natgillin/translations-raw huggingface dataset:
Do not stop using EDURANT without talking to your doctor first.
Ne prenehajte jemati zdravila EDURANT, ne da bi se prej posvetovali z zdravnikom.
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE-5) sildenafil*
The absolute bioavailability of EDURANT is unknown.
Absolutna biološka uporabnost zdravila EDURANT ni znana.
Edurant should be used during pregnancy only if the potential benefit justifies the potential risk.
Zdravilo EDURANT se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
Paediatric population (12 to less than 18 years of age)
Pediatrična populacija (od 12 do manj kot 18 let starosti)
Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Rilpivirin se in vitro v približno 99,7% veže na proteine v plazmi, predvsem na albumine.
A nutritional drink (e.g. protein-rich) alone does not replace a meal.
Samo hranljiv napitek (na primer proteinski napitek) ne nadomesti obroka.
Resistance was defined as the emergence of any resistance-associated mutation at failure.
Odpornost je bila določena kot pojav katere koli z odpornostjo povezane mutacije ob neuspešnosti zdravljenja.
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.
Tako zaradi možnosti prenosa HIV kot tudi zaradi možnosti neželenih reakcij pri dojenih otrocih je treba materam naročiti, naj ne dojijo, če prejemajo rilpivirin.
If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.
Če jemljete didanozin (zdravilo za zdravljenje okužbe s HIV), prilagajanje odmerkov ni potrebno.
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.
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.
Your doctor will discuss with you which combination of medicines is best for you.
Zdravnik vam bo pojasnil, katera kombinacija zdravil je za vas najboljša.
- Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
- Zdravniku povejte, če jemljete katerokoli zdravilo, ki lahko povzroči življenjsko nevarne motnje srčnega ritma (torsade de pointes)
CCR5 Antagonists Maraviroc
antagonisti receptorjev CCR5 maravirok
60-100 mg once daily, individualised dose
60-100 mg enkrat na dan, odmerek prilagojen posamezniku
HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via breast milk.
Matere, ki so okužene s HIV, ne smejo dojiti, saj bi z mlekom lahko okužile otroka.
Each carton contains one bottle of 30 tablets.
Ena škatla vsebuje en vsebnik s 30 tabletami.
It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.
Priporočeno je, da bolnik filmsko obloženo tableto pogoltne celo z vodo, tablet ne sme žvečiti ali zdrobiti.
Postpartum (6-12 Weeks) (n=11)
obdobje po porodu (6-12 tednov) (n=11)
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.
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.
In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
V študijah prisotnost mutacij V90I in V189I ob izhodišču ni vplivala na odziv.
EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
Zdravilo EDURANT ni primerno za otroke, mlajše od 12 let, saj uporaba zdravila pri tej populaciji ni zadostno preučena.
Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila EDURANT - če ste alergični na rilpivirin ali katero koli sestavino tega zdravila (navedeno poglavju 6).
The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Med zdravljenjem z rilpivirinom je najpogosteje odkrita substitucija E138K, pogosto v kombinaciji s substitucijo M184I.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Medicinal products that affect rilpivirine exposure
Zdravila, ki vplivajo na izpostavljenost rilpivirinu
NARCOTIC ANALGESICS Methadone*
NARKOTIČNI ANALGETIKI metadon*
6 cells/l (range: 25 to 983 × 10
6 celic/l (razpon: 25 do 983 x 10
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.
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.
EDURANT has only been used in a limited number of patients of 65 years or older.
Zdravilo EDURANT je uporabljalo le malo bolnikov, ki so bili stari 65 let ali več.
Virologic failure and development of resistance
Virološki neuspeh zdravljenja in razvoj odpornosti na zdravljenje
All other drug-drug interactions shown are predicted.
Vse druge prikazane interakcije med posameznimi zdravili so ocenjene s predvidevanjem.
MACROLIDE ANTIBIOTICS Clarithromycin
MAKROLIDNI ANTIBIOTIKI klaritromicin eritromicin
HMG CO-A REDUCTASE INHIBITORS Atorvastatin*
ZAVIRALCI HMG CO-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).
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)
What EDURANT is and what it is used for What you need to know before you take EDURANT How to take EDURANT
Kaj je zdravilo EDURANT in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo EDURANT Kako jemati zdravilo EDURANT Možni neželeni učinki
The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Najpogostejši resni, z zdravljenjem povezani neželeni učinki so bili poročani pri 7 (1,0%) bolnikih, ki so prejemali rilpivirin.
The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Porazdelitve rilpivirina v druge razdelke izven plazme (na primer v cerebrospinalno tekočino ali v izločke genitalnega trakta) pri ljudeh niso ovrednotili.
Most ADRs were Grade 1 or 2.
Največ neželenih učinkov je bilo 1. ali 2. stopnje.
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.
Na voljo je le malo podatkov o možnosti za farmakodinamsko medsebojno delovanje med rilpivirinom in zdravili, ki podaljšujejo interval QTc na EKG.
Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Alternativno pa se lahko razmisli tudi o zamenjavi protiretrovirusnega zdravljenja (glejte poglavja 4.4, 4.6, 5.1 in 5.2).
Rilpivirine was well tolerated during pregnancy and postpartum.
Rilpivirin je bil med nosečnostjo in po porodu dobro prenosljiv.
Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
Med nosečnostjo so opazili manjšo izpostavljenost rilpivirinu, zato je treba virusno breme skrbno spremljati.
EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Zdravila EDURANT niso preskušali pri bolnikih s predhodnim virološkim neuspehom na katero drugo protiretrovirusno zdravljenje.
In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
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.
What you need to know before you take EDURANT
Kaj morate vedeti, preden boste vzeli zdravilo EDURANT
When you stop taking rifabutin, take one tablet of EDURANT once a day.
Ko prenehate jemati rifabutin, vzemite eno tableto zdravila EDURANT enkrat na dan.
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.
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.
The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.
Farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, mlajših od 12 let, še raziskujejo.
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.
Sama substitucija K103N ni povzročila zmanjšane občutljivosti na rilpivirin, kombinacija K103N in L100I pa je vodila v 7-kratno zmanjšanje občutljivosti na rilpivirin.
Other medicines and EDURANT
Druga zdravila in zdravilo EDURANT
Only H2-receptor antagonists that can be dosed once daily should be used.
Uporabljajo se lahko samo antagonisti H2-receptorjev, ki se lahko odmerjajo enkrat na dan.
EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
EDURANT vsebuje rilpivirin, ki ga uporabljamo za zdravljenje okužbe s humanim virusom imunske pomanjkljivosti (HIV - Human Immunodeficiency Virus).
Rilpivirine is excreted in the milk of rats.
Rilpivirin se izloča v mleko pri podganah.
When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Pri zaužitju zdravila EDURANT samo s hranljivo pijačo z visoko vsebnostjo proteinov je izpostavljenost za 50% manjša kot pri zaužitju zdravila skupaj z obrokom.
Then take the next dose as usual.
Naslednji odmerek nato vzemite po običajnem razporedu.
* The interaction between rilpivirine and the medicinal product was evaluated in a clinical study.
Medsebojno delovanje med rilpivirinom in tem zdravilom so ocenjevali v klinični študiji.
Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Nekatera zdravila lahko vplivajo na koncentracijo zdravila EDURANT v krvi, če jih jemljete sočasno z zdravilom EDURANT.
Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Pomembni podatki o sestavinah zdravila EDURANT Zdravilo EDURANT vsebuje laktozo.
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 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.
Fluconazole Itraconazole Posaconazole Voriconazole
flukonazol itrakonazol posakonazol vorikonazol
If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
Če jemljete rifabutin (zdravilo za zdravljenje nekaterih bakterijskih okužb), vzemite dve tableti zdravila EDURANT enkrat na dan.
A risk for increases in dabigatran plasma concentrations cannot be excluded.
Tveganja za zvečanje plazemskih koncentracij dabigatrana ne moremo izključiti.
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%).
Najpogostejši neželeni učinki (vseh stopenj, večji ali enaki 10%) so bili glavobol (19,4%), depresija (19,4%), nespečnost (13,9%) in navzea (11,1%).
Interaction table Interaction studies have only been performed in adults.
Preglednica medsebojnih delovanj zdravil Študije medsebojnega delovanja so izvedli le pri odraslih.
Tenofovir disoproxil fumarate*
tenofovir dizoproksil fumarat*
EDURANT works by reducing the amount of HIV in your body.
Zdravilo EDURANT deluje tako, da zmanjša količino virusa HIV v telesu.
(inhibition of intestinal P-gp)
(zaviranje intestinalnega P-gp)
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).
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).
It can be opened by pushing the screw cap down while turning it anti-clockwise.
Vsebnik lahko odprete tako, da navojno zaporko pritisnete navzdol in jo hkrati zavrtite v nasprotni smeri urinega kazalca.
EDURANT has mainly been studied in patients with normal renal function.
Zdravilo EDURANT so preučevali v glavnem pri bolnikih z normalnim delovanjem ledvic.
Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Izpostavljenost rilpivirinu je bila pri bolnikih, okuženih s HIV-1, večinoma manjša kot pri zdravih osebah.
The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Varnost in učinkovitost rilpivirina pri otrocih starih < 12 let še nista bili dokazani.
Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, nenukleozidni zaviralci reverzne transkriptaze, oznaka ATC: J05AG05
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).
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).
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).
Izpostavljenost rilpivirinu je bila za približno 40% manjša pri odmerjanju zdravila EDURANT na tešče v primerjavi z zaužitjem zdravila skupaj z obrokom z normalno kalorično vrednostjo (533 kcal) ali z obrokom z visoko kalorično vrednostjo in z visoko vsebnostjo maščob (928 kcal).
If you forget to take EDURANT
Če ste pozabili vzeti zdravilo EDURANT
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).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij zdravljenja okužbe s humanim virusom imunske pomanjkljivosti (HIV-1) z rilpivirinom za eno ali več podskupin pediatrične populacije bolnikov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Po peroralnem odmerjanju doseže rilpivirin najvišjo koncentracijo v plazmi večinoma po 4-5 urah.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Primeri takih reakcij so citomegalovirusni retinitis, generalizirane in/ali fokalne mikobakterijske okužbe in pljučnica, ki jo povzroča gliva Pneumocystis jirovecii.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Nadaljne ukrepe je potrebno izvesti glede na klinične indikacije ali priporočila Nacionalnega centra za zastrupitve.
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Rilpivirin ne zavira človeških celičnih polimeraz DNA α, β in γ.
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
V klinični študiji rilpivirin ni pomembno vplival na farmakokinetiko digoksina.
ANTIMYCOBACTERIALS Rifabutin*
ZDRAVILA PROTI MIKOBAKTERIJAM rifabutin*
EDURANT is used in combination with other HIV medicines to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Zdravilo EDURANT se uporablja v kombinaciji z drugimi zdravili proti HIV za zdravljenje mladostnikov in odraslih, starih 12 let in več, okuženih s HIV, ki še nikoli niso prejemali zdravil proti HIV.
Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Izdelovalec Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
GLUKOKORTIKOIDI deksametazon (apliciran sistemsko, razen v enkratnem odnerku)
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči stopnji resnosti.
EDURANT must be taken orally, once daily with a meal (see section 5.2).
Zdravilo EDURANT je treba jemati peroralno, enkrat na dan, z obrokom (glejte poglavje 5.2).
Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Pomožne snovi z znanim učinkom Ena filmsko obložena tableta vsebuje 56 mg laktoze monohidrata.
common decreased appetite increased triglycerides (fasted)
pogosti zmanjšan apetit zvečana koncentracija trigliceridov (na tešče)
Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
drugi okrepljeni zaviralci proteaze (atazanavir/ritonavir, fosamprenavir/ritonavir, sakvinavir/ritonavir, tipranavir/ritonavir)
There were no safety concerns identified in the week 240 analyses.
V analizi podatkov po 240 tednih se niso pojavila nobena vprašanja glede varnosti zdravila.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Zdravila, ki inducirajo ali zavirajo encim CYP3A, lahko vplivajo na izločanje rilpivirina (glejte poglavje 5.2).
A meal is important to get the right levels of active substance in your body.
Obrok je pomemben, da učinkovina v telesu lahko doseže pravo koncentracijo.
Rilpivirine is primarily metabolised and eliminated by the liver.
Rilpivirin se presnavlja in izloča predvsem preko jeter.
Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Rilpivirin v kombinaciji z osnovno shemo zdravljenja so ocenjevali v klinični študiji pri 19 nosečnicah med drugim in tretjim trimesečjem, in po porodu.
If you belong to this age group, please discuss the use of EDURANT with your doctor.
Če spadate v to starostno skupino, se o uporabi zdravila EDURANT pogovorite z zdravnikom.
There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Podatki o uporabi rilpivirina pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti) (glejte poglavja 4.4, 5.1 in 5.2).
Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
V študijah na živalih ni bilo nobenih znakov za pomembno toksično delovanje na zarodek oziroma plod ali za vpliv na sposobnost razmnoževanja.
It is not known whether rilpivirine is excreted in human milk.
Ni znano, ali se rilpivirin izloča v materino mleko.
However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient's ability to drive or operate machinery.
Pri nekaterih bolnikih, ki so jemali zdravilo EDURANT, so poročali o utrujenosti, omotici in somnolenci, kar je treba upoštevati pri ocenjevanju bolnikovih sposobnosti vožnje ali upravljanja strojev.
At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5, 4.8 and 5.2).
Pri odmerkih, večjih od terapevtskih (75 in 300 mg enkrat na dan) je bil rilpivirin povezan s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavja 4.5, 4.8 in 5.2).
QT prolonging medicinal products
Zdravila, ki podaljšujejo interval QT
- In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
- Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavijo tudi avtoimunske bolezni (stanje, do katerega pride, ko imunski sistem napade zdravo telesno tkivo).
In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
V primeru prevelikega odmerka se lahko pojavi glavobol, slabost, omotica in/ali nenormalne sanje.
The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.
Farmakokinetični parametri za nevezani (aktivni) rilpivirin so bili med nosečnostjo, v primerjavi z obdobjem po porodu, manj zmanjšani kot za celokupni rilpivirin.
(induction of CYP3A due to high rilpivirine dose in the study)
(indukcija encimov CYP3A zaradi velikega odmerka rilpivirina v študiji)
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.
V študiji, v kateri so primerjali 8 bolnikov z blago okvaro jeter (Child-Pugh stopnje A) z 8 ustreznimi kontrolnimi bolniki in 8 bolnikov z zmerno okvaro jeter (Child-Pugh stopnje B) z 8 ustreznimi kontrolnimi bolniki, je bila izpostavljenost rilpivirinu po večkratnem odmerjanju za 47% večja pri bolnikih z blago okvaro jeter in za 5% večja pri bolnikih z zmerno okvaro jeter.
Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams.
Simptomi prevelikega odmerjanja lahko vključujejo glavobol, navzeo, vrtoglavico, in/ali nenormalne sanje.
You must take EDURANT together with other HIV medicines.
Zdravilo EDURANT morate jemati skupaj z drugimi zdravili za okužbo s HIV.
A bottle with child resistant closure containing 30 film-coated tablets.
Vsebnik z za otroke varno zaporko s 30 filmsko obloženimi tabletami.
Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Bolniki v kontrolni skupini so v obeh delih študije prejemali efavirenz 600 mg enkrat na dan poleg zdravil po osnovni shemi.