natgillin/translations-raw huggingface dataset:
Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Eviplera z azolnimi antimikotiki lahko povzroči povečanje koncentracij rilpivirina v plazmi (zaviranje encimov CYP3A).
AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
AUC: ↔ Cmax: ↔ Cmin: ↑ 25 %
Didanosine/Tenofovir disoproxil
dinadozin/dizoproksiltenofovirat
Sildenafil (50 mg single dose)/ Rilpivirine1
sildenafil (enkratni odmerek 50 mg)/rilpivirin1 sildenafil: AUC: ↔
Darunavir/Ritonavir/Emtricitabine Interaction not studied.
darunavir/ritonavir/emtricitabin
ANTIDIABETICS Metformin/Emtricitabine
metformin/emtricitabin
Ethinylestradiol/Norethindrone/ Tenofovir disoproxil
Cmax: ↔ norgestimat/etinilestradiol/dizoproksiltenofovirat norgestimat: AUC: ↔
AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
R(-) metadon: AUC: ↓ 16 % Cmin: ↓ 22 % Cmax: ↓ 14 %
• Diarrhoea, being sick (vomiting), feeling sick (nausea)
• driska, bruhanje, občutek siljenja na bruhanje (navzea)
AUC: ↔ Cmin: ↔ Cmax: ↔
rifabutin: AUC: ↔ Cmin: ↔ Cmax: ↔
Excipients
ANTIKONVULZANTI
IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/ Emtricitabine
takrolimus/dizoproksiltenofovirat/emtricitabin takrolimus: AUC: ↔
Rilpivirine: AUC: ↔
rifampicin: AUC: ↔ Cmax: ↔
Contents of the pack and other information What Eviplera contains
Shranjevanje zdravila Eviplera Vsebina pakiranja in dodatne informacije
Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily)
Priporočilo glede sočasne uporabe z zdravilom Eviplera simeprevir (150 mg enkrat dnevno)/rilpivirin (25 mg enkrat dnevno)
Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms/0.5 ml Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms/0.5 ml Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms/0.5 ml Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms/0.5 ml
Oligosaharid meningokoka skupine A 10 mikrogramov, vezan na beljakovino CRM197 bakterije Corynebacterium diphtheriae 16,7 do 33,3 mikrograme/0,5 ml Oligosaharid meningokoka skupine C 5 mikrogramov, vezan na beljakovino CRM197 bakterije Corynebacterium diphtheriae 7,1 do 12,5 mikrogramov/0,5 ml Oligosaharid meningokoka skupine W135 5 mikrogramov, vezan na beljakovino CRM197 bakterije Corynebacterium diphtheriae 3,3 do 8,3 mikrograme/0,5 ml Oligosaharid meningokoka skupine Y 5 mikrogramov, vezan na beljakovino CRM197 bakterije Corynebacterium diphtheriae 5,6 do 10,0 mikrogramov/0,5 ml
5 vials + 5 vials
5 vial + 5 vial
Invented Name
Številka EU Izmišljeno
EU/1/99/128/032 Viraferon 30 million IU
EU/1/99/128/001 Viraferon 1 milijon
1 injection set = injection syringe + 2 injection needles + cleansing swab 2 injection set = injection syringe + injection needle + cleansing swab injection set = injection needle + cleansing swab 4 injection set = injection syringe + injection needle + 2 cleansing swabs
Injekcijski set = injekcijska brizga + 2 injekcijski igli + čistilni tampon 2 Injekcijski set = injekcijska brizga + injekcijska igla + čistilni tampon
IU/0.5ml
1,0 ml (1 milijon i.e./ml)
1.0 ml (10 million IU/ml) 10 vials + 10 ampoules + 10 injection sets1
10 vial + 10 ampul + 10 injekcijskih setov
Discussion of the data available
Razprava o podatkih, ki so na voljo
The duration of treatment is unlimited.
Trajanje zdravljenja ni omejeno.
81379 München Germany
81379 München Nemčija
Inform the veterinary surgeon if the animal is taking, or has recently taken, any other medicines.
Obvestite veterinarja, če vaša žival jemlje ali je pred kratkim jemala katerokoli drugo zdravilo.
Calle de la Marina, 206 08013 Barcelona Spain
Calle de la Marina, 206 08013 Barcelona Španija
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite katerikoli resen učinek ali druge znake, ki v teh navodilih niso omenjeni, o tem obvestite svojega veterinarja.
14 Boulevard Richelieu 92500 Rueil Malmaison France
14 Boulevard Richelieu 92500 Rueil Malmaison Francija
In a pivotal study, no such effect of treatment was seen.
V osrednji študiji takih učinkov zdravljenja niso opazili.
Overall summary of the scientific evaluation of Fortekor and associated names (see annex I) 1.
Splošni povzetek znanstvenega vrednotenja zdravila Fortekor in povezanih imen (glejte Prilogo I) 1.
Biochemiestraße 10 6250 Kundl Austria
Biochemiestraße 10 6250 Kundl Avstrija
In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC, and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Po načelih o napotitvenih postopkih v skladu s členom 34(1) Direktive 2001/82/ES je Švedska dne 16. septembra 2010 poslala revidirano obvestilo o napotitvenem postopku v skladu s členom 34(1) Direktive 2001/82/ES ter razširila obseg napotitvenega postopka za vsa jakosti in formulacije tablet zdravila Fortekor in povezana imena.
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.
Incidenca neželenih učinkov je bila majhna (ocenjen delež 0,0066-0,037 %) in ni mogoče izključiti, da so neželeni učinki povezani hudo osnovno boleznijo.
PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Dopolniti na nacionalni ravni.
ATCvet code: QC09AA07
Koda ATCvet: QC09AA07
“Product name” (to be completed nationally) should be given orally once daily, with or without food.
„Ime izdelka” (dopolniti na nacionalni ravni) je treba dajati peroralno enkrat dnevno, s hrano ali brez nje.
Always follow the dosing instructions given by the veterinary surgeon.
Vedno upoštevajte navodila za odmerjanje, ki vam jih je dal veterinar.
Therefore due to divergent national decisions taken by Member States concerning the authorisations of Fortekor and associated names (5 mg benazepril gydrochloride film-coated tablet), on 16 October 2009, Sweden triggered a referral under Article 34(1) of Directive 2001/82/EC, as amended.
Zaradi različnih nacionalnih odločitev držav članic v zvezi z odobritvijo zdravila Fortekor in povezanih imen (5 mg benazeprilhidroklorid filmsko obložene tablete) je Švedska dne 16. oktobra 2009 sprožila napotitveni postopek v skladu s členom 34(1) Direktive 2001/82/ES, kakor je spremenjena.
Claudius Prinsenlaan 142 4818 CP Breda The Netherlands
Claudius Prinsenlaan 142 4818 CP Breda Nizozemska
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.
Indikacija mora vsebovati dejstvo, da je pričakovani učinek verjeten zamik razvoja bolezni, pri čemer ozdravitve ne gre pričakovati.
Therefore, appropriate text should be included in relevant sections of the Fortekor product information.
To pomeni, da je treba v ustrezna poglavja informacij o zdravilu Fortekor vključiti ustrezno besedilo.
When comparing treated animals with placebo, no effect on survival (primary endpoint) was demonstrated.
Primerjava živali, zdravljenih s placebom, ni pokazala učinka na preživetje (primarna končna točka).
The differences between groups of cats were, however, minor compared to baseline, and recovery during the study complicated the interpretation of data.
Razlika med skupinami mačk, ki je bila sicer glede na izhodišče majhna, in okrevanje v času študije pa sta zapletla razlago podatkov.
Also, a slight significant overall difference in proteinuria was recorded.
Zabeležili so tudi majhno pomembno skupno razliko v proteinuriji.
Also, no statistically significant difference in UPC could be demonstrated overall for the treatment period.
Prav tako ni bilo mogoče dokazati splošne statistično pomembne razlike v UPC za obdobje zdravljenja.
This is likely due to the effect of the medication in reducing the blood pressure within the kidney and is therefore not necessarily a reason for treatment to be stopped, unless the animal is showing other adverse reactions.
To je verjetno posledica učinka zdravila na zniževanje krvnega pritiska v ledvicah in zato ni nujno razlog za prekinitev terapije, razen če žival kaže druge neželene reakcije.
A significant overall difference in UPC was also recorded.
Zabeležili so tudi pomembno splošno razliko v UPC.
Since there is little discrepancy in the approved product information between Member States regarding pharmacodynamic properties, pharmacokinetic properties, target animal tolerance and the indication for treatment of heart failure in dogs, only minor changes of the product literature are proposed.
Ker obstaja majhna neskladnost odobrenih informacij o zdravilu med državami članicami glede farmakodinamičnih lastnosti, farmakokinetičnih lastnosti, tolerance pri ciljnih živalih in indikacije za zdravljenje srčnega popuščanja pri psih, so predlagane le manjše spremembe dokumentacije za zdravilo.
The difference in UPC was statistically significant in the group with UPC ≥ 1.0 but not in the group with UPC ≥ 0.2.
Razlika v UPC je bila statistično pomembna v skupini z UPC ≥ 1,0, ne pa tudi v skupini z UPC ≥ 0,2.
When sub-grouping the animals it was shown that the reduction in urine protein was most prominent in the small group of animals with UPC ≥ 1.0.
Pri razvrstitvi živali v podskupine se je pokazalo, da je bilo zmanjšanje proteinov v urinu najbolj izrazito v majhni skupini živali z UPC ≥ 1,0.
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).
Torej zavira učinke angiotenzina II in aldosterona, vključno z vazokonstrikcijo tako arterij kot ven, zadrževanjem natrija in vode v ledvicah ter učinki preoblikovanja (vključno s patološko srčno hipertrofijo in z degenerativnimi spremembami ledvic).
Do not use during pregnancy or lactation (section 4.7).
Ne uporabljajte med brejostjo ali laktacijo (poglavje 4.7).
The benefit connected to benazepril treatment of dogs with heart failure is sufficiently support by previously presented data.
Koristi, povezane z zdravljenjem psov s srčnim popuščanjem z benazeprilom, so dovolj podprte s prej predstavljenimi podatki.
Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Zdravilo Fortekor in povezana imena je zdravilo za uporabo v veterinarski medicini, ki vsebuje benazeprilhidroklorid v obliki 2,5 mg, 5 mg in 20 mg aromatiziranih tablet ter 5 mg in 20 mg filmsko obloženih tablet, namenjenih za uporabo pri psih in mačkah.
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.
Podatki o varnosti iz kliničnih preskušanj niso prinesli nobenih izsledkov, ki bi nakazovali na potrebo po omejitvi uporabe zdravila Fortekor pri mačkah, kar kažejo tudi podatki o farmavigilanci.
4.2 Indications for use, specifying the target species Dogs:
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Psi:
It could be noted, however, that the median difference in survival between treated cats and placebo with an initial urine protein to creatinine ratio (UPC) ≥ 1.0 was large, but no statistical support for an effect difference was gained.
Vendar pa je bilo mogoče opaziti, da je bila mediana razlika v preživetju med zdravljenimi mačkami in mačkami, ki so dobivale placebo, z začetnim razmerjem proteinov v urinu glede na kreatinin (UPC - urine protein to creatinine ratio) ≥ 1,0 velika, vendar statistična podpora za razliko v učinku ni bila pridobljena.
Results with regard to secondary endpoints (proteinuria), however, indicated a beneficial effect of benazepril treatment.
Rezultati pa so glede sekundarnih končnih točk (proteinurija) pokazali koristen učinek zdravljenja z benazeprilom.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, indications, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, indikacij, imetnikov dovoljenja za promet v državah članicah
Thus, the chronic kidney disease indication in dogs where approved should be deleted.
Zato je treba indikacijo za kronično bolezen ledvic pri psih črtati, kjer je bila odobrena.
NAME OF THE MARKETING AUTHORISATION HOLDER NOVARTIS
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM NOVARTIS
• 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;
• CVMP ocenil primarni obseg napotitvenega postopka glede učinkovitosti zdravila za zdravljenje bolezni ledvic pri mačkah in psih;
Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Delovanje ledvic in znake hipotenzije (letargija, slabost itd.) je treba skrbno spremljati in jih po potrebi zdraviti.
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.
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.
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.
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.
DATE OF REVISION OF THE TEXT To be completed nationally.
DATUM REVIZIJE BESEDILA Dopolniti na nacionalni ravni.
• 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;
• 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;
Standard dose Double dose 0.5 tablet
Standardni odmerek Dvojni odmerek 0,5 tablete
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.
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.
Weight of cat (kg)
Masa mačke (kg)
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
Benazepril in benazeprilat se v veliki meri vežeta na plazemske beljakovine (85 - 90 %), v tkivih pa ju večinoma najdemo v jetrih in ledvicah.
A beneficial effect of benazepril was noted on appetite for the group with initial UPC ≥ 1.0.
Koristne učinke benazeprila na apetit so opazili v skupini z začetnim UPC ≥ 1,0.
The indication for use of Fortekor in CKD could therefore be accepted but should be limited to cats with proteinuria.
Indikacija za uporabo zdravila Fortekor pri kronični bolezni ledvic se lahko zato sprejme, vendar jo je treba omejiti na mačke s proteinurijo.
Proteinuria has in recent years been demonstrated as a prognostic factor for CKD in cats.
V zadnjih letih so pokazali, da je proteinurija prognostični dejavnik za kronično bolezen ledvic pri mačkah.
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.
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.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite priložena navodila.
According to the expert group there is some (although limited) scientific evidence for effect of ACEI for treatment of dogs with proteinuria.
Strokovna skupina meni, da obstajajo nekateri (čeprav omejeni) znanstveni dokazi za učinek zaviralcev ACE pri zdravljenju psov s proteinurijo.
Special warnings for dogs
Posebna opozorila za pse
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).
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).
Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary.
Vaš veterinar lahko priporoči pozorno spremljanje delovanje ledvic in znakov hipotenzije (letargija, slabost itd.) ter njihovo zdravljenje, če je potrebno.
NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dopolniti na nacionalni ravni.
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.
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.
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.
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.
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.
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.
Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is >1.
Mačka: Eksperimentalno za zmanjševanje proteinurije pri kronični ledvični odpovedi, pri kateri je osnovno beljakovine/kreatinin razmerje PCR > 1.
A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
Zmerno povečanje plazemskih koncentracij kreatinina po uporabi zaviralcev ACE je združljivo z zmanjšanjem glomerularne hipertenzije, ki jo povzročajo ta sredstva, in zato ni nujno razlog za prekinitev terapije v odsotnosti drugih znakov.
In the preclinical studies presented by the marketing authorisation holders, basic pharmacokinetic and pharmacodynamic properties of benazepril treatment in cats were described.
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.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients To be completed nationally.
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Dopolniti na nacionalni ravni.
The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.
Zdravljenje lahko izboljša odpornost proti naporu in podaljša preživetje psov z zmernim do težkim srčnim popuščanjem.
“Product name” (to be completed nationally) may increase food consumption and body weight in cats.
„Ime izdelka” (dopolniti na nacionalni ravni) lahko poveča uživanje hrane in telesno maso pri mačkah.
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.
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.
“Product name” (to be completed nationally) reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
„Ime izdelka” (dopolniti na nacionalni ravni) znižuje krvni pritisk in volumensko obremenitev srca pri psih s kongestivnim srčnim popuščanjem.
Whereas:
Ugotovi se, da je:
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.
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.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs.
V farmakokinetiki benazeprilata ni opazne razlike, če se benazepril hidroklorid daje nahranjenim ali teščim psom.
Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out.
Medsebojnega delovanja z diuretiki, ki zadržujejo kalij, kot so spironolakton, triamteren ali amilorid, ni mogoče izključiti.
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.
Ne uporabljajte pri brejih ali doječih psicah ali mačkah, saj varnost benazepril hidroklorida ni bila ugotovljena med brejostjo in laktacijo pri teh vrstah.
SPECIAL STORAGE CONDITIONS To be completed nationally.
POSEBNA NAVODILA ZA SHRANJEVANJE Dopolniti na nacionalni ravni.
Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin
Zdravljenje srčnega popuščanja pri psih, tudi kot dodatek diuretiku furosemidu in/ali antiaritmičnemu zdravilu digoksinu
Additional precautions to be completed nationally if needed.
Posebne varnostne ukrepe dopolniti na nacionalni ravni, če je potrebno.