FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - vomiting - muscle pain (myalgia) - joint pain (arthralgia) - decreased numbers of white blood cells (granulocytopenia) - abnormal liver function tests - decreased blood phosphorus - increased blood pressure
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - tnaqqis fl-għadd ta' ċelloli bojod (granuloċitopenija) - reazzjonijiet allerġiċi (sensittività eċċessiva) - uġigħ ta' ras - tħossok ma tiflaħx (nawsea) - remettar - uġigħ addominali - ippurgar artab (dijarea) - infjammazzjoni tal-fwied (epatite) - tħossok għajjien (għeja kbira) - deni - testijiet tal-funzjoni tal-fwied mhux normali
English: rd month and then regularly thereafter.
Maltese: et xahar u wara dan jibqgħu sejrin b'mod regolari.
English: Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Maltese: Punti ta' riferiment prinċipali tal-istudju (perċentwali ta' pazjenti b'falliment fit-trattament) u punti ta' riferiment sekondarji tal-istudju kif ukoll t-terapija fl-isfond kienu simili għall-istudju oriġinali 2NN.
English: If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Maltese: ULN qabel jew waqt it-trattament, it-testijiet ta' fwied iridu jiġu sorveljati aktar ta' spiss waqt il-visti regolari fil-klinika.
English: Viramune 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Maltese: Viramune 200 mg pilloli, skont l-iskeda ta' dożaġġ deskritta hawn fuq, huma adattati għal tfal akbar, partikularment adolexxenti, taħt l-età ta' 16-il sena li jiżnu iktar minn 50 kg jew li l-erja tas-superfiċje tal-ġisem tagħhom tkun ta' iżjed minn 1.25 m2 skont il-formula ta' Mosteller.
English: Viramune is also supplied as 200 mg tablets for older children and adults.
Maltese: Viramune jiġi wkoll f'pilloli ta' 200 mg għal tfal akbar u adulti.
English: It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving nevirapine.
Maltese: Huwa rakkomandat li ommijiet infettati b'HIV ma jreddgħux lill-uliedhom biex jevitaw ir-riskju li jgħaddu l-HIV wara t-twelid u li l-ommijiet għandhom jieqfu jreddgħu jekk ikunu qed jieħdu nevirapine.
English: Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Maltese: Ribavirin ma jinibixxix l-enzimi ta' ċitokrom P450, u m'hemm l-ebda evidenza minn studji dwar it-tossiċità li ribavirin jinduċi l-enzimi tal-fwied.
English: White to off-white homogenous suspension.
Maltese: Viramune huwa disponibbli wkoll f'għamla likwida bħala suspensjoni likwida.
English: Calculation of the volume of Viramune oral suspension (50 mg/5 ml) required for paediatric dosing after the two weeks lead-in period.
Maltese: Kalkulazzjoni tal-volum ta' Viramune suspensjoni orali (50 mg/5 ml) meħtieġa għal dożaġġ lil pazjenti pedjatriċi wara l-perjodu lead-in ta' ġimagħtejn.
English: Triglycerides (mg/dL) * Percent change is the median of within-patient changes from baseline for patients with both baseline and week 48 values and is not a simple difference of the baseline and week 48 mean values, respectively.
Maltese: Triglycerides (mg/dL) * Il-bidla perċentwali hi l-medjan tat-tibdil fil-pazjenti mil-linja bażi għal pazjenti kemm bil-valuri fil linja bażi kif ukoll il-valuri f'ġimgħa 48 valuri u mhijiex differenza sempliċi tal-valuri medji fil-linja bażi u f'ġimgħa 48, rispettivament.
English: Two new substitutions on codons previously associated with nevirapine resistance were observed: one patient with Y181I in the Viramune prolonged-release group and one patient with Y188N in the Viramune immediate-release group; resistance to nevirapine was confirmed by phenotype.
Maltese: Żewġ sostituzzjonijiet ġodda fuq kodoni li qabel kienu assoċjati ma' reżistenza għal nevirapine ġew osservati: pazjent wieħed b'Y181I fil-grupp ta' Viramune li jerħi l-mediċina bil-mod u pazjent wieħed b'Y188N fil-grupp ta' Viramune li jerħi l-mediċina fil-pront; ir-reżistenza għal nevirapine ġiet ikkonfermata mill-fenotip.
English: A durable response to Viramune for at least three years was documented in this study, and equivalence within a 10 % range was demonstrated between Viramune 200 mg twice daily and efavirenz with respect to treatment failure.
Maltese: Rispons fit-tul għal Viramune għal tal-anqas tliet snin ġie dokumentat f'dan l-istudju, u ekwivalenza f'medda ta' 10% ġiet murija bejn Viramune 200 mg li jingħata darbtejn kuljum u efavirenz fir-rigward ta' falliment għat-trattament.
English: Nevirapine: exposure: 100% compared with historical data where nevirapine was administered alone.
Maltese: Espożizzjoni għal Nevirapine: 100% meta mqabbel ma' tagħrif storiku meta nevirapine ngħata waħdu.
English: They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue nevirapine and immediately seek medical evaluation, which should include liver function tests.
Maltese: Għandhom ikunu wkoll infurmati li jekk jiżviluppaw sintomi ta' epatite, dan għandu jwassalhom biex iwaqqfu nevirapine minnufih u ifittxu għal evalwazzjoni medika, li għandha tinkludi testijiet dwar il-funzjonament talfwied.
English: Viramune oral suspension can be taken by children of all age groups.
Maltese: Is-suspensjoni orali Viramune tista' tittieħed minn tfal ta' kull età.
English: You must take Viramune together with other antiretroviral medicines.
Maltese: Inti għandek tieħu Viramune flimkien ma' mediċini antiretrovirali oħra.
English: Common headache
Maltese: Mhux komuni
English: Viramune oral suspension is a white to off-white homogenous suspension.
Maltese: Is-suspensjoni orali Viramune hija suspensjoni omoġena li tista' tkun minn bajda sa ofwajt.
English: Physicians and patients should be vigilant for prodromal signs or findings of hepatitis, such as anorexia, nausea, jaundice, bilirubinuria, acholic stools, hepatomegaly or liver tenderness.
Maltese: Kemm it-tobba kif ukoll il-pazjenti għandhom ikunu attenti ħafna għal sinjali prodromażli jew riżultati ta' epatite, bħal anoreksja, dardir, suffejra, bilirubinurja, purgar akoliku, epatomegalija jew sensittività fil-fwied.
English: Predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts >250 cells/mm
Maltese: Responder viroloġiku (HIV-1 RNA <50 kopji/ml) Kollass viroloġiku - Qatt imrażżan sa ġimgħa 48 - Rebound
English: 24 July 2014 EMA/444346/2014
Maltese: EMA/444346/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Maltese: +44 (0)20 7418 8427 E-mail: 19TUpress@ema.europa.euU1
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Kuntatt tal-uffiċjali tagħna tal-istampa Monika Benstetter jew Martin Harvey
English: Methadone is a synthetic opioid (a morphine-like substance).
Maltese: Methadone huwa opjojde sintetiku (sustanza bħal morfina).
English: Povidone is available in different molecular weights.
Maltese: Povidon huwa disponibbli f'piżijiet molekulari differenti.
English: Oral solutions have been authorised in Denmark, Finland, Malta, Norway, Sweden and the United Kingdom; oral tablets have been authorised in Denmark, Finland, Hungary, Iceland, Norway, Romania, Spain and Sweden.
Maltese: Mediċini ta' methadone li fihom povidon ġew awtorizzati permezz ta' proċeduri nazzjonali f'diversi pajjiżi Ewropej. Soluzzjonijiet orali ġew awtorizzati fid-Danimarka, il-Finlandja, Malta, in-Norveġja, lIsvezja u r-Renju Unit; pilloli orali ġew awtorizzati fid-Danimarka, il-Finlandja, l-Ungerija, l-Islanda, inNorveġja, ir-Rumanija, Spanja u l-Isvezja.
English: The review of oral methadone medicines containing povidone was initiated on 10 April 2014 under Article 107i of Directive 2001/83/EC, also known as the ‘urgent Union procedure'.
Maltese: Ir-reviżjoni ta' mediċini orali ta' methadone li fihom povidon inbdiet fl-10 t'April 2014 skont l-Artikolu 107i tad-Direttiva 2001/83/KE, magħrufa wkoll bħala l-‘proċedura urġenti tal-Unjoni'.
English: • Some methadone oral solutions contain an additive, povidone.
Maltese: • Xi soluzzjonijiet orali ta' methadone fihom addittiv, povidon.
English: More about the procedure
Maltese: 9T
English: Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights.
Maltese: Xi formulazzjonijiet orali ta' methadone fihom ukoll laddittiv povidon, li huwa disponibbli f'piżijiet molekulari differenti.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Maltese: Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta l-Istati Membri tal-Unjoni Ewropea (UE).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lillIstati Membri tal-UE, huwa responsabbli biex jiżgura standards ta' sigurtà armonizzati għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.
English: The safety of oral methadone medicines containing povidone was reviewed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
Maltese: Is-sigurtà ta' mediċini ta' methadone orali li fihom povidon ġiet riveduta mill-Kumitat dwar ilValutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA, wara rapporti ta' avvenimenti avversi serji f'pazjenti li kienu jew qegħdin jabbużaw mid-droga fin-Norveġja, li wassal għas-sospensjoni ta' soluzzjonijiet orali ta' methadone li fihom povidon K90 mis-suq Norveġiż.
English: The PRAC assessed the available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone from post-marketing reports and the published literature, and a group of experts (which included pathologists and addiction experts) was consulted for advice.
Maltese: Il-PRAC evalwa id-dejta ta' sigurtà disponibbli dwar ir-riskji assoċjati mal-użu ħażin b'injezzjoni ta' mediċini ta' methadone li fihom povidon minn rapporti ta' wara t-tqegħid fis-suq u l-letteratura ppubblikata, u ġie kkonsultat grupp ta' esperti (li inkluda patoloġisti u esperti dwar id-dipendenza) għal pariri.
English: Methadone-containing medicines are used to treat drug addiction in patients dependent on opioids (such as heroin); methadone prevents or reduces opiate withdrawal symptoms.
Maltese: Mediċini li fihom methadone jintużaw biex jikkuraw dipendenza minn drogi f'pazjenti dipendenti minn opjojdi (bħal eroina); methadone jipprevjeni jew inaqqas sintomi ta' irtirar ta' opjati.
English: The povidone contained in oral methadone solutions has a high molecular weight (known as K90), while the povidone used in methadone tablets has a low molecular weight (e.g. K25 and K30).
Maltese: Il-povidon li fihom soluzzjonijiet ta' methadone orali għandu piż molekulari għoli (magħruf bħala K90), filwaqt li povidon użat f'pilloli ta' meghadone għandu piż molekulari baxx (eż. K25 u K30).
English: • Patients taking methadone oral solutions with povidone K90 as part of their rehabilitation program will be switched to other methadone medicines, which do not pose the same risk of povidone accumulating inside vital organs.
Maltese: • Pazjenti li qed jieħdu soluzzjonijiet orali ta' methadone b'povidon K90 bħala parti mill-programm ta' riabilitazzjoni tagħhom sejrin jinqalbu għal mediċini ta' methadone oħrajn, li ma jippreżentawx l-istess riskju ta' povidon li jakkumula ġewwa organi vitali.
English: The PRAC recommendation was sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Irrakkomandazzjoni tal-PRAC intbagħtet lill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u lProċeduri Deċentralizzati - Uman (CMDh), li adotta pożizzjoni finali.
English: • While these medicines are suspended, healthcare professionals should switch their patients to alternative methadone products.
Maltese: • Filwaqt li dawn il-mediċni huma sospiżi, professjonisti tal-kura tas-saħħa jistgħu jaqilbu lill-pazjenti tagħhom għal prodotti ta' methadone alternattivi.
English: Oral methadone medicines are available as solutions or tablets; only oral methadone products containing povidone were concerned by this review.
Maltese: Mediċini orali ta' methadone huma disponibbli bħala soluzzjonijiet jew pilloli; prodotti orali ta' methadone li fihom povidon biss kienu kkonċernati b'din ir-reviżjoni.
English: • Because of the potential harm that could derive from such a misuse (injection into a vein), methadone solutions containing povidone K90 will be suspended.
Maltese: • Minħabba l-ħsara potenzjali li tista' tiġi minn tali użu ħażin (injezzjoni f'vina), soluzzjonijiet ta' methadone li fihom povidon K90 sejrin jiġu sospiżi.
English: Methadone is used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids such as heroin.
Maltese: Methadone jintuża fi programmi ta' riabilitazzjoni biex jipprevjeni jew inaqqas sintomi ta' rtirar f'pazjenti dipendenti fuq opjojdi bħall-eroina.
English: • Cases of povidone deposits and serious adverse reactions (e.g. anaemia and pathological fractures) have been reported in intravenous drug abusers.
Maltese: • Każijiet ta' depożiti ta' povidon u reazzjonijiet avversi serji (eż. anemija u fratturi patoloġiċi) ġew irrappurtati f'pazjenti li jabbużaw bid-droga fil-vina.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-reviżjoni saret l-ewwel mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: The risk of harm is reduced with low molecular weight povidone (e.g. K25 and K30) as this type of povidone is excreted from the body and is not expected to accumulate inside the cells as high molecular weight povidone does.
Maltese: Ir-riskju ta' ħsara huwa mnaqqas b'povidon b'piż molekulari baxx (eż. K25 u K30) minħabba li dan it-tip ta' povidon jiġi eliminat millġisem u mhuwiex mistenni li jakkumula ġewwa ċ-ċelloli kif jagħmel povidon b'piż molekulari għoli.
English: Different types of povidone are available, which vary in their molecular weight (a measure of the size of the molecule).
Maltese: Hemm tipi differenti ta' povidon disponibbli, li jvarjaw fil-piż molekulari tagħhom (kujl tad-daqs tal-molekula).
English: • Methadone is used to treat drug addiction in patients depending on opioids (such as heroin).
Maltese: • Methadone jintuża biex jikkura dipendenza minn drogi f'pazjenti dipendenti minn opjojdi (bħalleroina).
English: For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does.
Maltese: Għal pilloli ta' methadone li fihom povidon b'piż molekulari iktar baxx (eż. K25 u K30), id-dejta disponibbli wriet li dan it-tip ta' povidon jiġi eliminat mill-ġisem u ma jakkumulax ġewwa ċelloli bħal ma jagħmel povidon b'piż molekulari għoli.
English: • The risk of harm is reduced with low molecular weight povidone since it is expected to be readily excreted and not to accumulate inside cells.
Maltese: • Ir-riskju ta' ħsara huwa mnaqqas b'povidon b'piż molekulari baxx minħabba li huwa mistenni li jkun eliminat faċilment u ma jakkumulax ġewwa ċ-ċelloli.
English: • Some oral methadone solutions contain high molecular weight povidone (K90), which can be harmful if injected as it is retained in the body and may cause tissue damage.
Maltese: • Xi soluzzjonijiet orali ta' methadone fihom povidon b'piż molekulari għoli (K90), li jista' jkun ta' ħsara kbira jekk jiġi injettat għaliex jinżamm fil-ġisem u jista' jikkawża ħsara lit-tessuti.
English: • Since no measures could be identified to minimise the potential harm with methadone oral solutions containing high molecular weight povidone, these solutions will be suspended.
Maltese: • Minħabba li ebda miżuri ma setgħu jiġu identifikati biex inaqqsu il-ħsara potenzjali ta' soluzzjonijiet orali ta' methadone li fihom povidon b'piż molekulari għoli, dawn is-soluzzjonijiet sejrin jiġu sospiżi.
English: The above recommendations are based on available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone.
Maltese: Ir-rakkomandazzjonijiet ta' hawn fuq huma bbażati fuq dejta ta' sigurtà disponibbli dwar ir-riskji assoċjati ma' użu ħażin b'injezzjoni ta' mediċini ta' methadone li fihom povidon.
English: Treatment with methadone should be given in the context of a wider rehabilitation program.
Maltese: Kura b'methadone għandha tingħata f'kuntest ta' programm ta' riabilitazzjoni usa'.
English: It followed the decision of NOMA, the Norwegian medicines agency, to suspend the only methadone-containing oral solution that contains high molecular weight povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Maltese: Ġiet wara deċiżjoni ta' NOMA, l-aġenzija tal-mediċini Norveġiża, biex tissospendi l-unika soluzzjoni orali li fiha methadone li fiha povidon b'piż molekulari għoli preżenti fis-suq nazzjonali, fuq il-bażi ta' rapporti ta' avvenimenti avversi serji f'pazjenti li kienu jew għadhom jabbużaw mid-drogi fin-Norveġja.
English: • Patients who have questions or concerns should consult their doctor or another healthcare professional.
Maltese: • Pazjenti li għandhom mistoqsijiet jew tħassib għandhom jikkonsultaw lit-tabib tagħhom jew professjonista tal-kura tas-saħħa ieħor.
English: Q3 2026
Maltese: K3 2026
English: 100 to 139
Maltese: 100 sa 139
English: 50 to 74a
Maltese: 50 sa 74a
English: 0 NC
Maltese: 0 NC NC
English: Age, sex, weight, and race
Maltese: Età, sess, piż, u razza
English: Normal (≥140)
Maltese: Normali (>140)
English: Date of first authorisation: 03 May 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 03 Mejju 2019
English: 75 to 99
Maltese: 75 sa 99
English: Less than 50a, b
Maltese: Inqas minn 50a, b
English: It may harm them,
Maltese: L-effett li tieħu Waylivra mal-alkoħol mhux magħruf.
English: Observed Value
Maltese: Valur Osservat
English: Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen.
Maltese: Kull ml fih 200 mg volanesorsen sodium, ekwivalenti għal 190 mg volanesorsen.
English: Store in a refrigerator (2 ° - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
English: Common (N, %)
Maltese: Komuni (N,%)
English: Lipid Parameter (g/L for apoC-III, apoB, apoB-48; mmol/L for cholesterol, triglycerides)
Maltese: Parametru ta' Lipidi (g/L għal apoC-III, apoB, apoB-48: mmol/L għal kolesterol, trigliċeridi)
English: Contusion (3, 3%)
Maltese: Kontużjoni (3, 3%)
English: Discontinue treatment Glucocorticoids recommended
Maltese: Waqqaf it-trattament Glucocorticoids rakkomandati
English: Single use.
Maltese: Doża unika.
English: Parameter at Month 3a
Maltese: Parametru fix-Xahar 3a
English: Relative Difference in Change vs Placebo
Maltese: Differenza Relattiva fil-Bidla vs Plaċebo
English: NC = not calculated
Maltese: NC = (not calculated) mhux ikkalkulat
English: Table 2: Summary of adverse reactions in clinical studies in patients with FCS (N=86) System Organ Class
Maltese: Tabella 2: Sommarju ta' reazzjonijiet avversi fi studji kliniċi f'pazjenti b'FCS (N=86) Sistema tal-Klassifika tal-Organi
English: Effects of Waylivra on lipid parameters
Maltese: Effetti ta' Waylivra fuq parametri ta' lipidi
English: Thrombocytopenia (10, 12%)
Maltese: Tromboċitopenija (10, 12%)
English: % Change
Maltese: Bidla %
English: After the Injection 12.
Maltese: Wara l-Injezzjoni 12.
English: PC: {number} SN: {number} NN: {number}
Maltese: M'għandekx togħrok is-sit wara li tkun injettajt.
English: In vitro studies indicate that volanesorsen is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 or inducer of CYP1A2, CYP2B6, or CYP3A4.
Maltese: Studji in vitro jindikaw li volanesorsen mhux impeditur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A4 jew induttur ta' CYP1A2, CYP2B6, jew CYP3A4.
English: Waylivra 285 mg injection volanesorsen
Maltese: Waylivra 285 mg injezzjoni volanesorsen
English: Pharmacotherapeutic group:{Not yet assigned}, ATC code: {Not yet assigned} Mechanism of action
Maltese: Kategorija farmakoterapewtika:{mhux assenjat}, Kodiċi ATC:
English: Clinically relevant pharmacokinetic interactions are not expected between volanesorsen and substrates, inducers or inhibitors of cytochrome P450 (CYP) enzymes, and drug transporters.
Maltese: Interazzjonijiet farmakokinetiċi klinikament rilevanti mhumiex mistennija bejn volanesorsen u substrati, indutturi jew impedituri ta' enzimi ta' ċitokrom P450 (CYP) u trasportaturi tal-mediċina.
English: *p-value < 0.0001 (primary efficacy endpoint) Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model)
Maltese: *valur p < 0.0001 (punt aħħari primarju ta' effikaċja) Differenza = Medja LS ta' [Bidla % volanesorsen - Bidla % Plaċebo] (Mudell ANCOVA)
English: In vitro studies show that volanesorsen is not a substrate or inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptides (OATP1B1, OATP1B3), bile salt export pump (BSEP), organic cation transporters (OCT1, OCT2), or organic anion transporters (OAT1, OAT3).
Maltese: Studji in vitro juru li volanesorsen mhux substrat jew impeditur ta' P-glikoproteina (P-gp), il-proteina ta' reżistenza tal-kanċer tas-sider (BRCP, breast cancer resistance protein), polipeptidi organiċi li jittrasportaw anjoni (organic anion transporting polypeptides, OATP1B1, OATP1B3), pompa ta' esportazzjoni ta' melħ tal-bila (BSEP, bile salt export pump), trasportaturi organiċi ta' katjoni (OCT1, OCT2, organic cation transporters), jew trasportaturi organiċi ta' enijens (OAT1, OAT3, organic anion transporters).
English: There are limited data available in subjects >75 years of age.
Maltese: Hemm dejta limitata disponibbli għallindividwi >75 sena.
English: Platelet Count (x109/L)
Maltese: Għadd ta' Plejtlits (x109/L)
English: CS16-volanesorsen (Index Study Baselinea, N=3)
Maltese: CS16-volanesorsen (Linja Bażi tal-Istudju tal-Indiċia, N=3)
English: Mean body mass index was 25 kg/m2.
Maltese: Indiċi tal-massa korporali (BMI) medju kien ta' 25 kg/m2.
English: Placebo (N=31)
Maltese: (N=31)
English: Inject Waylivra
Maltese: Injetta Waylivra
English: % change from Baseline in APPROACH n
Maltese: Bażi f'APPROACH n
English: Some accumulation in AUC and Cmax was observed for the 50 to 100 mg dose.
Maltese: Xi akkumulazzjoni fl-AUC u Cmax kienet osservata fid-doża ta' 50 għal 100 mg.
English: LDL-C Levels
Maltese: Livelli ta' LDL-C