FrancophonIA/ELRC3.0 huggingface dataset:
English: Enviage must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Maltese: Enviage m'għandux jittieħed ma' ciclosporin (mediċinia li tnaqqas l-attività tas-sistema immunitarja), quinidine (użat biex jirregola taħbit tal-qalb li jkun irregolari) jew verapamil (użat fit-trattament ta' problemi tal-qalb).
English: What is Enviage?
Maltese: Għal xiex jintuża Enviage?
English: Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Maltese: Enviage ġie studjat f'14-il studju ewlieni li fihom ħadu sehem iktar minn 10,000 pazjent b'ipertensjoni essenzjali.
English: The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
Maltese: L-iktar effett sekondarju komuni ta' Enviage (li deher f'bejn pazjent wieħed u 10 minn kull 100) hu dijarrea.
English: What is the risk associated with Enviage?
Maltese: X'inhu r-riskju assoċjat ma' Enviage?
English: How has Enviage been studied?
Maltese: Kif ġie studjat Enviage?
English: Other information about Enviage:
Maltese: Tagħrif ieħor dwar Enviage:
English: Why has Enviage been approved?
Maltese: Għaliex ġie approvat Enviage?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Maltese: Timblokka l-attività ta' enzima umana magħrufa bħala renina, li għandu x'jaqsam mal-produzzjoni ta' sustanza msejħa anġjotensina I filġisem.
English: This may reduce the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan jista' jnaqqas ir-riskji assoċjati ma' pressjoni għolja tad-demm, bħal puplesija.
English: The effects of Enviage were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Enviage għall-ewwel ġew ittestjati f'mudeli sperimentali qabel ma ġew studjati filbnedmin.
English: For the full list of all side effects reported with Enviage, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati ma' Enviage, ara l-Fuljett ta' Tagħrif.
English: Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
Maltese: Fi tlettax minn dawn l-istudji ħadu sehem pazjenti b'ipertensjoni bejn ħafifa u moderata, u fl-istudju l-ieħor ħadu sehem pazjenti b'ipertensjoni gravi.
English: Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Maltese: Enviage waħdu kien iktar effikaċi mill-plaċebo u kien effikaċi daqs it-trattamenti komparattivi fittnaqqis tal-pressjoni.
English: The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Maltese: Id-doża rrakkomandatata ta' Enviage hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall-ipertensjoni.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Enviage.
Maltese: Fil-pazjenti li kellhom 65 sena jew iktar u f'dawk li kienu qed jieħdu dożi ogħla ta' Enviage kien hemm tnaqqis ikbar fil-pressjoni.
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Maltese: ‘Essenzjali' tfisser li l-ipertensjoni ma għandhiex kawża evidenti.
English: Enviage is used to treat essential hypertension (high blood pressure).
Maltese: Enviage jintuża fit-trattament tal-ipertensjoni essenzjali.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Enviage fit-trattament tal-ipertensjoni essenzjali huma ikbar mir-riskji tiegħu.
English: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: eema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: What is Lympreva?
Maltese: X'inhu Lympreva?
English: The company that applied for authorisation is Biovest Europe Ltd.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Biovest Europe Ltd.
English: The company provided data in experimental models from the scientific literature.
Maltese: Il-kumpanija ppreżentat data f'mudelli sperimentali mid-dokumentazzjoni xjentifika.
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Lympreva (dasiprotimut-T) EMA/372519/2015
English: On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin's lymphoma.
Maltese: Fit-23 ta' April 2015, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Lympreva, maħsub għall-kura ta' pazjenti b'linfoma follikulari mhux ta' Hodgkin.
English: Lympreva was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 August 2006, for the treatment of follicular lymphoma.
Maltese: Lympreva kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit28 ta' Awwissu 2006, għall-kura ta' linfoma follikulari.
English: The company also presented the results of one main study involving a total of 177 adults with follicular lymphoma who had responded to induction treatment with an established therapy known as PACE (prednisone, doxyrubicin, cyclophosphamide, and etoposide) and who had no sign of their disease.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studju ewlieni wieħed li jinvolvi total ta' 177 adult b'linfoma follikulari li kienu rrispondew għall-kura induttiva b'terapija stabbilita magħrufa bħala PACE (pednisone, doxyrubicin, cyclophosphamide, u etoposide) u li ma kellhom ebda sinjal tal-marda tagħhom.
English: In addition, the effectiveness of Lympreva following induction treatment with the current standard of care (the so-called ‘anti-CD20' therapies) has not been demonstrated.
Maltese: Barra minn hekk, l-effikaċja ta' Lympreva wara lkura ta' induzzjoni bl-istandard attwali ta' kura ('l hekk imsejħa terapiji "kontra s-CD-20") ma ntwerietx.
English: It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF).
Maltese: Kien mistenni li jintuża flimkien ma' mediċina oħra msejħa fattur li jistimula l-kolonji ta' granuloċiti makrofaġi (GM-CSF).
English: It was to be available as a suspension for injection under the skin.
Maltese: Kellu jiġi bħala suspensjoni għal injezzjoni taħt il-ġilda.
English: Patients were given either Lympreva together with GM-CSF, or haemocyanin with GM-CSF.
Maltese: Ilpazjenti ngħataw Lympreva flimkien ma' GM-CSF, jew haemocyanin ma' GM-CSF.
English: What was Lympreva expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Lympreva?
English: The medicine is made up of a protein found in the patient's lymphoma cells, attached to a molecule called haemocyanin, which helps to activate the immune system against the lymphoma cells.
Maltese: Il-mediċina hija magħmula minn proteina li tinstab fiċ-ċelloli tal-limnfoma tal-pazjent, inwaħħla ma' molekula msejħa haemocyanin, li tgħin biex tattiva lis-sistema immunitarja kontra ċċelloli tal-linfoma.
English: Lympreva is a medicine that contains the active substance dasiprotimut-T.
Maltese: Lympreva huwa mediċina li fiha s-sustanza attiva dasiprotimut-T.
English: Lympreva was expected to be used to treat adults with follicular non-Hodgkin's lymphoma, a cancer of a type of white blood cells called ‘B cells'.
Maltese: Lympreva huwa tip ta' mediċina ta' "immunoterapija kontra l-kanċer", mediċina maħsuba biex tistimula s-sistema immunitarja tal-pazjent (id-difiżi naturali tal-ġisem) biex b'hekk tattakka u toqtol iċ-ċelloli tal-kanċer.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent m'hemm ebda prova klinika jew programm ta' użu ta' kompassjoni b'Lympreva.
English: When injected into the patient's body, these lymphoma-specific proteins are expected to stimulate certain components of the immune system to attack and kill the lymphoma cells.
Maltese: Meta jiġu injettati fil-ġisem tal-pazjent, dawn il-proteini speċifiċi għal-linfoma huma mistennija li jistimulaw ċerti komponenti mis-sistema immunitarja biex jattakkaw u joqtlu ċ-ċelloli tal-linfoma.
English: Valsartan 320
Maltese: Valsartan 320 Losartan 150
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Macrogol 4000
Maltese: Ipromelloża (sostituzzjoni tip 2910.3 mPa.s) Dijossidu tat-titanju (E171) Makrogol 4000
English: Frequency Copalia HCT
Maltese: Frekwenza Copalia HCT
English: Copalia 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: Copalia 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: Due to the hydrochlorothiazide component, Copalia 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, Copalia 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: Copalia HCT with food, drink and alcohol
Maltese: Copalia HCT ma' ikel, xorb u alkoħol
English: Due to the hydrochlorothiazide component, Copalia HCT is contraindicated in symptomatic hyperuricaemia.
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Copalia HCT hu kontraindikat f'iperurikemija sintomatika.
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Copalia 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'Copalia 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: See also information under the heading “Do not take Copalia HCT”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Copalia HCT”.
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Copalia HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Copalia HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Copalia 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'Copalia HCT (71%) meta mqabbel ma' kull wieħed mit-tliet terapiji l-oħra b'taħlita ta' żewġ mediċini (45-54%) (p<0.
English: Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Minħabba l-komponent valsartan, Copalia HCT huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: Copalia 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: Copalia 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: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Copalia HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Copalia HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: No formal interaction studies with other medicinal products have been performed with Copalia HCT.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni ma' prodotti mediċinali oħrajn b'Copalia HCT.
English: Concomitant use of Copalia 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' Copalia 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: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Copalia 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' Copalia 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: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Copalia HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Copalia 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 (Copalia HCT), ma kien hemm l-ebda evidenza ta' tossiċità sistemika jew ta' organi fil-mira li jaffettwaw b'mod avvers l-iżvilupp ta' Copalia HCT għall-użu kliniku fil-bniedem.
English: No dose adjustment of Copalia 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' Copalia HCT għall-pazjenti li għandhom indeboliment renali minn ħafif għal moderat (GFR ≥30 ml/min/1.73 m
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Copalia 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'Copalia HCT kienu sturdament u pressjoni baxxa (0.7%).
English: In the controlled trial of Copalia 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' Copalia HCT, l-effetti kontra xulxin li valsartan 320 mg u hydrochlorthiazide 25 mg għandhom fuq il-potassju fis-serum bejn wieħed u ieħor ibbilanċjaw lillxulxin f'ħafna mill-pazjenti.
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Copalia 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 Copalia HCT (amlodipine/valsartan/HCT) u amlodipine, valsartan u HCT waħedhom.
English: The reductions in systolic/diastolic blood pressure with Copalia 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'Copalia 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: Copalia HCT was studied in a double-blind, active controlled study in hypertensive patients.
Maltese: Copalia HCT kien studjat fi studju double-blind ikkontrollat b'mod attiv f'pazjenti bi pressjoni għolja.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakokinetiku Linearità
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: The safety profile of Copalia HCT presented below is based on clinical studies performed with Copalia HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Maltese: Il-profil ta' sigurtà ta' Copalia HCT ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmulin b'Copalia HCT u fuq il-profil ta' sigurtà magħruf tal-komponenti individwali amlodipine, valsartan u hydrochlorthiazide.
English: When Copalia 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 Copalia 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: Copalia 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: Copalia 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: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Copalia HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Copalia 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' Copalia HCT kienu żgħar u konsistenti mal-mekkaniżmu farmakoloġiku ta' azzjoni tas-sustanzi meta jingħataw waħedhom.
English: Copalia HCT individual component
Maltese: Komponent individwali ta' Copalia HCT
English: If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide, Copalia HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil-bilanċ tal-potassju.
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: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
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);
English: Copalia 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: Copalia 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: Copalia 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: Copalia 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: Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Maltese: Copalia HCT hu kontraindikat f'pazjenti b'indeboliment gravi tal-kliewi, anurija jew li qed jagħmlu ddijaliżi (ara sezzjoni 4.3).
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Copalia 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, Copalia HCT mhuwiex addattat għal dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Copalia HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Copalia HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.