FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika, a ne smiju trajati dulje od 24 sata na temperaturi od 2°C do 8°C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Effect of cyclosporine
Croatian: Učinak ciklosporina
English: This difference is not clinically relevant.
Croatian: Ova razlika nije klinički značajna.
English: PREVYMIS may be started before or after engraftment.
Croatian: PREVYMIS se može uvesti prije ili nakon prihvaćanja presatka (engl. engraftment).
English: The safety and efficacy of letermovir use for more than 100 days has not been studied in clinical trials.
Croatian: Sigurnost i djelotvornost primjene letermovira tijekom više od 100 dana nisu se ispitivale u kliničkim ispitivanjima.
English: The time needed to reach steady state of a specific affected medicinal product will also influence the time needed to reach full effect on the plasma concentrations.
Croatian: Vrijeme potrebno da konkretan zahvaćeni lijek postigne stanje dinamičke ravnoteže također će utjecati na vrijeme potrebno za postizanje punog učinka na koncentracije u plazmi.
English: • Amphotericin B (lipid complex)
Croatian: • amfotericin B (lipidni kompleks)
English: The preparation and administration instructions are the same for either dose.
Croatian: Upute za pripremu i primjenu jednake su za obje doze.
English: If you are also taking a medicine for high cholesterol (see list of medicines in section “Other medicines and PREVYMIS” below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever.
Croatian: Ako uzimate i lijek za povišen kolesterol (pogledajte popis lijekova u dijelu 'Drugi lijekovi i PREVYMIS' u nastavku), morate odmah obavijestiti svog liječnika ako osjetite bol u mišićima nepoznatog uzroka, a osobito ako se ne osjećate dobro ili imate vrućicu.
English: Dose adjustment of midazolam should be considered
Croatian: Treba razmotriti prilagodbu doze midazolama
English: For adequate contraceptive effect to be ensured with an oral contraceptive, products containing EE and LNG should be chosen.
Croatian: Kako bi se osigurao odgovarajući kontracepcijski učinak oralnog kontraceptiva, treba odabrati lijekove koji sadrže EE i LNG.
English: Development
Croatian: Razvoj
English: Monitoring of CMV DNA
Croatian: Praćenje CMV DNK
English: There is a theoretical risk of reduced exposure due to induction but the size of the effect and thus clinical relevance is presently unknown.
Croatian: Postoji teoretski rizik od smanjene izloženosti zbog indukcijskog učinka, no veličina tog učinka trenutno nije poznata, a time ni njegov klinički značaj.
English: The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka PREVYMIS u bolesnika mlađih od 18 godina nisu ustanovljene.
English: There are some medicines you must not take with PREVYMIS.
Croatian: Postoje određeni lijekovi koje ne smijete uzimati zajedno s lijekom PREVYMIS.
English: The tablets shall be swallowed whole with some water.
Croatian: Tablete treba progutati cijele, s malo vode.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AX18
Croatian: Farmakoterapijska skupina: Antivirotici za sustavnu primjenu, antivirotici koji djeluju direktno, ATK oznaka: J05AX18
English: There were no effects on female fertility in rats.
Croatian: Nije bilo učinaka na plodnost ženki štakora.
English: Letermovir may be administered orally with or without food as has been done in the clinical studies (see section 4.2).
Croatian: Letermovir se peroralno može uzimati s hranom ili bez nje, kako se uzimao u kliničkim ispitivanjima (vidjeti dio 4.2).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PREVYMIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili obustaviti/privremeno prekinuti primjena lijeka PREVYMIS, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Weeks Post-Transplant
Croatian: Tjedni nakon presađivanja
English: Cyclosporin A (n=162, 90)
Croatian: Ciklosporin A (n=162, 90)
English: When ending treatment, it takes 10-14 days for the inhibitory effect to disappear.
Croatian: Pri završetku liječenja potrebno je 10 - 14 dana za prestanak inhibicijskog učinka.
English: The relevance to humans is unknown.
Croatian: Značaj ovoga za ljude nije poznat.
English: These data are the effect of rifampicin on letermovir 24 hours after final rifampicin dose.
Croatian: Ovi su podaci učinak rifampicina na letermovir 24 sata nakon posljednje doze rifampicina.
English: Polyamide/Aluminium/PVC - Aluminium blister cards.
Croatian: Poliamidna/aluminijska/PVC - aluminijska blister kartica.
English: Antibiotics nafcillin
Croatian: Antibiotici nafcilin
English: No (n=276, 153)
Croatian: Ne (n=276, 153)
English: • changes in taste
Croatian: • promjene osjeta okusa
English: Manufacturer Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Belgium
Croatian: Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Belgija
English: Do not stop taking PREVYMIS without talking to your doctor first.
Croatian: Nemojte prestati uzimati PREVYMIS bez prethodnog razgovora sa svojim liječnikom.
English: Yes (n=49, 17)
Croatian: Da (n=49, 17)
English: The most common primary reasons for transplant were acute myeloid leukemia (38%), myeloblastic syndrome (15%), and lymphoma (13%).
Croatian: Najčešći primarni razlozi za transplantaciju bili su akutna mijeloična leukemija (38%), mijeloblastični sindrom (15%) i limfom (13%).
English: Monitoring is also recommended if changing route of administration.
Croatian: Praćenje se preporučuje i kada se mijenja put primjene.
English: However, Amphotericin B (liposomal) is incompatible (see section 6.2).
Croatian: Međutim, amfotericin B (liposomski) nije kompatibilan (vidjeti dio 6.2).
English: • allergic reaction (hypersensitivity) - the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling.
Croatian: • alergijska reakcija (preosjetljivost) - znakovi mogu uključivati piskanje pri disanju, otežano disanje, osip ili koprivnjaču, svrbež, oticanje
English: Letermovir - Placebo Difference (%) and 95% C.I.
Croatian: Razlika letermovir - placebo (%) i 95% CI
English: Do not shake.
Croatian: Nemojte je tresti.
English: Risk stratum
Croatian: Stratum rizika
English: Do not stop taking PREVYMIS
Croatian: Nemojte prestati uzimati PREVYMIS
English: The estimated treatment difference of -23.5% was statistically significant (one-sided p-value <0.0001).
Croatian: Procijenjena razlika između liječenja od -23,5% bila je statistički značajna (jednostrana p-vrijednost < 0,0001).
English: Reduced intensity conditioning (n=86, 48)
Croatian: Kondicioniranje smanjenog intenziteta (n=86, 48)
English: The tablet is 21.2 mm long and 10.3 mm wide.
Croatian: Tableta je duga 21,2 mm i široka 10,3 mm.
English: Additional monitoring may be recommended; refer to the prescribing information for such medicinal products.
Croatian: Može se preporučiti dodatno praćenje; vidjeti informacije o lijeku za te lijekove.
English: For additional information, see section 4.2.
Croatian: Za dodatne informacije vidjeti dio 4.2.
English: PREVYMIS should be started after HSCT.
Croatian: Liječenje lijekom PREVYMIS treba započeti nakon HSCT-a.
English: High Risk (n=102, 45) Low Risk (n=223, 125)
Croatian: Visok rizik (n=102, 45) Nizak rizik (n=223, 125)
English: You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS.
Croatian: Možete zamoliti liječnika ili ljekarnika da Vam daju popis lijekova koji bi mogli ući u interakciju s lijekom PREVYMIS.
English: Among the 565 treated subjects, 373 subjects received letermovir (including 99 subjects who received at least one IV dose) and 192 received placebo (including 48 subjects who received at least one IV dose).
Croatian: Od 565 liječenih ispitanika njih 373 primala su letermovir (uključujući 99 ispitanika koji su primili najmanje jednu i.v. dozu), dok je njih 192 primalo placebo (uključujući 48 ispitanika koji su primili najmanje jednu i.v. dozu).
English: These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to letermovir.
Croatian: Ti inhibitori polimeraze DNK potpuno su aktivni protiv virusnih populacija sa supstitucijama koje uzrokuju rezistenciju na letermovir.
English: Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.
Croatian: Vaš liječnik ili ljekarnik reći će Vam je li sigurno uzimati PREVYMIS s drugim lijekovima.
English: Letermovir vs Placebo Stratified log-rank test, two-sided p-value <0.0001
Croatian: Letermovir naspram placeba Stratificiran log-rang test, dvostrana p-vrijednost < 0,0001
English: The mutations map to UL56 and occur in amino acid residues between 231 and 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
Croatian: Mapiranje mutacija upućuje na gen UL56 i pokazuje da se one javljaju u aminokiselinskim ostacima između položaja 231 i 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
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.
Croatian: Procijenjena razlika (95% CI za razliku) iznosila je -26,1% (-45,9%, -6,3%), uz nominalnu jednostranu p-vrijednost < 0,0048.
English: Metabolism and nutrition disorders Uncommon decreased appetite
Croatian: Poremećaji metabolizma i prehrane Manje često smanjen apetit
English: How to take • Swallow the tablet whole with some water.
Croatian: Kako uzeti lijek • Tabletu progutajte cijelu, s malo vode.
English: No major metabolites are detected in plasma.
Croatian: U plazmi nisu pronađeni značajniji metaboliti.
English: Variations of colour within this range do not affect the quality of the product.
Croatian: Nijanse boje unutar tog raspona ne utječu na kvalitetu lijeka.
English: What PREVYMIS is and what it is used for
Croatian: Što je PREVYMIS i za što se koristi
English: If you forget to take PREVYMIS
Croatian: Ako ste zaboravili uzeti PREVYMIS
English: Clinical monitoring and dose adjustment may be needed.
Croatian: Možda će biti potrebno kliničko praćenje i prilagodba doze.
English: After oral administration of radio-labeled letermovir, 93.3% of radioactivity was recovered in faeces.
Croatian: Nakon peroralne primjene radioaktivno označenog letermovira, 93,3% radioaktivnosti pronađeno je u fecesu.
English: ↑ midazolam IV:
Croatian: ↑ midazolam i.v.:
English: Unless a particular enzyme or transporter is also inhibited (see below) induction can be expected.
Croatian: Osim ako ujedno ne inhibira određeni enzim ili prijenosnik (vidjeti u nastavku), može se očekivati indukcijski učinak.
English: Detailed information is presented below.
Croatian: Detaljnije informacije nalaze se u nastavku.
English: Unless otherwise specified, interaction studies have been performed with oral letermovir without cyclosporine.
Croatian: Osim ako nije drugačije navedeno, ispitivanja interakcija provedena su s oralnim letermovirom bez ciklosporina.
English: General toxicity
Croatian: Općenita toksičnost
English: However, if your immune system is weak after you get a bone marrow transplant, you may be at high risk of becoming ill from CMV.
Croatian: Međutim, ako Vam je imunološki sustav oslabljen nakon presađivanja koštane srži, postoji visok rizik da će CMV uzrokovati bolest.
English: When letermovir is combined with cyclosporine:
Croatian: Kada se letermovir primjenjuje u kombinaciji s ciklosporinom:
English: Due to time dependent inhibition and simultaneous induction the net enzyme inhibitory effect may not be reached until after 10-14 days.
Croatian: Zbog inhibicije ovisne o vremenu i istodobne indukcije, za postizanje neto inhibicijskog učinka na enzim može biti potrebno 10 - 14 dana.
English: Do not take PREVYMIS if any of the above apply to you.
Croatian: Nemojte uzimati PREVYMIS ako se nešto od navedenog odnosi na Vas.
English: Twelve percent (12%) of subjects were positive for CMV DNA at baseline.
Croatian: Dvanaest posto (12%) ispitanika bilo je pozitivno na CMV DNK na početku ispitivanja.
English: It is very important that you do not miss or skip doses of PREVYMIS.
Croatian: Vrlo je važno da ne propustite ili preskočite dozu lijeka PREVYMIS.
English: Urinary excretion of letermovir was negligible (<2% of dose).
Croatian: Izlučivanje letermovira mokraćom bilo je zanemarivo (< 2% doze).
English: • swelling of hands or feet
Croatian: • oticanje šaka i stopala.
English: The CMV genes UL56 and UL89 encode subunits of CMV DNA terminase.
Croatian: Geni CMV-a UL56 i UL89 kodiraju podjedinice terminaze CMV DNK.
English: This is because it has not been studied in pregnancy and it is not known if PREVYMIS will harm your baby while you are pregnant.
Croatian: Naime, PREVYMIS se nije ispitivao tijekom trudnoće, pa nije poznato hoće li naškoditi Vašem djetetu dok ste trudni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with PREVYMIS in one or more subsets of the paediatric population for prophylaxis of cytomegalovirus infection (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka PREVYMIS u jednoj ili više podskupina pedijatrijske populacije za profilaksu citomegalovirusne infekcije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials.
Croatian: Sljedeće su nuspojave zabilježene u bolesnika koji su primali PREVYMIS u kliničkim ispitivanjima.
English: Endothelin antagonists bosentan
Croatian: Antagonisti endotelina bosentan
English: • If cyclosporine dosing is temporarily interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
Croatian: • Ako se primjena ciklosporina privremeno prekine zbog visokih razina ciklosporina, nije potrebno prilagođavati dozu lijeka PREVYMIS.
English: Table 1: Interactions and dose recommendations with other medicinal products.
Croatian: Tablica 1: Interakcije i preporuke za doziranje kod primjene s drugim lijekovima.
English: NC=F, Non-Completer=Failure.
Croatian: NC=F, prerani prekid=neuspješno liječenje.
English: The tablet should not be divided, crushed, or chewed.
Croatian: Tableta se ne smije lomiti, drobiti ni žvakati.
English: The active substance is letermovir.
Croatian: Djelatna tvar je letermovir.
English: PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary.
Croatian: PREVYMIS tablete i koncentrat za otopinu za infuziju mogu se međusobno zamjenjivati prema odluci liječnika, bez potrebe za prilagođavanjem doze.
English: It is unknown whether letermovir may affect the exposure of piperacillin/tazobactam, amphotericine B and micafungin.
Croatian: Nije poznato može li letermovir utjecati na izloženost piperacilinu/tazobaktamu, amfotericinu B i mikafunginu.
English: This is because your doctor may have to change your medicines or change the dose of your medicines:
Croatian: Naime, liječnik će možda morati promijeniti te lijekove ili prilagoditi njihovu dozu:
English: Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
Croatian: Profilaksa letermovirom dulja od 100 dana zahtijeva pažljivu ocjenu omjera koristi i rizika.
English: n (%) = Number (percent) of subjects in each sub-category.
Croatian: N = broj ispitanika u svakoj liječenoj skupini. n (%) = broj (postotak) ispitanika u svakoj podskupini.
English: Close monitoring and/or dose adjustment of co-administered CYP3A substrates is recommended (see section 4.5).
Croatian: Preporučuje se pažljivo praćenje i/ili prilagodba doze istodobno primijenjenih supstrata CYP3A (vidjeti dio 4.5).
English: Note that the table is not extensive but provides examples of clinically relevant interactions.
Croatian: Treba napomenuti da tablica ne uključuje sve moguće interakcije, već daje primjere klinički značajnih interakcija.
English: 95% CIs and p-value for the treatment differences in percent response were calculated using stratumadjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (high or low risk).
Croatian: 95% CI i p-vrijednosti za razlike između liječenja s obzirom na postotni odgovor izračunate su Mantel-Haenszelovom metodom prilagođenom za stratum, pri čemu je razlika ponderirana prema harmoničnoj srednjoj vrijednosti veličine uzorka po skupini za svaki stratum (visok ili nizak rizik).
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 33.2% higher in Asians compared to Whites.
Croatian: Prema populacijskim farmakokinetičkim analizama, procjenjuje se da je AUC letermovira 33,2% viši u Azijaca nego u bijelaca.
English: The tablet is 16.5 mm long and 8.5 mm wide.
Croatian: Tableta je duga 16,5 mm i široka 8,5 mm.
English: Incompatible medicinal products
Croatian: Inkompatibilni lijekovi
English: * Population post-hoc predictions from the population PK analysis using Phase 3 data
Croatian: *Populacijska post-hoc predviđanja iz populacijske farmakokinetičke analize, na temelju podataka iz ispitivanja faze 3
English: Inhibitors of P-gp/BCRP
Croatian: Inhibitori P-gp-a/BCRP-a
English: The acyl-glucuronide is unstable in faeces.
Croatian: Acil-glukuronid je nestabilan u fecesu.
English: In vitro data indicate that letermovir is an inhibitor of OAT3; therefore, letemovir may be an OAT3 inhibitor in vivo.
Croatian: Podaci in vitro pokazuju da je letermovir inhibitor OAT3; stoga bi letermovir mogao biti inhibitor OAT3 in vivo.
English: Dosage adjustment
Croatian: Prilagodba doze
English: • significant decrease of concomitant medicinal product plasma concentrations which may lead to reduced therapeutic effect of the concomitant medicinal product.
Croatian: • značajan pad koncentracija istodobno primijenjenih lijekova u plazmi, što može smanjiti terapijski učinak istodobno primijenjenih lijekova.
English: No dose adjustment is required based on age.
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob.
English: Medicinal products mainly eliminated through metabolism or influenced by active transport Letermovir is a general inducer in vivo of enzymes and transporters.
Croatian: Lijekovi koji se uglavnom eliminiraju metabolizmom ili na koje utječe aktivan prijenos Letermovir je općenito induktor enzima i prijenosnika in vivo.
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).
Croatian: Produljena profilaksa letermovirom tijekom više od 100 dana nakon transplantacije mogla bi koristiti nekim bolesnicima u kojih postoji visok rizik od kasne reaktivacije CMV-a (vidjeti dio 5.1).
English: Number of Subjects at Risk Letermovir
Croatian: Broj ispitanika pod rizikom Letermovir
English: This is because PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works.
Croatian: Naime, PREVYMIS može utjecati na način na koji drugi lijekovi djeluju, a i drugi lijekovi mogu utjecati na način na koji PREVYMIS djeluje.
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.
Croatian: Medijan dobi iznosio je 54 godine (raspon: 18 - 78 godina), a 56 (15,0%) ispitanika bilo je u dobi od 65 ili više godina; 58% ispitanika bili su muškarci: 82% ispitanika bili su bijelci, 10% Azijci, 2% crnci ili afričkog podrijetla, dok je njih 7% bilo hispanskog ili latinoameričkog podrijetla.
English: Prophylaxis with PREVYMIS should continue through 100 days post-transplant.
Croatian: Profilaksu lijekom PREVYMIS treba nastaviti tijekom 100 dana nakon transplantacije.
English: Differences in exposure across treatment regimens are not clinically relevant; efficacy was consistent across the range of exposures observed in P001.
Croatian: Razlike u izloženosti kod različitih režima liječenja nisu klinički značajne; djelotvornost je bila postojana kroz cijeli raspon razina izloženosti opažen u ispitivanju P001.
English: The increase in midazolam plasma concentration may be greater when oral midazolam is administered with letermovir at the clinical dose than with the dose studied.
Croatian: Porast koncentracija midazolama u plazmi može biti veći kada se oralni midazolam primjenjuje zajedno s letermovirom u kliničkoj dozi nego u dozi koja se ispitivala.
English: Antiepileptic medicinal products (see also general text) carbamazepine, phenobarbital
Croatian: Antiepileptici (vidjeti i tekst s općim informacijama) karbamazepin, fenobarbital
English: • amiodarone - used to correct irregular heartbeats
Croatian: • amiodaron - koristi se za liječenje nepravilnih otkucaja srca
English: • midazolam - used as a sedative
Croatian: • midazolam - koristi se kao sredstvo za smirenje (sedativ)
English: Letermovir is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors (ganciclovir, cidofovir, and foscarnet).
Croatian: Letermovir je potpuno aktivan protiv virusnih populacija sa supstitucijama koje uzrokuju rezistenciju na inhibitore polimeraze CMV DNK (ganciklovir, cidofovir i foskarnet).
English: PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant.
Croatian: Liječenje lijekom PREVYMIS može započeti na dan transplantacije, a najkasnije 28 dana nakon transplantacije.
English: Your medicine or dose may then need to be changed.
Croatian: Možda će tada biti potrebno promijeniti lijek ili dozu.
English: • Compatible medicinal products are listed below.
Croatian: • U nastavku su navedeni kompatibilni lijekovi.
English: HIV antivirals (ritonavir, lopinavir)
Croatian: antivirusni lijekovi protiv HIV-a (ritonavir, lopinavir)
English: Primary efficacy endpoint (Proportion of subjects who failed prophylaxis by Week 24)
Croatian: Primarna mjera ishoda za djelotvornost (Udio ispitanika u kojih je profilaksa bila neuspješna do 24. tjedna)
English: Letermovir also appears to be subject to P-gp and BCRP mediated efflux in the liver and intestine (see section 5.2).
Croatian: Čini se da letermovir podliježe i efluksu posredovanom P-gp-om i BCRP-om u jetri i crijevima (vidjeti dio 5.2).
English: The net effect in vivo is unknown.
Croatian: Neto učinak in vivo nije poznat.
English: In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja preporučuje se nadzirati bolesnika zbog moguće pojave nuspojava te uvesti odgovarajuće simptomatsko liječenje.
English: In patients in whom letermovir prophylaxis was initiated and the baseline CMV DNA test was subsequently found to be positive, prophylaxis could be continued if PET criteria had not been met (see section 5.1).
Croatian: U bolesnika kojima je uvedena profilaksa letermovirom, a naknadno je utvrđeno da im je nalaz početnog testa na CMV DNK bio pozitivan, profilaksa se mogla nastaviti ako nisu bili ispunjeni kriteriji za PET (vidjeti dio 5.1).
English: The inter-individual variability for bioavailability was estimated to be approximately
Croatian: Procijenjena interindividualna varijabilnost bioraspoloživosti iznosila je približno 37%.