FrancophonIA/ELRC3.0 huggingface dataset:
English: Amendments to be included in the product information The DUSs results showed that approximately 9% of patients exposed to HES solutions for infusion were critically ill, approximately 5-8% of patients had renal impairment and approximately 3-4% of patients had sepsis.
Maltese: Ir-riżultati tad-DUSs urew li madwar 9% tal-pazjenti esposti għal soluzzjonijiet għall-infużjoni ta' HES kienu morda serjament, madwar 5-8% tal-pazjenti kellhom indeboliment tal-kliewi u madwar 3-4% tal-pazjenti kellhom sepsis.
English: • It will allow targeting HCPs in charge of the administration of the medicinal product who have an important role in ensuring adherence to the adequate use of HES solutions for infusion.
Maltese: • Dan se jippermetti l-immirar ta' HCPs inkarigati mill-amministrazzjoni tal-prodott mediċinali li għandhom rwol importanti biex jiżguraw l-aderenza għall-użu adegwat tas-soluzzjonijiet għallinfużjoni ta' HES.
English: The CMDh noted the PRAC conclusions that no new safety data was provided that would change the conclusions on the safety profile established in the previous referrals for HES solutions for infusion.
Maltese: Is-CMDh innota lkonklużjonijiet tal-PRAC li ma ġiet ipprovduta l-ebda data ta' sikurezza ġdida li tbiddel il-konklużjonijiet dwar il-profil tas-sigurtà stabbilit fir-referenzi preċedenti għal soluzzjonijiet għall-infużjoni ta' HES.
English: On the contrary, the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) and five Scandinavian learned societies supported the suspension of the marketing authorisations for HES solutions for infusion.
Maltese: Għall-kuntrarju, is-Soċjetà Skandinava talAnestesjoloġija u l-Mediċina għal Kura Intensiva (SSAI) u ħames soċjetajiet mgħallma Skandinavi appoġġaw is-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal soluzzjonijiet għall-infużjoni ta' HES.
English: The PRAC noted that the clinical studies imposed following previous referrals procedures (TETHYS and PHOENICS) to characterise the efficacy and safety in trauma and elective surgery, which is currently the target population for which the product is indicated are ongoing.
Maltese: Il-PRAC innota li l-istudji kliniċi imposti wara proċeduri ta' referenza preċedenti (TETHYS u PHOENICS) sabiex jiġu kkaratterizzati l-effikaċja u s-sigurtà f'kirurġija għat-trawmi u f'kirurġija elettiva, li bħalissa hija l-popolazzjoni fil-mira li għaliha huwa indikat il-prodott, għadhom għaddejjin.
English: Overall, taking into account the divergences amongst the experts on some important issues, the position from the PRAC members on the national situation regarding the clinical use of these products and the stakeholders submissions, PRAC did not consider the clinical utility of these products to outweigh the risk of mortality and renal failure to the proportion of patients with critical illness or sepsis that continue to be exposed to HES solutions for infusion.
Maltese: B'mod globali, meta jiġu kkunsidrati d-diverġenzi fost l-esperti dwar xi kwistjonijiet importanti, ilpożizzjoni mill-membri tal-PRAC dwar is-sitwazzjoni nazzjonali fir-rigward tal-użu kliniku ta' dawn ilprodotti u l-preżentazzjonijiet tal-partijiet ikkonċernati, il-PRAC ma qiesx li l-utilità klinika ta' dawn il prodotti tegħleb ir-riskju ta' mortalità u insuffiċjenza tal-kliewi għall-proporzjon ta' pazjenti b'mardserju jew sepsis li jibqgħu jiġu esposti għal soluzzjonijiet għall-infużjoni ta' HES.
English: The CMDh discussed whether measures to mitigate the risks associated with HES solutions for infusion, including in particular the risk of increased mortality and renal failure in critically ill patients and patients with sepsis would be effective and feasible, taking into account new elements provided by the MAHs and Member States.
Maltese: Is-CMDh iddiskuta jekk il-miżuri biex jittaffew ir-riskji assoċjati ma' soluzzjonijiet għall-infużjoni ta' HES, inkluż b'mod partikolari r-riskju ta' mortalità miżjud u ta' insuffiċjenza renali f'pazjenti morda b'mod kritiku u f'pazjenti b'sepsis ikunux effettivi u fattibbli, billi jitqiesu elementi ġodda pprovduti millMAHs u l-Istati Membri.
English: (2) Addition of a prominent warning at the top of the SmPC and PL.
Maltese: (2) Żieda ta' twissija prominenti fil-parti ta' fuq tal-SmPC u l-fuljett ta' tagħrif (PL).
English: • With regards to the two separate DUSs conducted to assess the effectiveness of the risk minimisation measures imposed as an outcome of the 2013 referral, PRAC concluded that these studies, despite limitations due to possible misclassification, are representative of the clinical usage in the European Union and that key results are reliable.
Maltese: • Fir-rigward taż-żewġ DUSs separati li saru biex tiġi vvalutata l-effettività tal-miżuri talminimizzazzjoni tar-riskju imposti bħala eżitu tar-referenza tal-2013, il-PRAC ikkonkluda li dawn l-istudji, minkejja limitazzjonijiet minħabba klassifikazzjoni ħażina possibbli, huma rappreżentattivi tal-użu kliniku fl-Unjoni Ewropea u li r-riżultati ewlenin huma affidabbli.
English: The PRAC concluded that the claimed clinical utility for these products does not outweigh the risk of mortality and renal failure to the proportion of patients with critical illness or sepsis that continues to be exposed to HES solutions for infusion.
Maltese: Il-PRAC ikkonkluda li l-utilità klinika mitluba għal dawn il-prodotti ma tissuperax ir-riskju ta' mortalità u insuffiċjenza renali għall-proporzjon ta' pazjenti b'mard kritiku jew sepsis li tibqa' esposta għal soluzzjonijiet għall-infużjoni ta' HES.
English: The PRAC concluded that no additional risk minimisation measure or combination of risk minimisation measures, to sufficiently ensure safe and effective use of HES solutions for infusion could be identified.
Maltese: Il-PRAC ikkonkluda li ma setgħet tiġi identifikata l-ebda miżura addizzjonali ta' minimizzar tar-riskju jew kombinazzjoni ta' miżuri ta' minimizzar tar-riskju, biex tiżgura b'mod suffiċjenti użu sigur u effettiv ta' soluzzjonijiet għall-infużjoni ta' HES.
English: • Furthermore, the PRAC considered options for measures to further mitigate these risks, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists, restricted access and distribution system to accredited hospitals/physicians.
Maltese: • Barra minn hekk, il-PRAC ikkunsidra għażliet għal miżuri tal-minimizzar tar-riskju għal mitigazzjoni ulterjuri ta' dawn ir-riskji, inkluż tibdil fl-informazzjoni dwar il-prodott, komunikazzjoni diretta għall-professjonisti tal-kura tas-saħħa, materjal edukattiv, twissija dwar il-kontenitur primarju tal-prodotti, reġistrazzjoni għal formola ta' medikazzjoni, skeda ta' riċetti/listi ta' kontroll, aċċess ristrett u sistema ta' distribuzzjoni lil sptarijiet/tobba akkreditati.
English: As result of the reviews, the PRAC recommended that use of HES solutions for infusion should be restricted to the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Maltese: Irriżultati jindikaw li r-restrizzjonijiet implimentati fl-użu ma jiġux osservati biżżejjed.
English: In particular, the CMDh took into consideration the additional details from the MAHs on the proposed controlled access program.
Maltese: B'mod partikolari, is-CMDh qies id-dettalji addizzjonali mill-MAHs dwar ilprogramm ta' aċċess ikkontrollat propost.
English: The CMDh noted the concerns raised by PRAC on some models of controlled access program for HES solutions for infusion, in particular regarding feasibility due to the difficulty to define relevant prescribers / departments / hospitals and their effectiveness.
Maltese: Is-CMDh innota t-tħassib imqajjem mill-PRAC dwar xi mudelli ta' programm ta' aċċess ikkontrollat għal soluzzjonijiet għall-infużjoni ta' HES, b'mod partikolari rigward il-fattibilità minħabba d-diffikultà biex jiġu definiti preskritturi / dipartimenti / sptarijiet rilevanti u l-effettività tagħhom.
English: The final training materials, including communication media and distribution modalities should be agreed with the National Competent Authorities.
Maltese: Il-materjal ta' taħriġ finali, inklużi l-midja tal-komunikazzjoni u l-modalitajiet ta' distribuzzjoni għandhom jiġu miftiehma mal-Awtoritajiet Nazzjonali Kompetenti.
English: The PRAC considered other further risk minimisation measures to sufficiently minimise this exposure, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists.
Maltese: Il-PRAC ikkunsidra li miżuri tal-minimizzazzjoni tar-riskju ulterjuri oħrajn jimminimizzaw biżżejjed dan l-esponiment, inkluż tibdil fl-informazzjoni dwar il-prodott, komunikazzjoni diretta għall-professjonisti tal-kura tas-saħħa, materjal edukattiv, twissija dwar il-kontenitur primarju tal-prodotti, reġistrazzjoni għal formola ta' medikazzjoni, skeda ta' riċetti/listi ta' kontroll.
English: • This measure will act as a reminder at time of administration, which is important in an emergency setting.
Maltese: • Din il-miżura taġixxi bħala tfakkira fil-ħin tal-amministrazzjoni, li hija importanti f'ambjent ta' emerġenza.
English: The PRAC also noted that the current clinical experience suggests that it is difficult to clearly separate patient populations where randomised clinical trials have shown serious harm from populations targeted by the approved indication.
Maltese: Il-PRAC innota wkoll li l-esperjenza klinika attwali tissuġġerixxi li huwa diffiċli li l-popolazzjonijiet tal-pazjent jiġu sseparati b'mod ċar fejn provi kliniċi randomizzati wrew ħsara serja minn popolazzjonijiet fil-mira mill-indikazzjoni approvata.
English: Indeed, the CMDh noted the results of the DUSs whereby there was adherence to some of the key restrictions of use recommended following the 2013 referrals (i.e. the maximum daily dose and treatment duration).
Maltese: Tabilħaqq, is-CMDh innota r-riżultati tad-DUSs fejn kien hemm konformità ma' wħud mirrestrizzjonijiet ewlenin ta' użu rakkomandat wara r-riferimenti tal-2013 (jiġifieri id-doża massima ta' kuljum u t-tul tal-kura).
English: As an overall conclusion, the CMDh considered that the risk minimisation described above would be feasible and effective and will have a synergistic effect as they allow targeting specific HCPs at all the steps of the prescription and administration of HES solutions for infusion.
Maltese: Bħala konklużjoni ġenerali, is-CMDh qies li l-minimizzazzjoni tar-riskju deskritta hawn fuq tkun fattibbli u effettiva u jkollha effett sinerġistiku minħabba li dawn jippermettu l-immirar ta' HCPs speċifiċi filpassi kollha tal-preskrizzjoni u l-amministrazzjoni ta' soluzzjonijiet għall-infużjoni ta' HES.
English: Packaging Package size
Maltese: Ippakkjar Daqs talpakkett
English: EU (MA) Number Invented name
Maltese: Numru tal-UE Isem kummerċjali
English: OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward * Significant difference vs.
Maltese: OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward * Differenza sinjifikanti vs.
English: Change from BL -1.8
Maltese: Tibdil minn BL -1.8
English: Change from BL -0.3
Maltese: Tibdil minn BL -0.3
English: Azilsartan is metabolised to two primary metabolites.
Maltese: Azilsartan huwa metabolizzat għal żewġ metaboliti primarji.
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola
English: Serum creatinine
Maltese: Serum krejatinina
English: For Edarbi, olmesartan medoxomil and valsartan, respectively dizziness was observed at an incidence of 3.0%, 3.3% and 1.8%; headache at 4.8%, 5.5% and 7.6% and dyslipidemia at 3.5%, 2.4% and 1.1%.
Maltese: Għal Edarbi, olmesartan medoximil u valsartan, ripettivament sturdament kien osservat b'inċidenza ta' 3.0%, 3.3% u 1.8%, uġigħ ta' ras ta' 4.8%, 5.5% u 7.6% u dislipidemja ta' 3.5%, 2.4% u 1.1%.
English: 14, 28, 30, 56, 90 or 98 tablets.
Maltese: 14, 28, 30, 56, 90 jew 98 pillola.
English: Manufacturer: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co.
English: Change from BL -2.1 -14.3 * -14.5 * -17.6 * -14.9 Study 2
Maltese: Tibdil minn BL -2.1 -14.3 * -14.5* -17.6 * -14.9 Studju 2
English: In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was +30%, +25% and +95% increased.
Maltese: F'pazjenti b'indeboliment renali ħafif, moderat, u sever esponiment totali lejn azilsartan (AUC) żdied b' +30%, +25% u + 95%.
English: Azilsartan is highly bound to plasma proteins (> 99%), mainly serum albumin.
Maltese: Azilsartan hu marbut mal-proteini filplażma (> 99%), prinċipalment mal-albumina fis-serum.
English: Additional information
Maltese: Informazzjoni addizzjonali
English: Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Ireland
Maltese: Bray Business Park Kilruddery Co Wicklow Irlanda
English: The major enzyme responsible for azilsartan metabolism is CYP2C9.
Maltese: L-enżima prinċipali responsabbli għall-metaboliżmu azilsartan hija CYP2C9.
English: The possibility of similar effects cannot be excluded with Edarbi.
Maltese: Il-possibbiltà ta' effetti simili ma tistax tiġi eskluża b'Edarbi.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain, ATC Code: C09CA09
Maltese: Sustanzi li jaġixxu fuq is-sistema renin-angiotensin, antagonisti tarriċetturi anġjotensina II, sempliċi, Kodiċi ATC: C09CA09
English: Change from BL -1.4 -12.2 * -13.5 * -14.6 *† -12.6 Study 2
Maltese: Tibdil minn BL -1.4 -12.2 * -13.5 * -14.6 *†
English: Dual blockade of the RAAS
Maltese: Imblokk doppju tal-RAAS
English: Mannitol (E 421) Fumaric acid (E 297) Sodium hydroxide Hydroxypropylcellulose (E 463) Croscarmellose sodium Microcrystalline cellulose (E 460) Magnesium stearate (E 572)
Maltese: Microcrystalline cellulose (E 460) Magnesium stearate (E 572)
English: Rash, pruritus Angioedema
Maltese: Raxx, ħakk Anġjoedema
English: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
Maltese: Takeda Pharma A/S, Dybendal Alle 10, 2630
English: Takeda Pharma A/S Tlf: +45 46 77 11 11
Maltese: Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11
English: Aluminum blisters integrated with desiccant.
Maltese: Folji tal-aluminju integrati b'dessikant.
English: Placebo Edarbi 20 mg
Maltese: Plaċebo Edarbi 20 mg
English: Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Maltese: Edarbi jiġi provdut f'folji ta' 14-il pillola jew 15-il pillola ġo kartun li fihom 14, 28, 56 jew 98 pillola u folji integrati b'dessikant b'jew 14-il pillola jew 15-il pillola f'kartun li jkun fih 14, 28, 30, 56, 90 jew 98 pillola.
English: Takeda AS
Maltese: Takeda UAB
English: Uncommon Fatigue Peripheral oedema
Maltese: Għeja kbira Edema periferali
English: Tecnimede - Sociedade Técnicio-Medicinal, S.A Tel: +351 21 041 41 00
Maltese: Tecnimede, Sociedade Técnicio-Medicinal, S.ATel: +351 932 333 108
English: Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
Maltese: B'mod ġenerali, 51% talpazjenti kienu rġiel u 26% kellhom 65 sena jew aktar (5% ≥ 75 sena); 67% kienu bojod u 19% kienu suwed.
English: In seven double blind controlled studies, a total of 5,941 patients (3,672 given Edarbi, 801 given placebo, and 1,468 given active comparator) were evaluated.
Maltese: Fis-seba' studji doppji għomja kkontrollati, total ta' 5,941 pazjent (3,672 mogħtija Edarbi, 801 mogħtija plaċebo, u 1468 mogħtija komparatur attiv) kienu evalwati.
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inklużi inibituri COX-2 selettivi, aċidu aċitilsaliċiliku > 3 g/kuljum), u NSAIDs mhux selettivi Meta l-antagonisti tar-riċetturi ta' anġjotensina II huma mogħtija simultanjament ma' NSAIDs (i.e inibituri COX-2 selettivi, aċidu aċitilsaliċiliku (> 3 g/kuljum), u NSAIDs mhux selettivi), attenwazzjoni tal-effett anti-ipertensiv tista' sseħħ.
English: Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and elderly (age range 65-85 years) patients.
Maltese: Il-farmakokinetiċi ta' azilsartan ma jvarjawx b'mod sinifikanti bejn pazjenti żgħażagħ (ta' etajiet bejn it-18 u 45 sena) u anzjani (ta' etajiet bejn 65-85 sena).
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Maltese: SBP: LS Tibdil Medju mill-Linja Bażi (BL) sas-6 Ġimgħa (mm Hg) (LOCF) Studju 1
English: 14, 28, 56 or 98 tablets; or
Maltese: 14, 28, 56 jew 98 pillola; jew
English: The estimated absolute oral bioavailability of azilsartan medoxomil based on plasma levels of azilsartan is approximately 60%.
Maltese: Il-bijodisponibiltà orali assoluta stmata ta' azilsartan medoxomil bbażata fuq livelli fil-plażma ta' azilsartan hi madwar 60%.
English: Elimination Following an oral dose of
Maltese: Eliminazzjoni Wara doża orali ta'
English: C-labelled azilsartan medoxomil, approximately 55% of radioactivity was recovered in faeces and approximately 42% in urine, with 15% of the dose excreted in urine as azilsartan.
Maltese: C-tabellata ta' azilsartan medoxomil, madwar 55% ta' radjoattività kienet irkuprata fl-ippurgar u madwar 42% fl-awrina, b'15% tad-doża mneħħija fl-awrina bħala azilsartan.
English: Administration of Edarbi for up to 5 days in subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment resulted in slight increase in azilsartan exposure (AUC increased by 1.3 to 1.6 fold, see section 4.2).
Maltese: L-amministrazzjoni ta' Edarbi sa 5 ijiem f'suġġetti b'indeboliment ħafif ta' indeboliment epatiku (Child-Pugh A) jew moderat (Child-Pugh B) rriżulta f'żieda żgħira f'esposizzjoni ta' azilsartan (AUC żied minn 1.3 għal 1.6 il-darba (ara sezzjoni 4.2)).
English: Takeda UAB Tel: +370 521 09 070 lt-info@takeda.com
Maltese: Tel: +370 521 09 070 lt-info@takeda.com
English: - The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma mannitol, aċidu fumariku, idrossidu tas-sodju, idroksipropilċellulosi, sodju kroskarmellosju, ċellulosi mikrokristallina, u sterat tal-manjesju.
English: The volume of distribution of azilsartan is approximately 16 litres.
Maltese: Il-volum ta' distribuzzjoni ta' azilsartan huwa madwar 16 litru.
English: Doses were force-titrated at Week 2 from 20 to 40 mg and 40 to 80 mg for Edarbi, and 20 to 40 mg and 160 to 320 mg, respectively, for olmesartan medoxomil and valsartan
Maltese: Id-dożi kienu titrati b'forza fit-2 Gimgħa minn 20 sa 40 mg u 40 sa 80 mg ta' Edarbi, u 20 sa 40 mg u 160 sa 320 mg, rispettivament, għal olmesartan medoxomil u valsartan
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-krejatinina fosfokinażi fid-demm
English: No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Maltese: Ma kien hemm ebda interazzjonijiet klinikament sinjifikanti rrappurtati fl-istudji ta' azilsartan medoxomil azilsartan jew azilsartan meta ġie mogħti ma' amlodipin, antaċidi, klortalidon, digoxin, flukonażol, gliburid, ketokonażol, metformin u warfarina.
English: Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium) Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium) Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Maltese: Edarbi 20 mg: Kull pillola fiha 20 mg azilsartan medoxomil (bħala potassju) Edarbi 40 mg: Kull pillola fiha 40 mg azilsartan medoxomil (bħala potassju) Edarbi 80 mg: Kull pillola fiha 80 mg azilsartan medoxomil (bħala potassju)
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Maltese: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) kien studju maħsub biex jittestja l-benefiċċju li jiżdied aliskiren ma' terapija standard ta' inibitur ta' ACE jew imblokkatur tar-riċetturi ta' angiotensin II f'pazjenti b'dijabete mellitus tip 2 u mard kroniku tal-kliewi, mard kardjovaskulari, jew it-tnejn.
English: During controlled clinical studies in healthy subjects, once daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well tolerated.
Maltese: Waqt studji kliniċi kkontrollati f'persuni f'saħħithom, dożi mogħtija darba kuljum sa 320 mg ta' azilsartan medoxomil kienu amministrati għal 7 ijiem u kienu tollerati sew.
English: Date of first authorisation: 7 December 2011 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 7 ta' Diċembru 2011
English: Tlf: + 47 6676 3030 infonorge@takeda.com
Maltese: Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
English: Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks.
Maltese: Effett kważi massimu anti-ipertensiv hu evidenti wara ġimgħatejn, bl-effetti massimi milħuqa sa 4 ġimgħat.
English: Key Secondary End Point:
Maltese: Punt Ewlieni Aħħari Sekondarju:
English: The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Edarbi fit-tfal u adolexxenti ta' età minn 0 sa < 18-il sena għadhom ma ġewx determinati s'issa.
English: Elderly (65 years and over)
Maltese: Anzjani (65 sena u akbar)
English: Coadministration of Edarbi 40 and 80 mg with a calcium channel blocker (amlodipine) or a thiazidetype diuretic (chlortalidone) resulted in additional blood pressure reductions compared with the other antihypertensive alone.
Maltese: L-amministrazzjoni ta' Edarbi 40 u 80 mg flimkien ma' imblokkatur tal-kanali tal-kalċju (amlodipine) jew dijuretiku tat-tip tijazide (klortalidon) irriżulta fi tnaqqis miżjud fil-pressjoni tad-demm meta mqabbla ma' l-anti-ipertensiv ieħor waħdu.
English: 24 Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Maltese: 24-Siegħa Medja SBP: LS Tibdil Medju mill-Linja Bażi (BL) sas-6 Ġimgħa (mm Hg) Studju 1
English: Azilsartan and M-II showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Maltese: Azilsartan u M-II ma wrew l-ebda evidenza ta' mutaġeniċità u attività klastoġeniku rilevanti fi studji in vitro u l-ebda evidenza ta' karċinoġeniċità fil-firien u ġrieden.
English: Edarbi 40 mg tablets
Maltese: Edarbi 40 mg pilloli
English: Small mean increases of serum uric acid were observed with Edarbi (10.8 µmol/l) compared with placebo (4.3 µmol/l).
Maltese: placebo (4.3 µmol/l).
English: The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 ml/min.
Maltese: Iż-żmien tal-eliminazzjoni bin-nofs ta' azilsartan hi madwar 11-il siegħa u t-tneħħija renali hi ta' madwar 2.3 ml/min.
English: Based on in vitro studies, carboxymethylenebutenolidase is involved in the hydrolysis in the intestine and liver.
Maltese: Skond studji in-vitro, carboxymethylenebutenolidase huwa involut f'idroliżi fl-intestin u fil-fwied.