qanastek/EMEA-V3 huggingface dataset:
Netherlands Netherlands Poland Portugal Portugal Portugal Portugal Portugal Portugal Portugal Portugal Romania Slovenia Slovenia Slovenia Spain Spain
L- Olanda L- Olanda Il- Polonja Il- Portugall Il- Portugall Il- Portugall Il- Portugall Il- Portugall Il- Portugall Il- Portugall Il- Portugall Ir- Rumanija Is- Slovenja Is- Slovenja Is- Slovenja Spanja Spanja Spanja L- Iżvezja L- Iżvezja L- Iżvezja
Cozaar 50 Cozaar 100 COZAAR COZAAR COZAAR 100 mg COZAAR IC COZAAR IC – Titulação LORTAAN IC LORTAAN IC- Titulação LORTAAN LORTAAN 100mg COZAAR, comprimate filmate, 50 mg Cozaar 12,5 mg filmsko oblož ene tablete Cozaar 50 mg filmsko oblož ene tablete Cozaar 100 mg filmsko oblož ene tablete Cozaar 12,5 mg Inicio Cozaar 50 mg
Cozaar 50 Cozaar 100 COZAAR COZAAR COZAAR 100 mg COZAAR IC COZAAR IC – Titulação LORTAAN IC LORTAAN IC - Titulação LORTAAN LORTAAN 100mg COZAAR, comprimate filmate, 50 mg Cozaar 12, 5 mg filmsko obložene tablete Cozaar 50 mg filmsko obložene tablete Cozaar 100 mg filmsko obložene tablete Cozaar 12, 5 mg Inicio Cozaar 50 mg Cozaar 100 mg Cozaar 12, 5 mg filmdragerade tabletter Cozaar 12, 5 mg + 50 mg filmdragerade tabletter Cozaar 50 mg filmdragerade tabletter 72
United Kingdom United Kingdom United Kingdom Iceland Norway
L- Iżvezja Ir- Renju Unit Ir- Renju Unit Ir- Renju Unit L- Iżlanda In- Norveġja
COZAAR 50 MG FILM-COATED TABLETS COZAAR 25 MG FILM-COATED TABLETS COZAAR 100MG FILM-COATED TABLETS Cozaar Cozaar
Cozaar 100 mg filmdragerade tabletter COZAAR 50 MG FILM- COATED TABLETS COZAAR 25 MG FILM- COATED TABLETS COZAAR 100MG FILM- COATED TABLETS Cozaar Cozaar
last approved in
Dan il- fuljett kien approvat l- aħħar f ’
EMEA/ CHMP/ 494721/ 2008
EMEA/ CHMP/ 494735/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar and associated names
OPINJONI WARA RIFERIMENT SKOND L- ARTIKOLU 30 GĦAL Cozaar u ismijiet assoċjati
International Non-Proprietary Name (INN): losartan
Denominazzjoni Komuni Internazzjonali (DKI): losartan
Cozaar and associated names, 12,5 mg, 25mg, 50 mg, 100 mg, film-coated tablets is an orally active angiotensin II (Ang- II) receptor antagonist, losartan, acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Cozaar u l- ismijiet assoċjati, 12, 5 mg, 25 mg, 50 mg, 100 mg, pilloli miksijin b’ rita huwa antagonista riċettur tat- tip angiotensin II (Ang - II) attiv oralment, losartan, li jaġixxi fuq is- subtip tar- riċettur AT1, b’ hekk jimblokka l- effett ta ’ Ang- II fil- kaskada tas- sistema ta ’ anġjotensin tar- renin (RAS).
Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, and microalbuminuria (> 30 mg/ 24 hours) or proteinuria (> 900 mg/ 24 hours).
Losartan jista ’ jdewwem ukoll in- nefropatija dijabetika u huwa indikat ukoll għat- tnaqqis tal- progressjoni tal- mard renali f’ pazjenti b’ dijabete tip 2, u b’ mikroalbuminurija (> 30 mg/ 24 sigħat) jew bi proteinurija (> 900 mg/ 24 sigħat).
On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar and associated names for the following indications:
Fit- 23 ta ’ Frar 2007, id- Danimarka ippreżentat lill- EMEA riferment skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata, sabiex jiġu armonizzati s- sommarji tal- karatteristiċi tal- prodott, il- fuljett ta ’ tagħrif u t- tikketta awtorizzati fuq livell nazzjonali tal- prodott mediċinali Cozaar u l- ismijiet assoċjati għall- indikazzjonijiet li ġejjin:
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; Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG; 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.
Il- kura ta ’ pressjoni għolja essenzjali; Il- kura ta ’ mard renali f’ pazjenti bi pressjoni għolja u b’ dijabete mellitus ta ’ tip 2 bi proteinurija > 0. 5 g/ kuljum bħala parti minn kura kontra l - pressjoni għolja; It- tnaqqis tar- riskju ta ’ puplesija f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari tax- xellug dokumentata b’ ECG; Il- kura ta ’ kollass kroniku tal- qalb (f’ pazjenti ≥ 60 sena), meta kura b’ inibituri ACE ma tkunx ikkunsidrata xierqa minħabba inkompatibilità, b’ mod speċjali minħabba sogħla, jew kontraindikazzjoni.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Matul il- laqgħa tiegħu tal- 21 – 24 ta ’ April 2008, is- CHMP, fid- dawl tad- dejta ġenerali ippreżentata u tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, Tikketta u Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ April 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, tikketta u fuljett ta ’ tagħrif għal Cozaar u l- ismijiet assoċjati.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/ EEA
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
(Invented) name
Isem (Ivvintat)
oral
orali
4 Member State EU/ EEA
2 Stat Membru EU/ EEA
Box 23490 Nicosia Cyprus
Box 23490 Nicosia Ċipru
5 Member State EU/ EEA
3 Stat Membru EU/ EEA
6 Member State EU/ EEA
4 Stat Membru EU/ EEA
2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France
2 and 4, rue Lionel Terray 92500 RUEIL- MALMAISON Franza
7 Member State EU/ EEA
5 Stat Membru EU/ EEA
8 Member State EU/ EEA
6 Stat Membru EU/ EEA
9 Member State EU/ EEA
7 Stat Membru EU/ EEA
Marketing Authorisation Holder GR-144 51 Athens
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq GR- 144 51 Athens
Hard gelatine capsules
Kapsuli iebsa tal- ġelatina
10 Member State EU/ EEA
8 Stat Membru EU/ EEA
11 Member State EU/ EEA
9 Stat Membru EU/ EEA
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR Ir- Renju Unit
12 Member State EU/ EEA
10 Stat Membru EU/ EEA
Hard capsules
Kapsuli iebsa
13 Member State EU/ EEA
11 Stat Membru EU/ EEA
14 Member State EU/ EEA
12 Stat Membru EU/ EEA
15 Member State EU/ EEA
13 Stat Membru EU/ EEA
16 Member State EU/ EEA
14 Stat Membru EU/ EEA
Slovak Republic
ls- Slovakkja
Prague Czech Republic
Prague Ir- Repubblika Ċeka
17 Member State EU/ EEA
15 Stat Membru EU/ EEA
18 Member State EU/ EEA
16 Stat Membru EU/ EEA
19 Member State EU/ EEA
17 Stat Membru EU/ EEA
20 Member State EU/ EEA
18 Stat Membru EU/ EEA
21 Member State EU/ EEA
19 Stat Membru EU/ EEA
22 ANNEX II
20 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENIFIĊI U RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
23 SCIENTIFIC CONCLUSIONS
21 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DIOVAN AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ DIOVAN U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Diovan contains valsartan, an orally Angiotensin II Receptor Antagonist (AIIRA).
Diovan fih valsartan, Angiotensin II Receptor Antagonist (AIIRA) li jittieħed mill- ħalq.
Diovan was included in the list of products for Summary of Products Characteristics (SPC) harmonization, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended, as the above-mentioned medicinal product does not have the same SPC across all EU Member States, Iceland and Norway.
Diovan ġie inkluż fil- lista ta ’ prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodott (SPC), imfassla mill- CMD( h), skont l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendata, minħabba li l - prodott mediċinali msemmi fuq ma għandux l- istess SPC fl- Istati Membri tal- UE kollha, fl- Iżlanda u fin- Norveġja.
Critical Evaluation A number of areas of disharmony in the product information for Diovan have been evaluated by the CHMP and a revised PI was adopted.
Evalwazzjoni Kritika Numru ta ’ oqsma ta ’ nuqqas ta ’ konformità fil- fuljett ta ’ tagħrif għal Diovan ġew evalwati mill- CHMP u ġie adottat Fuljett ta ’ Tagħrif rivedut.
The main areas for harmonisation were as follows.
L- oqsma ewlenin għall- armonizzazzjoni kienu dawn.
4.1 - Therapeutic Indications
4. 1 – Indikazzjonijiet Terapewtiċi
Regarding the indication in hypertension, the CHMP considered that valsartan is an established therapy for hypertension and there is no substantial discrepancy between the national SPCs.
Dwar l- indikazzjoni fil- pressjoni għolja, il- CHMP qies li valsartan huwa terapija stabbilita għall - pressjoni għolja u ma hemm ebda diskrepanza sostanzjali bejn l- SPCs nazzjonali.
The CHMP was also of the opinion that the 320 milligram dose provides a modest, statistically significant additional reduction in MSDBP and MSSBP compared to 160mg and a similarly modest increase in the rate of blood pressure control.
Il- CHMP kien ukoll tal- opinjoni li doża ta ’ 320 milligramma tipprovdi tnaqqis addizzjonali modest, statistikament sinjifikanti fl- MSDBP u MSSBP meta mqabbla ma ’ 160mg u żieda modesta simili fir- rata tal- kontroll tal- pressjoni tad- demm.
The proposed harmonized text for this section is acceptable by the majority of CHMP members in regard to this indication; therefore the following wording was adopted:
It- test armonizzat propost għal din is- sezzjoni huwa aċċettabbli mill - maġġoranza tal- membri tal- CHMP fir- rigward ta ’ din l- indikazzjoni; għaldaqstant ġiet adottata din il - formolazzjoni:
“ Treatment of essential hypertension”
“ Trattament ta ’ pressjoni għolja essenzjali ”
Regarding the indication in recent myocardial infarction the CHMP noted that this indication was limited to patients intolerants to ACE inhibitors in some Member States.
Fir- rigward tal- indikazzjoni f’ infart mijokardijaku riċenti, il- CHMP innota li din l- indikazzjoni kienet limitata għal pazjenti intolleranti għal inibituri ACE f’ xi Stati Membri.
The CHMP considered the VALIANT study which demonstrated that valsartan given as monotherapy is at least as effective as captopril given as monotherapy in the reduction of total mortality after an acute myocardial infarction.
Il- CHMP ikkunsidra l- istudju VALIANT li wera li valsartan meta mogħti bħala monoterapija huwa għallinqas effettiv daqs captopril meta mogħti bħala monoterapija fit- tnaqqis tal- mortalità totali wara infart mijokardijaku akut.
The results for the pre-specified secondary endpoints support that valsartan is as effective as captopril.
Ir - riżultati għal punti ta ’ tmiem sekondarji speċifikati minn qabel jappoġġjaw il- fatt li valsartan huwa effikaċi daqs captopril.
Considering the non inferiority in clinical outcome of valsartan compared to current standard treatment, an ACEI, the CHMP adopted the following harmonised wording for this indication:
Wara li kkunsidra n- nuqqas ta ’ inferjorità f’ riżultat kliniku ta ’ valsartan meta mqabbel mal- kura standard attwali, ACEI, il- CHMP adotta l- formolazzjoni armonizzata li ġejja għal din l- indikazzjoni:
“ Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction”
“ Kura ta ’ pazjenti klinikament stabbli b’ indeboliment sintomatiku tal- qalb jew b’ disfunzjoni sistolika ventrikolari tax- xellug asintomatika wara infart mijokardijaku riċenti (12- il siegħa – 10 ijiem) ”
The therapeutic indication for heart failure is supported primarily by a large long-term morbidity trial Valsartan Heart Failure Trial (Val-HeFT) Valsartan reduced the risk related to first morbid event, mortality, the total number of Heart Failure (HF) hospitalizations.
Valsartan naqqas ir - riskju relatat mal- ewwel episodju tal- morbidità, il- mortalità, in- numru totalità ta ’ żjarat l- isptar minħabba Indeboliment tal- Qalb (HF).
Valsartan also demonstrated beneficial effects on signs and symptoms of HF.
Valsartan wera wkoll effetti ta ’ benefiċċju fuq sinjali u sintomi ta ’ HF.
This indication was approved in all Member States and the CHMP adopted the following wording:
Din l- indikazzjoni ġiet approvata fl- Istati Membri kollha u l- CHMP adotta l - formolazzjoni li ġejja:
“ Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors could not be used, or as add-on therapy to ACE inhibitors when beta blockers could not be used”
“ Kura ta ’ indeboliment tal- qalb sintomatiku meta inibituri ta ’ Angiotensin Converting Enzyme (ACE) ma setgħux jintużaw, jew bħala terapija addizzjonali għal inibituri ACE meta beta blockers ma setgħux jintużaw ”
4.2 - Posology
4. 2 – Pożoloġija u metodu ta ’ kif għandu jingħata
The first area of disagreement is about the use of triple combination (Valsartan + ACEI+ BB) in chronic HF.
L- ewwel qasam ta ’ nuqqas ta ’ ftehim huwa fir- rigward tal- użu ta ’ kombinazzjoni tripla (Valsartan + ACEI + BB) f’ HF kronika.
The dosing schedule for the therapeutic use of valsartan in heart failure was based on the Val-HeFT study.
22 L- iskeda tad- dożaġġ għall- użu terapewtiku ta ’ valsartan f’ indeboliment tal- qalb kienet ibbażata fuq l - istudju ta ’ Val- HeFT.
In addition the VALIANT study demonstrated that mortality was not increased in patients receiving the triple combination.
Barra minn hekk, l- istudju VALIANT wera li l- mortalità ma żdieditx f’ pazjenti li kienu qiegħdin jirċievu l- kombinazzjoni tripla.
Therefore in the situation of potential use of the triple combination
Għalhekk fis- sitwazzjoni ta ’ użu potenzjali tal - kombinazzjoni tripla, it- test fi ħdan l- SPC ġie aġġustat sabiex jindika li l- attenzjoni hija dovuta (aktar milli “ mhux rakkomandata ”)
24 the text within the SPC has been adjusted to indicate that caution (rather than “ not recommended”) is appropriate
Il- CHMP qies li hemm ftit appoġġ għall- użu tal- kombinazzjoni tripla s’ issa.
The CHMP considered that there is little support for the triple combination use so far.
Fl- opinjoni tal- CHMP, il - kliem “ mhux rakkomandata ” għandu jintuża sakemm ikun hemm evidenza tal- profil benefiċċju/ riskju aktar solida u ta ’ appoġġ għall- kombinazzjoni tripla.
In CHMP’ s opinion the wording “ not recommended” should be used until there is more solid supportive benefit/ risk-profile evidence to triple combination.
Għaldaqstant, il- MAH għandu jindirizza n - nuqqas ta ’ benefiċċju kliniku (addizzjonali) u ż- żieda fl- episodji avversi.
Therefore the MAH should address the lack of (additional) clinical benefit and increased adverse events In conclusion; the CHMP adopts the revised text: “ The recommended starting dose of Diovan is 40 mg twice daily.
Bħala konklużjoni; il- CHMP jadotta t- test rivedut: “ Id- doża rakkomandata tal- bidu ta ’ Diovan hija 40 mg darbtejn kuljum.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Titrazzjoni ’ l fuq sa 80 mg u 160 mg darbtejn kuljum għandha ssir f’ intervalli ta ’ mill- inqas ġimagħtejn sal- ogħla doża, kif ittollerata mill- pazjent.
Consideration should be given to reducing the dose of concomitant diuretics.
Għandha tingħata kunsiderazzjoni għat- tnaqqis tad- doża ta ’ dijuretiċi li jingħataw fl- istess ħin.
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Id- doża massima ta ’ kuljum mogħtija fi provi kliniċi hija 320 mg f’ dożi maqsumin.
Valsartan may be administered with other heart failure therapies.
Valsartan jista ’ jingħata ma ’ terapiji oħrajn ta ’ indeboliment tal- qalb.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Madankollu, il- kombinazzjoni tripla ta ’ inibitur ACE, beta blocker u valsartan mhijiex rakkomandata (ara sezzjonijiet 4. 4 u 5. 1).
Evaluation of patients with heart failure should always include assessment of renal function .”
Evalwazzjoni tal- pazjent b’ indeboliment tal- qalb għandha dejjem tinkludi evalwazzjoni tal- funzjoni renali. ”
Acknowledging the comments from the CHMP and the Rapporteurs and in the absence of any new data regarding triple therapy with valsartan, the MAH proposed to substitute the wording “ the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended” in chronic heart failure as requested in the relevant sections of the SPC (sections 4.2 and 4.4).
Wara li għaraf il- kummenti mill- CHMP u mir- Rapporteurs u fin- nuqqas ta ’ xi dejta ġdida dwar terapija tripla b’ valsartan, il- MAH ippropona li jissostitwixxi l- kliem “ il- kombinazzjoni tripla ta ’ inibitur ACE, beta blocker u valsartan mhijiex rakkomandata ” f’ indeboliment kroniku tal- qalb kif mitlub fis- sezzjonijiet relevanti tal- SPC (sezzjonijiet 4. 2 u 4. 2).
The CHMP proposed wording has been accepted by the MAH.
Il- formolazzjoni proposta tal- CHMP ġiet aċċettata mill- MAH.
The issue has been solved
Il- kwistjoni ġiet solvuta.
In section 4.2 there are also differences in SPC across Member States in relation to the dosage recommendation in patients with renal and hepatic impairment.
F’ sezzjoni 4. 2 hemm ukoll xi differenzi fl- SPC ta ’ Stat Membru u ieħor fir- rigward tar - rakkomandazzjoni tad- dożaġġ f’ pazjenti b’ indeboliment tal- kliewi u tal- fwied.
Regarding renal impairment, the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine clearance rate > 10 ml/ min) is supported by both efficacy and safety data from Study 27 and by pharmacokinetic data from Study 12.
Fir- rigward tal- indeboliment tal- kliewi, l- użu ta ’ valsartan 80 mg bħala d- doża tal- bidu, mingħajr aġġustament fid- dożaġġ, f’ pazjenti b’ funzjoni renali mnaqqsa (rata ta ’ eliminazzjoni tal- kreatinina > 10 ml/ min) hija appoġġjata minn dejta kemm tal- effikaċja kif ukoll tas- sigurtà minn Studju 27 u minn dejta farmakokinetika minn Studju 12.
In Study 27 the kinetic of valsartan was also investigated in hypertensive patients with impairment of renal function (creatine clearance rate:
Fl- Istudju 27, il- kinetika ta ’ valsartan ġiet investigata wkoll f’ pazjenti bi pressjoni għolja b’ indeboliment tal- funzjoni renali (rata ta ’ eliminazzjoni tal- kreatinina:
The CHMP considered that the elimination of valsartan at steady-state is similar in patients with renal impairment when compared with healthy volunteers and adopted the following wording: “ No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min .”
Il- CHMP qies li l- eliminazzjoni ta ’ valsartan b’ rata fissa hija simili f’ pazjenti b’ indeboliment renali meta mqabbla ma ’ voluntiera b’ saħħithom u adotta l- formolazzjoni li ġejja: “ Ebda aġġustament fid- dożaġġ ma huwa meħtieġ għal pazjenti b’ eliminazzjoni tal- kreatinina > 10 ml/ min. ”
Regarding hepatic impairment, the CHMP noted that the majority of valsartan is eliminated, mainly as unchanged drug in the bile, through hepatic clearance.
Rigward indeboliment tal- fwied, il- CHMP innota li l- maġġoranza ta ’ valsartan hija eliminata, prinċipalment bħala mediċina mhux mibdula fil- belgħun, permezz ta ’ eliminazzjoni mill- fwied.
Valsartan does not undergo extensive biotransformation and 70% of the available dose is excreted.
Valsartan ma jgħaddix minn bijotrasformazzjoni estensiva u 70% tad- doża disponibbli tiġi eliminata mill- ġisem.
The potential for hepatic function per se to affect the kinetics of valsartan is therefore limited, except in the case of biliary obstruction or cholestatic liver disease (defined as an alkaline phosphatase concentration > 2 X Upper Limit of Normal).
Il- potenzjal għall- funzjoni tal- fwied fih innifsu li jaffettwa l- kinetiċi ta ’ valsartan huwa għalhekk limitat, għajr fil- każ ta ’ ostruzzjoni biljari jew marda tal- fwied kolestatika (definita bħala konċentrazzjoni ta ’ alkaline phosphatase > 2 X il- Limitu ta ’ Fuq tan- Normal).
In Study 46, the exposure to valsartan was determined in patients with mild and moderate impairment of liver function.
Fl- Istudju 46, l - esponiment għal valsartan ġie stabbilit f’ pazjenti b’ indeboliment ħafif għal moderat tal- funzjoni tal - fwied.
Exposure to valsartan is not correlated with the degree of liver dysfunction, although the presence of liver disease tended to increase the valsartan plasma AUC.
Esponiment għal valsartan mhuwiex korrelatat mal- grad ta ’ disfunzjoni tal- fwied, għalkemm il - preżenza tal- marda tal- fwied kellha t- tendenza li żżid l- AUC tal- plasma ta ’ valsartan.
Based on the modest magnitude of the observed increase in AUC, and the wide therapeutic index for valsartan, no initial dose adjustment is considered necessary in patients with mild to moderate impairment of hepatic function (without cholestasis).
Abbażi tad- daqs modest taż- żieda osservata fl- AUC, u l- indiċi terapewtiku wiesa ’ għal valsartan, ebda aġġustament fid - doża inizjali ma huwa meqjus neċessarju f’ pazjenti b’ indeboliment ħafif għal moderat tal- funzjoni epatika (mingħajr kolestażi).
Based on a pharmacokinetic study, the dose of valsartan should not exceed 80 mg in these patients and should be used with caution.
Abbażi ta ’ studju farmakokinetiku, id- doża ta ’ valsartan ma għandhiex taqbeż 80 mg f’ dawn il- pazjenti u għandha tintuża b’ attenzjoni.
Valsartan should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
Valsartan ma għandux jingħata lil pazjenti b’ indeboliment sever tal- fwied, ċirrożi jew ostruzzjoni biljari.
The wording proposed by the MAH in the SPC was acceptable to the CHMP and the following wording was adopted: “ In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4) .”
Il- formolazzjoni proposta mill - MAH fl- SPC kienet aċċettabbli għall- CHMP u ġiet adottata l- formolazzjoni li ġejja: “ F’ pazjenti b’ indeboliment tal- fwied ħafif għal moderat mingħajr kolestażi, id- doża ta ’ valsartan ma għandhiex taqbeż 80 mg (ara sezzjoni 4. 4). ”
4.3 - Contraindications There was disagreement on whether the use of Diovan should be contraindicated in patients with renal failure.
23 4. 3 – Kontra- indikazzjonijiet Kien hemm nuqqas ta ’ ftehim fuq jekk l- użu ta ’ Diovan għandux ikun kontra- indikat f’ pazjenti b’ indeboliment tal- fwied.
Having assessed the data available, the CHMP considered that the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine
Wara li vvaluta d- dejta disponibbli, il- CHMP qies li l- użu ta ’ valsartan 80 mg bħala d- doża tal- bidu, mingħajr aġġustament fid- doża, f’ pazjenti b’ funzjoni renali mnaqqsa (rata ta ’ eliminazzjoni tal- kreatinina > 10 ml/ min) huwa appoġġjat kemm minn dejta dwar l- effikaċja kif ukoll minn dejta dwar is- sigurtà minn studji varji.
The safety and tolerability of valsartan in patients with severe renal failure (creatinine clearance of < 10 ml/ min) was not evaluated in any clinical study.
Is- sigurtà u t- tollerabbiltà ta ’ valsartan f’ pazjenti b’ funzjoni tal- kliewi severa (eliminazzjoni tal- kreatinina ta ’ < 10 ml/ min) ma ġew evalwati f’ ebda studju kliniku.
However, no safety issue can be predicted because valsartan would not have specific safety issues associated with renal failure in general.
Madankollu, ebda kwistjoni dwar is- sigurtà ma tista ’ tiġi mbassra minħabba li valsartan ma jkollux kwistjonijiet speċifiċi dwar is- sigurtà assoċjati mal- indeboliment tal- kliewi b’ mod ġenerali.
The CHMP considered it acceptable to remove this contraindication, as the primary route of elimination of valsartan is via biliary route and renal clearance accounts for less than 30% of plasma clearance.
Il- CHMP qies li jkun aċċettabbli li din il- kontra- indikazzjoni titneħħa, minħabba li r- rotta primarja ta ’ eliminazzjoni ta ’ valsartan hija permezz tar- rotta biljari u l- eliminazzjoni mill- kliewi tammonta għal inqas minn 30% tal- eliminazzjoni mill- plasma.
Based on this data, the tolerability would be expected to be similar between those two groups.
Abbażi ta ’ din id- dejta, it- tollerabbiltà tkun mistennija li tkun simili bejn dawk iż- żewġ gruppi.
The CHMP also considered that in view of the fact that Diovan is eliminated via the biliary route, it should be contraindicated in patients with severe liver diseases and “ should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
Il- CHMP qies ukoll li minħabba l- fatt li Diovan jiġi eliminat permezz tar- rotta biljari, għandu jkun kontra- indikat f’ pazjenti b’ mard tal- fwied sever u “ ma għandux jingħata lil pazjenti b’ indeboliment epatiku sever, ċirrożi jew ostruzzjoni biljari.
With reference to the contraindication for the use of Diovan during pregnancy or lactation, the CHMP in line with the recommendations of the Pharmacovigilance experts considered that the contraindication shall be removed and the following recommendation included in the specific section relevant to pregnancy and lactation as follows: “ Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
B’ referenza għall- kontra- indikazzjoni għall- użu ta ’ Diovan matul it- tqala jew treddigħ, il- CHMP f’ konformità mar- rakkomandazzjonijiet tal- esperti tal - Farmakoviġilanza qies li l- kontra- indikazzjoni għandha titneħħa u r- rakkomandazzjoni li ġejja għandha tiġi inkluża fis- sezzjoni speċifika relevanti għat- tqala u t- treddigħ kif ġej: “ Minħabba li ma hemm ebda informazzjoni disponibbli fir- rigward tal- użu ta ’ valsartan matul it- treddigħ, Diovan (Valsartan) mhuwiex rakkomandat u kura alternattiva bi profili tas- sigurtà stabbilti aħjar matul it - treddigħ huma preferibbli, b’ mod speċjali waqt il- kura ta ’ tarbija tat- twelid jew ta ’ tarbija li twieldet qabel ”.
4.5 - Interaction with other medicinal products and other forms of interaction
4. 5 – Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The CHMP considered the precautions for the concomitant use of other medicinal products containing or raising the level of potassium and adopted the following wording: “ If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
Il- CHMP qies il- prekawzjonijiet għall- użu fl- istess ħin ma ’ prodotti mediċinali oħrajn li fihom jew li jgħollu l- livell tal- potassju u adotta l- formolazzjoni li ġejja: “ Jekk prodott mediċinali li jaffettwa l - livelli tal- potassju jitqies neċessarju f’ kombinazzjoni ma ’ valsartan, il- monitoraġġ tal- livelli tal - plasma tal- potassju huwa rakkomandat ”.
The CHMP also considered that special precaution would be needed for patients with hepatic impairment and/ or cholestasis, as the majority of valsartan is eliminated, mainly as unchanged drug in the bile, by hepatic clearance.
Il- CHMP qies ukoll li prekawzjoni speċjali tkun meħtieġa għal pazjenti b’ indeboliment tal- fwied u/ jew kolestażi, minħabba li l- maġġoranza ta ’ valsartan tiġi eliminata, prinċipalment bħala mediċina mhux mibdula fil- belgħun, permezz ta ’ eliminazzjoni mill- fwied.
Based on the wide therapeutic index for valsartan, no initial dose adjustment is considered necessary in patients with mild to moderate impairment of hepatic function (without cholestasis).
Abbażi tad- daqs modest taż- żieda osservata fl- AUC, u l- indiċi terapewtiku wiesa ’ għal valsartan, ebda aġġustament fid- doża inizjali ma huwa meqjus neċessarju f’ pazjenti b’ indeboliment ħafif għal moderat tal- funzjoni epatika (mingħajr kolestażi).
The CHMP agreed about the proposed wording for precautions in dosing Diovan, considering that no dosage adjustment is required for patients with a creatinine clearance > 10ml/ min and that in patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Il- CHMP qabel fuq il- formolazzjoni proposta għal prekawzjonijiet fid- dożaġġ ta ’ Diovan, filwaqt li qies li ebda aġġustament fid- dożaġġ ma huwa meħtieġ għal pazjenti b’ eliminazzjoni tal- kreatinina > 10 ml/ min u li f’ pazjenti b’ indeboliment tal- fwied ħafif għal moderat mingħajr kolestażi, id- doża ta ’ valsartan ma għandhiex taqbeż 80 mg (ara sezzjoni 4. 4).
Sessions 4.5, 5.1, and 5.2 have been updated in order to guarantee the safety of the medicine.
Is- Sezzjonijiet 4. 5, 5. 1, u 5. 2 ġew aġġornati sabiex jiggarantixxu s- sigurtà tal- mediċina.
The following sentence has been added to Section 5.2: “ Diovan has not been studied in patients with severe hepatic dysfunction”.
Is- sentenza li ġejja ġiet miżjuda mas- Sezzjoni 5. 2: “ Diovan ma ġiex studjat f’ pazjenti b’ disfunzjoni tal- fwied severa ”.
In patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis no data are available, therefore valsartan should be used with caution in these patients.
Ma hemm l- ebda dejta disponibbli għal pazjenti b’ eliminazzjoni tal- kreatinina < 10ml/ min u f’ pazjenti li jkunu qiegħdin jagħmlu dijaliżi, għalhekk, valsartan għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
4.8 - Undesirable effect
24 4. 8 – Effetti mhux mixtieqa
The main discussion for this section concerned the presentation of ADRs in the SPC.
Id- diskussjoni ewlenija għal din is- sezzjoni kellha x’ taqsam mal- preżentazzjoni ta ’ ADRs fl- SPC.
The MAH created a single table containing all relevant ADRs from all three indications: hypertension, post- MI, and CHF.
Il - MAH ħoloq tabella waħdanija li fiha l- ADRs kollha relevanti mit- tliet indikazzjonijiet kollha: pressjoni għolja, post - MI, u CHF.
However, the CHMP, requested to summarize all indications in one table, according to the ` Guideline of SPC `.
Madankollu, il- CHMP, talab li l- indikazzjonijiet kollha jitqassru u jinġabru f’ tabella waħda, skont il - ‘ Linja gwida tal- SPC ’.
The MAH proposed to add indication-specific foot-notes, but the CHMP considered that the proposed extensive use of footnotes has little value for the prescriber and ADRs have been moved to the frequency category representing the highest frequency (see attached SPC and PIL).
Il- MAH ippropona li jiżdiedu noti ta ’ qiegħ il- paġna speċifiċi għall- indikazzjonijiet, madankollu il- CHMP qies li l- użu estensiv propost tan- noti ta ’ qiegħ il- paġna għandu ftit valur għal min jagħti r- riċetta u l- ADRs tressqu għall- kategorija tal - frekwenzi li tirrappreżenta l- ogħla frekwenza (ara l- SPC u l- PIL mehmużin).
26 GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Awtorizzazzjoni għat- Tqegħid fis- Suq ġew evalwati abbażi tad- dokumentazzjoni sottomessa u d - diskussjoni xjentifika fi ħdan il- Kumitat,
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Diovan and associated names (see Annex I).
il- CHMP irrakkomanda l- emendar tal- Awtorizzazzjoni( jiet) Għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif tagħhom huma stabbiliti fl- Anness III għal Diovan u l- ismijiet assoċjati (ara l- Anness I).
27 ANNEX III
25 ANNESS III
28 SUMMARY OF PRODUCT CHARACTERISTICS
26 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I – To be completed nationally]
Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b’ rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
One film-coated tablet contains 40 mg of valsartan One capsule contains 40 mg of valsartan One film-coated tablet contains 80 mg of valsartan One capsule contains 80 mg of valsartan One film-coated tablet contains 160 mg of valsartan One capsule contains 160 mg of valsartan One film-coated tablet contains 320 mg of valsartan
Pillola waħda miksija b’ rita fiha 40 mg valsartan Kapsula waħda fiha 40 mg valsartan Pillola waħda miksija b’ rita fiha 80 mg valsartan Kapsula waħda fiha 80 mg valsartan Pillola waħda miksija b’ rita fiha 160 mg valsartan Kapsula waħda fiha 160 mg valsartan Pillola waħda miksija b’ rita fiha 320 mg valsartan
Recent myocardial infarction Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Infart mijokardijaku reċenti Kura ta ’ pazjenti klinikament stabbli li għandhom insuffiċjenza sintomatika tal- qalb jew disfunzjoni sistolika mhux sintomatika tal- ventriklu tax- xellug wara infart mijokardijaku reċenti (12- il siegħa - għaxart ijiem) (ara sezzjonijiet 4. 4 u 5. 1).
Heart failure Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Insuffiċjenza tal- qalb Kura ta ’ insuffiċjenza sintomatika tal- qalb meta inibituri ta ’ Angiotensin Converting Enzyme (ACE) ma jistgħux jiġu wżati, jew bħala terapija miżjuda ma ’ inibituri ta ’ ACE meta mblokkaturi tar- riċetturi beta ma jistgħux jiġu wżati (ara sezzjonijiet 4. 4 u 5. 1).
Hypertension Treatment of essential hypertension.
Pressjoni għolja Kura ta ’ pressjoni għolja essenzjali.
Heart failure Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
28 Kura ta ’ insuffiċjenza sintomatika tal- qalb meta inibituri ta ’ Angiotensin Converting Enzyme (ACE) ma jistgħux jiġu wżati, jew bħala terapija miżjuda ma ’ inibituri ta ’ ACE meta mblokkaturi tar- riċetturi beta ma jistgħux jiġu wżati (ara sezzjonijiet 4. 4 u 5. 1).
30 Hypertension Treatment of essential hypertension.
Pressjoni għolja Kura ta ’ pressjoni għolja essenzjali.
Posology
Pożoloġija:
Recent myocardial infarction In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
Infart mijokardijaku reċenti F’ pazjenti klinikament stabbli, it- terapija tista ’ tinbeda minn 12- il siegħa wara infart mijokardijaku.
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Wara doża tal- bidu ta ’ 20 mg darbtejn kuljum, valsartan għandu jiġi ttitrat għal 40 mg, 80 mg, u 160 mg darbtejn kuljum fuq il- ftit ġimgħat ta ’ wara.
The starting dose is provided by the 40 mg divisible tablet.
Id- doża tal- bidu hija pprovduta mill- pillola ta ’ 40 mg li tinqasam.
The target maximum dose is 160 mg twice daily.
Id- doża massima mmirata hija 160 mg darbtejn kuljum.
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
Ġeneralment, huwa rrakkomandat li l- pazjenti jilħqu livell ta ’ doża ta ’ 80 mg darbtejn kuljum sa ġimagħtejn wara l- bidu tal- kura u li d- doża massima mmirata ta ’ 160 mg darbtejn kuljum, tintlaħaq fi żmien tliet xhur, skond it- tolleranza tal- pazjent.
If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dosage reduction.
Jekk isseħħ pressjoni baxxa sintomatika jew disfunzjoni renali, għandu jiġi kkunsidrat tnaqqis fid- doża.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e. g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
Valsartan jista ’ jiġi wżat f’ pazjenti kkurati b’ terapiji ta ’ wara infart mijokardijaku oħra, eż. trombolitiċi, acetylsalicylic acid, imblukkaturi tar- riċetturi beta, statins, u dijuretiċi.
The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
It- taħlita ma ’ inibituri ta ’ ACE mhux irrakkomandata (ara sezzjonijiet 4. 4 u 5. 1).
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Valutazzjoni ta ’ pazjenti wara infart mijokardijaku għandha dejjem tinkludi valutazzjoni tal- funzjoni renali.
Heart failure The recommended starting dose of Diovan is 40 mg twice daily.
Insuffiċjenza tal- qalb Id- doża rrakkomandata tal- bidu ta ’ Diovan hija 40 mg darbtejn kuljum.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Titrazzjoni ’ l fuq sa 80 mg u 160 mg darbtejn kuljum għandha ssir f’ intervalli ta ’ mill- inqas ġimagħtejn sa l- ogħla doża, skond kif ittollerata mill- pazjent.
Consideration should be given to reducing the dose of concomitant diuretics.
Għandu jiġi kkunsidrat tnaqqis tad- doża tad- dijuretiċi mogħtija fl- istess waqt.
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Id- doża massima ta ’ kuljum mogħtija fi provi kliniċi hija 320 mg f’ dożi maqsuma.
Valsartan may be administered with other heart failure therapies.
Valsartan jista ’ jingħata ma ’ terapiji oħra għall- insuffiċjenza tal- qalb.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Madankollu, t- taħlita tripla ta ’ inibitur ta ’ ACE, imblokkatur tar- riċetturi beta u valsartan mhijiex irrakkomandata (ara sezzjonijiet 4. 4 u 5. 1).
Evaluation of patients with heart failure should always include assessment of renal function.
Valutazzjoni ta ’ pazjenti b’ insuffiċjenza tal- qalb għandha dejjem tinkludi valutazzjoni tal- funzjoni renali.
Hypertension The recommended starting dose of Diovan is 80 mg once daily.
Pressjoni għolja Id- doża rrakkomandata tal- bidu ta ’ Diovan hija 80 mg darba kuljum.
The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks.
L- effett li jbaxxi l- pressjoni huwa essenzjalment preżenti fi żmien ġimagħtejn, u l- effetti massimi jintlaħqu fi żmien 4 ġimgħat.
In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
F’ xi pazjenti fejn il- pressjoni tad- demm ma tkunx ikkontrollata b’ mod xieraq, id- doża tista ’ tiżdied għal 160 mg u sa massimu ta ’ 320 mg.
Diovan may also be administered with other antihypertensive agents.
Diovan jista ’ jingħata wkoll ma ’ sustanzi oħra li jbaxxu l- pressjoni.
The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients.
F’ dawn il- pazjenti, ż- żjieda ta ’ dijuretiku bħal hydrochlorothiazide se jnaqqas aktar il- pressjoni tad- demm.
The target maximum dose is 160 mg twice daily.
Id- doża massima mmirata hija 160 mg darbtejn kulum.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e. g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
29 Valsartan jista ’ jiġi wżat f’ pazjenti kkurati b’ terapiji ta ’ wara infart mijokardijaku oħra, eż. trombolitiċi, acetylsalicylic acid, imblokkaturi tar- riċetturi beta, statins, u dijuretiċi.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the
Titrazzjoni ’ l fuq sa 80 mg u 160 mg darbtejn kuljum għandha ssir f’ intervalli ta ’ mill- inqas ġimagħtejn sa l- ogħla doża, skond kif ittollerata mill- pazjent.
Consideration should be given to reducing the dose of concomitant diuretics.
Għandu jiġi kkunsidrat tnaqqis fid- doża tad- dijuretiċi mogħtija fl- istess waqt.
The recommended starting dose of Diovan is 80 mg once daily.
Pressjoni għolja Id- doża rrakkomandata tal- bidu ta ’ Diovan hija 80 mg darba kuljum.
Method of administration Diovan may be taken independently of a meal and should be administered with water.
Metodu ta ’ kif jingħata Diovan jista ’ jittieħed b’ mod indipendenti mill- ikel u għandu jingħata ma ’ l- ilma.
Additional information on special populations
Informazzjoni oħra dwar popolazzjonijiet speċjali
Elderly No dose adjustment is required in elderly patients.
Anzjani L- ebda aġġustament fid- doża ma huwa meħtieġ f’ pazjenti anzjani.
Renal impairment No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min (see sections 4.4 and 5.2)
Indeboliment renali L- ebda aġġustament fid- doża ma huwa meħtieġ f’ pazjenti bi tneħħija tal- krejatinina ta ’ > 10 ml/ min (ara sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Indeboliment epatiku F’ pazjenti b’ indeboliment epatiku ħafif sa moderat mingħajr kolestasi, id- doża ta ’ valsartan m’ għandhiex taqbeż 80 mg.
Diovan is contraindicated in patients with severe hepatic impairment and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Diovan huwa kontra- indikat f’ pazjenti b’ indeboliment epatiku sever u f’ pazjenti b’ kolestasi (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Paediatric patients Diovan is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi Diovan mhux irrakkomandat għall- użu fit- tfal taħt l- età ta ’ 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
-Hypersensitivity to the active substance or to any of the excipients. -Severe hepatic impairment, biliary cirrhosis and cholestasis. -Second and third trimester of pregnancy (see sections 4.4 and 4.6).
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. - Indeboliment epatiku sever, ċirrożi biljari u kolestasi. - It- tieni jew it- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6).
Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
30 L- użu flimkien ma ’ supplimenti ta ’ potassium, dijuretiċi li ma jitilfux potassium, sostitwenti tal- melħ li fihom potassium, jew sustanzi oħra li jistgħu jżidu l- livelli tal- potassium (eparina, eċċ.) mhux irrakkomandat.
Monitoring of potassium should be undertaken as appropriate.
Sorveljanza tal- potassium għandha ssir skond il- bżonn.
Sodium- and/ or volume-depleted patients In severely sodium-depleted and/ or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Pazjenti bi tnaqqis fis- sodium u/ jew fil- volum F’ pazjenti bi tnaqqis sever fis- sodium u/ jew fil- volum, bħal dawk li qed jirċievu dożi għolja ta ’ dijuretiċi, f’ każijiet rari tista ’ sseħħ pressjoni baxxa sintomatika wara l- bidu tat- terapija b’ Diovan.
Sodium and/ or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Tnaqqis fis- sodium u/ jew fil- volum għandu jiġi kkoreġut qabel tinbeda kura b’ Diovan, per eżempju billi titnaqqas id- doża tad- dijuretiku.
32 In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Stenosi ta ’ l- arterja renali F’ pazjenti bi stenosi bilaterali ta ’ l- arterja renali jew stenosi lejn kilwa waħda, l- użu sikur ta ’ Diovan ma ġiex stabbilit.
Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
L- għoti għal tul ta ’ żmien qasir ta ’ Diovan lil 12- il pazjent bi pressjoni għolja renovaskulari sekondarja għal stenosi unilaterali ta ’ l- arterja renali ma kkawża l- ebda bidliet sinifikanti fl - emodinamika renali, fil- krejatinina fis- serum jew fin- nitrogen fid- demm mill- urea (BUN).
However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Madankollu, sustanzi oħra li jaffettwaw is- sistema renin- angiotensin jistgħu jżidu l- urea fid- demm u l - krejatinina fis- serum f’ pazjenti bi stenosi unilaterali ta ’ l- arterja renali, għalhekk sorveljanza tal - funzjoni renali hija rrakkomandata meta pazjenti huma kkurati b’ valsartan.
Kidney transplantation There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Trapjant tal- kliewi Bħalissa m’ hemmx esperjenza dwar l- użu sikur ta ’ Diovan f’ pazjenti li kellhom trapjant tal- kliewi reċenti.
Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Iperaldosteroniżmu primarju Pazjenti b’ iperaldosteroniżmu primarju m’ għandhomx jiġu kkurati b’ Diovan peress li s- sistema renin - angiotensin tagħhom mhux attivata.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Stenosi tal- valvula aortika u mitrali, kardomijopatija ipertrofika ostruttiva Bħal bil- vażodilataturi l- oħra kollha, kawtela speċjali hija indikata f’ pazjenti li jsofru minn stenosi aortika jew mitrali, jew kardomijopatija ipertrofika ostruttiva (HOCM).
Impaired renal function No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min.
Indeboliment fil- funzjoni renali L- ebda aġġustament fid- doża ma huwa meħtieġ għall- pazjenti bi tneħħija tal- krejatinina ta ’ > 10 ml/ min.
There is currently no experience on the safe use in patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 5.2).
Bħalissa m’ hemmx esperjenza dwar l- użu sikur f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 10 ml/ min u f’ pazjenti li qed jagħmlu dijalisi, għalhekk valsartan għandu jintuża b’ kawtela f’ dawn il - pazjenti (ara sezzjonijiet 4. 2 u 5. 2).