FrancophonIA/ELRC3.0 huggingface dataset:
English: • you take the following herbal product:
Slovenian: • če jemljete naslednji rastlinski pripravek:
English: • high blood creatinine - shown in blood tests
Slovenian: • zvišanje vrednosti kreatinina v krvi - ugotovljeno s krvnimi preiskavami
English: • Famotidine
Slovenian: • famotidin
English: Letermovir vs Placebo Stratified log-rank test, two-sided p-value <0.0001
Slovenian: Letermovir v primerjavi s placebom Stratificirani log-rank test, dvostranska p-vrednost <0,0001
English: ↓ =decrease, ↑ =increase ↔ =no clinically relevant change One-way interaction study assessing the effect of letermovir on the concomitant medicinal product.
Slovenian: ↓ = zmanjšanje, ↑ = povečanje ↔ = brez klinično pomembne spremembe Enosmerna študija medsebojnega delovanja, ki je vrednotila vpliv letermovirja na sočasno uporabljeno zdravilo.
English: It is unknown whether letermovir is excreted in human milk.
Slovenian: Ni znano, ali se letermovir izloča v materino mleko.
English: The tablet should not be divided, crushed, or chewed.
Slovenian: Tablete se ne sme lomiti, drobiti ali žvečiti.
English: Prolonged letermovir prophylaxis beyond 100 days post-transplant may be of benefit in some patients at high risk for late CMV reactivation (see section 5.1).
Slovenian: Dolgotrajna profilaksa z letermovirjem, ki traja več kot 100 dni po presaditvi, lahko koristi nekaterim bolnikom z visokim tveganjem za pozno reaktivacijo okužbe s CMV (glejte poglavje 5.1).
English: Among the 565 treated subjects, 373 subjects received letermovir (including 99 subjects who received at least one IV dose) and 192 received placebo (including 48 subjects who received at least one IV dose).
Slovenian: Med 565 zdravljenimi preiskovanci je 373 preiskovancev prejemalo letermovir (vključno z 99 preiskovanci, ki so prejeli vsaj en intravenski odmerek), 192 preiskovancev pa placebo (vključno z 48 preiskovanci, ki so prejeli vsaj en intravenski odmerek).
English: Antibiotics nafcillin
Slovenian: Antibiotiki nafcilin
English: No major metabolites are detected in plasma.
Slovenian: V plazmi niso odkrili pomembnih presnovkov.
English: • significant decrease of concomitant medicinal product plasma concentrations which may lead to reduced therapeutic effect of the concomitant medicinal product.
Slovenian: • pomembno zmanjšanje plazemske koncentracije sočasno uporabljenega zdravila, kar lahko zmanjša terapevtski učinek sočasno uporabljenega zdravila.
English: The medicine helps stop you from getting ill from CMV (‘cytomegalovirus').
Slovenian: Zdravilo pomaga preprečiti, da bi zboleli zaradi CMV ("citomegalovirusa").
English: • you take either of these medicines:
Slovenian: • če jemljete katero od naslednjih zdravil:
English: If a dose is missed, it should be given to the patient as soon as possible.
Slovenian: Izpuščeni odmerek mora bolnik prejeti čimprej.
English: • Cyclosporine, tacrolimus, sirolimus
Slovenian: • ciklosporin, takrolimus, sirolimus
English: Letermovir reached steady-state in 9 to 10 days with an accumulation ratio of 1.2 for AUC and 1.0 for Cmax.
Slovenian: Letermovir je dosegel stanje dinamičnega ravnovesja v 9 do 10 dneh, z razmerjem kopičenja 1,2 za vrednost AUC in 1,0 za vrednost Cmax.
English: • feeling very tired (fatigue)
Slovenian: • občutek hude utrujenosti
English: General toxicity
Slovenian: Splošna toksičnost
English: Randomisation was stratified by investigational site and risk (high vs. low) for CMV reactivation at the time of study entry.
Slovenian: Randomizacija je bila razslojena gleda na mesto raziskovanja in tveganje (visoko v primerjavi z nizkim) za reaktivacijo CMV v času vključitve v študijo.
English: One subject had a letermovir-resistant GV (V236M).
Slovenian: Ena oseba je imela proti letermovirju odporno GV (V236M).
English: Antiepileptic medicinal products (see also general text) carbamazepine, phenobarbital
Slovenian: Antiepileptiki (glejte tudi splošno besedilo) karbamazepin, fenobarbital
English: General information about differences in exposure between different letermovir treatment regimens -The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in section 5.2).
Slovenian: Splošne informacije o razlikah v izpostavljenosti pri različnih režimih zdravljenja z letermovirjem - Ocenjena plazemska izpostavljenost letermovirju se razlikuje glede na režim njegove uporabe (glejte preglednico v poglavju 5.2).
English: The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila PREVYMIS pri bolnikih, mlajših od 18 let, nista bili dokazani.
English: 95% CIs and p-value for the treatment differences in percent response were calculated using stratumadjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (high or low risk).
Slovenian: 95 % intervali zaupanja in p-vrednost za razlike med zdravljenjema v odstotku odziva so bili izračunani po Mantel-Haenszel-ovi metodi s prilagoditvijo za stratum in razliko, ponderirano s harmonično sredino velikosti vzorca na skupino za vsak stratum (visoko ali nizko tveganje).
English: The inter-individual variability for bioavailability was estimated to be approximately
Slovenian: Interindividualna variabilnost biološke uporabnosti je bila ocenjena na približno 37 %.
English: HIV antivirals (ritonavir, lopinavir)
Slovenian: protivirusna zdravila za HIV (ritonavir, lopinavir)
English: This medicine does not require any special temperature storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila glede temperature.
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 33.2% higher in Asians compared to Whites.
Slovenian: Na osnovi analiz populacijske farmakokinetike ocenjujejo, da je vrednost AUC letermovirja pri Azijcih za 33,2 % večja kot pri belcih.
English: The tablet is 16.5 mm long and 8.5 mm wide.
Slovenian: Tableta je 16,5 mm dolga in 8,5 mm široka.
English: o pimozide - used for Tourette's syndrome o ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
Slovenian: o pimozid - uporablja se pri Tourettovem sindromu o alkaloide ergot (kot sta ergotamin ali dihidroergotamin) - uporabljajo se pri migrenskih glavobolih
English: Additional blood tests may be needed to monitor the following medicinal products:
Slovenian: Za spremljanje naslednjih zdravil bo zdravnik morda moral opraviti dodatne krvne preiskave:
English: Interaction not studied.
Slovenian: Medsebojnega delovanja niso raziskali.
English: Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.
Slovenian: Zdravnik ali farmacevt vam bosta povedala, če je zdravilo PREVYMIS varno jemati skupaj z drugimi zdravili.
English: The net effect in vivo is unknown.
Slovenian: Neto učinek in vivo ni znan.
English: (15.0%) subjects were 65 years of age or older: 58% were male; 82% were White; 10% were Asian; 2% were Black or African; and 7% were Hispanic or Latino.
Slovenian: Mediana starosti je bila 54 let (v razponu od 18 do 78 let), 56 preiskovancev (15,0 %) je bilo starih 65 let ali starejših, 58 % preiskovancev je bilo moških, 82 % belcev, 10 % Azijcev, 2 % črncev ali Afričanov, 7 % pa hispanskega ali latinskega porekla.
English: Serum creatinine levels should be closely monitored in these patients.
Slovenian: Pri takšnih bolnikih je treba skrbno spremljati vrednosti kreatinina v serumu.
English: Concomitant use is not recommended.
Slovenian: Sočasna uporaba ni priporočljiva.
English: See also the general text on DDIs above.
Slovenian: Glejte tudi splošno besedilo o interakcijah med zdravili zgoraj.
English: The adverse reactions are listed below by body system organ class and frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
English: PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant.
Slovenian: Zdravilo PREVYMIS se lahko začne uporabljati na dan presaditve in najkasneje 28 dni po presaditvi.
English: Unless otherwise specified, interaction studies have been performed with oral letermovir without cyclosporine.
Slovenian: Če ni navedeno drugače, so študije interakcij izvedli s peroralno uporabljenim letermovirjem brez ciklosporina.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with PREVYMIS in one or more subsets of the paediatric population for prophylaxis of cytomegalovirus infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom PREVYMIS za eno ali več podskupin pediatrične populacije za profilakso okužbe s citomegalovirusom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Do not take PREVYMIS if any of the above apply to you.
Slovenian: Ne jemljite zdravila PREVYMIS, če se kar koli od navedenega zgoraj nanaša na vas.
English: Letermovir was administered either orally or IV; the dose of letermovir was the same regardless of the route of administration.
Slovenian: Letermovir so uporabljali peroralno ali intravensko, odmerek letermovirja pa je bil enak ne glede na pot uporabe.
English: • bosentan - for high blood pressure in the vessels in the lungs
Slovenian: • bosentan - uporablja se pri visokem krvnem tlaku v žilah pljuč
English: • glyburide, repaglinide - for high blood sugar
Slovenian: • gliburid, repaglinid - uporabljata se pri visokem krvnem sladkorju
English: Letermovir is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors (ganciclovir, cidofovir, and foscarnet).
Slovenian: Letermovir je polno aktiven proti virusnim populacijam s substitucijami, ki povzročajo odpornost proti zaviralcem DNA polimeraze CMV (ganciklovir, cidofovir in foskarnet).
English: * Population post-hoc predictions from the population PK analysis using Phase 3 data
Slovenian: * Populacijsko post-hoc predvidevanje iz analize populacijske farmakokinetike na osnovi podatkov 3. faze
English: See list under “Do not take PREVYMIS if you take either of these medicines.”
Slovenian: Glejte seznam pod naslovom “Ne jemljite zdravila PREVYMIS, če jemljete katero od naslednjih zdravil.”
English: • midazolam - used as a sedative
Slovenian: • midazolam - uporablja se kot pomirjevalo
English: Clinically significant CMV infection
Slovenian: razlogi za neuspeh klinično pomembna CMV-okužba
English: One subject (who received 60 mg/day) had a letermovir resistant genotypic variant (GV) (V236M).
Slovenian: Ena oseba (ki je prejemala odmerek 60 mg/dan) je imela proti letermovirju odporno genotipsko varianto (GV) (V236M).
English: • possible clinically significant adverse reactions from greater exposure of concomitant medicinal products or letermovir.
Slovenian: • možne klinično pomembne neželene učinke zaradi večje izpostavljenosti sočasno uporabljenim zdravilom ali letermovirju.
English: Concomitant use of dabigatran should be avoided due to risk of reduced dabigatran efficacy.
Slovenian: Sočasni uporabi dabigatrana se je treba izogibati zaradi tveganja zmanjšane učinkovitosti dabigatrana.
English: Effect of letermovir on other medicinal products
Slovenian: Vpliv letermovirja na druga zdravila
English: Letermovir is extensively bound (98.2%) to human plasma proteins, independent of the concentration range (3 to 100 mg/L) evaluated, in vitro.
Slovenian: Letermovir se v veliki meri (98,2 %) veže na človeške plazemske proteine, neodvisno od razpona koncentracije (3 do 100 mg/l), ovrednotenega in vitro.
English: • abnormalities in laboratory tests of liver function
Slovenian: • nepravilnosti, ugotovljene pri laboratorijskih preiskavah za oceno delovanja jeter
English: Letermovir is a moderate inducer of enzymes and transporters.
Slovenian: Letermovir je zmerni induktor encimov in prenašalcev.
English: In vitro results indicate that letermovir is a substrate of P-gp/BCRP.
Slovenian: Rezultati in vitro kažejo, da je letermovir substrat za P-gp/BCRP.
English: Administration See section 4.2.
Slovenian: Aplikacija Glejte poglavje 4.2.
English: -An example of a medicinal product which is mainly eliminated by CYP2C8 is repaglinide (see Table 1).
Slovenian: - Primer zdravila, ki se v glavnem izloča s pomočjo CYP2C8, je repaglinid (glejte preglednico 1).
English: How to take • Swallow the tablet whole with some water.
Slovenian: Kako jemati zdravilo • Tableto pogoltnite celo z malo vode.
English: Incompatible medicinal products
Slovenian: Inkompatibilna zdravila
English: Plasticizers Diethylhexyl-phthalate (DEHP), tris (2-ethylhexyl) trimellitate (TOTM), butyl benzyl phthalate (BBP)
Slovenian: Plastifikatorji dietilheksilftalat (DEHP), tris-(2-etilheksil)-trimelitat (TOTM), butil-benzilftalat (BBP)
English: The median EC50 value of letermovir against a collection of clinical CMV isolates in a cell-culture model of infection was 2.1 nM (range = 0.7 nM to 6.1 nM, n=74).
Slovenian: Mediana vrednosti EC50 letermovirja proti zbirki kliničnih izolatov CMV v modelu okužbe na celični kulturi je znašala 2,1 nM (razpon = 0,7 nM do 6,1 nM; n = 74).
English: Do not stop taking PREVYMIS without talking to your doctor first.
Slovenian: Ne prenehajte jemati zdravila PREVYMIS, ne da bi se prej posvetovali z zdravnikom.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of letermovir in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje letermovirja v mleko (glejte poglavje 5.3).
English: How to take PREVYMIS 4.
Slovenian: Kako jemati zdravilo PREVYMIS 4.
English: This medicinal product must not be used with other intravenous bags and infusion set materials except those mentioned in section 6.6.
Slovenian: Zdravila se ne sme uporabljati z drugimi intravenskimi vrečkami in infuzijskimi kompleti iz drugih materialov, razen s tistimi, ki so omenjeni v poglavju 6.6.
English: Concomitant use of repaglinide and letermovir with or without cyclosporine is not recommended.
Slovenian: Sočasna uporaba repaglinida in letermovirja, s ciklosporinom ali brez njega, ni priporočljiva.
English: In HSCT recipients, letermovir AUC was estimated using population pharmacokinetic analyses using Phase 3 data (see Table 4).
Slovenian: Pri prejemnikih HSCT so vrednost AUC letermovirja ocenili z analizami populacijske farmakokinetike na osnovi podatkov 3. faze (glejte preglednico 4).
English: Plasma concentrations of medicinal products transported by OAT3 may be increased.
Slovenian: Plazemske koncentracije zdravil, ki se prenašajo z OAT3, se lahko zvišajo.
English: It is known that hydroxypropylbetadex can cause kidney vacuolation in rats when given intravenously at doses greater than 50 mg/kg/day.
Slovenian: Znano je, da lahko hidroksipropilbetadeks pri podganah povzroči vakuolizacijo ledvic, če se ga uporablja intravensko v odmerkih, večjih od 50 mg/kg/dan.
English: In order to optimise the sterility assurance level (SAL) of the manufacturing process, the marketing authorisation holder should implement the measures outlined in the Post Approval Change Management Protocol (PACMP) agreed with the CHMP concerning development, validation and introduction of terminal sterilisation.
Slovenian: Z namenom optimizacije zagotavljanja ravni sterilnosti (SAL) proizvodnega procesa mora imetnik dovoljenja za promet z zdravilom izvesti ukrepe glede razvoja, validacije in uvedbe končne sterilizacije.
English: If dose adjustments of concomitant medicinal products are made due to treatment with PREVYMIS, doses should be readjusted after treatment with PREVYMIS is completed.
Slovenian: Če se zaradi zdravljenja z zdravilom PREVYMIS odmerke sočasno uporabljenih zdravil prilagodi, jih je treba po zaključku zdravljenja z zdravilom PREVYMIS znova prilagoditi.
English: At baseline, 50% of subjects received a myeloablative regimen, 52% were receiving cyclosporine, and 42% were receiving tacrolimus.
Slovenian: V izhodišču je 50 % preiskovancev prejelo mieloablativni režim, 52 % preiskovancev je prejemalo ciklosporin, 42 % pa takrolimus.
English: Compatible intravenous solutions and other medicinal products
Slovenian: Kompatibilne intravenske raztopine in druga zdravila
English: Expected: ↓ letermovir (P-gp/UGT induction)
Slovenian: Pričakovano: ↓ letermovir (indukcija P-gp/UGT)
English: NC=F, Non-Completer=Failure.
Slovenian: “Nedokončanje = neuspeh” (NC = F - Non-Completer = Failure).
English: Some saturation was observed at lower concentrations.
Slovenian: Pri manjših koncentracijah so opazili nekoliko nasičenja.
English: • allergic reaction (hypersensitivity) - the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling.
Slovenian: • alergijska reakcija (preobčutljivost) - med znaki so lahko piskajoče dihanje, težko dihanje,
English: Close monitoring and/or dose adjustment of co-administered CYP3A substrates is recommended (see section 4.5).
Slovenian: Priporočljivo je skrbno spremljanje in/ali prilagoditev odmerkov sočasno uporabljenih substratov za CYP3A (glejte poglavje 4.5).
English: Any intravenous bags or infusion set materials not listed below should not be used.
Slovenian: Intravenskih vrečk ali infuzijskih kompletov iz materialov, ki niso navedeni v nadaljevanju, ne smete uporabljati.
English: It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.
Slovenian: Ni znano, če bi dializa v pomembnejšem obsegu odstranila zdravilo PREVYMIS iz sistemske cirkulacije.
English: In patients in whom letermovir prophylaxis was initiated and the baseline CMV DNA test was subsequently found to be positive, prophylaxis could be continued if PET criteria had not been met (see section 5.1).
Slovenian: Pri bolnikih, pri katerih se je začela profilaksa z letermovirjem, naknadno pa se ugotovi, da je bil izhodiščni test CMV DNA pozitiven, se profilaksa lahko nadaljuje, če niso izpolnjena merila za uvedbo predbolezenskega zdravljenja (glejte poglavje 5.1).
English: PVC, polyethylene (PE), polybutadiene (PBD), silicone rubber (SR), styrene-butadiene copolymer (SBC), styrene-butadiene-styrene copolymer (SBS), polystyrene (PS)
Slovenian: PVC, polietilen (PE), polibutadien (PBD), silikonska guma (SR), stiren-butadienski kopolimer (SBC), stiren-butadien-stirenski kopolimer (SBS), polistiren (PS)
English: • If you are not sure what to do, call your doctor or pharmacist.
Slovenian: • Če niste prepričani, kaj storiti, se posvetujte z zdravnikom ali farmacevtom.
English: Letermovir may increase the plasma concentrations of medicinal products transported by OATP1B1/3 such as many of the statins (see section 4.5 and Table 1).
Slovenian: Letermovir lahko poveča plazemske koncentracije zdravil, ki se prenašajo z OATP1B1/3, kot so številni statini (glejte poglavje 4.5 in preglednico 1).
English: Prophylaxis with PREVYMIS should continue through 100 days post-transplant.
Slovenian: Profilaktično zdravljenje z zdravilom PREVYMIS se mora nadaljevati 100 dni po presaditvi.
English: Therefore, letermovir may potentially lead to decreased plasma exposure and possibly reduced efficacy of co-administered medicinal products that are mainly eliminated through metabolism or by active transport.
Slovenian: Letermovir lahko tako povzroči zmanjšanje plazemske izpostavljenosti in verjetno zmanjšano učinkovitost sočasno uporabljenih zdravil, ki se izločajo v glavnem s presnovo ali aktivnim transportom.
English: This is because your doctor may have to change your medicines or change the dose of your medicines:
Slovenian: Zdravnik bo zdravila morda moral zamenjati ali spremeniti njihov odmerek:
English: PREVYMIS should be started after HSCT.
Slovenian: Zdravljenje z zdravilom PREVYMIS je treba začeti po HSCT.
English: No known letermovir resistance mutations map to UL89.
Slovenian: Ni znanih rezistenčnih mutacij proti letermovirju na UL89.
English: In vitro data indicate that letermovir is an inhibitor of OAT3; therefore, letemovir may be an OAT3 inhibitor in vivo.
Slovenian: Podatki in vitro kažejo, da je letermovir zaviralec OAT3, zato je lahko letermovir zaviralec OAT3 in vivo.
English: Letermovir inhibits the CMV DNA terminase complex which is required for cleavage and packaging of viral progeny DNA.
Slovenian: Letermovir zavira kompleks DNA terminaze CMV, ki je potreben za cepitev in pakiranje DNA novih virusov.
English: Effect of other medicinal products on letermovir
Slovenian: Vpliv drugih zdravil na letermovir
English: The medicinal product interactions described are based on studies conducted with PREVYMIS or are predicted medicinal product interactions that may occur with PREVYMIS (see sections 4.3, 4.4, 5.1, and 5.2).
Slovenian: Opisane interakcije med zdravil temeljijo na študijah, izvedenih z zdravilom PREVYMIS, ali pa so pričakovane interakcije med zdravili, ki bi se lahko pojavile pri uporabi zdravila PREVYMIS (glejte poglavja 4.3, 4.4, 5.1 in 5.2).
English: Each mL of concentrate contains 20 mg/mL.
Slovenian: En ml koncentrata vsebuje 20 mg/ml.
English: Letermovir was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis assays, chromosomal aberration in Chinese Hamster Ovary cells, and in an in vivo mouse micronucleus study.
Slovenian: Letermovir ni bil genotoksičen v skupini preizkusov in vitro in in vivo, vključujoč preizkus mutagenosti na mikrobih, preizkus kromosomskih aberacij na ovarijskih celicah kitajskega hrčka ter mikrojedrno študijo pri miših in vivo.
English: PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary.
Slovenian: Tablete zdravila PREVYMIS in koncentrat za raztopino za infundiranje zdravila PREVYMIS se po presoji zdravnika lahko uporabljajo medsebojno zamenljivo, pri čemer odmerka ni treba prilagajati.
English: High Risk (n=102, 45) Low Risk (n=223, 125)
Slovenian: vir matičnih celic visoko tveganje (n = 102, 45) nizko tveganje (n = 223, 125)
English: • cyclosporine, tacrolimus, sirolimus - used to prevent transplant rejection
Slovenian: • ciklosporin, takrolimus, sirolimus - uporabljajo se za preprečevanje zavrnitve presadka
English: Twelve percent (12%) of subjects were positive for CMV DNA at baseline.
Slovenian: V izhodišču je bilo 12 % preiskovancev pozitivnih na CMV DNA.
English: The mutations map to UL56 and occur in amino acid residues between 231 and 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
Slovenian: Mutacije kažejo na UL56 in se pojavijo v aminokislinskih ostankih med 231 in 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
English: Pimozide and ergot alkaloids are contraindicated (see section 4.3).
Slovenian: Uporaba pimozida in alkaloidov ergot je kontraindicirana (glejte poglavje 4.3).
English: Patients should be instructed that if they miss a dose of PREVYMIS, they should take it as soon as they remember.
Slovenian: Bolnikom je treba naročiti, da morajo pozabljeni odmerek zdravila PREVYMIS vzeti takoj, ko se na to spomnijo.