FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no developmental toxicity observed up to the highest exposure tested (2-fold the AUC at the RHD).
Croatian: Nisu opaženi toksični učinci na razvoj pri najvišoj ispitivanoj razini izloženosti (2 puta većoj od AUC-a nakon primjene preporučene doze za ljude).
English: There were no cases of kidney injury caused by hydroxypropylbetadex in human studies of intravenously administered letermovir with treatment durations of up to 47 days.
Croatian: U ispitivanjima intravenske primjene letermovira u ljudi u trajanju do 47 dana nisu zabilježeni slučajevi oštećenja bubrega uzrokovanog hidroksipropilbetadeksom.
English: • Add one single-dose vial of (either 12 mL (240 mg dose) or 24 mL (480 mg dose)) of PREVYMIS concentrate for solution for infusion to a 250 mL pre-filled IV bag containing either 0.9% sodium chloride or 5% dextrose, and mix the diluted solution by gentle inversion.
Croatian: • Dodajte sadržaj jedne jednodozne bočice (12 ml [doza od 240 mg] ili 24 ml [doza od 480 mg]) PREVYMIS koncentrata za otopinu za infuziju u napunjenu infuzijsku vrećicu volumena 250 ml koja sadrži 0,9%-tnu otopinu natrijeva klorida ili 5%-tnu otopinu glukoze, a zatim nježnim okretanjem promiješajte razrijeđenu otopinu.
English: Administration instructions for PREVYMIS concentrate for solution for infusion
Croatian: Upute za primjenu PREVYMIS koncentrata za otopinu za infuziju
English: If a vial is added to a 250 mL IV diluent bag, the final concentration ranges of letermovir would be 0.9 mg/mL (for 240 mg dose) and 1.8 mg/mL (for 480 mg dose).
Croatian: Ako se sadržaj bočice dodaje u infuzijsku vrećicu volumena 250 ml sa sredstvom za razrjeđivanje, konačna koncentracija letermovira iznosit će 0,9 mg/ml (za dozu od 240 mg) te 1,8 mg/ml (za dozu od 480 mg).
English: ↓ voriconazole AUC 0.56 (0.51, 0.62) Cmax 0.61 (0.53, 0.71)
Croatian: ↓ vorikonazol AUC 0,56 (0,51; 0,62) Cmax 0,61 (0,53; 0,71)
English: No known letermovir resistance mutations map to UL89.
Croatian: Mapiranje je pokazalo da se nijedna poznata mutacija koja uzrokuje rezistenciju na letermovir ne nalazi u genu UL89.
English: When PREVYMIS is co-administered with cyclosporine, use of these statins is contraindicated.
Croatian: Kada se PREVYMIS primjenjuje zajedno s ciklosporinom, primjena navedenih statina je kontraindicirana.
English: Letermovir may substantially increase plasma concentrations of these statins.
Croatian: Letermovir može znatno povisiti koncentracije tih statina u plazmi.
English: Expected: ↔ letermovir
Croatian: Očekivano: ↔ letermovir
English: Vacuolation was noted in the kidneys of rats administered IV letermovir formulated with 1500 mg/kg/day of the cyclodextrin excipient hydroxypropylbetadex.
Croatian: Vakuolizacija je opažena u bubrezima štakora koji su primili i.v. letermovir u formulaciji s ciklodekstrinskom pomoćnom tvari hidroksipropilbetadeksom u dozi od 1500 mg/kg na dan.
English: Sodium hydroxide (E524) Water for injections
Croatian: 6.1 Popis pomoćnih tvari hidroksipropilbetadeks (ciklodekstrin) natrijev klorid natrijev hidroksid (E524) voda za injekcije
English: The process involves the hepatic uptake transporters OATP1B1 and 3 followed by UGT1A1/3 catalysed glucuronidation.
Croatian: U tom procesu sudjeluju prijenosnici za unos tvari u jetru OATP1B1 i OATP1B3, nakon čega slijedi glukuronidacija katalizirana putem UGT1A1/3.
English: If you have a kidney disease, talk to your doctor before you receive this medicine.
Croatian: Ako imate bubrežnu bolest, razgovarajte s liječnikom prije primjene ovog lijeka.
English: Each 480 mg vial contains 46 mg sodium (main component of cooking/table salt).
Croatian: Jedna bočica od 480 mg sadrži 46 mg natrija (glavnog sastojka kuhinjske soli).
English: PREVYMIS concentrate for solution for infusion vials are for single use only.
Croatian: PREVYMIS bočice s koncentratom za otopinu za infuziju namijenjene su samo za jednokratnu primjenu.
English: Immunosuppressants cyclosporine (50 mg single dose)/ letermovir (240 mg daily)
Croatian: Imunosupresivi ciklosporin (jedna doza od 50 mg)/letermovir (240 mg na dan)
English: Table 2: Adverse reactions identified with PREVYMIS Frequency
Croatian: Tablica 2: Nuspojave zabilježene kod primjene lijeka PREVYMIS
English: PO:
Croatian: NN:
English: Each film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
Croatian: Jedna filmom obložena tableta sadrži 240 mg letermovira ili 480 mg letermovira.
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.
Croatian: PREVYMIS 480 mg filmom obložena tableta je ružičasta ovalna, bikonveksna tableta s utisnutom oznakom '595' na jednoj strani i logotipom MSD na drugoj strani.
English: Co-administration of PREVYMIS with these antivirals is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i ovih antivirusnih lijekova se ne preporučuje.
English: What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg film-coated tablets
Croatian: Kako PREVYMIS izgleda i sadržaj pakiranja PREVYMIS 240 mg filmom obložene tablete
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.
Croatian: 240 mg filmom obložena tableta je žuta ovalna tableta s utisnutom oznakom '591' na jednoj strani i logotipom MSD na drugoj strani.
English: Catheters Radiopaque polyurethane
Croatian: Kateteri radionepropusni poliuretan
English: When PREVYMIS is co-administered with cyclosporine, atorvastatin is contraindicated.
Croatian: Kada se PREVYMIS primjenjuje istodobno s ciklosporinom, atorvastatin je kontraindiciran.
English: Concomitant use is not recommended with PREVYMIS alone.
Croatian: Istodobna primjena s lijekom PREVYMIS primijenjenim samostalno se ne preporučuje.
English: This medicine contains less than 1 mmol sodium (23 mg) per 480 mg tablet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti od 480 mg, tj. zanemarive količine natrija.
English: Each 240 mg vial contains 23 mg sodium (main component of cooking/table salt).
Croatian: Jedna bočica od 240 mg sadrži 23 mg natrija (glavnog sastojka kuhinjske soli).
English: Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Croatian: Mikrokristalična celuloza (E460), umrežena karmelozanatrij (E468), povidon (E1201), koloidni, bezvodni silicijev dioksid (E551), magnezijev stearat (E470b).
English: This medicine contains less than 1 mmol sodium (23 mg) per 240 mg tablet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti od 240 mg, tj. zanemarive količine natrija.
English: • quinidine - for abnormal heart rhythms.
Croatian: • kinidin - koristi se za liječenje poremećaja srčanog ritma
English: CMV mutants with reduced susceptibility to letermovir have been confirmed in cell culture.
Croatian: U staničnoj su kulturi potvrđeni mutirani oblici CMV-a smanjene osjetljivosti na letermovir.
English: • PREVYMIS concentrate for solution for infusion is compatible with 0.9% sodium chloride and
Croatian: • PREVYMIS koncentrat za otopinu za infuziju kompatibilan je s 0,9%-tnom otopinom natrijeva klorida i 5%-tnom otopinom glukoze.
English: AUC 0.88 (0.80, 0.96) Cmax 0.75 (0.63, 0.89)
Croatian: ↔ digoksin AUC 0,88 (0,80; 0,96) Cmax 0,75 (0,63; 0,89)
English: Medicinal products transported by P-gp in the intestine Letermovir is an inducer of intestinal P-gp.
Croatian: Lijekovi koje prenosi P-gp u crijevima.
English: Add one single-dose vial (either 12 mL (240 mg dose) or 24 mL (480 mg dose)) of PREVYMIS concentrate for solution for infusion to a 250 mL pre-filled IV bag containing either 0.9% sodium chloride or 5% dextrose, and mix the diluted solution by gentle inversion.
Croatian: Dodajte sadržaj jedne jednodozne bočice PREVYMIS koncentrata za otopinu za infuziju (od 12 ml [doza od 240 mg] ili 24 ml [doza od 480 mg]) u napunjenu infuzijsku vrećicu volumena 250 ml koja sadrži 0,9%-tnu otopinu natrijeva klorida ili 5%-tnu otopinu glukoze, a zatim nježnim okretanjem promiješajte razrijeđenu otopinu.
English: PREVYMIS 480 mg concentrate for solution for infusion Each vial contains 480 mg (24 mL per vial) of letermovir.
Croatian: PREVYMIS 480 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 480 mg (24 ml po bočici) letermovira.
English: See also general information on induction above regarding time courses of the interaction.
Croatian: Za vremenski tijek interakcije vidjeti i prethodno navedene opće informacije o indukciji.
English: 240 mg IV, with cyclosporine
Croatian: 240 mg i.v, uz ciklosporin
English: (induction of CYP2C19)
Croatian: (indukcija CYP2C19)
English: Donor mismatch Matched related (n=108, 58)
Croatian: Podudaran krvni srodnik (n=108, 58)
English: phenytoin
Croatian: fenitoin
English: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Povidone (E1201) Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Croatian: Jezgra tablete celuloza, mikrokristalična (E460) karmelozanatrij, umrežena (E468) povidon (E1201) silicijev dioksid, koloidni, bezvodni (E551) magnezijev stearat (E470b)
English: Incompatible IV bags and infusion set materials PREVYMIS is incompatible with polyurethane-containing IV administration set tubing.
Croatian: Inkompatibilne infuzijske vrećice i infuzijski setovi PREVYMIS je inkompatibilan s cijevima za intravensku primjenu koje sadrže poliuretan.
English: How to take PREVYMIS 4.
Croatian: 3. Kako uzimati PREVYMIS
English: PREVYMIS 480 mg tablets letermovir
Croatian: PREVYMIS 480 mg tablete letermovir
English: (intestinal P-gp induction)
Croatian: (indukcija P-gp-a u crijevima)
English: (CYP3A, OATP1B1/3 inhibition)
Croatian: (inhibicija CYP3A, OATP1B1/3)
English: voriconazole (200 mg twice daily)/ letermovir (480 mg daily)
Croatian: vorikonazol (200 mg dvaput na dan)/letermovir (480 mg na dan)
English: ↔ posaconazole AUC 0.98 (0.82, 1.17) Cmax 1.11 (0.95, 1.29)
Croatian: ↔ posakonazol AUC 0,98 (0,82; 1,17) Cmax 1,11 (0,95; 1,29)
English: Frequent monitoring for adverse reactions related to amiodarone is recommended during co-administration.
Croatian: Preporučuje se često kontrolirati bolesnike tijekom istodobne primjene zbog mogućih nuspojava povezanih s primjenom amiodarona.
English: Statinassociated adverse events such as myopathy should be closely monitored.
Croatian: Potrebno je pažljivo praćenje zbog mogućih nuspojava povezanih sa statinima, kao što je miopatija.
English: • Folic acid
Croatian: • folatna kiselina telavancin
English: PREVYMIS 240 mg concentrate for solution for infusion Each vial contains 240 mg (12 mL per vial) of letermovir.
Croatian: 240 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 240 mg (12 ml po bočici) letermovira.
English: 480 mg Oral, no cyclosporine
Croatian: 480 mg peroralno, bez ciklosporina
English: • Fentanyl citrate
Croatian: • fentanilcitrat
English: These antivirals may decrease plasma concentration of letermovir.
Croatian: Ovi antivirusni lijekovi mogu sniziti koncentracije letermovira u plazmi.
English: Herbal products St. John's wort (Hypericum perforatum)
Croatian: Biljni lijekovi gospina trava (Hypericum perforatum)
English: ↔mycophenolic acid AUC 1.08 (0.97, 1.20) Cmax 0.96 (0.82, 1.12)
Croatian: ↔ mikofenolatna kiselina AUC 1,08 (0,97; 1,20) Cmax 0,96 (0,82; 1,12)
English: Frequent monitoring for adverse reactions related to these medicinal products is recommended during co-administration.
Croatian: Preporučuje se često kontrolirati bolesnike tijekom istodobne primjene zbog mogućih nuspojava povezanih s primjenom tih lijekova.
English: Multiple dose rifampicin decreases plasma concentrations of letermovir.
Croatian: Višestruke doze rifampicina snizuju koncentracije letermovira u plazmi.
English: Each vial contains 240 mg or 480 mg letermovir.
Croatian: Jedna bočica sadrži 240 mg ili 480 mg letermovira.
English: The recommended dose of PREVYMIS is one 480 mg tablet once a day.
Croatian: Preporučena doza lijeka PREVYMIS je jedna tableta od 480 mg jedanput na dan.
English: 480 mg IV, no cyclosporine
Croatian: 480 mg i.v, bez ciklosporina
English: When PREVYMIS is co-administered with cyclosporine, dabigatran is contraindicated.
Croatian: Kada se PREVYMIS primjenjuje istodobno s ciklosporinom, dabigatran je kontraindiciran.
English: Each 480 mg dose (24 mL vial) of this medicinal product contains 3600 mg hydroxypropylbetadex (cyclodextrin).
Croatian: Jedna doza ovog lijeka od 480 mg (bočica od 24 ml) sadrži 3600 mg hidroksipropilbetadeksa (ciklodekstrin).
English: Co-administration of PREVYMIS and rifabutin is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i rifabutina se ne preporučuje.
English: Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin).
Croatian: Jedna doza ovog lijeka od 240 mg (bočica od 12 ml) sadrži 1800 mg hidroksipropilbetadeksa (ciklodekstrin).
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of PREVYMIS in combination with cyclosporine and alfentanil or fentanyl.
Croatian: Kod istodobne primjene lijeka PREVYMIS u kombinaciji s ciklosporinom i alfentanila ili fentanila potrebno je pažljivo pratiti klinički status bolesnika zbog moguće depresije disanja i/ili produljene sedacije.
English: Caution is advised if other OATP1B1/3 inhibitors are added to letermovir combined with cyclosporine.
Croatian: Preporučuje se oprez ako se kombinaciji letermovira i ciklosporina dodaju drugi inhibitori OATP1B1/3.
English: 240 mg Oral, with cyclosporine
Croatian: 240 mg peroralno, uz ciklosporin
English: • Famotidine
Croatian: • famotidin takrolimus
English: PREVYMIS 480 mg sterile concentrate letermovir
Croatian: PREVYMIS 480 mg sterilni koncentrat letermovir
English: posaconazole (300 mg single dose)/ letermovir (480 mg daily)
Croatian: posakonazol (jedna doza od 300 mg)/letermovir (480 mg na dan)
English: Co-administration of PREVYMIS and rifampicin is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i rifampicina se ne preporučuje.
English: Each 480 mg dose (24 mL vial) of this medicine contains 3600 mg cyclodextrin.
Croatian: Jedna doza lijeka od 480 mg (bočica od 24 ml) sadrži 3600 mg ciklodekstrina.
English: Expected: ↑ CYP3A metabolised opioids
Croatian: Očekivano: ↑ opioidi koji se metaboliziraju putem CYP3A
English: Posology PREVYMIS is also available for oral administration (240 mg and 480 mg film-coated tablets).
Croatian: PREVYMIS je dostupan i u obliku za peroralnu primjenu (filmom obložene tablete od 240 mg i 480 mg).
English: Co-administration of PREVYMIS and nevirapine is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i nevirapina se ne preporučuje.
English: Each 12 mL vial contains 240 mg letermovir.
Croatian: Jedna bočica od 12 ml sadrži 240 mg letermovira.
English: • Tigecycline
Croatian: • ganciklovirnatrij tigeciklin
English: • Daptomycin
Croatian: • daptomicin mikafungin
English: Each film-coated tablet contains 240 mg of letermovir.
Croatian: Jedna filmom obložena tableta sadrži 240 mg letermovira.
English: Each film-coated tablet contains 480 mg of letermovir.
Croatian: Jedna filmom obložena tableta sadrži 480 mg letermovira.
English: Sedatives midazolam (1 mg single dose IV)/ letermovir (240 mg once daily PO)
Croatian: Sedativi midazolam (jedna doza od 1 mg i.v.)/letermovir (240 mg jedanput na dan peroralno)
English: Letermovir may decrease the plasma concentrations of dabigatran and may decrease efficacy of dabigatran.
Croatian: Letermovir može sniziti koncentracije dabigatrana u plazmi i smanjiti njegovu djelotvornost.
English: 31 May 2020 (PACMP Step 2)
Croatian: (2. korak prema PACMP-u)
English: Close clinical monitoring should be exercised during administration of PREVYMIS with quinidine.
Croatian: Kod istodobne primjene lijeka PREVYMIS i kinidina potrebno je pažljivo pratiti klinički status bolesnika.
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion
Croatian: 240 mg koncentrat za otopinu za infuziju PREVYMIS 480 mg koncentrat za otopinu za infuziju
English: Blister for 240 mg film-coated tablets
Croatian: Blister za 240 mg filmom obložene tablete
English: The recommended dose of PREVYMIS is 480 mg once a day.
Croatian: Preporučena doza lijeka PREVYMIS je 480 mg jedanput na dan.
English: ↔ acyclovir AUC 1.02 (0.87, 1.2) Cmax 0.82 (0.71, 0.93)
Croatian: ↔ aciklovir AUC 1,02 (0,87; 1,2) Cmax 0,82 (0,71; 0,93)
English: (600 mg once daily PO)/ letermovir (480 mg once daily PO)
Croatian: (600 mg jedanput na dan peroralno)/ letermovir (480 mg jedanput na dan peroralno)
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).
Croatian: Ako se PREVYMIS primjenjuje istodobno s ciklosporinom, dozu lijeka PREVYMIS treba smanjiti na 240 mg jedanput na dan (vidjeti dijelove 4.5 i 5.2).
English: Hepatobiliary disorders Uncommon alanine aminotransferase increased, aspartate aminotransferase increased
Croatian: Poremećaji jetre i žuči Manje često povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često grčevi u mišićima
English: Letermovir may increase the plasma concentrations of amiodarone.
Croatian: Letermovir može povisiti koncentracije amiodarona u plazmi.
English: Each 24 mL vial contains 480 mg of letermovir.
Croatian: Jedna bočica od 24 ml sadrži 480 mg letermovira.
English: midazolam (2 mg single dose PO) / letermovir (240 mg once daily PO)
Croatian: midazolam (jedna doza od 2 mg peroralno)/letermovir (240 mg jedanput na dan peroralno)
English: sirolimus (2 mg single dose)/ letermovir (480 mg daily)
Croatian: sirolimus (jedna doza od 2 mg)/letermovir (480 mg na dan)
English: PREVYMIS 240 mg tablets letermovir
Croatian: 240 mg tablete letermovir
English: Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin.
Croatian: Jedna doza lijeka od 240 mg (bočica od 12 ml) sadrži 1800 mg ciklodekstrina.
English: PREVYMIS vials are for single use only.
Croatian: PREVYMIS bočice namijenjene su samo za jednokratnu primjenu.
English: PREVYMIS should not be administered as an intravenous push or bolus.
Croatian: PREVYMIS se ne smije primijeniti brzom ili bolusnom intravenskom injekcijom.
English: 240 mg film-coated tablets
Croatian: 240 mg filmom obložene tablete
English: Blister for 480 mg film-coated tablets
Croatian: Blister za 480 mg filmom obložene tablete
English: Co-administration of PREVYMIS and thioridazine is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i tioridazina se ne preporučuje.
English: • Fluconazole
Croatian: • vorikonazola
English: Co-administration of PREVYMIS and etravirine is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i etravirina se ne preporučuje.
English: (Sum of OATP1B1/3 and/or Pgp inhibition and P-gp/UGT induction)
Croatian: (Zbroj inhibicije OATP1B1/3 i/ili P-gp-a i indukcije P-gp-a/UGT-a)
English: Co-administration of PREVYMIS and bosentan is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i bosentana se ne preporučuje.
English: Expected: ↔ valacyclovir
Croatian: Očekivano: ↔ valaciklovir
English: • Ceftriaxone sodium
Croatian: • ceftarolin pantoprazolnatrij
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).
Croatian: Ako se PREVYMIS primjenjuje istodobno s ciklosporinom, dozu lijeka PREVYMIS treba smanjiti na 240 mg jedanput na dan (vidjeti dijelove 4.2 i 5.1).
English: Co-administration of PREVYMIS and nafcillin is not recommended.
Croatian: Istodobna primjena lijeka PREVYMIS i nafcilina se ne preporučuje.
English: Letermovir may decrease the plasma concentrations of warfarin.
Croatian: Letermovir može sniziti koncentracije varfarina u plazmi.
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion letermovir
Croatian: 240 mg koncentrat za otopinu za infuziju PREVYMIS 480 mg koncentrat za otopinu za infuziju letermovir
English: Antifungals fluconazole (400 mg single dose)/letermovir (480 mg single dose)
Croatian: Antimikotici flukonazol (jedna doza od 400 mg)/letermovir (jedna doza od 480 mg)
English: Refer to the respective prescribing information
Croatian: Vidjeti odgovarajuće informacije o lijeku
English: 480 mg film-coated tablets
Croatian: 480 mg filmom obložene tablete
English: Uncommon abdominal pain
Croatian: Manje često bol u abdomenu
English: Letermovir may increase the plasma concentrations of quinidine.
Croatian: Letermovir može povisiti koncentracije kinidina u plazmi.
English: (CYP2C9/19 induction)
Croatian: (indukcija CYP2C9/19)
English: (OATP1B1/3 and/or P-gp inhibition)
Croatian: (inhibicija OATP1B1/3 i/ili P-gp-a)
English: (OATP1B1/3 and/or BCRP inhibition)
Croatian: (inhibicija OATP1B1/3 i/ili BCRP-a)
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets
Croatian: 240 mg filmom obložene tablete PREVYMIS 480 mg filmom obložene tablete
English: tacrolimus (5 mg single dose)/ letermovir (480 mg daily)
Croatian: takrolimus (jedna doza od 5 mg)/letermovir (480 mg na dan)
English: Rifabutin may decrease plasma concentrations of letermovir.
Croatian: Rifabutin može sniziti koncentracije letermovira u plazmi.
English: Discard if discolouration or visible particles are observed.
Croatian: Bacite je ako primijetite da je promijenila boju ili da sadrži vidljive čestice.
English: Letermovir may increase the plasma concentrations of glyburide.
Croatian: Letermovir može povisiti koncentracije gliburida u plazmi.
English: When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in concentrations of sirolimus may be greater than with PREVYMIS alone.
Croatian: Porast koncentracija sirolimusa može biti veći kada se PREVYMIS primjenjuje istodobno s ciklosporinom nego kada se PREVYMIS primjenjuje sam.
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets letermovir
Croatian: 240 mg filmom obložene tablete PREVYMIS 480 mg filmom obložene tablete letermovir
English: This should be taken into consideration by patients on a controlled sodium diet. PREVYMIS 480 mg concentrate for solution for infusion contains 46 mg (or 2.0 mmol) sodium per dose.
Croatian: PREVYMIS 480 mg koncentrat za otopinu za infuziju sadrži 46 mg (ili 2,0 mmol) natrija po dozi.
English: How you are given PREVYMIS
Croatian: Kako ćete primati PREVYMIS
English: Modafinil may decrease plasma concentrations of letermovir.
Croatian: Modafinil može sniziti koncentracije letermovira u plazmi.
English: Bioavailability of letermovir was estimated to be approximately 85% with 240 mg once daily oral letermovir co-administered with cyclosporine in patients.
Croatian: Kada se letermovir bolesnicima primjenjivao peroralno u dozi od 240 mg jedanput na dan zajedno s ciklosporinom, procijenjena bioraspoloživost letermovira iznosila je približno 85%.
English: Antivirals acyclovir (400 mg single dose)/ letermovir (480 mg daily)
Croatian: Antivirotici aciklovir (jedna doza od 400 mg)/letermovir (480 mg na dan)
English: Efficacy and safety has not been demonstrated for patients with ESRD.
Croatian: Djelotvornost i sigurnost nisu dokazane u bolesnika u terminalnoj fazi bubrežne bolesti.
English: Breast-feeding is not recommended while taking PREVYMIS.
Croatian: Ne preporučuje se primjena lijeka PREVYMIS tijekom dojenja.
English: • Potassium chloride
Croatian: • ceftriaksonnatrij kalijev klorid
English: mycophenolate mofetil (1 g single dose)/ letermovir (480 mg daily)
Croatian: mofetilmikofenolat (jedna doza od 1 g)/letermovir (480 mg na dan)
English: (600 mg single dose IV)/ letermovir (480 mg single dose PO)
Croatian: (jedna doza od 600 mg i.v.)/ letermovir (jedna doza od 480 mg peroralno)
English: PREVYMIS 480 mg film-coated tablets
Croatian: PREVYMIS 480 mg filmom obložene tablete
English: • Once diluted, the solution of PREVYMIS is clear, and ranges from colourless to yellow.
Croatian: • Otopina lijeka PREVYMIS je nakon razrjeđivanja bistra te bezbojna do žuta.