FrancophonIA/ELRC3.0 huggingface dataset:
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Slovenian: Zelo veliki odmerki irbesartana (≥ 500 mg/kg/dan) so pri podganah in opicah makako sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so posledica hipotenzivnega učinka zdravila, ki povzroči zmanjšani pretok v ledvicah.
English: An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Slovenian: Pri ženskah, ki so se zdravile z irbesartanom, so v primerjavi z ženskami, ki so se zdravile z amlodipinom, opazili povečano pogostost nefatalnih MI in kapi, medtem ko se je v celotni populaciji zmanjšalo število hospitalizacij zaradi srčne odpovedi.
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Slovenian: Presnova irbersartana večinoma poteka prek CYP2C9, nekaj pa se ga presnovi tudi z glukuronidacijo.
English: An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
Slovenian: V prvih treh mesecih zdravljenja niso opazili izboljšanja hitrosti glomerulne filtracije.
English: - Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Slovenian: - Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, motnje pri spolnih aktivnostih, bolečina v prsnem košu.
English: The demonstration of renal benefit of Ifirmasta in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Slovenian: Koristi zdravljenja z zdravilom Ifirmasta za ledvice pri bolnikih z visokim krvnim tlakom in z diabetesom tipa 2 so pokazale raziskave, v katerih so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (gl. poglavja 4.3, 4.4, 4.5 in 5.1).
English: When Ifirmasta is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Če dajemo zdravilo Ifirmasta bolnikom z okvarjenim ledvičnim delovanjem, je priporočljiv reden nadzor koncentracije kalija in kreatinina v serumu.
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Slovenian: Pri bolnikih na hemodializi je treba pretehtati možnost uporabe manjšega začetnega odmerka (75 mg) (gl. poglavje 4.4).
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Slovenian: Pri diabetičnih bolnikih z visokim krvnim tlakom s kroničnim ledvičnim odpovedovanjem in izraženo proteinurijo se je hiperkaliemija (≥ 5,5 mEq/l) pojavila pri 46,3 % bolnikov, ki so dobivali irbesartan, in pri 26,3 % bolnikov, ki je dobivala placebo.
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, blokatorjev 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: There is no experience regarding the administration of Ifirmasta in patients with a recent kidney transplantation.
Slovenian: S predpisovanjem zdravila Ifirmasta bolnikom po nedavni presaditvi ledvic ni nobenih izkušenj.
English: Such conditions should be corrected before the administration of Ifirmasta.
Slovenian: Ta stanja je treba uravnati, preden se bolniku predpiše zdravilo Ifirmasta.
English: At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Slovenian: Po koncu tritedenskega obdobja se je primarna spremenljivka učinkovitosti - najnižji sistolični krvni tlak, izmerjen sede - v primerjavi z izhodiščem znižala za povprečno 11,7 mm Hg (pri majhnem odmerku), 9,3 mm Hg (pri srednjem odmerku) oz. 13,2 mm Hg (pri velikem odmerku).
English: No specific information is available on the treatment of overdosage with Ifirmasta.
Slovenian: Specifični podatki o zdravljenju preodmerjanja z irbesartanom niso na voljo.
English: Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Slovenian: Na serumsko koncentracijo kalija irbesartan v priporočenih odmerkih ne vpliva značilno.
English: Ifirmasta 75 mg film-coated tablets Ifirmasta 150 mg film-coated tablets Ifirmasta 300 mg film-coated tablets
Slovenian: Ifirmasta 75 mg filmsko obložene tablete Ifirmasta 150 mg filmsko obložene tablete Ifirmasta 300 mg filmsko obložene tablete
English: Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
Slovenian: Največje znižanje krvnega tlaka je bilo doseženo 3 do 6 ur po jemanju zdravila, antihipertenzivni učinek pa je trajal najmanj 24 ur.
English: Close monitoring of serum potassium in patients at risk is recommended (see section 4.5).
Slovenian: Pri ogroženih bolnikih je priporočljivo redno spremljanje koncentracije kalija v serumu (gl. poglavje 4.5).
English: The dose may later be increased to 300 mg once daily depending on blood pressure response.
Slovenian: Kasneje se ga lahko poveča na 300 mg enkrat na dan, odvisno od znižanja krvnega tlaka.
English: Therefore, the use of Ifirmasta is not recommended.
Slovenian: Jemanje zdravila Ifirmasta zato ni priporočljivo.
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Slovenian: Pri bolnikih, zdravljenih z irbesartanom, so pogosto (1,7 %) opazili pomembno povečanje plazemske kreatininske kinaze.
English: Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively.
Slovenian: V placebo skupini je ciljni krvni tlak doseglo 60 % bolnikov, v skupini, ki se je zdravila z irbesartanom, 76 %, v skupini, ki je jemala amlodipin, pa 78 %.
English: Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Slovenian: Po potrebi so za doseganje načrtovanega krvnega tlaka uporabljali dodatne antihipertenzive (brez zaviralcev ACE, antagonistov receptorjev za angiotenzin II in dihidropiridinskih zaviralcev kalcija).
English: Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Ifirmasta has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Slovenian: Znani so podatki o varnem jemanju irbesartana in drugih antihipertenzivov, npr. zaviralcev adrenergičnih receptorjev beta, zaviralcev kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnih diuretikov.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Slovenian: V kliničnih raziskavah hidroklorotiazid ni vplival na farmakokinetiko irbesartana.
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 delovanja ledvic.
English: Renal impairment and kidney transplantation
Slovenian: Ledvična okvara in presaditev ledvic:
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
Slovenian: Neznana: preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica, anafilaktične reakcije,
English: orthostatic hypotension* Uncommon: flushing
Slovenian: ortostatska hipotenzija* Občasni: rdečica
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Slovenian: Medtem ko so v vseh skupinah dosegli podoben krvni tlak, je imelo v skupini, ki je jemala 300 mg irbesartana (5,2 %), proteinurijo manj oseb kot v placebo skupini (14,9 %) ali v skupini, ki je jemala irbesartan 150 mg (9,7 %).
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Slovenian: Korigirana povprečna sprememba najnižjih vrednosti diastoličnega krvnega tlaka, izmerjenega sede, je bila 3,8 mm Hg (pri majhnem odmerku), 3,2 mm Hg (pri srednjem odmerku) oz. 5,6 mm Hg (pri velikem odmerku).
English: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Slovenian: Pri bolnikih z visokim krvnim tlakom in z diabetesom tipa 2 moramo zdravljenje začeti z enkratnim dnevnim odmerkom po 150 mg irbesartana in ga postopno povečevati do 300 mg enkrat na dan, kar je priporočeni vzdrževalni odmerek za zdravljenje ledvične bolezni.
English: The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Slovenian: Običajni priporočeni začetni in vzdrževalni odmerek je 150 mg zdravila Ifirmasta enkrat na dan.
English: Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Slovenian: Dnevni odmerek po 150 mg povzroči podobne 24-urne vrednosti in srednje vrednosti 24-urnega krvnega tlaka, kot če isti dnevni odmerek damo v dveh odmerkih.
English: The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.
Slovenian: Kasneje se ga lahko poveča na 300 mg (dve tableti) enkrat na dan, odvisno od znižanja krvnega tlaka.
English: The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
Slovenian: Kasneje se ga lahko poveča na 300 mg (štiri tablete) enkrat na dan, odvisno od znižanja krvnega tlaka.
English: Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc
Slovenian: Jedro tablete manitol hidroksipropilceluloza nizkosubstituirana hidroksipropilceluloza (LH-21) nizkosubstituirana hidroksipropilceluloza (LH-11) smukec makrogol 6000 hidrogenirano ricinusovo olje
English: Reproductive system and breast disorders: Uncommon: sexual dysfunction
Slovenian: Motnje reprodukcije in dojk: Občasni: motnje spolnosti
English: The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Slovenian: Farmakokinetika digoksina se ob sočasnem jemanju irbesartana ni spremenila.
English: In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Slovenian: Pri bolnikih z lažjo ali srednje hudo cirozo farmakokinetični parametri irbesartana niso bili pomembno spremenjeni.
English: There is no clinical experience in patients with severe hepatic impairment.
Slovenian: Z zdravljenjem bolnikov s hudo jetrno okvaro ni kliničnih izkušenj.
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Slovenian: Preizkušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom in diabetesom tipa 2 (IRMA 2) je pokazalo, da 300 mg irbesartana pri bolnikih z mikroalbuminurijo upočasni napredovanje v proteinurijo.
English: White, oval tablets.
Slovenian: Tablete so bele barve, ovalne oblike.
English: Blood and lymphatic system disorders: Not known:
Slovenian: Bolezni krvi in limfatičnega sistema: Neznana: trombocitopenija
English: Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Slovenian: Presnavlja se v jetrih s konjugacijo z glukuronidom in z oksidacijo.
English: In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Slovenian: V sekundarnem izidu fatalnih in nefatalnih srčno-žilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo v primerjavi s placebo skupino opaziti povečano pogostost nefatalnih miokardnih infarktov (MI) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini, ki se je zdravila z irbesartanom.
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).
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) (gl. poglavje 5.3).
English: Ifirmasta 300 mg film-coated tablets 14 tablets: EU/1/08/480/013
Slovenian: Ifirmasta 300 mg filmsko obložene tablete 14 tablet: EU/1/08/480/013
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Slovenian: Pri odmerkih, ki so večji od 600 mg (dvakrat več od priporočenega odmerka), so opazili nesorazmerno majhno povečanje peroralne absorpcije; mehanizem tega pojava ni pojasnjen.
English: Ifirmasta 150 mg film-coated tablets 14 tablets: EU/1/08/480/007
Slovenian: Ifirmasta 150 mg filmsko obložene tablete 14 tablet: EU/1/08/480/007
English: Intravascular volume depletion
Slovenian: Zmanjšan intravaskularni volumen:
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: Zdravljenje z irbesartanom so raziskovali tudi pri otrocih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšani uporabi pri otrocih.
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function, - if you are going to have an operation (surgery) or be given anaesthetics,
Slovenian: V tem primeru bo zdravnik morda moral redno opravljati krvne preiskave, še posebej tiste, s katerimi bo v primeru slabega delovanja ledvic spremljal vrednosti kalija v krvi.
English: Nervous system disorders: Common:
Slovenian: Bolezni živčevja: Pogosti:
English: When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Slovenian: Upoštevati pa je treba, da se med zdravljenjem lahko pojavita omotica ali utrujenost.
English: Cardiac disorders: Uncommon: tachycardia
Slovenian: Srčne bolezni: Občasni: tahikardija
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: V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Ifirmasta, poročali o naslednjih neželenih učinkih: - 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 vrednosti kalija v krvi.
English: Potassium supplements and potassium-sparing diuretics:
Slovenian: Dodatki kalija in diuretiki, ki varčujejo s kalijem:
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Pri bolnikih z aortno ali mitralno stenozo ali obstruktivno hipertrofično kardiomiopatijo je tako kot pri drugih vazodilatatorjih potrebna posebna previdnost.
English: The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
Slovenian: Dnevni odmerki od 150 do 300 mg pri bolnikih, ki so jim krvni tlak merili v ležečem ali sedečem položaju, so 24 ur po odmerku znižali sistolični oz. diastolični krvni tlak za 8 do 13 oz. 5 do 8 mm Hg več, kot se je znižal pri bolnikih v placebo skupini.
English: Respiratory, thoracic and mediastinal disorders: Uncommon: cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasni: kašelj
English: Ifirmasta 75 mg film-coated tablets Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).
Slovenian: Ifirmasta 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg irbesartana (v obliki klorida).
English: Because no information is available regarding the use of Ifirmasta during breast-feeding, Ifirmasta is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Podatkov o uporabi zdravila Ifirmasta med dojenjem ni na voljo, zato uporaba zdravila Ifirmasta med dojenjem ni priporočljiva.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Slovenian: Kaže, da je hiperplazija/hipertrofija ledvičnih jukstaglomerulnih celic pri človeku, ki jemlje terapevtske odmerke, nepomembna.
English: A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Slovenian: Po ponavljajočem odmerjanju enkrat na dan so ugotovili kopičenje irbesartana v plazmi (18 %).
English: Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 16 mg castor oil.
Slovenian: Ifirmasta 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 16 mg ricinusovega olja.
English: hepatitis, abnormal liver function
Slovenian: Neznana: hepatitis, motnje v delovanju jeter
English: What Ifirmasta looks like and contents of the pack Ifirmasta 75 mg film-coated tablets are: white, oval film-coated tablets.
Slovenian: Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 75 mg filmsko obložene tablete so bele barve, ovalne oblike.
English: Ifirmasta 75 mg film-coated tablets Irbesartan
Slovenian: Ifirmasta 75 mg filmsko obložene tablete irbesartan
English: Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 8 mg castor oil.
Slovenian: Ifirmasta 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 8 mg ricinusovega olja.
English: Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).
Slovenian: Ifirmasta 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki klorida).
English: How to store Ifirmasta
Slovenian: Shranjevanje zdravila Ifirmasta
English: Ifirmasta 150 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Ifirmasta 150 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
English: What Ifirmasta looks like and contents of the pack Ifirmasta 300 mg film-coated tablets are: white, oval film-coated tablets.
Slovenian: Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 300 mg filmsko obložene tablete so bele barve, ovalne oblike.
English: The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba antagonistov angiotenzina II v prvem trimesečju ni priporočljiva (gl. poglavje 4.4).
English: Ifirmasta 75 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Ifirmasta 75 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
English: Ifirmasta 300 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Ifirmasta 300 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
English: Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).
Slovenian: Ifirmasta 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki klorida).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Film coating:
Slovenian: Bolezni sečil:
English: What Ifirmasta looks like and contents of the pack Ifirmasta 150 mg film-coated tablets are: white, oval film-coated tablets.
Slovenian: Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 150 mg filmsko obložene tablete so bele barve, ovalne oblike.
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Slovenian: Pri bolnikih, pri katerih z odmerkom irbesartana, ki ga jemljejo enkrat na dan, ni dosežen nadzor krvnega tlaka, je treba uvesti še majhen odmerek hidroklorotiazida (12,5 mg), prav tako enkrat na dan.