FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Če ga ne zdravimo, lahko poškoduje krvne žile v možganih, srcu in ledvicah, kar lahko povzročimožgansko kap, popuščanje srca ali odpoved ledvic.
English: Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Slovenian: Preveliko odmerjanje zdravila Diovan lahko povzroči izrazito hipotenzijo, ki lahko vodi v motnje zavesti, cirkulacijski kolaps in/ali šok.
English: • difficulty in breathing or swallowing
Slovenian: • težave z dihanjem in s požiranjem
English: Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Slovenian: Valsartan je peroralno aktiven, močan in specifičen antagonist receptorjev angiotenzina II.
English: A causal relationship to Diovan has not been established.
Slovenian: Vzročne povezanosti z zdravilom Diovan niso ugotovili.
English: Put the end of the oral syringe into the mouth.
Slovenian: Odprti konec brizge za peroralno dajanje vstavite v usta.
English: Sodium and/or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Slovenian: Pomanjkanje natrija in hipovolemijo je treba pred začetkom zdravljenja z zdravilom Diovan odpraviti, na primer z zmanjšanjem odmerka diuretika.
English: The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Slovenian: Varnostni profil iz kontroliranih kliničnih študij pri odraslih bolnikih po miokardnem infarktu in/ali srčnim popuščanjem se razlikuje od splošnega profila varnosti pri hipertenzivnih bolnikih.
English: • The active substance is valsartan.
Slovenian: • Zdravilna učinkovina je valsartan.
English: It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Slovenian: Deluje selektivno na receptorje podvrste AT1, ki so odgovorni za znane učinke angiotenzina II.
English: 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).
Slovenian: Po intravenski uporabi je plazemski očistek valsartana približno 2 l/uro, njegov ledvični očistek pa 0,62 l/uro (približno 30 % celotnega očistka).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Diovan in all subsets of the paediatric population in heart failure and heart failure after recent myocardial infarction.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Diovan za vse skupine pediatrične populacije za srčno popuščanje in za srčno popuščanje po nedavnem miokardnem infarktu.
English: • if you are taking medicines that increase the amount of potassium in your blood.
Slovenian: • če jemljete zdravila, ki povečujejo količino kalija v krvi.
English: - Hypersensitivity to the active substance or to any of the excipients.
Slovenian: - Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
English: If any of these apply to you, tell your doctor before you take Diovan.
Slovenian: Če karkoli od naštetega velja za vas, obvestite svojega zdravnika, preden uporabite zdravilo Diovan.
English: In the first study, the efficacy of valsartan was confirmed compared to placebo but a dose-response could not be demonstrated.
Slovenian: V prvi študiji so dokazali učinkovitost valsartana v primerjavi s placebom, niso pa mogli potrditi odvisnosti odziva od odmerka.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Slovenian: Volumen porazdelitve valsartana v stanju dinamičnega ravnovesja je po intravenskem vnosu okrog 17 litrov, kar kaže, da se valsartan v tkiva ne porazdeli v veliki meri.
English: 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.
Slovenian: Pogostnost neželenih učinkov ni videti sorodna z velikostjo odmerka ali s trajanjem zdravljenja, pa tudi ne s spolom, starostjo ali raso.
English: • if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
Slovenian: • če izgubite veliko tekočine (dehidracija) zaradi driske, bruhanja ali velikih odmerkov tablet za odvajanje vode (diuretikov),
English: 130 00 Praha 3
Slovenian: U Nákladového nádraží 10 130 00 Praha 3
English: • Wipe the outside of the oral syringe with a clean, dry tissue.
Slovenian: • Brizgo za peroralno dajanje z zunanje strani obrišite s čisto in suho krpo.
English: Diovan oral solution contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Slovenian: Diovan peroralna raztopina vsebuje metilparahidroksibenzoat, ki lahko povzroča alergijske reakcije (lahko zakasnele).
English: • medicines that increase the amount of potassium in your blood.
Slovenian: • zdravila, ki lahko zvišajo količino kalija v vaši krvi.
English: Treatment of hypertension in children and adolescents 6 to 18 years of age.
Slovenian: Zdravljenje hipertenzije pri otrocih in mladostnikih, starih od 6 do 18 let.
English: Do not take Diovan:
Slovenian: Ne jemljite zdravila Diovan:
English: • that can be used if the prescribed dose requires filling the syringe several times.
Slovenian: • ki jo uporabite, kadar je za odmerjanje predpisanega odmerka treba večkrat napolniti brizgo.
English: The final study report should be submitted by the last quarter of 2010.
Slovenian: Zaključno poročilo o študiji mora biti predloženo najpozneje do zadnjega četrtletja leta 2010,
English: In hypertensive patients with type 2 diabetes and microalbuminuria, valsartan has been shown to reduce the urinary excretion of albumin.
Slovenian: Pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2 in z mikroalbuminurijo se je pokazalo, da valsartan zmanjša izločanje albumina v urinu.
English: Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Slovenian: Zdravilo Diovan sodi v skupino zdravil, znano pod imenom antagonisti receptorjev angiotenzina II, ki pomagajo uravnavati visok krvni tlak.
English: Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap).
Slovenian: Zaporko odstranite s steklenice tako, da jo močno pritisnete navzdol in jo obrnete v smeri, ki je nasprotna smeri urinega kazalca (kot kaže puščica na vrhu zaporke).
English: Valsartan does not inhibit ACE (also known as kininase II) which converts Ang I to Ang II and degrades bradykinin.
Slovenian: Valsartan ne zavira angiotenzinske konvertaze ACE (znane tudi kot kininaza II), ki pretvarja angiotenzin I v angiotenzin II in razkraja bradikinin.
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Slovenian: • nekatere vrste zdravil za lajšanje bolečin, ki se imenujejo nesteroidna protivnetna zdravila
English: • fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
Slovenian: • zvišana telesna temperatura, vneto grlo ali razjede v ustih zaradi okužbe (simptomi nizke koncentracije belih krvnih celic, imenovane tudi nevtropenija)
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Slovenian: Zato sta na začetku zdravljenja priporočena spremljanje ledvične funkcije in zadosten vnos tekočin.
English: Fitting the press in bottle adapter into a new bottle of medicine
Slovenian: Vstavljanje pritisnega nastavka za steklenico v novo steklenico z zdravilom
English: No children below the age of 1 year were enrolled in these studies.
Slovenian: V ti dve študiji niso vključevali otrok, ki bi bili mlajši od 1 leta.
English: Indirect comparisons suggest that, the oral bioavailability of valsartan with the solution is approximately 2-fold higher than the tablets.
Slovenian: Posredne primerjave kažejo, da je peroralna biološka uporabnost valsartana pri uporabi raztopine približno 2krat večja kot pri uporabi tablet.
English: In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Slovenian: Pri marmozetkah so bile pri podobnih odmerkih spremembe podobne, vendar bolj resne, še zlasti v ledvicah, kjer so se pojavile spremembe, podobne nefropatiji, ki so vključevale zvišanje ravni sečnine in kreatinina.
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Slovenian: • mišični krči, nenormalen srčni ritem (znaki hiperkaliemije)
English: Preparing a dose of medicine
Slovenian: Pripravljanje odmerka zdravila
English: 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.
Slovenian: Za vse neželene učinke, o katerih so poročali na podlagi izkušenj po začetku trženja zdravila in laboratorijskih izvidov, pogostnosti ni mogoče ugotoviti, zato je njihova pogostnost navedena kot "neznana".
English: 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.
Slovenian: Uporaba zdravila Diovan ni priporočena za matere, ki dojijo, zato lahko vaš zdravnik izbere drugo zdravljenje, če želite dojiti, še zlasti, če gre za novorojenčka ali nedonošenčka.
English: • low blood pressure with or without symptoms such as dizziness and fainting when standing up
Slovenian: • nizek krvni pritisk s simptomi, kot sta omotičnost in izguba zavesti pri vstajanju, ali brez teh simptomov
English: 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.
Slovenian: Iz tega razloga ni mogoče izključiti možnosti, da bi bili navedeni pojavi lahko klinično pomembni pri otrocih, ki so mlajši od 1 leta, hkrati pa zaradi predkliničnih podatkov ni nobenih pomislekov glede varne uporabe zdravila pri otrocih, ki so starejši od 1 leta.
English: • Do this after each time that you use the oral syringe.
Slovenian: • To opravite po vsaki uporabi brizge za peroralno dajanje.
English: Children less than 6 years of age
Slovenian: Otroci, stari manj kot 6 let
English: Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mmHg from the baseline, respectively.
Slovenian: V celoti je pri treh ravneh odmerkov valsartana (nizki, srednji in visoki) prišlo do pomembnega znižanja sistoličnega krvnega tlaka za 8, 10 oziroma 12 mmHg od izhodiščnih vrednosti.
English: If the prescribed dose requires filling the syringe several times, you can empty the measured doses of medicine from the syringe into the dosing cup and then check the total volume of solution.
Slovenian: Če morate za odmerjanje predpisanega odmerka večkrat napolniti brizgo za peroralno dajanje, lahko odmerjene količine zdravila iz brizge izpraznite v merico, v kateri lahko preverite celotno količino odmerjene raztopine.
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Slovenian: Druge bolezni, pri katerih je stimuliran renin-angiotenzinski sistem Pri bolnikih, pri katerih je delovanje ledvic lahko odvisno od aktivnosti renin-angiotenzinskega sistema, (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem), je bilo zdravljenje z zaviralcem angiotenzinske konvertaze povezano z oligurijo in/ali s progresivno azotemijo, v redkih primerih tudi z akutno odpovedjo ledvic in/ali s smrtjo.
English: Administration of Diovan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Slovenian: Uporaba pri odraslih Pri bolnikih s hipertenzijo zdravilo Diovan zniža krvni tlak, ne da bi vplivalo na srčno frekvenco.
English: However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Slovenian: Vendar pa lahko druga zdravila, ki vplivajo na renin-angiotenzinski sistem, povečajo vrednosti dušika sečnine v krvi in kreatinina v serumu pri bolnikih z enostransko stenozo ledvične arterije, zato je med zdravljenjem bolnikov z valsartanom priporočeno spremljanje ledvične funkcije.
English: • unusual bleeding or bruising (signs of thrombocytopenia)
Slovenian: • nenavadne krvavitve ali modrice (znaki trombocitopenije)
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Slovenian: Znižanje sistoličnega 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).
English: Take special care with Diovan:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Diovan:
English: If you stop taking Diovan
Slovenian: Če prenehate jemati zdravilo Diovan
English: • Rinse the cup with clean water.
Slovenian: • Merico sperite s čisto vodo.
English: Use in children under 6 years of age.
Slovenian: uporabo pri otrocih, mlajših od šest let,
English: In the second study, higher doses of valsartan were associated with greater BP reductions, but the dose response trend did not achieve statistical significance and the treatment difference compared to placebo was not significant.
Slovenian: V drugi študiji se je pokazala povezava med višjimi odmerki in večjim znižanjem krvnega tlaka, vendar trend odvisnosti odziva od odmerka ni dosegel statistične značilnosti, pa tudi razlika zaradi zdravljenja v primerjavi s placebom ni bila statistično značilna.
English: Therefore, if switching from Diovan tablets to Diovan oral solution is considered essential on clinical grounds, the valsartan dose should be adjusted as described in the table below and blood pressure should be carefully monitored.
Slovenian: Če kaže, da je prehod z uporabe Diovan tablet na uporabo Diovan peroralne raztopine iz kliničnih razlogov nujno potreben, je treba odmerke valsartana prilagoditi tako, kot je navedeno v spodnji preglednici, pri tem pa je treba skrbno spremljati krvni tlak.
English: 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).
Slovenian: Pri podganah so odmerki, toksični za mater, (600 mg/kg/dan) v zadnjih dneh brejosti in med dojenjem povzročili zmanjšano preživetje, nižjo telesno maso, upočasnitev razvoja (neprirasel uhelj in odprt ušesni kanal) (glejte poglavje 4.6) pri potomstvu.
English: The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Slovenian: Namen študije je bil določiti optimalni odmerek valsartana za zmanjšanje izločanja albumina z urinom pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2.
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Slovenian: Povprečna absolutna biološka uporabnost je 23 % po zaužitju tablet in 39 % po zaužitju raztopine.
English: As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Slovenian: Ker je valsartan antagonist angiotenzina II, ni mogoče izključiti, da je uporaba zdravila Diovan lahko sorodna z okvaro delovanja ledvic.
English: Diovan works by blocking the effect of angiotensin II.
Slovenian: Zdravilo Diovan deluje tako, da zavira delovanje angiotenzina II.
English: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Slovenian: Zaključili so, da je 160-320 mg valsartana doseže klinično pomembno zmanjšanje izločanja albumina z urinom pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2.
English: If you forget to take Diovan
Slovenian: Če ste pozabili vzeti zdravilo Diovan
English: Slowly pull the plunger out until the top edge of the black ring inside is exactly level with the marker.
Slovenian: Počasi vlecite bat navzdol tako dolgo, da bo zgornji rob črnega obroča natančno pokril izbrano oznako.
English: Abrupt withdrawal of Diovan has not been associated with rebound hypertension or other adverse clinical events.
Slovenian: Po nenadni prekinitvi jemanja zdravila Diovan ni prišlo do povratne hipertenzije ali drugih neželenih kliničnih dogodkov.
English: The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih študijah, na podlagi izkušenj po začetku trženja zdravila in laboratorijskih izvidov, so po organskih sistemih našteti v spodnji preglednici.
English: 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).
Slovenian: Kratkotrajna uporaba zdravila Diovan pri dvanajstih bolnikih z enostransko stenozo ledvične arterije in renovaskularno hipertenzijo ni povzročila pomembnih sprememb ledvične hemodinamike, koncentracije kreatinina v serumu ali dušika sečnine v krvi (blood urea nitrogen - BUN).
English: What Diovan looks like and contents of the pack Diovan 3 mg/ml oral solution is a clear, colourless to pale yellow solution.
Slovenian: Izgled zdravila Diovan in vsebina pakiranja Diovan 3 mg/ml peroralna raztopina je bistra brezbarvna do bledo rumena raztopina.
English: You can take Diovan with or without food.
Slovenian: Zdravilo Diovan je mogoče jemati s hrano ali brez nje.
English: 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.
Slovenian: Poleg tega lahko sočasna uporaba antagonistov angiotenzina II in nesteroidnih protivnetnih zdravil povzroči povečano tveganje za poslabšanje delovanja ledvic in zvišanje koncentracije kalija v serumu.
English: If you have further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: Before you measure your dose you need to get rid of any large bubbles that may be trapped in the oral syringe.
Slovenian: Preden boste odmerili pravilno količino zdravila, morate odstraniti večje mehurčke, ki se lahko pojavijo v brizgi za peroralno dajanje.
English: There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Slovenian: Presaditev ledvic Trenutno ni izkušenj o varni uporabi zdravila Diovan pri bolnikih, ki so jim nedavno presadili ledvico.
English: • that consists of a clear plastic tube with a plunger inside.
Slovenian: • ki je sestavljena iz prozorne plastične cevi z batom.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Slovenian: Čeprav ni na voljo podatkov glede tveganja pri uporabi antagonistov angiotenzina II iz kontroliranih epidemioloških študij, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: In another clinical study involving 300 hypertensive paediatric patients 6 to 18 years of age, eligible patients were randomized to receive valsartan or enalapril tablets for 12 weeks.
Slovenian: V drugi klinični študiji, v katero je bilo vključenih 300 hipertenzivnih pediatričnih bolnikov v starosti od 6 do 18 let, so bolnike, ki so bili primerni za vključitev, randomizirali tako, da so 12 tednov prejemali tablete z bodisi valsartanom ali enalaprilom.
English: Each ml solution contains 0.3 g sucrose, 1.62 mg methyl parahydroxybenzoate (E218) and 5 mg poloxamer (188)
Slovenian: En mililiter raztopine vsebuje 0,3 g saharoze, 1,62 mg metilparahidroksibenzoata (E218) in 5 mg poloksamera (188).
English: • slowly pull the plunger all the way out so that the oral syringe fills with medicine.
Slovenian: • počasi vlecite bat tako dolgo, da se brizga povsem napolni z zdravilom,
English: If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised.
Slovenian: Če je ocenjeno, da je zdravilo, ki vpliva na koncentracijo kalija, potrebno uporabiti v kombinaciji z valsartanom, je priporočeno spremljanje koncentracije kalija v plazmi.
English: 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.
Slovenian: Po zaviranju receptorja AT1 z valsartanom lahko zvišana koncentracija angiotenzina II v plazmi stimulira nezavrte receptorje podvrste AT2, ki, kot kaže, izravnavajo učinek receptorjev AT1.
English: • Dry the cup with a clean tissue and place it back over the cap of the bottle.
Slovenian: • Obrišite jo s čisto krpo in jo namestite spet na zaporko na steklenici.
English: 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.
Slovenian: Pri otrocih in mladostnikih s hipertenzijo, pri katerih so pogosto prisotne tudi bolezenske spremembe ledvic, je priporočena previdnost pri sočasni uporabi valsartana in drugih učinkovin, ki zavirajo delovanje sistema renin-angiotenzin-aldosteron, kar lahko zviša koncentracijo kalija v serumu.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: [Izpolni država članica]
English: 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.
Slovenian: Pri večini bolnikov pride do antihipertenzivnega učinka v 2 urah po vnosu posamičnega peroralnega odmerka, do največjega znižanja krvnega tlaka pa pride v 4 do 6 urah.
English: 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).
Slovenian: Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija Kot pri uporabi drugih vazodilatatorjev je potrebna posebna pozornost pri bolnikih z aortno ali mitralno stenozo ali s hipertrofično obstruktivno kardiomiopatijo (hypertrophic obstructive cardiomyopathy - HOCM).