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.
DESCRIPTION
Euvax B is a white, slightly opalescent suspension.
COMPOSITION
1 ml of the above vaccine contains :
– Active ingredient : Purified HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 µg
– Adjuvant :Aluminum Hydroxide Gel (as Al) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg
– Preservative :Thimerosal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01 w/v%
– Excipients : Potassium phosphate, monobasic, Sodium phosphate, dibasic, Sodium chloride.
INDICATION AND USAGE
Immunization against infection caused by all known subtypes of Hepatitis B virus.
DOSAGE AND ADMINISTRATION
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;
– 1st dose : at elected date
– 2nd dose : 1 month after the first dose
– 3rd 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 immunisation 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.
CONTRAINDICATIONS
Hepatitis B vaccine is contraindicated for use in persons with hypersensitivity to any component of Euvax B.
WARNINGS AND PRECAUTIONS
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 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.
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.
Pregnancy and 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.
ADVERSE REACTIONS
Common :
– Local reactions such as erythema, pain, swelling or minor fever may rarely occur; these symptoms disappear in 2 days.
Rare :
– Hyperthermia (above 38.8°C).
– Systemic reactions such as 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-Barré syndrome.
STORAGE CONDITIONS
Do not exceed the expiry date stated on the external packaging.
Store between + 2° C and +8° C (in a refrigerator). Do not freeze.
** One voucher is only valid for one dose.
DESCRIPTION
Euvax B is a white, slightly opalescent suspension.
COMPOSITION
1 ml of the above vaccine contains :
– Active ingredient : Purified HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 µg
– Adjuvant :Aluminum Hydroxide Gel (as Al) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg
– Preservative :Thimerosal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01 w/v%
– Excipients : Potassium phosphate, monobasic, Sodium phosphate, dibasic, Sodium chloride.
INDICATION AND USAGE
Immunization against infection caused by all known subtypes of Hepatitis B virus.
DOSAGE AND ADMINISTRATION
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;
– 1st dose : at elected date
– 2nd dose : 1 month after the first dose
– 3rd 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 immunisation 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.
CONTRAINDICATIONS
Hepatitis B vaccine is contraindicated for use in persons with hypersensitivity to any component of Euvax B.
WARNINGS AND PRECAUTIONS
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 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.
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.
Pregnancy and 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.
ADVERSE REACTIONS
Common :
– Local reactions such as erythema, pain, swelling or minor fever may rarely occur; these symptoms disappear in 2 days.
Rare :
– Hyperthermia (above 38.8°C).
– Systemic reactions such as 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-Barré syndrome.
STORAGE CONDITIONS
Do not exceed the expiry date stated on the external packaging.
Store between + 2° C and +8° C (in a refrigerator). Do not freeze.
** One voucher is only valid for one dose.