FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MARKETING AUTHORISATION HOLDER NOVARTIS
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM NOVARTIS
English: • the CVMP considered the primary scope of the referral regarding the efficacy of the product for the treatment of renal disorders in cats and dogs;
Slovenian: • CVMP ocenil primarni obseg napotitvenega postopka glede učinkovitosti zdravila za zdravljenje bolezni ledvic pri mačkah in psih;
English: Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Slovenian: Delovanje ledvic in znake hipotenzije (letargija, slabost itd.) je treba skrbno spremljati in jih po potrebi zdraviti.
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.
Slovenian: Diuretiki in/ali antiaritmiki se lahko uporabijo skupaj z benazeprilom, če je to ustrezno ocenjeno s strani veterinarja, vendar se lahko uporabi tudi sam benazepril, kadarkoli je to ustrezno.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da za različne jakosti in formulacije predloži predloge za usklajeno besedilo informacij o zdravilu in podporne podatke glede dveh ciljnih živalskih vrst, ki sta predstavljali osnovo za mnenje CVMP.
English: DATE OF REVISION OF THE TEXT To be completed nationally.
Slovenian: DATUM REVIZIJE BESEDILA Dopolniti na nacionalni ravni.
English: • the CVMP reviewed the summaries of products characteristics, labelling and package leaflets proposed by the marketing authorisation holders and considered all the overall submitted data;
Slovenian: • CVMP pregledal povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki jih predlaga imetnik dovoljenja za promet z zdravilom, in upošteval vse zgoraj predložene podatke;
English: Standard dose Double dose 0.5 tablet
Slovenian: Standardni odmerek Dvojni odmerek 0,5 tablete
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.
Slovenian: CVMP zato priporoča spremembo dovoljenja za promet z zdravilom za povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, kot je navedeno v prilogi III, za zdravilo Fortekor in povezana imena, kot je navedeno v prilogi I.
English: Weight of cat (kg)
Slovenian: Masa mačke (kg)
English: Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
Slovenian: Benazepril in benazeprilat se v veliki meri vežeta na plazemske beljakovine (85 - 90 %), v tkivih pa ju večinoma najdemo v jetrih in ledvicah.
English: A beneficial effect of benazepril was noted on appetite for the group with initial UPC ≥ 1.0.
Slovenian: Koristne učinke benazeprila na apetit so opazili v skupini z začetnim UPC ≥ 1,0.
English: The indication for use of Fortekor in CKD could therefore be accepted but should be limited to cats with proteinuria.
Slovenian: Indikacija za uporabo zdravila Fortekor pri kronični bolezni ledvic se lahko zato sprejme, vendar jo je treba omejiti na mačke s proteinurijo.
English: Proteinuria has in recent years been demonstrated as a prognostic factor for CKD in cats.
Slovenian: V zadnjih letih so pokazali, da je proteinurija prognostični dejavnik za kronično bolezen ledvic pri mačkah.
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.
Slovenian: Zato omejitve za uporabo zdravila Fortekor pri mačkah niso indicirane, vendar je treba pripomniti, da se zaradi možnega začetnega hipotenzivnega učinka zdravljenja z zaviralcem angiotenzin-konvertaze (ACE) benazeprila ne sme dajati živalim s hipotenzijo, hipovolemijo, hiponatriemijo ali akutno ledvično odpovedjo.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite priložena navodila.
English: According to the expert group there is some (although limited) scientific evidence for effect of ACEI for treatment of dogs with proteinuria.
Slovenian: Strokovna skupina meni, da obstajajo nekateri (čeprav omejeni) znanstveni dokazi za učinek zaviralcev ACE pri zdravljenju psov s proteinurijo.
English: Special warnings for dogs
Slovenian: Posebna opozorila za pse
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).
Slovenian: V tej študiji, v katero je bilo vključenih 49 lastniških psov s kronično boleznijo ledvic, niso opazili učinka na preživetje v primerjavi s placebom (primarna končna točka) ali kliničnih znakov v celotni skupini ali pri psih, stratificiranih v skladu z začetnim UPC > 0,5 (kar predstavlja pse s proteinurijo).
English: Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary.
Slovenian: Vaš veterinar lahko priporoči pozorno spremljanje delovanje ledvic in znakov hipotenzije (letargija, slabost itd.) ter njihovo zdravljenje, če je potrebno.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dopolniti na nacionalni ravni.
English: In some Member States, however, applications to extend the indication to CKD in cats were not approved, and there are therefore differences in the product information of Fortekor between Member States.
Slovenian: V nekaterih državah članicah pa vloga za razširjenje indikacije za zdravljenje kronične bolezni ledvic pri mačkah ni bila odobrena, zato obstajajo med državami članicami razlike v informacijah o zdravilu Fortekor.
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.
Slovenian: Strokovna skupina je izrazila nekaj možnih temeljev za zdravljenje z zaviralci ACE v primerih s proteinurijo, čeprav ni soglasja o kliničnih merilih, ki bi upravičili uvedbo zdravljenja.
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.
Slovenian: Med napotitvenim postopkom so opazili različne nacionalne odločitve držav članic glede dovoljenja za promet z zdravilom za ciljno živalsko vrsto psov, kjer so nekatere države članice za zdravilo odobrile indikacijo ledvične odpovedi.
English: Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is >1.
Slovenian: Mačka: Eksperimentalno za zmanjševanje proteinurije pri kronični ledvični odpovedi, pri kateri je osnovno beljakovine/kreatinin razmerje PCR > 1.
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.
Slovenian: Zmerno povečanje plazemskih koncentracij kreatinina po uporabi zaviralcev ACE je združljivo z zmanjšanjem glomerularne hipertenzije, ki jo povzročajo ta sredstva, in zato ni nujno razlog za prekinitev terapije v odsotnosti drugih znakov.
English: In the preclinical studies presented by the marketing authorisation holders, basic pharmacokinetic and pharmacodynamic properties of benazepril treatment in cats were described.
Slovenian: V predkliničnih študijah, ki jih je predložil imetnik dovoljenja za promet z zdravilom, so opisane osnovne farmakokinetične in farmakodinamične lastnosti zdravljenja z benazeprilom pri mačkah.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients To be completed nationally.
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Dopolniti na nacionalni ravni.
English: The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.
Slovenian: Zdravljenje lahko izboljša odpornost proti naporu in podaljša preživetje psov z zmernim do težkim srčnim popuščanjem.
English: “Product name” (to be completed nationally) may increase food consumption and body weight in cats.
Slovenian: „Ime izdelka” (dopolniti na nacionalni ravni) lahko poveča uživanje hrane in telesno maso pri mačkah.
English: the CVMP, concluded that the overall benefit/risk balance for this product remains positive, except for the chronic kidney disease in dogs, subject to the recommended changes in the product information.
Slovenian: zato je CVMP sklenil, da ostane splošno razmerje med koristmi in tveganji za to zdravilo pozitivno, razen za kronično bolezen ledvic pri psih, za katero se v informacije o zdravilu vnesejo priporočene spremembe.
English: “Product name” (to be completed nationally) reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
Slovenian: „Ime izdelka” (dopolniti na nacionalni ravni) znižuje krvni pritisk in volumensko obremenitev srca pri psih s kongestivnim srčnim popuščanjem.
English: Whereas:
Slovenian: Ugotovi se, da je:
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.
Slovenian: Glede kronične bolezni ledvic pri psih podatki, izpeljani iz osrednjega (in edinega) kliničnega preskušanja, in dodatni bibliografski podatki ne dajejo dovolj informacij za sklepanje o ustreznem odmerku in ne podprejo ustrezne koristi med klinično uporabo.
English: There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs.
Slovenian: V farmakokinetiki benazeprilata ni opazne razlike, če se benazepril hidroklorid daje nahranjenim ali teščim psom.
English: Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out.
Slovenian: Medsebojnega delovanja z diuretiki, ki zadržujejo kalij, kot so spironolakton, triamteren ali amilorid, ni mogoče izključiti.
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.
Slovenian: Ne uporabljajte pri brejih ali doječih psicah ali mačkah, saj varnost benazepril hidroklorida ni bila ugotovljena med brejostjo in laktacijo pri teh vrstah.
English: SPECIAL STORAGE CONDITIONS To be completed nationally.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Dopolniti na nacionalni ravni.
English: Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin
Slovenian: Zdravljenje srčnega popuščanja pri psih, tudi kot dodatek diuretiku furosemidu in/ali antiaritmičnemu zdravilu digoksinu
English: Additional precautions to be completed nationally if needed.
Slovenian: Posebne varnostne ukrepe dopolniti na nacionalni ravni, če je potrebno.
English: Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal failure.
Slovenian: Ne uporabljajte v primeru hipotenzije (nizkega krvnega pritiska), hipovolemije (nizkega krvnega volumna), hiponatriemiji (nizki ravni natrija v krvi) ali akutne odpovedi ledvic.
English: It is indicated in chronic renal insufficiency to slow down its progression.
Slovenian: Indicirano pri kronični ledvični insuficienci za zmanjševanje njenega napredovanja.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite priložena navodila.
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.
Slovenian: Vendar v študiji, s katero so preučili učinke enalaprila in podpira to mnenje, ustreznega odmerka za zdravljenje kronične bolezni ledvic z benazeprilom niso določili1.
English: <Manufacturer for the batch release:> To be completed nationally
Slovenian: <Izdelovalec, odgovoren za sprostitev serije:> dopolniti na nacionalni ravni
English: The appropriate harmonised indication should be “Reduction of proteinuria associated with chronic kidney disease”.
Slovenian: Ustrezna usklajena indikacija naj bo »Zmanjšanje proteinurije, povezane s kronično boleznijo ledvic«.
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.
Slovenian: Previdnostni ukrep v skladu s tem zaključkom je treba dodati k informacijam o zdravilu, da se zmanjša tveganje pri zdravljenju psov s srčnim popuščanjem in sočasno boleznijo ledvic.
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.
Slovenian: V študijah tolerance niso zabeležili pomembnih ali od odmerka odvisnih kliničnih znakov patoloških izsledkov, z izjemo blage hipertrofije/hiperplazije jukstaglomerulnih celic ledvic po zdravljenju, ki je ciljni odmerek preseglo od 10- do 20-krat.
English: ADVICE ON CORRECT ADMINISTRATION To be completed nationally if needed.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Dopolniti na nacionalni ravni, če je potrebno.
English: Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care.
Slovenian: Zato je treba sočasno uporabo nesteroidnih protivnetnih zdravil ali drugih zdravil s hipotenzivnim učinkom obravnavati previdno.
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.
Slovenian: Podatke o učinkovitosti zdravljenja z benazeprilom so pridobili v enem ekstenzivnem osrednjem kliničnem terenskem preskušanju, v katerega je bilo vključenih 193 lastniških mačk s spontano kronično boleznijo ledvic.
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.
Slovenian: Nadalje so kot ustrezen ocenili previdnostni ukrep glede kombinacije nesteroidnih protivnetnih zdravil zaradi tveganja, povezanega z znižanjem krvnega tlaka pri psih z boleznijo ledvic.
English: To be completed nationally.
Slovenian: Dopolniti na nacionalni ravni.
English: 15561 HOLARGOS GREECE
Slovenian: Av.Mesogeion 198 15561 HOLARGOS Grčija
English: Therapy should consist of intravenous infusion of warm isotonic saline.
Slovenian: Terapija naj vključuje intravensko infuzijo tople fiziološke raztopine.
English: Some dogs with congestive heart failure may exhibit vomiting or fatigue during treatment.
Slovenian: Pri nekaterih psih s kongestivnim srčnim popuščanjem se lahko med zdravljenjem pojavita bruhanje in utrujenost.
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.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Dopolniti na nacionalni ravni.
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.
Slovenian: Imetniki dovoljenja za promet z zdravilom so predložili predlog za usklajene informacije o zdravilu in podatke, ki podpirajo zdravljenje bolezni srca in ledvic.
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.
Slovenian: Podatki o farmakovigilanci, zbrani od prve pridobitve dovoljenja za promet z zdravilom Fortekor za uporabo pri mačkah, kažejo, da najpogostejši neželeni učinki, o katerih so poročali, vključujejo bruhanje, letargijo, anoreksijo in drisko.
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.
Slovenian: Poudarili so, da naj se z zaviralci ACE ne zdravi noben pes z nestabilno boleznijo ledvic 4. stopnje zaradi tveganja za zmanjšano hitrost glomerularne filtracije ali poslabšanje azotemije.
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.
Slovenian: Začasna strokovna skupina se je strinjala, da v javno dostopni literaturi ni dokazov, ki bi podprli uporabo zaviralcev ACE pri zdravljenju psov s kronično boleznijo ledvic na splošno, in da prav tako ni znanstvene literature ali kliničnih izkušenj, ki bi jasno dokazovale učinkovitost zaviralcev ACE pri zdravljenju vseh psov s kronično boleznijo ledvic.
English: In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Slovenian: Če pride do zaužitja, takoj poiščite zdravniško pomoč in pokažite etiketo ali navodilo za uporabo.
English: Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Slovenian: Ne uporabljajte v primeru srčnega popuščanja zaradi aortne ali pljučne stenoze.
English: Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Slovenian: Embriotoksični učinki (malformacije sečil ploda) so bili ugotovljeni pri raziskavah na laboratorijskih živalih (podganah) v maternalno netoksičnih odmerkih.
English: PACKAGE SIZE To be completed nationally.
Slovenian: VELIKOST PAKIRANJA Dopolniti na nacionalni ravni.
English: “Product name” (to be completed nationally) also increased the appetite of the cats, particularly in more advanced cases.
Slovenian: Poleg tega je „ime izdelka” (dopolniti na nacionalni ravni) povečal apetit mačk, še posebej v bolj napredujočih primerih.
English: In addition, benazepril has demonstrated teratogenic effects in laboratory animals, and reduction in ovary/oviduct weights was previously observed at treatment of female cats.
Slovenian: Benazepril je na laboratorijskih živalih pokazal tudi teratogene učinke, predhodno pa so pri mačjih samicah, ki so prejemale benazepril, opazili tudi zmanjšanje mase jajčnikov/jajcevodov.
English: PHARMACEUTICAL FORM Tablets.
Slovenian: FARMACEVTSKA OBLIKA Tablete.
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.
Slovenian: Z uporabo eksperimentalnega modela pri mačkah, pri katerih so opravili nefrektomijo, je kronično zdravljenje z benazeprilom znižalo glomerularni kapilarni tlak, povečalo koeficient glomerularne ultrafiltracije, ohranjalo stopnjo glomerularne filtracije (GFR - Glomerular Filtration Rate) enega nefrona pri preostalih nefronih in zmanjšalo sistemsko hipertenzijo.
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.
Slovenian: Kombinacija „ime izdelka” (dopolniti na nacionalni ravni) in drugih antihipertenzivnih zdravil (npr. zaviralcev kalcijevih kanalčkov, beta blokerjev ali diuretikov), anestetikov ali pomirjeval lahko povzroči aditivne hipotenzivne učinke.
English: Special warnings for dogs and cats
Slovenian: Posebna opozorila za pse in mačke
English: Do not use in case of hypersensitivity to the active substance benazepril hydrochloride or to any ingredient of the tablets.
Slovenian: Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino benazepril hidroklorid ali katerokoli sestavino tablet.
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.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih V primeru kronične ledvične bolezni bo vaš veterinar pred začetkom zdravljenja preveril stanje hidracije vašega hišnega ljubljenčka in lahko priporočil, da se med zdravljenjem izvajajo redne krvne preiskave z namenom spremljanja plazemskih koncentracij kreatinina in števila eritrocitov v krvi.
English: Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs.
Slovenian: Benazeprilat se v 54 % izloča prek žolčne in v 46 % prek sečne poti pri psih.
English: “Product name” (to be completed nationally) tablets are flavoured and are taken voluntarily by most dogs.
Slovenian: „Ime izdelka” (dopolniti na nacionalni ravni) tablete so aromatizirane in jih večina psov vzame prostovoljno.
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.
Slovenian: Načeloma niso ugotovili tveganj, zaradi katerih bi bilo treba omejiti uporabo zdravila Fortekor pri mačkah s kronično boleznijo ledvic ali psih s srčnim popuščanjem, razen tistih, ki so navedena v informacijah o zdravilu s popravki.
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.
Slovenian: Benazeprilat je zelo močan in selektiven zaviralec angiotenzinske konvertaze (ACE), in sicer prepreči pretvorbo neaktivnega angiotenzina I v aktivni angiotenzin II ter s tem tudi zmanjša sintezo aldosterona.
English: Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Slovenian: Ne uporabljajte v primeru hipotenzije, hipovolemije, hiponatriemije ali akutne odpovedi ledvic.
English: The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.
Slovenian: Sistemska biološka uporabnost je nepopolna (~ 13 % pri psih) zaradi nepopolne absorpcije (38 % pri psih, < 30 % pri mačkah) in presnove prvega prehoda.
English: The appropriate harmonised indication should be “Treatment of congestive heart failure in dogs”.
Slovenian: Ustrezna usklajena indikacija mora biti »Zdravljenje kongestivnega srčnega popuščanja pri psih«.