natgillin/translations-raw huggingface dataset:
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.
Da bi dosegli bolj popolno zaviranje škodljivih učinkov prevelike aktivnosti RAAS, ki se pojavi ob srčnem popuščanju, je priporočljivo uporabiti antagoniste aldosterona, kot je spironolakton, sočasno z ACE zaviralci, da se specifično blokira učinke aldosterona (ne glede na izvor), preko kompetitivnega antagonizma na mineralokortikoidnih receptorjih.
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.
Zdravilo povzroči dolgotrajno zaviranje aktivnosti ACE v plazmi pri psih, z več kot 95% zaviranjem ob najvišjem učinku in pomembno aktivnostjo (>80%) še 24 ur po odmerku.
Ceva Santé Animale 10, av. de la Ballastière 33500 Libourne France
Ceva Santé Animale 10, av. de la Ballastière 33500 Libourne Francija
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine:
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.
Tablete vsebujejo govejo aromo za izboljšanje okusnosti in so jih v terenski študiji, narejeni pri psih s kronično degenerativno boleznijo zaklopk, psi v 92% vzeli v celoti in prostovoljno skupaj z ali brez hrane.
Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
Po peroralnem dajanju 2 to 4 mg/kg, se absorpcija poviša linearno.
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.
Benazeprilat je močan in selektiven zaviralec angiotenzin-konvertirajočega encima (ACE), s čimer preprečuje pretvorbo neaktivnega angiotenzina I v aktivni angiotenzin II.
This veterinary medicinal product does not require any special storage conditions.
Za to zdravilo za uporabo v veterinarski medicini ni posebnih navodil za shranjevanje.
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.
Koncentracije benazeprilata se znižajo v dveh fazah: začetna hitra faza predstavlja izločitev prostega zdravila, končna faza pa odraža sprostitev benazeprilata, ki je bil vezan na ACE, predvsem v tkivih.
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.
Sočasna uporaba tega zdravila za uporabo v veterinarski medicini z NSAIDi lahko zmanjša njegovo anti-hipertenzično delovanje, natriuretični učinek in poviša nivo serumskega kalija.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Ne uporabite pri psih s hipoadrenokorticizmom, hiperkaliemijo ali hiponatriemijo.
Pack sizes of 30 or 90 tablets.
Velikost pakiranja 30 in 90 tablet.
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.
Pri eksperimentalnih vzorcih pri psih se je pokazalo, da dolgotrajno zdravljenje z antagonisti aldosterona prepreči progresivno disfunkcijo in zmanjša preoblikovanje levega prekata pri psih s kronično srčno odpovedjo.
Secretion of aldosterone can also be stimulated by factors other than Angiotensin-II, notably K+ increase or ACTH.
Sproščanje aldosterona lahko stimulirajo tudi drugi faktorji, ne le angiotenzin II, opazno povišanje K+ ali ACTH.
After the oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
Po peroralnem dajanju radiološko označenega spironolaktona psom so ugotovili 70 % odmerka v blatu in 20 % v urinu.
CLINICAL PARTICULARS 4.1 Target species
4.1 Ciljne živalske vrste
A slight increase in aldosterone blood levels may be observed in animals on treatment.
Pri zdravljenih živalih lahko opazimo rahlo povišanje aldosterona v krvi.
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.
Nosečnice naj pazijo, da ne pride do nenamerne peroralne izpostavjenosti, saj je bilo ugotovljeno, da inhibitorji ACE vplivajo na nerojenega otroka med nosečnostjo pri ljudeh.
The tablets should be administered either mixed with a small amount of food offered to the dog just prior to the main meal, or with the meal itself.
Tablete dajemo pomešane z manjšo količino hrane ponujene psu tik pred glavnim obrokom ali pa s samim obrokom.
Bodyweight (kg) of dog
Telesna masa (kg) psa
The mean volumes of distribution of 7-α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Volumna distribucije 7-α-tiometil-spironolaktona in kanrenona sta približno 153 in 177 litrov.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
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).
Klinične študije časa preživetja so pokazale, da taka kombinacija poveča pričakovano življenjsko dobo psov s kongestivnim srčnim popuščanjem z 89% zmanjšanjem relativnega tveganja za srčno smrt, ocenjeno pri psih, zdravljenih s spironolaktonom v kombinaciji z benazeprilom (kot hidroklorid), v primerjavi s psi, zdravljenimi z benazeprilom (kot hidroklorid) samim (umrljivost je bila klasificirana kot smrt ali evtanazija zaradi odpovedi srca).
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.
Spironolakton in njegovi aktivni metaboliti (vključno z 7-α-tiometil-spironolaktonom in kanrenonom) delujejo kot specifični antagonisti aldosterona, ki svoje učinke kažejo s kompetitivno vezavo na mineralokortikoidne receptorje v ledvicah, srcu in krvnih žilah.
Do not use in case of hypersensitivity to Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na zaviralce angiotenzin konvertirajočega encima (zaviralci ACE) ali na katerokoli pomožno snov.
Benazepril hydrochloride (HCl)
Benazeprilijev hidroklorid (HCl) (benazeprili HCl)
MANUFACTURER'S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE Lot {številka}
Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Spironolakton zmanjša izločanje digoksina in zato poviša nivo plazemskega digoksina.
This fixed combination product should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
Zdravilo za uporabo v veterinarski medicini s to kombinacijo naj se uporablja samo pri psih, ki potrebujejo obe zdravilni učinkovini sočasno v določenem odmerku.
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.
Spironolakton se hitro in v celoti metabolizira v jetrih v aktivna metabolita, 7-α-tiometil-spironolakton in kanrenon, ki sta primarna metabolita pri psih.
PACKAGE SIZE
Velikost pakiranja
Therefore, the product should be used with caution with other veterinary medicinal products which induce, inhibit, or which are metabolised by these enzymes.
Zato naj se zdravilo za uporabo v veterinarski medicini previdno uporablja skupaj z drugimi zdravili za uporabo v veterinarski medicini, ki inducirajo, zavirajo ali se presnavljajo s temi encimi.
ANNEX III LABELLING AND PACKAGE LEAFLET
DODATEK III OZNAČEVANJE IN NAVODILO ZA UPORABO
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.
Tablete dajemo skupaj s hrano, pomešane z manjšo količino hrane, ponujene psu tik pred glavnim obrokom ali pa skupaj s samim obrokom.
Shelf-life after first opening the bottle: 6 months.
Rok uporabnosti po prvem odprtju stične ovojnine: 6 mesecev.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE V EGP, ČE STA RAZLIČNA
Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney.
Zato zavira učinke angiotenzina II, ki vključujejo vazoknstrikcijo arterij in ven, zadrževanje natrija in vode v ledvicah.
In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium, and subsequently water excretion, and potassium retention.
V ledvicah spironolakton inhibira aldosteronsko inducirano zadrževanje natrija, kar vodi k zvečanemu izločanju natrija in posledično izločanju vode in zadrževanju kalija.
The resulting reduction in extracellular volume decreases the cardiac preload and left atrial pressure.
Posledično zmanjšanje ekstracelularnega volumna zmanjša pritok v srce in pritisk v levem atriju.
The administration of deoxycorticosterone with the product may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Dajanje deoksikortikosterona skupaj s tem zdravilom za uporabo v veterinarski medicini lahko vodi do zmernega zmanjšanja natriuretičnega učinka (zmanjšanje izločanja urinskega natrija) spironolaktona.
Benazepril and benazeprilat are rapidly distributed, mainly in liver and kidney.
Benazepril in benazeprilat se hitro distribuirata, v glavnem v jetra in ledvice.
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.
Prav tako je bila opažena od odmerka odvisna, a zmerna kompenzatorna fiziološka hipertrofija cone glomeruloze nadledvične žleze, pri 3 kratnem in večjem odmerku od priporočenega odmerka.
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.
Po peroralnem zaužitju benazeprilijevega hidroklorida so najvišje vrednosti benazeprila dosežene hitro in se hitro znižajo, ko jetrni encimi zdravilo delno pretvorijo v benazeprilat.
For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support, as appropriate).
Zdravljenje kongestivnega srčnega popuščanja zaradi kronične degenerativne bolezni zaklopk pri psih (z diuretično podporo, če je to potrebno).
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC ODGOVOREN ZA SPROSTITEV SERIJE
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
Izločanje benazeprilata pri psih z okvaro ledvic ni ovirano, zato v primeru okvare ledvic ni potrebno prilagajati odmerka benazeprila.
The plasma clearances of canrenone and 7-αthiomethyl-spironolactone are 1.5 l/h/kg bw and 0.9 l/h/kg bw respectively.
Plazemski klirens kanrenona in 7-α-tiometilspironolaktona je 1.5 l/h/kg in 0.9 l/h/kg.
The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is unstable at assay.
Farmakokinetika spironolaktona temelji na njegovih metabolitih, ker je sam spironolakton nestabilen.
Benazepril and benazeprilat are extensively bound to plasma proteins, and in tissues are found mainly in the liver and kidney.
Benazepril in benazeprilat se v veliki meri vežeta na proteine v plazmi, v tkivih pa se nahajata predvsem v jetrih in ledvicah.
Benazepril, by preventing the formation of Angiotensin-II, inhibits the detrimental effects of vasoconstriction and stimulation of aldosterone release.
Benazepril deluje tako, da preprečuje nastajanje angiotenzina II, zavira škodljive učinke vazokonstrikcije in stimulira sproščaje aldosterona.
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.
Priporoča se redna kontrola delovanja ledvic in nivoja serumskega kalija pri psih z ledvično okvaro, saj je pri njih povečana verjetnost pojava hiperkaliemije med zdravljenjem s tem zdravilom za uporabo v veterinarski medicini.
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)
EU/2/12/142/001 (1 x 30 tablet 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tablet 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tablet 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tablet 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tablet 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tablet 10 mg/80 mg)
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
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.
Ker je terapevtski indeks za digoksin zelo ozek, je priporočljivo pazljivo spremljanje stanja živali, ki prejemajo digoksin in kombinacijo benazeprila (hidroklorid) in spironolakona.
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.
Ker je terapevtski indeks za digoksin zelo ozek, je priporočljivo pazljivo spremljanje stanja živali, ki prejemajo digoksin in kombinacijo spironolakona in benazeprilijevega hidroklorida.
EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
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.
Furosemid je bil uporabljen v kombinaciji s benazeprilijevim hidrokloridom in spironolaktonom pri psih s srčnim popuščanjem brez pojava kliničnih znakov neželenega medsebojnega delovanja.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, ACE inhibitors, combinations.
Farmakoterapevtska skupina: zaviralci ACE, kombinacija.
Spironolactone is mainly excreted via its metabolites.
Spironolakton se največ izloča v obliki metabolitov.
Benazepril hydrochloride is a prodrug hydrolysed in vivo into its active metabolite, benazeprilat.
Benazeprilijev hidroklorid je prekurzor, ki se hidrolizira in vivo v aktiven metabolit, benazeprilat.
Benazeprilat is excreted via the biliary and the urinary route in dogs.
Benzaeprilat se izloča preko žolča in urina pri psih.
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.
V stabilnem stanju najvišjo Cmax 324 μg/l in 66 μg/l dosežeta primarna metabolita, 7-α-tiometil-spironolakton in kanrenon, v 2 in 4 urah po odmerjanju.
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.
Po večkratnih peroralnih odmerkih 2 mg spironolaktona na kg (z 0.25 mg benazeprilijevega hidroklorida na kg) 7 zaporednih dni, ni bilo opaziti akumulacije.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 30 tablet
Do not use during pregnancy and lactation (see section "Pregnancy and lactation ").
Ne uporabite v obdobju brejosti in laktacije (glej poglavje ''Uporaba v obdobju brejosti, laktacije ali nesnosti'').
People with known hypersensitivity to spironolactone or benazepril should avoid contact with the product.
Osebe z znano preobčutljivostjo na benazepril ali spironolakton naj se izogibajo stiku z zdravilom za uporabo v veterinarski medicini.
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.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Furosemid je bil uporabljen v kombinaciji s benazeprilijevim hidrokloridom in spironolaktonom pri psih s srčnim popuščanjem brez pojava kliničnih znakov neželenega medsebojnega delovanja.
Unchanged benazepril and hydrophilic metabolites account for the remainder.
Preostanek sestavljajo nespremenjen benazepril in hidrofilni metaboliti.
30 tablets 90 tablets
90 tablet
EXP {month/year} Once opened, use within 6 months.
Načeto/odprto zdravilo porabite v 6 mesecih.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination.
V nasprotju z ljudmi, pri kliničnih preizkusih s to kombinacijo ni bilo opaziti povečanega pojava hiperkaliemije pri psih.
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)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/142/001 (1 x 30 tablet, 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tablet, 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tablet, 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tablet, 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tablet, 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tablet, 10 mg/80 mg)
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.
Po večkratnih peroralnih odmerkih 0.25 mg benazeprilijevega hidroklorida na kg (z 2 mg spironolaktona na kg) 7 zaporednih dni, je najvišja koncentracija benazeprila (Cmax 52,4 ng/ml) dosežena v Tmax 1,4 urah.
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.
Pred začetkom zdravljenja s benazeprilom in spironolaktonom, je potrebno oceniti delovanje ledvic in nivo serumskega kalija, še posebno pri psih, ki so lahko oboleli za hipoadrenokorticizmom, hiperkaliemijo ali hiponatriemijo.
80 mg The tablets are brown coloured, palatable, oblong shaped with a score line and chewable.
Tablete so rjave, okusne, ovalne oblike, z zarezo in žvečljive.
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.
V terenski študiji, narejeni pri psih s kronično degenerativno boleznijo zaklopk, je 85,9% psov pokazalo dobro skladnost z zdravljenjem (≥90% predpisanih tablet je bilo uspešno odmerjenih) v obdobju treh mesecev.
Cardboard box of 1 bottle of 90 tablets
Kartonska škatla z 1 plastenko po 30 tablet Kartonska škatla z 1 plastenko po 90 tablet
Aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction, although the precise mechanism of action is not yet clearly defined.
Čeprav natančen mehanizem delovanja še ni definiran, aldosteron pospešuje miokardialno fibrozo, miokardialno in vaskularno preoblikovanje in endotelialno disfunkcijo.
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.
Sočasna uporaba tega zdravila za uporabo v veterinarski medicini z drugimi anti-hipertenzivnimi zdravili (npr. zaviralci kalcijevih kanalčkov, β zaviralci ali diuretiki), anestetiki ali sedativi lahko vodi do dodatnih hipotenzivnih učinkov.
STATEMENT OF ACTIVE SUBSTANCES
Seznam pomožnih snovi
The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section "Special precautions for use in animals").
Sočasna uporaba tega zdravila za uporabo v veterinarski medicini z drugimi zdravili, ki zadržujejo kalij (kot so ß zaviralci, zaviralci kalcijevih kanalčkov, zaviralci angiotenzin receptorjev) lahko vodi do hiperkaliemije (glej poglavje ''Posebni previdnostni ukrepi za uporabo pri živalih").
The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section 4.5).
Sočasna uporaba tega zdravila za uporabo v veterinarski medicini z drugimi zdravili, ki zadržujejo kalij (kot so ß zaviralci, zaviralci kalcijevih kanalčkov, zaviralci angiotenzin receptorjev) lahko vodi do hiperkaliemije (glej poglavje 4.5).
Bottle of 90 tablets
Plastenka po 90 tablet
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.
Cardalis žvečljive tablete dajemo psom enkrat dnevno v odmerku 0.25 mg/kg telesne mase benazeprilijevega hidroklorida (HCl) in 2 mg/kg telesne mase (t.m.)
benazepril HCl 2.5 mg, spironolactone 20 mg benazepril HCl 5 mg, spironolactone 40 mg benazepril HCl 10 mg, spironolactone 80 mg
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) benazeprili HCl 2,5 mg, spironolactonum 20 mg benazeprili HCl 5 mg, spironolactonum 40 mg benazeprili HCl 10 mg, spironolactonum 80 mg
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije