FrancophonIA/ELRC3.0 huggingface dataset:
English: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 3 g/l and 1 volume percent, respectively) were observed in placebo-controlled monotherapy studies.
Maltese: Tnaqqis żgħar fl-emoglobina u ematokrit (tnaqqis medju ta' madwar 3 g/lu 1 volum fil-mija, rispettivament) kienu osservati fi studji b'monoterapija kontrollati bi plaċebo.
English: (medicines to relieve pain and inflammation) - Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and inflammation) - Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets') or salt substitutes containing potassium - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Maltese: (mediċini biex itaffu l-uġigħ u infjammazzjoni) - Aċidu aċetilsaliċikliku jekk tieħu' aktar minn 3 g kuljum (mediċina biex ittaffi l-uġigħ u infjammazzjoni) - Mediċini li jżidu l-ammont tal-potassju fid-demm tiegħek; dawn jinkludu supplimenti tal potassju, mediċini li jġemmgħu il-potassju (ċertu "pilloli tal-ilma") jew sostituti tal-melħ li fihom potassju - Eparina (mediċina għall traqqiq tad-demm) - Dijuretiċi (pilloli tal-ilma) - Aliskiren jew mediċini oħrajn li jbaxxu l-pressjoni tad-demm tiegħek (inibitur ta' enzima li tibdel angiotensin jew imblokkatur ta' riċettur ta' angiotensin II, bħal enalapril, lisinopril,
English: Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues (see section 5.2).
Maltese: Azilsartan medoxomil hija prodroga attiva mill-ħalq li rapidament tinbidel għal frazzjoni attiva, azilsartan, li b'mod selettiv jantagonizza l-effetti ta' anġjotensina II billi jimblokka l-legatura tagħha mar-riċettur AT1 fit-tessuti multipli (ara sezzjoni 5.2).
English: Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets
Maltese: Edarbi 20 mg pilloli Edarbi 40 mg pilloli Edarbi 80 mg pilloli
English: België/Belgique/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: Pack sizes:
Maltese: Data tal-aħħar tiġdid:
English: Takeda Pharma AB Tel: + 46 8 731 28 00 infosweden@takeda.com
Maltese: Tel: + 46 8 731 28 00 infosweden@takeda.com
English: - The concomitant use of Edarbi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1).
Maltese: - L-użu fl-istess ħin ta' Edarbi ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 mL/min/1.73m2) (ara sezzjonijiet 4.5
English: Food does not affect the bioavailability of azilsartan (see section 4.2).
Maltese: L-ikel ma jaffettwax il-bijodisponibilità ta' azilsartan (ara sezzjoni 4.2).
English: Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Maltese: Reazzjonijiet avversi kienu rapportati bi frekwenza simili għad-doża ta' Edarbi 20 mg kif ukoll bid-dożi ta' 40 mg u 80 mg fi studju bil-plaċebo bħala kontroll.
English: Intravascular volume depletion
Maltese: Tnaqqis fil-volum intravaskulari
English: Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Dejta minn provi kliniċi wriet li imblokk doppju tal-RAAS permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5
English: Edarbi is indicated for the treatment of essential hypertension in adults.
Maltese: Edarbi hu indikat għal kura ta' pressjoni għolja essenzjali f'adulti.
English: Edarbi 20 mg tablets
Maltese: Edarbi 20 mg pilloli
English: Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata fuq ir-riskju b'antagonisti tar-riċetturi ta' angiotensin II, riskji simili jistgħu jkunu jeżistu għal din ilklassi ta'prodotti mediċinali.
English: Edarbi 80 mg tablets
Maltese: Edarbi 80 mg pilloli
English: In vitro studies indicated that interactions based on esterase inhibition are unlikely.
Maltese: .2) Studji in-vitro indikaw li interazzjonijiet ibbażżati fuq l-inibizzjoni ta' esterases hija mprobbabli.
English: The tablets are white round debossed with “ASL” on one side and either “20”, “40” or “80” on the other.
Maltese: Il-pilloli huma bojod tondi b'”ASL” imbuzzat fuq naħa waħda u jew “20”, “40” jew “80” fuq in-naħa l-oħra.
English: Azilsartan medoxomil is rapidly hydrolysed to the active moiety azilsartan by esterases in the gastrointestinal tract and/or during drug absorption (see section 5.2).
Maltese: Azilsartan medoxomil huwa jdorilizzat malajr għas-sustanza attiva ta' azilsartan minn esterases talapparat gastrointestinali u/jew waqt l-assorbiment tal-medicina (ara sezzjoni 5
English: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.
Maltese: Pilloli bojod għal kważi bojod tondi, b'dijametru ta' 7.6 mm, b' “ASL” imbuzzat fuq naħa waħda u “40” fuq in-naħa l-oħra.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwentippubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Carton
Maltese: Kartuna
English: Edarbi 40 mg tablets Azilsartan medoxomil
Maltese: Edarbi 40 mg pilloli Azilsartan medoxomil
English: In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity.
Maltese: Fi studji ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina, azilsartan medoxomil u M-II, il-metabolit prinċipali tal-bniedem, kienu eżaminati għal tossiċità b'doża ripetuta, tossiċità fir-riproduzzjoni, mutaġeniċità u karċinoġeniċità.
English: Takeda Italia S.p.A. Tel: +39 06 5026 01
Maltese: Tel: +39 06 5026 01
English: ΒΙΑΝΕΞ Α.Ε.
Maltese: TA' EĊĊIPJENTI
English: These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports.
Maltese: Reazzjonijiet avversi bbażati fuq dejta miġbura (dożi 40 u 80 mg) huma mniżżla hawn taħt skond ilklassifika tas-sistema tal-organi u termini preferuti.Dawn huma kklassifikati skond il-frekwenza, bilkonvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), inklużi rapporti iżolati.
English: If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Maltese: Jekk ikun hemm pressjoni baxxa sintomatika, trattament ta' għajnuna għandha tingħata u sinjali vitali mmonitorjati.
English: Edarbi 20 mg tablets Azilsartan medoxomil
Maltese: Edarbi 20 mg pilloli Azilsartan medoxomil
English: This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
Maltese: Din il-mediċina hi użata biex tikkura pressjoni għolja (ipertensjoni essenzjali) f'pazjenti adulti (ta' età ta' ‘l fuq minn 18-il sena).
English: Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets Azilsartan medoxomil
Maltese: Edarbi 20 mg pilloli Edarbi 40 mg pilloli Edarbi 80 mg pilloli Azilsartan medoxomil
English: Edarbi 80 mg tablets Azilsartan medoxomil
Maltese: Edarbi 80 mg pilloli Azilsartan medoxomil
English: Primary end point:
Maltese: Punt aħħari primarju:
English: Activated renin-angiotensin-aldosterone system (RAAS) In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS (e.g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment with medicinal products that affect this system, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Maltese: F'pazjenti li t-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti fuq l-attività tal-RAAS (eż. pazjenti b'insuffiċjenza tal-qalb, indeboliment renali serju jew stenosi tal-arterja renali), kura bi prodotti mediċinali li jaffettwaw din is-sistema, bħall-inibituri tal-enżimi li jikkonvertu l-anġjotensina (ACE - angiotensin-converting enzyme) u l-antagonisti tar-riċetturi ta' anġjotensina II, ġiet assoċjata ma' pressjoni baxxa akuta, ażotemija, oligurja jew b'mod rari, insuffiċjenza renali akuta.
English: Blood pressure reductions compared with placebo based on 24 hour mean blood pressure by ambulatory blood pressure monitoring (ABPM) and clinic blood pressure measurements at trough are shown in the table below for both studies.
Maltese: Tnaqqis fil- pressjoni tad-demm mqabbel ma' placebo bbażat fuq 24 siegħa ta' pressjoni tad-demm medja permezz ta' treġija ambulatorju tal-pressjoni tad-demm (ABPM) u pressjoni taddemm klinika bil-qieghda huma murija fit-tabella hawn taħt.
English: In addition, plasma esterases are involved in the hydrolysis of azilsartan medoxomil to azilsartan.
Maltese: Barra min hekk, esterases tal-plasma huma involuti fl-idroliżi ta' azilsartan medoxomil f'azilsartan.
English: In the reproduction toxicity studies, there were no effects on male or female fertility.
Maltese: Fl-istudji tat-tossiċità fir-riproduzzjoni, ma kienx hemm effetti fuq il-fertilità maskili jew femminili.
English: No initial dose adjustment with Edarbi is necessary in elderly patients (see section 5.2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension.
Maltese: M'hemmx bżonn ta' aġġustament inizjali fid-doża b'Edarbi f'pazjenti anzjani (ara sezzjoni 5.2), għalkemm konsiderazzjoni tista' tingħata sa 20 mg bħala doża tal-bidu fl-anzjani akbar (≥ 75 sena), li jistgħu jkunu f'riskju ta' pressjoni baxxa.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Suomi/Finland Takeda Oy
Maltese: Magyarország Takeda Pharma
English: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.
Maltese: Pilloli bojod għal kważi bojod tondi, b'dijametru ta' 9.6 mm, b' “ASL” imbuzzat fuq naħa waħda u “80” fuq in-naħa l-oħra.
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Maltese: EU/1/11/734/001 14-il pillola EU/1/11/734/002 28 pillola EU/1/11/734/012 30 pillola EU/1/11/734/003 56 pillola EU/1/11/734/013 90 pillola EU/1/11/734/004 98 pillola EU/1/11/734/005 14-il pillola EU/1/11/734/006 28 pillola EU/1/11/734/014 30 pillola EU/1/11/734/007 56 pillola EU/1/11/734/015 90 pillola EU/1/11/734/008 98 pillola EU/1/11/734/016 14-il pillola EU/1/11/734/009 28 pillola EU/1/11/734/017 30 pillola EU/1/11/734/010 56 pillola EU/1/11/734/018 90 pillola EU/1/11/734/011 98 pillola EU/1/11/734/019 14-il pillola EU/1/11/734/020 28 pillola EU/1/11/734/021 56 pillola EU/1/11/734/022 98 pillola EU/1/11/734/023 14-il pillola EU/1/11/734/024 28 pillola EU/1/11/734/025 56 pillola EU/1/11/734/026 98 pillola
English: It is important to keep taking Edarbi every day at the same time.
Maltese: Huwa importanti li tkompli tieħu Edarbi fl-istess ħin kuljum.
English: Angiotensin II is the principal pressor agent of the RAAS, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
Maltese: II huwa l-aġent prinċipali li jikkawza id-djieq tal-vini jew arterji tal-RAAS, b'effetti li jinkludu vażokostrizzjoni, stimulazzjoni ta' sintesi u ħelsien ta' aldosteron, stimulazzjoni kardijaka, u riassorbiment renali ta' sodju.
English: In particular, tell your doctor if you are taking any of the following medicines: - Lithium (a medicine for mental health problems) - Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib
Maltese: B'mod partikolari, għid lit-tabib tiegħek jekk qed tieħu xi waħda minn dawn il-mediċini imsemmijin hawn taħt: - Litju (mediċina għall-problemi tal-mard mentali) - Mediċini anti-infjammatorji mhux sterojdi (NSAIDs), bħal ibuprofen, diclofenac jew celecoxib
English: White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other.
Maltese: Pilloli bojod għal kważi bojod tondi, b'dijametru ta' 6.0 mm, b' “ASL” imbuzzat fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: There was no evidence of QT/QTc prolongation at a dose of 320 mg of azilsartan medoxomil.
Maltese: Ma kienx hemm evidenza ta' QT/QTc b'doża ta' 320 mg ta' azilsartan medoxomil.
English: Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Maltese: Kull pillola fiha 40 mg azilsartan medoxomil (bħala potassju)
English: The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
Maltese: L-inċidenza ta' reazzjonijiet avversi b'dan it-trattament ma kienux affettwatati minn sess, età, jew razza.
English: For patients with possible depletion of intravascular volume or salt depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics), Edarbi should be initiated under close medical supervision and consideration can be given to 20 mg as a starting dose (see section 4.4).
Maltese: Għal pazjenti bi tnaqqis possibbli fil-volum intravaskulari jew tnaqqis fil-melħ (eż. pazjenti b'rimettar, dijarea jew li jieħdu dożi għolja ta' dijuretiċi), Edarbi għandu jinbeda taħt superviżjoni medika stretta u konsiderazzjoni tista' tingħata sa 20 mg bħala doża tal-bidu (ara 4.4 ).
English: Uncommon Muscle spasms
Maltese: Croscarmellose sodium
English: Each tablet contains 20 mg azilsartan medoxomil (as potassium)
Maltese: Kull pillola fiha 20 mg azilsartan medoxomil (bħala potassju)
English: Pharmacokinetics of azilsartan do not differ significantly between males and females.
Maltese: Farmakokinetiċi ta' azilsartan ma jvarjawx b'mod sinifikanti bejn maskili u femminili.
English: Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Edarbi is taken alone (less than 1 in 100 users).
Maltese: Nefħa tal-idejn, għekiesi jew saqajn huma aktar komuni (f'inqas minn 1 minn kull 10 utenti) meta Edarbi jittieħed ma' amlodipine (imblokkatur tal-kanali tal-kalċju għal kura ta' ipertensjoni) milli meta Edarbi huwa meħud waħdu (inqas minn 1 f'kull 100 utenti).
English: telmisartan, irbesartan).
Maltese: ramipril jew valsartan, telmisartan, irbesartan).
English: Effect on cardiac repolarisation
Maltese: Effett fuq ir-ripolarizzazzjoni kardijaka
English: Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing.
Maltese: Linearità/nuqqas ta' linearità Il-proporzjonalità fid-doża fl-espożizzjoni ġiet stabbilita għal azilsartan fil-firxa tad-doża medoxomil azilsartan ta' 20 mg sa 320 mg wara dożaġġ singolu jew multiplu.
English: Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs).
Maltese: Edarbi fih is-sustanza attiva li jisimgħa azilsartan medoxomil u tappartieni lill-klassi ta' mediċini li jisimhom antagonisti tar-riċetturi ta' anġjotensina II (AIIRAs).
English: Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks.
Maltese: B'dożi ta' 20, 40 jew 80 mg Edarbi ġie evalwat għas-sigurtà f'studji kliniċi f'pazjenti kkurati sa 56 ġimgħa.
English: Hemoglobin and hematocrit
Maltese: Tfal u adolexxenti
English: Placebo at 0.05 level within the framework of the step-wise analysis † Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise analysis # Maximum dose achieved in study 2.
Maltese: Komparatur(i) f'livell ta' 0.05 fil-qafas tal-analiżi ta' pass-għaqli #
English: Furthermore, concomitant use of angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Maltese: Barra minn hekk, l-użu konkomitanti ta' antagonisti tar-riċetturi ta' anġjotensina u NSAIDs jista' jwassal għal riskju akbar ta' deterjorament tal-funzjoni renali u żieda fil-potassju fis-serum.
English: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Maltese: Kull pillola fiha 80 mg azilsartan medoxomil (bħala potassju)
English: In rats and dogs, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Maltese: Fil-firien u klieb, żieda fl-attività fir-renin fil-plażma u ipertrofija/iperplasija taċ-ċelluli renali ġukstaglomerulari kienu osservati.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta ttqala tkun iddijanjostikata, il-kura b'antagonisti tar-riċetturi ta' angiotensin II għandha titwaqqaf immedjatament, u, jekk ikun xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: Blockade of the AT1 receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increases in plasma renin activity and angiotensin II circulating levels do not overcome the antihypertensive effect of azilsartan.
Maltese: Imblokk tar-riċettur AT1 jinibixxi r-rispons regolatorju negattiv ta' anġjotensina II fuq it-tnixxija tarrenin, iżda ż-żidiet li jirriżultaw fl-attività tar-renin fil-plażma u livelli li jiċċirkulaw tal-anġjotensina
English: Uric acid
Maltese: Aċidu Uriku
English: Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels.
Maltese: L-użu konkomitanti ta' dijuretiċi li jġemmgħu l-potassju, supplimenti tal-potassju, sostituti tal-melħ li fihom il-potassju, jew prodotti mediċinali oħra (eż. eparina) jistgħu iżidu il-livelli tal-potassju.
English: Blister
Maltese: Sturdament
English: The most common adverse reaction was dizziness.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' fejn tingħata
English: Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the RAAS.
Maltese: Pazjenti b'iperaldosteroniżmu primarju ġeneralment mhux ser jirrispondi għal prodotti mediċinali antiipertensivi li jaġixxu permezz ta' inibizzjoni tal-RAAS.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II hu kontra-indikat matul it-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
Maltese: Ibbażat fuq konsiderazzjonijiet farmakoloġiċi, il-manifestazzjoni prinċipali ta' doża eċċessiva x'aktarx li jkun ipotensjoni sintomatika u sturdament.
English: Coadministration of Edarbi with diuretics, such as chlortalidone, resulted in a greater incidence of creatinine elevations, an observation consistent with that of other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors.
Maltese: L-għoti ta' Edarbi flimkien ma' dijuretiċi, bħal klortalidon, wasslet għal inċidenza akbar ta' żiediet ta' krejatinina, osservazzjoni konsistenti ma' dik ta' antagonisti oħra tar-riċetturi anġjotensina II u inibituri tal-enżimi li jikkonvertu anġjotensina.
English: EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Maltese: EU/1/11/734/016 14-il pillola EU/1/11/734/009 28 pillola EU/1/11/734/017 30 pillola EU/1/11/734/010 56 pillola EU/1/11/734/018 90 pillola EU/1/11/734/011 98 pillola EU/1/11/734/027 14-il pillola EU/1/11/734/028 28 pillola EU/1/11/734/029 56 pillola EU/1/11/734/030 98 pillola
English: In these clinical studies, adverse reactions associated with treatment with Edarbi were mostly mild or moderate, with an overall incidence similar to placebo.
Maltese: F'dawn l-istudji kliniċi, reazzjonijiet avversi assoċjati mal-kura b'Edarbi kienu l-aktar ħfief jew moderati, b'inċidenza globali simili għal plaċebo.
English: Rebound hypertension was not observed following abrupt cessation of Edarbi therapy after 6 months of treatment.
Maltese: Ma kienx osservat ritorn ta' ipertensjoni wara waqfien f'daqqa tat-terapija b'Edarbi wara 6 xhur ta' kura.
English: EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets
Maltese: EU/1/11/734/005 14-il pillola EU/1/11/734/006 28 pillola EU/1/11/734/014 30 pillola EU/1/11/734/007 56 pillola EU/1/11/734/015 90 pillola EU/1/11/734/008 98 pillola EU/1/11/734/023 14-il pillola EU/1/11/734/024 28 pillola EU/1/11/734/025 56 pillola EU/1/11/734/026 98 pillola
English: As with other angiotensin II receptor antagonists the combination of lithium and Edarbi is not recommended (see section 4.5).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II mhuwiex rakkomandat matul l-ewwel trimestru tattqala (ara sezzjoni 4.4).