natgillin/translations-raw huggingface dataset:
This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier.
V analizo so bili vključeni podatki 690 bolnikov iz študije ECHO in 678 bolnikov iz študije THRIVE, in sicer podatki bolnikov, ki so zaključili 96 tednov zdravljenja, in tistih, ki so predčasno prekinili zdravljenje.
There is no specific antidote for overdose with EDURANT.
Za zdravljenje v primeru prevelikega odmerjanja zdravila EDURANT ni specifičnega antidota.
75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner.
75 ml vsebnik iz polietilena visoke gostote (HDPE) s polipropilensko (PP) za otroke varno zaporko in indukcijsko zataljeno folijo.
Uncommon: - signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome)
Občasni neželeni učinki: - znaki ali simptomi vnetja ali okužbe, na primer vročina, mrazenje, potenje (sindrom obnove imunskega odgovora)
Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Virološki izid pri mladostnikih v študiji TMC278-C213 - analiza podatkov po 48. in 240 tednih; ITT-TLOVR* 48. teden n=36
The safety and efficacy of EDURANT in children aged < 12 years have not yet been established.
Varnost in učinkovitost zdravila EDURANT pri otrocih, mlajših od 12 let, še nista bili dokazani.
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
nenormalnih laboratorijskih izvidih AST/ALT ali zvečanju koncentracije transaminaz, stopnje 3-4, niso poročali.
HIV Integrase Strand Transfer Inhibitors Raltegravir*
zaviralci prenosa zapisa integraze HIV raltegravir*
* compared to 25 mg once daily rilpivirine alone
* v primerjavi s samo 25 mg rilpivirina enkrat na dan
Patients co-infected with hepatitis B and/or hepatitis C virus In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected.
Bolniki, ki imajo sočasno okužbo z virusom hepatitisa B in/ali virusom hepatitisa C Pri bolnikih, ki so imeli sočasno okužbo z virusom hepatitisa B in/ali virusom hepatitisa C in so prejemali rilpivirin, je bila pojavnost povečanja koncentracij jetrnih encimov večja, kot pri bolnikih, ki so prejemali rilpivirin, vendar niso imeli sočasne okužbe.
Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Psihiatrične motnje zelo pogosti nespečnost pogosti nenormalne sanje depresija motnje spanja depresivno razpoloženje
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI resistant HIV-1.
Sevi, odporni na rilpivirin, so bili selekcionirani v celičnih kulturah, ki so izhajale iz divjega tipa HIV-1 različnega izvora in podvrst, pa tudi iz HIV-1, ki so bili odporni na NNRTI.
Lansoprazole Rabeprazole Pantoprazole Esomeprazole
lansoprazol rabeprazol pantoprazol esomeprazol
BR=background regimen N=number of subjects
BR = (angl.: background regimen) osnovna shema zdravljenja N = število preiskovancev
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo posrednih ali neposrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible.
Če to opazite v 12 urah od takrat, ko običajno vzamete zdravilo EDURANT, morate tableto vzeti čimprej.
Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Rezistenco na rilpivirin so določili kot spremembo stopnje (FC - fold change) v vrednosti EC50 nad biološko zgornjo mejo (BCO - biological cut-off) testa občutljivosti.
(reduced absorption due to gastric pH increase)
(zmanjšana absorpcija zaradi zvečanja pH v želodcu)
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/ml) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/ml).
Poleg tega se je pokazalo, da rilpivirin deluje tudi proti celi vrsti primarnih izolatov HIV-1 skupine M (podvrste A, B, C, D, F, G, H), in sicer z vrednostmi EC50 od 0,07 do 1,01 nmol/l (0,03 do 0,37 ng/ml), in primarnih izolatov skupine O, in sicer z vrednostmi EC50 od 2,88 do 8,45 nmol/l (1,06 do 3,10 ng/ml).
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Pri nekaterih bolnikih z napredovalo okužbo s HIV, ki so imeli oportunistično okužbo kdaj prej, se lahko kmalu po začetku zdravljenja okužbe s HIV pojavijo simptomi in znaki vnetja, povezani s prejšnjimi okužbami.
Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48.
Šest preiskovancev je zaradi virološkega neuspeha zdravljenje prekinilo do 48 tedna, 3 preiskovanci pa po 48. tednu.
As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
Tako, kot pri drugih protiretrovirusnih zdravilih se je treba pri zdravljenju z zdravilom EDURANT ravnati po rezultatih testiranja odpornosti.
The observed hepatocellular findings in mice may be rodent-specific.
Hepatocelularne spremembe, ki so jih opažali pri miših, so lahko specifične za glodalce.
Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Presnovne in prehranske motnje zelo pogosti zvečana celokupna koncentracija holesterola (na tešče) zvečana celokupna koncentracija LDL (na tešče)
BR=background regimen
BR = (angl.: background regimen) osnovna shema zdravljenja
300 mg once daily (+ 50 mg once daily rilpivirine)
300 mg enkrat na dan (+ 50 mg rilpivirina enkrat na dan)
In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
V analizi podatkov po 48 tednih je imelo 31 od 62 bolnikov pomanjkljiv virološki odziv na rilpivirin sočasno z NNRTI in NRTI RAMs, od teh 31 bolnikov jih je imelo 17 kombinacijo E138K in M184I.
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.
V tej interakcijski študiji so uporabljali višji odmerek rilpivirina od priporočenega, da bi lahko ocenili največji učinek na sočasno uporabljano zdravilo.
These resistance-associated mutations were derived from in vivo data involving treatment-naïve subjects only and therefore cannot be used to predict the activity of rilpivirine in subjects who have virologically failed an antiretroviral-containing regimen.
Te mutacije, povezane z odpornostjo, so določili na osnovi in vivo podatkov samo pri bolnikih, ki še niso prejemali protiretrovirusnih zdravil in jih zato ne moremo uporabljati za napovedovanje aktivnosti rilpivirina pri bolnikih, ki so bili virološko neuspešni na shemah zdravljenja z drugimi protiretrovirusnimi zdravili.
R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
R(-) metadon AUC ↓ 16% R(-) metadon Cmin ↓ 22% R(-) metadon Cmax ↓ 14% rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * na podlagi podatkov kontrolnih oseb iz preteklih študij
Response (confirmed < 50 HIV-1 RNA copies/ml)
Potrjen odziv na zdravljenje (< 50 kopij RNK virusa HIV-1/ml)
In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment.
V združeni analizi rezistence po 96 tednih zdravljenja so opazili nižjo stopnjo virološke odpovedi v drugih 48 tednih kot v prvih 48 tednih zdravljenja.
Trimester of pregnancy (n=13)
tretje trimesečje nosečnosti (n=13)
As with other antiretroviral medicinal products, resistance testing should guide the use of rilpivirine (see section 5.1).
Tako, kot pri drugih protiretrovirusnih zdravilih, se je o uporabi rilpivirina treba odločiti na osnovi rezultatov testiranja odpornosti (glejte poglavje 5.1).
No human data on the effect of rilpivirine on fertility are available.
O vplivu rilpivirina na plodnost pri ljudeh ni podatkov.
Most of these discontinuations occurred in the first 48 weeks of treatment.
Do večine prekinitev je prišlo v prvih 48 tednih zdravljenja.
- The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
- Druge sestavine zdravila v sredici filmsko obložene tablete so laktoza monohidrat, premrežen natrijev karmelozat, povidon K30, polisorbat 20, silicificirana mikrokristalna celuloza in magnezijev stearat.
The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Farmakokinetika izpostavljenosti rilpivirinu je pri bolnikih s sočasno okužbo primerljiva s tisto pri bolnikih brez sočasne okužbe.
Renal elimination of rilpivirine is negligible.
Izločanje rilpivirina skozi ledvice je zanemarljivo.
Do not stop using EDURANT
Ne prenehajte jemati zdravila EDURANT
Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Rilpivirin ni induciral kromosomskih okvar pri in vivo mikronukleusnem testu pri miših.
- clarithromycin, erythromycin (antibiotics) - cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
- klaritromicin, eritromicin (antibiotiki) - cimetidin, famotidin, nizatidin ali ranitidin (antagonisti histaminskih receptorjev H2, ki jih uporabljamo pri zdravljenju razjed v želodcu ali črevesju ali za lajšanje zgage zaradi kislega refluksa).
EDURANT contains lactose
Zdravilo EDURANT vsebuje laktozo
During the clinical development program (1,368 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE)), 55.7% of subjects experienced at least one adverse drug reaction (see section 5.1).
V razvojnem kliničnem programu (1.368 bolnikov iz dveh nadzorovanih študij faze III TMC278-C209 (ECHO) in TMC278-C215 (THRIVE)) se je najmanj en neželen učinek pojavil pri 55,7% preiskovancev (glejte poglavje 5.1).
There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
Podatki o uporabi zdravila EDURANT pri bolnikih z blago ali zmerno okvaro jeter (Child-Pugh stopnje A ali B) so omejeni.
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
V preglednici 1 so našteta ugotovljena in teoretična medsebojna delovanja z izbranimi protiretrovirusnimi in drugimi zdravili.
The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively.
Mediana vrednost trajanja izpostavljenosti bolnika je bila 104,3 tedna v skupini, ki je prejemala rilpivirin in 104,1 tedna v skupini, ki je prejemala efavirenz.
HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
zaviralci HIV proteaze (HIV PI) - pri sočasni uporabi nizkih odmerkov ritonavirja darunavir/ritonavir*
In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
Pri bolnikih z začetnim virusnim bremenom ≤ 100.000 kopij/ml, je 9 od 27 bolnikov z virološkim neuspehom zdravljenja z rilpivirinom pokazalo zaradi zdravljenja nastalo rezistenco na rilpivirin (genotipska analiza) z naslednjo pogostnostjo fenotipske navzkrižne rezistence: na etravirin 4/9, na efavirenz 3/9 in na nevirapin 1/9.
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Ker se rilpivirin v velikem obsegu veže na proteine v plazmi, ga v večji meri skorajda ni mogoče odstraniti s hemodializo ali s peritonealno dializo (glejte poglavje 4.2).
Of these virologic failures, 9 out of 24 and 4 out of 14 were in subjects with a baseline viral load < 100,000 copies/ml, respectively.
Od teh jih je bilo 9 od 24 oziroma 4 od 14 pri bolnikih z začetnim virusnim bremenom < 100.000 kopij/1 ml.
Efavirenz + BR N=682
efavirenz + zdravila po osnovni shemi n=682
Therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje mora uvesti zdravnik, ki ima izkušnje z obravnavo bolnikov s HIV.
As a precautionary measure, it is preferable to avoid the use of EDURANT during pregnancy.
Zaradi zagotovitve varnosti, se je uporabi rilpivirina med nosečnostjo bolje izogibati.
No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
V študijah na živalih niso opažali nobenega klinično pomembnega vpliva na plodnost (glejte poglavje 5.3).
Lactose monohydrate Hypromellose 2910 6 mPa.s Titanium dioxide E171 Macrogol 3000
Obloga tablete laktoza monohidrat hipromeloza 2910 6 mPas titanov dioksid E171 makrogol 3000 triacetin
digoxin AUC ↔ digoxin Cmin NA digoxin Cmax ↔
digoksin AUC ↔ digoksin Cmin NS digoksin Cmax ↔
Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/ml).
Rilpivirin deluje proti laboratorijskim sevom divjega tipa HIV-1 v akutno okuženih linijah celic T z mediano vrednostjo koncentracije učinkovitosti (EC50) za HIV-1/IIIB 0,73 nmol/l (0,27 ng/ml).
AZOLE ANTIFUNGAL AGENTS Ketoconazole*
AZOLNI ANTIMIKOTIKI ketokonazol*
Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
Rezultati analize populacijske farmakokinetike pri bolnikih, okuženih s HIV, kažejo, da rasna pripadnost nima klinično pomembnega vpliva na izpostavljenost rilpivirinu.
What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Kaj vsebuje zdravilo EDURANT - Učinkovina je rilpivirin v obliki rilpivirinijevega klorida.
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/ml), treatment of HIV-2 infection with rilpivirine is not recommended in the absence of clinical data.
Rilpivirin je in vitro v manjši meri pokazal tudi delovanje proti HIV-2, in sicer z vrednostmi EC50 od 2.510 do 10.830 nmol/l (920 do 3.970 ng/ml), vendar za zdravljenje okužbe s HIV-2 uporaba rilpivirina ni priporočena, saj o tem ni kliničnih podatkov.
For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Pri bolnikih, pri katerih je bilo zdravljenje z rilpivirinom neuspešno in se je pri njih pojavila odpornost na rilpivirin, so večinoma opazili navzkrižno odpornost tudi na druge odobrene NNRTI (etravirin, efavirenz, nevirapin).
In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P450 (CYP) 3A system.
Poskusi in vitro kažejo, da se rilpivirin presnavlja predvsem z oksidativnim metabolizmom, ki ga posreduje sistem citokroma P450 (CYP) 3A.
The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%).
Najpogosteje poročani neželeni učinki (≥ 2%), najmanj zmerne jakosti, so bili depresija (4,1%), glavobol (3,5%), nespečnost (3,5%), izpuščaj (2,3%) in bolečina v trebuhu (2,0%).
EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Zdravilo EDURANT je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe s humanim virusom imunske pomanjkljivosti tipa 1 (HIV-1 - Human Immunodeficiency Virus-1) pri bolnikih, starih 12 let in več, ki še niso prejemali protiretrovirusnih zdravil in virusnim bremenom ≤ 100.000 kopij RNK HIV-1/ml.
There were no patients who discontinued treatment due to ADRs.
Noben bolnik ni prekinil zdravljenja zaradi neželenih učinkov.
OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
DRUGA ZDRAVILA ANTIKONVULZIVI karbamazepin okskarbazepin fenobarbital fenitoin
In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see section 5.2).
Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo se kombinacija rilpivirina in močnega zaviralca CYP3A (npr. zaviralca HIV proteaze, okrepljenega z ritonavirjem) lahko uporablja le v primeru, da so koristi zdravljenja večje od tveganja (glejte poglavje 5.2).
Trimester of pregnancy (n=15)
drugo trimesečje nosečnosti (n=15)
It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Spada v skupino zdravil, ki jih uporabljamo pri okužbi s HIV in se imenujejo nenukleozidni zaviralci reverzne transkriptaze (NNRTInon-nucleoside reverse transcriptase inhibitors).
Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
Presnova rilpivirina poteka večinoma preko citokroma P450 (CYP)3A.
The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
Filmska obloga vsebuje laktozo monohidrat, hipromelozo 2910 6 mPas, titanov dioksid E171, makrogol 3000 in triacetin.
300 mg once daily (+ 25 mg once daily rilpivirine)
300 mg enkrat na dan (+ 25 mg rilpivirina enkrat na dan)
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
In vitro je rilpivirin zaviralec prenašalca MATE-2K z IC50 < 2,7 nM.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Pri bolnikih, okuženih s HIV, s hudo imunsko pomanjkljivostjo ob uvedbi kombinirane protiretrovirusne terapije (CART), se lahko pojavi vnetna reakcija na asimptomatske ali prikrite oportunistične okužbe.
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Rilpivirin je diaril-pirimidinski nenukleozidni zaviralec reverzne transkriptaze (NNRTI) HIV-1.
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.
En preiskovanec je po 48. tednih zdravljenje prekinil zaradi neželenega učinka, po analizi podatkov po 240. tednu pa zdravljenja zaradi neželenega učinka ni prekinil noben dodaten preiskovanec.
How to take EDURANT
Kako jemati zdravilo EDURANT
Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Pri odmerjanju zdravila EDURANT na tešče ali samo s hranljivo pijačo se koncentracije rilpivirina v plazmi lahko zmanjšajo, kar lahko zmanjša terapevtski učinek zdravila EDURANT (glejte poglavje 4.2).
HIV treatment does not cure HIV infection!
Jemanje zdravil proti HIV, ne pozdravi okužbe s HIV.
rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum.
Med tretjim trimesečjem nosečnosti pa so bile vrednosti Cmax, AUC24h in Cmin za celokupni rilpavirin za 20%, 31% in 42% manjše v primerjavi z obdobjem po porodu.
# to emtricitabine/lamivudine % (n/N)
# na emtricitabin/lamivudin % (n/N) odpornost na rilpivirin % (n/N)
White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Bela do umazano bela okrogla bikonveksna filmsko obložena tableta premera 6,4 mm z vtisnjenima oznakama "TMC" na eni strani in "25" na drugi.
The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Vpliv priporočenega odmerka 25 mg rilpivirina enkrat na dan na interval QTcF so ocenjevali v randomizirani, s placebom in aktivno (z moksifloksacinom 400 mg enkrat na dan) kontrolirani navzkrižni študiji s 60 zdravimi odraslimi, in sicer s 13 meritvami v 24 urah v stanju dinamičnega ravnovesja.
If you take more EDURANT than you should Contact your doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila EDURANT, kot bi smeli Takoj obvestite svojega zdravnika ali farmacevta.
EDURANT 25 mg film-coated tablets
EDURANT 25 mg filmsko obložene tablete
Alternatively, switching to another ART regimen could be considered.
Alternativno se lahko razmisli tudi o zamenjavi protiretrovirusnega zdravljenja.
In patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution.
Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo je pri uporabi rilpivirina potrebna previdnost.
For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.
Pri odraslih bolnikih, ki še niso prejemali protiretrovirusnih zdravil Za analizo rezistence je bila uporabljena obsežnejša definicija virološkega neuspeha zdravljenja kot pri primarni analizi učinkovitosti.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Janssen-Cilag SpA
It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.
Zdravila EDURANT ni priporočljivo kombinirati z drugimi nenukleozidnimi zaviralci reverzne transkriptaze (NNRTI), kot so delavirdin, efavirenz, etravirin in nevirapin.
The combination of rilpivirine and dabigatran etexilate should be used with caution.
Kombinacijo rilpivirina in dabigatran eteksilata je treba uporabljati previdno.
Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
O uporabi zdravila EDURANT se je treba odločiti na osnovi rezultatov testiranja odpornosti (glejte poglavji 4.4 in 5.1).
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.
Pri nobenem od 10 novorojencev preiskovank, ki so zdravljenje v študiji zaključile in za katere je bil znan status HIV, ni prišlo do prenosa virusa z matere na otroka.
No clinically relevant drug-drug interactions are expected.
Ni pričakovati klinično pomembnih medsebojnih delovanj.
Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Kancerogeni vpliv rilpivirina so ocenjevali na miših in podganah, ki so jim zdravilo dajali do 104 tedne z oralno gavažo.