natgillin/translations-raw huggingface dataset:
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
0, 5 mg odmerek lahko bolnik jemlje z ali brez hrane, medtem ko mora 1 mg odmerek vzeti vsaj 2 uri pred ali 2 uri po obroku.
Doses are lower for patients who have kidney problems, for whom the oral solution can be used.
Pri bolnikih z ledvičnimi težavami, pri katerih se lahko uporabi peroralno raztopino, so odmerki nižji.
The treatment duration is determined according to the patient’ s response.
Trajanje zdravljenja se določi glede na terapevtski odziv bolnika.
Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Entekavir moti delovanje virusnega encima DNA polimeraze, ki je udeležen pri tvorjenju virusne DNA.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Entekavir ustavi virusovo tvorjenje DNA, in mu prepreči razmnoževanje in širjenje.
The effects of Baraclude were first tested in experimental models before being studied in humans.
Učinki zdravila Baraclude so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The effectiveness of Baraclude in chronic hepatitis B was compared with that of lamivudine in 3 main clinical studies.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Učinkovitost zdravila Baraclude pri kroničnem hepatitisu B je bila primerjana s tisto, ki jo ima zdravilo lamivudin, v treh glavnih kliničnih študijah.
Patients were mostly male, aged between 35 and 44 years of age, and they received at least one year of treatment with either Baraclude or lamivudine.
Bolniki so bili v glavnem moški, stari med 35 in 44 let in so prejeli vsaj eno leto zdravljenja bodisi z zdravilom Baraclude ali zdravilom lamivudin.
Two studies (1,363 patients) were carried out in nucleoside-naïve patients (these are patients who have not been treated with nucleoside analogues before).
Dve študiji (1363 bolnikov) sta bili izvedeni na bolnikih, ki se še niso zdravili z nukleozidi (ti bolniki se pred tem še niso zdravili z nukleozidnimi analogi).
The other study (293 patients) was carried out in patients who had become refractory to lamivudine treatment.
Druga študija (293 bolnikov) je bila izvedena na bolnikih, ki so postali neodzivni na zdravljenje z zdravilom lamivudin.
The studies measured the effectiveness of the treatment by looking at how the liver damage had evolved after 48 weeks treatment (using a liver biopsy, when a sample of liver tissue is taken and examined under a microscope) as well as measuring other signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA circulating in the blood of the patients.
V študijah se je učinkovitost zdravljenja merila z opazovanjem razvoja poškodb jeter po 48 tednih zdravljenja (ob uporabi biopsije jeter, z odvzemom vzorca jeter in njegovo preiskavo pod mikroskopom), kakor tudi z merjenjem drugih znakov bolezni, kot so ravni jetrnega encima (ALT) ali virusne DNA, ki kroži v krvi bolnikov.
What benefit has Baraclude shown during the studies?
Kakšne koristi je zdravilo Baraclude izkazalo med raziskavami?
Baraclude was more effective than lamivudine in treatment-naïve patients: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
Zdravilo Baraclude je bilo pri zdravljenju bolnikov, ki se še niso zdravili, bolj učinkovito od zdravila lamivudin: izboljšanje stanja jeter je bilo opaziti pri malce več kot 70% bolnikov, ki so bili zdravljeni z zdravilom Baraclude, v primerjavi z malce več kot 60% bolnikov, ki so bili zdravljeni z zdravilom lamivudin.
These results were seen both in patients who were ‘ HBeAg positive ’ (infected with the common hepatitis B virus) and in those who were ‘ HBeAg negative ’ (infected with a virus that has mutated, leading to a form of chronic hepatitis B that is more difficult to treat).
Ti rezultati so bili opazni tako pri bolnikih, ki so bili „ HBeAG pozitivni “ (okuženi z običajnim virusom hepatitisa B) in tisti, ki so bili „ HBeAG negativni “ (okuženi z virusom, ki je mutiral, kar je privedlo do oblike kroničnega hepatitisa B, ki jo je težje zdraviti).
Baraclude was also more effective than lamivudine in patients refractory to lamivudine:
Zdravilo Baraclude je bilo od zdravila lamivudin bolj učinkovito tudi pri bolnikih, neodzivnih na lamivudin:
55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
55% bolnikov, zdravljenih z zdravilom Baraclude je izkazalo izboljšanje stanja jeter, v primerjavi z 28% tistih, ki so bili zdravljeni z zdravilom lamivudin.
At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, when 4% of those treated with lamivudine showed the same results.
Ob koncu študije je 55% bolnikov zdravljenih z zdravilom Baraclude imelo običajno raven ALT in nedokazljivo virusno DNA v krvi, medtem ko je iste rezultate izkazalo 4% tistih, zdravljenih z zdravilom lamivudin.
In clinical studies, the most common side effects were headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).
V kliničnih študijah so bili najpogostejši neželeni učinki glavobol (opažen pri 9% bolnikov), utrujenost (opešanost, 6%), omotica (4%) in navzeja (slabost, 3%).
For the full list of side effects reported with Baraclude, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Baraclude, najdete v Navodilih za uporabo.
Baraclude should not be used in people who may be hypersensitive (allergic) to entecavir or any of the other ingredients.
Zdravila Baraclude ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) entekavir ali katerokoli drugo sestavino zdravila.
Patients and doctors need to be aware that Baraclude belongs to a group of medicines, the nucleoside analogues, which have been known to cause ‘ lactic acidosis’: when the level of the chemical lactic acid becomes abnormally high in the blood, causing nausea, vomiting and stomach pain.
Bolniki in zdravniki se morajo zavedati, da zdravilo Baraclude spada v skupino zdravil imenovanih nukleozidni analogi, za katere je znano, da povzročajo „ laktacidozo “: kadar raven kemične mlečne kisline v krvi zraste nenormalno visoko povzroča navzejo, bruhanje in bolečine v želodcu.
Patients also need to know that they may also suffer a worsening of their liver disease.
Bolniki se morajo zavedati tudi dejstva, da lahko pride do poslabšanja njihove bolezni jeter.
This can happen during the treatment, or after it has been stopped.
Do tega lahko pride med zdravljenjem ali po prenehanju tega.
Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Odpornost na entekavir (virus postane neobčutljiv na protivirusno zdravilo) je bilo opaziti pri bolnikih, neodzivnih na lamivudin.
As resistance may have an impact on effectiveness, this will be closely monitored during long-term follow-up.
Ker ima odpornost morebiten vpliv na učinkovitost, bo slednje potrebno skrbno opazovati med dolgotrajnim nadziranjem.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Baraclude had shown that it was as or more effective than the current treatment for hepatitis B virus infections.
Odbor za zdravila za uporabo v humani medicini (CHMP) vsaj enako ali večjo učinkovitost kot trenutno zdravljenje mnenja, da so koristi zdravila Baraclude pri zdravljenju kompenzirano boleznijo jeter večje kot z njim povezana dovoljenja za promet z zdravilom Baraclude.
They decided that Baraclude’ s benefits are greater than its risks for the treatment of patients with chronic hepatitis B with compensated liver disease.
meni, da je zdravilo Baraclude dokazalo okužb z virusom hepatitisa B.
They recommended that Baraclude be given marketing authorisation.
Odbor je priporočil odobritev
Other information about Baraclude:
Druge informacije o zdravilu Baraclude:
The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude to BRISTOL-MYERS SQUIBB PHARMA EEIG on 26 June 2006.
Evropska Komisija je dovoljenje za promet z zdravilom Baraclude, veljavno po vsej Evropski uniji, odobrila družbi BRISTOL- MYERS SQUIBB PHARMA EEIG dne 26. junija 2006.
The full EPAR for Baraclude can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Baraclude je na voljo tukaj.
This summary was last updated in 05-2006.
Ta povzetek je bil nazadnje posodobljen 05- 2006.
Content
Vsebina (koncentracija)
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
bottle (HDPE) bottle (HDPE) blister (alu/ alu) blister (alu/ alu)
Plastenka (HDPE) Pretisni omot (alu/ alu) Plastenka (HDPE) Pretisni omot (alu/ alu)
30 tablets 30 tablets 30 x 1 tablets 30 x 1 tablets
30 tablet 30 x 1 tableta 30 tablet 30 x 1 tableta
Oral solution
Peroralna raztopina Filmsko obložena tableta Filmsko obložena tableta
Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba
bottle (HDPE)
Plastenka (HDPE) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu)
90 x 1 tablets 90 x 1 tablets
1 plastenka + merilna žlička 90 x 1 tableta 90 x 1 tableta
Baraclude 0.5 mg film-coated tablets
Baraclude 0, 5 mg filmsko obložene tablete
Each tablet contains 0.5 mg entecavir (as monohydrate).
Vsaka tableta vsebuje 0, 5 mg entekavirja (v obliki monohidrata).
Excipients: each tablet contains 120.5 mg lactose.
Vsaka tableta vsebuje 120, 5 mg laktoze.
White to off-white and triangular-shaped tablet with “ BMS ” debossed on one side and “ 1611” on the other.
Na eni strani ima vtisnjeno oznako “ BMS ”, na drugi strani pa “ 1611 ”.
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Zdravilo Baraclude je indicirano za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) pri odraslih s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin- aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ ali fibrozo.
This indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Indikacija temelji na podatkih kliničnega preskušanja pri HBeAg pozitivnih in HBeAg negativnih bolnikih, okuženih s HBV, ki se še niso zdravili z nukleozidi.
With respect to patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Glede bolnikov s hepatitisom B, neodzivnim na lamivudin, glejte poglavji 4. 4 in 5. 1.
Baraclude should be taken orally, once-daily.
Zdravilo Baraclude mora bolnik jemati peroralno enkrat na dan.
Nucleoside naïve patients: the recommended dose is 0.5 mg once daily, with or without food.
Bolniki, ki se še niso zdravili z nukleozidi: priporočeni odmerek je 0, 5 mg enkrat na dan, s hrano ali brez nje.
Lamivudine-refractory patients (i. e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before or more than 2 hours after a meal) (see section 5.2).
Bolniki morajo priporočeni odmerek jemati na prazen želodec (več kot 2 uri pred ali več kot 2 uri po obroku) (glejte poglavje 5. 2).
Duration of therapy: the optimal duration of treatment is unknown.
Trajanje zdravljenja: optimalno trajanje zdravljenja ni znano.
In HBeAg positive patients, treatment should be administered at least until HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Pri HBeAg pozitivnih bolnikih mora zdravljenje trajati vsaj do serokonverzije HBe (izginotje HBeAg in HBV DNA ter pojav protiteles anti- HBe v dveh zaporednih vzorcih seruma, odvzetih z vsaj 3 - do 6- mesečnim vmesnim presledkom) ali do serokonverzije HBs, oziroma do izgube učinkovitosti (glejte poglavje 4. 4).
In HBeAg negative patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Pri HBeAg negativnih bolnikih mora zdravljenje trajati vsaj do serokonverzije HBs ali do pojava znakov izgube učinkovitosti.
Baraclude is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
2 Otroci in mladostniki: zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Baraclude pri otrocih, mlajših od 18 let, ni priporočljiva.
The dose should be adjusted according to the patient ’ s renal function (see dosage recommendations in renal impairment and section 5.2).
Odmerek je treba prilagoditi glede na delovanje ledvic (glejte priporočila za odmerjanje pri okvari ledvic in poglavje 5. 2).
Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Okvara ledvic: očistek entekavirja se zmanjšuje z zmanjševanjem kreatininskega očistka (glejte poglavje 5. 2).
Dose adjustment is recommended for patients with creatinine clearance < 50 ml/ min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Pri bolnikih s kreatininskim očistkom < 50 ml/ min, vključno z bolniki, ki se zdravijo s hemodializo ali kontinuirano ambulantno peritonealno dializo (CAPD - "continuous ambulatory peritoneal dialysis"), priporočamo prilagoditev odmerka.
Creatinine clearance (ml/ min)
Odmerjanje * zdravila Baraclude Kreatininski očistek (ml/ min)
Lamivudine-refractory
Bolniki, neodzivni na lamivudin
0.5 mg once daily 0.25 mg once daily* OR 0.5 mg every 48 hours
0, 5 mg enkrat na dan 0, 25 mg enkrat na dan * ALI 0, 5 mg vsakih 48 ur
1 mg once daily 0.5 mg once daily
1 mg enkrat na dan 0, 5 mg enkrat na dan
0.15 mg once daily* OR 0.5 mg every 72 hours
0, 15 mg enkrat na dan * ALI 0, 5 mg vsakih 72 ur
0.3 mg once daily* OR 0.5 mg every 48 hours
0, 3 mg enkrat na dan * ALI 0, 5 mg vsakih 48 ur
< 10 Haemodialysis or CAPD**
< 10 Hemodializa ali CAPD **
0.05 mg once daily* OR 0.5 mg every 5-7 days
0, 05 mg enkrat na dan * ALI 0, 5 mg vsakih 5- 7 dni
0.1 mg once daily* OR 0.5 mg every 72 hours
0, 1 mg enkrat na dan * ALI 0, 5 mg vsakih 72 ur
* for doses < 0.5 mg Baraclude oral solution is recommended. ** on haemodialysis days, administer entecavir after haemodialysis.
* za odmerke < 0, 5 mg priporočamo uporabo Baraclude peroralne raztopine. ** na dan hemodialize bolniki vzamejo entekavir po hemodializi.
Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Okvara ledvic: pri bolnikih z okvaro ledvic priporočamo prilagoditev odmerka (glejte poglavje 4. 2).
Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
Zanje so značilna prehodna povišanja vrednosti serumske ALT.
After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Pri nekaterih bolnikih se po uvedbi protivirusnega zdravljenja vrednosti serumske ALT lahko povišajo, medtem ko se vrednosti serumske HBV DNA zmanjšajo (glejte poglavje 4. 8).
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Pri bolnikih s cirozo je tveganje za jetrno
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
3 dekompenzacijo po poslabšanju hepatitisa lahko večje, zato jih je treba med zdravljenjem skrbno nadzirati.
3 Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
O akutnem poslabšanju hepatitisa so poročali tudi po prekinitvi zdravljenja hepatitisa B.
However, severe exacerbations, including fatalities, have been reported.
Poslabšanja po zdravljenju so običajno povezana z naraščanjem HBV DNA in domnevno večinoma sama izzvenijo, vendar pa so poročali tudi o hudih poslabšanjih, vključno s smrtnimi primeri.
Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Delovanje jeter je treba v rednih časovnih presledkih nadzirati tako klinično kot laboratorijsko še vsaj 6 mesecev po prekinitvi zdravljenja hepatitisa B.
If appropriate, resumption of hepatitis B therapy may be warranted.
Zdravljenje hepatitisa B bo morda treba ponovno uvesti.
Patients with decompensated cirrhosis: a higher rate of serious hepatic adverse events has been observed in patients with decompensated cirrhosis compared with rates in patients with compensated liver function.
Bolniki z dekompenzirano cirozo: v primerjavi z bolniki s kompenziranim delovanjem jeter so pri bolnikih z dekompenzirano cirozo opazili večji odstotek resnih jetrnih neželenih dogodkov.
This observation is based on limited experience in 45 patients with Child-Pugh score ≥ 7 at the start of entecavir treatment.
Ta opažanja temeljijo na omejenih izkušnjah pri 45 bolnikih, ki so ob začetku zdravljenja z entekavirjem imeli ≥ 7 točk po Child- Pugh- ovi lestvici.
These patients should be regularly monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function and antiviral response during treatment, and if treatment is discontinued, for at least 6 months thereafter.
Pri teh bolnikih je med zdravljenjem in še vsaj 6 mesecev po prekinitvi zdravljenja treba redno nadzirati tako klinične, virološke in serološke parametre, povezane s hepatitisom B, kot tudi delovanje jeter in ledvic ter protivirusni odziv.
Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Pri bolnikih z znaki insuficience jeter med ali po zdravljenju mora biti nadzor ustrezno pogostejši.
Lactic acidosis and severe hepatomegaly with steatosis: occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Laktacidoza in huda hepatomegalija s steatozo: pri uporabi nukleozidnih analogov so poročali o pojavih laktacidoze (brez hipoksemije), ki se je včasih končala smrtno in je bila običajno povezana s hudo hepatomegalijo in jetrno steatozo.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
V primeru nenadnega povišanja vrednosti aminotransferaz, pojava progresivne hepatomegalije ali metabolične acidoze/ laktacidoze neznane etiologije je treba zdravljenje z nukleozidnimi analogi prekiniti.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.
Hujši primeri, ki so se včasih končali smrtno, so bili povezani s pankreatitisom, z odpovedjo jeter/ jetrno steatozo, odpovedjo ledvic in s povišanimi vrednostmi serumskega laktata.
Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Odpornost in posebna previdnost pri bolnikih, neodzivnih na lamivudin: mutacije HBV polimeraze, ki kodirajo substitucije, povezane z odpornostjo na lamivudin, lahko vodijo do kasnejšega pojava sekundarnih substitucij, vključno s tistimi, ki so povezane z odpornostjo na entekavir (ETVr).
Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance.
Pri bolnikih s HBV, odpornim na lamivudin, obstaja večje tveganje za nadalnji razvoj odpornosti na entekavir kot pri bolnikih brez odpornosti na lamivudin.
In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
Pri bolnikih s suboptimalnim virološkim odzivom po 24 tednih zdravljenja z entekavirjem je treba razmisliti o spremembi terapevtske sheme (glejte poglavji 4. 5 in 5. 1).
Liver transplant recipients: there are limited data on efficacy and safety of entecavir in liver transplant recipients.
Pri bolnikih s presajenimi jetri, ki se zdravijo s ciklosporinom ali takrolimusom, je treba pred začetkom zdravljenja z entekavirjem skrbno oceniti delovanje ledvic.
Renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Pri teh bolnikih je treba delovanje ledvic skrbno nadzirati tudi med zdravljenjem z entekavirjem (glejte poglavje 5. 2).
Co-infection with hepatitis C or D: there are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Sočasna okužba z virusom hepatitisa C ali D: podatki o učinkovitosti entekavirja pri bolnikih s sočasno okužbo z virusom hepatitisa C ali D niso na voljo.
Human immunodeficiency virus (HIV)/ HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/ HBV co-infected patients not
4 Bolniki s sočasno okužbo z virusoma humane imunske pomanjkljivosti (HIV) in HBV, ki sočasno ne prejemajo protiretrovirusnega zdravljenja: pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se sočasno niso zdravili z učinkovito obliko zdravljenja okužbe z virusom HIV, uporabe entekavirja niso ovrednotili.
Emergence of HIV resistance has been observed when entecavir was used to treat chronic hepatitis B infection in patients with HIV infection not receiving highly active antiretroviral therapy (HAART) (see section 5.1).
Pri z virusom HIV okuženih bolnikih, ki se niso zdravili z visoko aktivno obliko protiretrovirusnega zdravljenja (“ highly active antiretroviral therapy ” [režim HAART]), so pri zdravljenju kronične okužbe z virusom hepatitisa B z entekavirjem poročali o pojavu odpornosti virusa HIV (glejte poglavje 5. 1).
Therefore, therapy with entecavir should not be used for HIV/ HBV co-infected patients who are not receiving HAART.
Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se ne zdravijo po režimu HAART, se entekavir torej ne sme uporabljati.
HIV/ HBV co-infected patients receiving concomitant antiretroviral therapy: entecavir has been studied in 68 adults with HIV/ HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Bolniki s sočasno okužbo z virusoma HIV in HBV, ki sočasno prejemajo protiretrovirusno zdravljenje: uporabo entekavirja so proučevali pri 68 odraslih bolnikih s sočasno okužbo z virusoma HIV/ HBV, ki so se zdravili po režimu HAART, ki je vključeval lamivudin (glejte poglavje 5. 1).