton uden nogen kliniske tegn på bivirkninger.
English: Benazepril, by preventing the formation of Angiotensin-II, inhibits the detrimental effects of vasoconstriction and stimulation of aldosterone release.
Danish: Benazepril forhindrer de ødelæggende effekter af vasokonstriktion og stimulering af aldosteronfrigørelsen ved at hæmme dannelsen af angiotensin II.
English: However, regular monitoring of renal function and serum potassium levels is recommended in dogs with renal impairment, as they may have an increased risk of hyperkalaemia during treatment with this product.
Danish: Hos hunde med renal svækkelse anbefales regelmæssig monitorering af renalfunktion og serumkalium, da der kan være en øget risiko for hyperkaliæmi.
English: Special precautions for storage
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
English: Chewable tablet.
Danish: Tyggetabletter.
English: Reversible prostatic atrophy in entire male dogs treated with spironolactone was noted in a Target Animal Safety study at the recommended dose.
Danish: I ”Target Animal Safety study” blev der påvist en reversibel atrofi af prostata hos intakte hanhunde behandlede med den anbefalede dosis af spironolakton.
English: Cardboard box of 1 bottle of 90 tablets
Danish: Kartonæske med et glas à 90 tabletter
English: There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.In a field study conducted in dogs with chronic degenerative valvular disease 85.9% of dogs showed good compliance with treatment (≥ 90% of prescribed tablets successfully administered) over a three month period.
Danish: I et feltstudium udført hos hunde med kronisk degenerativ valvulær sygdom viste 85,9% af hundene god kompliance i forhold til behandlingen (administration af over 90% af de ordinerede tabletter var vellykket) over en tre måneders periode.
English: benazepril HCl 2.5 mg, spironolactone 20 mg benazepril HCl 5 mg, spironolactone 40 mg benazepril HCl 10 mg, spironolactone 80 mg
Danish: benazepril hydroklorid 2,5 mg, spironolakton 20 mg benazepril hydroklorid 5 mg, spironolakton 40 mg benazepril hydroklorid 10 mg, spironolakton 80 mg
English: 4.5 Special precautions for use
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr
English: The concomitant administration of this veterinary medicinal product with other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may potentially lead to additive hypotensive effects.
Danish: Samtidig administration af veterinærlægemiddelet med andre antihypertensive stoffer (som f.eks. kalciumkanalblokkere, β-blokkere eller diuretika), anæstetika eller sedativa kan potentielt have en additiv, hypotensiv effekt.
English: Cardalis 2.5 mg/20 mg tablets
Danish: Cardalis 2,5 mg/20 mg tabletter
English: At steady state, mean Cmax of 324 μg/l and 66 μg/l are achieved for the primary metabolites, 7-α-thiomethyl-spironolactone and canrenone, 2 and 4 hours post-dosing, respectively.
Danish: For de primære metabolitter, 7-α-thiomethyl-spironolakton og canrenon opnås i ligevægt gennemsnitlige Cmax-værdier på 324 μg/l og 66 μg/l henholdsvis 2 og 4 timer efter dosering.
English: Interaction with other medicinal products and other forms of interactionFurosemide has been used together with this combination of benazepril (hydrochloride) and spironolactone in dogs with heart failure without any clinical evidence of adverse interactions.
Danish: Furosemid er hos hunde med hjerteinsufficiens blevet anvendt sammen med benazepril (hydroklorid) og spironolakton uden nogen kliniske tegn på bivirkninger.
English: The resulting reduction in extracellular volume decreases the 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: After multiple oral doses of 2 mg spironolactone per kg (with 0.25 mg benazepril hydrochloride per kg) for 7 consecutive days, no accumulation is observed.
Danish: Der observeredes ingen akkumulering efter indgivelse af adskillige orale doser på 2 mg spironolakton (med 0,25 mg benazepril hydroklorid pr. kg) i 7 på hinanden følgende dage.
English: Cardalis chewable tablets should be administered to the dog once a day at a dosage of 0.25 mg/kg bodyweight (bw) benazepril hydrochloride (HCl) and 2 mg/kg bodyweight spironolactone, according to the following dosage table.
Danish: Cardalis tyggetabletter bør administreres til hunden én gang dagligt med en dosering på 0,25 mg/kg legemsvægt benazepril hydroklorid (HCl) og 2 mg/kg lgm.
English: The concomitant administration of the product with other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may potentially lead to additive hypotensive effects.
Danish: Samtidig administration af veterinærlægemidlet med andre antihypertensive stoffer (som f.eks. kalciumkanalblokkere, β-blokkere eller diuretika), anæstetika eller sedativa kan potentielt have en additiv, hypotensiv effekt.
English: Pregnancy and lactation
Danish: Anvendelse under drægtighed og diegivning
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril (as hydrochloride) with laboratory animals (rats) at maternally nontoxic doses.
Danish: Bør ikke anvendes til drægtige og diegivende dyr, da der i kliniske studier med benazepril (som hydroklorid) hos laboratoriedyr (rotter) er observeret tegn på udviklingsrelateret toksicitet (misdannelse af urinvejene hos fostre).