natgillin/translations-raw huggingface dataset:
Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Bolniki morajo pred zdravljenjem in po njem popiti zadostne količine tekočine ter prejemati ustrezne dodatke vitamina D in kalcija.
The full EPAR and risk management plan summary for Zoledronic acid Teva Generics can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Zoledronska kislina Teva Generics sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used in patients who are at risk of fractures (broken bones) and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Uporablja se pri bolnikih, pri katerih obstaja tveganje za zlome (zlomljene kosti), in pri bolnikih, pri katerih je osteoporoza povezana z dolgotrajnim zdravljenjem z glukokortikoidi (vrsto steroidov).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics has been shown to be comparable to Aclasta.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Zoledronska kislina Teva Generics primerljivo z zdravilom Aclasta.
In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Pri ženskah je osteoporoza pogostejša v obdobju po menopavzi, ko se zmanjša količina ženskega hormona estrogena.
In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Pri Pagetovi bolezni se kostnina hitreje razgrajuje, ko pa kostno tkivo ponovno zraste, je šibkejše kot običajno.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Generics.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Teva Generics.
It is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Uporablja se za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah, pri katerih je že nastopila menopavza, in pri moških.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Generics on 27 March 2014.
Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Teva Generics, veljavno po vsej Evropski uniji, izdala 27. marca 2014.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Deluje tako, da prepreči delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
This means that Zoledronic acid Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aclasta.
Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Zoledronska kislina Teva Generics generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Zoledronic acid Teva Generics be approved for use in the EU.
Priporočil je, da se zdravilo Zoledronska kislina Teva Generics odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Generics?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina Teva Generics?
This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Zaradi tega se pri osteoporozi zmanjša izguba kostne mase, pri Pagetovi bolezni pa dejavnost bolezni.
Zoledronic acid Teva Generics is also used to treat Paget's disease of the bone in adults.
Zdravilo Zoledronska kislina Teva Generics se uporablja tudi za zdravljenje Pagetove bolezni kosti pri odraslih.
For more information about treatment with Zoledronic acid Teva Generics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zoledronska kislina Teva Generics preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This can be repeated once a year in patients being treated for osteoporosis.
Pri bolnikih, ki se zdravijo zaradi osteoporoze, se lahko postopek ponovi enkrat na leto.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Zoledronska kislina Teva Generics in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In the treatment of Paget's disease, Zoledronic acid Teva Generics must only be used by a doctor who has experience in the treatment of the disease.
Pri zdravljenju Pagetove bolezni sme zdravilo Zoledronska kislina Teva Generics uporabljati samo zdravnik, ki ima izkušnje z zdravljenjem te bolezni.
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Osteoporoza se pojavi, ko rast nove kostnine ni več zadostna, da bi nadomestila naravno razgradnjo kostnega tkiva.
Zoledronic acid Teva Generics is a medicine that contains zoledronic acid (5mg).
Zoledronska kislina Teva Generics je zdravilo, ki vsebuje zoledronsko kislino (5 mg).
For practical information about using Zoledronic acid Teva Generics, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zoledronska kislina Teva Generics naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes.
Zdravilo Zoledronska kislina Teva Generics se daje z infundiranjem, ki traja najmanj 15 minut.
What are the benefits and risks of Zoledronic acid Teva Generics?
Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina Teva Generics?
Zoledronic acid Teva Generics is usually given, but additional infusions can be considered if the patient's disease comes back.
Pri Pagetovi bolezni se zdravilo Zoledronska kislina Teva Generics običajno infundira samo enkrat, lahko pa se razmisli o dodatnih infuzijah, če se bolezen pri bolniku ponovi.
A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina Teva Generics je bil pripravljen načrt obvladovanja tveganj.
Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Aclasta odtehtajo znana tveganja.
Other information about Zoledronic acid Teva Generics
Druge informacije o zdravilu Zoledronska kislina Teva Generics
Zoledronic acid Teva Generics zoledronic acid
Zoledronska kislina Teva Generics zoledronska kislina
What is Zoledronic acid Teva Generics and what is it used for?
Kaj je zdravilo Zoledronska kislina Teva Generics in za kaj ga uporabljamo?
Zoledronic acid Teva Generics is a ‘generic medicine'.
Zdravilo Zoledronska kislina Teva Generics je „generično zdravilo“.
The active substance in Zoledronic acid Teva Generics, zoledronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Zoledronska kislina Teva Generics, zoledronska kislina, je difosfonat.
Why is Zoledronic acid Teva Generics approved?
Zakaj je bilo zdravilo Zoledronska kislina Teva Generics odobreno?
No additional studies were needed as Zoledronic acid Teva Generics is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Ker je zdravilo Zoledronska kislina Teva Generics generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Aclasta, niso bile potrebne nobene dodatne študije.
How does Zoledronic acid Teva Generics work?
Kako zdravilo Zoledronska kislina Teva Generics deluje?
See the package leaflet for full details.
Za več informacij glejte navodilo za uporabo.
Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription.
Zdravilo Zoledronska kislina Teva Generics je na voljo v obliki raztopine za infundiranje (kapalno infuzijo) v veno.
How has Zoledronic acid Teva Generics been studied?
Kako je bilo zdravilo Zoledronska kislina Teva Generics raziskano?
How is Zoledronic acid Teva Generics used?
Kako se zdravilo Zoledronska kislina Teva Generics uporablja?
It is not intended to provide practical advice on how to use Zoledronic acid Teva Generics.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Unopened vial: 30 months After opening: Use immediately
Neodprta viala: 30 mesecev Po odprtju: uporabite takoj
Date of first authorisation: 8 January 2018
Datum prve odobritve: 08. januar 2018
The relative importance of these pathways is unknown.
Relativni pomen teh poti ni znan.
(The net effect is not known).
(Neto učinek ni znan).
The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
Kategorije neuspeha se medsebojno izključujejo in temeljijo na hierarhiji kategorij v navedenem vrstnem redu.
CMV is a virus that a lot of people have without knowing.
CMV je virus, ki ga ima veliko ljudi, ne da bi se tega sploh zavedali.
• Take it with or without food.
• Vzemite ga skupaj s hrano ali brez nje.
Normally, CMV just stays in their body and it does not hurt them.
CMV je običajno le prisoten v telesu in ne povzroča škode.
Detailed information is presented below.
Podrobne informacije so predstavljene v nadaljevanju.
N = number of subjects in each treatment group.
N = število preiskovancev v vsaki skupini zdravljenja.
n (%) = Number (percent) of subjects in each sub-category.
n (%) = število (odstotek) preiskovancev v vsaki podkategoriji.
This difference is not clinically relevant.
Ta razlika ni klinično pomembna.
Each vial is packaged in a carton.
Ena viala je pakirana v škatlo.
• Compatible medicinal products are listed below.
• Kompatibilna zdravila so navedena v nadaljevanju.
# (see section 4.4).
# (glejte poglavje 4.4).
The potential interaction between letermovir and these medicinal products have not been investigated.
Možnih interakcij med letermovirjem in temi zdravili niso raziskali.
The time needed to reach steady state of a specific affected medicinal product will also influence the time needed to reach full effect on the plasma concentrations.
Čas, ki je potreben za dosego stanja dinamičnega ravnovesja določenega zadevnega zdravila, vpliva tudi na čas, potreben za dosego popolnega učinka na plazemske koncentracije.
31 May 2020 (PACMP Step 2)
31. maj 2020 (Korak 2
Monitoring of CMV DNA
Spremljanje CMV DNA
The median time to starting letermovir was 9 days after transplantation.
Mediana časa do začetka uporabe letermovirja je bila 9 dni po presaditvi.
If you experience any of these effects, do not drive or use machines until the effect wears off.
V primeru pojava katerega koli od teh učinkov ne smete upravljati vozil ali strojev, dokler učinek ne mine.
There is a theoretical risk of reduced exposure due to induction but the size of the effect and thus clinical relevance is presently unknown.
Obstaja teoretično tveganje za zmanjšanje izpostavljenosti zaradi indukcije, vendar pa obseg učinka in posledično klinični pomen trenutno ni znan.
For adequate contraceptive effect to be ensured with an oral contraceptive, products containing EE and LNG should be chosen.
Za zagotovitev ustreznega kontraceptivnega učinka s peroralnim kontraceptivom je treba izbrati zdravila, ki vsebujejo EE in LNG.
EC50 values for these mutations are 13- to 8,262-fold higher than those for the wild-type reference virus.
Vrednosti EC50 za te mutacije so od 13- do 8.262-krat večje od vrednosti za referenčni virus divjega tipa.
The full induction effect can be expected after 10-14 days of letermovir treatment.
Popoln indukcijski učinek se lahko pričakuje po 10-14 dneh zdravljenja z letermovirjem.
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
The preparation and administration instructions are the same for either dose.
Navodila za pripravo in aplikacijo so enaka za oba odmerka.
Monitoring is also recommended if changing route of administration.
Spremljanje je priporočljivo tudi v primeru spremembe poti uporabe.
• you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na letermovir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Also tell your doctor if you are taking any of the following medicines.
Zdravnika obvestite tudi, če jemljete katero od naslednjih zdravil.
Weeks Post-Transplant
Tedni po presaditvi
Table 1: Interactions and dose recommendations with other medicinal products.
Preglednica 1: Interakcije in priporočila glede odmerjanja z drugimi zdravili.
Opioid agonists Examples: alfentanil, fentanyl
Opioidni agonisti Primeri: alfentanil, fentanil
Variations of colour within this range do not affect the quality of the product.
Razlike v barvi v tem okviru ne vplivajo na kakovost zdravila.
The relevance to humans is unknown.
Pomen tega za človeka ni znan.
Take your next dose at the usual time.
Vzemite le naslednji odmerek zdravila ob običajnem času.
The safety and efficacy of letermovir use for more than 100 days has not been studied in clinical trials.
Varnosti in učinkovitosti letermovirja za uporabo več kot 100 dni v kliničnih preskušanjih niso raziskali.
Clinical monitoring and dose adjustment may be needed.
Morda bo potreben klinični nadzor in prilagoditev odmerka.
Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C and for 48 hours at 2 to 8 °C.
Dokazano je bilo, da je zdravilo med uporabo kemijsko in fizikalno stabilno 48 ur pri temperaturi 25 °C in 48 ur pri temperaturi od 2 °C do 8 °C.
• If you forget a dose, take it as soon as you remember.
• Če ste odmerek pozabili vzeti, ga vzemite takoj, ko se spomnite.
There are no data from the use of letermovir in pregnant women.
Podatkov o uporabi letermovirja pri nosečnicah ni.
Effect on concentration Mean ratio (90 % confidence interval) for AUC, Cmax (likely mechanism of action)
Vpliv na koncentracijo Povprečno razmerje (90 % interval zaupanja) za vrednost AUC in Cmax (verjetni mehanizem delovanja)
The net effect in vivo on the other listed enzymes and transporters is not known.
Neto učinek in vivo na druge navedene encime in prenašalce ni znan.
Carcinogenesis Carcinogenicity studies with letermovir have not been conducted.
Kancerogenost Študij kancerogenosti z letermovirjem niso izvedli.
Cross-resistance is not likely with medicinal products with a different mechanism of action.
Navzkrižna odpornost z zdravili z drugačnim mehanizmom delovanja ni verjetna.
For additional information, see section 4.2.
Za dodatne informacije glejte poglavje 4.2.
You will get PREVYMIS as an infusion (drip) into a vein and it will take about 1 hour.
Zdravilo PREVYMIS boste prejeli v obliki infuzije (kapljic) v veno, ki bo trajala približno 1 uro.
Due to time dependent inhibition and simultaneous induction the net enzyme inhibitory effect may not be reached until after 10-14 days.
Zaradi časovno odvisnega zaviranja in sočasne indukcije je neto zaviralni učinek encima lahko dosežen šele po 10-14 dneh.
The inter-individual variability for CL is estimated to be 24.6%.
Interindividualna variabilnost očistka je bila ocenjena na 24,6 %.
PREVYMIS is not for use in children and adolescents under 18 years old.
Zdravilo PREVYMIS ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Cumulative proportion of subjects with CMV DNAemia or disease (%)
Kumulativni delež oseb s CMV DNA-emijo ali boleznijo (%)
Approach to handling missing values: Non-Completer=Failure (NC=F) approach.
Pristop k obravnavanju manjkajočih vrednosti: pristop “nedokončanje = neuspeh” (NC = F - Non-Completer = Failure).
Urinary excretion of letermovir was negligible (<2% of dose).
Izločanje letermovirja v urin je bilo zanemarljivo (< 2 % odmerka).
No (n=276, 153)
ne (n = 276, 153)
If you are also taking a medicine for high cholesterol (see list of medicines in section “Other medicines and PREVYMIS” below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever.
Če jemljete tudi zdravilo proti zvišanem holesterolu (glejte seznam zdravil v poglavju "Druga zdravila in zdravilo PREVYMIS spodaj"), morate nemudoma obvestiti zdravnika, če se pri vas pojavi nepojasnjena bolečnost mišic ali bolečina v mišicah, še posebej, če se slabo počutite in imate zvišano telesno temperaturo.
These data are the effect of rifampicin on letermovir 24 hours after final rifampicin dose.
Ti podatki so za učinek rifampicina na letermovir 24 ur po zadnjem odmerku rifampicina.
Letermovir may be administered orally with or without food as has been done in the clinical studies (see section 4.2).
Letermovir se lahko peroralno uporablja skupaj s hrano ali brez nje, tako kot so ga uporabljali v kliničnih študijah (glejte poglavje 4.2).
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AX18
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX18
Effect of cyclosporine
Vpliv ciklosporina
When ending treatment, it takes 10-14 days for the inhibitory effect to disappear.
Po končanem zdravljenju traja 10-14 dni, da zaviralni učinek izzveni.
It is unknown whether letermovir may affect the exposure of piperacillin/tazobactam, amphotericine B and micafungin.
Ni znano, ali letermovir vpliva na izpostavljenost piperacilinu/tazobaktamu, amfotericinu B in micafunginu.
The safety and efficacy of letermovir has been established in patients with a negative CMV DNA test result prior to initiation of prophylaxis.
Varnost in učinkovitost letermovirja sta bili dokazani pri bolnikih z negativnim rezultatom testa CMV DNA pred začetkom profilakse.
Peripheral blood (n=241, 117)
periferna kri (n = 241, 117)
These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to letermovir.
Ti zaviralci DNA polimeraze so polno aktivni proti virusnim populacijam s substitucijami, ki povzročajo odpornost proti letermovirju.
Yes (n=49, 17)
da (n = 49, 17)
Name and address of the manufacturer(s) responsible for batch release Schering-Plough Labo NV
Ime in naslov izdelovalca, odgovornega za sproščanje serij Schering-Plough Labo NV
Patients should not double their next dose or take more than the prescribed one.
Bolniki ne smejo podvojiti naslednjega odmerka ali vzeti večjega odmerka od predpisanega.
In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted.
V primeru prevelikega odmerjanja je priporočljivo bolnika spremljati glede pojava neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
Differences in exposure across treatment regimens are not clinically relevant; efficacy was consistent across the range of exposures observed in P001.
shemami zdravljenja niso klinično pomembne, učinkovitost pa je bila konsistentna v celotnem razponu izpostavljenosti, opaženih v P001.
Cyclosporin A (n=162, 90)
ciklosporin A (n = 162, 90)
Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
Pri profilaktičnem zdravljenju z letermovirjem, ki traja več kot 100 dni, je treba skrbno ovrednotiti razmerje med koristjo in tveganjem.
You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS.
Zdravnika ali farmacevta lahko prosite za seznam zdravil, ki lahko medsebojno delujejo z zdravilom PREVYMIS.
The estimated difference (95% CI for the difference) was -26.1% (-45.9%, -6.3%), with a nominal one-sided p-value <0.0048.
Ocenjena razlika (95 % IZ za razliko) je znašala -26,1 % (-45,9 %; -6,3 %), z nominalno enostransko p-vrednostjo < 0,0048.
• Take PREVYMIS at the same time every day.
• Zdravilo PREVYMIS vzemite vsak dan ob istem času.
The estimated treatment difference of -23.5% was statistically significant (one-sided p-value <0.0001).
Ocenjena razlika med zdravljenjema je znašala -23,5 % in je bila statistično pomembna (enostranska p-vrednost < 0,0001).
What PREVYMIS is and what it is used for 2.
Kaj je zdravilo PREVYMIS in za kaj ga uporabljamo 2.
Inhibitors of P-gp/BCRP
Zaviralci P-gp/BCRP
Table 1 provides a listing of established or potentially clinically significant medicinal product interactions.
V preglednici 1 je naveden seznam znanih ali potencialno klinično pomembnih interakcij.
Note that the table is not extensive but provides examples of clinically relevant interactions.
Upoštevati je treba, da preglednica ne vključuje vsega, temveč prikazuje le primere klinično pomembnih interakcij.
The tablet is 21.2 mm long and 10.3 mm wide.
Tableta je 21,2 mm dolga in 10,3 mm široka.
You will get PREVYMIS once a day.
Zdravilo PREVYMIS boste prejemali enkrat na dan.
Reduced intensity conditioning (n=86, 48)
V korist placeba kondicioniranje z zmanjšano intenzivnostjo (n = 86, 48)
When letermovir is combined with cyclosporine:
Kadar se letermovir uporablja v kombinaciji s ciklosporinom:
After oral administration of radio-labeled letermovir, 93.3% of radioactivity was recovered in faeces.
Po peroralni uporabi radioaktivno označenega letermovirja se je v blatu izločilo 93,3 % radioaktivnosti.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PREVYMIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom PREVYMIS, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Unless a particular enzyme or transporter is also inhibited (see below) induction can be expected.
Razen če določene encime ali prenašalce tudi zavira (glejte v nadaljevanju), lahko pričakujemo indukcijo.
The majority of letermovir-related components in plasma is unchanged parent (96.6%).
Glavna z letermovirjem povezana komponenta v plazmi je nespremenjena učinkovina (96,6 %).
The acyl-glucuronide is unstable in faeces.
Acil-glukuronid je v blatu nestabilen.
The most common primary reasons for transplant were acute myeloid leukemia (38%), myeloblastic syndrome (15%), and lymphoma (13%).
Najpogostejši primarni razlogi za presaditev so bili akutna mieloična levkemija (38 %), mieloblastični sindrom (15 %) in limfom (13 %).
• you take the following herbal product:
• če jemljete naslednji rastlinski pripravek:
• high blood creatinine - shown in blood tests
• zvišanje vrednosti kreatinina v krvi - ugotovljeno s krvnimi preiskavami
• Famotidine
• famotidin
Letermovir vs Placebo Stratified log-rank test, two-sided p-value <0.0001
Letermovir v primerjavi s placebom Stratificirani log-rank test, dvostranska p-vrednost <0,0001