natgillin/translations-raw huggingface dataset:
Emtriva is also available as a 10 mg/ ml oral solution for use in infants older than 4 months of age, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Zdravilo Emtriva je pri dojenčkih starejših od 4- ih mesecev, otrocih in bolnikih, ki ne morejo pogoltniti trdih kapsul ter bolnikih z ledvično insuficienco na voljo tudi v obliki 10 mg/ ml peroralne raztopine.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ ml oral solution.
Prosimo, upoštevajte povzetek glavnih značilnosti Emtriva 10 mg/ ml peroralne raztopine.
2 presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
2 Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine, zagotavljalo podoben plazemski nivo kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5. 2).
There are no safety and efficacy data available in patients over the age of 65 years.
Ni razpoložljivih podatkov o varnosti in učinkovitosti uporabe pri bolnikih, starejših od 65 let.
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
Emtricitabin se izloča preko ledvic in izpostavljenost emtricitabinu je pomembno narasla pri bolnikih z ledvično insuficienco (glejte poglavje 5. 2).
Dose or dose interval adjustment is required in all patients with creatinine clearance < 50 ml/ min (see section 4.4).
Pri vseh bolnikih z očistkom kreatinina < 50 ml/ min je potrebno prilagoditi odmerek ali časovni interval med posameznima odmerkoma (glejte poglavje 4. 4).
The table below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
Spodnja tabela prikazuje smernice prilagoditve časovnega intervala med posameznima odmerkoma za 200 mg trde kapsule glede na stopnjo ledvične insuficience.
The safety and efficacy of these dose interval adjustment guidelines have not been clinically evaluated.
Varnost in učinkovitost teh smernic prilagoditve časovnega intervala med posameznima odmerkoma še nista bili klinično ovrednoteni.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Zaradi tega je potrebno pri teh bolnikih pozorno spremljati klinični odziv na zdravljenje in ledvično funkcijo (glejte poglavje 4. 4).
Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/ ml oral solution to provide a reduced daily dose of emtricitabine.
Bolniki z ledvično insuficienco so lahko zdravljeni tudi z Emtriva 10 mg/ ml peroralno raztopino za zagotovitev zmanjšanega dnevnega odmerka emtricitabina.
Creatinine Clearance (CLcr) (ml/ min)
Očistek kreatinina (CLcr) (ml/ min) < 15
< 15
Pripročen
(functionally anephric, requiring intermittent haemodialysis)* Recommended
Ena 200 mg trda
One 200 mg hard One 200 mg hard One 200 mg hard One 200 mg hard
Ena 200 mg trda Ena
dose interval for 200 mg hard capsules
200 mg trda
capsule every 24 hours
24 ur
capsule every 48 hours
48 ur
capsule every 72 hours
72 ur
capsule every 96 hours
96 ur
* Assumes a 3 h haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
* Predpostavlja 3- urno hemodializo trikrat tedensko, z začetkom vsaj 12 ur po uporabi zadnjega odmerka emtricitabina.
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
Zato priporočila o ustreznih odmerkih ni mogoče narediti.
No data are available on which to make a dosage recommendation in paediatric patients with renal insufficiency.
Podatki o priporočenem odmerjanju za pediatrične bolnike z ledvično insuficienco niso na voljo.
No data are available on which to make a dose recommendation for patients with hepatic insufficiency.
Podatkov o priporočenem odmerjanju za bolnike z jetrno insuficienco ni na voljo.
However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
Vendar pa je, ob upoštevanju minimalne presnove emtricitabina in izločanja preko ledvic, malo verjetno, da bi bila pri bolnikih z jetrno insuficienco potrebna prilagoditev odmerka (glejte poglavje 5. 2).
If Emtriva is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Če se jemanje zdravila Emtriva prekine pri bolnikih s hkratno HIV in HBV okužbo, je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4. 4).
Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine.
Emtriva se ne sme jemati z nobenimi drugimi zdravili, ki vsebujejo emtricitabin ali zdravili, ki vsebujejo lamivudin.
It must be used in combination with other antiretrovirals.
Uporabljati se mora v kombinaciji z drugimi antiretrovirusnimi zdravili.
Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Prosimo, upoštevajte tudi povzetek glavnih značilnosti drugih antiretrovirusnih zdravil kombiniranih pri zdravljenju.
Patients receiving emtricitabine 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.
Zato mora biti bolnik pod skrbnim kliničnim nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s HIV povezanimi obolenji.
Patients should be advised that antiretroviral therapies, including emtricitabine, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Bolnike je potrebno opozoriti, da antiretrovirusna terapija, vključno z uporabo emtricitabina, ne zmanjšuje nevarnosti prenosa okužbe z virusom HIV na drugo osebo pri spolnih odnosih ali okužbi s krvjo.
Appropriate precautions should continue to be used.
Potrebno je nadaljevati s primernimi previdnostnimi ukrepi.
Patients should also be informed that emtricitabine is not a cure for HIV infection.
Bolnike je tudi potrebno seznaniti, da emtricitabin ni zdravilo za okužbo z virusom HIV.
Renal function:
Ledvična funkcija:
Emtricitabine exposure may be markedly increased in patients with moderate or severe renal insufficiency (creatinine clearance < 50 ml/ min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Izpostavljenost emtricitabinu se lahko pomembno poveča pri bolnikih z zmerno ali resno ledvično insuficienco (očistek kreatinina < 50 ml/ min), ki prejemajo dnevni odmerek 200 mg emtricitabina v obliki trdih kapsul ali 240 mg v obliki peroralne raztopine.
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/ ml oral solution) is required in all patients with creatinine clearance < 50 ml/ min.
Posledično je pri vseh bolnikih z očistkom kreatinina < 50 ml/ min potrebna ali prilagoditev intervala odmerka (pri uporabi Emtriva 200 mg trdih kapsul) ali znižanje dnevnega odmerka emtricitabina (pri uporabi Emtriva 10 mg/ ml peroralne raztopine).
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Varnost in učinkovitost smernic prilagoditve časovnega intervala med posameznima odmerkoma, ki so predstavljene v poglavju 4. 2, temeljita na farmakokinetičnih podatkih pri enkratnem odmerku in modeliranju ter še nista bili klinično ovrednoteni.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (see sections 4.2 and 5.2).
Zato je potrebno pozorno nadzorovati klinični odziv na zdravljenje in ledvično funkcijo pri bolnikih, ki se zdravijo z emtricitabinom s podaljšanimi intervali med odmerki (glejte poglavji 4. 2 in 5. 2).
Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Posebno pozornost zahteva sočasna uporaba emtricitabina in zdravil, ki se izločajo iz telesa z aktivno tubularno sekrecijo, ker lahko takšna sočasna uporaba, zaradi kompeticije za to pot izločanja, vodi k povišanju serumskih koncentracij bodisi emtricitabina bodisi sočasno uporabljenega zdravila (glejte poglavje 4. 5).
Lactic acidosis:
Laktična acidoza:
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Laktična acidoza, običajno povezana s hepatično steatozo, je bila ugotovljena ob uporabi analogov nukleozidov.
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Zgodnji simptomi (simptomatične hiperlaktatemije) vključujejo benigne prebavne simptome (slabost, bruhanje in bolečine v trebuhu), nespecifičen občutek slabosti, izgubo teka, izgubo teže, respiratorne simptome (naglo in/ ali globoko dihanje) ali nevrološke simptome (motorična oslabelost).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Laktična acidoza ima za posledico visoko smrtnost in jo lahko spremlja vnetje pankreasa, odpoved delovanja jeter ali ledvic.
Lactic acidosis generally occurred after a few or several months of treatment.
Laktična acidoza v splošnem nastopi šele po nekaj mesecih zdravljenja.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Zdravljenje z analogi nukleozidov se mora prekininiti ob ugotovljeni simptomatični hiperlaktatemiji in presnovni/ laktični acidozi, napredujoči hepatomegaliji ali ob hitro rastočem nivoju aminotransferaz.
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).
Previdnostni ukrepi so potrebni pri uporabi analogov nukleozidov pri vsakemu bolniku (posebno pri debelih ženskah) s hepatomegalijo, hepatitisom ali drugim znanim rizičnim faktorjem obolenja jeter in hepatične steatoze (vključujoč določena zdravila in alkohol).
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Posebno rizično skupino lahko predstavljajo bolniki, dodatno okuženi s hepatitisom C, ki se dodatno zdravijo z alfa interferonom in ribavirinom.
4 unknown.
4 Bolniki s povečanim tveganjem morajo biti pod skrbnim nadzorom.
A connection between visceral lipomatosis and protease inhibitors, and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Domnevana je povezava med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in nukleozidnimi zaviralci reverzne transkriptaze.
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.
Večje tveganje za lipodistrofijo je povezano z individualnimi faktorji kot so npr. višja starost ter faktorji zdravil kot npr. daljše trajanje antiretrovirusnega zdravljenja in spremljajoče presnovne motnje.
Clinical examination should include evaluation for physical signs of fat redistribution.
Klinični pregledi morajo vsebovati ovrednotenje fizičnih znakov prerazporeditve telesne maščobe.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Potrebno je merjenje vrednosti lipidov v serumu in vrednost glukoze v krvi na tešče.
Lipid disorders should be managed as clinically appropriate.
Lipidne bolezni morajo biti primerno klinično obravnavane.
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.
Te bolnike je potrebno opazovati v skladu s standardno prakso.
Patients with chronic hepatitis B or C infection treated with combination antiretroviral therapy are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events.
Pri bolnikih s kronično okužbo s hepatitisom B ali C, ki se zdravijo s kombiniranim antiretrovirusnim zdravljenjem, je povečana možnost resnega in potencialno usodnega neželenega delovanja jeter.
Patients co-infected with hepatitis B virus (HBV):
Bolniki, ki so okuženi hkrati še z virusom hepatitisa B (HBV):
The use of emtricitabine in patient with chronic HBV induces the same mutation pattern in the YMDD motif observed with lamivudine therapy.
Uporaba emtricitabina pri bolnikih s kronično okužbo z virusom HBV povzroča enak vzorec mutacij v motivu YMDD, kot je opažen pri terapiji z lamivudinom.
Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
Takšno poslabšanje je bilo opaženo po prekinitvi zdravljenja z emtricitabinom pri bolnikih z okužbo HBV brez hkratne okužbe z virusom HIV in je bilo primarno odkrito s povišanjem serumskega nivoja alanin- aminotransferaze (ALT) z dodatnim ponovnim pojavom HBV DNA.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/ or postnatally to nucleoside analogues.
Obstajajo poročila o mitohondrijski disfunkciji pri HIV- negativnih dojenčkih, ki so bili in utero in/ ali postnatalno izpostavljeni nukleozidnim analogom.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactataemia, hyperlipasaemia).
Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija) in presnovne motnje (hiperlaktatemija, hiperlipazemija).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Poročali so o nekaterih primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
Whether the neurological disorders are transient or permanent is currently unknown.
Trenutno ni znano ali so te 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, tudi HIV- negativn, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, je treb klinično in laboratorijsko spremljati ter jih v primeru relevantnih znakov ali simptomov glede možne mitohondrijske disfunkcije temeljito preiskati.
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.
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART, combination antiretroviral therapy)
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
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 ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART, combination antiretroviral therapy) ali obojim.
5 combination antiretroviral therapy (CART).
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In vitro, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms:
In vitro emtricitabin ni inhibiral presnovnih reakcij kateregakoli od naslednjih vpletenih izooblik humanih CYP450:
1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
1A2, 2A6, 2B6, 2C9, 2C19, 2D6 in 3A4.
There are no clinically significant interactions when emtricitabine is co-administered with indinavir, zidovudine, stavudine, famciclovir or tenofovir disoproxil fumarate.
Ni klinično pomembnih interakcij, ko se emtricitabin uporablja skupaj z: indinavirom, zidovudinom, stavudinom, famciklovirom ali tenofovir disoproksil fumaratom.
With the exception of famciclovir and tenofovir disoproxil fumarate, the effect of co-administration of emtricitabine with medicinal products that are excreted by the renal route, or other medicinal products known to affect renal function, has not been evaluated.
Z izjemo famciklovira in tenofovir disoproksil fumarata niso bili ovrednoteni učinki sočasne uporabe emtricitabina z zdravili, ki se izločajo po ledvični poti, ali z drugimi zdravili, za katera je znano, da vplivajo na ledvično funkcijo.
Consequently, the use of emtricitabine in combination with lamivudine or zalcitabine for the treatment of HIV infection cannot be recommended at this time.
Zaradi tega uporaba emtricitabina v kombinaciji z lamivudinom ali zalcitabinom za zdravljenje okužbe z virusom HIV za sedaj še ni priporočljiva.
The safety of emtricitabine in human pregnancy has not been established.
Varnost uporabe emtricitabina v času nosečnosti še ni bila ugotovljena.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to pregnancy, foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive emtricitabina na nosečnost, razvoj plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Emtricitabine should be used during pregnancy only if necessary.
Emtricitabin smete uporabljati med nosečnostjo samo, če je potrebno.
Given that the potential risks to developing human foetuses are unknown, the use of emtricitabine in women of childbearing potential must be accompanied by the use of effective contraception.
Glede na to, da potencialni vpliv na razvoj humanega zarodka ni znan, morajo ženske v rodni dobi uporabljati emtricitabin skupaj z učinkovitim kontracepcijskim sredstvom.
It is not known if emtricitabine is excreted in human milk.
Ni znano, ali se emtricitabin pri doječih materah izloča z mlekom.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Priporočljivo je, da ženske, ki so okužene z virusom HIV, pod nobenim pogojem ne dojijo svojih dojenčkov, da bi se tako izognili prenosu okužbe z virusom HIV.
Assessment of adverse reactions is based on data from three studies in adults (n=1,479) and three paediatric studies (n=169).
Ugotavljanje neželenih reakcij temelji na podatkih treh študij z odraslimi bolniki (n=1. 479) in treh pediatričnih študij (n=169).
In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received emtricitabine (n=814) or comparator medicinal product (n=665) for 48 weeks in combination with other antiretroviral medicinal products.
V študijah z odraslimi bolniki je 1. 039 bolnikov, ki se zdravijo prvič, in 440 bolnikov, ki se zdravijo že dalj časa, prejemalo emtricitabin (n=814) ali primerljivo zdravilo (n=665) 48 tednov v kombinaciji z drugimi antiretrovirusnimi zdravili.
In three paediatric studies, treatment-naïve (n=123) and treatment-experienced (n=46) paediatric patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
V treh pediatričnih študijah so bili pediatrični bolniki, ki se zdravijo prvič (n=123) in pediatrični bolniki, ki se zdravijo že dalj časa (n=46) v starosti od 4 mesecev do 18 let, zdravljeni z emtricitabinom v kombinaciji z drugo antiretrovirusno učinkovino.
6 The adverse reactions with suspected (at least possible) relationship to treatment in adults are listed below by body system organ class and absolute frequency.
Neželene reakcije z domnevno (vsaj možno) zvezo z zdravljenjem pri odraslih bolnikih so navedene spodaj glede na organske sisteme in absolutno frekvenco.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10) or uncommon (≥ 1/ 1,000, < 1/ 100).
Frekvence so definirane kot zelo pogoste (≥ 1/ 10), pogoste (≥ 1/ 100, < 1/ 10) ali občasne (≥ 1/ 1. 000, < 1/ 100).
Common: neutropenia Uncommon: anaemia
Pogosto: neutropenija Občasno: anemija
Common: hypertriglyceridaemia, hyperglycaemia
Pogosto: hipertrigliceridemija, hiperglikemija
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Ob uporabi analogov nukleozidov je bil opažen pojav laktične acidoze, običajno povezane s hepatično steatozo (glejte poglavje 4. 4).
Common: insomnia, abnormal dreams
Pogosto: nespečnost, nenavadne sanje
Very common: headache Common: dizziness
Zelo pogosto: glavobol Pogosto: omotica
Very common: diarrhoea, nausea Common: vomiting, abdominal pain, elevated amylase including elevated pancreatic amylase, elevated serum lipase, dyspepsia
Zelo pogosto: driska, slabost Pogosto: bruhanje, bolečine v trebuhu, zvišana amilaza vključno z zvišano pankreasno amilazo, povišanje serumske lipaze, dispepsija
Common: hyperbilirubinaemia, elevated serum aspartate aminotransferase (AST) and/ or elevated serum alanine aminotransferase (ALT)
Pogosto: hiperbilirubinemija, povišanje serumske aspartat- aminotransferaze (AST) in/ ali povišanje serumske alanin- aminotransferaze (ALT)
Common: allergic reaction, urticaria, vesiculobullous rash, pustular rash, maculopapular rash, pruritus, rash, and skin discolouration (hyper-pigmentation)
Pogosto: alergijska reakcija, koprivnica, vezikulobulozni izpuščaj, pustulozni izpuščaj, makulopapulozni izpuščaj, srbečica, rdečica ter sprememba obarvanosti kože (hiperpigmentacija)
Very common: elevated creatine kinase
Zelo pogosto: povišanje kreatinske kinaze
Common: asthenia, pain
Pogosto: astenija, bolečina
In addition to the adverse reactions reported in adults, anaemia was common and skin discolouration (hyper-pigmentation) was very common in paediatric patients.
Poleg neželenih reakcij, o katerih so poročali pri odraslih, je bila pri pediatričnih bolnikih pogosta anemija in zelo pogosta sprememba obarvanosti kože (hiperpigmentacija).
The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV.
7 Neželene reakcije pri bolnikih, ki so hkrati okuženi še s HBV, so podobne tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe s HBV.