qanastek/EMEA-V3 huggingface dataset:
Therefore, the CHMP considered that this is an acceptable indication.
Għaldaqstant, is- CHMP ikkunsidra li din hija indikazzjoni aċċettabbli.
-Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy” (“ LIFE indication” )” During the referral procedure, the MAH proposed amending the indication to substitute “ cardiovascular morbidity and mortality” with “ stroke”.
- “ Tnaqqis fir- riskju ta ’ morbidità u mortalità f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikulari xellugija ” (“ indikazzjoni LIFE ”) ” Waqt il- proċedura ta ’ referenza, il- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) ippropona li tiġi emendata l- indikazzjoni li tissostitwixxi “ morbidità u mortalità kardjovaskulari ” b ’ “ attakk ta ’ puplesija ”.
After careful evaluation, the CHMP considered that this indication is acceptable.
Wara evalwazzjoni bir- reqqa, is- CHMP ikkunsidra li din l- indikazzjoni hija aċċettabbli.
The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i. e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only.
L- istudju LIFE ġie vvalutat fil- passat u dan wassal għar- reġistrazzjoni ta ’ l- indikazzjoni iktar estensiva, jiġifieri t- tnaqqis tal- morbidità u tal- mortalità kardjovaskulari (kif imkejlin bl - inċidenza kkumbinata ta ’ mewt KV, attakk ta ’ puplesija u MI (attakk tal- qalb)) minflok ta ’ attakk ta ’ puplesija biss.
This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Din hija l- indikazzjoni proposta fil- preżent mill- applikant u ġiet irreġistrata fi 15- il Stat Membru ta ’ l- UE.
The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Ir- raġuni għal din l- indikazzjoni iktar wiesgħa hija li l- istudju LIFE ma kienx studju kkontrollat bi plaċebo, li studja l- effett fuq attakk ta ’ puplesija biss meta mqabbel ma ’ plaċebo, iżda kien studju kkontrollat attivament, li qabbel kura kontra l- pressjoni għolja ibbażata fuq losartan ma ’ kura kontra l- pressjoni għolja ibbażata fuq atenolol permezz ta ’ l- użu ta ’ punt ta ’ tmiem primarju kompost ta ’ mewt KV, attakk ta ’ puplesija u MI (attakk tal- qalb).
In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Dan jindika li l- effett benefiku muri ta ’ l- imblokkar- beta fuq il- morbidità u l - mortalità KV in ġenerali kien ukoll preżenti għal losartan.
Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned.
Minn dak iż- żmien ’ l hawn, l- effett ta ’ benefiku ta ’ atenolol fir- rigward tal- morbidità u tal- mortalità ġie ddubitat.
As a consequence the observed 25% risk reduction with losartan versus atenolol brings the protective effect of losartan on stroke in the same range as for other antihypertensives.
B’ konsegwenza ta ’ dan it- tnaqqis fir- riskju osservat ta ’ 25% b’ losartan meta mqabbel ma ’ atenolol iġib l- effett protettiv ta ’ losartan fuq l- attakk ta ’ puplesija fl- istess medda ta ’ mediċini oħrajn kontra l- pressjoni għolja.
18
14 Għaldaqstant, l- indikazzjoni proposta kienet ikkunsidrata approvabbli wara vot ta ’ maġġoranza mill - plenum tas- CHMP u hija appoġġjata bil- formolazzjoni li ġejja: “ tnaqqis ta ’ riskju ta ’ attakk ta ’ puplesija f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari xelluġija, iddokkumentata b’ ECG ”.
- Renal protection in patients with Type-2 diabetes and proteinuria
- Protezzjoni renali f’ pazjenti b’ dijabete tip- 2 u proteinurja
The CHMP considered the benefit/ risk ratio of this indication is positive.
Is- CHMP ikkunsidra l- proporzjon ta ’ riskju/ benefiċċju għal din l- indikazzjoni bħala wieħed pożittiv.
The proposed indication is based on the results from the RENAAL study, where the effect of losartan was investigated on a composite primary endpoint of renal endpoints and mortality in patients with Type II diabetes mellitus with proteinuria.
L- indikazzjoni proposta hija bbażata fuq ir- riżultati mill- istudju RENAAL, fejn l- effett ta ’ losartan kien investigat fuq punt ta ’ tmiem primarju kompost ta ’ punti ta ’ tmiem renali u mortalità f’ pazjenti b’ dijabete mellitus Tip II bi proteinurja.
Treatment with losartan, as compared with placebo, resulted in a 16.1% risk reduction in the number of patients reaching the primary composite endpoint.
Kura b’ losartan, kif imqabbla ma ’ plaċebo, irriżultat fi tnaqqis ta ’ 16. 1% fir- riskju fin- numru ta ’ pazjenti li kienu qegħdin jilħqu l- punt ta ’ tmiem primarju kompost.
There was also a significant risk reduction for doubling of the serum creatinine and for end-stage renal failure in the patient group treated with losartan.
Kien hemm ukoll tnaqqis sinjifikanti fir- riskju għall- irdoppjar tal- kreatinin fis- serum u għal indeboliment renali fi stadju ta ’ tmiem fil- grupp ta ’ pazjenti kkurati b’ losartan.
These findings were regarded as clinically relevant for this group of patients.
Dawn is- sejbiet kienu meqjusin bħala klinikament relevanti għal dan il- grupp ta ’ pazjenti.
Therefore, the CHMP proposed that the indication should be re-worded to “ Treatment of renal disease in patients with hypertension and Type II diabetes mellitus with proteinuria > 0.5g/ day as part of an antihypertensive treatment” to reflect the inclusion criteria of the RENAAL study.
Għaldaqstant, is- CHMP ippropona li l- indikazzjoni għandha tkun ifformulata mill- ġdid għal “ Kura ta ’ mard renali f’ pazjenti bi pressjoni għolja u b’ dijabete mellitus Tip II bi proteinurja > 0. 5g/ jum bħala parti minn kura kontra l- pressjoni għolja ” biex tirrifletti l- kriterji ta ’ inklużjoni ta ’ l- istudju RENAAL.
- Heart Failure (as second line, when ACE inhibitors are unsuitable).
- Falliment tal- Qalb (bħala t- tieni għażla, meta impedituri ACE ma jkunux addattati).
The CHMP was concerned that the benefit/ risk ratio of this indication could not be adequately established.
Is- CHMP kien imħasseb li l- proporzjon bejn il- benefiċċju/ riskju ta ’ din l- indikazzjoni ma setax jiġi stabbilit b’ mod adegwat.
This indication is primarily based on the results of the clinical trials ELITE I and II.
Din l- indikazzjoni hija primarjament ibbażata fuq ir- riżultati tal- provi kliniċi ELITE I u II.
The CHMP considered that the data from these trials may not be sufficient to demonstrate the claimed benefit.
Is- CHMP ikkunsidra li d- dejta minn dawn il- provi tista ’ ma tkunx biżżejjed biex turi l - benefiċċju kklejmjat.
Whilst the ELITE I indicated an reduction in risk of mortality due to heart failure in patients taking losartan, as compared to captopril, the ELITE II study was not powered to establish equal efficacy between losartan and captopril.
Waqt li ELITE I indika tnaqqis fir- riskju ta ’ mortalità dovuta għal falliment tal - qalb f’ pazjenti li jkunu qegħdin jieħdu losartan, meta mqabbel ma ’ captopril, l- istudju ELITE II ma kienx imfassal biex jistabbilixxi effikaċja indaqs bejn losartan u captopril.
Furthermore, the study provided no information on the effect that higher doses of losartan (greater than 50mg) could have on improving efficacy.
Barra minn hekk, l- istudju ma pprovda l- ebda tagħrif fuq l- effett li jista ’ jkollhom dożi iktar għoljin ta ’ losartan (ikbar minn 50mg) fuq it- titjib fl- effikaċja.
Importantly, an ongoing study (HEAAL) comparing 50mg with 150mg losartan in patients with heart failure, may give relevant information on the dosing issue and address other open issues such as the negative results observed in patients on beta-blockers and losartan.
Importanti huwa l- fatt li studju li qiegħed isir bħalissa (HEAAL) li jqabbel 50mg ma ’ 150mg losartan f’ pazjenti b’ falliment tal- qalb, jista ’ jagħti tagħrif relevanti fuq il - kwistjoni tad- dożaġġ u jindirizza kwistjonijiet miftuħin oħrajn bħalma huma riżultati negattivi osservati f’ pazjenti fuq imblokkaturi- beta u losartan.
After a majority voting at the CHMP plenum, the CHMP recommended that the following wording be proposed to reflect the data from the ELITE I and II studies, within a second-line indication: “ Treatment of chronic heart failure (in patients aged 60 or over), when treatment with ACE inhibitors is not considered suitable due to incompatibility or contraindications.
Wara vot ta ’ maġġoranza fil- plenum tas- CHMP, is- CHMP irrakkomanda li tkun proposta l - formolazzjoni li ġejja biex tirrifletti d- dejta mill- istudji ELITE I u II, fi ħdan indikazzjoni tat- tieni għażla: “ Kura ta ’ indeboliment kroniku tal- qalb (f’ pazjenti ta ’ età ta ’ 60 sena jew aktar), meta kura b’ impedituri ACE ma tkunx ikkunsidrata addattata minħabba inkompatibilità jew kontraindikazzjoniet.
Patients with heart failure who have been stabilised with an ACE inihibitor should not be switched to losartan.
Pazjenti b’ indeboliment tal- qalb li ġew stabbilizzati b’ impeditur ACE m’ għandhomx jinqalbu għal losartan.
The patients should have a left ventricular ejection fraction equal to or greater than 40% and should be stabilised under the treatment of the chronic heart failure.
Il- pazjenti għandu jkollhom frazzjoni ta ’ tfigħ il- barra ventrikolari xellugija daqs jew ikbar minn 40% u għandhom ikunu stabbilizzati bil- kura ta ’ indeboliment kroniku tal- qalb.
The combination of losartan with a beta-blocker should be used with caution”.
Il- kombinazzjoni ta ’ losartan ma ’ imblokkatur- beta għandha tintuża b’ kawtela ”.
Contra-indications (SPC section 4.3) The CHMP considered that the following contra-indications needed to be included in the SPC for Cozaar in all MSs:
Kontraindikazzjonijiet (SPC sezzjoni 4. 3) Is- CHMP ikkunsidra li l- kontra- indikazzjonijiet li ġejjin ħtieġu li jiġu inklużi fl- SPC għal Cozaar fl- MSs kollha:
Pregnancy and lactation; Severely reduced liver function; Angina pectoris; Myocardial infraction; Cerebrovascular disease; Renal artery stenosis; Kidney transplant patients.
Tqala u treddigħ; Funzjoni tal- fwied imnaqqsa severament; Anġina pektoris, Infart majokardjali; Mard ċerebrovaskulari; Stenożi ta ’ l- arterja renali; Pazjenti bi trapjant tal- kliewi.
Special warnings and precautions for use (SPC section 4.4) The CHMP considered that the following warnings needed to be included in the SPC for Cozaar in all MSs:
Twissijiet speċjali u prekawzjonijiet għal użu (SPC sezzjoni 4. 4) Is- CHMP ikkunsidra li t- twissijiet li ġejjin ħtieġu li jkunu inklużi fl- SPC għal Cozaar fl- MSs kollha:
Hypersensitivity; Angioedema; Surgery; Anaesthesia; Haemodialysis; Kidney transplant; Black patients; Obstructive valvular disease.
Ipersensittività; Anġjoedima; Kirurġija; Anestesija; Emodijaliżi; Trapjant tal- kliewi; Pazjenti suwed; Mard valvulari ostruttiv.
Pregnancy and Lactation The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) needed to be amended to include the outcome of the PhVWP report on ACE Inhibitors and angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/ CHMP/ PhVWP/ 474692/ 2007).
Tqala u Treddigħ Is- CHMP qies li t- test li jikkonċerna t- tqala u t- treddigħ fl- SPC (sezzjonijiet 4. 3, 4. 4 u 4. 6) kien jeħtieġ li jiġi emendat biex jinkludi l- effett tar- rapport PhVWP fuq Impedituri ACE u fuq antagonisti tar - riċetturi angiotensin II (AIIRAs) u rakkomandazzjonijiet fuq l- użu waqt l- ewwel trimestru tat- tqala (EMEA/ CHMP/ PhVWP/ 474692/ 2007).
Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
It- Tqala u Treddigħ għandhom ikunu kontraindikati u l -
Use of losartan in children and adolescents
15 formolazzjoni addattata għandha tiġi inkluża fis- sezzjonijiet 4. 3, 4. 4 u 4. 6 ta ’ l- SPC, u fis- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif.
19 Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
Użu ta ’ losartan fit- tfal u adolexxenti Abbażi tad- dejta sottomessa waqt il- proċedura ta ’ Referenza ta ’ l- Artikolu 30 u r- riżultat tal - valutazzjoni ta ’ proġett ta ’ qsim tax- xogħol ta ’ l- UE ta ’ dawn id- dejta pedjatriċi, is- CHMP qies li l - konklużjonijiet tal- Proġett ta ’ Qsim tax- Xogħol Pedjatriku Ewropew fuq losartan ħtieġ li jkun inkorporat fis- sezzjonijiet 4. 2, 4. 4, 4. 8, 5. 1 u 5. 2 tas- Sommarju tal- Karatteristiċi tal- Prodott u s - sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif.
The following wording has been added to SPC section 4.2 Posology and Method of Administration:
Il- formolazzjoni li ġejja ġiet miżjuda f’ sezzjoni 4. 2 tal- SPC, Pożoloġija u Metodu ta ’ kif għandu jingħata:
Paediatric hypertension There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1:
Pressjoni għolja pedjatrika Hemm tagħrif limitat fuq l- effikaċja u s- sigurtà ta ’ losartan fi tfal u adolexxenti ta ’ età ta ’ bejn is- 6 snin u s- 16- il sena għall- kura ta ’ pressjoni għolja (ara 5. 1:
Pharmacodynamic properties).
Tagħrif farmakodinamiku).
Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2:
Tagħrif limitat huwa disponibbli fi tfal bi pressjoni għolja ta ’ aktar minn xahar (ara 5. 2:
Pharmacokinetic properties).
Tagħrif farmakokinetiku).
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg.
Għal pazjenti li jistgħu jibilgħu pilloli, id- doża rrakkomandata hija 25 mg darba kuljum f’ pazjenti > 20 sa < 50 kg.
In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
F’ każijiet eċċezzjonali d- doża tista ’ tiżdied għal massimu ta ’ 50 mg darba kuljum.
Dosage should be adjusted according to blood pressure response.
Id - dożaġġ għandu jkun aġġustat skond ir- reazzjoni tal- pressjoni tad- demm.
In patients > 50 kg, the usual dose is 50 mg once daily.
F’ pazjenti > 50 kg, id- doża normali ta ’ kuljum hija 50 mg darba kuljum.
In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
F’ każijiet eċċezzjonali d- doża tista ’ tiġi aġġustata sa massimu ta ’ 100 mg darba kuljum.
Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in paediatric patients.
Dożi ta ’ aktar minn 1. 4 mg/ kg (jew f’ eċċess ta ’ 100 mg) kuljum ma ġewx studjati f’ pazjenti pedjatriċi.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
Losartan mhuwiex irrakkomandat għal użu fi tfal taħt l- età ta ’ 6 snin, minħabba li hemm tagħrif limitat f’ dawn il- gruppi ta ’ pazjenti
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Mhuwiex irrakkomandat fi tfal b’ rata ta ’ filtrazzjoni glomerulari < 30 ml / min / 1. 73 m2, minħabba li ma hemm l- ebda tagħrif disponibbli (ara wkoll sezzjoni 4. 4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Losartan mhuwiex irrakkomandat fi tfal b’ indeboliment tal- fwied (ara wkoll sezzjoni 4. 4).
The following wording has been added to SPC Section 4.4 Special warnings and precautions for use:
Il- formolazzjoni li ġejja ġiet miżjuda ma ’ Sezzjoni 4. 4 tal- SPC Twissijiet speċjali u prekawzjonijiet għall- użu:
Hypotension and Electrolyte/ Fluid Imbalance Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/ or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni Baxxa u Żbilanċ Elettroliti/ Fluwidu Pressjoni baxxa sintomatika, speċjalment wara l- ewwel doża u wara li tiżdied id- doża, tista ’ sseħħ f’ pazjenti li huma nieqsin mill- volum u/ jew mis- sodju b’ terapija dijuretika qawwija, restrizzjoni ta ’ melħ fid- dieta, dijarea jew remettar.
This also applies to children.
Dawn il- kundizzjonijiet għandhom ikunu kkoreġuti qabel l- għoti ta ’ < COZAAR >, jew għandha tintuża doża tal- bidu iktar baxxa (ara sezzjoni 4. 2).
Liver Function Impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
Dan japplika ukoll għat- tfal Indeboliment tal- Funzjoni tal- Fwied Abbażi ta ’ tagħrif farmakokinetiku, li juri żieda sinifikattiva fil- konċentrazzjonijiet ta ’ losartan fil - plażma f’ pazjenti ċirrotiċi, għandha tkun ikkunsidrata doża iktar baxxa għal pazjenti bi storja ta ’ indeboliment tal- fwied.
There is no therapeutic experience with losartan in patients with severe hepatic impairment.
Ma hemm l- ebda esperjenza terapewtika b’ losartan f’ pazjenti b’ indeboliment sever tal- fwied.
Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3and 5.2).
Għaldaqstant, losartan m’ għandux jingħata f’ pazjenti b’ indeboliment sever tal- fwied (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Losartan mhuwiex irrakkomandat fi tfal b’ indeboliment tal- fwied (ara sezzjoni 4. 2).
Renal Function Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Indeboliment tal- Funzjoni tal- Kliewi Bħala konsegwenza ta ’ l- impediment tas- sistema renin- angiotensin, ġie rrapportat tibdil fil- funzjoni tal- kliewi, inkluż indeboliment tal- kliewi (b’ mod partikolari, f’ pazjenti li l- funzjoni tal- kliewi tagħhom hija dipendenti fuq is- sistema renin angiotensin aldosterone bħal dawk b’ indeboliment kardijaku sever
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon 20 discontinuation of therapy.
Bħal b’ mediċini oħrajn li jaffettwaw is- sistema renin - angiotensin- aldosterone, żidiet fil- ureja fid- demm u kreatinin fis- serum ġew irrapportati wkoll f’ pazjenti bi stenożi bilaterali ta ’ l- arterja renali jew bi stenożi ta ’ l- arterja għal kilwa solitarja.
Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Minħabba li ma hemm l- ebda tagħrif disponibbli, losartan mhuwiex irrakkomandat fi tfal b’ rata ta ’ filtrazzjoni glomerulari < 30ml / min / 1. 73 m2 (ara sezzjoni 4. 2).
Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Il- funzjoni tal- kliewi għandha tkun sorveljata regolarment waqt kura b’ losartan minħabba li din tista ’ tiddeterjora.
This applies particularly when losartan is given in the presence of other conditions (fever, dehydratation) likely to impair renal function.
Dan japplika partikolarment meta losartan jingħata fil- preżenza ta ’ kundizzjonijiet oħrajn (deni, deidratazzjoni) li x’ aktarx jimpedixxu l- funzjoni tal- kliewi.
Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.
Użu konkomitanti ta ’ losartan u impedituri- ACE wera li jimpedixxi l- funzjoni tal- kliewi.
Therefore, concomitant use is not recommended.
Għaldaqstant, użu konkomitanti mhuwiex irrakkomandat.
The following wording has been added to SPC Section 4.8 Undesirable effects:
Il- formolazzjoni li ġejja ġiet miżjuda ma ’ sezzjoni 4. 8 tal- SPC Effetti mhux mixtieqa:
The adverse experience profile for paediatric patients appears to be similar to that seen in adult patients.
Il- profil ta ’ esperjenza avversa għal pazjenti pedjatriċi jidher li huwa simili għal dak li jidher f’ pazjenti adulti.
Data in the paediatric population are limited.
It- tagħrif fil- popolazzjoni pedjatrika huwa limitat.
The following wording has been added to SPC Section 5.1. Pharmacodynamic Properties:
Il- formolazzjoni li ġejja ġiet miżjuda ma ’ sezzjoni 5. 1. tal- SPC Tagħrif farmakodinamiku:
Paediatric Hypertension The antihypertensive effect of Cozaar was established in a clinical study involving 177 hypertensive paediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Pressjoni Għolja Pedjatrika L- effett kontra l- pressjoni għolja ta ’ Cozaar kien stabbilit fi studju kliniku li involva 177 pazjent pedjatriku bi pressjoni għolja ta ’ bejn 6 snin u 16- il sena b’ piż korporju > 20 kg u b’ rata ta ’ filtrazzjoni glomerulari > 30 ml / min / 1. 73 m2.
Patients who weighted > 20kg to< 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily.
Pazjenti li kienu jiżnu > 20kg sa < 50 kg irċievew jew 2. 5, 25 jew 50 mg ta ’ losartan kuljum u pazjenti li kienu jiżnu > 50 kg irċievew jew 5, 50 jew 100 mg ta ’ losartan kuljum.
At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dose- dependent manner.
Fi tmiem it- tliet ġimgħat, l- għoti ta ’ losartan darba kuljum niżżel il- pressjoni tad - demm ta ’ l- iktar parti baxxa b’ mod dipendenti fuq id- doża.
Overall, there was a dose-response.
B’ mod ġenerali, kien hemm reazzjoni dipendenti fuq id- doża.
The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg).
Ir- relazzjoni doża- reazzjoni saret ovvja ħafna fil- grupp ta ’ doża baxxa meta mqabbel mal- grupp tad- doża tan- nofs (perijodu I: - 6. 2 mmHg vs. - 11. 65 mmHg), iżda kienet imnaqqsa meta l- grupp ta ’ doża tan- nofs tqabbel mal- grupp ta ’ doża għolja (perijodu I: - 11. 65 mmHg vs. - 12. 21 mmHg).
The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/ kg, did not appear to offer consistent antihypertensive efficacy.
Id- dożi l- iktar baxxi studjati, 2. 5 mg u 5 mg, li jikkorrespondu għal doża medja ta ’ kuljum ta ’ 0. 07 mg / kg, ma dehrux li joffru effikaċja konsistenti kontra l- pressjoni għolja.
These results were confirmed during period II of the study where patients were randomized to continue losartan or placebo, after three weeks of treatment.
Dawn ir- riżultati kienu kkonfermati waqt perijodu II ta ’ l- istudju fejn pazjenti kienu rrandomizzati biex ikomplu losartan jew plaċebo, wara tliet ġimgħat ta ’ kura.
The difference in blood pressure increase as compared to placebo was largest in the middle dose group (6.70 mm Hg middle dose vs.
Id- differenza fiż- żieda fil- pressjoni tad- demm kif imqabbla ma ’ plaċebo kienet l- ikbar fil- grupp tan- nofs (6. 70 mm Hg doża tan- nofs vs.
5.38 mmHg high dose).
5. 38 mmHg doża għolja).
The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.
Iż- żieda fil- pressjoni tad- demm dijastolika ta ’ l- iktar parti baxxa kienet l - istess f’ pazjenti li kienu qegħdin jirċievu plaċebo u f’ dawk li kienu qegħdin ikomplu losartan fl- inqas doża f’ kull grupp, u dan jerġa ’ jissuġġerixxi li l- iktar doża baxxa f’ kull grupp ma kellhiex effett sinjifikanti kontra l- pressjoni għolja.
Long-term effects of losartan on growth, puberty and general development have not been studied.
Effetti fit- tul ta ’ losartan fuq it- tkabbir, il- pubertà u l- iżvilupp ġenerali ma ġewx studjati.
The long-term efficacy of antihypertensive therapy with losartan in childhood to reduce cardiovascular morbidity and mortality has also not been established.
L- effikaċja fit- tul ta ’ terapija kontra l- pressjoni għolja b’ losartan fit- tfulija sabiex tnaqqas il- morbidità u l - mortalità kardjovaskulari ma ġietx stabbilita.
The following wording has been added to SPC Section 5.2 Pharmacokinetic properties:
Il- formolazzjoni li ġejja ġiet miżjuda ma ’ sezzjoni 5. 2 tal- SPC Tagħrif Farmakokinetiku:
Pharmacokinetics in paediatric patients The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients > 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).
Farmakokinetiċi f’ pazjenti pedjatriċi Il- farmakokinetiċi ta ’ losartan ġew investigati f’ 50 pazjent pedjatriku bi pressjoni għolja > xahar sa < 16- il sena ta ’ età wara għoti orali ta ’ darba kuljum ta ’ madwar 0. 54 sa 0. 77 mg / kg ta ’ losartan (dożi medji).
The results showed that the active metabolite is formed from losartan in all age groups.
Ir- riżultati wrew li l- metabolit attiv huwa ffurmat minn losartan fil- gruppi ta ’ l- età kollha.
The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
Ir- riżultati wrew parametri farmakokinetiċi bejn wieħed u ieħor simili ta ’ losartan wara għoti orali fit- trabi u fi tfal żgħar li jkunu għadhom kif telqu jimxu, tfal ta ’ qabel l- età ta ’ l- iskola, tfal ta ’ età ta ’ l- iskola u adolexxenti.
The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Il- parametri farmakokinetiċi għall- metabolit varjaw sewwa bejn il- gruppi ta ’ l- età.
When comparing preschool children with adolescents these differences became statistically significant.
Meta t- tfal ta ’ qabel l- età ta ’ l- iskola tqabblu ma ’ adolexxenti, dawn id- differenzi saru statistikament
Exposure in infants/ toddlers was comparatively high.
L- espożizzjoni fi trabi/ tfal żgħar li jkunu għadhom kif telqu jimxu kien komparattivament għoli.
21 The following wording has been added to the Package Leaflet Section 2 Before you take Cozaar:
Il- formolazzjoni li ġejja ġiet miżjuda ma ’ Sezzjoni 2 tal- Fuljett ta ’ Tagħrif, Qabel tieħu Cozaar:
Use in children and adolescents
Użu fi tfal u adolexxenti
< COZAAR > has been studied in children.
< COZAAR > ġie studjat fit- tfal.
For more information, talk to your doctor.
Għal aktar tagħrif, kellem lit- tabib tiegħek..
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, tikketti u
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, tikketti u fuljetti ta ’ tagħrif proposti mid- Detenturi ta ’ l -
indications:
indikazzjonijiet li ġejjin:
Treatment of essential hypertension
Kura ta ’ pressjoni għolja essenzjali
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/ day as part of an antihypertensive treatment
Kura ta ’ mard tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete mellitus tip 2 bi proteinurja > 0. 5 g/ kuljum bħala parti mill- kura kontra l- pressjoni għolja
Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (See section 5.1 Life Study, Race)
Tnaqqis fir- riskju ta ’ attakk ta ’ puplesija f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari xellugija ddokumentata mill- ECG (Ara Sezzjoni 5. 1 Studju Life, Razza)
Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Kura ta ’ falliment kroniku tal- qalb (f’ pazjenti ≥ 60 sena), meta kura b’ impedituri ACE mhijiex ikkunsidrata addattata minħabba inkompatibilità, speċjalment sogħla, jew kontraindikazzjoni.
Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Pazjenti b’ indeboliment tal- qalb li ġew stabbilizzati b’ impeditur ACE m’ għandhomx jinqalbu għal fuq losartan.
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure
Il- pazjenti għandu jkollhom frazzjoni ta ’ tfigħ ’ l barra ventrikolari xellugija ≤ 40% u għandhom ikunu stabbilizzati taħt il- kura ta ’ indeboliment kroniku tal- qalb.
- The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of
- L- użu ta ’ losartan f’ pazjenti pedjatriċi għandu jkun inkluż f’ sezzjonijiet 4. 2, 4. 4, 4. 8, 5. 1 u 5. 2 tal -
the SPC, and the relevant sections of the Package Leaflet.
SPC, u fis- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif.
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar and associated names (see Annex I).
Is- CHMP irrakkomanda l- emenda ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq, li s- Sommarju tal - Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif għalihom huma stabbiliti fl- Anness III għal Cozaar u ismijet assoċjati (ara l- Anness I).
22 ANNEX III
18 ANNESS III
23 SUMMARY OF PRODUCT CHARACTERISTICS
19 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Cozaar and associated names (see Annex I) 12.5 mg film-coated tablets Cozaar and associated names (see Annex I) 25 mg film-coated tablets Cozaar and associated names (see Annex I) 50 mg film-coated tablets Cozaar and associated names (see Annex I) 100 mg film-coated tablets
Cozaar u ismijiet assoċjati (ara Anness I) 12. 5 mg pilloli miksija b’ rita Cozaar u ismijiet assoċjati (ara Anness I) 25 mg pilloli miksija b’ rita Cozaar u ismijiet assoċjati (ara Anness I) 50 mg pilloli miksija b’ rita Cozaar u ismijiet assoċjati (ara Anness I) 100 mg pilloli miksija b’ rita
Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Kull Pillola ta ’ 12. 5 mg Cozaar fiha 12. 5 mg ta ’ losartan (bħala mluħa tal- potassju).
Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Kull Pillola ta ’ 25 mg Cozaar fiha 25 mg ta ’ losartan (bħala mluħa tal- potassju).
Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Kull Pillola ta ’ 50 mg Cozaar fiha 50 mg ta ’ losartan (bħala mluħa tal- potassju).
Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Kull Pillola ta ’ 100 mg Cozaar fiha 100 mg ta ’ losartan (bħala mluħa tal- potassju).
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Kull pillola ta ’ Cozaar 12. 5 mg fiha 25. 5 mg lactose monohydrate.
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Kull pillola ta ’ Cozaar 25 mg fiha 12. 75 mg lactose monohydrate.
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Kull pillola ta ’ Cozaar 50 mg fiha 25. 5 mg lactose monohydrate.
Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Kull pillola ta ’ Cozaar 100 mg fiha 51. 0 mg lactose monohydrate.
Film-coated tablets
Pilloli miksija b’ rita.
Cozaar 12,5 mg tablet Blue, oval film-coated tablets marked 11 on one side and plain on the other.
Cozaar pillola ta ’ 12. 5 mg Pilloli ta ’ lewn blu f’ għamla ovali, miksijin b’ rita u mmarkati b’ 11 fuq naħa waħda u mingħajr marka fuq in- naħa l- oħra.
Cozaar 25 mg tablet White, oval unscored film-coated tablets marked 951 on one side and plain on the other..
Cozaar pillola ta ’ 25 mg Pilloli bojod f’ għamla ovali, mhux imnaqqxa u miksijin b’ rita, immarkati b’ 951 fuq naħa waħda u mingħajr marka fuq in- naħa l- oħra.
Cozaar 50 mg tablet White, oval film-coated tablets marked 952 on one side and scored on the other .< The tablet can be divided into equal halves .>
Cozaar pillola ta ’ 50 mg Pilloli bojod f’ għamla ovali, miksijin b’ rita, immarkati b’ 952 fuq naħa u mnaqqxa fuq in- naħa l- oħra. < Il- pillola tista ’ tinqasam f’ nofsijiet ugwali. >
Cozaar 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Cozaar pillola ta ’ 100 mg Pilloli bojod f’ għamla ta ’ demgħa, miksijin b’ rita, immarkati b’ 952 fuq naħa u mingħajr marka fuq in- naħa l- oħra.
• Treatment of essential hypertension. • Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/ day as part of an antihypertensive treatment.
• Trattament ta ’ pressjoni essenzjali għolja. • Trattament għall- mard tal- kliewi f’ pazjenti li għandhom pressjoni għolja b’ dijabete melittus ta ’ tip 2 bi protejnurja ≥ 0. 5 g/ kuljum bħala parti minn trattament kontra l- pressjoni.
25 • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
21 • Trattament ta ’ insuffiċjenza kronika tal- qalb (f’ pazjenti ≥ 60 sena), meta t- trattament b’ impedituri ACE mhux ikkonsidrat xieraq minħabba inkompatibilità, speċjalment sogħla, jew kontra- indikazzjonijiet.
Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Pazjenti b’ insuffiċjenza kardijaka li ġew stabilizzati b’ impeditur ACE m’ għandhomx jinqalbu fuq losartan.
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure. • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Studju LIFE, Razza).
Losartan tablets should be swallowed with a glass of water.
Il- pilloli Losartan jistgħu jinbelgħu ma ’ tazza ilma.
Cozaar may be administered with or without food.
Cozaar jista ’ jiġi amministrat ma ’ l- ikel jew fuq stonku vojt.
Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients.
Pressjoni għolja Id- doża li wieħed jibda biha u d- doża ta ’ manteniment hija ta ’ 50 mg darba kuljum għal maġġoranza tal- pazjenti.
The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
L- effett massimu kontra l- pressjoni għolja jintlaħaq fi żmien 3- 6 ġimgħat minn wara li tinbeda t- terapija.
Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning).
Xi pazjenti għandhom mnejn jirċievu benefiċċju addizzjonali meta d- doża tiżdied għal 100 mg darba kuljum.
Cozaar may be administered with other antihypertensive agents, especially with diuretics (e. g. hydrochlorothiazide).
Cozaar jista ’ jiġi mogħti ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja, speċjalment mad- dijuretiċi (eż. hydrochlorothiazide).
Pediatric hypertension There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1:
Pressjoni għolja fi tfal Hemm biss tagħrif ristrett dwar l- effikaċja u s- sigurtà ta ’ losartan fi tfal u adoloxxenti ta ’ bejn l- etajiet ta ’ 6 snin u 16- il sena għat- trattament ta ’ pressjoni għolja (ara sezzjoni 5. 1:
Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2:
Tagħrif farmakokinetiku limitat huwa disponibbli għal tfal bi pressjoni għolja li għandhom aktar minn xahar (ara sezzjoni 5. 2:
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg.
Għal pazjenti li jistgħu jibilgħu l- pilloli, id- doża rakkomandata hi ta ’ 25 mg darba kuljum f’ pazjenti b’ piż ta ’ > 20 sa < 50 kg.
In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
F’ każijiet eċċezzjonali id- doża tista ’ tiżdid għal 50 mg darba kuljum.
Dosage should be adjusted according to blood pressure response.
Id- doża għandha tiġi aġġustata skond ir- rispons tal- pressjoni tad- demm.
In patients > 50 kg, the usual dose is 50 mg once daily.
F’ pazjenti li jiżnu > 50 kg id- doża li ġeneralment tingħata hi ta ’ 50 mg kuljum.
In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
F’ każijiet eċċezzjonali id- doża tista tiġi aġġustata għal massimu ta ’ 100 mg kuljum.
Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Dożi ta ’ aktar minn 1. 4 mg/ kg (jew b’ aktar minn 100 mg) kuljum ma ġewx studjati f’ pazjenti tfal.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
Losartan mhux rakkomandat għal użu fi tfal li għandhom anqas minn 6 snin, peress li tagħrif limitat hu disponibbli f’ dawn il- gruppi ta ’ pazjenti.
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Mhux rakkomandat fi tfal b’ rata ta ’ filtrazzjoni glomerulari < 30 ml / min / 1. 73 m2, peress li l- ebda tagħrif mhu disponibbli (ara wkoll sezzjoni 4. 4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Losartan huwa wkoll mhux rakkomandat fi tfal b’ indeboliment epatiku (ara wkoll sezzjoni 4. 4).
Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/ day The usual starting dose is 50 mg once daily.
Pazjenti dijabetiċi ta tip II bi protejnurja u bil- pressjoni għolja Id- doża li wieħed ġeneralment jibda biha hija ta ’ 50 mg darba kuljum.
The dose may be increased to 100 mg once daily based on blood pressure response from one month after initiation of therapy onwards.
Id- doża tista ’ tiġi miżjuda għal 100 mg darba kuljum skond ir- rispons għal pressjoni tad- demm wara xahar mill- bidu tat- terapija ’ l quddiem.
Cozaar may be administered with other antihypertensive agents (e. g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e. g. sulfonylureas, glitazones and glucosidase inhibitors).
Cozaar jista ’ jiġi mogħti ma ’ mediċini ta ’ kontra l- pressjoni għolja oħrajn (eż., dijuretiċi, impedituri tal- kanali tal- kalċju, impedituri alfa - jew beta - u mediċini li jaġixxu b’ mod ċentrali) kif ukoll ma ’ l- insulina u mediċini ipogliċemiċi komuni oħra (eż. sulfonylureas, glitazones u impedituri ta ’ glucosidase).
Heart Failure The usual initial dose of Cozaar in patients with heart failure is 12.5 mg once daily.
Insuffiċjenza tal- Qalb Id- doża inizjali ta ’ Cozaar li ġeneralment tingħata f’ pazjenti li għandhom insuffiċjenza kardijaka hi ta ’ 12. 5 mg darba kuljum.
The dose should generally be titrated at weekly intervals (i. e.
Id- doża għandha ġeneralment tiġi titrata f’ intervalli kull ġimgħa (i. e.
12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
12. 5 mg kuljum, 25 mg kuljum, 50 mg kuljum) għal doża ta ’ manteniment ġenerali ta ’ 50 mg darba kuljum, kif ittolerata mill- pazjent.
26 Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG The usual starting dose is 50 mg of Cozaar once daily.
22 Tnaqqis fir- riskju ta ’ puplesija f’ pazjenti bi pressjoni għolja li għandhom ipertropija fil- ventrikula tax- xellug iddokumentata b’ ECG Id- doża inizjali ta ’ Cozaar li ġeneralment tingħata hi ta ’ 50 mg darba kuljum.
A low dose of hydrochlorothiazide should be added and/ or the dose of Cozaar should be increased to 100 mg once daily based on blood pressure response.
Doża baxxa ta ’ hydrochlorothiazide għandha tiġi magħduda u/ jew id- doża ta ’ Cozaar għandha tiġi miżjuda għal 100 mg darba kuljum skond ir- rispons għal pressjoni tad- demm.
Use in patients with intravascular volume depletion:
L- użu f’ pazjenti bi zvojtjar tal- volum intravaskulari:
For patients with intravascular volume-depletion (e. g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).
Għal pazjenti b’ volum intravaskulari mnaqqas (eż. dawk ikkurati b’ doża għolja ta ’ dijuretiċi), doża inizjali ta ’ 25 mg darba kuljum għandha tiġi kkonsidrata (ara sezzjoni 4. 4).
Use in patients with renal impairment and haemodialysis patients:
L- użu f’ pazjenti b’ indeboliment renali u emodijaliżi:
No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
L- ebda aġġustament fid- doża inizjali ma hu meħtieġ f’ pazjenti li għandhom indeboliment renali u emodijaliżi.
Use in patients with hepatic impairment:
L- użu f’ pazjenti f’ indeboliment epatiku:
A lower dose should be considered for patients with a history of hepatic impairment.
Doża mnaqqsa għandha tiġi kkonsidrata għal pazjenti li għandhom storja ta ’ indeboliment epatiku.
There is no therapeutic experience in patients with severe hepatic impairment.
M’ hemmx esperjenza epatika f’ pazjenti b’ indeboliment epatiku sever.
Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Għalhekk, losartan huwa kontra- indikat f’ pazjenti b’ indeboliment epatiku sever (ara sezzjonijiet 4. 3 u 4. 4)
Use in Elderly Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
L- użu fl- anzjani Għalkemm konsiderazzjoni għandha tingħata sabiex it- terapija tibda tingħata bil- pilloli ta ’ 25 mg f’ pazjenti li għandhom aktar minn 75 sena, l- aġġustament fid- doża mhuwiex ġeneralment meħtieġ fl - anzjani
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1).
Sensittività eċċessiva għas- sustanza( i) attiva( i) jew għal xi sustanzi mhux attivi (ara sezzjonijiet 4. 4 u 6. 1).
2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6) Severe hepatic impairment
It- tieni u t- tielet trimestru ta ’ tqala (ara sezzjonijiet 4. 4 u 4. 6) Treddigħ Indeboliment epatiku sever
Hypersensitivity Angiooedema.
Sensittività eccessiva Anġjodema.
Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Pazjenti bi storja ta ’ anġjodema (nefħa fil- wiċċ, ix- xofftejn, il- griżmejn, u / jew l- ilsien) għandhom jiġu monitorati mill- qrib (ara sezzjoni 4. 8).
Hypotension and Electrolyte/ Fluid Imbalance Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/ or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni Baxxa u Żbilanċ ta ’ l- Elettrolitiċi/ Fluwidu Pressjoni sintomatika baxxa, speċjalment wara l- ewwel doża u wara żieda fid- doża x’ aktarx isseħħ f’ pazjenti li għandhom volum u/ jew sodju żvojtat minħabba terapija dijuretika vigoruża, mluħa dijetetiċi restritti, dijarea jew remettar).
These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see section 4.2).
Dawn il- kundizzjonijiet għandhom jiġu kkoreġuti qabel l- għoti ta ’ Cozaar, jew doża iniżjali aktar baxxa għandha tintuża (ara sezzjoni 4. 2).
This also applies to children.
Dan japplika wkoll għat- tfal
In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations’ and ‘ Post-marketing experience - Investigations’ Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/ min should be closely monitored.
Għalhekk, il- valuri tal- konċentrazzjonijiet ta ’ potassju u tat- tneħħija ta ’ kreatinina fil- plażma għandhom jiġu sorvelljati mill- qrib speċjalment f’ pazjenti b’ insuffiċjenza kardijaka u bi tneħħija ta ’ kreatinina ta ’ bejn 30- 50 ml/ min.
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
L- użu konġunt ta ’ dijuretiċi li ma jinkoraġixxux it- teħid ta ’ potassju, supplimenti ta ’ potassju u sostituti mluħa li fihom il- potassju ma ’ losartan mhumiex rakkomandati (ara sezzjoni 4. 5).
27 Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
23 Indeboliment fil- Funzjoni tal- Fwied Minn tagħrif farmakokinetiku li juri konċentrazzjonijiet sinifikament ogħla ta ’ losartan fil- plażma f’ pazjenti b’ ċirrosi, doża aktar baxxa għandha tiġi kkonsidrata għal pazjenti li għandhom indeboliment epatiku.
Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Għalhekk losartan m’ għandux jingħata lil pazjenti b’ indeboliment epatiku sever (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Losartan ukoll mhux rakkomandat fi tfal b’ indeboliment epatiku (ara sezzjoni 4. 2).
Renal Function Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Indeboliment tal- Funzjoni tal- Kliewi Bħala konsegwenza ta ’ l- impediment tas- sistema renin- angiotensin, bidliet fil- funzjoni renali li jinkludi insuffiċjenza renali ġew irrapportati (b’ mod partikolari f’ pazjenti li l- funzjoni renali tagħhom tiddependi fuq is- sistema ta ’ renin angiotensin aldosterone bħal dawk li għandhom insuffiċjenza kardijaka severa jew disturbi fil- funzjonament renali li kienu jeżistu minn qabel).
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Bħal fil- każ ta ’ mediċini oħra li jaffettwaw is- sistema renin- angiotensin- aldosterone, żidied fl- urea fid- demm u fil- kreatinina fis- serum ġew irrapportati wkoll f’ pazjenti bi stenosi bilaterali ta ’ l- arterja renali jew stenosi ta ’ l- arterja għal kilwa waħda, b’ dawn il- bidliet fil- funzjoni renali jistgħu jkunu riversibbli meta titwaqqaf it- terapija.
Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Losartan għandu jintuża b’ kawtela f’ pazjenti bi stenosi bilaterali ta ’ l- arterja renali jew stenosi ta ’ l- arterja b’ kilwa solitarja.
Use in pediatric patients with renal function impairment Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
L- użu f’ pazjenti tfal b’ indeboliment fil- funzjoni renali Losartan mhux rakkomandat fi tfal li r- rata ta ’ filtrazzjoni glomerulari hi ta ’ < 30 ml/ min/ 1. 73 m2 peress li l- ebda tagħrif mhu disponibbli.
Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Il- funzjoni renali għandha tiġi monitorata regolarment waqt t- trattament b’ losartan peress li tista ’ tisfaxxa.