TUBERSOL (Page 3 of 3)

Altered Immune Status

Impaired or attenuated cell mediated immunity (CMI) can potentially cause a false negative tuberculin reaction. Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection including viral infections (e.g., measles, mumps, chickenpox and HIV), live virus vaccinations (e.g., measles, mumps, rubella, oral polio and yellow fever), overwhelming tuberculosis, other bacterial infections, leukemia, sarcoidosis, fungal infections, metabolic derangements, low protein states, diseases affecting lymphoid organs, drugs (corticosteroids and many other immunosuppressive agents), and malignancy or stress. (7)(16)(17) A TST should be deferred for patients with major viral infections or live-virus vaccination in the past month. Persons with the common cold may be tuberculin tested.

Because TST results in HIV-infected individuals are less reliable as CD4 counts decline, screening should be completed as early as possible after HIV-infection occurs. (17)

Booster Effect and Two-Step Testing

If tuberculin testing will be conducted at regular intervals, for instance among healthcare workers or prison workers, two-step testing should be performed as a baseline to avoid interpreting a booster effect as a tuberculin conversion. If the first test showed either no reaction or a small reaction, the second test should be performed one to four weeks later. Both tests should be read and recorded at 48 to 72 hours. Patients with a second tuberculin test (booster) response of ≥10 mm should be considered to have experienced past TB infection. (13)(18)

Persons who do not boost when given repeat tests at one week, but whose tuberculin reactions change to positive after one year, should be considered to have newly acquired tuberculosis infection and managed accordingly. (6)

HOW SUPPLIED

TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is supplied in:

1 mL multi-dose vial (10 tests). NDC No. 49281-752-78; package of 1 vial, NDC No. 49281-752-21

5 mL multi-dose vial (50 tests). NDC No. 49281-752-98; package of 1 vial, NDC No. 49281-752-22

The stopper of the vial for this product does not contain natural latex rubber.

STORAGE

Store at 2° to 8°C (35° to 46°F). (19) Do not freeze. Discard product if exposed to freezing.

Protect from light. Tuberculin PPD solutions can be adversely affected by exposure to light. The product should be stored in the dark except when doses are actually being withdrawn from the vial. (20)

A vial of TUBERSOL which has been entered and in use for 30 days should be discarded. (21)

Do not use after expiration date.

REFERENCES

1
Landi S. Preparation, purification, and stability of tuberculin. Appl Microbiol 1963;11:408-412.
2
Landi S, et al. Preparation and characterization of a large batch of tuberculin purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.
3
Landi S, et al. Adsorption of tuberculin PPD to glass and plastic surfaces. Bull. WHO 1966;35:593-602.
4
Landi S, et al. Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions. Am Rev Respir Dis 1971;104:385-393.
5
Landi S, et al. Stability of dilute solutions of tuberculin purified protein derivative. Tubercle 1978;59:121-133.
6
Menzies D. Interpretation of repeated tuberculin tests. Am J Respir Crit Care Med 1999;159:15-21.
7
American Thoracic Society: Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376-1395.
8
CDC. Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010. MMWR 2010; 59 (RR-5):1-25.
9
CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000;49(RR-6):23-5.
10
Froeschle JE, et al. Immediate hypersensitivity reactions after use of tuberculin skin testing. Clin Infect Dis 2002;34:e12-13.
11
Brickman HF, et al. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics: 1975;55:392-396.
12
CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-36.
13
CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005;54(RR-17):1-141.
14
CDC. The role of BCG vaccine in the prevention and control of tuberculosis in the United States. A joint statement by the Advisory Council for the Elimination of Tuberculosis and the Advisory Committee on Immunization Practices. MMWR 1996; 45(RR-4):1-18.
15
CDC. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis: Recommendations from the National Tuberculosis Controllers Association and CDC. MMWR 2005;54(RR-15):1-37.
16
Mori and Shiozawa. Suppression of tuberculin hypersensitivity caused by rubella infection. Am Rev Respir Dis 1985;886-888.
17
CDC. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Recommendations from the CDC, the National Institutes of Health, and the HIV Medicine Association of Infectious Diseases Society of America. MMWR 2009;58(RR-4):1-207.
18
CDC. Prevention and control of tuberculosis in correctional and detention facilities: Recommendations from the CDC. MMWR 2006;55(RR-9):1-44.
19
Landi S, et al. Stability of dilute solution of tuberculin purified protein derivative at extreme temperatures. J Biol Stand 1981;9:195-199.
20
Landi S, et al. Effect of light on tuberculin purified protein derivative solutions. Am Rev Respir Dis 1975;111:52-61.
21
Landi S, et al. Effect of oxidation on the stability of tuberculin purified protein derivative (PPD) In: International Symposium on Tuberculins and BCG Vaccine. Basel: International Association of Biological Standardization, 1983. Dev Biol Stand 1986;58:545-552.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Product Information as of
October 2021

TUBERSOL is a registered trademark of Sanofi Pasteur. ©, 2021 TUBERSOL® , Sanofi Pasteur Limited — All rights reserved

PRINCIPAL DISPLAY PANEL — 1 mL Vial Label

Tuberculin Purified
Protein Derivative
(Mantoux)
TUBERSOL®

Multi-dose vial
1 mL (10 Tests)

Test dose: 5 TU/0.1 mL ID.

Protect from light.

Discard opened product after 30 days.

Rx only

Sanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Vial Carton

NDC 49281-752-21
PPD

Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®

Tween Stabilized Solution

Test dose: 5 TU/0.1 mL intradermally.

Multi-dose vial (10 Tests)5 Tuberculin units per test

Rx only

sanofi

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label

Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®

Multi-dose vial 5 mL (50 Tests)

Test dose: 5 TU/0.1 mL ID.

Protect from light.

Discard opened product after 30 days.

Rx only

Sanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

NDC 49281-752-22
PPD

Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®

Tween Stabilized Solution

Rx only

Test dose: 5 TU/0.1 mL intradermally.

Multi-dose vial (50 Tests)5 Tuberculin units per test

sanofi

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Carton
(click image for full-size original)
TUBERSOL tuberculin purified protein derivative injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49281-752
Route of Administration INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tuberculin Purified Protein Derivative (Tuberculin Purified Protein Derivative) Tuberculin Purified Protein Derivative 5 [iU] in 0.1 mL
Inactive Ingredients
Ingredient Name Strength
Polysorbate 80 0.0125 uL in 0.1 mL
Phenol 0.35 mg in 0.1 mL
Product Characteristics
Color WHITE (clear colorless) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-752-21 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (49281-752-78)
1 NDC:49281-752-78 1 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (49281-752-21)
2 NDC:49281-752-22 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (49281-752-98)
2 NDC:49281-752-98 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (49281-752-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103941 08/15/1956
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE (49281-752)

Revised: 01/2024 Sanofi Pasteur Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.