Bioshoot

After reconstitution, 1 dose (0.5 mL) contains: Active ingredient: Rabies virus produced in Vero cells, CTN-1V strain ≥2.5 IU.
The Specification is 0.5 ml/vial after reconstitution. 1 vial (0.5 ml) per single human dose. The vaccine titer should be not less than 2.5 IU.
The vaccine is a preparation of rabies fixed virus CTN-1V inoculated in to Vero Cell. After cultivation by bioreactor, harvest the virus suspension; further perform the concentration, inactivation, and purification. The vaccine is formulated by adding human albumin, dextran 40 and sucrose through freeze-drying process. The freeze-dried vaccine looks like a crisp cake which turns into a transparent liquid after reconstitution, without any preservative.
Excipients/Inactive Ingredients: Human Albumin, Dextran 40, Sucrose, Sodium Chloride, Potassium Chloride, Potassium phosphate Monobasic, Dibasic Sodium Phosphate.
Diluent: Sterile Water for Injection.

Pharmacology: Pharmacodynamics: Vaccination of this stimulates immunity against rabies virus.
Pharmacokinetics: Not Applicable.

Inoculation of this vaccine can induce immunity against rabies virus to prevent rabies.

Add attached diluent in a labeled amount. Reconstitute and shake well before injection. The vaccine shall be injected intramuscularly in the deltoid of upper arm, for children it is recommended to inject the vaccine into the muscle at anterolateral thigh.
Pre-exposure immunization: Subject is injected with one dose of vaccine on Day 0, Day 7, Day 21 or Day 28, total 3 doses during complete pre-exposure immunization schedule.
Vaccination of subjects already immunized: Patient had complete post-exposure immunization schedules within 1 year. Bitten by a suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively.
Patient had complete post-exposure immunization schedule 1 year ago. Bitten by a suspected rabid animal, complete post - exposure immunization schedule is required.
Patient had complete immunization schedule and booster immunization within 3 years. Bitten by a suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively.
Patient had complete immunization schedule and booster immunization 3 years ago. Bitten by a suspected rabid animal, complete post-exposure immunization is required.

Because rabies is a fatal disease, there are no contraindications for post-exposure immunization.
Pre-exposure vaccination: Subject with known allergic reactions to any ingredients contained in the vaccine, including excipients.
The person who has acute disease, seriously chronic disease, acute exacerbation of chronic disease and fever.
The person is with uncontrolled epilepsy and other progressive neurological disorders.

Use with caution: Family and individual who have a history of convulsion, chronic diseases, a history of epilepsy, allergies.
Lactation and pregnant women.
Drugs such as epinephrine should be available to help with occasional emergency allergies. Subjects should be observed for at least 30 minutes after the injection.
Avoid alcohol, strong tea and other irritating foods and strenuous exercise.
No buttock injection, no intravascular injection.
Post-exposure immunization procedure should follow the principles of timely, adequate, and entire process. Subjects who are allergic may go to a hospital for anti-allergic treatment and complete whole course injection.

Woman during pregnancy cannot use this product (pre-exposure).

Common adverse reactions: After vaccination was finished within 24h, there may be redness, pain, itching at the injection point. Generally, no need for further treatment, the symptom can be relieved spontaneously. Systemic reactions, like fever, weakness, headache, dizziness, joint pain, muscle pain, vomiting, abdominal pain, etc., generally do not need further treatment, the symptom can be relieved spontaneously.
Rare adverse reactions: Transient moderate or above moderate fever reaction: Physical method and symptomatic treatment should be adopted to prevent high fever convulsions.
Extremely rare adverse reactions: Allergic rash: Generally, if urticaria occurs within 72 hours after vaccination, go to the doctor promptly and anti-allergy treatment should be given.
Anaphylactic shock: Generally, it occurs within 1 hour after vaccination. Epinephrine injection and other emergency treatment should be on time.
Allergic purpura: Go to the doctor if there is anaphylactoid purpura reaction. Corticosteroids should be given for anti-allergy treatment. Purpura nephritis may occur for delay or improper treatment. Angioneurotic edema and nervous system reactions should be treated on time.

Treatment with corticosteroids or immunosuppressant interferes with antibody production and leads to vaccination failure.

Do not use: Vaccine bottles have cracks, unclear labels; expired vaccine; any abnormal appearance such as turbidity after reconstitution.
Use the vaccine immediately after it is opened.
The vaccine and anti-rabies serum or human rabies immunoglobulin must not be administered with the same syringe in the same injection site.
Avoid freezing.

Stored and transported at 2-8°C, Protect from light. Do not freeze.

Vaccines, Antisera & Immunologicals

J07BG - Rabies vaccines ; Used for active immunizations.

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