natgillin/translations-raw huggingface dataset:
Development of YMDD mutant HBV is associated with reduced treatment response in some patients, as evidenced by increased HBV DNA levels and ALT elevations from previous on-therapy levels, progression of signs and symptoms of hepatitis disease and/or worsening of hepatic necroinflammatory findings.
Razvoj YMDD mutiranog HBV povezan je sa smanjenim terapijskim odgovorom u nekih bolesnika, što se dokazuje povećanim razinama HBV DNK i ALT u odnosu na vrijednosti prije liječenja, progresijom znakova i simptoma hepatitisa i/ili pogoršanjem nalaza nekroze i upale jetre.
The difference in the HBeAg seroconversion rates (HBeAg and HBV DNA loss with HBeAb detection) between placebo and lamivudine was not statistically significant in this population (rates after one year were 13 % (12/95) for placebo versus 22 % (42/191) for lamivudine; p=0.057).
HbeAb) između placeba i lamivudina u ovoj populaciji nije bila statistički značajna (stope su nakon godinu dana iznosile 13% (12/95) za placebo, a 22% (42/191) za lamivudin; p=0,057).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR ORAL SOLUTION
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA ORALNU OTOPINU
1 Remove the child-proof bottle cap (A).
Uklonite sigurnosni zatvarač za djecu (A).
In patients with decompensated liver disease, lamivudine should always be used in combination with a second agent, without cross-resistance to lamivudine, to reduce the risk of resistance and to achieve rapid viral suppression.
Kod bolesnika s dekompenziranom bolešću jetre, lamivudin se uvijek treba upotrijebiti u kombinaciji s drugim lijekom bez križne rezistencije na lamivudin kako bi se izbjegao rizik rezistencije na lamivudin i kako bi se postigla brza supresija virusa.
For the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive treatment with lamivudine or the combination lamivudine-zidovudine, the dose of lamivudine prescribed for HIV infection (usually 150 mg/twice daily in combination with other antiretrovirals) should be maintained.
Za liječenje bolesnika koji su istodobno zaraženi i HIV-om te dobivaju ili planiraju dobivati terapiju koja uključuje lamivudin ili kombinaciju lamivudin-zidovudin, ne treba mijenjati dozu lamivudina propisanu za liječenje HIV-infekcije (obično 150 mg/dva puta na dan u kombinaciji s drugim antiretrovirusnim lijekovima).
A very rare side effect (these may affect up to 1 in 10,000 people) is:
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) su:
Progression to cirrhosis occurred in 4/68 (6 %) patients with the YMDD mutant, whereas no patients without the mutant progressed to cirrhosis.
Progresija u cirozu zabilježena je u 4/68 (6 %) bolesnika s YMDD tipom virusa, dok se to nije dogodilo ni u jednog bolesnika bez YMDD tipa virusa.
After two years of treatment in this study, ALT normalisation and undetectable HBV DNA occurred in 30/69 (43 %) and 32/68 (47 %) patients respectively and improvement in necroinflammatory score in 18/49 (37 %) patients.
Nakon dvije godine liječenja u toj studiji u 30/69 (43%) bolesnika normalizirane su razine ALT, u 32/68 (47%) razina HBV DNK je bila nemjerljiva, a u 18/49 (37%) bolesnika zabilježeno je i poboljšanje nekroinflamatornog rezultata.
How to take Zeffix
Kako uzimati Zeffix
It is also only a weak inhibitor of mammalian DNA polymerases alpha and beta.
Slab je inhibitor alfa i beta DNK polimeraza u sisavaca.
In patients with either HBeAg positive or HBeAg negative CHB, the development of YMDD (tyrosine-methionine-aspartate-aspartate) mutant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels.
Klinička rezistencija U HBeAg pozitivnih ili HBeAg negativnih bolesnika s kroničnim hepatitisom B, razvoj mutiranog virusa tipa YMDD (tirozin-metionin-aspartat-aspartat) može dovesti do smanjenog terapijskog odgovora na lamivudin, koji se očituje porastom HBV DNK i ALT u odnosu na prijašnje razine tijekom liječenja.
84 film-coated tablets
28 filmom obloženih tableta 84 filmom obložene tablete
However, disease progression in YMDD subjects in the lamivudine group was lower than the disease progression in the placebo group (23/209, 11 % versus 38/214, 18 % respectively).
Ipak, progresija bolesti u bolesnika s YMDD tipom virusa liječenih lamivudinom bila je niža nego u skupini koja je dobivala placebo (23/209, 11%, odnosno 38/214, 18%).
Rhabdomyolysis * In Phase III studies frequency observed in the lamivudine treatment group was not greater than observed in the placebo group
* U fazi III ispitivanja učestalost zabilježena u skupini liječenoj lamivudinom bila je veća od one u skupini koja ja dobivala placebo
The other ingredients are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.
Drugi sastojci su: saharoza, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), citratna kiselina, propilenglikol, natrijev citrat, umjetna aroma jagode, umjetna aroma banane, pročišćena voda.
These medicines should not be used with Zeffix:
Sljedeći se lijekovi ne smiju primjenjivati istovremeno s lijekom Zeffix:
Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B.
4.2 Doziranje i način primjene Terapiju lijekom Zeffix treba započeti liječnik s iskustvom u liječenju kroničnog hepatitisa B.
How much to take The usual dose of Zeffix is one tablet (100 mg lamivudine) once a day.
Koliku dozu lijeka uzeti Uobičajena doza lijeka Zeffix je jedna tableta (100 mg lamivudina) jedanput na dan.
Viral suppression was maintained (follow-on study NUC20917) with combined therapy during the second year of treatment to week 104 with patients having continued improvement in virologic and biochemical responses.
Viralna supresija je održavana (na temelju studije NUC20917) s kombiniranom terapijom tijekom druge godine terapije do 104. tjedna te se bolesnicima i virološki i biokemijski odgovor nastavio poboljšavati.
• if you have ever had other types of liver disease, such as hepatitis C
• ako ste nekad imali drugi tip bolesti jetre, naprimjer hepatitis C • ako ste izrazito pretili (posebno ako ste žena)
In a double-blind study in CHB patients with YMDD mutant HBV and compensated liver disease (NUC20904), with a reduced virological and biochemical response to lamivudine (n=95), the addition of adefovir dipivoxil 10 mg once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ml compared to a median increase of 0.3 log10 copies/ml in those patients receiving lamivudine monotherapy.
U dvostruko slijepom ispitivanju u bolesnika s kroničnim hepatitisom B s YMDD mutiranim HBV-om i kompenziranom bolešću jetre (NUC20904) koji su imali smanjeni virološki i biokemijski odgovor na lamivudin (n=95), dodavanje adefovir dipivoksila u dozi od 10 mg jedanput na dan postojećoj dozi lamivudina od 100 mg tijekom 52 tjedna dovelo je do medijana smanjenja HBV DNK-a od 4,6 log10 kopija/ml u usporedbi s medijanom povećanja od 0,3 log10 kopija/ml u bolesnika koji su primali samo lamivudin.
Patients should be informed that malaise and fatigue have been reported during treatment with lamivudine.
Bolesnicima treba reći da su tijekom liječenja lamivudinom prijavljeni malaksalost i umor.
Don't take this medicine after the expiry date shown on the carton and blister.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
HBV viral subpopulations with reduced susceptibility to lamivudine (YMDD mutant HBV) have been identified with extended therapy.
Pri dugotrajnoj terapiji otkrivene su subpopulacije HBV-a sa smanjenom osjetljivošću na lamivudin (YMDD tip virusa).
Hepatitis B infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Infekcija hepatitisa B širi se spolnim odnosom s nekim tko ima infekciju ili putem zaražene krvi
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).
• smanjenje broja krvnih stanica važnih za zgrušavanje krvi (trombocitopenija).
If you get any side effects
Ako primijetite nuspojave
Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).
Stoga se ne preporučuje istodobna primjena lamivudina i kladribina (vidjeti dio 4.4).
Each film-coated tablet contains 100 mg of lamivudine.
Jedna filmom obložena tableta sadrži 100 mg lamivudina.
There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues.
Zabilježena je poremećena funkcija mitohondrija u dojenčadi koja su bila izložena analozima nukleozida in utero i/ili po rođenju.
* Zeffix oral solution containing 5 mg/ml lamivudine.
* Zeffix oralna otopina sadržava 5 mg/ml lamivudina.
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 60-70 times higher than the anticipated clinical plasma levels.
U in vivo ispitivanjima u dozama koje dovode do koncentracija u plazmi koje su 60 -70 puta više nego predviđene kliničke koncentracije lamivudin nije pokazao genotoksičnost.
PHARMACEUTICAL FORM AND CONTENTS Each bottle contains 240 ml oral solution The pack contains an oral applicator.
Jedna boca sadrži 240 ml oralne otopine Pakiranje sadrži aplikator za primjenu kroz usta.
First dose of Zeffix oral solution
Prva doza Zeffix oralne otopine
The mean lamivudine CSF/serum concentration ratio 2-4 hours after oral administration was approximately 0.12.
Srednja vrijednost omjera koncentracija lamivudina u cerebrospinalnoj tekućini i serumu 24 sata nakon peroralne primjene iznosi oko 0,12.
Do not stop treatment with Zeffix without your doctor's advice.
Ne prekidajte liječenje lijekom Zeffix ako Vam to nije savjetovao liječnik.
These patients should be monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function, and antiviral response during treatment (at least every month), and, if treatment is discontinued for any reason, for at least 6 months after treatment.
U tih bolesnika treba tijekom terapije pratiti kliničke, virološke i serološke parametre povezane s hepatitisom B, funkciju jetre i bubrega te protuvirusni odgovor (barem jednom mjesečno).
Those with HBV DNA levels greater than 200 copies/mL at 6 months (24 weeks) of lamivudine therapy had a 60 % chance of developing the YMDD mutant compared with 8 % of those with HBV DNA levels less than 200 copies/mL at 24 weeks of lamivudine therapy.
Mogućnost razvoja YMDD mutiranog tipa virusa iznosila je 60% u bolesnika čije su razine HBK DNK bile više od 200 kopija/ml nakon 6 mjeseci (24 tjedna) liječenja lamivudinom, u odnosu na 8% u onih čije su razine HBV DNK bile manje od 200 kopija/ml nakon 24 tjedna liječenja lamivudinom.
For patients who are being treated with lamivudine and subsequently become pregnant consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Za bolesnice koje su ostale trudne tijekom liječenja lamivudinom, mora se uzeti u obzir mogućnost rekurentne pojave hepatitisa u slučaju prekida liječenja lamivudinom.
Addition of 10 mg adefovir dipivoxil once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ml.
Dodavanje adefovir dipivoksila u dozi od 10 mg jedanput na dan postojećoj dozi lamivudina od 100 mg tijekom 52 tjedna dovelo je do medijana smanjenja HBV DNK-a od 4,6
Frequency of emergence of YMDD mutant HBV and impact on the treatment response Lamivudine monotherapy results in the selection of YMDD mutant HBV in approximately 24 % of patients following one year of therapy, increasing to 69 % following 5 years of therapy.
Monoterapija lamivudinom dovodi do selekcije YMDD tipa virusa u oko 24% bolesnika nakon godinu dana liječenja te se povećava na 69% nakon 5 godina liječenja.
Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
U toksikološkim studijama na životinjama lamivudin primijenjen u visokim dozama nije uzrokovao toksičnost niti jednog organa.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 28 tablet box, 84 tablet box
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP kutija s 28 tableta, kutija s 84 tablete
In patients without the mutant, 20/27 (74 %) had improvements in necroinflammatory activity and 2/27 (7 %) had worsening.
Kod bolesnika bez tog tipa virusa, u 20/27 (74%) zabilježeno je poboljšanje nekroinflamatorne aktivnosti, a pogoršanje u 2/27
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SOLUTION
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA BOCU ZA ORALNU OTOPINU
Placental transfer of lamivudine has been shown to occur in humans.
Pokazalo se da lamivudin prolazi kroz placentu u ljudi.
Limited data in patients undergoing liver transplantation show that impairment of hepatic function does not impact significantly on the pharmacokinetics of lamivudine unless accompanied by renal dysfunction.
Ograničeni podaci o bolesnicima kojima je transplantirana jetra pokazuju da oštećenje funkcije jetre ne utječe značajno na farmakokinetiku lamivudina ako nije udruženo s oštećenjem bubrega.
In assays relating to potential substance effects on mitochondrial structure and DNA content and function, lamivudine lacked appreciable toxic effects.
U ispitivanjima potencijalnog djelovanja lijeka na mitohondrijsku strukturu te sadržaj i funkciju DNK,
- Baseline 3
- početne vrijednosti3
Zeffix will not stop you passing hepatitis B infection on to other people.
Zeffix neće spriječiti da infekciju hepatitisa B
You must not stop taking Zeffix without consulting your doctor.
Ne smijete prestati uzimati Zeffix ako Vam to nije savjetovao liječnik.
Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
U pokusima akutne toksičnosti na životinjama primjena lamivudina u vrlo visokim dozama nije dovela do toksičnosti organa.
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique /Belgien
How much to take The usual dose of Zeffix is 20 ml (100 mg lamivudine) once a day.
Uobičajena doza lijeka Zeffix je 20 ml (100 mg lamivudina) jedanput na dan.
Patients categorised as non-YMDD mutant were those with > 95% wild-type HBV at all annual time-points during the 5-year study period
Bolesnici bez YMDD mutiranog tipa virusa definirani su kao oni > 95% divljeg tipa HBV-a na svakom godišnjem mjerenju tijekom petogodišnjeg razdoblja gornja granica normale
Cladribine
Kladribin
Grunwaldzka 189 60-322 Poznan Poland
GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189 60-322 Poznan Poljska
If you are pregnant, think you may be pregnant or are planning to have a baby:
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete: razgovarajte sa svojim liječnikom o rizicima i prednostima uzimanja lijeka Zeffix tijekom trudnoće.
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 product@gsk.com
How to store Zeffix
Kako čuvati Zeffix
Zeffix contains sucrose.
Zeffix sadrži saharozu.
SPECIAL STORAGE CONDITIONS Do not store above 25C
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C
In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine based on therapeutic guidelines should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment (see section
Da bi se smanjio rizik od rezistencije u bolesnika koji lamivudin uzimaju kao monoterapiju, treba razmotriti prelazak na drugi lijek ili dodavanje drugog lijeka bez ukrižene rezistencije s lamivudinom, prema terapijskim smjernicama, ako vrijednosti serumskog HBV DNK ostanu detektabilne nakon 24 tjedna liječenja ili dulje od toga (vidjeti dio 5.1).
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
Exacerbations on treatment
Trajanje liječenja
The combination of lamivudine with cladribine is not recommended (see section 4.5).
Ne preporučuje se istovremeno uzimanje lamivudina i kladribina (vidjeti dio 4.5).
 Use a condom when you have oral or penetrative sex.  Don't risk blood transfer - for example, don't share needles.
• Spriječite rizik od zaraze putem krvi - primjerice, nemojte razmjenjivati injekcijske igle.
See the diagram and instructions after section 6 of this leaflet for how to measure and take a dose of medicine.
Na kraju dijela 6 ove upute pogledajte dijagram i upute kako izmjeriti i kako uzeti dozu lijeka . Ako uzmete više lijeka Zeffix nego što ste trebali
PHARMACEUTICAL FORM AND CONTENTS Each bottle contains 240 ml oral solution
Jedna boca sadrži 240 ml oralne otopine
A common side effect (these may affect up to 1 in 10 people) is:
Česte nuspojave (mogu se javiti u do 1 na 10 osoba) su:
An oral solution of Zeffix is available for people who need a lower than usual dose, or who can't take tablets.
Za osobe koje trebaju manju dozu od uobičajene ili koje ne mogu uzimati tablete dostupna je oralna otopina.
• In patients with HBeAg negative CHB (pre-core mutant), without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
• U HBeAg negativnih bolesnika s kroničnim hepatitisom B ("divlji tip" virusa), a bez ciroze, liječenje treba provoditi najmanje do serokonverzije HBs ili do dokazanog gubitka djelotvornosti.
There is no information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine.
Postoje ograničeni podatci o prijenosu HBV-a s majke na plod u trudnica koje su liječene lamivudinom.
In patients with YMDD mutant HBV, 18/39 (46 %) had improvements in necroinflammatory activity and 9/39 (23 %) had worsening.
U 18/39 (46 %) bolesnika s YMDD tipom virusa zabilježeno je poboljšanje nekroinflamatorne aktivnosti, a u 9/39 (23 %) je zabilježeno pogoršanje.
HIV co-infection
Istovremena zaraza HIV-om
ALT 2 x baseline value; and bilirubin >2 x ULN and 2 x baseline value *Each patient may be represented in one or more category.
ALT ≥2 x početne vrijednosti; i bilirubin >2 x GGN i ≥2 x početne vrijednosti
In patients with YMDD mutant HBV, 41/82 (50 %) patients had improvement in liver inflammation and 40/56 (71 %) patients without YMDD mutant HBV had improvement.
U 41/82 (50 %) bolesnika s YMDD tipom virusa kao i u 40/56 (71%) bolesnika bez YMDD tipa virusa zabilježeno je poboljšanje upale jetre.
Don't store above 25 °C.
Ne čuvati na temperaturi iznad 25°C.
Experience in patients with HBeAg positive CHB and compensated liver disease In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 1618 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
HBV DNK [34-57 % bolesnika bilo je ispod granice detekcije laboratorijskog testa (Abbott Genostics hibridizacijski test u otopini, LLOD < 1,6 pg/ml)}, normalizirala razinu ALT (40-72% bolesnika), potakla serokonverziju HbeAg (nestanak HbeAg i pojavu HbeAb protutijela uz gubitak HBV DNK [uobičajenim testovima], 16-18 % bolesnika), poboljšala histološke nalaze (u 38-52 % bolesnika Knodellov histološki indeks aktivnosti [HAI] smanjio se za ≥ 2 boda) i usporila progresiju fibroze (u 3-17% bolesnika) te progresiju u cirozu.
Some people taking Zeffix or other similar medicines are more at risk of serious side effects.
Rizik od pojave ozbiljnih nuspojava povećan je u nekih ljudi koji uzimaju Zeffix ili neki drugi sličan lijek.
Zeffix 100 mg film-coated tablets lamivudine
Zeffix 100 mg filmom obložene tablete lamivudin
Zeffix 5 mg/ml oral solution lamivudine
Zeffix 5 mg/ml oralna otopina lamivudin
Contains amongst others: sugar (sucrose), and preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
šećer (saharozu), i konzervanse: metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216)
In patients without YMDD mutant HBV, 14/22 (64 %) showed improvement in necroinflammatory score and 1/22 (5 %) patients worsened compared to pre-treatment.
U 14/22 (64%) bolesnika koji nisu imali YMDD mutirani HBV zabilježeno je poboljšanje nekroinflamatornog rezultata, dok se u 1/22 (5%) bolesnika stanje pogoršalo u odnosu na ono prije liječenja.
HBeAg seroconversion was increased in patients with elevated ALT levels; 77 % (20/26) of patients with pre-treatment ALT > 2 x ULN seroconverted.
Do serokonverzije je došlo u 77 % (20/26) bolesnika koji su prije liječenja imali razine ALT >2 x veće od gornje granice normale.
In patients who have YMDD mutant HBV, a switch to or addition of an alternative agent without cross resistance to lamivudine based on therapeutic guidelines should be considered (see section 5.1).
U bolesnika s YMDD tipom virusa treba razmotriti prelazak na drugi lijek ili dodavanje drugog lijeka bez ukrižene rezistencije s lamivudinom prema terapijskim smjernicama (vidjeti dio 5.1).
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Ispitivanja na bolesnicima s oštećenjem funkcije bubrega pokazuju da poremećaj u funkciji bubrega utječe na eliminaciju lamivudina.
Initial data indicate the efficacy of lamivudine in patients with HBeAg negative CHB is similar to patients with HBeAg positive CHB, with 71 % of patients having HBV DNA suppressed below the detection limit of the assay, 67 % ALT normalisation and 38 % with improvement in HAI after one year of treatment.
HBV DNK ispod granice detekcije u 71 % bolesnika, normalizacijom ALT u 67% bolesnika te poboljšanjem HAI rezultata u 38% bolesnika nakon godinu dana liječenja.
Laboratory parameters to be monitored should include (as a minimum) serum ALT, bilirubin, albumin, blood urea nitrogen, creatinine, and virological status: HBV antigen/antibody, and serum HBV DNA concentrations when possible.
(najmanje) ALT u serumu, bilirubin, albumin, ureju, kreatinin te virološki status: HBV
In patients with the mutant, 4/26 (15 %) patients showed improvement in necroinflammatory score and 8/26 (31 %) patients worsened compared to pretreatment.
Od bolesnika s YMDD mutiranim HBV, 4/26 (15%) je imalo poboljšanje nekroinflamatornog rezultata, dok se u 8/26 (31%) bolesnika stanje pogoršalo u odnosu na ono prije liječenja.
1 Patients designated as YMDD mutant were those with 5% YMDD mutant HBV at any annual time-point during the 5-year period.
Bolesnici s YMDD mutiranim tipom virusa definirani su kao oni ≥5 % YMDD mutiranog HBV na barem jednom od godišnjih mjerenja tijekom petogodišnjeg razdoblja.
Don't store above 30 °C.
Ne čuvati na temperaturi iznad 30°C.
The clinical status of the patient and the adverse reaction profile of lamivudine should be borne in mind when considering the patient's ability to drive or operate machinery.
Prilikom razmatranja bolesnikove sposobnosti upravljanja vozilima i rada sa strojevima, treba imati na umu klinički status bolesnika i profil nuspojava lamivudina.
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PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET