RECVAX® 20μg Recombinant Hepatitis B Vaccine

[Drug name]
Generic name:Recombinant Hepatitis B Vaccine (Hansenula Polymorpha)
English name:Recombinant Hepatitis B Vaccine (Hansenula Polymorpha)
Pinyin: Chongzu Yixing Ganyan Yimiao (Hanxun Jiaomu)
[Composition and Description]
This product is prepared by purifying hepatitis B virus surface antigen (HBsAg) expressed by recombinant Hansenula Polymorpha yeast and adding aluminum adjuvant. It is a milky white suspension that can be layered due to precipitation and easily shaken and dispersed.
[Active ingredient]hepatitis B virus surface antigen.
[Excipients]aluminum hydroxide, sodium chloride.
[Vaccinated subjects]
This vaccine is indicated for hepatitis B susceptible individuals 16 years of age and older. Especially the medical staff engaged in medical work and laboratory personnel in contact with blood.
[Actions and usage]Vaccination stimulates immunity against hepatitis B virus. Used for prevention of hepatitis B.
[Regulation]0.5 ml per vial, 0.5 ml per human dose, containing HBsAg 20μg.
[Immunization Procedures and Doses]
(1) Intramuscular injection into the deltoid muscle of the upper arm.
(2) The immunization schedule was 3 doses, which were administered at 0, 1, and 6 months, with a human dose of 20μg/0.5 ml every time.
[Adverse Reactions]
Common adverse reactions:
Pain and tenderness may be felt at the injection site within 24 hours after vaccination and will disappear spontaneously within 2-3 days in most cases. Rare adverse reactions:
(1) Vaccinees may experience transient febrile reactions within 72 hours after vaccination , which generally lasts for 1 to 2 days and resolves spontaneously.
(2) Mild to moderate redness, swelling and pain at the inoculation site generally last for 1 to 2 days and can be relieved spontaneously without treatment.
(3) Induration may occur at the inoculation site and is usually absorbed spontaneously in 1-2 months.
Very rare adverse reactions:
(1) Local aseptic suppuration: Pus is generally repeatedly aspirated with a syringe, and in severe cases (ulceration), necrotic tissue needs to be removed by expansion, the disease lasts for a long time, and finally can be absorbed and healed.
(2) Allergic reactions: allergic rash, Arthur reaction. Arthur reaction generally appears about 10 days after inoculation, local redness and swelling lasts for a long time, and solid alcohols can be used for systemic and local treatment.
(3) Anaphylactic shock: It generally occurs within 1 hour after injection of the vaccine and should be treated with timely injection of epinephrine and other rescue measures.
[Do not avoid]
(1) Known hypersensitivity to any component of the vaccine, including excipients, formaldehyde, and yeast.
(2) Patients suffering from acute diseases, severe chronic diseases, acute exacerbation of chronic diseases and fever.
(3) Patients with uncontrolled epilepsy and other progressive neurological disorders.
(4) Patients who were allergic to previous vaccination with combined hepatitis A and B vaccine or monovalent hepatitis B vaccine.
[Precautions]
(1) Use with caution in patients with the following conditions: family and personal history of convulsions, chronic diseases, history of epilepsy, allergic constitution.
(2) For patients in the incubation period of hepatitis B, it is not clear whether vaccination with HUMIRA can prevent hepatitis B.
(3) Because intradermal injections and intramuscular injections into the buttock do not achieve optimal immunity, vaccination by these routes should be avoided; however, because intramuscular injections can cause bleeding in patients with thrombocytopenia and bleeding disorders, these patients can be injected subcutaneously in exceptional cases. This product should not be administered intravenously under any circumstances.
(4) Shake well before giving the injection; the vaccine container should be opened and used immediately.
(5) Vaccines with lumps that do not disperse, cracks in vaccine containers, unclear labels, or expired failures should not be used
(6) Epinephrine and other drugs should be available to prevent emergency use in case of occasional severe allergic reactions. Those receiving the injection should be observed in the field for at least 30 minutes after the injection.
(7) Do not freeze.
(8) Patients with abnormalities such as fever and convulsion after the first injection generally do not receive the second injection. For infants whose mother is HBsAg and/or HBeAg positive , the doctor should follow the instructions for the second and third injections.
(9) Use in Specific Populations:
Pregnant women:There is no relevant study data in this population, and it is necessary to fully weigh the advantages and disadvantages before deciding whether to use this product.
(10) Drug interactions: concurrent administration with other vaccines: Clinical studies on the effect of concurrent (first, second or simultaneous) administration of other vaccines on the immunogenicity of this vaccine have not been conducted. Currently no data are available to assess the impact of co-administration of this product with other vaccines.
Immunosuppressive drugs: including immunosuppressive agents, chemotherapeutic drugs, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids, which may reduce the immune response of the body to HUMIRA.
Patients receiving treatment: Consultation with a physician is recommended to avoid possible drug-drug interactions.
[Storage Storage]Store and transport at 2-8℃, protected from light.
[Package] The internal packaging materials are prefilled syringe and borosilicate glass bottle. Prefilled syringe: 0.5 ml × 1 vial/box; borosilicate glass bottle: 0.5 ml × 1 vial/box, 0.5 ml × 3 vial/box, 0.5 ml × 30 vial/box .
[Effective period]36 months.

Product Feature And Application
This product is suitable for individuals who are susceptible to hepatitis B and are 16 years of age or older. It is especially recommended for healthcare workers engaged in medical practice and laboratory personnel who come into contact with blood.

Adults vaccinated with RECVAX® 20μg also have an ideal immune effect
Data from the vaccination of over 800 college students with 20μg Hansenula Polymorpha hepatitis B vaccine shows a seroconversion rate of 99.41% and an antibody titer of 1511.88 mIU/mL.