natgillin/translations-raw huggingface dataset:
Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Karmustin Obvius, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Carmustine Obvius are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Karmustin Obvius stalno spremljajo.
It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription.
Dajati se mora pod nadzorom zdravnika z izkušnjami pri uporabi zdravil proti raku, predpisovanje in izdaja zdravila pa je le na recept.
There was no need for ‘bioequivalence' studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije bioekvivalence, s katero bi raziskali, ali se zdravilo Karmustin Obvius absorbira podobno kot referenčno zdravilo in tako doseže enake ravni učinkovine v krvi, ni bila potrebna.
Because cancer cells tend to grow and multiply more than normal
Ker rakave celice bolj rastejo in razmnožujejo kot normalne celice, so bolj dovzetne za delovanje tega zdravila.
This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zdravilo Karmustin Obvius se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
Carmustine Obvius is given by infusion (drip) into a vein.
Zdravilo Karmustin Obvius se daje z infundiranjem (kapalno infuzijo) v veno.
Therefore, the Agency's view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Karmustin Obvius enako kot pri zdravilu Carmubris odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
How has Carmustine Obvius been studied?
Kako je bilo zdravilo Karmustin Obvius raziskano?
How is Carmustine Obvius used?
Kako se zdravilo Karmustin Obvius uporablja?
How does Carmustine Obvius work?
Kako zdravilo Karmustin Obvius deluje?
Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011
Datum prve odobritve: 26. junij 2006 Datum zadnjega podaljšanja: 26. junij 2011
That expiry date refers to the last day of that month.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
After each use, rinse the spoon with water and allow it to air dry.
Po vsaki uporabi žličko splaknite z vodo in jo posušite na zraku.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Iron oxide red
rdeči železov oksid
ULN=upper limit of normal, LLN=lower limit of normal.
ULN=zgornja meja normalne vrednosti, LLN=spodnja meja normalne vrednosti.
10.7% e 27% e 41.3% e
10,7% e 27% e 41,3% e 43,6% e a
Baraclude with food and drink
Zdravilo Baraclude skupaj s hrano in pijačo
In most cases you may take Baraclude with or without food.
V večini primerov lahko zdravilo Baraclude jemljete skupaj s hrano ali brez nje.
Baraclude reduces the amount of virus in your body, and improves the condition of the liver.
Zdravilo Baraclude zmanjša količino virusa v telesu in izboljša stanje jeter.
Keep the bottle in the outer carton in order to protect from light.
Plastenko shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Each carton contains either:
Vsaka škatla vsebuje:
The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Izdelovalec merilne žličke: Comar Plastics Division, One Comar Place, Buena, NJ 08310, ZDA.
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni ‘brez natrija'.
Stable or improved CTP scoreb,d MELD score
Stabilna ali izboljšana ocena po lestvici CTPb,d
Swallow the medicine directly from the measuring spoon.
Zdravilo pogoltnite neposredno iz merilne žličke.
By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Pri 48-tedenskem spremljanju po zdravljenju se je pri znatnem števili HBeAg negativnih bolnikov odziv izgubil.
Authorised Representative in the EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany
Pooblaščeni zastopnik za Comar Plastics v Evropskem gospodarskem prostoru: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Nemčija.
Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2).
Nekateri bolniki morajo jemati zdravilo Baraclude na prazen želodec (glejte Zdravilo Baraclude skupaj s hrano in pijačo v poglavju 2).
If you forget to take Baraclude
Če ste pozabili vzeti zdravilo Baraclude
Normalization of:f
Normalizacija vrednosti:e
Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Pogostnost je definirana kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000).
The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Kumulativni delež pojavnosti hepatocelularnega karcinoma (HCC) med študijo je znašal 12% (12/102).
Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose.
Žličko držite navpično (pokonci) in jo počasi napolnite do oznake, ki označuje predpisani odmerek.
Take Baraclude as long as your doctor has told you.
Zdravilo Baraclude jemljite tako dolgo, kot vam je predpisal zdravnik.
Patients may be dosed with or without food.
Bolniki lahko odmerek jemljejo s hrano ali brez nje.
A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Pri 4urni hemodializi se je odstranilo ≈ 13% odmerka, pri CAPD pa 0,3%.
The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below:
Pravilen odmerek Baraclude peroralne raztopine za otroke in mladostnike se izračuna na osnovi telesne mase, bolnik pa ga jemlje peroralno (skozi usta) enkrat na dan kot je prikazano v nadaljevanju:
Do not dilute or mix this solution with water or anything else.
Raztopine ne smete redčiti ali jo mešati z vodo ali s čim drugim.
Children and adolescents (from 2 to less than 18 years of age) can take Baraclude with or without food.
Otroci in mladostniki (stari od 2 leti do manj kot 18 let) lahko zdravilo Baraclude jemljejo skupaj s hrano ali brez nje.
Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
zdravilo Baraclude spada v skupino zdravil, ki lahko povzročijo laktacidozo (čezmerno kopičenje mlečne kisline v krvi) in povečanje jeter.
This medicinal product must not be mixed with water, other solvents or other medicinal products.
Zdravila ne smemo mešati z vodo, drugimi topili ali drugimi zdravili.
Baraclude will not control your HIV infection.
Zdravilo Baraclude ne more nadzirati okužbe z virusom HIV.
It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.
Pomembno je, da ženske v rodni dobi med zdravljenjem z zdravilom Baraclude za preprečitev nosečnosti uporabljajo učinkovito metodo kontracepcije.
If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time.
Pozabljeni odmerek zdravila Baraclude vzemite takoj, ko je to mogoče, naslednji odmerek pa nato vzemite ob običajnem času.
Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark.
Žličko držite tako, da so volumske oznake obrnjene k vam in preverite, da je napolnjena do ustrezne oznake.
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.
vprašajte svojega zdravnika ali vaša jetra delujejo normalno, in če ne, kako lahko nenormalno delovanje jeter vpliva na zdravljenje z zdravilom Baraclude.
do not stop taking Baraclude without your doctor's advice since your hepatitis may worsen after stopping treatment.
zdravila Baraclude ne smete nehati jemati brez nasveta zdravnika, saj se hepatitis po prekinitvi zdravljenja lahko poslabša.
Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily.
V primeru zamenjave zdravljenja, če vam je zdravnik zdravilo Baraclude predpisal zato, ker je bilo predhodno zdravljenje z zdravilom z učinkovino lamivudin neuspešno, morate zdravilo Baraclude jemati enkrat na dan na prazen želodec.
Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija
Other medicines and Baraclude
Druga zdravila in zdravilo Baraclude
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko dedno težavo intolerance za fruktozo tega zdravila ne smejo jemati.
Lactose: this medicinal product contains 120.5 mg of lactose in each 0.5 mg daily dose or 241 mg of lactose in each 1 mg daily dose.
Laktoza: Zdravilo vsebuje 120,5 mg laktoze v vsakem 0,5 mg dnevnem odmerku ali 241 mg laktoze v vsakem 1 mg dnevnem odmerku.
HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa
HBV DNA < 50 i.e./ml in serokonverzija HBeAga HBV DNA < 50 i.e./mla Serokonverzija HBeAga Normalizacija ALTa
Baraclude should not be used during pregnancy unless clearly necessary.
Zdravila Baraclude ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Substitucije, ki so jih opazili pri kliničnih izolatih (rtT184A, C, F, G, I, L, M ali S; rtS202 C, G ali I; in/ali rtM250I, L ali V), v primerjavi z divjim tipom virusa še dodatno zmanjšajo občutljivost za entekavir za 16- do 741krat.
Severe Managed with CAPD
Zdravljenje s CAPD
You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Zdravila Baraclude za zdravljenje okužbe z virusom hepatitisa B ne smete jemati, če sočasno ne jemljete tudi zdravil za zdravljenje okužbe z virusom HIV, saj se v nasprotnem primeru lahko učinkovitost zdravil za zdravljenje okužbe z virusom HIV v prihodnosti zmanjša.
Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml
Pomožne snovi z znanim učinkom 380 mg maltitola/ml 1,5 mg metilparahidroksibenzoata/ml 0,18 mg propilparahidroksibenzoata/ml 0,3 mg natrija/ml
HBV DNA < 50 IU/mLa
HBV DNA < 50 i.e./mla
This medicinal product contains maltitol.
Zdravilo vsebuje maltitol.
Maltitol: Baraclude oral solution contains maltitol.
Maltitol: Baraclude peroralna raztopina vsebuje maltitol.
Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
To je pomembno, ker se zdravilo Baraclude iz telesa izloča skozi ledvice in vam bo zdravnik morda moral odmerek ali odmerno shemo prilagoditi.
For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available
Za otroke in mladostnike (stare od 2 leti do manj kot 18 let), je zdravilo Baraclude na voljo v obliki peroralne raztopine ali 0,5 mg tablet
The recommended once-daily dose in paediatric patients weighing at least 10 kg, is presented in the table below.
Priporočeno odmerjanje enkrat na dan pri pediatričnih bolnikih s telesno maso vsaj 10 kg je prikazano v spodnji preglednici.
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Varnost in učinkovitost entekavirja so vrednotili tudi v aktivno nadzorovanem kliničnem preskušanju, izvedenem pri 191 bolnikih, ki so bili okuženi z virusom HBV in so imeli dekompenzirano bolezen jeter, ter v kliničnem preskušanju pri 68 bolnikih, ki so bili sočasno okuženi z virusom HBV in virusom HIV.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolniki z redkimi dednimi težavami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/galaktoze tega zdravila ne smejo jemati.
Also contains lactose monohydrate.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo monohidrat.
As an alternative, in case the oral solution is not available, the dose can be adjusted by increasing the dosage interval, also shown in the table.
Če peroralne raztopine ni na voljo, se odmerek alternativno lahko prilagodi tudi s podaljšanjem odmernega intervala, kar je tudi prikazano v preglednici.
Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium.
Natrij: En ml tega zdravila vsebuje 0,015 mmol (ali 0,3 mg) natrija.
What Baraclude is and what it is used for What you need to know before you take Baraclude How to take Baraclude
Kaj je zdravilo Baraclude in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Baraclude Kako jemati zdravilo Baraclude Možni neželeni učinki
decompensated liver disease (see section 4.4).
z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours.
Mehanizem delovanja: Entekavir je nukleozidni analog gvanozina, ki deluje proti polimerazi HBV in se učinkovito fosforilizira v aktivno trifosfatno (TP) obliko, katere znotrajcelični razpolovni čas je 15 ur.
If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Če vam je zdravnik naročil, da morate jemati zdravilo Baraclude na prazen želodec, to pomeni vsaj 2 uri po obroku in vsaj 2 uri pred naslednjim obrokom.
Patients treated with Baraclude have reported the following side effects: common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Pri bolnikih, ki so se zdravili z zdravilom Baraclude, so poročali o naslednjih neželenih učinkih: pogosti (pri več kot 1 od 100 bolnikov): glavobol, insomnija (nespečnost), utrujenost (močna oslabelost), omotica, somnolenca (zaspanost), bruhanje, driska, slabost, dispepsija (prebavne motnje) in povečane vrednosti jetrnih encimov v krvi.
For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Za ustrezno odmerjanje pri pediatrični populaciji je zdravilo Baraclude na voljo v obliki peroralne raztopine ali 0,5 mg filmsko obloženih tablet.
Hepatobiliary disorders common: increased transaminases
pogosti: povečane vrednosti transaminaz
Each 1 mg film-coated tablet contains 241 mg lactose.
Vsaka 1 mg filmsko obložena tableta vsebuje 241 mg laktoze.
d ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
≥ 1 log10 povečanje nad najnižjo vrednostjo HBV DNA, določene s PCR, potrjeno z zaporednimi meritvami ali ob koncu časovnega okvira.
Also contains: maltitol, preservatives E216, E218.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: maltitol, konzervansa E216 in E218.
In studies in patients with compensated liver disease, histological improvement was defined as a ≥ 2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
V študijah pri bolnikih s kompenzirano boleznijo jeter, je bilo izboljšanje histološke slike definirano kot zmanjšanje stopnje vnetja in nekroze po Knodell-u ("Knodell necro-inflammatory score") za 2 ali več točk od izhodiščne vrednosti in brez poslabšanja stopnje fibroze po Knodell-u ("Knodell Fibrosis Score").
A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended.
Pri zmanjšanju dnevnega odmerka priporočamo uporabo Baraclude peroralne raztopine, kot je prikazano v preglednici.
There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Podatki pri bolnikih s sočasno okužbo z virusom HIV z nizkim številom CD4 celic (< 200 celic/mm3) so omejeni.
Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Jedro tablete: krospovidon, laktoza monohidrat, magnezijev stearat, mikrokristalna celuloza in povidon.
Titanium dioxide Hypromellose Macrogol 400
Obloga tablete: titanov dioksid hipromeloza makrogol 400
At least 32.6 kgb
9,5 ml vsaj 32,6 kgb
The film-coated tablets (tablets) are pink and triangular-shaped.
Filmsko obložene tablete (tablete) so rožnate barve in trikotne oblike.
You should not breast-feed during treatment with Baraclude.
Med zdravljenjem z zdravilom Baraclude ne smete dojiti.
Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Neodzivnost na lamivudin HBeAg pozitivni (študija 026) ETV 1,0 mg enkrat na dan
Baraclude must not be used during pregnancy unless specifically directed by your doctor.
Zdravila Baraclude med nosečnostjo ne smete uporabljati brez izrecnega navodila zdravnika.
Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Zdravilo Baraclude se lahko uporablja pri otrocih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter).
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets.
Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko, ki vsebujejo 30 filmsko obloženih tablet.
What Baraclude looks like and contents of the pack
Izgled zdravila Baraclude in vsebina pakiranja
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake “EXP”.
Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml
Vsaka škatlica vsebuje merilno žličko (polipropilen), ki ima oznake od 0,5 ml do 10 ml.
Liver transplant recipients: the safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.
Bolniki s presajenimi jetri: Varnost in učinkovitost entekavirja v odmerku 1 mg enkrat na dan so vrednotili v eno-skupinski študiji pri 65 bolnikih s presajenimi jetri, pri katerih so presaditev opravili zaradi zapletov kronične okužbe z virusom HBV in so imeli v času presaditve vrednost HBV DNA < 172 i.e./ml (približno 1.000 kopij/ml).
However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following.
Če ste se predhodno zdravili z učinkovino lamivudin, morate upoštevati naslednje.
It is recommended that the dosing spoon be rinsed with water after each daily dose.
Priporočamo, da bolnik po vsakem zaužitju dnevnega odmerka merilno žličko splakne z vodo.
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) 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) (glejte poglavje 5.1) 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.
Excipients with known effect Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Pomožne snovi z znanim učinkom Vsaka 0,5 mg filmsko obložena tableta vsebuje 120,5 mg laktoze.
Year 1 Year 2 Year 3a Year 4a Year 5a
1. leto 2. leto 3. letoa 4. letoa 5. letoa
Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.
Zdravila Baraclude se ne sme uporabljati pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg.
Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Parahidroksibenzoati: Baraclude peroralna raztopina vsebuje konzervansa metilparahidroksibenzoat in propilparahidroksibenzoat, ki lahko povzročita alergijske reakcije (ki so lahko zapoznele).
Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥ 50 IU/ml at Week 48 or
Genotipska vrednotenja so bila izvedena pri vseh bolnikih z razpoložljivimi vzorci, pri katerih je do 96. tedna prišlo do povečanja virusnega bremena (“virologic breakthrough”), ali so imeli v 48. tednu ali 96. tednu vrednost HBV DNA ≥ 50 i.e./ml.
Assessment of adverse reactions is based on experience from postmarketing surveillance and four clinical studies in which 1,720 patients with chronic hepatitis B infection and compensated liver disease received double-blind treatment with entecavir (n = 862) or lamivudine (n = 858) for up to 107 weeks (see section 5.1).
Neželeni učinki so bili ocenjeni na podlagi podatkov iz spremljanja zdravila po prihodu na trg in štirih kliničnih študij, v katerih je 1.720 bolnikov s kroničnim hepatitisom B in kompenzirano boleznijo jeter med dvojno slepim zdravljenjem, ki je trajalo do 107 tednov, prejemalo entekavir (n = 862) ali lamivudin (n = 858) (glejte poglavje 5.1).
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 in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Bolniki, neodzivni na lamivudin (to je z dokazano viremijo med zdravljenjem z lamivudinom ali prisotnostjo mutacij, povezanih z odpornostjo na lamivudin [LVDr]) (glejte poglavji 4.4 in 5.1): Priporočeni odmerek za odrasle je 1 mg enkrat na dan. Bolniki morajo priporočeni odmerek jemati na prazen želodec (več kot 2 uri pred in več kot 2 uri po obroku) (glejte poglavje 5.2).