natgillin/translations-raw huggingface dataset:
Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Tenofoviralafenamid in vitro ni zaviralec humane urid uridindifosfat-glukuroniltransferaze (UGTuridine diphosphate glucuronosyltransferase) 1A1.
• stomach pain or discomfort
• bolečine ali nelagodje v trebuhu
c One patient who was not on FTC/RPV/TDF prior to screening was excluded from the analysis.
c Iz analize je bil izključen en bolnik, ki pred presejanjem ni prejemal FTC/RPV/TDF.
ANTICOAGULANTS Dabigatran etexilate
ANTIKOAGULANTI dabigatraneteksilat
Lansoprazole Rabeprazole Pantoprazole Esomeprazole Dexlansoprazole
lansoprazol rabeprazol pantoprazol esomeprazol dekslansoprazol
Croscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
premreženi natrijev karmelozat, laktoza (v obliki monohidrata), magnezijev stearat, mikrokristalna celuloza, polisorbat 20, povidon.
• St. John's wort (Hypericum perforatum)
• šentjanževka (Hypericum perforatum)
decreased white blood cell count1, decreased haemoglobin1, decreased platelet count1
zmanjšanje števila belih krvnih celic1, zmanjšanje hemoglobina1, zmanjšanje števila krvnih ploščic1
severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
hude kožne reakcije s sistemskimi simptomi4, angioedem5,6, pruritus3, urtikarija6
3 Adverse reactions identified from clinical studies of emtricitabine + tenofovir alafenamide-containing products.
3 Neželeni učinki, ki so jih zabeležili v kliničnih študijah zdravil, ki vsebujejo emtricitabin + tenofoviralafenamid.
Rilpivirine exposures were bioequivalent when comparing Odefsey 200/25/25 mg to one rilpivirine (as hydrochloride) 25 mg film-coated tablet following single dose administration to healthy subjects (n = 95) under fed conditions.
Izpostavljenosti rilpivirinu so bile biološko enakovredne pri primerjavi zdravila Odefsey 200/25/25 mg z eno 25 mg filmsko obloženo tableto rilpivirina (v obliki klorida) po zaužitju enkratnega odmerka pri zdravih osebah (n = 95), po hrani.
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in E/C/F/TAF-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48 and 326 cells/mm3 in E/C/F/TAF-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
Povprečno povečanje od začetnega števila celic CD4+ je bilo 230 celic/mm3 pri bolnikih, zdravljenih z E/C/F/TAF in v 48. tednu 211 celic/mm3 pri bolnikih, zdravljenih z E/C/F/TDF (p = 0,024), v 144. tednu pa 326 celic/mm3 pri bolnikih, zdravljenih z E/C/F/TAF, in 305 celic/mm3 pri bolnikih, zdravljenih z E/C/F/TDF (p = 0,06).
No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment.
Odmerka zdravila Odefsey ni treba prilagoditi pri bolnikih z blago (stopnje A po Child-Pughu) ali zmerno (stopnje B po Child-Pughu) jetrno okvaro.
• omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole
• omeprazol, esomeprazol, dekslansoprazol, lansoprazol, pantoprazol, rabeprazol
In studies in virologically suppressed adult patients, through 96 weeks of treatment there were minimal changes or decreases in albuminuria (UACR) in patients receiving Odefsey compared with increases from baseline in patients who stayed on FTC/RPV/TDF or EFV/FTC/TDF.
V študijah pri odraslih bolnikih z virološko supresijo so po 96 tednih zdravljenja opazili minimalne spremembe ali zmanjšanje albuminurije (UACR) pri bolnikih, ki so prejemali zdravilo Odefsey, v primerjavi s povečanji glede na začetne vrednosti pri bolnikih, ki so nadaljevali s prejemanjem FTC/RPV/TDF ali EFV/FTC/TDF.
2 Study conducted with emtricitabine/rilpivirine/tenofovir disoproxil fumarate fixed-dose combination tablet.
2 Študija je bila opravljena z emtricitabinom/rilpivirinom/dizoproksiltenofovirijevim fumaratom v obliki tablete s fiksno kombinacijo odmerkov.
Interaction not studied with tenofovir alafenamide.
Interakcij s tenofoviralafenamidom niso preučevali.
Table 2: Tabulated list of adverse reactions
Preglednica 2: Seznam neželenih učinkov v preglednici Pogostnost
The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to < 18 years and weighing at least 32 kg. No patients discontinued rilpivirine due to adverse reactions.
Ocena varnosti rilpivirina temelji na podatkih iz 48. tedna ene odprte študije (TMC278-C213) z enim krakom pri 36 pediatričnih bolnikih, starih od 12 do < 18 let, s telesno maso vsaj 32 kg. Noben bolnik zdravljenja ni prekinil zaradi neželenih učinkov.
Emtricitabine did not inhibit in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Emtricitabin in vitro ni zaviral presnavljanja zdravil, ki se biotransformirajo s katerokoli od pomembnejših izooblik glavnega humanega CYP.
The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had CD4+ cell counts < 200 cells/mm3.
Povprečna začetna vrednost števila celic CD4+ je bila 427 celic/mm3 (razpon: 01.360) in 13 % jih je imelo število celic CD4+ < 200 celic/mm3.
Table 6: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Preglednica 6: Farmakokinetične lastnosti emtricitabina in tenofoviralafenamida pri mladostnikih in odraslih, ki se predhodno niso zdravili s protiretrovirusnimi zdravili
Do not breast-feed during treatment with Odefsey.
Med zdravljenjem z zdravilom Odefsey ne dojite.
H2-antagonists should not be taken in a twice a day regimen.
Antagonistov receptorjev H2 ne jemljite z režimom dvakrat dnevno.
In Studies GS-US-292-0104 and GS-US-292-0111, E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
V študijah GS-US-292-0104 in GS-US-292-0111 se je zdravilo E/C/F/TAF izkazalo za statistično boljše pri doseganju HIV-1 RNA < 50 kopij/ml v primerjavi z E/C/F/TDF v 144. tednu.
In the pooled analysis for TMC278-C209 and TMC278-C215 of 1,096 patients who received a background regimen (BR) of FTC/TDF, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz (EFV) arms.
V združeni analizi za TMC278-C209 in TMC278-C215 1096 bolnikov, ki so prejemali osnovno shemo zdravljenja (BR-background regimen) s FTC/TDF, so demografske in začetne značilnosti uravnotežili med krakoma rilpivirina in efavirenza (EFV).
Discontinued for non-AE reasone
Prekinitev, ne zaradi AEe
Table 4: Virologic outcomes of randomised treatment of Studies TMC278-C209 and TMC278-C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with FTC/TDF) at Week 48 (primary) and Week 96
Preglednica 4: Virološki izidi randomiziranega zdravljenja v študijah TMC278-C209 in TMC278-C215 (združeni podatki za bolnike, ki so prejemali rilpivirinijev klorid ali efavirenz v kombinaciji s FTC/TDF) v 48. tednu (primarna) in v 96. tednu
• decrease in haemoglobin in your blood
• zmanjšanje hemoglobina v krvi
f Includes patients who discontinued for reasons other than an AE, death, or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
f Vključevalo je bolnike, ki so sodelovanje prekinili zaradi drugih razlogov kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
48. ali 144. tedna Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtie
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric patients in Study C213 (33 to 93 kg), similar to what was observed in adults.
V študiji C213 telesna masa (33 do 93 kg) ni vplivala na farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, kar je podobno ugotovitvam pri odraslih.
There are a limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine and tenofovir alafenamide in pregnant women (see sections 4.4, 5.1 and 5.2).
Podatki o uporabi rilpivirina in tenofoviralafenamida pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti) (glejte poglavja 4.4, 5.1 in 5.2).
Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Zdravilo Odefsey je indicirano za zdravljenje odraslih in mladostnikov (starih 12 let in več s telesno maso vsaj 35 kg), okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) brez znanih mutacij, povezanih z rezistenco na razred nenukleozidnih zaviralcev reverzne transkriptaze (NNRTInon-nucleoside reverse transcriptase inhibitor), tenofovir ali emtricitabin in z virusno obremenitvijo
• Any medicines used for treating HIV • Any medicines containing:
• Katera koli zdravila, ki vsebujejo:
Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 2,396 patients received emtricitabine + tenofovir alafenamide given with elvitegravir + cobicistat as a fixed-dose combination tablet, pooled data from 686 patients who received rilpivirine 25 mg once daily in combination with other antiretroviral medicinal products in the controlled studies TMC278-C209 and TMC278-C215, 754 patients who received Odefsey in Studies GS-US-366-1216 and GS-US-366-1160, and post-marketing experience.
2.396 bolnikov prejemalo emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, združenih podatkih 686 bolnikov, ki so prejemali 25 mg rilpivirina enkrat dnevno v kombinaciji z drugimi protiretrovirusnimi zdravili v kontroliranih študijah TMC278-C209 in TMC278-C215, 754 bolnikov, ki so prejemali zdravilo Odefsey v študijah GS-US-366-1216 in GS-US-366-1160, in izkušnjah v obdobju trženja.
The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C, and M230I.
Najpogosteje opažene substitucije aminokisline, ki so se pojavile, so vključevale: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C in M230I.
• Use effective contraception while taking Odefsey.
• Med jemanjem zdravila Odefsey morate uporabljati učinkovito kontracepcijo.
Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations, ATC code: J05AR19
Farmakoterapevtska skupina: zdravilo za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije.
If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule.
Če bolnik izpusti odmerek zdravila Odefsey v roku 12 ur od časa, ko ga običajno vzame, naj vzame zdravilo Odefsey s hrano takoj, ko je mogoče, nato pa nadaljuje z običajnim režimom odmerjanja.
Odefsey should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Zdravilo Odefsey je treba uporabljati previdno pri sočasnem dajanju zdravil z znanim tveganjem za
(n = 313)c
TDF (n = 313)c
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusno terapijo, obstaja povečano tveganje za hude in potencialno usodne neželene učinke na delovanje jeter.
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Tenofoviralafenamid je nukleotidni zaviralec reverzne transkriptaze (NtRTI - nucleotide reverse transcriptase inhibitor) in fosfonoamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 RT. Rilpivirine does not inhibit the human cellular DNA
Aktivnost rilpivirina poteka s pomočjo nekompetitivnega zaviranja HIV-1 RT. Rilpivirin ne zavira humanih celičnih DNA-polimeraz α, β in mitohondrijske DNA-polimeraze γ.
Median plasma HIV-1 RNA was 5.0 log10 copies/mL and median CD4+ cell count was 255 cells/mm3.
Mediana plazemska HIV-1 RNA je bila 5,0 log10 kopij/ml, mediano število celic CD4+ je bilo 255 celic/mm3.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 in vitro.
Tenofoviralafenamid in vitro ni zaviralec CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali
The pharmacokinetics of rilpivirine in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age receiving rilpivirine 25 mg once daily was comparable to that in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, okuženih z virusom HIV-1, starih od 12 do < 18 let, ki se predhodno niso zdravili s protiretrovirusnimi zdravili in ki prejemajo 25 mg rilpivirina enkrat dnevno, je bila primerljiva s tisto pri predhodno nezdravljenih odraslih, okuženih z virusom HIV-1, ki prejemajo 25 mg rilpivirina enkrat dnevno.
- omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease)
omeprazol, dekslansoprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol (uporabljajo se za preprečevanje in zdravljenje razjed na želodcu, zgage in refluksne bolezni)
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)
Priporočilo glede sočasne uporabe z zdravilom Odefsey norgestimat (0,180/0,215/0,250 mg enkrat dnevno)/etinilestradiol (0,025 mg enkrat dnevno)/emtricitabin/ tenofoviralafenamid (200/25 mg enkrat dnevno)
Co-administration of Odefsey with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Opazili so, da sočasna uporaba zdravila Odefsey z zdravili, ki zavirajo aktivnost encima CYP3A, povzroči povečane koncentracije rilpivirina v plazmi.
Concomitant use where caution is recommended
Sočasna uporaba, pri kateri se priporoča previdnost Zaviralci encima CYP
Thirty-six patients had a median age of 14.5 years and were 55.6% female, 88.9% Black, and 11.1% Asian.
Mediana starost šestintridesetih bolnikov je bila 14,5 let, 55,6 % je bilo žensk, 88,9 % črncev in
If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine, take it at least 12 hours before or at least 4 hours after Odefsey.
Če jemljete antagonist receptorjev H2, kot so famotidin, cimetidin, nizatidin ali ranitidin, ga vzemite vsaj 12 ur pred jemanjem zdravila Odefsey ali najmanj 4 ure po tem.
In studies in treatment-naïve adult patients, E/C/F/TAF was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001).
V študijah pri predhodno nezdravljenih bolnikih je bilo E/C/F/TAF do vključno 144. tedna zdravljenja povezano z manjšim zmanjšanjem mineralne gostote kosti (MGK), ki se je merila z dvoenergijsko rentgensko absorpciometrijsko analizo (DXA) kolka (povprečna sprememba: -0,8 % v primerjavi z -3,4 %, p < 0,001) in ledvene hrbtenice (povprečna sprememba: -0,9 % v primerjavi z -3,0 %,
In a study of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 48 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
V študiji emtricitabina in tenofoviralafenamida v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov (E/C/F/TAF) pri odraslih z okužbo HIV-1 s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi se je učinkovitost ohranila do konca 48. tedna, vendar je bila izpostavljenost emtricitabinu značilno večja kot pri bolnikih z normalnim delovanjem ledvic.
In Study GS-US-292-0109, the efficacy and safety of switching from either EFV/FTC/TDF, FTC/TDF plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to E/C/F/TAF FDC tablet were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 959 switching to E/C/F/TAF, n = 477 Stayed on Baseline Regimen [SBR]).
V študiji GS-US-292-0109 so učinkovitost in varnost prehoda z EFV/FTC/TDF, FTC/TDF + atazanavir (okrepljenim s kobicistatom ali ritonavirjem) ali E/C/F/TDF na E/C/F/TAF v obliki tablete FDC ocenili z randomizirano, odprto študijo virološke supresije (HIV-1 RNA < 50 kopij/ml) pri odraslih bolnikih, okuženih z virusom HIV-1 (n = 959, ki so prešli na E/C/F/TAF, n = 477, ki so ostali na začetnem režimu (SBR - Stayed on Baseline Regimen,)).
Changes in serum creatinine for rilpivirine-containing regimens The pooled data from the Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients also demonstrate that serum creatinine increased and estimated glomerular filtration rate (eGFR) decreased over 96 weeks of treatment with rilpivirine.
Spremembe serumskega kreatinina pri režimih, ki vsebujejo rilpivirin Združeni podatki iz študij faze III TMC278-C209 in TMC278-C215, za predhodno nezdravljene bolnike, kažejo tudi na povečanje serumskega kreatinina in zmanjšanje ocenjene hitrosti glomerularne filtracije (eGFR-estimated glomerular filtration rate) v 96 tednih zdravljenja z rilpivirinom.
Some medicinal products should not be co-administered with Odefsey (see sections 4.3 and 4.5).
Zdravila Odefsey se ne sme dajati sočasno z nekaterimi drugimi zdravili (glejte poglavji 4.3 in 4.5).
Overall response and a subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase 3 clinical studies, TMC278-C209 and TMC278-C215, for patients receiving the FTC/TDF BR) are presented in Table 4.
Analiza celokupnega odziva in podskupine virološkega odziva (< 50 HIV-1 RNA kopij/ml) tako v 48. tednu kot tudi v 96. tednu in virološkega neuspeha glede na začetno vrednost virusne obremenitve (združeni podatki iz dveh kliničnih študij faze III, TMC278-C209 in TMC278-C215, za bolnike, ki so prejemali FTC/TDF BR) so predstavljeni v preglednici.
Sofosbuvir metabolite GS-331007:
presnovek sofosbuvirja GS-331007: AUC: ↔
Odefsey should be used with caution in patients with moderate hepatic impairment.
Pri uporabi zdravila Odefsey pri bolnikih z zmerno jetrno okvaro je potrebna previdnost.
At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF FDC tablet.
V 144. tednu je 83,1 % (197/237 bolnikov) ohranilo HIV-1 RNA < 50 kopij/ml po prehodu na E/C/F/TAF v obliki tablete FDC.
Clinical efficacy of Odefsey was established from studies conducted with emtricitabine + tenofovir alafenamide when given with elvitegravir + cobicistat as an E/C/F/TAF FDC tablet, from studies conducted with rilpivirine when given with FTC/TDF as individual components or as a FTC/RPV/TDF FDC tablet, and from studies conducted with Odefsey.
Klinično učinkovitost zdravila Odefsey so dokazali v študijah, ki so jih opravili z emtricitabinom in tenofoviralafenamidom v kombinaciji z elvitegravirjem in kobicistatom v obliki E/C/F/TAF FDC v študijah, ki so jih izvedli z rilpivirinom v kombinaciji s FTC/TDF v obliki tablete s posameznimi učinkovinami ali v obliki tablete FTC/RPV/TDF FDC, in v študijah, ki so jih izvedli z zdravilom
There are no pharmacokinetic data on emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis.
Farmakokinetičnih podatkov o emtricitabinu ali tenofoviralafenamidu pri bolnikih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min), ki niso na kronični hemodializi, ni.
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide expressed a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Izolati HIV-1 z zmanjšano občutljivostjo za tenofoviralafenamid izražajo mutacijo K65R v HIV-1 RT.
5 Adverse reaction identified through post-marketing surveillance for emtricitabine-containing products.
5 Neželeni učinek, opredeljen v okviru nadzora v obdobju trženja zdravil za zdravila, ki vsebujejo emtricitabin.
Intracellular tenofovir is subsequently phosphorylated to the active metabolite tenofovir diphosphate.
Znotrajcelični tenofovir se nato fosforilira v aktivni presnovek tenofovir difosfat.
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching.
Bolniki so imeli virološko supresijo (HIV-1 RNA < 50 kopij/ml) vsaj
HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
ZAVIRALCI REDUKTAZE HMG CoA atorvastatin (40 mg enkrat dnevno)/rilpivirin1
Patients had a mean age of 15 years (range 12-17), were 56% female, 12% Asian, and 88% Black.
Bolniki so imeli povprečno starost 15 let (razpon: 12-17) in 56 % je bilo žensk, 12 % Azijcev in 88 % črncev.
Co-administration of Odefsey and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Opazili so, da sočasna uporaba zdravila Odefsey in zdravil, ki inducirajo CYP3A, povzroči zmanjšanje koncentracij rilpivirina v plazmi, kar lahko potencialno povzroči izgubo virološkega odziva na zdravilo Odefsey (glejte poglavje 4.3) in možno rezistenco na rilpivirin in na razred NNRTI.
If you vomit more than 4 hours after taking Odefsey you do not need to take another tablet until your next regularly scheduled tablet.
Če bruhate več kot 4 ure po zaužitju zdravila Odefsey, vam ni treba vzeti še ene tablete, dokler ni čas za naslednjo tableto po vašem režimu jemanja.
Do not stop taking Odefsey Do not stop taking Odefsey without talking to your doctor.
Ne prenehajte jemati zdravila Odefsey, ne da bi se posvetovali z zdravnikom.
These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Ta zdravila lahko zvišajo količino rilpivirina in tenofoviralafenamida (učinkovini v zdravilu Odefsey) v vaši krvi.
e Includes patients who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
e Vključuje bolnike, ki so prekinili sodelovanje zaradi razlogov, ki niso neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3) with the components of Odefsey.
Študije na živalih z učinkovinami zdravila Odefsey ne kažejo na neposredne ali posredne škodljive vplive na sposobnost razmnoževanja (glejte poglavje 5.3).
Paracetamol (500 mg single dose)/ Rilpivirine1
ANALGETIKI paracetamol (500 mg enkratni odmerek)/rilpivirin1