Euvax-B

Purified HBsAg.

1 ml of the Euvax-B vaccine contains: Purified HBsAg 20 µg.
Adjuvant: Aluminum Hydroxide Gel (as Al) 0.5 mg.
Euvax-B consists of highly purified, non infectious particles of Hepatitis B surface antigen (HBsAg) adsorbed onto aluminum salts as an adjuvant. 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.
Excipients/Inactive Ingredients: Monobasic potassium phosphate, Dibasic sodium phosphate, Sodium chloride and thimerosal as a preservative in multidose vials only.

Immunization against infection caused by all known subtypes of Hepatitis B virus.

Euvax-B is for intramuscular use only.
One pediatric dose (neonates, infants, and children aged up to and including 15 years of age) is 0.5 ml containing 10 µg of HBsAg.
One adult dose (from 16 years) is 1.0 ml containing 20 µg of HBsAg.
The immunization regimen consists of three doses of vaccine given according to the following schedule; 1^st dose: at elected date; 2^nd dose: 1 month after the first dose; 3^rd dose: 6 months after the first dose.
Booster vaccination: the WHO does not recommend booster vaccination, 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. However, some local vaccination programmes worldwide currently include a recommendation for a booster dose, and these should be respected.
An alternative 0, 1 and 2 months schedule and a 12 months booster can be used in certain populations (e.g. neonates born from Hepatitis B-infected mothers, someone who has 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.

Hepatitis B vaccine is contraindicated for use in persons with hypersensitivity to any component of Euvax-B.

General precautions: 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 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 vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Thimerosal (an organomercuric compound) has been used in the manufacturing process of this medicinal product. Therefore, sensitization reactions may occur.
Precautions for usage: Shake before administration, since a fine white deposit with a clear colorless supernatant may form during storage.
Euvax-B should not be administered in the gluteal region and it must not be administered intravenously.
In preterm babies (<2,000 grams), it is advisable to check antibody titers one month after the third dose to assess the need for a booster dose.
Use in Pregnancy & Lactation: The effect of the HBsAg on foetal development has not been assessed. However, as with all inactivated viral vaccines, the risks to the foetus are considered to be negligible. Euvax-B should be used during pregnancy only when clearly needed.
The effect on breast-fed infants of the administration of Euvax-B to their mothers has not been evaluated in clinical studies. No contraindication has been established.

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

Gastrointestinal disorders: Rare: nausea.
Common: abdominal pain, diarrhea, vomiting.
General disorders and administration site conditions: Rare: malaise, fatigue.
Common: fever, induration, oedema, tenderness, inflammation.
Very common: injection site pain.
Infections and infestations: Uncommon: moniliasis, rhinitis.
Investigations: Rare: transient increase of transaminase.
Metabolism and nutrition disorders: Common: anorexia.
Musculoskeletal and connective tissue disorders: Rare: myalgia, arthritis.
Nervous system disorders: Very rare: optic neuritis, facial paralysis, Guillain-Barre syndrome, aggravation of disseminated sclerosis.
Rare: headache, dizziness.
Common: crying abnormal, somnolence.
Pregnancy, puerperium and perinatal conditions: Uncommon: jaundice neonatal.
Psychiatric disorders: Common: insomnia, nervousness, irritability.
Skin and subcutaneous tissue disorders: Common: rash erythematous, erythema.
Uncommon: pityriasis rosea, rash, rash maculo-papular.
Vascular disorders: Common: hematoma.

Store between +2°C and +8°C (in a refrigerator). Do not freeze.

Vaccines, Antisera & Immunologicals

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

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