FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/730/049 EU/1/11/730/057 EU/1/11/730/050 EU/1/11/730/058 EU/1/11/730/051 EU/1/11/730/052 EU/1/11/730/059 EU/1/11/730/055
Maltese: EU/1/11/730/058 EU/1/11/730/051 EU/1/11/730/052 EU/1/11/730/059 EU/1/11/730/055
English: Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia.
Maltese: L-użu konkomitanti ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, ma' imblukkaturi beta jista' jżid ir-riskju ta' ipergliċemija.
English: • ringing noise in ears
Maltese: ˗ Rażi ta' skambju anjoniku
English: In a subset of 588 patients in which patients >65 years were scarcely represented and those aged >75 years were very scarcely represented, the combination of aliskiren/amlodipine/hydrochlorothiazide (300/10/25 mg) produced a systolic/diastolic mean blood pressure reduction of 39.7/21.1 mmHg from baseline, compared to 31.3/18.74 mmHg for aliskiren/amlodipine (300/10 mg), 25.5/12.5 mmHg for aliskiren/hydrochlorothiazide (300/25 mg) and 29.2/16.4 mmHg for amlodipine/hydrochlorothiazide (10/25 mg) (the subset constitutes patients without aberrant readings, defined as a difference between systolic blood pressure (SBP) readings ≥10 mmHg at baseline or endpoint).
Maltese: F'sottogrupp ta' 588 pazjent fejn il-pazjenti kellhom >65 sena ftit li xejn kienu rrappreżentati u dawk li kellhom 75 sena kienu ftit li xejn irrappreżentati, il-kombinazzjoni ta' aliskiren/amlodipine/hydrochlorothiazide (300/10/25 mg) pproduċiet tnaqqis medju fil-pressjoni sistolika/dijastolika tad-demm ta' 39.7/21.1 mmHg mil-linja bażi, meta mqabbel mal31.
English: EU/1/11/730/001 EU/1/11/730/009 EU/1/11/730/002 EU/1/11/730/010 EU/1/11/730/003 EU/1/11/730/004 EU/1/11/730/011 EU/1/11/730/007
Maltese: EU/1/11/730/001 EU/1/11/730/009 EU/1/11/730/002 EU/1/11/730/010
English: The incidence of peripheral oedema for Rasitrio in a short-term double active-controlled study was 7.1% compared to 8.0% for aliskiren/amlodipine, 4.1% for amlodipine/hydrochlorothiazide and 2.0% for aliskiren/hydrochlorothiazide dual combinations.
Maltese: L-inċidenza ta' edima periferali għal Rasitrio waqt studju kkontrollat bl-attiv fuq perjodu qasir ta' żmien kienet ta' 7.1% mqabbel mat-8.0% għal aliskiren/amlodipine, 4.1% għall-kombinazzjonijiet doppji b'amlodipine/hydrochlorothiazide u 2.0% għal aliskiren/hydrochlorothiazide.
English: Photosensitivity reactions
Maltese: sensittività eċċessiva)
English: - medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G. - medicines to reduce blood pressure, including methyldopa.
Maltese: - mediċini li jistgħu jnaqqsu l-ammont ta' potassju fid-demm tiegħek, bħal dijuretiċi (pilloli tal ilma), kortikosterojdi, lassativi, carbenoxolone, amphotericin jew penisillin G. - mediċini oħra li jikkuraw pressjoni għolja, inkuż metildopa.
English: Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Maltese: It-tollerabbiltà kienet komparabbli fiż-żewġ gruppi ttrattati, madanakollu s-sogħla kienet aktar irrappurtata b'ramipril milli b'aliskiren (14.2% vs. 4.4%), filwaqt li d-dijarea kienet aktar komuni b'aliskiren milli b'ramipril (6.6% vs. 5.0%).
English: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Maltese: Ma dehru l-ebda interazzjonijiet rilevanti b'mod kliniku ma' atenolol, digoxin, amlodipine jew cimetidine.
English: Rasitrio has been administered to more than 1,155 patients in completed clinical trials, including 182 patients for one year or more.
Maltese: Rasitrio ngħata lil aktar minn 1,155 pazjent waqt provi kliniċi kompluti, inkluż lil 182 pazjent għal sena jew aktar.
English: Rasitrio is contraindicated in patients with severe hepatic impairment.
Maltese: Rasitrio hu kontraindikat f'pazjenti b'indeboliment epatiku sever.
English: Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Maltese: Hydrochlorothiazide ġeneralment jiġi mneħħi bħala sustanza mhux mibdula.
English: - Beta blockers and diazoxide
Maltese: ˗ Imblukkaturi beta u dijazossidu
English: Aliskiren is a substance that belongs to a group of medicines called renin inhibitors.
Maltese: Aliskiren huwa sustanza li jagħmel parti minn grupp ta' mediċini msejħa inibituri ta' renin.
English: Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
Maltese: Ostruzzjoni tal-passaġġ 'il barra tal-ventriklu tax-xellug (eż. stenożi aortika ta' grad għoli).
English: In an 8-week study in 754 hypertensive geriatric patients aged 65 years or older and geriatric patients aged 75 years or older (30%) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Maltese: Fi studju ta' 8 ġimgħat f'754 pazjent ġerjatriku bi pressjoni għolja li għandu 65 sena jew aktar u pazjenti ġerjatriċi li għandhom 75 sena jew aktar (30%) l-għoti ta' aliskiren b'dożi ta' 75 mg, 150 mg u 300 mg pprovdewx tnaqqis superjuri statistikament sinifikanti fil-pressjoni tad-demm (kemm sistolika u dijastolika) meta mqabbel ma' plaċebo.
English: Therefore particular caution is recommended when administering Rasitrio to patients aged 65 years and over, and extreme caution in patients aged 75 years or older (see sections 4.2, 4.4, 4.8 and 5.1).
Maltese: Għaldaqstant huwa rrakkomandat li jkun hemm kawtela partikulari meta jingħata Rasitrio lil pazjenti li għandhom 65 sena u aktar, u kawtela estrema f'pazjenti li għandhom 75 sena jew aktar (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.1).
English: In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients (aged 6-17 years) given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
Maltese: Fi studju farmakokinetiku ta' kura b'aliskiren f'39 pazjent pedjatriku bi pressjoni għolja (età minn 6-17-il sena) li ngħataw dożi ta' 2 mg/kg jew 6 mg/kg ta' aliskiren kuljum bħala granijiet (3.125 mg/pillola), il-parametri farmakokinetiċi kienu jixbhu lil dawk fl-adulti.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu calendar blisters: Single pack containing 14, 28, 56, 98 tablets
Maltese: - Alu: Pakkett wieħed li fih 14, 28, 56, 98 pillola
English: Thrombocytopenia sometimes with purpura
Maltese: Tromboċitopenija, xi kultant b'purpura
English: General In the event of severe and persistent diarrhoea, Rasitrio therapy should be stopped (see section 4.8).
Maltese: Fil-każ ta 'dijarea severa u persistenti, it-terapija b'Rasitrio għandha titwaqqaf (ara sezzjoni 4.8).
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive medicinal products.
Maltese: Pressjoni baxxa kienet ukoll mhux komuni (<1%) waqt terapija kkombinata bi prodotti mediċinali kontra lpressjoni għolja oħrajn.
English: Chloride deficit is generally mild and usually does not require treatment.
Maltese: Iddefiċjenza tal-kloru tkun ġeneralment ħafifa u normalment ma teħtieġx trattament.
English: A population pharmacokinetic study has been conducted in 74 hypertensive children aged from 1 to 17 years (with 34 patients aged 6 to 12 years and 28 patients aged 13 to 17 years) receiving amlodipine between 1.25 and 20 mg given either once or twice daily.
Maltese: Studju farmakokinetiku ta' popolazzjoni sar f'74 tifel u tifla bejn l-età ta' 1 u 17-il sena (b'34 pazjent bejn l-età ta' 6 u 12-il sena u 28 pazjent bejn l-età ta' 13 u 17-il sena) li kellhom pressjoni għolja u li kienu qed jieħdu amlodipine f'doża bejn 1.25 u 20 mg mogħti darba jew darbtejn kuljum.
English: The blood-pressure-lowering effect in patients with moderate to severe hypertension was independent of age, gender, race, body mass index and overweight-associated disorders (metabolic syndrome and diabetes).
Maltese: L-effett fittbaxxija tal-pressjoni tad-demm f'pazjenti bi pressjoni għolja minn moderata għal gravi kien indipendenti mill-età, is-sess, ir-razza, l-indiċi tal-massa tal-ġisem u distubi assoċjati mal-piż żejjed (sindrome metabolika u dijabete).
English: Hyperuricaemia, hypomagnesaemia, hyponatraemia
Maltese: Iperuriċemija, ipomanjesimija, iponatrimija
English: EU/1/11/730/037 EU/1/11/730/045 EU/1/11/730/038 EU/1/11/730/046 EU/1/11/730/039 EU/1/11/730/040 EU/1/11/730/047 EU/1/11/730/043
Maltese: EU/1/11/730/038 EU/1/11/730/046 EU/1/11/730/039 EU/1/11/730/040
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda f'kull 1,000 ruħ)
English: Aliskiren/amlodipine/hydrochlorothiazide combination The safety profile of Rasitrio presented below is based on clinical studies performed with Rasitrio and the known safety profile of the individual components aliskiren, amlodipine and hydrochlorothiazide.
Maltese: Il-profil ta' sigurtà ta' Rasitrio ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmula b'Rasitrio u l-profil ta' sigurtà magħruf tal-komponenti individwali aliskiren, amlodipine u hydrochlorothiazide.
English: The pharmacokinetics of Rasitrio have not been investigated.
Maltese: Il-farmakokinetiċi ta' Rasitrio ma ġewx investigati.
English: Rasitrio is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Maltese: Rasitrio hu trattament għal kontra l-pressjoni għolja effettiv mogħti darba kuljum lil pazjenti adulti, huma x'inhma s-sess, l-età, l-indiċi tal-massa tal-ġisem u l-etniċità.
English: No data is available in hypertensive patients with severe renal impairment (serum creatinine ≥150 μmol/l or 1.70 mg/dl in women and ≥177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Maltese: Ma teżistix informazzjoni dwar pazjenti b'sensittività eċċessiva b'indeboliment gravi tal-kliewi (kreatinina fis-serum ta' ≥150 μmol/l jew 1.70 mg/dl fin-nisa u ta' ≥177 μmol/l jew 2.00 mg/dl flirġiel u/jew stima tar-rata ta' filtrazzjoni mill-glomeruli (GFR) ta' <30 ml/min/1.73 m2).
English: Aliskiren is minimally excreted via the renal route, and only 0.6% of the aliskiren dose is recovered in urine following oral administration (see section 5.2).
Maltese: Aliskiren jitneħħa b'mod minimu permezz tarrotta renali, u wara għoti orali 0.6% biss tad-doża ta' aliskiren hija rkuprata fl-awrina (ara sezzjoni 5.2).
English: No interactions - In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,
Maltese: Ebda interazzjoni - Fi studji ta' interazzjoni klinika, amlodipine ma affettwax il-farmakokinetiċi ta' atorvastatin,
English: With amlodipine, available data suggest that gross overdose could result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Maltese: B'amlodipine, it-tagħrif disponibbli jissuġġerixxi li doża eċċessiva ħafna tista' tirriżulta f'vasodilatazzjoni periferali eċċessiva u possibbilment f'takikardija reflex.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC 0tau by 67% in hypertensive patients.
Maltese: Fi stadju stabbli ikliet b'kontenut baxx ta' xaħam inaqqsu s-Cmax b'76% u l-AUC0-tau b'67% f'pazjenti bi pressjoni għolja.
English: - steroids.
Maltese: • sturdament.
English: • sleep disturbances
Maltese: • disturb fil-vista
English: The mean weight of patients concomitantly treated with furosemide and 300 mg aliskiren (84.6 kg) was higher than the weight of patients treated with furosemide alone (83.4 kg).
Maltese: Il-piż medju tal-pazjenti li kienu kkurati b'furosemide flimkien ma' 300 mg aliskiren (84.6 kg) kien aktar mill-piż tal-pazjenti kkurati b'furosemide waħdu (83.4 kg).
English: itchy rash
Maltese: TAGĦRIF
English: After multiple doses of furosemide (60 mg/day) co-administered with aliskiren (300 mg/day) to patients with heart failure the urinary sodium excretion and the urine volume were reduced during the first 4 hours by 31% and 24%, respectively, as compared to furosemide alone.
Maltese: Wara ħafna dożi ta' furosemide (60 mg/jum) mogħti ma' aliskiren (300 mg/jum) lill-pazjenti b'insuffiċjenza tal-qalb, it-tneħħija tas-sodium malawrina u l-volum tal-awrina waqt l-ewwel 4 sigħat tnaqqsu b'31% u 24%, rispettivament, meta mqabbla ma' furosemide waħdu.
English: In patients with mild to moderate renal impairment, a 3-fold increase in hydrochlorothiazide AUC has been observed.
Maltese: F'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat, dehret żieda tripla fl-AUC ta' hydrochlorothiazide.
English: In patients ≥65 years the incidence was 10.2% with Rasitrio versus up to 5.4% with dual combinations.
Maltese: 2% b'Rasitrio kontra l-5.4% b'kombinazzjonijiet doppji.
English: Patients with history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Maltese: Pazjenti bi storja ta' anġjoedima jistgħu jkunu f'riskju akbar li jġarrbu anġjoedima waqt kura b'aliskiren (ara sezzjonijiet 4.3 u 4.8).
English: Information on Rasitrio interactions
Maltese: Informazzjoni dwar interazzjonijiet ta' Rasitrio
English: Asthenia, pyrexia
Maltese: Popolazzjoni pedjatrika
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Maltese: Thiazides għandhom jitwaqqfu qabel ma jsiru testijiet għallfunzjoni tal-paratajrojd.
English: Metabolism and nutrition disorders Very rare
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari ħafna
English: Impotence, gynaecomastia
Maltese: Pazjenti ġerjatriċi
English: In patients with severe hypertension (SBP ≥180 mmHg), the reduction in blood pressure from baseline for Rasitrio and the dual combinations respectively was 49.5/22.5 mmHg compared to 38.1/17.6 mmHg with aliskiren/amlodipine combination (300/10 mg), 33.2/14.3 mmHg with aliskiren/hydrochlorothiazide (300/25 mg) and 39.9/17.8 mmHg with amlodipine/hydrochlorothiazide (10/25 mg).
Maltese: 5/22.5 mmHg mqabbel mat-38.1/17.6 mmHg b'kombinazzjoni b'aliskiren/amlodipine (300/10 mg), 33.2/14.3 mmHg b'aliskiren/hydrochlorothiazide (300/25 mg) u 39.9/17.
English: Acute renal failure, renal impairment
Maltese: Insuffiċjenza akuta tal-kliewi, indeboliment tal-kliewi
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
Maltese: F'pazjenti bil-pressjoni għolja b'funzjoni renali normali, dożi terapewtiċi ta' amlodipine wasslu għalltnaqqis fir-reżistenza fil-vini renali u żieda fir-rata ta' filtrazzjoni fil-glomeruli u ċirkolazzjoni effettiva tal-plażma renali, mingħajr ma tinbidel il-frazzjoni ta' filtrazzjoni jew proteina fl-awrina.
English: Geriatric patients aged 75 years and over
Maltese: Pazjenti Ġerjatriċi li għandhom 75 sena u aktar
English: Aliskiren was evaluated for cardiovascular and/or renal benefit in a double blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR <60 ml/min/1.73 m2) with or without cardiovascular disease.
Maltese: Aliskiren kien evalwat għall-benefiċċju kardjovaskulari u/jew tal-kliewi fi studju randomised, doubleblind, kontrollat bi plaċebo f'8,606 pazjent b'dijabete tat-tip 2 u b'mard tal-kliewi kroniku (evidenzjat minn u proteinurja u/jew GFR <60 ml/min/1.73 m bi jew mingħajr mard kardjovaskulari.
English: • severe upper stomach pain
Maltese: • sturdament, mejt meta tkun bilwieqfa
English: • bruising and frequent infections (aplastic anaemia)
Maltese: • tbenġil u infezzjonijiet frekwenti (anemija aplastika)
English: • swelling
Maltese: • fwawar
English: A population pharmacokinetic analysis in patients with hypertension did not indicate any clinically relevant changes in the steady-state exposure (AUC) and Cmax of aliskiren, amlodipine and hydrochlorothiazide compared to the corresponding dual therapies.
Maltese: Analiżi farmakokinetika fost popolazzjoni ta' pazjenti bi pressjoni għolja ma writx xi tibdiliet klinikament relevanti fl-espożizzjoni fi stat stabbli (AUC) u fis-Cmax ta' aliskiren, amlodipine u hydrochlorothiazide meta mqabbel mat-terapiji doppji korrispondenti.
English: Store Rasitrio tablets in the original package in order to protect from moisture.
Maltese: Aħżen il-pilloli Rasitrio fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Rasitrio is contraindicated in hypertensive patients with severe renal impairment (GFR <30 ml/min/1.73 m2) or anuria (see sections 4.2. and 4.3).
Maltese: Rasitrio hu kontraindikat f'pazjenti bi pressjoni għolja b'indeboliment tal-kliewi (GFR <30 ml/min/1.73 m2) (ara sezzjonijiet 4.2 u 4.3).
English: - Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Maltese: ˗ Sustanzi antikolinerġiċi u prodotti mediċinali oħrajn li jaffettwaw il-motilità gastrika Il-bijodisponibbiltà ta' dijuretiċi tat-tip thiazide tista' tiżdied b'sustanzi antikolinerġiċi (eż. atropina, biperiden), mid-dehra minħabba tnaqqis fil-moviment gastrointestinali spontanju u r-rata ta' tbattil talistonku.
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol and triglycerides, and uric acid.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorthiazide, jistgħu jibdlu t-tolleranza għall-glukosju u jgħollu llivelli ta' kolesterol, u trigliċeridi u aċidu uriku fis-serum.
English: Linearity The increase in mean AUC is linear and dose proportional in the therapeutic range.
Maltese: Linearità Iż-żieda fil-medja tal-AUC hija lineari u fi proporzjon mad-doża fil-medda terapewtika.
English: What Rasitrio is
Maltese: X'inhu Rasitrio
English: Description of selected adverse events:
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula:
English: Compared to a diuretic (hydrochlorothiazide, HCTZ), aliskiren 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.
Maltese: Meta mqabbel ma' dijuretiku (hydrochlorothiazide - HCTZ), aliskiren 300 mg naqqas il-pressjoni sistolika/dijastolika tad-demm b'17.0/12.3 mmHg, imqabbel ma' 14.
English: Hyperkalaemia
Maltese: Alkolożi iperkloremika
English: Anaphylactic reactions, hypersensitivity reactions
Maltese: Reazzjonijiet anafilattiċi, reazzjonijiet ta' sensittività eċċessiva
English: Thiazide-induced hypokalaemia or hypomagnesaemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4).
Maltese: Jista' jkun hemm bżonn ta' aġġustament tad-doża tal-prodott mediċinali antidijabetiku (ara sezzjoni 4.4).
English: You should not take this medicine with grapefruit juice.
Maltese: M'għandekx tieħu din il-mediċina mal-meraq tal-grejpfrut.
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Maltese: -, b'hekk jeffettwa il-mekkaniżmi li bihom jerġgħu jiġu assorbiti l-elettroliti: iżid direttament l-eskrezzjoni ta' sodju u kloru 'madwar l-istess ammont, u indirettament b'din l-azzjoni dijuretika billi jnaqqas ilvolum tal-plażma, b'konsegwenza ta' żidiet fl-attività tar-renin fil-plażma, sekrezzjoni ta' aldosterone u telf tal-potassju fl-awrina u tnaqqis tal-potassju fis-serum.
English: Impotence
Maltese: Vaskulite
English: • swelling of hands, ankles and feet (peripheral oedema).
Maltese: • nefħa tal-idejn, għekiesi u saqajn (edima periferali).
English: What Rasitrio contains - Each Rasitrio 150 mg/5 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: X'fih Rasitrio - Kull pillola Rasitrio miksija b'rita tal-150 mg/5 mg/12.5 mg fiha 150 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Maltese: Ir-riskju ta' ipokalimja huwa akbar f'pazjenti b'ċirrożi tal-fwied, pazjenti li jkunu qed jingħataw dijureżi mgħaġġla, pazjenti li ma jkunux qed jieħdu ammont xieraq ta' elettroliti u pazjenti li jkunu qed jirċievu terapija fl-istess ħin b'kortikosterojdi jew ormon adrenokortikotropiku (ACTH) (ara sezzjonijiet 4.5 u 4.8).
English: • severe upper stomach pain (pancreatitis)
Maltese: • tibdil fid-drawwiet tal-ippurgar (inkluż dijarea u stitikezza)
English: In a randomised, double blind, active controlled, 36-week study in elderly patients whose blood pressure was not controlled with aliskiren/HCTZ 300/25 mg (SBP ≥140 mmHg), clinically meaningful further BP reduction was seen at week 36 endpoint for patients who received Rasitrio at a dose of 300/10/25 mg (from reductions in msSBP/msDBP of 15.0/8.6 mmHg at week 22 to reductions of 30.8/14.1 mmHg at week 36 endpoint).
Maltese: Waqt studju ta' 36 ġimgħa randomizzat, double-blind, ikkontrollat bl-attiv fost pazjenti anzjani li għandhom il-pressjoni tad-demm mhux ikkontrollata b'aliskiren/HCTZ 300/25 mg (SBP ≥140 mmHg), kien hemm tnaqqis ieħor sinifikanti klinikament fil-pressjoni tad-demm fl-endpoint tas-36 ġimgħa f'pazjenti mogħtija Rasitrio f'doża ta' 300/10/25 mg (minn tnaqqis fl-msSBP/msDBP ta' 15.
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Maltese: Każ ta' adenoma fil-kolon u każ ta' adenokarċinoma fil-musrana l-għamja li kien irreġistrat f'firien b'doża ta' 1,500 mg/kg/jum ma kinux statistikament sinifikanti.
English: However, as with other medicinal products acting on the renin-angiotensin-aldosterone system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Maltese: Madanakollu, kif jiġri bi prodotti mediċinali oħra li jaħdmu fuq is-sistema tar-renin-angiotensin-aldosterone, hemm żieda fir-riskju ta' insuffiċjenza tal-kliewi, inkluż insuffiċjenza akuta tal-kiewi, meta l-pazjenti bi stenożi tal-arterja renali jiġu kkurati b'aliskiren.
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Maltese: Intwera li hemm riċettur li għandu affinità għolja fil-kortiċi renali bħala s-sit ewlieni fejn jeħel u jaħdem id-dijuretiku thiazide u jiġi inibit it-trasport ta' NaCl fit-tubu distali konvolut.
English: Light pink, ovaloid convex film-coated tablet with bevelled edges, with “LIL” debossed on one side and “NVR” on the other.
Maltese: Pillola miksija b'rita roża ċar, konvessa f'forma ta' bajda bil-ġnub tasturati, b'“LIL” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: - Grapefruit juice
Maltese: Pressjoni għolja
English: Due to the hydrochlorothiazide component, Rasitrio is contraindicated for use in patients with anuria and in patients with severe renal impairment (GFR <30 ml/min/1.73 m2).
Maltese: Minħabba l-komponent hydrochlorthiazide, Rasitrio huwa kontraindikat għall-użu f'pazjenti b'nuqqas ta' produzzjoni ta' awrina u f'pazjenti b'indeboliment renali sever (GFR <30 ml/min/1.73 m2).