FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products metabolised by CYP3A
Slovenian: Zdravila, ki se presnavljajo s CYP3A
English: The changes in letermovir exposure in subjects with moderate hepatic impairment are not clinically relevant.
Slovenian: Spremembe izpostavljenosti letermovirju pri preiskovancih z zmerno okvaro jeter niso klinično pomembne.
English: The process involves the hepatic uptake transporters OATP1B1 and 3 followed by UGT1A1/3 catalysed glucuronidation.
Slovenian: Proces vključuje jetrna vnosna prenašalca OATP1B1 in 3, ki mu sledi glukuronidacija, ki jo katalizira UGT1A1/3.
English: What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg and 480 mg concentrate for solution for infusion is a clear, colourless liquid.
Slovenian: Izgled zdravila PREVYMIS in vsebina pakiranja Zdravilo PREVYMIS 240 mg in 480 mg koncentrat za raztopino za infundiranje je bistra brezbarvna tekočina.
English: The CMV genes UL56 and UL89 encode subunits of CMV DNA terminase.
Slovenian: Podenote DNA terminaze CMV kodirata gena CMV UL56 in UL89.
English: CYP2C9 is likely also induced.
Slovenian: Verjetno gre tudi za indukcijo CYP2C9.
English: Any unused portion of the infusion solution should be discarded.
Slovenian: Neporabljeno raztopino za infundiranje je treba zavreči.
English: Catheters Radiopaque polyurethane
Slovenian: Katetri radiopačni poliuretan
English: Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.
Slovenian: Pri sočasni uporabi zdravila PREVYMIS z zdravili, ki so zaviralci prenašalcev OATP1B1/3, se plazemske koncentracije letermovirja lahko povečajo.
English: However, if your immune system is weak after you get a bone marrow transplant, you may be at high risk of becoming ill from CMV.
Slovenian: Če imunski sistem po opravljeni presaditvi kostnega mozga oslabi, se tveganje za razvoj bolezni zaradi CMV lahko poveča.
English: (CYP2C8 induction, CYP2C8 and OATP1B inhibition)
Slovenian: (indukcija CYP2C8, zaviranje CYP2C8 in OATP1B)
English: However, Amphotericin B (liposomal) is incompatible (see section 6.2).
Slovenian: Amfotericin B (lipidni kompleks) je kompatibilen z zdravilom PREVYMIS, amfotericin B (liposomski) pa ni kompatibilen (glejte poglavje 6.2).
English: Compatible intravenous bags and infusion set materials
Slovenian: Kompatibilni materiali intravenskih vrečk in infuzijskih kompletov
English: • carbamazepine, phenobarbital, phenytoin - for fits or seizures
Slovenian: • karbamazepin, fenobarbital, fenitoin - uporablja se pri krčih ali epileptičnih napadih
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.
Slovenian: Vrednost AUC nevezanega letermovirja je bila pri preiskovancih z zmerno okvaro jeter (Child-Pugh B [CP-B], ocena 7-9) za približno 81 % večja, pri preiskovancih s hudo okvaro jeter (Child-Pugh C [CPC], ocena 10-15) pa za 4-krat večja kot pri zdravih preiskovancih.
English: -Examples of moderate inducers include thioridazine, modafinil, ritonavir, lopinavir, efavirenz and etravirine.
Slovenian: - Primeri zmernih induktorjev so: tioridazin, modafinil, ritonavir, lopinavir, efavirenz in etravirin.
English: If you have a kidney disease, talk to your doctor before you receive this medicine.
Slovenian: Če imate bolezen ledvic, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: Concentrate for solution for infusion (sterile concentrate) Clear, colourless liquid pH between 7 and 8
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) bistra, brezbarvna tekočina
English: Figure 2: P001: Forest plot of the proportion of subjects initiating anti-CMV PET or with CMV end-organ disease through Week 24 post-transplant by selected subgroups (NC=F approach, FAS population)
Slovenian: Slika 2: P001: Drevesni diagram deleža preiskovancev z uvedenim predbolezenskim zdravljenjem (PET) CMV ali s prizadetostjo organov s CMV v 24. tednu po presaditvi po izbranih podskupinah (pristop NC = F, populacija FAS)
English: • Daptomycin
Slovenian: • daptomicin
English: • If cyclosporine dosing is temporarily interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
Slovenian: • Če se zdravljenje s ciklosporinom zaradi visokih vrednosti ciklosporina začasno prekine,
English: Do not break, crush, or chew the tablet.
Slovenian: Tablete ne lomite, drobite ali žvečite.
English: • fentanyl - for severe pain
Slovenian: • fentanil - uporablja se pri hudi bolečini
English: The increase in midazolam plasma concentration may be greater when oral midazolam is administered with letermovir at the clinical dose than with the dose studied.
Slovenian: Razmisliti je treba o prilagoditvi odmerka midazolama Povečanje plazemskih koncentracij midazolama je lahko večje, če se peroralni midazolam uporablja z letermovirjem v kliničnem odmerku in ne v preučevanem odmerku.
English: -Examples of P-gp/BCRP inhibitors include clarithromycin,erythromycin, azitromycin, itraconazole, ketoconazole, verapamil, quinidine, fluvoxamine, ranolazine, and some of the HIV protease inhibitors.
Slovenian: - Primeri zaviralcev P-gp/BCRP so: klaritromicin, eritromicin, azitromicin, itrakonazol, ketokonazol, verapamil, kinidin, fluvoksamin, ranolazin in nekateri zaviralci proteaze HIV.
English: PREVYMIS is an antiviral prescription medicine that contains the active substance letermovir.
Slovenian: Zdravilo PREVYMIS je protivirusno zdravilo (na recept), ki vsebuje učinkovino letermovir.
English: • quinidine - for abnormal heart rhythms.
Slovenian: • kinidin - uporablja se pri motnjah srčnega ritma
English: PREVYMIS concentrate for solution for infusion contains hydroxypropylbetadex.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje vsebuje hidroksipropilbetadeks.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given PREVYMIS.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro preden prejmete zdravilo PREVYMIS.
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).
Slovenian: Ireverzibilno toksičnost za moda so opazili le pri podganah pri sistemskih izpostavljenostih (AUC), ki so bile ≥ 3-krat večje od izpostavljenosti človeka pri uporabi priporočenega odmerka za človeka.
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).
Slovenian: Če se vsebina viale doda v 250 ml intravensko vrečko z vehiklom, končna koncentracija letermovirja znaša 0,9 mg/ml (za odmerek 240 mg) in 1,8 mg/ml (za 480 mg odmerek).
English: 240 mg IV, with cyclosporine
Slovenian: 240 mg i.v., s ciklosporinom
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)
Slovenian: Slika 1: P001: Kaplan-Meierjevi krivulji časa do začetka predbolezenskega zdravljenja (PET) CMV ali pojava prizadetosti organov s CMV do 24. tedna po presaditvi pri prejemnikih HSCT (populacija FAS)
English: Interaction at steady state not studied.
Slovenian: Medsebojnega delovanja v stanju dinamičnega ravnovesja niso raziskali.
English: If you take more PREVYMIS than you should If you take more PREVYMIS than you should, call your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila PREVYMIS, kot bi smeli Če ste vzeli večji odmerek zdravila PREVYMIS, kot bi smeli, se nemudoma posvetujte z zdravnikom.
English: Nervous system disorders Uncommon dysgeusia, headache
Slovenian: Bolezni živčevja Občasni disgevzija, glavobol
English: FAS=Full analysis set; FAS includes randomised subjects who received at least one dose of study medicine, and excludes subjects with detectable CMV DNA at baseline.
Slovenian: FAS vključuje randomizirane preiskovance, ki so prejeli vsaj en odmerek raziskovanega zdravila, izključuje pa preiskovance, ki so imeli v izhodišču določljivo raven CMV DNA.
English: Immune system disorders Uncommon hypersensitivity
Slovenian: Bolezni imunskega sistema Občasni preobčutljivost
English: Compatible intravenous bags and infusion set materials PREVYMIS is compatible with the following intravenous bags and infusion set materials.
Slovenian: Kompatibilni materiali intravenskih vrečk in infuzijskih kompletov Zdravilo PREVYMIS je kompatibilno z naslednjimi materiali intravenskih vrečk in infuzijskih kompletov.
English: Letermovir is an inhibitor of OATP1B1/3 transporters.
Slovenian: Letermovir je zaviralec prenašalcev OATP1B1/3.
English: The Non-Completer=Failure (NC=F) approach was used, where subjects who discontinued from the study prior to Week 24 post-transplant or had a missing outcome at Week 24 post-transplant were counted as failures.
Slovenian: Uporabljen je bil pristop “nedokončanje = neuspeh” (NC = F - Non-Completer = Failure), tako da so izide preiskovancev, ki so bili iz študije izključeni pred 24. tednom po presaditvi ali pa podatek o izidu v 24. tednu po presaditvi ni bil na voljo, obravnavali kot neuspeh.
English: etravirine
Slovenian: etravirin
English: Expected; ↔ fluconazole ↔ letermovir
Slovenian: Pričakovano: ↔ flukonazol ↔ letermovir
English: • Do not take two doses of PREVYMIS at the same time to make up for a missed dose.
Slovenian: • Ne vzemite dvojnega odmerka zdravila PREVYMIS, če ste pozabili vzeti prejšnji odmerek.
English: In HSCT recipients, bioavailability of letermovir was estimated to be approximately 35% with 480 mg once daily oral letermovir administered without cyclosporine.
Slovenian: Pri prejemnikih HSCT je ocenjena biološka uporabnost letermovirja pri uporabi letermovirja v peroralnem odmerku 480 mg enkrat na dan brez ciklosporina znašala približno 35 %.
English: With NC=F approach, subjects who discontinued from the study prior to Week 24 post-transplant or had a missing outcome at Week 24 post-transplant were counted as failures.
Slovenian: S pristopom NC = F so bolnike, ki so bili izključeni iz študije pred 24. tednom po presaditvi, ali pa podatek o izidu v 24. tednu po presaditvi ni bil na voljo, obravnavali kot neuspeh.
English: When PREVYMIS is co-administered with cyclosporine, the plasma concentrations of repaglinide is expected to increase due to the additional OATP1B inhibition by cyclosporine.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, se pričakuje, da se bodo plazemske koncentracije repaglinida povečale zaradi dodatnega zaviranja OATP1B s ciklosporinom.
English: Letermovir may decrease the plasma concentrations of dabigatran and may decrease efficacy of dabigatran.
Slovenian: Letermovir lahko zmanjša plazemske koncentracije dabigatrana in zmanjša učinkovitost dabigatrana.
English: The size of the induction effect is dependent on letermovir route of administration and whether cyclosporine is concomitantly used.
Slovenian: Obseg indukcijskega učinka je odvisen od poti uporabe letermovirja in od tega ali je bil sočasno uporabljen ciklosporin.
English: Each 480 mg film-coated tablet contains 6.4 mg of lactose (as monohydrate).
Slovenian: Ena 480 mg filmsko obložena tableta vsebuje 6,4 mg laktoze (v obliki monohidrata).
English: If you also take cyclosporine, your doctor will decrease the dose of PREVYMIS to 240 mg once a day.
Slovenian: Če jemljete tudi ciklosporin, bo zdravnik odmerek zdravila PREVYMIS zmanjšal na 240 mg enkrat na dan.
English: Letermovir may substantially increase plasma concentrations of these statins.
Slovenian: Letermovir lahko znatno poveča plazemske koncentracije teh statinov.
English: Oral contraceptives ethinylestradiol (EE) (0.03 mg)/ levonorgestrel (LNG) (0.15 mg) single dose/ letermovir (480 mg daily)
Slovenian: Peroralni kontraceptivi etinilestradiol (EE) (0,03 mg)/ levonorgestrel (LNG) (0,15 mg) enkratni odmerek/letermovir (480 mg dnevno)
English: How to take PREVYMIS
Slovenian: Kako jemati zdravilo PREVYMIS
English: Combined hepatic and renal impairment
Slovenian: Kombinirana okvara jeter in ledvic
English: Other medicines and PREVYMIS
Slovenian: Druga zdravila in zdravilo PREVYMIS
English: Therefore, the plasma concentrations of medicinal products that are substrates of these enzymes or transporters may increase or decrease when co-administered with letermovir.
Slovenian: Pri sočasni uporabi z letermovirjem se plazemske koncentracije zdravil, ki so substrati za te encime ali prenašalce, lahko torej povečajo ali zmanjšajo.
English: Co-administration of PREVYMIS and carbamazepine or phenobarbital is not recommended.
Slovenian: Sočasna uporaba zdravila PREVYMIS in karbamazepina ali fenobarbitala ni priporočljiva.
English: Medicinal products transported by OATP1B1/3
Slovenian: Zdravila, ki se prenašajo z OATP1B1/3
English: -Examples of such medicinal products include certain immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus), HMG-CoA reductase inhibitors, and amiodarone (see Table 1).
Slovenian: - Primeri takšnih zdravil so: določena zdravila za zaviranje imunske odzivnosti (npr. ciklosporin, takrolimus, sirolimus), zaviralci HMG-CoA reduktaze in amiodaron (glejte preglednico 1).
English: If it is time for the next dose, skip the missed dose and go back to the regular schedule.
Slovenian: Če je že čas za naslednji odmerek, se izpuščeni odmerek izpusti in nadaljujte z dajanjem zdravila ob običajnem času.
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.
Slovenian: Toksičnosti za moda niso opazili niti pri miših niti pri opicah pri največjih raziskovanih odmerkih pri izpostavljenostih, ki so bile do 4-krat (miši) in 2-krat (opice) večje od izpostavljenosti človeka pri uporabi priporočenega odmerka za človeka.
English: This medicine contains less than 1 mmol sodium (23 mg) per 480 mg tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 480 mg tableto, kar v bistvu pomeni ‘brez natrija'.
English: See also general information on induction above regarding time courses of the interaction.
Slovenian: Glede časovnega poteka interakcije glejte tudi splošne informacije o indukciji, navedene zgoraj.
English: -Examples of such medicinal products include HMG Co-A reductase inhibitors, fexofenadine, repaglinide and glyburide (see Table 1).
Slovenian: - Primeri takšnih zdravil so: zaviralci reduktaze HMG-CoA, feksofenadin, repaglinid in gliburid (glejte preglednico 1).
English: Primary efficacy endpoint
Slovenian: Primarni opazovani dogodek učinkovitosti
English: However, caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Slovenian: Vendar se pri dodajanju zaviralca P-gp/BCRP k zdravljenju z letermovirjem v kombinaciji s ciklosporinom priporoča previdnost.
English: Each 240 mg film-coated tablet contains 4 mg of lactose (as monohydrate).
Slovenian: Ena 240 mg filmsko obložena tableta vsebuje 4 mg laktoze (v obliki monohidrata).
English: ↑ tacrolimus AUC 2.42 (2.04, 2.88) Cmax 1.57 (1.32, 1.86) (CYP3A inhibition)
Slovenian: ↑ takrolimus AUC 2,42 (2,04; 2,88) Cmax 1,57 (1,32; 1,86) (zaviranje CYP3A)
English: Caution is advised if other OATP1B1/3 inhibitors are added to letermovir combined with cyclosporine.
Slovenian: Previdnost se priporoča, kadar se pri zdravljenju z letermovirjem v kombinaciji s ciklosporinom uporabijo še drugi zaviralci OATP1B1/3.
English: Posology PREVYMIS is also available as concentrate for solution for infusion (240 mg and 480 mg).
Slovenian: Zdravilo PREVYMIS je na voljo tudi v obliki koncentrata za raztopino za infundiranje (240 mg in 480 mg).
English: Each 240 mg vial contains 23 mg sodium (main component of cooking/table salt).
Slovenian: Ena 240 mg viala vsebuje 23 mg natrija (glavna sestavina kuhinjske soli).
English: Viral resistance
Slovenian: Virusna odpornost
English: Administration of PREVYMIS may result in a clinically relevant increase in plasma concentrations of co-administered medicinal products that are OATP1B1/3 substrates.
Slovenian: Pri uporabi zdravila PREVYMIS se lahko klinično pomembno povečajo plazemske koncentracije sočasno uporabljenih zdravil, ki so substrati za OATP1B1/3.
English: PREVYMIS concentrate for solution for infusion requires dilution (see section 6.6) prior to administration.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti (glejte poglavje 6.6).
English: Efficacy consistently favoured letermovir across subgroups including low and high risk for CMV reactivation, conditioning regimens, and concomitant immunosuppressive regimens (see Figure 2).
Slovenian: V podskupinah, vključno z nizkim in visokim tveganjem za reaktivacijo CMV, režimom kondicioniranja in režimom sočasnega imunosupresivnega zdravljenja, je bila učinkovitost konsistentno v korist letermovirja (glejte sliko 2).
English: Dose adjustment of CYP3A metabolised opioids may be needed
Slovenian: Odmerek opioidov, ki se presnavljajo s CYP3A, bo morda treba prilagoditi
English: Each 480 mg vial contains 46 mg sodium (main component of cooking/table salt).
Slovenian: Ena 480 mg viala vsebuje 46 mg natrija (glavna sestavina kuhinjske soli).
English: When PREVYMIS is co-administered with cyclosporine, use of these statins is contraindicated.
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, je uporaba teh statinov kontraindicirana.
English: (P-gp/UGT induction)
Slovenian: (indukcija P-gp/UGT)
English: The entire contents of the IV bag should be administered.
Slovenian: Infundirati je treba celotno vsebino infuzijske vrečke.
English: -An example of medicinal product transported by OATP2B1 is celiprolol.
Slovenian: - Primer zdravila, ki se prenaša z OATP2B1, je: celiprolol.
English: Table 4: Letermovir AUC (ng•hr/mL) values in HSCT Recipients Treatment Regimen
Slovenian: Preglednica 4: Vrednosti AUC (ng•h/ml) letermovirja pri prejemnikih HSCT režim zdravljenja mediana (90 % napovedni interval)*
English: -Examples of strong inducers include rifampicin, phenytoin, carbamazepine, St. John's wort (Hypericum perforatum), rifabutin and phenobarbital.
Slovenian: - Primeri močnih induktorjev so: rifampicin, fenitoin, karbamazepin, šentjanževka (Hypericum perforatum), rifabutin in fenobarbital.
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: This medicine contains less than 1 mmol sodium (23 mg) per 240 mg tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 240 mg tableto, kar v bistvu pomeni ‘brez natrija'.
English: Expected: ↓ dabigatran
Slovenian: Pričakovano: ↓ dabigatran
English: • changes in taste
Slovenian: • spremembe čuta za okušanje
English: If letermovir is co-administered with cyclosporine, the recommended dose of letermovir is 240 mg once daily (see section 4.2).
Slovenian: Če se letermovir uporablja skupaj s ciklosporinom, je priporočeni odmerek letermovirja 240 mg enkrat na dan (glejte poglavje 4.2).
English: Gastrointestinal disorders Common nausea, diarrhoea, vomiting
Slovenian: Bolezni prebavil Pogosti navzea, diareja, bruhanje
English: This is because it is not known if PREVYMIS gets in your breast milk and will be passed to your baby.
Slovenian: Ni znano, ali se zdravilo PREVYMIS izloča v materino mleko in se tako prenese na dojenčka.
English: Overall (N=325, 170)
Slovenian: stratum tveganja skupaj (N = 325, 170)
English: Some patients have reported fatigue (feeling very tired) or vertigo (feeling like you are spinning) during treatment with PREVYMIS.
Slovenian: Nekateri bolniki so med zdravljenjem z zdravilom PREVYMIS poročali o utrujenosti ali vrtoglavici (občutku vrtenja).
English: After uptake, glucuronidation of letermovir is mediated by UGT1A1 and 3.
Slovenian: Po vnosu se letermovir glukuronidira s pomočjo UGT1A1 in 3.
English: Your medicine or dose may then need to be changed.
Slovenian: Morda bo potrebno zamenjati zdravilo oziroma spremeniti odmerek.
English: You should not be given PREVYMIS if:
Slovenian: Zdravila PREVYMIS ne smete prejeti:
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.
Slovenian: Pri opicah, ki so prejemale letermovir, pri sistemski izpostavljenosti, ki je bila na osnovi AUC približno 2-krat večja od izpostavljenosti človeka pri uporabi priporočenega odmerka za človeka, na osnovi histopatološkega vrednotenja, meritve velikosti mod, analize hormonov v krvi (folikle stimulirajoči hormon, inhibin B in testosteron) in vrednotenja sperme (število semenčic, gibljivost in morfologija) niso ugotovili znakov toksičnosti za moda.
English: The mean apparent terminal half-life for letermovir is approximately 12 hours with 480 mg IV letermovir in healthy subjects.
Slovenian: Povprečni navidezni končni razpolovni čas letermovirja pri zdravih preiskovancih po intravenski uporabi letermovirja v odmerku 480 mg znaša približno 12 ur.
English: PREVYMIS is compatible with the following intravenous bags and infusion set materials.
Slovenian: Zdravilo PREVYMIS je kompatibilno z naslednjimi materiali intravenskih vrečk in infuzijskih kompletov.
English: Carbamazepine or phenobarbital may decrease plasma concentrations of letermovir.
Slovenian: Karbamazepin ali fenobarbital lahko zmanjšata plazemske koncentracije letermovirja.
English: Non-myeloablative (n=85, 37)
Slovenian: haploidentičen dajalec nemieloblativni (n = 85, 37)
English: • Tacrolimus
Slovenian: • takrolimus
English: Each mL contains 20 mg of letermovir.
Slovenian: En ml vsebuje 20 mg letermovirja.
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: • Pantoprazole sodium
Slovenian: • natrijev pantoprazolat
English: Incompatible intravenous bags and infusion set materials PREVYMIS concentrate for solution for infusion is incompatible with polyurethane-containing IV administration set tubing.
Slovenian: Inkompatibilne intravenske vrečke in materiali infuzijskih kompletov Zdravilo PREVYMIS koncentrat za raztopino za infundiranje ni kompatibilno s sistemi za intravensko dajanje, ki vsebujejo poliuretan.
English: ↑ cyclosporine AUC 1.66 (1.51, 1.82) Cmax 1.08 (0.97, 1.19) (CYP3A inhibition)
Slovenian: ↑ ciklosporin AUC 1,66 (1,51; 1,82) Cmax 1,08 (0,97; 1,19) (zaviranje CYP3A)
English: Co-administration of PREVYMIS with oral midazolam (a CYP3A substrate) results in 2-3-fold increased midazolam plasma concentrations.
Slovenian: Pri sočasni uporabi zdravila PREVYMIS s peroralnim midazolamom (substrat za CYP3A) so se plazemske koncentracije midazolama povečale za 2-3-krat.
English: In vivo studies are available investigating the net effect on CYP3A4, P-gp, OATP1B1/3 additionally on CYP2C19.
Slovenian: Na voljo so študije, izvedene in vivo, v katerih so, poleg na CYP2C19, raziskali tudi neto učinek na CYP3A4, P-gp in OATP1B1/3.
English: Storage of diluted solution
Slovenian: Shranjevanje razredčene raztopine
English: (OATP1B1/3 inhibition CYP3A inhibition, CYP2C9 induction)
Slovenian: (zaviranje OATP1B1/3, zaviranje CYP3A, indukcija CYP2C9)
English: (CYP3A inhibition)
Slovenian: (zaviranje CYP3A)
English: If PREVYMIS is coadministered with cyclosporine (a potent OATP1B1/3 inhibitor), the recommended dose of PREVYMIS is 240 mg once daily (see Table 1 and sections 4.2 and 5.2).
Slovenian: Če se zdravilo PREVYMIS uporablja sočasno s ciklosporinom (močan zaviralec OATP1B1/3), je priporočeni odmerek zdravila PREVYMIS 240 mg enkrat na dan (glejte preglednico 1 ter poglavji 4.2 in 5.2).