FrancophonIA/ELRC3.0 huggingface dataset:
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Dafiro HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Maltese: Statistikament proporzjon akbar ta' pazjenti kisbu kontroll tal-pressjoni (<140/90 mmHg) b'Dafiro HCT (71%) meta mqabbel ma' kull wieħed mit-tliet terapiji l-oħra b'taħlita ta' żewġ mediċini (45-54%)
English: Heart failure and coronary artery disease/post-myocardial infarction
Maltese: Insuffiċjenza tal-qalb u mard tal-arterji koronarji/infart postmijokardijaku
English: Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi, għal derivattivi ta' sulfonamid oħra, għal derivati ta' diidropiridina, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Biotransformation Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Maltese: Bijotransformazzjoni L-hydrochlorthiazide huwa eliminat primarjament bħala kompost mhux mibdul.
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 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-kalċju) jew lisinopril 10-40 mg/kuljum (inibitur ta' ACE) bħala terapiji tal-bidu ma' dawk ta' dijuretiċi thiazide, chlorthalidone 12.5-25 mg/kuljum fi pressjoni għolja minn ħafifa sa moderata.
English: Multipack: 280 (20 packs of 14) film-coated tablets.
Maltese: Pakkett b'ħafna: 280 (20 pakkett ta' 14) pillola miksija b'rita.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Maltese: Filplażma kien identifikat metabolit hydroxy f'konċentrazzjonijiet baxxi (anqas minn 10% tal-AUC ta' valsartan).
English: Concomitant use of Dafiro HCT 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 HCT 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: Hydrochlorothiazide is eliminated from plasma with a half-life averaging 6 to 15 hours in the terminal elimination phase.
Maltese: Hydrochlorothiazide jitneħħa mill-plażma b'medja tal-half-life ta' bejn 6 u 15-il siegħa fil-fażi ta' eliminazzjoni terminali.
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
Maltese: Pressjoni baxxa eċċessiva, li tinkludi pressjoni baxxa mal-waqqaf, dehret f'1.7% tal-pazjenti kkurati bl-ogħla doża ta' Dafiro HCT (10 mg/320 mg/25 mg) meta mqabbla ma' 1.8% tal-pazjenti fuq valsartan/hydrochlorthiazide (320 mg/25 mg), 0.4% tal-pazjenti fuq amlodipine/valsartan (10 mg/320 mg), u 0.2% tal-pazjenti fuq hydrochlorthiazide/amlodipine (25 mg/10 mg) fi prova kkontrollata f'pazjenti bi pressjoni minn moderata sa qawwija mhux ikkumplikata.
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Maltese: L-eliminazzjoni tal-amlodipine mill-plażma tinqasam f'żewġ fażijiet, b'half-life ta' eliminazzjoni terminali ta' madwar 30 sa 50 siegħa.
English: antipsychotics, antiepileptics;
Maltese: III u xi antipsikotiċi.
English: Due to the valsartan component, Dafiro HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Minħabba l-komponent valsartan, Dafiro HCT huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: Aortic and mitral valve stenosis
Maltese: Stenożi tal-valv tal-aorta u mitrijali
English: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Dafiro HCT for clinical use in humans.
Maltese: F'varjetà ta' studji ta' sigurtà qabel l-istudju kliniku, magħmula f'diversi speċi ta' annimali b' amlodipine, valsartan, hydrochlorthiazide, valsartan/hydrochlorthiazide, amlodipine/valsartan u amlodipine/valsartan/hydrochlorthiazide (Dafiro HCT), ma kien hemm l-ebda evidenza ta' tossiċità sistemika jew ta' organi fil-mira li jaffettwaw b'mod avvers l-iżvilupp ta' Dafiro HCT għall-użu kliniku fil-bniedem.
English: Uncommon (may affect up to 1 in 100 people): • severely decreased urine output (decreased kidney function)
Maltese: Mhux komuni (jistgħu jaffettwaw mhux aktar minn persuna 1 f'100): • għamil tal-awrina mnaqqas ħafna (tnaqqis fil-funzjoni renali)
English: • confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
Maltese: • konfużjoni, għeja, ġbid u spażi tal-muskoli, nifs mgħaġġel (alkalożi ipokloremika)
English: • medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin or penicillin G;
Maltese: • mediċini li jistgħu jnaqqsu l-ammont ta' potassju fid-demm tiegħek, bħal dijuretiċi (pilloli talilma), kortikosterojdi, lassativi, amphotericin jew penisillin G;
English: • severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Maltese: • reazzjonijiet severi tal-ġilda fosthom raxx qawwi fil-ġilda, ħorriqija, ħmura fil-ġilda fuq ġismek kollu, ħakk qawwi, infafet, tqaxxir u nefħa fil-ġilda, infjammazzjoni tal-membrani mukużi
English: Novartis Pharma GmbH Roonstrasse 25
Maltese: Novartis Pharma GmbH
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw mhux aktar minn persuna 1 f'100):
English: • disorders combining rigidity, tremor and/or movement disorders
Maltese: • disturbi li jikkombinaw riġidità, rogħda, u/jew disturbi fil-moviment
English: No dose adjustment of Dafiro HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Maltese: M'hemmx bżonn ta' aġġustar tad-doża ta' Dafiro HCT għall-pazjenti li għandhom indeboliment renali minn ħafif għal moderat (GFR ≥30 ml/min/1.73 m
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Dijossidu tat-titanju (E171) Ossidu tal-ħadid, isfar (E172)
English: • taste abnormalities
Maltese: • togħma abnormali
English: No formal interaction studies with other medicinal products have been performed with Dafiro HCT.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni ma' prodotti mediċinali oħrajn b'Dafiro HCT.
English: • medicines that may increase blood sugar levels (beta blockers, diazoxide);
Maltese: • mediċini li jistgħu jżidu l-livelli taz-zokkor fid-demm (imblukkaturi beta, diazoxide);
English: • increased muscle tension
Maltese: • żieda fit-tensjoni tal-muskoli
English: 56 x 1 film-coated tablet (unit dose) 98 x 1 film-coated tablet (unit dose) 280 x 1 film-coated tablet (unit dose)
Maltese: 98 x pillola 1 miksija b'rita (doża waħda)
English: Agranulocytosis, bone marrow failure
Maltese: Skumdità, telqa tal-ġisem Mhux komuni
English: • ankle swelling (oedema)
Maltese: • sfura fil-ġilda (suffejra)
English: The reductions in systolic/diastolic blood pressure with Dafiro HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Maltese: It-tnaqqis fil-pressjoni sistolika/dijastolika b'Dafiro HCT kien 7.6/5.0 mmHg aktar minn dak b'valsartan/hydrochlorthiazide, 6.2/3.3 mmHg aktar minn dak b'amlodipine/valsartan, u 8.2/5.3 mmHg aktar minn dak b'amlodipine/hydrochlorthiazide.
English: Weight decrease
Maltese: Insuffiċjenza u indeboliment
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Dafiro HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati skont il-Klassi tas-Sistemi u Organi MedDRA u l-frekwenza, jikkonċernaw Dafiro HCT (amlodipine/valsartan/HCT) u amlodipine, valsartan u HCT waħedhom.
English: The safety profile of Dafiro HCT presented below is based on clinical studies performed with Dafiro HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Maltese: Il-profil ta' sigurtà ta' Dafiro HCT ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmulin b'Dafiro HCT u fuq il-profil ta' sigurtà magħruf tal-komponenti individwali amlodipine, valsartan u hydrochlorthiazide.
English: The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
Maltese: L-użu ta' hydrochlorothiazide jista' jkun li jrid jerġa' jiġi kkunsidrat f'pazjenti li esperjenzaw NMSC qabel (ara wkoll sezzjoni 4.8).
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Maltese: Reazzjonijiet fil-ġilda bħal f'lupus erythematosus, riattivazzjoni ta' lupus erythematosus fil-ġilda
English: In the controlled trial of Dafiro HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Maltese: Fil-prova kkontrollata ta' Dafiro HCT, l-effetti kontra xulxin li valsartan 320 mg u hydrochlorthiazide 25 mg għandhom fuq il-potassju fis-serum bejn wieħed u ieħor ibbilanċjaw lill-xulxin f'ħafna millpazjenti.
English: Dual blockage of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Maltese: Imblokk doppju ta' RAAS permezz tal-użu kombinat ta' inibituri ta' ACE, ARBs jew aliskiren għalhekk mhuwiex rakkomandat (ara sezzjonijiet 4.5 u 5.1).
English: Dizziness postural, dizziness exertional
Maltese: Disturbi taddemm u tassistema limfatika
English: • blistering skin (sign of a condition called dermatitis bullous)
Maltese: • infafet fil-ġilda (sinjal ta' kondizzjoni msejħa dermatite bl-infafet)
English: • medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
Maltese: • mediċini biex iżidu l-pressjoni bħal adrenalina jew noradrenalina; mediċini li jintużaw għall-HIV/AIDS (eż. ritonavir, indinavir, nelfinavir);
English: Medicinal products affecting serum potassium level
Maltese: Tibdiliet fl-elettroliti tas-serum
English: • loss of pain sensation
Maltese: • telf tas-sensazzjoni tal-uġigħ
English: Dafiro HCT was studied in a double-blind, active controlled study in hypertensive patients.
Maltese: Dafiro HCT kien studjat fi studju double-blind ikkontrollat b'mod attiv f'pazjenti bi pressjoni għolja.
English: Other medicines and Dafiro HCT
Maltese: Mediċini oħra u Dafiro HCT
English: Digitalis glycosides
Maltese: • ġilda tieklok
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: • depression
Maltese: • dipressjoni
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Maltese: Ġie osservat riskju akbar ta' kanċer tal-ġilda mhux melanoma (NMSC) [karċinoma ta' ċellola bażali (BCC) u karċinoma ta' ċellola skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali tal-Kanċer tadDanimarka.
English: Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Maltese: Dafiro HCT hu kontraindikat f'pazjenti b'indeboliment gravi tal-kliewi, anurija jew li qed jagħmlu ddijaliżi (ara sezzjoni 4.3).
English: • dantrolene (infusion for severe body temperature abnormalities);
Maltese: • dantrolene (infużjoni għal anormalitajiet severi fit-temperatura tal-ġisem); vitamina D u mluħa tal-kalċju.
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Dafiro HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents.
Maltese: Fl-istudju kliniku kkontrollat ta' 8 ġimgħat, it-tibdiliet fil-parametri tal-laboratorju osservati bit-taħlita ta' Dafiro HCT kienu żgħar u konsistenti mal-mekkaniżmu farmakoloġiku ta' azzjoni tas-sustanzi meta jingħataw waħedhom.
English: Valsartan and
Maltese: Losartan
English: When Dafiro HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Maltese: Meta Dafiro HCT jintuża f'pazjenti b'indeboliment renali huwa rrakkomandat li jsir monitoraġġ minn żmien għal żmien tal-elettroliti tas-serum (inkluż il-livelli tal-potassju), tal-kreatinina u tal-aċidu uriku fis-serum.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Dafiro HCT were dizziness and hypotension (0.7%).
Maltese: F'din il-prova kkontrollata b'mod attiv, l-aktar raġunijiet komuni għalfejn kellha titwaqqaf it-terapija b'Dafiro HCT kienu sturdament u pressjoni baxxa (0.7%).
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u l-esponiment għal hydrochlorothiazide: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll talpopolazzjoni, bl-użu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95% CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni 4.4).
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Maltese: M'hemmx bidla fil-kinetiċi ta' hydrochlorothiazide minn dożi ripetuti, u lakkumulazzjoni hi minima meta tingħata doża darba kuljum.
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita huma pilloli kannella fl-isfar, ovali b'“NVR” fuq naħa waħda u b'“VFL” fuq in-naħa l-oħra.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: 98 film-coated tablets
Maltese: 98 pillola miksija b'rita
English: Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC.
Maltese: L-azzjonijiet ta' fotosensittività ta' hydrochlorothiazide jistgħu jaġixxu bħala mekkaniżmu possibbli għal NMSC.
English: • sleeplessness
Maltese: • ebusija
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.
Maltese: Żidiet riversibbli tal-konċentrazzjonijiet ta' lithium fisserum u tossiċità kienu rrappurtati waqt li lithium kien qiegħed jingħata flimkien ma' inibituri ta' ACE, ma' antagonisti tar-riċettur ta' angiotensin II, inkluż valsartan jew thiazides.
English: Haemodynamically unstable heart failure after acute myocardial infarction.
Maltese: Insuffiċjenza tal-qalb emodinamikament instabbli wara infart mijokardijaku akut.
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Maltese: L-għoti fl-istess ħin ta' inibituri tat-trasportatur tat-teħid (rifampicin, ciclosporin) jew tattrasportatur tal-effluss (ritonavir) jista' jżid l-espożizzjoni sistemika għal valsartan.
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 320 mg valsartan u 25 mg hydrochlorthiazide.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Dafiro HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat mingħajr kolestażi, l-ogħla doża rrakkomandata hija ta' 80 mg valsarta, u għaldaqstant, Dafiro HCT mhuwiex addattat għal dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Dafiro HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Ten per cent of original amlodipine and 60% of amlodipine metabolites are excreted in urine.
Maltese: Għaxra fil-mija tal-amlodipine oriġinali u 60% tal-metaboliti tal-amlodipine jitneħħew flawrina.
English: fever (erythema multiforme)
Maltese: Arritmiji (inkluż
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Maltese: Dafiro HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita pilloli sofor, ovali b'“NVR” fuq naħa waħda u b'“VEL” fuq in-naħa l-oħra.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Maltese: Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita huma pilloli kannella fl-isfar, ovali b'“NVR” fuq naħa waħda u b'“VHL” fuq in-naħa l-oħra.
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side.
Maltese: Pilloli kannella fl-isfar, b'forma ovali, konvessi fuq iż-żewġ naħat, bix-xifer tasturat, imnaqqxin b'“NVR” fuq naħa waħda u b'“VHL” fuq in-naħa l-oħra.
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.
Maltese: Hija rrakkomandata kawtela f'pazjenti b'insuffiċjenza tal-qalb u b'mard tal-arterji koronarji, b'mod partikulari meta tingħata logħla doża ta' Dafiro HCT, 10 mg/320 mg/25 mg.
English: The safety of Dafiro HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Maltese: Is-sigurtà ta' Dafiro HCT ġiet evalwata bl-ogħla doża ta' 10 mg/320 mg/25 mg fi studju kliniku wieħed ikkontrollat li sar fuq perjodu qasir ta' żmien (8 ġimgħat) b'2,271 pazjent, li minnhom 582 irċevew valsartan flimkien ma' amlodipine u hydrochlorthiazide.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Dafiro HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Dafiro HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: • anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
Maltese: • nitrogliċerina u nitrati oħra, jew sustanzi oħra msejħa “vażodilaturi”; mediċini oħra li jikkuraw pressjoni għolja, inkuż metildopa; rifampiċin (jintuża, per eżempju, biex jikkura t-tuberkulosi), erythromycin, clarithromycin (antibijotiċi); St.
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Dafiro HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: • sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
Maltese: • għatis/imnieħer iqattar ikkawżati minn infjammazzjoni fir-rita tal-imnieħer (rinite)
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
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), yellow iron oxide (E172), red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża (sostituzzjoni tip 2910.3 mPa.s), makrogol 4000, talc, dijossidu tattitanju (E171), ossidu tal-ħadid isfar (E172), ossidu tal-ħadid aħmar (E172).
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).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża (sostituzzjoni tip 2910.3 mPa.s), makrogol 4000, talc, dijossidu tattitanju (E171).
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 12.5 mg hydrochlorthiazide.