natgillin/translations-raw huggingface dataset:
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 Tega neželenega učinka niso opazili v študijah faze III, v katerih so preučevali emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom, ali v študijah 3. faze z zdravilom Odefsey, temveč je bil opredeljen v kliničnih študijah ali izkušnjah v obdobju trženja za emtricitabin pri uporabi z drugimi protiretrovirusnimi zdravili.
It is not known whether emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes. 
Ni znano, ali so emtricitabin ali tenofoviralafenamid zaviralci drugih encimov UGT.
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. 
Pri bolnikih s hudo ledvično okvaro ali z ESRD so lahko koncentracije v plazmi zvišane zaradi spremenjene absorpcije, porazdelitve in/ali presnove zdravila kot posledica ledvične disfunkcije.
What Odefsey looks like and contents of the pack 
Izgled zdravila Odefsey in vsebina pakiranja
nausea1, 3, increased pancreatic amylase1 
navzea1,3, zvišanje pankreatične amilaze1
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. 
Povprečna plazemska koncentracija v stanju dinamičnega ravnovesja 24 ur po odmerjanju, pred naslednjim odmerkom je bila enaka ali večja kot povprečna vrednost IC90 in vitro za aktivnost proti-HIV-1.
The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E. 
Mutacije, povezane z rezistenco na NRTI, ki so se razvile pri 3 ali več bolnikih, so bile: K65R, K70E, M184V/I in K219E.
Pooled treatment outcomes at 48 weeks are shown in Table 3. 
Združeni izidi zdravljenja v 48. tednu so prikazani v preglednici 3.
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. 
Bolniki z začetno virusno obremenitvijo > 100,000 HIV-1 RNA kopij/ml, pri katerih se je pojavil virološki neuspeh, so imeli višjo stopnjo rezistence na NNRTI, nastale med zdravljenjem.
b n = 23 adolescents (GS-US-292-0106, population PK analysis). 
b n = 23 mladostnikov (GS-US-292-0106, populacijska FK-analiza).
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex US). 
b V obeh študijah so bili bolniki stratificirani glede na začetno vrednost HIV-1 RNA (≤ 100.000 kopij/ml, > 100.000 kopij/ml do ≤ 400.000 kopij/ml ali > 400.000 kopij/ml), po številu celic CD4+ (< 50 celic/μl, 50-199 celic/μl ali ≥ 200 celic/μl) in po regiji (ZDA ali zunaj ZDA).
After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively. 
Po enkratnem peroralnem odmerku [14C]-rilpivirina se je povprečno 85 % radioaktivnosti izločilo v blatu in 6,1 % v urinu.
Only H2-receptor antagonists that can be dosed once daily should be used. 
Uporabljajte samo antagoniste receptorjev H2, ki jih je mogoče odmerjati enkrat dnevno.
While taking Odefsey you may still develop infections or other illnesses associated with HIV infection. 
Med jemanjem zdravila Odefsey se lahko pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
It is important not to miss a dose of Odefsey. 
Pomembno je, da ne pozabite vzeti odmerka zdravila Odefsey.
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion. 
Tenofovir se izloča preko ledvic tako z glomerularno filtracijo kot z aktivno tubularno sekrecijo.
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 začetku zdravljenja z E/C/F/TAF je imelo 72 bolnikov vsaj 6 mesecev supresijo HIV (HIV-1 RNA < 50 kopij/ml) s supresijo HBV DNA ali brez nje in kompenzirano jetrno funkcijo.
Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food Do not chew, crush or split the tablet. 
Mladostniki, stari 12 let in več, s telesno maso vsaj 35 kg: ena tableta na dan s hrano Tablete ne žvečite, drobite in ne delite.
At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults. 
V 48. tednu je 92 % (46/50) doseglo HIV-1 RNA < 50 kopij/ml, podobno stopnjam odziva v študijah predhodno nezdravljenih odraslih, okuženih s HIV-1.
If you forget to take Odefsey 
Če ste pozabili vzeti zdravilo Odefsey
On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment. 
Ob dneh hemodialize je treba zdravilo Odefsey dati po koncu zdravljenja s hemodializo.
The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3. 
Na porazdelitev tenofoviralafenamida v telesu lahko vplivata dejavnost OATP1B1 in OATP1B3.
Hepatitis B and/or hepatitis C virus co-infection The pharmacokinetics of emtricitabine, rilpivirine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus. 
Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C Farmakokinetične lastnosti emtricitabina, rilpivirina in tenofoviralafenamida pri bolnikih s hkratno okužbo z virusom hepatitisa B in/ali C niso v celoti ovrednotili.
In a study comparing 8 patients with mild hepatic impairment (Child-Pugh Class A) to 8 matched controls and 8 patients with moderate hepatic impairment (Child-Pugh Class B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment. 
V študiji so primerjali 8 bolnikov z blago jetrno okvaro (stopnje A po Child-Pughu) z 8 ustreznimi kontrolnimi preiskovanci in 8 bolnikov z zmerno jetrno okvaro (stopnje B po Child-Pughu) z 8 ustreznimi kontrolnimi preiskovanci, pri čemer je bila izpostavljenost rilpivirinu iz več odmerkov za 47 % višja pri bolnikih z blago jetrno okvaro in 5 % višja pri bolnikih z zmerno jetrno okvaro.
Discontinuation of Odefsey therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. 
Odefsey pri bolnikih s hkratno okužbo s HIV in virusom HBV je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1). 
Poročali niso o nobenih laboratorijskih anomalijah stopnje 3-4 za AST/ALT ali neželenih učinkov z zvišanjem transaminaz stopnje 3-4 (glejte poglavje 5.1).
Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum. 
Rilpivirin (ena od učinkovin zdravila Odefsey) v kombinaciji z osnovno shemo zdravljenja je bil ocenjen v študiji TMC114HIV3015 pri 19 nosečnicah med 2. in 3. trimesečjem in po porodu.
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 filmsko obložena tableta v obliki kapsule, z dimenzijami 15 mm x 7 mm, z vtisnjenim znakom „GSI“ na eni strani tablete in „255“ na drugi strani tablete.
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. 
Po podatkih iz študij medsebojnega delovanja, opravljenih z učinkovinami zdravila Odefsey, se ne pričakujejo nobena klinično pomembna medsebojna delovanja, kadar se zdravilo Odefsey uporablja v kombinaciji z naslednjimi zdravili: buprenorfin, nalokson in norbuprenorfin.
• If you notice within 12 hours of the time you usually take Odefsey, you must take the tablet as soon as possible. 
• Če to opazite v roku 12 ur od časa, ko zdravilo Odefsey običajno vzamete, morate tableto vzeti čim prej.
A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp). 
Tveganja za povečanje koncentracij dabigatrana v plazmi ni mogoče izključiti (zaviranje črevesnega P-gp).
In Studies GS-US-292-0104 and GS-US-292-0111, the rate of virologic success was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA, or baseline CD4+ cell count). 
V študijah GS-US-292-0104 in GS-US-292-0111, je bila stopnja virološke uspešnosti podobna pri vseh podskupinah bolnikov (starost, spol, rasa, začetna vrednost HIV-1 RNA ali začetno število celic CD4+).
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 je bila vezava emtricitabina na humane plazemske proteine < 4 % in je neodvisna od koncentracije v razponu med 0,02-200 µg/ml.
Odefsey has not been studied in patients with severe hepatic impairment (Child Pugh Class C); therefore, Odefsey is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2). 
Zdravila Odefsey niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po Child-Pughu); zato se uporaba zdravila Odefsey pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
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. 
Pričakuje se, da zdravila, ki inducirajo aktivnost P-gp (npr. rifampicin, rifabutin, karbamazepin, fenobarbital), zmanjšajo absorpcijo tenofoviralafenamida, kar povzroči zmanjšanje koncentracije tenofoviralafenamida v plazmi ter lahko povzroči izgubo terapevtskega učinka zdravila Odefsey in razvoj rezistence.
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. 
Dvainpetdeset odstotkov izolatov HIV-1 z nastalo rezistenco v kraku z rilpivirinom je razvilo sočasne mutacije NNRTI in NRTI, najpogosteje E138K in M184V.
Clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients. 
saj je morda pri nekaterih bolnikih treba prilagoditi vzdrževalno zdravljenje z metadonom.
What Odefsey is and what it is used for What you need to know before you take Odefsey How to take Odefsey 
Kaj je zdravilo Odefsey in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Odefsey Kako jemati zdravilo Odefsey Možni neželeni učinki
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Odefsey. 
Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti tenofoviralafenamidu in tenofovirju, ki je bila približno 4-krat oz. 17-krat večja od pričakovane po dajanju zdravila Odefsey.
Odefsey contains lactose 
Zdravilo Odefsey vsebuje laktozo
Patients co-infected with HIV and hepatitis B or C virus 
Bolniki s hkratno okužbo z virusom HIV in virusom hepatitisa B ali C
• If you are currently taking any of the following medicines: - carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures) - rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis) 
• Če trenutno uporabljate katero koli od naslednjih zdravil: karbamazepin, okskarbazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije in preprečevanje epileptičnih napadov) rifabutin, rifampicin in rifapentin (uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza)
Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2). 
Zdravljenje z zdravilom Odefsey je treba prekiniti pri bolnikih z ocenjenim CrCl, ki med zdravljenjem pade pod 30 ml/min (glejte poglavje 5.2).
If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). 
Če ste pomotoma zaužili odmerek zdravila Odefsey, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).
In patients who entered the studies with mild or moderate renal impairment, the serum creatinine increase observed was similar to that seen in patients with normal renal function. 
Pri bolnikih, ki so študiji začeli z blago ali zmerno ledvično okvaro, so opazili podobno povečanje serumskega kreatinina kot pri bolnikih z normalnim delovanjem ledvic.
Rilpivirine has not been studied in patients with severe hepatic impairment (Child Pugh Class C) (see section 4.2). 
Rilpivirina niso preučevali pri bolnikih s hudo jetrno okvaro (stopnje C po Child-Pughu) (glejte poglavje 4.2).
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets. 
Na voljo so naslednje velikosti pakiranj: škatle z 1 HDPE vsebnikom s po 30 filmsko obloženimi tabletami in škatle s po 90 (3 HDPE vsebniki po 30) filmsko obloženimi tabletami.
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. 
Stopnja virološkega neuspeha pri bolnikih, zdravljenih z emtricitabinom/dizoproksiltenofovirijevim fumaratom + rilpivirinom, je bila v 48. tednu 9,5 % in v 96. tednu 11,5 %, v kraku z emtricitabinom/dizoproksiltenofovirijevim fumaratom + efavirenzom pa 4,2 % oz. 5,1 %.
These increases do not reflect a change in actual glomerular filtration rate (GFR). 
Te spremembe se ne obravnavajo kot klinično pomembne, saj ne kažejo na spremembo dejanske hitrosti glomerularne filtracije (GFR-glomerular filtration rate).
c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis). 
c n = 539 (TAF) ali 841 (TFV) odraslih (GS-US-292-0111 in GS-US-292-0104, populacijska FK-analiza).
Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour). 
Poročali so o nekaterih primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
• If you notice 12 hours or more after the time you usually take Odefsey, then do not take the missed dose. 
• Če to opazite po 12 urah ali več od časa, ko običajno vzamete zdravilo Odefsey, pozabljenega odmerka ne vzemite.
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 vsebniki po 30) filmsko obloženih tablet
Reduced absorption, increase in gastric pH 
Zmanjšana absorpcija, povečanje vrednosti pH v želodcu.
FTC = emtricitabine; TAF = tenofovir alafenamide; TFV = tenofovir, N/A = not applicable Data are presented as mean (%CV). 
FTC = emtricitabin; TAF = tenofoviralafenamid; TFV = tenofovir, N/A = ne velja
• low platelet count (a type of blood cell involved in clotting blood) 
• nizko število krvnih ploščic (vrsta krvnih celic, ki sodeluje pri strjevanju krvi)
The safety and efficacy of Odefsey in patients with significant underlying liver disorders have not been established. 
Varnost in učinkovitost zdravila Odefsey pri bolnikih s pomembnejšimi sočasnimi jetrnimi boleznimi nista bili dokazani.
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. 
Poleg tega v klinični študiji medsebojnega delovanja s tenofoviralafenamidom, ki je bolj občutljiv na zaviranje črevesnega P-gp, rilpivirin ni vplival na izpostavljenost tenofoviralafenamidu pri sočasnem dajanju, kar pomeni, da rilpivirin ni in vivo zaviralec P-gp.
• 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, učinkovina, ki se uporablja za zmanjšanje moči imunskega sistema: Ta učinkovina lahko poveča količino rilpivirina in tenofoviralafenamida (sestavini zdravila Odefsey) v krvi.
Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg. 
Zdravilo Odefsey se uporablja pri odraslih in mladostnikih, starih 12 let in več, s telesno maso vsaj 35 kg.
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Odefsey pri otrocih, mlajših od 12 let, ali s telesno maso < 35 kg, še nista bili dokazani.
antacids (aluminium/magnesium hydroxide or calcium carbonate) 
antacidi (npr. aluminijev ali magnezijev hidroksid, kalcijev karbonat)
Table 5: Virologic outcomes of Studies GS-US-366-1216 and GS-US-366-1160 at Weeks 48a and 
Preglednica 5: Virološki izidi v študijah GS-US-366-1216 in GS-US-366-1160 v 48.a in 96.b tednu
If you are taking an antacid such as aluminium/magnesium hydroxide, or calcium carbonate, take it at least 2 hours before or at least 4 hours after Odefsey. 
Če jemljete antacid, kot je aluminijev/magnezijev hidroksid ali kalcijev karbonat, ga vzemite vsaj 2 uri pred jemanjem zdravila Odefsey ali najmanj 4 ure po tem.
c P-value for the superiority test comparing the percentages of virologic success was from the CMH (Cochran-Mantel-Haenszel) test stratified by the prior treatment regimen (EFV/FTC/TDF, FTC/TDF plus boosted atazanavir, or E/C/F/TDF). 
c Vrednost P za test superiornosti v primerjavi odstotkov virološkega uspeha je bil po testu CMH (Cochran-Mantel-Haenszel) stratificiran po predhodnem režimu zdravljenja (EFV/FTC/TDF, FTC/TDF z ojačanim atazanavirjem ali E/C/F/TDF).
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. 
V izkušnjah v obdobju trženja so poročali o hudih kožnih reakcijah s sistemskimi simptomi za emtricitabin/rilpivirin/dizoproksiltenofovirijev fumarat, vključno z izpuščaji, ki jih spremljajo vročina, mehurji, konjunktivitis, angioedem, zvišane vrednosti preiskav jetrne funkcije in/ali eozinofilija.
The use of Odefsey in children aged 11 years or under or weighing less than 35 kg has not yet been studied. 
Uporabe zdravila Odefsey pri otrocih, starih 11 let ali manj, ali s telesno maso manj kot 35 kg, še niso preučili.
There were no clinical signs or symptoms suggestive of adrenal or gonadal dysfunction in adults. 
Klinično pomembnih znakov ali simptomov, ki bi kazali na disfunkcijo nadledvične žleze ali gonad, ni bilo.
Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate. 
Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po dajanju tenofoviralafenamida v primerjavi z dizoproksiltenofovirijevim fumaratom so študije kancerogenosti in peri- ter postnatalne študije pri podganah izvedli samo z dizoproksiltenofovirijevim fumaratom.
In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected. 
Pri bolnikih s sočasno okužbo z virusom hepatitisa B ali C, ki so prejemali rilpivirin, je bila pogostnost zvišanja jetrnih encimov večja kot pri bolnikih brez sočasne okužbe, ki so prejemali rilpivirin.
N/A = not applicable 1 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product. 
1 To študijo interakcij so opravili z višjim odmerkom od priporočenega za rilpivirinijev klorid za ocenitev največjega učinka na sočasno dano zdravilo.
• If you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsades de Pointes). 
• Če jemljete katera koli zdravila, ki bi lahko povzročila smrtno nevarno neenakomerno bitje srca
Odefsey is a grey, capsule-shaped, film-coated tablet debossed on one side with “GSI” and “255” on the other side. 
Zdravilo Odefsey so sive filmsko obložene tablete v obliki kapsule z vtisnjenim znakom „GSI“ na eni strani in številko „255“ na drugi strani.
abdominal pain1, 3, vomiting1, 3, increased lipase1, abdominal discomfort1, dry mouth1, flatulence3, diarrhoea3 
bolečine v trebuhu1,3, bruhanje1,3, zvišanje lipaze1, nelagodje v trebuhu1, suha usta1, flatulenca3, driska3
In treatment-naïve adult patients 
Pri predhodno nezdravljenih odraslih bolnikih
FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz. 
Pokazalo se je, da FTC/TDF + rilpivirinijev klorid ni slabši pri doseganju HIV-1 RNA < 50 kopij/ml v primerjavi z FTC/TDF + efavirenz.
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1 
ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE5) sildenafil (enkratni odmerek 50 mg)/rilpivirin1
Considering all of the available in vitro data and data generated in treatment-naïve patients, the following resistance-associated mutations in HIV-1 RT, when present at baseline, may affect the activity of Odefsey: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L and the combination of L100I and K103N. 
Glede na vse podatke in vitro in podatke za predhodno nezdravljene bolnike, lahko naslednje mutacije reverzne transkriptaze HIV-1, povezane z rezistenco, če so prisotne na začetku, vplivajo na delovanje zdravila Odefsey: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L in kombinacija L100I in K103N.
(may affect more than 1 in 10 people) 
pojavijo se lahko pri več kot 1 od 10 bolnikov
 If you are taking any of these medicines, do not take Odefsey and tell your doctor immediately. 
 Če jemljete katero od teh zdravil, ne jemljite zdravila Odefsey in o tem nemudoma obvestite svojega zdravnika.
It is not known whether rilpivirine or tenofovir alafenamide are excreted in human milk. 
Ni znano, ali se rilpivirin ali tenofoviralafenamid izločata v materino mleko.
Co-administration is not recommended. 
Sočasno dajanje se ne priporoča.