natgillin/translations-raw huggingface dataset:
• medicines that increase the amount of potassium in your blood.
• zdravila, ki lahko zvišajo koli ino kalija v vaši krvi.
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• nizek krvni pritisk s simptomi, kot sta omoti nost in izguba zavesti pri vstajanju, ali brez teh simptomov
The mean daily dose of Diovan in Val-HeFT was 254 mg.
Povpre ni odmerek zdravila Diovan na dan v študiji Val-HeFT je bil 254 mg.
Adult patients with high blood pressure: The usual dose is 80 mg daily.
Odrasli bolniki z visokim krvnim tlakom: Obi ajni odmerek je 80 mg na dan.
Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Znižanje sistoli nega krvnega tlaka je bilo pri bolnikih, ki so prejemali valsartan (za 15 mmHg) primerljivo s tistim pri bolnikih, ki so prejemali enalapril (za 14 mmHg) (vrednost p za ne-inferiornost <0,0001).
In hypertensive patients with type 2 diabetes and microalbuminuria, valsartan has been shown to reduce the urinary excretion of albumin.
Pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2 in z mikroalbuminurijo se je pokazalo, da valsartan zmanjša izlo anje albumina v urinu.
A causal relationship to Diovan has not been established.
Vzro ne povezanosti z zdravilom Diovan niso ugotovili.
In the first study, the efficacy of valsartan was confirmed compared to placebo but a dose-response could not be demonstrated.
V prvi študiji so dokazali u inkovitost valsartana v primerjavi s placebom, niso pa mogli potrditi odvisnosti odziva od odmerka.
However, if it is almost time for your next dose, skip the dose you missed.
e je že skoraj as za naslednji odmerek, presko ite odmerek, ki ste ga pozabili vzeti.
Hypertrophy of the renal juxtaglomerular cells was also seen in both species.
Pri obeh vrstah so opazili tudi hipertrofijo ledvi nih jukstaglomerularnih celic.
The frequency of some side effects may vary depending on your condition.
Pogostnost nekaterih neželenih u inkov lahko niha glede na vaše stanje.
5.3 Preclinical safety data
5.3 Predklini ni podatki o varnosti
Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%).
Osnovno zdravljenje je vklju evalo zaviralce ACE (93 %), diuretike (86 %), digoksin (67 %) in antagoniste adrenergi nih receptorjev beta (36 %).
Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Po intravenski uporabi je plazemski o istek valsartana približno 2 l/uro, njegov ledvi ni o istek pa 0,62 l/uro (približno 30 % celotnega o istka).
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Nose nost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups.
Umrljivost iz vseh vzrokov je bila podobna (p = NS) v skupini z valsartanom (19,7 %) in s placebom (19,4 %).
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
Pri klini no stabilnih bolnikih je mogo e zdravljenje za eti že 12 ur po miokardnem infarktu.
This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.
Zato je zelo pomembno, da hodite na preglede k zdravniku, tudi e se po utite dobro.
Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mm Hg from the baseline, respectively.
V celoti je pri treh ravneh odmerkov valsartana (nizki, srednji in visoki) prišlo do pomembnega znižanja sistoli nega krvnega tlaka za 8, 10 oziroma 12 mmHg od izhodiš nih vrednosti.
Composite mortality and morbidity risk was significantly reduced by 18.3% (95% CI: 8% to 28%) with valsartan compared with placebo (31.0% vs. 36.3%).
Tveganje glede sestavljene umrljivosti in obolevnosti je bilo z valsartanom zna ilno manjše za 18,3 % (95 % IZ: 8% do 28%) v primerjavi s placebom (31,0% v primerjavi z 36,3%).
In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a one-year open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed.
V dvojno slepi randomizirani študiji z 90 otroci, ki so bili stari od 1 leta do 6 let, in v enoletnem odprtem podaljšanju te študije so zabeležili dva primera smrti in posamezne primere izrazitega zvišanja koncentracije jetrnih aminotransferaz.
The study had two primary endpoints: all cause mortality (time to death) and composite mortality and heart failure morbidity (time to first morbid event) defined as death, sudden death with resuscitation, hospitalisation for heart failure, or administration of intravenous inotropic or vasodilator agents for four hours or more without hospitalisation.
Študija je imela dva primarna cilja opazovanja: umrljivost iz vseh vzrokov ( as do smrti) in cilj opazovanja, sestavljen iz umrljivosti in obolevnosti zaradi sr nega popuš anja ( as do prvega bolezenskega dogodka), ki je bil opredeljen kot smrt, nenadna smrt z oživljanjem, hospitalizacija zaradi sr nega popuš anja ali dajanje intravenskih inotropnih zdravil ali vazodilatorjev štiri ure ali ve brez hospitalizacije.
What Diovan is and what it is used for Before you take Diovan How to take Diovan Possible side effects How to store Diovan Further information
Kaj je zdravilo Diovan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Diovan Kako jemati zdravilo Diovan Možni neželeni u inki
Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
Kratkotrajna uporaba zdravila Diovan pri dvanajstih bolnikih z enostransko stenozo ledvi ne arterije in renovaskularno hipertenzijo ni povzro ila pomembnih sprememb ledvi ne hemodinamike, koncentracije kreatinina v serumu ali dušika se nine v krvi (blood urea nitrogen - BUN).
• if you have severe liver disease.
• e imate hudo bolezen jeter,
In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg).
V nekaterih primerih lahko zdravnik predpiše višje odmerke (npr. 160 mg ali 320 mg).
Important information about some of the ingredients of Diovan [To be completed nationally]
Pomembne informacije o nekaterih sestavinah zdravila Diovan [Izpolni država lanica]
If you have further questions on the use of this product, ask your doctor or pharmacist.
e imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
In a second study in which 75 children aged 1 to 6 years were randomised, no significant liver transaminase elevations or death occurred with valsartan treatment.
V drugi študiji, v kateri so randomizirali 75 otrok, starih od 1 leta do 6 let, pri zdravljenju z valsartanom ni prišlo do bistvenega zvišanja koncentracije jetrnih aminotransferaz ali do smrti.
There was no difference between valsartan and captopril in all-cause mortality based on age, gender, race, baseline therapies or underlying disease.
Med valsartanom in kaptoprilom ni bilo razlik glede umrljivosti iz vseh vzrokov po starosti, spolu, rasi, predhodnem zdravljenju in osnovni bolezni.
Consequently, a clinical relevance in children <1 year of age cannot be excluded, while preclinical data do not indicate a safety concern for children older than 1 year.
Iz tega razloga ni mogo e izklju iti možnosti, da bi bili navedeni pojavi lahko klini no pomembni pri otrocih, ki so mlajši od 1 leta, hkrati pa zaradi predklini nih podatkov ni nobenih pomislekov glede varne uporabe zdravila pri otrocih, ki so starejši od 1 leta.
160 mg 80 kg to 160 kg 320 mg
80 kg do 160 kg 320 mg
For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Tako so na primer neželeni u inki kot sta omoti nost ali zmanjšano delovanje ledvic manj pogosta pri odraslih bolnikih, ki se zdravijo zaradi visokega krvnega pritiska, kot pri odraslih bolnikih, ki se zdravijo zaradi sr nega popuš anja ali po nedavnem sr nem infarktu.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofi na kardiomiopatija Kot pri uporabi drugih vazodilatatorjev je potrebna posebna pozornost pri bolnikih z aortno ali mitralno stenozo ali s hipertrofi no obstruktivno kardiomiopatijo (hypertrophic obstructive cardiomyopathy - HOCM).
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Najve ji dnevni odmerek, ki so ga uporabili v klini nih preskušanjih, je bil 320 mg v razdeljenih odmerkih.
Doses higher than those listed have not been studied and are therefore not recommended.
Odmerkov, ki presegajo navedene v preglednici, niso prou evali in jih zato ni priporo eno uporabljati.
For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Kaže, da terapevtski odmerki valsartana pri ljudeh ne vplivajo na hipertrofijo ledvi nih jukstaglomerularnih celic.
You can take Diovan with or without food.
Zdravilo Diovan je mogo e jemati s hrano ali brez nje.
In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Pri bolnikih z blago do zmerno okvaro jeter brez holestaze odmerek valsartana ne sme presegati 80 mg.
- Second and third trimester of pregnancy (see sections 4.4 and 4.6).
- Drugo in tretje trimese je nose nosti (glejte poglavji 4.4 in 4.6)
In patients receiving an ACE inhibitor without a beta-blocker, all cause mortality was similar (p=NS) in the valsartan (21.8%) and placebo (22.5%) groups.
Pri bolnikih, ki so prejemali zaviralec ACE brez antagonista adrenergi nih receptorjev beta, je bila umrljivost iz vseh vzrokov podobna (p = NS) v skupini z valsartanom (21,8 %) in s placebom (22,5 %).
In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Pri podganah so odmerki, toksi ni za mater, (600 mg/kg/dan) v zadnjih dneh brejosti in med dojenjem povzro ili zmanjšano preživetje, nižjo telesno maso, upo asnitev razvoja (neprirasel uhelj in odprt ušesni kanal) (glejte poglavje 4.6) pri potomstvu.
The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
Pogostnost neželenih u inkov ni videti sorodna z velikostjo odmerka ali s trajanjem zdravljenja, pa tudi ne s spolom, starostjo ali raso.
Valsartan was also effective in prolonging the time to and reducing cardiovascular mortality, hospitalisation for heart failure, recurrent myocardial infarction, resuscitated cardiac arrest, and non-fatal stroke (secondary composite endpoint).
Valsartan je bil u inkovit tudi pri podaljšanju asa do kardiovaskularne smrti in zmanjševanju kardiovaskularne umrljivosti, hospitalizacij zaradi sr nega popuš anja, ponovitev miokardnega infarkta, zastoja srca z uspešnim oživljanjem in možganske kapi, ki ni smrtna (sekundarni sestavljen cilj opazovanja).
Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Uporaba zdravila Diovan ni priporo ena za matere, ki dojijo, zato lahko vaš zdravnik izbere drugo zdravljenje, e želite dojiti, še zlasti, e gre za novorojen ka ali nedonošen ka.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
e katerikoli neželeni u inek postane resen ali e opazite katerikoli neželeni u inek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Method of administration Diovan may be taken independently of a meal and should be administered with water.
Na in uporabe Zdravilo Diovan je mogo e jemati neodvisno od obrokov, treba pa ga je zaužiti z vodo.
The safety profile of valsartan was consistent with the clinical course of patients treated in the postmyocardial infarction setting.
Varnostne lastnosti valsartana so se ujemale s klini nim potekom pri bolnikih, ki so jih zdravili v okviru zdravljenja po miokardnem infarktu.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency.
Za vse neželene u inke, o katerih so poro ali na podlagi izkušenj po za etku trženja zdravila in laboratorijskih izvidov, pogostnosti ni mogo e ugotoviti, zato je njihova pogostnost navedena kot "neznana".
Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Poleg tega lahko so asna uporaba antagonistov angiotenzina II in nesteroidnih protivnetnih zdravil povzro i pove ano tveganje za poslabšanje delovanja ledvic in zvišanje koncentracije kalija v serumu.
The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age.
Antihipertenzivno delovanje valsartana so ocenjevali v dveh randomiziranih, dvojno slepih klini nih študijah s 561 pediatri nimi bolniki v starosti od 6 do 18 let.
• if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section).
• e ste nose i ve kot 3 mesece (tudi v zgodnji nose nosti raje ne jemljite zdravila Diovan)glejte poglavje nose nost.
In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg).
V nekaterih primerih lahko zdravnik predpiše višje odmerke (odmerke lahko zviša na 160 mg oziroma na najve 320 mg).
Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
V kombinaciji s hidroklorotiazidom je mogo e dose i pomembno dodatno znižanje krvnega tlaka.
The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Namen študije je bil dolo iti optimalni odmerek valsartana za zmanjšanje izlo anja albumina z urinom pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2.
AUC and Cmax values of valsartan are almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day).
Vrednosti AUC in Cmax valsartana se pove ujejo linearno in so v mejah klini nega odmerjanja (40 do 160 mg dvakrat na dan) skoraj sorazmerne ve anju odmerka.
Consideration should be given to reducing the dose of concomitant diuretics.
Razmisliti je treba o zmanjšanju odmerkov so asno uporabljenih diuretikov.
In hypertension in children and adolescents, where underlying renal abnormalities are common, caution is recommended with the concomitant use of valsartan and other substances that inhibit the renin angiotensin aldosterone system which may increase serum potassium.
Pri otrocih in mladostnikih s hipertenzijo, pri katerih so pogosto prisotne tudi bolezenske spremembe ledvic, je priporo ena previdnost pri so asni uporabi valsartana in drugih u inkovin, ki zavirajo delovanje sistema renin-angiotenzin-aldosteron, kar lahko zviša koncentracijo kalija v serumu.
Paediatric population
Pediatri na populacija
These cases occurred in a population who had significant comorbidities.
Do tega je prišlo v populaciji otrok, ki so imeli so asno še druge pomembne bolezni.
If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
e nehote vzamete preve tablet, pokli ite svojega zdravnika, farmacevta ali v bolnišnico.
The increased plasma levels of Ang II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor, which appears to counterbalance the effect of the AT1 receptor.
Po zaviranju receptorja AT1 z valsartanom lahko zvišana koncentracija angiotenzina II v plazmi stimulira nezavrte receptorje podvrste AT2, ki, kot kaže, izravnavajo u inek receptorjev AT1.
- Post-myocardial infarction and/or heart failure (studied in adult patients only)
- Stanje po miokardnem infarktu in/ali sr no popuš anje (prou evano samo pri odraslih bolnikih)
If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
e ga ne zdravimo, lahko poškoduje krvne žile v možganih, srcu in ledvicah, kar lahko povzro i možgansko kap, sr no popuš anje ali odpoved ledvic.
The primary benefit was a 27.5% (95% CI: 17 to 37%) reduction in risk for time to first heart failure hospitalisation (13.9% vs. 18.5%).
Primarna korist je bilo 27,5 % (95 % IZ: 17 do 37 %) manjše tveganje glede asa do prve hospitalizacije zaradi sr nega popuš anja (13,9 % v primerjavi z 18,5 %).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Epidemiološki podatki niso pokazali teratogenega u inka pri nose nicah, ki so bile v prvem trimese ju nose nosti izpostavljene zaviralcem ACE, vendar pa majhnega pove anja tveganja ni možno izklju iti.
Not all pack sizes may be marketed
Ni nujno, da so v prometu vsa navedena pakiranja.
• severely decreased kidney function (signs of acute renal failure)
• zelo zmanjšano delovanje ledvic (znak akutne ledvine odpovedi)
Abrupt withdrawal of Diovan has not been associated with rebound hypertension or other adverse clinical events.
Po nenadni prekinitvi jemanja zdravila Diovan ni prišlo do povratne hipertenzije ali drugih neželenih klini nih dogodkov.
Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 24 hours with tablets and 1-2 hours with solution formulation.
Po peroralni uporabi samo valsartana doseže ta najvišjo koncentracijo v plazmi v 2-4 urah po zaužitju tablet in v 1-2 urah po zaužitju raztopine.
In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
V neklini nih študijah varnosti so visoki odmerki valsartana (200 do 600 mg/kg telesne mase) pri podganah povzro ili zmanjšanje parametrov rde ih krvnih celic (ertirocitov, hemoglobina, hematokrita) in znake spremenjene ledvi ne hemodinamike (nekoliko zvišana se nina v plazmi in hiperplazija ledvi nih tubulov ter bazofilija pri samcih).
Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Valsartan je peroralno aktiven, mo an in specifi en antagonist receptorjev angiotenzina II.
Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
Pri ocenjevanju nevrokognitivnih sposobnosti in razvoja pri pediatri nih bolnikih, starih od 6 do 16 let, po zdravljenju z zdravilom Diovan v obdobju do 1 leta niso opažali nobenega neugodnega vpliva, ki bi bil v celoti klini no pomemben.
• if you have liver disease.
• e imate bolezen jeter,
Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Povpre na absolutna biološka uporabnost je 23 % po zaužitju tablet in 39 % po zaužitju raztopine.
Strength Pharmaceutical Form Route of administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe
Administration of Diovan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Pri bolnikih s hipertenzijo zdravilo Diovan zniža krvni tlak, ne da bi vplivalo na sr no frekvenco.
Recent myocardial infarction
Nedavni miokardni infarkt
Like all medicines, Diovan can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Diovan neželene u inke, ki pa se ne pojavijo pri vseh bolnikih.
The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1).
Uporaba kombinacije kaptoprila in valsartana ni pokazala dodatnih klini nih koristi, pove alo pa se je tveganje za neželene u inke v primerjavi z uporabo posameznih zdravil (glejte poglavji 4.2 in 5.1).
Results appearing to favour placebo (composite mortality and morbidity was 21.9% in placebo vs. 25.4% in valsartan group) were observed for those patients receiving the triple combination of an ACE inhibitor, a beta blocker and valsartan.
Opazili so rezultate v korist placeba (sestavljena umrljivost in obolevnost je bila 21,9 % pri placebu v primerjavi s 25,4 % v skupini z valsartanom) pri bolnikih, ki so prejemali trojno kombinacijo zaviralca ACE, antagonista adrenergi nih receptorjev beta in valsartana.
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• e se zdravite po sr nem napadu ali zaradi sr nega popuš anja, bo morda zdravnik preveril delovanje vaših ledvic,
A long term study in the younger age group (1 to 5 years old).
Zaklju no poro ilo o študiji mora biti predloženo najpozneje do zadnjega etrtletja leta 2010, dolgoro no študijo v mlajši starostni skupini (starost otrok od 1 do 5 let).
Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
S tem so se ujemali tudi rezultati meritev diastoli nega tlaka, ki ga je valsartan znižal za 9,1 mmHg, enalapril pa za 8,5 mmHg.
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
e ste vzeli ve ji odmerek zdravila Diovan, kot bi smeli e ob utite hudo omoti nost in/ali omedlevico, se takoj povežite s svojim zdravnikom in se ulezite.
In patients who continued to receive the medium and high doses of valsartan, systolic blood pressure at trough was -4 and -7 mm Hg lower than patients who received the placebo treatment.
Pri bolnikih, ki so nadaljevali zdravljenje s srednje visokimi in z visokimi odmerki valsartana, je bila najnižja vrednost sistoli nega krvnega tlaka nižja za 4 oziroma 7 mmHg od vrednosti pri bolnikih, ki so prejemali placebo.
If you stop taking Diovan
e prenehate jemati zdravilo Diovan
Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
eprav ni na voljo podatkov glede tveganja pri uporabi antagonistov angiotenzina II iz kontroliranih epidemioloških študij, lahko podobno tveganje obstaja tudi za to skupino zdravil.
All-cause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Umrljivost iz vseh vzrokov je bila podobna v skupini z valsartanom (19,9 %), s kaptoprilom (19,5 %) in v skupini s kombinacijo valsartana in kaptoprila (19,3 %).
Daily oral dosing of neonatal/juvenile rats (from a postnatal day 7 to postnatal day 70) with valsartan at doses as low as 1 mg/kg/day (about 10-35% of the maximum recommended paediatric dose of 4 mg/kg/day on systemic exposure basis) produced persistent, irreversible kidney damage.
Vsakodnevno peroralno odmerjanje valsartana novorojenim/mladim podganam (od 7. do 70. dne po porodu) v višini samo 1 mg/kg/dan (kar je približno 10-35 % najvišjega priporo enega pediatri nega odmerka 4 mg/kg/dan glede na sistemsko izpostavljenost zdravilu) je povzro ilo persistentno neozdravljivo okvaro ledvic.