natgillin/translations-raw huggingface dataset:
In patients with severe renal impairment or end-stage renal disease, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
U bolesnika s teškim oštećenjem funkcije bubrega ili s bolešću bubrega u završnoj fazi, koncentracije u plazmi mogu se povećati zbog promjene apsorpcije lijeka, distribucije i/ili metabolizma sekundarno u odnosu na poremećaj funkcije bubrega.
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.
Također je bilo reklasifikacija primarne analize u 48. tjednu od kojih je najčešća reklasifikacija od virološkog neuspjeha do prekida koji nije uzrokovan štetnim događajem.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Lijekovi koji induciraju ili inhibiraju CYP3A mogu utjecati na klirens rilpivirina (vidjeti dio 5.2).
arthralgia3
artralgija3
The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Supstitucija K65R, a također i K70E, imale su za posljedicu smanjenu osjetljivost na abakavir, didanozin, lamivudin, emtricitabin i tenofovir, ali zadržanu osjetljivost na zidovudin.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Tenofoviralafenamid nije pokazao mutagenost ni klastogenost u konvencionalnim testovima genotoksičnosti.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
In vitro vezanje emtricitabina za proteine ljudske plazme bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02-200 µg/ml.
Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
Na temelju ispitivanja interakcije između lijekova provedenih s komponentama lijeka Odefsey, ne očekuju se klinički značajne interakcije kada se Odefsey kombinira sa sljedećim lijekovima: buprenorfin, nalokson i norbuprenorfin.
2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
2 Ova nuspojava nije uočena u fazi 3 ispitivanja emtricitabina + tenofoviralafenamida u kombinaciji sa elvitegravirom + kobicistatom ili u fazi 3 ispitivanja s lijekom Odefsey, ali je prepoznata u kliničkim ispitivanjima ili iskustvima nakon stavljanja u promet za emtricitabin kad se koristi s drugim antiretrovirusnim lijekovima.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Postoje izvješća o poremećenoj funkciji mitohondrija kod HIV-negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ona su se pretežno odnosila na liječenje s režimima koji su sadržavali zidovudin.
Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Primjenu lijeka Odefsey potrebno je izbjegavati u bolesnika s procijenjenim CrCl ≥ 15 ml/min i < 30 ml/min, ili < 15 ml/min koji nisu na kroničnoj hemodijalizi, jer sigurnost primjene lijeka Descovy u ovih populacija nije ustanovljena.
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Odefsey u djece mlađe od 12 godina ili težine < 35 kg nisu još ustanovljene.
There is no specific antidote for overdose with Odefsey.
Ne postoji specifičan protulijek za predoziranje lijekom Odefsey.
Of the 62 patients who were HBV suppressed at baseline, 59 remained suppressed and 3 had missing data.
Od 62 bolesnika koji su imali supresiju HBV-a pri ishodištu, 59 ih je zadržalo supresiju, a za 3 bolesnika podaci nisu poznati.
Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Tenofoviralafenamid nije inhibitor ili induktor CYP3A in vivo.
The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36).
Udio bolesnika s HIV-1 RNK < 50 kopija/ml u 48. tjednu (TLOVR) bio je 72,2% (26/36).
Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Bolesnici s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml koji su iskusili virološki neuspjeh, imali su višu stopu novonastale rezistencije na NNRTI skupinu tijekom liječenja.
Each bottle contains silica gel desiccant and polyester coil.
Jedna boca sadrži sredstvo za sušenje od silika gel i poliestersku vaticu.
Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Ishodi liječenja u ispitivanjima GS-US-366-1216 i GS-US-366-1160 prikazani su u tablici 5.
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 Obuhvaća bolesnike koji su prekinuli liječenje zbog štetnih događaja ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskog okvira, ako su posljedično virološki podaci o liječenju tijekom određenog okvira bili nedostupni.
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 i adolescenti u dobi od 12 godina i stariji, s tjelesnom težinom od najmanje 35 kg Jedna tableta uzima se jedanput na dan s hranom (vidi dio 5.2).
In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, the only single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were K101P and Y181V/I.
U panelu sa 67 HIV-1 rekombinantnih laboratorijskih sojeva s jednom mutacijom na RT pozicijama povezanom s rezistencijom na NNRTI, jedine pojedinačne mutacije povezane s rezistencijom vezanom uz gubitak osjetljivosti na rilpivirin bile su K101P i Y181V/I.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
In vitro vezanje tenofovira za proteine ljudske plazme je < 0,7% i ne ovisi o koncentraciji u rasponu od 0,01-25 µg/ml.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa) također su zabilježeni u stanju imunološke reaktivacije; međutim, prijavljeno vrijeme do nastupa poremećaja više varira i ti događaji mogu se pojaviti puno mjeseci nakon početka liječenja.
Reduced absorption, increase in gastric pH
Smanjena apsorpcija, povećanje zelučanih pH-vrijednosti
• Ciclosporin, a medicine used to reduce the strength of the body's immune system: This medicine can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
• Ciklosporin, lijek koji se koristi za smanjenje jačine imunološkog sustava organizma: Ovaj lijek može povećati količinu rilpivirina i tenofoviralafenamida (komponente lijeka Odefsey) u Vašoj krvi.
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)
Norgestimat (0,180/0,215/0,250 mg jedanput na dan)/etinilestradiol (0,025 mg jedanput na dan)/ emtricitabin/tenofoviralafenamid (200/25 mg jedanput na dan)
Following administration of tenofovir alafenamide, plasma [14C] -radioactivity showed a time-dependent profile, with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Nakon primjene tenofoviralafenamida, [14C]-radioaktivnost u plazmi pokazala je profil ovisan o vremenu s tenofoviralafenamidom kao najzastupljenijim u prvih nekoliko sati i mokraćnom kiselinom u preostalom razdoblju.
At the start of treatment with E/C/F/TAF, the 72 patients had been HIV suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Na početku liječenja E/C/F/TAF-om, 72 bolesnika imala su supresiju HIV-a (HIV-1 RNK < 50 kopija/ml) najmanje 6 mjeseci sa ili bez supresije HBV DNA i imali su kompenziranu funkciju jetre.
It is important not to miss a dose of Odefsey.
Važno je da ne propustite uzeti dozu lijeka Odefsey.
Other medicines and Odefsey Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Elderly No dose adjustment of Odefsey is required in elderly patients (see section 5.2).
Nije potrebna prilagodba doze lijeka Odefsey u starih bolesnika (vidjeti dio 5.2).
nausea1, 3, increased pancreatic amylase1
mučnina1,3, povišena pankreasna amilaza1
Odefsey is a grey, capsule-shaped, film-coated tablet debossed on one side with “GSI” and “255” on the other side.
Odefsey je siva, filmom obložena tableta u obliku kapsule s utisnutom oznakom „GSI“ na jednoj strani i brojem „255“ na drugoj strani tablete.
Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Relevantni primjeri obuhvaćaju citomegalovirusni retinitis, generalizirane i/ili žarišne mikobakterijske infekcije te upalu pluća uzrokovanu s Pneumocystis jirovecii.
The mean steady-state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Srednja vrijednost najniže koncentracije u plazmi pri dinamičkoj ravnoteži 24 sata nakon primjene doze bila je jednaka ili veća od srednje vrijednosti IC90 in vitro za anti-HIV-1 djelovanje.
Additionally, in a clinical drug-drug interaction study with tenofovir alafenamide, which is more sensitive to intestinal P-gp inhibition, rilpivirine did not affect tenofovir alafenamide exposures when administered concurrently, indicating that rilpivirine is not a P-gp inhibitor in vivo.
Osim toga, u kliničkom ispitivanju interakcije s tenofoviralafenamidom, koji je osjetljiviji na inhibiciju crijevnog P-gp, rilpivirin nije utjecao na izloženosti tenofoviralafenamidu kada je davan istodobno, što pokazuje da rilpivirin nije inhibitor
Discontinuation of Odefsey therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekid terapije lijekom Odefsey u bolesnika istodobno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
Rilpivirine is primarily metabolised by CYP3A.
Rilpivirin se prvenstveno metabolizira putem CYP3A.
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide expressed a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Izolati virusa HIV-1 sa smanjenom osjetljivošću na tenofoviralafenamid izražavali su mutaciju K65R u HIV-1 RT; dodatno je kratkotrajno uočena i mutacija K70E u HIV-1 RT.
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Ovo treba uzeti u obzir kod svakog djeteta in utero izloženog analozima nukleoz(t)ida, kod kojih su jako poremećeni klinički nalazi zbog nepoznatog uzroka, što se posebno odnosi na neurološke nalaze.
Rilpivirine has not been studied in patients with severe hepatic impairment (Child Pugh Class C) (see section 4.2).
Rilpivirin nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 4.2).
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching.
Virus je u bolesnika bio suprimiran (HIV-1 RNK < 50 kopija/ml) tijekom najmanje 6 mjeseci prije prebacivanja na drugu terapiju.
Children and adolescents Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Nemojte davati ovaj lijek djeci u dobi od 11 godina i mlađoj ili ako imaju težinu manju od 35 kg.
Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Rilpivirin pokazao je aktivnost protiv laboratorijskih sojeva divljega tipa virusa HIV-1 u akutno zaraženoj T-staničnoj liniji s medijanom vrijednosti EC50 za HIV-1/IIIB od 0,73 nM (0,27 ng/ml).
No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Nije potrebna prilagodba doze lijeka Odefsey u odraslih ili adolescenata (u dobi od najmanje 12 godina i s tjelesnom težinom od najmanje 35 kg) s procijenjenim klirensom kreatinina (CrCl) ≥ 30 ml/min.
Of the 10 patients who were not HBV suppressed at baseline (HBV DNA ≥ 29 IU/mL), 7 became suppressed, 2 remained detectable, and 1 had missing data.
Od 10 bolesnika koji nisu imali supresiju HBV-a na početku (HBV DNA ≥ 29 IU/ml), u 7 je došlo do supresije, 2 su zadržala detektibilnost, a za jednog bolesnika podaci nisu poznati.
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Rilpivirin je in vitro inhibitor transportera MATE-2K s vrijednošću IC50 < 2,7 nM.
It is not known whether emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.
Nije poznato jesu li emtricitabin ili tenofoviralafenamid inhibitori drugih UGT enzima.
Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs at Week 48.
Od bolesnika koji su na početku bili HBsAg pozitivni, 3/70 (4,3%) postiglo je serokonverziju u anti-HBs u 48. tjednu.
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Više bolesnika s virološkim neuspjehom u liječenju rilpivirinom nego onih s virološkim neuspjehom u liječenju efavirenzom, razvilo je rezistenciju povezanu s lamivudinom/emtricitabinom (vidjeti dio 5.1).
On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.
Na dane hemodijalize, Odefsey treba primijeniti nakon završetka postupka hemodijalize.
Liver toxicity associated with liver enzyme induction was observed in rodents.
Toksičnost za jetru povezana s indukcijom enzima jetre uočena je kod glodavaca.
dyspepsia3
dispepsija3
Based on these limited data, the safety profile of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet, in patients with HIV/HBV co-infection, was similar to that in patients with HIV-1 monoinfection.
Na temelju ovih ograničenih podataka, sigurnosni profil emtricitabina + tenofoviralafenamida u kombinaciji s elvitegravirom i kobicistatom u obliku tablete s fiksnom kombinacijom u bolesnika koji su istodobno bili zaraženi HIV-om/HBV-om bio je sličan onome u bolesnika zaraženih samo virusom HIV-1.
Severe skin reactions with systemic symptoms have been reported during post-marketing experience of emtricitabine/rilpivirine/tenofovir disoproxil fumarate including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Teške reakcije na koži sa sistemskim simptomima zabilježene su tijekom iskustava nakon stavljanja emtricitabina/rilpivirina/tenofovirdizoproksilfumarata u promet uključujući osipe praćene groznicom, plikovima, konjunktivitisom, angioedemom, povišenim vrijednostima rezultata testova funkcije jetre i/ili eozinofilijom.
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased rilpivirine exposure (AUC) by 13-72%.
U odnosu na stanje natašte, primjena lijeka Odefsey u zdravih odraslih ispitanika zajedno s hranom, rezultirala je povećanom izloženošću rilpivirinu (AUC) za 13-72%.
Following multiple dose oral administration of emtricitabine to 20 HIV-1 infected subjects, the (mean ± SD) area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 h•µg/mL.
Nakon peroralne primjene višestruke doze emtricitabina u 20 ispitanika zaraženih virusom HIV-1, (srednja vrijednost ± SD) površina ispod krivulje koncentracija-vrijeme tijekom 24-satnog intervala doziranja (AUC) bila je 10,0 ± 3,1 µg•h/ml.
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
Sojevi rezistentni na rilpivirin odabrani su u staničnoj kulturi počevši od HIV1 virusa divljeg tipa različitog podrijetla i podtipova kao i HIV1 virusi rezistentni na NNRTI.
Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Odefsey and development of resistance.
Očekuje se da će lijekovi koji induciraju aktivnost P-gp-a (npr. rifampicin, rifabutin, karbamazepin, fenobarbital) smanjiti apsorpciju tenofoviralafenamida, što uzrokuje smanjenje koncentracije tenofoviralafenamida u plazmi, koje može dovesti do gubitka terapijskog učinka lijeka Odefsey i razvoja rezistencije.
Thirty-six patients had a median age of 14.5 years and were 55.6% female, 88.9% Black, and 11.1% Asian.
Za 36 bolesnika je medijan dobi bio 14,5 godina i bilo je 55,6% žena, 88,9% crnaca i 11,1% azijata.
FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz.
FTC/TDF + rilpivirinklorid bio je neinferioran u postizanju HIV-1 RNK < 50 kopija/ml u usporedbi s FTC/TDF + efavirenz.
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased tenofovir alafenamide exposure (AUC) by 45-53%.
U odnosu na stanje natašte, primjena lijeka Odefsey na zdravim odraslim ispitanicima zajedno s hranom rezultirala je povećanom izloženošću tenofoviralafenamidu (AUC) za 45-53%.
Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Odefsey je indiciran za liječenje odraslih osoba i adolescenata (u dobi od 12 godina i starijih, s tjelesnom težinom od najmanje 35 kg) zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) bez poznatih mutacija povezanih s rezistencijom na skupinu inhibitora nenukleozidne reverzne transkriptaze (NNRTI), tenofovir ili emtricitabin i s virusnim opterećenjem ≤ 100 000 HIV-1 RNK kopija/ml (vidjeti dijelove 4.2, 4.4 i 5.1).
Due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Zbog povećane stabilnosti u plazmi i intracelularne aktivacije hidrolizom pomoću katepsina A, tenofoviralafenamid je djelotvorniji od tenofovirdizoproksilfumarata u koncentriranju tenofovira u mononuklearnim stanicama periferne krvi (PBMC) (uključujući limfocite i druge ciljne stanice virusa HIV-a) i makrofage.
Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Ispitivanja na životinjama ne ukazuju na štetan učinak emtricitabina, rilpivirinklorida ili tenofoviralafenamida na plodnost (vidjeti dio 5.3).
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 in vitro.
Tenofoviralafenamid nije inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6 in vitro.
If you forget to take Odefsey
Ako ste zaboravili uzeti lijek Odefsey
• If you notice 12 hours or more after the time you usually take Odefsey, then do not take the missed dose.
• Ako to primijetite 12 ili više sati nakon propuštene doze lijeka Odefsey, onda nemojte uzeti propuštenu dozu.
The virologic failure rate in patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine at Week 48 and Week 96 was 9.5% and 11.5% respectively, and 4.2% and 5.1% in the emtricitabine/tenofovir disoproxil fumarate + efavirenz arm.
Stopa virološkog neuspjeha u bolesnika liječenih s emtricitabinom/tenofovirdizoproksil fumaratom + rilpivirinom u 48. i 96. tjednu iznosila je 9,5% odnosno 11,5%, te 4,2% i 5,1% u skupini koja prima emtricitabin/tenofovirdizoproksilfumarat + efavirenz.
Fifty-two percent of HIV-1 isolates with emergent resistance in the rilpivirine arm developed concomitant NNRTI and NRTI mutations, most frequently E138K and M184V.
Pedeset dva postotka HIV-1 izolata s novonastalom rezistencijom u skupini liječenoj rilpivirinom razvilo je istodobne NNRTI i NRTI mutacije, najčešće E138K i M184V.
Discontinued due to adverse event (AE)
Prekid zbog štetnog događaja
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Tenofovir se eliminira bubrezima putem glomerularne filtracije i aktivne tubularne sekrecije.
Odefsey should be used with caution in patients with moderate hepatic impairment.
Odefsey se treba oprezno koristiti u pacijenata s umjerenim oštećenjem funkcije jetre.
Lower exposures of rilpivirine (one of the components of Odefsey) were observed during pregnancy; therefore viral load should be monitored closely.
Tijekom trudnoće opažene su manje izloženosti rilpivirinu (jedna od komponenti lijeka Odefsey); stoga je potrebno pažljivo pratiti virusno opterećenje.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase (UGT), the enzyme responsible for glucuronidation.
Osim toga, emtricitabin nije inhibirao uridin-5'-difosfoglukuronil transferazu (UGT), enzim odgovoran za glukuronidaciju.
The safety and efficacy of Odefsey in patients with significant underlying liver disorders have not been established.
Sigurnost i djelotvornost primjene lijeka Odefsey u bolesnika s podležećim značajnim bolestima jetre nisu ustanovljene.
Some medicinal products should not be co-administered with Odefsey (see sections 4.3 and 4.5).
Neki lijekovi ne smiju se primjenjivati istodobno s lijekom Odefsey (vidjeti dijelove 4.3 i 4.5).
 If you are taking any of these medicines, do not take Odefsey and tell your doctor immediately.
Ako uzimate bilo koji od ovih lijekova, nemojte uzimati lijek Odefsey i odmah o tome obavijestite svog liječnika.
• Medicines for stomach ulcers, heartburn or acid reflux such as:
• Lijekove za čireve želuca i dvanaesnika, žgaravicu ili gastroezofagealnu refluksnu bolest poput:
Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b
Ukupni odgovor (HIV-1 RNK < 50 kopija/ml (TLOVRa))b
Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet.
Siva filmom obložena tableta u obliku kapsule veličine 15 mm x 7 mm, s utisnutom oznakom „GSI” na jednoj strani tablete i „255” na drugoj strani tablete.