natgillin/translations-raw huggingface dataset:
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Umrljivost pri laktacidozi je velika in je lahko povezana s pankreatitisom in jetrno ali ledvično odpovedjo.
Lactic acidosis generally occurred after a few or several months of treatment.
Laktacidoza se je na splošno pojavila po nekaj ali več mesecih zdravljenja.
Treatment with nucleoside analogues must be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Zdravljenje z nukleozidnimi analogi je treba prekiniti, kadar se pojavijo simptomatska hiperlaktatemija in metabolna acidoza/ laktacidoza, progresivna hepatomegalija ali hitro rastoče koncentracije aminotransferaze.
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
4 Pri dajanju nukleozidnih analogov kateremukoli bolniku (zlasti ženskam s prekomerno telesno maso) s hepatomegalijo, hepatitisom ali drugim znanim dejavnikom tveganja za bolezen jeter in jetrno steatozo (vključno z nekaterimi zdravili in alkoholom) je potrebna previdnost.
Co-infection with hepatitis C and treatment with alpha interferon and ribavirin may constitute a special risk.
Sočasna okužba z virusom hepatitisa C in zdravljenje z interferonom alfa in ribavirinom lahko predstavljata posebno tveganje.
Patients at increased risk must be followed closely.
Bolnike s povečanim tveganjem je treba pozorno spremljati.
Opportunistic infections: 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.
Oportunistične okužbe: 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.
Transmission of HIV: patients must be advised that antiretroviral therapies, including Atripla, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Prenos virusa HIV: bolnike je treba seznaniti s tem, da za protiretrovirusno zdravljenje, vključno z zdravljenjem z zdravilom Atripla, ni bilo dokazano, da bi preprečevalo nevarnost prenosa virusa HIV na druge osebe s spolnimi odnosi ali okuženo krvjo.
Appropriate precautions must continue to be used.
Še naprej morajo uporabljati ustrezno zaščito.
Liver disease: the pharmacokinetics, safety and efficacy of Atripla have not been established in patients with significant underlying liver disorders (see section 5.2).
Okvare jeter: farmakokinetike, varnosti in učinkovitosti zdravila Atripla pri bolnikih s pomembnimi obstoječimi jetrnimi boleznimi niso ugotovili (glejte poglavje 5. 2).
Since efavirenz is principally metabolised
Uporaba zdravila Atripla je kontraindicirana pri bolnikih s hudo jetrno okvaro (glejte poglavje 4. 3).
4 by the cytochrome P450 (CYP450) system, caution should be exercised in administering Atripla to patients with mild-to-moderate liver disease.
Efavirenz predvsem presnavlja sistem citokrom P450 (CYP450), zato je pri uporabi zdravila Atripla pri bolnikih z blago do zmerno jetrno boleznijo potrebna previdnost.
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).
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pri bolnikih z obstoječo motnjo delovanja jeter, vključno s kroničnim aktivnim hepatitisom, je pogostnost nepravilnosti v delovanju jeter med kombiniranim protiretrovirusnim zdravljenjem večja, zato jih je treba spremljati skladno s standardno prakso.
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.
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Pri takih bolnikih je treba pretehtati možnost prekinitve ali prenehanja zdravljenja (glejte poglavje 4. 8).
Patients with HIV and hepatitis B (HBV) or C virus (HCV) co-infection: patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolniki s sočasno okužbo z virusom HIV in s hepatitisom B (HBV) ali C (HCV): pri bolnikih s kroničnim hepatitisom B ali C, ki prejemajo kombinirano protiretrovirusno zdravljenje, je tveganje za hude in potencialno smrtne neželene učinke v jetrih povečano.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Pri farmakodinamičnih študijah samostojnega in kombiniranega zdravljenja z emtricitabinom in tenofovirjem so ugotovili delovanje proti HBV (glejte poglavje 5. 1).
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Omejene klinične izkušnje kažejo, da emtricitabin in tenofovirdizoproksil fumarat v protiretrovirusnem kombiniranem zdravljenju za nadzor okužbe s HIV kažeta delovanje proti HBV.
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
If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Mogoče bo upravičena ponovna uvedba zdravljenja hepatitisa B.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Pri bolnikih z napredovalo jetrno boleznijo ali cirozo jeter prekinitev zdravljenja ni priporočljiva, poslabšanje hepatitisa po zdravljenju namreč lahko povzroči jetrno dekompenzacijo.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Psihiatrični simptomi: pri bolnikih, ki so prejemali efavirenz, so poročali o psihiatričnih neželenih učinkih.
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Videti je, da je pri bolnikih s psihiatričnimi boleznimi v anamnezi, tveganje za te resne psihiatrične neželene učinke večje.
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).
Nervous system symptoms: symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Simptomi živčevja: v kliničnih študijah pri bolnikih, ki so prejemali 600 mg efavirenza na dan, so pogosto poročali o neželenih učinkih, ki so med drugim vključevali naslednje simptome: omotico, nespečnost, somnolenco, motnje koncentracije in nenormalne sanje.
Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil fumarate.
Omotico so opazili tudi v kliničnih študijah z emtricitabinom in tenofovirdizoproksil fumaratom.
Headache has been reported in clinical studies with emtricitabine (see section 4.8).
V kliničnih študijah z emtricitabinom so poročali tudi o glavobolu (glejte poglavje 4. 8).
5 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of a known medical history of seizures.
Epileptični napadi: pri bolnikih, ki se zdravijo z efavirenzom, so opazili konvulzije, navadno pri bolnikih z epileptičnimi napadi v anamnezi.
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
V študiji interakcij med zdravili so se plazemske koncentracije karbamazepina zmanjšale pri sočasni uporabi karbamazepina z efavirenzom (glejte poglavje 4. 5).
Atripla is not recommended for patients with moderate or severe renal impairment.
Uporabe zdravila Atripla pri bolnikih z zmerno ali hudo ledvično okvaro ne priporočamo.
Patients with moderate or severe renal impairment require a dose adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Pri bolnikih z zmerno ali hudo ledvično okvaro je potrebna prilagoditev odmerkov emtricitabina in tenofovirdizoproksil fumarata, ki je ni mogoče doseči s kombinirano tableto (glejte poglavji 4. 2 in 5. 2).
If concomitant use of Atripla and nephrotoxic agents (e. g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) is unavoidable, renal function must be monitored weekly (see section 4.5).
Če se sočasni uporabi zdravila Atripla in nefrotoksičnih zdravil (npr. aminoglikozidov, amfotericina B, foskarneta, ganciklovirja, pentamidina, vankomicina, cidofovirja, interlevkina- 2) ni mogoče izogniti, je treba ledvično funkcijo nadzorovati tedensko (glejte poglavje 4. 5).
Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).
Pri klinični uporabi tenofovirdizoproksil fumarata so poročali o ledvični odpovedi, ledvični okvari, zvišanem kreatininu, hipofosfatemiji in proksimalni tubulopatiji (vključno s Fanconijevim sindromom) (glejte poglavje 4. 8).
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 every four weeks during the first year and then every three months.
Pred začetkom zdravljenja z zdravilom Atripla priporočamo določitev kreatininskega očistka pri vseh bolnikih in nadzor delovanja ledvic (očistek kreatinina in koncentracija fosfatov v serumu) vsake štiri tedne v prvem letu zdravljenja ter pozneje vsake tri mesece.
In patients with a history of renal dysfunction or in patients who are at risk for renal dysfunction, consideration must be given to more frequent monitoring of renal function.
Pri bolnikih z motnjami v delovanju ledvic v anamnezi ali pri bolnikih s tveganjem za motnje v delovanju ledvic je potrebno razmisliti o pogostejšem spremljanju delovanja ledvic.
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving Atripla, renal function must be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Če je pri kateremkoli bolniku, ki prejema zdravilo Atripla, koncentracija fosfata v serumu < 1, 5 mg/ dl (0, 48 mmol/ l) ali če se kreatininski očistek zmanjša na < 50 ml/ min, je treba delovanje ledvic znova oceniti v enem tednu, vključno z meritvami koncentracije glukoze v krvi, kalija v krvi in glukoze v urinu
Since Atripla is a combination product and the dosing interval of the individual components cannot be altered, treatment with Atripla must be interrupted in patients with confirmed creatinine clearance < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Ker je Atripla kombinirano zdravilo, spreminjanje intervala odmerjanja posameznih učinkovin ni mogoče, zato je treba pri bolnikih s potrjenim kreatininskim očistkom < 50 ml/ min ali zmanjšano koncentracijo fosfata v serumu na < 1, 0 mg/ dl (0, 32 mmol/ l) zdravljenje prekiniti.
Where discontinuation of therapy with one of the components of Atripla is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil fumarate are available.
Kadar je indicirana prekinitev zdravljenja z eno izmed učinkovin zdravila Atripla ali če je prilagoditev odmerka nujna, so na voljo efavirenz, emtricitabin in tenofovirdizoproksil fumarat v ločenih zdravilih.
Skin reactions: mild-to-moderate rash has been reported with the individual components of Atripla.
Kožne reakcije: pri posameznih učinkovinah zdravila Atripla so poročali o blagem do zmernem izpuščaju.
Appropriate antihistamines and/ or corticosteroids may improve tolerability and hasten the resolution of rash.
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).
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).
Pojavnost multiformnega eritema ali Stevens- Johnsonovega sindroma je bila približno 0, 1%.
Patients who discontinued treatment with other non-nucleoside reverse transcriptase inhibitors due to rash may be at higher risk of developing rash during treatment with Atripla.
Pri bolnikih, pri katerih je bilo zdravljenje z drugimi nenukleozidnimi zaviralci reverzne transkriptaze zaradi izpuščaja prekinjeno, je lahko tveganje za nastanek izpuščaja med zdravljenjem z zdravilom Atripla večje.
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Lipodistrofija in motnje presnove: pri bolnikih s HIV je bilo kombinirano protiretrovirusno zdravljenje povezano s prerazporeditvijo telesnega maščevja (lipodistrofijo).
The long-term consequences of these events are currently unknown.
Dolgoročne posledice teh dogodkov trenutno niso znane.
A connection between visceral lipomatosis and protease inhibitors (PI) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Domneva se povezava med visceralno lipomatozo in zaviralci proteaze (ZP) ter lipoatrofijo in nukleozidnimi zaviralci reverzne transkriptaze (nucleoside reverse transcriptase inhibitors – NRTI).
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug-related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Povečano tveganje za pojav lipodistrofije je povezano z individualnimi dejavniki, kot je višja starost, ter z dejavniki, povezanimi z zdravili, kot je dolgotrajno protiretrovirusno zdravljenje in s tem povezane presnovne motnje.
Clinical examination should include evaluation for physical signs of fat redistribution.
Zdravniški pregled mora vključevati oceno telesnih znakov prerazporeditve maščevja.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Pozornost je treba nameniti merjenju vrednosti serumskih lipidov na tešče in glukoze v krvi.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Neustrezne vrednosti lipidov je treba ustrezno klinično obravnavati (glejte poglavje 4. 8).
6 Effect of food: the administration of Atripla with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in frequency of adverse reactions (see section 4.8).
Vpliv hrane: pri uporabi zdravila Atripla skupaj s hrano se lahko poveča izpostavljenost efavirenzu (glejte poglavje 5. 2) in lahko pride do povečanja pogostnosti neželenih učinkov (glejte poglavje 4. 8.).
Mitochondrial dysfunction: nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Motnje delovanja mitohondrijev: raziskave in vitro in in vivo so pokazale, da nukleozidni in nukleotidni analogi povzročajo okvare mitohondrijev različnih stopenj.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/ or postnatally to nucleoside analogues.
Pri otrocih, negativnih za HIV, ki so bili in utero in/ ali postnatalno izpostavljeni nukleozidnim analogom, so poročali o motnji delovanja mitohondrijev.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactataemia, hyperlipasaemia).
Glavni neželeni učinki, o katerih so poročali, so hematološke motnje (anemija, nevtropenija), presnovne motnje (hiperlaktatemija, hiperlipazemija).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Poročali so o nekaterih nevroloških motnjah s poznim začetkom (hipertonija, konvulzije, nenormalno vedenje).
Whether the neurological disorders are transient or permanent is currently unknown.
Trenutno ni znano, ali so nevrološke motnje prehodne ali trajne.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Vse otroke, in utero izpostavljene nukleozidnim in nukleotidnim analogom, celo otroke, negativne za HIV, je treba klinično in laboratorijsko pregledati ter če so prisotni ustrezni znaki in simptomi, popolnoma preiskati zaradi možnosti morebitne motnje delovanja mitohondrijev.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Te ugotovitve ne vplivajo na trenutna nacionalna priporočila za uporabo protiretrovirusnega zdravljenja pri nosečnicah za preprečevanje vertikalnega prenosa HIV.
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunske reaktivacije: pri bolnikih, okuženih s HIV, s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART – combination antiretroviral therapy) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
7 okužbe z mikobakterijami in pljučnica, povzročena z bakterijo Pneumocystis jiroveci (nekoč znana kot Pneumocystis carinii).
Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long term exposure to combination antiretroviral therapy (CART).
Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV in/ ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART – combination antiretroviral therapy).
Bone: in a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Kosti: v 144- tedenski nadzorovani klinični študiji, v katerem so primerjali tenofovirdizoproksil fumarat s stavudinom v kombinaciji z lamivudinom in efavirenzom pri bolnikih, ki še niso prejemali protiretrovirusnih zdravil, so v obeh skupinah opazili majhno zmanjšanje mineralne gostote kosti v kolku in hrbtenici.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
Po 144 tednih so bila zmanjšanja mineralne gostote kosti hrbtenice in spremembe kostnih bioloških označevalcev glede na izhodiščno vrednost pri skupini, ki je prejemala tenofovirdizoproksil fumarat, pomembno večje.
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Kostne anomalije (ki redko prispevajo k zlomom) so lahko povezane s proksimalno renalno tubulopatijo (glejte poglavje 4. 8).
Other antiretroviral agents: no data are available on the safety and efficacy of Atripla in combination with other antiretroviral agents.
Druga protiretrovirusna zdravila: podatkov o varnosti in učinkovitosti zdravila Atripla v kombinaciji z drugimi protiretrovirusnimi zdravili ni na voljo.
Didanosine: co-administration of Atripla and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil fumarate (see section 4.5).
Didanozin: sočasne uporabe zdravila Atripla in didanozina ne priporočamo, saj se izpostavljenost didanozinu po sočasni uporabi s tenofovirdizoproksil fumaratom pomembno poveča (glejte poglavje 4. 5).
Atripla should be avoided in patients with HIV-1 harbouring the K65R, M184V/ I or K103N mutation (see sections 4.1 and 5.1).
Bolniki z mutacijami virusa HIV- 1: uporabi zdravila Atripla se je treba izogibati pri bolnikih, ki so okuženi z virusom HIV- 1 z mutacijami K65R, M184V/ I ali K103N (glejte poglavji 4. 1 in 5. 1).
Excipients: this medicinal product contains 1 mmol (23.6 mg) of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.
Pomožne snovi: zdravilo vsebuje 1 mmol (23, 6 mg) natrija na odmerek, kar je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
7 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No drug interaction studies have been conducted using Atripla.
Študij interakcij zdravila Atripla z drugimi zdravili niso opravili.
As Atripla contains efavirenz, emtricitabine and tenofovir disoproxil fumarate, any interactions that have been identified with these agents individually may occur with Atripla.
Zdravilo Atripla vsebuje efavirenz, emtricitabin in tenofovirdizoproksil fumarat, zato se pri njegovi uporabi lahko pojavijo katerekoli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.