natgillin/translations-raw huggingface dataset:
Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal failure.
Ne uporabljajte v primeru hipotenzije (nizkega krvnega pritiska), hipovolemije (nizkega krvnega volumna), hiponatriemiji (nizki ravni natrija v krvi) ali akutne odpovedi ledvic.
It is indicated in chronic renal insufficiency to slow down its progression.
Indicirano pri kronični ledvični insuficienci za zmanjševanje njenega napredovanja.
Read the package leaflet before use.
Pred uporabo preberite priložena navodila.
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.
Vendar v študiji, s katero so preučili učinke enalaprila in podpira to mnenje, ustreznega odmerka za zdravljenje kronične bolezni ledvic z benazeprilom niso določili1.
<Manufacturer for the batch release:> To be completed nationally
<Izdelovalec, odgovoren za sprostitev serije:> dopolniti na nacionalni ravni
The appropriate harmonised indication should be “Reduction of proteinuria associated with chronic kidney disease”.
Ustrezna usklajena indikacija naj bo »Zmanjšanje proteinurije, povezane s kronično boleznijo ledvic«.
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.
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.
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.
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.
ADVICE ON CORRECT ADMINISTRATION To be completed nationally if needed.
NASVET O PRAVILNI UPORABI ZDRAVILA Dopolniti na nacionalni ravni, če je potrebno.
Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care.
Zato je treba sočasno uporabo nesteroidnih protivnetnih zdravil ali drugih zdravil s hipotenzivnim učinkom obravnavati previdno.
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.
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.
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.
Nadalje so kot ustrezen ocenili previdnostni ukrep glede kombinacije nesteroidnih protivnetnih zdravil zaradi tveganja, povezanega z znižanjem krvnega tlaka pri psih z boleznijo ledvic.
To be completed nationally.
Dopolniti na nacionalni ravni.
15561 HOLARGOS GREECE
Av.Mesogeion 198 15561 HOLARGOS Grčija
Therapy should consist of intravenous infusion of warm isotonic saline.
Terapija naj vključuje intravensko infuzijo tople fiziološke raztopine.
Some dogs with congestive heart failure may exhibit vomiting or fatigue during treatment.
Pri nekaterih psih s kongestivnim srčnim popuščanjem se lahko med zdravljenjem pojavita bruhanje in utrujenost.
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.
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Dopolniti na nacionalni ravni.
The marketing authorisation holders have provided proposals for harmonized product information and data in support of treatment of cardiac as well as renal disorders.
Imetniki dovoljenja za promet z zdravilom so predložili predlog za usklajene informacije o zdravilu in podatke, ki podpirajo zdravljenje bolezni srca in ledvic.
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.
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.
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.
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.
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.
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.
In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Če pride do zaužitja, takoj poiščite zdravniško pomoč in pokažite etiketo ali navodilo za uporabo.
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Ne uporabljajte v primeru srčnega popuščanja zaradi aortne ali pljučne stenoze.
Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Embriotoksični učinki (malformacije sečil ploda) so bili ugotovljeni pri raziskavah na laboratorijskih živalih (podganah) v maternalno netoksičnih odmerkih.
PACKAGE SIZE To be completed nationally.
VELIKOST PAKIRANJA Dopolniti na nacionalni ravni.
“Product name” (to be completed nationally) also increased the appetite of the cats, particularly in more advanced cases.
Poleg tega je „ime izdelka” (dopolniti na nacionalni ravni) povečal apetit mačk, še posebej v bolj napredujočih primerih.
In addition, benazepril has demonstrated teratogenic effects in laboratory animals, and reduction in ovary/oviduct weights was previously observed at treatment of female cats.
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.
PHARMACEUTICAL FORM Tablets.
FARMACEVTSKA OBLIKA Tablete.
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.
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.
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.
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.
Special warnings for dogs and cats
Posebna opozorila za pse in mačke
Do not use in case of hypersensitivity to the active substance benazepril hydrochloride or to any ingredient of the tablets.
Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino benazepril hidroklorid ali katerokoli sestavino tablet.
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.
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.
Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs.
Benazeprilat se v 54 % izloča prek žolčne in v 46 % prek sečne poti pri psih.
“Product name” (to be completed nationally) tablets are flavoured and are taken voluntarily by most dogs.
„Ime izdelka” (dopolniti na nacionalni ravni) tablete so aromatizirane in jih večina psov vzame prostovoljno.
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.
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.
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.
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.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Ne uporabljajte v primeru hipotenzije, hipovolemije, hiponatriemije ali akutne odpovedi ledvic.
The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.
Sistemska biološka uporabnost je nepopolna (~ 13 % pri psih) zaradi nepopolne absorpcije (38 % pri psih, < 30 % pri mačkah) in presnove prvega prehoda.
The appropriate harmonised indication should be “Treatment of congestive heart failure in dogs”.
Ustrezna usklajena indikacija mora biti »Zdravljenje kongestivnega srčnega popuščanja pri psih«.
In consideration of the fact that sufficient information to support efficacy during treatment of chronic kidney disease in dogs has not been presented, no information on appropriate dose for this condition is available and treatment of CKD is connected to particular risks, the benefit-risk balance for treatment of dogs with chronic kidney disease was regarded as negative.
Ob upoštevanju dejstva, da zadostne informacije za podporo učinkovitosti pri zdravljenju kronične bolezni ledvic pri psih niso bile predložene, da ni podatkov o ustreznem odmerku za to bolezen ter da je zdravljenje kronične bolezni ledvic povezano s posebnimi tveganji, je ocena razmerja med tveganji in koristmi pri zdravljenju psov s kronično boleznijo ledvic negativna.
Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Benazeprilat je zelo močan in selektiven zaviralec ACE, in sicer prepreči pretvorbo neaktivnega angiotenzina I v aktivni angiotenzin II ter s tem tudi zmanjša sintezo aldosterona.
Pre-existing conditions resulting in decreased renal perfusion should be corrected before ACEI treatment is initiated since ACEI can cause acute renal failure in these cases when angiotensin II-dependent glomerular filtration is blocked.
Obstoječe bolezni, ki povzročijo zmanjšanje ledvične perfuzije, je treba pred uvedbo zdravljenja z zaviralci ACE uspešno zdraviti, saj lahko zaviralci ACE pri teh mačkah povzročijo akutno ledvično odpoved, če je glomerularna filtracija, odvisna od angiotenzina II, zavirana.
Do not use during pregnancy or lactation.
Ne uporabljajte v obdobju brejosti ali laktacije.
Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys.
Zmanjšanje glomerularnega krvnega pritiska lahko zavre napredovanje ledvične bolezni z zaviranjem nadaljnje poškodbe ledvic.
“Product name” (to be completed nationally) tablets are flavoured and are taken voluntarily by most dogs and cats.
„Ime izdelka” (dopolniti na nacionalni ravni) tablete so aromatizirane in jih večina psov in mačk vzame prostovoljno.
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).
Zdravilo Fortekor je bilo prvotno odobreno za uporabo pri psih za zdravljenje srčnega popuščanja, vendar je bila v številnih državah članicah (EU/EGP) z nacionalnimi vlogami za spremembe dodano zdravljenje kronične bolezni ledvic pri mačkah.
This in combination with the collected body of data presented in bibliographic references and an increased experience among experts as well as extensive use of benazepril in treatment of CKD in cats indicate that treatment with ACEI is beneficial in cases of CKD in cats with persistent renal proteinuria.
To je v kombinaciji z zbranimi podatki predstavljeno v bibliografskih virih, večje izkušnje strokovnjakov ter ekstenzivna uporaba benazeprila za zdravljenje kronične bolezni ledvic pri mačkah pa nakazujejo, da je zdravljenje z zaviralci ACE koristno za primere kronične bolezni ledvic pri mačkah s persistentno ledvično proteinurijo.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazepril hidroklorid je predzdravilo, hidrolizirano in vivo v aktivni metabolit, benazeprilat.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključki in razlogi za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo
The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs) and first pass metabolism.
Sistemska biološka uporabnost je nepopolna (~ 13 % pri psih) zaradi nepopolne absorpcije (38 % pri psih) in presnove prvega prehoda.
The product is authorised for the treatment of heart failure in dogs and in some Member States for treatment of chronic kidney disease in cats and dogs.
Zdravilo je odobreno za zdravljenje srčnega popuščanja pri psih, v nekaterih državah članicah pa tudi za zdravljenje kronične bolezni ledvic pri mačkah in psih.
In the absence of sufficient data in cats (and dogs), it cannot be ruled out that benazepril treatment during pregnancy could be potentially harmful.
Ker podatkov za mačke (in pse) ni, ni mogoče izključiti morebitne škodljivosti zdravljenja z zdravilom benazepril med brejostjo.
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.
Odmerek se lahko podvoji, še vedno se ga daje enkrat dnevno, do najmanjšega odmerka 0,5 mg/kg (razpon 0,5 - 1,0), če veterinar presodi in svetuje, da je to klinično potrebno.
Tablets for dogs
Tablete za pse.
No effect of “Product name” (to be completed nationally) on survival in cats with CKD has been shown, but “Product name” (to be completed nationally) increased the appetite of the cats, particularly in more advanced cases.
Dokazanega ni bilo nobenega učinka „ime izdelka” (dopolniti na nacionalni ravni) na preživetje pri mačkah s KLB, vendar pa je „ime izdelka” (dopolniti na nacionalni ravni) povečal apetit mačk, še posebej v bolj napredujočih primerih.
Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs and 85% via the biliary and 15% via the urinary route in cats.
Benazeprilat se v 54 % izloča prek žolčne in v 46 % prek sečne poti pri psih ter v 85 % prek žolčne in v 15 % prek sečne poti pri mačkah.
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.
Podatki iz kliničnih preskušanj v povezavi z bibliografskimi podatki in izkušnje kliničnih strokovnjakov v zadostni meri podpirajo koristnost zdravljenja z benazeprilom za mačke s kronično boleznijo ledvic in proteinurijo.
Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child during pregnancy in humans.
Noseče ženske morajo biti posebno pozorne, da preprečijo nenameren stik z usti, saj je bilo ugotovljeno, da zaviralci ACE vplivajo na nerojenega otroka med nosečnostjo pri ljudeh.
Use during pregnancy, lactation
Uporaba v obdobju brejosti, laktacije
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.
Koncentracije benazeprilata upadajo dvofazno: začetna hitra faza (t1/2 = 1,7 ure pri psih in t1/2 = 2,4 ure pri mačkah) predstavlja sproščanje prostega zdravila, medtem ko zaključna faza (t1/2 = 19 ur pri psih in t1/2 = 29 ur pri mačkah) odraža sproščanje benazeprilata, ki je bil vezan na ACE, predvsem v tkivih.
<Marketing authorisation holder <and manufacturer>>: To be completed nationally
<Imetnik dovoljenja za promet z zdravilom <in izdelovalec>>: dopolniti na nacionalni ravni
MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Dopolniti na nacionalni ravni.
Dogs: Treatment of heart failure at stages 2,3 and 4.
Psi: Zdravljenje srčnega popuščanja pri stopnji 2, 3 in 4.
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.
Pri psih in mačkah s kronično ledvično boleznijo lahko pride do zmernega povišanja vrednosti kreatinina, indikatorja delovanja ledvic, v krvi.
Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Noseče ženske morajo biti posebno pozorne, da preprečijo nenameren stik z usti, saj je bilo ugotovljeno, da zaviralci angiotenzinske konvertaze (ACE) vplivajo na nerojenega otroka med nosečnostjo pri ljudeh.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Benazepril hydrochloride
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Benazepril hidroklorid
INDICATIONS “Product name” (to be completed nationally) belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.
INDIKACIJA(E) „Ime izdelka” (dopolniti na nacionalni ravni) spada v skupino zdravil, imenovanih zaviralci angiotenzinske konvertaze (ACE).
For reduction of proteinuria associated with chronic kidney disease in cats.
Za zmanjševanje proteinurije, povezane s kronično ledvično boleznijo pri mačkah.
In dogs with chronic kidney disease there may be a moderate increase in levels of creatinine, an indicator of kidney function, in the blood.
Pri psih s kronično ledvično boleznijo lahko pride do zmernega povišanja vrednosti kreatinina, indikatorja delovanja ledvic, v krvi.
The efficacy and safety of “product name” (to be completed nationally) has not been established in dogs below 2.5 kg body weight.
Učinkovitost in varnost „ime izdelka” (dopolniti na nacionalni ravni) nista bili ugotovljeni pri psih s telesno maso pod 2,5 kg.
2100 Köpenhamn Danmark
2100 Köpenhamn Danska
Your veterinary surgeon may recommend to monitor plasma potassium concentrations when using “product name” (to be completed nationally) in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium).
Vaš veterinar lahko priporoči spremljanje plazemskih koncentracij kalija pri uporabi „ime izdelka” (dopolniti na nacionalni ravni) v kombinaciji z diuretikom, ki zadržuje kalij, zaradi tveganja hiperkalemije (visok krvni kalij).
In cats and dogs with chronic kidney disease, “product name” (to be completed nationally) may increase plasma creatinine concentrations at the start of therapy.
Pri mačkah in psih s kronično ledvično boleznijo lahko „ime izdelka” (dopolniti na nacionalni ravni) poveča plazemske koncentracije kreatinina na začetku zdravljenja.
However, a precaution regarding use in dogs with instable kidney disease should be added to the product information since Fortekor treatment of dogs with heart failure and concomitant instable kidney disease could further deteriorate renal function.
Vendar je treba k informacijam o zdravilu Fortekor dodati previdnostno opozorilo za uporabo pri psih z nestabilno boleznijo ledvic, saj lahko zdravljenje z zdravilom Fortekor pri psih s srčnim popuščanjem in sočasno nestabilno boleznijo ledvic dodatno poslabša delovanje ledvic.
Weight of dog (kg)
Masa psa (kg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carboard box
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla
Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks.
Benazepril zmanjša maso jajčnikov/jajcevodev pri mačkah, če ga 52 tednov dajemo dnevno po 10 mg/kg.
Given that no risks has been identified during treatment of cats that would restrict the use and furthermore, that sufficient support for efficacy is available, the benefit-risk balance is regarded positive for Fortekor for the following indication in cats: “Reduction of proteinuria associated with chronic kidney disease”.
Ker pri zdravljenju mačk niso opredelili tveganj, ki bi omejila uporabo, in ker je na voljo dovolj podpornih podatkov za učinkovitost, je ocena razmerja med tveganji in koristmi za zdravilo Fortekor pozitivna za naslednje indikacije pri mačkah: »Zmanjšanje proteinurije, povezane s kronično boleznijo ledvic«.
2100 København Ø Danmark
2100 København Ø Danska
2100 Kööpenhamina Tanska
2100 Kööpenhamina Danska
Pharmacotherapeutic group: ACE Inhibitors, plain.
Farmakoterapevtska skupina: Zaviralci ACE, navadni.
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.
Za razliko od drugih zaviralcev ACE se benazeprilat izloča enakovredno tako prek žolčne kot prek sečne poti pri psih ter v 85 % prek žolčne in v 15 % prek sečne poti pri mačkah, zaradi česar odmerka „ime izdelka” (dopolniti na nacionalni ravni) v primeru ledvične insuficience ni treba prilagajati.