natgillin/translations-raw huggingface dataset:
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.
U oku pasa bila je prisutna minimalna infiltracija histiocita kod izloženosti tenofoviralafenamidu i tenofoviru koja je bila približno 4 odnosno 17 puta veća od one očekivane nakon primjene lijeka Odefsey.
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/mL), group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/mL), and showed limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/mL).
Rilpivirin je također demonstrirao antivirusnu aktivnost protiv širokog spektra primarnih izolata HIV-1 skupine M (podtip A, B, C, D, F, G, H) s vrijednostima EC50 od 0,07 do 1,01 nM (0,03 do 0,37 ng/ml), primarnih izolata skupine O s vrijednostima EC50 od 2,88 do 8,45 nM (1,06 do 3,10 ng/ml) i pokazao ograničenu in vitro aktivnost protiv virusa HIV-2 s vrijednostima EC50 od 2510 do 10 830 nM (920 do 3970 ng/ml).
Odefsey 200 mg/25 mg/25 mg film-coated tablets
NAZIV LIJEKA Odefsey 200 mg/25 mg/25 mg filmom obložene tablete
Odefsey should generally be avoided but may be used with caution in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Iako Odefsey općenito treba izbjegavati u odraslih sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi, može ga se primijeniti s oprezom ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dio 4.2).
While you are taking Odefsey
Dok uzimate lijek Odefsey
e Includes patients who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
e Obuhvaća bolesnike koji su prekinuli liječenje iz drugih razloga, a ne zbog štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja, itd.
In the pooled analysis for TMC278-C209 and TMC278-C215 of 1,096 patients who received a background regimen (BR) of FTC/TDF, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz (EFV) arms.
U objedinjenoj analizi za Ispitivanja TMC278-C209 i TMC278-C215 na 1096 bolesnika koji su primali osnovni režim (BR, od engl. background regimen) lijeka FTC/TDF, demografske i početne karakteristike bile su izjednačene između skupina liječenih rilpivirinom i efavirenzom (EFV).
In Studies GS-US-292-0104 and GS-US-292-0111, E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
U ispitivanjima GS-US-292-0104 i GS-US-292-0111, E/C/F/TAF je pokazao statističku superiornost u postizanju vrijednosti HIV-1 RNK < 50 kopija/ml u usporedbi s E/C/F/TDF u 144. tjednu.
If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine, take it at least 12 hours before or at least 4 hours after Odefsey.
Ako uzimate H2-antagonist kao što je famotidin, cimetidin, nizatidin ili ranitidin, uzmite ga najmanje 12 sata prije ili najmanje 4 sata nakon uzimanja lijeka Odefsey.
Croscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
Jezgra tablete: umrežena karmelozanatrij, laktoza (u obliku hidrata), magnezijev stearat, mikrokristalična celuloza, polisorbat 20, povidon.
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in E/C/F/TAF-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48 and 326 cells/mm3 in E/C/F/TAF-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
Srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ bila je 230 stanica/mm3 u bolesnika liječenih E/C/F/TAF (p = 0,024) te 211 stanica/mm3 u bolesnika liječenih E/C/F/TDF (p = 0,024) u 48. tjednu i 326 stanica/mm3 u bolesnika liječenih E/C/F/TAF te 305 stanica/mm3 u bolesnika liječenih E/C/F/TDF (p = 0,06) u 144. tjednu.
decreased appetite1, increased triglycerides (fasted)1
smanjeni tek1, povišeni trigliceridi (natašte)1
Do not stop taking Odefsey Do not stop taking Odefsey without talking to your doctor.
Nemojte prestati uzimati lijek Odefsey bez prethodnog razgovora sa svojim liječnikom.
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Tenofoviralafenamid je nukleotidni inhibitor reverzne transkriptaze (NtRTI) i prolijek tenofovira (analog 2'-deoksiadenozin monofosfata).
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 Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 96. tjedna; bolesnike koji su rano prekinuli liječenje ispitivanim lijekom zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz drugih razloga, a ne zbog nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
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 Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 144. tjedna; bolesnike koji su rano prekinuli liječenje ispitivanim lijekom zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz drugih razloga, a ne zbog štetnih događaja, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
Rilpivirine exposures were bioequivalent when comparing Odefsey 200/25/25 mg to one rilpivirine (as hydrochloride) 25 mg film-coated tablet following single dose administration to healthy subjects (n = 95) under fed conditions.
Izloženosti rilpivirinu bile su bioekvivalentne prilikom usporedbe Odefsey 200/25/25 mg i jedne filmom obložene tablete rilpivirina (u obliku klorida) od 25 mg nakon primjene jedne doze u zdravih ispitanika (n = 95) u sitom stanju.
The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had CD4+ cell counts < 200 cells/mm3.
Srednja početna vrijednost broja CD4+ stanica bila je 427 stanica/mm3 (raspon 0-1360), a 13% imalo je broj CD4+ stanica < 200 stanica/mm3.
1 Adverse reactions identified from rilpivirine clinical studies.
umor1,3 1 Nuspojave prepoznate u kliničkim ispitivanjima rilpivirina.
2 Study conducted with emtricitabine/rilpivirine/tenofovir disoproxil fumarate fixed-dose combination tablet.
2 Ispitivanje je provedeno s emtricitabinom/rilpivirinom/tenofovirdizoproksilfumaratom u obliku tablete s fiksnom kombinacijom doza.
It is not known whether rilpivirine or tenofovir alafenamide are excreted in human milk.
Nije poznato izlučuju li se rilpivirin ili tenofoviralafenamid u majčino mlijeko.
f Includes patients who discontinued for reasons other than an AE, death, or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
f Obuhvaća bolesnike koji su prekinuli liječenje iz drugih razloga a ne zbog štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
teške reakcije na koži sa sistemskim simptomima4, angioedemom5,6, svrbežom3, urtikarijom6
The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C, and M230I.
Najčešće uočene novonastale supstitucije aminokiseline uključivale su: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C i M230I.
Table 4: Virologic outcomes of randomised treatment of Studies TMC278-C209 and TMC278-C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with FTC/TDF) at Week 48 (primary) and Week 96
Tablica 4: Virološki ishodi randomiziranog liječenja u Ispitivanju TMC278-C209 i TMC278-C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s FTC/TDF) u 48. (primarno) i 96. tjednu
Paracetamol (500 mg single dose)/ Rilpivirine1
Paracetamol (jedna doza od 500 mg)/rilpivirin1
The median age was 36 years, 78% were male and 62% White and 24% Black/African American.
Medijan dobi bio je 36 godina, 78% su bili muškarci, 62% su bili bijelci, 24% crnci/afroamerikanci.
Antimycobacterials Rifampicin/ Rilpivirine
Antimikobakterijski lijekovi Rifampicin/rilpivirin
• Any medicines used for treating HIV • Any medicines containing:
• Bilo koji lijek koji sadržava:
Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide
Odefsey 200 mg/25 mg/25 mg filmom obložene tablete emtricitabin/rilpivirin/tenofoviralafenamid
Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Prekid liječenja ispitivanim lijekom zbog štetnog događajaa ili smrti te posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/ml Prekid liječenja ispitivanim lijekom iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/ml e Podaci iz okvira ispitivanja nedostaju, ali je ispitivani lijek primjenjivan
If you vomit more than 4 hours after taking Odefsey you do not need to take another tablet until your next regularly scheduled tablet.
Ako povraćate nakon što je prošlo više od 4 sata od uzimanja lijeka Odefsey, ne morate uzeti još jednu tabletu prije sljedeće tablete prema redovitom rasporedu.
Treatment-naïve HIV-1 infected adult patients The efficacy of rilpivirine is based on the analyses of 96 weeks data from two randomised, double-blind, controlled studies in treatment-naïve patients (TMC278-C209 and emtricitabine + tenofovir disoproxil fumarate subset of TMC278-C215).
Odrasli bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni Djelotvornost rilpivirina utemeljena je na analizi podataka iz 96 tjedana u dva randomizirana, dvostruko slijepa, kontrolirana ispitivanja bolesnika koji prethodno nisu bili liječeni (TMC278-C209 i podskupini u TMC278-C215 s emtricitabinom + tenofovirdizoproksilfumaratom).
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Farmakokinetika rilpivirina nije ispitivana u bolesnika s insuficijencijom bubrega.
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).
U ispitivanjima s lijekom Odefsey provedenim u odraslih bolesnika u kojih je virus bio suprimiran, povećanja BMD-a bila su opažena 96 tjedana nakon prebacivanja na Odefsey u usporedbi s minimalnim promjenama kod održavanja primjene FTC/RPV/TDF ili EFV/FTC/TDF za kuk (srednja vrijednost promjene 1,6% za Odefsey naspram -0,6% za FTC/RPV/TDF, p < 0,001; 1,8% za Odefsey naspram -0,6% za EFV/FTC/TDF, p < 0,001) i kralježnicu (srednja vrijednost promjene 2,0% za
At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
U 48. tjednu, 92% bolesnika (66/72) zadržalo je HIV-1 RNK < 50 kopija/ml nakon prebacivanja na E/C/F/TAF.
AUC: ↑ 2% Cmin: ↑ 2% Cmax: ↑ 1%
AUC: ↑ 2% Cmax: ↑ 2% Cmax: ↑ 1%
Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg + 100 mg once daily)3/
Sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg + 100 mg jedanput na dan)3/
c There were 17 new virologic failures between the Week 48 primary analysis and Week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
c Bilo je 17 novih viroloških neuspjeha između primarne analize 48. tjedna i 96. tjedna (6 bolesnika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml i 11 bolesnika s početnim virusnim opterećenjem > 100 000 kopija/ml).
insomnia1
somnolencija1
Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH).
Očekuju se značajna smanjenja koncentracije rilpivirina u plazmi (smanjena apsorpcija, povećanje zelučanih pH-vrijednosti).
In studies in treatment-naïve adult patients, E/C/F/TAF was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001).
U ispitivanjima u odraslih bolesnika koji prethodno nisu bili liječeni, E/C/F/TAF bio je povezan s manjim smanjenjima mineralne gustoće kosti (BMD) u usporedbi s E/C/F/TDF u 144 tjedna liječenja prema analizi rezultata dobivenih dvoenergetskom apsorpciometrijom rendgenskih zraka (DXA) kuka (srednja vrijednost promjene: -0,8% naspram -3,4%, p < 0,001) i lumbalne kralježnice (srednja vrijednost promjene: -0,9% naspram -3,0%, p < 0,001).
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Nisu zapažene klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl > 15 ml/min i < 30 ml/min) u ispitivanju tenofoviralafenamida faze I.
The use of Odefsey in children aged 11 years or under or weighing less than 35 kg has not yet been studied.
Primjena lijeka Odefsey u djece u dobi od 11 godina i mlađoj s tjelesnom težinom manjom od 35 kg još nije ispitana.
The NNRTI resistance-associated mutations that developed most commonly were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
Mutacije povezane s NNRTI rezistencijom, koje su se najčešće razvijale, bile su: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y i F227C.
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received E/C/F/TAF for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis.
U bolesnika istodobno zaraženih HIV-om i HBV-om U kliničkom ispitivanju bolesnika s HIV virološkom supresijom koji su istodobno zaraženi kroničnim hepatitisom B, koji su primali E/C/F/TAF tijekom 48 tjedana (GS-US-292-1249, n = 72), 2 bolesnika bila su kvalificirana za analizu rezistencije.
In Study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen.
Ispitivanju GS-US-292-0109, prebacivanje s režima temeljenog na tenofovirdizoproksilfumaratu na E/C/F/TAF bilo je superiorno u održavanju HIV-1 RNK < 50 kopija/ml u usporedbi s ostankom na početnom režimu.
Exposures of emtricitabine and tenofovir alafenamide given with elvitegravir + cobicistat achieved in 24 paediatric patients aged 12 to < 18 years were similar to exposures achieved in treatment-naïve adults (Table 6).
Postignute izloženosti emtricitabinu i tenofoviralafenamidu koji su se davali s elvitegravirom i kobicistatom u 24 pedijatrijska bolesnika u dobi od 12 do < 18 godina bile su slične izloženostima postignutima u odraslih koji prethodno nisu bili liječeni (tablica 6).
In studies in virologically suppressed adult patients, through 96 weeks of treatment there were minimal changes or decreases in albuminuria (UACR) in patients receiving Odefsey compared with increases from baseline in patients who stayed on FTC/RPV/TDF or EFV/FTC/TDF.
U ispitivanjima u odraslih bolesnika u kojih je virus bio suprimiran, u 96 tjedana liječenja u bolesnika koji su primali Odefsey zabilježene su minimalne promjene ili smanjenja albuminurije (UACR), u usporedbi s porastom u odnosu na početne vrijednosti u bolesnika koji su ostali na kombinaciji FTC/RPV/TDF ili EFV/FTC/TDF.
ANALGESICS
ANALGETICI
Clinical efficacy of Odefsey was established from studies conducted with emtricitabine + tenofovir alafenamide when given with elvitegravir + cobicistat as an E/C/F/TAF FDC tablet, from studies conducted with rilpivirine when given with FTC/TDF as individual components or as a FTC/RPV/TDF FDC tablet, and from studies conducted with Odefsey.
Klinička djelotvornost lijeka Odefsey ustanovljena je na temelju ispitivanja provedenih s emtricitabinom i tenofoviralafenamidom kada se daju s elvitegravirom i kobicistatom kao E/C/F/TAF tableta s fiksnom kombinacijom na temelju ispitivanja provedenih s rilpivirinom kada se daje s FTC/TDF kao individualne komponente ili kao FTC/RPV/TDF tableta s fiksnom kombinacijom te ispitivanja provedenih s lijekom Odefsey.
In open-label Study GS-US-292-1249, the efficacy and safety of E/C/F/TAF were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
U otvorenom Ispitivanju GS-US-292-1249, djelotvornost i sigurnost E/C/F/TAF-a procijenjene su u odraslih bolesnika istodobno zaraženih virusom HIV-1 i kroničnim hepatitisom B. Šezdeset devet od 72 bolesnika prethodno su bili na antiretrovirusnoj terapiji koja je sadržavala TDF.
3 Adverse reactions identified from clinical studies of emtricitabine + tenofovir alafenamide-containing products.
3 Nuspojave prepoznate u kliničkim ispitivanjima lijekova koji sadrže emtricitabin + tenofoviralafenamid.
ANTIARRHYTHMICS Digoxin/ Rilpivirine
ANTIARITMICI Digoksin/rilpivirin
Overall response and a subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase 3 clinical studies, TMC278-C209 and TMC278-C215, for patients receiving the FTC/TDF BR) are presented in Table 4.
Ukupni odgovor i analiza podgrupe virološkog odgovora (< 50 HIV-1 RNK kopija/ml) i u 48. tjednu i 96. tjednu, te virološki neuspjeh prema početnom virusnom opterećenju (objedinjeni podaci iz dva klinička ispitivanja faze 3, TMC278-C209 i TMC278-C215, za bolesnike koji su primali FTC/TDF BR) prikazani su u tablici 4.
Significant dose dependent decreases in rilpivirine plasma concentrations are expected (induction of CYP3A).
Očekuju se značajna smanjenja koncentracije rilpivirina u plazmi ovisno o dozi (indukcija CYP3A).
In the Week 144 pooled analysis of antiretroviral-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in the Phase 3 studies GS-US-292-0104 and GS-US-292-0111, the development of one or more primary resistance-associated mutations was observed in HIV-1 isolates from 12 of 866 (1.4%) patients treated with E/C/F/TAF.
U objedinjenoj analizi u 144. tjednu bolesnika koji prethodno nisu bili antiretrovirusno liječeni i primali su elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid (E/C/F/TAF) u ispitivanjima GS-US-292-0104 i GS-US-292-0111 faze 3, uočen je razvoj jedne ili više primarnih mutacija povezanih s rezistencijom u HIV-1 izolatima u 12 od 866 (1,4%) bolesnika liječenih s E/C/F/TAF.
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.
Prebacivanje na Odefsey u 96. tjednu bilo je neinferiorno u održavanju HIV-1 RNK < 50 kopija/ml u usporedbi s bolesnicima koji su u uspitivanjima ostali na FTC/RPV/TDF ili EFV/FTC/TDF.
• omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole
• omeprazol, esomeprazol, dekslanzoprazol, lanzoprazol, pantoprazol, rabeprazol
-2.0% (95% CI: -5.9% to 1.8%)
-2,0% (95% CI: -5,9% do 1,8%)
The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range 1.3-7.0) and 23% of patients had baseline viral loads > 100,000 copies/mL.
Srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,5 log10 kopija/ml (raspon 1,3-7,0), a 23% imalo je početno virusno opterećenje > 100 000 kopija/ml.
Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Potrebno je prekinuti liječenje lijekom Odefsey u bolesnika u kojih procijenjeni CrCl tijekom liječenja opada na vrijednosti ispod 30 ml/min (vidjeti dijelove 5.1 i 5.2).
If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule.
Ako bolesnik propusti uzeti dozu lijeka Odefsey, a prošlo je manje od 12 sati od propuštene doze, bolesnik mora što prije uzeti lijek Odefsey s hranom i potom ga nastaviti uzimati prema uobičajenom rasporedu.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (NRTI) i analog 2'-deoksicitidina.
• Signs of inflammation or infection • Joint pain, stiffness or bone problems
• Znakove upale ili infekcije • bol u zglobovima, ukočenost ili tegobe s kostima.
Rilpivirine: AUC: ↔
Tenofoviralafenamid: AUC: ↓
Patients had a mean age of 15 years (range 12-17), were 56% female, 12% Asian, and 88% Black.
Bolesnici su imali srednju vrijednost dobi 15 godina (raspon 12-17), 56% su bili žene, 12% azijati i 88% crnci.
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.
U ispitivanjima u odraslih bolesnika koji prethodno nisu bili liječeni, E/C/F/TAF bio je povezan s manjim utjecajem na parametre sigurnosti primjene za bubrege (mjereno prema eGFRCG i omjeru proteina i kreatinina u mokraći [engl. urine protein to creatinine ratio, UPCR] nakon 144 tjedna liječenja te omjeru albumina i kreatinina u mokraći [engl. urine albumin to creatinine ratio, UACR] nakon 96 tjedana liječenja ) u usporedbi s E/C/F/TDF.
In the Week 96 pooled analysis for patients receiving emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) + rilpivirine hydrochloride in the Phase 3 clinical studies TMC278-C209 and TMC278-C215, HIV-1 isolates from 43 patients had an amino acid substitution associated with NNRTI (n = 39) or NRTI (n = 41) resistance.
U objedinjenoj analizi u 96. tjednu za bolesnike koji su primali emtricitabin/tenofovirdizoproksilfumarat (FTC/TDF) + rilpivirinklorid u kliničkim ispitivanjima TMC278-C209 i TMC278-C215 faze 3, HIV-1 izolati 43 bolesnika imali su supstituciju aminokiselina povezanu s NNRTI (n = 39) ili NRTI (n = 41) rezistencijom.
Emtricitabine displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Emtricitabin je pokazao antivirusnu aktivnost u staničnoj kulturi na podtipove virusa HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i aktivnost protiv HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).