FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take PREVYMIS
Croatian: Što morate znati prije nego počnete uzimati PREVYMIS
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.
Croatian: AUC nevezanog letermovira bio je približno 115% veći u ispitanika s umjerenim oštećenjem funkcije bubrega (eGFR od 31,0 do 56,8 ml/min/1,73 m2) te 81% veći u bolesnika s teškim oštećenjem funkcije bubrega (eGFR od 11,9 do 28,1 ml/min/1,73 m2) nego u zdravih ispitanika.
English: quinidine
Croatian: kinidin
English: Effect of letermovir on other medicinal products
Croatian: Učinak letermovira na druge lijekove
English: Non-myeloablative (n=85, 37)
Croatian: Nemijeloablacijski (n=85, 37)
English: • Ampicillin sodium/Sulbactam sodium • Human insulin
Croatian: • ampicilinnatrij/sulbaktamnatrij humani inzulin
English: Co-administration of PREVYMIS with voriconazole (a CYP2C19 substrate) results in significantly decreased voriconazole plasma concentrations, indicating that letermovir is an inducer of CYP2C19.
Croatian: Istodobna primjena lijeka PREVYMIS i vorikonazola (supstrata CYP2C19) značajno snizuje koncentracije vorikonazola u plazmi, što ukazuje na to da je letermovir induktor CYP2C19.
English: PREVYMIS is compatible with the following intravenous bags and infusion set materials.
Croatian: PREVYMIS je kompatibilan sa sljedećim infuzijskim vrećicama i infuzijskim setovima.
English: -Examples of such medicinal products include warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide (see Table 1).
Croatian: - Primjeri takvih lijekova uključuju varfarin, vorikonazol, diazepam, lansoprazol, omeprazol, esomeprazol, pantoprazol, tilidin, tolbutamid (vidjeti Tablicu 1).
English: Polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and polyolefin (polypropylene and polyethylene)
Croatian: Infuzijske vrećice polivinilklorid (PVC), etilenvinilacetat (EVA) i poliolefin (polipropilen i polietilen)
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.
Croatian: Prema NC=F pristupu neuspjeh se definirao kao svi ispitanici s klinički značajnom CMV infekcijom ili oni koji su prijevremeno prekinuli sudjelovanje u ispitivanju ili za koje su nedostajali podaci o ishodu do 24. tjedna nakon transplantacije.
English: Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena dabigatrana, atorvastatina, simvastatina, rosuvastatina ili pitavastatina (vidjeti dio 4.5).
English: In the fertility and early embryonic development studies in the rat, there were no effects of letermovir on female fertility.
Croatian: U ispitivanjima plodnosti te ranog embrionalnog razvoja na štakorima nisu primijećeni učinci letermovira na plodnost ženki.
English: The effect is expected to be less pronounced for oral letermovir without cyclosporine, than IV letermovir with or without cyclosporine, or oral letermovir with cyclosporine.
Croatian: Očekuje se da će učinak biti manje izražen nakon peroralne primjene letermovira bez ciklosporina nego nakon intravenske primjene letermovira u kombinaciji s ciklosporinom ili bez njega ili nakon peroralne primjene letermovira u kombinaciji s ciklosporinom.
English: • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
Croatian: • statine, kao što su atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin koriste se za liječenje visokih vrijednosti kolesterola
English: What you need to know before you are given PREVYMIS
Croatian: Što morate znati prije nego počnete primati PREVYMIS
English: Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.
Croatian: Letermovir može smanjiti izloženost supstratima CYP2C9 i/ili CYP2C19, što može dovesti do supterapijskih vrijednosti.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given PREVYMIS.
Croatian: Ako niste sigurni, razgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom prije nego što primite PREVYMIS.
English: • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
Croatian: • omeprazol, pantoprazol - koriste se za liječenje želučanog vrijeda i drugih želučanih tegoba.
English: If it is time for the next dose, skip the missed dose and go back to the regular schedule.
Croatian: Ako je već vrijeme za sljedeću dozu, treba preskočiti propuštenu dozu i nastaviti s primjenom prema uobičajenom rasporedu.
English: Expected: ↑ or ↓ repaglinide
Croatian: Očekivano: ↑ ili ↓ repaglinid
English: One subject had a letermovir-resistant GV (V236M).
Croatian: Jedan je ispitanik imao genotipsku varijantu koja uzrokuje rezistenciju na letermovir (V236M).
English: Refer to the respective prescribing information (see section 4.4).
Croatian: Vidjeti odgovarajuće informacije o lijeku (vidjeti dio 4.4).
English: • If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
Croatian: • Ako se primjena ciklosporina prekine nakon uvođenja lijeka PREVYMIS, sljedeću dozu lijeka PREVYMIS treba povećati na 480 mg jedanput na dan.
English: -Examples of such medicinal products include certain immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus), HMG-CoA reductase inhibitors, and amiodarone (see Table 1).
Croatian: - Primjeri takvih lijekova uključuju određene imunosupresive (npr. ciklosporin, takrolimus, sirolimus), inhibitore HMG-CoA reduktaze i amiodaron (vidjeti Tablicu 1).
English: • Morphine sulfate
Croatian: • anidulafungin morfinsulfat
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.
Croatian: Kompatibilne intravenske otopine i drugi lijekovi PREVYMIS koncentrat za otopinu za infuziju kompatibilan je s 0,9%-tnom otopinom natrijeva klorida i 5%-tnom otopinom glukoze.
English: The adverse reaction profile was similar to that of the clinical dose of 480 mg/day.
Croatian: Profil nuspojava bio je sličan onome opaženome uz kliničku dozu od 480 mg na dan.
English: The changes in letermovir exposure due to moderate or severe renal impairment are not considered to be clinically relevant.
Croatian: Promjene u izloženosti letermoviru zbog umjerenog ili teškog oštećenja funkcije bubrega ne smatraju se klinički značajnima.
English: Letermovir inhibits the CMV DNA terminase complex which is required for cleavage and packaging of viral progeny DNA.
Croatian: Letermovir inhibira kompleks terminaze citomegalovirusne DNK (CMV DNK), koji je neophodan za cijepanje i pakiranje DNK virusnog potomstva.
English: Concentrate for solution for infusion 1 vial
Croatian: Koncentrat za otopinu za infuziju 1 bočica
English: Letermovir exposure increased in a greater than doseproportional manner with both oral or IV administration.
Croatian: Izloženost letermoviru povećala se više nego proporcionalno dozi i kod peroralne i kod i.v. primjene.
English: In vitro, letermovir is an inhibitor of CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1, and OAT3 at in vivo relevant concentrations.
Croatian: Letermovir je in vitro inhibitor CYP3A, CYP2C8, CYP2B6, BCRP-a, UGT1A1, OATP2B1 i OAT3 pri koncentracijama koje su relevantne in vivo.
English: Medicinal products metabolised by CYP2C8
Croatian: Lijekovi koji se metaboliziraju putem CYP2C8
English: Infusion set materials
Croatian: Infuzijski setovi
English: Factors associated with CMV DNAemia after Week 14 post-transplant among letermovir-treated subjects included high risk for CMV reactivation at baseline, GVHD, use of corticosteroids, and CMV negative donor serostatus.
Croatian: Faktori povezani s prisutnošću CMV DNK u krvi nakon 14. tjedna nakon transplantacije među ispitanicima liječenima letermovirom uključivali su visok rizik od reaktivacije CMV-a na početku ispitivanja, GVHD, primjenu kortikosteroida i seronegativnost davatelja na CMV.
English: Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.
Croatian: Istodobna primjena lijeka PREVYMIS i lijekova koji su inhibitori prijenosnika OATP1B1/3 može povisiti koncentracije letermovira u plazmi.
English: Fatigue and vertigo have been reported in some patients during treatment with PREVYMIS, which may influence a patient's ability to drive and use machines (see section 4.8).
Croatian: U nekih su bolesnika tijekom liječenja lijekom PREVYMIS prijavljeni umor i vrtoglavica, koji mogu utjecati na bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: If you are taking PREVYMIS with cyclosporine, do not take the following medicines: o dabigatran - used for blood clots o atorvastatin, simvastatin, rosuvastatin, pitavastatin -for high cholesterol
Croatian: Ako uzimate PREVYMIS zajedno s ciklosporinom, nemojte uzimati sljedeće lijekove: o dabigatran - koristi se za liječenje krvnih ugrušaka o atorvastatin, simvastatin, rosuvastatin, pitavastatin - koriste se za liječenje visokih vrijednosti kolesterola.
English: This medicine does not require any special temperature storage conditions.
Croatian: Ovaj lijek ne zahtijeva čuvanje na određenoj temperaturi.
English: (CYP3A inhibition)
Croatian: (inhibicija CYP3A)
English: PREVYMIS concentrate for solution for infusion must be diluted prior to intravenous use.
Croatian: PREVYMIS koncentrat za otopinu za infuziju mora se razrijediti prije intravenske primjene.
English: Inhibitors of OATP1B1 or 3
Croatian: Inhibitori OATP1B1 ili 3
English: Concomitant administration with ergot alkaloids: (see sections 4.4 and 4.5).
Croatian: Istodobna primjena s ergot alkaloidima (vidjeti dijelove 4.4 i 4.5).
English: Both elimination pathways involve active uptake into the hepatocyte through the hepatic uptake transporters OATP1B1/ 3.
Croatian: Oba puta eliminacije uključuju aktivan unos u hepatocit putem prijenosnika za unos tvari u jetru OATP1B1/3.
English: Blood to plasma partitioning of letermovir is 0.56 and independent of the concentration range (0.1 to 10 mg/L) evaluated in vitro.
Croatian: Omjer letermovira u krvi i plazmi ocijenjen in vitro iznosi 0,56 i neovisan je o rasponu koncentracija (0,1 - 10 mg/l).
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.
Croatian: AUC nevezanog letermovira bio je približno 81% veći u ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B [CP-B], rezultat: 7 - 9) te 4 puta veći u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C [CP-C], rezultat: 10 - 15) nego u zdravih ispitanika.
English: PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other medicinal products and diluent combinations except those listed below.
Croatian: PREVYMIS se ne smije primjenjivati istodobno kroz istu intravensku liniju (ili kanilu) s drugim lijekovima ni u kombinaciji s drugim sredstvima za razrjeđivanje osim onih navedenih u nastavku.
English: PREVYMIS concentrate for solution for infusion must be diluted prior to intravenous (IV) use.
Croatian: PREVYMIS koncentrat za otopinu za infuziju mora se razrijediti prije intravenske (i.v.) primjene.
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).
Croatian: U mužjaka štakora opažena je smanjena koncentracija sperme, smanjen motilitet spermija i smanjena plodnost pri sistemskoj izloženosti približno ≥ 3 puta većoj od AUC-a koji se postiže u ljudi nakon primjene preporučene doze za ljude (vidjeti dio 'Općenita toksičnost').
English: If you take more PREVYMIS than you should If you take more PREVYMIS than you should, call your doctor straight away.
Croatian: Ako uzmete više lijeka PREVYMIS nego što ste trebali, odmah se obratite svom liječniku.
English: Letermovir is an inhibitor of OATP1B1/3 transporters.
Croatian: Letermovir je inhibitor prijenosnika OATP1B1/3.
English: General information about differences in exposure between different letermovir treatment regimens -The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in section 5.2).
Croatian: - Procijenjena izloženost letermoviru u plazmi razlikuje se ovisno o režimu doziranja koji se koristi (vidjeti tablicu u dijelu 5.2).
English: Expected: ↓omeprazole
Croatian: Očekivano: ↓omeprazol
English: -Examples of OATP1B1 inhibitors include gemfibrozil, erythromycin, clarithromycin, and several protease inhibitors (atazanavir, simeprevir).
Croatian: - Primjeri inhibitora OATP1B1 uključuju gemfibrozil, eritromicin, klaritromicin i nekoliko inhibitora proteaze (atazanavir, simeprevir).
English: No dose adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu lijeka PREVYMIS u bolesnika s blagim (Child-Pugh stadij A) do umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
English: • thioridazine - for psychiatric disorders
Croatian: • tioridazin - koristi se za liječenje psihijatrijskih poremećaja
English: Medicinal products metabolised by CYP2B6, UGT1A1 or transported by BCRP or OATP2B1 Letermovir is a general inducer in vivo but has also been observed to inhibit CYP2B6, UGT1A1, BCRP, and OATP2B1 in vitro.
Croatian: Lijekovi koji se metaboliziraju putem CYP2B6 i UGT1A1 ili koje prenose BCRP ili OATP2B1 Letermovir je općenito induktor in vivo, ali je opaženo da in vitro inhibira CYP2B6, UGT1A1, BCRP i OATP2B1.
English: Expected: ↑ HMG-CoA reductase inhibitors
Croatian: Očekivano: ↑ inhibitori HMG-CoA reduktaze
English: In rabbits, maternal toxicity (including mortality and abortions) was noted at 225 mg/kg/day (approximately 2-fold the AUC at the RHD); in the offspring, an increased incidence of malformations and variations in the vertebrae and ribs were observed.
Croatian: U kunića je toksičnost za majku (uključujući smrt i pobačaje) primijećena pri dozi od 225 mg/kg na dan (izloženost približno 2 puta veća od AUC-a nakon primjene preporučene doze za ljude); u mladunčadi je opažena povećana incidencija malformacija i varijacija kralježaka i rebara.
English: • Administer as an intravenous infusion only.
Croatian: • Primijeniti isključivo intravenskom infuzijom.
English: No dose adjustment of PREVYMIS is recommended for patients with mild, moderate, or severe renal impairment.
Croatian: Ne preporučuje se prilagođavati dozu lijeka PREVYMIS u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
English: PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant.
Croatian: Liječenje lijekom PREVYMIS treba započeti liječnik koji ima iskustva u liječenju bolesnika nakon alogene transplantacije hematopoetskih matičnih stanica.
English: Monitoring of amiodarone concentrations should be performed regularly when amiodarone is co-administered with PREVYMIS
Croatian: Potrebno je redovito kontrolirati koncentracije amiodarona kada se on primjenjuje istodobno s lijekom PREVYMIS
English: PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Croatian: Primjena lijeka PREVYMIS ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 5.2).
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).
Croatian: Ireverzibilna toksičnost za testise opažena je samo u štakora pri sistemskoj izloženosti (AUC) koja je bila ≥ 3 puta veća od izloženosti u ljudi pri preporučenoj dozi za ljude.
English: -An example of medicinal product transported by OATP2B1 is celiprolol.
Croatian: - Primjer lijeka koji prenosi OATP2B1 je celiprolol.
English: etravirine
Croatian: etravirin
English: Immune system disorders Uncommon hypersensitivity
Croatian: Poremećaji imunološkog sustava Manje često preosjetljivost
English: Letermovir demonstrated superior efficacy over placebo in the analysis of the primary endpoint, as shown in Table 3.
Croatian: U analizi podataka o primarnoj mjeri ishoda letermovir je pokazao superiornu djelotvornost u odnosu na placebo, kako je prikazano u Tablici
English: The anticipated clinical exposure to hydroxypropylbetadex with intravenously administered letermovir is expected to be approximately 3600 mg/day for a letermovir dose of 480 mg.
Croatian: Očekuje se da će klinička izloženost hidroksipropilbetadeksu kod intravenske primjene letermovira iznositi približno 3600 mg na dan pri dozi letermovira od 480 mg.
English: Mismatched related (n=52, 18) Matched unrelated (n=122, 70)
Croatian: Krvni srodnik s nepodudarnošću (n=52, 18) Podudaran darivatelj koji nije krvni srodnik (n=122, 70)
English: • carbamazepine, phenobarbital, phenytoin - for fits or seizures
Croatian: • karbamazepin, fenobarbital, fenitoin - koriste se za liječenje napadaja
English: Co-administration of PREVYMIS and carbamazepine or phenobarbital is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i karbamazepina i fenobarbitala se ne preporučuje.
English: Concomitant use is not recommended.
Croatian: Ne preporučuje se istodobna primjena.
English: Oral contraceptives ethinylestradiol (EE) (0.03 mg)/ levonorgestrel (LNG) (0.15 mg) single dose/ letermovir (480 mg daily)
Croatian: Oralni kontraceptivi etinilestradiol (EE) (0,03 mg)/ levonorgestrel (LNG) (0,15 mg), jedna doza/letermovir (480 mg na dan)
English: ↑ tacrolimus AUC 2.42 (2.04, 2.88) Cmax 1.57 (1.32, 1.86) (CYP3A inhibition)
Croatian: ↑ takrolimus AUC 2,42 (2,04; 2,88) Cmax 1,57 (1,32; 1,86) (inhibicija CYP3A)
English: In monkeys administered letermovir, there was no evidence of testicular toxicity based on histopathologic evaluation, measurement of testicular size, blood hormone analysis (follicle stimulating hormone, inhibin B and testosterone) and sperm evaluation (sperm count, motility and morphology) at systemic exposures approximately 2-fold the AUC in humans at the RHD.
Croatian: U majmuna koji su primali letermovir, histopatološka ocjena, mjerenje veličine testisa, analiza hormona u krvi (folikulostimulirajući hormon, inhibin B i testosteron) i ocjena spreme (broj, motilitet i morfologija spermija) nisu pokazali dokaze toksičnosti za testise pri sistemskoj izloženosti približno 2 puta većoj od AUC-a koji se postiže u ljudi nakon primjene preporučene doze za ljude.
English: The size of the CYP3A inhibitory effect is dependent on letermovir route of administration and whether cyclosporine is concomitantly used.
Croatian: Jačina inhibicijskog učinka na CYP3A ovisi o putu primjene letermovira i o tome primjenjuje li se istodobno i ciklosporin.
English: • oral contraceptive steroids-for birth control
Croatian: • oralni steroidni kontraceptivi - koriste se za kontrolu začeća
English: -Examples of moderate inducers include thioridazine, modafinil, ritonavir, lopinavir, efavirenz and etravirine.
Croatian: - Primjeri umjerenih induktora uključuju tioridazin, modafinil, ritonavir, lopinavir, efavirenz i etravirin.
English: o St. John's wort (Hypericum perforatum)
Croatian: o gospinu travu (Hypericum perforatum)
English: • alfentanil - for severe pain
Croatian: • alfentanil - koristi se za liječenje jake boli
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.
Croatian: U štakora je toksičnost za majku (uključujući smanjenje prirasta tjelesne težine) primijećena pri dozi od 250 mg/kg na dan (kojom se postiže izloženost približno 11 puta veća od AUC-a nakon primjene preporučene doze za ljude); u mladunčadi je opažena smanjena tjelesna težina ploda uz usporeno okoštavanje, blago edematozni plodovi i povećana incidencija skraćenih pupčanih vrpci te varijacija i malformacija kralježaka, rebara i zdjelice.
English: Testicular toxicity was not observed in mice and monkeys at the highest doses tested at exposures up to 4-fold and 2-fold, respectively, the exposures in humans at the RHD.
Croatian: Toksičnost za testise nije opažena ni u miševa ni u majmuna pri najvišim ispitivanim dozama, kojima su postignute razine izloženosti do 4 odnosno 2 puta veće od onih koje se postižu u ljudi nakon primjene preporučene doze za ljude.
English: Co-administration of PREVYMIS with oral midazolam (a CYP3A substrate) results in 2-3-fold increased midazolam plasma concentrations.
Croatian: Istodobna primjena lijeka PREVYMIS i oralnog midazolama (supstrata CYP3A) povisuje koncentracije midazolama u plazmi 2 - 3 puta.
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)
Croatian: Slika 1: P001: Kaplan-Meierova krivulja vremena do uvođenja PET-a protiv CMV-a ili razvoja bolesti ciljnog organa uzrokovane CMV-om do 24. tjedna nakon transplantacije u primatelja HSCT-a (FAS populacija)
English: Increased monitoring of cyclosporine, tacrolimus, sirolimus is generally recommended the first 2 weeks after initiating and ending letermovir (see section 4.5) as well as after changing route of administration of letermovir.
Croatian: Općenito se preporučuje pojačano praćenje koncentracija ciklosporina, takrolimusa i sirolimusa tijekom prva 2 tjedna nakon uvođenja i nakon prekida primjene letermovira (vidjeti dio 4.5), kao i nakon promjene puta primjene letermovira.
English: In HSCT recipients, co-administration of cyclosporine increased plasma concentrations of letermovir due to inhibition of OATP1B.
Croatian: U primatelja HSCT-a istodobna primjena ciklosporina povisila je koncentracije letermovira u plazmi zbog inhibicije OATP1B.
English: Based on population pharmacokinetic analyses, the mean steady-state volume of distribution is estimated to be 45.5 L following intravenous administration in HSCT recipients.
Croatian: Prema populacijskim farmakokinetičkim analizama, procijenjena srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže nakon intravenske primjene u primatelja HSCT-a iznosi 45,5 l.
English: This is because it is not known if PREVYMIS gets in your breast milk and will be passed to your baby.
Croatian: Naime, nije poznato izlučuje li se PREVYMIS u majčino mlijeko i hoće li se prenijeti na dijete.
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).
Croatian: Ne preporučuje se istodobna primjena lijeka PREVYMIS (s ciklosporinom ili bez njega) i snažnih ili umjerenih induktora prijenosnika (npr. P-gp-a) i/ili enzima (npr. UGT-ova) jer to može dovesti do supterapijske izloženosti letermoviru (vidjeti Tablicu 1).
English: If monitoring is applied, this is recommended the first 2 weeks after initiating and ending letermovir (see section 4.4) as well as after changing route of letermovir administration.
Croatian: Ako se provodi praćenje, preporučuje se to činiti tijekom prva 2 tjedna nakon uvođenja i nakon prekida primjene letermovira (vidjeti dio 4.4), kao i nakon promjene puta primjene letermovira.