FrancophonIA/ELRC3.0 huggingface dataset:
English: (likely due to induction of CYP2C19)
Slovenian: (verjetno zaradi indukcije CYP2C19)
English: What you need to know before you take PREVYMIS 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PREVYMIS 3.
English: PREVYMIS concentrate for solution for infusion vials are for single use only.
Slovenian: Viale zdravila PREVYMIS koncentrat za raztopino za infundiranje so namenjene le za enkratno uporabo.
English: Based on population pharmacokinetic analyses, letermovir steady-state apparent CL is estimated to be 4.84 L/hr following intravenous administration of 480 mg in HSCT recipients.
Slovenian: Na osnovi analiz populacijske farmakokinetike ocenjeni navidezni očistek letermovirja v stanju dinamičnega ravnovesja pri prejemnikih HSCT po intravenski uporabi 480 mg odmerka znaša 4,84 l/uro.
English: Do not use the vial if the solution is discoloured or contains visible particles.
Slovenian: Če je raztopina obarvana ali vsebuje vidne delce, viale ne uporabite.
English: Vacuolation was noted in the kidneys of rats administered IV letermovir formulated with 1500 mg/kg/day of the cyclodextrin excipient hydroxypropylbetadex.
Slovenian: Vakuolizacijo so opazili v ledvicah podgan, ki so intravensko prejemale letermovir v farmacevtski obliki, ki je vsebovala 1.500 mg/kg/dan ciklodekstrinske pomožne snovi hidroksipropilbetadeksa.
English: What you need to know before you are given PREVYMIS 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo PREVYMIS 3.
English: Antipsychotics thioridazine
Slovenian: Antipsihotiki tioridazin
English: PREVYMIS 240 mg concentrate for solution for infusion contains 23 mg (or 1.0 mmol) sodium per dose.
Slovenian: Zdravilo PREVYMIS 240 mg koncentrat za raztopino za infundiranje vsebuje 23 mg (ali 1,0 mmol) natrija na odmerek.
English: No dose adjustment required.
Slovenian: Prilagoditev odmerka ni potrebna.
English: Pink oval, bi-convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and MSD logo on the other side.
Slovenian: Roza, ovalna tableta, bikonveksne oblike, velikosti 21,2 mm x 10,3 mm, z vtisnjeno oznako “595” na eni in logotipom MSD na drugi strani.
English: Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide yellow (E172), iron oxide red (only for 480 mg tablets) (E172), carnauba wax (E903).
Slovenian: Filmska obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) triacetin (E1518) rumeni železov oksid (E172) rdeči železov oksid (le v 480 mg tabletah) (E172) karnauba vosek (E903)
English: PREVYMIS concentrate for solution for infusion is a clear, colourless solution.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je bistra, brezbarvna raztopina.
English: • After dilution, administer PREVYMIS via intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Slovenian: • Po redčenju zdravilo PREVYMIS aplicirajte v obliki intravenske infuzije preko perifernega ali centralnega venskega katetra.
English: If you miss your appointment to get PREVYMIS It is very important that you do not miss or skip doses of PREVYMIS.
Slovenian: Če niste prejeli predvidenega odmerka zdravila PREVYMIS Zelo pomembno je, da ne izpustite ali pozabite nobenega odmerka zdravila PREVYMIS.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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.
Slovenian: • Vsebino ene viale z enkratnim odmerkom (bodisi 12 ml (odmerek 240 mg) bodisi 24 ml (odmerek 480 mg)) zdravila PREVYMIS koncentrat za raztopino za infundiranje dodajte v 250 ml napolnjeno intravensko vrečko, ki vsebuje 0,9 % natrijev klorid ali 5 % glukozo, in razredčeno raztopino premešajte s previdnim obračanjem.
English: Concomitant administration with ergot alkaloids: (see sections 4.4 and 4.5).
Slovenian: Sočasna uporaba alkaloidov ergot (glejte poglavji 4.4 in 4.5).
English: The 240 mg and 480 mg concentrate for solution for infusion is packaged in clear, glass vials.
Slovenian: 240 mg in 480 mg koncentrat za raztopino za infundiranje je na voljo v prozorni stekleni viali.
English: • Ceftaroline
Slovenian: • ceftarolin
English: • If cyclosporine is initiated after starting PREVYMIS, the next dose of PREVYMIS should be decreased to 240 mg once daily.
Slovenian: • Če se zdravljenje s ciklosporinom uvede po začetku zdravljenja z zdravilom PREVYMIS, je treba naslednji odmerek zdravila PREVYMIS zmanjšati na 240 mg enkrat na dan.
English: Each carton contains four (4) cardboard, each containing a 7-count blister card for a total of 28 tablets.
Slovenian: Ena škatla vsebuje štiri (4) kartonske ovitke s pretisnim omotom s 7 tabletami, tako da ena škatla vsebuje skupaj 28 tablet.
English: (CYP3A, OATP1B1/3 inhibition)
Slovenian: (zaviranje CYP3A, OATP1B1/3)
English: General disorders and administration site conditions Uncommon fatigue, oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije Občasni utrujenost, periferni edem
English: Intravenous use after dilution Single use only
Slovenian: intravenska uporaba po redčenju samo za enkratno uporabo
English: Do not use this medicine after the expiry date which is stated on the carton and blister card after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: (P-gp induction)
Slovenian: (indukcija P-gp)
English: (primarily CYP3A inhibition and CYP2C8 inhibition or induction)
Slovenian: (predvsem zaviranje CYP3A in zaviranje ali indukcija CYP2C8)
English: Expected: ↑ quinidine
Slovenian: Pričakovano: ↑ kinidin
English: Marked increases in letermovir unbound exposure are anticipated in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 4.2).
Slovenian: Pri bolnikih z zmerno okvaro jeter v kombinaciji z zmerno ali hudo okvaro ledvic se pričakuje izrazito povečanje izpostavljenosti nevezanemu letermovirju (glejte poglavje 4.2).
English: Posology PREVYMIS is also available for oral administration (240 mg and 480 mg film-coated tablets).
Slovenian: Zdravilo PREVYMIS je na voljo tudi za peroralno uporabo (240 mg in 480 mg filmsko obložene tablete).
English: Inhibitors of OATP1B1 or 3
Slovenian: Zaviralci OATP1B1 ali 3
English: Each 480 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Slovenian: Ena 480 mg filmsko obložena tableta vsebuje manj kot 1 mmol (23 mg) natrija.
English: ↓ voriconazole AUC 0.56 (0.51, 0.62) Cmax 0.61 (0.53, 0.71)
Slovenian: ↓ vorikonazol AUC 0,56 (0,51; 0,62) Cmax 0,61 (0,53; 0,71)
English: (intestinal P-gp induction)
Slovenian: (indukcija črevesnega P-gp)
English: Favors Placebo
Slovenian: letermovir placebo
English: • Hydrocortisone sodium succinate
Slovenian: • hidrokortizon natrijev sukcinat
English: There is no experience with human overdose with PREVYMIS.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila PREVYMIS pri človeku ni.
English: • Voriconazole
Slovenian: • vorikonazol
English: PREVYMIS 480 mg concentrate for solution for infusion Each vial contains 480 mg (24 mL per vial) of letermovir.
Slovenian: PREVYMIS 480 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 480 mg (24 ml na vialo) letermovirja.
English: Herbal products St. John's wort (Hypericum perforatum)
Slovenian: Pripravki rastlinskega izvora šentjanževka (Hypericum perforatum)
English: Donor mismatch Matched related (n=108, 58)
Slovenian: neujemanje dajalca usklajen soroden (n = 108, 58)
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.
Slovenian: Vsebino ene viale z enkratnim odmerkom (bodisi 12 ml (odmerek 240 mg) bodisi 24 ml (odmerek 480 mg)) zdravila PREVYMIS koncentrat za raztopino za infundiranje dodajte v 250 ml napolnjeno intravensko vrečko, ki vsebuje 0,9 % natrijev klorid ali 5 % glukozo, in razredčeno raztopino premešajte s previdnim obračanjem.
English: -Examples of medicinal products that are metabolised by CYP2B6 include bupropion.
Slovenian: - Primer zdravila, ki se presnavlja s CYP2B6, je: bupropion.
English: • voriconazole - for fungal infections
Slovenian: • vorikonazol - uporablja se za zdravljenje glivičnih okužb
English: (Sum of OATP1B1/3 and/or Pgp inhibition and P-gp/UGT induction)
Slovenian: (vsota zaviranja OATP1B1/3 in/ali P-gp ter indukcije P-gp/UGT)
English: Expected: ↑ glyburide
Slovenian: Pričakovano: ↑ gliburid
English: PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh C) uporaba zdravila PREVYMIS ni priporočljiva (glejte poglavje 5.2).
English: Bioavailability of letermovir was estimated to be approximately 85% with 240 mg once daily oral letermovir co-administered with cyclosporine in patients.
Slovenian: Ocenjena biološka uporabnost letermovirja je pri bolnikih pri uporabi letermovirja v peroralnem odmerku 240 mg enkrat na dan skupaj s ciklosporinom znašala približno 85 %.
English: PREVYMIS should be administered as an intravenous (IV) infusion only.
Slovenian: Zdravilo PREVYMIS je treba aplicirati samo v obliki intravenske (i.v.)
English: 480 mg Oral, no cyclosporine
Slovenian: 480 mg peroralno, brez ciklosporina
English: Frequent monitoring for adverse reactions related to these medicinal products is recommended during co-administration.
Slovenian: Pri sočasni uporabi je priporočljivo pogosto spremljanje neželenih učinkov teh zdravil.
English: Cardiovascular medicinal products digoxin (0.5 mg single dose)/ letermovir (240 mg twice daily)
Slovenian: Zdravila za bolezni srca in ožilja digoksin (0,5 mg enkratni odmerek)/letermovir (240 mg dvakrat na dan)
English: Mutagenesis
Slovenian: Mutagenost
English: After dilution, PREVYMIS should be administered by intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Slovenian: Po redčenju je treba zdravilo PREVYMIS aplicirati v obliki intravenske infuzije preko perifernega ali centralnega venskega katetra.
English: • Tigecycline *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Slovenian: • fentanilijev citrat *Za potrditev kompatibilnosti pri sočasni uporabi glejte povzetke glavnih značilnosti zdravila.
English: (600 mg once daily PO (24 hours after rifampicin)) letermovir (480 mg once daily PO)
Slovenian: (600 mg enkrat dnevno p.o. (24 ur po rifampicinu)) letermovir (480 mg enkrat dnevno p.o.)
English: Each 12 mL vial contains 240 mg letermovir.
Slovenian: Ena 12 ml viala vsebuje 240 mg letermovirja.
English: PREVYMIS concentrate for solution for infusion must be diluted prior to intravenous (IV) use.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je treba pred intravensko (i.v.)
English: Each 240 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Slovenian: Ena 240 mg filmsko obložena tableta vsebuje manj kot 1 mmol (23 mg) natrija.
English: Frequent monitoring of sirolimus whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of sirolimus adjusted accordingly Frequent monitoring of sirolimus concentrations is recommended at initiation or discontinuation of cyclosporine coadministration with PREVYMIS.
Slovenian: Med zdravljenjem je treba pogosto spremljati koncentracije sirolimusa v polni krvi, prav tako pa tudi pri spremembi poti uporabe zdravila PREVYMIS in ukinitvi zdravljenja z zdravilom PREVYMIS ter odmerek sirolimusa ustrezno prilagoditi Pri uvedbi ali ukinitvi uporabe ciklosporina skupaj z zdravilom PREVYMIS je priporočljivo pogosto spremljanje koncentracij sirolimusa.
English: Frequent monitoring for adverse reactions related to amiodarone is recommended during co-administration.
Slovenian: Pri sočasni uporabi je priporočljivo pogosto spremljanje neželenih učinkov amiodarona.
English: Frequent monitoring of cyclosporine whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of cyclosporine adjusted accordingly cyclosporine (200 mg single dose)/ letermovir (240 mg daily)
Slovenian: Med zdravljenjem je treba pogosto spremljati koncentracije ciklosporina v polni krvi, prav tako pa tudi pri spremembi poti uporabe zdravila PREVYMIS in ukinitvi zdravljenja z zdravilom PREVYMIS, ter odmerek ciklosporina ustrezno prilagoditi ciklosporin (200 mg enkratni odmerek)/letermovir (240 mg dnevno)
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.
Slovenian: Pri kuncih so toksičnost za samice (vključno z umrljivostjo in splavi) opazili pri odmerku 225 mg/kg/dan (približno 2-kratna vrednost AUC pri uporabi priporočenega odmerka za človeka).
English: What you need to know before you are given PREVYMIS
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo PREVYMIS
English: Each film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
Slovenian: Ena filmsko obložena tableta vsebuje 240 mg letermovirja ali 480 mg letermovirja.
English: Close clinical monitoring should be exercised during administration of PREVYMIS with quinidine.
Slovenian: Med uporabo zdravila PREVYMIS s kinidinom je potrebno skrbno klinično spremljanje.
English: Administration instructions for PREVYMIS concentrate for solution for infusion
Slovenian: Navodila za aplikacijo zdravila PREVYMIS koncentrat za raztopino za infundiranje
English: 480 mg IV, no cyclosporine
Slovenian: 480 mg i.v., brez ciklosporina
English: Expected: ↔ letermovir
Slovenian: Pričakovano: ↔ letermovir
English: If you are on a low sodium diet, talk to your doctor before you are given this medicine.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: There was no developmental toxicity observed up to the highest exposure tested (2-fold the AUC at the RHD).
Slovenian: Škodljivih vplivov na razvoj do največje raziskane izpostavljenosti (2-kratna vrednost AUC pri uporabi priporočenega odmerka za človeka) niso opazili.
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).
Slovenian: Pri samcih podgan so pri sistemski izpostavljenosti, ki je bila na osnovi AUC ≥ 3-krat večja od izpostavljenosti človeka pri uporabi priporočenega odmerka za človeka, opazili zmanjšano koncentracijo semenčic, zmanjšano gibljivost semenčic in zmanjšano plodnost (glejte Splošna toksičnost).
English: Thirty-seven percent (37%) of subjects were engrafted at baseline.
Slovenian: V izhodišču je bila vsaditev opravljena pri 37 % preiskovancev.
English: • Ceftriaxone sodium
Slovenian: • natrijev ceftriaksonat
English: No dose adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment.
Slovenian: Pri bolnikih z blago (Child-Pugh A) do zmerno (Child-Pugh B) okvaro jeter prilagoditev odmerka zdravila PREVYMIS ni potrebna.
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.
Slovenian: PREVYMIS 480 mg filmsko obložena tableta je roza, ovalna tableta, bikonveksne oblike, z vtisnjeno oznako “595” na eni in logotipom MSD na drugi strani.
English: HMG-CoA reductase inhibitors atorvastatin (20 mg single dose)/ letermovir (480 mg daily)
Slovenian: Zaviralci reduktaze HMG-CoA atorvastatin (20 mg enkratni odmerek)/letermovir (480 mg dnevno)
English: Do not shake PREVYMIS vial.
Slovenian: Viale zdravila PREVYMIS ne stresajte.
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.
Slovenian: Pri uporabi zdravila PREVYMIS v kombinaciji s ciklosporinom in alfentanilom ali fentanilom je treba skrbno klinično spremljati respiratorno depresijo in/ali podaljšano sedacijo.
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.
Slovenian: PREVYMIS 240 mg filmsko obložena tableta je rumena, ovalna tableta z vtisnjeno oznako “591” na eni in logotipom MSD na drugi strani.
English: ↓ phenytoin
Slovenian: ↓ fenitoin
English: • Methotrexate
Slovenian: • metotreksat
English: AUC 0.88 (0.80, 0.96) Cmax 0.75 (0.63, 0.89)
Slovenian: ↔ digoksin AUC 0,88 (0,80; 0,96) Cmax 0,75 (0,63; 0,89)
English: In HSCT recipients, co-administration of cyclosporine increased plasma concentrations of letermovir due to inhibition of OATP1B.
Slovenian: Pri prejemnikih HSCT se je pri sočasni uporabi ciklosporina zaradi zaviranja OATP1B plazemska koncentracija letermovirja povečala.
English: Efficacy and safety has not been demonstrated for patients with ESRD.
Slovenian: Učinkovitost in varnost pri bolnikih s končno ledvično odpovedjo nista bili dokazani.
English: Once diluted, the solution of PREVYMIS is clear, and ranges from colourless to yellow.
Slovenian: Razredčena raztopina zdravila PREVYMIS je bistra in brezbarvna do rumena.
English: Table 2: Adverse reactions identified with PREVYMIS Frequency
Slovenian: Preglednica 2: Neželeni učinki zdravila PREVYMIS Pogostnost
English: PREVYMIS 240 mg film-coated tablets Each film-coated tablet contains 240 mg of letermovir.
Slovenian: PREVYMIS 240 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 240 mg letermovirja.
English: Each vial contains 240 mg or 480 mg letermovir.
Slovenian: Ena viala vsebuje 240 mg ali 480 mg letermovirja.
English: PREVYMIS vials are for single use only.
Slovenian: Viale zdravila PREVYMIS so namenjene samo za enkratno uporabo.
English: (induction of CYP2C19)
Slovenian: (indukcija CYP2C19)
English: Monitoring of amiodarone concentrations should be performed regularly when amiodarone is co-administered with PREVYMIS
Slovenian: Če se amiodaron uporablja skupaj z zdravilom PREVYMIS, je treba pogosto spremljati koncentracije amiodarona kinidin
English: • Potassium chloride
Slovenian: • kalijev klorid
English: When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in plasma concentrations of CYP3A metabolised opioids may be greater.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, se plazemske koncentracije opioidov, ki se presnavljajo s CYP3A, lahko povečajo v večjem obsegu.
English: PREVYMIS 240 mg concentrate for solution for infusion Each vial contains 240 mg (12 mL per vial) of letermovir.
Slovenian: PREVYMIS 240 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 240 mg (12 ml na vialo) letermovirja.
English: Each 24 mL vial contains 480 mg of letermovir.
Slovenian: Ena 24 ml viala vsebuje 480 mg letermovirja.
English: Each 480 mg dose (24 mL vial) of this medicine contains 3600 mg cyclodextrin.
Slovenian: En 480 mg odmerek (24 ml na vialo) tega zdravila vsebuje 3.600 mg ciklodekstrina.
English: Frequent monitoring of tacrolimus whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of tacrolimus adjusted accordingly tacrolimus (5 mg single dose)/ letermovir (80 mg twice daily)
Slovenian: Med zdravljenjem je treba pogosto spremljati koncentracije takrolimusa v polni krvi, prav tako pa tudi pri spremembi poti uporabe zdravila PREVYMIS in ukinitvi zdravljenja z zdravilom PREVYMIS ter odmerek takrolimusa ustrezno prilagoditi takrolimus (5 mg enkratni odmerek)/letermovir (80 mg dvakrat na dan)
English: • PREVYMIS concentrate for solution for infusion is compatible with 0.9% sodium chloride and
Slovenian: • Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je kompatibilno z 0,9 % raztopino natrijevega klorida in 5 % raztopino glukoze.
English: What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg film-coated tablets
Slovenian: Izgled zdravila PREVYMIS in vsebina pakiranja PREVYMIS 240 mg filmsko obložene tablete
English: PREVYMIS 480 mg film-coated tablets Each film-coated tablet contains 480 mg of letermovir.
Slovenian: PREVYMIS 480 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 480 mg letermovirja.
English: Concomitant medicinal product
Slovenian: Priporočila glede sočasne uporabe z zdravilom PREVYMIS
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.
Slovenian: V študijah pri človeku med intravensko uporabo letermovirja in trajanjem zdravljenja do 47 dni ni bilo primerov poškodbe ledvic zaradi hidroksipropilbetadeksa.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: There was no testicular toxicity in rats at exposures (AUC) similar to the exposures in humans at the RHD.
Slovenian: Pri podganah toksičnosti za moda pri izpostavljenostih (AUC), ki so bile podobne izpostavljenostim človeka pri uporabi priporočenega odmerka za človeka, niso ugotovili.
English: phenytoin
Slovenian: fenitoin
English: ↔mycophenolic acid AUC 1.08 (0.97, 1.20) Cmax 0.96 (0.82, 1.12)
Slovenian: ↔ mikofenolna kislina AUC 1,08 (0,97; 1,20) Cmax 0,96 (0,82; 1,12)
English: • Tigecycline
Slovenian: • tigeciklin
English: Discard any unused portion.
Slovenian: Neporabljeno zdravilo zavrzite.
English: ↔ posaconazole AUC 0.98 (0.82, 1.17) Cmax 1.11 (0.95, 1.29)
Slovenian: ↔ posakonazol AUC 0,98 (0,82; 1,17) Cmax 1,11 (0,95; 1,29)
English: PREVYMIS 240 mg tablets letermovir
Slovenian: PREVYMIS 240 mg tablete letermovir
English: When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in concentrations of sirolimus may be greater than with PREVYMIS alone.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, se koncentracije sirolimusa lahko povečajo v večjem obsegu kot pri uporabi zdravila PREVYMIS samega.
English: Hepatobiliary disorders Uncommon alanine aminotransferase increased, aspartate aminotransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov Občasni zvišanje vrednosti alanin-aminotransferaze, zvišanje vrednosti aspartat-aminotransferaze Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni mišični krči
English: In preclinical distribution studies, letermovir is distributed to organs and tissues with the highest concentrations observed in the gastrointestinal tract, bile duct and liver and low concentrations in the brain.
Slovenian: Največje koncentracije so opazili v prebavilih, žolčnih izvodilih in jetrih, koncentracije v možganih pa so bile majhne.
English: Letermovir may increase the plasma concentrations of amiodarone.
Slovenian: Letermovir lahko poveča plazemske koncentracije amiodarona.
English: Refer to the respective prescribing information (see section 4.4).
Slovenian: Glejte ustrezne povzetke glavnih značilnosti zdravila (glejte poglavje 4.4).
English: Anti-arrhythmic medicinal products amiodarone
Slovenian: Antiaritmiki amiodaron
English: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Povidone (E1201) Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Slovenian: povidon (E1201) brezvodni koloidni silicijev dioksid (E551) magnezijev stearat (E470b)