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BCG Vaccine (Bacillus Calmette-Guerin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

TB Exposed Tuberculin Skin Test-Negative Infants and Children

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

TB Exposed Health Care Workers (HCW) in High Risk Settings

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

Exposed Health Care Workers in Low Risk Settings

BCG vaccination is not recommended for HCWs in settings in which the risk for M. tuberculosis transmission is low.3

DOSAGE AND ADMINISTRATION

Preparation of Agent

The preparation of the BCG VACCINE suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG VACCINE has been prepared. A separate area for the preparation of the BCG VACCINE suspension is recommended. All equipment, supplies and receptacles in contact with BCG VACCINE should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves, and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

Using aseptic methods, 1 mL of Sterile Water for Injection, U.S.P. at 4—25C (39—77F), is added to one vial of vaccine (see Pediatric Dose below for pediatric use). Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

Persons administering vaccines should take necessary precautions to minimize risk for spreading disease. Hands should be washed before each new patient is seen. Syringes and needles used for applications must be sterile and preferably disposable to minimize the risk of contamination. A separate needle and syringe should be used for each application. Disposable needles and the multiple puncture device should be discarded as biohazardous waste in labeled, puncture-proof containers to prevent inadvertent needlestick injury or reuse.20 After use, any unused vaccine and all materials exposed to the product should be immediately placed in a biohazard container and disposed of in an appropriate manner.

Reconstituted vaccine should be kept refrigerated, protected from exposure to direct sunlight, and used within 2 hours. Freezing of the reconstituted product is not recommended.

Note: DO NOT filter the contents of the BCG VACCINE vial. Precautions should be taken to avoid exposing the BCG VACCINE to direct sunlight. Bacteriostatic solutions must be avoided. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitution should result in a uniform suspension of the bacilli.

Treatment and Schedule

BCG vaccination is reserved for persons who have a reaction of <5mm induration after skin testing with 5 TU of PPD tuberculin. The preferred method of skin testing is the Mantoux tuberculin skin-test using 0.1 mL of 5 tuberculin units (TU) of purified protein derivative (PPD).3 It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculous infection.

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 vaccine is administered percutaneously utilizing a sterile multiple puncture device. The multiple puncture device consists of a plastic holder for a thin, wafer-like stainless steel plate 7/8" by 1 1/8", from which 36 points protrude. After the vaccine is prepared, the skin site is cleansed with an alcohol or acetone sponge and allowed to dry thoroughly. The preferred site is the deltoid region. The arm is positioned to maintain a horizontal surface where the vaccine is to be placed. The immunizing dose of 0.2—0.3 mL of BCG VACCINE is dropped from the syringe and needle onto the cleansed surface of the skin and spread over a 1" by 2" area using the edge of the multiple puncture device. The arm is grasped firmly from underneath, tensing the skin. The multiple puncture device is centered over the vaccine and firm downward pressure is applied such that the device points are well buried in the skin. Maintain pressure for 5 seconds. Do not "rock" the device. Pressure underneath the arm is then released and the device is removed. In a successful procedure the points puncture the skin. If the points merely indent the skin, the procedure must be repeated. After successful puncture, spread vaccine as evenly as possible over the puncture area with the edge of the device. An additional 1—2 drops of BCG VACCINE may be added to ensure a very wet vaccination site. A multiple puncture device is used once and discarded in standard biohazardous sharps containers. No dressing is required; however, it is recommended that the site be loosely covered and kept dry for 24 hours. The patient should be advised that the vaccine contains live organisms. Although the vaccine will not survive in a dry state for long, infection of others is possible.

Tuberculin reactivity resulting from BCG vaccination should be documented. A vaccinated person should be tuberculin skin tested 2—3 months after BCG administration, and the test results, in millimeters of induration, should be recorded in the person's medical record.9 Vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after 2—3 months.

Pediatric Dose

In infants less than 1 month old, the dosage of BCG VACCINE should be reduced by one-half, by using 2 mL of Sterile Water for Injection, U.S.P. at 4—25C (39—77F) when reconstituting. If a vaccinated infant remains tuberculin negative to 5 TU on skin testing, and if indications for vaccination persist, the infant should receive a full dose after 1 year of age.

HOW SUPPLIED

BCG VACCINE is supplied in a box of one 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 Organon Teknika Corporation LLC, 100 Rodolphe Street, Building 1300, Durham, NC 27712; telephone number (800) 662-6842.

Storage

The intact vials of BCG VACCINE should be stored refrigerated at 2—8C (36—46F).

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.

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