qanastek/EMEA-V3 huggingface dataset:
In the first kidney disease study, Irbesartan BMS was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Fl- ewwel studju dwar il- mard tal- kliewi, Irbesartan BMS irriżulta aktar effikaċi mill- plaċebo biex inaqqas ir- riskju ta 'ħsara tal- kliewi skond it- tneħħija tal- proteina.
In the second kidney disease study, Irbesartan BMS reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Fit- tieni studju dwar il- mard tal - kliewi, Irbesartan BMS naqqas b' 20% meta mqabbel mal- plaċebo r- riskju (tnaqqis relattiv) ta 'rduppjar tal- livelli ta' kreatinina fid- demm, tal- bżonn ta 'trapjant ta' kilwa jew ta 'dijaliżi, jew taż- żmien qabel il - mewt tal- pazjent matul l- istudju.
There was a 23% relative risk reduction compared with amlodipine.
Meta mqabbel ma 'l- amlodipina, kien hemm 23% tnaqqis tar- riskju relattiv.
The main benefit was on the effect on blood creatinine levels.
Il- benefiċċju ewlieni kien fl- effett fuq il- livelli tal- kreatinina fid- demm.
What is the risk associated with Irbesartan BMS?
X' inhuma r- riskji assoċjati ma 'Irbesartan BMS?
The most common side effects with Irbesartan BMS (seen in more than 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
L- effetti sekondarji l- aktar komuni b' Irbesartan BMS (li dehru f' bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, għeja kbira u żieda fil- livelli ta 'kreatina kinażi fid- demm (creatine kinase, enzima li tinsab fil- muskoli).
In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease have the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Barra minn hekk, f' aktar minn pazjent wieħed minn 100 bid- dijabete tat- tip 2 u mard tal- kliewi kellhom dawn l- effetti sekondarji: iperkaljemija (livelli għoljin ta 'potassju fid- demm), sturdament ortostatiku (sturdament meta l- pazjent iqum bil- wieqfa), ipotensjoni ortostatika (pressjoni tad- demm baxxa meta l- pazjent iqum bil- wieqfa) kif ukoll uġigħ muskoloskeletriku (fil- ġogi).
For the full list of all side effects reported with Irbesartan BMS, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Irbesartan BMS, ara l- Fuljett ta' Tagħrif.
Irbesartan BMS should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Irbesartan BMS ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan jew għal xi ingredjent ieħor tiegħu.
Its use during the first three months of pregnancy is not recommended.
Mhuwiex rakkomandat l- użu tagħha waqt l- ewwel tliet xhur tat - tqala.
Why has Irbesartan BMS been approved?
Għaliex ġie approvat Irbesartan BMS?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Irbesartan BMS huma ogħla mir- riskji tiegħu għat- trattament ta' l- ipertensjoni essenzjali u tal- mard renali f' pazjenti li jbatu minn ipertensjoni u mid- dijabete mellitu tat- tip 2.
The Committee recommended that Irbesartan BMS be given marketing authorisation.
Il- Kumitat irrakkomanda li Irbesartan BMS jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Irbesartan BMS:
Aktar tagħrif dwar Irbesartan BMS:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Irbesartan BMS lil Bristol- Myers Squibb Pharma EEIG fid- 19 ta 'Jannar 2007.
The full EPAR for Irbesartan BMS is available here.
L- EPAR sħiħ għal Irbesartan BMS jista 'jiġi kkonsultat hawn.
Irbesartan BMS 75 mg tablets.
Irbesartan BMS 75 mg pilloli.
Each tablet contains 75 mg irbesartan.
Kull pillola fiha 75 mg irbesartan.
15.37 mg of lactose monohydrate per tablet.
15. 37 mg ta 'lactose monohydrate kull pillola.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2771 imnaqqax fuq in- naħa l- oħra.
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Kura għall- mard renali f’ pazjenti li għandhom pressjoni għolja u dijabete mellitus ta ’ tip 2 bħala parti mill- kura kontra il- pressjoni għolja (ara sezzjoni 5. 1).
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Id- doża li ġeneralment irrikmandata fil- bidu u ta ’ manteniment hija ta ’ 150 mg darba kuljum, ma ’ l - ikel jew mingħajru.
Irbesartan BMS at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Irbesartan BMS b’ doża ta ’ 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l- 24 siegħa għall- pressjoni tad- demm minn 75 mg.
However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Madankollu, doża ta ’ 75 mg fil- bidu tal- kura tista ’ tiġi kkonsidrata, speċjalment f’ pazjenti fuq emodijalisi u anzjani ’ il fuq minn 75 sena.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan BMS can be increased to 300 mg, or other anti-hypertensive agents can be added.
F’ pazjenti li mhumiex ikkontrollati biżżejjed b’ 150 mg darba kuljum, id- doża ta ’ Irbesartan BMS tista ’ tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta ’ kontra l- pressjoni għolja.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan BMS (see section 4.5).
B' mod partikolari, iż- żjieda ta 'dijuretiku bħal hydrochlorothiazide ntwera li jkollha effett ta' tisħiħ ma 'Irbesartan BMS (ara sezzjoni 4. 5).
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.
F’ pazjenti li għandhom dijabete ta ’ tip 2 u jbatu minn pressjoni għolja, il- kura mogħtija fil- bidu hija ta ’ 150 mg ta ’ irbesartan darba kuljum u tiġi titrata għal 300 mg darba kuljum bħala l- aħjar doża ta ’ manteniment ippreferuta għall- kura tal- mard renali.
The demonstration of renal benefit of Irbesartan BMS 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 section 5.1).
Il- benefiċċju renali muri b’ Irbesartan BMS f’ pazjenti b’ dijabete ta ’ tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja kif meħtieġ, biex jintlaħaq il- livell mixtieq ta ’ pressjoni (ara sezzjoni 5. 1).
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Indeboliment renali: m’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ indeboliment renali.
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.
Wieħed għandu jikkonsidra doża inqas fil- bidu (75 mg) f’ pazjenti li qed jagħmlu l- emodijalisi.
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan BMS.
Tnaqqis fil- volum intravaskulari: tnaqqis fil- volum u/ jew ta ’ sodju għandu jiġi kkoreġut qabel ma jingħata Irbesartan BMS.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Indeboliment epatiku: m’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ indeboliment epatiku ħafif għal moderat.
There is no clinical experience in patients with severe hepatic impairment.
Għad m’ hemmx esperjenza klinika f’ pazjenti b’ indeboliment epatiku sever.
2 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.
2 Anzjani: għalkemm għandha tiġi ikkonsidrata li tinbeda l- kura b' doża fil- bidu ta ’ 75 mg f’ pazjenti ’ il fuq minn 75 sena, ġeneralment m’ hemmx bżonn ta 'aġġustament tad- doża f’ anzjani.
Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Pazjenti pedjatriċi: irbesartan mhux irrakkomandat għall- użu fit- tfal u l- addoloxxenti peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjonijiet 4. 8, 5. 1 u 5. 2).
Hypersensitivity to the active substances or to any of the excipients (see section 6.1).
Sensittività eċċessiva għas- sustanzi attivi, jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Second and third trimester of pregnancy (see sections 4.4 and 4.6).
It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6).
Lactation (see section 4.6).
Treddigħ (ara sezzjoni 4. 6).
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.
Tnaqqis fil- volum intravaskulari: pressjoni baxxa sintomatika, speċjalment wara l- ewwel doża, tista ’ tinħass f’ pazjenti li jbatu minn tnaqqis ta ’ volum u/ jew ta 'sodju minħabba terapija dijuretika qawwija, dieta ristretta mill- melħ, dijarea jew rimettar.
Such conditions should be corrected before the administration of Irbesartan BMS.
Dawn il- kondizzjonijiet għandhom jiġu kkoreġuti qabel tinbeda l- kura b’ Irbesartan BMS.
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Pressjoni għolja renovaskulari: hemm riskju ikbar ta ’ pressjoni baxxa severa u ta ’ insuffiċjenza renali meta pazjenti li għandhom stenosi bilaterali ta ’ l- arterja renali jew stenosi ta ’ l- arterja b’ kilwa waħda taħdem, jiġu kkurati b’ mediċini li jaffettwaw is- sistema renin- angiotensin- aldosterone.
While this is not documented with Irbesartan BMS, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Irbesartan BMS, effetti simili għandhom ikunu antiċipati b’ antagonisti tar- riċetturi angiotensin- II.
Renal impairment and kidney transplantation: when Irbesartan BMS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Irbesartan BMS jintuża f’ pazjenti b’ indeboliment renali, hija irrikmandata osservanza perjodika tal- livelli tal- potassju u tal- krejatinina fis- serum.
There is no experience regarding the administration of Irbesartan BMS in patients with a recent kidney transplantation.
M’ hemmx esperjenza fuq l- għoti ta 'Irbesartan BMS lil pazjenti li reċentement kellhom trapjant tal - kliewi.
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.
Pazjenti bi pressjoni għolja li għandhom dijabete ta ’ tip 2 u mard renali: l- effetti ta ’ irbesartan kemm fuq il- proċessi renali kif ukoll dawk kardjovaskulari ma kinux l- istess fis- settijiet tal- gruppi kollha, waqt analiżi li saret fl- istudju ma ’ pazjenti b’ mard renali avvanzat.
In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
B' mod partikolari, dawn dehru inqas favorevoli f’ nisa u f’ individwi mhux bojod (ara sezzjoni 5. 1).
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan BMS, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Iperkalimja: bħalma jiġri b’ mediċini oħra li jaffettwaw is- sistema ta ’ renin- angiotensin- aldosterone, iperkalimja tista ’ sseħħ waqt il- kura b’ Irbesartan BMS, speċjalment fil- preżenza t’ indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad- dijabete, u/ jew insuffiċjenza tal- qalb.
Close monitoring of serum potassium in patients at risk is recommended (see section 4.5).
Huwa rrakkomandat monitoraġġ mill- qrib tal- potassju fis- serum f' pazjenti f' riskju (ara sezzjoni 4. 5).
Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
Lithium: it- taħlit ta 'litju u Irbesartan BMS mhuwiex rakkomandat (ara sezzjoni 4. 5).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenosi tal- valv mitrali u aortiku, kardjomiopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vasodilaturi oħra, attenzjoni speċjali hija indikata f’ pazjenti li jbatu minn stenosi tal- valv mitrali u aortiku jew kardjomiopatija ipertrofika ostruttiva.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għal prodotti mediċinali ta ’ kontra l- pressjoni għolja li jaħdmu billi jimpedixxu s- sistema renin- angiotensin.
Therefore, the use of Irbesartan BMS is not recommended.
Għalhekk, l- użu ta ’ Irbesartan BMS mhuwiex irrikmandat.
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.
Ġenerali: f’ pazjenti li għandhom it- ton vaskulari u l- funzjoni renali tagħhom jiddependu l- aktar mill - attività tas- sistema renin- angiotesin- aldosterone (p. e. pazjenti li jbatu minn insuffiċjenza tal- qalb konġestiva jew mard renali, inkluż stenosi ta ’ l- arterja renali), il- kura b’ inibituri ta ’ enzimi li jikkonvertu angiotensin jew antagonisti tar- riċetturi t ’ angiotensin- II li jaffettwaw din is- sistema ġew assoċjati ma ’ pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali.
As with any anti- hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħal ma jiġri b’ kull mediċina kontra il- pressjoni għolja, it- tnaqqis eċċessiv ta ’ pressjoni f’ pazjenti li jbatu
3 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Kif osservat f’ inibituri ta ’ enzimi li jikkonvertu angiotensin, irbesartan u l- antagonisti ta ’ angiotensin l- oħrajn huma apparentament inqas effettivi biex iniżżlu l- pressjoni f’ nies suwed milli f’ dawk li mhumiex suwed, possibilment minħabba li hemm prevelanza ogħla ta ’ renin baxx f’ popolazzjoni ta ’ razza sewda bi pressjoni għolja (ara sezzjoni 5. 1).
Lactose: this medicinal product contains lactose.
Lactose: dan il- prodott mediċinali fih il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti b' disturbi ereditarji rari ta 'intolleranza għall - galactose, bid- defiċjenza ta' Lapp lactase jew bi problemi ta 'assorbiment ħażin ta' glucose- galactose m' għandhomx jieħdu dan il- prodott mediċinali.
Paediatric patients: 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).
Pazjenti pedjatriċi: irbesartan ġie studjat f' popalazzjonijiet ta 'tfal bejn is- 6 snin u s- 16- il sena imma it - tagħrif kurrenti mhuwiex biżżejjed biex jappoġġja estensjoni ta' l- użu fuq tfal sakemm ikun hemm aktar tagħrif disponibbli (ara sezzjonijiet 4. 8, 5. 1 u 5. 2).
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan BMS has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Dijuretiċi u mediċini oħra kontra l- pressjoni għolja: mediċini oħra kontra l- pressjoni għolja jistgħu jżidu l- effetti ta ’ tnaqqis fil- pressjoni ta ’ irbesartan; madankollu Irbesartan BMS ingħata mingħajr periklu ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja, bħal beta- blockers, imblokkaturi tal- kanali ta ’ calcium li jaħdmu fit- tul, u dijuretiċi thiazides.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan BMS (see section 4.4).
Kura li ssir qabel b' dożi għoljin ta 'dijuretiċi tista' tirriżulta f' nuqqas fil- volum u riskju ta 'pressjoni baxxa meta tinbeda l- kura b' Irbesartan BMS (ara sezzjoni 4. 4).
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Supplimenti tal- potassium u dijuretiċi potassium- sparing: ibbażat fuq l- esperjenza bl- użu ta ’ mediċini oħra li jaffettwaw lis- sistema ta ’ renin- angiotensin, l- użu konkomitanti ta ’ dijuretiċi potassium - sparing, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium jew mediċini oħra li jżidu il- livelli tal- potassium fis- serum (eż. ħeparina) jistgħu jwasslu għal żidiet tal- potassium fis- serum u, għalhekk, mhumiex irrikmandati (ara sezzjoni 4. 4).
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Lithium: żjidiet riversibbli tal- konċentrazzjonijiet u tossiċità ta ’ lithium fis- serum ġew irrapportati waqt l- amministrazzjoni konkomitanti ta ’ lithium ma ’ inibituri ta ’ enzimi li jikkonvertu angiotensin.
Similar effects have been very rarely reported with irbesartan so far.
Effetti simili ġew irrapportati rarament ħafna b’ irbesartan s' issa.
Therefore, this combination is not recommended (see section 4.4).
Għaldaqstant, din it- taħlita mhix rakkomandata (ara sezzjoni 4. 4).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Jekk tinħass il- ħtieġa ta ’ din il- kombinazzjoni, monitoraġġ b’ attenzjoni tal- livelli tal- lithium fis- serum hija irrikmandata.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Mediċini anti- infjammatorji mhux sterojdi: meta jingħataw antagonisti ta 'angiotensin II flimkien ma' mediċini anti- infjammatorji mhux sterojdi (i. e. inibituri COX- 2 selettivi, acetylsalicylic acid (> 3 g/ kuljum) u NSAIDs mhux selettivi), jista 'jkun hemm attenwazzjoni ta' l- effett kontra l- pressjoni għolja.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Bħalma jseħħ bl- inibituri ACE, l- użu konkomitanti ta 'antagonisti ta' angiotensin II u NSAIDs jista 'jirriżulta f' żjieda fir- riskju li teħżien il- funzjoni renali, inkluża l- possibbilità ta' insuffiċjenza renali akuta, u żjieda fil- potassium fis- serum, speċjalment f' pazjenti li diġà kellhom funzjoni renali bagħtuta.
The combination should be administered with caution, especially in the elderly.
It- taħlita għandha tintuża b' attenzjoni speċjalment fl- anzjani.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il- pazjenti għandhom ikunu idrati biżżejjed u għandha tingħata kunsiderazzjoni għall- monitoraġġ tal- funzjoni renali wara li tinbeda kura konkomitanti, u kull ċertu żmien wara.
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Aktar informazzjoni dwar l- interazzjonijiet ta 'irbesartan: fi studji kliniċi, il- farmakokinetika ta' irbesartan mhix affettwata minn hydrochlorothiazide.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
4 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
Ma kinux osservati interazzjonijiet farmakokinetiċi jew farmakodinamiċi sinifikanti meta irbesartan ingħata flimkien ma 'warfarina, prodott mediċinali metabolizzat minn CYP2C9.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Ma ġewx evalwati l- effetti ta ’ indutturi ta ’ CYP2C9 bħal rifampicin fuq il- farmakokinetiċi t’ irbesartan.
The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Il- farmakokinetika ta 'digoxin ma tbidlitx bit- teħid flimkien ma' irbesartan.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk seħħet espożizzjoni għall- AIIRAs mit- tieni trimestru tat- tqala, huwa rrakkomandat kontroll bl - ultrasound tal- funzjoni renali u tal- kranju.
Irbesartan BMS is contraindicated (see section 4.3) during lactation.
Irbesartan BMS huwa kontra- indikat (ara sezzjoni 4. 3) waqt it- treddigħ.
It is not known whether irbesartan is excreted in human milk.
Mhux magħruf jekk irbesartan jitneħħiex fil- ħalib uman.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan jitneħħa fil- ħalib ta ’ firien li jreddgħu.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni.
Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.
Fuq il- bażi tal- karatteristiċi farmakodinamiċi tiegħu, irbesartan aktarx ma jaffettwax din il- ħila.
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Waqt is- sewqan jew tħaddim ta ’ magni, wieħed għandu jżomm f’ moħħu li xi kultant jista ’ jħoss xi sturdament jew għeja waqt kura kontra l- pressjoni għolja.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Il- frekwenza ta ’ l- effetti avversi msemmija hawn taħt hija definita bl- użu ta ’ din il- konvenzjoni: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1, 000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F' kull sezzjoni ta 'frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Hypertension: in placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Pressjoni għolja: fi studji kliniċi ikkontrollati bi plaċebo f’ pazjenti bi pressjoni għolja, l- inċidenza totali ta ’ effetti avversi ma kinetx differenti bejn dawk li ħadu irbesartan (56. 2%) u l- grupp li ħa l - plaċebo (56. 5%).
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%).
Twaqqif minħabba xi effetti avversi kliniċi jew tal- laboratorju kienu inqas frekwenti fil- pazjenti kkurati b’ irbesartan (3. 3%) milli fil- pazjenti ikkurati bil- plaċebo (4. 5%).
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
L- inċidenza ta ’ effetti avversi ma kinetx relatata mad- doża (doża li ngħatat fil- firxa rrikmandata), sess, età, razza, jew matul il- kura.
In placebo-controlled trials in which 1,965 patients received irbesartan, the following adverse drug reactions were reported:
Waqt provi ikkontrollati bil- plaċebo fejn 1, 965 pazjent bi pressjoni għolja rċevew irbesartan, l- effetti avversi li ġew irrapportati huma dawn li ġejjin:
Nervous system disorders:
5 Disturbi fis- sistema nervuża:
Cardiac disorders:
Distrubi fil- qalb:
Uncommon:
Mhux komuni: takikardija
Uncommon:
Mhux komuni: fwawar
5 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
Uncommon:
Mhux komuni: sogħla
Uncommon:
dardir/ rimettar
nausea/ vomiting diarrhea, dyspepsia/ heartburn
Mhux komuni: dijarea, dispepsja/ qrusa fl- istonku
Uncommon:
Mhux komuni: disfunzjoni sesswali
Uncommon:
għeja kbira
fatigue chest pain
Mhux komuni: uġigħ fis- sider
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
żidiet sinifikanti tal- krejatina kinazi fil- plażma ġew osservati frekwentement (1. 7%) f’ individwi li ħadu l- kura b’ irbesartan.
None of these increases were associated with identifiable clinical musculoskeletal events.
L- ebda minn dawn iż- żidiet ma ġew assoċjati ma ’ episodji muskolu- skeletriċi li jistgħu jiġu identifikati klinikament.
Hypertension and type 2 diabetes with renal disease: in addition to the adverse drug reactions mentioned under hypertension, 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.
msemmija taħt ipertensjoni, f’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u funzjoni renali normali, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f’ 0. 5% tal- pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil- grupp tal- plaċebo.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, the following additional adverse reactions were reported in > 2% of patients and in excess of placebo:
F’ pazjenti dijabetiċi bi pressjoni għolja u b’ insuffiċjenza renali kronika u b’ proteinuria li tidher, effetti oħra avversi ġew irrapportati f ’ > 2% tal- pazjenti u iżjed milli fil- grupp tal- plaċebo:
orthostatic dizziness
sturdament ortostatiku
orthostatic hypotension
pressjoni baxxa ortostatika
Common:
Disturbi muskolu- skeltrali, tal- connective tissue u fl- għadam Komuni:
musculoskeletal pain
uġigħ muskolu- skeltrali
Hyperkalaemia occurred more often in diabetic patients treated with irbesartan than with placebo.
Iperkalimja ġrat iktar frekwenti f’ pazjenti dijabetiċi ikkurati b’ irbesartan milli bil- plaċebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% (i. e. very common) of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u b’ funzjoni renali normali, iperkalimja (≥ 5. 5mEq/ L) ġrat f’ 29. 4% (jiġifieri komuni ħafna) tal- pazjenti fil- grupp li ħadu 300 mg ta ’ irbesartan u f’ 22% tal- pazjenti fil- grupp tal- plaċebo.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% (i. e. very common) of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ insuffiċenzja renali kronika u bi proteinuria li tidher, iperkalimja (≥ 5. 5 mEq/ L) ġrat f’ 46. 3% (jiġifieri komuni ħafna) tal- pazjenti fil- grupp ta ’ irbesartan u f’ 26. 3% tal- pazjenti fil- grupp tal- plaċebo.
A decrease in haemoglobin, which was not clinically significant, has been observed in 1.7% (i. e. common) of hypertensive patients with advanced diabetic renal disease treated with irbesartan.
Tnaqqis fl - emoglobina, li ma kienx klinikament sinifikanti, ġie osservat f’ 1. 7% (jiġifieri komuni) tal- pazjenti bi pressjoni għolja b’ mard avvanzat dijabetiku renali kkurati b’ irbesartan.
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
6 Ir- reazzjonijiet avversi li ġejjin ġew irrappurtati waqt l- esperjenza ta 'wara t- tqegħid fuq is- suq; ittieħdu minn rapporti spontanji li l- inċidenzi għalihom ma jistgħux jiġu stabbiliti:
As with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema have been reported
Bħal antagonisti oħra tar- riċettur ta ’ angiotensin- II, kienu rrapportati każijiet rari ta 'reazzjonijiet ta' sensittività eċċessiva bħal raxx, urtikarja, anġjoedema
Hyperkalaemia
Iperkalimja
6 Nervous system disorders:
Disturbi fis- sistema nervuża:
Tinnitus
Żarżir fil- widnejn
Dysgeusia
Disgeweżja
Hepato-biliary disorders:
Disturbi fil- fwied u fil- marrara:
Hepatitis, abnormal liver function
Epatite, funzjoni anormali tal- fwied
Musculoskeletal, connective tissue and bone disorders:
Disturbi muskolu- skeltrali, tal- connective tissue u fl- għadam:
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Artralġja, uġigħ fil- muskoli (f' xi każijiet assoċjat ma 'livelli miżjuda tal- kinażi tal- kreatina fil- plażma), bugħawwieġ fil- muskoli
Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Indeboliment renali li jinkudi każijiet ta 'insuffiċjenza renali f' pazjenti f' riskju (ara sezzjoni 4. 4)
Leukocytoclastic vasculitis
Vaskulite lewkoċitoklastika
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Pazjenti pedjatriċi: fi prova randomised ta '318- il tifel u tifla bi pressjoni għolja u adoloxxenti ta' bejn is- 6 u s- 16- il sena, dawn l- effetti avversi relatati li ġejjin ġraw fil- fażi ta 'tliet ġimgħat double- blind: uġigħ ta' ras (7. 9%), pressjoni baxxa (2. 2%), sturdament (1. 9%), sogħla (0. 9%).
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.
4. 9 Doża eċċessiva
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Esperjenza f’ adulti esposti għal dożi sa 900 mg/ jum għal 8 ġimgħat ma uriet ebda tossiċità.
The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
L- iktar manifestazzjonijiet probabbli ta ’ doża eċċessiva huma mistennija li jkunu pressjoni baxxa, u takikardija; bradikardija tista ’ wkoll tiġi ikkaġunata minn doża eċċessiva.
No specific information is available on the treatment of overdose with Irbesartan BMS.
M’ hemmx biżżejjed informazzjoni speċifika disponibbli fuq il- kura tad- doża eċċessiva b’ Irbesartan BMS.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Il- pazjent għandu jkun osservat mill- viċin u l- kura għandha tkun sintomatika u ta ’ għajnuna.
Suggested measures include induction of emesis and/ or gastric lavage.
Miżuri issuġġeriti jinkludu induzzjoni tar- rimettar u / jew tal- ħasil gastriku.
Activated charcoal may be useful in the treatment of overdose.
Il- faħam attivat jista ’ jkun utli fi trattament ta ’ doża eċċessiva.
Irbesartan is not removed by haemodialysis.
Irbesartan ma jitneħħiex b' emodijlasi.
Angiotensin-II antagonists, plain.
Antagonisti ta 'angiotensin- II, sempliċi.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
7 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
Mechanism of action: 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.
Kif jaħdem: huwa mistenni li jimblokka l- azzjonijiet kollha ta ’ angiotensin- II medjati mir- riċettur AT1, mingħajr m’ għandu x’ jaqsam ma ’ l- oriġini jew rotta ta ’ sintesi ta ’ l - angiotensin- II.
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.
L- antagoniżmu selettiv tar- riċetturi ta ’ angiotensin- II (AT1) jirriżulta f’ żidiet fil- livelli fil- plażma ta ’ renin u fil- livelli ta ’ angiotensin- II u fi tnaqqis fil- konċentrazzjoni tal- plażma aldosterone.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Il- livelli tal- potassium fis - serum mhumiex affettwati b' mod sinifikanti minn irbesartan waħdu fid- dożi rrikmandati.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ma jimpedixxix ACE (kininase- II), enzima li tiġġenera angiotensin- II u tiddiżintegra ukoll il - bradikinina f’ metaboliti inattivi.
7 Clinical efficacy:
Effikaċja klinika:
Hypertension Irbesartan lowers blood pressure with minimal change in heart rate.
Pressjoni għolja Irbesartan iniżżel il- pressjoni b’ tibdil minimali fir- rata tat- taħbit tal- qalb.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg.
It- tnaqqis fil- pressjoni huwa relatat mad- doża ta ’ darba kuljum fid- doża tal- ġurnata b’ tendenza li tilħaq plateau b’ dożi ’ il fuq minn 300 mg.
Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i. e.
Dożi ta ’ 150- 300 mg darba kuljum iniżżlu il- pressjoni meħudha meta pazjent ikun mindud jew bil- qiegħda (i. e.
24 hours after dosing) by an average of 8-13/ 5-8 mm Hg (systolic/ diastolic) greater than those associated with placebo.
24 siegħa wara id- doża) b’ medja ta ’ 8- 13/ 5- 8 mm Hg (sistolika/ dijastolika) aktar milli minn dawk bil- plaċebo.
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
L- ogħla tnaqqis fil- pressjoni jseħħ fi żmien 3- 6 sigħat wara li jingħata u l- effett tat- tnaqqis tal - pressjoni jinżamm mill- inqas għal 24 siegħa.
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
F’ 24 siegħa it- tnaqqis tal- pressjoni kien 60% - 70% ta ’ l - ogħla rispons fid- diastolika u sistolika bid- dożi rrikmandati.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Doża darba kuljum ta ’ 150 mg tat respons fl- inqas livell u dak medju ta ’ 24 siegħa simili għad- doża li tingħata darbtejn kuljum bl- istess total tad - doża.
The blood pressure lowering effect of Irbesartan BMS is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
L- effett li għandu Irbesartan BMS li jbaxxi l- pressjoni jidher fi żmien 1- 2 ġimgħat, bl- effett massimu jseħħ f’ 4- 6 ġimgħat wara li tinbeda t- terapija.
The antihypertensive effects are maintained during long term therapy.
L- effetti kontra l- pressjoni għolja jibqgħu jinżammu waqt kura fit- tul.
After withdrawal of therapy, blood pressure gradually returns toward baseline.
Wara li titwaqqaf it- terapija, il- pressjoni gradwalment tirritorna lejn il- linja bażi.
Rebound hypertension has not been observed.
Ma ġiet osservata ebda rebound ta ’ pressjoni għolja.
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
L- effetti ta ’ irbesartan u dijuretiċi tat- tip thiazide li jniżżlu il- pressjoni huma addittivi.
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).
F’ pazjenti li mhux ikkontrollati sew b’ irbesartan waħdu, iż- żieda ta ’ doża baxxa ta ’ hydrochlorothiazide (12. 5 mg) ma ’ irbesartan darba kuljum tirriżulta fi tnaqqis aktar tal- pressjoni fl- inqas livell ta ’ 7- 10/ 3- 6 mm/ Hg (sistolika/ dijastolika) aġġustata għall- plaċebo.
The efficacy of Irbesartan BMS is not influenced by age or gender.
L- effikaċja ta ’ Irbesartan BMS ma hijiex influwenzata bl- età jew sess.
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Bħal fil- każi ta ’ mediċini oħra li jaffettwaw is- sistema renin- angiotensin, pazjenti suwed bi pressjoni għolja wrew ferm inqas respons għal monoterapija b’ irbesartan.
When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e. g.
Meta irbesartan ingħata flimkien ma ’ doża baxxa ta ’ hydrochlorothiazide (p. e.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
12. 5 mg kuljum), ir- respons anti- ipertensiv f’ pazjenti suwed jilħaq lil dak f’ pazjenti bojod.
There is no clinically important effect on serum uric acid or urinary uric acid secretion.
M’ hemmx effett ta ’ importanza klinika fil- livelli tal- uric acid fis- serum jew fil- ħruġ tal- uric acid ma ’ l- awrina.
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Tnaqqis tal- pressjoni tad- demm b' 0. 5 mg/ kg (baxx), 1. 5 mg/ kg (medju) u 4. 5 mg/ kg (għoli) livelli mixtieqa ddożati ta 'irbesartan kienu evalwati fi 318- il tifel u tifla u adoloxxenti ta' bejn is- 6 u s- 16- il sena bi pressjoni għolja jew f' riskju (dijabetiċi, passat ta 'pressjoni għolja fil- familja) fuq perjodu ta' tliet ġimgħat.
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Fl- aħħar tat- tliet ġimgħat it- tnaqqis medju mill- linja bażi fil- varjabbli primarju ta 'effikaċja, il- pressjoni tad- demm sistolika meħuda meta pazjent ikun bil- qiegħda (SeSBP) kienet 11. 7 mmHg (doża baxxa), 9. 3 mmHg (doża medja), 13. 2 mmHg (doża għolja).
No significant difference was apparent between these doses.
L- ebda differenza sinifikanti ma kienet tidher bejn dawn id- dożi.
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows:
Il- bidla medja aġġustata fil- pressjoni tad- demm diastolika meħuda meta pazjent ikun bil- qiegħda (SeDBP) kienet kif ġej:
3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
3. 8 mmHg (doża baxxa), 3. 2 mmHg (doża medja), 5. 6 mmHg (doża għolja).
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).
Fuq il- perjodu tal- ġimagħtejn ta 'wara fejn il - pazjenti ġew re- randomised jew għal prodott mediċinali attiv jew għal plaċebo, il- pazjenti fuq plaċebo kellhom żidiet ta' 2. 4 u 2. 0 mmHg fis- SeSBP u SeDBP meta mqabbla ma 'bidliet rispettivi ta' +0. 1 u - 0. 3 mmHg f' dawk fuq id- dożi kollha ta 'irbesartan (ara sezzjoni 4. 2).
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.
IDNT kienet prova
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
8 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
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 Irbesartan BMS on the progression of renal disease and all-cause mortality were examined.
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete tip 2, proteinuria ≥ 900 mg/ jum u krejatinina fis - serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 sena) ta ’ Irbesartan BMS fuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan BMS, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Irbesartan BMS, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Il- pazjenti fil- gruppi ta ’ kura kollha tipikament irċevew bejn 2 u 4 mediċini kontra l- pressjoni għolja (p. e. dijuretiċi, beta blockers, alpha blockers) biex laħqu il- livell imfassal minn qabel ta ’ pressjoni ta ’ ≤ 135/ 85 mmHg jew tnaqqis ta ’ 10 mmHg fil- pressjoni sistolika jekk il- linja bażi kienet > 160 mmHg.
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.
Sittin fil- mija (60%) ta ’ pazjenti fil- grupp tal- plaċebo leħqu dan it- targit tal- pressjoni filwaqt li din il- figura kienet 76% u 78% fil- gruppi t’ irbesartan u amlodipine rispettivament.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Irbesartan b’ mod sinifikattiv naqqas ir- riskju relattiv fl- endpoint primarju kombinat fejn il- krejatinina fis- serum tirdoppja, mard renali fl- aħħar stadju (ESRD) jew mortalità mill - kawżi kollha.
When the individual components of the primary endpoint were
Madwar 33% tal- pazjenti fil- grupp t’ irbesartan laħqu l- endpoint primarju renali kompost mqabbel ma ’ 39% u 41% fil- gruppi tal- plaċebo u amlodipine [20% tnaqqis relattiv tar- riskju kontra l - plaċebo (p = 0. 024) u 23% tnaqqis relattiv tar- riskju mqabbel ma ’ amlodipine (p = 0. 006)].
8 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.
Meta il - komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l- ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza posittiva fit- tnaqqis f’ ESRD u tnaqqis sinifikanti fil - krejatinina fis- serum milli tirdoppja ġew osservati.
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Sotto gruppi ta ’ sess, razza, età, tul tad- dijabete, l- linja bażi tal- pressjoni, krejatinina fis- serum, u rata ta ’ tneħħija t’ albumina ġew assessjati għall- effett tal- kura.
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.
Fis- sotto gruppi tan- nisa u ta 'dawk ta ’ razza sewda li irrappreżentaw 32% u 26% rispettivament tal- popolazzjoni kollha li ħadet sehem fl - istudju, ma deherx benefiċċju renali, għalkemm l- intervalli ta ’ kunfidenza ma jeskluduhx.
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 placebo- based regimen.
Għall - endpoint sekondarju ta ’ każijiet kardjovaskulari fatali u mhux fatali, ma kienx hemm differenza bejn it- tlett gruppi tal- pazjenti fil- popolazzjoni totali, għalkemm inċidenza akbar ta ’ MI mhux fatali ġiet murija f’ nisa u inċidenza inqas ta ’ MI mhux fatali ġiet murija f’ irġiel fil- grupp t’ irbesartan kontra l - grupp ibbażat fuq il- plaċebo.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Kien hemm żieda fl- inċidenza ta ’ MI mhux fatali u puplesija f’ nisa fil - grupp bil- kura fuq l- irbesartan meta mqabbel mal- grupp bil- kura ibbażata fuq amlodipine, waqt li l - ammissjoni fl- isptar minħabba kollass tal- qalb naqset fil- popolazzjoni kollha.
However, no proper explanation for these findings in women has been identified.
Madankollu, spjegazzjoni xierqa għal dawn is- sejbiet fin- nisa għadha ma ġietx identifikata.
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.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
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 (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
IRMA 2 kien studju double blind ikkontrollat bil- plaċebo ta ’ morbożità f’ 590 pazjenti b’ tip 2 ta ’ dijabete, mikroalbuminuria (30- 300 mg/ jum) u funzjoni renali normali (krejatinina fis- serum ≤ 1. 5 mg/ dl fl- irġiel u < 1. 1 mg/ dl fin- nisa).