BCG for intradermal injection

Mycobacterium tuberculosis is an intracellular parasite, so the human body's specific immunity against tuberculosis is mainly cellular immunity. BCG vaccination is the artificial inoculation of non-toxic BCG (tuberculosis) for the first infection. After being processed by macrophages, its antigen information is transmitted to immune-active cells, causing T cells to differentiate and proliferate, forming sensitized lymphocytes. When the body encounters tuberculosis infection again, macrophages and sensitized lymphocytes are rapidly activated to perform immune functions and cause specific immune responses. The release of lymphokines is one of the immune functions of sensitized lymphocytes. Among them, chemokines (MCF) can attract macrophages and neutrophils, causing them to move to the site where antigens interact with sensitized lymphocytes. Macrophage inhibitory factor (MIF) can inhibit the movement of macrophages and neutrophils entering the inflammatory area, causing them to stay in the site of inflammation or pathogen aggregation, which is conducive to their function. MIF can cause macrophages to adhere and significantly increase the phagocytic reaction. The main function of macrophage activation factor (MAF) is to increase the phagocytic and digestive ability of macrophages, and strengthen the ability of macrophages to process antigens, thereby improving the immunogenicity of antigens. Therefore, at the site of tuberculosis invasion, macrophages condense and phagocytose tuberculosis in large quantities. Under the action of mycobacterium growth inhibitory factor, it can also inhibit the growth of tuberculosis bacteria in cells, until digestion, and finally eliminate them, forming specific immunity to tuberculosis. After BCG enters the body, it causes specific immune response while also producing a relatively wide range of nonspecific immune effects, which is related to the interaction of lymphokines produced by T cells, the direct killing effect of T cells themselves, and humoral immune factors. Clinically applied to: 1 Infants under 3 months old and children with negative old tuberculin test diluted with 5IUPPD (PPD is a pure protein derivative of tuberculin) or 5IU (48-72 hours after PPD or tuberculin test is negative, local nodules below 5mm are negative), intradermal vaccination to prevent tuberculosis. 2 It is currently used to treat malignant melanoma, or as an adjuvant therapy after radical surgery or chemotherapy for lung cancer, acute leukemia, and malignant lymphoma, and has a certain effect. 3 Dead BCG is also used to prevent colds in children, treat asthmatic bronchitis in children, and prevent and treat chronic bronchitis in adults.

This product is made by lyophilizing BCG after culture.

To prevent tuberculosis, the vaccination targets infants under 3 months old or children with negative tuberculin test results.

1. The vaccination targets are infants under 3 months old or children who have a negative test result with 5IU diluted old tuberculin or 5IUPPD (tuberculin protein derivative) (local nodules below 5mm 48-72 hours after the tuberculin or PPD test). 2. To dilute the vaccine, use a sterile 1 ml syringe to quantitatively add the diluent attached to the product into the freeze-dried BCG ampoule for intradermal injection, leave it for about 1 minute, shake the ampoule to dissolve it, and then use the syringe to pump back and forth several times to mix it thoroughly. Each ampoule must be used up within half an hour from the time of dilution to prevent contamination. 3. Vaccination method: First, use 75℅ alcohol to disinfect the skin slightly below the middle of the deltoid muscle on the outside of the upper arm, then use a sterile 1 ml blue-heart syringe (25-26 gauge needle) to absorb the shaken vaccine and inject 0.1 ml intradermally.

About 2 weeks after vaccination, local redness, swelling, infiltration, suppuration, and small ulcers will appear. In severe cases, appropriate treatment should be taken. The following reactions may occasionally occur during vaccination: 1. Lymph node inflammation: About 1-2 months after vaccination, the lymph nodes in the neck, armpits, and above and below the clavicle will swell (greater than 1.0 cm). In patients with excessive reactions, the lymph nodes will swell significantly, and abscesses or ruptures may form, or there will be small pus scars at the vaccination site. The reaction of intradermal injections is often stronger than that of the scratch method. In addition, those who are positive in the old tuberculin (OT) test may also have a stronger reaction after vaccination. Type 2 lupus reaction: related to the residual virulence of the tuberculosis strain. 3. Scars: Scar protrusions are formed due to abundant granulation tissue, sometimes in the form of keloids, which are more common in those who do not perform OT tests but directly scratch the skin for vaccination.

1. Patients with tuberculosis, acute infectious diseases, nephritis, heart disease, immunodeficiency, eczema or skin diseases. 2. Patients with acute diseases, burns, disease recovery (between the end of the disease and recovery of health), recently vaccinated with smallpox vaccine, and patients with urinary tract infection. (Foreign data) 3. Suppression of immune response due to the use of the following drugs or treatments: alkylating agents, antimetabolites, radiotherapy, steroids. (Foreign data) 4. Reduced immune response due to the following diseases: systemic malignant tumors, HIV infection, gamma interferon receptor deficiency, leukemia, lymphoma. (Foreign data) 5. BCG should not be used for fever caused by infectious diseases or fever of unknown cause. (Foreign data) 6. Infants or children with reduced immunity. (Foreign data) Use with caution.

1. Immunosuppressants (such as cyclosporine, leflunomide, sirolimus, tacrolimus, etc.): Immunosuppressants will lead to reduced immunity, and live bacterial vaccination will lead to serious or even fatal infections. 2. Glucocorticoids: As a rule, patients with immunosuppression caused by large doses of glucocorticoids (daily dosage exceeding 10 mg of prednisone or equivalent amount of other glucocorticoids for more than 2 consecutive weeks) should not receive attenuated vaccine immunization. Immunosuppression caused by large amounts of steroids will produce an incomplete response to attenuated vaccines. However, low-medium doses of glucocorticoids, short-term (less than 14 days) systemic use; local use; or low-medium doses, long-term replacement therapy with short-acting glucocorticoids and intra-articular, intracapsular, and Achilles tendon glucocorticoid injections should not be considered contraindications to vaccination. Steroid doses in replacement therapy, such as treatment of Addison's disease, have no immunosuppressive effect. 3. Theophylline: BCG vaccination can significantly increase the average plasma half-life of theophylline. Most patients will experience a brief and mild rise in plasma theophylline levels.

After reconstitution according to the labeled amount, each bottle contains 1 ml (10 human doses), containing 0.5 mg of BCG. The number of live bacteria per 1 mg of BCG should not be less than 1.0×106 CFU

Chengdu Institute of Biological Products Co., Ltd.

• Founded in:

  1981-11-25

• Address:

  No. 379, Section 3, Jinhua Road, Jinjiang District, Chengdu

• Tax NO.:

  9151000020181000XC

• Registered Funds:

  1.07 billion yuan

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