qanastek/EMEA-V3 huggingface dataset:
As for any medicine that acts directly on the RAS, Rasilez should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Bħal kull mediċina oħra li taħdem direttament fuq ir - RAS, Rasilez m’ għandux jintuża waqt l- ewwel trimestru tat- tqala jew f’ nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it- tieni u t- tielet trimestri (ara sezzjoni 4. 3).
If pregnancy is detected during therapy, Rasilez should be discontinued accordingly.
Jekk jinsab li hemm tqala waqt it- terapija, Rasilez għandu jitwaqqaf kemm jista ’ jkun malajr kif ikun xieraq.
Rasilez was secreted in the milk of lactating rats.
Rasilez għadda fil- ħalib ta ’ firien li kienu qed ireddgħu.
Rasilez has negligible influence on the ability to drive and use machines.
Rasilez ftit li xejn għandu influwenza fuq il- ħila biex issuq u tħaddem magni.
Rasilez has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Rasilez ġie evalwat għas- sigurtà f’ aktar minn 7, 800 pazjent, li kienu jinkludu aktar minn 2, 300 li ingħataw kura għal aktar minn 6 xhur, u aktar minn 1, 200 għal aktar minn sena.
Treatment with Rasilez resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Kura b’ Rasilez wasslet għal inċidenza globali ta ’ reazzjonijiet avversi simili għal plaċebo sa ’ 300 mg.
The incidence of cough was similar in placebo (0.6%) and Rasilez treated (0.9%) patients.
L- inċidenza tas- sogħla kienet simili f’ pazjenti ikkurati bi plaċebo (0. 6%) u b’ Rasilez (0. 9%).
Angioedema has occurred during treatment with Rasilez.
Anġjoedema seħħet waqt il- kura b’ Rasilez.
In controlled clinical trials, angioedema occurred rarely during treatment with Rasilez with rates comparable to treatment with placebo or hydrochlorothiazide.
Fi provi kliniċi kkontrollati, anġjoedema seħħet b’ mod rari waqt il- kura b’ Rasilez b’ rati li setgħu jitqabblu mal- kura bi plaċebo jew hydrochlorthiazide.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Rasilez.
Sejbiet tal- laboratorju Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f’ parametri standard tal- laboratorju kienu assoċjati b’ mod mhux komuni ma ’ l- għoti ta ’ Rasilez.
In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Fi studji kliniċi f’ pazjenti bi pressjoni għolja, Rasilez ma kellux effetti klinikament importanti fuq il- kolesterol totali, lipoproteina tal- kolesterol ta ’ densità għolja (HDL- C), trigliċeridi ta ’ waqt is- sawm, glucose ta ’ waqt is- sawm jew uric acid.
Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Rasilez alone (0.9% compared to 0.6% with placebo).
Żiediet tal- potassium fis- serum kienu minuri u mhux frekwenti f’ pazjenti bil - pressjoni għolja naturali kkurata b’ Rasilez waħdu (0. 9% imqabbla ma ’ 0. 6% bil- plaċebo).
However, in one study where Rasilez was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Madankollu, fi studju wieħed fejn Rasilez intuża ma ’ ACEI f’ popolazzjoni ta ’ pazjenti dijabetiċi iż - żiediet tal- potassium fis- serum kienu aktar frekwenti (5. 5%).
The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
L- aktar ħaga li x’ aktarx tidher b’ doża eċċessiva ta ’ Rasilez tkun pressjoni baxxa, relatata ma ’ l- effett ta ’ aliskiren li jbaxxi l- pressjoni.
6 Hypertension In hypertensive patients, once-daily administration of Rasilez at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
6 Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Rasilez b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- ogħla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Rasilez has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Rasilez kien studjat f’ 1, 864 pazjent ta ’ etajiet minn 65 sena ’ l fuq, u f’ 426 pazjent ta ’ etajiet minn 75 sena ’ l fuq.
Rasilez monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Studji b’ monoterapija b’ Rasilez urew li l- effetti li jbaxxi l- pressjoni kienu jitqabblu ma ’ klassijiet oħra ta ’ aġenti li jbaxxu l- pressjoni inklużi ACEI u ARB.
Compared to a diuretic (hydrochlorothiazide - HCTZ), Rasilez 300 mg lowered systolic/ diastolic blood pressure by 17.0/ 12.3 mmHg, compared to 14.4/ 10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Meta mqabbel ma ’ dijuretiku (hydrochlorothiazide - HCTZ), Rasilez 300 mg naqqas il- pressjoni sistolika/ dijastolika tad- demm b’ 17. 0/ 12. 3 mmHg, imqabbel ma ’ 14. 2/ 10. 5 mmHg għal HCTZ 25 mg wara 12- il ġimgħa ta ’ kura.
In diabetic hypertensive patients, Rasilez monotherapy was safe and effective.
F’ pazjenti dijabetiċi bil- pressjoni għolja, monoterapija ta ’ Rasilez kienet sigura u effettiva.
Combination therapy studies are available for Rasilez added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Hemm studji b’ terapija ta ’ kombinazzjoni għal Rasilez miżjud mad- dijuretiku hydrochlorthiazide, l - ACEI ramipril, l- imblukkatur tal- kanali tal- calcium amlodipine, l- antagonist tar- riċettur ta ’ l - angiotensin valsartan, u l- imblukkatur beta atenolol.
Rasilez induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Rasilez ikkawża tnaqqis fil- pressjoni tad- demm akbar meta żdied ma ’ hydrochlorthiazide u ma ’ ramipril.
In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Rasilez 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/ amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
F’ pazjenti li ma kellhomx rispons xieraq għall- 5 mg ta ’ l- imblokkatur tal- kanali tal- calcium amlodipine, iż- żieda ta ’ Rasilez 150 mg kellu effett li jbaxxi l- pressjoni simili għal dak miksub meta d- doża ta ’ amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta ’ edema (aliskiren 150 mg/ amlodipine 5 mg 2. 1% vs amlodipine 10 mg 11. 2%).
Rasilez in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Rasilez flimkien ma ’ l- antagonist tar - riċettur ta ’ angiotensin valsartan wera effett ta ’ tnaqqis fil- pressjoni akbar fl- istudju li kien imfassal apposta sabiex jiġi mistħarreġ l- effett tat- terapija kombinata.
In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Rasilez 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
F’ pazjenti obeżi li għandhom il- pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl- inklużjoni ta ’ Rasilez 300 mg ipprovdiet tnaqqis addizzjonali fil- pressjoni tad- demm li seta ’ jitqabbel ma ’ kura bl- inklużjoni ta ’ irbesartan 300 mg jew amlodipine 10 mg.
In diabetic hypertensive patients, Rasilez provided additive blood pressure reductions when added to ramipril, while the combination of Rasilez and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
F’ pazjenti dijabetiċi li għandhom il- pressjoni għolja, Rasilez ipprovda tnaqqis addittiv tal- pressjoni tad- demm meta ngħata ma ’ ramipril, filwaqt li l- kombinazzjoni ta ’ Rasilez u ramipril kellha anqas każijiet ta ’ sogħla (1. 8%) minn ramipril (4. 7%).
Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Rasilez alone.
Pressjoni baxxa żżejjed kienet mhux komuni (0. 1%) f’ pazjenti bi pressjoni għolja mingħajr komplikazzjoni li kienu kkurati b’ Rasilez waħdu.
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Rasilez 150 mg was well tolerated.
Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb iż- żieda ta ’ Rasliez 150 mg kienet tollerata sew.
However the clinical significance of this reduction is unknown.
Il- livelli ta ’ peptajd natrijuretiku tat- tip- B (BNP) kienu mnaqqsa b’ 25% fil- fergħa ta ’ Rasilez meta mqabbla mal- plaċebo għalkemm is- sinifikat kliniku għadu mhux magħruf.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Rasilez 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
Fi studju ta ’ 6 xhur ta ’ 599 pazjent bi pressjoni għolja, dijabete mellitus tat- tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta ’ sfond adattata għal kontra l - pressjoni għolja, iż- żieda ta ’ Rasilez 300 mg kisbet tnaqqis ta ’ 20% kontra plaċebo, i. e. minn 58 mg/ mmol għal 46 mg/ mmol, fil- proporzjon ta ’ l- albumina mal- krejatina fl- awrina (UACR).
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Rasilez and placebo, respectively.
Il - proporzjon tal- pazjenti li kellhom tnaqqis fil- UACR b’ mill- anqas 50% mill- linja bażi sat- tragward finali kien ta ’ 24. 7% u 12. 5% għal Rasilez u l- plaċebo, rispettivament.
Rasilez did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Rasilez ma effettwax il - konċentrazzjoni fis- serum tal- krejatinina iżda kien assoċjat ma ’ żieda fil- frekwenza (4. 2% vs 1. 9%
7 Beneficial effects of Rasilez on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Rasilez fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
No adjustment of the initial dosage of Rasilez is required in patients with mild to severe renal impairment, however caution should be exercised in patients with severe renal impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Rasilez f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone Silica, colloidal anhydrous Hypromellose Macrogol Talc Iron oxide, black (E 172) Iron oxide, red (E 172) Titanium dioxide (E 171)
Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone Silica, colloidal anhydrous Hypromellose Macrogol Talc Iron oxide, black (E 172) Iron oxide, red (E 172) Titanium dioxide (E 171)
Rasilez 300 mg film-coated tablets
Rasilez 300 mg pilloli miksijin b’ rita
Paediatric patients (below 18 years) Rasilez is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti tfal (taħt it- 18- il sena) Rasilez mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
4.3 Contraindications
11 4. 3 Kontra- indikazzjonijiet
11 Second and third trimesters of pregnancy (see section 4.6).
It- tieni u t- tielet trimestri tat- tqala (ara sezzjoni 4. 6).
When administered with atorvastatin, steady-state Rasilez AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC
Co- administration of Rasilez had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Meta Rasilez ingħata ma ’ atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il- farmakokinetika tagħhom.
As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
Għalhekk, m’ hemmx bżonn ta ’ aġġustar tad- doża għal Rasilez jew ta ’ dawn il- prodotti mediċinali li jingħataw miegħu.
Digoxin bioavailability may be slightly decreased by Rasilez.
Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Rasilez.
12 Preliminary data suggest that irbesartan may decrease Rasilez AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Rasilez.
It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of volume overload.
Għalhekk huwa irrakkomandat li l- effetti jkunu monitorati meta tinbeda u tkun qed tiġi
13 increases in serum potassium.
13 aġġustata t- terapija ta ’ furosemide biex dan ma jkunx sotto- utilizzat f’ sitwazzjonijiet kliniċi ta ’ volum żejjed.
15 Hypertension In hypertensive patients, once-daily administration of Rasilez at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Rasilez b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- oghla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Rasilez did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Rasilez ma effettwax il -
16 Beneficial effects of Rasilez on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Rasilez fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Rasilez f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
Rasilez 150 mg film-coated tablets Aliskiren
Rasilez 150 mg pilloli miksijin b’ rita Aliskiren
Rasilez 300 mg film-coated tablets Aliskiren
Rasilez 300 mg pilloli miksijin b’ rita Aliskiren
What Rasilez is and what it is used for 2.
X’ inhu Rasilez u għalxiex jintuża 2.
Before you take Rasilez 3.
Qabel ma tieħu Rasilez 3.
How to take Rasilez 4.
Kif għandek tieħu Rasilez 4.
How to store Rasilez 6.
Kif taħżen Rasilez 6.
WHAT RASILEZ IS AND WHAT IT IS USED FOR
X’ INHU RASILEZ U GĦALXIEX JINTUŻA
Rasilez belongs to a new class of medicines called renin inhibitors.
Rasliez jagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
Rasilez helps to lower high blood pressure.
Rasilez jgħin biex ibaxxi l- pressjoni tad- demm għolja.
BEFORE YOU TAKE RASILEZ
QABEL MA TIEĦU RASILEZ
Do not take Rasilez
Tieħux Rasilez
Take special care with Rasilez
Oqgħod attent ħafna b’ Rasilez
If any of these apply to you, tell your doctor before you take Rasilez.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Rasilez.
The use of Rasilez in children and adolescents is not recommended.
L- użu ta ’ Rasilez fi tfal u adolexxenti mhux rakkomandat.
Taking Rasilez with food and drink You should take Rasilez with a light meal once a day, preferably at the same time each day.
Meta tieħu Rasilez ma ’ l- ikel u max- xorb Għandek tieħu Rasilez ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Rasilez together with grapefruit juice.
M’ għandekx tieħu Rasilez mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Rasilez if you are pregnant.
Tqala u treddigħ Tieħux Rasilez jekk ħriġt tqila.
Do not breast-feed if you are taking Rasilez.
Treddax jekk qed tieħu Rasilez.
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Rasilez.
Qabel issuq karozza, tħaddem makkinarju, jew tagħmel attivitajiet oħra li jeħtieġu konċentrazzjoni, għandhekk taċċerta ruħek li tkun taf x’ tip ta ’ reazjoni jkollok għall- effetti ta ’ Rasilez.
HOW TO TAKE RASILEZ
KIF GĦANDEK TIEĦU RASILEZ
Always take Rasilez exactly as your doctor has told you.
Dejjem għandek tieħu Rasilez skond il- parir eżatt tat- tabib.
Your doctor may prescribe Rasilez together with other medicines used to treat high blood pressure.
It- tabib tiegħek jista ’ jordnalek Rasilez ma ’ mediċini oħra li jintużaw biex jikkuraw il- pressjoni tad- demm għolja.
You should take Rasilez with a light meal once a day, preferably at the same time each day.
Għandek tieħu Rasilez ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Rasilez together with grapefruit juice.
M’ ghandekx tieħu Rasilez mal- meraq tal- grejpfrut.
If you take more Rasilez than you should If you have accidentally taken too many Rasilez tablets, consult a doctor immediately.
Jekk tieħu Rasilez aktar milli suppost Jekk bi żball ħadt wisq pilloli Rasilez, ikkonsulta mat- tabib tiegħek minnufih.
If you forget to take Rasilez If you forget to take a dose of Rasilez, take it as soon as you remember and then take the next dose at its usual time.
Jekk tinsa tieħu Rasilez Jekk tinsa tieħu doża ta ’ Rasilez, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
However, if it is almost time for your next dose you should simply take the next tablet
Iżda, jekk ikun kważi wasal il- ħin tad- doża li jmissek għandek sempliċement tieħu l- pillola li jkun imissek fil- ħin tas- soltu.
Like all medicines, Rasilez can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rasilez jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE RASILEZ
KIF TAĦŻEN RASILEZ
Do not use Rasilez after the expiry date which is stated on the carton and blister.
Tużax Rasilez wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Rasilez contains
X’ fih Rasilez
What Rasilez looks like and contents of the pack Rasilez 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL ” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Rasilez u l- kontenuti tal- pakkett Rasilez 150 mg pilloli miksijin b’ rita huma pilloli roża ċar, konvessi miż- żewġ naħat, tondi, ittimbrati ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
Rasilez is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Rasilez jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
However, if it is almost time for your next dose you should simply take the next tablet
Jista ’ jkollok bżonn attenzjoni medika.
45 at the usual time.
45 Jekk tinsa tieħu Rasilez Jekk tinsa tieħu doża ta ’ Rasilez, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
What Rasilez looks like and contents of the pack Rasilez 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Rasilez u l- kontenuti tal- pakkett Rasilez 300 mg pilloli miksijin b’ rita huma pilloli aħmar ċar, konvessi miż- żewġ naħat, f’ għamla ovali, ittimbrati ‘ IU ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
46 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This document is a summary of the European Public Assessment Report (EPAR).
Sommarju tal- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta ’ Valutazzjoni (EPAR).
What is Rasilez HCT?
X’ inhu Rasilez HCT?
Rasilez HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide.
Rasilez HCT huwa mediċina li fiha s- sustanzi attivi aliskiren u l- idroklorotijażide (hydrochlorothiazide).
It is available as oval tablets (white:
Huwa disponibbli f’ pilloli ovali (bojod:
150 mg aliskiren and 12.5 mg hydrochlorothiazide; pale yellow:
150 mg aliskiren u 12. 5 mg idroklorotijażide; ta ’ lewn isfar mitfi:
150 mg aliskiren and 25 mg hydrochlorothiazide; pale violet:
150 mg aliskiren u 25 mg idroklorotijażide; vjola ċari:
300 mg aliskiren and 12.5 mg hydrochlorothiazide; light yellow:
300 mg aliskiren u 12. 5 mg idroklorotijażide; sofor ċari:
300 mg aliskiren and 25 mg hydrochlorothiazide).
300 mg aliskiren u 25 mg idroklorotijażide).
What is Rasilez HCT used for?
Għal xiex jintuża Rasilez HCT?
Rasilez HCT is used to treat essential hypertension (high blood pressure) in adults. ‘ Essential ’ means that no specific cause for the hypertension can be found.
Rasilez HCT jintuża fit- trattament tal- ipertensjoni essenzjali (pressjoni tad- demm għolja) fl- adulti. ‘ Essenzjali ’ tfisser li ma tkunx tista ’ tinstab kawża speċifika għall- ipertensjoni.
Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone.
Rasilez HCT jintuża f’ pazjenti bi pressjoni tad- demm li ma tkunx tista ’ tiġi kkontrollata b’ mod adegwat b’ aliskiren jew b’ idroklorotijażide meħudin waħedhom.
It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Jista ’ jintuża wkoll f’ pazjenti bi pressjoni tad- demm ikkontrollata b’ mod adegwat b’ aliskiren u b’ idroklorotijażide meħudin f’ pilloli separati biex jissostitwixxi l- istess dożi taż- żewġ sustanzi attivi.
How is Rasilez HCT used?
Kif jintuża Rasilez HCT?
It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Rasilez HCT.
Id- doża rakkomandata ta ’ Rasilez HCT hija pillola waħda kuljum li għandha tittieħed ma ’ ikla ħafifa preferibbilment fl- istess ħin tal- ġurnata kuljum iżda ma ’ Rasilez HCT ma għandux jittieħed il- meraq tax- xadokk tal- ikel (grapefruit juice).
The dose depends on the doses of aliskiren and/ or hydrochlorothiazide that the patient was taking before.
Id- doża tiddependi mid- dożi ta ’ aliskiren u/ jew idroklorotijażide li l- pazjent kien qed jieħu qabel.
Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Rasilez HCT.
Il- pazjenti li qabel kienu jieħdu aliskiren jew idroklorotijażide aktarx ikun jeħtieġ jieħdu ż- żewġ sustanzi f’ pilloli separati u d- dożi jkunulhom aġġustati qabel ma jaqilbu għal Rasilez HCT.
After two to four weeks of taking Rasilez HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.
Wara li jieħdu Rasilez HCT minn ġimagħtejn sa erba ’ ġimgħat, tista ’ tiżdied id- doża għall- pazjenti li l - pressjoni tad- demm tagħhom tibqa ’ mhux ikkontrollata.
In patients already adequately controlled with the two active substances, the dose of Rasilez HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.
Fil- pazjenti kkontrollati b’ mod adegwat biż- żewġ sustanzi attivi, id- doża ta ’ Rasilez HCT għandha tkun fiha l- istess dożi ta ’ aliskiren u idroklorotijażide li l- pazjenti kien qed jieħu qabel.
Rasilez HCT should be used with caution in patients who have problems with their liver and it must not be used in patients with severe liver or kidney problems.
Rasilez HCT għandu jintuża b’ kawtela fil- pazjenti li għandhom problemi bil- kliewi u ma għandux jintuża fil- pazjenti bi problemi gravi fil- fwied jew fil- kliewi.
How does Rasilez HCT work?
Kif jaħdem Rasilez HCT?
Rasilez HCT contains two active substances, aliskiren and hydrochlorothiazide.
Rasilez HCT fih żewġ sustanzi attivi, aliskiren u l- idroklorotijażide.
Aliskiren is a renin inhibitor.
Aliskiren huwa inibitur tar- renina.
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Jimblokka l- attività tal- enzima umana magħrufa bħala renina li għandha x’ taqsam mal- produzzjoni ta ’ sustanza bl- isem anġjotensina I fil- ġisem.
Angiotensin I is converted into the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- anġjotensina I tinbidel fl- ormon anġjotensina II, li hi sustanza b’ saħħitha li ddejjaq l- arterji u l- vini qawwi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
(vasoconstrictor).
By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Bl- imblukkar tal- produzzjoni tal- anġjotensina I, il- livelli kemm tal- anġjotensina I kif ukoll tal- anġjotensina II jonqsu.
This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
Dan jikkawża t- twessigħ tal- arterji u tal- vini (vasodilation) biex b’ hekk tonqos il- pressjoni tad- demm.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
L- idroklorotijażide huwa dijuretiku, tip ieħor ta ’ trattament għall- ipertensjoni.
It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Taħdem billi tiżdied il - kwantità ta ’ awrina li toħroġ u b’ hekk tnaqqas il- kwantità ta ’ fluwidu fid- demm kif ukoll il- pressjoni tad- demm.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Il- kombinazzjoni taż- żewġ sustanzi attivi tipproduċi effett ulterjuri li hu dak tatt- tnaqqis tal- pressjoni tad- demm aktar minn waħda miż- żewġ mediċini waħedhom.
By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad- demm, jitnaqqas ir- riskju kkawżat minn pressjoni għolja, bħall- puplesija.
How has Rasilez HCT been studied?
Kif ġie studjat Rasilez HCT?
Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Enviage, Sprimeo, Tekturna and Riprazo.
Aliskiren meħud waħdu ilu awtorizzat fl- Unjoni Ewropea (UE) minn Awwissu 2007 bħala Rasilez, Enviage, Sprimeo, Tekturna u Riprazo.
The company presented information used in the assessment of aliskiren and from the published literature to support its application for Rasilez HCT, as well as information from additional studies.
Il- kumpanija ppreżentat informazzjoni użata fil- valutazzjoni ta ’ aliskiren u meħuda mil- letteratura ppubblikata għas- sostenn tal- applikazzjoni tagħha għal Rasilez HCT kif ukoll l- informazzjoni meħuda minn studji addizzjonali.
Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Kumplessivament, il- kumpanija ppreżentat ir- riżultati ta ’ disa ’ studji ewlenin li involvew total ta ’ 9, 000 pazjent li jbatu minn ipertensjoni essenzjali.
Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Il- maġġoranza tal- istudji involviet pazienti b’ ipertensjoni minn ħafifa għal moderata u studju ieħor involva pazjenti b’ ipertensjoni gravi.
The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
L- istudji qabbli l- kombinazzjoni ta ’ aliskiren ma ’ idroklorotijażide ma ’ plaċebo (trattament finta), ma ’ aliskiren jew idroklorotijażide meħudin waħedhom jew ma ’ mediċini oħra għall- ipertensjoni (valsartan, irbesartan, lisinopril jew amlodipina).
The studies lasted for between eight weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
It- tul ta ’ żmien tal- istudji varja bejn tmien ġimgħat u sena u l - kejl ewlieni tal- effikaċja kien il- bidla fil- pressjoni tad- demm matul il- fażi ta ’ mistrieħ tat- taħbit tal - qalb (pressjoni dijastolika) jew waqt il- fażi ta ’ kontrazzjoni tal- kmamar tal- qalb (pressjoni sistolika).
Three additional studies were carried out to show that the active substances were absorbed in the body in the same way when they taken as separate tablets and as Rasilez HCT.
Twettqu tliet studji addizzjonali biex juru li s- sustanzi attivi ġew assorbiti mill- ġisem fl- istess mod bħal meta kienu ttieħdu f’ pilloli separati u f’ Rasilez HCT.
What benefit has Rasilez HCT shown during the studies?
Liema benefiċċju wera Rasilez HCT fl- istudji mwettqa?
Rasilez HCT was more effective than placebo in reducing blood pressure.
Rasilez HCT irriżulta iktar effikaċi mill- plaċebo biex inaqqas il- pressjoni tad- demm.
In patients whose blood pressure was not adequately controlled on either aliskiren or hydrochlorothiazide alone, switching to the combination resulted in greater falls in blood pressure than remaining on one active substance alone.
Meta l- pazjenti li l- pressjoni tad- demm tagħhom ma kinitx ikkontrollata b’ mod adegwat b’ aliskiren jew b’ idroklorotijażide meħudin waħedhom qalbu għall- kombinazzjoni, dan irriżulta fi tnaqqis akbar tal - pressjoni tad- demm milli meta baqgħu jieħdu sustanza attiva waħda biss.
What is the risk associated with Rasilez HCT?
X’ inhu r- riskju assoċjat ma ’ Rasilez HCT?
The most common side effect with Rasilez HCT (seen in between 1 and 10 patients in 100) is diarrhoea.
L- effett sekondarju l- aktar komuni b’ Rasilez HCT (li deher f’ bejn pazjent 1 u 10 minn 100) hu dijarrea.
For the full list of all side effects reported with Rasilez HCT, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Rasilez HCT, ara l- Fuljett ta ’ Tagħrif.
Rasilez HCT should not be used in people who may be hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides.
Rasilez HCT ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal aliskiren, għall- idroklorotijażide, għal kwalunkwe mis- sustanzi l- oħra jew għas- sulfonamidi.
It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, who have severe kidney or liver problems, or whose blood potassium levels are too low or blood calcium levels are too high.
Ma għandux jintuża fil- pazjenti li kellhom anġjoedema (neħfa taħt il- ġilda) b’ aliskiren, li għandhom problemi gravi bil- kliewi jew bil- fwied, jew b’ livelli ta ’ potassju fid- demm baxxi wisq jew dawk tal- kalċju għoljin wisq.
It must not be taken with ciclosporin (a medicine that reduces the activity of the immune system) or other medicines that may slow down the breakdown of aliskiren in the body, such as quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Ma għandux jittieħed flimkien maċ- ċiklosporina (mediċina li tnaqqas l- attività tas- sistema immunitaria) jew ma ’ mediċini oħra li jistgħu jnaqqsu r- ritmu tal- metabolizzazzjoni tal- aliskiren fil - ġisem, bħall- quinidine (użata biex tikkoreġi l- aritmija kardijaka [taħbit irregolari tal- qalb]) jew verapamil (użata għat- trattament tal- problemi kardijaċi).
It must not be used in women who are more than three months pregnant or breast-feeding.
Din il- mediċina ma għandhiex tintuża minn nisa li ilhom aktar minn tliet xhur tqal jew li jreddgħu.
Its use during the first three months of pregnancy is not recommended.
Mhuwiex rakkomandat l- użu tagħha waqt l - ewwel tliet xhur tat- tqala.
Why has Rasilez HCT been approved?
Għaliex ġie approvat Rasilez HCT?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasilez HCT’ s benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone, or adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Rasilez HCT huma akbar mir- riskji tiegħu għat- trattament tal- ipertensjoni essenzjali f’ adulti li l - pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod adegwat b’ aliskiren jew b’ idroklorotijażide użati waħedhom, jew ikkontrollata b’ mod adegwat b’ aliskiren u b’ idroklorotijażide, mogħtija fl- istess ħin, fl- istess dożaġġ bħal fil- kombinazzjoni.
The Committee recommended that Rasilez HCT be given marketing authorisation.
Il- Kumitat irrakkomanda li Rasilez HCT jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rasilez HCT:
Aktar tagħrif dwar Rasilez HCT:
The European Commission granted a marketing authorisation valid throughout the EU for Rasilez HCT to Novartis Europharm Limited on 16 January 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Rasilez HCT lil Novartis Europharm Limited fi 16 ta ’ Jannar 2009.
2/ 3 This summary was last updated in 12-2008.
2/ 3 L- EPAR sħiħ għal Rasilez HCT jista ’ jiġi kkonsultat hawn.
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Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg 150 mg / 12.5 mg
150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 12. 5 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg
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Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC)
folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC)
7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 90 tablets (multipack) 98 tablets (multipack) 280 tablets (multipack) 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 56 x 1 tablets 90 tablets 98 tablets 98 x 1 tablets (multipack)
7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 90 pillola (b’ ħafna folji) 98 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 56 x 1 pillola 90 pillola 98 pillola 98 x 1 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 90 pillola (b’ ħafna folji) 98 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 56 x 1 pillola
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Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
150 mg / 12.5 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg
150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PCTFE/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC)
folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC)
280 tablets (multipack) 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 90 tablets (multipack) 98 tablets (multipack) 280 tablets (multipack) 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets
90 pillola 98 pillola 98 x 1 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 90 pillola (b’ ħafna folji) 98 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 56 x 1 pillola
1/ 3 EU/ 1/ 08/ 491/ 036 EU/ 1/ 08/ 491/ 037 EU/ 1/ 08/ 491/ 038 EU/ 1/ 08/ 491/ 039
EU/ 1/ 08/ 491/ 057 EU/ 1/ 08/ 491/ 058 EU/ 1/ 08/ 491/ 059 EU/ 1/ 08/ 491/ 060 EU/ 1/ 08/ 491/ 061 EU/ 1/ 08/ 491/ 062 EU/ 1/ 08/ 491/ 063 EU/ 1/ 08/ 491/ 064 EU/ 1/ 08/ 491/ 065
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg 150 mg / 25 mg
300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 12. 5 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC)
folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC)
56 x 1 tablets 90 tablets 98 tablets 98 x 1 tablets (multipack)
90 pillola 98 pillola 98 x 1 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola
EU/ 1/ 08/ 491/ 040 EU/ 1/ 08/ 491/ 041 EU/ 1/ 08/ 491/ 042 EU/ 1/ 08/ 491/ 043 EU/ 1/ 08/ 491/ 044 EU/ 1/ 08/ 491/ 045 EU/ 1/ 08/ 491/ 046 EU/ 1/ 08/ 491/ 047 EU/ 1/ 08/ 491/ 048 EU/ 1/ 08/ 491/ 049 EU/ 1/ 08/ 491/ 050 EU/ 1/ 08/ 491/ 051 EU/ 1/ 08/ 491/ 052 EU/ 1/ 08/ 491/ 053 EU/ 1/ 08/ 491/ 054 EU/ 1/ 08/ 491/ 055 EU/ 1/ 08/ 491/ 056 EU/ 1/ 08/ 491/ 057 EU/ 1/ 08/ 491/ 058 EU/ 1/ 08/ 491/ 059
EU/ 1/ 08/ 491/ 066
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT
150 mg / 25 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg 300 mg / 12.5 mg
300 mg / 25 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali