natgillin/translations-raw huggingface dataset:
The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance. 
Pred in po tem, ko se cepivo pretrese, ga je potrebno vizualno pregledati glede morebitne prisotnosti tujih delcev in/ali spremenjenega fizikalnega videza.
Psychiatric disorders: Rare: nervousness 
Psihiatrične motnje: Redki: živčnost
Healthy subjects 
Zdrave osebe
Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine. 
V kliničnih preskušanjih je bilo z 2.476 odmerki cepiva Fendrix cepljenih 82 predhemodializnih in hemodializnih bolnikov ter 713 zdravih oseb, ki so bile stare 15 let ali več, kar je omogočilo dokumentirati reaktogenost cepiva.
Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine. 
Pričeto osnovno cepljenje po shemi 0, 1, 2 in 6 mesecev je potrebno dokončati s cepivom Fendrix in ne z drugimi komercialno dostopnimi cepivi proti hepatitisu B.
Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies). 
Cepivo Fendrix sproži nastanek specifičnih humoralnih protiteles proti HBsAg (protiteles proti-HBs).
• feeling thirsty 
• občutek žeje,
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
Immune system disorders: Rare: allergy 
Bolezni imunskega sistema: Redki: alergija
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines. 
Ker so predhemodializni in hemodializni bolniki še posebej izpostavljeni okužbi s HBV, in ker je pri njih tveganje za kronično okužbo večje, je potrebno razmisliti o previdnostnih ukrepih, npr. cepljenje z obnovitvenim odmerkom, da bi tako zagotovili takšen zaščitni titer protiteles kot je definiran z nacionalnimi priporočili in smernicami.
If concomitant administration of specific hepatitis B immunoglobulin and Fendrix is required, these should be given at different injection sites. 
Če je potrebno sočasno dajanje specifičnih imunoglobulinov proti hepatitisu B in cepiva Fendrix, je odmerka potrebno dati na različni mesti.
If you are not sure, talk to your doctor or pharmacist before having Fendrix. 
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden prejmete cepivo Fendrix.
The following side effects may happen with this vaccine. 
Med uporabo tega cepiva se lahko pojavijo naslednji neželeni učinki.
Fendrix has moderate influence on the ability to drive and use machine. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo Fendrix ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
However, in circumstances where exposure to HBV has recently occurred (e.g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites. 
V okoliščinah, kjer je pred kratkim prišlo do izpostavljenosti HBV (npr. vbod z okuženo iglo) in je potrebno sočasno cepljenje s cepivom Fendrix ter dajanje običajnega odmerka HBIg, je odmerek cepiva Fendrix in odmerek HBIg potrebno injicirati na različni mesti.
• The active substance in 1 dose (0.5 ml) of Fendrix is: Hepatitis B surface antigen 1, 2, 3 
• Zdravilna učinkovina v 1 odmerku (0,5 ml) cepiva Fendrix je: površinski antigen virusa hepatitisa B 1, 2, 3
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients). 
4.1 Terapevtske indikacije Cepivo Fendrix je indicirano pri mladostnikih in odraslih, starejših od 15 let, za aktivno imunizacijo bolnikov z ledvično insuficienco (vključno s predhemodializnimi in hemodializnimi bolniki) proti okužbi z vsemi znanimi podtipi virusa hepatitisa B (HBV).
Fendrix should be injected intramuscularly in the deltoid region. 
Cepivo Fendrix je potrebno injicirati intramuskularno v deltoidno mišico.
• numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy). 
• omrtvičenost ali šibkost rok in nog (nevropatija), vnetje živcev (nevritis), šibkost in paraliza udov, ki pogosto napreduje na prsni koš in obraz (Guillain-Barréjev sindrom),
What Fendrix looks like and contents of the pack 
Izgled cepiva Fendrix in vsebina pakiranja
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10. 
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) s priloženo injekcijsko iglo ali brez v pakiranju po 1, ali brez priloženih injekcijskih igel v pakiranju po
An anti-HBs antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection. 
Titer protiteles proti-HBs ≥10 i.e./l je v skladu z zaščito pred okužbo z virusom hepatitisa B.
• Fendrix may not protect you from being ill if you have already caught the hepatitis B virus. 
• Cepivo Fendrix vas morda ne bo zaščitilo pred boleznijo, če ste že okuženi z virusom hepatitisa B.
• other reactions where the injection was given. 
• druge reakcije na mestu injiciranja.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
Kot vsa cepiva ima lahko tudi cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Pre-haemodialysis and haemodialysis patients 
Predhemodializni in hemodializni bolniki
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6). 
Predklinični podatki na osnovi običajnih študij na živalih (akutna toksičnost in toksičnost pri ponavljajočih se odmerkih, farmakološke varnosti za kardiovaskularni in respiratorni sistem in škodljivi vplivi na sposobnost razmnoževanja vključno z brejostjo in peri- ter postnatalnim razvojem psičkov do odstavitve) ne kažejo posebnega tveganja za človeka (glejte poglavje 4.6).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having Fendrix. 
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom,
Frequencies are reported as: Very common: (≥1/10) Common: 
Pogostnost je navedena kot: Zelo pogosti:
• Not all pack sizes may be marketed. 
• Na trgu ni vseh navedenih pakiranj.
Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine. 
Cepivo Fendrix je mogoče uporabiti tudi kot obnovitveno injekcijo po ciklusu drugačne vrste cepiva proti hepatitisu B.
Tell your doctor if you are taking, have recently taken, might take any other medicines or have recently received any other vaccine. 
Druga zdravila in cepivo Fendrix Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo ali cepivo.
How Fendrix works 
Kako deluje cepivo Fendrix
At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine. 
V 36. mesecu je 80,4 % omenjenih bolnikov še imelo zaščitni titer protiteles (titer proti-HBs ≥10 i.e./l) v primerjavi z 51,3 % bolnikov, ki so bili cepljeni s komercialno dostopnim cepivom proti hepatitisu B.
• patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the blood 
• bolnike na hemodializi, pri kateri naprava za dializo odstrani odpadne snovi iz krvi, • bolnike, ki se bodo s hemodializo zdravili v prihodnje.
Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the foetus. 
Med nosečnostjo se lahko cepi le nosečnice, pri katerih pričakovane koristi cepljenja prevladajo nad možnim tveganjem za plod.
• Fendrix contains two things called “MPL” (a non-toxic purified fat derivative from bacteria) and 
• Cepivo Fendrix vsebuje dve sestavini: ena se imenuje "MPL" (to je nestrupen, prečiščen maščobni izvleček bakterij), druga pa "aluminijev fosfat".
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITH SEPARATE NEEDLE 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 
1 NAPOLNJENA INJEKCIJSKA BRIZGA S PRILOŽENO INJEKCIJSKO IGLO 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ INJEKCIJSKE IGLE
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency. 
Neželene reakcije, o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da so ali bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
Fendrix should not be given to subjects suffering from acute severe febrile illness. 
S cepivom Fendrix se ne sme cepiti oseb, ki imajo hudo akutno vročinsko bolezen.
After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine. 
Po zaključenem osnovnem cepljenju s štirimi odmerki cepiva (npr. v 7. mesecu) je bilo 90,9 % oseb, ki so bile cepljene s cepivom Fendrix serozaščitenih (≥10 i.e/l) pred okužbo z virusom hepatitisa B v primerjavi s 84,4 % oseb v kontrolni skupini, ki so bile cepljene s komercialno dostopnim cepivom proti hepatitisu B.
You may feel tired or get a headache after receiving Fendrix. 
Potem, ko prejmete cepivo Fendrix, se lahko počutite utrujeni ali se vam pojavi glavobol.
No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated. 
Podatki o sočasnem dajanju cepiva Fendrix in drugih cepiv ali specifičnih imunoglobulinov proti hepatitisu B niso bili pridobljeni.
The vaccine may not prevent hepatitis B infection in such cases. 
V takšnih primerih je možno, da preventiva hepatitisa B ne bo uspešna.
Special posology recommendation for known or presumed exposure to HBV: 
Posebna priporočila glede odmerjanja v primeru znane ali domnevne izpostavljenosti virusu hepatitisa B:
(≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100) 
(≥1/1.000 do<1/100)
Additionally, the following side effects have also been reported with other hepatitis B vaccines: 
Poleg tega so bili z drugimi cepivi proti hepatitisu B opisani še naslednji neželeni učinki.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency. 
Neželene reakcije, o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
Vaccination should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the infant. 
Cepi se lahko le doječe matere, pri katerih pričakovane koristi cepljenja prevladajo nad možnim tveganjem za dojenega otroka.
In pre-haemodialysis and haemodialysis patients: 
Predhemodializni in hemodializni bolniki:
These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. 
Opaženi so bili številni dejavniki, ki zmanjšujejo imunski odziv na cepiva proti hepatitisu B. Med te dejavnike spadajo višja starost, moški spol, debelost, kajenje, način uporabe in nekatere kronične osnovne bolezni.
The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects. 
Pri vseh 82 predhemodializnih in hemodializnih bolnikih je bil reaktogeni profil na splošno primerljiv s tistim pri zdravih osebah.
Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported. 
nevropatiji, nevritisu (vključno z Guillain-Barréjevim sindromom, optičnim nevritisem in multiplo sklerozo), encefalitisu, encefalopatiji, meningitisu in konvulzijah.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intramuskularna uporaba
• if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6). 
Cepiva Fendrix ne smete prejeti: • če ste alergični na zdravilno učinkovino ali na katero koli sestavino tega cepiva (navedeno v poglavju 6).
The vaccine must not be used if any change in the appearance of the vaccine has taken place. 
Če se opazi kakršnakoli sprememba v videzu, se cepivo ne sme uporabiti.
• red, raised skin rash 
• nad nivo kože privzdignjen kožni izpuščaj,
There are no data from use of Fendrix during lactation. 
Ni podatkov o uporabi cepiva Fendrix med dojenjem.
Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines. 
S cepivom Fendrix se ne sme cepiti oseb s preobčutljivostjo po predhodnem cepljenju z drugimi cepivi proti hepatitisu B.
• Fendrix may need to be given at the same time as an injection of hepatitis B “immuno-globulins”. 
• Cepivo Fendrix boste morda morali dobiti hkrati z injekcijo imunoglobulinov proti hepatitisu B.
Shake well before use 
Pred uporabo pretresite
Antibody persistence 
Persistenca protiteles
Clinical trial data 
KLINIČNI PODATKI
GlaxoSmithKline A.E.B.E. 
Ελλάδα GlaxoSmithKline A.E.B.E.
Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients. 
S cepivom Fendrix se ne sme cepiti oseb, ki so preobčutljive za aktivne sestavine ali katerokoli pomožno snov cepiva Fendrix.
• Make sure you finish the complete course of four injections. 
• Preverite, ali ste prejeli vse štiri načrtovane odmerke cepiva.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/0299/001 - pack of 1 with separate needle EU/1/04/0299/002 - pack of 1 without needle EU/1/04/0299/003 - pack of 10 without needles 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/0299/001 - pakiranje po 1 s priloženo injekcijsko iglo
• stomach and digestion problems. 
• težave z želodcem ali s prebavo.
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology. 
2adsorbiran na aluminijev fosfat (skupno 0,5 miligramov Al3+) 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case basis by the physician. 
Cepljenje je lahko primerno, saj je pri teh bolnikih možna huda okužba z virusom hepatitisa B. Odločitev o cepljenju proti hepatitisu B mora torej zdravnik pretehtati od primera do primera.
• You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine. 
• Med cepljenjem s cepivom Fendrix in katerimkoli drugim cepivom mora biti presledek vsaj 2 do 3
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated. 
Podatki o cepljenju s cepivom Fendrix in sočasnem dajanju specifičnih imunoglobulinov proti hepatitisu B (HBIg) niso bili pridobljeni.
These make the vaccine work quicker, better and last for longer. 
Ti sestavini dosežeta, da cepivo deluje hitreje,
It cannot protect you against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis B virus. 
• Cepivo Fendrix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa B. Ne more vas zaščititi pred drugimi okužbami, ki lahko prizadenejo jetra - tudi če imajo te okužbe podobne znake, kot jih povzroča virus hepatitisa B.
General disorders and administration site conditions: Very common: injection site swelling, fatigue, pain, redness Common: fever 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: oteklost na mestu injiciranja, utrujenost, bolečine, pordelost
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients. 
Predhemodializni in hemodializni bolniki: Dokazano je bilo, da pri predhemodializnih in hemodializnih bolnikih protitelesa proti-HBs persistirajo vsaj 36 mesecev po osnovnem cepljenju (0, 1, 2, 6 mesec) s cepivom Fendrix.
• Store in the original package in order to protect from light. 
• Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
How much is given 
Koliko cepiva boste prejeli
Rare: vertigo 
Redki: vrtoglavica
The presence of a minor infection such as a cold, is not a contraindication for immunisation. 
prehlad, ni kontraindikacija za cepljenje.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. 
Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki morata biti v takšnem primeru nemudoma na voljo.
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population. 
En mesec po prejemu tretjega odmerka (npr. v 3. mesecu) je bil opažen zaščitni titer specifičnih humoralnih protiteles (titer proti-HBs ≥10 i.e./l) pri 74,4 % s cepivom Fendrix cepljenih bolnikov (N = 82), v primerjavi z 52,4 % bolnikov v kontrolni skupini, ki so bili cepljeni z dvema odmerkoma za to populacijo komercialno dostopnega cepiva proti hepatitisu B (N = 83).
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. 
Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po imunizaciji s cepivom Fendrix pričakuje tudi preventiva hepatitisa D.
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines. 
Zelo redko so bile s cepivi proti hepatitisu B opisane tudi anafilaksija, alergijske reakcije, vključno z anafilaktoidnimi reakcijami, in podobne serumski bolezni.
Nervous system disorders: Common: headache 
Bolezni živčevja: Pogosti: glavobol
Very common (these may occur with more than 1 in 10 doses of the vaccine) 
Zelo pogosti (pojavijo se lahko pri več kot 1 na 10 odmerkov cepiva):
SPECIAL STORAGE CONDITIONS Store in a refrigerator 
POSEBNA NAVODILA ZA SHRANJEVANJE
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 
Fendrix suspenzija za injiciranje Adsorbirano cepivo proti hepatitisu B (rDNA) z adjuvansom
Booster dose: 
Obnovitveni odmerek:
Muskuloskeletal and connective tissue disorders: Rare: tendinitis, back pain 
Redki: tendinitis, bolečine v hrbtu
1 pre-filled syringe 1 separate needle 1 dose (0.5 ml) 
1 napolnjena injekcijska brizga 1priložena injekcijska igla 1 odmerek (0,5 ml)
• back pain, swelling of your tendons. 
• bolečine v hrbtu, otekanje kit
Store in the original package in order to protect from light 
Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini
• pain or discomfort where the injection was given. 
• občutek utrujenosti, • bolečina ali neugodje na mestu injiciranja.
Infections and infestations: Rare: viral infection 
Redki: virusne okužbe
• The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice). 
občutek hude utrujenosti, temen urin, bledo blato in porumenelost kože ali oči (zlatenica).
• hot flushes 
• vročinski oblivi,
No increase in the incidence or severity of these adverse reactions was seen with subsequent doses of the primary vaccination schedule. 
Po prejemu nadaljnjih odmerkov po shemi osnovnega cepljenja ni bilo opaženo povečanje pojavnosti ali resnosti teh neželenih reakcij.
Additional doses may need to be considered for subjects who do not respond or have a sub-optimal response to a course of vaccinations. 
Pri osebah brez ali s suboptimalnim odzivom na cepljenje bo morda potrebno razmisliti o dodatnih odmerkih.
- Second injection - 1 month after the first injection. 
• Dobili jih boste v 6 mesecih: - prva injekcija - na datum, ki se ga boste dogovorili z zdravnikom - druga injekcija - 1 mesec po prvi injekciji - tretja injekcija - 2 meseca po prvi injekciji - četrta injekcija - 6 mesecev po prvi injekciji
Rare (these may occur with up to 1 in 1,000 doses of the vaccine) 
Redki (pojavijo se lahko pri največ 1 na 1.000 odmerkov cepiva):
How to store Fendrix 
Shranjevanje cepiva Fendrix
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Fendrix. 
Pri osebah, pri katerih obstaja tveganje, da serozaščita po končanem cepljenju s cepivom Fendrix ne bo dosežena, je potrebno razmisliti o serološkem testiranju.
Hepatitis B surface antigen1, 2, 3 
1 odmerek (0,5 ml): površinski antigen virusa hepatitisa B1, 2, 3
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue 
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika; • če ste kdaj imeli alergijsko reakcijo na katerokoli cepivo proti hepatitisu B;
Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine. 
Po končanem osnovnem cepljenju s cepivom Fendrix ali katerimkoli drugim komercialno dostopnim rekombinantnim cepivom proti hepatitisu B, se cepivo Fendrix lahko uporabi za obnovitveni odmerek.
1 pre-filled syringe 1 dose (0.5 ml) 
1 odmerek (0,5 ml)
Uncommon: other injection site reaction Rare: rigors, hot flushes, thirst, asthenia 
Redki: mrzlica, valovi vročine, žeja, astenija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fendrix suspension for injection 
Navodilo za uporabo Fendrix suspenzija za injiciranje
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively. 
V 3. mesecu so bili v kontrolni skupini geometrični srednji titri 50,1 i.e./l, titre protiteles proti-HBs ≥100 i.e./l pa je imelo
PREFILLED SYRINGE 
• Navodilo shranite.