RECOMBINANTHEPATITISBVACCINE（YEAST）
DESCRIPTION： Vecon Recombinant Hepatitis B Vaccine（Yeast） is a non-infectious subunit vaccine derived from hepatits B surface antigen(HBsAg) produced in genetically engineered yeast cells which carry the gene coding for HBsAg. Cells of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg are cultured b fermentation, and HBsAg is released from harvested yeast cells by cell breakage, and then purified by procedures of physical and chemical treatment. No yeast DNA is detectable but less than 1% yeast protein may present in the vaccine. Each lot of Vecon Recombinant Hepatitis B Vaccine(Yeast) is tested for safety, efficacy and sterility according to Pharmacopoeia of the Peoples’ Republic of China(2005), Volume Ⅲ.
The vaccine is a sterile suspension for intramuscular injection. It may form a fine white deposit with a clear colorless supermatant upon storage. After thorough agitation, it becomes a slightly opaque, white suspension without particulate matter and discoloration.
Vecon Recombinant Hepatitis B Vaccine(Yeast) is supplied in two formulation.
Pediatric/Adolescent Formulation, each 0.5mL dose contains 5mcg of HBsAg, adsorbed on 0.25mg aluminum(provided as aluminum hydroxide).
Adult Formulation, each 0.5mL dose contains 10mcg, adsorbed on 0.25 mg aluminum(provided as aluminum hydroxied), and 0.5-1.0 mcg thimerosal as preservative.
INDICATIONS AND USAGE: Vecon Recombinant Hepatitis B Vaccin(Yeast) is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
Vaccination with Vecon Recombinant Hepatitis B Vaccin(Yeast) is recommended for:
1) Infants including those born to HBsAg positive mothers(high-risk infants).
2) Children and adolescents.
3) Adults, especially medical personnel and laboratory personnel contacting blood.
Revaccination: A booster dose may not be required within 5 years after the primary 0,1,6 months vaccination regimen, but if the anti-HBs titre is below 10mIU/mL, a booster dose I recommended.
CONTRAINDICATIONS: Febrile illness, acute or chronic serious disease. Hypersensitivity to yeast or any other component of the vaccine.
WARNINGS: Patients who develops symptoms suggestive of hypersensitivity after an injection should not receive further injection of the vaccine. Because hepatitis B has a long incubation period, the vaccine may not prevent hepatitis B infection in those patients who had unrecognized hepatitis B infection at the time of vaccination administration.
PRECAUTIONS：
General：Epinephrine（1：1000）should be available for immediate use should an acute anaphylactic reaction occur. The physician should review medical history of the patient and assess the benefits and risks of using the vaccine. Use of the vaccine should be delayed if the patient has any serious active infection including febrile illness, unless, in the opinion of the physician, withholding the vaccine entails a greater risk. In administering the vaccine to individuals with severely compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk, caution and appropriate care should be exercised.
Pregnancy: it is not established whether the vaccine would cause fetal harm when administered to a pregnant women or affect reproduction capacity. Unless clearly needed, the vaccine should not be given to a pregnant woman.
Nursing Mothers: when administering the vaccine to a nursing woman, caution should be exercised as many drugs are excreted in human milk.
Pediatric Use: Vecon Recombinant Hepatitis B Vaccine(Yeast) has been shown to be usually well-tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine.
ADVERSE REACTIONS: The most commonly reported adverse reactions are injection site reactions such as soreness, erythema and swelling. These reactions are mild and usually subside within two days after vaccination. Uncommonly systemic complaints such as fever, headache, nausea, dizziness and fatigue have been observed but the causal relationship with the vaccine has not been established.
DOSAGE AND ADMINISTRATION: (1)Shake thoroughly before use to maintain suspension of the vaccine at the time of administration. Do not use if particulate matter and discoloration is observed in the vaccine. (2)Vecon Recombinant Hepatitis B Vaccine(Yeast) is for intramuscular injection, the preferred injection site for adults is the deltoid muscle; the recommended intramuscular injection site for infants and young children is the anterolateral thigh, while the deltoid muscle may also be hosen as the injection site. (3)Pediatric/Adolescent Formulation is recommended for infants and children 15 years and below. Adult Formulation is recommended for adults and children 16 years and above; (4)Use the vaccine as supplied. (5)Use the full recommended dose of the vaccine.
The vaccination regimen consists of 3 doses of vaccine given according toe th following schedule:
First dose: Within 24 hours after birth for new born, and at elected date for others.
Second dose: 1month after the first dose.
Third dose: 6 months after the first dose.
US Immunization Practices Advisory Committee(ACIP) recommends that if the mother is determined to be HBsAg positive within 7 days of delivery, the infant also should be given a dose of HBIG(0.5mL)immediately. The first dose of Vecon Recombinant Hepatitis B Vaccine(Yeast) may be given at the same time as HBIG, but it should be administered in the opposite anterolateral thigh or deltoid muscle.
HOW SUPPLIED:
No. 12-E-V-05-05: Vecon Recombinant Hepatitis B Vaccine(Yeast) for use in infants and children 15 years and below is supplied as 5 mcg/0.5mL of HBsAg single-dose vial, color coded with a light green stripe on the label and carton.
No. 12-E-A-05-05: Vecon Recombinant Hepatitis B Vaccine(Yeast) for use in infants and children15 years and below is supplied as 5 mcg/0.5mL HBsAg in a 0.5mL single- dose ampoule, color coded with a green stripe on the label and carton.
No. 12-E-V-10-10: Vecon Recombinant Hepatitis B Vaccine(Yeast) for use in children and adults 16 years and above is supplied as 10 mcg/1.0mL of HBsAg in a 0.5 mL single-dosevil, color coded wit a light blue stripe on the label and carton.
No. 12-E-A-10-10: Vecon Recombinant Hepatitis B Vaccine(Yeast) for use in children and adults 16 years and above is supplied as 10mcg/0.5mL of HBsAg in a 1.0mL single-dose ampoule, color coded with a blue stripe on the label and carton.
Storage: Store vials and ampoules at 2-8℃(36℉-46℉). Exceeding the recommended storage temperature range may reduce potency. Do no freeze since freezing destroys potency.
EXPIRY DATE:
The shelf life of Vecon Recombinant Hepatitis B Vaccine(Yeast) is 3 years. The expiry date is shown on the label. Use before the expiry date.
P.R.CHINA LICENSE NO.S20053054
S19983018
Manufactured and distributed domestically by:
Shenzhen Kangtai Biological Products Co., Ltd.
Shenzhen, P.R.China
12-E-V-05-05/12-E-A-05-05/12-E-V-10-10/12-E-A-10-10
