natgillin/translations-raw huggingface dataset:
Package size perforated unit dose blister (PVC/Alu) 5 x 2 tablets l t o r
Peroralno Perforiran pretisni omot za enkratni odmerek (PVC/Alu)
(See section 5.3).
(glejte poglavje 5.1).
Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
Datum pridobitve dovoljenja za promet: 27. avgust 1997 Datum zadnjega podaljšanja dovoljenja: 27. avgust 2007
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
Patients with high blood pressure
Bolniki z visokim krvnim tlakom
However, no proper explanation for these findings in women has been identified.
Za te ugotovitve pri ženskah niso našli ustrezne razlage.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Bolnika se mora skrbno nadzorovati, zdravljenje pa mora biti simptomatsko in podporno.
None of these increases were associated with identifiable clinical musculoskeletal events.
Nobeno od teh povečanj ni bilo povezano s prepoznavnimi kliničnimi mišičnoskeletnimi pojavi.
Similar effects have been very rarely reported with irbesartan so far.
O podobnih učinkih do sedaj poročajo pri irbesartanu zelo redko.
The volume of distribution is 53-93 litres.
Volumen porazdelitve je 53-93 litrov.
These adverse reactions are derived from spontaneous reports.
Ti neželeni učinki izhajajo iz spontanih poročil.
Therefore, this combination is not recommended (see section 4.4).
Zato se takšne kombinacije ne priporoča (glejte poglavje 4.4).
The safety and efficacy of Aprovel in children aged 0 to 18 has not been established.
Varnost in učinkovitost zdravila Aprovel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Izkušnje pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/dan, niso odkrile toksičnosti.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Vezava na plazemske beljakovine je približno 96%, z zanemarljivo vezavo na krvne celice.
Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Od teh 23 otrok je bilo pri 21-ih farmakokinetiko možno primerjati s farmakokinetiko pri odraslih (dvanajst otrok starejših od 12 let, devet otrok starih od 6 do 12 let).
Activated charcoal may be useful in the treatment of overdose.
Aktivno oglje je lahko koristno pri zdravljenju prevelikega odmerjanja.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Upočasnitev napredovanja v klinično proteinurijo je bila vidna že v prvih treh mesecih in se je nadaljevala preko dveletnega obdobja.
The antihypertensive effects are maintained during long term therapy.
Antihipertenzivni učinek se vzdržuje z dolgotrajno terapijo.
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Pogostost neželenih dogodkov ni bila povezana z velikostjo odmerka (v mejah priporočenega odmerjanja), s spolom, starostjo, raso ali trajanjem zdravljenja.
No significant difference was apparent between these doses.
Razlike med temi odmerki niso bile značilne.
The terminal elimination half-life of irbesartan is 11-15 hours.
Končni razpolovni eliminacijski čas irbesartana je 11-15 ur.
It is important that you continue to take Aprovel until your doctor tells you otherwise.
Pomembno je, da zdravilo Aprovel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 4.8, 5.1 in 5.2 vendar priporočil o odmerjanju ni mogoče dati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki navedeni v zaporedju padajoče resnosti.
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Običajni priporočeni začetni in vzdrževalni odmerek je 150 mg enkrat na dan, s hrano ali brez.
The predefined blood pressure goal was ≤ 135/85 mmHg.
Ciljni krvni tlak je bil ≤135/85 mmHg.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Glavni metabolit v obtoku je irbesartan glukuronid (približno 6%).
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja natančno preberete navodilo, ker vsebuje za vas pomembne podatke!
musculoskeletal pain*
mišičnoskeletna bolečina*
However, there was no difference in the half-life and accumulation of irbesartan.
Vendar pa ni bilo nobene razlike v razpolovnem času in kopičenju irbesartana.
Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Rezultati so pokazali, da so bili Cmax, AUC in očistek primerljivi tistim pri odraslih, ki so dobivali 150 mg irbesartana na dan.
See also information under the heading “Do not take Aprovel”.
Glejte tudi informacije pod naslovom “Ne jemljite zdravila Aprovel”.
In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
In sicer, so bili videti manj ugodni pri ženskah in pri ne-belcih (glejte poglavje 5.1).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Če je takšna kombinacija nedvoumno potrebna, se priporoča skrbno nadzorovanje serumske ravni litija.
The combination should be administered with caution, especially in the elderly.
Kombinacijo je predvsem pri starejših bolnikih treba uporabljati previdno.
Therefore, the use of Aprovel is not recommended.
Zato uporaba zdravila Aprovel ni priporočljiva.
You can take Aprovel with or without food.
Zdravilo Aprovel lahko jemljete s hrano ali brez nje.
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Po 24 urah je bilo zmanjšanje krvnega tlaka 60-70% ustreznega največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
Concomitant food intake does not significantly influence the bioavailability of irbesartan.
Sočasen vnos hrane ne vpliva pomembno na biološko razpoložljivost irbesartana.
All of these changes were considered to be caused by the pharmacological action of irbesartan.
Za vse te spremembe se domneva, da so posledica farmakološkega delovanja irbesartana.
If you forget to take Aprovel
Če ste pozabili vzeti zdravilo Aprovel
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Sledeča tabela predstavlja neželene učinke zdravila o katerih so poročali v s placebom kontroliranih preskušanjih, v katerih je sodelovalo 1.965 bolnikov z visokim krvnim tlakom, ki so prejemali irbesartan.
However the terminal half-life was not significantly altered.
Vendar pa ni bilo pomembnih sprememb končnega razpolovnega časa.
Irbesartan does not require metabolic activation for its activity.
Za svojo učinkovitost irbesartan ne potrebuje metabolične aktivacije.
(It is also better to avoid Aprovel in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
(Jemanju zdravila Aprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
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).
Other medicines and Aprovel
Druga zdravila in zdravilo Aprovel
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 older people.
Čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
O mutagenosti, klastogenosti ali karcinogenosti ni nobenih dokazov.
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Irbesartan se po peroralni uporabi dobro absorbira: študije absolutne biološke razpoložljivosti so dale vrednosti približno 60-80%.
After withdrawal of therapy, blood pressure gradually returns toward baseline.
Po ukinitvi terapije se krvni tlak postopno vrne na začetno vrednost.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality.
Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
Hypertension and type 2 diabetes with renal disease
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Med 26-tedenskim odprtim obdobjem tega preskušanja so bila najpogostejša laboratorijska odstopanja zvišanje kreatinina (6,5%) in zvišanje vrednosti kreatinin-kinaze (CK) pri 2% otrok.
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Pri upravljanju z vozili ali stroji se mora upoštevati, da se med zdravljenjem lahko pojavita omotica ali utrujenost.
No specific information is available on the treatment of overdose with Aprovel.
Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Aprovel niso na voljo.
Aprovel 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 Aprovel enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Morda bodo potrebne krvne preiskave, če jemljete: dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki) zdravila, ki vsebujejo litij
Aprovel with food and drink Aprovel can be taken with or without food.
Zdravilo Aprovel skupaj s hrano in pijačo Zdravilo Aprovel lahko jemljete s hrano ali brez nje.
The usual dose is 150 mg once a day (two tablets a day).
Običajen odmerek je 150 mg enkrat na dan (dve tableti).
Irbesartan lowers blood pressure with minimal change in heart rate.
Irbesartan znižuje krvni tlak z minimalno spremembo srčnega utripa.
In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Med randomiziranim preskušanjem pri 318 hipertenzivnih otrocih in mladostnikih, starih od 6 do 16 let, so se med 3-tedensko dvojno slepo fazo pojavili naslednji neželeni učinki: glavobol (7,9%), hipotenzija (2,2%), omotica (1,9%), kašelj (0,9%).
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatinkinaze v plazmi), mišični krči
The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Kot manifestacijo prevelikega odmerjanja je najverjetneje pričakovati hipotenzijo in tahikardijo; zaradi prevelikega odmerka se lahko pojavi tudi bradikarija.
PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
FARMACEVTSKA OBLIKA IN VSEBINA 14 tablet 28 tablet 56 tablet 56 x 1 tableta 98 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
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 bilo klinično pomembno.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
Pri zajčjih samicah so opazili splav ali zgodnjo resorpcijo pri odmerkih, pomembno toksičnih za samico, vključno s smrtjo.
Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines.
Na podlagi farmakodinamičnih lastnosti ni verjetno, da bi irbesartan poslabšal sposobnost vožnje in upravljanja s stroji.
The study examined the long-term effects (2 years) of Aprovel 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 Aprovel 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).
What you need to know before you take Aprovel
Kaj morate vedeti preden boste vzeli zdravilo Aprovel
Please see section 2 “Aprovel contains lactose”.
Prosimo, glejte tudi poglavje 2 »Zdravilo Aprovel vsebuje laktozo«.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Aprovel (glejte poglavje 4.4).
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Farmakokinetiko irbesartana so ocenili pri 23 hipertenzivnih otrocih po uporabi posamičnega in večkratnih dnevnih odmerkov irbesartana (2 mg/kg) do največjega dnevnega odmerka 150 mg štiri tedne.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ne zavira ACE (kininaze-II), to je encima, ki tvori angiotenzin II in tudi razgrajuje bradikinin v neučinkovite metabolite.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Primarni aldosteronizem: bolniki s primarnim aldosteronizmom se na splošno ne odzivajo na antihipertenzive, ki delujejo preko inhibicije sistema renin-angiotenzin.
30 - 56 x 1 - 90 tablets:
30 - 56 x 1 - 90 tablet:
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
Paediatric population: 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).
Pediatrična populacija: Irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
Older people
Starejši bolniki
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Za terapevtske odmerke pri človeku kaže, da je hiperplazija/hipertrofija ledvičnih jukstaglomerulnih celic brez pomena.
For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Imetnik dovoljenja za promet z zdravilom mora za N-nitrozodimetilamin (NDMA) in N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino:
Such conditions should be corrected before the administration of Aprovel.
Ta stanja se mora korigirati, preden se uporabi zdravilo Aprovel.
Renal impairment and kidney transplantation: when Aprovel 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 Aprovel bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Vendar pa je treba pretehtati možnost uvajanja zdravljenja s 75 mg, zlasti pri bolnikih na hemodializi in starejših od 75 let.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Ravnotežne koncentracije v plazmi so dosežene v 3 dneh po začetku enkrat-dnevnega režima odmerjanja.
Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Manj kot 2% odmerka irbesartana se izloči z urinom v nespremenjeni obliki.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Po peroralni ali intravenski uporabi 14C irbesartana, prispeva 80-85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
Irbesartan is not removed by haemodialysis.
Irbesartan se s hemodializo ne odstranjuje.
Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Zdravilo Aprovel spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
Aprovel is indicated in adults for the treatment of essential hypertension.
Zdravilo Aprovel je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
What Aprovel is and what it is used for
Kaj je zdravilo Aprovel in za kaj ga uporablamo
Suggested measures include induction of emesis and/or gastric lavage.
Priporočeni ukrepi vključujejo sprožitev bruhanja in/ali izpiranje želodca.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Približno 33% bolnikov v skupini z irbesartanom je doseglo primarno povezan ledvični izid v primerjavi s 39% pri placebu in 41% v skupini z amlodipinom [20% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0,024) in 23% relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0,006)].
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Pričakovani učinek je blokada vseh učinkov angiotenzina II, ki se prenašajo preko receptorja AT1, ne glede na izvor ali sintezno pot angiotenzina-II.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Bolnikom so postopoma povečevali odmerek zdravila Aprovel od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Učinki označeni z zvezdico (*) se nanašajo na neželene učinke o katerih so dodatno poročali pri > 2% diabetičnih bolnikov z visokim krvnim tlakom s kronično ledvično insuficienco in izraženo proteinurijo in večjim deležem kot pri placebu.
Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel.
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Aprovel prekinete, še preden zanosite ali takoj, ko se izkaže, da ste zanosili, in vam predpisal zdravljenje z drugim zdravilom.
An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
V prvih treh mesecih zdravljenja niso opazili spremljajočega izboljšanja hitrosti glomerularne filtracije (GFR).
The total body and renal clearance are 157176 and 3-3.5 ml/min, respectively.
Celokupni telesni in ledvični očistek je 157-176 oziroma 3-3,5 ml/min.
If you get any of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.
Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Aprovel takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Kot pri vseh antihipertenzivih, ima lahko izrazito zmanjšanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično srčnožilno boleznijo za posledico miokardni infarkt ali kap.
Furthermore, 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).
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
In vitro študije kažejo, da se irbesartan primarno oksidira z citokrom P450 encimom CYP2C9; izoencim CYP3A4 ima zanemarljiv učinek.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo.
IDNT je bilo dvojno slepo, kontrolirano preskušanje vpliva zdravila Aprovel na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Zelo pogosti: Hiperkaliemija* se je pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom pogosteje kot pri bolnikih, ki so dobivali placebo.
If you take more Aprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Aprovel, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.