FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Slovenian: Kinetika hidroklorotiazida se po večkratni uporabi ne spremeni, kopičenje pa je ob uporabi enkrat na dan minimalno.
English: These findings appear to have no relevance to the use of therapeutic doses of valsartan in humans.
Slovenian: Kaže, da ti izsledki nimajo nobenega pomena za uporabo terapevtskih odmerkov valsartana pri ljudeh.
English: Since a proportion of patients might achieve blood pressure control by only increasing one of the components, and considering a safety issue, with regards to ADR allowing dose titration with both components, the CHMP recommended the titration of only one component at the same time.
Slovenian: Ker delež bolnikov lahko doseže nadzor krvnega tlaka s povečanjem le ene od sestavin in ob upoštevanju vprašanja varnosti, je CHMP, glede na to, da neželeni učinki zdravila dovoljujejo titracijo odmerka z obema sestavinama, priporočil titracijo le ene sestavine naenkrat.
English: Diovan Comp 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).
Slovenian: Uporaba zdravila Diovan Comp ni priporočena v zgodnjem obdobju nosečnosti, zdravila pa ne smete jemati po tretjem mesecu nosečnosti, saj lahko resno škoduje vašemu otroku, če zdravilo jemljete v tem obdobju (glejte poglavje o nosečnosti).
English: Section 4.6 - Pregnancy and Lactation
Slovenian: Poglavje 4.6 - Nosečnost in dojenje
English: In a pharmacokinetics trial in patients with mild (n=6) to moderate (n=5) hepatic dysfunction, exposure to valsartan was increased approximately 2-fold compared with healthy volunteers.
Slovenian: V farmakokinetični študiji pri bolnikih z blago (n=6) do zmerno (n=5) motnjo delovanja jeter je bila izpostavljenost valsartanu približno dvakrat večja kot pri zdravih prostovoljcih.
English: Denmark Novartis Healthcare A/S Lyngbyvej 172
Slovenian: Novartis Healthcare A/S Lyngbyvej 172
English: Overdose with valsartan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Slovenian: Preveliko odmerjanje valsartana lahko povzroči izrazito hipotenzijo, ki lahko vodi v motnje zavesti, cirkulacijski kolaps in/ali šok.
English: Also, should be taken into account the overall favourable benefit/risk profile of the valsartan/HCTZ 160/25 and 320/25 mg.
Slovenian: Prav tako je treba upoštevati celotno ugodno razmerje med koristmi/tveganji za valsartan/hidroklorotiazid 160/25 in 320/25 mg.
English: • if you are more than 3 months pregnant (it is also better to avoid Diovan Comp in early pregnancy - see pregnancy section).
Slovenian: • če ste noseči več kot 3 mesece (tudi v zgodnji nosečnosti se je bolje izogibati uporabi zdravila
English: The absorption of hydrochlorothiazide, after an oral dose, is rapid (tmax about 2 h), with similar absorption characteristics for both suspension and tablet formulations.
Slovenian: Absorpcija hidroklorotiazida po zaužitju je hitra (tmax približno 2 uri), absorpcijske značilnosti pa so podobne pri obeh pripravkih, suspenziji in tabletah.
English: • blistering of the lips, eyes or mouth
Slovenian: • mehurjast izpuščaj na ustnicah, očeh ali v ustih
English: • if you suffer from hyperaldosteronism.
Slovenian: • če imate hiperaldosteronizem.
English: Regarding the use of Diovan Comp during pregnancy and lactation, the CHMP decided to delete lactation as a contraindication in the revised SPC.
Slovenian: Glede uporabe zdravila Diovan Comp med nosečnostjo in dojenjem je CHMP odločil, da bo izbrisal dojenje kot kontraindikacijo v popravljenem povzetku glavnih značilnosti zdravila.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally]
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: [Izpolni država članica]
English: The CHMP adopted the following: “The recommended dose of Diovan Comp X mg/Y mg is one film-coated tablet once daily.
Slovenian: CHMP je sprejel sledeče: „Priporočen odmerek zdravila Diovan Comp X mg/Y mg je ena filmsko obložena tableta dnevno.
English: Regarding the Sodium and/or volume-depleted patients, the CHMP agreed to delete the last sentence of this paragraph considering this was textbook knowledge: “Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular weakness, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting”
Slovenian: V primeru bolnikov, osiromašenih z natrijem, in/ali volumsko osiromašenih bolnikov se je CHMP strinjal, da se izbriše zadnji stavek tega odstavka, saj je mnenja, da je to osnovno znanje: „Opozorilni znaki neravnovesja tekočin ali elektrolitov so suha usta, žeja, šibkost, letargija, dremavost, nemir, bolečine v mišicah ali krči, mišična šibkost, hipotenzija, oligurija, tahikardija in gastrointestinalne motnje kot je slabost ali bruhanje.”
English: As expected for a compound which is cleared almost exclusively via the kidneys, renal function has a marked effect on the kinetics of hydrochlorothiazide (see section 4.3).
Slovenian: Kot je mogoče pričakovati pri spojini, ki se izloča skoraj izključno preko ledvic, ima delovanje ledvic izrazit vpliv na kinetiko hidroklorotiazida (glejte poglavje 4.3).
English: • faintness, fainting on standing up
Slovenian: • omedlevica, izguba zavesti pri vstajanju
English: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours.
Slovenian: Po peroralni uporabi samo valsartana doseže ta najvišjo koncentracijo v plazmi v 2-4 urah.
English: A harmonised wording regarding pregnancy across the Angiotensin II Receptor Antagonists (AIIRA) class was introduced in October 2007 (Recommendations from EMEA Pharmacovigilance Working Party regarding the use of ACE inhibitors & AIIRAs in pregnancy).
Slovenian: Usklajeno besedilo glede nosečnosti in skupine antagonistov angiotenzin II receptorjev je bilo predstavljeno oktobra 2007 (Priporočila delovne skupine za farmakovigilanco pri Evropski agenciji za zdravila glede uporabe zaviralcev ACE (encima angiotenzin-konvertaze) in antagonistov angiotenzin II receptorjev med nosečnostjo).
English: The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms, stabilisation of the circulatory condition being of prime importance.
Slovenian: Ukrepi zdravljenja so odvisni od časa zaužitja in vrste ter izraženosti simptomov; pri čemer je najbolj pomembno stabilizirati stanje krvnega obtoka.
English: The use of Diovan Comp in patients with severe chronic heart failure has not been established.
Slovenian: Uporaba zdravila Diovan Comp pri bolnikih s hudim kroničnim srčnim popuščanjem ni dognana.
English: Elderly No dose adjustment is required in elderly patients.
Slovenian: Starejši Pri starejših bolnikih ni treba prilagajati odmerka.
English: The CHMP considered mentioning in this section a text on transporter proteins involved in uptake and elimination of valsartan and hydrochlorothiazide.
Slovenian: CHMP je razpravljal o omembi besedila o transportnih beljakovinah, vključenih v absorbcijo in izločanje valsartana in hidroklorotiazida, v tem poglavju.
English: • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”).
Slovenian: • Hidroklorotiazid sodi v skupino zdravil z imenom tiazidni diuretiki (ki jim pravimo tudi tablete za odvajanje vode).
English: In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
Slovenian: Pri študijah medsebojnega delovanja zdravil z valsartanom niso opazili klinično pomembnih interakcij z valsartanom ali katerokoli od naslednjih učinkovin: cimetidin, varfarin, furosemid, digoksin, atenolol, indometacin, hidroklorotiazid, amlodipin in glibenklamid.
English: Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Boljša izbira so alternativna zdravila z uveljavljenim boljšim varnostnim profilom za uporabo med dojenjem, še zlasti pri dojenju novorojenčka ali nedonošenčka.
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Slovenian: Valsartan je močno vezan na beljakovine v serumu (94-97 %), predvsem na albumin.
English: If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.
Slovenian: Če nehote vzamete preveč tablet, pokličite svojega zdravnika, farmacevta ali v bolnišnico.
English: Medicinal products that could induce torsades de pointes
Slovenian: Zdravila, ki lahko sprožijo torsades de pointes
English: The potential toxicity of the valsartan - hydrochlorothiazide combination after oral administration was investigated in rats and marmosets in studies lasting up to six months.
Slovenian: Potencialno toksičnost kombinacije valsartan - hidroklorotiazid po peroralni uporabi so raziskovali na podganah in marmozetkah v študijah, ki so trajale do 6 mesecev.
English: Therefore the use of Diovan Comp during breast feeding is not recommended.
Slovenian: Iz teh razlogov uporaba zdravila Diovan Comp med dojenjem ni priporočena.
English: Patients should be rehydrated before the administration.
Slovenian: Bolnike je treba pred uporabo kontrastnih sredstev rehidrirati.
English: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone 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.
Slovenian: Pri bolnikih, pri katerih je delovanje ledvic lahko odvisno od aktivnosti sistema renin-angiotenzinaldosteron, (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem), je bilo zdravljenje z zaviralci angiotenzinske konvertaze povezano z oligurijo in/ali s progresivno azotemijo, v redkih primerih tudi z akutno odpovedjo ledvic.
English: • if you have low levels of potassium in your blood.
Slovenian: • če imate znižano raven kalija v krvi.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: According to “Guideline on SPCs”, the CHMP placed ADR syncope in the frequency category “not known”.
Slovenian: V skladu s „Smernicami o povzetku glavnih značilnosti zdravila” je CHMP neželen učinek sinkope uvrstil v kategorijo pogostnosti „ni znana”.
English: Hepatic disease does not significantly affect the pharmacokinetics of hydrochlorothiazide.
Slovenian: Bolezni jeter ne vplivajo pomembno na farmakokinetične lastnosti hidroklorotiazida.
English: Valsartan works by blocking the effect of angiotensin II.
Slovenian: Valsartan deluje tako, da zavira delovanje angiotenzina II.
English: • cholestyramine and colestipol (medicines used to treat high levels of fats in the blood)
Slovenian: • holestiramin in holestipol (zdravili, ki ju uporabljamo pri zvišani ravni maščob v krvi)
English: This observed interaction has no impact on the combined use of valsartan and hydrochlorothiazide, since controlled clinical trials have shown a clear anti-hypertensive effect, greater than that obtained with either active substance given alone, or placebo.
Slovenian: Navedeno medsebojno delovanje na noben način ne vpliva na kombinirano uporabo valsartana in hidroklorotiazida, saj so rezultati kontroliranih kliničnih študij pokazali jasen antihipertenzivni učinek, ki je večji kot pri uporabi vsake posamezne učinkovine posebej ali pri jemanju placeba.
English: Considering that valsartan should not be administered in patients with severe hepatic impairment, biliary cirrhosis and cholestasis, the CHMP recommended to incorporate cross-references to sections 4.3, 4.4 and 5.2.
Slovenian: CHMP je ob upoštevanju, da se valsartan ne sme uporabljati pri bolnikih s hudo okvaro jeter, biliarno cirozo in holestazo, priporočil vključitev navzkrižnega sklicevanja na poglavja 4.3, 4.4 in 5.2.
English: The MAH justified the choice of not including information on the involvement of transporter proteins in section 4.5 of Diovan Comp SPC, in line with the outcome of the Diovan referral.
Slovenian: Imetnik dovoljenja za promet z zdravilom je izbiro, da ne bo vključil podatkov o vpletenosti transportnih beljakovin v poglavje 4.5 povzetka glavnih značilnosti zdravila Diovan Comp, utemeljil v skladu z izidom napotitvenega postopka za zdravilo Diovan.
English: Pressor amines (e.g. noradrenaline, adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Slovenian: Presorski amini (na primer noradrenalin, adrenalin) Lahko pride do zmanjšanega odziva na presorske amine, vendar ne v taki meri, da jih iz tega razloga ne bi uporabljali.
English: The combination of valsartan/HCTZ was generally well-tolerated and the adverse event and adverse drug reaction profiles were consistent with the pharmaceutical class.
Slovenian: Kombinacijo valsartana/hidroklorotiazida so bolniki na splošno dobro prenašali, profili neželenih učinkov in reakcij na zdravilo pa so bili v skladu s farmacevtskim razredom.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (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: Patients with severe chronic heart failure or other conditions with stimulation of the reninangiotensin-aldosterone-system
Slovenian: Bolniki s hudim kroničnim srčnim popuščanjem ali z drugimi boleznimi, pri katerih je stimuliran sistem renin-angiotenzin-aldosteron
English: Hence it cannot be excluded that because of the inhibition of the renin-angiotensin-aldosterone system the application of Diovan Comp as well may be associated with impairment of the renal function.
Slovenian: Iz tega razloga ni mogoče izključiti, da bi bila zaradi zaviranja sistema renin-angiotenzin-aldosteron tudi uporaba zdravila Diovan Comp povezana z motenim delovanjem ledvic.
English: Increase of dosage of probenecid or sulfinpyrazone may be necessary.
Slovenian: Včasih je treba zvišati odmerjanje probenecida ali sulfinpirazona.
English: • anti-cholinergic medicines, such as atropine or biperiden
Slovenian: • antiholinergična zdravila, kot sta atropin ali biperiden
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMETZ ZDRAVILOM V DRŽAVAH ČLANICAH
English: In rats, maternally toxic doses of valsartan (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: These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).
Slovenian: Ta zdravila lahko okrepijo delovanje hidroklorotiazida na koncentracijo kalija v serumu (glejte poglavje 4.4).
English: According with CHMP recommendation, have been included interaction with valsartan and interaction with hydroclortiazide.
Slovenian: V skladu s priporočili CHMP sta bili vključeni medsebojno delovanje z valsartanom in medsebojno delovanje s hidroklorotiazidom.
English: • lung infection; breathlessness
Slovenian: • pljučna okužba; zadihanost
English: This will help you to get the best results and lower the risk of side effects.
Slovenian: Tako bodo rezultati najboljši in tveganje neželenih učinkov najmanjše.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Slovenian: Kot pri vsakem bolniku, ki prejema diuretike, je treba občasno v ustreznih intervalih določati koncentracije elektrolitov v serumu.
English: Section 4.4 - Special Warnings and Precautions for Use
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
English: • if you have severe heart disease.
Slovenian: • če imate hudo srčno bolezen.
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously.
Slovenian: Nesteroidna protivnetna zdravila (NSAIDs), vključno s selektivnimi zaviralci COX-2, z acetilsalicilno kislino >3 g/dan in z neselektivnimi nesteroidnimi protivnetnimi zdravili (NSAIDs) Sočasna uporaba nesteroidnih protivnetnih zdravil lahko zmanjša antihipertenzivni učinek tako antagonistov angiotenzina II kot hidroklorotiazida.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
Slovenian: ciamemazin, sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol),
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, valsartan and diuretics; ATC code: C09D A03.
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina II in diuretiki, valsartan in diuretiki, oznaka ATC: C09DA03
English: • the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin and eyes)
Slovenian: • zvišana raven bilirubina v krvi (ki v hujših primerih lahko povzroči rumene oči in kožo)
English: • other medicines to lower your blood pressure, such as beta blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
Slovenian: • druga zdravila za zniževanje krvnega tlaka, kot so zaviralci adrenergičnih receptorjev beta ali metildopa, ali zdravila, ki zožijo krvne žile ali spodbujajo delovanje srca, kot sta noradrenalin ali adrenalin
English: However, these tests were performed separately with valsartan and hydrochlorothiazide, and produced no evidence of mutagenicity, chromosomal breakage or carcinogenicity.
Slovenian: Vendar pa so te teste opravili ločeno z valsartanom in s hidroklorotiazidom in pri tem niso opažali nobenih znakov mutagenosti, lomljenja kromosomov ali karcinogenosti.
English: Method of administration Diovan Comp can be taken with or without food and should be administered with water.
Slovenian: Način uporabe Zdravilo Diovan Comp je mogoče jemati s hrano ali brez nje, treba pa ga je zaužiti z vodo.
English: • skin peeling
Slovenian: • luščenje kože
English: Like all medicines, Diovan Comp can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Diovan Comp neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • some antibiotics (tetracyclines), anaesthetics and sedatives
Slovenian: • nekateri antibiotiki (tetraciklini), anestetiki in pomirjevala
English: Aortic and mitral valve stenosis, hypertrophic obstructive 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, hipertrofična obstruktivna 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).
English: For hydrochlorotiazide, >95% of the absorbed dose being excreted as unchanged compound in the urine.
Slovenian: Po peroralni uporabi se več kot 95 % absorbiranega odmerka hidroklorotiazida izloči v nespremenjeni obliki z urinom.
English: Regarding the highest dose only, the CHMP agreed the following: “If no relevant additional effect is seen with Diovan Comp 320 mg/25 mg after 8 weeks, treatment with an additional or alternative antihypertensive medicinal product should be considered (see section 5.1)”.
Slovenian: Samo v zvezi z najvišjim odmerkom je CHMP sprejel sledeče: „Če po 8 tednih ni opažen pomemben dodatni učinek zdravila Diovan Comp 320 mg/25 mg, je treba razmisliti o uporabi dodatnega ali alternativnega antihipertenzivnega zdravila (glejte poglavje 5.1)
English: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze odmerek valsartana ne sme presegati 80 mg (glejte poglavje 4.4).
English: • constipation, discomfort of the stomach or bowels, liver disorders (yellow skin or eyes)
Slovenian: • obstipacija, bolečine v želodcu ali črevesju, bolezni jeter (rumena koža ali oči)
English: 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).
Slovenian: Ti odmerki pri podganah (600 mg/kg/dan) so približno 18-krat večji od največjega priporočenega odmerka za ljudi na osnovi mg/m2 (izračun predvideva peroralni odmerek 320 mg/dan in 60-kg bolnika).
English: The valsartan - hydrochlorothiazide combination was not tested for mutagenicity, chromosomal breakage or carcinogenicity, since there is no evidence of interaction between the two substances.
Slovenian: Kombinacije valsartan - hidroklorotiazid niso testirali glede mutagenosti, povzročanja lomljenja kromosomov ali karcinogenosti, ker ni bilo nobenih znakov za interakcije med obema učinkovinama.
English: Hydrochlorothiazide is excreted in human milk.
Slovenian: Hidroklorotiazid se pri človeku izloča v materino mleko.
English: Reduction in serum potassium occurred more frequently in patients given 25 mg hydrochlorothiazide than in those given 12.5 mg hydrochlorothiazide.
Slovenian: Do znižanja koncentracije kalija v serumu je prišlo bolj pogosto pri bolnikih, ki so jemali 25 mg hidroklorotiazida, kot pri tistih, ki so jemali 12,5 mg hidroklorotiazida.
English: Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Slovenian: Po nenadni prekinitvi jemanja valsartana ni prišlo do povratne hipertenzije ali drugih neželenih kliničnih dogodkov.
English: The antihypertensive effect is substantially present within 2 weeks.
Slovenian: Do znatnega antihipertenzivnega učinka pride v 2 tednih.
English: mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine i.v.)
Slovenian: mizolastin, pentamidin, sparfloksacin, terfenadin, vinkamin i.v.
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 skupini preiskovancev, ki so jedli, in pri tistih, ki so vzeli zdravilo na tešče.
English: Patients were randomised 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.