natgillin/translations-raw huggingface dataset:
Liver toxicity associated with liver enzyme induction was observed in rodents. 
Pri glodavcih so opazili toksičen vpliv na jetra, povezan z induciranjem jetrnega encima.
Antimycobacterials Rifabutin/Emtricitabine 
Zdravila za zdravljenje okužb z mikobakterijami rifabutin/emtricitabin
Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil and didanosine were taken together. 
Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi (preveč mlečne kisline v krvi), ki je bila včasih smrtna.
Didanosine (400 mg once daily)/ Rilpivirine1 
didanozin(400 mg enkrat dnevno)/rilpivirin1
Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
atazanavir (300 mg enkrat dnevno)/ritonavir (100 mg enkrat dnevno)/dizoproksiltenofovirat (245 mg enkrat dnevno)
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1 
famotidin (40 mg enkratni odmerek, vzet 2 uri pred rilpivirinom)/rilpivirin1
Table 3: Phenotypic resistance and cross-resistance outcomes from studies C209 and C215 (pooled data) for patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil at week 96 (based on resistance analysis) 
Preglednica 3: Izidi fenotipske rezistence in navzkrižne rezistence iz študij C209 in C215 (združeni podatki) za bolnike, ki so prejemali rilpivirinijev klorid v kombinaciji z emtricitabinom/dizoproksiltenofoviratom, v 96. tednu (na podlagi analize rezistence)
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil (245 mg once daily) 
lopinavir (400 mg dvakrat dnevno)/ritonavir (100 mg dvakrat dnevno)/dizoproksiltenofovirat (245 mg enkrat dnevno)
 If you notice any of these symptoms tell your doctor. 
• težave pri gibanju  Če opazite katerega koli od teh simptomov, obvestite zdravnika.
Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1 
famotidin (40 mg enkratni odmerek, vzet 4 ure po rilpivirinu)/rilpivirin1
Maraviroc (300 mg twice daily)/ Tenofovir disoproxil (245 mg once daily) 
maravirok (300 mg dvakrat dnevno)/dizoproksiltenofovirat (245 mg enkrat dnevno)
• Decreases in potassium in the blood 
• zmanjšanje količine kalija v krvi
Rifabutin (300 mg once daily)/ Rilpivirine (50 mg once daily) 
rifabutin (300 mg enkrat dnevno)/rilpivirin (50 mg enkrat dnevno)
Povidone 
rabeprazol
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2). 
Pri bolnikih z zmerno ali hudo ledvično okvaro je treba interval odmerjanja emtricitabina in dizoproksiltenofovirata prilagoditi, česar pa s kombinirano tableto ni mogoče doseči (glejte poglavji 4.4 in 5.2).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 28. november 2011
• carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines to treat epilepsy and prevent seizures) • rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis) 
• karbamazepin, okskarbazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije in preprečevanje epileptičnih napadov)
Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
darunavir (300 mg enkrat dnevno)/ritonavir (100 mg enkrat dnevno)/dizoproksiltenofovirat (245 mg enkrat dnevno)
Efavirenz + Emtricitabine/ Tenofovir disoproxil n = 546 
Efavirenz + emtricitabin/dizoproksiltenofovirat n = 546
Antiretrovirals 
ANTIKOAGULANTI
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2). 
Pri bolnikih z zmerno ali hudo ledvično okvaro je treba interval odmerjanja emtricitabina in dizoproksiltenofovirata prilagoditi, česar pa s kombinirano tableto ni mogoče doseči (glejte poglavji 4.2 in 5.2).
Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis) 
Preglednica 6: Fenotipski izid rezistence iz študij C209 in C215 (združeni podatki za bolnike, ki so prejemali rilpivirinijev klorid ali efavirenz v kombinaciji z emtricitabinom/dizoproksiltenofoviratom) v 96. tednu (na podlagi analize rezistence)
Eviplera must not be used in combination with rifampicin as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Zdravila Eviplera se ne sme uporabljati v kombinaciji z rifampicinom, saj je verjetno, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij rilpivirina v plazmi (indukcija encimov CYP3A).
Atorvastatin/Tenofovir disoproxil 
atorvastatin/dizoproksiltenofovirat
Sildenafil/Tenofovir disoproxil 
sildenafil/dizoproksiltenofovirat
Metformin (850 mg single dose)/ Rilpivirine 
metformin (enkratni odmerek 850 mg)/rilpivirin metformin: AUC: ↔
PROTON PUMP INHIBITORS Omeprazole/Emtricitabine 
ZAVIRALCI PROTONSKE ČRPALKE omeprazol/emtricitabin
Very common: headache1, 2, 3, dizziness1, 2, 3 Common: 
glavobol1, 2, 3, omotičnost1, 2, 3
Rifabutin (300 mg once daily)/ Rilpivirine (25 mg once daily) 
rifabutin (300 mg enkrat dnevno)/rilpivirin (25 mg enkrat dnevno)
If Eviplera is stopped your doctor may recommend that you resume hepatitis B treatment. 
Če prenehate jemati zdravilo Eviplera, vam lahko zdravnik priporoči, da se začnete ponovno zdraviti proti hepatitisu B. Morda bodo pri vas potrebne krvne preiskave, ki bodo pokazale delovanje vaših jeter, 4 mesece po prenehanju zdravljenja.
By baseline viral load (copies/mL) 
Glede na začetno vrednost virusne obremenitve (kopij/ml)
Concomitant use of Eviplera with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). 
Sočasna uporaba zdravila Eviplera z zaviralci proteaze, okrepljenimi z ritonavirjem, povzroči povečanje koncentracij rilpivirina v plazmi (zaviranje encimov CYP3A).
There was no teratogenicity with rilpivirine in rats and rabbits. 
Pri podganah in kuncih rilpivirin ni bil teratogen.
Eviplera must not be used in combination with rifapentine as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Zdravila Eviplera se ne sme uporabljati v kombinaciji z rifapentinom, saj je verjetno, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij rilpivirina v plazmi (indukcija encimov CYP3A).
Famotidine/Tenofovir disoproxil 
famotidin/dizoproksiltenofovirat
(may affect up to 1 in 10 people) 
Pogosti:pojavijo se lahko pri največ 1 od 10 bolnikov
Cmax: ↓ 85% 
Cmin: ↓ 66 %
Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
simeprevir (150 mg enkrat dnevno)/ dizoproksiltenofovirat (245 mg enkrat dnevno)
• Fatty liver 
• zamaščena jetra
Posaconazole2 Voriconazole2 
flukonazol2 itrakonazol2 posakonazol2 vorikonazol2
*compared to 25 mg once daily rilpivirine alone 
Cmax: ↑ 43 %* *v primerjavi s 25 mg enkrat dnevno samo rilpivirina rifabutin/dizoproksiltenofovirat
Non-clinical data on tenofovir disoproxil reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. 
Predklinični podatki za dizoproksiltenofovirat na osnovi običajnih študij farmakološke varnosti, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
In treatment-naïve HIV-1 infected patients 
Pri predhodno nezdravljenih bolnikih, okuženih z virusom HIV-1
Rilpivirine + Emtricitabine/Tenofovir disoproxil n = 550 
Rilpivirin + emtricitabin/dizoproksiltenofovirat n = 550
The adverse reactions considered at least possibly related to treatment with the components of Eviplera from clinical study and post-marketing experience are listed in Table 2, below, by body system organ class and frequency. 
Spodaj v preglednici 2 so po organskih sistemih in pogostnosti navedeni neželeni učinki, ki so vsaj verjetno povezani z zdravljenjem z učinkovinami zdravila Eviplera na podlagi klinične študije in izkušenj v obdobju trženja zdravila.
Hypromellose 
ANALGETIKI
Treatment-naïve HIV-1 infected patients 
Predhodno nezdravljeni bolniki, okuženi z virusom HIV-1
Eviplera [outer packaging only] 
PODATKI V BRAILLOVI PISAVI Eviplera [samo na zunanji ovojnini]
A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to CPT classification. 
Osebe brez okužbe s HIV, ki so imele različne stopnje jetrne okvare po klasifikaciji CPT, so vzele enkratni 245 mg odmerek dizoproksiltenofovira.
If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine. 
Če jemljete antagonist H2, kot je famotidin, cimetidin, nizatidin ali ranitidin, ga vzemite vsaj 12 ur pred uporabo zdravila Eviplera ali najmanj 4 ure po tem.
Metformin/Tenofovir disoproxil 
metformin/dizoproksiltenofovirat
Atazanavir/Ritonavir/Rilpivirine Interaction not studied. 
atazanavir/ritonavir/rilpivirin
Omeprazole/Tenofovir disoproxil 
omeprazol/dizoproksiltenofovirat
• tenofovir disoproxil 
• dizoproksiltenofovirat
Hepatic impairment 
Virološki neuspehc
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.