FrancophonIA/ELRC3.0 huggingface dataset:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Danish: TEKSTEN “TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR
English: During the referral procedure it was noted that divergent national decisions on marketing authorisations have also been taken by Member States regarding the target species dogs where some Member States have authorised the product with an indication for renal failure.
Danish: Under henvisningsproceduren blev det konstateret, at der også er truffet divergerende nationale afgørelser om markedsføringstilladelse i medlemsstater, der anser måldyrearten for at være hunde, idet nogle medlemsstater har godkendt indikationen nyreinsufficiens.
English: In the pharmacovigilance data collected since the first authorisation of Fortekor for use in cats, the most frequently reported adverse events include emesis, lethargy, anorexia and diarrhoea.
Danish: I lægemiddelovervågningsdata indsamlet efter den første godkendelse af Fortekor til anvendelse hos katte var de hyppigst rapporterede bivirkninger emese, letargi, anoreksi og diarré.
English: The marketing authorisation holders were requested to provide, for the different strengths and formulations, proposals for harmonised product information and supportive data concerning the two target species which formed the basis for the CVMP opinion.
Danish: Indehaverne af markedsføringstilladelserne blev anmodet om for de forskellige styrker og formuleringer at fremsætte forslag til harmoniseret produktinformation samt understøttende data for de to måldyrearten, der var grundlag for CVMP's udtalelse.
English: Thus, no restrictions in the use of Fortekor in cats have been indicated, but it should be noted, however, that due to possible initial hypotensive effect of angiotensin converting enzyme inhibitor (ACEI) treatment, benazepril should not be administered to animals with hypotension, hypovolemia, hyponatremia or acute renal failure.
Danish: Der er derfor ikke indiceret begrænsninger i brugen af Fortekor til katte, men det skal bemærkes, at benazepril på grund af den mulige initiale hypotensive virkning af angiotensinkonvertasehæmmere (ACE-hæmmere) ikke bør administreres til dyr med hypotension, hypovolæmi, hyponatriæmi eller akut nyreinsufficiens.
English: Fortekor was initially authorised for use in dogs for the treatment of heart failure, but through national variation applications the treatment of chronic kidney disease (CKD) in cats has been added in several Member States (EU/EEA).
Danish: Fortekor blev oprindeligt godkendt til behandling af hunde for hjerteinsufficiens, men gennem nationale ændringsansøgninger er behandling af kronisk nyreinsufficiens hos katte blevet tilføjet i flere medlemsstater (EU/EØS).
English: Therefore the CVMP has recommended the variation of the marketing authorisations for which the summaries of product characteristics, labelling and package leaflets are set out in annex III for Fortekor and associated names as referred in annex I.
Danish: CHMP anbefalede derfor ændring af de markedsføringstilladelser, for hvilke produktresuméer, etikettering og indlægssedler fremgår af bilag III for Fortekor og relaterede navne (se bilag I).
English: In the tolerance studies, no significant or dose-related clinical signs of pathological findings were recorded apart from mild hypertrophy/hyperplasia of the juxtaglomerular cells in the kidneys after treatment with 10-20 times the recommended target dose.
Danish: I toleranceundersøgelserne blev der ikke registreret væsentlige eller dosisrelaterede kliniske tegn på patologiske fund bortset fra let hypertrofi/hyperplasi af nyrernes jukstaglomerulære celler efter behandling med 10-20 gange den anbefalede måldosis.
English: Safety data from clinical trials have not generated any findings that indicate the need for limitations in the use of Fortekor in cats, and this is reflected by pharmacovigilance data.
Danish: Sikkerhedsdataene fra de kliniske undersøgelser giver ikke anledning til begrænsninger i brugen af Fortekor hos katte, hvilket bekræftes af lægemiddelovervågningsdata.
English: The marketing authorisation holders have provided proposals for harmonized product information and data in support of treatment of cardiac as well as renal disorders.
Danish: Indehaverne af markedsføringstilladelserne har fremlagt forslag til harmoniseret produktinformation og data til støtte for behandlingen af såvel kardiale som renale sygdomme.
English: The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.
Danish: Behandlingen kan forbedre motionstolerancen og øge overlevelsen hos hunde med moderat til svært hjertesvigt.
English: However, the study supporting this opinion explored the effect from enalapril and an appropriate dose for treatment of CKD with benazepril has not been established1.
Danish: Den undersøgelse, der støtter den opfattelse, vedrørte imidlertid virkningen af enalapril, og der er ikke fastlagt en passende dosis ved behandling af kronisk nyreinsufficiens med benazepril1.
English: In principle, there are no risks identified that would lead to restrictions in the use of Fortekor in cats with CKD or dogs with heart failure other than those indicated in the product information with amendments.
Danish: I princippet er der ikke påvist risici, der kan medføre restriktioner i brugen af Fortekor til katte med kronisk nyreinsufficiens eller hunde med hjerteinsufficiens, ud over dem, der er angivet i produktinformationen som ændret.
English: 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.
Danish: En moderat øgning af plasma kreatinin koncentrationerne efter administration af ACE hæmmere er forenelig med reduktionen i glomerulær hypertension forårsaget af disse midler og er derfor ikke nødvendigvis en grund til at stoppe behandlingen, hvis der ikke er andre tegn.
English: Furthermore, a precaution regarding combination with non-steroidal anti-inflammatory drugs was regarded appropriate due to the risk connected to lowering the blood pressure in dogs with kidney disease.
Danish: Desuden blev det anset for passende med en forholdsregel vedrørende kombination med non-steroide antiinflammatoriske lægemidler på grund af den risiko, der er forbundet med at sænke blodtrykket hos hunde med nyreinsufficiens.
English: In this study, including 49 client owned dogs suffering from CKD, no effect was noted compared to placebo on survival (primary endpoint) or clinical signs neither for the entire group, nor for dogs stratified according to initial UPC > 0.5 (representing dogs with proteinuria).
Danish: I denne undersøgelse, der omfattede 49 privatejede hunde med kronisk nyreinsufficiens, blev der ikke konstateret nogen virkning i forhold til placebo på overlevelse (det primære endepunkt) eller kliniske tegn, hverken for hele gruppen eller for hunde stratificeret i henhold til initial UPC > 0,5 (dvs. hunde med proteinuri).
English: Proteinuria has in recent years been demonstrated as a prognostic factor for CKD in cats.
Danish: Proteinuri er i de senere år påvist at være en prognostisk faktor for kronisk nyreinsufficiens hos katte.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt
English: The expert group expressed some potential merits for ACEI treatment in case of proteinuria although no consensus exists regarding which clinical criteria would justify the initiation of treatment.
Danish: Ekspertgruppen nævnte nogle potentielle fordele af behandling med ACE-hæmmere ved proteinuri, skønt der ikke er konsensus om de kliniske kriterier, der bør kræves opfyldt ved iværksættelse af en sådan behandling.
English: An ad-hoc expert group (AHEG) was consulted regarding the scientific evidence base for ACEI in the treatment of chronic kidney disease in dogs.
Danish: En ad hoc-ekspertgruppe (AHEG) blev rådspurgt om det videnskabelige evidensgrundlag for ACEhæmmere til behandling af kronisk nyresygdom hos hunde.
English: Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
Danish: Det blokerer derfor effekterne medieret af angiotensin II og aldosteron, inklusiv vasokonstriktion af både arterier og vener, renal retention af natrium og vand og remodellerende effekter (inklusiv patologisk hjerte hypertrofi og degenerative renale ændringer).
English: Regarding the CKD in dogs, the data derived from the pivotal (and only) clinical trial and the additional bibliographic information does neither provide sufficient information to conclude on an appropriate dose nor adequate support for a beneficial effect during clinical use.
Danish: Hvad angår kronisk nyreinsufficiens hos hunde, kan der af den kliniske (og eneste) hovedundersøgelse og de supplerende bibliografiske oplysninger hverken uddrages tilstrækkelige oplysninger til at fastlægge en passende dosis eller tilstrækkelig støtte for en gavnlig virkning ved klinisk brug.
English: Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks.
Danish: Benazepril reducerede ovarie/æggeleder vægten hos katte, når det blev administreret med 10 mg/kg/dag i 52 uger.
English: According to the expert group there is some (although limited) scientific evidence for effect of ACEI for treatment of dogs with proteinuria.
Danish: Ifølge ekspertgruppen er der nogen (omend begrænset) videnskabelig evidens for virkningen af ACE-hæmmere til behandling af hunde med proteinuri.
English: Transient reversible hypotension may occur in cases of accidental overdose.
Danish: Forbigående reversibel hypotension kan forekomme i tilfælde af utilsigtet overdosering.
English: Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is >1.
Danish: Kat: Forsøgsvis for at reducere proteinuri i kronisk nyresvigt hvor protein/kreatinin ratio >1
English: Interactions with potassium-preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out.
Danish: Interaktioner med kaliumsparende diuretika såsom spironolakton, triamteren eller amilorid kan ikke udelukkes.
English: The indication should accommodate the fact that the effect to be expected is likely postponement of disease development whereas cure is not to be expected.
Danish: Af indikationen bør det fremgå, at virkningen kan forventes at bestå i bremsning af sygdommens udvikling, men ikke i helbredelse.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients To be completed nationally.
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Udfyldes nationalt
English: In the absence of sufficient data in cats (and dogs), it cannot be ruled out that benazepril treatment during pregnancy could be potentially harmful.
Danish: I mangel af tilstrækkelige data for katte (og hunde) kan potentielt skadelige virkninger af behandling med benazepril i drægtighedsperioden ikke udelukkes.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, indications, marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), dyrearter, indikationer, indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: “Product name” (to be completed nationally) reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) reducerer blodtrykket og fyldningsgraden af hjertet i hunde med kongestivt hjertesvigt.
English: SPECIAL STORAGE CONDITIONS To be completed nationally.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Vil blive udfyldt nationalt
English: Furthermore, ACEI treatment is contraindicated during pregnancy and lactation.
Danish: Desuden er ACE-hæmmere kontraindiceret under drægtighed og diegivning.
English: Special precautions for use in animals
Danish: Specielle advarsler for brug til dyr
English: Benefit assessment
Danish: Benefit-vurdering
English: A precaution in line with this conclusion should be added to the product information to reduce the risk when treating dogs with heart failure and concomitant kidney disease.
Danish: En forholdsregel i overensstemmelse med denne konklusion bør indsættes i produktinformationen for at mindske risikoen ved behandling af hunde med hjerteinsufficiens og ledsagende nyreinsufficiens.
English: Pre-existing conditions resulting in decreased renal perfusion should be corrected before ACEI treatment is initiated since ACEI can cause acute renal failure in these cases when angiotensin II-dependent glomerular filtration is blocked.
Danish: Præeksisterende sygdom forårsaget af den nedsatte renale perfusion bør korrigeres før påbegyndelse af behandling med en ACE-hæmmer, da ACE-hæmmere i sådanne tilfælde kan medføre akut nyreinsufficiens ved blokering af den angiotensin II-afhængige glomerulære filtration.
English: Additional precautions to be completed nationally if needed.
Danish: Yderligere instruktioner vil blive udfyldt nationalt hvis nødvendigt.
English: The appropriate harmonised indication should be “Treatment of congestive heart failure in dogs”.
Danish: Den harmoniserede indikation bør være "Behandling af kongestiv hjerteinsufficiens hos hunde".
English: Some dogs with congestive heart failure may exhibit vomiting or fatigue during treatment.
Danish: Nogle hunde med kongestivt hjertesvigt kan få opkastning eller udvise træthed under behandling.
English: The Netherlands
Danish: The Holland
English: Diuretics and/or antiarrhythmics may be used with benazepril when judged appropriate by the veterinarian, but whenever it is thought to be appropriate benazepril alone may be used.
Danish: Diuretika og/eller antiarrytmika kan bruges sammen med benazepril når det skønnes af den behandlende dyrlæge, men benazepril kan bruges alene når dette skønnes.
English: “Product name” (to be completed nationally) also increased the appetite of the cats, particularly in more advanced cases.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) øgede også appetitten hos kattene specielt i mere fremskredne tilfælde.
English: Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care.
Danish: Derfor bør samtidig brug af NSAIDer og anden medicin med hypotensiv virkning overvejes nøje.
English: The AHEG agreed that there is no evidence available in public literature to support the use of ACEI in the treatment of dogs with CKD in general and neither the scientific literature nor clinical experience would clearly provide evidence of the efficacy in ACEI in the treatment of all dogs with CKD.
Danish: I AHEG var der enighed om, at der i den publicerede litteratur generelt ikke er dokumentation, der støtter brugen af ACE-hæmmere til behandling af hunde med kronisk nyresygdom, og at der hverken af den videnskabelige litteratur eller af erfaringerne fra klinikken kan uddrages klar evidens for virkningen af ACE-hæmmere til behandling af alle hunde med kronisk nyreinsufficiens.
English: In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Danish: I tilfælde af utilsigtet indtagelse, søg straks læge og vis etiketten eller indlægssedlen til lægen.
English: Transient reversible hypotension (low blood pressure) may occur in cases of accidental overdose.
Danish: Forbigående reversibel hypotension (lavt blodtryk) kan opstå i tilfælde af utilsigtet overdosering.
English: Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal failure.
Danish: Må ikke anvendes i tilfælde af hypotension (lavt blodtryk), hypovolæmi (lavt blodvolumen), hyponatriæmi (lavt natriumindhold i blodet) eller akut nyresvigt.
English: It was emphasized that ACEI treatment should not be employed to any dog with unstable stage 4 kidney disease due to the risk for reduced glomerular filtration rate or worsening azotemia.
Danish: Det blev understreget, at ACE-hæmmere ikke bør anvendes til hunde med ustabil nyresygdom i stadie 4 på grund af risiko for nedsat glomerulær filtration eller forværring af azotæmi.
English: In cases of chronic kidney disease, your veterinarian will check the hydration status of your pet before starting therapy, and may recommend that regular blood tests are carried out during therapy in order to monitor plasma creatinine concentrations and blood erythrocyte counts.
Danish: I tilfælde af kronisk nyrelidelse vil dyrlægen undersøge væskestatus på dyret før behandling startes og måske anbefale, at der tages regelmæssige blodprøver under behandlingen for at følge plasma kreatinin koncentrationen og blod erytrocyttallet.
English: Dogs: Treatment of heart failure at stages 2,3 and 4.
Danish: Hund: Behandling af hjertesvigt i stadie 2, 3 og 4.
English: Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Danish: Bør ikke anvendes i tilfælde af svigtende cardiac output på grund af aorta- eller pulmonalstenose.
English: The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs) and first pass metabolism.
Danish: Den systemiske biotilgængelighed er ufuldstændig (~13 % i hunde), hvilket skyldes ufuldstændig absorption (38 % i hunde) og first pass metabolisme.
English: Special warnings for dogs and cats
Danish: Specielle advarsler for hunde og katte
English: Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses.
Danish: Embryotoksiske virkninger (føtal urinvejsmisdannelse) blev set i forsøg med laboratoriedyr (rotter) ved doser, der ikke er maternelt toksiske.
English: Novartis Veterina d.o.o.
Danish: Slovenien Novartis Veterina d.o.o.
English: No considerable deviations in pharmacokinetics of benazepril were noted after long-term treatment or in cats with renal insufficiency, and no adjustment of dose is therefore necessary.
Danish: Der sås ingen nævneværdige afvigelser i farmakokinetikken af benazepril efter langtidsbehandling eller hos katte med nyreinsufficiens, hvorfor dosisjustering ikke er nødvendig.
English: No data have been presented that clearly demonstrate benefit of benazepril treatment of cats with CKD on survival.
Danish: Der er ikke fremlagt data, der klart viser forbedret overlevelse ved behandling med benazepril af katte med kronisk nyreinsufficiens.
English: The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.
Danish: Den systemiske biotilgængelighed er ufuldstændig (~13 % i hunde), hvilket skyldes ufuldstændig absorption (38 % i hunde, <30 % i katte) og first pass metabolisme.
English: Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats.
Danish: Opkastning, anorexi, dehydrering, sløvhed og diarre er i sjældne tilfælde blevet rapporteret hos katte.
English: Data with regard to efficacy of benazepril treatment was obtained from one extensive pivotal clinical field trial including 193 client owned cats with spontaneous CKD.
Danish: Data vedrørende virkningen af behandling med benazepril fremgår af én omfattende klinisk hovedfeltundersøgelse, der omfattede 193 privatejede katte med spontan kronisk nyreinsufficiens.
English: Do not use in case of hypersensitivity to the active substance benazepril hydrochloride or to any ingredient of the tablets.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof benazeprilhydrochlorid eller nogen af indholdsstofferne i tabletten.
English: <Manufacturer for the batch release:> To be completed nationally
Danish: <Fremstiller af batchfrigivelse:> Vil blive udfyldt nationalt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
English: Repeated administration of “product name” (to be completed nationally) leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs and R=1.36 in cats with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).
Danish: Gentagen administration af ”Produkt navn” (vil blive udfyldt nationalt) fører til let bioakkumulation af benazeprilat (R=1,47 i hunde og R=1,36 i katte med 0,5 mg/kg), og steady state opnås inden for få dage (4 dage i hunde).
English: The product is authorised for the treatment of heart failure in dogs and in some Member States for treatment of chronic kidney disease in cats and dogs.
Danish: Produktet er godkendt til behandling af hjerteinsufficiens hos hunde og, i nogle medlemsstater, til behandling af kronisk nyreinsufficiens hos katte og hunde.
English: It is recommended to monitor plasma potassium levels when using “product name” (to be completed nationally) in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Danish: Det anbefales at monitorere plasma kalium niveauer, når der anvendes ”Produkt navn” (vil blive udfyldt nationalt) i kombination med et kaliumsparende diuretika på grund af risikoen for hyperkalæmi.
English: Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child during pregnancy in humans.
Danish: Gravide kvinder bør være særligt omhyggelige med at undgå utilsigtet indtagelse, da ACE hæmmere har vist sig at kunne påvirke det ufødte barn under graviditet hos mennesker.
English: No effect of “Product name” (to be completed nationally) on survival in cats with CKD has been shown, but “Product name” (to be completed nationally) increased the appetite of the cats, particularly in more advanced cases.
Danish: Der er ikke vist nogen effekt af ”Produkt navn” (vil blive udfyldt nationalt) på overlevelsen i katte med CDK, men ”Produkt navn” (vil blive udfyldt nationalt) øgede appetitten hos kattene, specielt i mere fremskredne tilfælde.
English: The appropriate harmonised indication should be “Reduction of proteinuria associated with chronic kidney disease”.
Danish: Den harmoniserede indikation bør være "Reduktion af proteinuri ved kronisk nyreinsufficiens".
English: 4.2 Indications for use, specifying the target species Dogs:
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Hunde:
English: Due to this a precaution for treatment of dogs with heart failure and concomitant uncontrolled kidney disease should be added to the product information.
Danish: Derfor bør en forholdsregel vedrørende behandling af hunde med hjerteinsufficiens og ledsagende ukontrolleret nyreinsufficiens indsættes i produktinformationen.
English: This in combination with the collected body of data presented in bibliographic references and an increased experience among experts as well as extensive use of benazepril in treatment of CKD in cats indicate that treatment with ACEI is beneficial in cases of CKD in cats with persistent renal proteinuria.
Danish: Sammen med data fra bibliografiske kilder, de øgede erfaringer hos eksperter og omfattende brug af benazepril til behandling af kronisk nyreinsufficiens hos katte peger dette på, at behandling med ACE-hæmmere er gavnlig ved kronisk nyreinsufficiens hos katte med persisterende renal proteinuri.
English: Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys.
Danish: Reduktion af glomerulær hypertension kan forsinke progressionen af nyrelidelse ved hæmning af yderligere skade på nyrerne.
English: “Product name” (to be completed nationally) may increase food consumption and body weight in cats.
Danish: ”Produkt navn” (vil blive udfyldt nationalt) kan øge foderindtagelsen og kropsvægten hos katte.