FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 31% of subjects were at high risk for reactivation as defined by one or more of the following criteria: Human Leukocyte Antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B or -DR, haploidentical donor; unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B,C and -DRB1; use of umbilical cord blood as stem cell source; use of ex vivo T-cell-depleted grafts; Grade 2 or greater Graft-Versus-Host Disease (GVHD), requiring systemic corticosteroids.
Slovenian: V izhodišču je 31 % preiskovancev imelo visoko tveganje za reaktivacijo, kar je bilo opredeljeno z enim ali več od naslednjih meril: HLA-soroden (humani levkocitni antigen) dajalec (sorodnik) z vsaj enim neujemanjem na enem od naslednjih treh mest HLA-gena: HLA-A, -B ali -DR, haploidentičen dajalec; nesoroden dajalec z vsaj enim neujemanjem na enem od naslednjih štirih mest HLA-gena: HLA-A, -B, -C in -DRB1; uporaba popkovnične krvi kot vira matičnih celic; uporaba presadkov ex vivo z izčrpanimi celicami T; bolezen presadka proti gostitelju (GVHD - Graft-Versus-Host Disease) stopnje 2 ali večje, ki je zahtevala uporabo sistemskih kortikosteroidov.
English: This is because PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works.
Slovenian: Zdravilo PREVYMIS namreč lahko vpliva na delovanje drugih zdravil, druga zdravila pa lahko vplivajo na delovanje zdravila PREVYMIS.
English: Changes in letermovir plasma concentrations due to inhibition of P-gp/BCRP are not anticipated to be clinically relevant.
Slovenian: Za spremembe plazemskih koncentracij letermovirja zaradi zaviranja P-gp/BCRP ni pričakovati, da bi bile klinično pomembne.
English: • Anti-thymocyte globulin
Slovenian: • antitimocitni globulin
English: • rifabutin, rifampicin - for mycobacterial infections
Slovenian: • rifabutin, rifampicin - uporabljata se pri okužbah z mikobakterijami
English: • This medicinal product must not be mixed with other medicinal products except those listed below.
Slovenian: • Zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, ki so navedena v nadaljevanju.
English: pantoprazole
Slovenian: pantoprazol
English: The tablets shall be swallowed whole with some water.
Slovenian: Tableto pogoltnite celo z malo vode.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Expected: ↓ pantoprazole
Slovenian: Pričakovano: ↓ pantoprazol
English: • nafcillin - for bacterial infections
Slovenian: • nafcilin - uporablja se pri bakterijskih okužbah
English: Risk of adverse reactions or reduced therapeutic effect due to medicinal product interactions The concomitant use of PREVYMIS and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to:
Slovenian: Tveganje za neželene učinke ali zmanjšanje terapevtskega učinka zaradi medsebojnega delovanja med zdravili Pri sočasni uporabi zdravila PREVYMIS in določenih zdravil lahko pride do znanega ali potencialno pomembnega medsebojnega delovanja med zdravili.
English: See the package leaflet for your other medicine for further information.
Slovenian: Prosimo, glejte tudi Navodilo za uporabo drugega zdravila za dodatne informacije.
English: The most frequently reported adverse reactions that led to discontinuation of PREVYMIS were nausea (1.6%), vomiting (0.8%), and abdominal pain (0.5%).
Slovenian: Najpogosteje poročani neželeni učinki, zaradi katerih je bilo treba uporabo zdravila PREVYMIS prekiniti, so bili navzea (1,6 %), bruhanje (0,8 %) in bolečina v trebuhu (0,5 %).
English: Letermovir was initiated after HSCT (Day 0-28 post-transplant) and continued through Week 14 post-transplant.
Slovenian: Zdravljenje z letermovirjem so uvedli po HSCT (0.-28. dan po presaditvi) in se je nadaljevalo do 14. tedna po presaditvi.
English: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials.
Slovenian: V nadaljevanju so navedeni neželeni učinki, ki so jih ugotovili pri bolnikih, ki so zdravilo PREVYMIS prejemali v kliničnih preskušanjih.
English: Table 3: P001: Efficacy results in HSCT recipients (NC=F Approach, FAS Population) Letermovir
Slovenian: Preglednica 3: P001: Rezultati učinkovitosti pri prejemnikih HSCT (pristop NC = F, populacija FAS)
English: Other systemically acting oral contraceptive steroids
Slovenian: Drugi peroralni steroidni kontraceptivi s sistemskim delovanjem
English: • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
Slovenian: • omeprazol, pantoprazol - uporabljata se pri razjedah želodca in drugih težavah z želodcem
English: Note: The proportion of subjects with detectable CMV viral DNA on Day 1 that developed clinically significant CMV infection in the letermovir group was 64.6% (31/48) compared to 90.9% (20/22) in the placebo group through Week 24 post-transplant.
Slovenian: Opomba: Delež preiskovancev z določljivo vrednostjo DNA virusa CMV na 1. dan, ki so razvili klinično pomembno CMV-okužbo, je 24. teden po presaditvi v skupini z letermovirjem znašal 64,6 % (31/48), v skupini s placebom pa 90,9 % (20/22).
English: The effect is expected to be less pronounced for oral letermovir without cyclosporine, than IV letermovir with or without cyclosporine, or oral letermovir with cyclosporine.
Slovenian: Pričakuje se, da bo učinek manj izrazit pri peroralni uporabi letermovirja brez ciklosporina, kot pri intravenski uporabi letermovirja s ciklosporinom ali brez njega ali peroralni uporabi letermovirja s ciklosporinom.
English: • Fentanyl citrate
Slovenian: • fentanilijev citrat
English: • amiodarone - used to correct irregular heartbeats
Slovenian: • amiodaron - uporablja se pri zdravljenju nepravilnega bitja srca
English: Letermovir also appears to be subject to P-gp and BCRP mediated efflux in the liver and intestine (see section 5.2).
Slovenian: Kaže, da je letermovir podvržen tudi s P-gp in BCRP posredovanemu efluksu v jetrih in črevesu (glejte poglavje 5.2).
English: This needs to be considered when the letermovir regimen is changed during treatment with a CYP2C9 or CYP2C19 substrate.
Slovenian: To je treba upoštevati, če se med zdravljenjem s substratom za CYP2C9 ali CYP2C19 spremeni režim zdravljenja z letermovirjem.
English: Week 14
Slovenian: 14. teden
English: Both elimination pathways involve active uptake into the hepatocyte through the hepatic uptake transporters OATP1B1/ 3.
Slovenian: Obe poti izločanja vključujeta aktivni vnos v hepatocit s pomočjo jetrnih vnosnih prenašalcev OATP1B1/3.
English: This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To ustreza 1,15 % priporočenega največjega dnevnega vnosa natrija za odrasle.
English: Based on population pharmacokinetic analyses, there is no difference in letermovir pharmacokinetics in females compared to males.
Slovenian: Na osnovi analiz populacijske farmakokinetike se farmakokinetika letermovirja pri ženskah ne razlikuje od farmakokinetike pri moških.
English: Metabolism and nutrition disorders Uncommon decreased appetite
Slovenian: Presnovne in prehranske motnje Občasni zmanjšanje apetita
English: • Administer as an intravenous infusion only.
Slovenian: • Aplicirajte le v obliki intravenske infuzije.
English: See Table 1 for steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations (see sections 4.3 and 4.5).
Slovenian: Za ukrepe za preprečevanje ali obvladovanje teh znanih ali potencialno pomembnih interakcij med zdravili, vključno s priporočili za odmerjanje, glejte preglednico 1 (glejte poglavji 4.3 in 4.5).
English: Letermovir - Placebo Difference (%) and 95% C.I.
Slovenian: Razlika med letermovirjem in placebom (%) in 95 % IZ
English: Elderly No dose adjustment of PREVYMIS is required based on age (see sections 5.1 and 5.2).
Slovenian: Starejši bolniki Prilagoditev odmerka zdravila PREVYMIS glede na starost ni potrebna (glejte poglavji 5.1 in 5.2).
English: The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting
Slovenian: Najpogosteje poročani neželeni učinki, ki so se pojavili pri vsaj 1 % preiskovancev v skupini, ki je prejemala zdravilo PREVYMIS, in s pogostnostjo, ki je bila večja od pogostnosti pri placebu, so bili: navzea (7,2 %), diareja (2,4 %) in bruhanje (1,9 %).
English: The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.
Slovenian: Druge sestavine zdravila so: hidroksipropilbetadeks (ciklodekstrin), natrijev klorid, natrijev hidroksid (E524), voda za injekcije.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Čas shranjevanja običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bilo redčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: Statinassociated adverse events such as myopathy should be closely monitored.
Slovenian: Skrbno je treba spremljati neželene učinke statinov, kot je miopatija.
English: Based on population pharmacokinetic analyses, there is no effect of age on letermovir pharmacokinetics.
Slovenian: Na osnovi analiz populacijske farmakokinetike starost nima vpliva na farmakokinetiko letermovirja.
English: Subjects were randomised (2:1) to receive either letermovir at a dose of 480 mg once daily adjusted to 240 mg when co-administered with cyclosporine, or placebo.
Slovenian: Preiskovance so randomizirali (2:1) na prejemanje letermovirja v odmerku 480 mg enkrat na dan, ki so ga pri uporabi skupaj s ciklosporinom prilagodili na 240 mg, ali placebo.
English: • dabigatran, warfarin - used to thin the blood or for blood clots
Slovenian: • dabigatran, varfarin - uporabljata se za redčenje krvi ali preprečevanje nastanka krvnih strdkov
English: In the fertility and early embryonic development studies in the rat, there were no effects of letermovir on female fertility.
Slovenian: V študijah plodnosti in zgodnjega embrionalnega razvoja pri podganah niso ugotovili vpliva letermovirja na plodnost samic.
English: There were no effects on female fertility in rats.
Slovenian: Pri podganah ni bilo vplivov na plodnost samic.
English: PREVYMIS is a medicine for adults who have recently had a bone marrow transplant.
Slovenian: Zdravilo PREVYMIS je zdravilo za odrasle, pri katerih so pred kratkim opravili presaditev kostnega mozga.
English: Letermovir demonstrated superior efficacy over placebo in the analysis of the primary endpoint, as shown in Table 3.
Slovenian: Analiza primarnega opazovanega dogodka je pokazala superiorno učinkovitost letermovirja nad placebom, kot je prikazano v preglednici 3.
English: Medicinal products metabolised by CYP2C9 and/or CYP2C19
Slovenian: Zdravila, ki se presnavljajo s CYP2C9 in/ali CYP2C19
English: Polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and polyolefin (polypropylene and polyethylene)
Slovenian: Materiali intravenskih vrečk polivinilklorid (PVC), etilen-vinil acetat (EVA) in poliolefin (polipropilen in polietilen)
English: In a Phase 3 trial (P001), DNA sequence analysis of the entire coding regions of UL56 and UL89 was performed on samples obtained from 22 letermovir-treated subjects, in the FAS population who experienced prophylaxis failure and for whom samples were available for analysis.
Slovenian: V preskušanju 3. faze (P001) so opravili sekvenčno analizo DNA celotnih kodirnih regij UL56 in UL89 v vzorcih 22 preiskovancev, zdravljenih z letermovirjem, iz celotne populacije za analizo (FAS population), pri katerih profilaksa ni bila uspešna, na voljo pa so bili vzorci za analizo.
English: A 1-sided p-value ≤0.0249 was used for declaring statistical significance.
Slovenian: Kot meja statistične pomembnosti je veljala 1-stranska p-vrednost ≤ 0,0249.
English: Endothelin antagonists bosentan
Slovenian: Antagonisti endotelinskih receptorjev bosentan
English: PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant.
Slovenian: Zdravljenje z zdravilom PREVYMIS mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolnikov, pri katerih je bila opravljena alogenska presaditev krvotvornih matičnih celic.
English: There are some medicines you must not take with PREVYMIS.
Slovenian: Nekaterih zdravil ne smete jemati skupaj z zdravilom PREVYMIS.
English: The changes in letermovir exposure due to moderate or severe renal impairment are not considered to be clinically relevant.
Slovenian: Spremembe izpostavljenosti letermovirju zaradi zmerne ali hude okvare ledvic ne veljajo za klinično pomembne.
English: This needs to be considered when the letermovir regimen is changed during treatment with an OATP1B1/3 substrate.
Slovenian: To je treba upoštevati, če se med zdravljenjem s substratom za OATP1B1/3 spremeni režim zdravljenja z letermovirjem.
English: ↑ or ↓ efavirenz (CYP2B6 inhibition or induction)
Slovenian: ↑ ali ↓ efavirenz (zaviranje ali indukcija CYP2B6)
English: No dose recommendation can be made for patients with end stage renal disease (ESRD) with or without dialysis.
Slovenian: Za bolnike s končno ledvično odpovedjo (ESRD - End Stage Renal Disease) na dializi ali brez nje priporočil za odmerjanje ne moremo podati.
English: Concomitant administration with pimozide (see sections 4.4 and 4.5).
Slovenian: Sočasna uporaba s pimozidom (glejte poglavji 4.4 in 4.5).
English: PREVYMIS may have minor influence on the ability to drive or use machines.
Slovenian: Zdravilo PREVYMIS ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: PREVYMIS should be used with caution with medicinal products that are CYP3A substrates with narrow therapeutic ranges (e.g., alfentanil, fentanyl, and quinidine) as co-administration may result in increases in the plasma concentrations of CYP3A substrates.
Slovenian: Zdravilo PREVYMIS je treba uporabljati previdno skupaj z zdravili, ki so substrati za CYP3A z ozko terapevtsko širino (npr. alfentanil, fentanil in kinidin), saj se pri sočasni uporabi lahko poveča plazemska koncentracija substratov za CYP3A.
English: Medicinal products mainly eliminated through metabolism or influenced by active transport Letermovir is a general inducer in vivo of enzymes and transporters.
Slovenian: Zdravila, ki se v glavnem izločajo s presnovo ali aktivnim transportom Letermovir je na splošno induktor encimov in prenašalcev in vivo.
English: In the pre- and post-natal developmental study, letermovir was administered orally to pregnant rats.
Slovenian: V študiji pre- in post-natalnega razvoja so breje podgane prejemale letermovir peroralno.
English: Mismatched related (n=52, 18) Matched unrelated (n=122, 70)
Slovenian: neusklajen soroden (n = 52, 18) usklajen nesoroden (n = 122, 70)
English: Letermovir affects the formation of proper unit length genomes and interferes with virion maturation.
Slovenian: Letermovir vpliva na tvorbo enot genomov pravilne dolžine in moti zorenje virionov.
English: If you forget to take PREVYMIS
Slovenian: Če ste pozabili vzeti zdravilo PREVYMIS
English: The adverse reaction profile was similar to that of the clinical dose of 480 mg/day.
Slovenian: Profil neželenih učinkov je bil podoben kot pri uporabi kliničnega odmerka 480 mg/dan.
English: Letermovir was absorbed rapidly with a median time to maximum plasma concentration (Tmax) of 1.5 to 3.0 hours and declined in a biphasic manner.
Slovenian: Absorpcija letermovirja je bila hitra, mediana časa do največje plazemske koncentracije (Tmax) je znašala 1,5 do 3,0 ure, upadanje pa je bilo dvofazno.
English: What PREVYMIS is and what it is used for
Slovenian: Kaj je zdravilo PREVYMIS in za kaj ga uporabljamo
English: PREVYMIS may have minor influence on your ability to drive and use machines (see section 4 Possible Side Effects below).
Slovenian: Zdravilo PREVYMIS ima lahko blag vpliv na sposobnost upravljanja vozil in strojev (glejte poglavje 4 Možni neželeni učinki v nadaljevanju).
English: In patients with moderate or severe renal impairment (creatinine clearance less than 50 mL/min) receiving PREVYMIS, accumulation of hydroxypropylbetadex, could occur (see section 5.3).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic (kreatininski očistek manjši od 50 ml/min) bi med uporabo zdravila PREVYMIS lahko prišlo do kopičenja hidroksipropilbetadeksa (glejte poglavje 5.3).
English: During Phase 1 clinical trials, 86 healthy subjects received doses ranging from 720 mg/day to 1440 mg/day of PREVYMIS for up to 14 days.
Slovenian: Med kliničnimi preskušanji 1. faze je 86 zdravih preiskovancev do 14 dni prejemalo zdravilo PREVYMIS v odmerkih od 720 mg/dan do 1.440 mg/dan.
English: The majority of letermovir was biliary excreted as unchanged parent with a minor amount (6% of dose) as an acyl-glucuronide metabolite in faeces.
Slovenian: Večina letermovirja se je izločila v žolč v obliki nespremenjene učinkovine, manjši del (6 % odmerka) pa v obliki presnovka acil-glukuronida v blatu.
English: Adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant To evaluate letermovir prophylaxis as a preventive strategy for CMV infection or disease, the efficacy of letermovir was assessed in a multicenter, double-blind, placebo-controlled Phase 3 trial (P001) in adult CMV-seropositive recipients [R+] of an allogeneic HSCT.
Slovenian: Odrasli, CMV-seropozitivni prejemniki [R+] alogenske presaditve krvotvornih matičnih celic Pri vrednotenju profilakse z letermovirjem za preprečevanje CMV-okužbe ali CMV-bolezni so učinkovitost letermovirja vrednotili v multicentričnem, dvojno slepem, s placebom nadzorovanem preskušanju 3. faze (P001) pri odraslih, CMV-seropozitivnih prejemnikih [R+] alogenske HSCT.
English: • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
Slovenian: • efavirenz, etravirin, nevirapin, lopinavir, ritonavir - uporabljajo se pri okužbi s HIV
English: Fatigue and vertigo have been reported in some patients during treatment with PREVYMIS, which may influence a patient's ability to drive and use machines (see section 4.8).
Slovenian: Med zdravljenjem z zdravilom PREVYMIS so pri posameznih bolnikih poročali o utrujenosti in vrtoglavici, kar lahko vpliva na sposobnost bolnika za vožnjo in upravljanje strojev (glejte poglavje 4.8).
English: Expected: ↓ warfarin
Slovenian: Pričakovano: ↓ varfarin
English: • Morphine sulfate
Slovenian: • morfinijev sulfat
English: For intravenous use only.
Slovenian: Način uporabe samo za intravensko uporabo
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 18.7% lower in subjects weighing 80-100 kg compared to subjects weighing 67 kg.
Slovenian: Na osnovi analiz populacijske farmakokinetike ocenjujejo, da je vrednost AUC letermovirja pri preiskovancih s telesno maso 80-100 kg za 18,7 % manjša kot pri preiskovancih s telesno maso 67 kg.
English: This is equivalent to 2.30% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To ustreza 2,30 % priporočenega največjega dnevnega vnosa natrija za odrasle.
English: Letermovir is partly eliminated by glucuronidation mediated by UGT1A1/1A3.
Slovenian: Letermovir se deloma odstrani z glukuronidacijo preko UGT1A1/1A3.
English: Letermovir inhibits CYP2C8 in vitro but may also induce CYP2C8 based on its induction potential.
Slovenian: Letermovir in vitro zavira CYP2C8, na osnovi svojega indukcijskega potenciala pa lahko tudi inducira CYP2C8.
English: If you are given more PREVYMIS than you should If you think you have been given too much PREVYMIS, tell your doctor straight away.
Slovenian: Če ste prejeli večji odmerek zdravila PREVYMIS, kot bi smeli Če menite, da ste prejeli prevelik odmerek zdravila PREVYMIS, o tem nemudoma obvestite zdravnika.
English: - Examples of medicinal products transported by BCRP include rosuvastatin and sulfasalazine.
Slovenian: - Primeri zdravil, ki se prenašajo z BCRP, so: rosuvastatin in sulfasalazin.
English: The pharmacokinetics of letermovir have been characterized following oral and IV administration in healthy subjects and HSCT recipients.
Slovenian: Farmakokinetiko letermovirja so raziskali pri peroralni in intravenski uporabi pri zdravih preiskovancih in prejemnikih HSCT.
English: The mechanism is likely saturation/autoinhibition of OATP1B1/3.
Slovenian: Mehanizem je verjetno zasičenost/avtoinhibicija OATP1B1/3.
English: In healthy subjects, oral administration of 480 mg single dose of letermovir with a standard high fat and high calorie meal did not have any effect on the overall exposure (AUC) and resulted in approximately 30% increase in peak levels (Cmax) of letermovir.
Slovenian: Pri zdravih preiskovancih peroralna uporaba letermovirja v enkratnem odmerku 480 mg skupaj s standardnim obrokom z veliko vsebnostjo maščob in kalorij ni vplivala na celokupno izpostavljenost (AUC), največje koncentracije (Cmax) letermovirja pa so se povečale za približno 30 %.
English: Additional effects of other products on letermovir relevant when combined with cyclosporine
Slovenian: Dodatni vplivi drugih zdravil na letermovir, v povezavi s sočasno uporabo s ciklosporinom
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden boste prejeli zdravilo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Expected: ↑ HMG-CoA reductase inhibitors
Slovenian: Pričakovano: ↑ zaviralci reduktaze HMG-CoA
English: Subjects had continued follow-up through Week 48 post-transplant.
Slovenian: Preiskovance so nato spremljali še naprej do 48. tedna po presaditvi.
English: Primary efficacy endpoint (Proportion of subjects who failed prophylaxis by Week 24)
Slovenian: primarni opazovani dogodek učinkovitosti (delež preiskovancev z neuspešno profilakso do 24. tedna)
English: List of compatible medicinal products when PREVYMIS and medicinal products* are prepared in 0.9% sodium chloride
Slovenian: Seznam kompatibilnih zdravil, če so zdravilo PREVYMIS in zdravila* pripravljeni v 0,9 % natrijevem kloridu
English: Concomitant use is not recommended glyburide
Slovenian: Sočasna uporaba ni priporočljiva gliburid
English: Medicinal products transported by the renal transporter OAT3
Slovenian: Zdravila, ki se prenašajo z ledvičnim prenašalcem OAT3
English: Number of Subjects at Risk Letermovir
Slovenian: Število ogroženih oseb Letermovir
English: • Magnesium sulfate
Slovenian: • magnezijev sulfat
English: • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
Slovenian: • statine, kot so atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin uporabljajo se pri visokem holesterolu
English: Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (see section 4.5).
Slovenian: Sočasna uporaba dabigatrana, atorvastatina, simvastatina, rosuvastatina ali pitavastatina je kontraindicirana (glejte poglavje 4.5).
English: The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see section 5.1).
Slovenian: Ocena varnosti zdravila PREVYMIS temelji na kliničnem preskušanju 3. faze (P001) pri prejemnikih HSCT, ki so 14 tednov po presaditvi prejemali zdravilo PREVYMIS ali placebo, nato pa so jih glede varnosti spremljali do 24. tedna po presaditvi (glejte poglavje 5.1).