FrancophonIA/ELRC3.0 huggingface dataset:
English: Switching from a TDF-based regimen to Odefsey may lead to slight increases in lipid parameters.
Slovenian: Prehod z režima, ki vsebuje TDF, na zdravilo Odefsey lahko povzroči rahlo povečanje lipidnih parametrov.
English: Contents of the pack and other information What Odefsey contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Odefsey
English: • If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na emtricitabin, rilpivirin, tenofoviralafenamid ali na katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: Missing data during window but on study drug
Slovenian: V oknu podatki manjkajo, a se uporablja študijsko zdravilo
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in oportunističnimi okužbami v zdravstveni zgodovini (okužbe, ki se pojavijo pri ljudeh z oslabljenim imunskim sistemom), se lahko znaki in simptomi vnetja zaradi prejšnjih okužb pojavijo kmalu po začetku zdravljenja HIV.
English: Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
Slovenian: Zdravila, ki vplivajo na aktivnost P-gp in BCRP, lahko povzročijo spremembe v absorpciji tenofoviralafenamida (glejte preglednico 1).
English: The decrease in the unbound free fraction of rilpivirine exposure (i.e., active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Slovenian: Zmanjšanje izpostavljenosti nevezani prosti frakciji rilpivirina (tj. aktivna) med nosečnostjo je bilo v primerjavi s poporodnim obdobjem manj izraženo kot za skupno izpostavljenost rilpivirinu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Odefsey in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Odefsey za eno ali več podskupin pediatrične populacije za zdravljenje okužbe z virusom HIV-1 pri ljudeh (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Once you start taking Odefsey, look out for:
Slovenian: Ko začnete jemati zdravilo Odefsey, bodite pozorni na:
English: Table 1: Interactions between Odefsey or its individual component(s) and other medicinal products
Slovenian: Preglednica 1: Interakcije med zdravilom Odefsey ali posameznimi učinkovinami zdravila in drugimi zdravili
English: • Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
Slovenian: • Metadon, učinkovina, ki se uporablja za zdravljenje zasvojenosti z opiati, saj bo moral zdravnik morda prilagoditi vaš odmerek metadona.
English: Patients co-infected with HIV and HBV who discontinue Odefsey should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Slovenian: Bolnike s hkratno okužbo s HIV in HBV, ki prekinejo zdravljenje z zdravilom Odefsey, je treba pozorneje opazovati in opravljati potrebne klinične in laboratorijske preiskave še vsaj nekaj mesecev po prenehanju zdravljenja.
English: increased transaminases (AST and/or ALT)1
Slovenian: zvišanje transaminaz (AST in/ali ALT)1
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4 to 5 hours.
Slovenian: Po peroralnem dajanju so največje koncentracije rilpivirina v plazmi običajno dosežene v roku 4-5 ur.
English: • severe skin reactions including rash accompanied by fever, swelling and liver problems
Slovenian: • hude kožne reakcije, vključno z izpuščajem, ki ga spremljajo vročina, otekanje in težave z jetri
English: The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Slovenian: Substitucija K103N sama ni povzročila manjše občutljivosti na rilpivirin, vendar pa je kombinacija K103N in L100I povzročila 7-krat manjšo občutljivost na rilpivirin.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
Slovenian: V primeru prevelikega odmerka je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8) in mu nuditi standardno podporno zdravljenje, vključno z opazovanjem kliničnega stanja bolnika in nadziranjem vitalnih znakov in EKG (interval QT).
English: EU/1/16/1112/001 30 film-coated tablets EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1112/001 30 filmsko obloženih tablet EU/1/16/1112/002 90 (3 vsebniki po 30) filmsko obloženih tablet
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Slovenian: Bolniki z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo v času kombinirane protiretrovirusne terapije (CART-combination antiretroviral therapy) več anomalij jetrne funkcije in jih je treba nadzirati v skladu s standardno prakso.
English: Odefsey comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Slovenian: Zdravilo Odefsey je na voljo v plastenkah po 30 tablet in v pakiranjih s po 3 plastenkami, od katerih vsaka vsebuje 30 tablet.
English: At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Slovenian: Na začetku je bila mediana eGFRCG 56 ml/min, 33 % bolnikov pa je imelo eGFRCG od 30 do 49 ml/min.
English: Odefsey is an antiviral medicine used to treat infection by the Human Immunodeficiency Virus (HIV).
Slovenian: Zdravilo Odefsey je protivirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV).
English: Induction of P-gp
Slovenian: Indukcija P-gp
English: Contains lactose (as monohydrate), see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo (v obliki monohidrata), za dodatne informacije glejte navodilo za uporabo.
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Slovenian: V klinični študiji rilpivirin ni pomembno vplival na farmakokinetične lastnosti digoksina.
English: In the Phase 3 studies (C209 and C215), 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 3 (C209 in C215) je bila nižja izpostavljenost rilpivirinu, podobna kot je bila opažena med nosečnostjo, povezana s povečanim tveganjem za virološki neuspeh, zato je treba skrbno spremljati virusno obremenitev (glejte poglavja 4.6, 5.1 in 5.2).
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Slovenian: Zato lahko zdravila, ki inducirajo ali zavirajo CYP3A, vplivajo na očistek rilpivirina (glejte poglavje 5.2).
English: Mitochondrial dysfunction following exposure in utero
Slovenian: Mitohondrijska disfunkcija kot posledica in utero izpostavljenosti
English: As a precautionary measure, it is preferable to avoid the use of Odefsey during pregnancy.
Slovenian: Iz previdnosti se je med nosečnostjo bolje izogibati uporabi zdravila Odefsey.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco na galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Slovenian: Normalizacija alanin-aminotransferaze (ALT) je bila dosežena pri 40 % (4/10) bolnikov, ki so ob izhodišču imeli ALT nad zgornjo mejo normalne vrednosti (ULN).
English: Mean values for the rilpivirine arm for both basal and ACTH-stimulated cortisol at Week 96 were within the normal range.
Slovenian: Povprečne vrednosti kraka z rilpivirinom za bazalni kortizol in kortizol po stimulaciji z ACTH v 96. tednu so bile znotraj normalnega razpona.
English: Adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet to be taken once daily with food (see section 5.2).
Slovenian: Odrasli in mladostniki, stari 12 let in več, s telesno maso vsaj 35 kg Jemlje se ena tableta enkrat dnevno s hrano (glejte poglavje 5.2).
English: Odefsey may interact with other medicines.
Slovenian: Zdravilo Odefsey lahko medsebojno deluje z drugimi zdravili.
English: Odefsey should be taken orally, once daily with food (see section 5.2).
Slovenian: Zdravilo Odefsey se jemlje enkrat dnevno, peroralno s hrano (glejte poglavje 5.2).
English: At supratherapeutic doses (75 mg once daily and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 4.9).
Slovenian: Pri odmerkih, višjih od terapevtskih (75 mg in 300 mg enkrat dnevno), rilpivirin povezujejo s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavji 4.5 in 4.9).
English: 1 Adverse reactions identified from rilpivirine clinical studies.
Slovenian: 1 Neželeni učinki, ki so jih zabeležili v kliničnih študijah rilpivirina.
English: 25-O-desacetyl-rifabutin:
Slovenian: 25-O-dezacetil-rifabutin:
English: As a result, the amounts of Odefsey or other medicines in your blood may be affected.
Slovenian: To lahko posledično vpliva na količino zdravila Odefsey ali drugih zdravil v vaši krvi.
English: a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Slovenian: a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima); okno v 144. tednu je med 966. in 1049. dnevom (vključno z njima).
English: e Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Slovenian: e Vključevalo je bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
English: Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Pri nekaterih bolnikih, ki jemljejo kombinirana protiretrovirusna zdravila, kot je zdravilo Odefsey, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva kot posledica pomanjkanja oskrbe kosti s krvjo).
English: Each tablet contains 189.8 mg lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 189,8 mg laktoze monohidrata.
English: A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Slovenian: Večje število podatkov o uporabi emtricitabina pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na njegovo malformacijsko ali feto/neonatalno toksičnost.
English: Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased rilpivirine exposure (AUC) by 13-72%.
Slovenian: Relativno glede na pogoje na tešče, je dajanje zdravila Odefsey zdravim odraslim osebam z obrokom, povzročilo večjo izpostavljenost rilpivirinu (AUC) za 13-72 %.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Slovenian: Biotransformacija emtricitabina vključuje oksidacijo tiolnega dela molekule, pri čemer nastanejo 3'-sulfoksid diastereomere (približno 9 % odmerka), in konjugacijo z glukuronsko kislino, pri čemer nastane 2'-O-glukuronid (približno 4 % odmerka).
English: In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
Slovenian: V tej študiji je bil varnostni profil pri mladostnikih podoben varnostnemu profilu pri odraslih bolnikih (glejte poglavje 5.1).
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Slovenian: Ker se rilpivirin močno veže na beljakovine, ni verjetno, da bi dializa odstranila pomembno količino učinkovine.
English: e e.g., lost to follow up, non-compliance, withdrew consent.
Slovenian: e Npr. izgubljeni za spremljanje, neskladnost, umik soglasja.
English: 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.
Slovenian: Z rilpivirinom se lahko zdravi samo mladostnike, pri katerih je verjetno, da bodo skrbno upoštevali protiretrovirusno zdravljenje, saj lahko suboptimalno upoštevanje povzroči razvoj rezistence ter izgubo možnosti zdravljenja v prihodnosti.
English: There were also reclassifications in the Week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Slovenian: Pri primarni analizi v 48. tednu je prišlo tudi do prerazvrstitve, pri čemer je bila najpogostejša prerazvrstitev iz skupine virološkega neuspeha v skupino prekinitev, ne zaradi AE.
English: Virologically suppressed adults in Study GS-US-292-0109
Slovenian: Odrasli z virološko supresijo v študiji GS-US-292-0109
English: If you are on dialysis, take your daily dose of Odefsey following completion of dialysis.
Slovenian: Če ste na dializi, vzemite svoj dnevni odmerek zdravila Odefsey po končani dializi.
English: The safety and efficacy of Odefsey in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Slovenian: Varnost in učinkovitost zdravila Odefsey pri bolnikih s hkratno okužbo s HIV-1 in virusom hepatitisa C (HCV) nista bili dokazani.
English: The pharmacokinetics of emtricitabine have not been studied in patients with varying degrees of hepatic insufficiency; however emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Slovenian: Farmakokinetičnih lastnosti emtricitabina pri bolnikih z različnimi stopnjami jetrne insuficience niso proučevali, vendar jetrni encimi emtricitabina ne presnavljajo v pomembnem obsegu, zato je vpliv jetrne okvare verjetno omejen.
English: Interactions between Odefsey or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Slovenian: Interakcije med zdravilom Odefsey ali posameznimi učinkovinami zdravila in sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom „↑“, zmanjšanje z „↓“, brez spremembe z „↔“).
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Slovenian: Rilpivirin in vitro zavira P-glikoprotein (P-gp) (50-odstotna inhibitorna koncentracija [IC50] je 9,2 µM).
English: Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Slovenian: Med temi 12 izolati HIV-1 so se pojavile mutacije M184V/I (n = 11) in K65R/N (n = 2) v RT ter T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) in N155H (n = 2) v integrazi.
English: EFV = efavirenz; RPV = rilpivirine a ITT TLOVR = Intention to treat time to loss of virologic response.
Slovenian: EFV = efavirenz; RPV = rilpivirin a ITT TLOVR = čas do izgube virološkega odziva v skupini z namenom zdravljenja.
English: Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Slovenian: Zdravilu Odefsey se je treba izogniti pri bolnikih z ocenjenim CrCl ≥ 15 ml/min in < 30 ml/min ali < 15 ml/min, ki niso na kronični hemodializi, saj varnosti zdravila Odefsey pri teh populacijah niso dokazali.
English: somnolence1
Slovenian: somnolenca1
English: Each bottle contains silica gel desiccant and polyester coil.
Slovenian: Vsak vsebnik vsebuje silikagelsko sušilno sredstvo in poliestrsko vato.
English: H2-antagonists can only be taken once a day if you take Odefsey.
Slovenian: Antagoniste receptorjev H2 lahko jemljete le enkrat dnevno, če jemljete zdravilo Odefsey.
English: Interaction not studied with any of the components of Odefsey.
Slovenian: Interakcije niso preučili z nobeno od učinkovin zdravila Odefsey.
English: The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Slovenian: Farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, mlajših od 12 let, se preučuje.
English: Odefsey contains lactose monohydrate.
Slovenian: Zdravilo Odefsey vsebuje laktozo monohidrat.
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Slovenian: Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom in imajo hude klinične izvide neznanega vzroka, zlasti nevrološke izvide.
English: The safety profile in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Slovenian: Varnostni profil pri bolnikih z blago do zmerno ledvično okvaro je bil podoben kot pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 5.1).
English: The adverse reactions in Table 2 are listed by system organ class and highest frequency observed.
Slovenian: Neželeni učinki v preglednici 2 so našteti po organskih sistemih in pogostnosti.
English: Following administration of tenofovir alafenamide, plasma [14C] -radioactivity showed a time-dependent profile, with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Slovenian: Po dajanju tenofoviralafenamida je plazemska [14C]-radioaktivnost pokazala časovno odvisni profil, pri tem je bil tenofoviralafenamid najbolj zastopana vrsta radioaktivnosti v prvih nekaj urah in sečna kislina v preostalem obdobju.
English: • increased fatty acids (triglycerides), bilirubin or lipase in the blood
Slovenian: • zvišanje maščobnih kislin (trigliceridov), bilirubina ali sladkorja lipaze v krvi
English: Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Slovenian: Izidi zdravljenj v študijah GS-US-366-1216 in GS-US-366-1160 so prikazani v preglednici 5.
English: As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Odefsey (see section 4.4).
Slovenian: Kot pri vseh drugih protiretrovirusnih zdravilih morajo biti testiranje rezistence in/ali podatki o rezistenci v anamnezi vodilo za uporabo zdravila Odefsey (glejte poglavje 4.4).
English: If you take more Odefsey than you should
Slovenian: Če ste vzeli večji odmerek zdravila Odefsey, kot bi smeli
English: No human data on the effect of Odefsey on fertility are available.
Slovenian: Ni podatkov o učinkih zdravila Odefsey na plodnost pri ljudeh.
English: increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
Slovenian: zvišanje skupnega holesterola (na tešče)1, zvišanje holesterola LDL (na tešče)1
English: decreased appetite1, increased triglycerides (fasted)1
Slovenian: zmanjšanje apetita1, zvišanje trigliceridov (na tešče)1
English: Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Slovenian: Zelo pogosti neželeni učinki (vseh stopenj) so bili glavobol, depresija, somnolenca in navzea.
English: Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Slovenian: Študije na živalih ne kažejo škodljivih učinkov emtricitabina, rilpivirinijevega klorida ali tenofoviralafenamida na plodnost (glej poglavje 5.3)
English: There is insufficient information on the effects of all the components of Odefsey in newborns/infants, therefore Odefsey should not be used during breast-feeding.
Slovenian: Podatki o učinku vseh učinkovin zdravila Odefsey na dojene novorojence/otroke so nezadostni, zato se zdravilo Odefsey med dojenjem ne sme uporabljati.
English: Resistance testing and/or historical resistance data should guide the use of Odefsey (see section 5.1).
Slovenian: Testiranje rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Odefsey (glejte poglavje 5.1).
English: • dexamethasone (oral and parenteral doses), except as a single dose treatment
Slovenian: • deksametazon (peroralni in parenteralni odmerki), razen pri zdravljenju z enkratnim odmerkom
English: The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Slovenian: Farmakokinetična izpostavljenost rilpivirinu pri bolnikih s sočasno okužbo je bila primerljiva s tisto pri bolnikih brez sočasne okužbe.
English: Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Slovenian: Rilpivirinijev klorid se pretežno presnavlja in izloča v jetrih.
English: When your supply of Odefsey starts to run low, get more from your doctor or pharmacist.
Slovenian: Ko se vaše zaloge zdravila Odefsey manjšajo, si ga priskrbite pri svojem zdravniku ali farmacevtu.
English: The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
Slovenian: Kombinacija emtricitabina, rilpivirina in tenofoviralafenamida ni bila antagonistična in dokazana je bila sinergijska protivirusna aktivnost v celični kulturi.
English: Tenofovir diphosphate inhibits HIV RT, resulting in DNA chain termination.
Slovenian: Tenofovir difosfat zavira HIV RT, kar povzroči prekinitev verige DNA.
English: In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were 21%, 29% and 35% lower, respectively, as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were 20%, 31% and 42% lower, respectively, as compared to postpartum.
Slovenian: Pri ženskah, ki so prejemale 25 mg rilpivirina enkrat dnevno med 2. trimesečjem nosečnosti, so bile srednje vrednosti med posameznicami za vrednosti celokupnega rilpivirina Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 21 %, 29 % in 35 %; med 3. trimesečjem nosečnosti pa so bile vrednosti Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 20 %, 31 % in 42 %.
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Slovenian: Farmakokinetičnih lastnosti rilpivirina niso proučevali pri bolnikih z ledvično insuficienco.