FrancophonIA/ELRC3.0 huggingface dataset:
English: In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function.
Danish: Hos mennesker kan kombinationen af ACE-hæmmere og non-steroide antiinflammatorika (NSAIDer) lede til reduceret anti-hypertensiv virkning eller svækket renal funktion.
English: However, benazepril treatment of dogs with unstable kidney disease involves an increased risk for deterioration of renal function due to the reduction of peripheral blood pressure leading to a decline in glomerular filtration rate and worsening azotemia.
Danish: Anvendelse af benazepril hos hunde med ustabil nyreinsufficiens indebærer imidlertid øget risiko for forværring af nyrefunktionen som følge af reduktionen af det perifere blodtryk, der medfører et fald i den glomerulære filtrationshastighed og dermed forværring af azotæmien.
English: In double-blind clinical trials in dogs with congestive heart failure, “product name” (to be completed nationally) was well tolerated with an incidence of adverse reactions lower than observed in placebotreated dogs.
Danish: I dobbeltblinde kliniske afprøvninger hos hunde med kongestivt hjertesvigt, var ”Produkt navn” (vil blive udfyldt nationalt) vel tolereret med en hyppighed af bivirkninger, der var lavere end hos hunde, der var blevet behandlet med placebo.
English: The duration of treatment is unlimited.
Danish: Behandlingen er livslang.
English: Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin
Danish: Hund Behandling af hjertesvigt hos hund, også sammen med diuretikummet furosemid og /eller det antiarrytmiske middle digoxin.
English: Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary.
Danish: Din dyrlæge vil måske anbefale, at nyrefunktionen og andre tegn på lavt blodtryk (sløvhed, svaghed osv) følges nøje og behandles hvis nødvendigt.
English: In consideration of the fact that sufficient information to support efficacy during treatment of chronic kidney disease in dogs has not been presented, no information on appropriate dose for this condition is available and treatment of CKD is connected to particular risks, the benefit-risk balance for treatment of dogs with chronic kidney disease was regarded as negative.
Danish: Da der ikke er fremlagt tilstrækkelige oplysninger til støtte for virkningen ved behandling af kronisk nyreinsufficiens hos hunde, foreligger der ikke oplysninger om en passende dosis ved denne sygdom, og da behandling af kronisk nyreinsufficiens er forbundet med særlige risici, blev benefit/risk forholdet for behandling af hunde med kronisk nyreinsufficiens anset for at være negativt.
English: Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours in dogs and t1/2=2.4 hours in cats) represents elimination of free drug, while the terminal phase (t1/2=19 hours in dogs and t1/2=29 hours in cats) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Danish: Benazeprilat koncentrationer aftager bifasisk: den initiale fase (t1/2=1,7 timer i hunde og t1/2 =2,4 timer i katte) repræsenterer eliminering af frit stof, mens den terminale fase (t1/2=19 timer i hunde og t1/2=29 timer i katte) afspejler frigivelsen af benazeprilat bundet til ACE hovedsageligt i vævet.
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only.
Danish: UDLEVERING OG BRUG, OM NØDVENDIGT Til dyr
English: However, a precaution regarding use in dogs with instable kidney disease should be added to the product information since Fortekor treatment of dogs with heart failure and concomitant instable kidney disease could further deteriorate renal function.
Danish: Der bør imidlertid indsættes en forholdsregel vedrørende behandling af hunde med ukontrolleret nyreinsufficiens i produktinformationen, da anvendelse af Fortekor hos hunde med hjerteinsufficiens og ledsagende ustabil nyreinsufficiens kan medføre yderligere forringelse af nyrefunktionen.
English: Given that in principle no risks has been identified during treatment of dogs that would restrict the use and furthermore, that sufficient support for efficacy is available the benefit-risk balance is regarded positive for Fortekor for the following indication in dogs: “Treatment of congestive heart failure in dogs”.
Danish: Da der ved behandling af hunde i princippet ikke er påvist risici, der bør medføre en begrænsning i anvendelsen, og da der desuden foreligger tilstrækkelig støtte for virkningen, anses benefit/riskforholdet for Fortekor for at være positivt ved følgende indikation hos hunde: "Behandling af kongestiv hjerteinsufficiens hos hunde".
English: Tablets for dogs
Danish: Tabletter til hund
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Vil blive udfyldt nationalt
English: Do not use in pregnant or lactating dogs or cats because the safety of benazepril hydrochloride has not been established during pregnancy or lactation in these species.
Danish: Må ikke anvendes til drægtige eller diegivende hunde eller katte, da sikkerheden af benazepril hydrochlorid ikke er blevet fastlagt under drægtighed eller diegivning hos disse arter.
English: In cats and dogs with chronic kidney disease, “product name” (to be completed nationally) may increase plasma creatinine concentrations at the start of therapy.
Danish: Hos katte og hunde med kronisk nyrelidelse, kan ”Produkt navn” (vil blive udfyldt nationalt) øge plasma kreatinin koncentrationerne i starten af behandlingen.
English: By the use of an experimental model with nephrectomised cats, chronic treatment with benazepril lowered glomerular capillary pressure, raised glomerular ultrafiltration coefficient, sustained single nephron Glomerular Filtration Rate (GFR) in remnant nephrons and reduced systemic hypertension.
Danish: I forsøgsmodeller med nefrektomerede katte mindskede kronisk behandling med benazepril det glomerulære kapillærtryk, øgede den glomerulære ultrafiltrationskoefficient, bevarede det enkelte nefrons glomerulære filtrationshastighed (GFR) for de tilbageværende nefroner og mindskede den systemiske hypertension.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller nogen af indholdsstofferne.
English: Do not use during pregnancy or lactation.
Danish: Må ikke bruges under drægtighed og diegivning.
English: DATE OF REVISION OF THE TEXT To be completed nationally.
Danish: DATO FOR ÆNDRING AF TEKSTEN Udfyldes nationalt
English: One clinical field trial was submitted to support effect of benazepril treatment of dogs with CKD.
Danish: Der blev fremlagt ét klinisk feltforsøg til støtte for virkningen af benazepril til behandling af hunde med kronisk nyreinsufficiens.
English: Given that no risks has been identified during treatment of cats that would restrict the use and furthermore, that sufficient support for efficacy is available, the benefit-risk balance is regarded positive for Fortekor for the following indication in cats: “Reduction of proteinuria associated with chronic kidney disease”.
Danish: Da der ved behandling af katte ikke er påvist risici, der bør medføre en begrænsning i anvendelsen, og da der desuden foreligger tilstrækkelig støtte for virkningen, anses benefit-risk forholdet for Fortekor for at være positivt ved følgende indikation hos katte: "Reduktion af proteinuri ved kronisk nyreinsufficiens".
English: To be completed nationally
Danish: Vil blive udfyldt nationalt
English: In dogs with chronic kidney disease, “product name” (to be completed nationally) may increase plasma creatinine concentrations at the start of therapy.
Danish: Hos hunde med kronisk nyrelidelse, kan ”Produkt navn” (vil blive udfyldt nationalt) øge plasma kreatinin koncentrationerne i starten af behandlingen.
English: To be completed nationally.
Danish: Vil blive udfyldt nationalt.
English: Data from clinical trials in conjunction with bibliographic information and experience of clinical experts is regarded to sufficiently support that benazepril treatment is beneficial for cats with CKD and proteinuria.
Danish: Data fra kliniske undersøgelser i forbindelse med bibliografiske oplysninger og erfaringer gjort af kliniske eksperter anses som tilstrækkeligt grundlag for den gavnlige virkning af benazepril hos katte med kronisk nyreinsufficiens og proteinuri.
English: Your veterinary surgeon may recommend to monitor plasma potassium concentrations when using “product name” (to be completed nationally) in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium).
Danish: Din dyrlæge vil måske anbefale, at følge plasma kalium koncentationer, når ”Produkt navn” (vil blive udsfyldt nationalt) anvendes i kombination med kaliumsparende diuretika på grund af risikoen for hyperkalæmi (højt blod kalium).
English: It is prescribed by the veterinary surgeon for the treatment of congestive heart failure in dogs and for reduction of proteinuria associated with chronic kidney disease in cats.
Danish: Det er ordineret af dyrlægen til behandling af kongestivt hjertesvigt hos hunde og til reduktion af proteinuri i forbindelse med kronisk nyresygdom hos katte.
English: “Product name” (to be completed nationally) reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months and in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in cats or dogs.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) reducerede erytrocyttallene i normale katte, når det blev doseret med 10 mg/kg en gang dagligt i 12 måneder og i normale hunde, når det blev doseret med 150 mg/kg en gang dagligt i 12 måneder, men denne virkning blev ikke observeret ved den anbefalede dosis ved kliniske afprøvninger i katte eller hunde.
English: Vomiting, poor appetite, dehydration, lethargy and diarrhoea have been reported on rare occasions in cats.
Danish: I sjældne tilfælde har opkastning, dårlig appetit, dehydrering, sløvhed og diarre været rapporteret hos katte.
English: Pharmacotherapeutic group: ACE Inhibitors, plain.
Danish: Farmakoterapeutisk gruppe: ACE-hæmmere, almindelig.
English: “Product name” (to be completed nationally) reduced erythrocyte counts in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in dogs.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) reducerede erytrocyttallene i normale hunde, når det blev doseret med 150 mg/kg en gang dagligt i 12 måneder, men denne virkning blev ikke observeret ved den anbefalede dosis ved kliniske afprøvninger i hunde.
English: Reduction of proteinuria associated with chronic kidney disease.
Danish: Reduktion af proteinuri associeret med kronisk nyrelidelse.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Læs indlægssedlen før brug
English: No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or cats) during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Der er ikke observeret nogen tegn på renal toksicitet (hos hunde eller katte) i kliniske afprøvninger, dog anbefales det, som det er rutine i tilfælde med kronisk nyrelidelse, at monitorere plasma kreatinin, urea og erytrocyttal under behandling.
English: In contrast with other ACE inhibitors, benazeprilat is excreted equally by both biliary and urinary routes in dogs and 85% via the biliary and 15% via the urinary route in cats, and therefore no adjustment of the dose of “product name” (to be completed nationally) is necessary in the treatment of cases with renal insufficiency.
Danish: I modsætning til andre ACE-hæmmere udskilles benazeprilat ligeligt via fæces og urin hos hunde og 85 % via fæces og 15 % via urin hos katte, og derfor er det ikke nødvendigt at reducere dosis af ”Produkt navn” (vil blive udfyldt nationalt) i tilfælde med nyre insufficiens.
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) Vil blive udfyldt nationalt
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products To be completed nationally.
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs and 85% via the biliary and 15% via the urinary route in cats.
Danish: 54 % af benazeprilat udskilles biliært, og 46 % udskilles renalt hos hunde, og 85 % udskilles biliært og 15 % renalt hos katte.
English: In dogs, peak benazeprilat concentrations (Cmax of 37.6 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.25 hours.
Danish: I hunde opnås makskoncentration af benazeprilat (Cmax på 37,6 ng/ml efter en dosis på 0,5 mg/kg benazeprilhydrochlorid) med en Tmax på 1,25 timer.
English: For cats over 2.5 kg Treatment of chronic renal insufficiency
Danish: Til katte over 2.5 kg Behandling af kronisk nyreinsufficiens
English: 2100 Kööpenhamina Tanska
Danish: 2100 Kööpenhamina Danmark
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Danish: Benazeprilhydrochlorid er et prodrug, som in vivo hydrolyseres til dets aktive metabolit, benazeprilat.
English: Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs.
Danish: 54 % af benazeprilat udskilles biliært, og 46 % udskilles renalt hos hunde.
English: After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs and within 2 hours in cats) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat.
Danish: Efter oral administration af benazepril hydrochlorid nås makskoncentration af benazepril hurtigt (Tmax 0,5 time i hunde og inden for 2 timer i katte) og aftager hurtigt, eftersom stoffet delvist metaboliseres af leverenzymer til benazeprilat.
English: Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours in dogs) represents elimination of free drug, while the terminal phase (t1/2=19 hours in dogs) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Danish: Benazeprilat koncentrationer aftager bifasisk: den initiale fase (t½=1,7 timer i hunde) repræsenterer eliminering af frit stof, mens den terminale fase (t½=19 timer i hunde) afspejler frigivelsen af benazeprilat bundet til ACE hovedsageligt i vævet.
English: In humans, the combination of ACE inhibitors and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) can lead to reduced anti-hypertensive efficacy or impaired kidney function.
Danish: Hos mennesker kan kombinationen af ACE-hæmmere og NSAIDer (Non-Steroidal Anti-Inflammatory Drugs) føre til reduceret blodtrykssænkende virkning eller svækket nyrefunktion.
English: ADVICE ON CORRECT ADMINISTRATION To be completed nationally if needed.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Udfyldes nationalt hvis nødvendigt.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Danish: DATO FOR SENESTE REVISION AF INDLÆGSSEDLEN Vil blive udfyldt nationalt.
English: “Product name” (to be completed nationally) causes long-lasting inhibition of plasma ACE activity in dogs and cats, with more than 95% inhibition at peak effect and significant activity (>80% in dogs and >90% in cats) persisting 24 hours after dosing.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) forårsager langvarig hæmning af plasma ACE aktivitet i hunde og katte med mere end 95 % hæmning ved maksimum effekt og signifikant aktivitet (>80 % i hunde og >90 % i katte), der vedvarer 24 timer efter dosering.
English: In cats, peak benazeprilat concentrations (Cmax of 77.0 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 2 hours.
Danish: I katte opnås makskoncentration af benazeprilat (Cmax på 77,0 ng/ml efter en dosis på 0,5 mg/kg benazeprilhydrochlorid) med en Tmax på 2 timer.
English: After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat.
Danish: Efter oral administration af benazeprilhydrochlorid nås makskoncentration af benazepril hurtigt (tmax 0,5 time i hunde) og aftager hurtigt, eftersom stoffet delvist metaboliseres af leverenzymer til benazeprilat.
English: PACKAGE SIZE To be completed nationally.
Danish: PAKNINGSSTØRRELSE Udfyldes nationalt
English: Treatment of congestive heart failure.
Danish: Behandling af kongestivt hjertesvigt.
English: The combination of “product name” (to be completed nationally) and other anti-hypertensive agents (e.g. calcium channel blockers, blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects.
Danish: Kombinationen af ”Produkt navn” (vil blive udfyldt nationalt) og andre anti-hypertensive midler (f.eks. calcium kanal blokkere, β-blokkere eller diuretika), anæstetika eller sedativer kan føre til øgede hypotensive virkninger.
English: 20 mg Tablets
Danish: 20 mg Tabletter
English: In dogs and cats with chronic kidney disease there may be a moderate increase in levels of creatinine, an indicator of kidney function, in the blood.
Danish: Hos hunde og katte med kronisk nyrelidelse kan der være en moderat stigning i niveauet af kreatinin i blodet, hvilket er en indikator på nyrefunktionen,.
English: 6.5 Nature and composition of immediate packaging To be completed nationally.
Danish: 6.5 Den indre emballagens art og indhold
English: <Marketing authorisation holder <and manufacturer>>: To be completed nationally
Danish: <Indehaver af markedsføringstilladelsen <og fremstiller af batchfrigivelse>: Vil blive udfyldt nationalt
English: In dogs with chronic kidney disease there may be a moderate increase in levels of creatinine, an indicator of kidney function, in the blood.
Danish: Hos hunde med kronisk nyrelidelse kan der være en moderat stigning i niveauet af kreatinin i blodet, hvilket er en indikator på nyrefunktionen.
English: “Product name” (to be completed nationally) causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80% in dogs) persisting 24 hours after dosing.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) forårsager langvarig hæmning af plasma ACE aktivitet i hunde med mere end 95 % hæmning ved maksimum effekt og signifikant aktivitet (>80 % i hunde), der vedvarer 24 timer efter dosering.
English: The dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary surgeon.
Danish: Dosis kan fordobles, stadig administreret en gang dagligt, til en minimumsdosis på 0,5 mg/kg (fra 0,5-1,0), hvis det vurderes klinisk nødvendigt og anbefales af dyrlægen.
English: For reduction of proteinuria associated with chronic kidney disease in cats.
Danish: Til reduktion af proteinuri i forbindelse med kronisk nyrelidelse hos katte.
English: Dogs and cats
Danish: Hund og kat
English: Tablets for cats and dogs
Danish: Tabletter til hunde og katte
English: In dogs with congestive heart failure, “product name” (to be completed nationally) has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions.
Danish: I hunde med kongestivt hjertesvigt, er ”Produkt navn” (vil blive udfyldt nationalt) blevet givet sammen med digoxin, diuretika, pimobendan og anti-arytmika uden påviselige bivirkninger.
English: The efficacy and safety of “product name” (to be completed nationally) has not been established in dogs below 2.5 kg body weight.
Danish: Virkningen og sikkerheden af ”Produkt navn” (vil blive udfyldt nationalt) er ikke blevet fastlagt i hunde på under 2,5 kg.
English: 2,5 mg Tablets
Danish: 2,5 mg Tabletter
English: In dogs with congestive heart failure, “product name” (to be completed nationally) has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic products without evidence of associated adverse reactions.
Danish: I hunde med kongestivt hjertesvigt er ”Produkt navn” (vil blive udfyldt nationalt) blevet givet samtidig med digoxin, diuretika, pimobendan og anti-arytmika uden bevis på associerede bivirkninger.
English: “Product name” (to be completed nationally) tablets are flavoured and are taken voluntarily by most dogs and cats.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) tabletter er tilsat smag og indtages frivilligt af de fleste hunde og katte.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Specielle advarsler for de personer der administrerer det veterinærmedicinske produkt til dyr Vask hænder efter brug.
English: For dogs over 20 kg Treatment of heart failure
Danish: Hund Til hunde over 20 kg Behandling af hjertesvigt
English: Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that “Product name” (to be completed nationally) significantly reduced levels of urine protein and urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
Danish: Placebokontrollerede kliniske feltstudier i katte med kronisk nyrelidelse (CKD) har demonstreret, at ”Produkt navn” (vil blive udfyldt nationalt) signifikant reducerer niveauerne af urin protein og urin protein/kreatinin forholdet (UPC); denne effekt er sandsynligvis medieret via reduceret glomerulær hypertension og gavnlig effekt på den glomerulære basalmembran.
English: “Product name” (to be completed nationally) tablets are flavoured and are taken voluntarily by most dogs.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) tabletter er tilsat smag og tages frivilligt af de fleste hunde.
English: Benazeprilat is a highly potent and selective inhibitor of the angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Danish: Benazeprilat er en stærkt potent og selektiv hæmmer af angiotensin konverterende enzym (ACE) og forhindrer således omdannelsen af inaktivt angiotensin I til aktivt angiotensin II og reducerer derved også dannelsen af aldosteron.
English: In a clinical trial in cats with chronic kidney disease, “Product name” (to be completed nationally) significantly reduced protein loss in the urine; this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
Danish: I et klinisk forsøg på katte med kronisk nyrelidelse reducerede ”Produkt navn” (vil blive udfyldt nationalt) signifikant protein tabet i urinen; denne effekt er sandsynligvis medieret via reduceret glomerulær hypertension og gavnlig effekt på den glomerulære basalmembran.
English: Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.
Danish: Hund: Symptomatisk terapi sammen med furosemid ved behandling af hjertesvigt forårsaget af mitralklapinsufficiens eller kongestiv cardiomyopati.
English: 4.5 Special precautions for use
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen til dyr