FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical controlled studies of efavirenz, nervous system symptoms of moderate to severe intensity were experienced by 19% (severe 2%) of patients, and 2% of patients discontinued therapy due to such symptoms.
Slovenian: V kontroliranih kliničnih študijah efavirenza je zmerne do hude simptome živčnega sistema doživelo 19 % (hude 2 %) bolnikov in 2 % bolnikov sta prenehala z zdravljenjem zaradi teh simptomov.
English: Insufficient safety data are available for children below 18 years of age.
Slovenian: Ni dovolj podatkov o varnosti pri otrocih, starih manj kot 18 let.
English: Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in elderly patients (over 65 years of age).
Slovenian: Farmakokinetične študije z efavirenzom, emtricitabinom ali tenofovirjem niso bile izvedene pri starejših bolnikih (nad 65 let starosti).
English: In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
Slovenian: Poleg tega vam bo zdravnik morda dal dodatni odmerek efavirenza za zdravljenje okužbe z virusom HIV.
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Slovenian: Rosuvastatin se v glavnem izloča nespremenjen prek blata, zato interakcij z efavirenzom ni pričakovati.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovine ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: EU/1/07/430/001 30 film-coated tablets EU/1/07/430/002 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/430/001 30 filmsko obloženih tablet EU/1/07/430/002 90 (3 vsebniki po 30) filmsko obloženih tablet
English: • a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
Slovenian: • občutek vrtenja ali nagibanja (vrtoglavica), žvižganje, piskanje ali drug vztrajen zvok v ušesu;
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Slovenian: Vendar so se po pričakovanju zvišanja AST in ALT v tej skupini bolnikov pojavila pogosteje kot v splošni populaciji bolnikov, okuženih z virusom HIV.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
Slovenian: Na splošno se priporoča, da ženske, okužene z virusom HIV, ne dojijo, da se prepreči prenos virusa HIV na dojenčka.
English: Both HIV and the ingredients of Atripla may pass through breast milk and cause serious harm to your baby.
Slovenian: Virus HIV in sestavine zdravila Atripla lahko preidejo v materino mleko ter resno škodijo otroku.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Slovenian: V nekaterih primerih bo zdravnik morda moral prilagoditi odmerek zdravila ali preveriti njegovo raven v krvi.
English: Sertraline:
Slovenian: sertralin:
English: Rare osteomalacia (manifested as bone pain and infrequently contributing to fractures)2,4, myopathy2
Slovenian: Redki osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom)2,4, miopatija4
English: Studies conducted with other medicinal products
Slovenian: Študije, opravljene z drugimi zdravili
English: In the open-label extended phase of study GS-01-934, where patients received Atripla on an empty stomach, 3 additional cases of resistance were seen.
Slovenian: V odprti podaljšani fazi študije GS-01-934, kjer so bolniki dobivali zdravilo Atripla na tešče, so opazili 3 dodatne primere odpornosti.
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Slovenian: Tenofovir se primarno izloča skozi ledvice tako z glomerulno filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenskem vnosu približno 70-80 % odmerka izloči nespremenjenega z urinom.
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Slovenian: Ne obravnava se, kot da je vzročno povezana z dizoproksiltenofoviratom v odsotnosti tega stanja.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastičnem vsebniku in škatli poleg oznake „EXP“.
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Slovenian: Zadostnih podatkov o prenašanju efavirenza v kombinaciji z majhnimi odmerki ritonavirja (100 mg, enkrat ali dvakrat na dan) ni na voljo.
English: Other macrolide antibiotics, such as erythromycin, have not been studied in combination with Atripla.
Slovenian: Drugih makrolidnih antibiotikov, kot je eritromicin, v kombinaciji z zdravilom Atripla niso preučevali.
English: - any signs of skin rash.
Slovenian: kakršnekoli znake kožnega izpuščaja.
English: The frequency of this is unknown (see section 4.4).
Slovenian: Pogostnost tega učinka ni znana (glejte poglavje 4.4).
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics.
Slovenian: Ni bilo dovolj podatkov, da bi ugotovili, ali zmerna ali huda jetrna okvara (razreda B ali C po ChildPughTurcotteovi lestvici) vpliva na farmakokinetiko efavirenza.
English: Possible serious side effects: tell your doctor immediately
Slovenian: Možni resni neželeni učinki: takoj se posvetujte z zdravnikom
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Slovenian: S hemodializo se lahko odstrani do 30 % odmerka emtricitabina in približno 10 % odmerka tenofovirja.
English: Refer to section 2 “Atripla contains sodium”.
Slovenian: Glejte poglavje 2 „Zdravilo Atripla vsebuje natrij“.
English: Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Slovenian: Zdravnik bo preveril ravni holesterola in vam po potrebi spremenil odmerek statina.
English: Both the K65R and M184V/I mutation remain fully susceptible to efavirenz.
Slovenian: Mutaciji K65R in M184V/I sta popolnoma občutljivi za efavirenz.
English: If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Atripla jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking Atripla).
Slovenian: Zato bo zdravnik morda v rednih presledkih opravil krvne preiskave, da preveri, kako dobro delujejo vaša jetra (glejte poglavje 3, Če ste prenehali jemati zdravilo Atripla).
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Slovenian: V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MGK opazili pri bolnikih, zdravljenih z dizoproksiltenofoviratom kot del režima, ki je vseboval okrepljenega zaviralca proteaze.
English: Following intravenous administration the volume of distribution of emtricitabine was approximately 1.4 l/kg.
Slovenian: Po intravenskem odmerku je volumen porazdelitve emtricitabina znašal približno 1,4 l/kg.
English: The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Slovenian: Klinični pomen te povezave ni znan, vendar pa možnost za povečanje pogostnosti in resnosti z efavirenzom povezanih neželenih učinkov ne more biti izključena.
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, antivirusna zdravila za zdravljenje infekcij s HIV-om, kombinacije, oznaka ATC: J05AR06.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three components of Atripla).
Slovenian: Pri nekaterih bolnikih so krvne preiskave ali simptomi pokazali, da se je hepatitis poslabšal po prenehanju jemanja emtricitabina ali dizoproksiltenofovirata (dve od treh učinkovin zdravila Atripla).
English: Efavirenz, one of the active components of Atripla, may remain in your blood for a time after therapy is stopped.
Slovenian: Efavirenz, ena izmed učinkovin zdravila Atripla, lahko ostane v krvi še nekaj časa po prenehanju zdravljenja.
English: Data on the clinical translation of the decrease in pharmacokinetic exposure are not available.
Slovenian: Podatki o kliničnem pomenu zmanjšanja farmakokinetične izpostavljenosti niso na voljo.
English: Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Slovenian: Izkušnje z efavirenzom pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila razreda NNRTI, so omejene.
English: Biliary fibrosis has been observed in rats.
Slovenian: Pri podganah so opazili biliarno fibrozo.
English: The silica gel desiccant is contained in a separate sachet and should not be swallowed.
Slovenian: Sušilno sredstvo iz silikagela je v posebni vrečki in ga ne smete pogoltniti.
English: Concomitant use of posaconazole and Atripla should be avoided unless the benefit to the patient outweighs the risk.
Slovenian: Sočasni uporabi pozakonazola in zdravila Atripla se je treba izogibati, razen če so koristi za bolnika večje od tveganja.
English: Efavirenz may also cause impaired concentration and/or somnolence.
Slovenian: Efavirenz lahko povzroči tudi motnje koncentracije in/ali somnolenco.
English: Immune system disorders: Common allergic reaction
Slovenian: Bolezni imunskega sistema: Pogosti alergijske reakcije
English: The pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Slovenian: Farmakokinetične lastnosti emtricitabina in tenofovirja so podobne pri bolnikih moškega in ženskega spola.
English: • breakdown of muscle, muscle pain or weakness
Slovenian: • razgradnja mišic, bolečina v mišicah ali šibkost;
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Slovenian: Biotransformacija emtricitabina vključuje oksidacijo tiolne skupine, pri čemer nastanejo diastereomeri 3'-sulfoksida (približno 9 % odmerka), in konjugacijo z glukuronsko kislino, pri čemer nastane 2'-O-glukuronid (približno 4 % odmerka).
English: PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Slovenian: PVR(KM): čisti virološki odziv, ocenjen po metodi Kaplan Meier (KM).
English: The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Slovenian: Varnosti in učinkovitosti zdravila Atripla pri zdravljenju kronične okužbe s HBV niso raziskovali.
English: Efavirenz plasma exposure may be increased in patients with homozygous G516T genetic variant of the CYP2B6 isozyme.
Slovenian: Plazemska izpostavljenost efavirenzu je lahko povečana pri bolnikih s homozigotno genetsko različico G516T izocima CYP2B6.
English: Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
Slovenian: Zaradi razlik pri teh parametrih med posameznimi bolniki in skrbi zaradi razvoja odpornosti je treba upoštevati smernice za zdravljenje okužbe z virusom HIV hkrati z razlogom za prekinitev zdravljenja.
English: Common cerebellar coordination and balance disturbances3, somnolence (2.0%)3, headache (5.7%)3, disturbance in attention (3.6%)3, dizziness dizziness headache
Slovenian: Pogosti motnje cerebelarne koordinacije in ravnotežja3, somnolenca (2,0 %)3, glavobol (5,7 %)3, motnje pozornosti (3,6 %)3, omotica omotica glavobol
English: Cholesterol levels should be periodically monitored.
Slovenian: Raven holesterola je treba redno spremljati.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Slovenian: Klinični izid opazovanega zmanjšanja najmanjše koncentracije boceprevira še ni bil neposredno ovrednoten.
English: In vitro binding of emtricitabine to human plasma proteins is < 4% and independent of concentrations over the range of 0.02 to 200 µg/ml.
Slovenian: In vitro je bila vezava emtricitabina na človeške plazemske beljakovine < 4 % in neodvisna od koncentracije v razponu med 0,02 in 200 µg/ml.
English: These immunosuppressants are not anticipated to impact exposure of efavirenz.
Slovenian: Ni pričakovati vpliva teh imunosupresivov na izpostavljenost efavirenzu.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Slovenian: Zelo je pomembno, da ne prekinete zdravljenja z zdravilom Atripla, saj se količina virusa lahko začne večati, tudi če zdravilo prenehate jemati samo za kratek čas.
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Slovenian: Emtricitabin se primarno izloča skozi ledvica - celoten odmerek se izloči z urinom (približno 86 %) in blatom (približno 14 %).
English: 2 Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Slovenian: 2 Mutacije povezane z analogom timidina (TAM = thymidine-analogue associated mutations), vključno z D67N (n=1) in K70R (n=1).
English: This medicine contains 23.6 mg sodium (main component of cooking/table salt) in each tablet.
Slovenian: To zdravilo vsebuje 23,6 mg natrija (glavne sestavine kuhinjske soli) na tableto.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Slovenian: Kostna toksičnost je bila diagnosticirana kot osteomalacija (pri opicah) in zmanjšana mineralna gostota kosti (BMD) (pri podganah in psih).
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Slovenian: • majhno število belih krvnih celic (zaradi česar ste lahko bolj dovzetni za okužbo);
English: Liver enzyme monitoring should be considered for all patients independent of pre-existing hepatic dysfunction or other risk factors.
Slovenian: Pri vseh bolnikih je treba razmisliti o nadziranju jetrnih encimov, ne glede na predhodni obstoj jetrne disfunkcije ali drugih dejavnikov tveganja.
English: Osteonecrosis: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Slovenian: Osteonekroza: Poročali so o primerih osteonekroze, zlasti pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo zdravljenju CART.
English: While taking Atripla you may still develop infections or other illnesses associated with HIV infection.
Slovenian: Med jemanjem zdravila Atripla se še vedno lahko pojavijo okužbe ali druge bolezni, povezane z okužbo s HIV.
English: - Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
Slovenian: - Bupropion, zdravilo, ki se uporablja za zdravljenje depresije ali za pomoč pri odvajanju od kajenja, ker bo zdravnik morda moral prilagoditi vaš odmerek bupropiona.
English: 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.
Slovenian: 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.
English: Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Slovenian: Za odstranitev neabsorbiranega efavirenza se lahko uporabi aktivno oglje.
English: - anorexia
Slovenian: - anoreksija.
English: It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Slovenian: Priporočamo, da se zdravilo Atripla jemlje na prazen želodec, po možnosti pred spanjem.
English: Monitoring of renal function may be indicated, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Slovenian: Morda bo potrebno spremljati ledvično funkcijo, še posebej pri bolnikih s spremljajočo sistemsko ali ledvično boleznijo ali pa pri bolnikih, ki jemljejo nefrotoksična zdravila.
English: Stevens-Johnson syndrome, erythema multiforme3, severe rash angioedema4
Slovenian: Stevens-Johnsonov sindrom, multiformni eritem3, hud izpuščaj angioedem4
English: Efavirenz: no clinically significant interaction.
Slovenian: efavirenz: ni klinično pomembnih interakcij.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Slovenian: Peroralna biološka uporabnost tenofovirja iz dizoproksiltenofoviratapri teščih bolnikih je bila približno 25 %.
English: - You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: - Med jemanjem tega zdravila lahko še vedno prenesete okužbo s HIV na druge, čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
English: Pharmacokinetic studies have not been performed with Atripla in infants and children under 18 years of age (see section 4.2).
Slovenian: Farmakokinetičnih študij z zdravilom Atripla pri dojenčkih in otrocih, starih manj kot 18 let, niso opravili (glejte poglavje 4.2).
English: 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).
Slovenian: 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).
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Slovenian: Za ocenjevanje njihove jetrne bolezni je treba v rednih presledkih opravljati laboratorijske preiskave (glejte poglavje 4.2).
English: Interaction only studied with sofosbuvir/velpatasvir.
Slovenian: Interakcije so preučili samo s sofosbuvirjem/velpatasvirjem.
English: These are listed under Do not take Atripla, at the start of section 2.
Slovenian: Ta zdravila so navedena v razdelku Ne jemljite zdravila Atripla, na začetku drugega poglavja.
English: Do not take a double dose to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili izpuščenega.
English: - Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
Slovenian: Neodvisno od tega, ali imate jetrno bolezen v anamnezi, bo vaš zdravnik razmislil o rednih krvnih preiskavah, da preveri, kako delujejo vaša jetra.
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Slovenian: - če imate bolezen srca, kot je nenormalen električni signal, kar se imenuje podaljšanje intervala QT.
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Slovenian: Po peroralni uporabi je razpolovni čas izločanja emtricitabina približno 10 ur.
English: 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.
Slovenian: 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.
English: abnormal dreams, insomnia
Slovenian: nenavadne sanje, nespečnost
English: These problems tend to occur more often in those who have a history of mental illness.
Slovenian: Te težave se pogosteje pojavijo pri bolnikih z duševno boleznijo v anamnezi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Efavirenz has also been shown to induce UGT1A1.
Slovenian: Izkazalo se je, da efavirenz spodbuja tudi UGT1A1.
English: • decreased sexual drive
Slovenian: • zmanjšana želja po spolnosti;
English: • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
Slovenian: • težave s spanjem, nenormalne sanje, težave s koncentracijo, dremavost;
English: • damage to kidney tubules
Slovenian: • poškodbe ledvičnih tubulov.
English: If you think you may have lactic acidosis, contact your doctor immediately.
Slovenian: Če menite, da imate laktacidozo, se takoj posvetujte s svojim zdravnikom.