BCG VACCINE- bacillus calmette-guerin substrain tice live antigen injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (UNII: 2XQ558L16Z) (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN - UNII:2XQ558L16Z)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN

Composition:

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg

Administration route:

PERCUTANEOUS

Therapeutic indications:

BCG VACCINE (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. As with any vaccine, immunization with BCG VACCINE may not protect 100% of susceptible individuals. The Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis has recommended that BCG vaccination be considered in the following circumstances.{3} BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.{3} BCG vaccination of HCWs should be considered on an individual basis in settings where (a) a high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin, (b) transmission of such drug resistant M. tuberculosis strains to HCWs and subsequent infection are likely, and (c) comprehensive TB infection control precautions have been implemented and have not been successful. Vaccination should not be required for employment or for assignment of HCWs in specific work areas. HCWs considered for BCG vaccination should be counseled regarding the risks and benefits associated with both BCG vaccinations and TB preventive therapy.{3} BCG vaccination is not recommended for HCWs in settings in which the risk for M. tuberculosis transmission is low.{3} BCG VACCINE for prevention of tuberculosis should not be given to persons (a) whose immunologic responses are impaired because of HIV infections, congenital immunodeficiency such as chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy or (b) whose immunologic responses have been suppressed by steroids, alkylating agents, antimetabolites, or radiation.{3} BCG VACCINE should not be administered to HIV-infected or immunocompromised infants, children, or adults. Prior to administration, the possibility of allergic reactions should be assessed. Allergy to any component of BCG VACCINE or an anaphylactic or allergic reaction to a previous dose of BCG VACCINE are contraindications for vaccination. BCG VACCINE is not a vaccine for the treatment of active tuberculosis. BCG VACCINE should not be used in infants, children, or adults with severe immune deficiency syndromes. Children with a family history of immune deficiency disease should not be vaccinated; if they are, an infectious disease specialist should be consulted and anti-tuberculous therapy administered if clinically indicated.{18} Please read this leaflet carefully before administering BCG VACCINE. The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. BCG vaccination should not be given to individuals previously infected with M. tuberculosis. The sterile, single-use multiple puncture device is for use with the BCG VACCINE only. Figure 1 Figure 2 Figure 5 Caution: Federal law restricts this device to sale by or on the order of a physician. Multiple puncture devices may be obtained separately from the Order Management Center, Merck Sharp & Dohme LLC, 351 North Sumneytown Pike, North Wales, PA 19454-2505, Telephone number: 800-637-2579.

Product summary:

BCG VACCINE is supplied in a box of one single-dose vial of BCG. Each vial contains 1 to 8 × 108 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0603-02. Multiple puncture devices may be obtained separately from the Order Management Center, Merck Sharp & Dohme LLC, 351 North Sumneytown Pike, North Wales, PA 19454-2505, Telephone number: 800-637-2579. The intact vials of BCG VACCINE should be stored refrigerated at 2-8°C (36-46°F). This agent contains live bacteria and should be protected from direct sunlight. The product should not be used after the expiration date printed on the label.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BCG VACCINE- BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
MERCK SHARP & DOHME LLC
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BCG VACCINE
(FOR PERCUTANEOUS USE)
DESCRIPTION
BCG VACCINE for percutaneous use is an attenuated, live culture
preparation of the
Bacillus of Calmette and Guerin (BCG) strain of _Mycobacterium
bovis_.{1} The TICE®
strain used in this BCG VACCINE preparation was developed at the
University of Illinois
from a strain originated at the Pasteur Institute.
The medium in which the TICE® BCG organism is grown for preparation
of the freeze-
dried cake is composed of the following ingredients: glycerin,
asparagine, citric acid,
potassium phosphate, magnesium sulfate, and iron ammonium citrate. The
final
preparation prior to freeze drying also contains lactose. The
freeze-dried BCG
preparation is delivered in vials, each containing 1 to 8 × 10 colony
forming units (CFU)
of BCG which is equivalent to approximately 50 mg wet weight.
Determination of_ in-vitro_
potency is achieved through colony counts derived from a serial
dilution assay.
Intradermal guinea pig testing is also used as an indirect measure of
potency.
Reconstitution requires addition of Sterile Water for Injection, USP
at 4-25°C (39-77°F).
For an adult dosage, 1 mL of Sterile Water for Injection, USP, should
be added to one
single-dose vial of vaccine. For a pediatric dosage, 2 mL of Sterile
Water for Injection,
USP, should be added to one single-dose vial of vaccine (see DOSAGE
AND
ADMINISTRATION).
No preservatives have been added.
CLINICAL PHARMACOLOGY
Tuberculosis (TB) is primarily an airborne communicable disease caused
by the
bacterium, _Mycobacterium tuberculosis._
Tuberculosis is an important global public health problem with an
estimated 8–10 million
cases and 2–3 million deaths occurring each year.{2} The control of
TB in the United
States has been a constant challenge particularly with the resurgence
in TB in the late
1980s and the early 1990s. In the United States, TB had declined
approximately 6%