FrancophonIA/ELRC3.0 huggingface dataset:
English: During the first 4 weeks of double-blind treatment, patients received triple combination aliskiren/amlodipine/hydrochlorothiazide (HCTZ) 150/5/12.5 mg (N=308), or dual combinations of aliskiren/HCTZ 150/12.5 mg (N=295), aliskiren/amlodipine 150/5 mg (N=282) and amlodipine/HCTZ 5/12.5 mg (N=295).
Maltese: Matul l-ewwel 4 ġimgħat ta' trattament double-blind, il-pazjenti ngħataw kombinazzjoni trippla ta' aliskiren/amlodipine/hydrochlorothiazide (HCTZ) 150/5/12.5 mg (N=308), jew kombinazzjoni doppja ta' aliskiren/HCTZ 150/12.5 mg (N=295), aliskiren/amlodipine 150/5 mg (N=282) u amlodipine/HCTZ 5/12.5 mg (N=295).
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172).
Maltese: L-ingredjenti loħrajn huma cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172).
English: Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Wimblehurst Road
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
Maltese: L-ingredjenti l-oħrajn huma cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
English: Side effects reported for Rasitrio are:
Maltese: L-effetti sekondarji rrappurtati b'Rasitrio huma:
English: Rasitrio was associated with a significant reduction in plasma renin activity (PRA) (-34%) from baseline while the dual combination of amlodipine with hydrochlorothiazide increased PRA (+170%).
Maltese: Rasitrio kien assoċjat ma' tnaqqis sinifikanti fl-attività tar-renin fil-plażma (PRA) (-34%) mil-linja bażi filwaqt li l-kombinazzjoni doppja ta' amlodipine ma' hydrochlorothiazide żiedet il-PRA (+170%).
English: Torasemide renal excretion is known to be mediated by organic anion transporters (OATs).
Maltese: It-tneħħija renali ta' torasemide hija magħrufa li hija medjata minn trasportaturi talanjoni organiċi (OATs - organic anion transporters).
English: When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by 50%.
Maltese: Meta ngħata ma' atorvastatin (80 mg), l-AUC u Cmax ta' aliskiren (300 mg) fi stat fiss żdiedu b'50%.
English: - Vitamin D and calcium salts
Maltese: ˗ Vitamina D u mluħa tal-kalċju
English: Electrolyte imbalance
Maltese: Żbilanċ tal-elettroliti
English: Not recommended (see section 4.2) - Grapefruit juice
Maltese: Mhux irrakkomandat (ara sezzjoni 4.2) - Meraq tal-grejpfrut
English: Patients aged 65 years old or over, are more susceptible to hypotension-related adverse reactions following treatment with Rasitrio (see sections 4.2, 4.8, 5.1 and 5.2).
Maltese: Pazjenti li għandhom 65 sena jew aktar, huma aktar suxxettibbli għal pressjoni baxxa minħabba reazzjonijiet mhux mixtieqa relatati wara t-trattament b'Rasitrio (ara sezzjonijiet 4.2, 4.8, 5.1 u 5.2).
English: Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide.
Maltese: Rasitrio fih tliet sustanzi attivi, imsejħin aliskiren, amlodipine u hydrochlorothiazide.
English: Tremor, dysgeusia, syncope, hypoesthesia, paraesthesia
Maltese: Rogħda, disgewżja, sinkope, ipoestesija, parestesija
English: - medicines for the treatment of gout, such as allopurinol.
Maltese: - mediċini użati għat-trattament tal-gotta, bħal allopurinol.
English: Hereditary or idiopathic angioedema.
Maltese: Anġjoedima ereditarja jew idjopatika.
English: • allergic reactions (hypersensitivity)
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva)
English: - Digoxine or digitalis glycosides
Maltese: - Digoxine jew glikosidi diġitali
English: - Moderate P-gp inhibitors
Maltese: - Inibituri moderati ta' P-gp
English: The following adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide:
Maltese: Ir-reazzjonijiet avversi li ġejjin irrappurtati f'pazjenti li ngħataw kura b'dijuretiċi thiazide biss, inkluż hydrochlorothiazide:
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Maltese: Ikliet b'kontenut għoli ta' xaħam inaqqsu s-Cmax b'85% u l-AUC b'70%.
English: In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
Maltese: F'individwi f'saħħithom, itraconazole (100 mg) iżid lAUC u s-Cmax ta' aliskiren (150 mg) b'6.5 darbiet u 5.8 darbiet, rispettivament.
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN), oral mucosal reactions, rash, pruritus, urticaria
Maltese: Reazzjonijiet avversi serji fuq il-ġilda (SCARs) li jinkludu s-sindrom ta' Stevens Johnson, nekroliżi epidermali tossika (TEN), reazzjonijiet mukużi fil-ħalq, raxx, ħakk, urtikarja
English: Aliskiren Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Maltese: Aliskiren Aliskiren huwa inibitur dirett tar-renin tal-bniedem, attiv b'mod orali, selettiv u potenti, mhux peptajd.
English: Investigations: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f'parametri standard tallaboratorju kienu assoċjati b'mod mhux komuni mal-għoti ta' aliskiren.
English: The apparent volume of distribution is 4-8 l/kg.
Maltese: Il-volum ta' distribuzzjoni li jidher huwa minn 4-8 l/kg.
English: The volume of distribution is approximately 21 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa madwar 21 l/kg.
English: Discontinuation of therapy due to a clinical adverse event occurred in 3.6% of patients treated with Rasitrio versus 2.4% in aliskiren/amlodipine, 0.7% in aliskiren/hydrochlorothiazide and 2.7% in amlodipine/hydrochlorothiazide.
Maltese: It-twaqqif tat-terapija minħabba episodju mhux mixtieq klinikament seħħ fi 3.6% talpazjenti ttrattati b'Rasitrio kontra 2.4% b'aliskiren/amlodipine, 0.7% b'aliskiren/hydrochlorothiazide u 2.7% b'amlodipine/hydrochlorothiazide.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of aliskiren.
Maltese: Indutturi ta' P-gp (St. John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-bijodisponibbiltà ta' aliskiren.
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Maltese: L-użu konkomittanti ta' aliskiren ma' ciclosporin u itraconazole, żewġ inibituri ta' Pglycoprotein (P-gp) qawwija ħafna, u inibituri ta' P-gp qawwija oħrajn (quinidine, verapamil), huwa kontraindikat (ara sezzjoni 4.5).
English: • decreased skin sensitivity
Maltese: • tnaqqis fis-sensittività tal-ġilda
English: In children 6 to 12 years and in adolescents 13-17 years of age the typical oral clearance (CL/F) was 22.5 and 27.4 l/hr respectively in males and 16.4 and 21.3 l/hr respectively in females.
Maltese: Fi tfal minn 6 sa 12-il sena u f'adolexxenti bejn l-età ta' 13-17-il sena it-tneħħija tipika wara għoti mill-ħalq (CL/F) kienet ta' 22.5 u 27.4 l/siegħa rispettivament fl-irġiel u 16.4 u 21.3 l/siegħa rispettivament fin-nisa.
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi kkalkulata mid-dejta disponibbli)
English: • kidney problems including acute renal failure (severely decreased urine output)
Maltese: • problemi bil-kliewi li jinkludu indeboliment akut tal-kliewi (tnaqqis serju fl-awrina)
English: - ketonazole, a medicine used to treat fungal infections.
Maltese: - ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet bil-fungu.
English: Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.
Maltese: Hydrochlorothiazide jagħmel parti minn grupp ta' mediċini li jissejħu dijuretiċi thiazide.
English: Smaller changes in furosemide pharmacokinetics and efficacy were observed with aliskiren 150 mg/day.
Maltese: Kienu osservati tibdiliet iżgħar fil-farmakokinetika u l-effikaċja ta' furosemide b'aliskiren 150 mg/jum.
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (78%).
Maltese: Aliskiren il-biċċa l-kbira jiġi eliminat bħala kompost kimiku mhux mibdul fl-ippurgar (78%).
English: Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Maltese: Wara assorbiment orali, il-konċentrazzjonijiet ta' aliskiren fil-plażma laħqu l-quċċata wara 1-3 sigħat.
English: • abnormal liver function test
Maltese: • test tal-funzjoni tal-fwied mhux normali
English: Rasitrio is contraindicated during the second and third trimesters (see section 4.3).
Maltese: Rasitrio huwa kontraindikat waqt it-tieni u t-tielet trimestri tat-tqala (ara sezzjoni 4.3).
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Maltese: Ma ġie rrappurtat l-ebda effett fuq l-intervall QT fi studju randomizzat, double-blind, kontrollat bi plaċebo u bis-sustanza attiva b'elettrokardjografija standard u Holter.
English: CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)
Maltese: KAXXA TAL-WIEĦED/KAXXA B'PAKKETT TA' ĦAFNA (folja mtaqqba b'ħafna dożi)
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Maltese: Il-potenzjal ta' interazzjonijiet fis-sit P-gp x'aktarx li jkun jiddependi mill-grad ta' inibizzjoni tat-trasportatur.
English: Information on Rasitrio
Maltese: Mediċini oħra u Rasitrio
English: Multipack containing 98 (2 packs of 49x1) tablets.
Maltese: Pakkett b'ħafna ta' 98 (2 pakketti ta' 49x1) pillola.
English: At steady state the non-linearity may be more pronounced.
Maltese: Fi stat fiss in-nuqqas ta' linearità jista' jkun jidher aktar.
English: Mechanisms responsible for deviation from linearity have not been identified.
Maltese: Mekkaniżmi responsabbli għad-devjazzjoni mil-linearità ma ġewx identifikati.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
Maltese: Doża eċċessiva b'hydrochlorothiazide hija assoċjata ma' nuqqas ta' elettroliti (ipokalimja, ipoklorimja, iponatrimja) u deidratazzjoni li tiġi minn dijureżi eċċessiva.
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidonebased therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Maltese: Madanakollu, ma kien hemm l-ebda differenza sinifikanti fil-mortalità minn kull kawża bejn terapija bbażata fuq amlodipine u terapija bbażata fuq chlorthalidone RR 0.96 95% CI [0.89-1.02] p=0.20.
English: Patients were force-titrated to higher doses after 4 weeks for an additional 4 weeks of double-blind treatment to aliskiren/amlodipine/HCTZ 300/10/25 mg, aliskiren/HCTZ 300/25 mg, aliskiren/amlodipine 300/10 mg and amlodipine/HCTZ 10/25 mg.
Maltese: Il-pazjenti kellhom żidiet sfurzati tad-dożi wara 4 ġimgħat matul 4 ġimgħat oħra ta' trattament double-blind b'aliskiren/amlodipine/HCTZ 300/10/25 mg, aliskiren/HCTZ 300/25 mg, aliskiren/amlodipine 300/10 mg u amlodipine/HCTZ 10/25 mg.
English: - digoxin or other digitalis glycosides (medicines used to treat heart problems).
Maltese: - digoxin jew gliċosidi diġitalis oħrajn (mediċini użati għat-trattament ta' problemi tal-qalb).
English: Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium is recommended when Rasitrio is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali affettwati minn disturbi tal-potassju fis-serum: Monitoraġġ perjodiku tal-potassju fis-serum huwa rrakkomandat meta Rasitrio jingħata ma' prodotti mediċinali affettwati minn disturbi tal-potassju fis-serum (eż. digitalis glycosides, antiarritmijaċi).
English: The adverse reactions previously reported with one of the individual components of Rasitrio (aliskiren, amlodipine and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Rasitrio.
Maltese: Ir-reazzjonijiet avversi rrappurtati qabel b'wieħed mill-komponenti individwali ta' Rasitrio (aliskiren, amlodipine u hydrochlorothiazide) u elenkati fil-paragrafi rispettivi dwar il-komponenti individwali jistgħu jseħħu b'Rasitiro.
English: Single pack containing 14, 28, 56 tablets Multipacks containing 98 tablets (2 packs of 49)
Maltese: Pakkett wieħed li fih 14, 28, 56 pillola Pakketti b'ħafna li fihom 98 pillola (2 pakketti b'49) Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: - Pressor amines (e.g. noradrenaline, adrenaline) Hydrochlorothiazide may reduce the response to pressor amines such as noradrenaline.
Maltese: - Pressor amines (eż. noradrenalina, adrenalina) Hydrochlorothiazide jista' jnaqqas ir-rispons ta' amini pressivi bħan-noradrenalina.
English: Multipack containing 98 (2 packs of 49) tablets.
Maltese: Pakkett b'ħafna ta' 98 (2 pakketti ta' 49) pillola.
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 dijalisi tkun ta' benefiċċju.
English: Paediatric population (age below 18 years)
Maltese: Popolazzjoni pedjatrika (età taħt it-18-il sena)
English: • dizziness.
Maltese: • konfużjoni.
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Maltese: It-thiazides, inkluż hydrochlorthiazide, jistgħu jżidu r-riskju ta' reazzjonijiet avversi kkawżati minn amantadina.
English: Hepatobiliary disorders Rare
Maltese: Disturbi psikjatriċi Rari
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Maltese: Studji dwar is-sigurtà farmakoloġika ma wrew l-ebda effetti avversi fuq il-funzjoni tas-sistema nervuża ċentrali, respiratorja jew kardjovaskulari.
English: Rasitrio was studied in a double-blind, randomised, active-controlled study in 1,181 patients of which 773 were classified as moderately hypertensive (msSBP 160-180 mmHg) and 408 as severely hypertensive (msSBP >180 mmHg) at baseline.
Maltese: Rasitrio kien studjat waqt studju double-blind, randomizzat, ikkontrollat bl-attiv fost 1,181 pazjent li minnhom 773 kienu kklassifikati bħala li għandhom pressjoni għolja b'mod moderat (msSBP 160-180 mmHg) u 408 bħala li għandhom pressjoni għolja gravi (msSBP >180 mmHg) fil-linja bażi.
English: Rasitrio is contraindicated in hypertensive patients with severe hepatic impairment (see sections 4.3 and 5.2).
Maltese: Rasitrio hu kontraindikat f'pazjenti bi pressjoni għolja b'indeboliment epatiku akut (ara sezzjonijiet 4.3 u 5.2).
English: - St. John's wort (hypericum perforatum), a herbal medicine used to elevate mood.
Maltese: John's wort (hypericum perforatum), mediċina tal-ħxejjex li tintuża biex ittejjeb il-burdata.
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal aliskiren miżjud mad-dijuretiku hydrochlorthiazide, imblukkaturi tal-kanal tal-kalċju amlodipine u l-imblukkatur beta atenolol.
English: In clinical studies in hypertensive patients, aliskiren had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Maltese: Fi studji kliniċi f'pazjenti bi pressjoni għolja, aliskiren 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 aċidu uriku.
English: It is also available in multi-packs of 98x1 tablet (2 packs of 49x1) in perforated unit dose blister.
Maltese: Disponibbli wkoll f'pakketti b'ħafna li fihom 98x1 pilloli (2 pakketti ta' 49x1) f'folji mtaqqbin b'ħafna dożi.
English: • pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia)
Maltese: • ġilda ċassa, għeja, qtugħ ta' nifs, awrina ta' lewn skur (anemija emolitika)
English: Erythema multiforme Musculoskeletal and connective tissue disorders Not known
Maltese: Eritema multiformi Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid and non-selective NSAIDs: As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs) inklużi inibituri selettivi cyclooxygenase-2 (inibituri COX-2), aċidu aċetilsaliċiliku, u NSAIDs mhux selettivi:
English: - Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Maltese: - L-għoti fl-istess ħin ta' aktar minn doża waħda ta' 10 mg amlodipine ma' 80 mg simvastatin irriżulta f'żieda ta' 77% fl-espożizzjoni għal simvastatin meta mqabbel ma' simvastatin waħdu.
English: Rasitrio is available in packs containing 30 or 90 tablets in blisters.
Maltese: Rasitrio huwa disponibbli f'pakketti li fihom 30 jew 90 pillola f'folji.
English: Due to the hydrochlorothiazide component, Rasitrio is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Rasitrio hu kontraindikat f'iperurikemija sintomatika (ara sezzjoni 4.3).
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters: 2 years
Maltese: Folji PVC/polychlorotrifluoroethylene (PCTFE) - Alu: Sentejn
English: Glycosuria
Maltese: Glikosurja
English: Hypertension
Maltese: Ipokalimja
English: Aliskiren is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
Maltese: Aliskiren mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (rata tal-filtrazzjoni fil-glomeruli (GFR) <30 ml/min/1.73 m2).
English: In this study, Rasitrio at a dose of 300/10/25 mg produced statistically significant mean blood pressure reductions (systolic/diastolic) from baseline of 37.9/20.6 mmHg compared to 31.4/18.0 mmHg with aliskiren/amlodipine combination (300/10 mg), 28.0/14.3 mmHg with aliskiren/hydrochlorothiazide (300/25 mg) and 30.8/17.0 mmHg with amlodipine/hydrochlorothiazide (10/25 mg) in patients with moderate to severe hypertension.
Maltese: F'dan l-istudju, Rasitrio b'doża ta' 300/10/25 mg wassal għal tnaqqis sinifikanti statistikament filpressjoni tad-demm (sistolika/dijastolika) mil-linja bażi ta' 37.9/20.6 mmHg mqabbel mal31.4/18.0 mmHg b'kumbinazzjoni ta' aliskiren/amlodipine (300/10 mg), 28.0/14.3 mmHg b'aliskiren/hydrochlorothiazide (300/25 mg) u 30.8/17.0 mmHg b'amlodipine/hydrochlorothiazide (10/25 mg) f'pazjenti li għandhom pressjoni għolja minn moderata għal gravi.
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, corticosteroids, laxatives, adrenocoricotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives).
Maltese: Madanakollu, dan l-effett ta' hydrochlorothiazide fuq il-potassju fis-serum ikun mistenni li jitqawwa minn prodotti mediċinali oħrajn assoċjati mat-telf ta' potassju u ipokalimja (eż. dijuretiċi kaljuretiċi oħrajn, kortikosterojdi, porog, ormon adrenokortikotropiku (ACTH), amphotericin, carbenoxolone, penicillin G, derivati ta' salicylic acid).
English: Cardiac disorders Common Uncommon Vascular disorders Uncommon Respiratory, thoracic and mediastinal disorders Uncommon Gastrointestinal disorders Common Hepatobiliary disorders Not known
Maltese: Disturbi vaskulari Komuni Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna
English: PA/Alu/PVC - Alu calendar blisters:
Maltese: Folji kalendarju PA/Alu/PVC - Alu:
English: The concomitant use of Rasitrio with angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEI) is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Maltese: Rasitrio ma' imblukkaturi tar-riċetturi ta' angiotensin II (ARB) jew impedituri tal-enzima li tikkonverti angiotensin (ACEI) huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: • itching, itchy rash (urticaria)
Maltese: • ħakk, raxx bil-ħakk (urtikarja)
English: *Based on patient weight of 50 kg
Maltese: 25 mg/kuljum u pazjent ta' 60 kg.)
English: Severe hepatic impairment.
Maltese: Indeboliment epatiku sever.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicinal products that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see section 4.8).
Maltese: Numru minn dawn il-pazjenti kellhom storja ta' anġjoedima jew sintomi li jissuġġerixxu anġjoedima, li f'xi każijiet seħħet wara użu ta' prodotti mediċinali oħra li jistgħu jikkawżaw anġjoedima, inkluż imblokkaturi tal-RAAS (impedituri tal-enzima li tikkonverti angiotensin jew imblokkaturi tar-riċettur ta' angiotensin) (ara sezzjoni 4.8).
English: Agranulocytosis, bone marrow depression, haemolytic anaemia, leucopenia
Maltese: Agranuloċitosi, dipressjoni tal-mudullun tal-għadam, anemija emolitika, lewkopenija
English: A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Maltese: Studju dwar interazzjoni tal-mediċina b'doża waħda f'individwi b'saħħithom wera li ciclosporin (200 u 600 mg) iżid is-Cmax ta' aliskiren 75 mg b'madwar 2.5 drabi u l-AUC b'madwar 5 darbiet.
English: • tiredness
Maltese: • stitikezza
English: Amlodipine elimination from plasma is biphasic with a terminal elimination half-life of approximately 30 to 50 hours.
Maltese: L-eliminazzjoni ta' amlodipine mill-plażma tinqasam f'żewġ fażijiet, b'half life ta' eliminazzjoni terminali ta' madwar 30 sa 50 siegħa.
English: - pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) (used especially in the patients over 65 years old).
Maltese: - mediċini użati biex itaffu l-uġigħ jew l-infjammazzjoni, speċjalment sustanzi anti-infjammatorji mhux sterojdi (NSAIDs), inkluż inibituri selettivi ta' cyclooxygenase-2 (inibituri Cox-2)
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6fold increase in AUC and Cmax, respectively.
Maltese: Wara li tingħata doża waħda fil-medda ta' dożi bejn 75 u 600 mg, meta d-doża tiġi rduppjata jkun hemm żieda ta' ~2.3 u 2.6 drabi fl-AUC u s-Cmax rispettivament.
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 urew li madwar 97.5% tal-amlodipine li jkun qed jiċċirkola jintrabat mal-proteini tal-plażma.