FrancophonIA/ELRC3.0 huggingface dataset:
English: In the body, a hormone called ‘thrombopoietin' stimulates the production of platelets by attaching to certain receptors (targets) in the bone marrow.
Maltese: Fil-ġisem, ormon imsejjaħ “trombopojetin” jistimula l-produzzjoni tal-pjastrini billi jeħel ma' ċerti riċetturi (miri) fil-mudullun.
English: How does Revolade work?
Maltese: Kif jintuża Revolade?
English: This study lasted 13 weeks and looked at the proportion of patients whose platelet count had increased to at least 50,000 per microlitre for at least 6 out of 8 weeks, between week 5 to 12 of the study in the absence of rescue medication.
Maltese: Dan listudju dam 13-il ġimgħa u ffoka fuq il-proporzjon ta' pazjenti li l-għadd ta' pjastrini tagħhom żdidilhom sa mill-inqas 50,000 għal kull mikrolitru għal tal-inqas 6 minn 8 ġimgħat, bejn il-5 ġimgħa u t-12-il ġimgħa tal-istudju fin-nuqqas ta' medikazzjoni ta' salvataġġ.
English: The most common side effects with Revolade in adults with ITP (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea and abnormal blood levels of certain liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni b'Revolade fl-adulti bl-ITP (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma nawżja (tħossok imdardar), dijarea u livelli tad-demm anormali ta' ċerti enzimi tal-fwied.
English: In children with ITP, the most common side effects include nose and throat infection, cough, fever, pain in the belly or in the mouth and throat, toothache and runny nose.
Maltese: Fit-tfal bl-ITP, l-effetti sekondarji l-aktar komuni jinkludu infezzjoni tal-imnieħer u tal-griżmejn, sogħla, deni, uġigħ fiż-żaqq jew fil-ħalq u fil-griżmejn, uġigħ fis-snien u mnieħer li jqattar.
English: • acquired severe aplastic anaemia (a disease in which the bone marrow does not make enough blood cells or platelets).
Maltese: • anemija aplastika severa miksuba (marda fejn il-mudullun ma jagħmilx biżżejjed ċelloli tad-demm jew pjastrini).
English: D-90429 Nuremberg Germany
Maltese: D-90429 Norimberga
English: Novartis Farmacéutica SA Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Maltese: Novartis Farmacéutica SA Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spanja
English: Dantrolene (infusion)
Maltese: Dantrolene (infużjoni)
English: Approximate size: diameter 8.20 mm.
Maltese: Daqs approssimattiv: dijametru 8.20 mm.
English: Date of first authorisation: 16 January 2007 Date of latest renewal: 21 November 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 16 Jannar 2007 Data tal-aħħar tiġdid: 21 Novembru 2011
English: MedDRA System organ class
Maltese: Sistema talKlassifika talOrgani MedDRA
English: Absolute bioavailability has been calculated as between 64% and 80%.
Maltese: Il-bijodisponibilità assoluta kienet kalkulata bejn 64% u 80%.
English: Stevens-Johnson syndrome
Maltese: Sindrome ta' StevensJohnson
English: Other possible side effects of Dafiro:
Maltese: Effetti sekondarji possibli oħra ta' Dafiro:
English: No data are available.
Maltese: M'hemm lebda data disponibbli.
English: Approximate size: 14.2 mm (length) x 5.7 mm (width).
Maltese: Daqs approssimattiv: 14.2 mm (tul) x 5.7 mm (wisa').
English: Mean absolute bioavailability is 23%.
Maltese: Il-medja tal-bijodisponibilità assoluta hija 23%.
English: Frequency Dafiro Amlodipine Valsartan
Maltese: Frekwenza Dafiro Amlodipine Valsartan
English: Grapefruit or grapefruit juice
Maltese: Grejpfrut jew meraq tal-grejpfrut
English: • Shock (including cardiogenic shock).
Maltese: • Xokk (inkluż xokk kardjoġeniku).
English: Exfoliative dermatitis
Maltese: Dermatite esfoljattiva
English: Cellulose microcrystalline Crospovidone (type A) Silica, colloidal anhydrous Magnesium stearate
Maltese: Qalba tal-pillola Cellulose microcrystalline Crospovidone (type A) Silica, colloidal anhydrous Magnesium stearate
English: Confusion.
Maltese: Konfużjoni.
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Maltese: Valsartan jintrabat b'mod qawwi mal-proteini tas-serum (94-97%), l-aktar ma' l-albumina tas-serum.
English: Hypertonia
Maltese: Ipertonja
English: Adverse reactions have been ranked under headings of frequency 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: Reazzjonijiet avversi kienu klassifikati taħt titli ta' frekwenzi bil-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: Similar outcomes have been reported with valsartan.
Maltese: Konsegwenzi simili kienu rappurtati b'valsartan.
English: Renal artery stenosis
Maltese: Stenożi ta' l-arterja renali
English: In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Maltese: L-użu ta' valsartan waħdu ma weriex nuqqas ta' qbil ta' sinifikat kliniku b'dawn is-sustanzi li ġejjin: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
English: Interactions common to the combination
Maltese: Interazzjonijiet komuni għall-kombinazzjoni
English: Oedema peripheral
Maltese: Edima periferali
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% versus 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% kontra 7.7%, RR 1.38, 95% CI [1.25-1.52] p <0.
English: Elimination: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Maltese: Valsartan juri kinetiċi ta' tħassir multi-esponenzjali (t½α <1 h t½ß madwar 9 h).
English: Very rare Not known
Maltese: Rari ħafna
English: Extrapyramidal syndrome
Maltese: Sindrome ekstrapiramidali
English: Biotransformation: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Maltese: Amlodipine huwa metabolizzat b'mod estensiv (madwar 90%) fil-fwied għal metaboli inattivi.
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Maltese: Total ta' 33,357 pazjent bi pressjoni għolja li kellhom 55 sena jew aktar kienu randomizzati u ġew segwiti għal medja ta' 4.9 snin.
English: The half-life of valsartan is 6 hours.
Maltese: Il-half life ta' valsartan hija 6 sigħat.
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Maltese: Livelli fil-plażma jilħqu stat fiss wara l-għotja kontinwa ta' 7-8-ijiem.
English: Photosensitivity reaction
Maltese: Reazzjonijiet ta' fotosensittività
English: Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Maltese: Pakkett b'ħafna: 280 (4 pakketti b'70) pillola miksija b'rita Pakkett b'ħafna: 280 (20 pakkett b'14) -il pillola miksija b'rita
English: Pack sizes: 56, 98 or 280 film-coated tablets.
Maltese: Daqsijiet tal-pakketti: 56, 98 jew 280 pillola miksija b'rita.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Maltese: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) kien studju maħsub biex jittestja l-benefiċċju li jiżdied aliskiren ma' terapija standard ta' inibitur ta' ACE jew ARB f'pazjenti b'dijabete mellitus tip 2 u mard kroniku tal-kliewi, mard kardjovaskulari, jew it-tnejn.
English: See also information under the heading “Do not take Dafiro”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Dafiro”.
English: Quincke oedema
Maltese: Edima ta' Quincke
English: The safety of Dafiro has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Maltese: Is-sigurtà ta' Dafiro ġiet meqjusa f'ħames studji kliniċi kontrollati b'5,175 pazjent, li 2,613 minnhom irċevew valsartan kombinat ma' amlodipine.
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-ventrikolu tax-xellug minn dijanjosi b'elettrokardjogramma jew elettrokardjografija (20.9%), tipjip attwali ta' sigaretti (21.9%).
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Maltese: L-età, sess, razza jew l-indiċi tal-massa tal-ġisem (≥30 kg/m2, <30 kg/m2) ma kellhomx effett fuq ir rispons għal Dafiro.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01
Maltese: Sustanzi li jaġixxu fuq is-sistema ta' renin-angiotensin; antagonisti ta' angiotensin II, kombinazzjonijiet; antagonisti ta' angiotensin II u imblokkaturi tal-kanal tal-kalċju, Kodiċi ATC:
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Hypromellose (sostituzzjoni tip 2910.3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
English: There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95% CI (0.90-1.07) p=0.65.
Maltese: Ma kien hemm l-ebda differenza sinifikanti fit-tragward finali primarju fil-proporzjon bejn terapija bbażata fuq amlodipine u terapija bbażata fuq chlorthalidone mar-riskju (RR) 0.98 95% CI (0.90-1.07) p=0.65.
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Maltese: Hypromellose (sostituzzjoni tip 2910.3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
English: Pack sizes: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4x70 or 20x14) film-coated tablets.
Maltese: Daqsijiet tal-pakketti: 7, 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b'rita u pakketti b'ħafna li jkun fihom 280 (4x70 jew 20x14) pillola miksija b'rita.
English: Toxic Epidermal Necrolysis
Maltese: Nekroliżi Epidermali Tossika
English: Distribution: Volume of distribution is approximately 21 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa madwar 21 l/kg.
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 to moderate hypertension.
Maltese: Studju randomizzat 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-kalċju) 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: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Maltese: • It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins.
Maltese: Studji in vitro b'amlodipine wrew li madwar 97.5% tal-mediċina li tkun qed tiċċirkola jintrabat mal-proteini tal-plażma.
English: • Concomitant use of Dafiro with aliskiren-containing products 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' Dafiro ma' prodotti li jkun fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: Elderly (age 65 years or over)
Maltese: Anzjani (età minn 65 sena ‘l fuq)
English: Elimination: 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: Other medicines and Dafiro
Maltese: Mediċini oħra u Dafiro
English: Confusion
Maltese: Konfużjoni
English: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, 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'ARBs, inibituri ta' ACE jew aliskiren Dejta minn provi kliniċi wriet li imblokk doppju ta' RAAS permezz tal-użu kombinat ta' inibituri ta' ACE, ARBs jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, 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: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Maltese: - Amlodipine huwa membru ta' grupp ta' sustanzi li jissejjħu “imblokkaturi tal-kanali ta'
English: • Haemodynamically unstable heart failure after acute myocardial infarction.
Maltese: • Insuffiċjenza tal-qalb emodinamikament instabbli wara infart mijokardijaku akut.
English: The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan.
Maltese: Is-sustanzi attivi ta' Dafiro huma amlodipine(bħala amlodipine besylate) u valsartan.
English: An increased incidence and severity of renal tubular basophilia/hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8-13 (valsartan) and 7-8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Żieda fin-numru ta' każijiet u severità ta' bażofilja/ hyalinisation tubulari renali, dilazzjoni u kasts, kif ukoll infjammazzjoni b'limfoċiti fl-interstizzju u ipertrofija ta' l-arterjola medjali instabu b'esponimenti ta' 8-13 (valsartan) u 7-8 (amlodipine) drabi d-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: Very rare Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzymes increased*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity.
Maltese: Rari ħafna Lewkoċitopenija, tromboċitopenija, reazzjonijiet allerġiċi, ipergliċemija, ipertonija, newropatija periferali, infart mijokardijaku, arritmija (fosthom bradikardija, takikardija ventrikolari u fibrillazzjoni atrijali), vaskulite, pankreatite, gastrite, iperplasija ġinġivali, epatite, suffejra, żieda fl-enzimi tal-fwied*, anġjoedema, eritema multiformi, urtikarja, dermatite esfoljattiva, sindrome ta' Stevens-Johnson, edema ta' Quincke, fotosensittività.
English: Amlodipine and valsartan exhibit linear pharmacokinetics.
Maltese: Amlodipine u valsartan għandhom farmakokinetiċi linjari.
English: Aortic and mitral valve stenosis
Maltese: Stenożi tal-valv ta' l-aorta u mitrijali
English: Hepatic impairment Dafiro is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Indeboliment tal-fwied Dafiro huwa kontra-indikat f'pazjenti b'indeboliment tal-fwied qawwi (ara sezzjoni 4.3).
English: Tabulated list of adverse reactions
Maltese: Lista f' tabella tar-reazzjonijiet avversi
English: In this study (baseline blood pressure 171/113 mmHg), a Dafiro regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Maltese: F'dan l-istudju (il-linja bażi tal-pressjoni tad-demm kienet 171/113 mmHg), b'reġimen ta' Dafiro ta' 5 mg/160 mg miżjuda għal 10 mg/160 mg naqqset il-pressjoni tad-demm ta' bilqiegħeda b'36/29 mmHg meta imqabbla ma' 32/28 mmHg b'reġimen ta' lisinopril/hydrochlorthiazide 10 mg/12.5 mg miżjuda għal 20 mg/12.5 mg.
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.
Maltese: Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] u VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE flimkien ma' ARB.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%.
Maltese: Il-proporzjon tad-doża materna rċevuta mit-tarbija ġiet stmata f'firxa interkwartili ta' 3 - 7%, b'massimu ta' 15%.
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
Maltese: Sustanzi li jinduċu CYP3A4 (sustanzi kontra l-konvulżjonijiet [eż carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum)
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Maltese: Fil-plażma kien identifikat metabolu hydroxy f'konċentrazzjonijiet baxxi (anqas minn 10% ta' l-AUC ta' valsartan).
English: Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors.
Maltese: Uħud minn dawn il-pazjenti kienu esperjenzaw anġjoedima bi prodotti mediċinali oħrajn, inkluż inibituri ta' ACE.
English: Visual disturbance
Maltese: Disturb fil-vista
English: Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Maltese: Dafiro jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b'ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola, jew 20 kartuna, kull waħda b'14 -il pillola.
English: Visual impairment
Maltese: Indeboliment fil-vista
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Maltese: Il-livell fejn ma jidhirx effett għall-effetti ta' l-iżvilupp kien osservat b'3- (valsartan) u 4-(amlodipine) darbiet l-esponiment kliniku (bażat fuq l-AUC).
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (sostituzzjoni tip 2910.3 mPa.s); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
English: Similar changes were found in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).
Maltese: Bidliet simili instabu fil-grupp ta' valsartan waħdu (esponiment 8.5-11.0-il darba d-doża klinika ta' 160 mg valsartan).
English: % of patients who experienced peripheral oedema
Maltese: % ta' pazjenti li kellhom edima periferali
English: • Severe hypotension.
Maltese: • Pressjoni baxxa severa.
English: Very rare* Not known
Maltese: Rari ħafna* Mhux magħruf
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (sostituzzjoni tip 2910.3 mPa.s); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
English: Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.
Maltese: Doża eċċessiva b'amlodipine tista' twassal għal vażodilatazzjoni periferali eċċessiva u, possibilment, reflex takikardja.
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Maltese: 001). 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: EU/1/06/371/001 EU/1/06/371/002 EU/1/06/371/003 EU/1/06/371/004 EU/1/06/371/005 EU/1/06/371/006 EU/1/06/371/007 EU/1/06/371/008 EU/1/06/371/025 EU/1/06/371/026 EU/1/06/371/027 EU/1/06/371/034 EU/1/06/371/037
Maltese: EU/1/06/371/005 EU/1/06/371/006 EU/1/06/371/007 EU/1/06/371/008 EU/1/06/371/025 EU/1/06/371/026 EU/1/06/371/027 EU/1/06/371/034
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-uzu ta' AIIRAs huwa kontraindikat fit-tieni u it-tielet trimestri tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Maltese: M'hemmx bżonn ta' tibdil fid-dożaġġ għall-pazjenti li għandhom indeboliment ħafif għal moderat (GFR >30 ml/min/1.73 m2).