qanastek/EMEA-V3 huggingface dataset:
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 bi prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin- aldosterone.
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Karvea, effetti simili għandhom ikunu antiċipati b’ antagonisti tar- riċetturi angiotensin- II.
Renal impairment and kidney transplantation: when Karvea 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 Karvea 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 Karvea in patients with a recent kidney transplantation.
M’ hemmx esperjenza fuq l- għoti ta 'Karvea lil pazjenti li reċentement kellhom trapjant tal- kliewi.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is- sistema ta ’ renin- angiotensin - aldosterone, iperkalimja tista ’ sseħħ waqt il- kura b’ Karvea, speċjalment fil- preżenza t’ indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad- dijabete, u/ jew insuffiċjenza tal- qalb.
Lithium: the combination of lithium and Karvea is not recommended (see section 4.5).
Lithium: it- taħlit ta 'litju u Karvea mhuwiex rakkomandat (ara sezzjoni 4. 5).
Therefore, the use of Karvea is not recommended.
Għalhekk, l- użu ta ’ Karvea mhuwiex irrikmandat.
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 minn kardjopatija iskemika jew minn mard kardjovaskulari iskemiku jista ’ jwassal għal infart mijokardijaku jew għal attakk ta ’ puplesija.
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).
3 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).
3 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi 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.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea 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 Karvea 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 Karvea (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' Karvea (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 ’ prodotti mediċinali 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 prodotti mediċinali 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).
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.
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
4 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
Karvea is contraindicated (see section 4.3) during breast-feeding.
Karvea huwa kontra- indikat (ara sezzjoni 4. 3) waqt it- treddigħ.
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 mat- tul tal - kura.
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.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminuria u funzjoni normali tal- kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f’ 0. 5% tal- pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil- grupp tal- plaċebo.
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
It- tabella li ġejja tippreżenta r- reazzjonijiet avversi tal- mediċina li ġew irrappurtati fi provi kliniċi kkontrollati bi plaċebo li fihom 1, 965 pazjent bi pressjoni għolja rċevew irbesartan.
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.
It- termini mmarkati bi stilla (*) jirreferu għar- reazzjonijiet avversi li ġew irrappurtati b’ mod addizzjonali f ’ > 2% tal- pazjenti dijabetiċi bi presssjoni għolja b’ insuffiċjenza renali kronika u proteinurja ċara u iżjed milli fil- grupp tal- plaċebo.
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).
5 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).
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.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ insuffiċenzja renali kronika u bi proteinuria li tidher, iperkalimja (≥ 5. 5 mEq/ L) ġrat f’ 46. 3% tal- pazjenti fil- grupp ta ’ irbesartan u f’ 26. 3% tal- pazjenti fil- grupp tal- plaċebo.
5 Common:
Komuni:
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.
F’ 1. 7% tal- pazjenti bi pressjoni għolja b’ mard dijabetiku avanzat renali kkurati b’ irbesartan, kien osservat tnaqqis fl- emoglobina *, li ma kienx klinikament sinifikanti.
tachycardia
Komuni:
Nervous system Common:
sturdament, sturdament ortostatiku *
disorders: dizziness, orthostatic dizziness*
Mhux komuni: sogħla
Respiratory, thoracic and mediastinal disorders:
Disturbi gastro- intestinali:
cough
dardir/ rimettar
Uncommon:
Mhux komuni: dijarea, dispepsja/ qrusa fl- istonku
nausea/ vomiting diarrhoea, dyspepsia/ heartburn
Komuni:
Musculoskeletal
uġigħ muskolu- skeltrali *
and connective tissue disorders:
Komuni:
Common:
Mhux komuni: fwawar
musculoskeletal pain*
għeja kbira
Vascular disorders:
Mhux komuni: uġigħ fis- sider
Common:
Mhux komuni:
Uncommon:
disfunzjoni sesswali
orthostatic hypotension* flushing
Disturbi ġenerali u
General disorders and administration site conditions:
kondizzjonijiet ta 'mnejn jingħata:
sexual dysfunction
disfunzjoni sesswali
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Ir- reazzjonijiet avversi li ġejjin ġew irrappurtati waqt l- esperjenza ta 'wara t- tqegħid fis- suq; ittieħdu minn rapporti spontanji u għalhekk, il- frekwenza ta ’ dawn ir- reazzjonijiet avversi mhix magħrufa:
Nervous system disorders:
6 Disturbi fis- sistema nervuża:
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali, tal- connective tissue u fl- għadam:
6 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
Hypersensitivity reactions such as angioedema, rash, urticaria
Bħal antagonisti oħra tar- riċettur ta ’ angiotensin- II, kienu rrapportati każijiet rari ta 'reazzjonijiet ta' sensittività eċċessiva bħal raxx, urtikarja, anġjoedema
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%).
No specific information is available on the treatment of overdose with Karvea.
M’ hemmx biżżejjed informazzjoni speċifika disponibbli fuq il- kura tad- doża eċċessiva b’ Karvea.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar - riċettur angiotensin- II (tip AT1).
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.
7 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 blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
L- effett li għandu Karvea 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.
7 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.
The efficacy of Karvea is not influenced by age or gender.
L- effikaċja ta ’ Karvea ma hijiex influwenzata bl- età jew sess.
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.
Pressjoni għolja u dijabete tip 2 b’ mard renali L- istudju “ Irbesartan u n- Nefropatija bid- Diabete (IDNT) ” juri li irbesartan inaqqas il- progressjoni tal - mard renali fil- pazjenti b’ insuffiċjenza renali kronika u b’ proteinuria li tidher.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Karvea, amlodipine and placebo.
IDNT kienet prova double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Karvea, 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 Karvea 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 ’ Karvea
Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, 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 ’ Karvea, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
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.
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)].
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)].
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.
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.
8 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.
The study examined the long-term effects (2 years) of Karvea 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).
L- istudju eżamina l- effetti fit- tul (sentejn) ta ’ Karvea fuq il- progressjoni għal proteinuria klinikali (li tidher) (ir- rata ta ’ tneħħija t’ albumina ma ’ l- urina (UAER) > 300 mg/ jum, u żjieda f ’ UAER ta ’ l- inqas 30% mill- linja bażi).
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Karvea 300 mg group (34%) than in the placebo group (21%).
Rigressjoni għal albuminuria normali (< 30 mg/ jum) kienet iktar frekwenti fil- grupp ta ’ Karvea 300 mg (34%) milli fil- grupp tal - plaċebo (21%).
Following oral or intravenous administration 14 of C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Wara l- għoti ta '14C irbesartan mill- ħalq jew ġol- vini, 80- 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Il- metabolit l- iktar importanti li jiċċirkola huwa irbesartan glucuronide
9 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Studji fuq annimali b’ irbesartan urew effetti tossiċi li jgħaddu (żieda fil- formazzjoni tal- ħofor fil- pelvi renali, hydroureter, jew edema ta ’ taħt il- ġilda) fil- feti tal- firien, li ġew riżolvuti wara it- twelid.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
Fil - fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
1 blister card of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Pakketti ta ’ 14- il pillola: kard ta ’ folji ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
10 Cartons of 28 tablets:
Pakketti ta ’ 28 pillola:
2 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
2 kards ta ’ folji ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
Cartons of 56 tablets:
Pakketti ta ’ 56 pillola:
4 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
4 kards ta ’ folji ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
Cartons of 98 tablets:
Pakketti ta ’ 98 pillola:
7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
7 kards ta ’ folji ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
Cartons of 56 x 1 tablet; 7 blister cards of 8 x 1 tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
Pakketti ta ’ 56 x 1 pillola; 7 kards ta ’ folji ta ’ 8 x 1 pilloli kull waħda f’ folji perforati tal - PVC/ PVDC/ Aluminju ta ’ doża waħda.
27 August 1997 Date of latest renewal:
27 t' Awissu 1997 Data ta 'l- aħħar tiġdid:
27 August 2007
27 t' Awissu 2007
Karvea 150 mg tablets.
Karvea 150 mg pilloli.
Each tablet contains 150 mg of irbesartan.
Kull pillola fiha 150 mg irbesartan.
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).
13 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).
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).
14 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).
13 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
14 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
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).
16 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).
15 Common:
Komuni:
Nervous system disorders:
17 Disturbi fis- sistema nervuża:
16 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
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.
18 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.
17 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.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 150 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Karvea, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
18 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.
19 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
20 Cartons of 28 tablets:
Pakketti ta ’ 28 pillola:
Karvea 300 mg tablets.
Karvea 300 mg pilloli.
Each tablet contains 300 mg of irbesartan.
Kull pillola fiha 300 mg irbesartan.
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).
24 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).
22 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
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).
25 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).
23 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
24 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
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).
27 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).
25 Common:
Komuni:
Nervous system disorders:
28 Disturbi fis- sistema nervuża:
26 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
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.
29 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.
27 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.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 300 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Karvea, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
28 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.
29 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
30 Cartons of 28 tablets:
Pakketti ta ’ 28 pillola:
Karvea 75 mg film-coated tablets.
Karvea 75 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 75 mg of irbesartan.
Kull pillola miksija b’ rita fiha 75 mg irbesartan.
25.50 mg of lactose monohydrate per film-coated tablet.
25. 50 mg ta 'lactose monohydrate kull pillola.
Film-coated tablet.
Pillola.
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).
35 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).
32 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
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).
36 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).
33 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
34 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
Karvea is contraindicated (see section 4.3) during breast-feeding. It is not known whether irbesartan is excreted in human milk.
Mhux magħruf jekk irbesartan jitneħħiex fil- ħalib uman.
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).
38 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).
35 Common:
Komuni:
tachycardia
Disturbi fis- sistema nervuża:
Nervous system Common:
Komuni:
disorders: dizziness, orthostatic dizziness*
sturdament, sturdament ortostatiku *
nausea/ vomiting diarrhoea, dyspepsia/ heartburn
Mhux komuni: dijarea, dispepsja/ qrusa fl- istonku
Musculoskeletal
Disturbi muskolu- skeltrali, tal- connective tissue u fl- għadam:
musculoskeletal pain*
uġigħ muskolu- skeltrali *
Uncommon:
pressjoni baxxa ortostatika *
orthostatic hypotension* flushing
Mhux komuni: fwawar
Uncommon: sexual dysfunction
Mhux komuni: disfunzjoni sesswali
Gastrointestinal disorders:
39 Disturbi gastro- intestinali:
36 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
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.
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.
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 -
37 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 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 Karvea 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 ’ Karvea fuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
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.
Sittin fil- mija (60%) ta ’ pazjenti fil- grupp tal- plaċebo leħqu dan
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.
41 it- targit tal- pressjoni filwaqt li din il- figura kienet 76% u 78% fil- gruppi t’ irbesartan u amlodipine rispettivament.
38 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.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Il- metabolit l- iktar importanti li jiċċirkola huwa irbesartan glucuronide (madwar 6%).
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
It- tneħħija mill -
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
42 ġisem kollu u renali huma 157- 176 u 3- 3. 5 ml/ min, rispettivament.
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40 years).
Il- valuri ta ’ irbesartan AUC u Cmax kienu xi ftit ogħla f’ individwi anzjani (≥ 65 - il sena) milli f’ individwi żgħar (18- 40 sena).
39 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
43 Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
40 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
1 blister card of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Pakketti ta ’ 14- il pillola miksija b’ rita: kard ta ’ folji ta ’ 14- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 28 film-coated tablets:
Pakketti ta ’ 28 pillola miksija b’ rita:
2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
2 kards ta ’ folji ta ’ 14- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 30 film-coated tablets:
Pakketti ta ’ 30 pillola miksija b’ rita:
2 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
2 kards ta ’ folji ta ’ 15- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 56 film-coated tablets:
Pakketti ta ’ 56 pillola miksija b’ rita:
4 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
4 kards ta ’ folji ta ’ 14- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 84 film-coated tablets:
Pakketti ta ’ 84 pillola miksija b’ rita:
6 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
6 kards ta ’ folji ta ’ 14- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 90 film-coated tablets:
Pakketti ta ’ 90 pillola miksija b’ rita:
6 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
6 kards ta ’ folji ta ’ 15- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
Cartons of 98 film-coated tablets:
Pakketti ta ’ 98 pillola miksija b’ rita:
7 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
7 kards ta ’ folji ta ’ 14- il pillola miksija b’ rita f’ folji tal - PVC/ PVDC/ Aluminium blisters.
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
7 kards ta ’ folji ta ’ 8 x 1 pilloli miksijin b’ rita f’ folji perforati tal- PVC/ PVDC/ Aluminju ta 'doża waħda.
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
44 BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
Karvea 150 mg film-coated tablets.
Karvea 150 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 150 mg of irbesartan.
Kull pillola miksija b’ rita fiha 150 mg irbesartan.
51.00 mg of lactose monohydrate per film-coated tablet.
51. 00 mg ta 'lactose monohydrate kull pillola.
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).
46 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).
42 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
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).
47 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).
43 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
44 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
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).
49 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).
45 Common:
Komuni:
Gastrointestinal disorders:
50 Disturbi gastro- intestinali:
46 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
47 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.
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.
52 it- targit tal- pressjoni filwaqt li din il- figura kienet 76% u 78% fil- gruppi t’ irbesartan u amlodipine rispettivament.
48 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.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
53 ġisem kollu u renali huma 157- 176 u 3- 3. 5 ml/ min, rispettivament.
49 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
54 Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
50 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
55 BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
Karvea 300 mg film-coated tablets.
Karvea 300 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 300 mg of irbesartan.
Kull pillola miksija b’ rita fiha 300 mg irbesartan.
102.00 mg of lactose monohydrate per film-coated tablet.
102. 00 mg ta 'lactose monohydrate kull pillola.
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).
57 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).
52 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
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).
58 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).
53 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
54 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
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).
60 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).
55 Common:
Komuni:
Gastrointestinal disorders:
61 Disturbi gastro- intestinali:
56 Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n- nutrizzjoni:
57 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.
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.
63 it- targit tal- pressjoni filwaqt li din il- figura kienet 76% u 78% fil- gruppi t’ irbesartan u amlodipine rispettivament.
58 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.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
64 ġisem kollu u renali huma 157- 176 u 3- 3. 5 ml/ min, rispettivament.
59 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
65 Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
60 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
3 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
3 kards ta ’ folji ta ’ 10 pilloli miksijin b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
9 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
9 kards ta ’ folji ta ’ 10 pilloli miksijin b’ rita f’ folji tal - PVC/ PVDC/ Aluminju.
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
66 BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
Karvea 75 mg tablets irbesartan
Karvea 75 mg pilloli irbesartan