natgillin/translations-raw huggingface dataset:
Produktets faste kombination bør kun anvendes til hunde, som har behov for, at begge aktive stoffer administreres samtidigt i dette faste forhold.
This fixed combination product should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
I meget sjældne tilfælde i spontane rapporter er der rapporteret opkastning.
Vomiting has been reported very rarely in spontaneous reports.
Très le Bois 22600 Loudéac Frankrig
Tres le Bois 22600 Loudeac France
Produktet bør derfor anvendes med forsigtighed sammen med andre veterinære lægemidler, som inducerer, hæmmer eller metaboliseres af disse enzymer.
Therefore, the product should be used with caution with other veterinary medicinal products which induce, inhibit, or which are metabolised by these enzymes.
Det muliggjorde også en hurtigere forbedring af hoste og aktivitetsniveau og en langsommere forringelse af hjertelyde og appetit.
It also allowed a quicker improvement of cough and activity and a slower degradation of cough, heart sounds and appetite.
Tabletten kan deles i halve.
The tablets can be divided into equal halves.
I tilfælde af en hunds utilsigtede indtagelse af mange Cardalis tyggetabletter er der ingen specifik antidot eller behandling.
In case of the accidental ingestion by a dog of many Cardalis chewable tablets, there is no specific antidote or treatment.
En moderat forøgelse i aldosteron-blodniveauet kan observeres hos dyr, som behandles.
A slight increase in aldosterone blood levels may be observed in animals on treatment.
Det anbefales at inducere vomitus samt at foretage lavage af ventriklen (afhængig af risikovurdering) og monitorere elektrolytter.
It is therefore recommended to induce vomiting, and then carry out gastric lavage (depending on the risk assessment) and monitor electrolytes.
Overdosering (symptomer, nødforanstaltninger, modgift)
Overdose (symptoms, emergency procedures, antidotes)
Hundens vægt (kg)
Bodyweight (kg) of dog
Denne hypertrofi synes ikke patologisk og er reversibel efter afbrydelse af behandlingen.
This hypertrophy does not seem to be linked to any pathology and was observed to be reversible upon discontinuation of the treatment.
Hvid plastglas (HDPE) med børnesikring i en kartonæske.
White plastic (HDPE) bottle with a child-resistant closure in a cardboard box.
Kunstig oksekødssmag Komprimerbart sukker Crospovidon
Artificial beef flavour Compressible sugar Crospovidone Magnesium stearate
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.
After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
(benazepril HCl)
(benazeprilum HCl)
Glassene er udstyret med børnesikret lukning.
The bottles are fitted with childproof caps.
Spironolakton nedsætter eliminationen af digoksin og hæver derved plasmakoncentrationen af digoksin.
Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Efter oral administrering af 2 til 4 mg/kg øges absorptionen lineært inden for måleområdet.
Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
Benazeprilatkoncentrationerne aftager bifasisk: den initiale hurtige fase repræsenterer elimination af det ubundne lægemiddel, mens den terminale fase afspejler frigørelse af benazeprilat, som var bundet til ACE - især i væv.
Benazeprilat concentrations decline biphasically: the initial fast phase represents elimination of free drug, while the terminal phase reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Derfor skal hunde, som sideløbende behandles med NSAIDs, monitoreres tæt og have korrekt væsketilførsel.
Therefore, dogs treated concomitantly with an NSAID should be closely monitored and correctly hydrated.
Administration af deoxykortikosteron sammen med produktet kan føre til en moderat reduktion af spironolaktons natriuretiske effekt (reduktion af natriumudskillelse i urinen).
The administration of deoxycorticosterone with the product may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Spironolakton kan forårsage både induktion og inhibition af cytokrom P450-enzymer, og kan derfor påvirke metabolismen af andre lægemidler, der metaboliseres på samme måde.
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could affect the metabolism of other substances utilizing these metabolic pathways.
Al uanvendt medicin eller affald herfra skal bortskaffes i overensstemmelse med de lokale krav.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Efter oral administration af radioaktivt mærket spironolakton til hunde blev 70 % af dosis genfundet i fæces og 20 % i urinen.
After the oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
Sekretionen af aldosteron kan også stimuleres af andre faktorer end Angiotensin II især af kaliumforøgelse eller ACTH.
Secretion of aldosterone can also be stimulated by factors other than Angiotensin-II, notably K+ increase or ACTH.
Laktosemonohydrat Cellulose, mikrokrystallinsk Povidon K30
Lactose monohydrate Cellulose microcrystalline Povidone K30
Bør ikke anvendes til dyr, der anvendes eller påtænkes anvendt til avl.
Do not use in dogs intended or used for breeding.
Bør ikke anvendes sammen med nonsteroide antiinflammatoriske stoffer (NSAID) til hunde med renal insufficiens.
Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency.
Produktet forårsager en langvarig hæmning af aktiviteten af ACE i plasma hos hunde med mere end 95% hæmning ved maksimalt niveau og vedvarende signifikant aktivitet (> 80%) 24 timer efter tildelingen.
The product causes a long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.
Særlige forsigtighedsregler der skal træffes af personer, der administrerer lægemidlet til dyr
Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.11 Tilbageholdelsestid(er)
4.11 Withdrawal period(s)
Farmakoterapeutisk gruppe: Stoffer med virkning på renin-angiotensin systemet, ACE-hæmmere, kombinationer.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, ACE inhibitors, combinations.
Pakningstørrelse: 30 eller 90 tabletter.
Pack sizes of 30 or 90 tablets.
Uforandret benazepril og hydrofile metabolitter udgør resten.
Unchanged benazepril and hydrophilic metabolites account for the remainder.
I det kardio-vaskulære system, forebygger spironolakton de nedbrydende effekter af aldosteron.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Samtidig brug af NSAIDs med veterinærlægemiddelet kan reducere dets antihypertensive og natriuretiske effekt og øge serumniveauet af kalium.
The concomitant use of NSAIDs with this veterinary medicinal product may reduce its antihypertensive effect, its natriuretic effect and increase the level of serum potassium.
Symptomatisk behandling som f.eks. væsketerapi bør ligeledes indledes.
Symptomatic treatment, e.g., fluid therapy, should also be provided.
Kombinationen af spironolakton og benazepril HCl er gavnlig, da begge påvirker renin-angiotensinaldosteron-systemet (RAAS) men på forskellige niveauer i kaskaden.
The association of spironolactone and benazepril is beneficial as both act on the renin-angiotensinaldosterone system (RAAS) but at different levels along the cascade.
For at opnå en mere fuldstændig hæmning af de ødelæggende virkninger af RAAS-overaktivitet, som opstår ved hjerteinsufficiens, kan det derfor anbefales at anvende aldosteron-antagonister som spironolakton sideløbende med ACE-hæmmere for specifikt at blokere aldosteron (uanset kilde) via kompetitiv antagonisme på mineralkortikoidreceptorer.
Therefore, to achieve a more complete inhibition of the deleterious effects of RAAS overactivity which occurs with heart failure, it is recommended to use aldosterone antagonists, such as spironolactone, concomitantly with ACE inhibitors to block specifically the activity of aldosterone (regardless of the source), through competitive antagonism on mineralocorticoid receptors.
Spironolakton udskilles hovedsageligt via dets metabolitter.
Spironolactone is mainly excreted via its metabolites.
Benazeprilat er en højst potent og selektiv hæmmer af det angiotensinkonverterende enzym (ACE) og forhindrer således omdannelsen af inaktiv angiotensin I til aktiv angiotensin II.
Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II.
I eksperimentelle hundemodeller blev det påvist, at langtidsterapi med en aldosteron-antagonist forhindrer den progressive dysfunktion af den venstre ventrikel og bremser remodelleringen af venstre ventrikel hos hunde med kronisk hjertesvigt.
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.
Derfor blokerer det de virkninger, der medieres af angiotensin II bl.a. vasokonstriktion af både vener og arterier og nyrernes tilbageholdelse af natrium og vand.
Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney.
Spironolakton metaboliseres hurtigt og fuldstændigt i leveren til dets aktive metabolitter, 7-αthiomethyl-spironolakton og canrenon, der er de primære metabolitter hos hunden.
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.
Tabletterne bør administreres med foder enten iblandet en lille mængde foder, der gives før resten af hundens foder, eller direkte i selve foderet.
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.
Benazepril og benazeprilat fordeles hurtigt hovedsageligt i lever og nyrer.
Benazepril and benazeprilat are rapidly distributed, mainly in liver and kidney.
30 tabletter 90 tabletter
30 tablets 90 tablets
Bør ikke anvendes i forbindelse med drægtighed og laktation (se afsnit ”Anvendelse under drægtighed og laktation”)
Do not use during pregnancy and lactation (see section "Pregnancy and lactation ").
Benazepril hydroklorid (HCl)
Benazepril hydrochloride (HCl)
Den systemiske biotilgængelighed er ufuldstændig pga. ufuldstændig absorption og førstepassagemetabolisme.
The systemic bioavailability of benazepril is incomplete due to incomplete absorption and first pass metabolism.
Gravide skal være særligt opmærksomme på at undgå utilsigtet indtagelse, da ACE-hæmmere hos mennesker har vist sig at kunne påvirke fosteret under graviditeten.
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.
Kontakt Deres dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Der er ingen signifikant forskel i farmakokinetikken af benazepril, uanset om benazepril (som hydroklorid) administreres med foder eller til fastende hunde.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril (as hydrochloride) is administered to fed or fasted dogs.
Produktet bør anvendes med forsigtighed hos hunde med leverdysfunktion, da denne lidelse kan ændre den ekstensive, hepatiske biotransformation af spironolakton.
The product should be used with caution in dogs with hepatic dysfunction because it may alter the extensive biotransformation of spironolactone in liver.
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.).
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.
Benazeprilats plasmaclearance påvirkes ikke hos hunde med nedsat nyrefunktion, og derfor er det ikke nødvendigt at justere benazepril-dosisen i tilfælde af nyreinsufficiens.
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
Utilsigtet indtagelse, særligt af børn, kan medføre bivirkninger som f.eks. døsighed, kvalme, opkastning og diarré, samt hududslæt.
Accidental ingestion, particularly by children, may lead to adverse events such as drowsiness, nausea and vomiting and diarrhoea, and skin rashes.
Da spironolakton har en antiandrogen effekt, bør veterinær lægemidlet ikke anvendes til hunde i vækst.
Due to the antiandrogenic effect of spironolactone, it is not recommended to administer the veterinary medicinal product to growing dogs.
Bør ikke anvendes i tilfælde af nedsat hjerteoutput pga. aortastenose eller pulmonær stenose.
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
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)
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)
Ceva Santé Animale 10, avenue de la Ballastière 33500 Libourne Frankrig
Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France
Aldosteronfrigørelsen er dog ikke fuldt kontrolleret af ACE-hæmmerne, fordi angiotensin II også produceres af ikke-ACE-ruter som chymase (fænomenet kendes som “aldosterongennembrud").
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”).
Det gennemsnitlige distributionsvolumen for 7-α-thiomethyl-spironolakton og canrenon er henholdsvis ca.153 liter og 177 liter.
The mean volumes of distribution of 7-α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
I nyrerne inhiberer spironolakton den aldosteron-inducerede natriumretention, hvilket fører til en øget udskillelse af natrium og dermed følgelig vand, samt retention af kalium.
In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium, and subsequently water excretion, and potassium retention.
Indehaver af markedsføringstilladelsen: Ceva Santé Animale 10, avenue de la Ballastière 33500 Libourne
Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
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).
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).
EXP {måneder/år} Anvendes inden 6 måneder efter anbrud/åbning
EXP {month/year} Once opened, use within 6 months.
Bør ikke anvendes til dyr, der lider af hypoadrenokorticisme, hyperkaliæmi eller hyponatriæmi.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Farmakokinetikken for spironolakton er baseret på dennes metabolitter, da spironolakton selv er meget ustabil ved prøvetagning.
The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is unstable at assay.
Efter oral administration af benazepril opnås maksimalkoncentration hurtigt og falder hastig, da lægemidlet via leverenzymer delvis metaboliseres til benazeprilat.
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.
B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Søg læge i tilfælde af utilsigtet indtagelse og vis indlægssedlen eller etiketten til lægen.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Benazepril udskilles hos hunde via biliær og urinær ekskretion.
Benazeprilat is excreted via the biliary and the urinary route in dogs.
Holdbarhed efter flaskens anbrud: 6 måneder
Shelf-life after first opening the bottle: 6 months.
Den gennemsnitlige opholdstid (MRT) for metabolitterne spænder fra 9-14 timer, og de distribueres fortrinsvis til mavetarmkanal, nyrer, lever og binyrer.
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.
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.
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.
Styrke og antallet af tabletter, der skal administreres: Cardalis 2,5 mg/20 mg tyggetabletter
Strength and number of tablets to be administered: Cardalis 2.5 mg/20 mg chewable tablets
Til behandling af kongestiv hjerteinsufficiens forårsaget af kronisk degenerativ valvulær sygdom hos hunde (i kombination med diuretika efter behov).
For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support, as appropriate).
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.
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.
Benazepril og benazeprilat er i stort omfang bundet til plasmaproteiner - forekomsten i væv er især i lever og nyre.
Benazepril and benazeprilat are extensively bound to plasma proteins, and in tissues are found mainly in the liver and kidney.
Benazepril HCl er et pro-drug, der hydrolyseres in vivo til dets aktive metabolit benazeprilat.
Benazepril hydrochloride is a prodrug hydrolysed in vivo into its active metabolite, benazeprilat.
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).
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).
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).
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).
Spironolakton
Spironolactone
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.
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.
Personer, der er overfølsomme over for benazepril eller spironolakton, bør undgå kontakt med veterinærlægemidlet.
People with known hypersensitivity to spironolactone or benazepril should avoid contact with the product.
FARMAKOLOGISK EGENSKABER
PHARMACOLOGICAL PROPERTIES
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.
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.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med et glas à 30 tabletter
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 1 bottle of 30 tablets
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.
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.
Dosisafhængig men moderat kompensatorisk, fysiologisk hypertrofi af binyrenes zona glomerulosa blev også observeret ved doser, der var 3 gange højere end den anbefalede.
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.