FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, letermovir is an inhibitor of CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1, and OAT3 at in vivo relevant concentrations.
Slovenian: Letermovir je in vitro zaviralec CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1 in OAT3 pri in vivo pomembnih koncentracijah.
English: If you are taking PREVYMIS with cyclosporine, do not take the following medicines: o dabigatran - used for blood clots o atorvastatin, simvastatin, rosuvastatin, pitavastatin -for high cholesterol
Slovenian: Če zdravilo PREVYMIS jemljete skupaj s ciklosporinom, ne smete jemati naslednjih zdravil: o dabigatran - uporablja se za preprečevanje nastanka krvnih strdkov o atorvastatin, simvastatin, rosuvastatin, pitavastatin - uporabljajo se pri zvišanem holesterolu
English: CMV DNA was monitored on a weekly basis until posttransplant Week 14, and subsequently bi-weekly until Week 24.
Slovenian: Vrednost CMV DNA so do 14. tedna po presaditvi spremljali enkrat na teden, nato pa dvakrat na teden do 24. tedna.
English: The major elimination pathways of letermovir is biliary excretion as well as direct glucuronidation.
Slovenian: Glavni poti izločanja letermovirja sta izločanje v žolč in neposredna glukuronidacija.
English: PREVYMIS may be started before or after engraftment.
Slovenian: Zdravilo PREVYMIS se lahko začne uporabljati pred vsaditvijo ali po njej.
English: Mismatched unrelated (n=43, 24)
Slovenian: neusklajen nesoroden (n = 43, 24)
English: Medicinal products metabolised by CYP2B6, UGT1A1 or transported by BCRP or OATP2B1 Letermovir is a general inducer in vivo but has also been observed to inhibit CYP2B6, UGT1A1, BCRP, and OATP2B1 in vitro.
Slovenian: Zdravila, ki se presnavljajo s CYP2B6 ali UGT1A1 ali prenašajo z BCRP ali OATP2B1 Letermovir je na splošno induktor in vivo, vendar pa so in vitro opazili tudi, da zavira CYP2B6, UGT1A1, BCRP in OATP2B1.
English: Infusion set materials
Slovenian: Materiali infuzijskih kompletov
English: The active substance is letermovir.
Slovenian: Učinkovina je letermovir.
English: Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).
Slovenian: Sočasna uporaba z rifampicinom je povzročila začetno povečanje plazemske koncentracije letermovirja (zaradi zavrtja OATP1B1/3 in/ali P-gp), ki ni klinično pomembno, čemur je sledilo klinično pomembno zmanjšanje plazemskih koncentracij letermovirja (zaradi indukcije P-gp/UGT) pri nadaljnji sočasni uporabi rifampicina (glejte preglednico 1).
English: -Examples of medicinal products transported by OAT3 includes ciprofloxacin, tenofovir, imipenem, and cilastin.
Slovenian: - Primeri zdravil, ki se prenašajo z OAT3, so: ciprofloksacin, tenofovir, imipenem in cilastin.
English: This is because it has not been studied in pregnancy and it is not known if PREVYMIS will harm your baby while you are pregnant.
Slovenian: Uporaba tega zdravila med nosečnostjo ni bila raziskana in ni znano, če lahko zdravilo PREVYMIS škoduje otroku, če ga jemljete med nosečnostjo.
English: The effect of letermovir on doses up to 960 mg given IV on the QTc interval was evaluated in a randomised, single-dose, placebo- and active-controlled (moxifloxacin 400 mg oral) 4-period crossover thorough QT trial in 38 healthy subjects.
Slovenian: Vpliv letermovirja v odmerkih do 960 mg, uporabljenih intravensko, na interval QTc so vrednotili v randomiziranem, s placebom in z zdravilno učinkovino (moksifloksacin 400 mg peroralno) nadzorovanem preskušanju QT z enkratnim odmerkom in 4 obdobji navzkrižnega prehoda pri 38 zdravih preiskovancih.
English: Concomitant administration with St. John's wort (Hypericum perforatum) (see section 4.5).
Slovenian: Sočasna uporaba s šentjanževko (Hypericum perforatum) (glejte poglavje 4.5).
English: *This table is not all inclusive.
Slovenian: *Preglednica ne vključuje vseh možnih interakcij.
English: • If you miss your appointment to get PREVYMIS, call your doctor straight away to reschedule your appointment.
Slovenian: • Če ste pozabili na dogovorjeni termin za prejem zdravila PREVYMIS, nemudoma pokličite zdravnika in se dogovorite za nov termin.
English: In a Phase 2b trial evaluating letermovir doses of 60, 120, or 240 mg/day or placebo for up to 84 days in 131 HSCT recipients, DNA sequence analysis of a select region of UL56 (amino acids 231 to 369) was performed on samples obtained from 12 letermovir-treated subjects who experienced prophylaxis failure and for whom samples were available for analysis.
Slovenian: V preskušanju faze 2b, v katerem so pri 131 prejemnikih HSCT do 84 dni vrednotili uporabo letermovirja v odmerkih 60, 120 ali 240 mg/dan ali placeba, so opravili sekvenčno analizo DNA izbranega predela UL56 (aminokisline od 231 do 369) v vzorcih 12 preiskovancev, zdravljenih z letermovirjem, pri katerih profilaksa ni bila uspešna, na voljo pa so bili vzorci za analizo.
English: Letermovir may decrease the plasma concentrations of CYP2C19 substrates.
Slovenian: Letermovir lahko zmanjša plazemske koncentracije substratov za CYP2C19.
English: Conditioning Regimen Myeloablative (n=154, 85)
Slovenian: imunosupresivni režim režim kondicioniranja mieloablativni (n = 154, 85)
English: Letermovir exposure increased in a greater than doseproportional manner with both oral or IV administration.
Slovenian: Izpostavljenost letermovirju se je tako pri peroralni kot intravenski uporabi povečevala več kot sorazmerno z odmerkom.
English: This will give the medicine the best chance to keep you from becoming ill from CMV after you get a bone marrow transplant.
Slovenian: Tako boste imeli najboljše možnosti, da vam zdravilo po presaditvi kostnega mozga prepreči bolezen zaradi CMV.
English: Oral anticoagulants warfarin
Slovenian: Peroralni antikoagulanti varfarin
English: Antidiabetic medicinal products repaglinide
Slovenian: Antidiabetiki repaglinid
English: This toxicity was characterized by seminiferous tubular degeneration, and oligospermia and cell debris in the epididymides, with decreased testicular and epididymides weights.
Slovenian: Značilnosti tega toksičnega učinka so bile degeneracija semenskih tubulov in oligospermija ter celični debri v obmodkih ob sočasnem zmanjšanju mase mod in obmodkov.
English: • Fluconazole
Slovenian: • flukonazol
English: CMV mutants with reduced susceptibility to letermovir have been confirmed in cell culture.
Slovenian: V celični kulturi so bili potrjeni mutanti CMV z zmanjšano občutljivostjo za letermovir.
English: Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.
Slovenian: Letermovir lahko zmanjša izpostavljenost substratom za CYP2C9 in/ali CYP2C19, kar lahko povzroči subterapevtske vrednosti.
English: Letermovir unbound AUC was approximately 115- and 81% higher in subjects with moderate (eGFR of 31.0 to 56.8 mL/min/1.73m2) and severe (eGFR of 11.9 to 28.1 mL/min/1.73m2) renal impairment, respectively, compared to healthy subjects.
Slovenian: Vrednost AUC nevezanega letermovirja je bila pri preiskovancih z zmerno okvaro ledvic (eGFR od 31,0 do 56,8 ml/min/1,73 m2) za približno 115 % večja, pri preiskovancih s hudo okvaro ledvic (eGFR od 11,9 do 28,1 ml/min/1,73 m2) pa za približno 81 % večja kot pri zdravih preiskovancih.
English: Expected: ↓omeprazole
Slovenian: Pričakovano: ↓ omeprazol
English: Letermovir is a moderate inhibitor of CYP3A in vivo.
Slovenian: Letermovir je in vivo zmeren zaviralec CYP3A.
English: When changing the route of administration, or if changing immunosuppressant, the recommendation concerning co-administration should be revisited.
Slovenian: Pri spremembi poti uporabe ali zamenjavi zdravila za zaviranje imunske odzivnosti je priporočilo za sočasno uporabo treba znova preučiti.
English: List of compatible medicinal products when PREVYMIS and medicinal products* are prepared in 5% dextrose
Slovenian: Seznam kompatibilnih zdravil, če so zdravilo PREVYMIS in zdravila* pripravljeni v 5 % glukozi.
English: Polyamide/Aluminium/PVC - Aluminium blister cards.
Slovenian: Pretisni omot iz poliamida/aluminija/PVC - aluminija.
English: Dosage adjustment
Slovenian: Prilagoditev odmerka
English: A dose adjustment may also be needed when changing route of administration or immunosuppressant.
Slovenian: Prilagoditev odmerka bo morda potrebna tudi pri spremembi poti uporabe ali zamenjavi zdravila za zaviranje imunske odzivnosti.
English: Compatible intravenous solutions and other medicinal products PREVYMIS concentrate for solution for infusion is compatible with 0.9% sodium chloride and 5% dextrose solutions.
Slovenian: Kompatibilne intravenske raztopine in druga zdravila Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je kompatibilno z 0,9 % raztopino natrijevega klorida in 5 % raztopino glukoze.
English: • thioridazine - for psychiatric disorders
Slovenian: • tioridazin - uporablja se pri psihiatričnih motnjah
English: In cases of clinically significant CMV DNAemia or disease, letermovir prophylaxis was stopped and standard-of-care pre-emptive therapy (PET) or treatment was initiated.
Slovenian: V primerih klinično pomembne CMV DNA-emije ali CMV-bolezni so profilakso z letermovirjem prekinili in uvedli standardno predbolezensko zdravljenje (PET - Pre-emptive Therapy) ali zdravljenje CMV-bolezni.
English: - Examples of medicinal products metabolised by UGT1A1 are raltegravir and dolutegravir.
Slovenian: - Primeri zdravil, ki se presnavljajo z UGT1A1, so: raltegravir in dolutegravir.
English: The primary efficacy endpoint of clinically significant CMV infection in P001 was defined by the incidence of CMV DNAemia warranting anti-CMV pre-emptive therapy (PET) or the occurrence of CMV end-organ disease.
Slovenian: Primarni opazovani dogodek učinkovitosti klinično pomembne okužbe s CMV je bil v P001 opredeljen s pojavnostjo CMV DNA-emije, ki je zahtevala predbolezensko zdravljenje (PET - Preemptive Therapy) ali pojav prizadetosti organov s CMV (CMV end-organ disease).
English: Week 0
Slovenian: 0. teden
English: If monitoring is applied, this is recommended the first 2 weeks after initiating and ending letermovir (see section 4.4) as well as after changing route of letermovir administration.
Slovenian: V primeru uvedbe spremljanja, se le-to priporoča v prvih 2 tednih po začetku in koncu zdravljenja z letermovirjem (glejte poglavje 4.4), pa tudi v primeru spremembe poti uporabe letermovirja.
English: • alfentanil - for severe pain
Slovenian: • alfentanil - uporablja se pri hudi bolečini
English: There is no specific antidote for overdose with PREVYMIS.
Slovenian: Specifični antidot za preveliko odmerjanje zdravila PREVYMIS ni na voljo.
English: The size of the CYP3A inhibitory effect is dependent on letermovir route of administration and whether cyclosporine is concomitantly used.
Slovenian: Obseg zaviralnega učinka CYP3A je odvisen od poti uporabe letermovirja in od tega, ali je bil sočasno uporabljen ciklosporin.
English: Subjects were monitored through Week 24 post-transplant for the primary efficacy endpoint with continued follow-up through Week 48 post-transplant.
Slovenian: Preiskovance so glede primarnega opazovanega dogodka učinkovitosti spremljali do 24. tedna po presaditvi, spremljanje pa se je nato nadaljevalo do 48. tedna po presaditvi.
English: PREVYMIS concentrate for solution for infusion is physically incompatible with amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je fizikalno inkompatibilno z amiodaronijevim kloridom, amfotericinom B (liposomskim), aztreonamom, cefepimijevim kloridom, ciprofloksacinom, ciklosporinom, diltiazemijevim kloridom, filgrastimom, gentamicinijevim sulfatom, levofloksacinom, linezolidom, lorazepamom, midazolamijevim kloridom, mofetilmikofenolat kloridom, ondansetronom in palonosetronom.
English: HIV medicinal products efavirenz
Slovenian: Zdravila za zdravljenje HIV efavirenz
English: Factors associated with CMV DNAemia after Week 14 post-transplant among letermovir-treated subjects included high risk for CMV reactivation at baseline, GVHD, use of corticosteroids, and CMV negative donor serostatus.
Slovenian: Dejavniki, ki so bili povezani s CMV DNA-emijo po 14. tednu po presaditvi, so pri preiskovancih, ki so se zdravili z letermovirjem, vključevali visoko tveganje za reaktivacijo CMV v izhodišču, bolezen presadka proti gostitelju (GVHD), uporabo kortikosteroidov in negativni CMV-serostatus dajalca.
English: PREVYMIS concentrate for solution for infusion must be diluted prior to intravenous use.
Slovenian: Zdravilo PREVYMIS koncentrat za raztopino za infundiranje je treba pred intravensko uporabo razredčiti.
English: -Examples of such medicinal products include warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide (see Table 1).
Slovenian: - Primeri takšnih zdravil so: varfarin, vorikonazol, diazepam, lansoprazol, omeprazol, esomeprazol, pantoprazol, tilidin in tolbutamid (glejte preglednico 1).
English: Administration of PREVYMIS may result in a clinically relevant decrease in plasma concentrations of co-administered medicinal products that are significantly transported by P-gp in the intestine such as dabigatran and sofosbuvir.
Slovenian: Pri uporabi zdravila PREVYMIS se lahko klinično pomembno zmanjšajo plazemske koncentracije sočasno uporabljenih zdravil, ki se v pomembnem obsegu prenašajo s P-gp v črevesu, kot sta dabigatran in sofosbuvir.
English: Expected: ↑ or ↓ repaglinide
Slovenian: Pričakovano: ↑ ali ↓ repaglinid
English: Co-administration of PREVYMIS with voriconazole (a CYP2C19 substrate) results in significantly decreased voriconazole plasma concentrations, indicating that letermovir is an inducer of CYP2C19.
Slovenian: Pri sočasni uporabi zdravila PREVYMIS in vorikonazola (substrat za CYP2C19) so se plazemske koncentracije vorikonazola izrazito zmanjšale, kar kaže, da je letermovir induktor CYP2C19.
English: Tacrolimus (n=145, 69)
Slovenian: V korist letermovirja takrolimus (n = 145, 69)
English: However, if it is nearly time for the next dose, skip the missed dose.
Slovenian: Če je že skoraj čas, da vzamete naslednji odmerek, pozabljeni odmerek izpustite.
English: The anticipated clinical exposure to hydroxypropylbetadex with intravenously administered letermovir is expected to be approximately 3600 mg/day for a letermovir dose of 480 mg.
Slovenian: Predvidena klinična izpostavljenost hidroksipropilbetadeksu med intravensko uporabo letermovirja je po pričakovanjih približno 3.600 mg/dan pri odmerku 480 mg letermovirja.
English: • PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other medicinal products and diluent combinations except those listed below.
Slovenian: • Zdravila PREVYMIS se ne sme aplicirati sočasno preko iste intravenske linije (ali kanile) z drugimi zdravili in kombinacijami vehiklov, razen tistimi, ki so navedeni v nadaljevanju.
English: ↑ midazolam IV:
Slovenian: ↑ midazolam i.v.
English: Type I (30 mL) clear glass vial with a 20 mm fluorocoated chlorobutyl stopper with aluminium flip-off cap containing 12 mL(medium green cap) or 24 mL (dark blue cap) of solution.
Slovenian: Viala (30 ml) iz prozornega stekla tipa I z 20 mm klorobutilnim zamaškom, prevlečenim s fluorom, in aluminijasto snemno zaporko, ki vsebuje 12 ml (zelena zaporka) ali 24 ml (temno modra zaporka) raztopine.
English: Coadministration of PREVYMIS may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates (see sections 4.3, 4.4, and 5.2).
Slovenian: Pri sočasni uporabi zdravila PREVYMIS se lahko klinično pomembno povečajo plazemske koncentracije sočasno uporabljenih substratov za CYP3A (glejte poglavja 4.3, 4.4 in 5.2).
English: PREVYMIS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila PREVYMIS ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Risk of ↓ contraceptive steroids Letermovir may reduce plasma concentrations of other oral contraceptive steroids thereby affecting their efficacy.
Slovenian: Letermovir lahko zmanjša plazemske koncentracije drugih peroralnih steroidnih kontraceptivov in tako vpliva na njihovo učinkovitost.
English: When PREVYMIS is co-administered with cyclosporine, pravastatin is not recommended while for fluvastatin, a dose reduction may be necessary
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom, uporaba pravastatina ni priporočljiva, odmerek fluvastatina pa bo morda treba zmanjšati .
English: Please note that the interaction potential and clinical consequences may be different depending on whether letermovir is administered orally or IV, and whether cyclosporine is concomitantly used.
Slovenian: Upoštevati je treba, da se lahko možnost za pojav interakcij in klinične posledice razlikujejo, če se letermovir uporablja peroralno ali intravensko in če se sočasno uporablja ciklosporin.
English: With NC=F approach, failure was defined as all subjects with clinically significant CMV infection or who prematurely discontinued from the study or had a missing outcome through Week 24 post-transplant visit window.
Slovenian: S pristopom NC = F je bil neuspeh opredeljen kot izid pri vseh preiskovancih s klinično pomembno CMV-okužbo, preiskovancih, ki so bili predčasno izključeni iz študije, ali preiskovancih brez podatka o izidu pri obisku v 24. tednu po presaditvi.
English: Letermovir does not prolong QTc to any clinically relevant extent following the 960 mg IV dose with plasma concentrations approximately 2-fold higher than the 480 mg IV dose.
Slovenian: Letermovir po intravenskem odmerku 960 mg ni povzročil podaljšanja QTc v nobenem klinično pomembnem obsegu, pri čemer pa so bile koncentracije v plazmi približno 2-krat večje kot pri uporabi odmerka 480 mg intravensko.
English: Blood to plasma partitioning of letermovir is 0.56 and independent of the concentration range (0.1 to 10 mg/L) evaluated in vitro.
Slovenian: Količnik porazdelitve letermovirja med krvjo in plazmo je 0,56 in po vrednotenju in vitro ni odvisen od razpona koncentracije (0,1 do 10 mg/l).
English: There were no differences in the incidence of or time to engraftment between the PREVYMIS and placebo groups.
Slovenian: Med skupino z zdravilom PREVYMIS in skupino s placebom v pojavnosti ali času vsaditve ni bilo razlik.
English: Irreversible testicular toxicity and impairment of fertility was observed in male rats, but not in male mice or male monkeys.
Slovenian: Pri samcih podgan so opazili ireverzibilno toksičnost za moda in motnje plodnosti, ne pa tudi pri samcih miši ali samcih opic.
English: o St. John's wort (Hypericum perforatum)
Slovenian: o šentjanževka (Hypericum perforatum)
English: PREVYMIS contains lactose monohydrate.
Slovenian: Zdravilo PREVYMIS vsebuje laktozo monohidrat.
English: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Slovenian: Zdravilo PREVYMIS je indicirano za preprečevanje reaktivacije okužbe s citomegalovirusom (CMV) in citomegalovirusne bolezni pri odraslih, CMV-seropozitivnih prejemnikih [R+] alogenske presaditve krvotvornih matičnih celic (HSCT - Haematopoietic Stem Cell Transplant).
English: Bone marrow (n=72, 43)
Slovenian: kostni mozeg (n = 72, 43)
English: This medicinal product contains 46 mg (2.0 mmol) sodium per 480 mg vial, equivalent to 2.30% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 46 mg (2,0 mmol) natrija na 480 mg vialo, kar ustreza 2,30 % s strani WHO priporočenega največjega dnevnega vnosa natrija, ki je 2 g za odrasle.
English: If you also take cyclosporine, your doctor will decrease the dose of PREVYMIS to one 240 mg tablet once a day.
Slovenian: Če jemljete tudi ciklosporin, bo zdravnik odmerek zdravila PREVYMIS zmanjšal na eno 240 mg tableto enkrat na dan.
English: PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other medicinal products and diluent combinations except those listed below.
Slovenian: Zdravila PREVYMIS se ne sme aplicirati sočasno preko iste intravenske linije (ali kanile) z drugimi zdravili in kombinacijami vehiklov, razen tistimi, ki so navedeni v nadaljevanju.
English: Letermovir may increase or decrease the plasma concentrations of repaglinide.
Slovenian: Letermovir lahko poveča ali zmanjša plazemske koncentracije repaglinida.
English: • If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
Slovenian: • Če se zdravljenje s ciklosporinom po uvedbi zdravljenja z zdravilom PREVYMIS prekine, je treba naslednji odmerek zdravila PREVYMIS povečati na 480 mg enkrat na dan.
English: Medicinal products metabolised by CYP2C8
Slovenian: Zdravila, ki se presnavljajo s CYP2C8
English: Comparing letermovir regimen administered without cyclosporine, the effect is more marked after iv than oral letermovir.
Slovenian: Pri režimu uporabe letermovirja brez ciklosporina je učinek izrazitejši pri intravenski kot pri peroralni uporabi letermovirja.
English: -Examples of OATP1B1 inhibitors include gemfibrozil, erythromycin, clarithromycin, and several protease inhibitors (atazanavir, simeprevir).
Slovenian: - Primeri zaviralcev OATP1B1 so: gemfibrozil, eritromicin, klaritromicin in nekateri zaviralci proteaze (atazanavir, simeprevir).
English: Inducers of drug metabolizing enzymes or transporters Co-administration of PREVYMIS (with or without cyclosporine) with strong and moderate inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended, as it may lead to subtherapeutic letermovir exposure (see Table 1).
Slovenian: Induktorji encimov, s katerimi se presnavljajo zdravila, ali induktorji prenašalcev zdravil Sočasna uporaba zdravila PREVYMIS (s ciklosporinom ali brez) z močnimi in zmernimi induktorji prenašalcev (npr. P-gp) in/ali encimov (npr. UGT) ni priporočljiva, saj lahko vodi do subterapevtske izpostavljenosti letermovirju (glejte preglednico 1).
English: When PREVYMIS is co-administered with these statins, a statin dose reduction may be necessary
Slovenian: Če se zdravilo PREVYMIS uporablja skupaj s temi statini, bo odmerek statina morda treba zmanjšati
English: • oral contraceptive steroids-for birth control
Slovenian: • peroralni steroidni kontraceptivi - uporabljajo se za preprečevanje nosečnosti
English: The magnitude of the OATP1B1/3 inhibition on co-administered medicinal products is likely greater when PREVYMIS is co-administered with cyclosporine (a potent OATP1B1/3 inhibitor).
Slovenian: Obseg zaviranja OATP1B1/3 sočasno uporabljenih zdravil bo verjetno večji, če se zdravilo PREVYMIS uporablja skupaj s ciklosporinom (močan zaviralec OATP1B1/3).
English: The tablet should be swallowed whole and may be taken with or without food.
Slovenian: Lahko se jo vzame s hrano ali brez nje.
English: Do not stop taking PREVYMIS
Slovenian: Ne prenehajte jemati zdravila PREVYMIS
English: Based on population pharmacokinetic analyses, the mean steady-state volume of distribution is estimated to be 45.5 L following intravenous administration in HSCT recipients.
Slovenian: Na osnovi analiz populacijske farmakokinetike ocenjeni povprečni volumen porazdelitve v stanju dinamičnega ravnovesja pri prejemnikih HSCT po intravenski uporabi znaša 45,5 l.
English: This medicinal product contains 23 mg (1.0 mmol) sodium per 240 mg vial, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 23 mg (1,0 mmol) natrija na 240 mg vialo, kar ustreza 1,15 % s strani WHO priporočenega največjega dnevnega vnosa natrija, ki je 2 g za odrasle.