FrancophonIA/ELRC3.0 huggingface dataset:
English: - Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/30” printed in red ink on one side.
Maltese: - Incresync 12.5 mg/30 mg pilloli miksija b'rita huma lewn il-ħawħ ċar, f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “12.5/30” stampati b'linka ħamra fuq naħa waħda.
English: - Incresync 12.5 mg/45 mg film-coated tablets (tablets) are pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/45” printed in red ink on one side.
Maltese: - Incresync 12.5 mg/45 mg pilloli miksija b'rita huma ta' lewn aħmar ċar, f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm hemm kemm “A/P” u “12.5/45” stampati b'linka ħamra fuq naħa waħda.
English: For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered.
Maltese: Għal pazjenti b'indeboliment tal-kliewi moderat (CrCl ≥ 30 sa ≤ 50 mL/min), nofs id-doża rakkomandata ta' alogliptin għandhom jingħataw.
English: Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Maltese: Kull pillola fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 25 mg alogliptin u 30 mg pioglitazone.
English: After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Maltese: Wara bidu tat-terapija b'Incresync, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex jiġi evalwat ir-rispons għat-trattament (eż. tnaqqis fl-HbA1c).
English: In these studies, 312 alogliptin/pioglitazone-treated patients were ≥ 65 years old.
Maltese: F'dawn l-istudji, 312-il pazjent ittrattat b'alogliptin/pioglitazone kellhom ≥ 65 sena.
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing anti-diabetic and cardiovascular therapy, for up to 3.5 years.
Maltese: Fi studju dwar ir-riżultati kardjovaskulari, PROactive, 5,238 pazjent b'dijabete mellitus tat-tip 2 u b'mard makrovaskulari maġġuri diġà eżistenti, intagħżlu b'mod każwali għal pioglitazone jew plaċebo flimkien ma' terapija antidijabetika u kardjovaskulari eżistenti, għal sa 3.5 snin.
English: Incresync 12.5 mg/30 mg film-coated tablets
Maltese: Incresync 12.5 mg/30 mg pilloli miksija b'rita
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Maltese: Kull pillola fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 25 mg alogliptin u 45 mg pioglitazone.
English: Incresync 12.5 mg/45 mg film-coated tablets
Maltese: Incresync 12.5 mg/45 mg pilloli miksija b'rita
English: For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2).
Maltese: Għal pazjenti b'indeboliment renali ħafif (tneħħija tal-kreatinina (CrCl) > 50 sa ≤ 80 mL/min), l-ebda aġġustament fid-doża ta' Incresync ma huwa meħtieġ (ara sezzjoni 5.2).
English: Overall, treatment with the recommended daily dose of 25 mg alogliptin in combination with pioglitazone improved glycaemic control.
Maltese: Globalment, it-trattament bid-doża rakkomandata ta' kuljum ta' 25 mg alogliptin flimkien ma' pioglitazone tejjeb il-kontroll gliċemiku.
English: 12.5 mg/45 mg film-coated tablets
Maltese: 12.5 mg/45 mg pilloli miksija b'rita
English: Placebo-corrected change from baseline in HbA1c (%)†
Maltese: Bidla medja talleast squares mil-linja bażi flHbA1c (%)†
English: Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Maltese: Żidiet proporzjonali fil-konċentrazzjoni fis-serum kienet osservata f'dozi minn 2-60 mg.
English: This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
Maltese: Dan kien iddeterminat bi tnaqqis klinikament rilevanti u statistikament sinifikanti fl-emoglobina glikosilata (HbA1c) u fil-glukosju fil-plażma wara s-sawm meta mqabbel ma' kontroll mil-linja bażi sal-punt aħħari tal-istudju.
English: For patients with moderate renal impairment, Incresync 12.5 mg/30 mg or 12.5 mg/45 mg should be administered once daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi, Incresync 12.5 mg/30 mg jew 12.5 mg/45 mg għandu jingħata darba kuljum.
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax u glycerol mono-oleate.
English: EU/1/13/842/001 10 film-coated tablets EU/1/13/842/002 14 film-coated tablets EU/1/13/842/003 28 film-coated tablets EU/1/13/842/004 30 film-coated tablets EU/1/13/842/005 56 film-coated tablets EU/1/13/842/006 60 film-coated tablets EU/1/13/842/007 90 film-coated tablets EU/1/13/842/008 98 film-coated tablets EU/1/13/842/009 100 film-coated tablets
Maltese: EU/1/13/842/001 10 pilloli miksija b'rita EU/1/13/842/002 14-il pillola miksija b'rita EU/1/13/842/003 28 pillola miksija b'rita EU/1/13/842/004 30 pillola miksija b'rita EU/1/13/842/005 56 pillola miksija b'rita EU/1/13/842/006 60 pillola miksija b'rita EU/1/13/842/007 90 pillola miksija b'rita EU/1/13/842/008 98 pillola miksija b'rita EU/1/13/842/009 100 pillola miksija b'rita
English: The physician educational pack should contain:
Maltese: Mhux magħruf:
English: Any macroscopic haematuria should be investigated before starting therapy.
Maltese: Kull ematurja makroskopika għandha tkun mistħarrġa qabel ma tinbeda t-terapija.
English: In a pooled analysis of the data from 13 studies, the overall incidences of cardiovascular death, non fatal myocardial infarction and non-fatal stroke were comparable in patients treated with 25 mg alogliptin, active control or placebo.
Maltese: F'analiżi miġbura tad-dejta minn 13-il studju, l-inċidenza ġlobali ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali u puplesija mhux fatali kienet komparabbli f'pazjenti kkurati b'25 mg alogliptin, kontroll attiv jew plaċebo.
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac, carnauba wax u glycerol mono-oleate.
English: In patients who fail to show an adequate response, Incresync should be discontinued.
Maltese: F'pazjenti li jonqsu li juru reazzjoni adegwata, Incresync għandu jitwaqqaf.
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac u black iron oxide (E172).
English: In addition, increased fatty deposition and infiltration were observed.
Maltese: Barra minn hekk, kienu osservati depożiti ogħla ta' grass u infiltrazzjoni.
English: 12.5 mg/30 mg film-coated tablets
Maltese: 12.5 mg/30 mg pilloli miksija b'rita
English: The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Maltese: Alogliptin bħala terapija aġġuntiva ma' pioglitazone Iż-żieda ta' alogliptin 25 mg darba kuljum mat-terapja bi pioglitazone (doża medja = 35.0 mg, bi jew mingħajr metformin jew sulphonylurea) irriżultat f'titjib statistikament sinifikanti mil-linja bażi fl-HbA1c u glukosju fil-plażma wara s-sawm f'Ġimgħa 26 meta mqabbel maż-żieda ta' plaċebo (Tabella 2).
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Maltese: Dan isir prinċipalment permezz ta' cytochrome P450 2C8 għalkemm iżoformi oħra jistgħu jkunu involuti fi grad inqas.
English: Breast-feeding
Maltese: TAL-PRODOT
English: Incresync 25 mg/30 mg film-coated tablets
Maltese: Incresync 25 mg/30 mg pilloli miksija b'rita
English: EU/1/13/842/028 10 film-coated tablets EU/1/13/842/029 14 film-coated tablets EU/1/13/842/030 28 film-coated tablets EU/1/13/842/031 30 film-coated tablets EU/1/13/842/032 56 film-coated tablets EU/1/13/842/033 60 film-coated tablets EU/1/13/842/034 90 film-coated tablets EU/1/13/842/035 98 film-coated tablets EU/1/13/842/036 100 film-coated tablets
Maltese: EU/1/13/842/028 10 pilloli miksija b'rita EU/1/13/842/029 14-il pillola miksija b'rita EU/1/13/842/030 28 pillola miksija b'rita EU/1/13/842/031 30 pillola miksija b'rita EU/1/13/842/032 56 pillola miksija b'rita EU/1/13/842/033 60 pillola miksija b'rita EU/1/13/842/034 90 pillola miksija b'rita EU/1/13/842/035 98 pillola miksija b'rita EU/1/13/842/036 100 pillola miksija b'rita
English: Incresync 25 mg/45 mg film-coated tablets
Maltese: Incresync 25 mg/45 mg pilloli miksija b'rita
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Maltese: Magyarország Takeda Pharma
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Maltese: Qabel id-distribuzzjoni tal-gwida għal dawk li jagħtu riċetta f'kull Stat Membru, id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jaqbel dwar il-kontenut u l-format tal-materjal edukattiv, flimkien ma' pjan ta' komunikazzjoni, mal-awtorità kompetenti nazzjonali.
English: EU/1/13/842/019 10 film-coated tablets EU/1/13/842/020 14 film-coated tablets EU/1/13/842/021 28 film-coated tablets EU/1/13/842/022 30 film-coated tablets EU/1/13/842/023 56 film-coated tablets EU/1/13/842/024 60 film-coated tablets EU/1/13/842/025 90 film-coated tablets EU/1/13/842/026 98 film-coated tablets EU/1/13/842/027 100 film-coated tablets
Maltese: EU/1/13/842/019 10 pilloli miksija b'rita EU/1/13/842/020 14-il pillola miksija b'rita EU/1/13/842/021 28 pillola miksija b'rita EU/1/13/842/022 30 pillola miksija b'rita EU/1/13/842/023 56 pillola miksija b'rita EU/1/13/842/024 60 pillola miksija b'rita EU/1/13/842/025 90 pillola miksija b'rita EU/1/13/842/026 98 pillola miksija b'rita EU/1/13/842/027 100 pillola miksija b'rita
English: In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo.
Maltese: 001) fit-triglycerides totali f'Ġimgħa 16 kif imkejjel minn bidla inkrementali mil-linja bażi wara l-ikel fl-AUC(0-8) meta mqabbel mal-plaċebo.
English: The relevance of this finding is unknown.
Maltese: Ir-rilevanza ta' dan ir-riżultat għadu mhux magħruf.
English: The efficacy and safety of the recommended doses of alogliptin and pioglitazone in a subgroup of patients with type 2 diabetes mellitus and ≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients < 65 years old.
Maltese: L-effikaċja u s-sigurtà tad-dożi rakkomandati ta' alogliptin u pioglitazone fil-sottogrupp ta' pazjenti b'dijabete mellitus ta' tip 2 u li kellhom ≥ 65 sena kienu riveduti u nstabu li huma konsistenti mal-profil miksub f'pazjenti ta' < 65 sena.
English: On this basis, M-IV contribution to efficacy is approximately 3-fold that of pioglitazone whilst the relative efficacy of M-II is minimal.
Maltese: Fuq din il-bażi, il-kontribuzzjoni ta' M-IV għall-effikaċja huwa madwar 3 darbiet dik ta' pioglitazone waqt l-effikaċja relattiva ta' M-II hija minima.
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Maltese: Il-ksur kien osservat fi 2.6% tan-nisa li kienu qed jieħdu pioglitazone meta mqabbel ma' 1.7% tan-nisa li kienu kkurati bi prodott komparatur.
English: EU/1/13/842/010 10 film-coated tablets EU/1/13/842/011 14 film-coated tablets EU/1/13/842/012 28 film-coated tablets EU/1/13/842/013 30 film-coated tablets EU/1/13/842/014 56 film-coated tablets EU/1/13/842/015 60 film-coated tablets EU/1/13/842/016 90 film-coated tablets EU/1/13/842/017 98 film-coated tablets EU/1/13/842/018 100 film-coated tablets
Maltese: EU/1/13/842/010 10 pilloli miksija b'rita EU/1/13/842/011 14-il pillola miksija b'rita EU/1/13/842/012 28 pillola miksija b'rita EU/1/13/842/013 30 pillola miksija b'rita EU/1/13/842/014 56 pillola miksija b'rita EU/1/13/842/015 60 pillola miksija b'rita EU/1/13/842/016 90 pillola miksija b'rita EU/1/13/842/017 98 pillola miksija b'rita EU/1/13/842/018 100 pillola miksija b'rita
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac u black iron oxide (E172)
English: The adverse reactions are listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont il-klassifika tas-sistema tal-organi u l-frekwenza.
English: No data are available with regard to overdose of Incresync.
Maltese: M'hemmx dejta disponibbli dwar doża eċċessiva ta' Incresync.
English: Common: - Symptoms of low blood sugar (hypoglycaemia) may occur when Incresync is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Maltese: • Sintomi ta' livell baxx ta' zokkor fid-demm (ipogliċemija) jistgħu jseħħu meta Incresync jittieħed flimkien ma' insulina jew sulphonylureas (eż. glipizide, tolbutamide, glibenclamide).
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Maltese: Wara għoti orali ta' pioglitazone radjutikkettat lil bniedem, it-tikketta miġbura kienet l-aktar fl-ippurgar (55%) u ammont inqas fl-awrina (45%).
English: The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Maltese: It-tnaqqis sinifikanti fl-HbA1c osservat b'alogliptin 25 mg flimkien ma' pioglitazone 30 mg u metformin kienu konsistenti tul il-perjodu kollu tat-trattament ta' 52 ġimgħa meta mqabbel ma' pioglitazone 45 mg u metformin (p<0.
English: Combination treatment with alogliptin and pioglitazone to pregnant rats slightly augmented pioglitazone-related foetal effects of growth retardation and visceral variations, but did not induce embryo-foetal mortality or teratogenicity.
Maltese: Trattament ta' kombinazzjoni b'alogliptin u pioglitazone fuq firien tqal żied ftit l-effetti marbuta ma' pioglitazone ta' dewmien fl-iżvilupp u varjazzjonijiet vixxerali, imma ma wassalx għal mortalità embrijofetali jew teratoġeniċità.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Maltese: Kważi nofs il-pazjenti kellhom infart mijokardjali preċedenti u madwar 20% kellhom puplesija.
English: Therapy with Incresync should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Maltese: It-terapija b'Incresync m'għandhiex tinbeda f'pazjenti li għandhom żieda fil-livelli ta' enzimi tal-fwied mil-linja bażi (ALT>2.5 x limitu ta' fuq tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju komuni komuni komuni nażofarinġite komuni sinusite mhux komuni komuni
English: Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
Maltese: Incresync huwa indikat bħala t-tieni jew it-tielet kura preferenzjali f'pazjenti adulti ta' 18-il sena jew aktar b'dijabete mellitus ta' tip 2:
English: Each 12.5 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Maltese: Kull pillola miksija b'rita ta' 12.5 mg/45 mg fiha alogliptin benzoate u pioglitazone hydrochloride ekwivalenti għal 12.5 mg ta' alogliptin u 45 mg ta' pioglitazone.
English: Gastrointestinal disorders abdominal pain common common gastroesophageal reflux disease common diarrhoea common dyspepsia common nausea common acute pancreatitis not known
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V. 4.9 Doża eċċessiva
English: Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known
Maltese: Għalkemm il-fertilità ma kinitx affettwata, żieda statistika żgħira ta' sperma anormali ġiet osservata fl-irġiel f'esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem fid-doża rakkomandata.
English: What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet:
Maltese: X'inhu Incresync Incresync fih żewġ mediċini differenti msejħin alogliptin u pioglitazone f'pillola waħda:
English: This has also been observed with other DPP-4 inhibitors.
Maltese: Dan ġie osservat ukoll b'impedituri oħra ta' DPP-4.
English: Weight gain
Maltese: Doża massima
English: Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side.
Maltese: Pilloli miksija b'rita lewn il-ħawħ, f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “25/30” stampati b'linka griża fuq naħa waħda,
English: Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side.
Maltese: Pilloli miksija b'rita lewn il-ħawħ ċar, f'għamla tonda (b'dijametru ta' madwar 8.7 mm), imżaqqin fiż-żewġ naħat li fuqhom hemm kemm “A/P” u “12.5/30” stampati b'linka ħamra fuq naħa waħda.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Maltese: L-għoti ta' pioglitazone flimkien ma' sulphonylureas ma jidhirx li jaffettwa il-farmakokinetika ta' sulphonylurea.
English: Combinations not studied
Maltese: Kombinazzjonijiet mhux studjati
English: Adults (≥ 18 years old) The dose should be individualised on the basis of the patient's current treatment regimen
Maltese: Adulti (≥ 18-il sena) Id-doża għandha tkun individwalizzata abbażi tal-programm ta' kura attwali.
English: The full EPAR and risk management plan summary for Vizamyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Vizamyl.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vizamyl.
English: In this re-analysis most readers could interpret the scans with a sensitivity of around 91% (91% of patients who had plaques were identified) and a specificity of 90% (90% of patients without plaques were correctly rated as not having plaques).
Maltese: F'din lanaliżi mill-ġdid ħafna mill-qarrejja setgħu jinterpretaw l-iskans b'sensittività ta' madwar 91% (91% tal-pazjenti li kellhom plakek ġew identifikati) u bi speċifiċità ta' 90% (90% tal-pazjenti mingħajr plakek ġew speċifikati b'mod korrett bħala li ma kellhomx plakek).
English: Why is Vizamyl approved?
Maltese: Għaliex ġie approvat Vizamyl?
English: The type of scan used with Vizamyl is called positron-emission tomography (PET).
Maltese: It-tip ta' skan użat b'Vizamyl huwa msejjaħ tomografija b'emissjoni ta' pożitroni (PET).
English: Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.
Maltese: Vizamyl huwa radjofarmaċewtiku (mediċina li fiha ammonti żgħar ta' sustanza radjoattiva) li fiha ssustanza attiva flutemetamol (18F); jintuża għal użu dijagnostiku biss.
English: What are the risks associated with Vizamyl?
Maltese: X'inhuma r-riskji assoċjati ma' Vizamyl?
English: The most common side effects with Vizamyl (seen in between 1 and 10 patients in 100) are flushing (reddening of the skin) and increased blood pressure.
Maltese: L-effetti sekondarji l-aktar komuni b'Vizamyl (li jistgħu jaffettwaw bejn 1 u 10 minn kull 100 pazjent) huma fwawar (ħmura tal-ġilda) u pressjoni tad-demm għolja.
English: The active substance in Vizamyl, flutemetamol (18F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Maltese: Is-sustanza attiva f'Vizamyl, flutemetamol (18F), hija radjofarmaċewtiku li titfa' ammonti żgħar ta' radjazzjoni u taħdem billi timmira u teħel ma' plakek β-amilojde fil-moħħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vizamyl fit-22 ta' Awwissu 2014.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%.
Maltese: Meta r-riżultati tal-awtopsji tqabblu mal-iskans PET, l-iskans intwerew li għandhom sensittività ta' bejn 81-93%.