FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Slovenian: V nadaljevanju so neželeni učinki navedeni po pogostnosti v skladu z naslednjim dogovorom: zelo pogosti: pri vsaj 1 od 10 bolnikov ali več pogosti: pri vsaj 1 od 100 in manj kot 1 od 10 bolnikov občasni: pri vsaj 1 od 1.000 in manj kot 1 od 100 bolnikov
English: If you forget to take Sabervel:
Slovenian: Če ste pozabili vzeti zdravilo Sabervel
English: Sabervel is used in adult patients
Slovenian: Zdravilo Sabervel uporabljamo pri odraslih bolnikih:
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
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: Pregnancy: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Slovenian: Nosečnost: Zdravljenja z antagonisti angiotenzina II se ne sme začeti med nosečnostjo.
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Sabervel (see section 4.5).
Slovenian: In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Sabervel (glejte poglavje 4.5).
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase
Slovenian: artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin kinaze v plazmi), mišični krči Bolezni sečil:
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Slovenian: Bolnikom so postopoma povečevali odmerek irbesartana od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Slovenian: Največje plazemske koncentracije so dosežene 1,5-2 uri po peroralni uporabi.
English: INSTRUCTIONS ON USE
Slovenian: Navodilo je bilo odobreno
English: Sabervel is indicated in adults for the treatment of essential hypertension.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Sabervel je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
English: • medicines containing lithium
Slovenian: • zdravila, ki vsebujejo litij
English: Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: HOW TO TAKE SABERVEL
Slovenian: KAKO JEMATI ZDRAVILO SABERVEL
English: Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Zdravila Sabervel ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "Upor.
English: • salt substitutes containing potassium
Slovenian: • nadomestke soli, ki vsebujejo kalij
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.
Slovenian: Na podlagi farmakodinamičnih lastnosti ni verjetno, da bi irbesartan poslabšal to sposobnost.
English: If you take more Sabervel than you should: If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Sabervel, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Slovenian: Čeprav to za zdravilo Sabervel ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Slovenian: Omejeno kopičenje irbesartana (<20%) v plazmi so opazili ob ponovitvah enkrat- dnevnega odmerjanja.
English: See also information under the heading “Do not take Sabervel”.
Slovenian: Glejte tudi informacije pod naslovom “Ne <jemljite> <uporabljajte> zdravila Sabervel.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, hipromeloza, magnezijev stearat Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400
English: 08184 - Palau-solità i Plegamans, Barcelona, Spain
Slovenian: ES-08184 - Palau-solità i Plegamans, Barcelona, Španija
English: Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Slovenian: Zdravilo Sabervel preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
English: Titanium dioxide (E171)
Slovenian: Filmska obloga: hipromeloza titanov dioksid (E171) makrogol 400
English: No dosage adjustment is necessary in elderly patients.
Slovenian: Prilagajanje odmerka za starejše bolnike ni potrebno.
English: • Very common : 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: če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
English: irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Slovenian: Poleg tega je irbesartan sprožil hiperplazijo/hipertrofijo jukstaglomerulnih celic (pri podganah pri ≥90 mg/kg/dan, pri makako opicah pri ≥10 mg/kg/dan).
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Sabervel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Slovenian: Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzin-aldosteron, se lahko tudi med zdravljenjem z zdravilom Sabervel pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ali odpovedi srca.
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
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
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: Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Slovenian: Litij: sočasna uporaba zdravila Sabervel in litija ni priporočljiva (glejte poglavje 4.5).
English: The concomitant use of Sabervel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: Sočasna uporaba zdravila Sabervel in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavji 4.5 in 5.1).
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Slovenian: Učinek zdravila irbesartana na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 4-6 tednov po začetku zdravljenja.
English: Sabervel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Zdravila Sabervel ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Slovenian: Diuretiki in drugi antihipertenzivi: drugi antihipertenzivi lahko povečajo hipotenzivni učinek irbesartana; vendar pa so zdravilo irbesartana varno uporabljali z drugimi antihipertenzivi, kot so antagonisti adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnimi diuretiki.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Slovenian: V skupini s 300 mg irbesartana je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
English: Musculoskeletal and connective tissue disorders: Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti:
English: hypersensitivity reactions such as angioedema, rash, urticaria
Slovenian: preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica
English: Sabervel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Sabervel ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
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, ki niso zadostno kontrolirani s samim irbesartanom, se z dodatno uvedbo nizkega odmerka hidroklorotiazida (12,5 mg) enkrat dnevno, poleg enkrat dnevnega odmerka irbesartana, doseže nadaljnje s placebomuravnano znižanje krvnega tlaka v celoti za 7-10/3-6 mmHg (sistolični/ diastolični).
English: • Patients with high blood pressure and type 2 diabetes with kidney disease
Slovenian: • Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic
English: Sabervel should not be given to children under 18 years of age.
Slovenian: Otroci in mladostniki, mlajši od 18 let, zdravila Sabervel ne smejo jemati.
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
Slovenian: Pri bolnikih na hemodializi se mora pretehtati možnost uporabe nižjega začetnega odmerka (75 mg) (glejte poglavje
English: Immune system disorders: Not known:
Slovenian: Bolezni imunskega sistema: Neznana:
English: In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Slovenian: Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Sabervel ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
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
Slovenian: Pri diabetičnih bolnikih z visokim krvnim tlakom s kronično ledvično insuficienco in izraženo proteinurijo, se je hiperkaliemija (≥ 5,5 mEq/l) pojavila pri 46,3% bolnikov, ki so dobivali irbesartan in pri 26,3% bolnikov v placebo skupini
English: • if you suffer from kidney problems
Slovenian: • če imate težave z ledvicami
English: Some side effects have been reported since marketing of Irbesartan Side effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Slovenian: Neželeni učinki, katerih pogostnost ni znana so: vrtoglavica, glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic in vnetje malih krvnih žil, predvsem kože (bolezen, znana kot levkocitoklastični vaskulitis).
English: Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Slovenian: Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji “Irbesartan Diabetic Nephropathy Trial" (IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
Slovenian: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne <jemljite>
English: hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all-cause mortality were examined.
Slovenian: Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥ 900 mg/dan in serumskim kreatininom 1,0-3,0 mg/dl, so raziskovali dolgotrajne učinke irbesartana (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
English: The demonstration of renal benefit of Sabervel 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 Sabervel za ledvice pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 so pokazale študije, kjer so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
English: If you get any of these symptoms or get short of breath, stop taking Sabervel and contact your doctor imme diate ly.
Slovenian: Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Sabervel takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
English: 15351 Pallini, Attiki, Greece
Slovenian: 15351 Pallini Attiki, Grčija
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Slovenian: Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat Brezvodni koloidni silicijev dioksid hipromeloza magnezijev stearat
English: Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: KAJ JE ZDRAVILO SABERVEL IN ZA KAJ GA UPORABLJAMO Zdravilo Sabervel spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
English: Following oral or intravenous administration of
Slovenian: Po peroralni ali intravenski uporabi
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Slovenian: Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) Obstajajo dokazi, da sočasna uporaba zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena poveča tveganje za hipotenzijo, hiperkaliemijo in zmanjšano delovanje ledvic (vključno z akutno odpovedjo ledvic).
English: Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses.
Slovenian: V študijah pri živalih so v zarodkih podgan in kunčjih samic odkrili z radioaktivnim izotopom označen irbesartan.
English: What Sabervel contains
Slovenian: Kaj vsebuje zdravilo Sabervel
English: IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function
Slovenian: IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30
English: • Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Slovenian: • Občasni: hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, motnje pri spolnih aktivnostih, bolečina v prsnem košu.
English: Metabolism and nutrition disorders: Not known:
Slovenian: Presnovne in prehranske motnje: Neznana:
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Slovenian: Jetrna okvara: pri bolnikih z lažjo do srednjo cirozo, farmakokinetični parametri irbesartana niso pomembno spremenjeni.
English: Side effects reported in clinical studies for patients treated with Irbesartan were:
Slovenian: V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Sabervel, poročali o naslednjih neželenih učinkih:
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: mg/kg/dan) so pri podganah in makako opicah sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Sistem farmakovigilance
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: 85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
English: Sabervel is unlikely to affect your ability to drive or use machines.
Slovenian: Verjetnost, da bi zdravilo Sabervel vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
English: There is no experience regarding the administration of Sabervel in patients with a recent kidney transplantation.
Slovenian: Sabervel pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (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 delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija)
English: M anufacture r:
Slovenian: Izde lovale c:
English: • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: • če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje
English: • if you get excessive vomiting or diarrhoea
Slovenian: • če začnete prekomerno bruhati ali dobite hudo drisko
English: Important information about some of the ingredients of Sabervel Sabervel contains lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Sabervel
English: The dose may later be increased to 300 mg once daily
Slovenian: Odmerek se lahko kasneje poveča na 300 mg enkrat na dan, odvisno od odziva krvnega tlaka.
English: In this leaflet: What Sabervel is and what it is used for
Slovenian: Navodilo vsebuje: Kaj je zdravilo Sabervel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sabervel
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Slovenian: Selektivni antagonistični učinek na receptorje angiotenzina II (AT1) povzroči povečanje plazemske ravni renina in angiotenzina
English: (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Slovenian: 300 mg/dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤1,5 mg/dl, pri ženskah <1,1 mg/dl).
English: INFORMATION IN BRAILLE Sabervel 75 mg
Slovenian: Sabervel 75 mg
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Slovenian: SeSBP zvišal za 2,4 mmHg in SeDBP za 2,0 mmHg, medtem ko se je bolnikom na vseh odmerkih irbesartana SeSBP spremenil za +0,1 mmHg in SeDBP za -0,3 mmHg (glejte poglavje 4.2).
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Slovenian: In vitro študije kažejo, da se irbesartan primarno oksidira z citokrom P450 encimom
English: Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Slovenian: Ledvična okvara: bolnikom s prizadeto ledvično funkcijo odmerka ni treba prilagajati.
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Slovenian: Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana upočasni napredovanje do izražene proteinurije.
English: 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Slovenian: 6 Dervenakion str. 15351 Pallini Attiki, Grčija
English: INFORMATION IN BRAILLE Sabervel 300 mg
Slovenian: Sabervel 300 mg
English: • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory
Slovenian: • za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
English: blood tests may show an increased level of potassium.
Slovenian: Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
English: dizziness, orthostatic dizziness*
Slovenian: driska, dispepsija/zgaga