FrancophonIA/ELRC3.0 huggingface dataset:
English: Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Slovenian: V epidemioloških študijah so ugotovili, da se zaradi dolgotrajnega zdravljenja s hidroklorotiazidom zmanjša nevarnost pojava bolezni srca in ožilja in umrljivosti zaradi njih.
English: Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for their activity.
Slovenian: Irbesartan in hidroklorotiazid sta peroralno aktivni učinkovini, ki za aktivnost ne potrebujeta biotransformacije.
English: Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Slovenian: Irbesartan ni vplival na plodnost podgan in njihovih potomcev v odmerkih, ki so povzročili prve znake toksičnih učinkov pri starših (glejte poglavje 5.3).
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Slovenian: Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95-odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,0-4,9) pri velikih odmerkih (~ 25.000 mg) in celo na 7,7 (5,7-10,5) pri največjih kumulativnih odmerkih (~ 100.000 mg) (glejte tudi poglavje 4.4).
English: Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years).
Slovenian: Zdravila Irbesartan/hidroklorotiazid Teva otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
English: Hypotension - Volume-depleted patients
Slovenian: Hipotenzija - zmanjšan intravaskularni volumen
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Slovenian: Presnova irbesartana večinoma poteka preko CYP2C9 in v manjšem obsegu z glukuronidacijo.
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Slovenian: Posledica hipokaliemije so mišični krči in/ali povdarjene srčne aritmije, povezane s sočasno uporabo digitalisovih glikozidov in nekaterih antiaritmikov.
English: Table 1.
Slovenian: Tabela 1.
English: • kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system;
Slovenian: • ledvične spremembe so se kazale kot blago zvečanje sečnine in kreatinina v serumu ter hiperplazija/hipertrofija jukstaglomerulnega aparata, kar je neposredna posledica interakcije med irbesartanom in sistemom renin-angiotenzin
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Slovenian: Kot pri vseh bolnikih, ki dobivajo diuretike, je treba periodično preverjati serumsko vrednost elektrolitov, v primernih časovnih intervalih.
English: No dosage adjustment is necessary in female patients.
Slovenian: Prilagoditev odmerka pri ženskah ni potrebna.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Zdravljenje je simptomatsko in podporno.
English: N-nitrosamines belong to a “cohort of concern” compounds in this guideline.
Slovenian: N-nitrozamini v navedenih smernicah spadajo med spojine iz „kohorte, ki vzbuja zaskrbljenost“.
English: At least 61 % of the oral dose is eliminated unchanged within 24 hours.
Slovenian: V 24 urah se v nespremenjeni obliki izloči najmanj 61 % peroralnega odmerka hidroklorotiazida.
English: The CHMP, as a consequence, considers that the benefit-risk balance of products containing candesartan, irbesartan, losartan, olmesartan, valsartan remains favourable subject to the conditions described above.
Slovenian: Odbor CHMP je posledično menil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo kandesartan, irbesartan, losartan, olmesartan ali valsartan, še naprej ugodno, če se upoštevajo zgoraj opisani pogoji.
English: In case of identification of other nitrosamines, this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan (e.g. changes to the manufacturing process).
Slovenian: Če se ugotovi prisotnost drugih nitrozaminov, je treba o tem takoj poročati pristojnim organom, skupaj s toksikološko oceno nečistote, klinično oceno pri izpostavljenih bolnikih, analizo osnovnih vzrokov in načrtom korektivnih ukrepov (npr. sprememb postopka proizvodnje).
English: Calcium salts
Slovenian: Kalcijeve soli
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys.
Slovenian: Hidroklorotiazid se ne presnavlja, temveč se hitro izloči skozi ledvice.
English: In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Slovenian: V študiji so ugotovili nekoliko višjo koncentracijo irbesartana pri ženskah s hipertenzijo.
English: If a child swallows some tablets, contact your doctor immediately.
Slovenian: Če tablete pogoltne otrok, se nemudoma posvetujte s svojim zdravnikom.
English: Renal artery stenosis - Renovascular hypertension
Slovenian: Stenoza ledvične arterije - renovaskularna hipertenzija
English: Obligatory risk assessments to be performed for manufacturing processes of the drug substances in order to evaluate the theoretical risk of N-nitrosamine formation and contamination
Slovenian: 1. obvezna izvedba ocen tveganja za postopke proizvodnje učinkovin z namenom ovrednotenja teoretičnega tveganja za nastajanje N-nitrozaminov in onesnaženje z njimi;
English: This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Slovenian: Ta fiksna kombinacija je namenjena za zdravljenje odraslih bolnikov pri katerih krvni tlak ni primerno urejen ob uporabi irbesartana ali hidroklorotiazida samega (glejte poglavje 5.1).
English: The potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Slovenian: Potencialno toksičnost kombinacije irbesartan/hidroklorotiazid so po peroralnem dajanju ocenjevali pri podganah in opicah, v raziskavah ki so trajale do 6 mesecev.
English: If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Slovenian: V kolikor je ponovna uporaba diuretika nujna, je izpostavljene dele kože priporočljivo zaščititi pred soncem ali umetnim UVA sevanjem.
English: • In case of detection of other N-nitrosamines this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan.
Slovenian: • če se odkrije prisotnost drugih N-nitrozaminov, je treba o tem takoj poročati pristojnim organom, skupaj s toksikološko oceno nečistote, klinično oceno pri izpostavljenih bolnikih, analizo osnovnih vzrokov in načrtom korektivnih ukrepov;
English: The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.
Slovenian: Nevarnost za pojav hipokaliemije je največja pri bolnikih z jetrno cirozo, tistih z obilno diurezo, bolnikih, ki peroralno ne prejemajo dovolj elektrolitov, in tistih, ki se sočasno zdravijo s kortikosteroidi ali ACTH.
English: Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Slovenian: Irbesartan preprečuje vezavo angiotenzina II na te receptorje, zato se krvne žile razširijo, krvni tlak pa zniža.
English: • Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination.
Slovenian: • na podlagi analize morebitnih osnovnih vzrokov je odbor CHMP presodil, da morajo vsi imetniki dovoljenj za promet z zdravili opraviti oceno tveganja postopkov proizvodnje, ki se uporabljajo za učinkovine v njihovih končnih zdravilih, in tako ovrednotiti tveganje za nastajanje N-nitrozaminov in onesnaženje z njimi;
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Slovenian: V tabeli 1 so navedeni neželeni učinki, prejeti s spontanimi poročili, in tisti, o katerih so poročali v s placebom nadzorovanih študijah.
English: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Slovenian: Tiazidne diuretike je treba dajati še posebej previdno bolnikom z okvarjeno jetrno funkcijo ali napredujočo jetrno boleznijo, saj lahko že majhna sprememba ravnovesja tekočin in elektrolitov povzroči jetrno komo.
English: The mean plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours.
Slovenian: Srednji razpolovni čas hidroklorotiazida je 5 do 15 ur.
English: When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:
Slovenian: Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje:
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Slovenian: Študije in vitro kažejo, da se irbesartan oksidira predvsem s pomočjo encima CYP2C9 citokroma P450; učinek izoencima CYP3A4 je zanemarljiv.
English: Electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Slovenian: (vključno s hipokaliemijo in hiponatriemijo, glejte poglavje 4.4), hiperurikemija, glikozurija, hiperglikemija, zvišanje vrednosti holesterola in trigliceridov
English: The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur.
Slovenian: Po prevelikem odmerjanju irbesartana se najpogosteje pojavita hipotenzija in tahikardija; pojavi se lahko tudi bradikardija.
English: Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: Irbesartan spada v skupino zdravil, poznanih kot antagonisti angiotenzina II.
English: • slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);
Slovenian: • blago zmanjšanje eritrocitnih parametrov (eritrocitov, hemoglobina in hematokrita)
English: See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Irbesartan/hidroklorotiazid Teva”.
English: The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Slovenian: Vpliva CYP2C9 induktorjev, kot je rifampicin, na farmakokinetiko irbesartana niso proučevali.
English: Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Slovenian: Bolniki, ki se zdravijo s hidroklorotiazidom, morajo biti obveščeni o tveganju za razvoj nemelanomskega kožnega raka, in treba jim je svetovati, naj si redno pregledujejo kožo in naj takoj obvestijo zdravnika, če najdejo kakršne koli na novo nastale sumljive kožne spremembe.
English: Management depends on the time since ingestion and the severity of the symptoms.
Slovenian: Ukrepanje je odvisno od tega, koliko časa je minilo od zaužitja prevelikega odmerka in kako hudi so simptomi.
English: Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Slovenian: Večina naštetih učinkov je verjetno posledica farmakološke aktivnosti irbesartana (blokade z angiotenzinom II inducirane inhibicije sproščanja renina in stimulacije celic, v katerih renin nastaja), in se pojavijo tudi med uporabo zaviralcev angiotenzinske konvertaze.
English: There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia.
Slovenian: Podatkov o tem, da bi irbesartan lahko zmanjšal ali preprečil nastanek z diuretiki povzročene hiponatriemije, ni.
English: Side effects associated with hydrochlorothiazide alone are:
Slovenian: Neželeni učinki, ki so povezani z jemanjem hidroklorotiazida samega:
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Slovenian: Hidroklorotiazida se ne sme uporabljati za zdravljenje gestacijskega edema, gestacijske hipertenzije ali preeklampsije zaradi nevarnosti zmanjšanja prostornine plazme in posledično zmanjšanega pretoka preko posteljice, brez pozitivnih učinkov na potek bolezni.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Slovenian: Diureza se zveča 2 uri po zaužitju hidroklorotiazida, njegov učinek je največji čez približno 4 ure, traja pa približno 6-12 ur.
English: When necessary, Irbesartan/HydrochlorothiazideTeva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Slovenian: Kadar je nujno, smejo bolniki poleg zdravila Irbesartan/hidroklorotiazid Teva jemati tudi drug antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
English: Limit in ppm in API
Slovenian: Meja za NDEA v ppm v učinkovini
English: Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Slovenian: Tiazidi vplivajo na mehanizem reabsorpcije elektrolitov v ledvičnih tubulih, in sicer tako, da neposredno zvečajo izločanje približno enakih količin natrija in klorida.
English: Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose.
Slovenian: V študijah pri samcih in samicah podgan plodnost in sposobnost razmnoževanja nista bili prizadeti niti pri peroralnih odmerkih irbesartana, ki so pri starših povzročili toksične učinke (od 50 do 650 mg/kg/dan), vključno s pogini pri največjih odmerkih.
English: Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: If Irbesartan/Hydrochlorothiazide Teva is used during breast feeding, doses should be kept as low as possible.
Slovenian: Če se zdravilo Irbesartan/hidroklrotiazid Teva uporablja med dojenjem, je treba uporabiti najmanjši možni odmerek.
English: It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Irbesartan/hidroklorotiazid Teva jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Slovenian: Celoten telesni očistek je 157 do 176 ml/min, ledvični pa 3 do 3,5 ml/min.
English: Adverse Reactions In Placebo-Controlled Trials and Spontaneous Reports Investigations:
Slovenian: Neželeni učinki v placebom nadzorovanih kliničnih študijah in spontana poročila
English: The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Slovenian: (5,6 %), utrujenost (4,9 %), navzea/bruhanje (1,8 %) in motnje uriniranja (1,4 %).
English: Table 3.
Slovenian: Tabela 3.
English: It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Slovenian: Znano je, da so s hidroklorotiazidom povezani neželeni učinki lahko pogostejši pri večjih odmerkih hidroklorotiazida.
English: The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-8 weeks.
Slovenian: Krvni tlak se zniža že po prvem odmerku irbesartana in hidroklorotiazida, izrazito v 1-2 tednih, najbolj pa v 6-8 tednih.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če pa je tako zdravljenje nujno, je priporočljivo skrbno spremljanje serumske vrednosti litija.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Slovenian: Na osnovi farmakološkega mehanizma delovanja hidroklorotiazida lahko njegova uporaba v drugem in tretjem trimesečju nosečnosti ogroža feto-placentarno perfuzijo in lahko pri plodu ali novorojenčku povzroči zlatenico, motnje elektrolitskega ravnovesja in trombocitopenijo.
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Slovenian: Kot z zaviralci ACE, sočasna uporaba antagonistov angiotenzina II in NSAID lahko poveča tveganje za poslabšanje delovanja ledvic, vključno z možno akutno ledvično odpovedjo, in zvišanje kalija v plazmi, še posebej pri bolnikih, ki že imajo slabše delovanje ledvic.
English: In addition, advancing age, comorbidity and use of anticoagulants were found to be strongly associated with both gastrointestinal and non-gastrointestinal complications.
Slovenian: Poleg tega so ugotovili, da so višja starost, pridružena motnja in uporaba antikoagulantov močno povezani z zapleti v prebavilih in zunaj prebavil.
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of non-black patients.
Slovenian: Če se irbesartanu doda majhen odmerek hidroklorotiazida (na primer 12,5 mg na dan), se antihipertenzivni učinek pri temnopoltih bolnikih približa tistemu pri netemnopoltih bolnikih.
English: Other antihypertensive agents
Slovenian: Drugi antihipertenzivi
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Slovenian: Nemelanomski kožni rak (bazalnocelični karcinom in ploščatocelični karcinom)
English: Furthermore, the target organ(s) of NDMA/NDEA toxicity in humans are still not sufficiently clear.
Slovenian: Še vedno tudi ni dovolj jasno, kateri so tarčni organi toksičnosti NDMA/NDEA pri človeku.
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol resins for lowering blood cholesterol.
Slovenian: Pomembno je, da zdravnika obvestite tudi, če jemljete druga zdravila za zniževanje krvnega tlaka, kortikosteroide, zdravila za zdravljenje raka, lajšanje bolečin, zdravila proti artritisu ali zdravili holestiramin in holestipol za zniževanje holesterola v krvi.
English: The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
Slovenian: Poleg tega bi bilo morda treba ponovo premisliti o uporabi hidroklorotiazida pri bolnikih, ki so že preboleli nemelanomskega kožnega raka (glejte tudi poglavje 4.8).
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Slovenian: Irbesartan ne zavira ACE (kininaza-II), encima, ki tvori angiotenzin II in razgrajuje bradikinin v neaktivne presnovke.
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Slovenian: Zaradi selektivnega antagonizma receptorjev angiotenzina II (AT1) se zvečata plazemski koncentraciji renina in angiotenzina II in zniža plazemska koncentracija aldosterona.
English: Table 2.
Slovenian: Tabela 2.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Slovenian: Irbesartan je močan selektivni antagonist receptorjev (podtipa AT1) angiotenzina II.
English: When Irbesartan/Hydrochlorothiazide Teva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Slovenian: Če zdravilo Irbesartan/hidroklorotiazid Teva uporablja pri bolnikih z okvarjeno ledvično funkcijo, je priporočena redna kontrola serumske koncentracije kalija, kreatinina in sečne kisline.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Slovenian: Ena od študij je vključevala 71.533 bolnikov z bazalnoceličnim karcinomom in 8.629 bolnikov s ploščatoceličnim karcinomom, ki so jih primerjali s kontrolnim vzorcem 1.430.833 bolnikov z bazalnoceličnim karcinomom in 172.462 bolnikov s ploščatoceličnim karcinom.
English: If calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;
Slovenian: Kadar dobiva bolnik pripravke s kalcijem ali zdravila, ki varčujejo s kalcijem (na primer vitamin D), je treba preverjati njegovo serumsko koncentracijo in odmerek kalcija po potrebi prilagoditi.
English: Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18
Slovenian: Vrednosti AUC in Cmax za irbesartan sta pri starejših osebah (≥ 65 let) nekoliko večji kot pri mlajših (18 do 40 let).
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
English: Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia.
Slovenian: Čeprav se med zdravljenjem s tiazidnimi diuretiki lahko pojavi hipokaliemija, pa sočasno zdravljenje z irbesartanom lahko zmanjša z diuretiki povzročeno hipokaliemijo.
English: Efficacy and safety of irbesartan/hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomised, double-blind, active-controlled, 8-week, parallel-arm study.
Slovenian: Učinkovitost in varnost kombinacije irbesartana in hidroklorotiazida kot začetnega zdravila za zdravljenje hude hipertenzije (definirana kot diastolični tlak v sedečem položaju (SeDBP) ≥ 110 mmHg) sta bili ovrednoteni z multicentrično, randomizirano, dvojno slepo, z učinkovino nadzorovano,