natgillin/translations-raw huggingface dataset:
In the week 96 pooled resistance analysis of the Phase III trials (ECHO and THRIVE), 42 out of 86 subjects with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis).
U analizi objedinjenih podataka o rezistenciji u 96. tjednu iz ispitivanja faze III (ECHO i THRIVE), kod 42 od 86 ispitanika s virološkim neuspjehom na rilpivirin, pojavila se rezistencija na rilpivirin (genotipska analiza).
If you notice after 12 hours, then skip that dose and take the next doses as usual.
Ako to primijetite nakon što je prošlo više od 12 sati, tada preskočite tu dozu i uzmite sljedeću tabletu u uobičajeno vrijeme.
Hepatobiliary disorders very common increased transaminases common increased bilirubin
Poremećaji jetre i žuči vrlo često povišene transaminaze često povišen bilirubin
No dose adjustment of EDURANT is required in older patients.
Prilagodba doze EDURANTA u starijih osoba nije potrebna.
The most commonly observed resistance-associated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Najčešće primijećene mutacije povezane s rezistencijom koje su se pojavile uključivale su L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C i M230I.
- The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
- Pomoćne tvari u jezgri filmom obložene tablete su laktoza hidrat, umrežena karmelozanatrij, povidon K30, polisorbat 20, silicirana mikrokristalična celuloza i magnezijev stearat.
In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz).
U analizi djelotvornosti objedinjenih podataka iz ispitivanja faze III u odraslih bolesnika tijekom 96 tjedana, bolesnici liječeni rilpivirinom s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml imali su veći rizik od virološkog neuspjeha (18,2% uz rilpivirin u odnosu na 7,9% uz efavirenz) u usporedbi s bolesnicima koji su imali početno virusno opterećenje ≤ 100 000 HIV-1 RNK kopija/ml (5,7% uz rilpivirin u odnosu na 3,6% uz efavirenz).
6 cells/l).
6 stanica/l).
400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
400 mg jedanput dnevno ketokonazol AUC ↓ 24% ketokonazol Cmin ↓ 66% ketokonazol Cmax ↔
Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/ml
Početne značajke bolesti Medijan početne HIV-1 RNK u plazmi (raspon) log10 kopija/ml
The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Učinak rilpivirina u preporučenoj dozi od 25 mg jedanput dnevno na QTcF interval procijenjen je u randomiziranom križnom ispitivanju kontroliranom placebom i djelatnom tvari (moksifloksacin 400 mg jedanput dnevno) u 60 zdravih odraslih ispitanika, uz 13 mjerenja tijekom 24 sata u stanju dinamičke ravnoteže.
If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule.
Ako je bolesnik propustio uzeti dozu EDURANTA unutar 12 sati od vremena kad je obično uzima, bolesnik mora što prije uzeti lijek uz obrok i nastaviti uzimati lijek prema uobičajenom rasporedu.
Most ADRs occurred in the first 48 weeks of treatment.
Većina nuspojava pojavila se tijekom prvih 48 tjedana liječenja.
If you vomit less than 4 hours after taking EDURANT, take another tablet with a meal.
Ako povraćate a prošlo je manje od 4 sata od uzimanja EDURANTA, uzmite drugu tabletu uz obrok.
Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Ispitanici u kojih se postigao virološki odgovor (dva uzastopna virusna opterećenja < 50 kopija/ml) i održao se do 48./96. tjedna.
There was no teratogenicity with rilpivirine in rats and rabbits.
Rilpivirin nije bio teratogen u štakora i kunića.
Rilpivirine-treated Resistance
Liječeni rilpivirinom Rezistencija
Considering all of the available in vitro and in vivo data in treatment-naïve subjects, the following resistance-associated mutations, when present at baseline, may affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, and M230L.
Razmatrajući sve dostupne podatke in vitro i in vivo za ispitanike koji prethodno nisu bili liječeni, na djelovanje rilpivirina mogu utjecati sljedeće mutacije povezane s rezistencijom kad su prisutne na početku: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I i M230L.
6 cells/l)
6 stanica/l)
Table 6 summarizes the week 48 and week 240 virologic outcome results for trial TMC278-C213.
Tablica 6 sažeto prikazuje rezultate viroloških ishoda u 48. i 240. tjednu ispitivanja TMC278-C213.
The pharmacokinetics, safety, tolerability and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase II trial in antiretroviral treatment-naïve HIV-1 infected adolescent subjects weighing at least 32 kg.
Farmakokinetika, sigurnost, podnošljivost i djelotvornost rilpivirina u dozi od 25 mg jedanput dnevno, u kombinaciji s osnovnim režimom po izboru ispitivača koji je sadržavao dva NRTI, bili su procijenjeni u ispitivanju TMC278-C213, otvorenom ispitivanju faze II s jednom skupinom ispitanika, u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnom terapijom, tjelesne težine od najmanje 32 kg.
Nervous system disorders very common headache dizziness common somnolence
Poremećaji živčanog sustava vrlo često glavobolja omaglica često somnolencija
It is not known whether rilpivirine is excreted in human milk.
Nije poznato izlučuje li se rilpivirin u majčino mlijeko u ljudi.
EDURANT 25 mg film-coated tablets rilpivirine
EDURANT 25 mg filmom obložene tablete rilpivirin
Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast-feed if they are receiving rilpivirine.
Zbog mogućnosti prijenosa HIV-a te zbog mogućnosti nuspojava u dojene novorođenčadi, majkama treba savjetovati da ne doje ako primaju rilpivirin.
Resistance outcome by background NRTI regimen used (pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis) tenofovir/ emtricitabine zidovudine/ lamivudine abacavir/ lamivudine
Tablica 5: Ishod rezistencije prema osnovnom NRTI režimu (analiza objedinjenih podataka iz ispitivanja ECHO i THRIVE u 96. tjednu) tenofovir/ emtricitabin zidovudin/ lamivudin abakavir/ lamivudin svi*
In ECHO, randomisation was stratified by screening viral load.
U ispitivanju ECHO, randomizacija je bila stratificirana prema virusnom opterećenju na probiru.
Medicinal products that are affected by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Rilpivirin u dozi od 25 mg jedanput dnevno najvjerojatnije neće imati klinički važan učinak na izloženost lijekovima koje metaboliziraju enzimi CYP-a.
Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
Rilpivirin se primarno metabolizira putem citokroma P450 (CYP)3A.
Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48 and week 240.
Ispitanici u kojih se postigao virološki odgovor (dva uzastopna virusna opterećenja < 50 kopija/ml) i održao se do 48./240. tjedna.
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Rilpivirin je diarilpirimidinski nenukleozidni inhibitor reverzne transkriptaze (NNRTI) virusa HIV-1.
What EDURANT looks like and contents of the pack White to off-white, film-coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.
Bijela do gotovo bijela, filmom obložena, okrugla, bikonveksna tableta s “TMC” utisnutim na jednoj strani i “25” na drugoj strani.
For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily.
Za bolesnike koji istodobno uzimaju rifabutin, doza EDURANTA mora se povisiti na 50 mg (dvije tablete od 25 mg), i uzeti jedanput dnevno.
Therefore, EDURANT is not recommended in patients with severe hepatic impairment (see section 4.2).
Stoga se primjena EDURANTA ne preporučuje u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily (see section 4.5).
Nakon prestanka istodobne primjene rifabutina, doza EDURANTA mora se smanjiti na 25 mg jedanput dnevno (vidjeti dio 4.5).
digoxin AUC ↔ digoxin Cmin NA digoxin Cmax ↔
digoksin AUC ↔ digoksin Cmin NP digoksin Cmax ↔
Gastrointestinal disorders very common nausea increased pancreatic amylase common abdominal pain vomiting increased lipase abdominal discomfort dry mouth
Poremećaji probavnog sustava vrlo često mučnina povišena pankreasna amilaza često bol u trbuhu povraćanje povišena lipaza osjećaj nelagode u trbuhu suha usta
The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in antiretroviral treatment-naïve HIV-1 infected patients 12 years of age and older.
Farmakokinetička svojstva rilpivirina procijenjena su u zdravih odraslih ispitanika i bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima u dobi od 12 godina i starijih.
- low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood
- depresivno raspoloženje - suha usta - nizak broj bijelih krvnih stanica i/ili trombocita, sniženje hemoglobina u krvi, povišenje triglicerida, lipaze i/ili bilirubina u krvi.
Virologic outcome in adult subjects in the ECHO and THRIVE trials (pooled data in the week 48 (primary) and week 96 analysis; ITT-TLOVR*) Outcome in the week 48 analysis
Tablica 4: Virološki ishod u odraslih ispitanika u ispitivanjima ECHO i THRIVE (analiza objedinjenih podataka u 48. tjednu (primarna) i 96. tjednu; ITT-TLOVR Ishod analize u 48. tjednu
Virologic failure in efficacy analysis: includes subjects who were rebounder (confirmed viral load ≥ 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load < 50 copies/ml, either ongoing or discontinued due to lack or loss of efficacy).
Virološki neuspjeh u analizi djelotvornosti: uključuje ispitanike s povratom virusnog opterećenja (potvrđeno virusno opterećenje ≥ 50 kopija/ml nakon postignutog odgovora) ili one u kojih se nikad nije postigla supresija (nije bilo potvrđeno virusno opterećenje < 50 kopija/ml, nastavili su ili prekinuli liječenje zbog izostanka ili gubitka djelotvornosti).
Significant decreases in rilpivirine plasma concentrations are expected.
Očekuju se značajna smanjenja koncentracije rilpivirina u plazmi.
In the rilpivirine arm in the week 96 analysis of the Phase III ECHO and THRIVE trials, mean change from baseline in total cholesterol (fasted) was 5 mg/dl, in HDL cholesterol (fasted) 4 mg/dl, in LDL cholesterol (fasted) 1 mg/dl, and in triglycerides (fasted) -7 mg/dl.
Kod skupine ispitanika liječenih rilpivirinom u analizi 96. tjedna ispitivanja ECHO i THRIVE faze III, srednja promjena ukupnog kolesterola (natašte) u odnosu na početnu vrijednost bila je 5 mg/dl, HDL kolesterola (natašte) 4 mg/dl, LDL kolesterola (natašte) 1 mg/dl, a triglicerida (natašte) -7 mg/dl.
In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
U ovoj analizi, mutacije povezane s rezistencijom (RAM-ovi) na NNRTI koje su se razvile u najmanje 2 virološka neuspjeha bile su: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y i F227C.
In patients with severe renal impairment or end-stage renal disease, the combination of EDURANT with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
U bolesnika s teškim oštećenjem bubrega ili u završnoj fazi bubrežne bolesti, kombinacija EDURANTA i jakog inhibitora CYP3A smije se primjenjivati samo ako korisni učinci nadilaze rizik.
Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
Ispitivanje TMC278-C204, bilo je randomizirano ispitivanje faze IIb s aktivnom kontrolom, provedeno je u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i sastojalo se od dva dijela: početnog djelomično slijepog dijela utvrđivanja doze [(rilpivirin) slijepe doze] do 96. tjedna, nakon kojeg je uslijedio dugotrajni dio ispitivanja otvorenog tipa.
At 96 weeks, the proportion of patients with < 50 HIV-1 RNA copies/ml receiving rilpivirine 25 mg (N=93) compared to patients receiving efavirenz (N=89) was 76% and 71%, respectively.
U 96 tjedana, udio bolesnika s < 50 HIV-1 RNK kopija/ml koji su primali rilpivirin od 25 mg (N = 93) iznosio je 76%, a udio bolesnika koji su primali efavirenz (N = 89) iznosio je 71%.
Liver toxicity associated with liver enzyme induction was observed in rodents.
U glodavaca je primijećena toksičnost za jetru povezana s indukcijom jetrenih enzima.
simeprevir AUC ↔ simeprevir Cmin ↔ simeprevir Cmax ↑ 10% rilpivirine AUC ↔ rilpivirine Cmin ↑ 25% rilpivirine Cmax ↔
simeprevir AUC ↔ simeprevir Cmin ↔ simeprevir Cmax ↑ 10% rilpivirin AUC ↔ rilpivirin Cmin ↑ 25% rilpivirin Cmax ↔
If you take these medicines, please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
Ako uzimate ovaj lijek tijekom uzimanja EDURANTA, molimo pažljivo pročitajte kako uzimati EDURANT u dijelu 3 “Upute za pravilnu primjenu u odraslih i adolescenata (u dobi od 12 do manje od 18 godina)”.
The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Preporuke za doziranje vrijede za preporučenu dozu rilpivirina od 25 mg jedanput dnevno.
EDURANT should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
EDURANT treba primjenjivati s oprezom kad se istovremeno primjenjuje s lijekom s poznatim rizikom za nastanak torsade de pointes.
No dose adjustment of EDURANT is required in older patients (see section 5.2).
U starijih osoba nije potrebno prilagođavati dozu EDURANTA (vidjeti dio 5.2).
Blood and lymphatic system disorders common decreased white blood cell count decreased haemoglobin decreased platelet count
Poremećaji krvi i limfnog sustava često snižen broj bijelih krvnih stanica snižen hemoglobin snižen broj trombocita
In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
U ispitivanju u zdravih ispitanika pokazalo se da doze rilpivirina iznad preporučenih (75 mg jedanput dnevno i 300 mg jedanput dnevno) produljuju QTc interval na EKG-u (vidjeti dio 5.1).
In THRIVE, randomisation was stratified by screening viral load and by N(t)RTI BR.
U ispitivanju THRIVE, randomizacija je bila stratificirana prema virusnom opterećenju na probiru i osnovnom režimu N(t)RTI-ja.
The safety assessment is based on the week 48 analysis of the single-arm, open-label, Phase II trial, TMC278-C213, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1).
Sigurnost je procijenjena na temelju analize u 48. tjednu otvorenog ispitivanja faze II s jednom skupinom ispitanika, TMC278-C213, u kojem je 36 adolescentnih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni anitretrovirusnim lijekovima, tjelesne težine od najmanje 32 kg, primilo rilpivirin (25 mg jedanput dnevno) u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.1).
The response rate (confirmed undetectable viral load < 50 HIV-1 RNA copies/ml) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
Stopa odgovora (potvrđeno nemjerljivo virusno opterećenje < 50 HIV-1 RNA kopija/ml) u 96. tjednu bila je usporediva između skupine liječene rilpivirinom i skupine liječene efavirenzom.
No clinically relevant drug-drug interactions are expected.
Ne očekuju se klinički važne interakcije lijekova.
Steady-state administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine.
U stanju dinamičke ravnoteže, primjena rilpivirina u dozi od 75 mg jedanput dnevno odnosno 300 mg jedanput dnevno rezultirala je srednjim Cmax od približno 2,6 puta odnosno 6,7 puta većim od srednje vrijednosti Cmax u stanju dinamičke ravnoteže primijećene uz preporučenu dozu rilpivirina od 25 mg jedanput dnevno.
The mean increase from baseline in CD4+ counts was 146 × 10
Srednje povećanje broja stanica CD4+ u odnosu na početnu vrijednost iznosilo je 146 × 10
If you take this medicine while taking
OD LIJEKA, AKO JE POTREBNO
rilpivirine AUC ↓ 42% rilpivirine Cmin ↓ 48% rilpivirine Cmax ↓ 31%
rilpivirin AUC ↓ 42% rilpivirin Cmin ↓ 48% rilpivirin Cmax ↓ 31%
raltegravir AUC ↑ 9% raltegravir Cmin ↑ 27% raltegravir Cmax ↑ 10% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
raltegravir AUC ↑ 9% raltegravir Cmin ↑ 27% raltegravir Cmax ↑ 10% rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
No clinically relevant drug-drug interaction is expected.
Ne očekuje se klinički važna interakcija lijekova.
If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium / magnesium hydroxide, calcium carbonate).
Ako uzimate antacid (lijek za liječenje bolesti povezanih s kiselinom u želucu, kao što su aluminijev/magnezijev hidroksid, kalcijev karbonat).
The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy (similar for the 2
Izloženost ukupnom rilpivirinu nakon uzimanja 25 mg rilpivirina jedanput na dan kao dijela antiretrovirusnog režima bila je niža tijekom trudnoće (slično za 2. i 3. tromjesečje) u usporedbi s postpartalnim razdobljem (vidjeti tablicu 7).
There were no safety concerns identified in the week 240 analyses.
Prema analizama provedenima u 240. tjednu, sigurnost primjene nije bila upitna.
Didanosine should be administered at least two hours before or at least four hours after rilpivirine.
Didanozin treba primijeniti najmanje dva sata prije ili najmanje četiri sata poslije rilpivirina.
If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.
Ako povraćate a prošlo je više od 4 sata od uzimanja EDURANTA, ne trebate uzeti drugu tabletu sve do sljedeće tablete koju uzmite prema uobičajenom rasporedu.
Table 2: ADRs reported in antiretroviral treatment-naïve HIV-1 infected adult patients treated with Rilpivirine (pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials) N=686 System Organ Class (SOC) Frequency Category ADRs (Rilpivirine + BR)
Tablica 2: Nuspojave zabilježene u odraslih bolesnika zaraženih s HIV-1 koji prije nisu primali antiretrovirusnu terapiju, liječenih rilpivirinom (objedinjeni podaci iz 96. tjedna analize iz ispitivanja faze III ECHO i THRIVE) N = 686 Organski sustav (SOC)
Increase in CD4+ cell count (mean)
Povećanje u broju CD4+ stanica (srednja vrijednost)
In the week 48 pooled resistance analysis from the Phase III trials, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
U 48. tjednu analize rezistencije na objedinjenim podacima iz ispitivanja faze III, za 62 (od ukupno 72) slučaja virološkog neuspjeha u skupini koja je primala rilpivirin postojali su podaci o rezistenciji na početku i u vrijeme neuspjeha.
The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively.
Medijan trajanja izloženosti bolesnika iznosio je 104,3 tjedana u skupini koja je primala rilpivirin odnosno 104,1 tjedan u skupini koja je primala efavirenz.
rd
D.
Site-directed NNRTI mutant virus
Virus s ciljanom mutacijom za NNRTI
Co-administration of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.
Istovremena primjena rilpivirina s lijekovima koji povećavaju želučani pH može rezultirati smanjenim koncentracijama rilpivirina u plazmi, što potencijalno može oslabiti terapijski učinak EDURANTA.
HIV NNRTIs NNRTIs (delavirdine, efavirenz, etravirine, nevirapine)
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) HIV-a NNRTI (delavirdin, efavirenz, etravirin, nevirapin)
ANTIDIABETICS Metformin* 850 mg single dose metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
Metformin* jedna doza od 850 mg metformin AUC ↔ metformin Cmin NP metformin Cmax ↔
- In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
- Nakon što počnete uzimati lijekove za liječenje HIV infekcije, dodatno uz oportunističke infekcije, također se mogu javiti autoimuni poremećaji (stanje u kojem imunološki sustav napada zdravo tjelesno tkivo).
EDURANT 25 mg film-coated tablets
NAZIV LIJEKA EDURANT 25 mg filmom obložene tablete
Median baseline CD4+ cell count (range), x 10
Medijan početnog broja stanica CD4+ (raspon), x 10
rilpivirine AUC ↑ 49% rilpivirine Cmin ↑ 76% rilpivirine Cmax ↑ 30%
rilpivirin AUC ↑ 49% rilpivirin Cmin ↑ 76% rilpivirin Cmax ↑ 30%
(reduced absorption due to gastric pH increase) H2-RECEPTOR ANTAGONISTS Famotidine* 40 mg single dose taken 12 hours before rilpivirine rilpivirine AUC ↓ 9% rilpivirine Cmin NA rilpivirine Cmax ↔
(smanjena apsorpcija zbog povišenog želučanog pH) ANTAGONISTI H2-RECEPTORA Famotidin* jedna doza od 40 mg uzeta 12 sati prije rilpivirina rilpivirin AUC ↓ 9% rilpivirin Cmin NP rilpivirin Cmax ↔
If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.
Ako je bolesnik propustio uzeti dozu EDURANTA a prošlo je više od 12 sati, bolesnik ne treba uzeti propuštenu dozu, nego treba nastaviti uzimati lijek prema uobičajenom rasporedu.
40 mg once daily atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↓ 9%
40 mg jedanput dnevno atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↓ 9%
20 mg once daily omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
20 mg jedanput dnevno omeprazol AUC ↓ 14% omeprazol Cmin NP omeprazol Cmax ↓ 14% rilpivirin AUC ↓ 40% rilpivirin Cmin ↓ 33% rilpivirin Cmax ↓ 40%