FrancophonIA/ELRC3.0 huggingface dataset:
English: In rabbits, maternal toxicity (including mortality and abortions) was noted at 225 mg/kg/day (approximately 2-fold the AUC at the RHD); in the offspring, an increased incidence of malformations and variations in the vertebrae and ribs were observed.
Maltese: Fil-fniek, it-tossiċità materna (inkluż mortalità u aborti) ġiet innutata b'225 mg/kg/jum (madwar darbtejn l-AUC bl-RHD); fil-frieħ ġew osservati, inċidenza miżjuda ta' malformazzjonijiet u varjazzjonijiet fil-vertebri u fil-kustilji.
English: The CMV genes UL56 and UL89 encode subunits of CMV DNA terminase.
Maltese: Il-ġeni ta' CMV UL56 u UL89 jikkodifikaw sottounitajiet ta' terminases tad-DNA ta' CMV.
English: Urinary excretion of letermovir was negligible (<2% of dose).
Maltese: L-eskrezzjoni urinarja ta' letermovir kienet negliġibbli (<2 % tad-doża).
English: Pack size: 1 vial.
Maltese: Kunjett 1.
English: PREVYMIS 240 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PREVYMIS 240 mg
English: DATE OF REVISION OF THE TEXT
Maltese: PREVYMISPREVYMISPREVYMIS
English: PREVYMIS is an antiviral prescription medicine that contains the active substance letermovir.
Maltese: PREVYMIS huwa mediċina antivirali li tingħata b'riċetta ta' tabib li fiha s-sustanza attiva letermovir.
English: The medicine helps stop you from getting ill from CMV (‘cytomegalovirus').
Maltese: Din il-mediċina tgħinek milli tkun ma tiflaħx b'CMV (“cytomegalovirus”).
English: The potential interaction between letermovir and these medicinal products have not been investigated.
Maltese: L-interazzjoni potenzjali bejn letermovir u dawn iil-prodotti mediċinali ma ġietx investigata.
English: In patients with moderate or severe renal impairment (creatinine clearance less than 50 mL/min) receiving PREVYMIS, accumulation of hydroxypropylbetadex, could occur (see section 5.3).
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat jew sever (tneħħija talkreatinina inqas minn 50 mL/min) li jirċievu PREVYMIS, jista' jkun hemm l-akkumulazzjoni ta' hydroxypropylbetadex (ara sezzjoni 5.3).
English: Clinically significant CMV infection
Maltese: Infezzjoni b'CMV klinikament sinifikanti‡
English: A 1-sided p-value ≤0.0249 was used for declaring statistical significance.
Maltese: 0249 għad-dikjarazzjoni ta' sinifikanza statistika.
English: -Examples of medicinal products that are metabolised by CYP2B6 include bupropion.
Maltese: -Eżempji ta' prodotti mediċinali li jiġu metabolizzati minn CYP2B6 jinkludu bupropion.
English: - An example of a medicinal product transported by OATP2B1 is celiprolol.
Maltese: -Eżempju ta' prodott mediċinali ttrasportat minn OATP2B1 huwa celiprolol.
English: Coadministration of PREVYMIS may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates (see sections 4.3, 4.4, and 5.2).
Maltese: L-għoti flimkien ta' PREVYMIS jista' jirriżulta f'żidiet klinikament relevanti fil-konċentrazzjonijiet fil-plażma ta' sottostrati ta' CYP3A mogħtija flimkien (ara sezzjonijiet 4.3, 4.4, u 5.2).
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AX18
Maltese: Antivirali għal użu sistemiku, antivirali b'azzjoni diretta, Kodiċi ATC:
English: Letermovir was initiated after HSCT (Day 0-28 post-transplant) and continued through Week 14 post-transplant.
Maltese: Letermovir inbeda wara HSCT (Jum 0-28 wara t-trapjant) u tkompla matul Ġimgħa 14 wara t-trapjant.
English: Concomitant administration with pimozide (see sections 4.4 and 4.5).
Maltese: L-għoti konkomitanti ma' pimozide (ara sezzjonijiet 4.4 u 4.5).
English: After oral administration of radio-labeled letermovir, 93.3% of radioactivity was recovered in faeces.
Maltese: Wara għoti orali ta' letermovir radjutikkettat, 93.3 % tar-radjuattività ġiet koperta mill-ġdid flippurgar.
English: Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.
Maltese: Letermovir għandu l-potenzjal li jnaqqas l-esponiment ta' sottostrati ta' CYP2C9 u/jew CYP2C9 u potenzjalment jirriżulta f'livelli sottoterapewtiċi.
English: (induction of CYP2C19)
Maltese: (induzzjoni ta' CYP2C19)
English: Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).
Maltese: L-għoti konkomitanti ma' rifampicin wassal għal żieda inizjali fil-konċentrazzjonijiet ta' letermovir fil-plażma (minħabba inibizzjoni ta' OATP1B1/3 u/jew ta' P-gp) li mhijiex klinikament relevanti, segwita minn tnaqqis klinikament rilevanti fil-konċentrazzjonijiet ta' letermovir fil-plażma (minħabba l-induzzjoni ta' P-gp/UGT) bl-għoti konkomitanti kontinwu ta' rifampicin (ara Tabella 1).
English: Twelve percent (12%) of subjects were positive for CMV DNA at baseline.
Maltese: Tnax fil-mija (12 %) tal-individwi kienu pożittivi għal DNA ta' CMV fil-linja bażi.
English: If PREVYMIS is coadministered with cyclosporine (a potent OATP1B1/3 inhibitor), the recommended dose of PREVYMIS is 240 mg once daily (see Table 1 and sections 4.2 and 5.2).
Maltese: Jekk PREVYMIS jingħata flimkien ma' PREVYMIS (inibitur qawwi ta' OATP1B1/3), id-doża rakkomandata ta' PREVYMIS hija ta' 240 mg darba kuljum (ara Tabella 1 u sezzjonijiet 4.2 u 5.2).
English: This difference is not clinically relevant.
Maltese: Din iddifferenza mhijiex klinikament relevanti.
English: Expected: ↑ CYP3A metabolised opioids
Maltese: Mistennija: ↑ opjojdi metabolizzati ta' CYP3A
English: • thioridazine - for psychiatric disorders
Maltese: • thioridazine - għal disturbi psikjatriċi
English: No data are available (see section 5.1).
Maltese: M'hemm lebda data disponibbli (ara sezzjoni 5.1).
English: Ear and labyrinth disorders Uncommon vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni vertigo
English: Blood to plasma partitioning of letermovir is 0.56 and independent of the concentration range (0.1 to 10 mg/L) evaluated in vitro.
Maltese: Il-partizzjoni tad-demm għall-plażma ta' letermovir hija ta' 0.56 u hija indipendenti mill-medda ta' konċentrazzjoni (0.1 sa 10 mg/L) evalwata in vitro.
English: PREVYMIS 240 mg tablets letermovir
Maltese: IL-PRODOTT MEDIĊINALI PREVYMIS 240 mg pilloli letermovir
English: (OATP1B1/3 and/or BCRP inhibition)
Maltese: (inibizzjoni ta' OATP1B1/3 u/jew BCRP)
English: -Examples of such medicinal products include certain immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus), HMG-CoA reductase inhibitors, and amiodarone (see Table 1).
Maltese: -Eżempji ta' prodotti mediċinali bħal dawn jinkludu ċerti immunosuppressanti (eż., cyclosporine, tacrolimus, sirolimus), inibituri ta' reductase HMG-CoA, u amiodarone (ara Tabella 1).
English: Letermovir does not prolong QTc to any clinically relevant extent following the 960 mg IV dose with plasma concentrations approximately 2-fold higher than the 480 mg IV dose.
Maltese: Letermovir ma jtawwalx il-QTc sa xi limitu klinikament relevanti wara d-doża 960 mg IV bil-konċentrazzjonijiet fil-plażma madwar darbtejn ogħla tad-doża 480 mg IV.
English: Concomitant administration with ergot alkaloids: (see sections 4.4 and 4.5).
Maltese: L-għoti konkomitanti ma' alkalojdi tal-ergotina: (ara sezzjonijiet 4.4 u 4.5).
English: (CYP3A inhibition)
Maltese: (inibizzjoni ta''CYP3A)
English: Letermovir was absorbed rapidly with a median time to maximum plasma concentration (Tmax) of 1.5 to 3.0 hours and declined in a biphasic manner.
Maltese: Letermovir ġie assorbit b'mod rapidu bi żmien medjan għal konċentrazzjoni massima fil-plażma (Tmax) ta' 1.5 sa 3.0 sigħat u naqas b'mod bifażiku.
English: Immunosuppressive Regimen
Maltese: Reżistenza inkroċjata
English: Letermovir may increase the plasma concentrations of glyburide.
Maltese: Letermovir jista' jżid ilkonċentrazzjonijiet fil-plażma ta' glyburide.
English: • midazolam - used as a sedative
Maltese: • midazolam - jintuża bħala sedattiv
English: • After dilution, administer PREVYMIS via intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Maltese: • Wara d-dilwizzjoni, agħti PREVYMIS permezz ta' infużjoni ġol-vini permezz ta' katerer periferali jew venuż ċentrali billi tuża ħin totali ta' madwar 60 minuta.
English: Monitoring of CMV DNA
Maltese: Monitoraġġ ta' DNA ta' CMV
English: PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Maltese: PREVYMIS mhuwiex rakkomandat għal pazjenti b'indeboliment tal-fwied sever (Child-Pugh Klassi C) (ara sezzjoni 5.2).
English: *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Maltese: *Irreferi għall-informazzjoni dwar il-preskrizzjoni biex tikkonferma l-kompatibbiltà ta' għoti flimkien simultanju.
English: Iron oxide yellow (E172) Iron oxide red (only for 480 mg tablets) (E172) Carnauba wax (E903)
Maltese: Ossidu tal-ħadid aħmar (għal pilloli 480 mg biss) (E172) Xama' tal-karnawba (E903)
English: One subject had a letermovir-resistant GV (V236M).
Maltese: Individwu wieħed kellu GV reżistenti għal letermovir (V236M).
English: Antifungals fluconazole (400 mg single dose)/letermovir (480 mg single dose)
Maltese: Antifungali fluconazole (400 mg doża waħda)/letermovir (480 mg doża waħda)
English: Each 480 mg dose (24 mL vial) of this medicinal product contains 3600 mg hydroxypropylbetadex (cyclodextrin).
Maltese: Kull doża ta' 480 mg (kunjett ta' 24 mL) ta' dan il-prodott mediċinali fiha 3,600 mg hydroxypropylbetadex (cyclodextrin).
English: Plasma concentrations of medicinal products transported by OAT3 may be increased.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali ttrasportati minn OAT3 jistgħu jiżdiedu.
English: If a vial is added to a 250 mL IV diluent bag, the final concentration ranges of letermovir would be 0.9 mg/mL (for 240 mg dose) and 1.8 mg/mL (for 480 mg dose).
Maltese: Jekk jiżdied kunjett ma' borża dilwenti IV ta' 250 mL, il-meded tal-konċentrazzjoni finali ta' letermovir ikunu 0.9 mg/mL (għal doża ta' 240 mg) u 1.8 mg/mL (għal doża ta' 480 mg).
English: (P-gp/UGT induction)
Maltese: (induzzjoni ta' P-gp/UGT)
English: The full induction effect can be expected after 10-14 days of letermovir treatment.
Maltese: L-effett tal-induzzjoni sħiħ jista' jiġi mistenni wara 10-14il jum ta' kura b'letermovir.
English: The elimination pathways of letermovir in vivo are biliary excretion and glucuronidation.
Maltese: Il-passaġġi ta' eliminazzjoni maġġuri ta' letermovir in vivo huma l-eskrezzjoni biljari u lglukuronidazzjoni.
English: ↑ tacrolimus AUC 2.42 (2.04, 2.88) Cmax 1.57 (1.32, 1.86) (CYP3A inhibition)
Maltese: ↑ tacrolimus AUC 2.42 (2.04, 2.88) Cmax 1.57 (1.32, 1.86)
English: In monkeys administered letermovir, there was no evidence of testicular toxicity based on histopathologic evaluation, measurement of testicular size, blood hormone analysis (follicle stimulating hormone, inhibin B and testosterone) and sperm evaluation (sperm count, motility and morphology) at systemic exposures approximately 2-fold the AUC in humans at the RHD.
Maltese: Fix-xadini maturi li ngħataw letermovir, ma kien hemm l-ebda evidenza ta' tossiċità testikulari abbażi ta' evalwazzjoni istopatoloġika, kejl tad-daqs tat-testikoli, analiżi tal-ormoni tad-demm (ormon follikolu stimulanti, inhibin B u testosteron) u evalwatazzjoni tal-isperma (għadd tal-isperma, motilità u morfoloġija) b'esponimenti sistemiċi madwar darbtejn l-AUC fil-bnedmin bl-RHD.
English: The 480 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Maltese: Il-pilloli 480 mg huma ppakkjati f'kartuna li fiha erba' (4) kards tal-kartun, kull wieħed fih kard ipperforata tal-Polyamide/Aluminium/PVC - Aluminium ta' għadd 7 għal total ta' 28 pillola.
English: Drug interactions
Maltese: Interazzjonijet mediċinali
English: Name and address of the manufacturer(s) responsible for batch release Schering-Plough Labo NV
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Schering-Plough Labo NV
English: Refer to the respective prescribing information (see section 4.4).
Maltese: Irreferi għall-informazzjoni dwar ilpreskrizzjoni rispettiva (ara sezzjoni 4.4).
English: • Add one single-dose vial of (either 12 mL (240 mg dose) or 24 mL (480 mg dose)) of PREVYMIS concentrate for solution for infusion to a 250 mL pre-filled IV bag containing either 0.9% sodium chloride or 5% dextrose, and mix the diluted solution by gentle inversion.
Maltese: • Żid kunjett ta' doża waħda ta' (jew 12 mL (doża ta' 240 mg) jew 24 mL (doża ta' 480 mg)) ta' PREVYMIS konċentrat għal soluzzjoni għall-infużjoni ma' borża IV mimlija għal-lest ta' 250 mL li jkun fiha jew 0.9 % sodium chloride jew 5 % dextrose, u ħawwad is-soluzzjoni dilwita b'inverżjoni bil-mod.
English: PREVYMIS 480 mg tablets letermovir
Maltese: IL-PRODOTT MEDIĊINALI PREVYMIS 480 mg pilloli letermovir
English: Film-coated tablet (tablet)
Maltese: Fil-koltura taċ-ċelluli
English: -Examples of such medicinal products include HMG Co-A reductase inhibitors, fexofenadine, repaglinide and glyburide (see Table 1).
Maltese: -Eżempji ta' prodotti mediċinali bħal dawn jinkludu inibituri ta''reductase HMG Co-A, fexofenadine, repaglinide u glyburide (ara Tabella 1).
English: General toxicity
Maltese: Tossiċità ġenerali
English: Effect of other medicinal products on letermovir
Maltese: Effett ta' prodotti mediċinali oħra fuq letermovir
English: The 240 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Maltese: Il-pilloli 240 mg huma ppakkjati f'kartuna li fiha erba' (4) kards tal-kartun, kull wieħed fih kard ipperforata tal-Polyamide/Aluminium/PVC - Aluminium ta' għadd 7 għal total ta' 28 pillola.
English: This medicinal product contains 23 mg (1.0 mmol) sodium per 240 mg vial, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 23 mg (1.0 mmol) sodju għal kull kunjett ta' 240 mg, ekwivalenti għal 1.15 % tat-teħid ta' kuljum massimu rakkomandat tal-WHO ta' 2 g sodju għal adult.
English: At baseline, 50% of subjects received a myeloablative regimen, 52% were receiving cyclosporine, and 42% were receiving tacrolimus.
Maltese: Fil-linja bażi, 50 % talindividwi rċivew reġimen majeloablattiv; 52 % kienu qed jirċievu cyclosporine;
English: Film-coating
Maltese: Uża immedjatament
English: The medicinal product interactions described are based on studies conducted with PREVYMIS or are predicted medicinal product interactions that may occur with PREVYMIS (see sections 4.3, 4.4, 5.1, and 5.2).
Maltese: L-interazzjonijiet bejn prodotti mediċinali deskritti huma bbażati fuq studji li saru bi PREVYMIS jew huma interazzjonijiet bejn prodotti mediċinali mbassra li jistgħu jsiru bi PREVYMIS (ara sezzjonijiet 4.3, 4.4, 5.1 u5.2).
English: • nafcillin - for bacterial infections
Maltese: • nafcillin - għal infezzjonijiet batteriċi
English: Letermovir may increase statin plasma concentrations.
Maltese: Letermovir jista' jżid ilkonċentrazzjonijiet fil-plażma ta' statin.
English: Dosage adjustment
Maltese: Tfal u adoloxxenti
English: Compatible intravenous solutions and other medicinal products
Maltese: Soluzzjonijiet intravenużi u prodotti mediċinali oħra kompatibbli
English: Each carton contains four (4) cardboard, each containing a 7-count blister card for a total of 28 tablets.
Maltese: Kull kartuna erba' (4) kards talkartuna, kull wieħed fih kard ipperforata ta' għadd 7 għal total ta' 28 pillola.
English: The anticipated clinical exposure to hydroxypropylbetadex with intravenously administered letermovir is expected to be approximately 3600 mg/day for a letermovir dose of 480 mg.
Maltese: L-esponiment kliniku antiċipat għal hydroxypropylbetadex b'letermovir mogħti ġol-vini huwa mistenni li jkun madwar 3600 mg/jum għal doża ta' letermovir ta' 480 mg.
English: In cases of clinically significant CMV DNAemia or disease, letermovir prophylaxis was stopped and standard-of-care pre-emptive therapy (PET) or treatment was initiated.
Maltese: F'każijiet ta' DNAemia jew marda b'CMV klinikament sinifkanti, il-profilassi ta' letermovir twaqqfet u nbdiet terapija preventiva (PET, pre-emptive therapy) standard ta' kura jew il-kura.
English: 5% dextrose solutions.
Maltese: 0.9 % sodium chloride u 5 % dextrose.
English: In HSCT recipients, letermovir AUC was estimated using population pharmacokinetic analyses using Phase 3 data (see Table 4).
Maltese: F'riċevituri ta' HSCT, l-AUC ta' letermovir kien stmat bl-użu tal-analiżijiet farmakokinetiċi talpopolazzjoni bl-użu ta' dejta ta' Fażi 3 (ara Tabella 4).
English: • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
Maltese: • omeprazole, pantoprazole - għal ulċeri fl-istonku u problemi oħra fl-istonku
English: In healthy subjects, oral administration of 480 mg single dose of letermovir with a standard high fat and high calorie meal did not have any effect on the overall exposure (AUC) and resulted in approximately 30% increase in peak levels (Cmax) of letermovir.
Maltese: F'individwi b'saħħithom, l-għoti orali ta' 480 mg doża waħda ta' letermovir b'ikla standard b'kontenut għoli ta' xaħam u kaloriji ma kellux effett fuq l-esponiment globali (AUC) u rriżulta f'madwar żieda ta' 30 % f'livelli massimi (Cmax) ta' letermovir.
English: Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin).
Maltese: Kull doża ta' 240 mg (kunjett ta' 12 mL) ta' dan il-prodott mediċinali fiha 1,800 mg hydroxypropylbetadex (cyclodextrin).
English: When PREVYMIS is co-administered with cyclosporine, atorvastatin is contraindicated.
Maltese: Meta PREVYMIS jingħata flimkien ma' cyclosporine, atorvastatin huwa kontraindikat.
English: Add one single-dose vial (either 12 mL (240 mg dose) or 24 mL (480 mg dose)) of PREVYMIS concentrate for solution for infusion to a 250 mL pre-filled IV bag containing either 0.9% sodium chloride or 5% dextrose, and mix the diluted solution by gentle inversion.
Maltese: Żid kunjett ta' doża waħda (jew 12 mL (doża ta' 240 mg) jew 24 mL (doża ta' 480 mg)) ta' PREVYMIS konċentrat għal soluzzjoni għall-infużjoni ma' borża IV mimlija għal-lest ta' 250 mL li jkun fiha jew 0.9 % sodium chloride jew 5 % dextrose, u ħawwad is-soluzzjoni dilwita b'inverżjoni bil-mod.
English: 480 mg IV, no cyclosporine
Maltese: 480 mg IV, l-ebda cyclosporine
English: Each mL contains 20 mg of letermovir.
Maltese: Kull ml fih 20 mg ta' letermovir.
English: PREVYMIS 480 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PREVYMIS 480 mg
English: Factors associated with CMV DNAemia after Week 14 post-transplant among letermovir-treated subjects included high risk for CMV reactivation at baseline, GVHD, use of corticosteroids, and CMV negative donor serostatus.
Maltese: Fatturi assoċjati ma' DNAemia b'CMV wara Ġimgħa 14 wara t-trapjant fost l-individwi kkurati b'letermovir kienu jinkludu riskju għoli għal riattivazzjoni ta' CMV fil-linja bażi, GVHD, u l-użu talkortikosterojdi, u serostatus tad-donatur negattiv għal CMV.
English: Each vial contains 240 mg or 480 mg letermovir.
Maltese: Kull kunjett fih 240 mg jew 480 mg letermovir.
English: (P-gp induction)
Maltese: (induzzjoni ta' P-gp)
English: Concentrate for solution for infusion (sterile concentrate) Clear, colourless liquid pH between 7 and 8
Maltese: GĦAMLA FARMAĊEWTIKA Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili) Likwidu ċar, bla kulur pH bejn 7 u 8
English: Posology PREVYMIS is also available as concentrate for solution for infusion (240 mg and 480 mg).
Maltese: PREVYMIS jiġi wkoll bħala konċentrat għal soluzzjoni għall-infużjoni (240 mg u 480 mg).
English: Metabolism and nutrition disorders Uncommon decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni nuqqas ta' aptit
English: 240 mg Oral, with cyclosporine
Maltese: 240 mg Orali, b'cyclosporine
English: Co-administration of PREVYMIS with voriconazole (a CYP2C19 substrate) results in significantly decreased voriconazole plasma concentrations, indicating that letermovir is an inducer of CYP2C19.
Maltese: L-għoti flimkien ta' PREVYMIS ma' voriconazole (sottostrat ta' CYP2C19) jirriżulta f'konċentrazzjonijiet fil-plażma ta' voriconazole mnaqqsa b'mod sinifikanti, li jindika li letermovir huwa induttur ta' CYP2C19.
English: The effect of letermovir on doses up to 960 mg given IV on the QTc interval was evaluated in a randomised, single-dose, placebo- and active-controlled (moxifloxacin 400 mg oral) 4-period crossover thorough QT trial in 38 healthy subjects.
Maltese: L-effett ta' letermovir fuq dożi sa 960 mg mogħtija IV fuq l-intervall QTc ġie evalwat fi prova QT dettaljata randomizzata, ta' doża waħda, ikkontrollata bil-plaċebo u b'mod attiv (moxifloxacin 400 mg orali) ta' 4 perjodi inkroċjata fi 38 individwu b'saħħithom.
English: Primary efficacy endpoint (Proportion of subjects who failed prophylaxis by Week 24)
Maltese: End-point tal-effikaċja primarju (Proporzjon ta' individwi li fallew il-profilassi sa Ġimgħa 24)
English: Due date
Maltese: ↓omeprazole
English: • Do not shake PREVYMIS vial.
Maltese: • Tħawwadx il-kunjett PREVYMIS.
English: Thirty-seven percent (37%) of subjects were engrafted at baseline.
Maltese: Sebħa u tletin fil-mija (37 %) tal-individwi tlaqqmu fil-linja bażi.
English: PREVYMIS should be used with caution with medicinal products that are CYP3A substrates with narrow therapeutic ranges (e.g., alfentanil, fentanyl, and quinidine) as co-administration may result in increases in the plasma concentrations of CYP3A substrates.
Maltese: PREVYMIS għandu jintuża b'kawtela ma' prodotti mediċinali li huma sottostrati ta' CYP3A b'meded terapewtiċi dojoq (eż., alfentanil, fentanyl, u quinidine) peress li l-għoti flimkien jista' jirriżulta f'żidiet fil-konċentrazzjonijiet fil-plażma ta' sottostrati ta' CYP3A.
English: Primary efficacy endpoint
Maltese: End-point tal-effikaċja primarju
English: During Phase 1 clinical trials, 86 healthy subjects received doses ranging from 720 mg/day to 1440 mg/day of PREVYMIS for up to 14 days.
Maltese: Matul il-provi kliniċi ta' Fażi 1, 86 individwu b'saħħithom irċivew dożi li jvarjaw minn 720 mg/jum sa 1440 mg/jum ta' PREVYMIS sa 14-il jum.
English: Medicinal products metabolised by CYP2B6, UGT1A1 or transported by BCRP or OATP2B1 Letermovir is a general inducer in vivo but has also been observed to inhibit CYP2B6, UGT1A1, BCRP, and OATP2B1 in vitro.
Maltese: Letermovir huwa induttur ġenerali in vivo iżda ġie osservat ukoll li jinibixxi CYP2B6, UGT1A1, BCRP, u OATP2B1 in vitro.
English: Each 480 mg dose (24 mL vial) of this medicine contains 3600 mg cyclodextrin.
Maltese: Kull doża ta' 480 mg (kunjett ta' 24 mL) ta' din il-mediċina fiha 3,600 mg cyclodextrin.
English: Based on population pharmacokinetic analyses, the mean steady-state volume of distribution is estimated to be 45.5 L following intravenous administration in HSCT recipients.
Maltese: Abbażi ta' analiżijiet farmakokinetiċi tal-popolazzjoni, il-volum medju fi stat fiss ta' distribuzzjoni huwa stmat li huwa 45.5 L wara għoti ġol-vini f'riċevituri ta' HSCT.
English: When PREVYMIS is co-administered with cyclosporine, dabigatran is contraindicated.
Maltese: Meta PREVYMIS jingħata flimkien ma' cyclosporine, dabigatran huwa kontraindikat.
English: It is known that hydroxypropylbetadex can cause kidney vacuolation in rats when given intravenously at doses greater than 50 mg/kg/day.
Maltese: Huwa magħruf li hydroxypropylbetadex jista' jikkawża vakwolazzjoni fil-kliewi fil-firien meta jingħata ġol-vini f'dożi ikbar minn 50 mg/kg/jum.
English: • possible clinically significant adverse reactions from greater exposure of concomitant medicinal products or letermovir.
Maltese: • reazzjonijiet avversi klinikament sinifikanti possibbli minn esponiment akbar ta' prodotti mediċinali konkomitanti jew ta' letermovir.