FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects had continued follow-up through Week 48 post-transplant.
Croatian: Ispitanike se nastavilo pratiti do 48. tjedna nakon transplantacije.
English: -An example of a medicinal product which is mainly eliminated by CYP2C8 is repaglinide (see Table 1).
Croatian: - Primjer lijeka koji se uglavnom eliminira putem CYP2C8 je repaglinid (vidjeti Tablicu 1).
English: You should not be given PREVYMIS if any of the above apply to you.
Croatian: Ne smijete primiti PREVYMIS ako se nešto od navedenog odnosi na Vas.
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).
Croatian: Letermovir može povisiti koncentracije u plazmi lijekova koje prenosi OATP1B1/3, kao što su mnogi statini (vidjeti dio 4.5 i Tablicu 1).
English: Expected: ↓ pantoprazole
Croatian: Očekivano: ↓ pantoprazol
English: Therefore, letermovir may potentially lead to decreased plasma exposure and possibly reduced efficacy of co-administered medicinal products that are mainly eliminated through metabolism or by active transport.
Croatian: Stoga letermovir može smanjiti izloženost u plazmi i potencijalno smanjiti djelotvornost istodobno primijenjenih lijekova koji se uglavnom eliminiraju metabolizmom ili aktivnim prijenosom.
English: Reproduction
Croatian: Reprodukcija
English: *This table is not all inclusive.
Croatian: *Tablica ne uključuje sve moguće interakcije.
English: • abnormalities in laboratory tests of liver function
Croatian: • odstupanja u nalazima laboratorijskih pretraga kojima se ocjenjuje funkcija jetre
English: A dose adjustment may also be needed when changing route of administration or immunosuppressant.
Croatian: Prilagodba doze možda će biti potrebna i kod promjene puta primjene ili promjene imunosupresiva.
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%).
Croatian: Najčešće prijavljene nuspojave koje su dovele do prekida primjene lijeka PREVYMIS bile su mučnina (1,6%), povraćanje (0,8%) i bol u abdomenu (0,5%).
English: o pimozide - used for Tourette's syndrome o ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
Croatian: o pimozid - koristi se za liječenje Tourettova sindroma o ergot alkaloide (kao što su ergotamin i dihidroergotamin) - koriste se za liječenje migrenskih glavobolja.
English: Tacrolimus (n=145, 69)
Croatian: Takrolimus (n=145, 69)
English: If dose adjustments of concomitant medicinal products are made due to treatment with PREVYMIS, doses should be readjusted after treatment with PREVYMIS is completed.
Croatian: Ako se doze istodobno primijenjenih lijekova prilagode zbog liječenja lijekom PREVYMIS, treba ih ponovno prilagoditi nakon što liječenje lijekom PREVYMIS završi.
English: PVC, polyethylene (PE), polybutadiene (PBD), silicone rubber (SR), styrene-butadiene copolymer (SBC), styrene-butadiene-styrene copolymer (SBS), polystyrene (PS)
Croatian: PVC, polietilen (PE), polibutadien (PBD), silikonska guma (SR), kopolimer stiren-butadien (SBC), kopolimer stiren-butadien-stiren (SBS), polistiren (PS)
English: Overall (N=325, 170)
Croatian: Ukupno (N=325, 170)
English: There are no data from the use of letermovir in pregnant women.
Croatian: Nema podataka o primjeni letermovira u trudnica.
English: This medicinal product must not be used with other intravenous bags and infusion set materials except those mentioned in section 6.6.
Croatian: Lijek ne smije koristiti s drugim infuzijskim vrećicama ni infuzijskim setovima osim onih navedenih u dijelu 6.6.
English: Letermovir reached steady-state in 9 to 10 days with an accumulation ratio of 1.2 for AUC and 1.0 for Cmax.
Croatian: Letermovir je dosegao stanje dinamičke ravnoteže nakon 9 do 10 dana, uz omjer akumulacije od 1,2 za AUC te 1,0 za Cmax.
English: Approach to handling missing values: Non-Completer=Failure (NC=F) approach.
Croatian: Postupanje s vrijednostima koje nedostaju: pristup "prerani prekid = neuspješno liječenje" (NC=F).
English: When PREVYMIS is co-administered with cyclosporine, pravastatin is not recommended while for fluvastatin, a dose reduction may be necessary
Croatian: Kada se PREVYMIS primjenjuje istodobno s ciklosporinom, primjena pravastatina se ne preporučuje, dok će za fluvastatin možda biti potrebno smanjenje doze
English: Expected: ↑ amiodarone
Croatian: Očekivano: ↑ amiodaron
English: ↓ =decrease, ↑ =increase ↔ =no clinically relevant change One-way interaction study assessing the effect of letermovir on the concomitant medicinal product.
Croatian: ↓ = smanjenje, ↑ = povećanje ↔ = nema klinički važne promjene Jednosmjerno ispitivanje interakcija u kojem se ocjenjivao učinak letermovira na istodobno primijenjen lijek.
English: -The combination of cyclosporine and letermovir may lead to more marked or additional effects on concomitant medicinal products as compared to letermovir alone (see Table 1).
Croatian: - Primjena ciklosporina u kombinaciji s letermovirom može dovesti do izraženijih ili dodatnih učinaka na istodobno primijenjene lijekove u odnosu na primjenu samo letermovira (vidjeti Tablicu 1).
English: Patients should not double their next dose or take more than the prescribed one.
Croatian: Bolesnici ne smiju udvostručiti sljedeću dozu niti uzeti veću dozu od propisane.
English: It is known that hydroxypropylbetadex can cause kidney vacuolation in rats when given intravenously at doses greater than 50 mg/kg/day.
Croatian: Zna se da hidroksipropilbetadeks može uzrokovati vakuolizaciju bubrega štakora kada se daje intravenski u dozama većima od 50 mg/kg na dan.
English: Effect of other medicinal products on letermovir
Croatian: Učinak drugih lijekova na letermovir
English: Serum creatinine levels should be closely monitored in these patients.
Croatian: U tih bolesnika treba pažljivo kontrolirati razine kreatinina u serumu.
English: Each mL of concentrate contains 20 mg/mL.
Croatian: Jedan ml koncentrata sadrži 20 mg/ml.
English: • possible clinically significant adverse reactions from greater exposure of concomitant medicinal products or letermovir.
Croatian: • potencijalne klinički značajne nuspojave zbog povećane izloženosti istodobno primijenjenim lijekovima ili letermoviru
English: • Cyclosporine, tacrolimus, sirolimus
Croatian: • ciklosporina, takrolimusa, sirolimusa
English: • dabigatran, warfarin - used to thin the blood or for blood clots
Croatian: • dabigatran, varfarin - koriste se za razrjeđivanje krvi ili krvnih ugrušaka
English: pantoprazole
Croatian: pantoprazol
English: Do not double the next dose or give more than the prescribed dose.
Croatian: Ne smije se udvostručiti sljedeća doza niti dati doza veća od propisane.
English: Proton pump inhibitors omeprazole
Croatian: Inhibitori protonske pumpe omeprazol
English: Table 1 provides a listing of established or potentially clinically significant medicinal product interactions.
Croatian: Tablici 1 navodi se popis utvrđenih ili potencijalno klinički značajnih interakcija s drugim lijekovima.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of letermovir in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci o primjeni u životinja pokazali su da se letermovir izlučuje u mlijeko (vidjeti dio 5.3).
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).
Croatian: Medijan vrijednosti EC50 letermovira protiv skupa kliničkih izolata CMV-a u modelu infekcije na staničnoj kulturi iznosio je 2,1 nM (raspon: 0,7 - 6,1 nM, n=74).
English: • Do not take two doses of PREVYMIS at the same time to make up for a missed dose.
Croatian: • Nemojte odjednom uzeti dvije doze lijeka PREVYMIS kako biste nadoknadili propuštenu dozu.
English: Letermovir was initiated after HSCT (Day 0-28 post-transplant) and continued through Week 14 post-transplant.
Croatian: Liječenje letermovirom započelo je nakon HSCT-a (između 0. i 28. dana nakon transplantacije) i trajalo je do 14. tjedna nakon transplantacije.
English: • After dilution, administer PREVYMIS via intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Croatian: • Nakon razrjeđivanja primijenite PREVYMIS intravenskom infuzijom putem perifernog ili centralnog venskog katetera tijekom ukupnog razdoblja od približno 60 minuta.
English: Other systemically acting oral contraceptive steroids
Croatian: drugi oralni steroidni kontraceptivi sa sistemskim djelovanjem
English: Other medicines and PREVYMIS
Croatian: Drugi lijekovi i PREVYMIS
English: When changing the route of administration, or if changing immunosuppressant, the recommendation concerning co-administration should be revisited.
Croatian: Kod promjene puta primjene ili promjene imunosupresiva treba ponovno provjeriti preporuku za istodobnu primjenu.
English: • you take the following herbal product:
Croatian: • ako uzimate sljedeći biljni lijek:
English: Plasticizers Diethylhexyl-phthalate (DEHP), tris (2-ethylhexyl) trimellitate (TOTM), butyl benzyl phthalate (BBP)
Croatian: Omekšivači dietilheksilftalat (DEHP), tris (2-etilheksil) trimelitat (TOTM), butilbenzilftalat (BBP)
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).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega (klirens kreatinina manji od 50 ml/min) liječenih lijekom PREVYMIS može doći do akumulacije hidroksipropilbetadeksa (vidjeti dio 5.3).
English: Mutagenesis
Croatian: Mutageneza
English: • high blood creatinine - shown in blood tests
Croatian: • visoke vrijednosti kreatinina u krvi (u nalazima krvnih pretraga)
English: Letermovir is a moderate inhibitor of CYP3A in vivo.
Croatian: Letermovir je umjeren inhibitor CYP3A in vivo.
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.
Croatian: Prema populacijskim farmakokinetičkim analizama, procjenjuje se da je AUC letermovira 18,7% niži u ispitanika tjelesne težine 80 - 100 kg nego u onih koji teže 67 kg.
English: If you are given more PREVYMIS than you should If you think you have been given too much PREVYMIS, tell your doctor straight away.
Croatian: Ako primite više lijeka PREVYMIS nego što ste trebali Ako mislite da ste primili previše lijeka PREVYMIS, o tome odmah obavijestite svog liječnika.
English: PREVYMIS may have minor influence on your ability to drive and use machines (see section 4 Possible Side Effects below).
Croatian: PREVYMIS može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima (pogledajte dio 4. 'Moguće nuspojave' u nastavku).
English: Antimycobacterials rifabutin
Croatian: Antimikobakterici rifabutin
English: This toxicity was characterized by seminiferous tubular degeneration, and oligospermia and cell debris in the epididymides, with decreased testicular and epididymides weights.
Croatian: Tu su toksičnost karakterizirali degeneracija seminifernih tubula te oligospermija i stanični otpad u epididimisima, uz smanjenu težinu testisa i epididimisa.
English: Randomisation was stratified by investigational site and risk (high vs. low) for CMV reactivation at the time of study entry.
Croatian: Randomizacija je bila stratificirana prema ispitivačkom mjestu i riziku od reaktivacije CMV-a (visok ili nizak) u trenutku uključivanja u ispitivanje.
English: This needs to be considered when the letermovir regimen is changed during treatment with a CYP2C9 or CYP2C19 substrate.
Croatian: To treba uzeti u obzir kada se režim primjene letermovira mijenja tijekom liječenja supstratom CYP2C9 ili CYP2C19.
English: There is no specific antidote for overdose with PREVYMIS.
Croatian: Nema specifičnog protulijeka za predoziranje lijekom PREVYMIS.
English: Cumulative proportion of subjects with CMV DNAemia or disease (%)
Croatian: Kumulativni udio ispitanika s prisutnošću CMV DNK u krvi ili CMV bolešću (%)
English: Compatible intravenous solutions and other medicinal products
Croatian: Kompatibilne intravenske otopine i drugi lijekovi
English: It is unknown whether letermovir is excreted in human milk.
Croatian: Nije poznato izlučuje li se letermovir u majčino mlijeko.
English: Changes in letermovir plasma concentrations due to inhibition of P-gp/BCRP are not anticipated to be clinically relevant.
Croatian: Ne očekuje se da će promjene koncentracija letermovira u plazmi zbog inhibicije P-gp-a/BCRP-a biti klinički značajne.
English: Elderly No dose adjustment of PREVYMIS is required based on age (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka PREVYMIS na temelju dobi (vidjeti dijelove 5.1 i 5.2).
English: Letermovir is extensively bound (98.2%) to human plasma proteins, independent of the concentration range (3 to 100 mg/L) evaluated, in vitro.
Croatian: Letermovir se u velikoj mjeri (98,2%) vezuje za proteine u ljudskoj plazmi in vitro, neovisno o rasponu koncentracije koji se ocjenjivao (3 - 100 mg/l).
English: Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products (see section 4.5).
Croatian: Indukcija može dovesti do sniženja koncentracija u plazmi nekih lijekova koji se metaboliziraju i prenose (vidjeti dio 4.5).
English: Carcinogenesis Carcinogenicity studies with letermovir have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti letermovira.
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.
Croatian: Najveći dio letermovira izlučio se putem žuči u obliku nepromijenjenog ishodišnog spoja, a manji dio (6% doze) kao acil-glukuronidni metabolit u fecesu.
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.
Croatian: Tijekom kliničkih ispitivanja faze 1, 86 zdravih ispitanika primalo je doze lijeka PREVYMIS u rasponu od 720 mg na dan do 1440 mg na dan tijekom najviše 14 dana.
English: A 1-sided p-value ≤0.0249 was used for declaring statistical significance.
Croatian: Za utvrđivanje statističke značajnosti koristila se jednostrana p-vrijednost ≤ 0,0249.
English: Pimozide and ergot alkaloids are contraindicated (see section 4.3).
Croatian: Primjena pimozida i ergot alkaloida je kontraindicirana (vidjeti dio 4.3).
English: Letermovir is partly eliminated by glucuronidation mediated by UGT1A1/1A3.
Croatian: Letermovir se djelomično eliminira glukuronidacijom u kojoj posreduje UGT1A1/1A3.
English: • bosentan - for high blood pressure in the vessels in the lungs
Croatian: • bosentan - koristi se za liječenje povišenog krvnog tlaka u krvnim žilama pluća
English: PREVYMIS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Primjena lijeka PREVYMIS ne preporučuje se tijekom trudnoće te u žena reproduktivne dobi koje ne koriste kontracepciju.
English: However, caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Croatian: Međutim, preporučuje se oprez ako se inhibitori P-gp-a/BCRP-a dodaju kombinaciji letermovira i ciklosporina.
English: • rifabutin, rifampicin - for mycobacterial infections
Croatian: • rifabutin, rifampicin - koriste se za liječenje infekcija uzrokovanih mikobakterijama
English: In vitro results indicate that letermovir is a substrate of P-gp/BCRP.
Croatian: Rezultati in vitro ukazuju na to da je letermovir supstrat P-gp-a/BCRP-a.
English: Additional effects of other products on letermovir relevant when combined with cyclosporine
Croatian: Dodatni učinci drugih lijekova na letermovir koji su relevantni kod primjene u kombinaciji s ciklosporinom
English: Administration See section 4.2.
Croatian: Primjena Vidjeti dio 4.2.
English: Therefore, the clinical consequences of drug interactions for letermovir will be dependent on which letermovir regimen is used and whether or not letermovir is combined with cyclosporine.
Croatian: Stoga će kliničke posljedice interakcija između lijekova za letermovir ovisiti o tome koji se režim liječenja letermovirom koristi i o tome primjenjuje li se on u kombinaciji s ciklosporinom ili ne.
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.
Croatian: Odrasli CMV-seropozitivni primatelji [R+] alogenih transplantata hematopoetskih matičnih stanica Radi ocjene profilakse letermovirom kao strategije za sprječavanje CMV infekcije ili bolesti, djelotvornost letermovira procjenjivala se u multicentričnom, dvostruko slijepom, placebom kontroliranom ispitivanju faze 3 (P001) u odraslih CMV-seropozitivnih primatelja [R+] alogenog HSCT-a.
English: *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Croatian: *Vidjeti informacije o lijeku za potvrdu kompatibilnosti za istodobnu primjenu.
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.
Croatian: Letermovir se brzo apsorbirao, uz medijan vremena do postizanja maksimalne koncentracije u plazmi (Tmax) od 1,5 do 3,0 sata, nakon čega su koncentracije padale u dvije faze.
English: • This medicinal product must not be mixed with other medicinal products except those listed below.
Croatian: • Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u nastavku.
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.
Croatian: PREVYMIS treba primjenjivati uz oprez zajedno s lijekovima uske terapijske širine koji su supstrati CYP3A (npr. alfentanil, fentanil i kinidin) jer njihova istodobna primjena može povisiti koncentracije supstrata CYP3A u plazmi.
English: It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.
Croatian: Nije poznato mogu li se dijalizom ukloniti značajnije količine lijeka PREVYMIS iz sistemske cirkulacije.
English: Oral anticoagulants warfarin
Croatian: Oralni antikoagulansi varfarin
English: Unopened vial: 30 months After opening: Use immediately
Croatian: Nakon otvaranja: primijeniti odmah.
English: PREVYMIS is a medicine for adults who have recently had a bone marrow transplant.
Croatian: PREVYMIS je lijek za odrasle osobe kojima je nedavno presađena koštana srž.
English: PREVYMIS may have minor influence on the ability to drive or use machines.
Croatian: PREVYMIS može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Letermovir ne produljuje QTc interval u klinički značajnoj mjeri nakon primjene i.v. doze od 960 mg, kojom se postižu koncentracije u plazmi približno dvostruko veće od onih koje se postižu i.v. dozom od 480 mg.
English: The dose of atorvastatin should not exceed 20 mg daily when co-administered with PREVYMIS
Croatian: Doza atorvastatina ne smije premašiti 20 mg na dan kad se primjenjuje istodobno s lijekom PREVYMIS
English: This will give the medicine the best chance to keep you from becoming ill from CMV after you get a bone marrow transplant.
Croatian: Tako ćete mu dati najbolju priliku da spriječi razvoj bolesti koju bi CMV mogao uzrokovati nakon presađivanja koštane srži.
English: Irreversible testicular toxicity and impairment of fertility was observed in male rats, but not in male mice or male monkeys.
Croatian: Opažena je ireverzibilna toksičnost za testise i štetan utjecaj na plodnost mužjaka štakora, ali ne i mužjaka miševa ili majmuna.
English: The majority of letermovir-related components in plasma is unchanged parent (96.6%).
Croatian: Letermovir se u plazmi u najvećoj mjeri javlja u obliku nepromijenjenog ishodišnog spoja (96,6%).
English: This needs to be considered when the letermovir regimen is changed during treatment with an OATP1B1/3 substrate.
Croatian: To treba uzeti u obzir kada se režim primjene letermovira mijenja tijekom liječenja supstratom OATP1B1/3.
English: See Table 1 for steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations (see sections 4.3 and 4.5).
Croatian: Tablici 1 navedeni su koraci za sprječavanje ili zbrinjavanje tih poznatih ili potencijalno značajnih interakcija između lijekova, uključujući preporuke za doziranje (vidjeti dijelove 4.3 i 4.5).
English: Therefore, the plasma concentrations of medicinal products that are substrates of these enzymes or transporters may increase or decrease when co-administered with letermovir.
Croatian: Stoga se koncentracije lijekova koji su supstrati tih enzima ili prijenosnika u plazmi mogu povisiti ili sniziti kod istodobne primjene s letermovirom.
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).
Croatian: Ocjena sigurnosti lijeka PREVYMIS temeljila se na kliničkom ispitivanju faze 3 (P001), provedenom u primatelja HSCT-a koji su primali PREVYMIS ili placebo do 14. tjedna nakon transplantacije, nakon čega je uslijedilo praćenje sigurnosti do 24. tjedna nakon transplantacije (vidjeti dio 5.1).
English: At baseline, 31% of subjects were at high risk for reactivation as defined by one or more of the following criteria: Human Leukocyte Antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B or -DR, haploidentical donor; unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B,C and -DRB1; use of umbilical cord blood as stem cell source; use of ex vivo T-cell-depleted grafts; Grade 2 or greater Graft-Versus-Host Disease (GVHD), requiring systemic corticosteroids.
Croatian: Na početku ispitivanja 31% ispitanika imalo je visok rizik od reaktivacije, koji definira jedan ili više od sljedećih kriterija: davatelj je krvni srodnik (brat ili sestra) s podudarnim humanim leukocitnim antigenima (HLA) koji ima najmanje jednu nepodudarnost (engl. mismatch) na jednom od sljedeća tri lokusa gena HLA: HLA-A, -B ili -DR, haploidentičan davatelj; davatelj nije krvni srodnik i ima najmanje jednu nepodudarnost na jednom od sljedeća četiri lokusa gena HLA: HLA-A, -B, -C i -DRB1; kao izvor matičnih stanica korištena je krv iz pupkovine; korišten je transplantat podvrgnut depleciji T-stanica ex vivo; reakcija presatka protiv primatelja (graft-versus-host disease, GVHD) 2. ili višeg stupnja, koja zahtijeva primjenu sistemskih kortikosteroida.
English: Subjects were randomised (2:1) to receive either letermovir at a dose of 480 mg once daily adjusted to 240 mg when co-administered with cyclosporine, or placebo.
Croatian: Ispitanici su bili randomizirani (2:1) za primanje letermovira u dozi od 480 mg jedanput na dan, koja je smanjena na 240 mg pri istodobnoj primjeni s ciklosporinom, ili za primanje placeba.
English: Risk of adverse reactions or reduced therapeutic effect due to medicinal product interactions The concomitant use of PREVYMIS and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to:
Croatian: Istodobna primjena lijeka PREVYMIS s određenim lijekovima može dovesti do poznatih ili potencijalno značajnih interakcija između lijekova, od kojih neke mogu uzrokovati: