natgillin/translations-raw huggingface dataset:
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.
d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
d Vključuje bolnike, ki so imeli v oknu 48. ali 96. tedna ≥ 50 kopij/ml, bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi razlogov, ki niso pomanjkanje ali izguba učinka, in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
GLUKOKORTIKOIDI deksametazon (sistemski, razen v obliki enkratnega odmerka)
Over 96 weeks of treatment with rilpivirine mean changes of 0.1 mg/dL (range: -0.3 mg/dL to 0.6 mg/dL) for creatinine and -13.3 mL/min/1.73 m2 (range: -63.7 mL/min/1.73 m2 to 40.1 mL/min/1.73 m2) for eGFR were observed.
V 96 tednih zdravljenja z rilpivirinom so opazili povprečno spremembo 0,1 mg/dl (razpon: -0,3 mg/dl do 0,6 mg/dl) za kreatinin in -13,3 ml/min/1,73 m2 (razpon: -63,7 ml/min/1,73 m2 do
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Odefsey.
Toksičen vpliv na kosti so opazili kot zmanjšano mineralno gostoto kosti pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj štirikrat večje kot izpostavljenost, pričakovana pri dajanju zdravila Odefsey.
Lower exposures of rilpivirine (one of the components of Odefsey) were observed during pregnancy; therefore viral load should be monitored closely.
Med nosečnostjo so opazili nižje izpostavljenosti rilpivirinu (ena izmed učinkovin zdravila Odefsey), zato je treba skrbno spremljati virusno obremenitev.
Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Nukleozidni in nukleotidni analogi povzročajo različno stopnjo okvare mitohondrijev, kar je najbolj izrazito pri stavudinu, didanozinu in zidovudinu.
The median increase from baseline for these parameters was greater in patients receiving FTC + TAF compared with patients receiving FTC + TDF (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Mediano povečanje od začetne vrednosti za te parametre je bilo večje pri bolnikih, ki so prejemali FTC + TAF, v primerjavi z bolniki, ki so prejemali FTC + TDF (p < 0,001 za razliko med skupinama zdravljenja za skupni holesterol na tešče, direktni LDL holesterol in HDL holesterol in trigliceride).
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.
V naboru 67 rekombinantnih laboratorijskih sevov virusa HIV-1 z eno mutacijo, povezano z rezistenco, na položajih RT, povezanih z rezistenco na NNRTI, sta bili edini mutaciji, povezani z rezistenco, ki sta bili povezani z izgubo občutljivosti na rilpivirin, K103N in Y181C.
In studies in treatment-naïve adult patients, E/C/F/TAF was associated with lower impact on renal safety parameters (as measured after 144 weeks treatment by eGFRCG and urine protein to creatinine ratio [UPCR] and after 96 weeks treatment by urine albumin to creatinine ratio [UACR]) compared to E/C/F/TDF.
V študijah predhodno nezdravljenih odraslih bolnikov je bilo zdravilo E/C/F/TAF povezano z manjšim vplivom na parametre varnosti za ledvice (izmerjeno po 144 tednih zdravljenja z eGFRCG in razmerjem med beljakovinami in kreatininom [Urine Protein to Creatinine Ratio - UPCR], po 96 tednih zdravljenja pa z razmerjem med albuminom v urinu in kreatininom [Urine Albumin to Creatinine Ratio - UACR]) v primerjavi z E/C/F/TDF.
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.
Po večkratnem peroralnem odmerjanju emtricitabina 20 preskušancem, okuženim s HIV-1, je bila (povprečna ± SD) površina pod krivuljo plazemskih koncentracij v odvisnosti od časa v 24-urnem intervalu odmerjanja (AUC) 10,0 ± 3,1 h•µg/ml.
Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH).
Pričakuje se pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija, povečanje vrednosti pH v želodcu).
Rilpivirine is primarily metabolised by CYP3A.
Rilpivirin se presnavlja pretežno s CYP3A.
Tenofovir alafenamide is a substrate of organic anion transporting polypeptide (OATP) 1B1 and OATP1B3 in vitro.
Tenofoviralafenamid je in vitro substrat organskega anionskega prenašalnega polipeptida (OATP - organic anion transporting polypeptide) 1B1 in OATP1B3.
d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
d Vključevalo je bolnike, ki so imeli v oknu 48. tedna ali 144. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase (UGT), the enzyme responsible for glucuronidation.
Emtricitabin tudi ni inhibiral uridin-5'-difosfoglukuronil-transferaze (UGT), encima, ki je odgovoren za glukuronidacijo.
Odefsey regimen
Režim z zdravilom Odefsey
 If this applies to you, do not take Odefsey and tell your doctor immediately.
 Če to velja za vas, ne jemljite zdravila Odefsey in o tem nemudoma obvestite svojega zdravnika.
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 podlagi teh omejenih podatkov je bil varnostni profil emtricitabina in tenofoviralafenamida v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1.
Treatment-naïve adults in Studies GS-US-292-0104 and GS-US-292-0111b
Predhodno nezdravljeni odrasli v študijah GS-US-292-0104 in GS-US-292-0111b
Recommendation concerning co-administration with Odefsey
Priporočilo glede sočasne uporabe z zdravilom Odefsey
In Odefsey studies in virologically suppressed adult patients, increases in BMD were noted at 96 weeks after switching to Odefsey compared to minimal changes with maintaining FTC/RPV/TDF or EFV/FTC/TDF at the hip (mean change 1.6% for Odefsey versus -0.6% for FTC/RPV/TDF, p < 0.001; 1.8% for Odefsey versus -0.6% for EFV/FTC/TDF, p < 0.001) and the spine (mean change 2.0% for Odefsey versus -0.3% for FTC/RPV/TDF, p < 0.001; 1.7% for Odefsey versus 0.1% for EFV/FTC/TDF, p < 0.001).
V študijah z zdravilom Odefsey so pri odraslih bolnikih z virološko supresijo v 96. tednu po prehodu na zdravilo Odefsey opazili povečanja MGK v primerjavi z minimalnimi spremembami pri bolnikih, ki so nadaljevali z uporabo FTC/RPV/TDF ali EFV/FTC/TDF, in sicer pri kolku (povprečna sprememba 1,6 % pri zdravilu Odefsey v primerjavi z -0,6 % pri FTC/RPV/TDF, p < 0,001; 1,8 % pri zdravilu Odefsey v primerjavi z -0,6 % pri EFV/FTC/TDF, p < 0,001) in hrbtenici (povprečna sprememba 2,0 % pri zdravilu Odefsey v primerjavi z -0,3 % pri FTC/RPV/TDF, p < 0,001; 1,7 % pri zdravilu Odefsey v primerjavi z 0,1 % pri EFV/FTC/TDF, p < 0,001).
Median (Q1, Q3) change from baseline at Week 144 in total cholesterol to HDL-cholesterol ratio was 0.2 (-0.3, 0.7) in patients receiving FTC + TAF and 0.1 (-0.4, 0.6) in patients receiving FTC + TDF (p = 0.006 for the difference between treatment groups).
Mediana (Q1, Q3) sprememba od začetne vrednosti v 144. tednu za razmerje med skupnim holesterolom in HDL holesterolom je bila 0,2 (-0,3, 0,7) pri bolnikih, ki so prejemali FTC + TAF, in 0,1 (-0,4, 0,6) pri bolnikih, ki so prejemali FTC + TDF (p = 0,006 za razliko med skupinama zdravljenja).
PC: {number} SN: {number} NN: {number} [Outer packaging only]
NN: {številka}[samo na zunanji ovojnini]
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Vsebnik iz polietilena visoke gostote (HDPE), s polipropilensko, za otroke varno zaporko z neprekinjeno nitko, obloženo z indukcijsko aktivirano aluminijasto folijo, ki vsebuje 30 filmsko obloženih tablet.
Co-administration of Odefsey with other medicinal products that inhibit P-gp and BCRP activity (e.g., ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, ciclosporin) is expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Pričakuje se, da sočasno dajanje zdravila Odefsey z drugimi zdravili, ki zavirajo aktivnost P-gp in BCRP (npr. ketokonazolom, flukonazolom, itrakonazolom, posakonazolom, vorikonazolom, ciklosporinom), poveča absorpcijo in koncentracijo tenofoviralafenamida v plazmi.
Odefsey should not be co-administered with medicinal products that can result in significant decreases in rilpivirine plasma concentrations (due to cytochrome P450 [CYP]3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Odefsey (see section 4.5), including:
Zdravila Odefsey se ne sme uporabljati v kombinaciji z zdravili, ki lahko povzročijo bistveno zmanjšanje koncentracij rilpivirina v plazmi (zaradi indukcije encima citokroma P450 [CYP]3A ali zvišanja vrednosti pH v želodcu), kar lahko zmanjša terapevtski učinek zdravila Odefsey (glejte poglavje 4.5), vključno z naslednjimi učinkovinami:
depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1
depresija1, nenavadne sanje1,3, motnje spanja1, depresivno razpoloženje1
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
V ločeni študiji 1. faze samo z emtricitabinom je bila povprečna sistemska izpostavljenost emtricitabinu večja pri bolnikih s hudo okvaro ledvic (ocenjeni CrCl < 30 ml/min) (33,7 µg•h/ml) kot pri preskušancih z normalnim delovanjem ledvic
Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild or moderate hepatic impairment.
Klinično pomembnih sprememb v farmakokinetičnih lastnostih tenofoviralafenamida ali njegovega presnovka tenofovirja pri bolnikih z blago ali zmerno jetrno okvaro niso opazili.
ketoconazole fluconazole itraconazole posaconazole voriconazole
ketokonazol flukonazol itrakonazol posakonazol vorikonazol
The median age was 36 years, 78% were male and 62% White and 24% Black/African American.
Mediana starost je bila 36 let, 78 % je bilo moških, 62 % je bilo belcev in 24 % črncev/afriških Američanov.
If you vomit less than 4 hours after taking Odefsey, take another tablet with food.
Če bruhate manj kot 4 ure po zaužitju zdravila Odefsey, vzemite še eno tableto s hrano.
Other medicines and Odefsey Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• Antifungal medicines used to treat fungal infections:
• antimikotike, ki se uporabljajo za zdravljenje glivičnih okužb:
Emtricitabine triphosphate competitively inhibits HIV-1 reverse transcriptase (RT), resulting in deoxyribonucleic acid (DNA) chain termination.
Emtricitabin trifosfat kompetitivno zavira reverzno transkriptazo (RT) HIV-1, kar povzroči prekinitev verige deoksiribonukleinske kisline (DNA, deoxyribonucleic acid).
At Week 96, switching to Odefsey was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on FTC/RPV/TDF or on EFV/FTC/TDF in respective studies.
V 96. tednu je bil prehod na zdravilo Odefsey neinferioren pri ohranjanju HIV-1 RNA < 50 kopij/ml v primerjavi z bolniki, ki so nadaljevali zdravljenje s FTC/RPV/TDF ali EFV/FTC/TDF v navedenih študijah.
Odefsey 200 mg/25 mg/25 mg film-coated tablets
IME ZDRAVILA Odefsey 200 mg/25 mg/25 mg filmsko obložene tablete
Odefsey should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Zdravila Odefsey se ne sme uporabljati sočasno z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
Table 3: Virologic outcomes of Studies GS-US-292-0104, GS-US-292-0111 at Week 48 and Week 144a, and GS-US-292-0109 at Week 48a
Preglednica 3: Virološki odzivi v študijah GS-US-292-0104 in GS-US-292-0111 v 48. tednu in 144. tednua in v študiji GS-US-292-0109 v 48. tednua
Elderly No dose adjustment of Odefsey is required in elderly patients (see section 5.2).
Odmerka zdravila Odefsey pri starejših bolnikih ni treba prilagoditi (glejte poglavje 5.2).