FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins.
Maltese: Studji in vitro b'amlodipine wrew li madwar 97.5% tal-amlodipine li jkun qed jiċċirkola jintrabat mal-proteini tal-plażma.
English: Magnesium stearate
Maltese: - Furosemide u torasemide
English: - clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections - amiodarone, a medicine used to treat abnormal heart rhythms - atorvastatin, a medicine used to treat high cholesterol - furosemide or torasemide, medicines belonging to the type known as diuretics, which are used to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling) - antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone) - rifampicin, a medicine used to prevent or treat infections - St. John's wort (hypericum perforatum), a herbal medicine used to elevate mood - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs) (used especially in patients over 65 years old) - diltiazem, a medicine used to treat heart problems - ritonavir, a medicine used to treat viral infection
Maltese: - amiodarone, mediċina li tintuża biex tikkura ritmu tal-qalb mhux normali - atorvastatin, mediċina li tintuża biex tikkura kolesterol għoli - furosemide jew torasemide, mediċini li jagħmlu parti minn dawk magħrufin bħala dijuretiċi, li jintużaw biex iżżid l-ammont tal-awrina li inti tagħmel u jintużaw ukoll biex jikkuraw ċertu tip ta' problema tal-qalb (insuffiċjenza tal-qalb) jew edima (nefħa) - antiepilettiċi (eż. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone) - rifampicin, mediċina li tintuża biex tilqa' kontra jew tikkura infezzjonijiet - St.
English: The adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekweza, b'dak li jseħħ l-aktar frekwenti msemmi l-ewwel, bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Maltese: Minħabba li amlodipine jeħel ħafna mal-proteini, mhuwiex probabbli li dijaliżi tkun ta' benefiċċju.
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, macrogol, talc and yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, macrogol, talc u iron oxide isfar (E172).
English: 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters) 280 tablets (20x14, PVC/PCTFE blisters)
Maltese: 98 pillola (2x49x1, folji b'dożi waħdiet PVC/PCTFE)
English: In a subset of 549 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 4.0/2.2 mmHg and 7.6/4.7 mmHg for the 150/10 mg and 300/10 mg strengths respectively compared to amlodipine 10 mg (the subset constitutes patients without aberrant readings, defined as difference in SBP ≥10 mmHg at baseline or endpoint).
Maltese: F'subsett ta' 549 pazjent, il-kombinazzjoni ta' aliskiren/amlodipine pproduċiet tnaqqis fil-pressjoni tad-demm medja sistolika/dijastolika addizzjonali ta' 4.0/2.2 mmHg u 7.6/4.7 mmHg għall-qawwiet 150/10 mg u 300/10 mg rispettivament meta mqabbla ma' amlodipine 10 mg (is-subsett jikkostitwixxi pazjenti mingħajr qari anormali, definita bħala differenza fl-SBP ≥10 mmHg fil-linja bażi jew punt ta' tmiem).
English: Taking into account the PRAC Assessment Report on the PSUR for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSURs għal aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Rasilamlo 150 mg/10 mg tablets
Maltese: Rasilamlo 150 mg/10 mg
English: There is no experience of overdose with Rasilamlo.
Maltese: Mediċini oħra u Rasilamlo
English: No data are
Maltese: DATA TA' SKADENZA
English: Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Maltese: Għalhekk, lużu ta' aliskiren u inibituri potenti ta' P-gp f'daqqa huwa kontraindikat (ara sezzjoni 4.3).
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive medicinal products.
Maltese: Pressjoni baxxa kienet ukoll mhux komuni (<1%) waqt terapija kombinata bi prodotti mediċinali kontra lpressjoni għolja oħrajn.
English: In an 8-week randomised, double-blind, placebo-controlled, parallel group factorial study in 1,688 randomised patients with mild to moderate hypertension, treatment with Rasilamlo at doses from 150 mg/5 mg to 300 mg/10 mg produced dose-dependent clinically meaningful mean blood pressure reductions (systolic/diastolic) ranging between 20.6/14.0 mmHg and 23.9/16.5 mmHg, respectively, compared to 15.4/10.2 mmHg for aliskiren 300 mg, 21.0/13.8 mmHg for amlodipine 10 mg and 6.8/5.4 mmHg with placebo in a population of patients with mean baseline blood pressure of 157.3/99.7 mmHg.
Maltese: Fi studju fattorjali, ta' gruppi paralleli, ikkontrollat bi plaċebo, double-blind, randomizzat u ta' tul ta' 8 ġimgħat f'1688 pazjent randomizzat b'ipertensjoni baxxa jew moderata, il-kura b'Rasilamlo f'dożi minn 150 mg/5 mg sa 300 mg/10 mg ipproduċiet tnaqqis fil-pressjoni tad-demm medja (sistolka/dijstolika) klinikament sinifikanti li jiddependi mid-doża li jvarja bejn 20.
English: Rasilamlo is not recommended in patients with severe renal impairment (GFR <30 ml/min/1.73 m
Maltese: Rasilamlo mhux irrakkomandat għallużu f'pazjenti b'indeboliment renali sever (GFR <30 ml/min/1.73 m
English: Rasilamlo 300 mg/10 mg tablets
Maltese: Rasilamlo 300 mg/10 mg
English: Rasilamlo 150 mg/5 mg tablets
Maltese: Rasilamlo 150 mg/5 mg
English: In a study in 847 randomised patients not adequately responsive to amlodipine 10 mg treatment, the combination of aliskiren/amlodipine 150 mg/10 mg and 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 11.0/9.0 mmHg and 14.4/11.0 mmHg respectively, which were statistically greater than for amlodipine 10 mg monotherapy.
Maltese: Fi studju fi 847 pazjent magħżula b'mod randomised li ma kinux qed jirrispondu b'mod xieraq għal kura b'amlodipine 10 mg, it-taħlita ta' aliskiren/amlodipine 150 mg/10 mg u 300 mg/10 mg tat tnaqqis medju ta' 11.0/9.0 mmHg u 14.4/11.0 mmHg rispettivament fil-pressjoni sistolika/dijastolika, li kien statistikament ogħla b'mod statistiku minn meta amlodipine 10 mg ingħata waħdu.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu calendar blisters: Single pack containing 14, 28, 56, 98 tablets Multi-packs containing 280 tablets (20 packs of 14)
Maltese: - Alu: Pakkett wieħed li fih 14, 28, 56, 98 pillola Pakketti b'ħafna li fihom 280 pillola (20 pakkett b'14)
English: Adverse reaction observed with monotherapy with amlodipine; * Peripheral oedema is a known, dose-dependent adverse reaction of amlodipine and has also been reported with aliskiren therapy in post-marketing experience.
Maltese: Reazzjoni avversa osservata b'monoterapija ta' amlodipine; * Edima periferali hija reazzjoni avversa, magħrufa, ta' amlodipine li tiddependi mid-doża u kienet irrappurtata wkoll b'terapija ta' aliskiren f'esperjenza ta' wara t-tqegħid fis-suq.
English: Rasilamlo 300 mg/5 mg tablets
Maltese: Rasilamlo 300 mg/5 mg
English: In a 8-week study in 754 hypertensive elderly (≥65 years) and very elderly patients (30% ≥75 years) 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 anzjan bi pressjoni għolja (≥65 sena) u pazjenti anzjani ħafna (30% ≥75 sena) l-għoti ta' aliskiren b'dożi ta' 75 mg, 150 mg u 300 mg pprovdew tnaqqis superjuri statistikament sinifikanti fil-pressjoni tad-demm (kemm sistolika u dijastolika) meta mqabbel ma' plaċebo.
English: A repeat-dose toxicity study was conducted in juvenile rats 8 days post-partum for 4 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Maltese: Sar studju ta' tossiċità b'doża ripetuta fuq firien mhux adulti ta' 8 ijiem post-partum għal 4 ġimgħat b'aliskiren f'doża ta' 30, 100 jew 300 mg/kg/jum.
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 tassodium mal-awrina u l-volum tal-awrina waqt l-ewwel 4 sigħat tnaqqsu b'31% u 24%, rispettivament, meta mqabbla ma' furosemide waħdu.
English: Effects of other medicinal products on amlodipine Caution required with concomitant use - CYP3A4 inhibitors
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq amlodipine Kawtela meħtieġa bl-użu fl-istess ħin - Inibituri ta' CYP3A4
English: At steady state meals with low fat content reduce Cmax by 76% and AUC 0-tau 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: In a subset of 584 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 7.9/4.8 mmHg and 11.7/7.7 mmHg for the 300/5 mg and 300/10 mg strengths respectively compared to aliskiren 300 mg (the subset constitutes patients without aberrant readings, defined as difference in systolic blood pressure (SBP) ≥10 mmHg at baseline or endpoint).
Maltese: F'subsett ta' 584 pazjent, il-kombinazzjoni ta' aliskiren/amlodipine ipproduċiet tnaqqis fil-pressjoni tad-demm medja sistolika/dijastolika addizzjonali ta' 7.9/4.8 mmHg u 11.7/7.7 mmHg għall-qawwiet 300/5 mg u 300/10 mg rispettivament meta mqabbla ma' aliskiren 300 mg (is-subsett jikkostitwixxi pazjenti mingħajr qari anormali, definit bħala differenza fil-pressjoni tad-demm sistolika (SBP) ≥10 mmHg fil-linja bażi jew punt ta' tmiem).
English: These studies indicate that excessive aliskiren exposure (>400-fold higher in 8-day old rats compared with adult rats) and high acute toxicity in juvenile rats are caused by immature MDR1, which suggests that in paediatric patients with immature MDR1, there is a potential for aliskiren overexposure (see sections 4.2, 4.3 and 5.2).
Maltese: Dawn l-istudji jindikaw li l-esponiment eċċessiv għal aliskiren (>400 darba ogħla f'firien fl-età ta' 8 ijiem meta mqabbel ma' firien adulti) u t-tossiċità akuta għolja f'firien mhux adulti jiġu kkawżati minn MDR1 immatura, li tissuġġerixxi li f'pazjenti pedjatriċi b'MDR1 immatura, hemm potenzjal ta' esponiment eċċessiv għal aliskiren (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Another repeat-dose toxicity study was conducted in juvenile rats 14 days post-partum for 8 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Maltese: Sar ukoll studju ieħor ta' tossiċità b'doża ripetuta fuq firien mhux adulti ta' 14-il jum post-partum għal 8 ġimgħat b'aliskiren f'doża ta' 30, 100 jew 300 mg/kg/jum.
English: In a double-blind, randomised placebocontrolled study in 1,688 patients with mild or moderate hypertension, discontinuation of therapy due to a clinical adverse event occurred in 1.7% of patients treated with Rasilamlo versus 1.5% of
Maltese: Fi studju double-blind, randomised ikkontrollat bi plaċebo f'1,688 pazjent bi pressjoni ħafifa jew moderata, it-twaqqif tal-kura minħabba każ kliniku avvers seħħ f'1.7% tal-pazjenti kkurati b'Rasilamlo versus 1.5% tal-pazjenti li ngħataw plaċebo.
English: Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
Maltese: Ostruzzjoni tal-passaġġ 'l barra tal-ventrikula tax-xellug (eż. stenożi aortika ta' grad għoli).
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, double-blind, 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: Keep your appointments with the doctor even if
Maltese: Jista' jkollok bżonn attenzjoni medika.
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Maltese: L-AUC huwa 50% ogħla fl-anzjani (>65 sena) milli f'individwi żgħażagħ.
English: , rhinitis
Maltese: , rinite
English: Renin inhibitors suppress the enzymatic activity of renin, and thereby block the formation of Angiotensin II, the major effector molecule of the renin-angiotensin-aldosterone system (RAAS).
Maltese: Inibituri ta' renin irażżnu l-attività enzimatika ta' renin, u b'hekk jimblokkaw il-formazzjoni ta' Angiotensin II, il-molekula prinċipali li tintrabat mal-proteini u taffettwa l-effett tagħhom fis-sistema ta' renin-angiotensin-aldosterone (RAAS).
English: , skin decolouration hyperhidrosis
Maltese: Magnesium stearate Silica colloidal anhydrous
English: Mechanisms responsible for deviation from linearity have not been identified.
Maltese: Mekkaniżmi responsabbli għad-devjazzjoni mill-linearità ma ġewx identifikati.
English: • runny nose
Maltese: • nawsja
English: Diarrhoea a, abdominal pain
Maltese: Dijarea a, uġigħ addominali
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Maltese: Il-farmakokinetika ta' amlodipine mhijiex effettwata b'mod sinifikanti mill-indeboliment renali.
English: - Each Rasilamlo 150 mg/10 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Maltese: - Kull pillola miksija b'rita ta' Rasilamlo 150 mg/10 mg fiha 150 mg aliskiren (bħala hemifumarate) u 10 mg amlodipine (bħala besylate).
English: , cough a,am
Maltese: , sogħla a,am
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever) (uncommon: may affect up to 1 in
Maltese: • Reazzjonijiet serji fil-ġilda (nekroliżi epidermali tossika u/jew reazzjonijiet fil-mukuża tal ħalq - ħmura fil-ġilda, infafet fix-xofftejn, fl-għajnejn jew il-ħalq, tqaxxir tal-ġilda, deni)
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by components of fruit juice in the gastrointestinal tract.
Maltese: Dan it-tnaqqis x'aktarx jiġri minħabba l-inibizzjoni, medjata minn polipeptajd organiku li jittrasporta il-joni, talassorbiment ta' aliskiren permezz ta' komponenti tal-meraq tal-frott mill-passaġġ gastrointestinali.
English: Arthralgia a,am
Maltese: Artralġja a,am
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 għall-tnaqqis fir-resistenza 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: Single pack containing 14, 28, 56 tablets Multi-packs containing 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14)
Maltese: Pakketti b'ħafna li fihom 98 pillola (2 pakketti b'49) u 280 pillola (20 pakkett b'14)
English: - Each Rasilamlo 300 mg/10 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Maltese: - Kull pillola miksija b'rita ta' Rasilamlo 300 mg/10 mg fiha 300 mg aliskiren (bħala hemifumarate) u 10 mg amlodipine (bħala besylate).
English: , hypotension c,a,am
Maltese: , pressjoni baxxa c,a,am
English: • trembling
Maltese: • fwawar
English: , gingival hyperplasia
Maltese: Hypromellose Macrogol
English: Reproductive system and breast disorders
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: , palpitations a,am
Maltese: , palpitazzjonijiet a,am
English: Caution required with concomitant use - P-gp interactions
Maltese: - Inibituri moderati ta' P-gp
English: Caution should be exercised when administering Rasilamlo to patients with hepatic impairment (see sections 4.2 and 5.2).
Maltese: Għandu jkun hemm kawtela meta Rasilamlo jingħata lil pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
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 reġistrat fi firien b'doża ta' 1,500 mg/kg/jum ma kinux statistikament sinifikanti.
English: - Each Rasilamlo 300 mg/5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Maltese: - Kull pillola miksija b'rita ta' Rasilamlo 300 mg/5 mg fiha 300 mg aliskiren (bħala hemifumarate) u 5 mg amlodipine (bħala besylate).
English: The doses in rats and rabbits provided systemic exposures of 1 to 4 and 5 times higher, respectively, than the maximum recommended human dose (300 mg).
Maltese: Id-dożi fil-firien u fniek kienu jipprovdu esponimenti sistemiċi ta' 1 sa 4 u 5 darbiet ogħla, rispettivament, mill-għola doża rrakkomandata fil-bniedem (300 mg).
English: - if you are between three and nine months pregnant - if you are taking any of the following medicines ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis) itraconazole (a medicine used to treat fungal infections) quinidine (a medicine used to correct heart rhythm) - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan - if the patient is less than 2 years of age - if you have very low blood pressure - if you are suffering from shock, including cardiogenic shock - if you have a narrowing of the aortic heart valve (aortic stenosis) - if you have heart failure after an acute heart attack If any of the above applies to you, do not take Rasilamlo and talk to your doctor.
Maltese: Mhux komuni (jistgħu jeffettwaw sa persuna waħda f'kull 100 ruħ): raxx tal-ġilda (dan jista' jkun sinjali ta' reazzjonijiet allerġiċi jew anġjoedima - ara l-effetti sekondarji “Rari” hawn taħt) problemi bil-kliewi li jinkludu indeboliment akut tal-kliewi (tnaqqis serju fl-awrina) reazzjonijiet serji fuq il-ġilda (nekroliżi epidermali tossika u/jew reazzjonijiet mukużi filħalq - ħmura fil-ġilda, infafet fix-xofftejn, fl-għajnejn jew il-ħalq, tqaxxir tal-ġilda, deni) sogħla ħakk raxx (inkluż raxx bil-ħakk u urtikarja) żieda fl-enzimi tal-fwied nuqqas ta' rqad bidliet fil-burdata (inkluż ansjetà) dipressjoni rogħda sens ta' togħma mibdul tintilef minn sensik għal għarrieda, għal ftit ħin tnaqqis fis-sensittività tal-ġilda tingiż jew titrix disturb fil-vista (inkluż vista doppja) żarżir fil-widnejn qtugħ ta' nifs imnieħer inixxi tibdil fid-drawwiet tal-ippurgar (inkluż dijarea u stitikezza)
English: The concomitant use of Rasilamlo with an ACEI or an ARB is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Rasilamlo ma' ACEI jew ARB hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR ta' <60 ml/min/1.73m2) (ara sezzjonijiet 4.5 u 5.1).
English: The combination at a dose of 300 mg/5 mg also showed statistically significantly greater blood pressure reduction than aliskiren 300 mg monotherapy.
Maltese: It-taħlita b'doża ta' 300 mg/5 mg uriet ukoll tnaqqis statistikament sinifikament ogħla fil-pressjoni minn meta aliskiren 300 mg ingħata waħdu.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara JIS/EXP.
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: Madankollu, 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: What Rasilamlo looks like and contents of the pack Rasilamlo 150 mg/5 mg film-coated tablets are light yellow, convex, oval film-coated tablets, with “T2” debossed on one side and “NVR” on the other.
Maltese: Il-pilloli miksijin b'rita Rasilamlo 150 mg/5 mg huma pilloli sofor ċari, konvessi, ovali, miksijin b'rita, b'“T2” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: In a study in 820 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/amlodipine 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 18.0/13.1 mmHg, which were statistically significantly greater than aliskiren 300 mg monotherapy.
Maltese: Fi studju ta' 820 pazjent magħżula b'mod randomised li ma kinux qed jirrispondu b'mod xieraq għal kura b'aliskiren 300 mg, it-taħlita ta' aliskiren/amlodipine 300 mg/10 mg tat tnaqqis medju ta' 18.0/13.1 mmHg fil-pressjoni sistolika/dijastolika, li kien sinifikament ogħla b'mod statistiku minn meta aliskiren 300 mg ingħata waħdu.
English: , jaundice a,am
Maltese: , urtikarja a,am
English: • decreased skin sensitivity
Maltese: , fotosensittività
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari ħafna
English: The ratio of lethal dose of 100 mg/kg/day and no-observed-adverse-effect-level (NOAEL) of 30 mg/kg/day is unexpectedly low.
Maltese: Bla mistenni, il-proporzjon ta' doża letali ta' 100 mg/kg/jum u l-livell bla effett ħażin osservat (NOAEL) ta' 30 mg/kg/jum irriżulta f'wieħed baxx.
English: Yellow, convex, ovaloid tablet with a bevelled edge, with “T7” debossed on one side and “NVR” on
Maltese: Pillola safra, konvessa, forma ta' bajda b'ġenb tasturat, b'“T7” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elderly patients.
Maltese: F'pazjenti anzjani, it-tneħħija ta' amlodipine għandha t-tendenza li tonqos hekk kif jiżdiedu l-AUC u l-half life tal-eliminazzjoni.