natgillin/translations-raw huggingface dataset:
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Ob potrjeni nose nosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, e je primerno, za eti alternativno zdravljenje (glejte poglavji 4.3 in
In a subgroup of patients not receiving an ACE inhibitor (n=366), the morbidity benefits were greatest.
Koristi v zvezi z obolevnostjo so bile najve je v podskupini bolnikov, ki niso prejemali zaviralca ACE (n = 366).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Neklini ni podatki na osnovi obi ajnih študij farmakološke varnosti, toksi nosti pri ponavljajo ih se odmerkih, genotoksi nosti in karcinogenega potenciala ne kažejo posebnega tveganja za loveka.
The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
V študiji MARVAL (Zmanjšanje mikroalbuminurije z valsartanom - Micro Albuminuria Reduction with Valsartan) so ocenili zmanjšanje izlo anja albumina z urinom (urinary albumin excretion - UAE) z valsartanom (v odmerku 80-160 mg/enkrat na dan) v primerjavi z amlodipinom ( v odmerku 5-10 mg/enkrat na dan), pri 332 bolnikih s sladkorno boleznijo tipa 2 (povpre na starost: 58 let; 265 moških) z mikroalbuminurijo (v skupini z valsartanom: 58 µg/min; v skupini z amlodipinom: 55,4 µg/min), z normalnim ali zvišanim krvnim tlakom in z ohranjenim delovanjem ledvic (koncentracija kreatinina v krvi < 120 µmol/l).
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - Izpolni država lanica]
In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak reduction of blood pressure is achieved within 4-6 hours.
Pri ve ini bolnikov pride do antihipertenzivnega u inka v 2 urah po vnosu posami nega peroralnega odmerka, do najve jega znižanja krvnega tlaka pa pride v 4 do 6 urah.
ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure patients are listed below.
Neželeni u inki, ki so se pojavljali pri odraslih bolnikih po miokardnem infarktu in/ali pri bolnikih s sr nim popuš anjem, so navedeni spodaj:
In patients with heart failure, the triple combination of an ACE inhibitor, a beta blocker and Diovan has not shown any clinical benefit (see section 5.1).
Pri bolnikih s sr nim popuš anjem uporaba trojne kombinacija zaviralca ACE, antagonista adrenergi nih receptorjev beta in zdravila Diovan ni pokazala klini nih koristi (glejte poglavje 5.1).
Use in paediatric patients aged 6 to 18 years with renal impairment Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Uporaba pri pediatri nih bolnikih, ki so stari od 6 do 18 let in imajo okvaro ledvic Pri pediatri nih bolnikih z o istkom kreatinina < 30 ml/min in pri pediatri nih bolnikih, ki se zdravijo z dializo, uporabe valsartana niso prou evali, zato pri teh bolnikih ni priporo ena.
Children and adolescents (6 to 18 years of age) with high blood pressure In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily.
Otroci in mladostniki (stari od 6 do 18 let) z visokim krvnim tlakom Za bolnike s telesno maso pod 35 kg je obi ajni odmerek 40 mg valsartana enkrat na dan. Za bolnike s telesno maso 35 kg ali ve je obi ajni za etni odmerek 80 mg valsartana enkrat na dan.
Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
V klini ni študiji, v katero je bilo vklju enih 261 hipertenzivnih pediatri nih bolnikov v starosti od 6 do 16 let, so bolniki s telesno maso < 35 kg v obliki tablet prejemali 10, 40 ali 80 mg valsartana na dan (nizke, srednje ali visoke odmerke), bolniki s telesno maso 35 kg pa so v obliki tablet prejemali 20, 80 ali 160 mg valsartana na dan (nizke, srednje ali visoke odmerke).
The average time to peak concentration and elimination half-life of valsartan in heart failure patients are similar to that observed in healthy volunteers.
Povpre ni as do najvišje koncentracije in razpolovni as izlo anja valsartana pri bolnikih s sr nim popuš anjem sta podobna kot pri zdravih prostovoljcih.
As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Kot pri odraslih je zdravilo Diovan kontraindicirano pri pediatri nih bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavji 4.3 in 5.2).
The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
V študiji zmanjševanja proteinurije z zdravilom Diovan (Diovan Reduction of Proteinuria - DROP) so naprej preu evali u inkovitost valsartana pri zmanjšanju izlo anja albumina z urinom pri 391 hipertenzivnih bolnikih (s krvnim tlakom 150/88 mmHg), s sladkorno boleznijo tipa 2, z albuminurijo (v povpre ju 102 µg/min; v obsegu 20-700 µg/min) in z ohranjenim delovanjem ledvic (s povpre no koncentracijo kreatinina v serumu 80 µmol/l).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Ob potrjeni nose nosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, e je primerno, za eti alternativno zdravljenje.
Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Zdravljenje simptomatskega sr nega popuš anja pri odraslih bolnikih v primerih, ko ni mogo e uporabiti zaviralcev angiotenzinske konvertaze (ACE), ali kot dodatno zdravljenje poleg zaviralcev ACE, ko ni mogo e uporabiti antagonistov adrenergi nih receptorjev beta (glejte poglavji 4.4 in 5.1).
The effect of the treatment can be influenced if Diovan is taken together with certain other medicines.
So asno jemanje nekaterih drugih zdravil lahko vpliva na u inek zdravljenja z zdravilom Diovan.
There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Obseg klini nih izkušenj z uporabo zdravila Diovan pri pediatri nih bolnikih z blago do zmerno okvaro jeter je omejen.
During repeated dosing, the antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks and persist during long-term therapy.
Po ve kratnem odmerjanju pride do znatnega znižanja krvnega tlaka v 2 tednih, v 4 tednih pa do najve jega u inka, ki se med dolgotrajnim zdravljenjem ohranja.
Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age.
Zdravljenje esencialne hipertenzije pri odraslih in hipertenzije pri otrocih in mladostnikih, starih od 6 do 18 let.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
e se izkaže, da je so asna uporaba obeh zdravil nujna, je priporo eno skrbno spremljanje koncentracije litija v serumu.
ANNEX II AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNA ILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
Val-HeFT was a randomised, controlled, multinational clinical trial of valsartan compared with placebo on morbidity and mortality in 5,010 NYHA class II (62%), III (36%) and IV (2%) heart failure patients receiving usual therapy with LVEF <40% and left ventricular internal diastolic diameter (LVIDD) >2.9 cm/m2.
Val-HeFT je bilo randomizirano, kontrolirano, multinacionalno klini no preskušanje valsartana v primerjavi s placebom glede obolevnosti in umrljivosti pri 5.010 bolnikih s sr nim popuš anjem razreda NYHA II (62 %), III (36 %) in IV (2 %), ki so prejemali obi ajno terapijo in so imeli iztisni delež levega prekata < 40 % in notranji diastoli ni premer levega prekata (left ventricular internal diastolic diameter - LVIDD) > 2,9 cm/m2.
• Tell your doctor if you are breast-feeding or about to start breast-feeding.
• Povejte svojemu zdravniku, e dojite ali nameravate za eti dojiti.
The mean duration of follow-up was nearly two years.
Bolnike so v povpre ju spremljali skoraj dve leti.
Hypertension Treatment of hypertension in children and adolescents 6 to 18 years of age.
Hipertenzija Zdravljenje hipertenzije pri otrocih in mladostnikih, starih od 6 do 18 let.
• decreased kidney function (signs of renal impairment)
• zmanjšano delovanje ledvic (znak ledvi ne okvare)
Diovan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Zdravilo Diovan je kontraindicirano pri bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavja 4.3, 4.4 in 5.2).
At the end of 2 weeks, valsartan reduced both systolic and diastolic blood pressure in a dose-dependent manner.
Po dveh tednih je valsartan v odvisnosti od odmerka znižal tako sistoli ni kot diastoli ni krvni tlak.
Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Pregled bolnikov po miokardnem infarktu mora vedno vklju evati oceno ledvi ne funkcije (glejte poglavje 4.2).
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država lanica]
Blood and lymphatic system disorders Not known
Bolezni krvi in limfati nega sistema neznana trombocitopenija
These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Ti odmerki pri podganah (200 do 600 mg/kg/dan) so približno 6-krat in 18-krat ve ji od najve jega priporo enega odmerka za ljudi na osnovi mg/m2 (izra un predvideva peroralni odmerek 320 mg/dan in 60-kg bolnika).
Use of Diovan in post-myocardial infarction patients commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Uporaba zdravila Diovan pri bolnikih po miokardnem infarktu pogosto povzro i dolo eno znižanje krvnega tlaka, vendar zaradi vztrajne simptomatske hipotenzije obi ajno ni potrebno prekiniti zdravljenja, e bolnik uporablja zdravilo v skladu z navodili za odmerjanje (glejte poglavje 4.2).
Adult patients after a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily.
Odrasli bolniki po nedavnem sr nem napadu: Po sr nem napadu zdravljenje ve inoma za nemo že 12 ur po napadu z nizkimi odmerki 20 mg dvakrat na dan. Odmerek 20 mg dobite tako, da razpolovite 40-miligramsko tableto.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
e se zdravite zaradi srnega popušanja, ni priporoena uporaba trojne kombinacija z zaviralci ACE in antagonisti adrenerginih receptorjev beta (zdravila za zdravljenje srnega popušanja).
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Zdravljenja z antagonisti angiotenzina II se ne sme za eti med nose nostjo.
Adult patients with heart failure: Treatment starts generally with 40 mg twice daily.
Odrasli bolniki s sr nim popuš anjem: Zdravljenje obi ajno za nemo s 40 mg dvakrat na dan.
These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Ti odmerki pri podganah (600 mg/kg/dan) so približno 18-krat ve ji od najve jega priporo enega odmerka za ljudi na osnovi mg/m2 (izra un predvideva peroralni odmerek 320 mg/dan in 60-kg bolnika).
Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Uporaba zdravila Diovan ni priporo ljiva v zgodnjem obdobju nose nosti, po tretjem mesecu nose nosti pa lahko povzro i resno škodo vašemu otroku (glejte poglavje Nose nost in dojenje).
This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
To je zlasti pomembno, e ima bolnik, ki prejema valsartan, še druge težave, ki lahko ovirajo delovanje ledvic ( e ima zvišano telesno temperaturo ali je dehidriran).
The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimese ju nose nosti (glejte poglavji 4.3 in 4.4).
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Po za etnem odmerku 20 mg dvakrat na dan je treba v naslednjih nekaj tednih odmerek valsartana postopno prilagajati na 40 mg, 80 mg in 160 mg dvakrat na dan. Za etni odmerek vzame bolnik v obliki 40-miligramske deljive tablete.
• dizziness
• omoti nost
Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Zdravilo Diovan uporabimo takrat, kadar ne moremo uporabiti zdravila iz skupine, ki se imenuje zaviralci angiotenzinske konvertaze (ACE) (zdravila pri zdravljenju sr nega popuš anja), lahko pa ga uporabimo poleg zaviralca ACE, kadar ne moremo uporabiti antagoniste adrenergi nih receptorjev beta (druga vrsta zdravil pri zdravljenju sr nega popuš anja).
Nausea, Diarrhoea
Bolezni prebavil ob asni navzea, diareja
Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs
Nesteroidna protivnetna zdravila (NSAIDs), vklju no s selektivnimi zaviralci COX-2, z acetilsalicilno kislino >3 g/dan) in z neselektivnimi nesteroidnimi protivnetnimi zdravili(NSAIDs) Pri so asni uporabi antagonistov angiotenzina II z nesteroidnimi protivnetnimi zdravili lahko pride do zmanjšanja antihipertenzivnega u inka.
Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Uporaba zdravila Diovan pri bolnikih s sr nim popuš anjem pogosto povzro i dolo eno znižanje krvnega tlaka, vendar zaradi vztrajne simptomatske hipotenzije obi ajno ni potrebno prekiniti zdravljenja, e bolnik uporablja zdravilo v skladu z navodili za odmerjanje (glejte poglavje 4.2).
One film-coated tablet contains 320 mg of valsartan.
Ena filmsko obložena tableta vsebuje 320 mg valsartana.
• to treat high blood pressure in children and adolescents 6 to 18 years of age.
• Za zdravljenje visokega krvnega tlaka pri otrocih in mladostnikih, ki so stari 6 do 18 let.
• to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age.
• Za zdravljenje visokega krvnega tlaka pri odraslih in pri otrocih ter mladostnikih, ki so stari od 6 do 18 let.
Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Natan no je treba spremljati delovanje ledvic in vrednosti kalija v serumu (glejte poglavji 4.4 in 5.2).
Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Pri otrocih in mladostnikih, ki so bili stari od 6 do 18 let in so že imeli kroni no bolezen ledvic, so pogosteje opažali hiperkaliemijo.
Renal function and serum potassium should be closely monitored (see sections 4.2 and 4.4).
Natan no je treba spremljati delovanje ledvic in vrednosti kalija v serumu (glejte poglavji 4.2 in 4.4).
Diovan 160 mg film-coated tablets can be used for three different conditions:
Diovan 160 mg filmsko obložene tablete je mogo e uporabljati pri zdravljenju treh bolezni:
High blood pressure increases the risk of heart attacks.
Visok krvni tlak pove uje tveganje za sr ni napad.
No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Pri pediatri nih bolnikih z o istkom kreatinina > 30 ml/min odmerkov ni treba prilagajati.
• increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
• zvišana koncentracija kalija v krvi (ki lahko v hudih primerih sproži miši ne kr e in nenormalen sr ni ritem)
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
Najve ji ciljni odmerek je 160 mg dvakrat na dan. Na splošno je priporo eno, da bolniki dosežejo raven odmerka 80 mg dvakrat na dan v dveh tednih po za etku zdravljenja in da dosežejo najve ji ciljni odmerek, 160 mg dvakrat na dan, v treh mesecih glede na to, kako bolnik odmerjanje prenaša.
No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Pri pediatri nih bolnikih z o istkom kreatinina > 30 ml/min odmerkov ni treba prilagajati (glejte poglavji 4.2 in 5.2).
In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Varnosti uporabe zdravila Diovan pri bolnikih z obojestransko stenozo ledvi ne arterije ali s stenozo arterije solitarne ledvice niso ugotavljali.
Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up.
Simptomi sr nega popuš anja vklju ujejo zadihanost ter otekanje stopal in nog zaradi zastajanja teko ine.
Maximum dose studied in clinical trials
Telesna masa najvišji odmerek, ki so ga prou evali v klini nih preskušanjih
Renal and urinary disorders, and obesity were the most common underlying medical conditions potentially contributing to hypertension in the children enrolled in these studies.
Med osnovnimi boleznimi, ki bi pri otrocih v teh študijah lahko prispevale k razvoju hipertenzije, so bile najbolj pogoste bolezni se il in debelost.
When a viable and mutually agreed study plan emerges from the dialogue, a new study will be initiated within one year.
e bo rezultat dialoga izvedljiv in obojestransko sprejet na rt za študijo, se bo nova študija za ela izvajati v roku enega leta, izvesti je treba primerjalno študijo biološke razpoložljivosti, ki bi potrdila relativno odmerjanje tablet in peroralne raztopine.
Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Boljša izbira so alternativna zdravila z uveljavljenim boljšim varnostnim profilom za uporabo med dojenjem, še zlasti pri dojenju novorojen ka ali nedonošen ka.
These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Navedeni u inki so pri akovani prekomerno izraženi farmakološki u inki zaviralcev angiotenzinske konvertaze in antagonistov receptorjev tipa 1 angiotenzina II.
Caution should be observed when initiating therapy in post-myocardial infarction patients.
Pri uvajanju zdravljenja pri bolnikih po miokardnem infarktu je potrebna previdnost.
No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Pri odraslih bolnikih z o istkom kreatinina > 10 ml/min odmerka ni treba prilagajati (glejte poglavji 4.2 in 5.2).
• decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood
• zmanjšana koncentracija hemoglobina in zmanjšan odstotek rde ih krvnih celic v krvi (ki lahko v hudih primerih povzro i anemijo)
Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
AUC) za okrog 40 % in njegovo najvišjo koncentracijo v plazmi (Cmax) za okrog 50 %, vendar pa je od približno 8. ure po odmerjanju koncentracija valsartana v plazmi približno enaka pri skupini preiskovancev, ki so jedli, in pri tistih, ki so vzeli zdravilo na teš e. Tega zmanjšanja AUC pa ne spremlja klini no pomembno zmanjšanje terapevtskega u inka, zato je valsartan mogo e dajati bodisi s hrano ali brez nje.
Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan.
Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila Diovan, saj jemanje zdravila Diovan v zgodnjem obdobju nose nosti ni priporo ljivo in lahko po tretjem mesecu nose nosti povzro i resno škodo vašemu otroku.
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Pregled bolnikov po miokardnem infarktu mora vedno vklju evati oceno ledvi ne funkcije.
Diovan 80 mg film-coated tablets can be used for three different conditions:
Diovan 80 mg filmsko obložene tablete je mogo e uporabljati pri zdravljenju treh bolezni:
5.1 Pharmacodynamic properties
5.1 Farmakodinami ne lastnosti
This dose is 6 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Navedeni odmerek 6-krat presega najvišji priporo eni odmerek na osnovi enote mg/m2 pri ljudeh (izra un temelji na predpostavki, da 60-kilogramski bolnik zaužije 320 mg valsartana na dan).
Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Zato sta na za etku zdravljenja priporo ena spremljanje ledvi ne funkcije in zadosten vnos teko in.
Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Pri pediatri nih bolnikih z o istkom kreatinina < 30 ml/min in pri pediatri nih bolnikih, ki se zdravijo z dializo, uporabe valsartana niso prou evali, zato pri teh bolnikih ni priporo ena.
One film-coated tablet contains 160 mg of valsartan.
Ena filmsko obložena tableta vsebuje 160 mg valsartana.
Diovan 40 mg film-coated tablets can be used for three different conditions:
Diovan 40 mg filmsko obložene tablete je mogo e uporabljati pri zdravljenju treh bolezni:
35 kg to <80 kg
35 kg do < 80 kg 160 mg
One film-coated tablet contains 40 mg of valsartan.
Ena filmsko obložena tableta vsebuje 40 mg valsartana.