FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study A/PK 02-P013, skin reactions were assessed in compliance with existing guidance on single dermal tolerance tests (CPMP/SWP/2145/00) and were rated negligible to slightly irritant for both test item and reference patch.
Slovenian: V študiji A/PK 02-P013 so kožne reakcije vrednotili skladno z obstoječimi smernicami o posamičnih preskusih kožne tolerance (CPMP/SWP/2145/00).
English: The RMS considered it to be reasonable and ethical to assess skin tolerability of opioid containing transdermal patches as part of comparative bioavailability studies.
Slovenian: Referenčna država članica je menila, da je razumno in etično vrednotiti kožno toleranco transdermalnih obližov z opioidom v okviru primerjalnih študij biološke enakovrednosti.
English: The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Slovenian: Zadržek je bil napoten na Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila za uporabo v humani medicini CMD(h) in referenčna država članica je izvedla vrednotenje.
English: Performing this model, statistically significant differences were found between treatments in both studies (the single dose study and the multiple dose study), and the point estimate of the odds ratio was 8.35 in the single dose study and 1.45 in the multiple dose study.
Slovenian: Točkovna ocena razmerja verjetnosti je bila 8,35 v študiji z enim odmerkom in 1,45 v študiji z več odmerki.
English: Following the approach of Kuss (Kuss O: How to use SAS for logistic regression with correlated data.
Slovenian: Predlagatelj je znova izračunal logistični mešani model s postopkom SAS NLMIXED (SAS, različica 9.1.3) s Kussovim pristopom (Kuss O: How to use SAS for logistic regression with correlated data.
English: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif
Slovenian: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster
English: They shall ensure that Glybera is only supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Slovenian: Zagotovile bodo, da se bo zdravilo Glybera dostavilo samo, če so zdravstveni delavci, vključeni v zdravljenje bolnika, prejeli izobraževalni komplet in če zdravnik, ki zdravilo predpiše, potrdi, da se bolnik strinja s sodelovanjem v registru.
English: The Member States shall agree the details of a restricted access programme and a disease registry with the MAH.
Slovenian: Države članice se bodo o podrobnostih programa z omejenim dostopom in registra bolezni dogovorile z imetnikom dovoljenja za promet z zdravilom.
English: There are four situations that require special attention:
Slovenian: Posebna pozornost je potrebna v štirih primerih:
English: Follow your doctor's instruction carefully.
Slovenian: Skrbno upoštevajte zdravnikova navodila.
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Slovenian: Datum prve odobritve: 28. november 2011 Datum zadnjega podaljšanja: 22. julij 2016
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Slovenian: Takšne reakcije so običajno opažali v prvih tednih ali mesecih po začetku CART.
English: Talk to your doctor first.
Slovenian: Najprej se pogovorite z zdravnikom.
English: The median duration of exposure for patients was 63.5 weeks.
Slovenian: Mediano trajanje izpostavljenosti bolnikov je bilo 63,5 tednov.
English: Observed difference (95% CI)
Slovenian: opažena razlika (95% IZ)
English: EDURANT has no or negligible influence on the ability to drive and use machines.
Slovenian: EDURANT nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Week 240 N=32
Slovenian: 240. teden n=32
English: - 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.
Slovenian: - Zdravniku povejte, če imate ali ste imeli težave z jetri, med drugim hepatitis B in/ali C in/ali težave z ledvicami.
English: In dogs, cholestasis-like effects were noted.
Slovenian: Pri psih so opazili holestazi podobne učinke.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Slovenian: Najpogostejše mutacije so bile enake po 48 in 96 tedenski analizi podatkov.
English: What EDURANT is and what it is used for
Slovenian: Kaj je zdravilo EDURANT in za kaj ga uporabljamo
English: 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.
Slovenian: Navodila za pravilno uporabo pri odraslih in mladostnikih (starih od 12 do manj kot 18 let) Priporočeni odmerek zdravila EDURANT je ena tableta enkrat na dan.
English: Recombinant clinical isolates
Slovenian: Rekombinantni klinični izolati
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Vse vnetne simptome je treba ovrednotiti in po potrebi uvesti ustrezno zdravljenje.
English: Effect of food on absorption
Slovenian: Vpliv hrane na absorpcijo zdravila
English: Alternatives should be considered, particularly for long-term use.
Slovenian: Zlasti za dolgotrajno uporabo je treba razmisliti o uporabi drugih učinkovin.
English: Paediatric population (less than 18 years of age)
Slovenian: Pediatrična populacija (mlajša od 18 let)
English: Where possible, alternatives such as azithromycin should be considered.
Slovenian: Če je le mogoče, je treba pretehtati možnost uporabe drugih zdravil, na primer azitromicina.
English: It is part of a treatment reducing the amount of virus in the blood.
Slovenian: Zdravilo sodeluje pri zmanjševanju količine virusa v krvi.
English: Even if you feel better, do not stop taking EDURANT or your other HIV medicines.
Slovenian: Tudi če se počutite bolje, ne prenehajte jemati niti zdravila EDURANT niti katerega od drugih zdravil proti okužbi s HIV.
English: Tell your doctor if you take: - rifabutin (a medicine to treat some bacterial infections).
Slovenian: Povejte zdravniku, če jemljete: - rifabutin (zdravilo za zdravljenje nekaterih bakterijskih okužb).
English: Death
Slovenian: smrt
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Slovenian: Končni razpolovni čas rilpivirina je približno 45 ur.
English: 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.
Slovenian: Zdravljenje prevelikega odmerjanja z rilpivirinom predstavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov in EKG (QT intervala) ter z opazovanjem kliničnega stanja bolnika.
English: This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.
Slovenian: V analizo je bilo vključenih 36 bolnikov, ki so zaključili vsaj 48 tednov zdravljenja ali so z zdravljenjem zaključili prej.
English: No new ADRs were identified compared to those seen in adults.
Slovenian: Novih neželenih učinkov, v primerjavi s tistimi, ki so jih opazili pri odraslih, niso ugotovili.
English: Do not stop using EDURANT without talking to your doctor first.
Slovenian: Ne prenehajte jemati zdravila EDURANT, ne da bi se prej posvetovali z zdravnikom.
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE-5) sildenafil*
English: The absolute bioavailability of EDURANT is unknown.
Slovenian: Absolutna biološka uporabnost zdravila EDURANT ni znana.
English: Edurant should be used during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Zdravilo EDURANT se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
English: Paediatric population (12 to less than 18 years of age)
Slovenian: Pediatrična populacija (od 12 do manj kot 18 let starosti)
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Slovenian: Rilpivirin se in vitro v približno 99,7% veže na proteine v plazmi, predvsem na albumine.
English: A nutritional drink (e.g. protein-rich) alone does not replace a meal.
Slovenian: Samo hranljiv napitek (na primer proteinski napitek) ne nadomesti obroka.
English: Resistance was defined as the emergence of any resistance-associated mutation at failure.
Slovenian: Odpornost je bila določena kot pojav katere koli z odpornostjo povezane mutacije ob neuspešnosti zdravljenja.
English: 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.
Slovenian: Tako zaradi možnosti prenosa HIV kot tudi zaradi možnosti neželenih reakcij pri dojenih otrocih je treba materam naročiti, naj ne dojijo, če prejemajo rilpivirin.
English: If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.
Slovenian: Če jemljete didanozin (zdravilo za zdravljenje okužbe s HIV), prilagajanje odmerkov ni potrebno.
English: 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.
Slovenian: Domnevajo, da do tovrstnih simptomov pride zaradi hitrega izboljšanja imunskega odziva telesa, ki telesu omogoča, da se spopade z okužbami, ki so bile prej prisotne brez očitnih simptomov.
English: Your doctor will discuss with you which combination of medicines is best for you.
Slovenian: Zdravnik vam bo pojasnil, katera kombinacija zdravil je za vas najboljša.
English: - Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
Slovenian: - Zdravniku povejte, če jemljete katerokoli zdravilo, ki lahko povzroči življenjsko nevarne motnje srčnega ritma (torsade de pointes)
English: CCR5 Antagonists Maraviroc
Slovenian: antagonisti receptorjev CCR5 maravirok
English: 60-100 mg once daily, individualised dose
Slovenian: 60-100 mg enkrat na dan, odmerek prilagojen posamezniku
English: HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via breast milk.
Slovenian: Matere, ki so okužene s HIV, ne smejo dojiti, saj bi z mlekom lahko okužile otroka.
English: Each carton contains one bottle of 30 tablets.
Slovenian: Ena škatla vsebuje en vsebnik s 30 tabletami.
English: It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.
Slovenian: Priporočeno je, da bolnik filmsko obloženo tableto pogoltne celo z vodo, tablet ne sme žvečiti ali zdrobiti.
English: Postpartum (6-12 Weeks) (n=11)
Slovenian: obdobje po porodu (6-12 tednov) (n=11)
English: 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.
Slovenian: 36 preiskovancev je imelo mediano starost 14,5 let (od 12 do 17 let), 55,6% je bilo žensk, 88,9% črncev in 11,1% preiskovancev je bilo azijskega porekla.
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Slovenian: V študijah prisotnost mutacij V90I in V189I ob izhodišču ni vplivala na odziv.
English: EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
Slovenian: Zdravilo EDURANT ni primerno za otroke, mlajše od 12 let, saj uporaba zdravila pri tej populaciji ni zadostno preučena.
English: Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila EDURANT - če ste alergični na rilpivirin ali katero koli sestavino tega zdravila (navedeno poglavju 6).
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Slovenian: Med zdravljenjem z rilpivirinom je najpogosteje odkrita substitucija E138K, pogosto v kombinaciji s substitucijo M184I.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Medicinal products that affect rilpivirine exposure
Slovenian: Zdravila, ki vplivajo na izpostavljenost rilpivirinu
English: NARCOTIC ANALGESICS Methadone*
Slovenian: NARKOTIČNI ANALGETIKI metadon*
English: 6 cells/l (range: 25 to 983 × 10
Slovenian: 6 celic/l (razpon: 25 do 983 x 10
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range (18 to 78 years) evaluated, with only 3 subjects aged 65 years or older.
Slovenian: Rezultati analize populacijske farmakokinetike pri bolnikih, okuženih s HIV, kažejo, da se farmakokinetične lastnosti rilpivirina ne razlikujejo po starostnih skupinah (od 18 do 78 let), ki so jih ocenjevali, pri čemer so bili samo 3 bolniki stari 65 let ali več.
English: EDURANT has only been used in a limited number of patients of 65 years or older.
Slovenian: Zdravilo EDURANT je uporabljalo le malo bolnikov, ki so bili stari 65 let ali več.
English: Virologic failure and development of resistance
Slovenian: Virološki neuspeh zdravljenja in razvoj odpornosti na zdravljenje
English: All other drug-drug interactions shown are predicted.
Slovenian: Vse druge prikazane interakcije med posameznimi zdravili so ocenjene s predvidevanjem.
English: MACROLIDE ANTIBIOTICS Clarithromycin
Slovenian: MAKROLIDNI ANTIBIOTIKI klaritromicin eritromicin
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin*
Slovenian: ZAVIRALCI HMG CO-A REDUKTAZE atorvastatin*
English: 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).
Slovenian: Ugotovitve pri mladostnikih (starih od 12 do manj kot 18 let) v preskušanju TMC278-C213 so bile v splošnem skladne s temi podatki (za podrobne informacije glejte poglavje 5.1)
English: What EDURANT is and what it is used for What you need to know before you take EDURANT How to take EDURANT
Slovenian: Kaj je zdravilo EDURANT in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo EDURANT Kako jemati zdravilo EDURANT Možni neželeni učinki
English: The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Slovenian: Najpogostejši resni, z zdravljenjem povezani neželeni učinki so bili poročani pri 7 (1,0%) bolnikih, ki so prejemali rilpivirin.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Slovenian: Porazdelitve rilpivirina v druge razdelke izven plazme (na primer v cerebrospinalno tekočino ali v izločke genitalnega trakta) pri ljudeh niso ovrednotili.
English: Most ADRs were Grade 1 or 2.
Slovenian: Največ neželenih učinkov je bilo 1. ali 2. stopnje.
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Slovenian: Na voljo je le malo podatkov o možnosti za farmakodinamsko medsebojno delovanje med rilpivirinom in zdravili, ki podaljšujejo interval QTc na EKG.
English: Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Slovenian: Alternativno pa se lahko razmisli tudi o zamenjavi protiretrovirusnega zdravljenja (glejte poglavja 4.4, 4.6, 5.1 in 5.2).
English: Rilpivirine was well tolerated during pregnancy and postpartum.
Slovenian: Rilpivirin je bil med nosečnostjo in po porodu dobro prenosljiv.
English: Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
Slovenian: Med nosečnostjo so opazili manjšo izpostavljenost rilpivirinu, zato je treba virusno breme skrbno spremljati.
English: EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Slovenian: Zdravila EDURANT niso preskušali pri bolnikih s predhodnim virološkim neuspehom na katero drugo protiretrovirusno zdravljenje.
English: In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
Slovenian: Pri teh bolnikih so opazili naslednjo fenotipsko navzkrižno rezistenco na druge NNRTI: na etravirin 32/42, na efavirenz 30/42 in na nevirapin 16/42.
English: What you need to know before you take EDURANT
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo EDURANT
English: When you stop taking rifabutin, take one tablet of EDURANT once a day.
Slovenian: Ko prenehate jemati rifabutin, vzemite eno tableto zdravila EDURANT enkrat na dan.
English: 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.
Slovenian: Kljub temu ne moremo povsem izključiti možnosti, da rilpivirin lahko zveča izpostavljenost drugim učinkovinam, ki jih prenaša P-glikoprotein in so bolj občutljive na zaviranje črevesnega P-gp, npr. dabigatran eteksilat.
English: The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.
Slovenian: Farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, mlajših od 12 let, še raziskujejo.
English: 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.
Slovenian: Sama substitucija K103N ni povzročila zmanjšane občutljivosti na rilpivirin, kombinacija K103N in L100I pa je vodila v 7-kratno zmanjšanje občutljivosti na rilpivirin.
English: Other medicines and EDURANT
Slovenian: Druga zdravila in zdravilo EDURANT
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Slovenian: Uporabljajo se lahko samo antagonisti H2-receptorjev, ki se lahko odmerjajo enkrat na dan.
English: EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Slovenian: EDURANT vsebuje rilpivirin, ki ga uporabljamo za zdravljenje okužbe s humanim virusom imunske pomanjkljivosti (HIV - Human Immunodeficiency Virus).
English: Rilpivirine is excreted in the milk of rats.
Slovenian: Rilpivirin se izloča v mleko pri podganah.
English: When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Slovenian: Pri zaužitju zdravila EDURANT samo s hranljivo pijačo z visoko vsebnostjo proteinov je izpostavljenost za 50% manjša kot pri zaužitju zdravila skupaj z obrokom.
English: Then take the next dose as usual.
Slovenian: Naslednji odmerek nato vzemite po običajnem razporedu.
English: * The interaction between rilpivirine and the medicinal product was evaluated in a clinical study.
Slovenian: Medsebojno delovanje med rilpivirinom in tem zdravilom so ocenjevali v klinični študiji.
English: Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Slovenian: Nekatera zdravila lahko vplivajo na koncentracijo zdravila EDURANT v krvi, če jih jemljete sočasno z zdravilom EDURANT.
English: Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Slovenian: Pomembni podatki o sestavinah zdravila EDURANT Zdravilo EDURANT vsebuje laktozo.
English: 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.
Slovenian: Virološki odziv se je v študiji v glavnem ohranil ves čas zdravljenja: med 12 preiskovankami, ki so študijo zaključile, se jih je 10 odzvalo na zdravljenje ob koncu študije, pri drugih 2 preiskovankah so opazili povečano virusno breme samo po porodu, pri vsaj eni preiskovanki zaradi suma na neustrezno adherenco.
English: Fluconazole Itraconazole Posaconazole Voriconazole
Slovenian: flukonazol itrakonazol posakonazol vorikonazol
English: If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
Slovenian: Če jemljete rifabutin (zdravilo za zdravljenje nekaterih bakterijskih okužb), vzemite dve tableti zdravila EDURANT enkrat na dan.
English: A risk for increases in dabigatran plasma concentrations cannot be excluded.
Slovenian: Tveganja za zvečanje plazemskih koncentracij dabigatrana ne moremo izključiti.
English: 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%).
Slovenian: Najpogostejši neželeni učinki (vseh stopenj, večji ali enaki 10%) so bili glavobol (19,4%), depresija (19,4%), nespečnost (13,9%) in navzea (11,1%).
English: Interaction table Interaction studies have only been performed in adults.
Slovenian: Preglednica medsebojnih delovanj zdravil Študije medsebojnega delovanja so izvedli le pri odraslih.
English: Tenofovir disoproxil fumarate*
Slovenian: tenofovir dizoproksil fumarat*
English: EDURANT works by reducing the amount of HIV in your body.
Slovenian: Zdravilo EDURANT deluje tako, da zmanjša količino virusa HIV v telesu.
English: (inhibition of intestinal P-gp)
Slovenian: (zaviranje intestinalnega P-gp)
English: 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).
Slovenian: Farmakokinetični podatki kažejo, da je bila celokupna izpostavljenost (AUC) rilpivirinu, kot delu protiretrovirusnega zdravljenja, približno 30% manjša med nosečnostjo kot po porodu (6-12 tednov).
English: It can be opened by pushing the screw cap down while turning it anti-clockwise.
Slovenian: Vsebnik lahko odprete tako, da navojno zaporko pritisnete navzdol in jo hkrati zavrtite v nasprotni smeri urinega kazalca.
English: EDURANT has mainly been studied in patients with normal renal function.
Slovenian: Zdravilo EDURANT so preučevali v glavnem pri bolnikih z normalnim delovanjem ledvic.
English: Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Slovenian: Izpostavljenost rilpivirinu je bila pri bolnikih, okuženih s HIV-1, večinoma manjša kot pri zdravih osebah.
English: The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Slovenian: Varnost in učinkovitost rilpivirina pri otrocih starih < 12 let še nista bili dokazani.
English: Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, nenukleozidni zaviralci reverzne transkriptaze, oznaka ATC: J05AG05
English: 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).
Slovenian: V študijah faze III so manjšo izpostavljenost rilpivirinu, podobno tisti, ki so jo opazili med nosečnostjo, povezovali s povečanim tveganjem za virološki neuspeh zdravljenja, zato je treba virusno breme skrbno spremljati (glejte poglavja 4.6, 5.1 in 5.2).