FrancophonIA/ELRC3.0 huggingface dataset:
English: Irreversible testicular toxicity was noted only in rats at systemic exposures (AUC) ≥3-fold the exposures in humans at the recommended human dose (RHD).
Maltese: It-tossiċità testikulari irreversibbli ġiet innutata biss fil-firien f'esponimenti sistemiċi (AUC) >3 darbiet l-esponimenti fil-bnedmin bid-doża rakkomandata fil-bniedem (RHD, recommended human dose).
English: These data are the effect of rifampicin on letermovir 24 hours after final rifampicin dose.
Maltese: Din id-data hija l-effett ta' rifampicin fuq letermovir 24 siegħa wara d-doża finali ta' rifampicin.
English: (Sum of OATP1B1/3 and/or Pgp inhibition and P-gp/UGT induction)
Maltese: (It-total tal-inibizzjoni ta' OATP1B1/3 u/jew ta' P-gp u l-induzzjoni ta' Pgp/UGT)
English: However, caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Maltese: Madankollu, hija rakkomandata l-kawtela jekk jiżdiedu inibituri ta' P-gp/BCRP ma' letermovir ikkombinat ma' cyclosporine.
English: Figure 1: P001: Kaplan-Meier plot of time to initiation of anti-CMV PET or onset of CMV endorgan disease through Week 24 post-transplant in HSCT recipients (FAS population)
Maltese: Figura 1: P001: P001: Plott ta' żmien Kaplan-Meier għall-bidu ta' PET għal kontra s-CMV jew bidu ta' marda tal-organu tal-aħħar stadju b'CMV matul Ġimgħa 24 wara t-trapjant f'riċevituri ta' HSCT (popolazzjoni FAS)
English: Prolonged letermovir prophylaxis beyond 100 days post-transplant may be of benefit in some patients at high risk for late CMV reactivation (see section 5.1).
Maltese: Profilassi mdewma ta' letermovir għal aktar minn 100 jum wara t-trapjant tista' tkun ta' benefiċċju f'xi pazjenti li jinsabu f'riskju għoli għal riattivazzjoni tas-CMV tard (ara Sezzjoni 5.1).
English: PREVYMIS 480 mg film-coated tablet is a pink oval, bi-convex tablet, debossed with “595” on one side and MSD logo on the other side.
Maltese: PREVYMIS 480 mg pillola miksija b'rita hija pillola roża, ovali, bikonvessa, imnaqqxa b'“595” fuq naħa waħda u l-logo MSD fuq in-naħa l-oħra.
English: Letermovir inhibits CYP2C8 in vitro but may also induce CYP2C8 based on its induction potential.
Maltese: Letermovir jinibixxi CYP2C8 in vitro iżda jista' jinduċi wkoll CYP2C9 abbażi tal-potenzjal ta' induzzjoni tiegħu.
English: This medicinal product contains 46 mg (2.0 mmol) sodium per 480 mg vial, equivalent to 2.30% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 46 mg (2.0 mmol) sodju għal kull kunjett ta' 480 mg, ekwivalenti għal 2.30 % tat-teħid ta' kuljum massimu rakkomandat tal-WHO ta' 2 g sodju għal adult.
English: Medicinal products mainly eliminated through metabolism or influenced by active transport Letermovir is a general inducer in vivo of enzymes and transporters.
Maltese: Prodotti mediċinali eliminati prinċipalment mill-metaboliżmu jew influwenzati minn trasport attiv.
English: Letermovir may decrease the plasma concentrations of warfarin.
Maltese: Letermovir jista' jnaqqas ilkonċentrazzjonijiet fil-plażma ta' warfarin.
English: midazolam (2 mg single dose PO) / letermovir (240 mg once daily PO)
Maltese: midazolam (doża waħda ta' 2 mg PO) / letermovir (240 mg darba kuljum PO)
English: PREVYMIS 240 mg sterile concentrate letermovir
Maltese: U MNEJN GĦANDU JINGĦATA PREVYMIS 240 mg konċentrat sterili letermovir
English: PREVYMIS 240 mg concentrate for solution for infusion contains 23 mg (or 1.0 mmol) sodium per dose.
Maltese: PREVYMIS 240 mg konċentrat għal soluzzjoni għall-infużjoni fih 23 mg (jew 1.0 mmol) sodju għal kull doża.
English: ↑ midazolam IV:
Maltese: Daqs tal-pakkett:
English: In rats, maternal toxicity (including decrease in body weight gain) was noted at 250 mg/kg/day (approximately 11-fold the AUC at the RHD); in the offspring, decreased foetal weight with delayed ossification, slightly oedematous foetuses, and increased incidence of shortened umbilical cords and of variations and malformations in the vertebrae, ribs, and pelvis were observed.
Maltese: Fil-firien, it-tossiċità materna (inkluż tnaqqis fiż-żieda fil-piż tal-ġisem) ġiet innutata b'250 mg/kg/jum (madwar 11-il darba l-AUC bl-RHD); fil-frieħ ġew osservati, piż tal-fetu mnaqqas b'ossifikazzjoni mdewma, feti ftit edamużi, u inċidenza miżjuda ta' kurduni umbilikali mqassra u ta' varjazzjonijiet u malformazzjonijiet fil-vertebri, fil-kustilji, u fil-pelvi.
English: The majority of letermovir was biliary excreted as unchanged parent with a minor amount (6% of dose) as an acyl-glucuronide metabolite in faeces.
Maltese: Il-maġġoranza ta' letermovir ġie eliminat b'mod biljari bħala wieħed oriġinarju mhux mibdul b'ammont żgħir (6% tad-doża) bħala metabolit acyl-glucuronide fl-ippurgar.
English: Administration of PREVYMIS may result in a clinically relevant decrease in plasma concentrations of co-administered medicinal products that are significantly transported by P-gp in the intestine such as dabigatran and sofosbuvir.
Maltese: L-għoti ta' PREVYMIS jista' jirriżulta fi tnaqqis klinikament relevanti tal-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali mogħtija flimkien li jiġu ttrasportati b'mod sinifikanti minn P-gp fil-musrana bħal dabigatran u sofosbuvir.
English: PREVYMIS 480 mg concentrate for solution for infusion Each vial contains 480 mg (24 mL per vial) of letermovir.
Maltese: PREVYMIS 480 mg konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 480 mg (24 mL għal kull kunjett) ta' letermovir.
English: PREVYMIS 480 mg sterile concentrate letermovir
Maltese: U MNEJN GĦANDU JINGĦATA PREVYMIS 480 mg konċentrat sterili letermovir
English: If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily (see sections 4.5 and 5.2).
Maltese: Jekk PREVYMIS jingħata flimkien ma' cyclosporine, id-dożaġġ ta' PREVYMIS għandu jitnaqqas għal 240 mg darba kuljum (ara sezzjonijiet 4.5 u 5.2).
English: • cyclosporine, tacrolimus, sirolimus - used to prevent transplant rejection
Maltese: • cyclosporine, tacrolimus, sirolimus - jintużaw biex jipprevjenu r-rifjut tat-trapjant
English: Therapeutic drug monitoring (TDM) is therefore recommended for voriconazole.
Maltese: Għalhekk huwa rakkomandat monitoraġġ tal-mediċina terapewtika (TDM, therapeutic drug monitoring) għal voriconazole.
English: This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.15 % tat-teħid tad-dieta ta' kuljum massimu rakkomandat ta' sodju għal adult.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħżin wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: (OATP1B1/3 and/or P-gp inhibition)
Maltese: (Inibizzjoni ta' OATP1B1/3 u/jew ta' P-gp)
English: This is equivalent to 2.30% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.30 % tat-teħid tad-dieta ta' kuljum massimu rakkomandat ta' sodju għal adult.
English: Sedatives midazolam (1 mg single dose IV)/ letermovir (240 mg once daily PO)
Maltese: Sedattivi midazolam (doża waħda ta' 1 mg IV)/ letermovir (240 mg darba kuljum PO)
English: Bioavailability of letermovir was estimated to be approximately 85% with 240 mg once daily oral letermovir co-administered with cyclosporine in patients.
Maltese: II-bijodisponibbiltà ta' letermovir ġiet stmata li kienet madwar 85 % b'240 mg letermovir orali darba kuljum mogħti flimkien ma' cyclosporine fil-pazjenti.
English: tacrolimus (5 mg single dose)/ letermovir (480 mg daily)
Maltese: tacrolimus (doża waħda ta' 5 mg)/letermovir (480 mg kuljum)
English: In a Phase 2b trial evaluating letermovir doses of 60, 120, or 240 mg/day or placebo for up to 84 days in 131 HSCT recipients, DNA sequence analysis of a select region of UL56 (amino acids 231 to 369) was performed on samples obtained from 12 letermovir-treated subjects who experienced prophylaxis failure and for whom samples were available for analysis.
Maltese: Fi prova ta' Fażi 2b li tevalwa dożi ta' letermovir ta' 60, 120, jew 240 mg/jum jew tal-plaċebo sa 84 jum f'131 riċevitur tal-HSCT, saret analiżi ta' sekwenza tad-DNA ta' reġjun magħżul ta' UL56 (amminoaċidi 231 sa 369) fuq kampjuni miksubin minn 12-il individwu kkurati b'letermovir li esperjenzaw insuffiċjenza tal-profilassi u li għalihom kien hemm kampjuni disponibbli għall-analiżi.
English: Refer to the respective prescribing information.
Maltese: #Irreferi għall-informazzjoni ta' preskrizzjoni rispettiva.
English: PREVYMIS 240 mg concentrate for solution for infusion Each vial contains 240 mg (12 mL per vial) of letermovir.
Maltese: PREVYMIS 240 mg konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 240 mg (12 mL għal kull kunjett) ta' letermovir.
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjoni terapewtiċi
English: Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin.
Maltese: Kull doża ta' 240 mg (kunjett ta' 12 mL) ta' din il-mediċina fiha 1,800 mg cyclodextrin.
English: Each film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
Maltese: Kull pillola miksija b'rita fiha 240 mg letermovir jew 480 mg letermovir.
English: Normally, CMV just stays in their body and it does not hurt them.
Maltese: Normalment, CMV sempliċiment jibqa' fil-ġisem u ma jagħmillhomx uġigħ.
English: • feeling like you are spinning (vertigo)
Maltese: • tħossok iddur (vertigo)
English: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 33.2% higher in Asians compared to Whites.
Maltese: Abbażi ta' analiżijiet farmakokinetiċi tal-popolazzjoni, l-AUC ta' letermovir hija stmata li hi 33.2 % ogħla fl-Asjatiċi meta mqabbla mal-Bojod.
English: In HSCT recipients, bioavailability of letermovir was estimated to be approximately 35% with 480 mg once daily oral letermovir administered without cyclosporine.
Maltese: F'riċevituri ta' HSCT, il-bijodisponibbiltà ta' letermovir ġiet stmata li kienet madwar 35 % b'480 mg letermovir orali darba kuljum mogħti mingħajr cyclosporine.
English: If letermovir is co-administered with cyclosporine, the recommended dose of letermovir is 240 mg once daily (see section 4.2).
Maltese: Jekk cyclosporine jingħata flimkien ma' cyclosporine, id-doża rakkomandata ta' cyclosporine hija ta' 240 mg darba kuljum (ara sezzjoni 4.2).
English: Posology PREVYMIS is also available for oral administration (240 mg and 480 mg film-coated tablets).
Maltese: PREVYMIS jiġi wkoll għal għoti orali (240 mg u 480 mg pilloli miksijin b'rita).
English: PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 5.2).
Maltese: PREVYMIS mhuwiex rakkomandat f'pazjenti b'indeboliment tal-fwied moderat ikkombinat ma' indeboliment tal-kliewi moderat jew sever (ara sezzjoni 5.2).
English: -An example of a medicinal product which is mainly eliminated by CYP2C8 is repaglinide (see Table 1).
Maltese: -Eżempju ta' prodott mediċinali li jiġi eliminat prinċipalment minn CYP2C8 huwa, repaglinide (ara Tabella 1).
English: • alfentanil - for severe pain
Maltese: • alfentanil - għal uġigħ sever
English: The acyl-glucuronide is unstable in faeces.
Maltese: L-acylglucuronide mhuwiex stabbli fl-ippurgar.
English: If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily (see sections 4.2 and 5.1).
Maltese: Jekk PREVYMIS jingħata flimkien ma' cyclosporine, id-dożaġġ ta' PREVYMIS għandu jitnaqqas għal 240 mg darba kujum (ara sezzjonijiet 4.2, u 5.1).
English: -Examples of strong inducers include rifampicin, phenytoin, carbamazepine, St. John´s wort (Hypericum perforatum), rifabutin and phenobarbital.
Maltese: -Eżempji ta' indutturi b'saħħithom jinkludu rifampicin, phenytoin, carbamazepine, St.
English: Each 480 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Maltese: Kull 480 mg pillola miksija b'rita fiha inqas minn 1 mmol sodju (23 mg).
English: In male rats, reduced sperm concentration, reduced sperm motility, and decreased fertility were observed at systemic exposures ≥ 3-fold the AUC in humans at the RHD (see General toxicology).
Maltese: Fil-firien irġiel, ġew innutati konċentrazzjoni tal-isperma mnaqqsa, motilità tal-isperma mnaqqsa, u fertilità mnaqqsa b'esponimenti sistemiċi ≥3 darbiet l-AUC filbnedmin bl-RHD (ara Tossikoloġija ġenerali).
English: Table 1 provides a listing of established or potentially clinically significant medicinal product interactions.
Maltese: Tabella 1 tipprovdi elenkar ta' interazzjonijiet bejn prodotti mediċinali stabbiliti jew oħrajn potenzjalment klinikament sinifikanti.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of letermovir in milk (see section 5.3).
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' letermovir fil-ħalib tas-sider (ara sezzjoni 5.3).
English: 480 mg Oral, no cyclosporine
Maltese: 480 mg Orali, l-ebda cyclosporine
English: Co-administration of PREVYMIS and nevirapine is not recommended.
Maltese: L-għoti konkomitanti ta' PREVYMIS u nevirapine mhuwiex rakkomandat.
English: In order to optimise the sterility assurance level (SAL) of the manufacturing process, the marketing authorisation holder should implement the measures outlined in the Post Approval Change Management Protocol (PACMP) agreed with the CHMP concerning development, validation and introduction of terminal sterilisation.
Maltese: Sabiex jiġi ottimizzat l-livell ta' assigurazzjoni ta' sterilità (SAL, sterility assurance level) tal-proċess ta' manifattura, id-detentur tal-awtorizzazzjoni għattqegħid fis-suq għandu jimplimenta l-miżuri deskritti fil-Protokoll tal-Ġestjoni tat-Tibdil wara l-Approvazzjoni (PACMP, Post Approval Change Management
English: PREVYMIS 240 mg film-coated tablet is a yellow oval tablet, debossed with “591” on one side and MSD logo on the other side.
Maltese: PREVYMIS 240 mg pillola miksija b'rita hija pillola safra, ovali mnaqqxa b'“591” fuq naħa waħda u l-logo MSD fuq in-naħa l-oħra.
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI PREVYMIS 240 mg pilloli miksijin b'rita PREVYMIS 480 mg pilloli miksijin b'rita
English: General disorders and administration site conditions Uncommon fatigue, oedema peripheral
Maltese: Disturbi ġenerali u kondizzjonijiet ta''mnejn jingħata Mhux komuni għeja, edema periferali
English: In vitro data indicate that letermovir is an inhibitor of OAT3; therefore, letemovir may be an OAT3 inhibitor in vivo.
Maltese: Prodotti mediċinali ttrasportati mit-trasportatur tal-kliewi OAT3 Dejta in vitro tindika li letermovir huwa inibitur ta' OAT3; għalhekk, letermovir jista' jkun inibitur ta' OAT3 in vivo.
English: Approach to handling missing values: Non-Completer=Failure (NC=F) approach.
Maltese: Approċċ biex jiġu mmaniġġjati valuri neqsin: Approċċ MaLestiex=Falliment (NC=F).
English: Subjects received CMV DNA monitoring weekly until post-transplant week 14 and then bi-weekly until post-transplant week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV DNAemia was considered clinically significant.
Maltese: L-individwi rċivew monitoraġġ tad-DNA tas-CMV kull ġimgħa sa ġimgħa 14 wara t-trapjant imbagħad kull ġimagħtejn sa ġimgħa 24 wara t-trapjant, bil-bidu ta' terapija preventiva għas-CMV standard ta' kura jekk DNAemia b'CMV ġiet ikkunsidrata klinikament sinifikanti.
English: Subjects were monitored through Week 24 post-transplant for the primary efficacy endpoint with continued follow-up through Week 48 post-transplant.
Maltese: L-individwi ġew immonitorjati matul Ġimgħa 24 wara ttrapjant għall-end-point tal-effikaċja primarju b'segwitu li kompla matul Ġimgħa 48 wara t-trapjant.
English: Effect of cyclosporine
Maltese: L-effett ta' cyclosporine
English: No maternal or developmental effects were noted at the dose of 50 mg/kg/day (approximately 2.5-fold the AUC at the RHD).
Maltese: Ma ġie nnutat l-ebda effett matern jew fuq liżvilupp bid-doża ta' 50 mg/kg/jum (madwar 2.5 darbiet l-AUC bl-RHD).
English: Note that the table is not extensive but provides examples of clinically relevant interactions.
Maltese: Innota li t-tabella ma tinkludix kollox iżda tipprovdi eżempji ta' interazzjonijiet klinikament relevanti.
English: (OATP1B1/3 inhibition)
Maltese: (inibizzjoni ta' OATP1B1/3)
English: Each 12 mL vial contains 240 mg letermovir.
Maltese: Kull kunjett ta' 12 mL fih 240 mg ta' letermovir.
English: The primary efficacy endpoint of clinically significant CMV infection in P001 was defined by the incidence of CMV DNAemia warranting anti-CMV pre-emptive therapy (PET) or the occurrence of CMV end-organ disease.
Maltese: L-end-point tal-effikaċja primarju ta' infezzjoni b'CMV klinikament sinifikanti f'P001 ġie definit skont l-inċidenza ta' DNAemia b'CMV li tippermetti terapija preventiva (PET, pre-emptive therapy) għal kontra s-CMV jew l-okkorrenza ta' marda tal-organu tal-aħħar stadju b'CMV.
English: The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see section 5.1).
Maltese: Il-valutazzjoni tas-sigurtà ta' PREVYMIS ġiet ibbażata fuq prova ta' Fażi 3, klinika (P001) f'riċevituri ta' HSCT li rċivew PREVYMIS jew il-plaċebo matul Ġimgħa 14 wara t-trapjant u li ġew segwiti għas-sigurtà matul Ġimgħa 24 wara t-trapjant (ara sezzjoni 5.1).
English: Each 480 mg film-coated tablet contains 6.4 mg of lactose (as monohydrate).
Maltese: Kull 480 mg pillola miksija b'rita fiha 6.4 mg ta' lattożju (bħala monoidrat).
English: (600 mg single dose IV)/ letermovir (480 mg single dose PO)
Maltese: (doża unika ta' 600 mg IV)/ letermovir (doża unika ta' 480 mg millħalq)
English: Compatible intravenous bags and infusion set materials PREVYMIS is compatible with the following intravenous bags and infusion set materials.
Maltese: PREVYMIS huwa kompatibbli mal-boroż intravenużi u materjali tas-sett tal-infużjoni li ġejjin.
English: Pink oval, bi-convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and MSD logo on the other side.
Maltese: Pillola roża, ovali, bikonvessa b'dimensjonijiet ta' 21.2 mm x 10.
English: Inducers of drug metabolizing enzymes or transporters Co-administration of PREVYMIS (with or without cyclosporine) with strong and moderate inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended, as it may lead to subtherapeutic letermovir exposure (see Table 1).
Maltese: Indutturi ta' enzimi jew trasportaturi li jimmetabolizzaw il-mediċina L-għoti flimkien ta' PREVYMIS (bi jew mingħajr cyclosporine) ma' indutturi b'saħħithom u moderati ta' trasportaturi (eż. P-gp) u/jew ta' enzimi (eż. UGTs) mhuwiex rrakkomandat, għaliex jista' jwassal għal esponiment sottoterapewtiku għal letermovir (ara Tabella 1).
English: o pimozide - used for Tourette's syndrome o ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
Maltese: • tieħu xi waħda minn dawn il-mediċini: o pimozide - jintuża għas-sindrome ta' Tourette o alkalojdi u ergot (bħal ergotamine u dihydroergotamine) - jintużaw għal uġigħ ta' ras ta' migranja.
English: Do not shake PREVYMIS vial.
Maltese: L-użu konkomitanti mhuwiex bi PREVYMIS waħdu.
English: Other medicines and PREVYMIS
Maltese: Mediċini oħra u PREVYMIS
English: With NC=F approach, failure was defined as all subjects with clinically significant CMV infection or who prematurely discontinued from the study or had a missing outcome through Week 24 post-transplant visit window.
Maltese: Bl-approċċ NC=F, il-falliment ġie definit bħala l-individwi kollha b'infezzjoni b'CMV klinikament sinifikanti jew li b'mod prematur waqfu mill-istudju jew li kellhom riżultat nieqes matul Ġimgħa 24 fiż-żmien tal-visti wara t-trapjant.
English: The magnitude of the OATP1B1/3 inhibition on co-administered medicinal products is likely greater when PREVYMIS is co-administered with cyclosporine (a potent OATP1B1/3 inhibitor).
Maltese: Id-daqs tal-inibizzjoni ta' OATP1B1/3 fuq prodotti mediċinali mogħtija flimkien aktarx huwa akbar meta PREVYMIS jingħata flimkien ma' cyclosporine (inibitur qawwi ta' OATP1B1/3).
English: Letermovir may increase or decrease the plasma concentrations of repaglinide.
Maltese: Letermovir jista' jżid jew inaqqas ilkonċentrazzjonijiet fil-plażma ta' repaglinide.
English: • glyburide, repaglinide - for high blood sugar
Maltese: • glyburide, repaglinide - għal zokkor għoli fid-demm
English: In a Phase 3 trial (P001), DNA sequence analysis of the entire coding regions of UL56 and UL89 was performed on samples obtained from 22 letermovir-treated subjects, in the FAS population who experienced prophylaxis failure and for whom samples were available for analysis.
Maltese: Fi prova ta' Fażi 3 (P001), saret analiżi ta' sekwenza tad-DNA ta' reġjuni ta' kkowdjar sħaħ ta' UL56 u UL89 fuq kampjuni miksubin minn 22 individwu kkurati b'letermovir, fil-popolazzjoni FAS li esperjenzaw insuffiċjenza tal-profilassi u li għalihom kien hemm kampjuni disponibbli għall-analiżi.
English: Other systemically acting oral contraceptive steroids
Maltese: Riskju ta' ↓ sterojdi kontraċettivi
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza għallgalattożju, id-defiċjenza tal-lattażi Lapp, jew malassorbiment tal-glukożju-galattożju ma għandhomx jieħdu dan il-prodott mediċinali.
English: Differences in exposure across treatment regimens are not clinically relevant; efficacy was consistent across the range of exposures observed in P001.
Maltese: Id-differenzi fl-esponiment fir-reġimens ta' kura mhumiex klinikament relevanti; l-effikaċja kienet konsistenti fil-medda ta' esponimenti osservati f'P001.
English: • Tigecycline *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Maltese: Fentanyl citrate *Irreferi għall-informazzjoni dwar il-preskrizzjoni biex tikkonferma l-kompatibbiltà ta' għoti flimkien simultanju.
English: Viral resistance
Maltese: Reżistenza virali
English: Infusion set materials
Maltese: Materjali tas-sett tal-infużjoni
English: (600 mg once daily PO (24 hours after rifampicin)) letermovir (480 mg once daily PO)
Maltese: (600 mg darba kuljum mill-ħalq (24 siegħa wara rifampicin)§/ letermovir (480 mg darba kuljum mill-ħalq)
English: • fentanyl - for severe pain
Maltese: • fentanyl - għal uġigħ sever
English: Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.
Maltese: L-għoti flimkien ta' letermovir ma' prodotti mediċinali oħra li huma inibituri ta' trasportaturi ta' OATP1B1/3 jista' jirriżulta f'żidiet fil-konċentrazzjonijiet fil-plażma ta' letermovir.
English: Concentrate for solution for infusion 1 vial
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1
English: • If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
Maltese: • Jekk jitwaqqaf cyclosporine wara l-bidu ta' PREVYMIS, id-doża li jmiss ta' PREVYMIS għandha tiżdied għal 480 mg darba kuljum.
English: Type I (30 mL) clear glass vial with a 20 mm fluorocoated chlorobutyl stopper with aluminium flip-off cap containing 12 mL(medium green cap) or 24 mL (dark blue cap) of solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ ċar tat-tip I (30 mL) b'tapp tal-chlorobutyl fluworokat ta' 20 mm b'tapp tat-tip flipoff tal-aluminju li fih 12 mL (tapp aħdar medju) jew 24 mL (tap blu skur) ta' soluzzjoni.
English: How to take PREVYMIS
Maltese: X'fih PREVYMIS
English: The entire contents of the IV bag should be administered.
Maltese: Agħti l-kontenut kollu tal borża IV.