natgillin/translations-raw huggingface dataset:
Common
Pogoste
vision blurred vertigo
vrtoglavica
nausea diarrhoea, vomiting, abdominal pain, flatulence, abdominal distension, dry mouth
navzea diareja, bruhanje, bolečina v trebuhu, flatulenca, napihnjen trebuh, suha usta
Very common Common Uncommon
Zelo pogoste Pogoste Občasne
rash pruritus, skin hyperpigmentation, dermatitis urticaria, dry skin, eczema
izpuščaj pruritus, hiperpigmentacija kože, dermatitis urtikarija, suha koža, ekcem
Common Uncommon
Pogoste Občasne
decreased appetite, increased appetite hypertriglyceridaemia, anorexia
povečan tek, zmanjšan tek hipertrigliceridemija, anoreksija
hot flush
naval vročine
20 Efavirenz+emtricitabine+tenofovir disoproxil fumarate (n=257) General disorders and administration site conditions:
Splošne težave in spremembe na mestu aplikacije:
fatigue, fever asthenia, feeling drunk
utrujenost, zvišana telesna temperatura astenija, občutek pijanosti
Psychiatric disorders:
24 efavirenz + emtricitabin + tenofovirdizoproksil fumarat (n = 257) Psihiatrične motnje:
abnormal dreams nightmares, depression, insomnia, sleep disorder, euphoric mood
nenormalne sanje nočne more, depresija, nespečnost, motnje spanja, evforično razpoloženje
paranoia, psychomotor agitation, delusion, confusional state, anxiety, aggression, nervousness, disorientation
paranoja, psihomotorična agitacija, blodnje, zmedenost, anksioznost, agresija, živčnost, dezorientiranost
Liver enzymes: in a 144-week clinical study (GS-01-934), elevations of aspartate aminotransferase (AST > 5 times ULN (upper limit of normal)) and of alanine aminotransferase (ALT > 5 times ULN) were reported in 3% and 2% of patients treated with efavirenz, emtricitabine, and tenofovir disoproxil fumarate (n=257) and 3% and 3% of patients treated with efavirenz and fixed-dose zidovudine/ lamivudine (n=254), respectively.
3% bolnikov, ki so prejemali efavirenz in fiksni odmerek zidovudina/ lamivudina (n = 254).
Adverse reactions associated with the individual components of Atripla The adverse reactions from clinical study and post-marketing experience with the individual components of Atripla in antiretroviral combination therapy are listed in Table 4 below by body system organ class and frequency.
Neželeni učinki, povezani s posameznimi učinkovinami zdravila Atripla Neželene reakcije iz klinične študije in postmarketinških izkušenj s posameznimi učinkovinami zdravila Atripla v protiretrovirusnem kombiniranem zdravljenju so razvrščene po organskem sistemu in pogostnosti v tabeli 4.
The most notable adverse reactions that have been reported in clinical studies with efavirenz are rash and nervous system symptoms.
Najpomembnejši neželeni učinki o katerih so poročali v kliničnih študijah z efavirenzem so bili izpuščaj ter simptomi živčnega sistema.
The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Pri uporabi efavirenza skupaj s hrano se lahko izpostavljenost efavirenzu zviša, kar lahko povzroči pogostejši pojav neželenih učinkov (glejte poglavje 4. 4).
There have been post-marketing reports in association with tenofovir disoproxil fumarate of renal and urinary disorders including renal failure, proximal tubulopathy (including Fanconi syndrome), acute tubular necrosis and nephrogenic diabetes insipidus.
Po pridobitvi dovoljenja za promet so v povezavi z uporabo tenofovirdizoproksil fumarata poročali o težavah s sečili, vključno z odpovedjo ledvic, okvaro proksimalnih tubulov (vključno s Fanconijevim sindromom), akutno nekrozo tubulov in z nefrogenim diabetesom insipidusom.
Adverse reactions associated with the individual components of Atripla based on clinical study and post-marketing safety experience
Neželene reakcije, povezane s posameznimi učinkovinami zdravila Atripla, na podlagi klinične študije in postmarketinških izkušenj o varnosti
Emtricitabine
emtricitabin
Tenofovir disoproxil fumarate
tenofovirdizoproksil fumarat
Common Uncommon Nervous system disorders:
Pogoste Občasne Bolezni živčevja:
neutropenia anaemia
Zelo pogoste Pogoste
Uncommon vision blurred Ear and labyrinth disorders:
somnolenca, glavobol, motnje pozornosti, omotica
Uncommon vertigo
Občasne
headache dizziness
konvulzije, amnezija, nenormalne misli, ataksija, motnje koordinacije, agitacija
dizziness
Občasne
21
25
Respiratory, thoracic and mediastinal disorders:
Občasne
Not known* Gastrointestinal disorders:
Ni znano * Bolezni prebavil:
Very common
Zelo pogoste
diarrhoea, nausea
diareja, navzea
diarrhoea, vomiting, nausea
diareja, bruhanje, navzea
Common diarrhoea, vomiting, abdominal pain, nausea Uncommon pancreatitis acute
diareja, bruhanje, bolečina v trebuhu, navzea
elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia
zvišana amilaza, vključno z zvišano pankreasno amilazo, zvišana serumska lipaza, bruhanje, bolečina v trebuhu, dispepsija
Not known* Renal and urinary disorders:
Občasne Ni znano * Bolezni sečil:
Not known* Skin and subcutaneous tissue disorders:
Zelo pogoste
Very common rash (all grades, 18%)
izpuščaj (vse stopnje, 18%)
renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy including Fanconi syndrome, nephritis, acute interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria
alergijska reakcija, vezikulobulozni izpuščaj, pustulozni izpuščaj, makulopapulozni izpuščaj, izpuščaj, pruritus, urtikarija, sprememba obarvanosti kože (povečana pigmentacija)
Common pruritus Uncommon Stevens-Johnson syndrome, erythema multiforme, severe rash (< 1%)
Stevens- Johnsonov sindrom, multiformni eritem, hud izpuščaj (< 1%)
allergic reaction, vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)
Ni znano *
Not known* photoallergic dermatitis Musculoskeletal and connective tissue disorders:
fotoalergijski dermatitis
rash
izpuščaj
Very common Not known* Metabolism and nutrition disorders:
26
elevated creatine kinase
efavirenz
rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
emtricitabin
Very common Common
tenofovirdizoproksil fumarat
hyperglycaemia, hypertriglyceridaemia
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
hypophosphataemia
zvišana kreatin- kinaza
Not known*
rabdomioliza, osteomalacija (ki se izraža kot bolečine v kosteh in redko prispeva k zlomom), mišična šibkost, miopatija
lactic acidosis, hypokalaemia
Presnovne in prehranske motnje:
22
Zelo pogoste Pogoste
Efavirenz
hiperglikemija, hipertrigliceridemija
Emtricitabine
hipofosfatemija
Tenofovir disoproxil fumarate
Ni znano * Splošne težave in spremembe na mestu aplikacije:
General disorders and administration site conditions:
laktacidoza, hipokaliemija
Common Not known*
Pogoste Ni znano *
asthenia
astenija
elevated serum aspartate aminotransferase (AST) and/ or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia
zvišana serumska aspartat - aminotransferaza (AST) in/ ali zvišana serumska alanin- aminotransferaza (ALT), hiperbilirubinemija
Not known*
Ni znano *
hepatic failure
jetrna odpoved
hepatitis, increased transaminases, hepatic steatosis
hepatitis, zvišane transaminaze, jetrna steatoza
Reproductive system and breast disorders:
Občasne
Uncommon Psychiatric disorders:
27 Psihiatrične motnje:
gynaecomastia
emtricitabin
depression (severe in 1.6%), anxiety, abnormal dreams, insomnia
depresija (huda pri 1, 6%), anksioznost, nenormalne sanje, nespečnost
suicide attempt, suicide ideation, mania, paranoia, hallucination, euphoric mood, affect lability, confusional state, aggression
poskus samomora, samomorilne misli, manija, paranoja, halucinacije, evforično razpoloženje, afektivna labilnost, konfuznost, agresivnost
completed suicide, psychosis, delusion, neurosis
uspešen samomor, psihoza, blodnje, nevroza
* These adverse reactions have been identified through post-marketing safety surveillance and the frequency is not known.
* Te neželene reakcije so opazili v obdobju postmarketinškega nadzora varnosti in njihova pogostnost ni znana.
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
Naslednje neželene reakcije, ki so navedene pod posameznimi organskimi sistemi zgoraj, se lahko pojavijo kot posledica proksimalne renalne tubulopatije: rabdomioliza, osteomalacija (ki se izraža kot bolečine v kosteh in redko prispeva k zlomom kosti), hipokaliemija, šibkost mišic, miopatija in hipofosfatemija.
These events are not considered to be causally associated with tenofovir disoproxil fumarate therapy in the absence of proximal renal tubulopathy.
V odsotnosti proksimalne renalne tubulopatije se teh dogodkov ne smatra za vzročno povezane z zdravljenjem s tenofovirdizoproksil fumaratom.
Rash with efavirenz: rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Izpuščaj pri uporabi efavirenza: izpuščaji so po navadi blagi do zmerni makulopapulozni kožni izbruhi, ki se pojavijo v prvih dveh tednih po začetku zdravljenja z efavirenzom.
In most patients rash resolves with continuing therapy with efavirenz within one month.
Pri nadaljevanju zdravljenja z efavirenzom izpuščaj pri večini bolnikov izgine v enem mesecu.
In clinical studies, 1.7% of patients treated with efavirenz discontinued therapy because of rash.
V kliničnih študijah je 1, 7% bolnikov, ki so prejemali efavirenz, zaradi izpuščaja prekinilo zdravljenje.
Efavirenz can be reinitiated in patients interrupting therapy because of rash.
Pri bolnikih, ki so prekinili zdravljenje zaradi izpuščaja, se zdravljenje z efavirenzom lahko nadaljuje znova.
Use of appropriate antihistamines and/ or corticosteroids is recommended when efavirenz is restarted.
Ob ponovnem začetku zdravljenja z efavirenzom priporočamo uporabo ustreznih antihistaminikov in/ ali kortikosteroidov.
Experience with efavirenz in patients who discontinued other antiretroviral agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class is limited.
Izkušnje z efavirenzom pri bolnikih, ki so prekinili zdravljenje z drugimi protiretrovirusnimi zdravili iz skupine nenukleoizidnih zaviralcev reverzne transkriptaze (NNRTI), so omejene.
Nine of these patients
19 bolnikov, ki so zaradi izpuščaja prekinili zdravljenje z nevirapinom, je prejemalo efavirenz.
23 developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Devet od teh bolnikov je med zdravljenjem z efavirenzom imelo blag do zmeren izpuščaj, dva pa sta zaradi izpuščaja prekinila zdravljenje.
Psychiatric symptoms with efavirenz: patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 4 with the frequency of events ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Psihiatrični simptomi pri uporabi efavirenza: videti je, da je tveganje za resne psihiatrične neželene reakcije, navedene v stolpcu s podatki o efavirenzu v tabeli 4, večje pri bolnikih s psihiatričnimi motnjami v anamnezi; pogostnost teh dogodkov je od 0, 3% za manične reakcije do 2, 0% za hudo depresijo in samomorilne misli.
Nervous system symptoms with efavirenz: in clinical controlled studies, nervous system symptoms of moderate-to-severe intensity were experienced by 19.4% of patients compared to 9.0% of patients receiving control regimens.
Simptomi živčevja pri uporabi efavirenza: v nadzorovanih kliničnih študijah je 19, 4% bolnikov imelo zmerne do hude simptome živčevja v primerjavi z 9, 0% bolnikov, ki so prejemali kontrolni režim zdravljenja.
These symptoms were severe in 2.0% of patients receiving efavirenz 600 mg daily and in 1.3% of patients receiving control regimens.
Ti simptomi so bili hudi pri 2, 0% bolnikov, ki so dobivali 600 mg efavirenza na dan, in pri 1, 3% bolnikov, ki so bili zdravljeni s kontrolnim režimom.
In clinical studies 2.1% of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.
V kliničnih študijah je 2, 1% bolnikov, zdravljenih s 600 mg efavirenza, prenehalo zdravljenje zaradi simptomov živčnega sistema.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first two to four weeks.
Simptomi živčevja se po navadi pojavijo prvi dan ali v prvih dveh dnevih zdravljenja in na splošno minejo po prvih dveh do štirih tednih.
Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
28 efavirenz jemlje skupaj s hrano, verjetno zaradi povečane koncentracije efavirenza v plazmi (glejte poglavje 5. 2).
Dosing at bedtime seems to improve the tolerability of these symptoms (see section 4.2).
Kaže, da odmerjanje pred spanjem izboljša prenašanje teh simptomov (glejte poglavje 4. 2).
Analysis of long-term data from a clinical study (median follow-up 180 weeks, 102 weeks and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.
Analiza dolgoročnih podatkov iz klinične študije (povprečno spremljanje 180 tednov pri bolnikih, zdravljenih z efavirenzom + zidovudinom + lamivudinom, 102 tedna pri bolnikih, zdravljenih z efavirenzom + indinavirjem, ter 76 tednov pri bolnikih, zdravljenih z indinavirjem + zidovudinom + lamivudinom) je pokazala, da je bila pojavnost novih simptomov živčnega sistema po 24 tednih zdravljenja pri bolnikih, zdravljenih z efavirenzom, na splošno podobna kot v kontrolni skupini.
Lactic acidosis: lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Laktacidoza: pri uporabi nukleozidnih analogov so poročali o laktacidozi, ki je bila po navadi povezana z jetrno steatozo (glejte poglavje 4. 4).
HIV/ HBV or HCV co-infected patients:
Bolniki, sočasno okuženi z virusi HIV in HBV ali HCV:
Only a limited number of patients were co-infected with HBV (n=13) or HCV (n=26) in study GS-01-934.
V študijo GS- 01- 934 je bilo vključeno le manjše število bolnikov, sočasno okuženih z virusom HBV (n=13) ali HCV (n=26).
The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/ HBV or HIV/ HCV was similar to that observed in patients infected with HIV without co-infection.
Profil neželenih učinkov efavirenza, emtricitabina in tenofovirdizoproksil fumarata pri bolnikih, sočasno okuženih z virusoma HIV in HBV ali virusoma HIV in HCV, je bil podoben profilu, ki so ga opazili pri bolnikih, okuženih z virusom HIV, ki pa niso sočasno okuženi z drugim virusom.
Amylase: in clinical studies, asymptomatic increases in serum amylase levels > 1.5 times the ULN were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Amilaza: v kliničnih študijah so asimptomatska zvišanja ravni serumskih amilaz > 1, 5- krat ZMN opazili pri 10% bolnikov, zdravljenih z efavirenzom, in pri 6% bolnikov iz kontrolne skupine.
The clinical significance of asymptomatic increases in serum amylase is unknown.
Klinični pomen asimptomatskih zvišanj serumske amilaze ni znan.
Lipids, lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin-resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Lipidi, lipodistrofija in spremembe presnove: kombinirano protiretrovirusno zdravljenje je povezano s spremembami presnove, kot so hipertrigliceridemija, hiperholesterolemija, odpornost na inzulin, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the 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).
Pri bolnikih, okuženih z virusom HIV, je kombinirano protiretrovirusno zdravljenje povezano s prerazporeditvijo telesnega maščevja (lipodistrofijo), vključno z izgubo periferne in obrazne podkožne maščobe, povečanjem intraabdominalne in visceralne maščobe, hipertrofijo dojk in dorzocervikalnim kopičenjem maščobe (bivolja grba) (glejte poglavje 4. 4).
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Sindrom imunske reaktivacije: pri bolnikih, okuženih z virusom HIV, s hudo imunsko pomanjkljivostjo ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART – combination antiretroviral therapy) lahko nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
Cannabinoid test interaction: efavirenz does not bind to cannabinoid receptors.
Interakcija s testom na kanabinoide: efavirenz se ne veže na kanabinoidne receptorje.
False positive urine cannabinoid test results have been reported in uninfected volunteers who received efavirenz.
Pri neokuženih prostovoljcih, ki so prejemali efavirenz, so poročali o lažno pozitivnem rezultatu urinskega kanabinoidnega testa.
False positive test results have only been observed with the CEDIA DAU Multi-Level THC assay, which is
Lažno pozitiven izvid so opazili samo pri večnivojski analizi THC, CEDIA DAU, ki se uporablja za presejalne teste, pri drugih kanabinoidnih testih, vključno s testom za potrditev pozitivnega rezultata, pa tega niso opazili.
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 (CART).
Osteonekroza: poročali so o primerih osteonekroze, zlasti pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
The frequency of this is unknown (see section 4.4).
Pogostnost tega učinka ni znana (glejte poglavje 4. 4).
If overdose occurs, the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
29 Če pride do prevelikega odmerjanja, je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4. 8) in mu nuditi standardno podporno zdravljenje.
Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
S hemodializo se lahko odstrani do 30% odmerka emtricitabina in približno 10% odmerka tenofovirja.
Antivirals for treatment of HIV infections, combinations, ATC code:
Zdravila za sistemsko zdravljenje virusnih infekcij (HIV), kombinacije, oznaka ATC:
Mechanism of action: efavirenz is an NNRTI of HIV-1.
Mehanizem delovanja: efavirenz je NNRTI za HIV- 1.
Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Efavirenz je nekompetitivni zaviralec reverzne transkriptaze (RT) HIV- 1 in ne zavira pomembno RT virusa humane imunske pomanjkljivosti (HIV- 2) ali celičnih polimeraz (α, β, γ, and δ) deoksiribonukleinske kisline (DNA).
Tenofovir disoproxil fumarate is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Tenofovirdizoproksil fumarat se in vivo pretvori v tenofovir, nukleozidni monofosfatni (nukleotidni) analog adenozinmonofosfata.
Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Emtricitabintrifosfat in tenofovirdifosfat kompetitivno zavirata reverzno transkriptazo HIV- 1, kar povzroči terminacijo verige DNA.
Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Toksičnost za mitohondrije pri pogojih in vitro ali in vivo ni bila dokazana.
Antiviral activity in vitro: efavirenz demonstrated antiviral activity against most non-clade B isolates (subtypes A, AE, AG, C, D, F, G, J, and N) but had reduced antiviral activity against group O viruses.
Protivirusna aktivnost in vitro: efavirenz je pokazal protivirusno delovanje proti večini izolatov, ki ne spadajo v skupino B (podtipi A, AE, AG, C, D, F, G, J in N), vendar pa ima proti virusom skupine O zmanjšano protivirusno delovanje.
Emtricitabine displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, and G.
Emtricitabin je pokazal protivirusno delovanje proti skupinam A, B, C, D, E, F in G virusa HIV- 1.
Tenofovir displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, G, and O.
Tenofovir je pokazal protivirusno delovanje proti skupinam A, B, C, D, E, F, G in O virusa HIV- 1.
Both emtricitabine and tenofovir showed strain specific activity against HIV-2 and antiviral activity against HBV.
Emtricitabin in tenofovir sta pokazala aktivnost, specifično za sev, proti virusu HIV- 2 in protivirusno aktivnost proti virusu HBV.
25 Resistance: resistance to efavirenz can be selected in vitro and resulted in single or multiple amino acid substitutions in HIV-1 RT, including L100I, V108I, V179D, and Y181C.
Odpornost: odpornost proti efavirenzu se lahko pojavi in vitro in povzroči enkratne ali večkratne substitucije aminokislin v RT virusa HIV- 1, vključno z L100I, V108I, V179D in Y181C.
Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Profili navzkrižne odpornosti na efavirenz, nevirapin in delavirdin in vitro so pokazali, da substitucija K103N povzroči izgubo občutljivosti za vse tri NNRTI- je.
The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
30 Možnost za navzkrižno odpornost med efavirenzom in zdravili NRTI je majhna zaradi različnih vezavnih mest in različnega mehanizma delovanja.
Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir.
Odpornost na emtricitabin ali tenofovir je bila opažena in vitro in pri nekaterih bolnikih, okuženih z virusom HIV- 1, zaradi razvoja substitucije na RT na mestu M184V ali M184I pri emtricitabinu in substitucije na RT na mestu K65R pri tenofovirju.
No other pathways of resistance to emtricitabine or tenofovir have been identified.
Drugih poti razvoja odpornosti na emtricitabin ali tenofovir niso ugotovili.
Emtricitabine-resistant viruses with the M184V/ I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Virusi, odporni na emtricitabin, z mutacijo M184V/ I so bili navzkrižno odporni na lamivudin, vendar so ohranili občutljivost za didanozin, stavudin, tenofovir in zidovudin.
Tenofovir disoproxil fumarate should be avoided in patients with HIV-1 harbouring the K65R mutation.
Uporabi tenofovirdizoproksil fumarata se je treba izogniti pri bolnikih, okuženih z virusom HIV- 1, ki ima mutacijo K65R.
Both the K65R and M184V/ I mutation remain fully susceptible to efavirenz.
Mutaciji K65R in M184V/ I sta popolnoma občutljivi za efavirenz.