natgillin/translations-raw huggingface dataset:
Patients co-infected with hepatitis B and/or hepatitis C virus 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.
Bolesnici istovremeno zaraženi virusom hepatitisa B i/ili C U bolesnika istovremeno zaraženih virusom hepatitisa B ili C koji primaju rilpivirin, incidencija povišenja jetrenih enzima bila je veća nego u bolesnika koji su primali rilpivirin i nisu bili istovremeno zaraženi tim virusima.
Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
Budući da je rilpivirin u visokom postotku vezan za proteine plazme, dijalizom se najvjerojatnije neće ukloniti značajna količina djelatne tvari.
EDURANT must be taken with a meal.
EDURANT se mora uzimati uz obrok.
Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
U primjeni EDURANTA treba se rukovoditi nalazima testiranja genotipske rezistencije (vidjeti dijelove 4.4 i 5.1).
Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Nemojte uzimati EDURANT u kombinaciji s bilo kojim od sljedećih lijekova, jer može utjecati na način djelovanja EDURANTA ili drugog lijeka: - karbamazepin, okskarbazepin, fenobarbital, fenitoin (lijekovi za liječenje epilepsije i sprječavanje napadaja) - rifampicin, rifapentin (lijekovi za liječenje nekih bakterijskih infekcija kao što je tuberkuloza) - omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (inhibitori protonske pumpe, koji se primjenjuju za sprječavanje i liječenje čira na želucu, žgaravice ili povrata želučane kiseline iz želuca) - deksametazon (kortikosteroid koji se primjenjuje u raznim stanjima, kao što su upala i alergijske reakcije) kad se uzima kroz usta ili daje injekcijom, osim kao liječenje jednokratnom dozom - pripravci koji sadrže gospinu travu (Hypericum perforatum) (biljni pripravci protiv depresije).
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Tako lijekovi koji induciraju ili inhibiraju CYP3A mogu utjecati na klirens rilpivirina (vidjeti dio 5.2).
Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Rilpivirin nije izazvao oštećenje kromosoma u mikronukleusnom testu in vivo u miševa.
If you take an H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or ranitidine).
Ako uzimate antagoniste H2-receptora (lijekovi koji se koriste za liječenje čira želuca ili crijeva ili ublažavanje žgaravice - zbog povrata želučane kiseline iz želuca (kao što su cimetidin, famotidin, nizatidin ili ranitidin).
ANTIARRHYTHMICS Digoxin*
ANTIARITMICI Digoksin*
Other NRTIs (abacavir, emtricitabine, lamivudine, stavudine and zidovudine)
Ostali NRTI-ji (abakavir, emtricitabin, lamivudin, stavudin i zidovudin)
What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Što EDURANT sadrži - Djelatna tvar je rilpivirin u obliku rilpivirinklorida.
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Tablica 1: INTERAKCIJE I PREPORUČENE DOZE S DRUGIM LIJEKOVIMA
Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Psihijatrijski poremećaji vrlo često nesanica često neuobičajeni snovi depresija poremećaji spavanja depresivno raspoloženje
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.
Ovo ispitivanje interakcija provedeno je s dozom rilpivirina većom od preporučene zbog procjene maksimalnog učinka na istovremeno primijenjeni lijek.
Reproductive toxicology studies
Ispitivanja reproduktivne toksičnosti
At the lowest tested doses in the carcinogenicity studies, the systemic exposures (based on AUC) to rilpivirine were 21-fold (mice) and 3-fold (rats), relative to those observed in humans at the recommended dose (25 mg once daily).
Kod najnižih ispitivanih doza u ispitivanjima kancerogenosti, sustavna izloženost (na temelju AUC) rilpivirinu bila je 21 puta (miševi) i 3 puta (štakori) veća u odnosu na onu primijećenu u ljudi pri preporučenoj dozi (25 mg jedanput dnevno).
Trimester of pregnancy (n=15)
2. tromjesečje trudnoće (n=15)
From the week 96 pooled resistance analysis, the resistance outcome for patients with protocol defined virological failure, and paired genotypes (baseline and failure) is shown in table 5.
Na temelju analize objedinjenih podataka 96. tjedna, ishod rezistencije u bolesnika s protokolom definiranim virološkim neuspjehom i spareni genotipovi (početni i neuspjeh) prikazani su u tablici 5.
In the open label part of the trial, patients originally randomised to one of the three doses of rilpivirine were all treated with rilpivirine 25 mg once daily in addition to a BR, once the dose for the Phase III studies was selected.
U dijelu ispitivanja otvorenog tipa, svi bolesnici prvobitno randomizirani na jednu od tri doze rilpivirina bili su liječeni rilpivirinom u dozi od 25 mg jedanput dnevno uz osnovni režim, nakon što je odabrana doza za ispitivanja faze III.
Lactose monohydrate Hypromellose 2910 6 mPa.s Titanium dioxide E171 Macrogol 3000
Ovojnica tablete laktoza hidrat hipromeloza 2910 6 mPa.s titanijev dioksid (E171) makrogol 3000 triacetin
The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%).
Najčešće prijavljene nuspojave (≥ 2%) koje su bile namjanje umjerenog intenziteta bile su depresija (4,1%), glavobolja (3,5%), nesanica (3,5%), osip (2,3%) i bol u abdomenu (2,0%).
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
U mokraći je neizmijenjeni rilpivirin otkriven samo u tragovima (< 1% doze).
The combination of rilpivirine and antacids should be used with particular caution.
Kombinaciju rilpivirina i antacida treba primjenjivati s posebnim oprezom.
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Budući da je rilpivirin u visokom postotku vezan za proteine plazme, najvjerojatnije se neće moći značajno ukloniti hemodijalizom ili peritonejskom dijalizom (vidjeti dio 4.2).
rabeprazole - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John's wort (Hypericum perforatum).
rabeprazol - sustavni glukokortikoid deksametazon, osim kao liječenje jednokratnom dozom - gospina trava (Hypericum perforatum).
White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Bijela do gotovo bijela, okrugla, bikonveksna, filmom obložena tableta promjera 6,4 mm s utisnutom oznakom “TMC” na jednoj strani i brojem “25” na drugoj strani.
Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
U oba se ispitivanja opazila slična djelotvornost rilpivirina čime se pokazala njegova neinferiornost u odnosu na efavirenz.
Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Uzmite antacid ili najmanje 2 sata prije ili najmanje 4 sata poslije EDURANTA (pogledajte dio 2 “Drugi lijekovi i EDURANT”).
Resistance to rilpivirine % (n/N)
Rezistencija na rilpivirin % (n/N)
(reduced absorption due to gastric pH increase)
(smanjena apsorpcija zbog povišenog želučanog pH)
It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Pripada skupini lijekova protiv HIV-a koji se zovu nenukleozidni inhibitori reverzne transkriptaze (NNRTI).
Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
Populacijska farmakokinetička analiza rilpivirina u bolesnika zaraženih HIV-om pokazala je da rasa nema klinički značajan utjecaj na izloženost rilpivirinu.
For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.
U odraslih ispitanika koji prethodno nisu bili liječeni Kod analize rezistencije, primijenjena je šira definicija virološkog neuspjeha nego u primarnoj analizi djelotvornosti.
Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Uzimanje EDURANTA natašte ili samo s hranjivim napitkom može rezultirati smanjenim koncentracijama rilpivirina u plazmi, što potencijalno može smanjiti terapijski učinak EDURANTA (vidjeti dio 4.2).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
U bolesnika u kojih terapija rilpivirinom nije bila uspješna i koji su razvili rezistenciju na rilpivirin općenito je opažena križna rezistencija na druge odobrene NNRTI-jeve (etravirin, efavirenz, nevirapin).
300 mg once daily (+ 25 mg once daily rilpivirine)
300 mg jedanput dnevno (+ 25 mg rilpivirina jedanput dnevno)
EDURANT at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
EDURANT u preporučenoj dozi od 25 mg jedanput dnevno nije povezan s klinički značajnim učinkom na QTc.
In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P450 (CYP) 3A system.
In vitro ispitivanja pokazuju da se rilpivirin primarno oksidativno metabolizira putem sustava citokroma P450 (CYP) 3A.
No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Prilagodba doze se ne predlaže, ali se savjetuje oprez u bolesnika s umjerenim oštećenjem jetre.
In patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution.
U bolesnika s teškim oštećenjem bubrega ili u završnoj fazi bolesti bubrega, rilpivirin treba primjenjivati s oprezom.
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme započinjanja CART-a može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke patogene i prouzročiti ozbiljna klinička stanja ili pogoršanje simptoma.
The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Djelotvornost i sigurnost primjene rilpivirina u djece mlađe od 12 godina još nisu utvrđene.
The combination of rilpivirine and dabigatran etexilate should be used with caution.
Kombinaciju rilpivirina i dabigatran eteksilata treba primjenjivati s oprezom.
Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Tablica 6: Virološki ishodi u adolescentnih ispitanika u ispitivanju TMC278-C213 - analiza tjedna 48 i tjedna 240; ITT-TLOVR* Tjedan 48 N=36
Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).
Odabrani klinički laboratorijski poremećaji (3. ili 4. stupnja) koji su nastali tijekom liječenja i smatrani su nuspojavama, prijavljeni u bolesnika liječenih EDURANTOM bili su povišena amilaza gušterače (3,8%), povišen AST (2,3%), povišen ALT (1,6%), povišen LDL kolesterol (natašte, 1,5%), sniženi leukociti (1,2%), povišena lipaza (0,9%), povišen bilirubin (0,7%), povišeni trigliceridi (natašte, 0,6%), snižen hemoglobin (0,1%), snižen broj trombocita (0,1%), i povišen ukupan kolesterol (natašte,
In patients with severe renal impairment or end-stage renal disease, EDURANT should be used with caution, as plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
EDURANT treba primjenjivati s oprezom u bolesnika s teškim oštećenjem funkcije bubrega ili u završnoj fazi bubrežne bolesti, jer koncentracije u plazmi mogu biti povišene zbog promijenjene apsorpcije, distribucije i/ili metabolizma lijeka uslijed poremećaja funkcije bubrega.
In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see section 5.2).
U bolesnika s teškim oštećenjem bubrega ili u završnoj fazi bolesti bubrega, kombinacija rilpivirina s jakim inhibitorom CYP3A (npr. inhibitor proteaze HIV-a pojačan ritonavirom) smije se primijeniti samo ako korist nadilazi rizik (vidjeti dio 5.2).
The incidence of virologic failure was higher in the rilpivirine arm than the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
U 96. tjednu incidencija virološkog neuspjeha bila je viša u skupini liječenoj rilpivirinom nego u skupini liječenoj efavirenzom; međutim većina viroloških neuspjeha pojavila se tijekom prvih 48 tjedana liječenja.
EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C).
EDURANT nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
* Intent-to-treat time to loss of virologic response.
* Vrijeme do gubitka virološkog odgovora u populaciji s namjerom liječenja.
If you are taking any of the above, ask your doctor about alternatives.
Ako uzimate bilo koji od gore navedenih lijekova, upitajte liječnika za savjet.
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine.
Ovo ispitivanje interakcije provedeno je s dozom rilpivirina višom od preporučene.
OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
OSTALI LIJEKOVI ANTIEPILEPTICI Karbamazepin Okskarbazepin Fenobarbital Fenitoin
In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score 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.
U ispitivanju u kojem se 8 bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) uspoređivalo s 8 odgovarajućih kontrolnih ispitanika te 8 bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B) s 8 odgovarajućih kontrolnih ispitanika, izloženost višestrukim dozama rilpivirina bila je 47% viša u bolesnika s blagim oštećenjem jetre i 5% viša u bolesnika s umjerenim oštećenjem jetre.
Concomitant use of EDURANT with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine.
Istovremena primjena EDURANTA s azolskim antimikoticima može prouzročiti povećanje koncentracije rilpivirina u plazmi.
Within each frequency grouping, ADRs are presented in order of decreasing frequency.
Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema učestalosti.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja liječenja kombiniranom antiretrovirusnom terapijom (CART) može se pojaviti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
By baseline CD4 count (× 10
Prema početnom broju CD4 (× 10
(inhibition of CYP3A enzymes)
(inhibicija enzima CYP3A)
Of those patients who were responders at week 96, 74% of patients receiving rilpivirine remained with undetectable viral load (< 50 HIV-1 RNA copies/ml) at week 240 compared to 81% of patients receiving efavirenz.
Od onih bolesnika koji su imali odgovor u 96. tjednu, 74% bolesnika koji su primili rilpivirin i dalje je imalo nemjerljivo virusno opterećenje (< 50 HIV-1 RNK kopija/ml) u 240. tjednu u usporedbi s 81% bolesnika koji su primili efavirenz.
How to store EDURANT
Kako čuvati EDURANT
In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment.
U analizi objedinjenih podataka o rezistenciji iz 96. tjedna, tijekom drugih 48 tjedana uočene su niže stope virološkog neuspjeha u odnosu na prvih 48 tjedana liječenja.
EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
EDURANT je, u kombinaciji s drugim antiretrovirusnim lijekovima, indiciran za liječenje bolesnika u dobi od 12 godina i starijih zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i imaju virusno opterećenje ≤ 100 000 HIV-1 RNA kopija/ml.
EDURANT should be used with caution in patients with moderate hepatic impairment.
EDURANT treba primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre.
In the week 240 resistance analysis of the TMC278-C213 trial, rilpivirine resistance-associated mutations (RAMs) were observed in 46.7% (7/15) of subjects with virologic failure and post-baseline genotypic data.
U analizi podataka o rezistenciji iz 240. tjedna ispitivanja TMC278-C213, mutacije povezane s rezistencijom (RAM-ovi) na rilpivirin uočene su u 46,7% (7/15) ispitanika s virološkim neuspjehom i genotipskim podacima u razdoblju nakon početka ispitivanja.
6 cells/l in the rilpivirine arm and +219 × 10
6 stanica/l u skupini koja je primala rilpivirin i +219 × 10
Immune system disorders uncommon immune reactivation syndrome
Poremećaji imunološkog sustava manje često sindrom imunološke reaktivacije
Table 4 below shows the results of the week 48 and the week 96 efficacy analysis for patients treated with rilpivirine and patients treated with efavirenz from the pooled data from the ECHO and THRIVE trials.
Tablica 4 pokazuje rezultate analize djelotvornosti u 48. i 96. tjednu u bolesnika liječenih rilpivirinom i bolesnika liječenih efavirenzom na temelju objedinjenih podataka iz ispitivanja ECHO i THRIVE.
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Više je bolesnika koji su imali virološki neuspjeh uz rilpivirin razvilo rezistenciju povezanu s lamivudinom/emtricitabinom nego onih koji su imali virološki neuspjeh uz efavirenz (vidjeti dio 5.1).
EDURANT must be taken with a meal (see section 5.2).
EDURANT se mora uzimati uz obrok (vidjeti dio 5.2).
After single dose oral administration of
Nakon peroralne primjene jedne doze
AZOLE ANTIFUNGAL AGENTS Ketoconazole*
AZOLNI ANTIMIKOTICI Ketokonazol*
The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
Ovojnica filmom obložene tablete sadrži laktozu hidrat, hipromelozu 2910 6 mPa.s, titanijev dioksid (E171), makrogol 3000 i triacetin.
In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
U bolesnika s početnim virusnim opterećenjem < 100 000 kopija/ml, 9 od 27 bolesnika s virološkim neuspjehom na rilpivirin, tijekom liječenja pojavila se rezistencija na rilpivirin (genotipska analiza), uz sljedeću učestalost fenotipske križne rezistencije: etravirin 4/9, efavirenz 3/9 i nevirapin 1/9.
No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
U ispitivanjima na životinjama nisu opaženi klinički važni učinci na plodnost (vidjeti dio 5.3).
Hepatitis B and/or hepatitis C virus co-infection
Istovremena infekcija virusom hepatitisa B i/ili C
Take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
H2-receptora najmanje 12 sati prije ili najmanje 4 sata poslije EDURANTA (pogledajte dio 2 “Drugi lijekovi i EDURANT”).
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
U nekih bolesnika s uznapredovalom HIV-infekcijom i oportunističkom infekcijom u povijesti bolesti, ubrzo nakon početka liječenja HIV-a mogu se pojaviti znakovi i simptomi upale prethodnih infekcija.
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 non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Bolesnici s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml koji su imali virološki neuspjeh pokazali su veću stopu rezistencije koja se pojavila uz liječenje na klasu nenukleozidnih inhibitora reverzne transkriptaze (NNRTI).
BR=background regimen N=number of subjects
BR = prateće liječenje N = broj ispitanika
The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Farmakokinetička izloženost rilpivirinu u bolesnika s istovremenom infekcijom bila je usporediva s onom u bolesnika bez istovremene infekcije.
The recommended dose of EDURANT is one 25 mg tablet taken once daily.
Preporučena doza EDURANTA je jedna tableta od 25 mg koja se uzima jedanput dnevno.
PROTON PUMP INHIBITORS Omeprazole*
INHIBITORI PROTONSKE PUMPE Omeprazol*
(induction of CYP3A enzymes)
(indukcija enzima CYP3A)
Concomitant use of rilpivirine with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Istovremena primjena rilpivirina s inhibitorima proteaze pojačanima ritonavirom uzrokuje povećanje koncentracije rilpivirina u plazmi, ali prilagodba doze nije potrebna.
If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal.
Ako bolesnik povraća unutar 4 sata od uzimanja lijeka, treba uzeti drugu tabletu EDURANTA uz obrok.
ANTACIDS Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Antacidi (npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat)