FrancophonIA/ELRC3.0 huggingface dataset:
English: Conversely, due to the irbesartan component of Ifirmacombi hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Slovenian: Zaradi irbesartana, ki ga vsebuje zdravilo Ifirmacombi, se lahko pojavi hiperkaliemija, zlasti pri bolnikih z ledvično okvaro in/ali srčnim popuščanjem ter sladkorno boleznijo.
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): - 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; - slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); - stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Slovenian: Pri podganah in opicah, ki so prejemale kombinacijo 10 mg irbesartana in 10 mg hidroklorotiazida na kg/dan ter 90 mg irbesartana in 90 mg hidroklorotiazida na kg/dan, so se po znižanju krvnega tlaka (pri čemer niso opazili pomembnih toksikoloških interakcij) zaradi dajanja ene učinkovine ali kombinacije dveh učinkovin pojavile naslednje spremembe: - ledvične spremembe, ki so se kazale kot blago povečanje sečnine in kreatinina v serumu ter hiperplazija/hipertrofija jukstaglomerulnega aparata, kar je neposredna posledica interakcije med irbesartanom in reninsko-angiotenzinskim sistemom; - blago zmanjšanje eritrocitnih parametrov (eritrocitov, hemoglobina in hematokrita); - pri nekaj podganah, ki so v študiji toksičnosti 6 mesecev dobivale po 90 mg irbesartana/kg/dan in 90 mg hidroklorotiazida/kg/dan ter kombinacijo irbesartana in hidroklorotiazida (10 mg in
English: Not known: hyperkalaemia
Slovenian: Neznana pogostnost: hiperkaliemija
English: There is no clinical experience with Ifirmacombi in patients with hepatic impairment.
Slovenian: Kliničnih izkušenj z uporabo zdravila Ifirmacombi pri bolnikih z jetrno okvaro ni.
English: Lithium: The combination of lithium and Ifirmacombi is not recommended (see section 4.5).
Slovenian: Litij Kombinacija litija in zdravila Ifirmacombi ni priporočena (glejte poglavje 4.5).
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Slovenian: Zaradi diuretičnega delovanja hidroklorotiazida se zmanjša plazemska prostornina, povečata pa se aktivnost renina in izločanje aldosterona; posledično se poveča izguba kalija in hidrogenkarbonata v seču ter zmanjša serumska koncentracija kalija.
English: Concomitant administration of hydrochlorothiazide and irbesartan has no effect on the pharmacokinetics of either medicinal product.
Slovenian: Sočasno jemanje irbesartana in hidroklorotiazida nima nobenega vpliva na farmakokinetiko posameznih učinkovin.
English: Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Slovenian: Zdravilo Ifirmacombi vsebuje hidroklorotiazid, zato za bolnike z zelo motenim ledvičnim delovanjem (kreatininski očistek < 30 ml/min) ni primeren.
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 z monoterapije na kombinirano zdravljenje.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Pri bolnikih s primarnim aldosteronizmom zdravljenje z antihipertenzivi, ki zavirajo reninskoangiotenzinski sistem, običajno ni učinkovito.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Slovenian: Podatki kliničnih preskušanj so pokazali, da je dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, antagonistov receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (gl. poglavja 4.3, 4.4. in 5.1).
English: Ifirmacombi is a combination of two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Zdravilo Ifirmacombi je kombinacija dveh učinkovin, irbesartana in hidroklorotiazida.
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Slovenian: Jemanje irbesartana in hidroklorotiazida v odmerkih do 300 mg irbesartana in 25 mg hidroklorotazida je varno tudi pri bolnikih, ki jemljejo tudi druge antihipertenzive, tudi blokatorje kalcijevih kanalčkov in adrenergičnih receptorjev beta.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Slovenian: V tabeli 1 so navedeni neželeni učinki, ki so jih bolniki navajali v spontanih poročilih, in tisti, o katerih so poročali v s placebom nadzorovanih študijah.
English: The use of Ifirmacombi during breast feeding is not recommended.
Slovenian: Uporaba zdravila Ifirmacombi med dojenjem ni priporočljiva.
English: Common side effects (may affect up to 1 in 10 people): - nausea/vomiting - abnormal urination - fatigue - dizziness (including when getting up from a lying or sitting position) - blood tests may show raised levels of an enzyme that measures the muscle and heart function
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - siljenje na bruhanje ali bruhanje - nenormalno uriniranje - utrujenost - omotica (tudi pri vstajanju iz ležečega ali sedečega položaja) - krvne preiskave lahko pokažejo zvišanje vrednosti encima, kar kaže na delovanje mišic in srca
English: In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mmHg, respectively).
Slovenian: Pri teh bolnikih so opazili stopnjevanje učinka na znižanje sistoličnega in diastoličnega krvnega tlaka (sistoličnega za 13,3 mm Hg, diastoličnega za 8,3 mm Hg).
English: Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Slovenian: Tiazidni diuretiki lahko povečajo hiperglikemični učinek blokatorjev beta in diazoksida.
English: Twelve percent (12%) of patients were diabetic, 34% were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.
Slovenian: Najpogostejša srčna bolezen je bila stabilna angina pektoris, ki jo je imelo 3,5 % bolnikov.
English: Ifirmacombi is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Slovenian: Zdravilo Ifirmacombi uporabljamo za zdravljenje zvišanega krvnega tlaka, če pri zdravljenju samo z irbesartanom ali samo s hidroklorotiazidom krvni tlak ni bil zadostno nadzorovan.
English: Ifirmacombi is not indicated in patients with severe hepatic impairment.
Slovenian: Zdravilo Ifirmacombi ni primerno za bolnike s hudo jetrno okvaro.
English: In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Slovenian: Pri bolnikih z ledvično okvaro in pri bolnikih na hemodializi farmakokinetični parametri irbesartana niso bistveno spremenjeni.
English: increases in blood urea nitrogen (BUN), creatinine and creatine kinase decreases in serum potassium and sodium
Slovenian: povečanje vrednosti sečnine, kreatinina in kreatin kinaze zmanjšanje vrednosti serumskega kalija in natrija
English: Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin sodium) may lead to increases in serum potassium.
Slovenian: Na podlagi izkušenj z drugimi zdravili, ki zavirajo reninsko-angiotenzinsko sistem, domnevamo, da se lahko serumska koncentracija kalija poveča pri sočasnem jemanju antikaliuretičnih diuretikov, pripravkov s kalijem, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki povečujejo serumske koncentracije kalija (npr. natrijev heparinat).
English: Common: Not known abnormal urination impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
Slovenian: motnje uriniranja okvara ledvičnega delovanja, vključno s posameznimi primeri ledvičnih odpovedi pri bolnikih s tveganjem (glejte poglavje 4.4)
English: Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Slovenian: V študijah na živalih so ugotovili prehodne toksične učinke (povečano votlino ledvičnega meha, hidroureter ali podkožni edem) pri podganjih plodih, ki pa so po rojstvu izginili.
English: You should also tell your doctor: - if you are on a low-salt diet - if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Ifirmacombi) - if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal - if you are going to have an operation (surgery) or be given anaesthetics - if you have changes in your vision or pain in one or both of your eyes while taking Ifirmacombi.
Slovenian: Svojemu zdravniku morate tudi povedati: - če imate dieto z zmanjšanim vnosom soli; - če imate znake, kot so nenormalna žeja, suha usta, splošna oslabelost, zaspanost, bolečine ali krči v mišicah, siljenje na bruhanje, bruhanje ali nenormalno hiter srčni utrip, ki so lahko posledica prevelikega učinka hidroklorotiazida (ki ga vsebuje zdravilo Ifirmacombi); - če vaša koža postane bolj občutljiva za sonce oziroma se znaki sončnih opeklin (pordelost, srbenje, otekline, pojav mehurjev) pojavijo hitreje kot normalno; - če imate predvideno operacijo (kirurški poseg) ali boste prejeli anestetik.
English: Aliskiren-containing products or ACE-inhibitors:
Slovenian: Zdravila, ki vsebujejo aliskiren ali zaviralci ACE
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
English: Common: Uncommon: Not known:
Slovenian: Pogosti: Občasni: Neznana pogostnost:
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano ledvično delovanje, oligohidramnij, zapoznelo zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvično odpoved, hipotenzijo, hiperkaliemijo) (glejte poglavje 5.3).
English: Not known: Anaphylactic reaction including anaphylactic shock
Slovenian: anafilaktična reakcija vključno z anafilaktičnim šokom
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Ifirmacombi.
Slovenian: Tiazidi zmanjšujejo ledvični očistek litija, zato se med zdravljenjem z zdravilom Ifirmacombi poveča nevarnost zastrupitve z litijem.
English: Ifirmacombi 300 mg/25 mg film-coated tablets EU/1/11/673/017-024
Slovenian: Ifirmacombi 300 mg/25 mg filmsko obložene tablete EU/1/11/673/017-024
English: Undesirable effects where the frequency is not known are: - headache, - ringing in the ears, - cough, - taste disturbance, - indigestion, - pain in joints and muscles, - liver function abnormal and impaired kidney function, - increased level of potassium in your blood and - allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Slovenian: Neželeni učinki, katerih pogostnost ni znana, so:glavobol, - zvonjenje v ušesih, - kašelj, - motnje okušanja, - prebavne motnje, - bolečine v sklepih in mišicah, - nenormalno jetrno delovanje, okvara ledvičnega delovanja, - zvišanje vrednosti kalija v krvi in - alergijske reakcije, kot so izpuščaj, koprivnica in lokalizirana oteklina obraza, ustnic, ust, jezika ali žrela, - poročali so tudi o zlatenici (rumeno obarvanje kože in/ali očesnih beločnic), ki se je pojavila občasno.
English: Non-steroidal anti-inflammatory drugs:
Slovenian: Nesteroidna protivnetna zdravila:
English: No specific information is available on the treatment of overdose with Ifirmacombi.
Slovenian: O zdravljenju posledic prevelikega odmerjanja zdravila Ifirmacombi ni specifičnih podatkov.
English: Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Slovenian: Dnevni odmerki, večji od 300 mg irbesartana in 25 mg hidroklorotiazida, niso priporočeni.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Slovenian: Na začetku zdravljenja z irbesartanom in tiazidnimi diuretiki ali brez njih se lahko zaradi predhodnega zdravljenja z velikimi odmerki diuretikov in posledično zmanjšanega intravaskularnega volumna poveča nevarnost pojava hipotenzije, če predhodno nismo uravnali intravaskularnega volumna (glejte poglavje 4.4).
English: Not known: transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Slovenian: Neznana pogostnost: prehodno zamegljen vid, ksantopsija, akutna kratkovidnost in sekundarni akutni glavkom z zaprtim zakotjem
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 jemljejo diuretike, je treba občasno preverjati serumsko koncentracijo elektrolitov.
English: Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi.
Slovenian: Neželeni učinki, o katerih so poročali po prihodu kombinacije irbesartana in hidroklorotiazida na tržišče - Po prihodu zdravila Ifirmacombi na tržišče so poročali še o nekaterih drugih neželenih učinkih.
English: What Ifirmacombi contains - The active substances are irbesartan and hydrochlorothiazide.
Slovenian: Kaj vsebuje zdravilo Ifirmacombi - Učinkovini sta irbesartan in hidroklorotiazid.
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Slovenian: Pri bolnikih z ledvično okvaro, pri katerih je kreatininski očistek ≥ 30 ml/min, prilagoditev odmerka ni potrebna (glejte poglavji 4.3 in 4.4).
English: Hydrochlorothirazide
Slovenian: Hidroklorotiazid
English: Not known: interstitial nephritis, renal dysfunction
Slovenian: Neznana pogostnost: intersticijski nefritis, motnje ledvičnega delovanja
English: Ifirmacombi should not be given to children under 18 years of age.
Slovenian: Otroci in mladostniki, mlajši od 18 let, zdravila Ifirmacombi ne smejo jemati.
English: Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Slovenian: Antiholinergična zdravila (npr. atropin, beperiden) lahko zmanjšajo motaliteto prebavil in praznjenje želodca, zato se poveča biološka uporabnost tiazidnih diuretikov.
English: Warnings and precautions Talk to your doctor before taking Ifirmacombi and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems or have a kidney transplant - if you suffer from heart problems - if you suffer from liver problems - if you suffer from diabetes - if you suffer from lupus erythematosus (also known as lupus or SLE) - if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
Slovenian: Pred začetkom jemanja zdravila Ifirmacombi se posvetujte z zdravnikom in če se karkoli od naslednjega nanaša na vas: - če začnete čezmerno bruhati ali dobite hudo drisko, - če imate težave z ledvicami ali presajeno ledvico, - če imate težave s srcem, - če imate težave z jetri, - če imate sladkorno bolezen, - če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus), - če imate primarni aldosteronizem (stanje, povezano s čezmernim izločanjem hormona aldosterona, kar povzroči zastajanje natrija in posledično zvišanje krvnega tlaka), - če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
English: Uncommon side effects (may affect up to 1 in 100 people): - diarrhoea - low blood pressure - fainting - heart rate increased - flushing - swelling - sexual dysfunction (problems with sexual performance) - blood tests may show lowered levels of potassium and sodium in your blood.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - driska - nizek krvni tlak - omedlevica - hiter srčni utrip - zardevanje - otekline - spolne motnje (težave pri spolnih odnosih) - krvne preiskave lahko pokažejo znižane vrednosti kalija in natrija v krvi Če imate težave zaradi katerega od navedenih neželenih učinkov, se posvetujte z zdravnikom.
English: Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Slovenian: V nespremenjeni obliki se s sečem izloči manj kot 2 % odmerka.
English: Ifirmacombi is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Slovenian: Zdravilo Ifirmacombi je kombinacija irbesartana, antagonista angiotenzina II, in tiazidnega diuretika hidroklorotiazida.
English: How to take Ifirmacombi
Slovenian: Kako jemati zdravilo Ifirmacombi
English: Oral use.
Slovenian: Uporablja se peroralno.
English: Therefore, the combination of lithium and Ifirmacombi is not recommended (see section 4.4).
Slovenian: Sočasno jemanje litija in zdravila Ifirmacombi zato ni priporočljivo (glejte poglavje 4.4).
English: Food does not affect the bioavailability of Ifirmacombi.
Slovenian: Sočasno uživanje hrane na biološko uporabnost zdravila Ifirmacombi ne vpliva.
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Slovenian: Tiazidi, ki povzročajo hipokaliemijo ali hipomagneziemijo, lahko sprožijo z digitalisom spodbujeno srčno aritmijo (glejte poglavje 4.4).
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Slovenian: Uporabo zaviralca ACE v kombinaciji z antagonistom receptorjev angiotenzina II so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets EU/1/11/673/009-016
Slovenian: Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete EU/1/11/673/009-016
English: The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Slovenian: Zaradi hidroklorotiazida, ki ga vsebuje zdravilo, je lahko test za ugotavljanje jemanja nedovoljenih substanc (antidopinški test) pozitiven.
English: The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Slovenian: Pri bolnikih, ki so se zdravili s kombinacijo, so poročali o enaki vrsti in pogostosti neželenih učinkov kot pri bolnikih, ki so se zdravili samo z eno učinkovino.
English: Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi.
Slovenian: Povedal vam bo tudi, kako prenehati jemati dosedanje zdravilo in kako začeti zdravljenje z zdravilom Ifirmacombi.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets EU/1/11/673/001-008
Slovenian: Ifirmacombi 150 mg/12,5 mg filmsko obložene tablete EU/1/11/673/001-008
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: Pri izpostavljenosti antagonistom angiotenzina II od drugega trimesečja nosečnosti dalje se priporoča ultrazvočni pregled lobanje in ledvičnega delovanja.
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: C je v obtoku 80 do 85 % nespremenjene učinkovine.
English: No dosage adjustment of Ifirmacombi is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro prilagoditev odmerka ni potrebna (glejte poglavje 4.3).
English: Irbesartan/hydrochlorothiazide combination
Slovenian: Kombinacija irbesartana in hidroklorotiazida
English: Adequate monitoring of serum potassium in patients at risk is recommended (see section 4.4).
Slovenian: Pri bolnikih s povečanim tveganjem je priporočeno redno preverjanje vrednosti kalija v serumu (glejte poglavje 4.4).
English: Renal impairment and kidney transplantation:
Slovenian: Ledvična okvara in presaditev ledvic
English: Other antihypertensive agents:
Slovenian: Drugi antihipertenzivi
English: These findings appear to have no relevance to the use of therapeutic doses of irbesartan/hydrochlorothiazide in humans.
Slovenian: Ugotovitve pa ne veljajo za terapevtske odmerke kombinacije irbesartana in hidroklorotiazida pri ljudeh.
English: jaundice hepatitis, abnormal liver function
Slovenian: zlatenica hepatitis, motnje jetrnega delovanja