natgillin/translations-raw huggingface dataset:
A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs. 
Zmerno povečanje plazemskih koncentracij kreatinina po uporabi zaviralcev ACE je združljivo z zmanjšanjem glomerularne hipertenzije, ki jo povzročijo ta zdravila, in zato ni nujno razlog za prekinitev terapije, če ni prisotnih drugih znakov.
Repeated administration of benazepril hydrochloride leads to slight bioaccumulation of benazeprilat (R = 1.47), steady state being achieved within a few days (4 days). 
Ponavljajoča se uporaba benazeprilijevega klorida vodi do rahle bioakumulacije benazeprilata (R = 1,47), pri čemer je dinamično ravnovesje doseženo v nekaj dneh (4 dni).
Benazepril and benazeprilat are extensively bound to plasma proteins (8590%), and in the tissues they are found mainly in the lung, liver and kidney. 
Benazepril in benazeprilat se v veliki meri vežeta na plazemske beljakovine (85 - 90 %), v tkivih pa ju večinoma najdemo v pljučih, jetrih in ledvicah.
People with known hypersensitivity to pimobendan or benazepril hydrochloride should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo na pimobendan ali benazeprilijev klorid naj se izogibajo stiku z zdravilom.
It also exhibits a vasodilatory action through the inhibition of phosphodiesterase type III activity. 
Ima tudi vazodilatatorni učinek skozi zaviranje aktivnosti fosfodiesteraze tipa III.
Benazeprilat is excreted via the biliary (54%) and urinary (46%) routes in dogs. 
Benazeprilat se pri psih izloča z žolčem (54 %) in urinom (46 %).
Renal function and signs of hypotension (lethargy, weakness, etc) should be monitored closely and treated as necessary. 
Delovanje ledvic in znake hipotenzije (letargija, slabost itd.) je treba skrbno spremljati in jih po potrebi zdraviti.
Therefore, benazepril blocks effects mediated by angiotensin II and aldosterone, including the vasoconstriction of arteries and veins, the retention of sodium and water by the kidney, and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes). 
Benazepril zavira učinke angiotenzina II in aldosterona, vključno z vazokonstrikcijo tako arterij kot ven, zadrževanjem natrija in vode v ledvicah ter učinki preoblikovanja (vključno s patološko hipertrofijo srca in z degenerativnimi spremembami ledvic).
Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic or pulmonary stenosis). 
Ne uporabite pri hipertrofični kardiomiopatiji ali kliničnih stanjih, pri katerih povečanje minutnega volumna srca ni mogoče zaradi funkcionalnih ali anatomskih razlogov (npr. aortne ali pljučne stenoze).
It increases the calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III). 
Povečuje občutljivost srčnih miofilamentov za kalcij in zavira fosfodiesterazo (tipa III).
Both tablet strengths are packaged in aluminium/aluminium blisters packaged into an outer cardboard box. 
Obe jakosti tablet sta pakirani v pretisnih omotih iz aluminija/aluminija in zunanji kartonski škatli.
The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol. 
Učinek pimobendana na povečanje krčljivosti srca je oslabljen v prisotnosti kalcijevega antagonista verapamila in antagonista β-receptorjev propranolola.
Any remaining half tablet should be placed back in the opened blister and stored (for a maximum of 1 day) in the original cardboard carton out of the sight and reach of children. 
Morebitno neuporabljeno polovico tablete vedno vrnite v prazen pretisni omot in shranite (za največ en dan) v originalni zunanji ovojnini na varnem mestu izven dosega otrok.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru: - zelo pogosti (med enim ciklom zdravljenja se pojavijo pri več kot 1 živali od 10 živali) - pogosti (pojavijo se pri 1 do 10 živalih od 100 živali) - občasni (pojavijo se pri 1 do 10 živalih od 1000 živali) - redki (pojavijo se pri 1 do 10 živalih od 10000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10000 živali, vključujoč posamezne primere)
The combination of FORTEKOR PLUS and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. 
Kombinacija zdravila FORTEKOR PLUS in drugih antihipertenzivnih zdravil (npr. zaviralcev kalcijevih kanalčkov, β-blokatorjev ali diuretikov), anestetikov ali pomirjeval lahko povzroči aditivne hipotenzivne učinke.
26 Rue de la Chapelle F-68330 Huningue 
Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue FRANCIJA
FORTEKOR PLUS is a fixed dose combination and should only be used in patients whose clinical signs are successfully controlled by administration of the same doses of the individual components (pimobendan and benazepril hydrochloride) given concurrently. 
FORTEKOR PLUS je kombinirano zdravilo in se sme uporabljati samo pri živalih, pri katerih klinične znake uspešno nadzorujemo s sočasnim dajanjem enakih odmerkov posameznih komponent (pimobendana in benazeprilijevega klorida).
4.4 Special warnings for each target species 
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary. 
Veterinar lahko priporoči pozorno spremljanje delovanja ledvic in znakov hipotenzije (letargija, slabost itd.) ter zdravljenje, če je potrebno.
Interactions with potassium-preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. 
Medsebojnega delovanja z diuretiki, ki zadržujejo kalij, kot so spironolakton, triamteren ali amilorid, ni mogoče izključiti.
The tablets are bilayered, oval, white and light brown, and can be divided into halves along the score line. 
Tablete so dvoplastne, ovalne, bele in svetlo rjave ter se lahko vzdolž zareze razpolovijo na enaka dela.
In dogs with congestive heart failure, benazepril hydrochloride and pimobendan have been given in combination with digoxin and diuretics without demonstrable adverse interactions. 
Psom s kongestivnim srčnim popuščanjem so dajali benazeprilijev klorid in pimobendan v kombinaciji z digoksinom in diuretiki brez dokazljivega neželenega medsebojnega delovanja.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister and carton after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na pretisnem omotu in škatli, za oznako »EXP«.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs. 
farmakokinetiki benazeprilata ni opazne razlike, če se benazeprilijev klorid daje nahranjenim ali teščim psom.
After the oral administration of FORTEKOR PLUS tablets at twice the recommended dose to dogs, peak levels of both compounds are attained rapidly (Tmax 0.5 h for benazepril hydrochloride and 0.85 h for pimobendan) with peak concentrations (Cmax) for benazepril hydrochloride of 35.1 ng/ml and 16.5 ng/ml for pimobendan. 
Po peroralni uporabi tablet FORTEKOR PLUS pri psih v dvakratnem priporočenem odmerku so najvišje koncentracije obeh spojin hitro dosežene (Tmax 0,5 ure za benazeprilijev klorid in 0,85 ure za pimobendan), z najvišjo koncentracijo (Cmax) benazeprilijevega klorida 35,1 ng/ml in najvišjo koncentracijo pimobendana 16,5 ng/ml.
Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal (kidney) failure. 
Ne uporabite pri hipotenziji (nizkem krvnem tlaku), hipovolemiji (premajhnem volumnu krvi), hiponatriemiji (nizki ravni natrija v krvi) ali akutni odpovedi ledvic.
Following oral administration of pimobendan alone the absolute bioavailability of the active ingredient is 60-63%. 
Po peroralni uporabi samega pimobendana je absolutna biološka uporabnost zdravilne učinkovine 6063 %.
The efficacy and safety of the product has not been established in dogs below 2.5 kg bodyweight or under 4 months of age. 
Učinkovitost in varnost zdravila nista bili ugotovljeni pri psih, lažjih od 2,5 kg ali mlajših od 4 mesecev.
In dogs with chronic kidney disease, benazepril may increase plasma creatinine concentrations at the start of therapy. 
Pri psih s kronično boleznijo ledvic lahko benazepril poveča plazemske koncentracije kreatinina na začetku zdravljenja.
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti ali laktacije
For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs. 
Za zdravljenje kongestivnega srčnega popuščanja zaradi insuficience atrioventrikularne zaklopke ali dilatativne kardiomiopatije pri psih.
In cases of chronic kidney disease, it is recommended to check the dog's hydration status before starting therapy, and to monitor its plasma creatinine and blood erythrocyte counts during therapy. 
V primerih kronične bolezni ledvic se priporoča, da pred začetkom zdravljenja preverite stanje hidracije psa ter da med zdravljenjem spremljate ravni kreatinina v plazmi in število eritrocitov v krvi.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
NAČIN IN POT(I) UPORABE
EU/2/15/185/001 (1 x 30 tablets, 1.25 mg/2.5 mg tablets) EU/2/15/185/002 (1 x 60 tablets, 1.25 mg/2.5 mg tablets) EU/2/15/185/003 (1 x 30 tablets, 5 mg/10 mg tablets) EU/2/15/185/004 (1 x 60 tablets, 5 mg/10 mg tablets) 
EU/2/15/185/0001 (1 x 30 tablet, 1,25 mg/2,5 mg tablete) EU/2/15/185/0002 (1 x 60 tablet, 1,25 mg/2,5 mg tablete) EU/2/15/185/0003 (1 x 30 tablet, 5 mg/10 mg tablete) EU/2/15/185/0004 (1 x 60 tablet, 5 mg/10 mg tablete)
The volume of distribution at steady state is 2.6 l/kg after intravenous administration of pimobendan alone, indicating that pimobendan is distributed readily into the tissues. 
Volumen porazdelitve v stanju dinamičnega ravnovesja je 2,6 l/kg po intravenskem dajanju samega pimobendana, kar kaže na to, da se pimobendan hitro porazdeli v tkiva.
It is not known if benazepril is secreted into the milk of lactating bitches. 
Ni znano, ali benazepril pri psicah v obdobju laktacije prehaja v mleko.
Laboratory studies in rats have shown that pimobendan is excreted into milk. 
Z laboratorijskimi študijami na podganah je bilo dokazano, da se pimobendan izloča z mlekom.
Each tablet contains 5 mg pimobendan and 10 mg benazepril hydrochloride. 
Vsaka tableta vsebuje 5 mg pimobendana in 10 mg benazeprilijevega klorida.
The tablets are breakable along the score line. 
Tablete se prelomijo vzdolž zareze.
Peak benazeprilat levels are seen after 1.9 h with peak concentrations (Cmax) of 43.4 ng/ml. 
Najvišje ravni benazeprilata so dosežene po 1,9 ure, ko je najvišja koncentracija (Cmax) 43,4 ng/ml.
In rare cases transient diarrhoea, anorexia or lethargy have been observed. 
V redkih primerih so opazili prehodno drisko, anoreksijo ali letargijo.
Body weight (kg) of dog 
Telesna masa psa (kg)
Pack Sizes 
Velikosti pakiranj
PHARMACEUTICAL FORM Tablets 
FARMACEVTSKA OBLIKA Tablete.
EU/2/15/185/001 (1 x 30 tablets, 1.25 mg/2.5 mg) EU/2/15/185/002 (1 x 60 tablets, 1.25 mg/2.5 mg) EU/2/15/185/003 (1 x 30 tablets, 5 mg/10 mg) 
EU/2/15/185/0001 (1 x 30 tablet, 1,25 mg/2,5 mg) EU/2/15/185/0002 (1 x 60 tablet, 1,25 mg/2,5 mg) EU/2/15/185/0003 (1 x 30 tablet, 5 mg/10 mg) EU/2/15/185/0004 (1 x 60 tablet, 5 mg/10 mg)
Pimobendan is oxidatively demethylated to its major active metabolite, O-desmethyl pimobendan. 
Pimobendan se oksidativno demetilira v glavni aktivni metabolit O-desmetilpimobendan.
The safety of FORTEKOR PLUS has not been tested in breeding, pregnant or lactating dogs. 
Varnost zdravila FORTEKOR PLUS ni bila preizkušena pri psih, ki so namenjeni za vzrejo ali so v obdobju brejosti ali laktacije.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure. 
Ne uporabite pri hipotenziji, hipovolemiji, hiponatriemiji ali akutni odpovedi ledvic.
FORTEKOR PLUS is a fixed combination product which should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose. 
FORTEKOR PLUS je kombinirano zdravilo, ki se sme uporabljati samo pri psih, ki potrebujejo sočasno zdravljenje z obema zdravilnima učinkovinama v takem odmerku.
In dogs with congestive heart failure benazepril hydrochloride reduces the blood pressure and volume load on the heart. 
Pri psih s kongestivnim srčnim popuščanjem benazeprilijev klorid znižuje krvni tlak in volumensko obremenitev srca.
Levels of benazepril decline quickly as the drug is partially metabolised by liver enzymes to benazeprilat. 
Ravni benazeprila upadajo hitro, ker jetrni encimi zdravilo delno presnovijo v benazeprilat.
In humans, the combination of ACE inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired kidney function. 
Pri ljudeh lahko kombinacija zaviralcev angiotenzinske konvertaze (ACE) in nesteroidnih protivnetnih zdravil (NSAID) vodi do zmanjšane antihipertenzivne učinkovitosti ali do okvare delovanja ledvic.
Do not use during pregnancy or lactation. 
Ne uporabite v obdobju brejosti ali laktacije.
As pimobendan is metabolised in the liver, the product should not be administered to dogs with severe hepatic insufficiency. 
Ker se pimobendan presnavlja v jetrih, se zdravila ne sme dajati psom s hudo okvaro jeter.
The plasma elimination half-life of pimobendan when dosed with FORTEKOR PLUS tablets is 0.5 h, consistent with the high clearance of the compound. 
Po odmerku tablet FORTEKOR PLUS je razpolovni čas izločanja pimobendana iz plazme 0,5 ure, kar je skladno z velikim očistkom učinkovine.
Do not use in case of hypersensitivity to pimobendan, to benazepril hydrochloride or to any ingredient of the tablets. 
Ne uporabite v primeru preobčutljivosti na pimobendan, benazeprilijev klorid ali katero koli pomožno snov v tabletah.
Therapy should consist of intravenous infusion(s) of warm isotonic saline as required. 
Terapija naj vključuje intravensko(e) infuzijo(e) tople fiziološke raztopine.
Interactions with other medicinal products and other forms of interaction: Inform the veterinary surgeon if the animal is taking, or has recently taken, any other medicines. 
Obvestite veterinarja, če žival dobiva ali je pred kratkim dobivala katero koli drugo zdravilo.
FORTEKOR PLUS is a combination of 2 active substances: pimobendan and benazepril hydrochloride. 
Farmakodinamične lastnosti FORTEKOR PLUS je kombinacija dveh zdravilnih učinkovin: pimobendana in benazeprilijevega klorida.
Pimobendan/Benazepril hydrochloride 
Pimobendan/benazeprilijev klorid
Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties. 
Pimobendan, derivat benzimidazol-piridazinona, je nesimpatikomimetična, neglikozidna inotropna učinkovina z močnimi vazodilatacijskimi lastnostmi.
The clearance of benazeprilat is not affected in dogs with impaired renal function; therefore no adjustment of the FORTEKOR PLUS dose is required in dogs with renal insufficiency. 
Pri psih z okvarami delovanja ledvic ni težav pri očistku benazeprilata, zaradi česar odmerka zdravila FORTEKOR PLUS v primeru ledvične insuficience ni treba prilagajati.
Laboratory studies in rats with benazepril have shown foetotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses. 
Z laboratorijskimi študijami z benazeprilom na podganah so bili dokazani fetotoksični učinki (malformacije sečil ploda) pri odmerkih, ki niso bili toksični za mater.
Laboratory studies in rats and rabbits with pimobendan have not shown any effect on fertility. 
Z laboratorijskimi študijami s pimobendanom na podganah in kuncih niso bili dokazani učinki na plodnost.
Silica, colloidal anhydrous Silicon dioxide anhydrous Sodium laurilsulfate Starch pregelatinised Succinic acid Sucrose 
Silicijev dioksid, brezvodni Natrijev lavrilsulfat Škrob, predgelirani Jantarna kislina Saharoza
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po uporabi si umijte roke.
Active substances: 
Zdravilni učinkovini:
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. 
Ne uporabite pri nezadostnem minutnem volumnu srca zaradi aortne ali pljučne stenoze.
Croscarmellose sodium Crospovidone 
Natrijeva kroskarmeloza Krospovidon
Laboratory studies in rats and rabbits with pimobendan have shown foetotoxic effects at maternotoxic doses. 
Z laboratorijskimi študijami s pimobendanom na podganah in kuncih so bili dokazani fetotoksični učinki pri uporabi odmerkov, toksičnih za mater.
Transient reversible hypotension (low blood pressure) may occur in accidental overdose. 
V primeru nenamernega prevelikega odmerjanja se lahko pojavi prehodna reverzibilna hipotenzija (nizek krvni tlak).
Pimobendan is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties. 
Pimobendan je nesimpatikomimetična, neglikozidna inotropna učinkovina z močnimi vazodilatacijskimi lastnostmi.
Benazepril increased the time to worsening of heart failure, and the time to death, improved clinical condition, reduced cough and improved exercise tolerance in dogs with symptomatic congestive heart failure caused by valvular disease or dilated cardiomyopathy. 
Pri psih s simptomatskim kongestivnim srčnim popuščanjem zaradi bolezni zaklopk ali dilatativne kardiomiopatije je benazepril podaljšal čas do poslabšanja srčnega popuščanja in čas do smrti, izboljšal splošno klinično stanje, zmanjšal kašelj ter izboljšal toleranco za telesno dejavnost.
A moderate positive chronotropic effect and vomiting may occur in rare cases. 
Pimobendan V redkih primerih se lahko pojavita zmeren pozitivni kronotropni učinek in bruhanje, vendar sta ta učinka odvisna od odmerka in se lahko preprečita z zmanjšanjem le-tega.
Pimobendan 
Kopovidon
The recommended dose range for FORTEKOR PLUS is 0.25-0.5 mg pimobendan per kg bodyweight and 0.5-1 mg benazepril hydrochloride per kg bodyweight divided into two daily doses. 
Priporočen razpon odmerkov zdravila FORTEKOR PLUS je 0,25 - 0,5 mg pimobendana na kg telesne mase in 0,5 - 1 mg benazeprilijevega klorida na kg telesne mase.
Benazeprilat is an inhibitor of ACE, thus reducing the blood pressure and volume load on the heart in dogs with congestive heart failure. 
Benazeprilat je zaviralec ACE in pri psih s kongestivnim srčnim popuščanjem znižuje krvni tlak in volumensko obremenitev srca.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
Transient reversible hypotension may occur in accidental overdose. 
V primeru nenamernega prevelikega odmerjanja se lahko pojavi prehodna reverzibilna hipotenzija.
It is therefore recommended to monitor plasma potassium levels when using FORTEKOR PLUS in combination with a potassium sparing diuretic because of the risk of hyperkalaemia. 
Pri uporabi zdravila FORTEKOR PLUS v kombinaciji z diuretikom, ki zadržuje kalij, je priporočljivo spremljanje ravni kalija v plazmi zaradi tveganja za hiperkaliemijo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
FORTEKOR PLUS 5 mg/10 mg tablets: 30 tablets or 60 tablets. 
FORTEKOR PLUS 5 mg/10 mg tablete: 30 ali 60 tablet.
Benazepril hydrochloride is a prodrug which is hydrolysed in vivo to its active metabolite, benazeprilat. 
Benazeprilijev klorid je predzdravilo, hidrolizirano in vivo v aktivni metabolit, benazeprilat.
FORTEKOR PLUS 1.25 mg/2.5 mg tablets: 30 tablets or 60 tablets. 
FORTEKOR PLUS 1,25 mg/2,5 mg tablete: 30 ali 60 tablet.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains 1.25 mg pimobendan and 2.5 mg benazepril hydrochloride. 
Vsaka tableta vsebuje 1,25 mg pimobendana in 2,5 mg benazeprilijevega klorida.
5 mg/10 mg tablets: pack sizes of 30 or 60 tablets. 
5 mg/10 mg tablete: velikosti pakiranj po 30 ali 60 tablet.
Benazepril hydrochloride is partially metabolised by liver enzymes to the active metabolite benazeprilat. 
Jetrni encimi benazeprilijev klorid delno presnovijo v aktivni metabolit benazeprilat.
1.25 mg/2.5 mg tablets: pack sizes of 30 or 60 tablets. 
1,25 mg/2,5 mg tablete: velikosti pakiranj po 30 ali 60 tablet.
The main active metabolite of pimobendan is eliminated with a plasma elimination half-life of 2.6 h. Pimobendan is excreted principally in the faeces and to a lesser extent in the urine. 
Pimobendan se izloča večinoma z blatom in v manjši meri z urinom.
- very rare (less than 1 animal in 10,000 animals, including isolated reports). 
- redki (pojavijo se pri 1 do 10 živalih od 10000 živali)
Strength and number of tablets to be administered FORTEKOR PLUS 1.25 mg/2.5 mg tablets 
Jakost in število odmerjenih tablet FORTEKOR PLUS 1,25 mg/2,5 mg tablete
Ask your veterinary surgeon or your pharmacist how to dispose of medicines no longer required. 
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
Special precautions for use in animals 
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih
NAME OF THE MARKETING AUTHORISATION HOLDER Elanco 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco
Benazepril hydrochloride 
Benazeprilijev klorid
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Elanco GmbHHeinz-Lohmann-Str. 4 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco GmbH
NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI FORTEKOR PLUS 1,25 mg/2,5 mg tablete za pse FORTEKOR PLUS 5 mg/10 mg tablete za pse
Your veterinary surgeon may therefore recommend the monitoring of plasma potassium concentrations when using FORTEKOR PLUS in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium). 
Zaradi tveganja za hiperkaliemijo (visoko raven kalija v krvi) lahko veterinar pri uporabi zdravila FORTEKOR PLUS v kombinaciji z diuretikom, ki zadržuje kalij, priporoči spremljanje plazemskih koncentracij kalija.
Elanco GmbH 
Imetnik dovoljenja za promet z zdravilom: Elanco GmbH
FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs 
NAVODILO ZA UPORABO FORTEKOR PLUS 1,25 mg/2,5 mg tablete za pse FORTEKOR PLUS 5 mg/10 mg tablete za pse
MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot
Artificial Special Dry Flavour Basic butylated methacrylate copolymer Copovidone 
Bazični butilmetakrilat, kopolimer
Polysorbate 80 
Celuloza, mikrokristalna Polisorbat 80
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 
- zelo redki (pojavijo se pri manj kot 1 živali od 10000 živali, vključujoč posamezne primere) Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Elanco France S.A.S 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije