Each mL of vaccine contains purified HBsAg 20 mcg. It also contains aluminum hydroxide gel (as aluminum) 0.5 mg as adjuvant, thimerosal 0.01 w/v% as preservative and the following excipients: Monobasic potassium phosphate, dibasic sodium phosphate and sodium chloride.
Euvax-B consists of highly purified, non-infectious particles of hepatitis B surface antigen (HBsAg) adsorbed onto aluminum salts as an adjuvant and preserved with thimerosal. It is a recombinant DNA hepatitis B vaccine derived from HBsAg produced by DNA recombinant technology in yeast cells (Saccharomyces cerevisiae).
The vaccine meets the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture.
Active immunization against infection caused by all known subtypes of hepatitis B virus.
Euvax-B is for IM use only.
Adults from 16 years: 1 mL (1 dose=20 mcg HBsAg).
Neonates, Infants and Children up to and including 15 years: 0.5 mL (1 dose=10 mcg HBsAg).
The immunization regimen consists of 3 doses of vaccine given according to the following schedule: 1st Dose: At elected date. 2nd Dose: 1 month after the 1st dose. 3rd Dose: 6 months after the 1st dose.
An alternative 0, 1 and 2 months schedule and a 12 months booster can be used in certain populations (eg, neonates born from hepatitis B-infected mothers, persons who have or might have been recently exposed to the virus, certain travelers to high-risk areas).
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 course.
Shake the bottle before administration, since a fine, white deposit with a clear, colorless supernatant may form during storage.
Persons with hypersensitivity to any component of Euvax-B.
Euvax-B should not be administered in the gluteal region and it must not be administered IV.
The administration of Euvax-B should be postponed in patients suffering from 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 (see Adverse Reactions).
It is considered that protection cannot be obtained by vaccination in patients in latent or progressive state of hepatitis B.
As with all injectable vaccine, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Use in pregnancy & lactation: The effect of 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 should be used during pregnancy only when clearly needed.
The effect on breastfed infants of the administration of Euvax-B to their mothers has not been evaluated in clinical studies. No contraindication has been established.
Common: Local reactions eg, erythema, pain, swelling or minor fever may rarely occur; these symptoms disappear in 2 days.
Rare: Hyperthermia (above 38.8°C). Systemic reactions eg, malaise, asthenia, headache, nausea, vomiting, dizziness, myalgia and arthritis. Skin rash and transient increase of transaminases.
Very Rare: A causal sequence of cause and effect could not be established for reports of multiple neuritis, optic neuritis, facial paralysis, exacerbation of multiple sclerosis and Guillain-Barré syndrome.
Store between +2°C and +8°C (in a refrigerator). Do not freeze.
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Vial 20 mcg/mL (white, slightly opalescent susp) x 0.5 mL (pediatric dose), 1 mL (adult dose).