natgillin/translations-raw huggingface dataset:
Postpartum (6-12 Weeks) (n=11)
Postpartalno (6-12 tjedana) (n=11)
Other medicines and EDURANT
Drugi lijekovi i EDURANT
Resistance was defined as the emergence of any resistance-associated mutation at failure.
Rezistencija je bila definirana kao pojava bilo kakve mutacije povezane s rezistencijom kod neuspjeha.
Even if you feel better, do not stop taking EDURANT or your other HIV medicines.
Čak i ako se osjećate bolje, nemojte prestati uzimati EDURANT ili druge lijekove protiv HIV-a.
All other drug-drug interactions shown are predicted.
Sve druge prikazane interakcije su predviđene.
No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
Nije se pojavio niti jedan prijenos s majke na dijete kod svih 10 novorođenčadi koju su rodile majke koje su završile ispitivanje i čiji je HIV status bio dostupan.
Virologic failure and development of resistance
Virološki neuspjeh i razvoj rezistencije
- Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C, and/or problems with your kidneys.
- Obavijestite liječnika ako imate ili ste imali probleme s jetrom, uključujući hepatitis B i/ili C, i/ili probleme s bubrezima.
Your doctor will discuss with you which combination of medicines is best for you.
Liječnik će razgovarati s Vama o kombinaciji lijekova koja je najbolja za Vas.
When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Kada se EDURANT uzimao samo s hranjivim proteinskim napitkom, izloženost je bila 50% niža nego kad se uzimao s obrokom.
EDURANT has only been used in a limited number of patients of 65 years or older.
EDURANT je bio ispitivan samo u ograničenog broja bolesnika u dobi od 65 godina ili starijih.
As a precautionary measure, it is preferable to avoid the use of EDURANT during pregnancy.
Kao mjera opreza, preporučuje se izbjegavati primjenu EDURANTA tijekom trudnoće.
Then take the next dose as usual.
Sljedeću dozu uzmite u uobičajeno vrijeme.
Your doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best.
Liječnik će Vam savjetovati koji se lijekovi protiv HIV-a mogu kombinirati s EDURANTOM i zajedno ćete odlučiti koja kombinacija najviše odgovara Vašim potrebama.
EDURANT has no or negligible influence on the ability to drive and use machines.
EDURANT ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Do not stop using EDURANT without talking to your doctor first.
Nemojte prestati uzimati EDURANT a da prethodno o tome niste razgovarali sa svojim liječnikom.
Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Datum posljednje obnove odobrenja: 22. srpnja 2016.
Paediatric population (12 to less than 18 years of age)
Pedijatrijska populacija (u dobi od 12 do manje od 18 godina)
Each carton contains one bottle of 30 tablets.
Jedna kutija sadrži jednu bocu s 30 tableta.
What EDURANT is and what it is used for What you need to know before you take EDURANT How to take EDURANT
Što je EDURANT i za što se koristi Što morate znati prije nego počnete uzimati EDURANT Kako uzimati EDURANT
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100).
Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Važne informacije o nekim sastojcima lijeka EDURANT EDURANT sadrži laktozu.
Interaction table Interaction studies have only been performed in adults.
Tablica interakcija Ispitivanja interakcija provedena su samo u odraslih.
It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Vjeruje se da ti simptomi nastaju zbog poboljšanog imunološkog odgovora organizma, što tijelu omogućuje da se bori protiv infekcija koje su mogle biti prisutne i bez vidljivih simptoma.
Rilpivirine is primarily metabolised and eliminated by the liver.
Rilpivirin se primarno metabolizira i eliminira putem jetre.
The terminal elimination half-life of rilpivirine is approximately 45 hours.
Terminalno poluvrijeme eliminacije rilpivirina iznosi približno 45 sati.
HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via breast milk.
Majke zaražene HIV-om ne smiju dojiti, jer postoji mogućnost da se dijete zarazi HIV-om putem majčinog mlijeka.
EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
EDURANT nije namijenjen za djecu mlađu od 12 godina, zato što nije dovoljno ispitan u tih bolesnika.
Recombinant clinical isolates
Rekombinantni klinički izolati
Rilpivirine was well tolerated during pregnancy and postpartum.
Rilpivirin se dobro podnosio tijekom trudnoće i postpartalno.
60-100 mg once daily, individualised dose
60-100 mg jedanput dnevno, individualizirana doza
The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Do supstitucije E138K došlo je najčešće tijekom liječenja rilpivirinom, obično u kombinaciji s M184I supstitucijom.
MACROLIDE ANTIBIOTICS Clarithromycin
MAKROLIDNI ANTIBIOTICI Klaritromicin
- Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats).
- Odmah obavijestite svog liječnika ako primijetite bilo kakve simptome infekcije (na primjer vrućicu, zimicu, znojenje).
It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.
Filmom obloženu tabletu preporučuje se progutati cijelu s vodom, bez žvakanja ili drobljenja.
Cimetidine Nizatidine Ranitidine
Cimetidin Nizatidin Ranitidin
If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.
Ako uzimate didanozin (lijek za liječenje HIV infekcije), nije potrebna prilagodba doze.
In dogs, cholestasis-like effects were noted.
U pasa su zabilježeni učinci slični kolestazi.
The trials were identical in design, with the exception of the background regimen (BR).
Ispitivanja su imala identičan dizajn, uz izuzetak pratećeg liječenja (BR engl. background regimen).
A meal is important to get the right levels of active substance in your body.
Obrok je važan zato da bi se dobile potrebne koncentracije djelatne tvari u Vašem tijelu.
The most common mutations were the same in the week 48 and week 96 analyses.
Najčešće mutacije bile su iste kod analiza u 48. i 96. tjednu.
Instructions for proper use in adults and adolescents (12 to less than 18 years of age) The recommended dose of EDURANT is one tablet once a day.
Upute za pravilnu primjenu u odraslih i adolescenata (u dobi od 12 do manje od 18 godina) Preporučena doza EDURANTA je jedna tableta jedanput dnevno.
N=number of subjects per treatment group; ND=not determined.
N = broj ispitanika u terapijskoj skupini; NO = nije određeno.
Make sure that you check the following points and tell your doctor if any of these apply to you.
Svakako provjerite sljedeće napomene i obavijestite liječnika ako se bilo koja odnosi na Vas.
This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.
Ova analiza uključivala je 36 bolesnika koji su završili najmanje 48 tjedana liječenja ili su ranije prekinuli liječenje.
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Ako primijetite bilo koji simptom infekcije ili druge simptome poput mišićne slabosti, slabosti koja počinje u šakama i stopalima te se širi gore prema trupu tijela, lupanja srca, tremora ili hiperaktivnosti, molimo Vas odmah obavijestite liječnika kako biste zatražili potrebno liječenje.
Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
Liječenje predoziranja rilpivirinom sastoji se od općih potpornih mjera koje uključuju nadzor vitalnih znakova i EKG-a (QT interval), kao i praćenje kliničkog stanja bolesnika.
Alternatively, switching to another ART regimen could be considered.
Alternativno se može uzeti u obzir prijelaz na drugi antiretrovirusni režim.
Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Neki lijekovi mogu utjecati na razinu EDURANTA u krvi kad se uzimaju istovremeno s EDURANTOM.
What you need to know before you take EDURANT
Što morate znati prije nego počnete uzimati EDURANT
Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
Liječnik može procijeniti težinu bolesti jetre ili bubrega prije nego što odluči možete li uzimati EDURANT.
Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati EDURANT ako ste alergični na rilpivirin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Potvrđene i teorijske interakcije s odabranim antiretrovirusnim i neantiretrovirusnim lijekovima navedene su u tablici 1.
Pregnant women should discuss the use of EDURANT with their doctor.
Trudnice trebaju razgovarati o primjeni lijeka EDURANT sa svojim liječnikom.
CCR5 Antagonists Maraviroc
Antagonisti receptora CCR5 Maravirok
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Nakon peroralne primjene, maksimalne koncentracije rilpivirina u plazmi najčešće su dostignute u roku od 4 do 5 sati.
The virologic response was generally preserved throughout the study: of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed only postpartum, for at least 1 subject due to suspected suboptimal adherence.
Virološki odgovor općenito je bio očuvan tijekom ispitivanja: od 12 ispitanica koje su završile ispitivanje, u 10 ispitanica postojala je supresija na kraju ispitivanja; u preostale 2 ispitanice porast virusnog opterećenja bio je uočen samo postpartalno, za najmanje 1 ispitanicu radi suspektne suboptimalne adherencije.
The absolute bioavailability of EDURANT is unknown.
Nije poznata apsolutna biološka raspoloživost EDURANTA.
The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Distribucija rilpivirina u druge odjeljke osim plazme (npr. cerebrospinalni likvor, sekrete genitalnog trakta) nije se procjenjivala u ljudi.
Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Alternativno se može uzeti u obzir prijelaz na drugi antiretrovirusni režim (vidjeti dijelove 4.4, 4.6, 5.1 i 5.2).
There is no specific antidote for overdose with EDURANT.
Ne postoji specifični antidot za predoziranje EDURANTOM.
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Nije bilo prijavljenih odstupanja u laboratorijskim nalazima za AST/ALT stupnja 3-4 niti nuspojava povišenja transaminaza stupnja 3-4.
N=number of subjects per treatment group.
N=broj ispitanika po liječenoj skupini.
Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Približno se 99,7% rilpivirina veže za proteine plazme in vitro, prvenstveno za albumin.
A nutritional drink (e.g. protein-rich) alone does not replace a meal.
Hranjivi napitak (npr. proteinski napitak) ukoliko se uzima sam, ne može zamijeniti obrok.
However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Međutim, preporučuje se kliničko praćenje, jer u nekih bolesnika može biti potrebno prilagoditi terapiju održavanja metadonom.
Other Antiviral Agents Ribavirin
Ostali antivirotici Ribavirin
Warnings and precautions Talk to your doctor or pharmacist before taking EDURANT.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete EDURANT.
EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
EDURANT sadrži rilpivirin koji se koristi za liječenje infekcije virusom humane imunodeficijencije (HIV).
Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Ispitivanjima na životinjama nije dokazana važna embrionalna ili fetalna toksičnost ni utjecaj na reproduktivnu funkciju.
Tell your doctor if you take: - rifabutin (a medicine to treat some bacterial infections).
Obavijestite svog liječnika ako uzimate: - rifabutin (lijek za liječenje nekih bakterijskih infekcija).
Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT.
Nemojte upravljati vozilima niti raditi sa strojevima ako osjećate umor, omaglicu ili pospanost dok uzimate EDURANT.
Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Samo adolescenati za koje je procijenjeno da se vjerojatno dobro pridržavaju režima antiretrovirusnog liječenja smiju biti liječeni rilpivirinom, budući da suboptimalno pridržavanje može dovesti do razvoja rezistencije i gubitka budućih mogućnosti liječenja.
The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus (HIV-1) infection (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja rilpivirina u jednoj ili više podskupina pedijatrijske populacije u liječenju infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
- Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
- Recite svom liječniku ako uzimate bilo koji lijek koji može uzrokovati nepravilne otkucaje srca potencijalno opasne za život (Torsade de Pointes).
EDURANT works by reducing the amount of HIV in your body.
EDURANT djeluje tako što smanjuje količinu virusa HIV-a u Vašem tijelu.
EDURANT must be taken with a meal to obtain optimal absorption.
EDURANT se mora uzimati uz obrok da bi se dobila optimalna apsorpcija.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Daljnje zbrinjavanje treba provoditi sukladno kliničkoj indikaciji ili preporukama nacionalnog centra za kontrolu otrovanja, ako on postoji.
In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
U ispitivanjima prisutnost mutacija V90I i V189I na početku nije utjecala na odgovor.
In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
U ovih bolesnika, zabilježena je slijedeća fenotipska križna rezistencija na druge NNRTI: etravirin 32/42, efavirenz 30/42 i nevirapin 16/42.
H2-receptor antagonists should not be taken in a twice a day regimen.
Antagonisti H2-receptora ne smiju se uzimati dva puta dnevno.
The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.
Medijan dobi 36 ispitanika bio je 14,5 godina (raspon: 12 do 17 godina), 55,6% ispitanika bilo je ženskog spola, 88,9% crne rase i 11,1% azijatske rase.
common decreased appetite increased triglycerides (fasted)
često smanjen apetit povišeni trigliceridi (natašte)
Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
Farmakoterapijska skupina: antivirusni lijekovi za sustavnu primjenu, nenukleozidni inhibitori reverzne transkriptaze, ATK oznaka: J05AG05.
EDURANT should be used with caution in this population (see section 4.2).
EDURANT treba primjenjivati s oprezom u ovoj populaciji (vidjeti dio 4.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Najčešće ozbiljne nuspojave povezane s liječenjem bile su prijavljene u 7 (1,0%) bolesnika koju su primali rilpivirin.
One subject discontinued due to an adverse event at week 48, and no additional subjects discontinued due to adverse events in the week 240 analysis.
Jedan ispitanik prekinuo je liječenje u 48. tjednu zbog štetnog događaja, a niti jedan dodatni ispitanik nije prekinuo liječenje zbog štetnog događaja tijekom analize u trajanju od 240 tjedana.
6 cells/l in patients receiving efavirenz.
6 stanica/l u bolesnika koji su primali efavirenz.
A bottle with child resistant closure containing 30 film-coated tablets.
Boca sa sigurnosnim zatvaračem za djecu sadrži 30 filmom obloženih tableta.
The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines.
Učinci EDURANTA ili drugih lijekova mogu se promijeniti ako uzimate EDURANT zajedno s nekim od niže navedenih lijekova.
HIV treatment does not cure HIV infection!
Liječenje HIV-a neće izliječiti HIV infekciju!
The ADRs are listed by system organ class (SOC) and frequency.
Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i učestalosti.
It can be opened by pushing the screw cap down while turning it anti-clockwise.
Može se otvoriti tako da zatvarač s navojem pritisnete prema dolje, dok ga okrećete u smjeru suprotnom od kazaljke na satu.
e.g. lost to follow-up, non-compliance, withdrew consent.
Npr. izgubljeni iz praćenja, nepridržavanje terapije, povlačenje pristanka.
There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Nije bilo novih sigurnosnih nalaza u usporedbi s poznatim sigurnosnim profilom rilpivirina u odraslih zaraženih HIVom-1 (vidjeti dijelove 4.2, 4.4 i 5.2).
Therapy should be initiated by a physician experienced in the management of HIV infection.
Liječenje treba započeti liječnik s iskustvom u liječenju HIV-infekcije.
There were no patients who discontinued treatment due to ADRs.
Nije bilo bolesnika koji su prekinuli liječenje zbog nuspojava.
The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Supstitucija K103N sama po sebi nije dovela do gubitka osjetljivosti na rilpivirin, ali je kombinacija K103N i L100I dovela do 7-strukog gubitka osjetljivosti na rilpivirin.
Rilpivirine + BR N=686
Rilpivirin + BR N = 686
Do not stop using EDURANT
Nemojte prestati uzimati EDURANT
EDURANT contains lactose
EDURANT sadrži laktozu
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Farmakokinetički podaci pokazuju da je ukupna izloženost (AUC) rilpivirinu kao dijelu antiretrovirusnog režima bila otprilike 30% niža tijekom trudnoće u usporedbi s postpartalnim razdobljem (6-12 tjedana).
Fluconazole Itraconazole Posaconazole Voriconazole
Flukonazol Itrakonazol Posakonazol Vorikonazol
HMG CO-A REDUCTASE INHIBITORS Atorvastatin*
INHIBITORI HMG KO-A REDUKTAZE Atorvastatin*
Findings in adolescents (12 to less than 18 years of age) in trial TMC278-C213 were generally in line with these data (for details see section 5.1).
Nalazi u adolescenata (u dobi od 12 do manje od 18 godina) u ispitivanju TMC278-C213 su općenito bili u skladu s tim podacima (za detalje vidjeti dio 5.1).
The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal).
Izloženost rilpivirinu bila je približno 40% niža kad se EDURANT uzimao natašte nego kad se uzimao uz obrok normalne kalorijske vrijednosti (533 kcal) ili visokokalorični obrok bogat mastima (928 kcal).
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
Međutim, ne može se potpuno isključiti da rilpivirin može povećati izloženost drugim lijekovima koje transportira P-glikoprotein, a koji su osjetljiviji na intestinalnu P-gp inhibiciju, npr. dabigatran eteksilat.
Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM).
Rilpivirin inhibira P-glikoprotein in vitro (IC50 je 9,2 μM).
It is not recommended to co-administer rilpivirine with other NNRTIs.
Ne preporučuje se istovremena primjena rilpivirina s drugim NNRTI-jima.
Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range])
Farmakokinetika ukupnog rilpivirina (srednja vrijednost ± SD, tmax: medijan [raspon])
Talk to your doctor or pharmacist if you are not sure.
Razgovarajte sa svojim liječnikom ili ljekarnikom ako niste sigurni.
This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier.
Ova je analiza uključila 690 bolesnika iz ispitivanja ECHO i 678 bolesnika iz ispitivanja THRIVE koji su završili 96 tjedana liječenja ili su ga prekinuli ranije.
In the Phase III studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
U ispitivanjima faze III, niže izloženosti riplivirinu, slične onima viđenima tijekom trudnoće, bile su povezane s povećanim rizikom od virološkog neuspjeha, stoga je virusno opterećenje potrebno pažljivo nadzirati (vidjeti dijelove 4.6, 5.1 i 5.2).
Response (confirmed < 50 HIV-1 RNA copies/ml)
S odgovorom (potvrđeno < 50 HIV-1 RNA kopija/ml)
In rats, there were no drug-related neoplasms.
U štakora nije bilo novotvorina povezanih s lijekom.
Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth
Česte: - abnormalni snovi - osip - bol u želucu - depresija - umor - povraćanje - omamljenost - smanjen apetit - poremećaj spavanja - nelagoda u želucu
Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Izloženost rilpivirinu općenito je bila niža u bolesnika zaraženih virusom HIV-1 nego u zdravih ispitanika.
Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams.
Simptomi predoziranja mogu uključivati glavobolju, mučninu, omaglicu i/ili abnormalne snove.
No human data on the effect of rilpivirine on fertility are available.
Nema dostupnih podataka o učinku rilpivirina na plodnost u ljudi.
The observed hepatocellular findings in mice may be rodent-specific.
Opaženi hepatocelularni nalazi u miševa mogu biti specifični za glodavce.
The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%).
Najčešće nuspojave (svih stupnjeva, veće ili jednake 10%) bile su glavobolja (19,4%), depresija (19,4%), somnolencija (13,9%), i mučnina (11,1%).