qanastek/EMEA-V3 huggingface dataset:
The study examined the long-term effects (2 years) of Irbesartan BMS 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 ’ Irbesartan BMS 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).
The predefined blood pressure goal was ≤ 135/ 85 mmHg.
L- għan predefinit kien għall- pressjoni ta ’ ≤ 135/ 85 mmHg.
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Mediċini kontra l- pressjoni għolja addizzjonali (li jeskludu inibituri t’ ACE, antagonisti tar- riċetturi angiotensin- II u dihydropyridine calcium blockers) ġew miżjuda skond il- ħtieġa biex igħinu fl- ilħuq ta 'l- għan tal- pressjoni.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Waqt li pressjoni simili ġiet milħuqa fil- gruppi kollha tal- kura, inqas individwi fil- grupp t’ irbesartan 300 mg (5. 2%) minn dawk bil- plaċebo (14. 9%) jew fil- grupp t’ irbesartan 150 mg (9. 7%) laħqu l- endpoint ta ’ proteinuria li tidher, li jfisser 70% ta ’ tnaqqis fir- risku relattiv meta mqabbel mal- plaċebo (p = 0. 0004) għal doża l- għolja.
An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
Titjib fl- istess ħin fir- rata tal- filtrazzjoni glomerulari (GFR) ma ġiex osservat waqt l- ewwel tlett xhur tal- kura.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Id- dewmien fil- progressjoni għal proteinuria klinika kien evidenti kmieni sa minn tlett xhur u baqa ’ għal iktar minn perjodu ta ’ 2 snin.
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Irbesartan BMS 300 mg group (34%) than in the placebo group (21%).
Rigressjoni għal albuminuria normali (< 30 mg/ jum) kienet iktar frekwenti fil- grupp ta ’ Irbesartan BMS 300 mg (34%) milli fil - grupp tal- plaċebo (21%).
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Wara li jingħata mill- ħalq, irbesartan jiġi assorbit sew: studji ta ’ bijodisponibiltà assoluta urew valuri ta ’ madwar 60% - 80%.
Concomitant food intake does not significantly influence the bioavailability of irbesartan.
It- teħid ta ’ l- ikel konkomitanti ma jaffettwax b’ mod sinifikkativ il - bijodisponibiltà t ’ irbesartan.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
L- irbit mal- proteini tal- plażma kien madwar 96%, b’ irbit negliġibbli ma ’ komponenti ċellulari tad- demm.
The volume of distribution is 53-93 litres.
Il- volum ta ’ distribuzzjoni huwa 53- 93 litru.
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 is metabolised by the liver via glucuronide conjugation and oxidation.
9 irbesartan mhux mibdul.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Irbesartan jiġi metabolizzat bil- fwied permezz tal- konjugazzjoni ma ’ glucoronide u ta ’ ossidazjoni.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Studji in vitro indikaw li irbesartan huwa primarjament ossidat bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibli.
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg.
Irbesartan jesibixxi farmakokinetika lineari u proporzjonata tad- doża fuq il- firxa mad- doża ta ’ 10 sa 600 mg.
A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Inqas minn żieda proporzjonali t’ assorbiment orali b’ dożi ’ il fuq minn 600 mg (id- doppju tad - doża massima rrikmandata) ġie osservat; għalfejn jiġri dan għadu mhux magħruf.
Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
L- ogħla konċentrazzjonijiet fil- plażma jintleħqu wara 1. 5- 2 sigħat wara li jittieħed mill- ħalq.
The total body and renal clearance are 157-176 and 3-3.5 ml/ min, respectively.
It- tneħħija mill - ġisem kollu u renali huma 157- 176 u 3- 3. 5 ml/ min, rispettivament.
The terminal elimination half-life of irbesartan is 11-15 hours.
Il- half- life t’ eliminazzjoni terminali t’ irbesartan hija 11- 15 sigħat.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Il- konċentrazzjonijiet fissi tal- plażma jintlaħqu wara 3 ijiem wara li tinbeda il- kura b’ doża ta ’ darba kuljum.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Akkumulazzjoni limitata t’ irbesartan (< 20%) giet osservata fil- plażma meta doża ta ’ darba kuljum kienet ripetuta.
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Fi studju, il- konċentrazzjoni tal - plażma t’ irbesartan ġiet osservata li kienet xi daqxejn ogħla f’ pazjenti nisa bi pressjoni għolja.
However, there was no difference in the half-life and accumulation of irbesartan.
Madanakollu, ma kienx hemm differenza fil- half- life u l- akkumulazzjoni t’ irbesartan.
No dosage adjustment is necessary in female patients.
Mhemmx bżonn ta ’ aġġustar tad- doża f’ pazjenti nisa.
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).
9 However the terminal half-life was not significantly altered.
Madankollu, il- half- life terminali ma tbiddlitx b’ mod sinifikattiv.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Irbesartan u il- metaboliti tiegħu jiġu eliminati permezz ta ’ sistemi biljari u renali.
After either oral or IV 14 administration of C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Wara l- għoti ta '14C irbesartan jew mill- ħalq jew ġol- vini, madwar 20% tar- radjuattività toħroġ ma ’ l- awrina u l - kumplament ma' l- ippurgar.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Il- farmakokinetiċi ta 'irbesartan kienu ikkalkulati fi 23 tifel u tifla bi pressjoni għolja wara l- għoti ta' doża waħda jew aktar kuljum ta 'irbesartan (2 mg/ kg) sa doża massima ta' kuljum ta '150 mg għal erba' ġimgħat.
Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Minn dawn it- 23 tifel u tifla, 21 setgħu jiġu evalwati għal taqbil ta 'farmakokinetiċi ma' adulti (tnax- il tifel u tifla 'l fuq minn 12- il sena, disa' t- itfal ta 'bejn 6 u 12- il sena).
Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Ir- riżultati wrew li Cmax, AUC u r- rati ta 'tneħħija setgħu jitqabblu ma' dawk osservati f' pazjenti adulti li jieħdu 150 mg irbesartan kuljum.
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Kienet osservata akkumulazzjoni limitata ta 'irbesartan (18%) fil- plażma meta kienet ripetuta doża waħda kuljum.
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.
Irbesartan is not removed by haemodialysis.
Irbesartan ma jitneħħiex b' emodijalisi.
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbidlux b’ mod sinifikanti.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Ma kienx hemm evidenza ta ’ tossiċità sistemika anormali jew tossiċità fl- organu affetwat b’ dożi klinikament rilevanti.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Fi studji mhux kliniċi ta ’ sigurtà, dożi għoljin ta ’ irbesartan (≥ 250 mg/ kg/ jum f’ firien u ≥ 100mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
B’ dożi għoljin ħafna (≥ 500 mg/ kg/ jum) tibdil diġenerattiv fil - kliewi (bħal nefrite interstizja, nefħa tubulari, tubi basofiliċi, żidiet fil- konċentrazjonijiet fil- plażma ta ’ l- urea u krejatinina) ġew stimulati b’ irbesartan f’ firien u f’ makakki u huma meqjusa bħala sekondarji għall- effetti ipotensivi tal- mediċina li kkaġunat tnaqqis fil- perfużjoni renali.
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Barra minn hekk, irbesartan ikkaġuna iperplasja/ ipertrofija taċ- ċelluli ġukstaglomerulari (f’ firien ≥ 90 mg/ kg/ jum, f’ makakki ≥ 10 mg/ kg/ jum).
All of these changes were considered to be caused by the pharmacological action of irbesartan.
Dan it- tibdil kollu kien ikkunsidrat li seħħ bl- azzjoni farmakoloġika ta ’ irbesartan.
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Għal dożi terapewtiċi ta ’ irbesartan fil- bnedmin, ma jidhirx li l- iperplasja/ ipertrofija taċ - ċelluli renali ġukstaglomerulari għandha rilevanza.
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Ma kienx hemm evidenza ta ’ mutaġeniċità, klastoġeniċità jew karċinoġeniċità.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Fil -
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
10 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
No teratogenic effects were observed in the rat or rabbit.
Ma ġewx osservati effetti teratoġeniċi fil- far u fil- fenek.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
10 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
14 tablets 28 tablets 56 tablets 98 tablets PVC/ PVDC/ Aluminium blisters
14- il pillola 28 pillola 56 pillola 98 pillola Folja tal- PVC/ PVDC/ Aluminju
56 x 1 tablets PVC/ PVDC/ Aluminium perforated unit dose blisters
56 x 1 pillola Folji: perforati tal- PVC/ PVDC/ Aluminju ta ’ doża waħda
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
19 January 2007 Date of last renewal:
19 ta ’ Jannar 2007 Data ta 'l- aħħar tiġdid:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
Irbesartan BMS 150 mg tablets.
Irbesartan BMS 150 mg pilloli.
Each tablet contains 150 mg irbesartan.
Kull pillola fiha 150 mg irbesartan.
30.75 mg of lactose monohydrate per tablet.
30. 75 mg ta 'lactose monohydrate kull pillola.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2772 imnaqqax fuq in- naħa l- oħra.
12 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.
13 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.
13 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).
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
15 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
14 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Nervous system disorders:
16 Disturbi fis- sistema nervuża:
15 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
17 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:
16 Nervous system disorders:
Disturbi fis- sistema nervuża:
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
18 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
17 Clinical efficacy:
Effikaċja klinika:
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
19 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
18 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.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
20 irbesartan mhux mibdul.
19 However the terminal half-life was not significantly altered.
Madankollu, il- half- life terminali ma tbiddlitx b’ mod sinifikattiv.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
21 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
20 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Irbesartan BMS 300 mg tablets.
Irbesartan BMS 300 mg pilloli.
Each tablet contains 300 mg irbesartan.
Kull pillola fiha 300 mg irbesartan.
61.50 mg of lactose monohydrate per tablet.
61. 50 mg ta 'lactose monohydrate kull pillola.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2773 imnaqqax fuq in- naħa l- oħra.
22 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.
24 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.
23 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).
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
26 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
24 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Nervous system disorders:
27 Disturbi fis- sistema nervuża:
25 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
28 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:
26 Nervous system disorders:
Disturbi fis- sistema nervuża:
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
29 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
27 Clinical efficacy:
Effikaċja klinika:
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
30 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
28 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.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
31 irbesartan mhux mibdul.
29 However the terminal half-life was not significantly altered.
Madankollu, il- half- life terminali ma tbiddlitx b’ mod sinifikattiv.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
32 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
30 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Irbesartan BMS 75 mg film-coated tablets.
Irbesartan BMS 75 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 75 mg 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 miksija b’ rita.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2871 imnaqqax fuq in- naħa l- oħra.
32 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.
35 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.
33 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).
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
37 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
34 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (see section 5.3).
Espożizzjoni għal terapija AIIRAs matul it- tieni u t- tielet trimestri hija magħrufa li twassal għal tossiċità tal- fetu uman (tnaqqis fil- funzjoni tal- kliewi, oligohydramnios, tnaqqis fl- ossifikazzjoni tal - għadam tar- ras) u tossiċità neonatali (nuqqas fil- funzjoni tal- kliewi, pressjoni baxxa, iperkalemija) (ara sezzjoni 5. 3).
Nervous system disorders:
38 Disturbi fis- sistema nervuża:
35 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
39 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:
36 Nervous system disorders:
Disturbi fis- sistema nervuża:
Pharmacotherapeutic group: angiotensin-II antagonists, plain.
Antagonisti ta 'angiotensin- II, sempliċi.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
40 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
37 Clinical efficacy:
Effikaċja klinika:
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
41 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
38 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.
The volume of distribution is 53 - 93 litres.
Il- volum ta ’ distribuzzjoni huwa 53- 93 litru.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
42 irbesartan mhux mibdul.
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
L- ogħla konċentrazzjonijiet fil- plażma jintleħqu wara 1. 5- 2 sigħat wara li jittieħed mill- ħalq.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
It- tneħħija mill - ġisem kollu u renali huma 157- 176 u 3- 3. 5 ml/ min, rispettivament.
The terminal elimination half-life of irbesartan is 11 - 15 hours.
Il- half- life t’ eliminazzjoni terminali t’ irbesartan hija 11- 15 sigħat.
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects
Il- valuri ta ’ irbesartan AUC u Cmax kienu xi ftit ogħla f’ individwi anzjani (≥ 65 - il sena) milli f’ individwi żgħar (18- 40 sena).
However the terminal half-life was not significantly altered.
Madankollu, il- half- life terminali ma tbiddlitx b’ mod sinifikattiv.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
43 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
40 Film-coating:
Kisja b' rita:
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Carnauba wax.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Carnauba wax.
14 tablets 28 tablets 56 tablets 84 tablets 98 tablets PVC/ PVDC/ Aluminium blisters
14- il pillola 28 pillola 56 pillola 84 pillola 98 pillola Folji tal- PVC/ PVDC/ Aluminju
56 x 1 tablets PVC/ PVDC/ Aluminium perforated unit dose blisters
56 x 1 pillola Folji perforati tal- PVC/ PVDC/ Aluminju ta ’ doża waħda
Irbesartan BMS 150 mg film-coated tablets.
Irbesartan BMS 150 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 150 mg 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 miksija b’ rita.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2872 imnaqqax fuq in- naħa l- oħra.
43 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.
46 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.
44 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).
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
48 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
45 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Nervous system disorders:
49 Disturbi fis- sistema nervuża:
46 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
50 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:
47 Nervous system disorders:
Disturbi fis- sistema nervuża:
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
51 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
48 Clinical efficacy:
Effikaċja klinika:
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
52 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
49 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.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
53 irbesartan mhux mibdul.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
54 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
51 Film-coating:
Kisja b' rita:
Irbesartan BMS 300 mg film-coated tablets.
Irbesartan BMS 300 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 300 mg 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 miksija b’ rita.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2873 imnaqqax fuq in- naħa l- oħra.
54 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.
57 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.
55 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).
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
59 b’ CYP2C9 u b’ mod inqas estensiv b’ glukoronidazzjoni.
56 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Nervous system disorders:
60 Disturbi fis- sistema nervuża:
57 Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
61 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:
58 Nervous system disorders:
Disturbi fis- sistema nervuża:
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
62 Irbesartan huwa antagonista qawwi, attiv mill- ħalq, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
59 Clinical efficacy:
Effikaċja klinika:
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
63 double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
60 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.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
64 irbesartan mhux mibdul.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
65 fniek, abort jew reassorbiment kmieni ta ’ l- embriju kienu innotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li nkludew mwiet.
62 Film-coating:
Kisja b' rita:
64 ANNEX II
67 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR IMPORT AND BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- IMPORTAZZJONI U L- ĦRUĠ TAL- LOTT
Names and addresses of the manufacturers responsible for import and batch release
Ismijiet u indirizzi tal- manifatturi responsabbli għall- importazzjoni u l- ħruġ tal- lott
Sanofi-Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi- Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT Ir- Renju Unit
Sanofi Winthrop Industrie 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 France
Sanofi Winthrop Industrie 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 Franza
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
The PSUR cycle of Irbesartan BMS is aligned with the cross-referred product, KARVEA, until otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Irbesartan BMS huma allinjat mal- prodott cross- referred, KARVEA, sakemm mhux speċifikat mod ieħor.
66 ANNEX III
69 ANNESS III
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
PAKKETT TA 'BARRA
Irbesartan BMS 75 mg tablets irbesartan
Irbesartan BMS 75 mg pilloli irbesartan
Each tablet contains: irbesartan 75 mg
Kull pillola fiha: irbesartan 75 mg
14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
14- il pillola 28 pillola 56 pillola 56 X 1 pillola 98 pillola
EU/ 1/ 06/ 375/ 001 14 tablets EU/ 1/ 06/ 375/ 002 28 tablets EU/ 1/ 06/ 375/ 003 56 tablets EU/ 1/ 06/ 375/ 004 56 x 1 tablets EU/ 1/ 06/ 375/ 005 98 tablets
EU/ 1/ 06/ 375/ 001 14- il pillola EU/ 1/ 06/ 375/ 002 28 pillola EU/ 1/ 06/ 375/ 003 56 pillola EU/ 1/ 06/ 375/ 004 56 x 1 pillola EU/ 1/ 06/ 375/ 005 98 pillola
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
14 - 28 - 56 - 98 tablets:
14 - 28 - 56 - 98 pilloli:
56 x 1 tablets:
56 x 1 pillola.
Irbesartan BMS 150 mg tablets irbesartan
Irbesartan BMS 150 mg pilloli irbesartan
Each tablet contains: irbesartan 150 mg
Kull pillola fiha: irbesartan 150 mg
EU/ 1/ 06/ 375/ 006 14 tablets EU/ 1/ 06/ 375/ 007 28 tablets EU/ 1/ 06/ 375/ 008 56 tablets EU/ 1/ 06/ 375/ 009 56 x 1 tablets EU/ 1/ 06/ 375/ 010 98 tablets
EU/ 1/ 06/ 375/ 006 14- il pillola EU/ 1/ 06/ 375/ 007 28 pillola EU/ 1/ 06/ 375/ 008 56 pillola EU/ 1/ 06/ 375/ 009 56 x 1 pillola EU/ 1/ 06/ 375/ 010 98 pillola
Irbesartan BMS 300 mg tablets irbesartan
Irbesartan BMS 300 mg pilloli irbesartan
Each tablet contains: irbesartan 300 mg
Kull pillola fiha: irbesartan 300 mg
EU/ 1/ 06/ 375/ 011 14 tablets EU/ 1/ 06/ 375/ 012 28 tablets EU/ 1/ 06/ 375/ 013 56 tablets EU/ 1/ 06/ 375/ 014 56 x 1 tablets EU/ 1/ 06/ 375/ 015 98 tablets
EU/ 1/ 06/ 375/ 011 14- il pillola EU/ 1/ 06/ 375/ 012 28 pillola EU/ 1/ 06/ 375/ 013 56 pillola EU/ 1/ 06/ 375/ 014 56 x 1 pillola EU/ 1/ 06/ 375/ 015 98 pillola
Irbesartan BMS 75 mg film-coated tablets irbesartan
Irbesartan BMS 75 mg pilloli miksijin b' rita irbesartan
14 tablets 28 tablets 56 tablets 56 x 1 tablets 84 tablets 98 tablets
14- il pillola 28 pillola 56 pillola 56 X 1 pilloli 84 pillola 98 pillola
EU/ 1/ 06/ 375/ 016 14 tablets EU/ 1/ 06/ 375/ 017 28 tablets EU/ 1/ 06/ 375/ 018 56 tablets EU/ 1/ 06/ 375/ 019 56 x 1 tablets EU/ 1/ 06/ 375/ 020 84 tablets EU/ 1/ 06/ 375/ 021 98 tablets
EU/ 1/ 06/ 375/ 016 14- il pillola EU/ 1/ 06/ 375/ 017 28 pillola EU/ 1/ 06/ 375/ 018 56 pillola EU/ 1/ 06/ 375/ 019 56 x 1 pillola EU/ 1/ 06/ 375/ 020 84 pillola EU/ 1/ 06/ 375/ 021 98 pillola
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
14 - 28 - 56 - 84 - 98 tablets:
14 - 28 - 56 - 84 - 98 pillola:
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan BMS 150 mg film-coated tablets irbesartan
Irbesartan BMS 150 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 06/ 375/ 022 14 tablets EU/ 1/ 06/ 375/ 023 28 tablets EU/ 1/ 06/ 375/ 024 56 tablets EU/ 1/ 06/ 375/ 025 56 x 1 tablets EU/ 1/ 06/ 375/ 026 84 tablets EU/ 1/ 06/ 375/ 027 98 tablets
EU/ 1/ 06/ 375/ 022 14- il pillola EU/ 1/ 06/ 375/ 023 28 pillola EU/ 1/ 06/ 375/ 024 56 pillola EU/ 1/ 06/ 375/ 025 56 x 1 pillola EU/ 1/ 06/ 375/ 026 84 pillola EU/ 1/ 06/ 375/ 027 98 pillola
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
86 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan BMS 300 mg film-coated tablets irbesartan
Irbesartan BMS 300 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 06/ 375/ 028 14 tablets EU/ 1/ 06/ 375/ 029 28 tablets EU/ 1/ 06/ 375/ 030 56 tablets EU/ 1/ 06/ 375/ 031 56 x 1 tablets EU/ 1/ 06/ 375/ 032 84 tablets EU/ 1/ 06/ 375/ 033 98 tablets
EU/ 1/ 06/ 375/ 028 14- il pillola EU/ 1/ 06/ 375/ 029 28 pillola EU/ 1/ 06/ 375/ 030 56 pillola EU/ 1/ 06/ 375/ 031 56 x 1 pillola EU/ 1/ 06/ 375/ 032 84 pillola EU/ 1/ 06/ 375/ 033 98 pillola
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
87 PACKAGE LEAFLET:
90 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 75 mg pilloli irbesartan
What Irbesartan BMS is and what it is used for 2.
X' inhu Irbesartan BMS u għalxiex jintuża 2.
Before you take Irbesartan BMS 3.
Qabel ma tieħu Irbesartan BMS 3.
How to take Irbesartan BMS 4.
Kif għandek tieħu Irbesartan BMS 4.
How to store Irbesartan BMS 6.
Kif taħżen Irbesartan BMS 6.
WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR
X' INHU IRBESARTAN BMS U GĦALXIEX JINTUŻA
Irbesartan BMS belongs to a group of medicines known as angiotensin-II receptor antagonists.
Irbesartan BMS jappartjeni għall- grupp ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi angiotensin- II.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
Angiontensin- II hija sustanza maħduma fil- ġisem li tagħqad mar- riċetturi fil- vini u ġġiegħelhom jibbiesu.
This results in an increase in blood pressure.
B’ hekk ikun hemm żieda fil- pressjoni.
Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan BMS jipprevjeni li angiotensin- II tingħaqad ma ’ dawn ir- riċetturi, u jwassal il- vini tad- demm biex jirrilassaw u b’ hekk il - pressjoni tinżel.
Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan BMS inaqqas ir- rata tat- tnaqqis tal- funzjoni tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete ta 'tip 2.
Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Irbesartan BMS jintuża biex jikkura pressjoni għolja tad- demm (pressjoni għolja) biex jipproteġi lill- kliewi f’ pazjenti bi pressjoni għolja ħafna, b’ dijabete ta ’ tip 2 u b’ evidenza mit- testijiet tal- laboratorju ta ’ indeboliment fil- funzjoni tal- kliewi.
BEFORE YOU TAKE IRBESARTAN BMS
QABEL MA TIEĦU IRBESARTAN BMS
Do not take Irbesartan BMS if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Tiħux Irbesartan BMS jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta 'Irbesartan BMS matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’
Irbesartan BMS should not be given to children and adolescents (under 18 years).
Irbesartan BMS m’ għandux jingħata lit- tfal u adoloxxenti (taħt it- 18- il sena).
Take special care with Irbesartan BMS Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan BMS for diabetic kidney disease.
Oqgħod attent ħafna b' Irbesartan BMS Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk tbati minn problemi fil- kliewi jekk tbati minn problemi tal- qalb jekk tirċievi Irbesartan BMS għal mard tal- kliewi dijabetiku.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics You must tell your doctor if you think that you are (or might become) pregnant.
F' dan il- każ, it- tabib tiegħek jista ’ jagħmel testijiet regolari tad- demm, speċjalment biex ikejjel il- livelli tal- potassium fid - demm f’ każ li il- funzjoni tal- kliewi tkun bagħtuta jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tingħata xi loppju
Irbesartan BMS is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Irbesartan BMS mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
88 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Irbesartan BMS does not usually interact with other medicines.
Ġeneralment, Irbesartan BMS ma għandux effetti ma ’ mediċini oħra.
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Jista ’ jkollok bżonn tagħmel kontrolli tad- demm jekk int qed tieħu: supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium, mediċini potassium- sparing (bħal ċerti dijuretiċi) mediċini li fihom il- lithium.
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Jekk tieħu ċerti taffejja ta ’ l- uġigħ, imsejħin mediċini ta ’ kontra l- infjammazzjoni mhux sterojdi, l - effett ta ’ irbesartan jista ’ jitnaqqas.
Taking Irbesartan BMS with food and drink Irbesartan BMS can be taken with or without food.
Meta tieħu Irbesartan BMS ma 'l- ikel u max- xorb Irbesartan BMS jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Usually, your doctor will advise you to take another medicine instead of Irbesartan BMS, as Irbesartan BMS is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Irbesartan BMS, minħabba li Irbesartan BMSmhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Irbesartan BMS before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan BMSqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Irbesartan BMS as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Irbesartan BMS malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Irbesartan BMS, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Irbesartan BMS, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Irbesartan BMS is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta 'magni Mhux mistenni li Irbesartan BMS itellfek milli issuq jew tħaddem magni.
However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Madanakollu, xi kultant sturdament u għejja jinħassu waqt il- kura ta ’ kontra il- pressjoni għolja.
If you experience these, talk to your doctor before attempting to drive or use machines.
Jekk tesperjenza dawn, kellem lit- tabib tiegħek qabel ma tipprova ssuq jew tħaddem magni.
Important information about some of the ingredients of Irbesartan BMS Irbesartan BMS contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Irbesartan BMS Irbesartan BMS fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e. g. lactose), contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti ma tittollerax xi zokkor (eż. lactose), għid lit- tabib qabel tieħu din il- mediċina.
HOW TO TAKE IRBESARTAN BMS
KIF GĦANDEK TIEĦU IRBESARTAN BMS
Always take Irbesartan BMS exactly as your doctor has told you.
Dejjem għandek tieħu Irbesartan BMS skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma 'l- ispiżjar tiegħek jekk ikollok xi dubju.
Method of administration Irbesartan BMS is for oral use.
Metodu ta ’ għoti Irbesartan BMS huwa għal użu mill- ħalq.
Swallow the tablets with a sufficient amount of fluid (e. g. one glass of water).
Ibla l- pilloli b’ ammont ta ’ likwidu biżżejjed (eż. tazza ilma).
You can take Irbesartan BMS with or without food.
Tista ’ tieħu Irbesartan BMS ma ’ l- ikel kif ukoll mingħajr ikel.
Try to take your daily dose at about the same time each day.
Ipprova ħu d- doża tiegħek ta ’ kuljum bejn wieħed u ieħor fl- istess ħin kuljum.
It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Irbesartan BMS sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.