natgillin/translations-raw huggingface dataset:
Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
Razine anti-HBs antitijela u serumu potrebno je kontrolirati najmanje svaka 2 do 4 tjedna te prema procjeni nadležnog liječnika tijekom najmanje pola godine.
It is strongly recommended that every time Zutectra is used (both at hospital or in a home treatment), the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Preporučuje se da se pri svakoj primjeni lijeka Zutectra (u bolnici i kod kuće) zabilježe naziv i serijski broj lijeka kako bi se sačuvao podatak o iskorištenim serijama.
The objectives of the open, prospective, single-arm clinical trial were the investigation of feasibility of home self-administration (including patient compliance), efficacy and safety of subcutaneous application of Zutectra in a population of stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver in 66 patients.
Ciljevi otvorenog prospektivnog kliničkog ispitivanja s jednom skupinom bili su ispitivanje izvedivosti samostalne primjene kod kuće (uključujući suradljivost ispitanika) te djelotvornost i sigurnost supkutane primjene lijeka Zutectra u populaciji stabilnih bolesnika tijekom dugoročnog liječenja radi profilakse ponovne infekcije transplantirane jetre na 66 bolesnika.
Choose the area where you will make the injection and make a note of it in the diary.
Injiciranje 1. Odaberite područje injiciranja i zabilježite taj podatak u dnevniku.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
You are likely to have more fatty tissue the closer you are to the hip and the further you are from the knee.
Više masnog tkiva nalazi se bliže kukovima, odnosno dalje od koljena.
The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below.
Nuspojave zabilježene u četiri ispitivanja sažete su i kategorizirane prema organskom sustavu MedDRA i učestalosti navedenima u nastavku.
The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Najbolja mjesta za injiciranje su tamo gdje je koža opuštena i mekana, kao na primjer na trbuhu, ruci, bedru ili stražnjici te daleko od zglobova, živaca i kostiju.
This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.
Ta se preporuka odnosi i na dokumentiranje u dnevniku liječenja u slučaju da bolesnik sam sebi daje lijek u okviru kućne njege.
Uncommon (may affect up to 1 in 100 people): - headache - upper abdominal pain (from your chest to the belly button)
Manje često (mogu se javiti u do 1 na 100 osoba): - glavobolja - bolovi u gornjem dijelu abdomena (od prsa do pupka)
The other ingredients are glycine and water for injections.
Pomoćne tvari su glicin i voda za injekcije.
Please tell your doctor or healthcare professional prior to treatment if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood.
Upozorenja i mjere opreza Obratite se svom liječniku ili zdravstvenom djelatniku prije nego što počnete uzimati lijek ako vam je rečeno da u krvi imate antitijela protiv imunoglobulina tipa IgA .
Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).
Često (mogu se javiti u do 1 na 10 osoba): - reakcije na mjestu injiciranja: bol, koprivnjača (urtikarija) na mjestu injiciranja, hematom (nakupljanje krvi u tkivu ispod kože), crvenilo na koži (eritem).
What Zutectra is and what it is used for
Što je Zutectra i za što se koristi
Slovenija MEDIS, d.o.o.
MEDIS, d.o.o.
Keep this leaflet.
Sačuvajte ovu uputu.
One non-serious adverse event was reported to be related to Zutectra (injection site haematoma).
Prijavljen je jedan štetni događaj povezan s lijekom Zutectra koji nije bio ozbiljan (hematom na mjestu injiciranja).
Serum HBs antibody concentrations above the minimum safety trough level of >100 IU/L were measured in all patients at all timepoints independent of the type of administration (investigator, caregiver or self-injection), the dose regimen (500 IU, 1000 IU, 1500 IU) or the treatment intervals.
Koncentracije HBs antitijela u serumu iznad najniže sigurnosne razine od >100 IU/l izmjerene su kod svih bolesnika u svim vremenskim točkama neovisno o vrsti primjene (ispitivač, njegovatelj ili samostalna primjena), režimu doziranja (500 IU, 1000 IU, 1500
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women.
Sigurnost ovog lijeka za primjenu tijekom ljudske trudnoće nije utvrđena u kontroliranim kliničkim ispitivanjima te ga treba davati oprezno trudnicama.
Pharmacotherapeutic group: Immune sera and immunoglobulins, Specific immunoglobulins, Hepatitis B immunoglobulin
Farmakoterapijska skupina: Imunoserumi i imunoglobulini, specifični imunoglobulini, hepatitis B imunoglobulin
After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Nakon primjene ovog lijeka trebao bi proći interval od najmanje 3 mjeseca prije cijepljenja živim atenuiranim virusnim cjepivima.
An allergic reaction may include sudden wheeziness, difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or tongue, rash or itching.
Alergijska reakcija može uključivati iznenadno piskanje, otežano disanje, brz puls, oticanje kapaka, lica, usnica, grla ili jezika, osip ili svrbež.
If some areas are too difficult for you to reach, you may need a caregiver to help you with these injections.
Ako neka mjesta nisu pristupačna, možda će Vam pri tim injiciranjima morati pomoći njegovatelj.
These include - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of virus/infections.
- pažljiv odabir donora krvi i plazme da bi se osiguralo isključivanje rizičnih osoba koje mogu prenijeti infekcije i - pregled svake donirane krvi i plazme radi znakova virusa/infekcija.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
U slučaju sumnje na alergijske ili anafilaktičke reakcije treba odmah prekinuti injiciranje.
Do not use Zutectra if you notice that the solution is cloudy or has particles.
Nemojte koristiti lijek Zutectra ako primijetite da je otopina mutna ili sadrži čestice.
Ensure that Zutectra is not administered into a blood vessel, because of the risk of shock.
Zutectra se ne smije primijeniti u krvnu žilu zbog rizika od nastanka šoka.
- Take the needle out of its sterile pack and fit the needle onto the syringe.
- Izvadite iglu iz sterilnog pakiranja i stavite je na štrcaljku.
Clean the injection site by wiping it in a circular motion with the alcohol swab.
Očistite mjesto injiciranja brisanjem kružnim pokretom gazom natopljenom alkoholom.
Thighs: Use middle and outer areas where you can pinch up tissue.
Bedra: upotrijebite središnji dio ili vanjske dijelove na kojima možete stisnuti tkivo.
MedDRA System Organ Class
Klasifikacija organskih sustava prema MedDRA-i
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Prolazno povećanje različitih pasivno prenesenih antitijela u krvi bolesnika nakon injiciranja imunoglobulina može prouzročiti lažno pozitivne rezultate u serološkim pretragama.
Buttocks: Use any area where you can pinch up tissue.
Stražnjica: upotrijebite bilo koji dio na kojem možete stisnuti tkivo.
Zutectra is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days.
Zutectra se polako apsorbira u krvni sustav primatelja i postiže maksimalnu razinu nakon odgode od 2 do
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Mjere koje se poduzimaju mogu imati ograničen učinak na viruse bez ovojnica poput parvovirusa B19.
During the 48-weeks treatment phase constant serum HBs antibody concentrations ≥ 100 IU/l were measured in all patients at all assessments with mean values of 312.0 ± 103.5 IU/l at the end of the treatment period.
Tijekom faze liječenja od 48 tjedana kod svih su ispitanika izmjerene stalne koncentracije HBs antitijela ≥ 100 IU/l u svim mjerenjima, sa srednjom vrijednošću od 312,0 ± 103,5 IU/l na kraju razdoblja liječenja.
The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B reinfection prophylaxis.
Potrebno je razmotriti istodobnu primjenu odgovarajućih virostatika kao standardne profilakse ponovne infekcije hepatitisom B.
- Examine the solution carefully.
- Pažljivo pregledajte otopinu.
This also applies to unknown or emerging viruses and other pathogens.
To se odnosi i na nepoznate ili novootkrivene viruse te druge patogene organizme.
Your doctor will tell you how much and how often you need to use Zutectra.
Vaš će Vam liječnik reći koliko i kada trebate uzimati lijek Zutectra.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Rijetko ljudski normalni imunoglobulini mogu uzrokovati iznenadni pad krvnog tlaka i u izoliranim slučajevima anafilaktički šok, čak i kada bolesnici nisu pokazali preosjetljivost prilikom prijašnje primjene.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE
If you forget to use Zutectra
Ako ste zaboravili primijeniti lijek Zutectra
The safety of this medicinal product for use in breast-feeding has not been established in controlled clinical trials and therefore should only be given with caution to breast-feeding mothers.
Sigurnost ovog lijeka za primjenu tijekom dojenja nije utvrđena u kontroliranim kliničkim ispitivanjima te ga stoga treba davati oprezno dojiljama.
In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels > 100 IU/l after extended periods between level controls.
Osim toga, bolesnik ili njegovatelj moraju se pridržavati tehnike injiciranja kao i režima doziranja kako bi se nakon duljih razdoblja između kontrola razine osigurale najniže razine anti-HBs-a u serumu > 100 IU/l.
Talk to your doctor about managing the dose.
Obratite se svom liječniku o načinu doziranja.
Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing.
Prije početka supkutanog liječenja lijekom Zutectra, odgovarajuće razine anti-HBs-a u serumu moraju se stabilizirati intravenskim imunoglobulinom protiv hepatitisa B na razine jednake ili više od 300 do 500 IU/l kako bi se osigurala odgovarajuća razina anti-HBs-a tijekom prelaska s intravenskog na supkutano doziranje.
No fatal case was observed during the study.
Tijekom ispitivanja nije bilo smrtnih ishoda.
Potential complications can often be avoided by ensuring that patients: are not sensitive to human normal immunoglobulin, by initially injecting the product slowly; are carefully monitored for any symptoms throughout the injection.
Moguće komplikacije često se mogu izbjeći: provjeravajući osjetljivost bolesnika na ljudski normalni imunoglobulin početnim sporim injiciranjem lijeka pažljivim promatranjem simptoma za vrijeme davanja injekcije.
The solution is clear and pale yellow or light brown.
. Otopina je prozirna i blijedožuta ili svijetlosmeđa.
Do not use this medicine after the expiry date which is stated on the outer carton and the syringe label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici štrcaljke iza oznake „Rok valjanosti“.
For subcutaneous use only.
Samo za supkutanu primjenu.
LIST OF EXCIPIENTS Excipients: Glycine, water for injections.
Pomoćne tvari: glicin, voda za injekcije.
Once the injection has been completed, dispose of all needles, syringes and empty glass containers without delay in a container intended for sharp objects you were provided with.
Nakon dovršetka injiciranja odmah odložite sve igle, štrcaljke i prazne staklene bočice u spremnik za oštre predmete koji ste dobili.
Zutectra must be brought to room temperature (approx. 23°C-27°C) before use.
Zutectra prije upotrebe mora postići sobnu temperaturu (približno 23 - 27 °C).
IgG subclass distribution:
Distribucija podklase IgG:
Store and transport refrigerated (2°C-8°C).
Čuvati i prevoziti na hladnom (2 °C - 8 °C).
• At the request of the European Medicines Agency.
Nadalje, nadopunjeni RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
A sufficient surveillance period with stable anti-HBs trough serum levels of > 100 IU/l as well as a fixed dosage regimen is required: the monitoring schedule of patients anti-HBs antibody levels (see above) needs to be closely followed.
Potrebno je odgovarajuće razdoblje nadzora uz stabilne najniže razine anti-HBs-a u serumu > 100 IU/l, kao i fiksni režim doziranja: potrebno je strogo se pridržavati rasporeda praćenja razina anti-HBs antitijela bolesnika (gore naveden).
Make sure you use Zutectra as prescribed and as instructed by your doctor to avoid the risk of a hepatitis B re-infection.
Svakako uzimajte lijek Zutectra prema uputama liječnika da biste izbjegli opasnost od ponovne infekcije hepatitisom B.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Pri proizvodnji lijekova od ljudske krvi ili plazme primjenjuju se određene mjere kojima se sprječava prijenos infekcija na bolesnike.
The weekly subcutaneous dose was 500 IU for patients with bodyweight < 75 kg (a dose increase to 1000 IU was allowed, if medically required to maintain a safety level of > 100 IU) and 1000 IU for patients with bodyweight ≥ 75 kg. 2 patients received a higher and 2 patients received a lower dose than recommended by the weight based dosing regimen.
Tjedna supkutana doza bila je 500 IU za bolesnike tjelesne težine < 75 kg (dopušteno je povećanje doze na 1000 IU ako je iz medicinskih razloga bilo potrebno održavanje sigurnosne razine od > 100 IU) te 1000 IU za bolesnike težine ≥ 75 kg.
No clinical signs of a hepatitis B re-infection were observed and no patient was tested HBsAg positive or HBV-DNA positive during the study which confirms that effective protection against Hepatitis B virus re-infection was provided by subcutaneous administration of Zutectra as part of the combination treatment with HBV virostatic therapy 8 - 18 days after orthotopic liver transplantation.
Nisu utvrđeni klinički znakovi ponovne infekcije hepatitisom B i nijedan bolesnik tijekom ispitivanja nije bio pozitivan na HBsAg ili na HBV-DNA, što potvrđuje da je supkutanom primjenom lijeka Zutectra u kombinaciji s liječenjem HBV-a virostaticima 8 - 18 dana od ortotopne transplantacije jetre pružena učinkovita zaštita od ponovne infekcije virusom hepatitisa B.
Patients must be monitored for serum anti-HBs antibody levels regularly.
Razine anti-HBs antitijela u serumu moraju se redovito kontrolirati.
Zutectra is presented as a solution for injection provided in pre-filled syringes (500 IU/ml - pack size of 5 in a blister).
Zutectra je otopina za injekciju koja se isporučuje u napunjenim štrcaljkama (500 IU/ml - pakiranje po 5
The objective of the open, prospective, single-arm clinical trial was the investigation of efficacy and safety of Zutectra for prevention of hepatitis B virus (HBV) re-infection ≥ one week after orthotopic liver transplantation in HBsAg and HBV-DNA negative patients.
Cilj otvorenog prospektivnog kliničkog ispitivanja s jednom skupinom bio je istražiti djelotvornost i sigurnost lijeka Zutectra za sprečavanje ponovne infekcije virusom hepatitisa B (HBV) ≥ tjedan dana nakon ortotopne transplantacije jetre u HBsAg i HBV-DNA negativnih bolesnika.
In isolated cases human normal immunoglobulins may cause an anaphylactic shock.
U izoliranim slučajevima ljudski normalni imunoglobulini mogu prouzročiti anafilaktički šok.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Ljudski imunoglobulin protiv hepatitisa B u rijetkim slučajevima može prouzročiti pad krvnog tlaka uz anafilaktičku reakciju, čak i u bolesnika koji su ranije podnosili liječenje ljudskim imunoglobulinom.
Most side effects observed with Zutectra were mild to moderate in nature.
Većina zabilježenih nuspojava lijeka Zutectra bile su blage do umjerene naravi.
Reg-Pharm spol.s.r.o.
Reg-Pharm spol.s.r.o. Fialková 45
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C-8°C).
POSEBNE MJERE ČUVANJA Čuvati i prevoziti na hladnom (2 °C - 8 °C).
Palpitations, cardiac discomfort Rare*
Srčani poremećaji palpitacije, nelagoda u prsnom košu rijetko*
You can inject Zutectra yourself without the help of your doctor, if they have trained you to do this.
Injiciranje lijeka samostalno ili od strane njegovatelja Lijek Zutectra možete injicirati sami, bez pomoći liječnika ako ste prošli odgovarajuću obuku.
What you need to know before you use Zutectra
Što morate znati prije nego počnete primjenjivati lijek Zutectra
Zutectra contains antibodies against the hepatitis B virus which are the body's own defensive substances to protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.
Zutectra sadrži antitijela protiv virusa hepatitisa B, a to su vlastite obrambene tvari tijela koje štite od hepatitisa B.
You should administer the injection immediately after opening the syringe.
Injekciju je potrebno dati odmah nakon otvaranja štrcaljke.
Solutions that are cloudy or have deposits should not be used.
Zamućene otopine ili otopine s talogom ne smiju se koristiti.
two alcohol swabs, one syringe of Zutectra, one needle suitable for subcutaneous injection.
dvije gaze natopljene alkoholom, jednu štrcaljku lijeka Zutectra,
D-63303 Dreieich Germany
D-63303 Dreieich
Kolarova 7, 10000 Zagreb T: +385 1 2303 446
Medis Adria d.o.o. Kolarova 7, 10000 Zagreb T: +385 1 2303 446
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV).
Mjere koje se poduzimaju smatraju se učinkovitima za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B (HBV), virusa hepatitisa C (HCV) te virusa hepatitisa
In total, 53/66 patients (80.3 %) used antiviral medication and 13 patients received monotherapy with Zutectra during this study.
Tijekom ovog ispitivanja antivirusne lijekove koristilo je ukupno 53 od 66 bolesnika (80,3 %), a ukupno 13 ispitanika primalo je monoterapiju lijekom Zutectra.
Zutectra is used to prevent re-infection of hepatitis B in adults who have had a liver transplant at least 1 week ago because they had liver failure caused by hepatitis B.
Zutectra se koristi za sprečavanje ponovne infekcije hepatitisom B u odraslih bolesnika najranije tjedan dana nakon transplantacije jetre zbog zatajenja jetre uzrokovanog hepatitisom B.
It is strongly recommended that every time that Zutectra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Preporučuje se bilježenje naziva i serijskog broja lijeka pri svakoj primjeni lijeka Zutectra kako bi se održala veza između bolesnika i serije lijeka.
Transmissible agents
Prenosivi uzročnici
Marketing Authorisation Holder and Manufacturer
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
5 D-63303 Dreieich Germany
5 D-63303 Dreieich
Important: Do not use on any area where you can feel lumps, bumps, firm knots, pain or on an area that is discoloured, indented, scabbed, or where the skin is broken.
Važno: Izbjegavajte dijelove tijela na kojima osjećate kvržice, izrasline, tvrde čvorove, bol ili dijelove tijela koji su promijenjene boje, uvučeni, s krastama ili oštećenom kožom.
- Remove the protective cap from the syringe.
- Skinite zaštitni zatvarač štrcaljke.
Biotest Hungaria Kft. Torbágy u. 15/A H-2045 Törökbálint Tel.: + 36 23 511 311
15/A H-2045 Törökbálint Tel.: + 36 23 511 311
4.7 Effects on ability to drive and use machines Hepatitis B immunoglobulin has no or negligible influence on the ability to drive and use machines.
Imunoglobulin protiv hepatitisa B ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
No other preparations may be added to the Zutectra solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.
Otopini lijeka Zutectra ne smiju se dodavati drugi preparati jer bi promjena koncentracije elektrolita ili pH
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Smatra se da mjere koje se poduzimaju učinkovito djeluju na viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), hepatitisa B i hepatitisa C te virus hepatitisa
Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Ljudski protein 150 mg/ml od kojeg je najmanje 96% IgG, sa sadržajem antitijela na površinski antigen virusa hepatitisa B (HBs) od 500 IU/ml.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ŠTRCALJKA
Water for injections
Otopina za injekciju
In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels.
U HBV-DNA negativnih odraslih bolesnika najranije tjedan dana nakon transplantacije jetre, supkutane injekcije lijeka Zutectra daju se, u skladu s najnižim razinama anti-HBs-a u serumu, jednom tjedno ili jednom u dva tjedna.
You should rotate the injection site at every injection.
Pri svakom injiciranju promijenite mjesto injiciranja.
It is hard to pinch up the tissue and inject Zutectra yourself using this site.
Na ovom mjestu teško ćete stisnuti tkivo i sami si ubrizgati lijek Zutectra.
Human protein 150 mg of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU.
150 mg ljudskog proteina od kojeg je najmanje 96 % IgG, sa sadržajem antitijela na površinski antigen virusa hepatitisa B (HBs) od 500 IU.
No treatment failure defined as positive HBV-DNA and HBsAg findings occurred during the entire observation period.
Tijekom cijelog razdoblja promatranja nije došlo do neuspjeha liječenja koji se definira kao pozitivan nalaz HBV-DNA i HBsAg.