natgillin/translations-raw huggingface dataset:
Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination. 
Imunski spomin proti hepatitisu B je bil dokazan s prisotnostjo anamnestičnega odziva na provokacijsko cepljenje proti hepatitisu B v starosti 9 let pri 93 % cepljenih, s pojavom geometrične srednje koncentracije 3692 (95 % IZ: 1886-7225)
Hexyon can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella vaccines, rotavirus vaccines or meningococcal vaccines. 
Cepivo Hexyon se lahko daje istočasno kot druga cepiva, kot so polisaharidna konjugirana cepiva proti pnevmokokom, cepiva proti ošpicam, mumpsu in rdečkam, cepiva proti rotavirusom ali cepiva proti meningokokom.
• Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E. 
• Cepivo Hexyon ne ščiti pred okužbo s hepatitisom, ki ga povzročajo drugi agensi, kot so hepatitis A, hepatitis C in hepatitis E.
Do not use Hexyon if your child: 
Cepivo Hexyon se ne sme uporabiti, če je vaš otrok
The long term capability of the acellular pertussis (aP) antigens contained in Hexyon to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule. 
Dolgoročno zmožnost brezceličnih antigenov oslovskega kašlja, ki jih vsebuje cepivo Hexyon, za zmanjšanje incidence oslovskega kašlja in nadzor bolezni v otroštvu so dokazali v desetletnem nacionalnem spremljanju oslovskega kašlja na Švedskem s petvalentnim cepivom DTaP-IPV/Hib z uporabo 3, 5, 12 mesečne sheme.
Multipack of 50 (5x10) (including blue box) 
Združeno pakiranje po 50 (5x10) (vklučeno modro okno)
Hexyon suspension for injection in pre-filled syringe Hexyon suspension for injection 
Hexyon suspenzija za injiciranje v napolnjeni injekcijski brizgi Hexyon suspenzija za injiciranje
Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexyon Antibody Thresholds 
Preglednica 3: Deleži serološke zaščite a v starosti 4,5 leta po cepljenju s cepivom Hexyon
The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexyon) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study. 
Uspešnost zaščite pred invazivnimi boleznimi, ki povzroča Hib Učinkovitost kombiniranih cepiv proti DTaP in Hib (pentavalentna in heksavalentna cepiva, vključno s cepivi, ki vsebujejo enak antigen Hib kot cepivo Hexyon) proti invazivnim boleznim, ki jih povzroča Hib, so dokazali v Nemčiji z obširno (več kot petletno obdobje spremljanja) opazovalno študijo v obdobju trženja.
Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexyon against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal). 
Učinkovitost cepiva z brezceličnimi antigeni oslovskega kašlja (aP), ki jih vsebuje cepivo Hexyon, proti tipičnemu oslovskemu kašlju v skladu z definicijo SZO (napadi kašlja, ki trajajo ≥ 21 dni), je dokumentirana v randomizirani dvojno slepi študiji pri dojenčkih z osnovno serijo treh odmerkov s cepivom DTaP v visoko endemični državi (Senegal).
Vaccination with Hexyon is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine (whole cell or acellular pertussis vaccines). 
Cepljenje s cepivom Hexyon je kontraindicirano, če je dojenček prebolel encefalopatijo neznanega izvora, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi cepivo proti oslovskemu kašlju (cepivo proti oslovskemu kašlju s celimi celicami ali acelularno).
OTHER Sanofi Pasteur Europe 
DRUGI PODATKI Sanofi Pasteur Europe
Table 1: Seroprotection/Seroconversion rates* one month after a primary vaccination with 2 or 3 doses of Hexyon 
Preglednica 1: Stopnja serozaščite/serokonverzije* en mesec po osnovnem cepljenju z 2 ali 3 odmerki cepiva Hexyon
• Very rare side effects (may affect up to 1 in 10,000 people) are: - episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE). 
• Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 cepljenih) so: - epizode, pri katerih je vaš otrok v šoku podobnem stanju oziroma je določen čas bled, mlahav in neodziven (hipotonične reakcije ali hipotonično-hiporesponzivne epizodeHHE).
Hexyon is provided as a suspension for injection in vial (0.5 ml). 
Cepivo Hexyon je na voljo kot suspenzija za injiciranje v viali (0,5 ml).
What Hexyon looks like and contents of the pack 
Izgled cepiva Hexyon in vsebina pakiranja
• Hexyon must be administered intramuscularly. 
• Cepivo Hexyon se daje intramuskularno.
Booster vaccination at 11-12 months of age after a two doses primary course 
Obnovitveno cepljenje pri starosti 1112 mesecih po osnovnem cepljenju z dvema odmerkoma
Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins. 
Cepivo Hexyon ne ščiti pred nalezljivimi boleznimi, ki jih povzročajo drugi tipi Haemophilusa influenzae, ali pred meningitisom drugačnega izvora.
The primary vaccination consists of two doses (with an interval of at least 8 weeks) or three doses (with an interval of at least 4 weeks) in accordance with the official recommendations. 
Osnovno cepljenja je sestavljeno iz dveh odmerkov (v presledku najmanj 8 tednov) ali treh odmerkov
To make sure that Hexyon is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child. 
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexyon Da bi se prepričali, da je cepivo Hexyon primerno za vašega otroka, je pomembno, da se pogovorite z zdravnikom ali medicinsko sestro, če kaj od spodaj navedenega velja za vašega otroka.
Data on concomitant administration of Hexyon with a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens. 
Podatki o sočasnem dajanju cepiva Hexyon z meningokoknim C konjugiranim cepivom ali z meningokoknim konjugiranim cepivom skupin A, C, W-135 in Y niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
When given at the same time with other vaccines, Hexyon will be given at different injection sites. 
Če se cepljenje opravlja sočasno z drugim cepivom bo cepivo Hexyon injicirano na različno mesto.
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose1 (0.5 ml) contains: 
En odmerek1 (0,5 ml) vsebuje:
Pack size of 1 or 10 pre-filled syringes with or without needle. 
Pakiranje po 1 ali 10 napolnjenih injekcijskih brizg z ali brez injekcijskih igel.
Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level. 
Sicer pa naj bi bila koncentracija protiteles po cepljenju ≥ izmerjeni pred imunizacijo.
Where a dose of hepatitis B vaccine is given at birth, Hexyon can be used for supplementary doses of hepatitis B vaccine from the age of six weeks. 
Če je bil otrok cepljen proti hepatitisu B ob rojstvu, se cepivo Hexyon lahko uporabi za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.
1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 50 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles 
suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga (0,5 ml) brez injekcijske igle 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igel 50 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igel 1 napolnjena injekcijska brizga (0,5 ml) z 1 injekcijsko iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z 10 injekcijskimi iglami
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
POGOJI IN OMEJITVE GLEDE VARNOSTI IN UČINKOVITOSTI ZDRAVILA
A dose of 0.5 ml is withdrawn using a syringe for injection. 
Odmerek 0,5 ml iz viale odvzamite s pomočjo injekcijske brizge.
Hexyon may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine. 
Cepivo Hexyon se lahko uporabi za obnovitveno cepljenje posameznikov, ki so bili pred tem cepljeni z drugim šestvalentnim cepivom ali petvalentnim cepivom DTaP-IPV/Hib povezanim z monovalentnim cepivom proti hepatitisu B.
When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexyon and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations. 
Če je bil ob rojstvu uporabljen odmerek cepiva proti hepatitisu B, je mogoče za zaporedno primarno cepljenje dojenčka uporabiti razpored heksavalentno/pentavalentno/heksavalentno s cepivom Hexyon in pentavalentnim cepivom DTaP-IPV/Hib v skladu z uradnimi priporočili.
N=322†† N=934 to 
N=249** N =123 do 220† N=322†† N=934 do
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 
1 Adsorbiran na hidratirani aluminijev hidroksid (0,6 mg Al3+).
Hexyon in vials 
Cepivo Hexyon v vialah
The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexyon (N=148) at 2, 4, 6 months of age. 
Imunski odzivi na antigena Hib in oslovskega kašlja po 2 odmerkih v starosti 2 in 4 mesece Imunski odziv na Hib (PRP) in antigene oslovskega kašlja (PT in FHA) je bil ovrednoten po prejemu dveh odmerkov v podskupini, ki je prejemala Hexyon (N=148) pri starosti 2, 4 in 6 mesecev.
• has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon. 
• imel motnje dihanja ali otekanje obraza (anafilaktično reakcijo) po cepljenju s cepivom Hexyon.
Pack size of 50 pre-filled syringes without needle. 
Pakiranje po 50 napolnjenih injekcijskih brizg brez injekcijskih igel.
There may be a clinically relevant interference in the antibody response of Hexyon and a varicella vaccine and these vaccines should not be administered at the same time. 
Klinično pomembne spremembe odziva protiteles se lahko pojavijo pri sočasni uporabi cepiv Hexyon in cepiva proti noricam, zato ju ne smemo uporabljati istočasno.
Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexyon Antibody Thresholds 
Preglednica 2: Stopnja serozaščite/serokonverzije* en mesec po obnovitvenem cepljenju s cepivom Hexyon
Multipack of 50 (5 packs of 10) pre-filled syringes without needle. 
Združeno pakiranje po 50 (5 pakiranj po 10) napolnjenih injekcijskih brizg brez injekcijskih igel.
Hexyon will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. 
Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ali Haemophilus influenzae tipa b. Vendar je mogoče pričakovati, da bo cepljenje preprečilo hepatitis D, saj se hepatitis D (ki ga povzroča agens delta) ne pojavi v odsotnosti okužbe s hepatitisom B.
Hexyon is provided as a suspension for injection in pre-filled syringe (0.5 ml). 
Cepivo Hexyon je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
Hexyon in pre-filled syringes EU/1/13/829/002 
Cepivo Hexyon v napolnjenih injekcijskih brizgah EU/1/13/829/002
Diphtheria Toxoid not less than 20 IU2 
davični toksoid ne manj kot 20 i.e.2
Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death. 
Oslovski kašelj lahko povzroči vnetje ušes, okužbo pljuč (bronhitis), ki lahko traja zelo dolgo, pljučno okužbo (pljučnico), krče,
Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexyon in children over 24 months of age has not been studied in clinical trials. 
Farmakoterapevtska skupina: Cepiva, kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA09
MARKETING AUTHORISATION NUMBER(S) EU/1/13/829/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/829/001
The administration of Hexyon must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components. 
Pri posameznikih z anamnezo resnih oziroma hudih reakcij v 48 urah po predhodni injekciji cepiva, ki je vsebovalo podobne komponente, je treba skrbno premisliti o cepljenju s cepivom Hexyon.
Hexyon in vials EU/1/13/829/001 
Cepivo Hexyon v vialah EU/1/13/829/001
Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). 
Cepivo Hexyon (DTaP-IPV-HB-Hib) je indicirano za osnovno in obnovitveno cepljenje dojenčkov in malčkov, starejših od šest tednov, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B,
Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexyon: 
Možni neželeni učinki O drugih neželenih učinkih, ki niso navedeni zgoraj, poročajo občasno pri drugih cepivih, ki vsebujejo cepiva proti davici, tetanusu, oslovskemu kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b vendar ne neposredno pri uporabi cepiva Hexyon:
Hexyon will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects). 
Kako uporabljati cepivo Hexyon Cepivo Hexyon bo vašemu otroku injiciral zdravnik ali medicinska sestra, saj sta usposobljen za uporabo cepiv in za obravnavo vseh občasnih hudih alergijskih reakcij na injekcijo.
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexyon. 
Anamneza vročinskih krčev in družinska anamneza krčev ali sindroma nenadne smrti dojenčka (SIDS
Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti PT (Seroconversion‡‡) (Vaccine response§) Anti FHA (Seroconversion‡‡) (Vaccine response§) 
Protitelesa proti davici (≥ 0,01 i.e./ml) Protitelesa proti tetanusu (≥ 0,01 i.e./ml) Protitelesa proti PT (Serokonverzija ‡‡) (odziv na cepljenje§) Protitelesa proti FHA (Serokonverzija ‡‡) (odziv na cepljenje§)
Hexyon - Carton for pre-filled syringe with two separate needles. 
Hexyon - škatla z napolnjeno injekcijsko brizgo, z dvema ločenima iglama.
Months N=249** N=204† N=178†† N=177 to 
Obnovitveno cepljenje v drugem letu starosti po treh odmerkih osnovnega cepljenja mesecev tednov mesecev mesecev N = 249** N = 204† N = 178†† N = 177 do 396‡
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexyon - Carton for vial. 
PODATKI NA ZUNANJI OVOJNINI Hexyon - škatla z vialami.
0.5 ml suspension in vial (type I glass) with a stopper (halobutyl). 
0,5 ml suspenzije v viali (steklo tipa I) z zamaškom (halobutil).
Hexyon is available in multipack comprising 5 cartons, each containing 10 pre-filled syringes without attached needle. 
Cepivo Hexyon je na voljo v združenem pakiranju 5 škatel, vsaka vsebuje 10 napolnjenih injekcijskih brizg brez injekcijskih igel.
Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age. 
Cepivo Hexyon ščiti vašega otroka pred davico, tetanusom, oslovskim kašljem, hepatitisom B, otroško paralizo in hudimi boleznimi, ki jih povzroča Haemophilus influenzae tipa b. Cepivo Hexyon se daje otrokom starejšim od šestih tednov.
Contents of the pack and other information What Hexyon contains The active substances are per dose (0.5 ml)1: Diphtheria Toxoid not less than 20 IU2 
Zdravilne učinkovine na odmerek (0,5 ml)1 so: davični toksoid ne manj kot 20 i.e.2
Anti-Polio type 2 (≥ 8 (1/dilution)) 
Protitelesa proti poliovirusu tipa 2 (≥ 8 (1/redčitev))
• has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process - after previous administration of Hexyon or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines. 
- na katero koli pomožno snov, navedeno v poglavju 6; - na gluteraldehid, formaldehid, neomicin, streptomicin ali polimiksin B, saj se te snovi uporabljajo pri procesu izdelave cepiva; - po predhodni aplikaciji cepiva Hexyon ali na katero koli cepivo, ki vsebuje cepiva proti davici, tetanusu, oslovskem kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexyon or a vaccine containing the same components or constituents. 
Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1, na sledove zaostankov (gluteraldehida, formaldehida, neomicina, streptomicina in polimiksina B), na katero koli cepivo proti oslovskemu kašlju ali preobčutljivost po predhodnem cepljenju s cepivom
Hexyon - Carton for pre-filled syringe with one separate needle. 
Hexyon - škatla z napolnjeno injekcijsko brizgo brez igle, z eno ločeno iglo.
After a 2-dose primary vaccination with Hexyon, a booster dose must be given. 
Po osnovnem cepljenju z 2-odmerkoma cepiva Hexyon mora otrok prejeti obnovitveni odmerek.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/829/009 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/829/009
History of an anaphylactic reaction after a previous administration of Hexyon. 
Pojav anafilaktične reakcije po predhodnem cepljenju s cepivom Hexyon.
Hexyon is available in pack containing 1,10 or 50 pre-filled syringes without attached needle. 
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1, 10 ali 50 napolnjenih injekcijskih brizg brez pritrjene igle.
Hexyon is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles. 
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z dvema ločenima iglama.
After a 3-dose WHO EPI schedule with Hexyon (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given. 
Po 3-odmerkih cepiva Hexyon po EPI shemi SZO (6, 10 in 14 tednov) in če cepljeni ni prejel cepiva proti hepatitisu B ob rojstvu, ga je treba cepiti z obnovitvenim odmerkom cepiva proti hepatitisu B. Potrebno je dati najmanj obnovitveni odmerek cepiva proti otroški paralizi.
Hexyon is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle. 
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z eno ločeno iglo.
After a 3-dose primary vaccination with Hexyon, a booster dose should be given. 
Po osnovnem cepljenju s 3-odmerki cepiva Hexyon mora otrok prejeti obnovitveni odmerek.
Pack of 1 or 10. 
Pakiranje po 1 ali
Contents of the pack and other information 
Shranjevanje cepiva Hexyon Vsebina pakiranja in dodatne informacije
Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age 
Imunski odziv na (PRP) in antigene PT in FHA en mesec po prejemu 2 odmerka, ki sta bila dana pri 2 in 4
With hepatitis B vaccination at birth 
S cepljenjem proti hepatitisu B ob rojstvu
No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4). 
razen v primeru imunosupresivnega zdravljenja (glejte poglavje 4.4).
How to store Hexyon 
Shranjevanje cepiva Hexyon
With hepatitis B vaccination at birth Without hepatitis B vaccination at birth 97.2 
s cepljenjem proti hepatitisu B ob rojstvu brez cepljenja proti hepatitisu B ob rojstvu
AUTHORISATION 
Pojavnost
Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France 
Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francija
Without hepatitis B vaccination at birth 
Brez cepljenja proti hepatitisu B ob rojstvu
• Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision 
(poliradikulonevritis), ohromelost obraza, motnje vida, nenadna zatemnitev ali izguba vida
In the absence of hepatitis B vaccination at birth, it is necessary to give a hepatitis B vaccine booster dose. 
Če cepljeni ni bil cepljen proti hepatitisu B ob rojstvu, je nujno obnovitveno cepljenje s cepivom proti hepatitisu B. Cepivo Hexyon se lahko uporabi za obnovitveno cepljenje.
When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexyon or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster. 
Če je cepljeni prejel cepivo proti hepatitisu B ob rojstvu in nato 3-odmerke osnovnega cepljenja, je priporočljivo obnovitveno cepljenje s cepivom Hexyon ali s petvalentnim cepivom DTaP-IPV/Hib.
(optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine. 
(optični nevritis) ter vnetna bolezen možganov in hrbtenjače (demielinizacija centralnega živčevja, multipla skleroza) o takšnih neželenih učinkih so poročali po aplikaciji cepiva, ki vsebuje antigen hepatitisa B. • otekanje ali obolenje možganov (encefalopatija/encefalitis)
Data on concomitant administration of a booster dose of Hexyon with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens. 
Podatki o sočasni uporabi obnovitvenega odmerka cepiva Hexyon in cepiva proti ošpicam, mumpsu in rdečkam niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
(polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine. 
- periferna nevropatija (poliradikulonevritis, obrazna paraliza), optični nevritis in demielinizacija centralnega živčevja (multipla skleroza) je bila poročana po aplikaciji cepiva, ki vsebuje antigen hepatitisa B - encefalopatija/encefalitis
Essential amino acids including L-phenylalanine Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment) Water for injections. 
dinatrijev hidrogenfosfat kalijev dihidrogenfosfat trometamol saharoza esencialne aminokisline, vključno z L-fenilalaninom natrijev hidroksid, ocetna kislina ali klorovodikova kislina (za uravnavanje pH) voda za injiciranje