natgillin/translations-raw huggingface dataset:
ethinylestradiol AUC ↑ 1.22 (1.13-1.31) ethinylestradiol Cmin ↔ 1.09 (1.01-1.18) ethinylestradiol Cmax ↑ 1.33 (1.21-1.46) norethindrone AUC ↔ 0.95 (0.90-0.99) norethindrone Cmin ↓ 0.78 (0.68-0.90) norethindrone Cmax ↔ 1.05 (0.98-1.12) etravirine AUC ↔ a etravirine Cmin ↔ a etravirine Cmax ↔ a
etinilestradiol AUC ↑ 1, 22 (1, 13- 1, 31) etinilestradiol Cmin ↔ 1, 09 (1, 01- 1, 18) etinilestradiol Cmax ↑ 1, 33 (1, 21- 1, 46) noretisteron AUC ↔ 0, 95 (0, 90- 0, 99) noretisteron Cmin ↓ 0, 78 (0, 68- 0, 90) noretisteron Cmax ↔ 1, 05 (0, 98- 1, 12) etravirin AUC ↔a etravirin Cmin ↔a etravirin Cmax ↔a
The combination of estrogen- and/ or progesterone-based contraceptives and INTELENCE can be used without dose adjustment.
Kombinacijo estrogenskih in/ ali progesteronskih kontraceptivov in zdravila INTELENCE lahko uporabljate brez prilagoditve odmerka.
St John’ s wort is expected to decrease the plasma concentrations of etravirine.
Pričakovati je, da bi sočasna uporaba povzročila zmanjšanje plazemskih koncentracij etravirina.
HMG CO-A REDUCTASE INHIBITORS
ZAVIRALCI HMG CO- A REDUKTAZE
Atorvastatin 40 mg q. d.
atorvastatin 40 mg q. d.
atorvastatin AUC ↓ 0.63 (0.58-0.68) atorvastatin Cmin ND atorvastatin Cmax ↓ 1.04 (0.84-1.30) 2-OH-atorvastatin AUC ↑ 1.27 (1.19-1.36) 2-OH-atorvastatin Cmin ND 2-OH-atorvastatin Cmax ↑ 1.76 (1.60-1.94) etravirine AUC ↔ 1.02 (0.97-1.07) etravirine Cmin ↔ 1.10 (1.02-1.19) etravirine Cmax ↔ 0.97 (0.93-1.02)
atorvastatin AUC ↓ 0, 63 (0, 58- 0, 68) atorvastatin Cmin ND atorvastatin Cmax ↓ 1, 04 (0, 84- 1, 30) 2- OH- atorvastatin AUC ↑ 1, 27 (1, 19- 1, 36) 2- OH- atorvastatin Cmin ND 2- OH- atorvastatin Cmax ↑ 1, 76 (1, 60- 1, 94) etravirin AUC ↔ 1, 02 (0, 97- 1, 07) etravirin Cmin ↔ 1, 10 (1, 02- 1, 19) etravirin Cmax ↔ 0, 97 (0, 93- 1, 02)
Fluvastatin Lovastatin Pravastatin Rosuvastatin Simvastatin
fluvastatin lovastatin pravastatin rosuvastatin simvastatin
No interaction between pravastatin and INTELENCE is expected.
Ni pričakovati nobenih medsebojnih delovanj med pravastatinom in zdravilom INTELENCE.
Lovastatin, rosuvastatin and simvastatin are CYP3A4 substrates and co-administration with INTELENCE may result in lower plasma concentrations of the HMG Co-A reductase inhibitor.
Lovastatin, rosuvastatin in simvastatin so substrati za CYP3A4 in njihova sočasna uporaba z zdravilom INTELENCE lahko povzroči manjše plazemske koncentracije zaviralca HMG Co- A reduktaze.
Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with INTELENCE may result in higher plasma concentrations of the HMG Co-A reductase inhibitor.
Fluvastatin in rosuvastatin se presnavljata s CYP2C9 in njuna sočasna uporaba z zdravilom INTELENCE lahko vodi do večjih plazemskih koncentracij zaviralca HMG Co- A reduktaze.
Dose adjustments for these HMG Co-A reductase inhibitors may be necessary.
Za te zaviralce HMG Co- A reduktaze je lahko potrebna prilagoditev odmerka.
Cyclosporine Sirolimus Tacrolimus
ciklosporin sirolimus takrolimus
Etravirine is expected to decrease plasma concentrations of cyclosporine, sirolimus or tacrolimus.
Pričakovati je, da etravirin zmanjša plazemske koncentracije ciklosporina, sirolimusa ali takrolimusa.
Co-administration with systemic immunosuppressants should be done with caution because plasma concentrations of cyclosporine, sirolimus or tacrolimus may be affected when co-administered with INTELENCE.
Pri sočasni uporabi s sistemskimi imunosupresivi je potrebna previdnost, ker so lahko plazemske koncentracije ciklosporina, sirolimusa ali takrolimusa spremenjene pri njihovi sočasni uporabi z zdravilom INTELENCE.
Methadone individual dose ranging from 60 mg to 130 mg q. d.
metadon enkratni odmerki od 60 mg to 130 mg q. d.
PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS
ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE- 5)
Sildenafil 50 mg single dose Vardenafil Tadalafil
sildenafil 50 mg enkraten odmerek vardenafil tadalafil
sildenafil AUC ↓ 0.43 (0.36-0.51) sildenafil Cmin ND sildenafil Cmax ↓ 0.55 (0.40-0.75) N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) N-desmethyl-sildenafil Cmin ND N-desmethyl-sildenafil Cmax ↓ 0.75 (0.59-0.96)
sildenafil AUC ↓ 0, 43 (0, 36- 0, 51) sildenafil Cmin ND sildenafil Cmax ↓ 0, 55 (0, 40- 0, 75) N- demetil- sildenafil AUC ↓ 0, 59 (0, 52- 0, 68) N- demetil- sildenafil Cmin ND N- demetil- sildenafil Cmax ↓ 0, 75 (0, 59- 0, 96)
Concomitant use of PDE-5 inhibitors with INTELENCE may require dose adjustment of the PDE-5 inhibitor to attain the desired clinical effect.
Pri sočasni uporabi zaviralcev PDE- 5 z zdravilom INTELENCE je lahko potrebna prilagoditev odmerka zaviralca PDE- 5 za doseganje želenega kliničnega učinka.
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
SELEKTIVNI ZAVIRALCI PONOVNEGA PRIVZEMA SEROTONINA (SSRI)
Paroxetine 20 mg q. d.
paroksetin 20 mg q. d.
paroxetine AUC ↔ 1.03 (0.90-1.18) paroxetine Cmin ↓ 0.87 (0.75-1.02) paroxetine Cmax ↔ 1.06 (0.95-1.20) etravirine AUC ↔ 1.01 (0.93-1.10) etravirine Cmin ↔ 1.07 (0.98-1.17) etravirine Cmax ↔ 1.05 (0.96-1.15)
paroksetin AUC ↔ 1, 03 (0, 90- 1, 18) paroksetin Cmin ↓ 0, 87 (0, 75- 1, 02) paroksetin Cmax ↔ 1, 06 (0, 95- 1, 20) etravirin AUC ↔ 1, 01 (0, 93- 1, 10) etravirin Cmin ↔ 1, 07 (0, 98- 1, 17) etravirin Cmax ↔ 1, 05 (0, 96- 1, 15)
Note:
Primerjava temelji na zgodovinski kontroli Opomba:
In drug-drug interaction studies, different formulations and/ or doses of etravirine were used which led to similar exposures and, therefore, interactions relevant for one formulation are relevant for the other.
V študijah medsebojnih delovanj med zdravili so uporabljali različne oblike in/ ali odmerke etravirina, s čimer so dosegli podobne stopnje izpostavljenosti, zato veljajo medsebojna delovanja, ki se nanašajo na eno obliko, hkrati tudi za drugo.
Pregnancy There are no adequate and well-controlled studies with etravirine in pregnant women.
Nosečnost Ni ustreznih in dobro nadzorovanih študij uporabe etravirina pri nosečnicah.
Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka in ploda, porod ali poporodni razvoj (glejte poglavje 5. 3).
INTELENCE should be used during pregnancy only if the potential benefit justifies the potential risk.
Zdravilo INTELENCE smete uporabljati v času nosečnosti samo, če morebitne koristi odtehtajo potencialno tveganje.
Breastfeeding It is not known whether etravirine is excreted in human milk.
Dojenje Ni znano, ali se etravirin izloča v materino mleko pri človeku.
Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed if they are receiving INTELENCE.
Zaradi nevarnosti prenosa virusa HIV in možnosti pojava neželenih učinkov pri dojenčkih morate matere poučiti, da med jemanjem zdravila INTELENCE ne smejo dojiti.
Fertility No human data on the effect of etravirine on fertility are available.
Plodnost Ni podatkov o vplivu etravirina na plodnost pri človeku.
In rats, there was no effect on mating or fertility with etravirine treatment (see section 5.3).
Pri podganah niso opazili vpliva na parjenje ali plodnost med zdravljenjem z etravirinom (glejte poglavje 5. 3).
No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed.
Študij o vplivu zdravila INTELENCE na sposobnost vožnje in upravljanja s stroji niso izvedli.
Adverse drug reactions such as somnolence and vertigo have been reported in INTELENCE treated subjects at incidences similar to placebo (see section 4.8).
Pojavnost neželenih učinkov kot sta somnolenca in vrtoglavica je bila pri preiskovancih, ki so jih zdravili z zdravilom INTELENCE, podobna kot pri placebu (glejte poglavje 4. 8).
There is no evidence that INTELENCE may alter the patient’ s ability to drive and operate machines, however, the adverse drug reaction profile should be taken into account.
Ni dokazov o tem, da bi zdravilo INTELENCE spremenilo bolnikovo sposobnost vožnje in upravljanja s stroji, vendar je treba kljub temu upoštevati profil njegovih neželenih učinkov.
The safety assessment is based on all data from 1,203 patients in the ongoing Phase III placebo-controlled trials DUET-1 and DUET-2 in antiretroviral treatment-experienced HIV-1 infected adult patients, 599 of whom received INTELENCE (200 mg b. i. d.) (see section 5.1).
Gre za odrasle bolnike, okužene s HIV- 1, ki so že prejeli protiretrovirusno zdravljenje, od tega jih je 599 prejemalo zdravilo INTELENCE (200 mg b. i. d.) (glejte poglavje 5. 1).
In these pooled trials, the median exposure for patients in the INTELENCE arm was 30 weeks.
V teh združenih preskušanjih je znašala mediana vrednost stopnje izpostavljenosti zdravilu pri bolnikih iz kraka študije z zdravilom INTELENCE 30 tednov.
The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 10% in the INTELENCE arm) of all intensities occurring in the Phase III studies were rash (17.0% in the INTELENCE arm versus 9.4% in the placebo arm), diarrhoea (15.0% versus 20.4%) and nausea (13.9% versus 11.1%).
Neželeni učinki (ADR) vseh jakosti (incidenca ≥ 10% v kraku študije z zdravilom INTELENCE), o katerih so najpogosteje poročali, in so se pojavljali v študijah III. faze, so bili: izpuščaj (17, 0% v kraku študije z zdravilom INTELENCE v primerjavi z 9, 4% v kraku študije s placebom), driska (15, 0% v primerjavi z 20, 4%) in navzea (13, 9% v primerjavi z 11, 1%).
The rates of discontinuation due to any adverse reaction were 5.8% in patients receiving INTELENCE and 4.5% in patients receiving placebo.
Pogostnosti ukinitve zdravila zaradi kateregakoli neželenega učinka sta znašali 5, 8% pri bolnikih, ki so prejemali zdravilo INTELENCE, in 4, 5% pri tistih, ki so prejemali placebo.
The most common ADR leading to discontinuation was rash (2.0% in the INTELENCE arm versus 0% in the placebo arm).
Najpogostejši neželeni učinek, ki je vodil do ukinitve zdravila, je bil izpuščaj (2, 0% v kraku študije z zdravilom INTELENCE v primerjavi z 0% v kraku študije s placebom).
Rash was most frequently mild to moderate, generally macular to maculopapular or erythematous, mostly occurred in the second week of therapy, and was infrequent after week 4.
Večinoma se je pojavljal v drugem tednu zdravljenja, po četrtem tednu je bil redek.
Rash was mostly self-limiting, and generally resolved within 1-2 weeks on continued therapy (see section 4.4).
10 Izpuščaj je bil večinoma omejen in je običajno minil po 1 do 2 tednih nadaljnjega zdravljenja (glejte poglavje 4. 4).
The incidence of rash was higher in women compared to men in the INTELENCE arm.
Incidenca tega izpuščaja je bila večja pri ženskah kot pri moških iz kraka študije z zdravilom INTELENCE.
The clinical data are limited and
Kar zadeva izrazitost izpuščaja ali ukinitev zdravila zaradi izpuščaja med spoloma ni bilo razlik.
10 an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reaction cannot be excluded (see section 4.4).
Klinični podatki so omejeni in povečanega tveganja za pojav kožnih reakcij pri bolnikih, ki so imeli v anamnezi kožne reakcije, povezane z jemanjem NNRTI, ni mogoče izključiti (glejte poglavje 4. 4).
ADRs of moderate intensity or greater (≥ grade 2) reported in patients treated with INTELENCE are summarised in the table below (background regimen is indicated as “ BR”).
Neželeni učinki (ADR) zmerne jakosti ali hujši (≥ 2. stopnje), o katerih so poročali pri bolnikih, zdravljenih z zdravilom INTELENCE, so povzeti v spodnji preglednici (osnovna shema zdravljenja je navedena kot “ BR ”).
Laboratory abnormalities considered ADRs are included in a paragraph below the table.
Nenormalni izvidi laboratorijskih preiskav, ki štejejo za neželene učinke, pa so našteti v odstavku pod preglednico.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100).
Po pogostnosti so neželeni učinki opredeljeni kot zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10) in občasni (≥ 1/ 1. 000 do < 1/ 100).
DUET-1 and DUET-2 trials System Organ Class (SOC)
Preskušanji DUET- 1 in DUET- 2 Razvrstitev po organskih sistemih (SOC)
myocardial infarction (0.5% vs 0.2%), atrial fibrillation (0.2% vs 0%), angina pectoris (0.3% vs 0.2%)
miokardni infarkt (0, 5% v primerjavi z 0, 2%), atrijska fibrilacija (0, 2% v primerjavi z 0%), angina pektoris (0, 3% v primerjavi z 0, 2%)
thrombocytopaenia (1.3% vs 1.3%), anaemia (3.5% vs 3.6%)
trombocitopenija (1, 3% v primerjavi z 1, 3%), anemija (3, 5% v primerjavi s 3, 6%)
common uncommon
občasni
peripheral neuropathy (2.8% vs 1.8%), headache (2.7% vs 4.1%) convulsion (0.3% vs 0.5%), syncope (0.3% vs 0.3%), amnesia (0.2% vs 0.2%), tremor (0.2% vs 0.3%), somnolence (0.7% vs 0.5%), paraesthesia (0.7% vs 0.7%), hypoaesthesia (0.3% vs 0.2%), hypersomnia (0.2% vs 0%)
konvulzije (0, 3% v primerjavi z 0, 5%), sinkopa (0, 3% v primerjavi z 0, 3%), amnezija (0, 2% v primerjavi z 0, 2%), tremor (0, 2% v primerjavi z 0, 3%), somnolenca (0, 7% v primerjavi z 0, 5%), parestezije (0, 7% v primerjavi z 0, 7%), hipestezija (0, 3% v primerjavi z 0, 2%), hipersomnija (0, 2% v primerjavi z 0%)
uncommon uncommon
občasni občasni
blurred vision (0.7% vs 0%) vertigo (0.2% vs 0.5%)
zamegljen vid (0, 7% v primerjavi z 0%) vrtoglavica (0, 2% v primerjavi z 0, 5%)
bronchospasm (0.2% vs 0%), exertional dyspnoea (0.5% vs 0.5%)
bronhospazem (0, 2% v primerjavi z 0%), dispneja pri naporu (0, 5% v primerjavi z 0, 5%)
gastrooesophageal reflux disease (1.5% vs 1.0%), diarrhoea (5.2% vs 9.6%), vomiting (2.3% vs 2.0%), nausea (4.7% vs 3.5%), abdominal pain (3.0% vs 2.5%), flatulence (1.0% vs 1.0%), gastritis (1.0% vs 0.7%)
gastroezofagealni refluks (1, 5% v primerjavi z 1, 0%), driska (5, 2% v primerjavi z 9, 6%), bruhanje (2, 3% v primerjavi z 2, 0%), navzea (4, 7% v primerjavi s 3, 5%), trebušne bolečine (3, 0% v primerjavi z 2, 5%), napenjanje (1, 0% v primerjavi z 1, 0%), gastritis (1, 0% v primerjavi z 0, 7%)
pancreatitis (0.7% vs 0.2%), haematemesis (0.2% vs 0%), stomatitis (0.2% vs 0.2%), constipation (0.3% vs 0.5%), abdominal distension (0.7% vs 1.0%), dry mouth (0.2% vs 0%), retching (0.2% vs 0%)
pankreatitis (0, 7% v primerjavi z 0, 2%), hematemeza (0, 2% v primerjavi z 0%), stomatitis (0, 2% v primerjavi z 0, 2%), zaprtje (0, 3% v primerjavi z 0, 5%), napihnjenost trebuha (0, 7% v primerjavi z 1, 0%), suha usta (0, 2% v primerjavi z 0%), siljenje na bruhanje ali bruhanje (0, 2% v primerjavi z 0%)
Renal and urinary disorders
Bolezni sečil Bolezni kože in
common
pogosti pogosti
renal failure (1.5% vs 1.5%)
ledvična odpoved (1, 5% v primerjavi z 1, 5%) izpuščaj (9, 0% v primerjavi s 3, 2%)
Skin and subcutaneous tissue disorders
11 podkožja
rash (9.0% vs 3.2%) swelling face (0.2% vs 0%), lipohypertrophy (0.3% vs 0.3%), night sweats (0.8% vs 0.8%), hyperhidrosis (0.5% vs 0.2%), prurigo (0.5% vs 0.5%), dry skin (0.3% vs 0.2%)
otekanje obraza (0, 2% v primerjavi z 0%), lipohipertrofija (0, 3% v primerjavi z 0, 3%), nočno potenje (0, 8% v primerjavi z 0, 8%), hiperhidroza (0, 5% v primerjavi z 0, 2%), prurigo (0, 5% v primerjavi z 0, 5%), suha koža (0, 3% v primerjavi z 0, 2%)
diabetes mellitus (1.0% vs 0.2%), hyperglycaemia (1.2% vs 0.5%), hypercholesterolaemia (3.5% vs 2.2%), hypertriglyceridaemia (4.7% vs 3.0%), hyperlipidaemia (1.5% vs 0.7%), dyslipidaemia (1.0% vs 0.3%)
sladkorna bolezen (1, 0% v primerjavi z 0, 2%), hiperglikemija (1, 2% v primerjavi z 0, 5%), hiperholesterolemija (3, 5% v primerjavi z 2, 2%), hipertrigliceridemija (4, 7% v primerjavi s 3, 0%), hiperlipidemija (1, 5% v primerjavi z 0, 7%), dislipidemija (1, 0% v primerjavi z 0, 3%)
anorexia (0.7% vs 0.8%)
anoreksija (0, 7% v primerjavi z 0, 8%)
common common uncommon
pogosti pogosti občasni
hypertension (2.8% vs 2.2%) fatigue (3.3% vs 4.0%) sluggishness (0.2% vs 0%)
hipertenzija (2, 8% v primerjavi z 2, 2%) utrujenost (3, 3% v primerjavi s 4, 0%) upočasnjenost (0, 2% v primerjavi z 0%)
immune reconstitution syndrome (0.2% vs 0.2%), drug hypersensitivity (0.7% vs 0.7%)
sindrom imunske reaktivacije (0, 2% v primerjavi z 0, 2%), preobčutljivost za zdravila (0, 7% v primerjavi z 0, 7%)
hepatitis (0.2% vs 0.3%), hepatic steatosis (0.2% vs 0%), cytolytic hepatitis (0.3% vs 0%), hepatomegaly (0.2% vs 0.2%)
hepatitis (0, 2% v primerjavi z 0, 3%), steatoza jeter (0, 2% v primerjavi z 0%), citolitični hepatitis (0, 3% v primerjavi z 0%), hepatomegalija (0, 2% v primerjavi z 0, 2%)
gynaecomastia (0.2% vs 0%)
ginekomastija (0, 2% v primerjavi z 0%)
anxiety (1.2% vs 1.7%), insomnia (1.8% vs 2.2%) confusional state (0.2% vs 0.2%), disorientation (0.2% vs 0.3%), nightmares (0.2% vs 0.2%), sleep disorders (0.5% vs 0.3%), nervousness (0.2% vs 0.2%), abnormal dreams (0.2% vs 0.2%)
zmedenost (0, 2% v primerjavi z 0, 2%), dezorientacija (0, 2% v primerjavi z 0, 3%), nočne more (0, 2% v primerjavi z 0, 2%), motnje spanja (0, 5% v primerjavi z 0, 3%), živčnost (0, 2% v primerjavi z 0, 2%), nenormalne sanje (0, 2% v primerjavi z 0, 2%)
Additional ADRs of at least moderate intensity observed in other trials were acquired lipodystrophy, angioneurotic oedema, erythema multiforme and haemorrhagic stroke, each reported in no more than 0.5% of patients.
Dodatni neželeni učinki najmanj zmerne jakosti, ki so jih opazili v drugih preskušanjih, so bili pridobljena lipodistrofija, angionevrotični edem, multiformni eritem in hemoragični možganski inzult
Stevens-Johnson Syndrome has been reported rarely (< 0.1%) during clinical development with INTELENCE.
redko (< 0, 1%) v kliničnem poteku zdravljenja z zdravilom INTELENCE.
Laboratory abnormalities Treatment emergent clinical laboratory abnormalities (grade 3 or 4), considered ADRs, reported in ≥ 2% of patients in the INTELENCE arm versus the placebo arm, respectively, were increases in amylase (7.5% vs 7.9%), lipase (2.7% vs 1.7%), total cholesterol (5.8% vs 4.1%), low density lipoprotein (LDL) (5.2% vs 5.4%), triglycerides (7.0% vs 4.3%), glucose (2.5% vs 2.0%), alanine aminotransferase (ALT) (2.5% vs 1.7%), aspartate amino transferase (AST) (2.5% vs 1.7%) and decreases in neutrophils (3.7% vs 6.3%).
Nenormalni izvidi laboratorijskih preiskav Nenormalni izvidi kliničnih laboratorijskih preiskav, ki so se pojavili med zdravljenjem (3. ali 4. stopnje) in so sodili med neželene učinke zdravila, ter so o njih poročali pri ≥ 2% bolnikov iz kraka študije prejemnikov zdravila INTELENCE v primerjavi s krakom študije prejemnikov placeba, so bili: povečanje vrednosti amilaze (7, 5% v primerjavi s 7, 9%), vrednosti lipaze (2, 7% v primerjavi z 1, 7%), skupne vrednosti holesterola (5, 8% v primerjavi s 4, 1%), vrednosti lipoproteinov majhne gostote (LDL) (5, 2% v primerjavi s 5, 4%), vrednosti trigliceridov (7, 0% v primerjavi s 4, 3%), vrednosti glukoze (2, 5% v primerjavi z 2, 0%), vrednosti alanin aminotransferaze (ALT) (2, 5% v primerjavi z 1, 7%) in vrednosti aspartat aminotransferaze (AST) (2, 5% v primerjavi z 1, 7%) ter zmanjšanje števila nevtrofilcev (3, 7% v primerjavi s 6, 3%).
Lipodystrophy Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
Lipodistrofija Kombinirana protiretrovirusna terapija je bila povezana s prerazporeditvijo telesnega maščevja (lipodistrofijo) pri bolnikih, okuženih s HIV, vključno z izgubo perifernega in obraznega subkutanega maščevja, povečanjem količine intraabdominalnega in visceralnega maščevja, hipertrofijo prsi in dorzocervikalnim kopičenjem maščevja (bivolja grba) (glejte poglavje 4. 4).
Immune reconstitution syndrome In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (immune reconstitution syndrome) (see section 4.4).
Sindrom imunske reaktivacije Pri bolnikih, okuženih s HIV, ki imajo hudo imunsko pomanjkljivost v času uvedbe kombinirane protiretrovirusne terapije, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične okužbe (sindrom imunske reaktivacije) (glejte poglavje 4. 4).
Osteonecrosis Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy.
12 Osteonekroza Poročali so o primerih osteonekroze, še posebej pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo okužbo s HIV in/ ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji.
The frequency of this is unknown (see section 4.4).
Pogostnost tega pojava ni znana (glejte poglavje 4. 4).
Additional information on special populations Patients co-infected with hepatitis B and/ or hepatitis C virus In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with INTELENCE compared to co-infected subjects in the placebo group.
Dodatne informacije o posebnih populacijah bolnikov Bolniki, ki so sočasno okuženi z virusom hepatitisa B in/ ali virusom hepatitisa C V združeni analizi izsledkov preskušanj DUET- 1 in DUET- 2 je bila pojavnost jetrnih dogodkov pri sočasno okuženih bolnikih, ki so jih zdravili z zdravilom INTELENCE, višja v primerjavi s sočasno okuženimi bolniki, ki so prejemali placebo.
INTELENCE should be used with caution in these patients (see also sections 4.4 and 5.2).
Pri teh bolnikih je potrebna previdnost pri uporabi zdravila INTELENCE (glejte tudi poglavji 4. 4 in 5. 2).
If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage.
Če je indicirano, lahko neabsorbirano zdravilno učinkovino odstranite tako, da izzovete bruhanje ali mu izperete želodec.
NNRTI (non-nucleoside reverse transcriptase inhibitor), ATC code: not yet assigned.
NNRTI (nenukleozidni zaviralec reverzne transkriptaze), oznaka ATC: še ni določena.
Mechanism of action Etravirine is an NNRTI of human immunodeficiency virus type 1 (HIV-1).
Mehanizem delovanja Etravirin je nenukleozidni zaviralec reverzne transkriptaze virusa človeške imunske pomanjkljivosti tipa 1 (HIV- 1).
Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Etravirin se veže naravnost na reverzno transkriptazo (RT) in zavira od RNA in od DNA odvisno aktivnost DNA polimeraze tako, da povzroči motnje na katalitičnem mestu encima.
Antiviral activity in vitro Etravirine exhibits activity against wild type HIV-1 in T-cell lines and primary cells with median EC50 values ranging from 0.9 to 5.5 nM.
Protivirusno delovanje in vitro Etravirin deluje proti divjemu tipu HIV- 1 v linijah celic T in v primarnih celicah, pri čemer se njegova mediana vrednost EC50 giblje v razponu od 0, 9 do 5, 5 nM (nmol/ l).
Etravirine demonstrates activity against HIV-1 group M (subtypes A, B, C, D, E, F, and G) and HIV-1 group O primary isolates with EC50 values ranging from 0.3 to 1.7 nM and from 11.5 to 21.7 nM, respectively.
Etravirin je pokazal delovanje tudi proti primarnim izolatom HIV- 1 iz skupine M (podtipi A, B, C, D, E, F in G) z vrednostmi EC50 v razponu od 0, 3 do 1, 7 nM ter primarnim izolatom HIV- 1 iz skupine O z vrednostmi EC50 v razponu od 11, 5 do 21, 7 nM.
Although etravirine demonstrates in vitro activity against wild type HIV-2 with median EC50 values ranging from 5.7 to 7.2 µM, treatment of HIV-2 infection with etravirine is not recommended in the absence of clinical data.
Čeprav je in vitro etravirin pokazal delovanje tudi proti divjemu tipu HIV- 2 z mediano vrednostjo EC50 v razponu od 5, 7 do 7, 2 µM, zdravljenje okužbe s HIV- 2 z etravirinom ni priporočljivo, ker ni kliničnih podatkov.
Etravirine retains activity against HIV-1 viral strains resistant to nucleoside reverse transcriptase and/ or protease inhibitors.
Etravirin je ohranil tudi delovanje proti virusnim sevom HIV- 1, ki so odporni za zaviralce nukleozidne reverzne transkriptaze in/ ali zaviralce proteaze.