FrancophonIA/ELRC3.0 huggingface dataset:
English: • Women already on chronic anticoagulant treatment require careful consideration of the benefitrisk of use of HRT.
Maltese: • In-nisa li huma diġà fuq kura kronika antikoagulanti jeħtieġu kunsiderazzjoni bir-reqqa talbenefiċċju u tar-riskju tal-użu ta' HRT.
English: Pharmacotherapeutic group: Other sex hormones and modulators of the genital system, ATC code: G03XX01.
Maltese: Oħrajn ormoni sesswali u modulaturi tas-sistema ġenitali,
English: Age range (yrs)
Maltese: Ħin wara d-dożaġġ (Sigħat)
English: Posology The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime.
Maltese: Id-doża rakkomandata hija ta' 6.5 mg prasterone (pessarju wieħed) mogħtija darba kuljum, qabel il ħin tal-irqad.
English: Intrarosa has not been studied in women with endometrial hyperplasia.
Maltese: Intrarosa ma ġiex studjat f'nisa b'iperplażja endometrijali.
English: In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods.
Maltese: F'nisa b'utru intatt, ir-riskju ta' iperplażja endometrijali u karċinoma jiżdied meta jingħataw estroġeni eżoġeni għal perjodi twal.
English: • a disease affecting the eardrum and hearing (otosclerosis);
Maltese: • marda li taffettwa t-tambur tal-widnejn u s-smigħ (otosklerożi);
English: Prasterone was not mutagenic or clastogenic in a standard battery of in vitro and in vivo studies.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Prasterone ma kienx mutaġeniku jew klastoġeniku f'batterija standard ta' studji in vitro u in vivo.
English: Blood clots in a vein (thrombosis)
Maltese: Koagulazzjoni f'vina (trombożi)
English: In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
Maltese: b'hekk iffaċilita t-tkabbir tal-flora batterika normali.
English: • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.
Maltese: • Għal prodotti tal-estroġenu għal applikazzjoni vaġinali li l-esponiment sistemiku tagħhom għallestroġenu jibqa' fil-medda normali ta' wara l-menopawża, mhuwiex rakkomandat li jiżdied proġestaġenu.
English: If prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Maltese: Jekk kirurġija elettiva tkun sejra tiġi segwita minn immobilizzazzjoni fit-tul, huwa rakkomandat li l-HRT titwaqqaf temporanjament minn 4 sa
English: 4 *no differentiation was made between ischaemic and haemorrhagic stroke.
Maltese: 4*ma saret l-ebda differenzjazzjoni bejn puplesija iskemika u emorraġika.
English: Via Provinciale Schito 131 IT-80058 Torre Annunziata Italy
Maltese: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA L-Italja
English: Absolute bioavailability has been estimated as between 64% and 80%.
Maltese: Il-biodisponibilità assoluta kienet stmata bejn 64% u 80%.
English: , exfoliative dermatitis
Maltese: , dermatite esfoljattiva
English: Date of first authorisation: 14 April 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 14 t'April 2011
English: , arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Maltese: , arritmija (inkluż bradikardija, takikardija tal-ventrikulu, u fibrillazzjoni tal-atriju)
English: Visual disturbance (including diplopia)
Maltese: Disturb fil-vista (inkluż diplopja)
English: Stevens-Johnson syndrome
Maltese: , is sindrome ta' Stevens-Johnson
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Maltese: Aliskiren jiġi metabolizzat mill-anqas mill-enzimi cytochrome P450.
English: , gastritis
Maltese: , gastrite
English: Adverse reaction observed with Rasilamlo;
Maltese: Reazzjoni avversa osservata b'Rasilamlo;
English: , thrombocytopenia
Maltese: , tromboċitopenija
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome a, toxic epidermal necrolysis (TEN)
Maltese: Reazzjonijiet avversi serji fil-ġilda (SCARssevere cutaneous adverse reactions) li jinkludu s-sindrome ta' Stevens Johnson a, nekroliżi epidermali tossika (TEN - toxic epidermal necrolysis)
English: A single dose study was conducted in juvenile rats aged 14, 21, 24, 28, 31 or 36 days post-partum.
Maltese: Sar studju b'doża waħda fuq firien mhux adulti fl-età ta' 14, 21, 24, 28, 31 jew 36 jum post-partum.
English: , syncope
Maltese: , sinkope
English: 280 tablets (20x14, PA/Alu/PVC blisters)
Maltese: 280 pillola (20x14, folji PA/Alu/PVC)
English: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites, with 10% of the parent compound and 60% of the metabolites excreted in the urine.
Maltese: Amlodipine huwa metabolizzat b'mod estensiv (madwar 90%) fil-fwied għal metaboli inattivi, b'10% tas-sustanza oriġinali u 60% tal-metaboliti jitneħħew mal-awrina.
English: , malaise
Maltese: , disgewżja
English: - Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Maltese: Bla interazzjonijiet - Komposti li kienu investigati fi studji ta' farmakokinetika klinika ta' aliskiren kienu jinkludu acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate u hydrochlorothiazide.
English: , gynaecomastia
Maltese: , ġinekomastja
English: Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% vs 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Maltese: Fost it-tragwardi finali sekondarji, l-inċidenza ta' insuffiċjenza tal-qalb (komponent ta' taħlita komposta ta' tragward finali kardjovaskulari) kienet ogħla b'mod sinifikanti fil-grupp ta' amlodipine meta mqabbla mal-grupp ta' chlorthalidone (10.2% vs 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
English: , purpura
Maltese: , alopeċja purpura
English: Rasilamlo 150 mg/5 mg film-coated tablets Rasilamlo 150 mg/10 mg film-coated tablets Rasilamlo 300 mg/5 mg film-coated tablets Rasilamlo 300 mg/10 mg film-coated tablets Aliskiren/amlodipine
Maltese: Rasilamlo 150 mg/5 mg pilloli miksijin b'rita Rasilamlo 150 mg/10 mg pilloli miksijin b'rita Rasilamlo 300 mg/5 mg pilloli miksijin b'rita Rasilamlo 300 mg/10 mg pilloli miksijin b'rita Aliskiren/amlodipine
English: Rasilamlo is available in packs containing 14, 28, 56 or 98 tablets (in calendar blisters), 30 or 90 tablets (in normal blisters) and 56x1 tablet (as perforated unit dose blisters).
Maltese: Rasilamlo jiġi f'pakketti li fihom 14, 28, 56 jew 98 pillola (ġo folji kalendarju), 30 jew 90 pillola (f'folji normali) u 56x1 pillola (bħala folji ta' doża waħda mtaqqbin).
English: 56x1 tablet (PVC/PCTFE single-unit-dose blisters)
Maltese: 56x1 pillola (folji b'dożi waħdiet PVC/PCTFE)
English: Study results indicated a non-significant effect of aliskiren with a hazard ratio of 0.92 (95% Confidence Interval: 0.76-1.12; p=0.41, aliskiren vs. placebo).
Maltese: Ir-riżultati tal-istudju wrew effett ċkejken ta' aliskiren bi proporzjon ta' periklu ta' 0.92% (95% Intervall ta' Kunfidenza: 0.76-1.12; p=0.41, aliskiren vs. placebo).
English: Plasma aliskiren exposure in rats aged 14 days was between 85- and 387fold higher than that in adult rats aged 64 days.
Maltese: L-esponiment ta' aliskiren fil-plażma f'firien fl-età ta' 14-il jum kien bejn 85 u 387 ogħla minn dak f'firien adulti fl-età ta' 64 jum.
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'indiviwi f'saħħithom, itraconazole (100 mg) iżid l-AUC u s-Cmax ta' aliskiren (150 mg) b'6.5 darbiet u 5.8 darbiet, rispettivament.
English: , dyspepsia
Maltese: , dispepsja
English: Rasilamlo is contraindicated during the second and third trimesters (see section 4.3).
Maltese: Rasilamlo huwa kontraindikat waqt ittieni u t-tielet trimestri tat-tqala (ara sezzjoni 4.3).
English: , peripheral oedema c,a,am
Maltese: , edima periferali c,a,am
English: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Maltese: Ir-rabta mal-proteini filplażma ta' aliskiren hija moderata (47-51%) u ma tiddependix fuq il-konċentrazzjoni.
English: Children from birth to less than 2 years (see sections 4.2 and 5.3).
Maltese: Tfal mit-twelid sal-età ta' inqas minn sentejn (ara sezzjonijiet 4.2 u 5.3).
English: PERFORATED UNIT DOSE BLISTER (PCTFE)
Maltese: FOLJI TA' DOŻA WAĦDA MTAQQBIN (PCTFE)
English: Aliskiren 150 mg (increased to 300 mg if tolerated) added to conventional therapy was evaluated in a double-blind placebo-controlled randomised trial in 1,639 patients with reduced ejection fraction hospitalised for an episode of acute heart failure (NYHA Class III-IV) who were haemodynamically stable at baseline.
Maltese: Aliskiren 150 mg (miżjud għal 300 mg jekk ittollerat) mogħti mat-terapija konvenzjonali kien evalwat waqt prova randomizzata double-blind ikkontrollata bil-plaċebo f'1,639 pazjent bilfrazzjoni tal-ejezzjoni mnaqqsa u li kellhom jiddaħħlu l-isptar minħabba episodju ta' insuffiċjenza akuta tal-qalb (NYHA Klassi III-IV) li kienu stabbli emodinamikament fil-linja bażi.
English: , peripheral neuropathy
Maltese: , newropatija periferali
English: Unit dose pack (perforated unit dose blister) containing 56x1 tablet Multi-packs of unit dose (perforated unit dose blister) containing 98x1 tablet (2 packs of 49x1)
Maltese: Pakkett b'dożi waħdiet (folja mtaqqba biex tinqata' doża waħda) li fihom 56x1 pillola Pakketti b'ħafna ta' dożi waħdiet (folja mtaqqba biex tinqata' doża waħda) li fihom 98x1 pillola (2 pakketti ta' 49x1)
English: An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
Maltese: Kien hemm żieda fl-inċidenza ta' iperkalemija (20.9% kontra 17.5%), fl-indeboliment tal-kliewi/insuffiċjenza tal-kliewi (16.6% kontra 12.1%) u fil-pressjoni baxxa (17.1% kontra 12.6%) fost il-grupp mogħti aliskiren imqabbel mal-plaċebo u kienet akbar fost il-pazjenti bid-dijabete.
English: General In the event of severe and persistent diarrhoea, Rasilamlo therapy should be stopped (see section 4.8).
Maltese: Ġenerali Fil-każ ta 'dijarea severa u persistenti, it-terapija b'Rasilamlo għandha titwaqqaf (ara sezzjoni 4.8).
English: The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Maltese: Il-pazjenti kellhom mill-anqas fattur ta' riskju addizzjonali ieħor għal mard koronarju tal-qalb li kien jinkludi infart mijokardijaku jew puplesija qabel (>6 xhur qabel ma ddaħħlu fl-istudju) jew dokumentazzjoni ta' mard kardjovaskulari aterosklerotiku ieħor (total 51.5%), dijabete tat-tip 2 (36.1%), kolesterol b'lipoproteina ta' densità għolja <35 mg/dl jew <0.906 mmol/l (11.6%), ipertrofija tal-ventrikulu tax-xellug minn dijanjosi b'elettrokardjogramma jew elettrokardjografija (20.9%), tipjip attwali ta' sigaretti (21.9%).
English: Multipack containing 98 (2 packs of 49) tablets.
Maltese: Pakkett b'ħafna fih 98 (2 pakketti b'49) pillola.
English: 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 tal-laboratorju kienu assoċjati b'mod mhux komuni mal-għoti ta' aliskiren.
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of aliskiren.
Maltese: Indutturi oħra ta' P-gp (St. John's Wort) jistgħu jnaqqsu l-bijodisponibbiltà ta' aliskiren.
English: BLISTERS (PVC/PCTFE OR PA/Alu/PVC) CALENDAR BLISTERS ONLY
Maltese: FOLJI (PVC/PCTFE JEW PA/Alu/PVC) FOLJI
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Maltese: Ikliet b'kontenut għoli ta' xaħam inaqqsu is-Cmax b'85% u l-AUC b'70%.
English: Adverse reaction observed with monotherapy with aliskiren;
Maltese: Reazzjoni avversa osservata b'monoterapija ta' aliskiren;
English: Novartis Poland Sp. z o.o.
Maltese: Novartis Hrvatska d.o.o.
English: • dry skin, rash, itchy rash
Maltese: • ġilda xotta, raxx, raxx bil-ħakk
English: Rasilamlo contains two active substances, called aliskiren and amlodipine.
Maltese: Rasilamlo fih żewġ sustanzi attivi, imsejħa aliskiren u amlodipine.
English: Hepatitis a,am
Maltese: Epatite a,am
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the
Maltese: Indutturi ta' P-gp (St. John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-bijodisponibbiltà ta' aliskiren.
English: • swelling, including swelling of hands, ankles or feet (peripheral oedema)
Maltese: • nefħa, inkluż nefħa fl-idejn, għekiesi jew saqajn (edima periferali),
English: A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild
Maltese: Studju randomised u double blind ta' morbidità u mortalità msejjaħ Prova b'kura Kontra l-Pressjoni Għolja u li Tbaxxi x-Xaħam fid-Demm biex tilqa' kontra Attakk tal-Qalb (ALLHAT) sar biex iqabbel terapiji aktar ġodda: amlodipine 2.5-10 mg/kuljum (imblukkatur tal-kanali tal-calcium) jew lisinopril 10-40 mg/kuljum (inibitur ACE) bħala terapiji tal-bidu ma' dawk ta' dijuretiċi thiazide, chlorthalidone 12.5-25 mg/kuljum fi pressjoni għolja minn ħafifa sa moderata.
English: Plasma aliskiren exposure (AUC) in rats aged 8 days was nearly 4-fold higher than that in rats aged 14 days at 100 mg/kg/day.
Maltese: L-esponiment ta' aliskiren fil-plażma (AUC) f'firien fl-età ta' 8 ijiem kien kważi 4 darbiet ogħla minn dak f'firien fl-età ta' 14-il jum li ngħataw doża ta' 100 mg/kg/jum.
English: Hyponatraemia a
Maltese: Iperkalimja a
English: Multipack containing 280 (20 packs of 14) tablets.
Maltese: Pakkett b'ħafna fih 280 (20 pakkett b'14) pillola.
English: Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Imblokk doppju ta' RAAS b'aliskiren, ARBs jew ACEIs Dejta minn provi kliniċi wriet li imblokk doppju ta' RAAS permezz tal-użu kombinat ta' ACEIs, ARBs jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, puplesija, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Rasilamlo is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Maltese: Rasilamlo huwa kontraindikat fi tfal mit-twelid sal-età ta' inqas minn sentejn u ma għandux jintuża fi tfal fl-età ta' sentejn sa inqas minn 6 snin minħabba tħassib ta' sigurtà dovut għal esponiment eċċessiv potenzjali għal aliskiren (ara sezzjonijiet 4.3, 4.4, 5.2 u 5.3).
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 uric acid.
English: At steady state the non-linearity may be more pronounced.
Maltese: Fi stat fiss in-nuqqas ta' linearità tista' tkun tidher aktar.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (GFR 89-60 ml/min/1.73 m and 59-30 ml/min/1.73 m 2, respectively, see sections 4.4 and 5.2).
Maltese: M'hemmx bżonn li jkun hemm aġġustamenti tad-doża tal-bidu għall-pazjenti li jkollhom indeboliment renali ħafif sa moderat (GFR ta' 89-60 ml/min/1.73 m u ta' 59-30 ml/min/1.73 m rispettivament, ara sezzjonijiet 4.4 u 5.2).
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 ġiex irrappurtat l-ebda effett fuq l-intervall QT fi studju randomised, double-blind, kontrollat bi plaċebo u bis-sustanza attiva b'elettrokardjografija standard u Holter.
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal aliskiren miżjud mad-dijuretiku hydrochlorthiazide u l-imblukkatur beta atenolol.
English: It is also available in multi-packs of 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14) in calendar blisters and 98x1 tablet (2 packs of 49x1) as perforated unit dose blisters.
Maltese: Huwa jiġi wkoll f'pakketti b'ħafna ta' 98 pillola (2 pakketti b'49) u 280 pillola (20 pakkett b'14) ġo folji kalendarju u 98x1 pillola (2 pakketti x 49x1) bħala folji ta' doża waħda mtaqqbin.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, renin inhibitors, ATC
Maltese: Sustanzi li jaħdmu fuq is-sistema tar-renin-angiotensin, inibituri tarrenin, Kodiċi ATC: C09XA53
English: The most frequent adverse reactions for Rasilamlo are hypotension and peripheral oedema.
Maltese: L-aktar reazzjonijiet avversi frekwenti għal Rasilamlo huma pressjoni baxxa u edema periferali.
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide isfar (E172) u iron oxide aħmar (E172).
English: **, liver failure a,
Maltese: **, insuffiċjenza tal-fwied a,
English: Limited safety data are available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children aged 6 to less than 18 years (see sections 4.8 and 5.2).
Maltese: Hija disponibbli dejta limitata dwar is-sigurtà minn studju farmakokinetiku tal-kura ta' aliskiren f'39 tifel u tifla li jbatu minn pressjoni għolja fl-età ta' bejn 6 snin u inqas minn 18-il sena (ara sezzjonijiet 4.8 u 5.2).
English: On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information.
Maltese: Abbażi ta' konklużjonijiet xjentifiċi għal aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, is-CHMP huwa tal-opinjoni li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide huwa favorevoli soġġett għall-bidliet proposti lill-informazzjoni tal-prodott.
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: Madankollu, 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: In clinical studies aliskiren has not been investigated 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 GFR <30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Maltese: Fl-istudji kliniċi, aliskiren ma ġiex investigat f'pazjenti li għandhom il-pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis-serum ≥150 μmol/l jew 1.70 mg/dl fin-nisa u ≥177 μmol/l jew 2.00 mg/dl fl-irġiel u/jew GFR stmata <30 ml/min/1.73 m2), li kellhom dijalisi filpassat, sindrome nefrotika jew pressjoni għolja renovaskulari.
English: The pharmacokinetics of aliskiren was evaluated in rats aged from 8 to 28 days after intravenous administration of aliskiren 3 mg/kg.
Maltese: Il-farmakokinetika ta' aliskiren ġiet evalwata f'firien fl-età ta' bejn 8 u 28 jum wara l-injezzjoni filvini ta' aliskiren f'doża ta' 3 mg/kg.
English: , hepatic enzymes increased (mostly consistent with cholestasis)
Maltese: , żieda tal-enzimi tal-fwied (ħafna minnhom konsistenti ma' kolestażi)
English: See also information under the heading “Do not take Rasilamlo”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Rasilamlo”.
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
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 (eż. quinidine), huwa kontra-indikat (ara sezzjoni 4.5).
English: The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Maltese: Il-profil ta' sigurtà ta' Rasilamlo ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmula b'Rasilamlo u l-profil ta' sigurtà magħruf tal-komponenti individwali aliskiren u amlodipine.
English: Aliskiren is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m
Maltese: Aliskiren mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (rata talfiltrazzjoni fil-glomeruli (GFR) <30 ml/min/1.73 m
English: Angioedema a, erythema a
Maltese: Anġjoedima a, eritema a
English: CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)
Maltese: KARTUNA TA' PAKKETT B'WIEĦED/KARTUNA TA' PAKKETT B'DOŻI WAĦDIET (folja mtaqqba biex tinqata' doża waħda)
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: No mortality or significant toxicity was observed.
Maltese: Ma ġiet osservata ebda mortalità jew tossiċità sinjifikanti.
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc u iron oxide isfar (E172).
English: , ankle swelling
Maltese: , ħalq xott