natgillin/translations-raw huggingface dataset:
2 Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
2 Mutacije povezane z analogom timidina (TAM = thymidine-analogue associated mutations), vključno z D67N (n=1) in K70R (n=1).
This medicine contains 23.6 mg sodium (main component of cooking/table salt) in each tablet.
To zdravilo vsebuje 23,6 mg natrija (glavne sestavine kuhinjske soli) na tableto.
Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Kostna toksičnost je bila diagnosticirana kot osteomalacija (pri opicah) in zmanjšana mineralna gostota kosti (BMD) (pri podganah in psih).
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• majhno število belih krvnih celic (zaradi česar ste lahko bolj dovzetni za okužbo);
Liver enzyme monitoring should be considered for all patients independent of pre-existing hepatic dysfunction or other risk factors.
Pri vseh bolnikih je treba razmisliti o nadziranju jetrnih encimov, ne glede na predhodni obstoj jetrne disfunkcije ali drugih dejavnikov tveganja.
Osteonecrosis: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Osteonekroza: Poročali so o primerih osteonekroze, zlasti pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo zdravljenju CART.
While taking Atripla you may still develop infections or other illnesses associated with HIV infection.
Med jemanjem zdravila Atripla se še vedno lahko pojavijo okužbe ali druge bolezni, povezane z okužbo s HIV.
- Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
- Bupropion, zdravilo, ki se uporablja za zdravljenje depresije ali za pomoč pri odvajanju od kajenja, ker bo zdravnik morda moral prilagoditi vaš odmerek bupropiona.
Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.
Izpostavljenost efavirenzu se lahko poveča, kadar se uporablja z zdravili (npr. z ritonavirjem) ali hrano (npr. s sokom grenivke), ki zavirajo delovanje encimov CYP3A4 ali CYP2B6.
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Za odstranitev neabsorbiranega efavirenza se lahko uporabi aktivno oglje.
- anorexia
- anoreksija.
It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Priporočamo, da se zdravilo Atripla jemlje na prazen želodec, po možnosti pred spanjem.
Monitoring of renal function may be indicated, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Morda bo potrebno spremljati ledvično funkcijo, še posebej pri bolnikih s spremljajočo sistemsko ali ledvično boleznijo ali pa pri bolnikih, ki jemljejo nefrotoksična zdravila.
Stevens-Johnson syndrome, erythema multiforme3, severe rash angioedema4
Stevens-Johnsonov sindrom, multiformni eritem3, hud izpuščaj angioedem4
Efavirenz: no clinically significant interaction.
efavirenz: ni klinično pomembnih interakcij.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risk of continued therapy outweighs the benefits (see section 4.8).
Bolnikom je treba svetovati, naj se v primeru pojava simptomov, kot so huda oblika depresije, psihoza ali misel na samomor, nemudoma posvetujejo s svojim zdravnikom, ki bo ocenil, ali so simptomi povezani z jemanjem efavirenza, in odločil, ali je tveganje nadaljevanja zdravljenja z efavirenzom večje od koristi (glejte poglavje 4.8).
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Atripla.
Če jemljete katerokoli od teh zdravil, bo zdravnik morda moral preveriti raven zdravila proti epilepsiji v krvi, da se prepriča, da se med jemanjem zdravila Atripla ni spremenila.
The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Peroralna biološka uporabnost tenofovirja iz dizoproksiltenofoviratapri teščih bolnikih je bila približno 25 %.
- You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
- Med jemanjem tega zdravila lahko še vedno prenesete okužbo s HIV na druge, čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
Pharmacokinetic studies have not been performed with Atripla in infants and children under 18 years of age (see section 4.2).
Farmakokinetičnih študij z zdravilom Atripla pri dojenčkih in otrocih, starih manj kot 18 let, niso opravili (glejte poglavje 4.2).
In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Pri neokuženih prostovoljcih so 10-dnevni večkratni odmerki 200-400 mg dnevno povzročili manjšo akumulacijo zdravila od pričakovane (22-42 % manjšo) in krajši končni razpolovni čas 40-55 ur (razpolovni čas enkratnega odmerka je 52-76 ur).
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Za ocenjevanje njihove jetrne bolezni je treba v rednih presledkih opravljati laboratorijske preiskave (glejte poglavje 4.2).
Interaction only studied with sofosbuvir/velpatasvir.
Interakcije so preučili samo s sofosbuvirjem/velpatasvirjem.
These are listed under Do not take Atripla, at the start of section 2.
Ta zdravila so navedena v razdelku Ne jemljite zdravila Atripla, na začetku drugega poglavja.
Do not take a double dose to make up for a forgotten tablet.
Ne vzemite dvojnega odmerka, da bi nadomestili izpuščenega.
- Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
Neodvisno od tega, ali imate jetrno bolezen v anamnezi, bo vaš zdravnik razmislil o rednih krvnih preiskavah, da preveri, kako delujejo vaša jetra.
- if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
- če imate bolezen srca, kot je nenormalen električni signal, kar se imenuje podaljšanje intervala QT.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Po peroralni uporabi je razpolovni čas izločanja emtricitabina približno 10 ur.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Atripla and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Pred začetkom zdravljenja z zdravilom Atripla je priporočljivo določiti kreatininski očistek pri vseh bolnikih in spremljati delovanje ledvic (očistek kreatinina in koncentracija fosfatov v serumu) po dveh do štirih tednih zdravljenja, po treh mesecih zdravljenja in zatem vsake tri do šest mesecev pri bolnikih brez dejavnikov tveganja za ledvice.
abnormal dreams, insomnia
nenavadne sanje, nespečnost
These problems tend to occur more often in those who have a history of mental illness.
Te težave se pogosteje pojavijo pri bolnikih z duševno boleznijo v anamnezi.
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Razgradnja mišic, mehčanje kosti (z bolečino v kosteh in včasih zlomi), bolečina v mišicah, mišična šibkost in znižanje ravni kalija ali fosfatov v krvi so lahko posledica poškodbe celic ledvičnih tubulov.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with Atripla needs to be weighed against the potential risks of significant liver toxicity.
Če obstaja dokaz za poslabšanje jetrne bolezni ali če se pojavijo trdovratna zvišanja serumskih transaminaz na več kot 5-kratno zgornjo mejo normalne vrednosti, je treba pretehtati korist nadaljevanja zdravljenja z zdravilom Atripla in možna tveganja pomembne toksičnosti za jetra.
Efavirenz has also been shown to induce UGT1A1.
Izkazalo se je, da efavirenz spodbuja tudi UGT1A1.
• decreased sexual drive
• zmanjšana želja po spolnosti;
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• težave s spanjem, nenormalne sanje, težave s koncentracijo, dremavost;
• damage to kidney tubules
• poškodbe ledvičnih tubulov.
If you think you may have lactic acidosis, contact your doctor immediately.
Če menite, da imate laktacidozo, se takoj posvetujte s svojim zdravnikom.
Patients receiving Atripla or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Pri bolnikih, ki prejemajo zdravilo Atripla ali katerokoli drugo protiretrovirusno zdravljenje, se lahko še naprej pojavljajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV, zato morajo ostati pod skrbnim nadzorom zdravnikov z izkušnjami pri zdravljenju bolnikov z boleznimi, povezanimi s HIV.
In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Pri otrocih, katerih matere so med nosečnostjo jemale nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors), je korist zaščite pred virusom HIV odtehtala tveganje za neželene učinke.
Combination of emtricitabine and tenofovir disoproxil: Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Kombinacija emtricitabina in dizoproksiltenofovirata: Študije genotoksičnosti in toksičnosti pri ponavljajočih se odmerkih, ki so trajale en mesec ali manj pri kombinaciji teh dveh učinkovin, niso pokazale poslabšanja toksikoloških učinkov v primerjavi s študijami posameznih učinkovin.
The net effect of co-administration is not clear.
Neto učinek sočasne uporabe ni razjasnjen.
Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime.
Zdravilo Atripla morate jemati na prazen želodec (kar pomeni 1 uro pred ali 2 uri po obroku), najbolje zvečer pred spanjem.
Please refer to the Summary of Product Characteristics for these medicinal products.
Prosimo, glejte Povzetke glavnih značilnosti teh posameznih zdravil.
Total active HMG Co-A reductase inhibitors:
Skupni aktivni zaviralci HMG Co-A reduktaze:
If this is unavoidable, your doctor will monitor your kidney function once a week.
Če se sočasnemu jemanju ni mogoče izogniti, bo vaš zdravnik enkrat tedensko preverjal delovanje ledvic.
Patients either changed to Atripla (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Bolniki so zamenjali zdravljenje in začeli prejemati zdravilo Atripla (N=203) ali pa so nadaljevali prvotno protiretrovirusno zdravljenje (N = 97).
These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Ti neželeni učinki se lahko pojavijo v prvem dnevu ali prvih dveh dneh zdravljenja in navadno izginejo po prvih dveh do štirih tednih.
The potential for interactions with efavirenz and other azole antifungals, such as ketoconazole, has not been studied.
Možnosti interakcij efavirenza in drugih azolskih antimikotikov, kot je ketokonazol, niso raziskovali.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Pri sočasnem protivirusnem zdravljenju hepatitisa B ali C glejte ustrezne Povzetke glavnih značilnosti teh zdravil.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Ugotovitve pri študijah na podganah in opicah kažejo, da je prišlo do z učinkovino povezanega zmanjšanja črevesne absorpcije fosfata s potencialnim sekundarnim zmanjšanjem BMD.
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended.
Zaradi dolgega razpolovnega časa efavirenza priporočamo uporabo ustrezne kontracepcije še 12 tednov po prekinitvi zdravljenja z zdravilom Atripla.
The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Povprečje razmerja koncentracije v plazmi in krvi je bilo približno 1,0, razmerje koncentracije v spermi in plazmi pa približno 4,0.
Use of Atripla in combination with saquinavir as the sole protease inhibitor is not recommended.
Uporaba zdravila Atripla v kombinaciji s sakvinavirjem kot edinim zaviralcem proteaze ni priporočljiva.
Approximately 14 to 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Približno 14-34 % radioaktivno označenega odmerka efavirenza se je izločilo z urinom, manj kot 1 % odmerka pa se je z urinom izločilo v obliki nespremenjenega efavirenza.
However, in some patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Vendar pa pri nekaterih bolnikih upad očistka kreatinina ni povsem izzvenel, kljub prekinitvi dizoproksiltenofovirata.
Atripla is not usually taken with other medicines that can damage your kidneys (see Other medicines and Atripla).
Zdravilo Atripla se po navadi ne jemlje skupaj z drugimi zdravili, ki lahko škodijo ledvicam (glejte Druga zdravila in zdravilo Atripla).
Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Uporabi zdravila Atripla se je treba izogibati pri sočasni ali nedavni uporabi nefrotoksičnih zdravil.
Norelgestromin (active metabolite):
norelgestromin (aktivni presnovek):
Efavirenz may be an inducer of CYP2C19 and CYP2C9; however, inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Efavirenz je morda induktor encimov CYP2C19 in CYP2C9; vendar so in vitro opazili tudi zaviranje in neto učinek sočasne uporabe s substrati teh encimov ni razjasnjen (glejte poglavje 5.2).
Data are available from 286 patients who switched to Atripla: 160 had previously received efavirenz, emtricitabine and tenofovir disoproxil, and 126 had previously received Combivir and efavirenz.
Na voljo so podatki o 286 bolnikih, ki so prešli na zdravilo Atripla: 160 jih je predhodno prejemalo efavirenz, emtricitabin in dizoproksiltenofovirat, 126 pa zdravilo Combivir ter efavirenz.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki jemljejo kombinirano protiretrovirusno zdravljenje, se lahko pojavi bolezen kosti, imenovana osteonekroza (smrt kostnega tkiva zaradi slabše prekrvavitve v kosteh).
Modified LOCF: Post-hoc analysis where patients who failed virologically or discontinued for adverse events were treated as failures; for other drop-outs, the LOCF (last observation carried forward) method was applied
Prilagojeni LOCF: Post-hoc analiza pri kateri so bili bolniki z virusnim neodzivom in bolniki pri katerih je bilo zdravljenje prekinjeno zaradi pojava neželenih učinkov obravnavani kot neuspeh; pri ostalih izključenih bolnikih pa je bila uporabljena metoda LOCF (last observation carried forward).
This loss is due to significant decreases in elbasvir/grazoprevir plasma concentrations caused by CYP3A4 or P-gp induction.
Ta izguba je posledica pomembnega zmanjšanja koncentracij elbasvirja/grazoprevirja v plazmi, ki jih povzroči indukcija CYP3A4 ali P-gp.
Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, Table 1).
Izpostavljenost raltegravirju (substratu UGT1A1) se v prisotnosti efavirenza zmanjša (glejte poglavje 4.5, Tabela 1).
The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Kostna toksičnost pri mladih odraslih podganah in psih se je pojavila pri izpostavljenostih, ki so bile ≥ 5-krat večje od izpostavljenosti pri pediatričnih ali odraslih bolnikih, kostna toksičnost pa se je pojavila pri mladih okuženih opicah pri zelo visokih izpostavljenostih po subkutanem odmerjanju (≥ 40-kratna izpostavitev pri bolnikih).
Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease
Ta učinek se je pojavil večinoma pri bolnikih z obstoječo jetrno boleznijo, vendar pa obstaja nekaj poročil o pojavu pri bolnikih, ki prej niso imeli jetrne bolezni;
The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical trials (n = 3,969) or exposed to emtricitabine in randomised controlled clinical trials (n = 1,563) or exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access programme (n = 7,319).
Kategorija pogostnosti je bila ocenjena s pomočjo statističnega izračuna na podlagi skupnega števila bolnikov, zdravljenih z efavirenzom v kliničnih preskušanjih (n = 3.969) ali izpostavljenih emtricitabinu v randomiziranih kontroliranih kliničnih preskušanjih (n = 1.563) ali izpostavljenih dizoproksiltenofoviratu v randomiziranih kontroliranih kliničnih preskušanjih v razširjenjem programu dostopa (n = 7.319).
Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
Vsaka od teh učinkovin, znanih kot protiretrovirusna zdravila, zavira encim (reverzno transkriptazo), ki je nujen za razmnoževanje virusa.
Atripla has not been evaluated in the presence of food.
Zdravila Atripla v prisotnosti hrane niso ocenjevali.
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Po peroralni uporabi je razpolovni čas izločanja tenofovirja približno 12 do 18 ur.
Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz (see section 4.8).
O hudem izpuščaju, ki ga spremljajo mehurji, vlažna deskvamacija ali ulceracija, so poročali pri manj kot 1 % bolnikov, zdravljenih z efavirenzom (glejte poglavje 4.8).
- if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
- če imate bolezen srca, kot je nenormalen električni signal, kar se imenuje podaljšanje intervala QT, zaradi česar imate večje tveganje za hude težave s srčnim ritmom (torsade de pointes).
Emtricitabine is rapidly absorbed with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Emtricitabin se hitro absorbira, največje koncentracije v plazmi pa so dosežene v 1 do 2 urah po zaužitju odmerka.
Voxilaprevir:↓
Pričakovano: voksilaprevir:↓
Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
13 % odmerka emtricitabina so odkrili v urinu v obliki treh presnovkov.
Appropriate antihistamines and/or corticosteroids may improve tolerability and hasten the resolution of rash.
Ustrezni antihistaminiki in/ali kortikosteroidi lahko izboljšajo prenosljivost in pospešijo izginotje izpuščaja.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.
Steklenica iz polietilena velike gostote (HDPE) s polipropilensko za otroke varno zaporko, ki vsebuje 30 filmsko obloženih tablet in sušilo iz silikagela.
Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Klinično pomembnih interakcij ni pričakovati, saj se simeprevir in emtricitabin izločata po različnih poteh.
Following intravenous administration the volume of distribution of tenofovir was approximately 800 ml/kg.
Po intravenskem odmerku je volumen porazdelitve tenofovirja znašal približno 800 ml/kg.
- Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin.
- Zdravila za zdravljenje bakterijskih okužb, vključno s tuberkulozo in z AIDS-om povezanim kompleksom Mycobacterium avium: Klaritromicin, rifabutin, rifampicin.
If you forget to take Atripla
Če ste pozabili vzeti zdravilo Atripla
What Atripla is and what it is used for What you need to know before you take Atripla How to take Atripla
Kaj je zdravilo Atripla in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Atripla Kako jemati zdravilo Atripla Možni neželeni učinki
Darunavir/ritonavir should be used with caution in combination with Atripla.
Darunavir/ritonavir je treba v kombinaciji z zdravilom Atripla uporabljati previdno.
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Upad Cmin atazanavirja lahko negativno vpliva na njegovo učinkovitost.
Patients co-infected with HIV and HBV who discontinue Atripla must be closely monitored with both clinical and laboratory follow-up for at least four months after stopping treatment with Atripla.
Bolnike s sočasno okužbo s HIV in HBV, ki prekinejo zdravljenje z zdravilom Atripla, je treba skrbno nadzorovati s kliničnim in laboratorijskim sledenjem vsaj še štiri mesece po prekinitvi zdravljenja z zdravilom Atripla.
Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Študije genotoksičnosti so pokazale pozitivne rezultate pri testu mišjega limfoma in vitro, dvoumne rezultate pri enem od sevov, ki so ga uporabili pri Amesovem testu, in rahlo pozitivne rezultate pri testu UDS pri primarnih podganjih hepatocitih.
Adverse reactions associated with the use of Atripla: Treatment-emergent adverse reactions considered possibly or probably related to Atripla reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of Atripla, include:
Neželeni učinki, povezani z uporabo zdravila Atripla: Neželene reakcije, ki so se pojavile pri zdravljenju in so morda ali verjetno povezane z zdravilom Atripla, o katerih so poročali v študiji AI266073 (več kot 48 tednov; n = 203), ki niso bile povezane s katero od posameznih sestavin zdravila Atripla, vključujejo:
Carcinogenicity studies in male mice, male and female rats were negative.
Študije kancerogenosti pri mišjih samcih, podganjih samcih in samicah so bile negativne.
Severe hepatic impairment (CPT, Class C) (see section 5.2).
Huda jetrna okvara (razreda C po lestvici CPT) (glejte poglavje 5.2).