FrancophonIA/ELRC3.0 huggingface dataset:
English: • being sick (vomiting)
Slovenian: • slabost (navzea)
English: Antimycobacterials rifabutin
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifabutin
English: PREVYMIS 480 mg tablets letermovir
Slovenian: PREVYMIS 480 mg tablete letermovir
English: Each film-coated tablet contains 240 mg of letermovir.
Slovenian: Ena filmsko obložena tableta vsebuje 240 mg letermovirja.
English: • modafinil - for wakefulness
Slovenian: • modafinil - uporablja se za vzdrževanje budnosti
English: When PREVYMIS is co-administered with cyclosporine, also refer to the sirolimus prescribing information for specific dosing recommendations for use of sirolimus with cyclosporine.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, za posebna priporočila glede odmerjanja pri uporabi sirolimusa skupaj s ciklosporinom glejte tudi povzetek glavnih značilnosti zdravila za sirolimus.
English: posaconazole (300 mg single dose)/ letermovir (480 mg daily)
Slovenian: posakonazol (300 mg enkratni odmerek)/letermovir (480 mg dnevno)
English: The recommended dose of PREVYMIS is one 480 mg tablet once a day.
Slovenian: Priporočeni odmerek zdravila PREVYMIS je ena 480 mg tableta enkrat na dan.
English: Letermovir may increase the plasma concentrations of glyburide.
Slovenian: Letermovir lahko poveča plazemske koncentracije gliburida.
English: midazolam (2 mg single dose PO) / letermovir (240 mg once daily PO)
Slovenian: midazolam (2 mg, enkratni odmerek p.o.)/ letermovir (240 mg enkrat na dan p.o.)
English: When PREVYMIS is co-administered with cyclosporine, atorvastatin is contraindicated.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, je uporaba atorvastatina kontraindicirana.
English: Breast-feeding is not recommended while taking PREVYMIS.
Slovenian: Med jemanjem zdravila PREVYMIS dojenje ni priporočljivo.
English: PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 5.2).
Slovenian: Pri bolnikih z zmerno okvaro jeter v kombinaciji z zmerno ali hudo okvaro ledvic uporaba zdravila PREVYMIS ni priporočljiva (glejte poglavje 5.2).
English: Co-administration of PREVYMIS and rifampicin is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in rifampicina ni priporočljiva.
English: Letermovir may increase the plasma concentrations of quinidine.
Slovenian: Letermovir lahko poveča plazemske koncentracije kinidina.
English: In healthy subjects, the geometric mean steady-state AUC and Cmax values were 71,500 ng•hr/mL and 13,000 ng/mL, respectively, with 480 mg once daily oral letermovir.
Slovenian: Pri zdravih preiskovancih je pri peroralni uporabi letermovirja v odmerku 480 mg enkrat na dan geometrična srednja vrednost AUC v stanju dinamičnega ravnovesja znašala 71.500 ng•h/ml, geometrična srednja vrednost Cmax v stanju dinamičnega ravnovesja pa 13.000 ng/ml.
English: Polyamide/Aluminium/PVC - Aluminium blister card. Each carton contains four (4) cardboard cards, each containing a 7-count blister card for a total of 28 tablets.
Slovenian: Vsak kartonski ovitek vsebuje pretisni omot iz poliamida/aluminija/PVC - aluminija s 7 tabletami, tako da ena škatla vsebuje skupaj 28 tablet.
English: voriconazole (200 mg twice daily)/ letermovir (480 mg daily)
Slovenian: vorikonazol (200 mg dvakrat na dan)/letermovir (480 mg dnevno)
English: How you are given PREVYMIS 4.
Slovenian: Kako se uporablja zdravilo PREVYMIS 4.
English: These antivirals may decrease plasma concentration of letermovir.
Slovenian: Ta protivirusna zdravila lahko zmanjšajo plazemsko koncentracijo letermovirja.
English: Each film-coated tablet contains 480 mg of letermovir.
Slovenian: Ena filmsko obložena tableta vsebuje 480 mg letermovirja.
English: This is because PREVYMIS has not been tested in this age group.
Slovenian: Zdravilo PREVYMIS v tej starostni skupini ni bilo raziskano.
English: Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin.
Slovenian: En 240 mg odmerek (12 ml na vialo) tega zdravila vsebuje 1.800 mg ciklodekstrina.
English: • swelling of hands or feet
Slovenian: • otekanje rok in nog
English: • Caspofungin
Slovenian: • kaspofungin
English: 240 mg film-coated tablets
Slovenian: 240 mg filmsko obložene tablete
English: Multiple dose rifampicin decreases plasma concentrations of letermovir.
Slovenian: Večkratni odmerki rifampicina zmanjšajo plazemsko koncentracijo letermovirja.
English: When PREVYMIS is co-administered with cyclosporine, refer also to the glyburide prescribing information for specific dosing recommendations.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, za specifična priporočila za odmerjanje gliburida glejte tudi ustrezen povzetek glavnih značilnosti zdravila.
English: It is very important that you do not miss or skip doses of PREVYMIS.
Slovenian: Zelo pomembno je, da odmerka zdravila PREVYMIS ne pozabite vzeti ali ga izpustite.
English: Co-administration of PREVYMIS and St. John's wort is contraindicated.
Slovenian: Sočasna uporaba zdravila PREVYMIS in šentjanževke je kontraindicirana.
English: Antifungals fluconazole (400 mg single dose)/letermovir (480 mg single dose)
Slovenian: Antimikotiki flukonazol (400 mg enkratni odmerek)/letermovir (480 mg enkratni odmerek)
English: Co-administration of PREVYMIS and rifabutin is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in rifabutina ni priporočljiva.
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of PREVYMIS with midazolam.
Slovenian: Pri sočasni uporabi zdravila PREVYMIS z midazolamom je treba skrbno klinično spremljati respiratorno depresijo in/ali podaljšano sedacijo.
English: The recommended dose of PREVYMIS is 480 mg once a day.
Slovenian: Priporočeni odmerek zdravila PREVYMIS je 480 mg enkrat na dan.
English: ↔ acyclovir AUC 1.02 (0.87, 1.2) Cmax 0.82 (0.71, 0.93)
Slovenian: ↔ aciklovir AUC 1,02 (0,87; 1,2) Cmax 0,82 (0,71; 0,93)
English: Each 480 mg dose (24 mL vial) of this medicinal product contains 3600 mg hydroxypropylbetadex (cyclodextrin).
Slovenian: En 480 mg odmerek (24 ml na vialo) tega zdravila vsebuje 3.600 mg hidroksipropilbetadeksa (ciklodekstrin).
English: sirolimus (2 mg single dose)/ letermovir (480 mg daily)
Slovenian: sirolimus (2 mg enkratni odmerek)/letermovir (480 mg dnevno)
English: (600 mg single dose PO)/ letermovir (480 mg single dose PO)
Slovenian: (600 mg enkratni odmerek p.o.)/ letermovir (480 mg enkratni odmerek p.o.)
English: Expected: ↔ valacyclovir
Slovenian: Pričakovano: ↔ valaciklovir
English: Renal and urinary disorders Uncommon blood creatinine increased
Slovenian: Bolezni sečil Občasni zvišanje vrednosti kreatinina v krvi
English: No dose adjustment of PREVYMIS is recommended for patients with mild, moderate, or severe renal impairment.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic prilagoditev odmerka zdravila PREVYMIS ne priporočamo.
English: Inspect vial contents for discolouration and particulate matter prior to dilution.
Slovenian: Pred redčenjem vsebino viale preglejte glede spremembe barve in prisotnosti delcev.
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets
Slovenian: PREVYMIS 240 mg filmsko obložene tablete PREVYMIS 480 mg filmsko obložene tablete
English: (OATP1B1/3 and/or BCRP inhibition)
Slovenian: (zaviranje OATP1B1/3 in/ali BCRP)
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.
Slovenian: Zdravilo PREVYMIS 480 mg koncentrat za raztopino za infundiranje vsebuje 46 mg (ali 2,0 mmol) natrija na odmerek.
English: • Ampicillin sodium
Slovenian: • natrijev ampicilinat
English: The dose of atorvastatin should not exceed 20 mg daily when co-administered with PREVYMIS
Slovenian: Pri sočasni uporabi z zdravilom PREVYMIS odmerek atorvastatina ne sme biti večji od 20 mg na dan
English: Immunosuppressants cyclosporine (50 mg single dose)/ letermovir (240 mg daily)
Slovenian: Zdravila za zaviranje imunske odzivnosti ciklosporin (50 mg enkratni odmerek)/letermovir (240 mg dnevno)
English: Co-administration of PREVYMIS and nevirapine is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in nevirapina ni priporočljiva.
English: • Ampicillin sodium/Sulbactam sodium • Human insulin
Slovenian: • natrijev ampicilinat/natrijev sulbaktamat
English: The elimination pathways of letermovir in vivo are biliary excretion and glucuronidation.
Slovenian: Letermovir se in vivo izloča z žolčem in glukuronidacijo.
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.
Slovenian: Na splošno je prva dva tedna po začetku ali koncu zdravljenja z letermovirjem pa tudi po spremembi poti uporabe letermovirja priporočljivo pogostejše spremljanje ciklosporina, takrolimusa in sirolimusa (glejte poglavje 4.5).
English: Proton pump inhibitors omeprazole
Slovenian: Zaviralci protonske črpalke omeprazol
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion
Slovenian: PREVYMIS 240 mg koncentrat za raztopino za infundiranje PREVYMIS 480 mg koncentrat za raztopino za infundiranje
English: Drug interactions
Slovenian: Interakcije z zdravili
English: 480 mg film-coated tablets
Slovenian: 480 mg filmsko obložene tablete
English: (OATP1B1/3 and/or P-gp inhibition)
Slovenian: (zaviranje OATP1B1/3 in/ali P-gp)
English: Vial label for 480 mg concentrate for solution for infusion
Slovenian: Nalepka za vialo za 480 mg koncentrat za raztopino za infundiranje
English: If they do not remember until it is time for the next dose, they should skip the missed dose and go back to the regular schedule.
Slovenian: Če je že čas za naslednji odmerek, naj pozabljeni odmerek izpustijo in nadaljujejo z jemanjem zdravila ob običajnem času.
English: For oral use.
Slovenian: Način uporabe za peroralno uporabo
English: Co-administration of PREVYMIS and thioridazine is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in tioridazina ni priporočljiva.
English: If concomitant administration is necessary, TDM for voriconazole is recommended the first 2 weeks after initiating or ending letermovir, as well as after changing route of administration of letermovir or immunosuppressant.
Slovenian: Če je potrebna sočasna uporaba, je prva 2 tedna po začetku ali koncu uporabe letermovirja pa tudi po spremembi poti uporabe letermovirja ali zamenjavi zdravila za zaviranje imunske odzivnosti priporočljivo spremljanje terapevtskih koncentracij (TDM) vorikonazola.
English: Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin).
Slovenian: En 240 mg odmerek (12 ml na vialo) tega zdravila vsebuje 1.800 mg hidroksipropilbetadeksa (ciklodekstrin).
English: PREVYMIS should not be administered as an intravenous push or bolus.
Slovenian: Zdravila PREVYMIS se ne sme aplicirati s hitro intravensko infuzijo ali bolusno injekcijo.
English: The recommended dosage of PREVYMIS is one 480 mg tablet once daily.
Slovenian: Priporočeni odmerek zdravila PREVYMIS je ena 480 mg tableta na dan.
English: Vial label for 240 mg concentrate for solution for infusion
Slovenian: Nalepka za vialo za 240 mg koncentrat za raztopino za infundiranje
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion letermovir
Slovenian: PREVYMIS 240 mg koncentrat za raztopino za infundiranje PREVYMIS 480 mg koncentrat za raztopino za infundiranje letermovir
English: Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products (see section 4.5).
Slovenian: Zaradi indukcije se lahko zmanjša plazemska koncentracija nekaterih zdravil, ki se presnavljajo ali prenašajo s temi encimi/prenašalci (glejte poglavje 4.5), zato je priporočljivo spremljanje terapevtskih koncentracij (TDM - Therapeutic Drug Monitoring) vorikonazola.
English: Frequent monitoring of glucose concentrations is recommended the first 2 weeks after initiating or ending letermovir, as well as after changing route of administration of letermovir.
Slovenian: Prva 2 tedna po začetku ali koncu uporabe letermovirja, pa tudi pri spremembi poti uporabe letermovirja, se priporoča pogosto spremljanje koncentracije glukoze.
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets letermovir
Slovenian: PREVYMIS 240 mg filmsko obložene tablete PREVYMIS 480 mg filmsko obložene tablete letermovir
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).
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, je treba odmerek zdravila PREVYMIS zmanjšati na 240 mg enkrat na dan (glejte poglavji 4.2 in 5.1).
English: Expected: ↑ CYP3A metabolised opioids
Slovenian: Pričakovano: ↑ opioidi, ki se presnavljajo s CYP3A
English: Co-administration of PREVYMIS with these antivirals is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS s temi protivirusnimi zdravili ni priporočljiva.
English: (CYP2C9/19 induction)
Slovenian: (indukcija CYP2C9/19)
English: Rifabutin may decrease plasma concentrations of letermovir.
Slovenian: Rifabutin lahko zmanjša plazemske koncentracije letermovirja.
English: PREVYMIS 480 mg film-coated tablets
Slovenian: PREVYMIS 480 mg filmsko obložene tablete
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).
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, je treba odmerek zdravila PREVYMIS zmanjšati na 240 mg na dan (glejte poglavji 4.5 in 5.2).
English: • Folic acid
Slovenian: • kalijev fosfat
English: When PREVYMIS is co-administered with cyclosporine, dabigatran is contraindicated.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, je uporaba dabigatrana kontraindicirana.
English: What you need to know before you take PREVYMIS
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PREVYMIS
English: Letermovir may decrease the plasma concentrations of warfarin.
Slovenian: Letermovir lahko zmanjša plazemske koncentracije varfarina.
English: Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and MSD logo on the other side.
Slovenian: PREVYMIS 240 mg filmsko obložene tablete Rumena, ovalna tableta, velikosti 16,5 mm x 8,5 mm, z vtisnjeno oznako “591” na eni in logotipom MSD na drugi strani.
English: PREVYMIS 240 mg sterile concentrate letermovir
Slovenian: PREVYMIS 240 mg koncentrat za raztopino za infundiranje letermovir
English: mycophenolate mofetil (1 g single dose)/ letermovir (480 mg daily)
Slovenian: mofetilmikofenolat (1 g enkratni odmerek)/letermovir (480 mg dnevno)
English: CMV DNAemia warranting anti-CMV PET
Slovenian: CMV DNA-emija, ki je zahtevala PET proti CMV 52 (16,0)
English: (600 mg once daily PO)/ letermovir (480 mg once daily PO)
Slovenian: (600 mg enkrat dnevno p.o.)/ letermovir (480 enkrat dnevno p.o.)
English: (OATP1B1/3 inhibition)
Slovenian: (zaviranje OATP1B1/3)
English: tacrolimus (5 mg single dose)/ letermovir (480 mg daily)
Slovenian: takrolimus (5 mg enkratni odmerek)/letermovir (480 mg dnevno)
English: • diarrhoea
Slovenian: • bruhanje
English: Medicinal products transported by P-gp in the intestine Letermovir is an inducer of intestinal P-gp.
Slovenian: Zdravila, ki se v črevesu prenašajo s P-gp
English: (CYP2C9 induction)
Slovenian: (indukcija CYP2C9)
English: Modafinil may decrease plasma concentrations of letermovir.
Slovenian: Modafinil lahko zmanjša plazemske koncentracije letermovirja.
English: fluvastatin, pravastatin
Slovenian: izpuščaj ali koprivnica, srbenje, otekanje
English: PREVYMIS 480 mg sterile concentrate letermovir
Slovenian: PREVYMIS 480 mg koncentrat za raztopino za infundiranje letermovir
English: Nevirapine may decrease plasma concentrations of letermovir.
Slovenian: Nevirapin lahko zmanjša plazemske koncentracije letermovirja.
English: Bosentan may decrease plasma concentrations of letermovir.
Slovenian: Bosentan lahko zmanjša plazemske koncentracije letermovirja.
English: Co-administration of PREVYMIS and etravirine is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in etravirina ni priporočljiva.
English: Nafcillin may decrease plasma concentrations of letermovir.
Slovenian: Nafcilin lahko zmanjša plazemske koncentracije letermovirja.
English: If you are breast-feeding or are planning to breast-feed, tell your doctor before taking this medicine.
Slovenian: Če dojite ali nameravate dojiti, o tem obvestite zdravnika, preden vzamete to zdravilo.
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.
Slovenian: Pri mladičih so opazili manjšo telesno maso plodov z zapoznelo osifikacijo, rahlo edematozne plodove in večjo pojavnost skrajšane popkovnice ter variacij in malformacij vretenc, reber in medenice.
English: Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Slovenian: Jedro tablete mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468), povidon (E1201), brezvodni koloidni silicijev dioksid (E551), magnezijev stearat (E470b) 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: Outer carton for 240 mg concentrate for solution for infusion
Slovenian: Škatla za 240 mg koncentrat za raztopino za infundiranje
English: Etravirine may decrease plasma concentrations of letermovir.
Slovenian: Etravirin lahko zmanjša plazemske koncentracije letermovirja.
English: PREVYMIS is not recommended in pregnancy.
Slovenian: Uporaba zdravila PREVYMIS med nosečnostjo ni priporočljiva.
English: Outer carton for 480 mg concentrate for solution for infusion
Slovenian: Škatla za 480 mg koncentrat za raztopino za infundiranje
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.
Slovenian: Zato so klinične posledice interakcij letermovirja odvisne od režima uporabe letermovirja in ali se letermovir uporablja v kombinaciji s ciklosporinom ali ne. - Pri sočasni uporabi ciklosporina in letermovirja lahko pride do izrazitejših ali dodatnih učinkov kot pri uporabi letermovirja samega (glejte preglednico 1).
English: PREVYMIS 240 mg film-coated tablets letermovir
Slovenian: PREVYMIS 240 mg filmsko obložene tablete letermovir
English: PREVYMIS 480 mg film-coated tablets letermovir
Slovenian: PREVYMIS 480 mg filmsko obložene tablete letermovir
English: Outer carton for 240 mg film-coated tablets
Slovenian: Pretisni omot za 240 mg filmsko obložene tablete
English: Letermovir may decrease the plasma concentrations of phenytoin.
Slovenian: Letermovir lahko zmanjša plazemske koncentracije fenitoina.
English: Antivirals acyclovir (400 mg single dose)/ letermovir (480 mg daily)
Slovenian: Protivirusna zdravila aciklovir (400 mg enkratni odmerek)/letermovir (480 mg dnevno)
English: Although not studied, when PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in atorvastatin plasma concentrations is expected to be greater than with PREVYMIS alone.
Slovenian: Pri sočasni uporabi zdravila PREVYMIS in ciklosporina se pričakuje, da se bo plazemska koncentracija atorvastatina povečala v večjem obsegu, kot pri uporabi zdravila PREVYMIS samega, čeprav tega niso raziskali.
English: PREVYMIS contains cyclodextrin
Slovenian: Zdravilo PREVYMIS vsebuje ciklodekstrin
English: Frequent monitoring of International Normalised Ratio (INR) should be performed when warfarin is coadministered with PREVYMIS treatment Monitoring is recommended the first 2 weeks after initiating or ending letermovir, as well as after changing route of administration of letermovir or immunosuppressant.
Slovenian: Spremljanje je priporočljivo prva 2 tedna po začetku ali koncu uporabe letermovirja, pa tudi po spremembi poti uporabe letermovirja ali zamenjavi zdravila za zaviranje imunske odzivnosti.
English: Thioridazine may decrease plasma concentrations of letermovir.
Slovenian: Tioridazin lahko zmanjša plazemske koncentracije letermovirja.
English: • Norepinephrine bitartrate
Slovenian: • noradrenalinijev bitartrat
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
English: Efavirenz may decrease plasma concentrations of letermovir.
Slovenian: Efavirenz lahko zmanjša plazemske koncentracije letermovirja.
English: The 480 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Slovenian: 480 mg tablete so pakirane v škatlo, ki vsebuje štiri (4) kartonske ovitke.
English: Co-administration of PREVYMIS and nafcillin is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in nafcilina ni priporočljiva.
English: The diluted solution should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Slovenian: Kadar raztopina in vsebnik to omogočata, morate razredčeno raztopino pred uporabo pregledati glede prisotnosti delcev in spremembe barve.
English: *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Slovenian: *Za potrditev kompatibilnosti pri sočasni uporabi glejte povzetke glavnih značilnosti zdravila.
English: Outer carton for 480 mg film-coated tablets
Slovenian: Pretisni omot za 480 mg filmsko obložene tablete
English: Blister for 240 mg film-coated tablets
Slovenian: Škatla za 240 mg filmsko obložene tablete
English: No maternal or developmental effects were noted at the dose of 50 mg/kg/day (approximately 2.5-fold the AUC at the RHD).
Slovenian: Pri odmerku 50 mg/kg/dan (približno 2,5-kratna vrednost AUC pri uporabi priporočenega odmerka za človeka) niso opazili učinkov pri samicah ali učinkov na razvoj.
English: The 240 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Slovenian: 240 mg tablete so pakirane v škatlo, ki vsebuje štiri (4) kartonske ovitke.
English: Blister for 480 mg film-coated tablets
Slovenian: Škatla za 480 mg filmsko obložene tablete
English: PREVYMIS contains lactose
Slovenian: Zdravilo PREVYMIS vsebuje laktozo
English: Phenytoin may decrease plasma concentrations of letermovir.
Slovenian: Fenitoin lahko zmanjša plazemske koncentracije letermovirja.
English: Intravenous use after dilution.
Slovenian: uporabo razredčiti.
English: Letermovir may increase statin plasma concentrations.
Slovenian: Letermovir lahko poveča plazemske koncentracijo statinov.
English: • Ganciclovir sodium
Slovenian: • natrijev ganciklovirat
English: ↔ fluconazole AUC 1.03 (0.99, 1.08) Cmax 0.95 (0.92, 0.99) ↔ letermovir AUC 1.11 (1.01, 1.23) Cmax 1.06 (0.93, 1.21)
Slovenian: ↔ flukonazol AUC 1,03 (0,99; 1,08) Cmax 0,95 (0,92; 0,99)
English: Subjects received CMV DNA monitoring weekly until post-transplant week 14 and then bi-weekly until post-transplant week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV DNAemia was considered clinically significant.
Slovenian: Vrednost CMV DNA so pri preiskovancih do 14. tedna po presaditvi spremljali enkrat na teden, do 24. tedna po presaditvi pa nato dvakrat na teden.
English: Reproduction
Slovenian: Dojenje