FrancophonIA/ELRC3.0 huggingface dataset:
English: -Examples of medicinal products transported by OAT3 includes ciprofloxacin, tenofovir, imipenem, and cilastin.
Maltese: -Eżempji ta' prodotti mediċinali ttrasportati minn OAT3 jinkludu ciprofloxacin, tenofovir, imipenem, u cilastin.
English: Anti-arrhythmic medicinal products amiodarone
Maltese: Prodotti mediċinali antiaritmiċi amiodarone
English: Letermovir is a moderate inducer of enzymes and transporters.
Maltese: Letermovir huwa induttur moderat ta' enzimi u trasportaturi.
English: Hydroxypropylbetadex (cyclodextrin) Sodium chloride
Maltese: Hydroxypropylbetadex (cyclodextrin)
English: PREVYMIS concentrate for solution for infusion is physically incompatible with amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
Maltese: PREVYMIS konċentrat għal soluzzjoni għall-infużjoni huwa inkompatibbli fiżikament ma' amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
English: -Examples of such medicinal products include warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide (see Table 1).
Maltese: -Eżempji ta' prodotti mediċinali bħal dawn jinkludu warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide (ara Tabella 1).
English: Expected: ↑ or ↓ repaglinide
Maltese: Mistennija: ↑ jew ↓ repaglinide
English: Medicinal products metabolised by CYP2C8
Maltese: Prodotti mediċinali metabolizzati minn CYP2C8
English: Proton pump inhibitors omeprazole
Maltese: Inibituri tal-pompa tal-proton omeprazole
English: • voriconazole - for fungal infections
Maltese: • voriconazole - għal infezzjonijiet fungali
English: ↑ or ↓ efavirenz (CYP2B6 inhibition or induction)
Maltese: ↑ jew ↓ efavirenz (inibizzjoni jew induzzjoni tas-CYP2B6)
English: Letermovir is extensively bound (98.2%) to human plasma proteins, independent of the concentration range (3 to 100 mg/L) evaluated, in vitro.
Maltese: Letermovir jeħel b'mod estensiv (98.2%) ma' proteini tal-plażma tal-bniedem, indipendenti millmedda tal-konċentrazzjoni (3 sa 100 mg/L) evalwata, in vitro.
English: Date of first authorisation: 8 January 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Jannar 2018
English: Table 3: P001: Efficacy results in HSCT recipients (NC=F Approach, FAS Population) Letermovir
Maltese: Tabella 3: P001: Riżultati tal-effikaċja f'riċevituri ta' HSCT (Approċċ NC=F, Popolazzjoni FAS) Letermovir
English: The tablet is 21.2 mm long and 10.3 mm wide.
Maltese: Il-pillola hija twila 21.2 mm u wiesgħa 10.3 mm.
English: Additional effects of other products on letermovir relevant when combined with cyclosporine
Maltese: Effetti addizzjonali ta' prodotti oħra fuq letermovir relevanti meta jiġi kkombinat ma' cyclosporine
English: In vitro, letermovir is an inhibitor of CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1, and OAT3 at in vivo relevant concentrations.
Maltese: In vitro, letermovir huwa inibitur ta' CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1, u OAT3 f'konċentrazzjonijiet relevanti in vivo.
English: Effect on concentration Mean ratio (90 % confidence interval) for AUC, Cmax (likely mechanism of action)
Maltese: Proporzjon medju (intervall ta' kunfidenza ta' 90 %) għal AUC, Cmax (mekkaniżmu ta' azzjoni probabbli)
English: Concomitant administration with St. John's wort (Hypericum perforatum) (see section 4.5).
Maltese: John's wort (Hypericum perforatum) (ara sezzjoni 4.5).
English: Medicinal products transported by OATP1B1/3
Maltese: Prodotti mediċinali ttrasportati minn OATP1B1/3
English: The tablet is 16.5 mm long and 8.5 mm wide.
Maltese: Il-pillola hija twila 16.5 mm u wiesgħa 8.5 mm.
English: • Amphotericin B (lipid complex)
Maltese: Amphotericin B (kumpless ta' lipidi)†
English: Polyamide/Aluminium/PVC - Aluminium blister cards.
Maltese: Kards ipperforati tal-Polyamide/Aluminium/PVC - Aluminium.
English: (15.0%) subjects were 65 years of age or older: 58% were male; 82% were White; 10% were Asian; 2% were Black or African; and 7% were Hispanic or Latino.
Maltese: L-età medjana kienet 54 sena (medda: 18 sa 78 sena); 56 (15.0 %) individwu kellhom 65 sena jew aktar: 58 % kienu rġiel; 82 % kienu Bojod, 10 % kienu Asjatiċi; 2 % kienu Suwed jew Afrikani; u 7 % kienu Ispaniċi jew Latini.
English: General information
Maltese: Informazzjoni ġenerali
English: Each mL of concentrate contains 20 mg/mL.
Maltese: Kull mL ta' konċentrat fih 20 mg/mL.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) jew rari ħafna (< 1/10,000).
English: The most frequently reported adverse reactions that led to discontinuation of PREVYMIS were nausea (1.6%), vomiting (0.8%), and abdominal pain (0.5%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti li wasslu għat-twaqqif ta' PREVYMIS kienu dardir (1.6 %), remettar (0.8 %) u uġigħ addominali (0.5 %).
English: • rifabutin, rifampicin - for mycobacterial infections
Maltese: • rifabutin, rifampicin - għal infezzjonijiet mikobatteriċi
English: Antiepileptic medicinal products (see also general text) carbamazepine, phenobarbital
Maltese: Prodotti mediċinali antiepilettiċi (ara wkoll it-test ġenerali) carbamazepine, phenobarbital
English: The most common primary reasons for transplant were acute myeloid leukemia (38%), myeloblastic syndrome (15%), and lymphoma (13%).
Maltese: L-aktar raġunijiet primarji komuni għat-trapjant kienu lewkimja majelojde akuta (38 %), sindrome majeloblastiku (15 %), u linfoma (13 %).
English: Expected: ↑ amiodarone
Maltese: ↑ amiodarone
English: For additional information, see section 4.2.
Maltese: Għal informazzjoni addizzjonali, ara sezzjoni 4.2.
English: • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
Maltese: • statini, bħal atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - għal kolesterol għoli
English: Oral contraceptives ethinylestradiol (EE) (0.03 mg)/ levonorgestrel (LNG) (0.15 mg) single dose/ letermovir (480 mg daily)
Maltese: Kontraċettivi orali ethinylestradiol (EE) (0.03 mg)/levonorgestrel (LNG)‡ doża waħda (0.15 mg)/ letermovir (480 mg kuljum)
English: Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide yellow (E172), iron oxide red (only for 480 mg tablets) (E172), carnauba wax (E903).
Maltese: Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), ossidu talħadid isfar (E172), ossidu tal-ħadid aħmar (għall-pilloli 480 mg biss) (E172), xama' tal-karnawba (E903).
English: Antibiotics nafcillin
Maltese: Antibijotiċi nafcillin
English: Immune system disorders Uncommon hypersensitivity
Maltese: Disturbi fis-sistema immuni Mhux komuni sensittività eċċessiva
English: • abnormalities in laboratory tests of liver function
Maltese: • anormalitajiet fit-testijiet tal-laboratorju tal-funzjoni tal-fwied
English: Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (see section 4.5).
Maltese: L-użu konkomitanti ta' dabigatran, atorvastatin, simvastatin, rosuvastatin jew pitavastatin huwa kontraindikat (ara sezzjoni 4.5).
English: Medicinal products transported by P-gp in the intestine Letermovir is an inducer of intestinal P-gp.
Maltese: Prodotti mediċinali ttrasportati minn P-gp fil-musrana Letermovir huwa induttur ta' P-gp intestinali.
English: - Examples of medicinal products transported by BCRP include rosuvastatin and sulfasalazine.
Maltese: -Eżempji ta' prodotti mediċinali ttrasportati minn BCRP jinkludu rosuvastatin u sulfasalazine.
English: (CYP2C8 induction, CYP2C8 and OATP1B inhibition)
Maltese: (induzzjoni ta' CYP2C8, inibizzjoni ta' CYP2C8 u OATP1B)
English: The inter-individual variability for CL is estimated to be 24.6%.
Maltese: Il-varjabbiltà interindividwali għal CL hija stmata li hi 24.6 %.
English: ↑ cyclosporine AUC 1.66 (1.51, 1.82) Cmax 1.08 (0.97, 1.19) (CYP3A inhibition)
Maltese: ↑ cyclosporine AUC 1.66 (1.51, 1.82) Cmax 1.08 (0.97, 1.19) (inibizzjoni ta' CYP3A)
English: Note: The proportion of subjects with detectable CMV viral DNA on Day 1 that developed clinically significant CMV infection in the letermovir group was 64.6% (31/48) compared to 90.9% (20/22) in the placebo group through Week 24 post-transplant.
Maltese: Nota: Il-proporzjon ta' individwi b'DNA virali identifikata b'CMV f'Jum 1 li żviluppaw infezzjoni b'CMV klinikament sinfiikanti fil-grupp ta' letermovir kien ta' 64.6 % (31/48) meta mqabbel ma' 90.9 % (20/22) fil-grupp tal-plaċebo f'Ġimgħa 24 wara t-trapjant.
English: List of compatible medicinal products when PREVYMIS and medicinal products* are prepared in 0.9% sodium chloride
Maltese: Lista ta' prodotti mediċinali kompatibbli meta PREVYMIS u prodotti mediċinali* jiġu ppreparati f'0.9% sodium chloride
English: Peripheral blood (n=241, 117)
Maltese: Stem Cell Source Peripheral blood (n=241, 117) Bone marrow (n=72, 43)
English: - Examples of medicinal products metabolised by UGT1A1 are raltegravir and dolutegravir.
Maltese: -Eżempji ta' prodotti mediċinali metabolizzati minn UGT1A1 huma raltegravir u dolutegravir.
English: (OATP1B1/3 inhibition CYP3A inhibition, CYP2C9 induction)
Maltese: (inibizzjoni ta' OATP1B1/3, inibizzjoni ta' CYP3A, induzzjoni ta' CYP2C9)
English: (intestinal P-gp induction)
Maltese: (induzzjoni ta' P-gp intestinali)
English: Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products (see section 4.5).
Maltese: L-induzzjoni tista' tikkawża konċentrazzjonijiet imnaqqsa fil-plażma ta' xi prodotti mediċinali metabolizzati u trasportati (ara sezzjoni 4.5).
English: Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and MSD logo on the other side.
Maltese: Pillola safra, ovali b'dimensjonijiet ta' 16.5 mm x 8.5 mm, imnaqqxa b'“591” fuq naħa waħda u bilmarka MSD fuq in-naħa l-oħra.
English: Medicinal products metabolised by CYP2C9 and/or CYP2C19
Maltese: Prodotti mediċinali metabolizzati minn CYP2C9/19 u/jew CYP2C19
English: Expected: ↑ HMG-CoA reductase inhibitors
Maltese: Mistennija: ↑ inibituri ta' reductase HMG-CoA
English: Letermovir is an inhibitor of OATP1B1/3 transporters.
Maltese: Letermovir huwa inibitur ta' trasportaturi ta' OATP1B1/3.
English: Letermovir is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors (ganciclovir, cidofovir, and foscarnet).
Maltese: Letermovir huwa attiv b'mod sħiħ kontra popolazzjonijiet virali b'reżistenza li tikkonferixxi massostituzzjonijiet għal inibituri tal-polimerażi tad-DNA ta' CMV (ganciclovir, cidofovir, u foscarnet).
English: The estimated difference (95% CI for the difference) was -26.1% (-45.9%, -6.3%), with a nominal one-sided p-value <0.0048.
Maltese: 1% (-45.9%, -6.3%), b'valur-p nominali ta' naħa waħda <0.0048.
English: CMV DNAemia warranting anti-CMV PET
Maltese: DNAemia b'CMV li tippermetti PET għal kontra sCMV
English: Letermovir unbound AUC was approximately 115- and 81% higher in subjects with moderate (eGFR of 31.0 to 56.8 mL/min/1.73m2) and severe (eGFR of 11.9 to 28.1 mL/min/1.73m2) renal impairment, respectively, compared to healthy subjects.
Maltese: L-AUC mhux marbut ta' letermovir kienet madwar 115 u 81 % ogħla f'individwi b'indeboliment talkliewi moderat (eGFR ta' 31.0 sa 56.8 mL/min/1.73m2) u sever (eGFR ta' 11.9 sa 28.1 mL/min/1.73m2), rispettivament, meta mqabbla ma' individwi b'saħħithom.
English: Non-myeloablative (n=85, 37)
Maltese: Non-myeloablative (n=85, 37) Immunosuppressive Regimen
English: -Examples of OATP1B1 inhibitors include gemfibrozil, erythromycin, clarithromycin, and several protease inhibitors (atazanavir, simeprevir).
Maltese: -Eżempji ta' inibituri ta' OATP1B1 jinkludu gemfibrozil, erythromycin, chlarithromycin, u diversi inibituri ta' protease (atazanavir, simeprevir).
English: One subject (who received 60 mg/day) had a letermovir resistant genotypic variant (GV) (V236M).
Maltese: Individwu wieħed (li rċieva 60 mg/jum) kellu varjant ġenotipiku (GV, genotypic variant) reżistenti għal letermovir (V236M).
English: Do not take PREVYMIS if:
Maltese: Tiħux PREVYMIS jekk:
English: -Examples of moderate inducers include thioridazine, modafinil, ritonavir, lopinavir, efavirenz and etravirine.
Maltese: - Eżempji ta' indutturi moderati jinkludu thioridazine, modafinil, ritonavir, lopinavir, efavirenz u etravirine.
English: Table 4: Letermovir AUC (ng•hr/mL) values in HSCT Recipients Treatment Regimen
Maltese: Tabella 4: Valuri AUC ta' letermovir (ng•hr/mL) f'Riċevituri ta' HSCT Reġimen ta' Kura
English: In healthy subjects, the geometric mean steady-state AUC and Cmax values were 71,500 ng•hr/mL and 13,000 ng/mL, respectively, with 480 mg once daily oral letermovir.
Maltese: F'individwi b'saħħithom, il-valuri ta' AUC u Cmax fi stat fiss medju ġeometriċi kienu 71,500 ng•hr/mL u 13,000 ng/mL, rispettivament, b'480 mg għoti orali ta' letermovir darba kuljum.
English: PREVYMIS concentrate for solution for infusion contains hydroxypropylbetadex.
Maltese: PREVYMIS konċentrat għal soluzzjoni għall-infużjoni fih hydroxypropylbetadex.
English: Letermovir reached steady-state in 9 to 10 days with an accumulation ratio of 1.2 for AUC and 1.0 for Cmax.
Maltese: Letermovir laħaq stat fiss f'9 sa 10 ijiem bi proporzjon ta' akkumulazzjoni ta' 1.2 għal AUC u ta' 1.0 għal Cmax.
English: The adverse reaction profile was similar to that of the clinical dose of 480 mg/day.
Maltese: Il-profil ta' reazzjonijiet avversi kien simili għal dak tad-doża klinika ta' 480 mg/jum.
English: • Ampicillin sodium/Sulbactam sodium • Human insulin
Maltese: Ampicillin sodium/Sulbactam sodium •
English: Letermovir may decrease the plasma concentrations of CYP2C19 substrates.
Maltese: Letermovir jista' jnaqqas ilkonċentrazzjonijiet fil-plażma ta' sottostrati ta' CYP2C19.
English: Letermovir unbound AUC was approximately 81%- and 4-fold higher in subjects with moderate (Child-Pugh Class B [CP-B], score of 7-9) and severe (Child-Pugh Class C [CP-C], score of 10-15) hepatic impairment, respectively, compared to healthy subjects.
Maltese: L-AUC mhux marbut ta' letermovir kienet madwar 81% u 4 darbiet ogħla f'individwi b'indeboliment tal-fwied moderat (Child-Pugh Class B [CP-B], punteġġ ta' 7-9) u sever (Child-Pugh Class C
English: The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.
Maltese: Is-sustanzi mhux attivi l-oħra huma: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), ilma għall-injezzjonijiet.
English: Co-administration of PREVYMIS and St. John's wort is contraindicated.
Maltese: John's wort huwa kontraindikat.
English: Letermovir may increase the plasma concentrations of quinidine.
Maltese: Letermovir jista' jżid ilkonċentrazzjonijiet fil-plażma ta' quinidine.
English: Immunosuppressants cyclosporine (50 mg single dose)/ letermovir (240 mg daily)
Maltese: Immunosuppressanti cyclosporine (doża waħda ta' 50 mg)/letermovir (240 mg kuljum)
English: It is unknown whether letermovir may affect the exposure of piperacillin/tazobactam, amphotericine B and micafungin.
Maltese: Mhuwiex magħruf jekk letermovir jistax jaffettwa l-esponiment ta' piperacillin/tazobactam, amphotericine B u micafungin.
English: List of compatible medicinal products when PREVYMIS and medicinal products* are prepared in 5% dextrose
Maltese: Lista ta' prodotti mediċinali kompatibbli meta PREVYMIS u prodotti mediċinali* jiġu ppreparati f'5 % dextrose
English: Hepatobiliary disorders Uncommon alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Disturbi fil-fwied u fil-marrara Mhux komuni żieda ta' alanine aminotransferase, żieda ta' aspartate aminotransferase
English: (CYP3A, OATP1B1/3 inhibition)
Maltese: (inibizzjoni ta' CYP3A, OATP1B1/3)
English: - Examples of P-gp/BCRP inhibitors include clarithromycin,erythromycin, azitromycin, itraconazole, ketoconazole, verapamil, quinidine, fluvoxamine, ranolazine, and some of the HIV protease inhibitors.
Maltese: Eżempji ta' inibituri ta' P-gp/BCRP jinkludu clarithromycin,erythromycin, azitromycin, itraconazole, ketoconazole, verapamil, quinidine, fluvoxamine, ranolazine, u xi inibituri ta' protease tal-HIV.
English: Elderly No dose adjustment of PREVYMIS is required based on age (see sections 5.1 and 5.2).
Maltese: Anzjani Mhu meħtieġ l-ebda aġġustament fid-doża ta' PREVYMIS abbażi tal-età (ara sezzjonijiet 5.1 u 5.2).
English: Letermovir was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis assays, chromosomal aberration in Chinese Hamster Ovary cells, and in an in vivo mouse micronucleus study.
Maltese: Letermovir ma kienx ġenotossiku f'batterija ta' assaġġi in vitro jew in vivo, inkluż assaġġi ta' mutaġenesi mikrobika, aberrazzjoni kromożika fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż u fi studju fuq il-mikronukleu tal-ġurdien in vivo.
English: No known letermovir resistance mutations map to UL89.
Maltese: Lebda mutazzjonijiet ta' reżistenza ta' letermovir ma jimmarkaw lejn UL89.
English: The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni li seħħu f'tal-inqas 1 % tal-individwi fil-grupp ta' PREVYMIS u bi frekwenza akbar mill-plaċebo kienu: dardir (7.2 %), dijarea (2.4 %), u remettar
English: No dose adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment.
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża ta' PREVYMIS abbażi ta' indeboliment tal-fwied ħafif (Child-Pugh Klassi A) sa moderat (Child-Pugh Klassi B).
English: • quinidine - for abnormal heart rhythms.
Maltese: • quinidine - għal ritmi tal-qalb aormali.
English: In vivo studies are available investigating the net effect on CYP3A4, P-gp, OATP1B1/3 additionally on CYP2C19.
Maltese: Huma disponibbli studji in vivo li jinvestigaw l-effett nett fuq CYP3A4, P-gp, OATP1B1/3 b'mod addizzjonali fuq CYP2C19.
English: No (n=276, 153)
Maltese: Yes (n=51, 19) No (n=274, 151)
English: Letermovir may increase the plasma concentrations of medicinal products transported by OATP1B1/3 such as many of the statins (see section 4.5 and Table 1).
Maltese: Letermovir jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali ttrasportati minn OATP1B1/3 bħal ħafna mill-istatini (ara sezzjoni 4.5 u Tabella 1).
English: Intravenous bag materials
Maltese: Materjali tal-borża intravenuża
English: -Examples of P-gp/BCRP inhibitors include clarithromycin,erythromycin, azitromycin, itraconazole, ketoconazole, verapamil, quinidine, fluvoxamine, ranolazine, and some of the HIV protease inhibitors.
Maltese: -Eżempji ta' inibituri ta' P-gp/BCRP jinkludu clarithromycin,erythromycin, azitromycin, itraconazole, ketoconazole, verapamil, quinidine, fluvoxamine, ranolazine, u xi ftit mill-inibituri ta' protease talHIV.
English: mycophenolate mofetil (1 g single dose)/ letermovir (480 mg daily)
Maltese: mycophenolate mofetil (doża waħda ta' 1 g)/letermovir (480 mg kuljum)
English: Mutagenesis
Maltese: Mutaġenesi
English: St. John's wort may decrease plasma concentrations of letermovir.
Maltese: John's wort jista' jnaqqas ilkonċentrazzjonijiet ta' letermovir filplażma.
English: Expected: ↔ letermovir
Maltese: Mistennija: ↓ letermovir
English: Reproduction
Maltese: Riproduzzjoni
English: The median EC50 value of letermovir against a collection of clinical CMV isolates in a cell-culture model of infection was 2.1 nM (range = 0.7 nM to 6.1 nM, n=74).
Maltese: Il-valur medjan tall-EC50 ta' letermovir kontra ġabra ta' iżolati kliniċi ta' CMV f'mudell ta' infezzjoni ta' kultura taċ-ċelluli kienet ta' 2.1 nM (medda = 0.7 nM sa 6.1 nM, n=74).
English: Vacuolation was noted in the kidneys of rats administered IV letermovir formulated with 1500 mg/kg/day of the cyclodextrin excipient hydroxypropylbetadex.
Maltese: Il-vakwolazzjoni ġiet innutata fil-kliewi tal-firien li ngħataw letermovir IV ifformulat b'1,500 mg/kg/jum tal-eċċipjent ta' cyclodextrin hydroxypropylbetadex.
English: • carbamazepine, phenobarbital, phenytoin - for fits or seizures
Maltese: • carbamazepine, phenobarbital, phenytoin - għal aċċesjonijiet jew attakki ta' puplesija
English: 240 mg IV, with cyclosporine
Maltese: 240 mg IV, b'cyclosporine
English: In vitro results indicate that letermovir is a substrate of P-gp/BCRP.
Maltese: Riżultati in vitro jindikaw li letermovir huwa sottostrat ta' P-gp/BCRP.
English: How to store PREVYMIS 6.
Maltese: Kif taħżen PREVYMIS 6.
English: Figure 2: P001: Forest plot of the proportion of subjects initiating anti-CMV PET or with CMV end-organ disease through Week 24 post-transplant by selected subgroups (NC=F approach, FAS population)
Maltese: Figura 2: P001: Plott forest tal-proporzjon ta' individwi li bdew PET għal kontra s-CMV jew b'marda tal-organu tal-aħħar stadju b'CMV matul Ġimgħa 24 wara t-trapjant minn sottogruppi magħżula (approċċ NC=F, popolazzjoni FAS)
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 18.7% lower in subjects weighing 80-100 kg compared to subjects weighing 67 kg.
Maltese: Abbażi ta' analiżijiet farmakokinetiċi tal-popolazzjoni, l-AUC ta' letermovir hija stmata li hi 18.7 % aktar baxxa f'individwi li jiżnu 80-100 kg meta mqabbel ma' individwi li jiżnu 67 kg.
English: Pimozide and ergot alkaloids are contraindicated (see section 4.3).
Maltese: Pimozide u alkalojdi tal-huma kontraindikati (ara sezzjoni 4.3).
English: Compatible intravenous solutions and other medicinal products PREVYMIS concentrate for solution for infusion is compatible with 0.9% sodium chloride and 5% dextrose solutions.
Maltese: Soluzzjonijiet intravenużi u prodotti mediċinali oħra kompatibbli PREVYMIS konċentrat għal soluzzjoni għall-infużjoni huwa kompatibbli ma' soluzzjonijiet ta' 0.9 % sodium chloride u 5 % dextrose.
English: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Maltese: PREVYMIS huwa indikat għall-profilassi tar-riattivazzjoni u tal-marda ta' cytomegalovirus (CMV, cytomegalovirus) f'riċevituri seropożittivi [R+] għas-CMV adulti ta' trapjant taċ-ċelluli staminali ematopojetiċi (HSCT, hematopoietic stem cell transplant ) alloġeniċi.
English: Adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant To evaluate letermovir prophylaxis as a preventive strategy for CMV infection or disease, the efficacy of letermovir was assessed in a multicenter, double-blind, placebo-controlled Phase 3 trial (P001) in adult CMV-seropositive recipients [R+] of an allogeneic HSCT.
Maltese: Sabiex tiġi vvalutata l-profilassi ta' letermovir bħala strateġija preventiva għal infezzjoni jew marda b'CMV, l-effikaċja ta' letermovir ġiet ivvalutata fi prova multiċentrika, double-blind, ikkontrollata bilplaċebo ta' Fażi 3 (P001) f'riċevituri seropożittivi [R+] għas-CMV adulti ta' HSCT alloġeniku.