Euvax-B

Euvax-B

vaccine, hepatitis b

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Recombinant hepatitis B vaccine.
Description
1 ml of the previously mentioned vaccine contains: Active ingredient: Purified HBsAg 20 μg.
Adjuvant: Aluminum Hydroxide Gel (as Al) 0.5 mg.
Excipients/Inactive Ingredients: Potassium phosphate, monobasic, Sodium phosphate, dibasic, Sodium chloride.
Euvax B consists of highly purified, non infectious particles of Hepatitis B surface antigen (HBsAg) adsorbed onto aluminum salts as an adjuvant. It is 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.
Action
Pharmacology: Pharmacodynamics: Higher antibody titers and lower ED50 values were observed with Euvax-B in mice than with plasma-derived HBsAg and also higher antibody titers than with commercially available rHBsAg in a comparison test to assess the potency of Euvax-B (see Tables 1 and 2).

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Click on icon to see table/diagram/image

Relevant information for Euvax-B: In order to evaluate the immunogenicity and safety of recombinant DNA yeast-derived hepatitis B vaccine (Euvax-B) by administration at intervals of 0-, 1- and 2-months and 0-, 1-, and 6-months and to compare the antibody titres after vaccination by a plasma-derived HBV vaccine with that by the recombinant HBV vaccine, 5 clinical trials were conducted among healthy Koreans. In addition, a small-scale clinical trial was done in Vietnam to evaluate the immunogenicity and safety of Euvax-B. Several different parameters were compared in these studies: difference in age and sex distribution, seroconversion rate, geometric mean titers between the experimental vaccine group (Euvax-B) and control vaccine group (plasma-derived vaccine), as well as safety in the Euvax-B group.
When small differences in sex and age distribution were observed, they had no consequence on the ability to compare between-group immunogenicity. There was no difference in the immunogenicity between the two groups when the same vaccination schedule was compared, but the 0-, 1- and 6-month schedule was considered to be better than the 0-, 1- and 2-month schedule for long-term immunogenicity. The immunogenicity of the recombinant HBV vaccine was as good as the plasma-derived HBV vaccine, when considering the seroconversion rates and the antibody titer levels.
There was no case observed of HBsAg seropositivity or episode of clinical hepatitis among study subjects during these studies. Adverse reactions observed in study groups after vaccination were mild and symptoms were temporary.
Overall, available data indicate that immunisation against hepatitis B using the yeast-derived recombinant hepatitis B vaccine produced by LG Chem, Ltd (Euvax-B) is efficacious for both the 2- and the 6-month schedules, making it possible to choose between 2- and 6-month schedule according to the vaccinee's convenience. The safety and immunogenicity of Euvax-B was documented in all age groups.
Indications/Uses
Immunization against infection caused by all known subtypes of Hepatitis B virus.
Dosage/Direction for Use
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.
Special 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.
Thimerosal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final 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.
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.
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 of 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
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 erythematosus, erythema. Uncommon: pityriasis rosea, rash, rash maculo-papular.
Vascular disorders: Common: hematoma.
Storage
Store between + 2° C and + 8° C (in a refrigerator). Do not freeze.
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Vaccine (white, slightly opalescent suspension in vial) 10 mcg/0.5 mL (pediatric) x 1's, 10's, 20's. 20 mcg/mL (adult) x 1's, 10's, 20's.
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