FrancophonIA/ELRC3.0 huggingface dataset:
English: A physician survey of clinical management and uses of medicinal products in pediatric patients with heart failure.
Slovenian: raziskavo med zdravniki o klinični obravnavi in uporabi zdravil pri pediatričnih bolnikih s srčnim popuščanjem.
English: • Once you have inserted it, do not remove it.
Slovenian: • Nastavka, ki ste ga vstavili, ne odstranjujte s steklenice.
English: However, no correlation was observed between plasma valsartan concentration versus degree of hepatic dysfunction.
Slovenian: Vendar pa korelacije med koncentracijami valsartana v plazmi v primerjavi s stopnjo jetrne disfunkcije niso opazili.
English: For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Slovenian: Kaže, da terapevtski odmerki valsartana pri ljudeh ne vplivajo na hipertrofijo ledvičnih jukstaglomerularnih celic.
English: At 24 weeks, UAE was reduced (p<0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Slovenian: Po 24 tednih se je izločanje albumina z urinom zmanjšalo (p < 0,001) za 42 % (-24,2 µg/min; 95 % IZ: -40,4 do -19,1) z valsartanom in približno za 3 % (-1,7 µg/min; 95 % IZ: -5,6 do 14,9) z amlodipinom kljub podobnemu obsegu zmanjšanja krvnega tlaka pri obeh skupinah.
English: 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.
Slovenian: Antihipertenzivno delovanje valsartana so ocenjevali v dveh randomiziranih, dvojno slepih kliničnih študijah s 561 pediatričnimi bolniki v starosti od 6 do 18 let.
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Slovenian: Pri bolnikih, ki so prejemali nizke odmerke valsartana, je bila najnižja vrednost sistoličnega krvnega tlaka podobna vrednosti pri bolnikih, ki so prejemali placebo.
English: Because of these inconsistencies, valsartan is not recommended in this age group (see section 4.8).
Slovenian: Zaradi navedenih neskladnosti v rezultatih uporaba valsartana ni priporočena za to starostno skupino (glejte poglavje
English: • Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Slovenian: • Po odprtju lahko steklenico do 3 mesece shranjujete pri temperaturi do 30 °C.
English: In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a oneyear open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed.
Slovenian: 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.
English: Diovan oral solution is not bioequivalent to the tablet formulation and patients should not be switched unless clinically essential.
Slovenian: Diovan peroralna raztopina nima enake biološke uporabnosti kot Diovan tablete in bolniki ne smejo prehajati z ene oblike zdravila na drugo, razen če je to potrebno iz kliničnih razlogov.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Slovenian: Otroke, katerih matere so prejemale antagoniste angiotenzina II je treba skrbno opazovati glede hipotenzije (glejte tudi poglavji 4.3 in 4.4).
English: 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.
Slovenian: Hrana zmanjša izpostavljenost valsartanu (merjeno z 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 skupi preiskovancev, ki so jedli, in pri tistih, ki so vzeli zdravilo na tešče.
English: Patients were randomized to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Slovenian: Bolniki so bili randomizirani v eno od 3 skupin z odmerki valsartana 160, 320 ali 640 mg enkrat na dan, ki so jih prejemali 30 tednov.
English: At the end of 2 weeks, valsartan reduced both systolic and diastolic blood pressure in a dose-dependent manner.
Slovenian: Po dveh tednih je valsartan v odvisnosti od odmerka znižal tako sistolični kot diastolični krvni tlak.
English: • If you weigh less than 35 kg o the usual dose is 20 mg of valsartan (corresponding to 7 ml of the solution).
Slovenian: • Če tehtate manj kot 35 kg: o je običajni odmerek 20 mg valsartana (kar ustreza 7 ml raztopine).
English: • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
Slovenian: • zvišane vrednosti jetrnih testov (kar lahko kaže na poškodbo jeter), vključno z zvišano koncentracijo bilirubina v krvi (ki lahko v hudih primerih povzroči porumenelost kože in oči)
English: 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.
Slovenian: Po večkratnem odmerjanju pride do znatnega znižanja krvnega tlaka v 2 tednih, v 4 tednih pa do največjega učinka, ki se med dolgotrajnim zdravljenjem ohranja.
English: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours with tablets and 1-2 hours with solution formulation.
Slovenian: 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.
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
Slovenian: • zmanjšana koncentracija hemoglobina in zmanjšan odstotek rdečih krvnih celic v krvi (ki lahko v hudih primerih povzroči anemijo)
English: In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Slovenian: V kontroliranih kliničnih študijah pri odraslih bolnikih s hipertenzijo je bila pogostnost vseh neželenih učinkov primerljiva s tisto pri placebu in v skladu s farmakologijo valsartana.
English: For children who are unable to swallow tablets, the use of the Diovan oral solution up to 80 mg valsartan (corresponding to 27 ml) is recommended.
Slovenian: Za otroke, ki ne morejo pogoltniti tablet, je priporočena uporaba Diovan peroralne raztopine v odmerkih do 80 mg valsartana (kar ustreza 27 ml raztopine).
English: 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.
Slovenian: Pri ocenjevanju nevrokognitivnih sposobnosti in razvoja pri pediatričnih 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 klinično pomemben.
English: Find the marker on the oral syringe that corresponds to the required amount of medicine.
Slovenian: Na brizgi za peroralno dajanje poiščite ustrezno oznako za količino zdravila, ki jo potrebujete.
English: Method of administration Diovan may be taken independently of a meal.
Slovenian: Način uporabe Zdravilo Diovan je mogoče jemati neodvisno od obrokov.
English: • The solution is supplied in a pack containing one 180 ml amber glass bottle with a childresistant screw cap and a yellow tamper evident ring.
Slovenian: • Raztopina je na voljo v pakiranju, ki vsebuje eno 180-mililitrsko steklenico iz rjavega stekla z navojno za otroke varno zaporko in rumenim varovalnim obročem.
English: Paediatric heart failure and recent myocardial infarction Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Slovenian: Srčno popuščanje in nedavni miokardni infarkt pri pediatričnih bolnikih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Diovan ni priporočljiva za zdravljenje srčnega popuščanja ali nedavnega miokardnega infarkta pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Slovenian: Ker pa je valsartan v veliki meri vezan na beljakovine v plazmi, ni verjetno, da bi se izločal med dializo.
English: - Severe hepatic impairment, biliary cirrhosis and cholestasis.
Slovenian: - Huda okvara jeter, biliarna ciroza in holestaza.
English: Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Slovenian: Po odprtju lahko steklenico do 3 mesece shranjujete pri temperaturi do 30°C.
English: Instructions for using the oral syringe and the dosing cup
Slovenian: Navodila za uporabo brizge za peroralno dajanje in merice
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in karcinogenega potenciala ne kažejo posebnega tveganja za človeka.
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Slovenian: Bolniki s pomanjkanjem natrija in/ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo, ki prejemajo velike odmerke diuretikov, lahko v redkih primerih po začetku zdravljenja z zdravilom Diovan pride do simptomatske hipotenzije.
English: The bottle contains 160 ml of solution.
Slovenian: Steklenica vsebuje 160 ml raztopine.
English: Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
Slovenian: S tem so se ujemali tudi rezultati meritev diastoličnega tlaka, ki ga je valsartan znižal za 9,1 mmHg, enalapril pa za 8,5 mmHg.
English: It is not recommended to switch between Diovan tablets and Diovan oral solution unless clinically required as there is insufficient information to guide an appropriate dose on switching between the two formulations.
Slovenian: Prehajanje z uporabe Diovan tablet na uporabo Diovan peroralne raztopine in obratno ni priporočeno, razen če je to potrebno iz kliničnih razlogov, saj ni dovolj podatkov, na podlagi katerih bi lahko svetovali uporabo ustreznih odmerkov pri prehajanju z ene oblike zdravila na drugo.
English: 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.
Slovenian: 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 priporočenega pediatričnega odmerka 4 mg/kg/dan glede na sistemsko izpostavljenost zdravilu) je povzročilo persistentno neozdravljivo okvaro ledvic.
English: The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Slovenian: Antihipertenzivno delovanje valsartana so ocenjevali v štirih randomiziranih, dvojno slepih kliničnih študijah s 561 pediatričnimi bolniki v starosti od 6 do 18 let in s 165 pediatričnimi bolniki v starosti od 1 leta do 6 let.
English: Kemistvägen 1B P.O.
Slovenian: Novartis Sverige AB Kemistvägen 1B P.O. Box 1150
English: 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).
Slovenian: Kot pri odraslih, je zdravilo Diovan kontraindicirano pri pediatričnih bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavji 4.3 in 5.2).
English: 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.
Slovenian: Pri bolnikih, ki so nadaljevali zdravljenje s srednje visokimi in z visokimi odmerki valsartana, je bila najnižja vrednost sistoličnega krvnega tlaka nižja za 4 oziroma 7 mmHg od vrednosti pri bolnikih, ki so prejemali placebo.
English: Diovan oral solution contains poloxamer (188) which may cause softened stools.
Slovenian: Diovan peroralna raztopina vsebuje poloksamer (188), ki lahko povzroča odvajanje mehkejšega blata.
English: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Slovenian: Sočasna uporaba kalijevih nadomestkov, diuretikov, ki varčujejo kalij, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povzročijo zvečanje koncentracije kalija (heparin, itd.), ni priporočena.
English: Slowly push the plunger in and swallow the medicine directly from the oral syringe.
Slovenian: Počasi potiskajte bat in zaužijte zdravilo neposredno iz brizge za peroralno dajanje.
English: Check that the plunger is pushed fully into the oral syringe.
Slovenian: Poglejte, ali je bat v brizgi za peroralno dajanje pritisnjen do konca.
English: • if you have severe kidney disease or if you are undergoing dialysis.
Slovenian: • če imate hude težave z ledvicami ali če se zdravite z dializo,
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (p<0.05).
Slovenian: V kliničnem preskušanju pri bolnikih, ki so imeli v anamnezi suh kašelj v času zdravljenja z zaviralcem ACE, je do kašlja prišlo pri 19,5 % preiskovancev, ki so dobivali valsartan, pri 19,0 % tistih, ki so prejemali tiazidni diuretik, in pri 68,5 % preiskovancev, ki so dobivali zaviralec ACE (p < 0,05).
English: Note: You may not be able to push the bottle adapter down fully but this does not matter as it will be forced into the bottle when you screw the cap back on.
Slovenian: Opozorilo: Nastavka za steklenico morda ne boste mogli potisniti do konca, vendar naj vas to ne skrbi.
English: Remove the oral syringe from the bottle adapter by gently twisting it out.
Slovenian: Brizgo za peroralno dajanje odstranite iz steklenice tako, da jo izvlečete z rahlim vrtenjem.
English: • diarrhoea
Slovenian: • diareja
English: Holding the open bottle upright on a table, push the bottle adapter firmly into the neck of the bottle as far as it will go.
Slovenian: Steklenico postavite pokonci na mizo in nastavek močno pritisnite v vrat steklenice, dokler se ne ustavi.
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Slovenian: Po 30 tednih je bila z valsartanom 160 mg sprememba izločanja albumina z urinom v odstotkih značilno manjša za 36 % od izhodiščne vrednosti (95 % IZ: 22 do 47 %), z valsartanom 320 mg pa za 44 % (95 % IZ: 31 do 54 %).
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Slovenian: V študiji s 26 pediatričnimi hipertenzivnimi bolniki (v starosti od 1 leta do 16 let), ki so prejeli en sam odmerek valsartana v obliki suspenzije (povprečno 0,9 do 2 mg/kg, pri čemer je bil najvišji odmerek 80 mg), je bilo izločanje valsartana (l/h/kg) primerljivo pri vseh starostih od 1 leta do 16 let, in podobno izločanju pri odraslih, ki uporabljajo isto obliko zdravila.
English: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Slovenian: Razen posameznih prebavnih motenj (kot so bolečine v trebuhu, navzea, bruhanje) in omotičnosti, med varnostnimi lastnostmi zdravila pri pediatričnih bolnikih, starih 6 do 18 let, in že opisanimi varnostnimi lastnostmi pri odraslih, niso ugotovili bistvenih razlik glede vrste, pogostnosti ali izraženosti neželenih učinkov.
English: These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Slovenian: To vključuje kalijeve nadomestke ali nadomestke soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem in heparin.
English: Use in paediatric patients aged 6 to 18 years with hepatic impairment As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Slovenian: Uporaba pri pediatričnih bolnikih, ki so stari od 6 do 18 let in imajo okvaro jeter Kot pri odraslih je zdravilo Diovan kontraindicirano pri pediatričnih bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavja 4.3, 4.4 in 5.2).
English: ANNEX II AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: • severely decreased kidney function (signs of acute renal failure)
Slovenian: • zelo zmanjšano delovanje ledvic (znak akutne ledvične odpovedi)
English: Valsartan is unlikely to be removed by haemodialysis.
Slovenian: Ni verjetno, da bi se valsartan lahko izločil s hemodializo.
English: ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure are listed below.
Slovenian: Neželeni učinki, ki so se pojavljali pri odraslih bolnikih po miokardnem infarktu in/ali odraslih bolnikih s srčnim popuščanjem, so navedeni spodaj:
English: • allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
Slovenian: • lahko pride do alergijskih reakcij z izpuščajem, s srbenjem in s koprivnico; simptomov zvišane telesne temperature, otekanja sklepov in bolečin v sklepih, bolečin v mišicah, otekanja bezgavk in/ali simptomov, podobni gripi (znaki serumske bolezni)
English: Subsequently, frequent blood pressure monitoring should be performed taking into account potential under-dosing and dose should be titrated further based on blood pressure response and tolerability.
Slovenian: Nato je treba bolniku pogosto meriti krvni tlak, upoštevati možnost, da prejema prenizek odmerek in odmerek titrirati glede na odziv krvnega tlaka in glede na to, kako bolnik prenaša odmerek.
English: Contains sucrose, methyl parahydroxybenzoate (E218) and poloxamer (188) (see leaflet for further information).
Slovenian: Vsebuje saharozo, metilparahidroksibenzoat (E218) in poloksamer (188) (za več podatkov glejte priloženo navodilo).
English: A bottle containing the medicine:
Slovenian: Steklenica z zdravilom:
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 4.4).
Slovenian: Trenutno ni izkušenj o varni uporabi pri bolnikih z očistkom kreatinina < 10 ml/min in pri bolnikih, ki se zdravijo z dializo, zato je treba pri teh bolnikih valsartan uporabljati previdno (glejte poglavji 4.2 in 4.4).
English: • 1 ml oral solution contains 3 mg of valsartan.
Slovenian: • 1 ml peroralne raztopine vsebuje 3 mg valsartana.
English: A doubling of exposure (AUC) was observed in patients with mild to moderate hepatic impairment compared to healthy subjects.
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro so v primerjavi z zdravimi osebami opazili podvojitev izpostavljenosti (AUC).
English: The signs may include rash, itching, hives.
Slovenian: Znaki reakcije lahko vključujejo izpuščaj, srbenje ali koprivnico.
English: POSSIBLE SIDE EFFECTS Like all medicines, Diovan can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Diovan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If you have accidentally taken more Diovan solution than you should, contact your doctor, pharmacist, or hospital.
Slovenian: Če nehote vzamete preveč Diovan raztopine, pokličite svojega zdravnika, farmacevta ali v bolnišnico.
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je treba zdravilo Diovan uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: • Do not store above 30°C.
Slovenian: • Shranjujte pri temperaturi do 30 °C.
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Slovenian: Zato pri bolnikih z okvarjenim delovanjem ledvic odmerka ni treba prilagajati (očistek kreatinina > 10 ml/min).
English: • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
Slovenian: • zadihanost, težave z dihanjem v ležečem položaju, oteklina stopal in nog (znaki srčnega popuščanja)
English: • if you have liver disease.
Slovenian: • če imate bolezen jeter,
English: 180 ml amber type III glass bottle with a white child resistant polypropylene cap, including a polyethylene sealing disk and a yellow tamper evident ring, in addition the pack includes one dispensing kit containing one 5 ml oral dosing polypropylene syringe, one press in bottle adapter and one 30 ml polypropylene dosing cup.
Slovenian: 180-mililitrska steklenica iz rjavega stekla (tipa III) z belo polipropilensko za otroke varno zaporko, ki jo dopolnjujeta še polietilenska zaporna ploščica in rumeni varovalni obroč; pakiranju je priložen tudi komplet za odmerjanje, ki vsebuje eno 5-mililitrsko polipropilensko brizgo za peroralno dajanje, en pritisni nastavek za steklenico in eno 30-mililitrsko polipropilensko merico.
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: • if you have severe liver disease.
Slovenian: • če imate hudo bolezen jeter,
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur.
Slovenian: Nesteroidna protivnetna zdravila (NSAIDs), vključno s selektivnimi zaviralci COX-2, z acetilsalicilno kislino >3 g/dan) in z neselektivnimi nesteroidnimi protivnetnimi zdravili(NSAIDs)
English: The effect of the treatment can be influenced if Diovan is taken together with certain other medicines.
Slovenian: Sočasno jemanje nekaterih drugih zdravil lahko vpliva na učinek zdravljenja z zdravilom Diovan.