natgillin/translations-raw huggingface dataset:
Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Rodopi Prefecture, Block No 5, Rodopi 69300, Grčija
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Celokupni telesni in ledvični očistek je 157176 oziroma 3-3,5 ml/min.
Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Mehanizem delovanja: Irbesartan je močan, peroralno delujoč, selektivni antagonist receptorjev za angiotenzin II (tip AT1).
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
Predložitev PSUR mora slediti časovnici predložitve PSUR referenčnega zdravila
• potassium-sparing medicines (such as certain diuretics)
• zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki)
Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Na splošno zagotavlja odmerek 150 mg zdravila Sabervel enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Hiperkaliemija* se je pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom pogosteje kot pri bolnikih, ki so dobivali placebo.
Taking Sabervel with food and drink Sabervel can be taken with or without food.
Jemanje zdravila Sabervel skupaj s hrano in pijačo Zdravilo Sabervel lahko jemljete s hrano ali brez nje.
C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
C irbesartana, se približno 20% radioaktivnosti izloči z urinom in preostanek z blatom.
• If you have any further questions, ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujete z zdravnikom ali s farmacevtom.
Such conditions should be corrected before the administration of Sabervel.
Ta stanja se mora korigirati, preden se uporabi zdravilo Sabervel.
Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters.
Škatle s 28, 56, 90 ali 98 filmsko obloženimi tabletami: v PVC/PVDC-aluminija/PVDC.
No specific information is available on the treatment of overdose with Sabervel.
Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Sabervel niso na voljo.
This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila
You can take Sabervel with or without food.
Zdravilo Sabervel lahko jemljete s hrano ali brez nje.
Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Cmax, AUC in očistek primerljivi tistim pri odraslih, ki so dobivali 150 mg irbesartana na dan.
Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6.1).
• potassium supplements
• dodatke kalija
Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Ledvična okvara in presaditev ledvic: pri dajanju zdravila Sabervel bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan se izloča z mlekom doječih podgan.
Therefore, the use of Sabervel is not recommended.
Zato uporaba zdravila Sabervel ni priporočljiva.
28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
28 filmsko obloženih tablet 56 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
Children should not take Sabervel
Otroci ne smejo jemati zdravila Sabervel
(It is also better to avoid Sabervel in early pregnancy
(Jemanju zdravila Sabervel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti)
The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila irbesartana na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
Your doctor will normally advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel.
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Sabervel prekinete še preden zanosite ali takoj, ko se izkaže, da ste zanosili in vam predpisal zdravljenje z drugim zdravilom.
Lactose: this medicinal product contains lactose.
Laktoza: to zdravilo vsebuje laktozo.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Sabervel (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Sabervel (glejte poglavje 4.4).
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
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
If you forget to take Sabervel:
Če ste pozabili vzeti zdravilo Sabervel
Sabervel is used in adult patients
Zdravilo Sabervel uporabljamo pri odraslih bolnikih:
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
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.
Pregnancy: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Nosečnost: Zdravljenja z antagonisti angiotenzina II se ne sme začeti med nosečnostjo.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Sabervel (see section 4.5).
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Sabervel (glejte poglavje 4.5).
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase
artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin kinaze v plazmi), mišični krči Bolezni sečil:
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.
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.
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Največje plazemske koncentracije so dosežene 1,5-2 uri po peroralni uporabi.
INSTRUCTIONS ON USE
Navodilo je bilo odobreno
Sabervel is indicated in adults for the treatment of essential hypertension.
4.1 Terapevtske indikacije Zdravilo Sabervel je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
• medicines containing lithium
• zdravila, ki vsebujejo litij
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
HOW TO TAKE SABERVEL
KAKO JEMATI ZDRAVILO SABERVEL
Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP.
Zdravila Sabervel ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "Upor.
• salt substitutes containing potassium
• nadomestke soli, ki vsebujejo kalij
Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.
Na podlagi farmakodinamičnih lastnosti ni verjetno, da bi irbesartan poslabšal to sposobnost.
If you take more Sabervel than you should: If you accidentally take too many tablets, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Sabervel, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Čeprav to za zdravilo Sabervel ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Omejeno kopičenje irbesartana (<20%) v plazmi so opazili ob ponovitvah enkrat- dnevnega odmerjanja.
See also information under the heading “Do not take Sabervel”.
Glejte tudi informacije pod naslovom “Ne <jemljite> <uporabljajte> zdravila Sabervel.
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, hipromeloza, magnezijev stearat Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400
08184 - Palau-solità i Plegamans, Barcelona, Spain
ES-08184 - Palau-solità i Plegamans, Barcelona, Španija
Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Zdravilo Sabervel preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Titanium dioxide (E171)
Filmska obloga: hipromeloza titanov dioksid (E171) makrogol 400
No dosage adjustment is necessary in elderly patients.
Prilagajanje odmerka za starejše bolnike ni potrebno.
• 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.
• Zelo pogosti: če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Poleg tega je irbesartan sprožil hiperplazijo/hipertrofijo jukstaglomerulnih celic (pri podganah pri ≥90 mg/kg/dan, pri makako opicah pri ≥10 mg/kg/dan).
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.
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.
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.
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
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
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).
Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Litij: sočasna uporaba zdravila Sabervel in litija ni priporočljiva (glejte poglavje 4.5).
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).
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).
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.
Učinek zdravila irbesartana na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 4-6 tednov po začetku zdravljenja.
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).
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).
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.
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.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
V skupini s 300 mg irbesartana je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
Musculoskeletal and connective tissue disorders: Common:
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti:
hypersensitivity reactions such as angioedema, rash, urticaria
preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica
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.
Zdravila Sabervel ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
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).
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).
• Patients with high blood pressure and type 2 diabetes with kidney disease
• Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic
Sabervel should not be given to children under 18 years of age.
Otroci in mladostniki, mlajši od 18 let, zdravila Sabervel ne smejo jemati.
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
Pri bolnikih na hemodializi se mora pretehtati možnost uporabe nižjega začetnega odmerka (75 mg) (glejte poglavje
Immune system disorders: Not known:
Bolezni imunskega sistema: Neznana:
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).
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).
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
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
• if you suffer from kidney problems
• če imate težave z ledvicami
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).
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).
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.
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.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne <jemljite>
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.
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.
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).
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).
If you get any of these symptoms or get short of breath, stop taking Sabervel and contact your doctor imme diate ly.
Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Sabervel takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
15351 Pallini, Attiki, Greece
15351 Pallini Attiki, Grčija
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat Brezvodni koloidni silicijev dioksid hipromeloza magnezijev stearat
Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists.
KAJ JE ZDRAVILO SABERVEL IN ZA KAJ GA UPORABLJAMO Zdravilo Sabervel spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
Following oral or intravenous administration of
Po peroralni ali intravenski uporabi
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
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).
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).
Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses.
V študijah pri živalih so v zarodkih podgan in kunčjih samic odkrili z radioaktivnim izotopom označen irbesartan.
What Sabervel contains
Kaj vsebuje zdravilo Sabervel
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
IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30
• Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
• Občasni: hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, motnje pri spolnih aktivnostih, bolečina v prsnem košu.
Metabolism and nutrition disorders: Not known:
Presnovne in prehranske motnje: Neznana:
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Jetrna okvara: pri bolnikih z lažjo do srednjo cirozo, farmakokinetični parametri irbesartana niso pomembno spremenjeni.
Side effects reported in clinical studies for patients treated with Irbesartan were:
V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Sabervel, poročali o naslednjih neželenih učinkih:
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.
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.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Sistem farmakovigilance
C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
Sabervel is unlikely to affect your ability to drive or use machines.
Verjetnost, da bi zdravilo Sabervel vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.