FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Esponiment għall-kura b'AIIRAs fit-tieni u t-tielet trimestri huwa magħruf li jinduċi tossiċità tal-fetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar tal-ossifikazzjoni tal-kranju) u tossiċità fittrabi wara t-twelid (indeboliment renali, pressjoni baxxa, iperkalemija)
English: • confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
Maltese: • konfużjoni, għeja, ġbid u spażi tal-muskoli, in-nifs jittieħed b'ħatf (alkalożi ipokloremika)
English: Antidiabetic agents (e.g. insulin and oral antidiabetic agents)
Maltese: Aġenti antidijabetiċi (eż. insulina u sustanzi antidijabetiċi mill-ħalq)
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Imprida 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' Imprida HCT kienu żgħar u konsistenti mal-mekkaniżmu farmakoloġiku ta' azzjoni tas-sustanzi meta jingħataw waħedhom.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Maltese: Fuq bażi tal-mekkaniżmu ta' azzjoni farmakoloġika ta' hydrochlorthiazide l-użu tiegħu waqt it-tieni u t-tielet trimestru jista' jikkomprometti l-perfużjoni talplaċenta u l-fetu u jista' jikkawża effetti fil-fetu u fit-tarbija tat-twelid bħal ikterus, disturb fil-bilanċ tal-elettroliti u tromboċitopenija.
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Maltese: Hydrochlorothiazide jista' jnaqqas ir-rispons ta' amini pressivi bħan-noradrenalina.
English: * Based on patient weight of 50 kg
Maltese: * Ibbażat fuq piż tal-pazjent ta' 50 kg
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Maltese: Jekk ilkumbinazzjoni tkun inevitabbli, huwa rrakkomandat li jsir monitoraġġ bir-reqqa tal-livelli tal-litju fis-serum (ara sezzjoni 4.4).
English: Nocturia
Maltese: Rimettar
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Maltese: Thiazides għandhom jitwaqqfu qabel ma jsiru testijiet għall-funzjoni talparatirojde.
English: Hyponatraemia
Maltese: Ċiklosporina
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 l-akkumulazzjoni hi minima meta tingħata doża darba kuljum.
English: • sleep disturbances
Maltese: Disturbi vaskulari
English: One blister contains 7, 10 or 14 film-coated tablets.
Maltese: Folja waħda fiha 7 pilloli, 10 pilloli jew 14-il pillola miksija b'rita.
English: Imprida HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Imprida HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: Film-coated tablet (tablet)
Maltese: Pillola miksija b'rita (pillola)
English: The maximum recommended dose of Imprida HCT is 10 mg/320 mg/25 mg.
Maltese: L-ogħla doża rrakkomandata ta' Imprida HCT hija ta' 10 mg/320 mg/25 mg.
English: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Maltese: Fi studju fit-tul, ikkontrollat bi plaċebo (PRAISE-2) b'amlodipine f'pazjenti b'insuffiċjenza tal-qalb ta' etjoloġija mhux iskemika b'NYHA (Klassifikazzjoni tal-Assoċjazzjoni tal-Qalb Ta' New York) III u IV, l-amlodipine kienet assoċjata ma' numru akbar ta' rapporti ta' edima fil-pulmun minkejja li ma kienx hemm differenza sinifikanti fin-numru ta' pazjenti li l-insuffiċjenza tal-qalb marret għall-agħar meta mqabbla mal-plaċebo.
English: What Imprida HCT looks like and contents of the pack Imprida 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: Id-Dehra ta' Imprida HCT u l-kontenuti tal-pakkett Imprida 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: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta t-tqala tkun iddijanjostikata, kura b'AIIRAs għandha titwaqqaf immedjatament, u, jekk xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Maltese: It-thiazides, inkluż hydrochlorthiazide, isaħħu l-azzjoni ta' derivati ta' curare.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).
Maltese: Issustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon; silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża, makrogol 4000, talc, dijossidu tat-titanju (E171).
English: The clinical translation of these pharmacokinetic variations may be more pronounced in the elderly.
Maltese: Ittraduzzjoni klinika ta' dawn il-varjazzjonijiet farmakokinetiċi tista' tkun aktar qawwija fl-anzjani.
English: Thrombocytopenia, sometimes with purpura
Maltese: Tromboċitopenija, xi kultant b'purpura
English: It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Maltese: Huwa rrakkomandat li d-doża ta' simvastatin tiġi limitata għal 20 mg kuljum f'pazjenti fuq amlodipine.
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorthiazide, jistgħu jibdlu t-tolleranza għall-glukosju u jgħollu llivelli ta' kolesterol, trigliċeridi u aċidu uriku fis-serum.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and increases in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Maltese: F'pazjenti bi pressjoni għolja b'funzjoni renali normali, dożi terapewtiċi ta' amlodipine wasslu għal tnaqqis fir-reżistenza fil-vini renali u żieda fir-rata ta' filtrazzjoni fil-glomeruli u għal ċirkolazzjoni effettiva tal-plażma renali, mingħajr ma tinbidel il-frazzjoni ta' filtrazzjoni jew proteina fl-awrina.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis.
Maltese: Doża eċċessiva ta' hydrochlorthiazide hija assoċjata ma' tnaqqis fl-elettroliti (ipokalimja, ipoklorimija) u ipovolimija kkawżata minn dijureżi eċċessiva.
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Imprida 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 Imprida HCT (amlodipine/valsartan/HCT) u amlodipine, valsartan u HCT waħedhom.
English: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Maltese: Kien hemm rapporti iżolati ta' anemija emolitika li seħħet meta hydrochlorthiazide intuża flimkien ma' metildopa.
English: Due to the valsartan component, Imprida HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Maltese: Minħabba l-komponent valsartan f'Imprida HCT huwa kontraindikat f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 4.3).
English: Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias.
Maltese: Studji dwar il-mutaġeniċità ma żvelawx effetti relatati mal-mediċina fil-livelli tal-ġeni jew talkromosomi.
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC.
Maltese: Pazjenti b'insuffiċjenza tal-fwied għandhom tneħħija ta' amlodipine imnaqqsa li tirriżulta f'żieda ta' madwar 40-60% fl-AUC.
English: The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Maltese: It-tneħħija renali hija magħmula minn filtrazzjoni passiva u sekrezzjoni attiva għal ġot-tubu ż-żgħir renali.
English: Each 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: Non-depolarising skeletal muscle relaxants (e.g. tubocurarine)
Maltese: Rilassanti tal-muskoli skeletriċi li mhumiex depolarizzanti (eż. tubocurarine)
English: Hypochloraemic alkalosis
Maltese: Alkolożi iperkloremika
English: What Imprida HCT looks like and contents of the pack Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Maltese: Id-Dehra ta' Imprida HCT u l-kontenuti tal-pakkett Imprida HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli bojod, ovali b'“NVR” fuq naħa waħda u b'“VCL” fuq in-naħa l-oħra.
English: Hyperuricaemia
Maltese: Ipomanjesimija
English: Pollakiuria
Maltese: Anġjoedima
English: • medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin or penicillin G; medicines to increase blood pressure such as adrenaline or noradrenaline; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used for oesophageal ulceration and inflammation (carbenoxolone); medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);
Maltese: • mediċini li jintużaw għal ulċeri u infjammazzjoni tal-osefagu (carbenoxolone); mediċini użati biex itaffu l-uġigħ jew l-infjammazzjoni, speċjalment sustanzi antiinfjammatorji mhux sterojdi (NSAIDs), inkluż inibituri selettivi ta' cyclooxygenase-2 (inibituri Cox-2);
English: Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with allergy and asthma.
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal hydrochlorthiazide huma aktar probabbli f'pazjenti b'allerġija u ażma.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors and thiazides such as hydrochlorothiazide.
Maltese: Żidiet riversibbli tal-konċentrazzjonijiet ta' litju fis-serum u tossiċità kienu rrappurtati bl-użu fl-istess ħin ta' inibituri ACE u thiazide bħal hydrochlorthiazide.
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Maltese: F'pazjenti b'insuffiċjenza severa tal-qalb li jkollhom funzjoni renali li tiddependi mill-attività tas-sistema renin-anġjotensin-aldosteron, kura b' inibituri ta' enzima tal-konverżjoni ta' anġjotensin (ACE) u antagonisti tar-riċettur ta' anġjotensin kienet assoċjata ma' oligurja u/jew ażotemja li tavvanza u (rarament) insuffiċjenza akuta renali u/jew mewt.
English: • trembling
Maltese: • rimettar
English: • itchy rash
Maltese: • ħalq xott
English: In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or
Maltese: Fi studji kliniċi ta' interazzjoni, amlodipine ma affettwax il-farmakokinetiċi ta' atorvastatin, digoxin, warfarin jew
English: Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VDL” on the other side.
Maltese: Pilloli bojod, b'forma ovali, konvessi fuq iż-żewġ naħat, bix-xifer tasturat, imnaqqxin b'“NVR” fuq naħa waħda u b'“VCL” fuq in-naħa l-oħra.
English: The safety of Imprida 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' Imprida 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: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Maltese: L-ogħla doża (għall-ġrieden, simili għal, u għall-firien id-doppju* tad-doża klinika massima rakkomandata ta' 10 mg fuq bażi ta' mg/m2) kienet simili għad-doża massima ttollerata għall-ġrieden iżda mhux għall-firien.
English: • cough
Maltese: • ħakk
English: Imprida HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Imprida HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: If hypokalaemia develops during hydrochlorothiazide therapy, Imprida HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide, Imprida HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil-bilanċ tal-potassju.
English: Hypomagnesaemia
Maltese: Anemija emolitika
English: • muscle relaxants (medicines to relax the muscles which are used during operations); nitroglycerin and other nitrates, or other substances called “vasodilators”; other medicines to treat high blood pressure, including methyldopa; rifampicin (used, for example, to treat tuberculosis);
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);
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Maltese: Fi studji mhux kliniċi dwar is-sigurtà, dożi għolja ta' valsartan (200 sa 600 mg/kg piż tal-ġisem) ikkawżaw tnaqqis fil-parametri ta' ċelluli ħomor tad-demm fil-firien (eritroċiti, emoglobina, ematokrita) u evidenza ta' bidliet fl-emodinamika renali (urea fil-plażma kemmxejn miżjuda, u iperplasija tubulari renali u bażofilja fl-irġiel).
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 12.5 mg hydrochlorthiazide.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).
Maltese: Issustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon; silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża, makrogol 4000, talc, ossidu tal-ħadid isfar (E172).
English: • headache
Maltese: • ebusija
English: When Imprida 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 Imprida 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: Each 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.
English: • weakness, bruising, fever and frequent infections
Maltese: • debbulizza, tbenġil, deni u infezzjonijiet frekwenti
English: • inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
Maltese: • infjammazzjoni tal-arterji u tal-vini b'sintomi bħal raxx, tikek vjola fl-aħmar, deni (vaskulite)
English: CARTON OF UNIT PACK
Maltese: KARTUNA TAL-PAKKETT B'WIEĦED
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 25 mg hydrochlorthiazide.
English: Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Maltese: L-għoti flimkien ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, jista' jżid l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal allopurinol.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Issustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon; silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża, makrogol 4000, talc, dijossidu tat-titanju (E171), ossidu talħadid isfar (E172).
English: Imprida HCT was studied in a double-blind, active controlled study in hypertensive patients.
Maltese: Imprida HCT kien studjat fi studju double-blind ikkontrollat b'mod attiv f'pazjenti bi pressjoni għolja.
English: Imprida HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Imprida HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon; silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża, makrogol 4000, talc, dijossidu tat-titanju (E171), ossidu talħadid isfar (E172), ossidu tal-ħadid aħmar (E172).
English: • vision disorder
Maltese: Indeboliment fil-vista
English: Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed.
Maltese: Kien hemm iponatrimija, akkumpanjata b'sintomi newroloġiċi (dardir, diżorjentazzjoni progressiva, apatija).
English: EU/1/09/570/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/570/048 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/570/047 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 25 mg hydrochlorthiazide.
English: What Imprida HCT looks like and contents of the pack Imprida 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: Id-Dehra ta' Imprida HCT u l-kontenuti tal-pakkett Imprida 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: What Imprida HCT looks like and contents of the pack Imprida 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: Id-Dehra ta' Imprida HCT u l-kontenuti tal-pakkett Imprida 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: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Maltese: Id-Dehra ta' Imprida HCT u l-kontenuti tal-pakkett Imprida HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli sofor ċari, ovali b'“NVR” fuq naħa waħda u b'“VDL” fuq in-naħa l-oħra.
English: Imprida HCT 10 mg/320 mg/25 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan, and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 10 mg amlodipine (bħala amlodipine besylate), 320 mg valsartan, u 25 mg hydrochlorthiazide.
English: EU/1/09/570/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/570/036 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/570/035 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża
English: Hydrochlorothiazide, a sulphonamide, has been associated with an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma.
Maltese: Hydrochlorothiazide, sulfonamid, kien assoċjat ma' reazzjoni idjosinkratika li twasssal għal mijopija tranżitorja gravi u għal glawkoma gravi tal-għeluq tal-angolu.
English: Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorthiazide, jistgħu jkabbru l-effett ipergliċemiku ta' dijazossidu.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Imprida 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, Imprida HCT mhuwiex addattat għal dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: fever (toxic epidermal necrolysis)
Maltese: tqaxxir tal-ġilda, deni (nekrolożi epidermali tossika)
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Imprida HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: EU/1/09/570/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/570/060 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/570/059 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Imprida HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Imprida HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade