FrancophonIA/ELRC3.0 huggingface dataset:
English: Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched T waves, have been observed in patients treated with Ranexa.
Maltese: Żidiet relatati mad-doża u mal-konċentrazzjoni fil-plażma fl-interval QTc (madwar 6 msek f'1000 mg darbtejn kuljum), tnaqqis fl-estensjoni tal-mewġa T, u f'xi każijiet mewġiet T taljati, ġew osservati f'pazjenti ikkurati b'Ranexa.
English: • Mild hepatic impairment (see sections 4.2 and 5.2).
Maltese: • Indeboliment tal-fwied ħafif (ara sezzjonijiet 4.2 u 5.2).
English: Moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Indeboliment tal-fwied moderat jew severi (ara sezzjonijiet 4.2 u 5.2).
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola li terħi l-mediċina bil-mod 60 pillola li terħi l-mediċina bil-mod 100 pillola li terħi l-mediċina bil-mod
English: Therefore, caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval (see section 4.5 also).
Maltese: Għaldaqstant, għandha tiġi osservata l-kawtela meta pazjenti bi storja ta' sindromu QT twil konġenitali jew bi storja fil-familja, meta pazjenti b'titwil fl-interval QT akkwistat, u meta pazjenti li qegħdin jiġu kkurati b'mediċini li jaffettwaw l-intervall QTc (ara wkoll sezzjoni 4.5).
English: If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), downtitration of Ranexa to 500 mg or 375 mg twice daily may be required.
Maltese: Jekk pazjent jesperjenza avvenimenti avversi relatati mal-kura (eż., sturdament, dardir, jew remettar) tista' teħtieġ titrazzjoni 'l isfel ta' Ranexa għal 500 mg jew 375 mg darbtejn kuljum.
English: Ranolazine AUC was unaffected in patients with mild hepatic impairment but increased 1.8-fold in patients with moderate impairment.
Maltese: L-AUC ta' ranolazine ma kienitx influwenzata f'pazjenti b'indeboliment tal-fwied ħafif iżda żdiedet 1.8-il darba f'pazjenti b'indeboliment moderat.
English: depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Maltese: quinidine, disopyramide, procainamide), erythromycin, u antidepressanti triċikliċi (eż. imipramine, doxepin, amitriptyline).
English: In male and female rats, oral administration of ranolazine that produced exposures (AUC) 3.6-fold or 6.6-fold higher than expected in humans, respectively, had no effect on fertility.
Maltese: Fil-firien irġiel u nisa, l-għoti mill-ħalq ta' ranolazine li pproduċa esponimenti (AUC) 3.6 drabi jew 6.6 drabi aktar minn dak mistenni fil-bniedem, rispettivament, ma kellu l-ebda effett fuq il-feritlità.
English: At the dose level 500 mg twice daily, co-administration of a potent inhibitor of CYP2D6 could result in an increase in ranolazine AUC of about 62%.
Maltese: Fil-livell ta' doża ta' 500 mg darbtejn kuljum, għoti flimkien ma' impeditur qawwi ta' CYP2D6 jista' jirriżulta f'żieda fl-AUC ta' ranolazine b'madwar 62%.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati f'sezzjoni 6.1.
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Ħorriqija, reazzjoni allerġika tal-ġilda
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/Aluminium blisters
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' PVC/PVDC/Aluminju ta' 15 jew 20 pilloli kull folja.
English: In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers.
Maltese: Barra dawn l-avvenimenti avversi, kienu osservati diplopja, letarġija, u ħass ħażin fi studju ta' dożaġġ eċċessiv intravenuż f'voluntiera f'saħħithom.
English: - certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
Maltese: - ċerti mediċini biex jikkuraw id-depressjoni (bupropion), psikożi, infezzjoni HIV (efavirenz), jew kanċer (cyclophosphamide). - ċerti mediċini li jintużaw sabiex tiġi kkurata l-iperkolesterolemija (eż simvastatin, lovastatin, atorvastatin).
English: Low weight: The incidence of adverse events was higher in patients with low weight (≤ 60 kg).
Maltese: L-inċidenza ta' avvenimenti avversi f'pazjenti b'piż baxx (≤ 60 kg) kienet ogħla.
English: What you need to know before you take Ranexa 3.
Maltese: X'għandek tkun taf qabel ma tieħu Ranexa 3.
English: Therefore, digoxin levels should be monitored following initiation and termination of Ranexa therapy.
Maltese: Għaldaqstant, il-livelli ta' digoxin għandhom jiġu sorveljati wara l-bidu u t-twaqqif ta' terapija Ranexa.
English: The potential for dose-related adverse events (e.g. nausea, dizziness) may also increase with increased plasma concentrations.
Maltese: Il-potenzjal għal avvenimenti avversi relatati mad-doża (eż. dardir, sturdament) jistgħu wkoll jiżdiedu mal-konċentrazzjonijiet fil-plażma.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine.
Maltese: Kull pillola fiha 375 mg ta' ranolazine.
English: Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 730
Maltese: Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
English: Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling, muscular weakness.
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Mhux komuni: uġigħ fl-estremità, bugħawwieġ, nefħa fil-ġogi, indebboliment muskolari.
English: The AUC of one pharmacologically active ranolazine metabolite was 5-fold increased in patients with severe renal impairment.
Maltese: L-AUC ta' wieħed mill-metaboliti farmakoloġikament attiv ta' ranolazine żdiedet b'5 darbiet f'pazjenti b'indeboliment tal-kliewi sever.
English: Five-hundred and sixty-five patients were randomised to receive an initial dose of Ranexa 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranexa 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily.
Maltese: Ħames mija u ħamsa u sittin pazjent kienu randomizzati biex jirċievu doża tal-bidu ta' Ranexa 500 mg darbtejn kuljum jew plaċebo għal ġimgħa, segwiti b'6 ġimgħat ta' kura b'Ranexa 1000 mg darbtejn kuljum jew plaċebo, f'addizjoni ma' kura konkomittanti b'amlodipine 10 mg darba kuljum.
English: The results showed that exercise duration was 31 seconds longer in ranolazine patients versus placebo patients (p = 0.002).
Maltese: Ir-riżultati wrew li t-tul ta' l-eżerċizzju kien 31 sekonda itwal f'pazjenti b'ranolazine meta mqabbla ma' pazjenti bi plaċebo (p = 0.002).
English: Ranexa demonstrated greater efficacy than placebo in prolonging exercise time at trough at 12 weeks for both doses studied when used as an add-on therapy.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: How to store Ranexa
Maltese: X'fiha Ranexa
English: The AUC of metabolites increased with decreased renal function.
Maltese: L-AUC tal-metaboliti żdiedet ma' tnaqqis fil-funzjoni tal-kliewi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ranolazine.
Maltese: Kull pillola fiha 500 mg ta' ranolazine.
English: General disorders and administration site conditions Common: asthenia.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni: astenja.
English: Absorption: The mean absolute bioavailability of ranolazine after oral administration of immediaterelease ranolazine tablets ranged from 35−50%, with large inter-individual variability.
Maltese: Il-bijodisponibilità ta' wara għoti orali ta' pilloli ranolazine li jerħuha immedjatament varjat minn 35−50%, b'varjabbilità kbira bejn l-individwi.
English: Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq kull folja ta' pilloli u fuq in-naħa ta' barra tal-kartuna u l-flixkun.
English: Tacrolimus, ciclosporin, sirolimus, everolimus: Increased plasma concentrations of tacrolimus, a CYP3A4 substrate, have been observed in patients after ranolazine administration.
Maltese: Żiediet tal-konċentrazzjoni ta' tacrolimus fil-plażma, sottostrat ta' CYP3A4, dehru f'pazjenti wara li rċievew ranolazine.
English: The 750 mg tablets are pale green and are engraved with 750 on one side.
Maltese: Pillola b'forma ovali ta' kulur aħdar ċar imnaqqxa b' 750 fuq naħa waħda.
English: PHARMACEUTICAL FORM Prolonged-release tablet
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Anxiety, difficulty sleeping, confusional state, hallucination Blurred vision, visual disturbance
Maltese: Viżjoni mċajpra, disturbi viżwali, stat konfużjonali, alluċinazzjoni Bidliet f'sensazzjoni (mess jew togħma), rogħda, għeja jew bla ħeġġa, ngħas, tħossok se jħossok ħażin, sturdament malli tqum
English: Excipients for all ranolazine prolonged-release tablets: Carnauba wax
Maltese: Sustanzi mhux attivi għall-pilloli ta' ranolazine kollha li jerħu l-mediċina bil-mod: Carnauba wax
English: In rats, no effects in fetuses was noted when mothers were exposed to 2-fold greater levels (AUC) than expected in humans, whereas decreased fetal weight and reduced ossification were observed when the exposure of mothers was 7.5-fold than those obtained in humans.
Maltese: Fil-firien, ma ġie nnutat l-eba effett fuq il-fetu meta l-ommijiet ġew esposti għal livelli (AUC) darbtejn ogħla minn dawk mistennija fil-bniedem, filwaqt li ġew osservati tnaqqis fil-piż tal-fetu u ossifikazzjoni mnaqqsa meta l-esponiment tal-ommijiet kien 7.5 drabi aktar minn dak li nkiseb fil-bniedem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of ranolazine.
Maltese: Kull pillola fiha 750 mg ta' ranolazine.
English: Throat tightness
Maltese: STRUZZJONIJIET DWAR L-UŻU
English: This is also recommended for other CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, sirolimus, everolimus).
Maltese: Dan huwa rakkomandat ukoll għas-sottostrati l-oħra ta' CYP3A4 b'medda terapewtika dejqa (eż. ciclosporin, sirolimus, everolimus).
English: This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull pillola li terħi l-mediċina bil-mod, li tista'tgħid hija essenzjalment ‘mingħajr sodium'.
English: • St. John's wort;
Maltese: John's wort;
English: Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Maltese: Ipromelloża (sostituzzjoni tip 2910.3 mPa.s) Makrogol 4000
English: * See section 4.4 Photosensitivity ** Mostly consistent with cholestasis
Maltese: * Ara sezzjoni 4.4 Fotosensittività ** Konsistenti l-aktar ma' kolestasi
English: 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: Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04 Novembru 2009
English: Approximate size: 19 mm (length) x 7.5 mm (width).
Maltese: Daqs approssimattiv: 19 mm (tul) x 7.5 mm (wisa').
English: Approximate size: 15 mm (length) x 5.9 mm (width).
Maltese: Daqs approssimattiv: 15 mm (tul) x 5.9 mm (wisa').
English: Very rare** Not known
Maltese: Rari ħafna**
English: Photosensitivity reaction*
Maltese: Reazzjonijiet ta' fotosensittività*
English: Novartis Pharma B.V. Tel: +31 26 37 82 111
Maltese: Nederland Novartis Pharma B.V. Tel: +31 26 37 82 111
English: High hydrochlorothiazide use (≥50000 mg cumulative) was associated with an adjusted odds ratio (OR) of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Maltese: Użu kbir ta' hydrochlorothiazide (≥50,000 mg kumulattiva) ġie assoċjat ma' proporzjon ta' probabiltà (OR) aġġustat ta' 1.29 (95% CI: 1.23-1.35) għal BCC u 3.98 (95% CI: 3.68-4.31) għal SCC.
English: Non-steroidal antiinflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs
Maltese: Mediċini antiinfjammatorji mhux sterojdi (NSAIDs), inklużi inibituri selettivi cyclooxygenase-2 (inibituri COX-2), aċidu aċetilsaliċiliku (>3 g/jum), u NSAIDs mhux selettivi
English: Volume of distribution is approximately 21 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa ta' madwar 21 l/kg.
English: Shock (including cardiogenic shock).
Maltese: Xokk (inkluż xokk kardjoġeniku).
English: Cellulose microcrystalline Crospovidone (type A) Silica, colloidal anhydrous Magnesium stearate
Maltese: Qalba tal-pillola Ċelluloża mikrokristallina Krospovidon (tip A) Silica, colloidal anhydrous Stearat tal-manjesju
English: Extrapyramidal syndrome
Maltese: Sindromu ekstrapiramidali
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 filgrupp 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: • visual disturbances
Maltese: • disturbi viżwali
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: Oħrajn: imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS)
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Maltese: Studju wieħed kien jinkludi popolazzjoni li kienet tikkonsisti minn 71,533 każ ta' BCC u 8,629 każ ta' SCC imqabbla ma' 14,430,833 u għal 172,462 kontroll tal-popolazzjoni rispettivament.
English: • abdominal bloating (gastritis)
Maltese: • nefħa addominali (gastrite)
English: Circulating hydrochlorothiazide is bound to serum proteins (40-70%), mainly serum albumin.
Maltese: L-hydrochlorthiazide li jiċċirkola huwa mwaħħal mal-proteini fis-serum (40-70%), l-aktar mal-albumina fis-serum.
English: 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: Amlodipine, valsartan and hydrochlorothiazide exhibit linear pharmacokinetics.
Maltese: Amlodipine, valsartan u hydrochlorthiazide għandhom farmakokinetiċi lineari.
English: • severely decreased urine output (possible signs of renal disorder or renal failure)
Maltese: • tnaqqis gravi fl-ammont ta' awrina (sinjali possibbli ta' disturb fil-kliewi jew insuffiċjenza renali)
English: • muscle relaxants (medicines to relax the muscles which are used during operations);
Maltese: • rilassanti tal-muskoli (mediċini li jirrissaw il-muskoli li jintużaw waqt l-operazzjonijiet);
English: The apparent volume of distribution is 4-8 l/kg.
Maltese: Il-volum ta' distribuzzjoni li jidher huwa ta' 4-8 l/kg.
English: Frequency Dafiro HCT
Maltese: Frekwenza Dafiro HCT
English: Dafiro HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Maltese: Dafiro HCT huwa disponibbli f'pakketti li fihom 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b'rita, f'pakketti multipli ta' 280 pillola (magħmulin minn 4 kartuniet, li kull waħda minnhom fiha 70 pillola, jew 20 kartuna, li kull waħda minnhom fiha 14-il pillola), u f'pakketti tal-isptar li fihom 56, 98 jew 280 pillola f'folji pperforati bid-dożi.
English: Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed (see also sections 4.4 and 5.1).
Maltese: Kanċer tal-ġilda mhux melanoma: skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn hydrochlorothiazide u NMSC (ara wkoll sezzjonijiet 4.4 u 5.1).
English: Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed.
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn hydrochlorothiazide u NMSC.
English: Biotransformation Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Maltese: Bijotrasformazzjoni L-amlodipine hija metabolizzata b'mod estensiv (madwar 90%) fil-fwied għal metaboli inattivi.
English: 70x1 film-coated tablets.
Maltese: 70x1 pillola miksija b'rita.
English: Multipack: 280 (4 packs of 70x1) film-coated tablets.
Maltese: Pakkett b'ħafna: 280 (4 pakketti ta' 70x1) pillola miksija b'rita.
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jista' jaffettwa mhux aktar minn persuna 1 f'10,000):
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Maltese: Minħabba l-komponent hydrochlorthiazide, Dafiro HCT huwa kontraindikat għall-użu f'pazjenti b'nuqqas ta' produzzjoni ta' awrina (ara sezzjoni 4.3) u f'pazjenti b'indeboliment renali sever (rata talfiltrazzjoni fil-glomeruli (GFR)<30 ml/min/1.73 m2) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Dafiro HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Dafiro HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated in symptomatic hyperuricaemia.
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Dafiro HCT hu kontraindikat f'iperurikemija sintomatika.
English: • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
Maltese: • mediċini li jintużaw għall-kura ta' infezzjonijiet tal-moffa (eż ketoconazole, itraconazole);
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, other combinations, ATC code: C09DX01.
Maltese: Sustanzi li jaġixxu fuq is-sistema renin-anġjotensin, antagonisti ta' anġjotensin II, kombinazzjonijiet oħrajn, Kodiċi ATC:
English: Thiazides potentiate the antihypertensive action of other antihypertensive drugs (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium channel blockers, ACE inhibitors, ARBs and Direct Renin Inhibitors [DRIs]).
Maltese: Thiazides iqawwu l-azzjoni kontra l-pressjoni għolja ta' pilloli oħrajn għall-kontra l-pressjoni (eż. guanethidine, methyldopa, imblukkatturi-beta, vażodilataturi, imblukkaturi tal-kanal tal-kalċju, inibituri ta' ACE, ARBs u Inibituri Diretti tar-Renin [DRIs]).
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jista' jaffettwa mhux aktar minn persuna 1 f'1,000):
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Maltese: Rari bradikardija, takikardija talventrikulu, u fibrillazzjoni tal-atriju)
English: Dafiro HCT with food, drink and alcohol
Maltese: Dafiro HCT ma' ikel, xorb u alkoħol
English: Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
Maltese: Valsartan ma jiġix mibdul b'mod estensiv peress li 20% tad-doża biss tiġi rkuprata bħala metaboli.
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 tar-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: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tkun stmata mid-data disponibbli):
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 ACE.
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Dafiro HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Maltese: Fit-8 ġimgħa, it-tnaqqis medju fil-pressjoni sistolika/dijastolika kien ta' 39.7/24.7 mmHg b'Dafiro HCT, 32.0/19.7 mmHg b'valsartan/hydrochlorthiazide, 33.5/21.5 mmHg b'amlodipine/valsartan, u 31.5/19.5 mmHg b'amlodipine/hydrochlorthiazide.
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 randomised u ġew segwiti għal medja ta' 4.9 snin.
English: Dafiro HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Maltese: Dafiro HCT jikkombina tliet sustanzi kontra l-pressjoni għolja b'mekkaniżmi kumplimentari sabiex tkun ikkontrollata l-pressjoni tad-demm f'pazjenti bi pressjoni għolja essenzjali: amlodipine huwa membru tal-klassi ta' antagonisti tal-kalċju u l-valsartan tal-klassi ta' mediċini li huma antagonisti ta' anġjotensin II u hydrochlorthiazide huwa membru tal-klassi ta' mediċini li huma dijuretiċi thiazide.
English: See also information under the heading “Do not take Dafiro HCT”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Dafiro HCT”.
English: Elderly (age 65 years or over)
Maltese: Pazjenti anzjani (età ta' 65 sena u aktar)