CONTENTS

Recombinant hepatitis B vaccine.

PRESENTATION

Vial (white, slightly opalescent suspension) 0.5 mL x 1's, 20's. 1 mL x 1's, 20's.

DESCRIPTION

One mL of Euvax B contains purified hepatitis B surface antigen (HBsAg) 20 mcg, aluminum hydroxide gel as aluminum 0.5 mg as adjuvant and thimerosal 0.004 w/v% as preservative. It also contains the following excipients: Monobasic potassium phosphate, dibasic sodium phosphate, sodium chloride.Euvax B consists of highly purified, noninfectious particles of 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.

INDICATIONS

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

DOSAGE & ADMINISTRATION

Adults (from 16 years): 1 mL containing 20 mcg of HBsAg.Children (Neonates, Infants and Children ³ 15 years): 0.5 mL containing 10 mcg of 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.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 (eg, 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.Euvax B is for IM use only. It should not be administered in the gluteal region and IV.

CONTRAINDICATIONS

Hypersensitivity to any component of Euvax B.

PRECAUTIONS

General: 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 vaccines, 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 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 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.

ADVERSE REACTIONS

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, 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-Barre syndrome.

CAUTIONS FOR USAGE

Instructions for Use and Handling: Shake before administration since a fine white deposit with a clear colorless supernatant may form during storage.

STORAGE

Store between 2°C and 8°C (in a refrigerator). Do not freeze.Shelf-Life: 36 months.