FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Maltese: Ma hemm ebda dejta disponibbli dwar l-effett ta' indutturi ta' CYP3A4 fuq amlodipine.
English: Due to the hydrochlorothiazide component, Imprida HCT is contraindicated in symptomatic hyperuricaemia.
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Imprida 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 Imprida 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'Imprida 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: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Imprida 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'Imprida HCT (71%) meta mqabbel ma' kull wieħed mit-tliet terapiji l-oħra b'taħlita ta' żewġ mediċini (45-54%) (p<0.
English: Amlodipine should be used with caution together with CYP3A4 inducers.
Maltese: Amlodipine Inibituri ta' CYP3A4
English: Vasculitis necrotising and toxic epidermal necrolysis
Maltese: Vaskulite li tinnekrotizza u nekroliżi epidermali tossika
English: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Maltese: Amlodipine huwa membru ta' grupp ta' sustanzi li jissejħu “imblukkaturi tal-kanali tal- kalċju”.
English: Tachycardia
Maltese: Takikardija
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 ACE, ARBs u Inibituri Diretti tar-Renin [DRIs]).
English: Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorthiazide, kienu rrappurtati li jħarrxu jew jattivaw lupus erythematosus sistemiku.
English: Caution should be used with: alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures); amantadine (anti-Parkinson therapy, also used to treat or prevent certain illnesses caused by viruses); anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia); anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood); simvastatin (a medicine used to control high cholesterol levels); ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis); cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide; digoxin or other digitalis glycosides (medicines used to treat heart problems); verapamil, diltiazem (heart medicines);
Maltese: Għandha tintuża kawtela ma': l-alkoħol, pilloli tal-irqad u anestetiċi (mediċini li bihom il-pazjenti jkunu jistgħu jagħmlu operazzjonijiet u proċeduri oħra); amantadina (kura kontra l-marda ta' Parkinson, tintuża wkoll biex tittratta jew tipprevjeni ċertu mard li ġej minn viruses); sustanzi antikolinerġiċi (mediċini li jintużaw għall-kura ta' diversi disturbi bħal brim gastrointestinali, spażmi fil-bużżieqa tal-awrina, ażma, tqalligħ minn ċaqliq, spażmi filmuskoli, marda ta' Parkinson u bħala għajnuna għall-anestesija); mediċini kontra l-aċċessjonijiet u mediċini li jistabbilizzaw il-burdata li jintużaw biex jikkuraw l-epilessija u disturb bipolari (eż. karbamazepina, fenobarbital,phenytoin, fosphenytoin, primidon); kolestiramina, kolestipol jew rażi oħrajn (sustanzi użati l-aktar fil-kura ta' livelli għoljin ta' xaħmijiet fid-demm);
English: These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data
Maltese: Dawn l-effetti sekondarji jistgħu jiġru b'ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn persuna 1 minn kull 10 li jużawh komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 100 li jużawh mhux komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 1,000 li jużawh rari: jaffettwaw minn persuna 1 sa 10 persuni minn kull 10,000 li jużawh rari ħafna: jaffettwaw inqas minn persuna 1 minn kull 10,000 li jużawh mhux magħruf: ma tistax tittieħed stima mid-data disponibbli
English: Special populations
Maltese: Eritema multiformi
English: Many feel normal.
Maltese: Ħafna nies iħossuhom normali.
English: Dyspnoea
Maltese: Dispepsja
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Imprida 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'Imprida HCT kienu sturdament u pressjoni baxxa (0.7%).
English: This could result in sub-therapeutic effects of thiazide diuretics.
Maltese: Dan jista' jwassal għal effetti sottoterapewtiċi tad-dijuretiċi thiazide.
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Imprida 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' Imprida 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: Elimination: 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: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Maltese: It-thiazides, inkluż hydrochlorthiazide, jistgħu jżidu rriskju ta' reazzjonijiet avversi kkawżati minn amantadina.
English: Lithium
Maltese: Litju
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Maltese: Fil-plażma kien identifikat metabolit hydroxy f'konċentrazzjonijiet baxxi (anqas minn 10% tal-AUC ta' valsartan).
English: Diarrhoea
Maltese: Pankreatite
English: • severely decreased urine output (possible signs of renal disorder or renal failure)
Maltese: • tnaqqis gravi fl-ammont ta' awrina li għaddi (sinjali possibbli ta' disturb fil-kliewi jew insuffiċjenza renali)
English: Muscle spasm
Maltese: • fsada spontanja
English: Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy.
Maltese: Reazzjonijiet avversi ġeneralment kienu ta' natura ħafifa u temporanja u xi drabi rari kien meħtieġ li titwaqqf it-terapija.
English: Common Uncommon
Maltese: Komuni ħafna
English: • lack of energy
Maltese: • nuqqas ta' enerġija
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' AIIRAs huwa kontraindikat fit-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Beta blockers and diazoxide
Maltese: Imblukkaturi beta u dijazossidu
English: Cough
Maltese: Kisja
English: Due to the valsartan component, Imprida HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Minħabba l-komponent valsartan, Imprida HCT huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: • allergic reaction with symptoms such as rash, itching
Maltese: • reazzjoni allerġika b'sintomi bħal raxx, ħakk
English: Talk to your doctor before drinking alcohol.
Maltese: Kellem lit-tabib tiegħek qabel ma tixrob l-alkoħol.
English: The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G and salicylic acid derivatives or antiarrhythmics.
Maltese: L-effett ipokalimiku ta' hydrochlorthiazide jista' jiżdied permezz tal-għoti flimkien ta' dijuretiċi kalijuretiċi, kortikosterojdi, lassattivi, ormon adrenokortikotropiku (ACTH), amfoteriċina, carbenoxolone, peniċillina G u derivattivi ta' aċidu saliċiliku jew antiarritmiċi.
English: Iron oxide, yellow (E172)
Maltese: Ossidu tal-ħadid, isfar (E172)
English: A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, or hydrochlorothiazide/amlodipine 25 mg/10 mg. At study initiation patients were assigned lower doses of their treatment combination and were titrated to their full treatment dose by week 2.
Maltese: Total ta' 2,271 pazjent bi pressjoni għolja minn moderata sa qawwija (medja ta' pressjoni sistolika/dijastolika ta'170/107 mmHg fil-linja bażi) irċevew kuri ta' amlodipine/valsartan/hydrochlorthiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorthiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, jew hydrochlorthiazide/amlodipine 25 mg/10 mg.
English: In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine,
Maltese: Bl-użu ta' valsartan waħdu ma nstabux interazzjonijiet ta' sinifikat kliniku b'dawn is-sustanzi li ġejjin: ċimetidina, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorthiazide, amlodipine, glibenclamide.
English: • facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Maltese: • raxx fil-wiċċ, uġigħ fil-ġogi, disturb fil-mukskoli, deni (lupus erythematosus)
English: No formal interaction studies with other medicinal products were performed with Imprida HCT.
Maltese: Ma sarux studji formali dwar interazzjonijiet ma' prodotti mediċinali oħrajn b'Imprida HCT.
English: • throat irritation
Maltese: • irritazzjoni fil-griżmejn
English: Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.
Maltese: Doża eċċessiva b'amlodipine tista' twassal għal vażodilatazzjoni periferali eċċessiva u, possibbilment, reflex takikardja.
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol.
Maltese: L-assorbiment ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, jonqos permezz ta' kolestiramina jew kolestipol.
English: Cardiac disorders Palpitations
Maltese: Disturbi fil-qalb Palpitazzjonijiet
English: Imprida 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: Imprida 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: Component of a multipack comprising 4 cartons, each containing 70 tablets.
Maltese: Komponent ta' pakkett b'ħafna magħmul minn 4 kartuniet, li kull waħda fiha 70 pillola.
English: • abnormal liver function test
Maltese: • għaraq eċċessiv
English: • muscle spasm
Maltese: • skumdità fl-istonku
English: No dosage adjustment of Imprida 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-dożaġġ ta' Imprida HCT għall-pazjenti li għandhom indeboliment renali minn ħafif għal moderat (GFR ≥30 ml/min/1.73 m2).Imprida
English: Elimination: 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: Multipacks of 280 tablets, comprising 20 cartons, each containing 14 tablets.
Maltese: Pakketti multipli b'280 pillola, magħmulin minn 20 kartuna, li kull waħda minnhom fiha 14-il pillola.
English: Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).
Maltese: Pazjenti b'indeboliment renali minn ħafif sa moderat jistgħu għalhekk jirċievu d-doża tal-bidu li tingħata s-soltu (ara sezzjonijiet 4.2 u 4.4).
English: Hypokalaemia
Maltese: Ipokalimja
English: 280 film-coated tablets
Maltese: 280 pillola miksija b'rita
English: Imprida HCT and older people (age 65 years and older) Imprida HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Maltese: Imprida HCT u pazjenti aktar avvanzati fl-età (età ta' 65 sena u aktar) Imprida HCT jista' jintuża minn persuni li għandhom 65 sena u aktar fl-istess doża bħal dik ta' adulti oħra u bl-istess mod kif ħadu diġà t-tliet sustanzi msejħa amlodipine, valsartan u hydrochlorthiazide.
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 (Imprida HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Imprida 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 (Imprida HCT), ma kien hemm l-ebda evidenza ta' tossiċità sistemika jew ta' organi fil-mira li jaffettwaw b'mod avvers l-iżvilupp ta' Imprida HCT għall-użu kliniku fil-bniedem.
English: The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Maltese: Ir-riżultati ta' studju in vitro bit-tessut tal-fwied talbniedem jindikaw li valsartan huwa substrat tattrasportatur tat-teħid epatiku OATP1B1 u tat-trasportatur tal-effluss epatiku MRP2.
English: Biotransformation: Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Maltese: L-hydrochlorthiazide huwa eliminat primarjament bħala kompost mhux mibdul.
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Maltese: Valsartan ma kellu l-ebda effetti avversi fuq il-prestazzjoni riproduttiva ta' firien irġiel jew nisa b'dożi orali ta' sa 200 mg/kg/kuljum.
English: Biotransformation: 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: In a subgroup of 283 patients focusing on ambulatory blood pressure monitoring, clinically and statistically superior reductions in 24-hour systolic and diastolic blood pressures were observed with the triple combination compared to valsartan/hydrochlorothiazide, valsartan/amlodipine, and hydrochlorothiazide/amlodipine.
Maltese: F'sottogrupp ta' 283 pazjent li kkonċentra fuq monitoraġġ ambulatorju tal-pressjoni, kien osservat tnaqqis klinikament u statistikament superjuri fil-pressjoni sistolika u dijastolika fuq medda ta' 24 siegħa bit-taħlita ta' tliet mediċini meta mqabbla ma' valsartan/hydrochlorthiazide, valsartan/amlodipine, u hydrochlorthiazide/amlodipine.
English: In patients with mild to moderate renal impairment, a 3-fold increase in hydrochlorothiazide AUC has been observed.
Maltese: F'pazjenti b'indeboliment talkliewi bejn ħafif u moderat, dehret żieda tripla fl-AUC ta' hydrochlorothiazide.
English: Gynaecomastia
Maltese: Ġinekomastja
English: • swelling
Maltese: • tqalligħ
English: • itchy rash and other types of rash
Maltese: • raxx bil-ħakk u tipi oħrajn ta' raxx
English: Titanium dioxide (E171) Iron oxide, yellow (E172)
Maltese: Dijossidu tat-titanju (E171) Ossidu tal-ħadid, isfar (E172)
English: • ringing noise in ears
Maltese: Rażi ta' skambju anjoniku
English: Elderly (age 65 years or over)
Maltese: Anzjani (età ta' 65 sena jew aktar)
English: Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients.
Maltese: Sensittività eċċessiva għas-sustanzi attivi, għal derivattivi ta' sulfonamid oħra, għal derivati ta' diidropiridina, jew għal xi sustanzi mhux attivi.
English: In one rat study, adverse effects were found on male fertility (see section 5.3).
Maltese: Fl-istudju li sar fuq far wieħed, kien hemm effetti avversi fuq il-fertilità maskili (ara sezzjoni 5.3).
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemmx data epidemjoloġika kkontrollata dwar ir-riskju b'Antagonisti tarRiċetturi ta' Anġjotensin II (AIIRAs), riskji jixxiebhu jistgħu jeżistu għal din il-klassi ta' mediċini.
English: Anticholinergic agents and other medicinal products affecting gastric motility
Maltese: Sustanzi antikolinerġiċi u prodotti mediċinali oħrajn li jaffettwaw ilmotilità gastrika
English: pulmonary oedema, pneumonitis)
Maltese: edima pulmonari, pnewmonite)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Maltese: L-għoti fl-istess ħin ta' aktar minn doża waħda ta' 10 mg amlodipine ma' 80 mg simvastatin irriżulta f'żieda ta' 77% fl-espożizzjoni għal simvastatin meta mqabbel ma' simvastatin waħdu.
English: Fertility There are no clinical studies on fertility with Imprida HCT.
Maltese: Fertilità Ma saru l-ebda studji kliniċi fuq il-fertilità b'Imprida HCT.
English: The reductions in systolic/diastolic blood pressure with Imprida 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'Imprida 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: In the controlled trial of Imprida 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' Imprida 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 safety profile of Imprida HCT presented below is based on clinical studies performed with Imprida HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Maltese: Il-profil ta' sigurtà ta' Imprida HCT ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmulin b'Imprida HCT u fuq il-profil ta' sigurtà magħruf tal-komponenti individwali amlodipine, valsartan u hydrochlorthiazide.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: • tiredness
Maltese: • sturdament
English: Abasia, gait disturbance
Maltese: Abasja, disturb fil-mixi
English: Reproductive toxicology
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: • weakness, bruising and frequent infections (aplastic anaemia)
Maltese: • dgħufija, tbenġil u infezzjonijiet frekwenti (anemija aplastika)
English: Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia.
Maltese: L-użu konkomitanti ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, ma' imblukkaturi beta jista' jżid irriskju ta' ipergliċemija.
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Dijossidu tat-titanju (E171) Ossidu tal-ħadid, isfar (E172) Ossidu tal-ħadid, aħmar (E172)
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure.
Maltese: L-użu fl-istess ħin ta' amlodipine ma' inibituri ta' CYP3A4 b'saħħithom jew moderati (inibituri tal-protease, antifungali tal-azole, makrolidi bħal erythromycin jew clarithromycin, verapamil jew diltiazem) jista' jagħti lok għal żieda sinifikanti fl-espożizzjoni għal amlodipine.
English: Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Maltese: Pakketti multipli b'280 pillola, magħmulin minn 4 kartuniet, li kull waħda minnhom fiha 70 pillola.
English: • sad mood (depression)
Maltese: • burdata ħażina (depressjoni)
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Maltese: Wara li jingħata ġol-vina, it-tneħħija ta' valsartan minn ġol-plażma hija ta' madwar 2 l/siegħa u t-tneħħija renali hija ta' 0.62 l/siegħa (madwar 30% tat-tneħħija totali).
English: Dantrolene (infusion) In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Maltese: Dantrolene (infużjoni) F'annimali, fibrillazzjoni ventrikulari letali u kollass kardjovaskulari ġew osservati f'assoċjazzjoni ma' iperkalemija, wara l-għoti ta' verapamil u dantrolene ġolvini.
English: Hydrochlorothiazide crosses the placenta.
Maltese: Hydrochlorthiazide jgħaddi minn ġol-plaċenta.