natgillin/translations-raw huggingface dataset:
Warning and precautions Talk to your doctor before taking Aprovel and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
Pred začetkom jemanja zdravila Aprovel se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Aprovel jemljete zaradi diabetične bolezni ledvic.
The demonstration of renal benefit of Aprovel 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 Aprovel 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).
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Pri bolnikih na hemodializi se mora pretehtati možnost uporabe nižjega začetnega odmerka (75 mg) (glejte poglavje 4.4).
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE /PODALJŠANJA DOVOLJENJA ZA PROMET
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 placebom-uravnano znižanje krvnega tlaka v celoti za 7-10/3-6 mmHg (sistolični/ diastolični).
If you experience these, talk to your doctor before attempting to drive or use machines.
V tem primeru se morate pred upravljanjem vozil ali strojev posvetovati s svojim zdravnikom.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Irbesartan in njegovi metaboliti se izločajo tako z žolčem kot preko ledvic.
The study of the “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
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 odloži napredovanje do izražene proteinurije.
There is no clinical experience in patients with severe hepatic impairment.
Pri bolnikih s hudo jetrno okvaro ni kliničnih izkušenj.
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.
V placebo skupini je doseglo ciljni krvni tlak 60% bolnikov, v skupini z irbesartanom 76% in v skupini z amlodipinom 78%.
leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
levkocitoklastični vaskulitis Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
 The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Pomožne snovi so laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza, silicijev dioksid, magnezijev stearat, titanov dioksid, makrogol 3000 in karnauba vosek.
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.
Zmanjšanje krvnega tlaka je odvisno od odmerka pri enkratnih dnevnih odmerkih in s tendenco doseganja platoja pri odmerkih večjih od 300 mg. Enkratni dnevni odmerki 150-300 mg v povprečju vseskozi (npr. 24 ur po odmerku) znižajo krvni tlak v ležečem ali sedečem položaju za 8-13/5-8 mmHg (sistolični/diastolični) več, kot se zniža s placebom.
Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Na voljo so tudi enoodmerni pretisni omoti s 56 x 1 tableto za uporabo v bolnišnicah.
nausea/vomiting
slabost/bruhanje
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Na serumsko raven kalija sam irbesartan v priporočenih odmerkih ne vpliva značilno.
hepatitis, abnormal liver function Skin and subcutaneous tissue disorders Not known:
hepatitis, motnje v delovanju jeter Bolezni kože in podkožja Neznana:
In 1,715 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 Aprovel 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 zdravila Aprovel (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
pri bolnikih zdravljenih z irbesartanom so pogosto (1,7%) opazili pomembno povečanje plazemske kreatinin kinaze.
Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.
Na voljo so tudi enoodmerni pretisni omoti s 56 x 1 filmsko obloženo tableto za uporabo v bolnišnicah.
The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Farmakokinetika digoksina se ob sočasnem dajanju irbesartana ni spremenila.
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.
Pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 moramo zdravljenje začeti z enkratnim dnevnim odmerkom 150 mg irbesartana in ga postopno povečevati do 300 mg enkrat dnevno, kar je priporočeni vzdrževalni odmerek za zdravljenje ledvične bolezni.
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalnim delovanjem ledvic, so poročali o ortostatski omotici in ortostatski hipotenziji pri 0,5% bolnikov (to je občasno), a več kot pri placebu.
No dosage adjustment is necessary in older people.
Prilagajanje odmerka za starejše bolnike ni potrebno.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000
Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3000 karnauba vosek
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
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.
hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock Metabolism and nutrition disorders Not known:
preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica, anafilaktične reakcije, anafilaktični šok Presnovne in prehranske motnje Neznana:
There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Na serumsko sečno kislino ali z urinom izločeno sečno kislino nima klinično pomembnega učinka.
Undesirable 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, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis),and severe allergic reactions (anaphylactic shock).
Neželeni učinki, katerih pogostnost ni znana, so: vrtoglavica, glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, zmanjšano število trombocitov, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic, vnetje malih krvnih žil, predvsem kože (bolezen, znana kot levkocitoklastični vaskulitis) in hude alergijske reakcije (anafilaktični šok).
Each tablet of Aprovel 75 mg contains 75 mg irbesartan.
Ena tableta zdravila Aprovel 75 mg vsebuje 75 mg irbesartana.
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.
Po potrebi, so za doseganje načrtovanega krvnega tlaka uporabljali dodatne antihipertenzive (brez zaviralcev ACE, antagonistov receptorjev za angiotenzin II in dihidropiridinskih zaviralcev kalcija).
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Bolniki morajo zaužiti primerno količino tekočine in po uvedbi sočasne uporabe je priporočljivo redno spremljanje delovanja ledvic.
Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
Ena tableta zdravila Aprovel 150 mg vsebuje 150 mg irbesartana.
 The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Pomožne snovi so mikrokristalna celuloza, premreženi natrijev karmelozat, laktoza monohidrat, magnezijev stearat, koloidni hidratirani silicijev dioksid, predgelirani koruzni škrob in poloksamer 188.
Some undesirable effects have been reported since marketing of Aprovel.
Prav tako so navedeni dodatni neželeni učinki, o katerih so poročali po pridobitvi dovoljenja za promet.
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
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.
V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
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.
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.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Splošno: pri bolnikih, pri katerih sta žilni tonus in ledvična funkcija pretežno odvisna od delovanja sistema renin-angiotenzin-aldosteron (npr. bolniki s hudim kongestivnim srčnim odpovedovanjem ali primarnimi ledvičnimi boleznimi, vključno s stenozo ledvične arterije), je zdravljenje z zaviralci angiotenzinske konvertaze (ACE) ali antagonisti angiotenzina II, ki vplivajo na ta sistem, povezano z akutno hipotenzijo, azotemijo, oligurijo ali v redkih primerih z akutno odpovedjo ledvic.
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.
Pri odmerkih večjih od 600 mg (dvakrat več od priporočenega odmerka), so opazili nesorazmerno manjše povečanje peroralne absorpcije; mehanizem tega pojava ni pojasnjen.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Bolniki z visokim krvnim tlakom z diabetesom tipa 2 in ledvično boleznijo: analiza rezultatov študije z bolniki z napredovalo ledvično boleznijo kaže, da učinki irbesartana tako na ledvične kot srčnožilne dogodke niso enotni znotraj podskupin.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Litij: pri sočasni uporabi litija in zaviralcev angiotenzinske konvertaze poročajo o reverzibilnem povečanju serumske koncentracije litija in o toksičnosti.
Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
Ena tableta zdravila Aprovel 300 mg vsebuje 300 mg irbesartana.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalno ledvično funkcijo, se je hiperkaliemija (≥ 5,5 mEq/l) pojavila pri 29,4% bolnikov, ki so prejemali 300 mg irbesartana, in pri 22% bolnikov v skupini s placebom.
Aprovel contains lactose.
Zdravilo Aprovel vsebuje laktozo.
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.
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.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
IME ZDRAVILA Aprovel 75 mg tablete
Side effects reported in clinical studies for patients treated with Aprovel were: 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.
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.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
IME ZDRAVILA Aprovel 75 mg tablete irbesartan NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje: irbesartan 75 mg SEZNAM POMOŽNIH SNOVI Pomožne snovi: vsebuje tudi laktozo monohidrat.
Aprovel 75 mg film-coated tablets irbesartan
Aprovel 75 mg filmsko obložene tablete irbesartan
Aprovel is unlikely to affect your ability to drive or use machines.
Verjetnost, da bi zdravilo Aprovel vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
No dosage adjustment is necessary in female patients.
Prilagajanje odmerka za bolnice ni potrebno.
SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Shranjujte pri temperaturi do 30°C.
Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Zmanjšan intravaskularni volumen: pri bolnikih, ki imajo zmanjšan volumen krvi in/ali pomanjkanje natrija zaradi intenzivnega zdravljenja z diuretiki, omejevanja vnosa soli s hrano, driske ali bruhanja, se lahko pojavi simptomatska hipotenzija, zlasti po prvem odmerku.
Because no information is available regarding the use of Aprovel during breast-feeding, Aprovel is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Aprovel med dojenjem ni na voljo, zato uporaba zdravila Aprovel med dojenjem ni priporočljiva.
What Aprovel contains  The active substance is irbesartan.
Zdravilna učinkovina je irbesartan.
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
IME ZDRAVILA Aprovel 300 mg tablete irbesartan NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje: irbesartan 300 mg SEZNAM POMOŽNIH SNOVI Pomožne snovi: vsebuje tudi laktozo monohidrat.
impaired renal function including cases of renal failure in patients at risk (see section 4.4)
motnje v delovanju ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4.4) Motnje reprodukcije in dojk Občasni:
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Po ponavljajočem odmerjanju enkrat na dan so ugotovili omejeno kopičenje irbesartana (18%) v plazmi.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets.
IME ZDRAVILA Aprovel 75 mg filmsko obložene tablete.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Splošno: pri bolnikih, pri katerih sta žilni tonus in ledvična funkcija pretežno odvisna od delovanja sistema renin-angiotenzin-aldosteron (npr. bolniki s hudim kongestivnim srčnim odpovedovanjem ali primarnimi ledvičnimi boleznimi, vključno s stenozo ledvične arterije), je zdravljenje z zaviralci angiotenzinske konvertaze (ACE) ali antagonisti angiotenzina II, ki vplivajo na ta sistem, povezano z akutno hipotenzijo, azotemijo, oligurijo ali v redkih primerih z akutno odpovedjo ledvic (glejte poglavje 4.5).
NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
IME ZDRAVILA Aprovel 150 mg tablete irbesartan NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje: irbesartan 150 mg SEZNAM POMOŽNIH SNOVI Pomožne snovi: vsebuje tudi laktozo monohidrat.
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 if you are taking any of the following medicines used to treat high blood pressure:
če imate predvideno operacijo (kirurški poseg) ali boste dobili anestetik če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Farmakoterapevtska skupina: Antagonisti angiotenzina II, enokomponentna zdravila oznaka ATC: C09CA04.
No dosage adjustment is necessary in patients with impaired renal function.
Bolnikom s prizadeto ledvično funkcijo odmerka ni treba prilagajati.
 If you have any further questions, ask your doctor or pharmacist.
Če imate dodatna vprašanja, se posvetujete z zdravnikom ali farmacevtom.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat hipromeloza silicijev dioksid magnezijev stearat
Aprovel 300 mg film-coated tablets irbesartan
Aprovel 300 mg filmsko obložene tablete irbesartan
Hepatic impairment
vrtoglavica, glavobol
Aprovel 150 mg film-coated tablets irbesartan
Aprovel 150 mg filmsko obložene tablete irbesartan
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Uporabo zaviralca ACE v kombinaciji z blokatorjem receptorjev angiotenzina II so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
6.1 Seznam pomožnih snovi mikrokristalna celuloza premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat koloidni hidratirani silicijev dioksid predgelirani koruzni škrob poloksamer 188
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
Nekaterim bolnikom, kot so bolniki, ki se zdravijo s hemodializo, in bolniki, starejši od 75 let, lahko zdravnik predpiše manjši odmerek, še posebej na začetku zdravljenja.
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets.
IME ZDRAVILA Aprovel 300 mg tablete
vertigo, headache Ear and labyrinth disorder Not known:
Ušesne bolezni, vključno z motnjami labirinta Neznana:
NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
IME ZDRAVILA Aprovel 150 mg tablete
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg film-coated tablets.
IME ZDRAVILA Aprovel 300 mg filmsko obložene tablete.
This results in an increase in blood pressure.
Ponovnega padca zvečanega krvnega tlaka niso opazili.
Aliskiren-containing products or ACE-inhibitors: 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).
Zdravila, ki vsebujejo aliskiren ali zaviralci ACE: 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 (glejte poglavja 4.3, 4.4. in
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.