Vaccine is indicated for active immunization against hepatitis B virus infection (HBV) caused by all known 
subtypes.

Posology 
1 dose, 10 micrograms (0.5ml suspension) is intended for use in neonates, infants and children aged up to 
and including 15 years of age. 
The primary immunization regimen consists of three doses: 
- 1
st dose: at elected date 
- 2
nd dose: 1 month after the first dose 
- 3
rd dose: 6 month after the first dose 
Booster vaccination: 
Under results of studies the WHO does not recommend booster vaccination among immunocompetent 
subjects who have responded to 3 doses, as it has been shown that 3 dose series of hepatitis B immunization 
protects for as long as 15 years, and that a protective anamnestic response occurs after exposure to HBV, 
even if protective antibodies have been lost over time. 
Official vaccination programs of booster vaccination should be respected.
2 
In special cases, when rapid optimal immune response is required i.e., neonates born from Hepatitis B 
infected mothers, someone who has been exposed to the virus (e.g. needle stick with contaminated needle) or 
certain travelers to high-risk areas an alternative schedule can be used: 
- 1
st dose: at elected date 
- 2
nd dose: 1 month after the first dose 
- 3
rd dose: 2 month after the first dose 
4
th dose: 12 months after the first dose to assure long term protection. 
Additional dose(s) of vaccine may be required in hemodialysis or immunodeficient patients, since protective 
antibody titers (≥10 IU/L) may not be obtained after the primary immunization series. 
Determination of antibodies titers is recommended. 
In cases where someone has or might have been recently exposed to the HBV (contamination by injured skin 
or mucosa, neonates born from Hepatitis B infected mothers) to be recommended the first dose of Euvax B 
vaccine administers simultaneously with HBIg. Injection must be given at a separate site. 
Method of administration 
Vaccine Euvax B should be injected intramuscularly in the deltoid region in children or in the anterolateral 
thigh in neonates, infants and young children.

The administration of Euvax B vaccine should be postponed in patients suffering from an acute, severe 
febrile illness. 
In patients suffering from multiple sclerosis, any stimulation of the immune system can induce exacerbation 
of their symptoms. Therefore, for these patients the benefits of vaccination against Hepatitis B should be 
weighed against the risks of exacerbation of multiple sclerosis. 
It is considered that vaccination in patients in latent or progressive states of Hepatitis B may not affect the 
course of these diseases. 
Because of the long incubation period of hepatitis B it is possible for unrecognized infection to be present at 
the time of immunization. The vaccine may not prevent hepatitis B infection in such cases. 
The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis 
A (HAV), hepatitis C (HCV) and hepatitis E (HEV) viruses. 
As with all injectable vaccines, appropriate medical treatment should be always readily available in 
case of rare anaphylactic reactions following the administration of the vaccine. 
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when 
administering the primary immunization series to very premature infants born < 28 weeks of gestation) and 
particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high 
in this group of infants, vaccination should not be withheld or delayed. 
Euvax B vaccine should not be administered in the buttock or intradermal since this may not guarantee 
optimal immune response. 
3 
Vaccine should not be administered intravenously. 

Hepatitis B vaccine can be given concomitantly with BCG, diphtheria, tetanus, pertussis, mumps, measles, 
rubella, and polio vaccines. 
Different vaccines should always be administered at different injection using different needles and syringes. 
Euvax B vaccine can be concomitantly administered with HBIg using at different injection site.

Pregnancy 
The effect of the HBsAg on fetal development has not been assessed. However, as with all inactivated viral 
vaccines, the risks to the fetus are considered to be negligible. 
Euvax B vaccine should be used during pregnancy only when clearly needed and the possible advantages 
outweigh the possible risks for the fetus. 
Lactation 
The effect on breast-fed infants of the administration of Euvax B vaccine to their mothers has not been 
evaluated in clinical studies. No contraindication has been established.

No available data.

Summary of the safety profile 
The most frequently reported adverse reaction from clinical trials is injection site pain (very common: 
≥1/10). Detailed information of adverse reactions from clinical trials and post-marketing surveillance is 
presented in the below tabulated summary table. 
Tabulated summary of adverse reactions 
Adverse drug reactions are listed below by system organ class and frequency as: 
Very common: ≥1/10 
Common: ≥1/100 to <1/10 
Uncommon: ≥1/1,000 to <1/100 
Rare: ≥1/10,000 to <1/1,000 
Very rare: <1/10,000

System Organ Class Frequency Adverse Reactions
Clinical trials
Infections and infestations Uncommon Moniliasis, Rhinitis
Metabolism and nutrition disorders Common Anorexia
Psychiatric disorders Common Insomnia, Nervousness, Irritability
Nervous system disorders
Common Somnolence
Rare Headache, Dizziness
Very rare
Optic neuritis, Facial paralysis, GuillainBarre syndrome, Aggravation of 
disseminated sclerosis

Vascular disorders Common Hematoma
Gastrointestinal disorders
Common Abdominal pain, Diarrhoea, Vomiting
Rare Nausea
Skin and subcutaneous tissue disorders
Common Rash erythematous, Erythema
Uncommon Pityriasis rosea, Rash, Rash maculopapular
Musculoskeletal and connective tissue 
disorders Rare Myalgia, Arthritis
Pregnancy, puerperium and perinatal 
conditions Uncommon Jaundice neonatal
General disorders and administration 
site conditions
Very 
common
Injection site pain
Common Fever, Induration, Oedema, Tenderness, 
Inflammation, Crying abnormal
Rare Malaise, Fatigue
Investigations Rare Transient increase of transaminase
Post-marketing surveillance
Infections and infestations Injection site abscess, Nasopharyngitis, 
Rhinitis
Blood and lymphatic system disorders Lymphadenopathy, Thrombocytopenia
Immune system disorders Hypersensitivity, Anaphylactic reaction
Metabolism and nutrition disorders Decreased appetite, Anorexia
Psychiatric disorders Anxiety, Insomnia
Nervous system disorders Convulsion, Hypotonia, Somnolence, 
Headache, Dizziness, Syncope
Cardiac disorders Tachycardia
Vascular disorders Hypotension
Respiratory, thoracic and mediastinal disorders Cough
Gastrointestinal disorders Vomiting, Diarrhoea, Nausea, Abdominal 
pain
Skin and subcutaneous tissue disorders Erythema, Urticaria, Rash, Pruritus, 
Petechiae
Musculoskeletal and connective tissue disorders
Myalgia, Pain in extremity, Muscle 
spasms, Musculoskeletal stiffness, 
Arthralgia
General disorders and administration site conditions
Injection site reactions(Erythema, 
Oedema, Pain, Inflammation, Swelling, 
Pruritus, Haematoma, Induration, 
Warmth), Pyrexia, Irritability, Malaise, 
Asthenia, Fatigue, Chills

Apnoea at premature infants (born < 28 weeks of gestation) (See 4.4). 
Because reactions from post-market surveillance are reported voluntarily from a population of uncertain size, 
it is not possible to reliably estimate their frequency. 

No available data in medical literature shown adverse effect of vaccine in cases of overdose.

Pharmacotherapeutic group: Hepatitis B vaccine, ATC code: J07BC01.
Euvax B vaccine contains purified hepatitis B surface antigen produced in yeast cells (Saccharomyces
cerevisiae) by recombinant DNA technology (gene coding for main surface antigen HBV implantation).
Euvax B vaccine induces high titers of humoral antibodies against HbsAg 
5 clinical trials were conducted in Korea to compare the immunogenicity and safety of Euvax B vaccine with 
plasma-derived vaccine (carriers plasma-derived hepatitis B antigen). Vaccines were administrated at 
intervals of 0, 1, and 2 months and 0, 1, and 6 months. The immunogenicity of the recombinant HBV 
vaccine was as good as the plasma-derived HBV vaccine, when considering the seroconversion rates and the 
Geometric Mean Titers.
Overall, available data indicate that both schedule 0, 1, 2 months and 0, 1, 6 months are effective, but 
schedule 0, 1, 6 to be better for long-term immunogenicity. 
There was no case observed of HBsAg seropositivity or episode of clinical hepatitis B among study subjects 
during these studies. Adverse reactions observed in study groups after vaccination were mild 
and symptoms were temporary. 
The safety and immunogenicity of Euvax B vaccine was documented in all age groups. 
In randomized, controlled clinical studies the immunogenicity of Euvax B vaccine and other recombinant 
DNA yeast-derived vaccine was compared. Results shown that immunization after Euvax B vaccine is not 
less than after compared vaccine. 
Infants vaccinated with Euvax B vaccine 10 mcg at intervals 0,1,6 months (first dose – 1st day of life) in 
infants, 100% (93/93) of subjects developed anti-HBs antibody titers > 10 mIU/ml correlates with protection 
to HBV infection. 
Geometric Mean Titers (GMT) were 2334.9 mIU/ml. Antibody titers were determined at month 8. 
In clinical study with subjects aged 10 to 15 years vaccinated with Euvax B vaccine 10 mcg at intervals 0, 1, 
6 months, 100% (91/91) of subjects developed anti-HBs antibody titers correlates with protection to HBV 
infection. Geometric Mean Titers (GMT) were 3396,0 mIU/ml. Antibody titers were determined 2 months 
after 3rd dose.. 
High antibody titers was observed in clinical studies with children and adults. 

Results of clinical study with healthy infants vaccinated with Euvax B vaccine immunized according to the 1 
day of life, 6th week and 14th week schedule demonstrated that 95% of subjects developed anti-HBs antibody 
titers > 10 mIU/ml correlates with protection to HBV infection. The concomitant administration Euvax B 
vaccine with pertussis vaccines at 6th and 14th week do not result in immune response to Euvax B vaccine. 
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
6 
Controlled studies shown that vaccination can be continued with Euvax B vaccine 10 mcg if Engerix 10 mcg 
was administered as first dose. This data concern 0, 1, 6 months schedule. 

Pharmacokinetic properties are not required for vaccines.

Preclinical data reveal no special hazard for humans based on overall studies with mono and multidoses.

Potassium Phosphate, Monobasic 
Sodium Phosphate, Dibasic, septahydrate 
Sodium Chloride 
Water for injection 
Adjuvant, presevative: see section 2

Euvax B should not be mixed with other vaccines.

Store in a refrigerator (2°C to 8°C). Do not freeze.

0.5 ml suspension in glass vials (type I glass) with chlorobutyl rubber stopper silicone covered in carton box 
. Box 1, 10 or 20 vials.
5.0 ml suspension in glass vials (type I glass) with chlorobutyl rubber stopper silicone covered in carton box 
. Box 10 vials.
Not all pack sizes may be marketed.

It should be well shaken before administration because upon storage, the content may present a fine white 
deposit with a clear colourless supernatant.