natgillin/translations-raw huggingface dataset:
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres. 
ali hepatitisu B dani hkrati s specifičnimi imunoglobulini, ni bilo opaziti vpliva na serokonverzijo, čeprav so titri protiteles lahko nižji.
Angioneurotic oedema, lichen planus, erythema multiforme 
Bolezni kože in podkožja angionevrotični edem, lichen planus, multiformni eritem
Twinrix Adult contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic). 
Obvestite zdravnika, če ste kdaj imeli alergijsko reakcijo na neomicin (antibiotik).
swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. 
Znaki hude alergijske reakcije so lahko izpuščaji, ki so lahko srbeči ali mehurjasti, oteklina okrog oči in obraza, težave pri dihanju in požiranju, nenaden padec krvnega tlaka in izguba zavesti.
Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines. 
Osebe, cepljene s cepivom Twinrix za odrasle, lahko prejmejo poživitveni odmerek posameznega monovalentnega cepiva.
The excretion of Twinrix Adult in milk has not been studied in animals. 
Študije izločanja cepiva Twinrix za odrasle v mleko pri živalih niso bile izvedene.
Concentrations (GMC) increased by 179-fold (GMC of 7234 mIU/ml) indicative of an immune memory response. 
(GMC 7.234 mi.e./ml), kar kaže na imunski spominski odziv.
If not, your doctor will advise you on the possible need to have extra doses. 
Če odziv ni zadovoljiv, vam bo zdravnik morda svetoval cepljenje z dodatnimi odmerki.
In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i.e. at months 1 and 2 after the initial dose). 
V klinični raziskavi so uporabili to shemo cepljenja in ugotovili, da je imelo 82 % cepljenih oseb zaščitni nivo anti-HBV protiteles v 1. tednu in 85 % cepljenih oseb v 5. tednu po aplikaciji tretjega odmerka (to je en in dva meseca po prvem odmerku).
• Swelling or infection of the brain (encephalitis) 
• oteklost ali okužba možganov (encefalitis),
Each injection is given on a separate visit. 
Ambulanto morate obiskati za vsak odmerek posebej.
Post-marketing surveillance 
Izkušnje v obdobju trženja
Make sure you finish the complete vaccination course of three injections. 
Preverite, če ste v okviru cepljenja prejeli vse tri predpisane odmerke.
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness 
Bolezni imunskega sistema anafilaksijske, alergijske reakcije vključno z anafilaktoidnimi reakcijami in serumski bolezni podobno stanje
Cases of overdose have been reported during post-marketing surveillance. 
Med spremljanjem cepiva po pridobitvi dovoljenja za promet so poročali o primerih prevelikega odmerjanja.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 
Kot pri vseh drugih parenteralnih cepivih mora biti zaradi redke možnosti anafilaktične reakcije na voljo ustrezno zdravljenje in zagotovljeno opazovanje osebe po cepljenju.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema redki limfadenopatija
Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include: 
Neželeni učinki se zelo redko pojavijo med kliničnimi študijami ali rutinskim cepljenjem s cepivom Twinrix ali enovalentnim cepivom proti hepatitisu A ali hepatitisu B.
As indicated in section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments. 
Kot je opisano v poglavju 2, se slab odziv na cepivo, lahko tudi brez dosežene zaščite proti hepatitisu B, pojavi bolj pogosto pri starejših osebah, pogosteje pri moških kot pri ženskah, kadilcih,
• Numbness or weakness of the arms and legs (neuropathy), paralysis 
• otrplost ali šibkost rok in nog (nevropatija), paraliza,
• Fourth dose: 
• četrti odmerek:
A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments. 
Pri osebah s prekomerno telesno maso so poročali o slabem odzivu na cepivo, tudi brez dosežene zaščite proti hepatitisu A. Slabši odziv na cepivo, tudi brez dosežene zaščite proti hepatitisu B, so opazili tudi pri starejših osebah, pogosteje pri moških kot pri ženskah, kadilcih, osebah s prekomerno telesno maso, osebah z dolgotrajnimi boleznimi ali osebah, ki jemljejo določena zdravila.
• Multiple sclerosis, swelling of the spinal cord (myelitis) 
• multipla skleroza, oteklost hrbtenjače (mielitis),
As with any vaccine, a protective immune response may not be elicited in all vaccinees. 
Kot cepljenje s katerim koli cepivom lahko tudi cepljenje s cepivom Twinrix za odrasle ne izzove zaščitnega imunskega odgovora pri vseh cepljenih osebah.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. 
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih,
1 pre-filled syringe + 1 needle 1 dose (1 ml) 
1 napolnjena injekcijska brizga + 1 igla 1 odmerek (1 ml)
• Pain and redness at the injection site 
• bolečina in rdečina na mestu vboda,
The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 56% at 7 and 48 months respectively, versus 80% and 43% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 31% after another licensed monovalent 10µg hepatitis B vaccine. 
mesecih in 56 % po 48 mesecih, po dajanju monovalentnega 20 µg cepiva proti hepatitisu B izdelovalca GlaxoSmithKline Biologicals pa 80 in 43 % (po 7 in po 48 mesecih) ter 71 in 31 % po dajanju nekega drugega monovalentnega 10 µg cepiva proti hepatitisu B z dovoljenjem za promet.
25 pre-filled syringes + 25 needles 25 x 1 dose (1 ml) 
25 napolnjenih injekcijskih brizg + 25 igel 25 x 1 odmerek (1 ml)
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives 
• škrlatne ali rdeče-škrlatne izbokline na koži (lihen planus), močan kožni izpuščaj
Twinrix Adult is a white, slightly milky liquid presented in a glass pre-filled syringe (1 ml). 
Cepivo Twinrix za odrasle je bela, rahlo mlečna tekočina v stekleni napolnjeni injekcijski brizgi
Re-suspension of the vaccine to obtain a uniform hazy white suspension 
Kako pretresti cepivo, da dobimo enotno, motno belo suspenzijo
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. 
Twinrix za odrasle se lahko izjemoma aplicira podkožno pri osebah s trombocitopenijo ali motnjami strjevanja krvi.
Adverse events reported following overdosage were similar to those reported with normal vaccine administration. 
Neželeni učinki so bili podobni tistim po navadnem cepljenju.
The 0, 7 and 21 day primary schedule plus a fourth dose at month 12 is for use in exceptional circumstances in adults. 
V izjemnih okoliščinah se pri odraslih lahko uporabi osnovno shemo cepljenja (0, 7. in 21.dan) z dodatnim četrtim odmerkom 12 mesecev po prvem odmerku.
• First dose: 
• prvi odmerek:
• Fever equal to or greater than 37.5°C 
• okužba zgornjih dihalnih poti, • zvišana telesna temperatura do 37.5°C ali višja.
Twinrix Adult can also be given as a total of three doses over 1 month. 
6 mesecev po prvem odmerku S cepivom Twinrix za odrasle ste lahko cepljeni tudi z vsemi tremi odmerki v enem mesecu.
- The active substances are: Hepatitis A virus (inactivated)1,2 
1 odmerek (1 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
• Diarrhoea, nausea 
• driska, siljenje na bruhanje,
Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection. 
4.1 Terapevtske indikacije Cepivo Twinrix za odrasle je indicirano za uporabo pri neimunih odraslih in mladostnikih, starih 16 let in več, pri katerih obstaja tveganje za okužbo z virusom hepatitisa A in virusom hepatitisa B. 4.2 Odmerjanje in način uporabe
How to store Twinrix Adult 
Kako uporabljati cepivo Twinrix za odrasle
When re-suspended, the vaccine will have a uniform hazy white appearance. 
Pred uporabo je treba cepivo pretresti, da ponovno postane enotnega, motno belega videza.
PHARMACEUTICAL FORM Suspension for injection. 
FARMACEVTSKA OBLIKA suspenzija za injiciranje motna bela suspenzija
• Second dose: 
• drugi odmerek:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Adult, suspension for injection 
IME ZDRAVILA IN POT(I) UPORABE Twinrix za odrasle suspenzija za injiciranje HAB cepivo i.m.
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines: 
Poročali so o naslednjih neželenih reakcijah po cepljenju s cepivom Twinrix ali z monovalentnima cepivoma proti hepatitisu A ali hepatitisu B izdelovalca GlaxoSmithKline: Infekcijske in parazitske bolezni meningitis
12 months after the first dose Your doctor will advise on the possible need for extra doses, and future booster dosing. 
Vaš zdravnik vam bo svetoval v primeru, da bi potrebovali dodatne odmerke cepiva in kasnejše poživitvene odmerke.
• Swollen glands in the neck armpit or groin (lymphadenopathy) 
• povečane bezgavke na vratu, pod pazduho ali v dimljah (limfadenopatija),
Swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon Fever (≥ 37.5°C) Rare 
srbenje in pojav modric), občutek slabosti občasni zvišana telesna temperatura (≥ 37,5 °C)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE
Very rare (These may occur in up to 1 in 10,000 doses of the vaccine): 
Zelo redki (ki se lahko pojavijo pri največ 1 od 10.000 odmerkov cepiva):
• Vomiting, stomach pain 
• bruhanje, bolečine v trebuhu, • boleče mišice,
10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml) 
10 napolnjenih injekcijskih brizg + 10 igel 10 x 1 odmerek (1 ml)
• Fits or seizures 
• krči ali napadi krčev,
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials. 
V kliničnih preskušanjih vpliva cepiva Twinrix za odrasle na embriofetalno, perinatalno in postnatalno preživetje ter razvoj prospektivno niso ovrednotili.
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 
3Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae)
Adult achieved seroprotective levels of anti-HBV antibodies (≥ 10 mIU/ml) and Geometric Mean 
En mesec po tem odmerku je 95 % oseb, cepljenih s cepivom Twinrix za odrasle, doseglo seroprotektivno koncentracijo protiteles anti-HBV (≥ 10 mi.e./ml), geometrijska srednja vrednost koncentracij (GMC - geometric mean concentrations) pa se je povečala za 179-krat
- The other ingredients in Twinrix Adult are: sodium chloride, water for injections. 
0,4 miligrama Al3+ - Pomožne snovi cepiva Twinrix za odrasle so: natrijev klorid in voda za injekcije.
Gastrointestinal symptoms, diarrhoea, nausea 
Bolezni prebavil pogosti gastrointestinalni simptomi, driska, navzea občasni bruhanje, bolečine v trebuhu*
Rare (These may occur in up to 1 in 1,000 doses of the vaccine): 
Redki (ki se lahko pojavijo pri največ 1 od 1000 odmerkov cepiva):
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artritis, mišična oslabelost
• Swelling, bruising or itching at the injection site 
• oteklina, pojav modric ali srbenja na mestu vboda,
These consist of nausea (feeling sick), fever and aches and pains. 
Kažejo se v obliki siljenja na bruhanje, povišane telesne temperature in bolečin.
No data on concomitant administration of Twinrix Adult with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated. 
Ni zbranih podatkov o sočasnem dajanju cepiva Twinrix za odrasle in specifičnih imunoglobulinov proti hepatitisu A ali hepatitisu B. Vsekakor pa, kadar sta bili monovalentni cepivi proti hepatitisu A
- Booster dose 
- Poživitveni odmerek
Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination: Nervous system disorders 
Pri spremljanju množične uporabe monovalentnih cepiv proti hepatitisu A in/ali hepatitisu B so dodatno poročali o naslednjih neželenih učinkih, ki so bili časovno povezani s cepljenjem: Bolezni živčevja multipla skleroza, mielitis, ohromelost obraza, polinevritis, kot je Guillain-Barréjev sindrom (z ascendentno paralizo), optični nevritis
• Feeling of pins and needles (paraesthesia) 
• občutek mravljinčenja (parestezija),
It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases. 
Obstaja možnost, da so osebe v času cepljenja v inkubacijski dobi za hepatitis A ali hepatitis B. Ni znano, če Twinrix za odrasle v teh primerih prepreči bolezni.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided. 
Cepiva se ne daje intradermalno ali intramuskularno v glutealno mišico, ker je mogoče, da se na ta način ne doseže ustreznega imunskega odgovora.
• Third dose: 
• tretji odmerek:
The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively. 
mesecev sta bili najbolj pogosto poročani neželeni reakciji bolečina in rdečina s pogostnostjo 37,6 %
Twinrix Adult, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) 
Twinrix za odrasle suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Thrombocytopenia, thrombocytopenic purpura 
Bolezni krvi in limfatičnega sistema trombocitopenija, trombocitopenična purpura
If not, you may not be fully protected against the diseases. 
V kolikor jih niste, obstaja možnost, da niste v celoti zaščiteni proti hepatitisu A in hepatitisu B.
A fourth dose is recommended at 12 months. 
Cepljenje s četrtim odmerkom je priporočljivo dvanajst mesecev po cepljenju s prvim odmerkom.
Uncommon Upper respiratory tract infection 
Infekcijske in parazitske bolezni občasni okužba zgornjih dihalnih poti
HAB vaccine 
Žilne bolezni vaskulitis
Very common Pain and redness at the injection site, fatigue 
Splošne težave in spremembe na mestu aplikacije takojšnja bolečina na mestu vboda
Common (These may occur in up to 1 in 10 doses of the vaccine): 
Pogosti (ki se lahko pojavijo pri največ 1 od 10 odmerkov cepiva):
Uncommon Myalgia Rare 
Žilne bolezni redki hipotenzija
10 x 1 dose (1 ml) 
10 napolnjenih injekcijskih brizg 10 x 1 odmerek (1 ml)
25 x 1 dose (1 ml) 
25 napolnjenih injekcijskih brizg 25 x 1 odmerek (1 ml)
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult. 
Pri bolnikih, pri katerih obstaja tveganje, da po osnovni shemi cepljenja s cepivom Twinrix za odrasle ne bodo razvili ustrezne serozaščite, je potrebno razmišljati o serološkem testiranju.
Vascular disorders 
intramuskularna uporaba
Suspension for injection in pre-filled syringe. 
kot psihološki odziv na injiciranje z iglo.
• Immediate injection site pain, stinging and burning feeling 
• bolezen očesnih živcev (optični nevritis), • takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek.
NAME OF THE MEDICINAL PRODUCT Twinrix Adult, suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). 
Twinrix za odrasle suspenzija za injiciranje cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Decreased appetite 
Presnovne in prehranske motnje redki zmanjšan apetit
• Tiredness 
• srbečica,
The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine. 
Za vse odmerke osnovnega cepljenja je potrebno uporabiti isto cepivo.
Additional doses may need to be considered for persons who do not respond or have a suboptimal response to a course of vaccinations. 
Bolniki z zmanjšanim odzivom na cepljenje ali brez bodo morda potrebovali dodatne odmerke.
Obesity (defined as BMI ≥ 30 kg/m2) has been observed to reduce the immune response to hepatitis A vaccines. 
Ugotovljeno je bilo, da prekomerna telesna masa (definirana z indeksom telesne mase (ITM) ≥ 30 kg/m2) zmanjša imunski odziv na cepiva proti hepatitisu A. Ugotovljeni so bili še številni drugi dejavniki, ki vplivajo na slabši imunski odziv po cepljenju s cepivi proti hepatitisu B. To so: višja starost, moški spol, debelost, kajenje, način dajanja cepiva ali nekatere obstoječe kronične bolezni.
Sodium chloride 
Adsorbiran na aluminijev fosfat
What Twinrix Adult looks like and contents of the pack 
Shranjevanje cepiva Twinrix za odrasle Vsebina pakiranja in dodatne informacije
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4). 
Vsekakor pa se lahko zaradi tega pričakuje pomanjkljiv imunski odgovor na cepljenje
• Dizziness 
• utrujenost.
Talk to your doctor or pharmacist before receiving Twinrix Adult if 
Opozorila in previdnostni ukrepi Pred začetkom cepljenja s cepivom Twinrix za odrasle se posvetujte z zdravnikom ali farmacevtom,
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111 
Tel: + 39(0)45 9218 111
Very common (These may occur in 1 in 10 doses or more of the vaccine): 
Zelo pogosti (ki se lahko pojavijo pri več kot 1 od 10 odmerkov cepiva): • glavobol,
• Joint swelling, muscular weakness 
(multiformni eritem), koprivnica, • oteklost sklepov, mišična oslabelost,
Turbid white suspension. 
- Navodilo shranite.
In a clinical study conducted in subjects over 40 years of age, the seropositivity rate for anti-HAV antibodies and seroprotection rate against hepatitis B of Twinrix Adult following a 0, 1, 6 months schedule were compared with the seropositivity and seroprotection rates of monovalent hepatitis A and B vaccines when administered in opposite arms. 
1-6) v primerjavi s seropozitivnostjo in stopnjo serumske zaščite po monovalentnih cepivih hepatitisa
Very common Headache Uncommon Dizziness Rare 
Bolezni kože in podkožja redki izpuščaj, srbenje zelo redki koprivnica
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines. 
Preobčutljivost po predhodnem cepljenju s cepivi proti hepatitisu A in/ali hepatitisu B. Cepljenje s cepivom Twinrix za odrasle je treba odložiti pri osebah, ki imajo težjo akutno vročinsko bolezen.
This can be fatal in some people. 
Pri nekaterih ljudeh je to lahko smrtno.
You need to be aware of the extra risks: 
Bodite pozorni na dodatna tveganja:
Let it dry completely before you use it again. 
Pustite ga, da se popolnoma posuši, preden ga ponovno uporabite.
Experience in children and adolescents 
Izkušnje pri otrocih in mladostnikih
No fatalities occurred, and the patients recovered. 
Smrtnih izidov ni bilo, bolniki pa so okrevali.
8 Repeat steps 3 to 7 in the same way until you have taken your whole dose. 
8 Na enak način ponavljajte korake od 3 do 7, dokler ne vzamete svojega celotnega odmerka.
• if you're seriously overweight (especially if you're a woman). 
• če imate znatno prekomerno telesno maso (še posebej, če ste ženska).
Stay in regular contact with your doctor 
Bodite v rednih stikih z vašim zdravnikom
Maintenance dose once daily 
Vzdrževalni odmerek enkrat dnevno
• Risk Management Plan (RMP) 
 Načrt obvladovanja tveganja (RMP)
- All patients 
- Vsi bolniki
This dose needs to be further substantiated. 
Ta odmerek je treba še dodatno potrditi.
However, formal interaction studies have not been performed. 
Vendar formalne študije o interakcijah še niso bile izvedene.
If you forget to take a dose, take it as soon as you remember. 
Če ste odmerek pozabili vzeti, ga vzemite takoj, ko se spomnite.
2 Hold the bottle. 
2 Držite stekleničko.
The neurological disorders might be transient or permanent. 
Nevrološke motnje so lahko prehodne ali trajne.
After first opening: 1 month 
Po prvem odprtju: 1 mesec
Subjects, % (no.) 
Osebe, % (št.)
Based on limited data in children aged 2 to 17 years, there were no new safety issues identified compared to adults. 
Na podlagi omejenih podatkov za otroke starosti med 2 in 17 let, ni bilo ugotovljenih novih varnostnih vprašanj v primerjavi z odraslimi.
Then continue your treatment as before. 
Nato nadaljujte z zdravljenjem tako, kot pred tem.
How to measure the dose and take the medicine 
Kako meriti odmerek in jemati zdravilo
There is a risk of your hepatitis getting worse (see section 2). 
Obstaja tveganje, da se vam hepatitis poslabša (glejte poglavje 2).
For example, if your dose is 20 ml, you need to take 2 applicator-fulls of medicine. 
Če je na primer vaš odmerek 20 ml, morate vzeti 2 polna aplikatorja zdravila.
If you are pregnant, think you may be pregnant or are planning to have a baby: 
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete nosečnost:
9 Take the applicator out of the bottle and wash it thoroughly in clean water. 
9 Vzemite aplikator iz stekleničke in ga skrbno operite s čisto vodo.
The observed half-life of elimination is 5 to 7 hours. 
Razpolovni čas izločanja je 5 do 7 ur.
Undetectable HBV DNA 
Nezaznavna HBV DNA
The safety and efficacy of Zeffix in infants, children and adolescents aged below 18 years have not been established. 
Varnost in učinkovitost zdravila Zeffix pri otrocih in mladostnikih starih manj kot 18 let ni bila dokazana.
5 Pull out the applicator plunger (D) until the applicator contains the first part of your full dose. 
5 Izvlecite bat aplikatorja (D), dokler aplikator ne vsebuje prvega dela vašega polnega odmerka.
Push the adapter (B) firmly into the neck of the bottle, as far as it will go. 
Potisnite nastavek (B) trdno v vrat stekleničke, kolikor daleč gre.
Swallow the tablet whole, with some water. 
Tableto pogoltnite celo z malo vode.
Keep it safely. 
Varno jo shranite.
Comparative data according to YMDD status were also available for histological assessment but only up to three years. 
Na voljo so tudi primerjalni podatki o histološki oceni glede na YMDD status, vendar le za obdobje do treh let.
Don't take a double dose to make up for a missed dose. 
Ne vzemite dvojnega odmerka, da bi nadoknadili izpuščeni odmerek.
Zeffix can be used during pregnancy if clinically needed. 
Zdravilo Zeffix se lahko uporablja med nosečnostjo, če je klinično potrebno.
Date of latest renewal: 23 June 2014 
Datum prve odobritve: 29. julij 1999 Datum zadnjega podaljšanja: 23. junij 2014
Most events have been self-limiting, however some fatalities have been observed. 
Večina dogodkov je minila sama, bilo pa je tudi nekaj smrtnih primerov.
See Section 4 for more information about the risks. 
Za več informacij glede tveganj glejte poglavje 4.
• if you have ever had other types of liver disease, such as hepatitis C 
• če ste kdaj imeli druge vrste bolezni jeter, kot npr. hepatitis C;