natgillin/translations-raw huggingface dataset:
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.
MANUFACTUR ER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Experience in CHB patients with advanced fibrosis or cirrhosis In a placebo-controlled study in 651 patients with clinically compensated chronic hepatitis B and histologically confirmed fibrosis or cirrhosis, lamivudine treatment (median duration 32 months) significantly reduced the rate of overall disease progression (34/436, 7.8 % for lamivudine versus 38/215, 17.7 % for placebo, p=0.001), demonstrated by a significant reduction in the proportion of patients having increased Child-Pugh scores (15/436, 3.4 % versus 19/215, 8.8 %, p=0.023) or developing hepatocellular carcinoma (17/436, 3.9 % versus 16/215, 7.4 %, p=0.047). 
7,8% za lamivudin u odnosu na 38/215, tj. 17,7% za placebo, p=0,001), što se očitovalo značajnim smanjenjem broja bolesnika s povećanim Child-Pugh indeksom (15/436, tj 3,4% prema 19/215, tj. 8,8%, p=0,023) ili onih koji su razvili hepatocelularni karcinom (17/436, tj.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse. 
Nakon prekida liječenja redovno treba pratiti razine ALT i HBV DNK u serumu radi mogućeg kasnijeg relapsa virusa.
Each ml of the oral solution contains 5 mg lamivudine 
Jedan ml oralne otopine sadrži 5 mg lamivudina
Experience in patients with HBeAg negative CHB 
Iskustvo u HBeAg negativnih bolesnika s kroničnim hepatitisom B
In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39 % of the subjects. 
39% ispitanika došlo je do kasnog virološkog relapsa.
Contains amongst others: sugar (sucrose), preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) 
šećer (saharozu), konzervanse: metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216)
Elevations of CPK 
Povišene razine CK
Each ml of oral solution contains 5 mg of lamivudine. 
Jedan ml oralne otopine sadrži 5 mg lamivudina.
• cladribine, used to treat hairy cell leukaemia Tell your doctor if you're being treated with any of these. 
• kladribin, koji se primjenjuje za liječenje leukemije vlasastih stanica
For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of lamivudine treatment. 
Nema dostatnih podataka o prednostima ponovnog uvođenja terapije lamivudinom u bolesnika kod kojih se nakon liječenja pojave dokazi o rekurentnom hepatitisu.
ALT elevations (see section 4.4) 
(vidjeti dio 4.2).
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
The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo. 
Udio bolesnika u kojih je zabilježen porast razina ALT nakon liječenja uz istodobni porast razina bilirubina, bio je malen i sličan u obje skupine bolesnika
Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see section decompensated liver disease in combination with a second agent, without cross-resistance to lamivudine (see section 4.2). 
Početak liječenja lamivudinom treba razmotriti samo kad primjena alternativnog antivirusnog lijeka s višom genetskom barijerom nije dostupna ili prikladna (vidjeti dio 5.1).
Thrombocytopenia Metabolism and nutrition disorders Very rare 
Poremećaji metabolizma i prehrane
of patients with pre-treatment ALT > 2 x ULN seroconverted. 
(20/26) bolesnika koji su prije liječenja imali razine ALT >2 x veće od gornje granice normale.
NAME OF THE MEDICINAL PRODUCT Zeffix 5 mg/ml oral solution Lamivudine 
Uputa o lijeku: Informacije za bolesnika Zeffix 5 mg/ml oralna otopina lamivudin
Talk to your doctor before you take Zeffix. 
Ako dojite ili planirate dojiti: razgovarajte sa svojim liječnikom prije nego počnete uzimati Zeffix.
Adverse reactions are listed below by system organ class and frequency. 
Nuspojave su navedene po organskim sustavima i učestalosti pojavljivanja.
: + 33 (0)1 39 17 84 44 diam@gsk.com 
Laboratoire GlaxoSmithKline Tél. : + 33 (0)1 39 17 84 44 diam@gsk.com
A side effect which may show up in blood tests is: • a decrease in the number of cells involved in blood clotting (thrombocytopenia). 
Česte nuspojave koje se mogu pojaviti u Vašim krvnim testovima su: • povišene vrijednosti enzima koji se stvara u mišićima (kreatin fosfokinaza) što može upućivati na oštećenje tjelesnog tkiva.
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline. 
Nakon započinjanja antivirusne terapije serumske razine ALT mogu se povećavati u nekih bolesnika istodobno sa smanjenjem serumskih razina HBV DNK.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg lamivudine 
Jedna filmom obložena tableta sadrži 100 mg lamivudina
The pharmacokinetics of lamivudine are unaffected by hepatic impairment. 
Oštećenje funkcije jetre ne utječe na farmakokinetiku lamivudina.
Five percent (3/56) of patients without the YMDD mutant and 13 % (11/82) of patients with YMDD mutant showed worsening in liver inflammation compared to pre-treatment. 
U 5% (3/56) bolesnika bez YMDD tipa virusa i 13% (11/82)
Sucrose (20 % w/v) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Citric acid (anhydrous) Propylene glycol 
6.1 Popis pomoćnih tvari saharoza (20 % m/V) metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) citratna kiselina (bezvodna) propilenglikol natrijev citrat umjetna aroma jagode umjetna aroma banane voda, pročišćena
Forty patients (HBeAg negative or HBeAg positive) with either decompensated liver disease or recurrent HBV following liver transplantation and YMDD mutant were enrolled into an open label arm of study NUC20904. 
U otvoreni dio ispitivanja NUC20904 uključeno je 40 bolesnika (HbeAg negativnih ili HbeAg pozitivnih) koji su imali dekompenziranu bolest jetre ili rekurentni HBV nakon transplantacije jetre i YMDD-mutirani HBV.
Accidentally taking too much Zeffix is unlikely to cause any serious problems. 
Mala je vjerojatnost ozbiljnijih problema u bolesnika koji su slučajno uzeli preveliku dozu lijeka Zeffix.
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com 
KG Tel.: + 49 (0)89 36044 8701 product.info@gsk.com
SPECIAL STORAGE CONDITIONS Do not store above 30C 
6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 30°C.
How to store Zeffix Keep this medicine out of the sight and reach of children. 
Kako uzimati Zeffix Uvijek uzimite ovaj lijek točno onako kako Vam je rekao liječnik.
Lactic acidosis Immune system disorders: Rare 
Poremećaji imunološkog sustava
Reduction of erythrocytes and neutrophil counts were identified as the effects most likely to be of clinical relevance. 
Zabilježeni klinički značajni učinci bili su smanjenje broja eritrocita i neutrofila.
ALT  2 x baseline value and absolute ALT > 500 IU/l 
ALT ≥ 2 x početne vrijednosti ALT ≥ 3 x početne vrijednosti † ALT ≥ 2 x početne vrijednosti i apsolutni ALT >
Česká republika GlaxoSmithKline s.r.o. 
GlaxoSmithKline Slovakia s. r. o.
NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets Lamivudine 
Uputa o lijeku: Informacije za bolesnika Zeffix 100 mg filmom obložene tablete lamivudin
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
Marketing Authorisation Holder 
Nositelj odobrenja za stavljanje u lijeka promet
NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets 
Zeffix 100 mg filmom obložene tablete
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111 
GlaxoSmithKline Pharmaceuticals s.a./n.v Tél/Tel : + 32 (0) 10 85 52 00
Hypromellose 
Angioedem
ALT  2 x baseline value 
- početni ALT > 2 x GGN
Clinical resistance 
Alergijske reakcije
Laboratoire GlaxoSmithKline Tél. 
GlaxoSmithKline Kft.
50 x 1 tablet(unit dose) 105 tablets 
50 x 1 tableta (jedinična doza)
Oral use Oral use blister (OPA/alu/PVC) blister (OPA/alu/PVC) 
blister (OPA/alu/PVC 105 tableta
Route of Administration 
Put primjene Pakovanje
It is available as tablets (200 mg). 
Dostupan je u obliku tableta (200 mg).