Product Introduction
AIM Honesty RECVAX®
[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, especially those who: (1) Newborns, especially mothers, are HBsAg and HBeAg positive. (2) Medical staff engaged in medical work and laboratory personnel exposed to blood.
[Actions and Usage] Vaccination stimulates immunity against hepatitis B virus. Used for prevention of hepatitis B.
[Regulation] 0.5 ml per vial (vial), 0.5 ml per human dose, containing 10μg HBsAg.
[Immunization procedures and doses] (1) was injected intramuscularly into the deltoid muscle of the upper arm. (2) The immunization schedule is three doses, administered at 0, 1, and 6 months, and newborns receive the first dose of vaccine within 24 hours of birth, one dose each time.
[Adverse reactions] Common adverse reactions: Pain and tenderness may be felt at the injection site within 24 hours after vaccination and disappear spontaneously within 2 to 3 days in most cases. Rare adverse reactions: (1) Transient febrile reactions may occur in vaccinees within 72 hours after vaccination and generally persist for 1 to 2 days and resolve spontaneously. (2) Mild to moderate redness, swelling and pain at the inoculation site. Generally, it lasts for 1 to 2 days and resolves spontaneously without treatment. Very rare adverse reactions: (1) Induration may occur at the inoculation site and is generally absorbed spontaneously in 1 to 2 months. (2) Local aseptic suppuration: Pus is generally repeatedly aspirated with a syringe, and in severe cases (ulceration) it is necessary to expand the wound to remove necrotic tissue, which lasts longer and can finally be absorbed and healed. (3) 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. (4) 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 attacks of chronic diseases and fever; (3) Pregnant women. (4) For uncontrolled epilepsy and other progressive neurological diseases;
[Precautions] (1) Use with caution in patients with the following conditions: family and individual history of convulsion, chronic diseases, history of epilepsy, and allergic constitution. (2) It should be shaken well when used, and should not be used if there are clots that do not disperse, foreign bodies, cracks in the vaccine bottle, or unclear labels. (3) Vaccine bottles should be used immediately when opened. (4) Drugs such as epinephrine should be available for 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. (5) If abnormal conditions such as high fever and convulsion occur after the first injection, the second injection is generally no longer injected, and for infants with maternal and fetal blocking, the second and third injections should be followed by the doctor 's advice. (6) Freezing is strictly prohibited.
[Storage Storage] Store and transport at 2-8℃, protected from light.
[Package Container] The inner packing materials are vials and prefilled syringes,：0.5 ml × 1 vial/box.
[Effective period] 36 months.