FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila INOmax večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: • patients of all ages who are undergoing or have undergone heart surgery and develop pulmonary hypertension.
Slovenian: • bolnikih vseh starosti, pri katerih bo ali je bil opravljen kirurški poseg na srcu in pri katerih se je pojavila pljučna hipertenzija.
English: What benefit has INOmax shown during the studies?
Slovenian: Kakšne koristi je zdravilo INOmax izkazalo med študijami?
English: It must not be used in babies who have right-to-left or significant left-to-right shunting of blood (abnormal circulation of blood in the heart).
Slovenian: Prav tako se ne sme uporabljati pri dojenčkih, ki imajo obvod krvi z desne na levo ali izrazit obvod krvi z leve na desno (nenormalen obtok krvi v srcu).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for INOmax.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo INOmax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about INOmax
Slovenian: Druge informacije o zdravilu INOmax:
English: INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 or 800 parts per million (ppm).
Slovenian: Zdravilo INOmax je plin za inhaliranje, ki vsebuje zdravilno učinkovino dušikov oksid, razredčen v plinu dušiku v koncentraciji 400 ali 800 delcev na milijon (ppm).
English: INOmax is used in combination with artificial ventilation and other medicines to help improve blood oxygen levels in the following groups of patients:
Slovenian: Zdravilo INOmax se uporablja v kombinaciji z umetnim predihavanjem in drugimi zdravili za izboljšanje koncentracije kisika v krvi pri naslednjih skupinah bolnikov:
English: The most common side effect with INOmax (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), hypokalaemia (low blood potassium levels), hypotension (low blood pressure), atelectasis (collapse of the whole, or part of a, lung), and hyperbilirubinaemia (high blood levels of bilirubin).
Slovenian: Najpogostejši neželeni učinki zdravila INOmax (opaženi pri več kot 1 bolniku izmed 10) je trombocitopenija (nizka koncentracija trombocitov v krvi), hipokaliemija (nizka raven kalija v krvi), hipotenzija (nizek krvni tlak), atelektaza (kolaps celih pljuč ali dela pljuč) in hiperbilirubinemija (visoka koncentracija bilirubina v krvi).
English: INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
Slovenian: Zdravilo INOmax se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) dušikov oksid ali drugo sestavino zdravila (dušik).
English: In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
Slovenian: V drugi glavni študiji je zunajtelesno membransko oksigenacijo potrebovalo 30 (31 %) novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi z 51 (57 %) izmed 89 novorojenčkov, ki so prejemali placebo.
English: INOmax is given after being diluted in an oxygen/air mixture supplied to the patient through the ventilator.
Slovenian: Zdravilo INOmax se daje razredčeno v mešanici kisika/zraka, ki se bolniku dovaja skozi ventilator.
English: In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
Slovenian: V prvi glavni študiji je umrlo ali potrebovalo zunajtelesno membransko oksigenacijo 52 (46 %) izmed 114 novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi s 77 (64 %) izmed 121 novorojenčkov, ki so prejemali placebo.
English: INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
Slovenian: Zdravilo INOmax so proučevali tudi v dveh glavnih študijah s 421 novorojenčki s pljučno hipertenzijo, rojenimi po vsaj 34 tednih nosečnosti.
English: In the published literature, INOmax treatment was shown to reduce the blood pressure in the lungs and improve heart function when used during or after heart surgery.
Slovenian: V objavljeni literaturi se je izkazalo, da je zdravljenje z zdravilom INOmax znižalo krvni tlak v pljučih in izboljšalo delovanje srca, kadar je bilo uporabljeno med operacijo srca ali po njej.
English: In these patients INOmax is used to help improve heart function and reduce blood pressure in the lungs.
Slovenian: Pri teh bolnikih se zdravilo INOmax uporablja za izboljšanje delovanje srca in znižanje krvnega tlaka v pljučih.
English: INOmax should only be used in units where staff have been trained in the use of a nitric oxide delivery system.
Slovenian: Zdravilo INOmax se sme uporabljati samo na oddelkih, katerih osebje je usposobljeno za uporabo sistema za dovajanje dušikovega oksida.
English: What is the risk associated with INOmax?
Slovenian: Kakšna tveganja so povezana z zdravilom INOmax?
English: The marketing authorisation holder is Linde Healthcare AB.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Linde Healthcare AB.
English: This was mainly due to a reduction in the need for ECMO, rather than a reduction in death rates.
Slovenian: Razlika je bila pretežno pogojena z zmanjšanjem potrebe po zunajtelesni membranski oksigenaciji in ne zmanjšanjem smrtnosti.
English: Because nitric oxide is a well-known chemical, the company used data from the published literature to support INOmax's use in newborn babies with pulmonary hypertension, and in adults and children undergoing heart surgery.
Slovenian: Ker je dušikov oksid dobro znana kemična snov, je družba v podporo uporabi zdravila INOmax pri novorojenčkih s pljučno hipertenzijo ter pri odraslih in otrocih pred operacijo srca uporabila podatke iz objavljene literature.
English: For the full list of all side effects reported with INOmax, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila INOmax, glejte navodilo za uporabo.
English: In newborn babies with breathing problems, treatment can be continued at this dose until there is improvement in oxygen levels, for a maximum of four days.
Slovenian: Zdravljenje s tem odmerkom se lahko pri novorojenčkih s težavami pri dihanju nadaljuje, dokler se koncentracija kisika ne izboljša, vendar ne sme trajati več kot štiri dni.
English: In the second study, 186 neonates with respiratory failure received either INOmax or placebo.
Slovenian: V drugi študiji je 186 novorojenčkov z respiratorno odpovedjo prejemalo bodisi zdravilo INOmax ali pa placebo.
English: When inhaled, it causes the vessels in the lungs to dilate (widen); this allows blood to flow more easily in the lungs to supply oxygen to the rest of the body and remove carbon dioxide, reducing pulmonary hypertension.
Slovenian: Pri vdihavanju povzroči širjenje žil v pljučih, kar omogoča lažje dovajanje krvi v pljuča za oskrbo preostalega telesa s kisikom in odstranjevanje ogljikovega dioksida, s čimer se zmanjšuje pljučna hipertenzija.
English: INOmax is used in these babies to improve oxygen supply levels and to reduce the need for extracorporeal membrane oxygenation (ECMO, a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).
Slovenian: Zdravilo INOmax se pri teh dojenčkih uporablja za izboljšanje koncentracije kisika in zmanjšanje potrebe po zunajtelesni membranski oksigenaciji (ECMO, tehnika za oksigenizacijo krvi zunaj telesa z uporabo naprave, podobne aparatu srce-pljuča);
English: Why has INOmax been approved?
Slovenian: Zakaj je bilo zdravilo INOmax odobreno?
English: In the two main studies in newborn babies with breathing problems, INOmax was more effective than placebo at reducing the need of ECMO.
Slovenian: V dveh glavnih študijah pri novorojenčkih s težavami pri dihanju je bilo zdravilo INOmax učinkovitejše od placeba pri zmanjševanju potrebe po zunajtelesni membranski oksigenaciji.
English: The active substance in INOmax, nitric oxide, is a naturally-occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax.
Slovenian: Zdravilna učinkovina v zdravilu INOmax, dušikov oksid, je kemična snov, ki je v telesu naravno prisotna in povzroča sproščanje mišic v steni krvnih žil.
English: The main measure of effectiveness was the proportion of neonates who needed ECMO.
Slovenian: Glavno merilo učinkovitosti je bil delež novorojenčkov, ki so potrebovali zunajtelesno membransko oksigenacijo.
English: In the first study, 235 neonates with respiratory failure received either INOmax or placebo (a dummy treatment).
Slovenian: V prvi študiji je 235 novorojenčkov z respiratorno odpovedjo prejemalo bodisi zdravilo INOmax ali pa placebo (zdravilo brez zdravilne učinkovine).
English: INOmax is used in patients who are undergoing artificial ventilation, once the ventilation is optimised.
Slovenian: Zdravilo INOmax se uporablja pri bolnikih, pri katerih se izvaja umetno predihavanje, po optimizaciji predihavanja.
English: How has INOmax been studied?
Slovenian: Kako je bilo zdravilo INOmax raziskano?
English: What is INOmax used for?
Slovenian: Za kaj se zdravilo INOmax uporablja?
English: How is INOmax used?
Slovenian: Kako se zdravilo INOmax uporablja?
English: How does INOmax work?
Slovenian: Kako zdravilo INOmax deluje?
English: What is INOmax?
Slovenian: Kaj je zdravilo INOmax?
English: and 5.1).
Slovenian: 4.5 in 5.1).
English: (see section 5.3).
Slovenian: (glejte poglavje 5.1).
English: This medicinal product should not be given to children under 18 years of age because the safety and efficacy have not yet been fully established.
Slovenian: Otroci in mladostniki Tega zdravila ne smete dajati otrokom, mlajšim od 18 let, ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
English: You may need to have blood checks if you take:
Slovenian: Morda bodo potrebe krvne preiskave, če jemljete:
English: If you suffer from heart problems
Slovenian: • če imate težave s srcem
English: Swensweg 5, Postbus 552 2003 RN Haarlem The Netherlands
Slovenian: Swensweg 5, Postbus 552 2003 RN Haarlem Nizozemska
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8, 5.1 in 5.2 vendar priporočil o odmerjanju ni mogoče dati.
English: Date of first authorisation: 30 October 2009 Date of latest renewal: 18 July 2014
Slovenian: Datum zadnjega podaljšanja: 18. julij 2014
English: Plasma protein binding is approximately 96 %, with negligible binding to cellular blood components.
Slovenian: Vezava na plazemske beljakovine je približno 96 %, z zanemarljivo vezavo na krvne celice.
English: You can take Irbesartan Teva with or without food.
Slovenian: Zdravilo Irbesartan Teva lahko jemljete s hrano ali brez nje.
English: • Second and third trimesters of pregnancy (see section 4.4 and 4.6).
Slovenian: • Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80 %.
Slovenian: Irbesartan se po peroralni uporabi dobro absorbira: študije absolutne biološke razpoložljivosti so dale vrednosti približno 60-80 %.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Slovenian: Tablete morate pogoltniniti z zadostno količino tekočine (npr. z enim kozarcem vode).
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Slovenian: Celokupni telesni in ledvični očistek je 157-176 oziroma 3-3,5 ml/min.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: zdravljenje pa mora biti simptomatsko in podporno.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Slovenian: Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
English: The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Slovenian: Glavni metabolit v obtoku je irbesartan glukuronid (približno 6 %).
English: The safety and efficacy of Irbesartan Teva in children aged 0 to 18 has not been established.
Slovenian: Varnost in učinkovitost zdravila Irbesartan Teva pri otrocih, starih od 0 do 18 let, nista bili dokazani.
English: At 24 hours the reduction of blood pressure was 60-70 % of the corresponding peak diastolic and systolic responses at the recommended doses.
Slovenian: Po 24 urah je bilo zmanjšanje krvnega tlaka 60-70 % ustreznega največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
English: The predefined blood pressure goal was ≤ 135/85 mm Hg.
Slovenian: Ciljni krvni tlak je bil ≤ 135/85 mmHg.
English: See also information under the heading “Do not take Irbesartan Teva”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Irbesartan Teva”.
English: 31-546 Kraków
Slovenian: Mogilska 80 31-546 Kraków
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Slovenian: Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥ 65 let) nekoliko večje kot pri mlajših (18-40 let).
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for elderly people.
Slovenian: Čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
English: If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: ATC code: C09C A04
Slovenian: Oznaka ATC: C09CA04.
English: The following presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Slovenian: Sledeča tabela predstavlja neželene učinke zdravila o katerih so poročali v s placebom kontroliranih preskušanjih, v katerih je sodelovalo 1.965 bolnikov z visokim krvnim tlakom, ki so prejemali irbesartan.
English: Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Slovenian: Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG Velika Britanija
English: Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Slovenian: Irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
English: if you are going to have an operation (surgery) or be given anaesthetics.
Slovenian: • če imate predvideno operacijo (kirurški poseg) ali boste dobili anestetik
English: Additional information on irbesartan interactions
Slovenian: Dodatni podatki o medsebojnem delovanju z irbesartanom
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Slovenian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG
English: It is important that you continue to take Irbesartan Teva until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Irbesartan Teva jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Teva” and “Warnings and precautions”).
Slovenian: Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma " Ne jemljite zdravila Irbesartan Teva" in "Opozorila in previdnostni ukrepi").
English: HU-4042 Debrecen
Slovenian: Pallagi út 13 HU-4042 Debrecen
English: No specific information is available on the treatment of overdose with irbesartan.
Slovenian: Specifični podatki o zdravljenju prevelikega odmerjanja z irbesartanom niso na voljo.
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 kontrolnih epidemioloških podatkov glede tveganja pri uporabi inhibitorjev angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5 %) and elevated CK values in 2 % of child recipients.
Slovenian: Med 26-tedenskim odprtim obdobjem tega preskušanja so bila najpogostejša laboratorijska odstopanja zvišanje kreatinina (6,5 %) in zvišanje vrednosti kreatinin-kinaze (CK) pri 2 % otrok.
English: While this is not documented with irbesartan, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Slovenian: Čeprav to za irbesartan ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
English: Diuretics and other antihypertensive agents
Slovenian: Diuretiki in drugi antihipertenzivi
English: Irbesartan Teva is indicated in adults for the treatment of essential hypertension.
Slovenian: Zdravilo Irbesartan Teva je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri podganah kažejo na izločanje irbesartana ali njegovih presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
English: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Slovenian: Hiperkaliemija* se je pogosteje pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom kot pri bolnikih, ki so dobivali placebo.
English: Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Slovenian: • Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic lahko krvne preiskave pokažejo zvišanje vrdnosti kalija v krvi.
English: In 1.7 % of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Slovenian: Pri 1,7 % bolnikov z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom, so opazili znižanje hemoglobina*, ki ni bilo klinično pomembno.
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9 %), hypotension (2.2 %), dizziness (1.9 %), cough (0.9 %).
Slovenian: Med randomiziranim preskušanjem pri 318 hipertenzivnih otrocih in mladostnikih, starih od 6 do 16 let, so se med 3-tedensko dvojno slepo fazo pojavili naslednji neželeni učinki: glavobol (7,9 %), hipotenzija (2,2 %), omotica (1,9 %), kašelj (0,9 %).
English: Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3 %) than for placebo-treated patients (4.5 %).
Slovenian: Prekinitev zaradi kateregakoli kliničnega ali laboratorijskega neželenega dogodka je bila pri bolnikih z irbesartanom manj pogosta (3,3 %) kot pri bolnikih s placebom (4,5 %).
English: Teva Pharmaceuticals Ireland L-Irlanda
Slovenian: Malta Teva Pharmaceuticals Ireland
English: If you forget to take Irbesartan Teva
Slovenian: Če ste pozabili vzeti zdravilo Irbesartan Teva
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30 % from baseline).
Slovenian: V raziskavi so proučevali dolgotrajne učinke (2 leti) irbesartana na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER > 300 mg/dan in povečanje UAER-a najmanj za 30 % začetne vrednosti).
English: Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Slovenian: Na splošno zagotavlja odmerek 150 mg enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 80 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 50 x 1 film-coated tablets 56 x 1 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet 50 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta
English: If a child swallows some tablets, contact your doctor immediately.
Slovenian: Če tablete pogoltne otrok, se nemudoma posvetujte z zdravnikom.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan (see section 4.4).
Slovenian: Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z irbesartanom (glejte poglavje 4.4).
English: The other side of the tablet debossed with number
Slovenian: Na drugi strani tablete je vtisnjena številka
English: UAB Sicor Biotech filiāle Latvijā
Slovenian: UAB Sicor Biotech
English: One side of the tablet debossed with the number “93”.
Slovenian: Na eni strani tablete je vtisnjena številka “93”.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Slovenian: Za terapevtske odmerke pri človeku kaže, da je hiperplazija/hipertrofija ledvičnih jukstaglomerulnih celic brez pomena.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Slovenian: IDNT je bilo dvojno slepo, kontrolirano preskušanje vpliva irbesartana na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
English: Less than 2 % of the dose is excreted in the urine as unchanged irbesartan.
Slovenian: Manj kot 2 % odmerka irbesartana se izloči z urinom v nespremenjeni obliki.