FrancophonIA/ELRC3.0 huggingface dataset:
English: Diarrhoea is also known to occur in cases of excessive dosing with cholic acid.
Slovenian: Znano je, da se pri čezmernem odmerjanju holne kisline pojavi tudi diareja.
English: WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KOLBAM Ne jemljite zdravila Kolbam:
English: Mild peripheral neuropathy
Slovenian: Bolezni živčevja blaga periferna nevropatija pogosti
English: No data regarding cholic acid treatment are available in patients with inborn errors of bile acid metabolism with hepatic impairment unrelated to their primary disease.
Slovenian: Pri bolnikih s prirojenimi okvarami presnove žolčnih kislin in jetrno okvaro, nepovezano s primarno boleznijo, ni na voljo nobenih podatkov o zdravljenju s holno kislino.
English: Mild nausea Mild reflux Moderate diarrhoea
Slovenian: Bolezni prebavil diareja pogosti blaga navzea blag refluks zmerna diareja pogosti pogosti pogosti refluksni ezofagitis pogosti
English: Study CAC-002-01, (an open-label, single-centre, nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-9110-10 and started on 1 Jan 2010.
Slovenian: Študija CAC-002-01 (odprta, enocentrična, nerandomizirana nadaljevalna študija kapsul holne kisline pri bolnikih s prirojenimi okvarami sinteze žolčnih kislin - an open-label, single-centre,
English: • feeling out of sorts (malaise)
Slovenian: • siljenje na bruhanje (blaga slabost),
English: Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
Slovenian: V študijah z večkratnimi odmerki, pri katerih se je holna kislina dajala sočasno s holesterolom, so poročali o povečani masi jeter in žolčnih kamnih.
English: NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules.
Slovenian: IME ZDRAVILA Kolbam 50 mg trde kapsule
English: Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid
Slovenian: Kolbam 250 mg trde kapsule holna kislina
English: Kolbam'.
Slovenian: Ne žvečite.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Slovenian: Po zmanjšanju odmerka so klinični znaki izginili,
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content
Slovenian: 6.1 Seznam pomožnih snovi
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <{DD. mesec LLLL}>
English: Titanium dioxide (E171)
Slovenian: Ovojnica kapsule: - želatina - titanov dioksid (E 171)
English: NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules.
Slovenian: IME ZDRAVILA Kolbam 250 mg trde kapsule
English: - The other ingredients are: Capsule content: Silicified microcrystalline cellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Kolbam 50 mg also contains Red iron oxide (E172).
Slovenian: - Druge sestavine zdravila so: Vsebina kapsule: - silicizirana mikrokristalna celuloza - magnezijev stearat
English: • sickness (mild nausea)
Slovenian: • mravljinčenje (blaga periferna nevropatija).
English: Titanium dioxide (E171) Red iron oxide (E172)
Slovenian: rdeči železov oksid (E 172)
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO
English: CONTENTS OF THE PACK AND OTHER INFORMATION What Kolbam contains - The active substance is cholic acid.
Slovenian: VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Kolbam
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of cholic acid.
Slovenian: Ena trda kapsula vsebuje 250 mg holne kisline.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cholic acid.
Slovenian: Ena trda kapsula vsebuje 50 mg holne kisline.
English: 50 mg Capsule shell Gelatin
Slovenian: Kolbam 50 mg trde kapsule holna kislina
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Slovenian: Zdravilo Kolbam je na voljo v obliki trdih kapsul.
English: • Gallstones
Slovenian: Fenian Street
English: Jaundice Increased serum transaminases Gallstones
Slovenian: transaminaz in koncentracij žolčnih kislin v serumu.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije splošno slabo počutje pogosti
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Packaging Content (concentration)
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015
Slovenian: Datum prve odobritve: 4. marec 2011 Datum zadnjega podaljšanja: 19. november 2015
English: The volume of distribution for irbesartan is 53-93 litres.
Slovenian: Porazdelitveni volumen irbesartana je 53 do 93 litrov.
English: Ifirmacombi should be taken at least one hour before or four hours after these medications;
Slovenian: Zdravilo Ifirmacombi je treba jemati vsaj eno uro pred jemanjem teh zdravil ali štiri ure kasneje.
English: What Ifirmacombi is and what it is used for
Slovenian: Kaj je zdravilo Ifirmacombi in za kaj ga uporabljamo
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Slovenian: Tablete morate pogoltniti z zadostno količino tekočine (npr. s kozarcem vode).
English: It is important that you continue to take Ifirmacombi until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Ifirmacombi jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: See also information under the heading “Do not take Ifirmacombi”.
Slovenian: Glejte tudi informacije pod naslovom "Ne jemljite zdravila Ifirmacombi".
English: The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Slovenian: Največji učinek na znižanje krvnega tlaka se običajno pojavi v 6 do 8 tednih po začetku zdravljenja.
English: During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Slovenian: Med 8-tedenskim zdravljenjem v nobeni skupini niso poročali o pojavu sinkope.
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 <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data)
Slovenian: Pogostost neželenih učinkov je v nadaljevanju navedena v skladu z naslednjim dogovorom: - 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), - neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Children and adolescents Ifirmacombi should not be given to children and adolescents (under 18 years).
Slovenian: Otroci in mladostniki Zdravila Ifirmacombi otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
English: See section 2 "Ifirmacombi contains sodium".
Slovenian: Glejte poglavje 2 "Zdravilo Ifirmacombi vsebuje natrij".
English: However the terminal half-life was not significantly altered.
Slovenian: Končna razpolovna časa se bistveno ne razlikujeta.
English: Primary aldosteronism:
Slovenian: Primarni aldosteronizem
English: If you take more Ifirmacombi than you should If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Ifirmacombi, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: You should discontinue Ifirmacombi treatment and seek medical attention.
Slovenian: Prenehajte z jemanjem zdravila Ifirmacombi in poiščite zdravniško pomoč.
English: The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Slovenian: Srednja starost bolnikov je bila 52,5 leta, 13 % bolnikov je bilo starih 65 let ali več.
English: The study recruited 58% males.
Slovenian: V študijo je bilo vključenih 58 % bolnikov moškega spola.
English: If Ifirmacombi is used during breast feeding, doses should be kept as low as possible.
Slovenian: Če se zdravilo Ifirmacombi uporablja med dojenjem, je treba uporabiti najmanjši možni odmerek.
English: Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA04.
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina I in diuretiki, oznaka ATC: C09DA04.
English: Such conditions should be corrected before initiating therapy with Ifirmacombi.
Slovenian: Ta stanja je treba popraviti pred začetkom zdravljenja z zdravilom Ifirmacombi.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: If you forget to take Ifirmacombi
Slovenian: Če ste pozabili vzeti zdravilo Ifirmacombi
English: - if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - Aliskiren
Slovenian: - če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka: - zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo, - aliskiren.
English: Film-coated tablet (tablet).
Slovenian: filmsko obložene tableta (tableta)
English: Uncommon: sexual dysfunction, libido changes
Slovenian: Občasni: motnje pri spolnosti, spremembe libida
English: Peak effects occurred at 3-6 hours.
Slovenian: Največji učinek je bil dosežen po 3 do 6 urah.
English: If this medicine does not help to reduce your blood pressure as required, the doctor will prescribe additional treatment to you.
Slovenian: Če to zdravilo ne pomaga znižati krvnega tlaka toliko, kot je potrebno, vam bo zdravnik predpisal dodatno zdravilo.
English: When necessary, Ifirmacombi may be administered with another antihypertensive medicinal product (see section 4.3, 4.4, 4.5 and 5.1).
Slovenian: Kadar je nujno, smejo bolniki poleg zdravila Ifirmacombi jemati tudi drug antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Slovenian: Glavni presnovek v obtoku je irbesartanov glukuronid (približno 6 %).
English: The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Slovenian: Primarni cilj te študije je bil primerjati odstotek bolnikov z nadzorovano vrednostjo diastoličnega tlaka v sedečem položaju (SeDBP < 90 mm Hg) v 5. tednu zdravljenja.
English: In addition increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Slovenian: Poleg tega so v študijah pogosto opazili tudi povečanje vrednosti sečnine v krvi (BUN) (2,3 %), kreatin kinaze (1,7 %) in kreatinina (1,1 %).
English: Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Slovenian: Na plazemske beljakovine se veže približno 68 % hidroklorotiazida; njegov porazdelitveni volumen je 0,83 do 1,14 l/kg.
English: What you need to know before you take Ifirmacombi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ifirmacombi
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, and 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 vrednosti holesterola v krvi.
English: Your doctor will normally advise you to stop taking Ifirmacombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ifirmacombi.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Ifirmacombi prekinete, še preden zanosite, ali takoj ko se izkaže, da ste zanosili, in vam predpisal zdravljenje z drugim zdravilom.
English: Alcohol: potentiation of orthostatic hypotension may occur;
Slovenian: Alkohol: Lahko se pojavi ortostatska hipotenzija.
English: In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Slovenian: V študijah, ki so trajale dolgo časa, so ugotovili, da je učinek kombinacije irbesartana in hidroklorotiazida trajal še več kot eno leto.
English: Since Ifirmacombi contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Slovenian: Zdravilo Ifirmacombi vsebuje hidroklorotiazid, zato njegova uporaba v prvem trimesečju nosečnosti ni priporočena.
English: Other medicines and Ifirmacombi
Slovenian: Druga zdravila in zdravilo Ifirmacombi
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Slovenian: Presnova irbesartana večinoma poteka prek CYP2C9 in v manjšem obsegu z glukuronidacijo.
English: Blister (OPA/Aluminium/PVC//Aluminium): 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets, in a box.
Slovenian: Pretisni omot (OPA/aluminij/PVC//aluminij): 14, 28, 30, 56, 56 x 1, 84, 90 in 98 filmsko obloženih tablet, v škatli.
English: Ifirmacombi with food, drink and alcohol Ifirmacombi can be taken with or without food.
Slovenian: Zdravilo Ifirmacombi skupaj s hrano in pijačo Zdravilo Ifirmacombi lahko jemljete skupaj s hrano ali brez nje.
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 poudarjene srčne aritmije, povezane s sočasno uporabo digitalisovih glikozidov in nekaterih antiaritmikov.
English: Boxes of 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets in blisters are available.
Slovenian: Na voljo so škatle po 14, 28, 30, 56, 56 x 1, 84, 90 in 98 filmsko obloženih tablet v pretisnih omotih.
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: Če je ponovna uporaba diuretika nujna, je izpostavljene dele kože priporočljivo zaščititi pred soncem ali umetnim UVA-sevanjem.
English: Metabolic and endocrine effects:
Slovenian: Presnova in endokrini učinki
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations
Slovenian: Tabela 1: Neželeni učinki v s placebom nadzorovanih kliničnih študijah in spontana poročila Preiskave
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 za pojav bolezni srca in ožilja in umrljivost zaradi njih.
English: - The other ingredients are:
Slovenian: - Druge sestavine zdravila:
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 poveča 2 uri po zaužitju hidroklorotiazida, njegov učinek je največji čez približno 4 ure, traja pa približno 6 do 12 ur.
English: What Ifirmacombi is and what it is used for What you need to know before you take Ifirmacombi How to take Ifirmacombi
Slovenian: Kaj je zdravilo Ifirmacombi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ifirmacombi Kako jemati zdravilo Ifirmacombi Možni neželeni učinki
English: Ifirmacombi can be taken once daily, with or without food.
Slovenian: Bolniki lahko zdravilo Ifirmacombi jemljejo enkrat na dan skupaj s hrano ali brez nje.
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 povečajo izločanje približno enakih količin natrija in klorida.
English: In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Slovenian: V študiji so ugotovili nekoliko večjo koncentracijo irbesartana pri ženskah s hipertenzijo.
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys.
Slovenian: Hidroklorotiazid se ne presnavlja, ampak se hitro izloči skozi ledvice.
English: Not known: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Slovenian: Neznana pogostnost: elektrolitsko neravnovesje (vključno s hipokaliemijo in hiponatriemijo, glejte poglavje 4.4), hiperurikemija, glikozurija, hiperglikemija ter povečanje vrednosti holesterola in trigliceridov
English: If this dose does not help to reduce your blood pressure as required, the doctor may prescribe Ifirmacombi 300 mg/25 mg to you.
Slovenian: Če ta odmerek ne pomaga znižati krvnega tlaka toliko, kot je potrebno, vam zdravnik lahko predpiše Ifirmacombi 300 mg/25 mg.
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: Side effects reported in clinical studies for patients treated with Ifirmacombi were:
Slovenian: Neželeni učinki, o katerih so med kliničnimi študijami poročali pri bolnikih, ki so se zdravili z zdravilom Ifirmacombi:
English: (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Slovenian: (encim kreatin kinaza), ali zvišanje vrednosti snovi, ki so merilo ledvičnega delovanja (sečnina v krvi, kreatinin)
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, obilno diurezo, bolnikih, ki peroralno ne prejemajo dovolj elektrolitov, in bolnikih, ki se sočasno zdravijo s kortikosteroidi ali ACTH.
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 irbesartana in hidroklorotiazida so po peroralnem dajanju ocenjevali pri podganah in opicah v raziskavah, ki so trajale do 6 mesecev.
English: You can take Ifirmacombi with or without food.
Slovenian: Zdravilo Ifirmacombi lahko jemljete s hrano ali brez nje.
English: Common: fatigue
Slovenian: Pogosti: utrujenost
English: Table 2: Adverse reactions reported with the use of irbesartan alone Blood and lymphatic system disorders
Slovenian: Tabela 2: Neželeni učinki, o katerih so poročali pri uporabi samega irbesartana Bolezni krvi in limfatičnega sistema
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: Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Slovenian: Antidiabetiki (peroralna zdravila in inzulini): Morda bo treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
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 še posebej previdno dajati bolnikom z okvarjenim jetrnim delovanjem ali napredujočo jetrno boleznijo, saj lahko že majhna sprememba tekočinskega ali elektrolitskega ravnovesja povzroči jetrno komo.
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Slovenian: Dvojna blokada sistema RAAS s hkratno uporabo zaviralcev ACE, antagonistov receptorjev angiotenzina II ali aliskirena zato ni priporočljiva (glejte poglavji 4.5 in 5.1).
English: abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Slovenian: Pri kuncih je po odmerkih, ki so pri samici povzročili pomembno toksičnost, prišlo do abortusa ali zgodnje absorpcije, vključno s smrtjo.
English: If you get any of the above symptoms or get short of breath, stop taking Ifirmacombi and contact your doctor immediately.
Slovenian: Če opazite katerega koli od zgoraj navedenih simptomov ali če se pojavi občutek težkega dihanja, zdravilo Ifirmacombi takoj prenehajte jemati in nemudoma poiščite zdravniško pomoč.
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Slovenian: V predkliničnih varnostnih študijah so veliki odmerki irbesartana (≥ 250 mg/kg/dan pri podganah in ≥ 100 mg/kg/dan pri opicah) povzročili zmanjšanje parametrov rdečih krvnih celic (eritrocitov, hemoglobina, hematokrita).
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 ob jemanju samega irbesartana ali samega hidroklorotiazida ni primerno urejen (glejte poglavje 5.1).
English: Efficacy and safety of the combination of irbesartan and hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, 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 mm Hg) sta bili ovrednoteni z multicentrično randomizirano dvojno slepo z učinkovino nadzorovano 8tedensko študijo paralelnih skupin.