FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Il-konċentrazzjonijiet ta' benazeprilat jonqsu bifażikament: il-fażi inizjali veloċi (t1/2=1.7 sigħat fil-klieb u t1/2=2.4 sigħat fil-qtates) tirrappreżenta l-eliminazzjoni ta' mediċina libera, filwaqt li l-fażi terminali (t1/2=19-il siegħa fil-klieb u t1/2=29 siegħa fil-qtates) tirrifletti r-rilaxx ta' benazeprilat li kien marbut ma' ACE, l-aktar fit-tessut.
English: Novartis Tiergesundheit GmbH
Maltese: Il-Ġermanja Novartis Tiergesundheit GmbH
English: The incidence of adverse events was low (estimated to 0.0066-0.037%), and it cannot be excluded that adverse events are related to severe underlying disease conditions.
Maltese: (stmata fi 0.0066-0.037%), u ma jistax jiġi eskluż li l-avveniment avversi huma relatati malkundizzjonijiet severi tal-marda.
English: Always follow the dosing instructions given by the veterinary surgeon.
Maltese: Dejjem għandek issegwi l-istruzzjonijiet tad-dożaġġ mogħtija mill-kirurgu veterinarju.
English: Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Maltese: Effetti embrijotossiċi (malformazzjoni tal-passaġġ urinarju fetali) ntwerew fi provi b'annimali tal-laboratorju (firien) f'dożi li maternalment mhumiex tossiċi.
English: The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.
Maltese: Il-biodisponibbiltà sistemika mhijiex kompleta (~13% fil-klieb) minħabba assorbiment mhux komplet (38% fil-klieb, <30% fil-qtates) u metaboliżmu talewwel mogħdija.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, indications, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi li fuqhom għandu jintuża lprodott, indikazzjonijiet, detenturi tal-awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs) and first pass metabolism.
Maltese: Il-biodisponibbiltà sistemika mhijiex kompleta (~13% fil-klieb) minħabba assorbiment mhux komplet (38% fil-klieb) u metaboliżmu tal-ewwel mogħdija.
English: Therapy should consist of intravenous infusion of warm isotonic saline.
Maltese: Il-kura għandha tikkonsisti minn infużjoni ġol-vini ta' salmura isotonika fietla.
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.
Maltese: Dejta fir-rigward tal-effikaċja ta' kura bil-benażepril inkisbet minn prova klinika estensiva pivotali fuq il-post li fiha ħadu sehem 193 qattus b'CKD spontanju li kienu jappartjenu għal klijenti.
English: For cats over 2.5 kg Treatment of chronic renal insufficiency
Maltese: Għal qtates ta' aktar minn 2.5 kg Kura ta' insuffiċjenza renali kronika
English: “Product name” 5 mg (to be completed nationally ) 0.5 tablet 1 tablet
Maltese: “Isem tal-prodott” 5 mg (li għandu jimtela fuq livell nazzjonali) 0.5 pillola 1 pillola
English: The appropriate harmonised indication should be “Reduction of proteinuria associated with chronic kidney disease”.
Maltese: Lindikazzjoni armonizzata xierqa għandha tkun “Tnaqqis ta' proteinurija assoċjata ma' mard kroniku talkliewi”.
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.
Maltese: Barra dan, il-benażepril uriet effetti teratoġeniċi f'annimali fil-laboratorju, u fil-passat ġie osservat tnaqqis fil-piżi tal-ovarji/ovidotti waqt il-kura ta' qtates femminili.
English: Weight of cat (kg) “Product name”2.5 mg (to be completed nationally ) 1 tablet 2 tablets
Maltese: Piż tal-qattus (kg) “Isem tal-prodott” 2.5 mg (li għandu jimtela fuq livell nazzjonali) 1 pillola 2 pilloli
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.
Maltese: Fi qtates, konċentrazzjonijiet massimi ta' benazeprilat (Cmax ta' 77.0 ng/ml wara doża ta' 0.5 mg/kg benazepril hydrochloride) jintlaħqu b'Tmax ta' sagħtejn.
English: Dog: Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.
Maltese: Kelb: Kura ta' indeboliment talqalb, b'mod speċjali kardjomijopatija dilatata u kollass mitrali.
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.
Maltese: Fi klieb b'kollass konġestiv tal-qalb, “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) ingħata f'kombinazzjoni ma' digoxin, dijuretiċi, pimobendan u prodotti mediċinali veterinarji anti-arritmiċi mingħajr interazzjonijiet avversi li jistgħu jintwerew.
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).
Maltese: Għoti ripetut ta' “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali)” iwassal għal bioakkumulazzjoni ħafifa ta' benazeprilat (R=1.47 fi klieb u R=1.36 fi qtates b'0.5 mg/kg), bi stat fiss jintlaħaq fi żmien ftit jiem (4 ijiem fil-klieb).
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.
Maltese: Studji prattiċi kliniċi kkontrollati bli plaċebo fi qtates b'mard kroniku tal-kliewi (CKD - chronic kidney disease) urew li “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) naqqas b'mod sinifikanti l-livell ta' proteina fl-awrina u l-proporzjon ta' proteina tal-awrina għal kreatinina (UPC); probabbilment li dan l-effett huwa medjat permezz ta' pressjoni għolja glomerulari u effetti ta' benefiċċju fuq il-membrana tal-qiegħ glomerulari.
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.
Maltese: Fid-data ta' farmakoviġilanza li nġabret sa mill-ewwel awtorizzazzjoni ta' Fortekor għall-użu fil-qtates, l-aktar avvenimenti avversi irrapportati b'mod komuni jinkludu rimettar, letarġija, anoreksja u dijarea.
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).
Maltese: Għaldaqstant, jimblokka l-effetti medjati minn anġjotensin II u aldosterone, inkluż il-vażokostrizzjoni kemm tal-arterji kif ukoll tal-vini, iż-żamma tas-sodju u l-ilma bl-effetti tal-kliewi u ta' rimudellar (inkluż ipertrofija kardijaka patoloġika u tibdil renali deġenerattiv).
English: INDICATIONS “Product name” (to be completed nationally) belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.
Maltese: INDIKAZZJONI(JIET) “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) jappartjeni għal grupp ta' mediċini msejħin inibituri tal-Enzim li Jikkonverti l-Anġjotensini (ACE- Angiotensin Converting Enzyme).
English: Dogs:
Maltese: Billi:
English: For cats -Treatment of chronic renal insufficiency
Maltese: Għall-qtates -Kura ta' insuffiċjenza renali kronika
English: “Product name” (to be completed nationally) belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) jappartjeni għal grupp ta' mediċini msejħin inibituri tal-Enzim li Jikkonverti l-Anġjotensini (ACE- Angiotensin Converting Enzyme).
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.
Maltese: Id-doża tista' tiġi rduppjata, xorta tibqa' tingħata darba kuljum, għal doża minima ta' 0.5 mg/kg (firxa ta' 0.5-1.0), jekk dan jitqies li jkun klinikament neċessarju u jkun rakkomandat minn kirurgu veterinarju.
English: Dogs: Treatment of heart failure at stages 2,3 and 4.
Maltese: Klieb Klieb: Kura ta' indeboliment talqalb fil-fażi 2, 3 u 4.
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.
Maltese: Ma ġiet osservata ebda evidenza ta' tossiċità renali tal-prodott mediċinali veterinarja (fi klieb u qtates) matul provi kliniċi, madankollu, bħalma hija r-rutina, f'każijiet ta' mard kroniku tal-kliewi, huwa rrakkomandat li l-kreatinina tal-plasma, l-urea u l-għedud tal-eritroċiti jiġu mmonitorjati waqt it-terapija.
English: Cats: Treatment of chronic renal failure.
Maltese: Kura ta' kollass renali kroniku.
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.
Maltese: Ġie kkonsultat grupp ta' esperti ad-hoc (AHEG) fir-rigward tal-bażi xjentifika ta' evidenza għal ACEI filkura ta' mard kroniku tal-kliewi fil-klieb.
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.
Maltese: F'kuntrast ma' inibituri ACE oħrajn, benazeprilat jintreħa b'mod ugwali kemm permezz ta' rotta biljari kif ukoll permezz ta' rotta urinarja fi klieb u 85% permezz tar-rotta biljari u 15% permezz tar-rotta urinarja fil-qtates, u għalhekk ma hemm bżonn ta' ebda aġġustament tad-doża ta' “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) fil-kura ta' każijiet b'insuffiċjenza renali.
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.
Maltese: Wara amministrazzjoni orali ta' benazepril hydrochloride, livelli massimi ta' benazepril inkisbu malajr (Tmas 0.5 siegħa fil-klieb) u jinżlu malajr hekk kif l-ingredjent attiv jiġi metabolizzat parzjalment minn enzimi tal-fwied għal benazeprilat.
English: No evidence of renal toxicity of the veterinary medicinal product has been observed in dogs 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.
Maltese: Ma ġiet osservata ebda evidenza ta' tossiċità renali tal-prodott mediċinali veterinarja fi klieb matul provi kliniċi, madankollu, bħalma hija r-rutina, f'każijiet ta' mard kroniku tal-kliewi, huwa rrakkomandat li lkreatinina tal-plasma, l-urea u l-għedud tal-eritroċiti jiġu mmonitorjati waqt it-terapija.
English: A beneficial effect of benazepril was noted on appetite for the group with initial UPC ≥ 1.0.
Maltese: Ġie nnotat effett fejjiedi tal-benażepril fuq l-aptit għall-grupp b'UPC inizjali ta' ≥ 1.0.
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.
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) jikkawża inibizzjoni dewwiema tal-attività talACE tal-plasma fil-klieb u fil-qtates, b'inibizzjoni ta' aktar minn 95% fl-effett massimu u attività sinifikanti (>80% fil-klieb u >90% fil-qtates) li tippersisti għal 24 siegħa wara d-dożaġġ.
English: Repeated administration of “product name” (to be completed nationally) leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).
Maltese: Għoti ripetut ta' “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali)” iwassal għal bioakkumulazzjoni ħafifa ta' benazeprilat (R=1.47 fi klieb b'0.5 mg/kg), bi stat fiss jintlaħaq fi żmien ftit jiem (4 ijiem fil-klieb).
English: Cats: Treatment of chronic renal insufficiency.
Maltese: Klieb: Kura ta' indeboliment talqalb.
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.
Maltese: Wara amministrazzjoni orali ta' benazepril hydrochloride, livelli massimi ta' benazepril inkisbu malajr (Tmas 0.5 siegħa fil-klieb u sagħtejn fil-qtates) u jinżlu malajr hekk kif l-ingredjent attiv jiġi metabolizzat parzjalment minn enzimi tal-fwied għal benazeprilat.
English: Norway
Maltese: Surrey
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.
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) naqqas l-għedud ta' ertroċiti fi qtates normali meta ddożati f'10 mg/kg piż tal-ġisem darba kuljum għal 12-il xahar u fi klieb normali meta ddożati f'150 mg/kg piż tal-ġisem darba kuljum għal 12-il xahar, iżda dan l-effett ma ġiex osservat fid-doża rakkomandata matul provi kliniċi fi qtates jew klieb.
English: Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.
Maltese: Klieb Kura ta' indeboliment tal-qalb, b'mod speċjali kardjomijopatija dilatata u kollass mitrali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Benazepril hydrochloride 20 mg For a full list of excipients, see section 6.1.
Maltese: Benazepril hydrochloride 20 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
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.
Maltese: Benazeprilat huwa inibitur qawwi ħafna u selettiv ta' enzim li jikkonverti anġjotensin (ACE), b'hekk jimpedixxi l-konverżjoni ta' anġjotensin I inattiv għal anġjotensin II attiv u b'hekk inaqqas ukoll is-sinteżi ta' aldosterone.
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.
Maltese: Il-kombinazzjoni ta' “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) u ingredjenti oħrajn kontra l-pressjoni għolja (eż, imblokkaturi tal-kanal tal-kalċju, imblokkaturi- jew dijuretiċi) anestetiċi jew sedattivi tista' twassal għal effetti addittivi ta' pressjoni baxxa.
English: Slow down of the progression of renal damage in chronic kidney disease with proteinuria.
Maltese: Tnaqqis tal-avvanz tal-ħsara renali f'mard kroniku talkliewi bi proteinurja.
English: In dogs with congestive heart failure, the dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight if judged necessary and advised by the veterinary surgeon.
Maltese: Fi klieb b'mard tal-qalb konġestiv, id-doża tista' tiġi rduppjata, xorta tibqa' tingħata darba kuljum, għal doża minima ta' 0.5 mg (firxa ta' 0.5-1.0) benazepril hydrochloride/kg piż tal-ġisem, jekk dan jitqies li jkun neċessarju u jkun rakkomandat minn kirurgu veterinarju.
English: Standard dose
Maltese: Doża eċċessiva
English: Pharmacotherapeutic group: ACE Inhibitors, plain.
Maltese: Riżultati fir-rigward ta' endpoints sekondarji (proteinurija), madankollu, indikaw effett fejjiedi ta' kura bil-benażepril.
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.
Maltese: Fi klieb jew qtates b'mard tal-kliewi kroniku, jista' jkun hemm żieda moderata fil-livelli ta' kreatinina, indikatur tal-funzjoni tal-kliewi, fid-demm.
English: Cats: “Product name” (to be completed nationally) should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
Maltese: Qtates: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) għandu jingħata oralment f'doża minima ta' 0.5 mg (firxa 0.5-1.0) benazepril hydrochloride/kg piż tal-ġisem darba kuljum, skont it-tabella li ġejja:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Benazepril hydrochloride 2.5 mg For a full list of excipients, see section 6.1.
Maltese: Benazepril hydrochloride 2.5 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
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.
Maltese: Fi klieb b'mard tal-kliewi kroniku, jista' jkun hemm żieda moderata fil-livelli ta' kreatinina, indikatur talfunzjoni tal-kliewi, fid-demm.
English: Treatment of heart failure at 2nd3rd and 4th stage.
Maltese: Klieb Kura ta' indeboliment tal-qalb filfażi 2, 3 u 4.
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.
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) jikkawża inibizzjoni dewwiema tal-attività talACE tal-plasma, b'inibizzjoni ta' aktar minn 95% fl-effett massimu u attività sinifikanti (>80% fil-klieb) li tippersisti għal 24 siegħa wara d-dożaġġ.
English: In cats with experimental renal insufficiency,“product name” (to be completed nationally) normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Maltese: Fil-qtates b'insuffiċjenza renali esperimentali, “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) innormalizza l-pressjoni kapillari glomerulari għolja u naqqas il-pressjoni tad-demm sistemika.
English: In cats with experimental renal insufficiency, “product name” (to be completed nationally) normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Maltese: Fil-qtates b'insuffiċjenza renali esperimentali, “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) innormalizza l-pressjoni kapillari glomerulari għolja u naqqas il-pressjoni tad-demm sistemika.
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.
Maltese: Dejta minn provi kliniċi flimkien ma' informazzjoni biblijografika u mill-esperjenza ta' esperti kliniċi hija meqjusa li tappoġġa b'mod suffiċjenti li l-kura bil-benażepril hija ta' benefiċċju għall-qtates b'CKD u bi proteinurija.
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.
Maltese: Fl-istudji ta' tolleranza, ma ġie rreġistrat l-ebda sinjal kliniku sinifikanti jew relatat mad-doża ta' sejbiet patoloġiċi minbarra ipertrofija ħafifa/iperplasija taċ-ċelloli jukstaglomerulari fil-kliewi wara kura b'1020 darba d-doża fil-mira rrakkomandata.
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).
Maltese: Fortekor kien inizjalment awtorizzat għall-użu fil-klieb għall-kura tal-insuffiċjenza tal-qalb, iżda permezz ta' applikazzjonijiet nazzjonali għall-varjazzjoni f'bosta Stati Membri (UE/ŻEE) żdiedet il-kura ta' mard kroniku tal-kliewi (CKD) fil-qtates.
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.
Maltese: Żieda moderata filkonċentrazzjonijiet tal-kreatinina fil-plasma wara għoti ta' inibituri ACE hija kompatibbli mat-tnaqqis filpressjoni għolja glomerulari indotta minn dawn l-ingredjenti, u għaldaqstant mhux neċessarjament hija raġuni għala għandha titwaqqaf il-kura fin-nuqqas ta' sinjali oħrajn.
English: For dogs over 5 kg Treatment of heart failure
Maltese: Għal klieb ta' aktar minn 5 kg Kura ta' indeboliment tal-qalb
English: Also, a slight significant overall difference in proteinuria was recorded.
Maltese: Barra dan, ġiet irreġistrata differenza globali sinifikanti żgħira fil-proteinurija.
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.
Maltese: Fil-bnedmin, il-kombinazzjoni ta' inibituri ACE ma' Mediċini Anti-Infjammatorji Mhux Sterojdali (NSAIDs) tista' twassal għal effikaċja mnaqqsa kontra l-pressjoni għolja jew għal funzjoni renali indebolita.
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.
Maltese: Fi klieb b'kollass konġestiv tal-qalb, “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) ingħata f'kombinazzjoni ma' digoxin, dijuretiċi, pimobendan u prodotti anti-arritmiċi mingħajr evidenza ta' reazzjonijiet avversi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Benazepril hydrochloride 5 mg For a full list of excipients, see section 6.1.
Maltese: Benazepril hydrochloride 5 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal failure.
Maltese: Tużax f'każijiet ta' pressjoni baxxa (pressjoni baxxa tad-demm), ipovolaemija (volum baxx tad-demm), iponatrimija (livelli baxxi ta' sodium fid-demm) jew kollass renali akut.
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.
Maltese: Jingħata minn kirurgu veterinarju għall-kura ta' kollass konġestiv tal-qalb fi klieb u għat-tnaqqis ta' proteinurja assoċjata ma' mard kroniku tal-fwied fil-qtates.
English: In cats “product name” (to be completed nationally) should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
Maltese: Fil-qtates, “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) għandu jingħata oralment f'doża minima ta' 0.5 mg (firxa 0.5-1.0) benazepril hydrochloride/kg piż tal-ġisem darba kuljum, skont it-tabella li ġejja: