natgillin/translations-raw huggingface dataset:
H2-RECEPTOR ANTAGONISTS
ANTAGONISTI RECEPTORJEV H2
The film-coated tablet should not be chewed, crushed or split.
Filmsko obložene tablete se ne sme žvečiti, zdrobiti ali razdeliti.
No new adverse reactions were identified compared to those seen in adults.
Ugotovljenih ni bilo nobenih novih neželenih učinkov v primerjavi s tistimi, ki so bili ugotovljeni pri odraslih.
increased bilirubin1
zvišanje bilirubina1
The proportion of virologic failures was 22.2% (8/36).
Delež virološkega neuspeha je bil 22,2 % (8/36).
Cmax: ↔* *based on historic controls
Cmax: ↔* *na podlagi zgodovinskih kontrol
If you are taking one of these medicines your doctor will either give you a different medicine, or recommend how and when you take that medicine:
Če jemljete katero od teh zdravil, vam bo zdravnik bodisi dal drugo zdravilo ali priporočal, kako in kdaj naj vzamete zdravilo.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Te ugotovitve ne vplivajo na trenutna nacionalna priporočila o uporabi protiretrovirusne terapije pri nosečnicah za preprečitev vertikalnega prenosa okužbe z virusom HIV.
Talk to your doctor about an alternative regimen (see How to take Odefsey).
Z zdravnikom se pogovorite o alternativnem režimu (glejte Kako jemati zdravilo Odefsey).
Discontinued due to adverse event (AE)
Smrt Prekinitev zaradi neželenega učinka (adverse event, AE)
If you have taken Odefsey during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če ste zdravilo Odefsey jemali med nosečnostjo, bo zdravnik morda opravljal redne krvne preiskave in druge diagnostične preglede, s katerimi bo spremljal razvoj vašega otroka.
These changes in adrenal safety parameters were not clinically relevant.
Te spremembe parametrov varnosti nadledvične žleze niso bile klinično pomembne.
Odefsey reduces the amount of HIV in your body.
Zdravilo Odefsey zmanjša količino virusa HIV v vašem telesu.
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Pogostnost je definirana kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do
b The difference of response rate at Week 48 is 1% (95% confidence interval -3% to 6%) using normal approximation.
b Razlika stopnje odziva v 48. tednu je 1 % (95-odstotni interval zaupanja -3 % do 6 %) z normalnim približanjem.
Whether such neurological disorders are transient or permanent is currently unknown.
Trenutno ni znano, ali so te nevrološke motnje prehodne ali trajne.
Stopping Odefsey can seriously affect your response to future treatment.
Prenehanje jemanja zdravila Odefsey lahko resno vpliva na vaš odziv na prihodnje zdravljenje.
Keep or take the tablet bottle with you so that you can easily describe what you have taken.
S seboj imejte vsebnik s tabletami, da boste lahko opisali, kaj ste zaužili.
Thirty-five percent of patients were on a treatment regimen that did not contain tenofovir disoproxil fumarate.
Petintrideset bolnikov je bilo na režimu zdravljenja, ki ni vseboval dizoproksiltenofovirijevega fumarata.
Findings in adolescents (12 to less than 18 years of age) in Study C213 were generally in line with these data (for details see section 5.1).
Ugotovitve pri mladostnikih (starih od 12 do 18 let) v študiji C213 so bile na splošno v skladu s temi podatki (za podrobnosti glejte poglavje 5.1).
There are no adequate and well-controlled studies of Odefsey or its components in pregnant women.
Ni ustreznih, dobro kontroliranih študij z zdravilom Odefsey ali njegovimi učinkovinami pri nosečnicah.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Vendar pa ni mogoče izključiti, da se izpostavljenost farmakološko aktivnemu, nevezanemu rilpivirinu pomembno poveča pri zmerni okvari.
3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
3 Študija je bila opravljena z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, pričakovane pri bolnikih, okuženih s HCV.
Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vsebniku poleg oznake {EXP}.
What Odefsey is and what it is used for
Kaj je zdravilo Odefsey in za kaj ga uporabljamo
There are insufficient data to justify the use in patients with prior NNRTI failure.
Podatki ne zadoščajo za utemeljitev uporabe pri bolnikih, kjer predhodno zdravljenje z NNRTI ni bilo uspešno.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Tenofovir se učinkovito odstrani s hemodializo s koeficientom ekstrakcije približno 54 %.
Possible side effects: tell a doctor immediately
Možni resni neželeni učinki: takoj obvestite svojega zdravnika
• increased levels of liver enzymes in the blood
• zvišane ravni jetrnih encimov v krvi
• problems with digestion resulting in discomfort after meals
• prebavne motnje, ki privedejo do slabega počutja po zaužitem obroku
ODE = Odefsey a Week 48 window was between Day 295 and 378 (inclusive).
ODE = Odefesey a Okno v 48. tednu je med 295. in 378. dnevom (vključno z njima).
The presence of V90I and V189I at baseline did not affect the response.
Prisotnost mutacij V90I in V189I na začetku ni vplivala na odziv.
In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
In vitro je vezava rilpivirina na humane plazemske proteine 99,7 %, v glavnem na albumin.
Therefore, information regarding drug-drug interactions with other antiretroviral medicinal products is not provided.
Informacije o medsebojnem delovanju z drugimi protiretrovirusnimi zdravili zato niso navedene.
In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Pri otrocih, katerih matere so jemale nukleozidne zaviralce reverzne transkriptaze (NRTI) med nosečnostjo, so bile koristi zaščite pred virusom HIV večje od tveganj za neželene učinke.
The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
Najpogosteje uporabljena kombinacija NRTI z rilpivirinom je bila FTC/TDF (24 preskušancev [66,7 %]).
Each of these active substances works by interfering with an enzyme called ‘reverse transcriptase', which is essential for the HIV-1 virus to multiply.
Vsaka od teh učinkovin deluje tako, da vpliva na encim, ki se imenuje „reverzna transkriptaza“ in je nujen za razmnoževanje virusa HIV-1.
• depressed mood
• depresivno razpoloženje
The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Razlika v stopnji novih viroloških neuspehov v analizi od 48. do 96. tedna med krakoma z rilpivirinom in efavirenzom ni bila statistično pomembna.
It is recommended that Odefsey be taken with food.
Priporočeno je jemanje zdravila Odefsey s hrano.
Odefsey is indicated for use as a complete regimen for the treatment of HIV-1 infection and should not be co-administered with other antiretroviral medicinal products.
Zdravilo Odefsey je indicirano za uporabo kot celovit režim za zdravljenje okužbe s HIV-1 in se ga ne sme uporabljati sočasno z drugimi protiretrovirusnimi zdravili.
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
• Dabigatran eteksilat, učinkovina, ki se uporablja za zdravljenje bolezni srca, saj bo moral zdravnik morda nadzirati ravni tega zdravila v vaši krvi.
A negative impact by NNRTI mutations other than those listed above (e.g., mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Drugega negativnega vpliva mutacij NNRTI, razen zgoraj navedenih (npr. mutacije K103N ali L100I kot samostojni mutaciji) ni mogoče izključiti, saj študije in vivo niso bile izvedene pri zadostnem številu bolnikov.
• Antibiotics used to treat bacterial infections containing:
• antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb in vsebujejo:
If you have hepatitis B infection, liver problems may become worse after you stop taking Odefsey.
Če imate okužbo s hepatitisom B, se lahko težave z jetri poslabšajo, ko prenehate jemati zdravilo Odefsey.
It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
Pomembno je, da zdravila Odefsey ne prenehate jemati, ne da bi se pogovorili z zdravnikom: glejte poglavje 3, Ne prenehajte jemati zdravila Odefsey.
If you have both HIV infection and hepatitis B, it is especially important not to stop your Odefsey treatment without talking to your doctor first.
Če ste okuženi tako z virusom HIV kot s hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Odefsey, ne da bi se prej posvetovali z zdravnikom.
The virologic response was generally preserved throughout the study: of the 12 patients that completed the study, 10 patients were suppressed at the end of the study; in the other 2 patients an increase in viral load was observed only postpartum, for at least 1 patient due to suspected suboptimal adherence.
Virološki odziv je bil v celotni študiji na splošno ohranjen: od 12 bolnic, ki so zaključilie študijo, je imelo na koncu študije supresijo 10 bolnic; pri drugih 2 bolnicah pa so povišanje virusne obremenitve opazili samo v obdobju po nosečnosti, pri čemer je bil pri najmanj 1 bolnici razlog domnevno neoptimalno sodelovanje z zdravljenjem.
It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Priporočljivo je, da ne dojite, da s tem preprečite prenos virusa preko mleka na dojenčka.
Co-administration should be used with caution.
Pri sočasni uporabi je potrebna previdnost.
Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Ex vivo je bila vezava tenofoviralafenamida na humane plazemske proteine v vzorcih, zbranih med kliničnimi študijami, približno 80 %.
The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Vrednosti srednje efektivne koncentracije (EC50) za emtricitabin so bile v razponu od 0,0013 do 0,64 µM.
Switching from a TDF-based regimen to Odefsey may lead to slight increases in lipid parameters.
Prehod z režima, ki vsebuje TDF, na zdravilo Odefsey lahko povzroči rahlo povečanje lipidnih parametrov.
Contents of the pack and other information What Odefsey contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Odefsey
• If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na emtricitabin, rilpivirin, tenofoviralafenamid ali na katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
Missing data during window but on study drug
V oknu podatki manjkajo, a se uporablja študijsko zdravilo
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in oportunističnimi okužbami v zdravstveni zgodovini (okužbe, ki se pojavijo pri ljudeh z oslabljenim imunskim sistemom), se lahko znaki in simptomi vnetja zaradi prejšnjih okužb pojavijo kmalu po začetku zdravljenja HIV.
Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
Zdravila, ki vplivajo na aktivnost P-gp in BCRP, lahko povzročijo spremembe v absorpciji tenofoviralafenamida (glejte preglednico 1).
The decrease in the unbound free fraction of rilpivirine exposure (i.e., active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Zmanjšanje izpostavljenosti nevezani prosti frakciji rilpivirina (tj. aktivna) med nosečnostjo je bilo v primerjavi s poporodnim obdobjem manj izraženo kot za skupno izpostavljenost rilpivirinu.
The European Medicines Agency has deferred the obligation to submit the results of studies with Odefsey in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Odefsey za eno ali več podskupin pediatrične populacije za zdravljenje okužbe z virusom HIV-1 pri ljudeh (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Once you start taking Odefsey, look out for:
Ko začnete jemati zdravilo Odefsey, bodite pozorni na:
Table 1: Interactions between Odefsey or its individual component(s) and other medicinal products
Preglednica 1: Interakcije med zdravilom Odefsey ali posameznimi učinkovinami zdravila in drugimi zdravili
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
• Metadon, učinkovina, ki se uporablja za zdravljenje zasvojenosti z opiati, saj bo moral zdravnik morda prilagoditi vaš odmerek metadona.
Patients co-infected with HIV and HBV who discontinue Odefsey should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolnike s hkratno okužbo s HIV in HBV, ki prekinejo zdravljenje z zdravilom Odefsey, je treba pozorneje opazovati in opravljati potrebne klinične in laboratorijske preiskave še vsaj nekaj mesecev po prenehanju zdravljenja.
increased transaminases (AST and/or ALT)1
zvišanje transaminaz (AST in/ali ALT)1
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4 to 5 hours.
Po peroralnem dajanju so največje koncentracije rilpivirina v plazmi običajno dosežene v roku 4-5 ur.
• severe skin reactions including rash accompanied by fever, swelling and liver problems
• hude kožne reakcije, vključno z izpuščajem, ki ga spremljajo vročina, otekanje in težave z jetri
The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Substitucija K103N sama ni povzročila manjše občutljivosti na rilpivirin, vendar pa je kombinacija K103N in L100I povzročila 7-krat manjšo občutljivost na rilpivirin.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
V primeru prevelikega odmerka je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8) in mu nuditi standardno podporno zdravljenje, vključno z opazovanjem kliničnega stanja bolnika in nadziranjem vitalnih znakov in EKG (interval QT).
EU/1/16/1112/001 30 film-coated tablets EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1112/001 30 filmsko obloženih tablet EU/1/16/1112/002 90 (3 vsebniki po 30) filmsko obloženih tablet
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Bolniki z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo v času kombinirane protiretrovirusne terapije (CART-combination antiretroviral therapy) več anomalij jetrne funkcije in jih je treba nadzirati v skladu s standardno prakso.
Odefsey comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Zdravilo Odefsey je na voljo v plastenkah po 30 tablet in v pakiranjih s po 3 plastenkami, od katerih vsaka vsebuje 30 tablet.
At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Na začetku je bila mediana eGFRCG 56 ml/min, 33 % bolnikov pa je imelo eGFRCG od 30 do 49 ml/min.
Odefsey is an antiviral medicine used to treat infection by the Human Immunodeficiency Virus (HIV).
Zdravilo Odefsey je protivirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV).
Contains lactose (as monohydrate), see leaflet for further information.
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo (v obliki monohidrata), za dodatne informacije glejte navodilo za uporabo.
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
V klinični študiji rilpivirin ni pomembno vplival na farmakokinetične lastnosti digoksina.
In the Phase 3 studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
V študijah faze 3 (C209 in C215) je bila nižja izpostavljenost rilpivirinu, podobna kot je bila opažena med nosečnostjo, povezana s povečanim tveganjem za virološki neuspeh, zato je treba skrbno spremljati virusno obremenitev (glejte poglavja 4.6, 5.1 in 5.2).
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Zato lahko zdravila, ki inducirajo ali zavirajo CYP3A, vplivajo na očistek rilpivirina (glejte poglavje 5.2).
Mitochondrial dysfunction following exposure in utero
Mitohondrijska disfunkcija kot posledica in utero izpostavljenosti
As a precautionary measure, it is preferable to avoid the use of Odefsey during pregnancy.
Iz previdnosti se je med nosečnostjo bolje izogibati uporabi zdravila Odefsey.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco na galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Normalizacija alanin-aminotransferaze (ALT) je bila dosežena pri 40 % (4/10) bolnikov, ki so ob izhodišču imeli ALT nad zgornjo mejo normalne vrednosti (ULN).
Mean values for the rilpivirine arm for both basal and ACTH-stimulated cortisol at Week 96 were within the normal range.
Povprečne vrednosti kraka z rilpivirinom za bazalni kortizol in kortizol po stimulaciji z ACTH v 96. tednu so bile znotraj normalnega razpona.
Adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet to be taken once daily with food (see section 5.2).
Odrasli in mladostniki, stari 12 let in več, s telesno maso vsaj 35 kg Jemlje se ena tableta enkrat dnevno s hrano (glejte poglavje 5.2).
Odefsey may interact with other medicines.
Zdravilo Odefsey lahko medsebojno deluje z drugimi zdravili.
Odefsey should be taken orally, once daily with food (see section 5.2).
Zdravilo Odefsey se jemlje enkrat dnevno, peroralno s hrano (glejte poglavje 5.2).
At supratherapeutic doses (75 mg once daily and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 4.9).
Pri odmerkih, višjih od terapevtskih (75 mg in 300 mg enkrat dnevno), rilpivirin povezujejo s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavji 4.5 in 4.9).
1 Adverse reactions identified from rilpivirine clinical studies.
1 Neželeni učinki, ki so jih zabeležili v kliničnih študijah rilpivirina.
As a result, the amounts of Odefsey or other medicines in your blood may be affected.
To lahko posledično vpliva na količino zdravila Odefsey ali drugih zdravil v vaši krvi.
a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima); okno v 144. tednu je med 966. in 1049. dnevom (vključno z njima).
e Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
e Vključevalo je bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki jemljejo kombinirana protiretrovirusna zdravila, kot je zdravilo Odefsey, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva kot posledica pomanjkanja oskrbe kosti s krvjo).
Each tablet contains 189.8 mg lactose monohydrate.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 189,8 mg laktoze monohidrata.
A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Večje število podatkov o uporabi emtricitabina pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na njegovo malformacijsko ali feto/neonatalno toksičnost.
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased rilpivirine exposure (AUC) by 13-72%.
Relativno glede na pogoje na tešče, je dajanje zdravila Odefsey zdravim odraslim osebam z obrokom, povzročilo večjo izpostavljenost rilpivirinu (AUC) za 13-72 %.
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Biotransformacija emtricitabina vključuje oksidacijo tiolnega dela molekule, pri čemer nastanejo 3'-sulfoksid diastereomere (približno 9 % odmerka), in konjugacijo z glukuronsko kislino, pri čemer nastane 2'-O-glukuronid (približno 4 % odmerka).
In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
V tej študiji je bil varnostni profil pri mladostnikih podoben varnostnemu profilu pri odraslih bolnikih (glejte poglavje 5.1).
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Ker se rilpivirin močno veže na beljakovine, ni verjetno, da bi dializa odstranila pomembno količino učinkovine.
e e.g., lost to follow up, non-compliance, withdrew consent.
e Npr. izgubljeni za spremljanje, neskladnost, umik soglasja.
Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Z rilpivirinom se lahko zdravi samo mladostnike, pri katerih je verjetno, da bodo skrbno upoštevali protiretrovirusno zdravljenje, saj lahko suboptimalno upoštevanje povzroči razvoj rezistence ter izgubo možnosti zdravljenja v prihodnosti.
There were also reclassifications in the Week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Pri primarni analizi v 48. tednu je prišlo tudi do prerazvrstitve, pri čemer je bila najpogostejša prerazvrstitev iz skupine virološkega neuspeha v skupino prekinitev, ne zaradi AE.
Virologically suppressed adults in Study GS-US-292-0109
Odrasli z virološko supresijo v študiji GS-US-292-0109
If you are on dialysis, take your daily dose of Odefsey following completion of dialysis.
Če ste na dializi, vzemite svoj dnevni odmerek zdravila Odefsey po končani dializi.