Vaccine Information: BCG VACCINE (Page 3 of 3)

Pediatric Dose

Do not administer INTRAVENOUSLY, SUBCUTANEOUSLY, INTRAMUSCULARLY, OR INTRADERMALLY. Administer the vaccine in the deltoid region.

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, USP at 4-25°C (39-77°F) 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 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.

Storage

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.

REFERENCES

1. Guerin C: The history of BCG. In: Rosenthal SR (ed): BCG VACCINE: Tuberculosis-Cancer. Littleton, MA, PSG Publishing Co., Inc. 1980; pp. 35-43.
2. Enarson, D, Murray, JF. Global Epidemiology of Tuberculosis. In: Rom, WN, Garay, SM (eds.); Tuberculosis. Boston, Little Brown and Company; 1996; pp. 57-76.
3. Centers for Disease Control and Prevention. The Role of BCG VACCINE in the Prevention and Control of Tuberculosis in the United States. MMWR 45(RR-4):1-18, 1996.
4. Centers for Disease Control and Prevention. Tuberculosis Morbidity – United States, 1998. MMWR 47(13):253-257.
5. Moore M, Ornarato IM, McCray E, Castro KG. Trends in Drug-Resistant Tuberculosis in the United States, 1993-1996. JAMA 1997;278:833-837.
6. Gordin FM, Matts JP, Miller C, Brown LS, Hafner R, John SL, et al: A Controlled Trial of Isoniazid in Persons with Anergy and Human Immunodeficiency Virus Infection Who are at High Risk for Tuberculosis. NEJM 1997;337:315-320.
7. Comstock, GW. Field trials of tuberculosis vaccines: How could we have done better? Controlled Clinical Trials 1994;15:247-276.
8. Colditz GA, Brewer TF, Berkey CS et al. Efficacy of BCG VACCINE in the prevention of tuberculosis. Meta-analysis of the published literature. JAMA 1994;271:698-709.
9. Centers for Disease Control and Prevention. Use of BCG VACCINE in the Control of Tuberculosis. MMWR 43:663-675, 1988.
10. Romanus V: Tuberculosis in bacillus Calmette-Guerin immunized and unimmunized children in Sweden: a ten-year evaluation following the cessation of general bacillus Calmette-Guerin immunization of the newborn in 1975. Pediatr Infect Dis 1987;6:272-280.
11. Smith PG: Case-control studies of the efficacy of BCG against tuberculosis. In: International union against tuberculosis, Proceeding of the XXVIth IUAT World Conference on Tuberculosis and Respiratory Diseases, Singapore. Professional Postgraduate Services, International, Japan, 1987:73-79.
12. Padungchan S, Konjanart S, Kasiratta S, et al: The effectiveness of BCG vaccination of the newborn against childhood tuberculosis in Bangkok. Bull WHO 1986;64:247-258.
13. Tidjani O, Amedone A, ten Dam HG: The protective effect of BCG vaccination of the newborn against childhood tuberculosis in an African community. Tubercle 1986;67:269-281.
14. Young TK, Hershfield ES: A case-control study to evaluate the effectiveness of mass neonatal BCG vaccination among Canadian Indians. Am J Public Health 1986;76:783-786.
15. Shapiro C, Cook N, Evans D, et al.: A case-control study of BCG and childhood tuberculosis in Cali, Columbia. Int J Epidemiol 1985;14:441-446.
16. Rosenthal SR, Loewinsohn E, Graham ML, Liveright D, Throne MG, Johnson V, Baston HC. BCG Vaccination Against Tuberculous in Chicago: a Twenty-year Study Statistically Analyzed. Pediatrics 1961;28:622-641.
17. Data on file, Merck Teknika LLC, Durham, NC, USA.
18. Lorin MI, Hsu KHK, Jacob SC: Treatment of tuberculosis in children. In: Symposium on anti-infective therapy. Pediatric Clinics of North America 1983;30:333-348.
19. Stone MM, Vannier AM, Storch SK, et al.: Brief report: meningitis due to iatrogenic BCG infection in two immunocompromised children. Lancet 1995;333:561-563.
20. Package Insert QuantiFERON®-TB Gold, Cellestis, Inc. July 2010.
21. Package Insert T-SPOT®-TB. Oxford Immunotec Ltd, July 2010.
22. Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities. MMWR 43:1-38, 1994.
23. Report of the Committee on the Control of Infectious Diseases. American Academy of Pediatrics 1988; 21st Edition.
24. Lotte A, Wazs-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E: BCG Complications. Adv Tuberc Res 1984;21:107-193.
25. Mande R: BCG Vaccination. Dawson of Pall Mall, London, UK, 1968, pp. 112-265.
26. Griffith AH: Ten cases of BCG overdose treated with isoniazid. Tubercle 1963;44:247-250.
27. Watkins SM: Unusual complications of BCG vaccination. Brit Med J 1971;1:442.

Manufactured for: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

Manufactured by: Merck Teknika LLC, Durham, NC 27712, USA

U.S. License No. 1747

For patent information: www.msd.com/research/patent

TICE is a registered trademark of The Board of Trustees of the University of Illinois, used under the license of Merck Teknika LLC, Durham, NC, USA.

Copyright © 2021-2022 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.
All rights reserved.

Revised: 08/2022

uspi-v914-pwi-2208r011

BCG VACCINE
(for Percutaneous Use)
Instructions for Use

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.

1.

The vaccine should only be administered percutaneously utilizing the supplied sterile, single-use multiple puncture device. Do not inject intravenously, subcutaneously, intramuscularly, or intradermally. The multiple puncture device consists of a plastic holder for a thin, wafer-like stainless steel plate from which 36 points protrude (Figure 1).

Figure 1

2.

After the vaccine is prepared, clean the skin site with an alcohol or acetone sponge and allow to dry thoroughly.

3.

Administer the vaccine in the deltoid region (Figure 2). Position the arm to maintain a horizontal surface where the vaccine is to be placed.

Figure 2

4.

Drop the immunizing dose of 0.2–0.3 mL of BCG VACCINE from the syringe and needle onto the cleansed surface of the skin (Figure 3) and spread over a 1″ by 2″ area using the smooth edge of the multiple puncture device (Figure 4).

Figure 3	Figure 4

5.

Grasp the arm firmly from underneath, tensing the skin. Center the multiple puncture device over the vaccine and apply firm downward pressure such that the device points are well buried in the skin (Figure 5).

Figure 5

6.

Maintain pressure for 5 seconds. Do not “rock” the device. Release the pressure underneath the arm and remove the device. In a successful procedure the points puncture the skin. If the points do not puncture the skin, the puncture procedure must be repeated.

7.

After successful puncture, spread vaccine as evenly as possible over the puncture area with the smooth edge of the device (Figure 4). An additional 1–2 drops of BCG VACCINE may be added to ensure a very wet vaccination site.

8.

Use the multiple puncture device once and discard in a standard biohazardous sharps container.

9.

Loosely cover the site and keep dry for 24 hours.

10.

Advise the patient that the vaccine contains live organisms. Although the vaccine will not survive in a dry state for long, infection of others is possible.

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.

Manufactured for:
Merck Teknika LLC, Durham, NC 27712, USA

For patent information: www.msd.com/research/patent

Copyright © 2021-2022 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.
All rights reserved.

Revised:08/2022

ifu-v914-pwi-2208r008

PRINCIPAL DISPLAY PANEL — Vial Carton

NDC 0052-0603-02

BCG VACCINE

(for Percutaneous Use)

Rx only

Single-Dose Vial

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

Product Information Product Type VACCINE Item Code (Source) NDC:0052-0603 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM Water glycerin asparagine citric acid monohydrate potassium phosphate, unspecified form MAGNESIUM SULFATE, UNSPECIFIED FORM ferric ammonium citrate

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0052-0603-02 1 VIAL in 1 CARTON contains a VIAL (0052-0603-01) 1 NDC:0052-0603-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (0052-0603-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103050 06/21/1989

Labeler — Merck Sharp & Dohme LLC (118446553)

Revised: 09/2022 Merck Sharp & Dohme LLC