Active ingredient: Tuberculin Antigen

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Tuberculin Antigen uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• References
• Tuberculin Antigen reviews

INDICATIONS AND USAGE

Tuberculin Antigen, Tuberculin Antigen Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease.

The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from Tuberculin Antigen skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm.

Previous BCG vaccination is not a contraindication to Tuberculin Antigen testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over Tuberculin Antigen skin test for persons 5 years of age and older who were previously vaccinated with BCG. (9)

CONTRAINDICATIONS

Allergy to any component of Tuberculin Antigen or an anaphylactic or other allergic reaction to a previous test of Tuberculin Antigen PPD is a contraindication to the use of Tuberculin Antigen.

Tuberculin Antigen should not be administered to:

• Persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous TST,
• Persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, (10)
• Persons with extensive burns or eczema.

WARNINGS

Hypersensitivity

Allergic reactions may occur following the use of Tuberculin Antigen even in persons with no prior history of hypersensitivity to the product components. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available.

Syncope

Syncope (fainting) can occur in association with administration of injectable medicines, including Tuberculin Antigen. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

PRECAUTIONS

GENERAL

Diagnostic Limitations

False positive or false negative Tuberculin Antigen skin test reactions may occur in some individuals.

False positive Tuberculin Antigen reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG.

Not all infected persons will have a delayed hypersensitivity reaction to a Tuberculin Antigen test.

Many factors have been reported to cause a decreased ability to respond to the Tuberculin Antigen test in the presence of tuberculous infection.

INFORMATION FOR PATIENTS

Prior to administration of Tuberculin Antigen, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible sensitivity to components of Tuberculin Antigen.

The healthcare provider should inform the patient of the need to return for the reading of the test. Self-reading of the test has been shown to be inaccurate and unreliable.

The healthcare provider should give the patient a permanent personal record. In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient. This permanent office record should contain the name of the product, date given, dose, manufacturer and lot number, as well as the test result in millimeters of induration (including 0 mm, if appropriate). Reporting results only as negative or positive is not satisfactory.

DRUG INTERACTIONS

Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents.

Reactivity to Tuberculin Antigen may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, Tuberculin Antigen testing should be delayed for >1 month after vaccination. (8) (12)

When Tuberculin Antigen screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of Tuberculin Antigen and the vaccine at separate sites is the preferred option.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Tuberculin Antigen has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.

PREGNANCY

Animal reproduction studies have not been conducted with Tuberculin Antigen. It is also not known whether Tuberculin Antigen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tuberculin Antigen should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether Tuberculin Antigen is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tuberculin Antigen is administered to a nursing woman.

PEDIATRIC USE

There is no contraindication to Tuberculin Antigen skin testing of infants. Infants <6 months of age who are infected with M. tuberculosis may not react to Tuberculin Antigen.

GERIATRIC USE

Clinical studies of Tuberculin Antigen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS

Induration at the Tuberculin Antigen injection site is the expected reaction for a positive skin test.

The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with Tuberculin Antigen.

General disorders and administration site conditions

• Injection site pain, injection site pruritus and injection site discomfort.
• Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection.
• Injection site hemorrhage and injection site hematoma up to three days after the administration of the test.
• Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons.
• Injection site scar as a result of strongly positive reactions.
• Pyrexia

Immune system disorders

• Hypersensitivity, including anaphylaxis/anaphylactic reactions, angiodema, urticaria

Respiratory, thoracic and mediastinal disorders

• Stridor, dyspnea

Skin and subcutaneous tissue disorders

• Rash, generalized rash

Nervous system disorders

• Presyncope, syncope sometimes resulting in transient loss of consciousness with injury

REPORTING OF ADVERSE EVENTS

To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE) or Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088 and www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

DOSAGE

Five Tuberculin Antigen units (TU) per test dose of 0.1 mL is the standard strength used for intradermal (Mantoux) testing.

METHOD OF ADMINISTRATION

Tuberculin Antigen is indicated for intradermal injection only. Do not inject intravenously, intramuscularly, or subcutaneously. If subcutaneous injection occurs, the test cannot be interpreted.

Inspect for extraneous particulate matter and/or discoloration before use. If these conditions exist, do not administer the product.

Use a separate syringe and needle for each injection. (13)

The following procedure is recommended for performing the Mantoux test:

• The preferred site of the test is the volar aspect of the forearm. Avoid areas on the skin that are red or swollen. Avoid visible veins.
• Clean the skin site with a suitable germicide and allow the site to dry prior to injection of the antigen.
• Administer the test dose (0.1 mL) of Tuberculin Antigen with a 1 mL syringe calibrated in tenths and fitted with a short, one-quarter to one-half inch, 26 or 27 gauge needle.
• Wipe the stopper of the vial with a suitable germicide and allow to dry before needle insertion. Then insert the needle gently through the stopper and draw 0.1 mL of Tuberculin Antigen into the syringe. Avoid injection of excess air with removal of each dose so as not to over pressurize the vial and possibly cause seepage at the puncture site.
• Insert the point of the needle into the most superficial layers of the skin with the needle bevel pointing upward and administer the dose by slow intradermal injection. If the intradermal injection is performed properly, a definite pale bleb will rise at the needle point, about 10 mm (³/₈") in diameter. This bleb will disperse within minutes. Do not dress the site.
• A drop of blood may appear at the administration site following injection. Blot the site lightly to remove the blood but avoid squeezing out the injected Tuberculin Antigen test fluid.

In the event of an improperly performed injection (ie, no bleb formed), repeat the test immediately at another site, at least 2 inches from the first site and circle the second injection site as an indication that this is the site to be read.

Inform the patient of the need to return for the reading of the test by a trained health professional. Self-reading may be inaccurate and is strongly discouraged.

INTERPRETATION OF THE TEST

The skin test should be read by a trained health professional 48 to 72 hours after administration of Tuberculin Antigen. Skin test sensitivity is indicated by induration only; redness should not be measured.

Measure the diameter of induration transversely to the long axis of the forearm and record the measurement in millimeters. (8) The tip of a ballpoint pen, gently pushed at a 45° angle toward the site of injection, will stop at the edge of induration.

Also record presence and size (if present) of necrosis and edema, although these are not used in the interpretation of the test.

Positive Reactions

Tuberculin Antigen reactivity may indicate latent infection, prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculous disease. Persons showing positive Tuberculin Antigen reactions should be considered positive by current public health guidelines and referred for further medical evaluation. (8) (10) The repeated testing of uninfected persons does not sensitize them to Tuberculin Antigen. (7) (8) (10)

The significance of induration measurements in diagnosing latent TB infection must be considered in terms of the patient's history and the risk of developing active TB disease as indicated in Table 1. (10)

Reaction ≥5 mm of Induration	Reaction ≥10 mm of Induration	Reaction ≥15 mm of Induration
HIV-positive persons Recent contacts of tuberculosis (TB) case patients Fibrotic changes on chest radiograph consistent with prior TB Patients with organ transplants and other immunosuppressed patients (receiving the equivalent of ≥15 mg/d of prednisone for 1 month or more)Risk of TB in patients treated with corticosteroids increases with higher dose and longer duration.	Recent immigrants (i.e., within the last 5 yrs) from high prevalence countries Injection drug users Residents or employeesFor persons who are otherwise at low risk and are tested at the start of employment, a reaction of ≥15 mm induration is considered positive. of the following high-risk congregate settings: prisons and jails, nursing homes and other long-term facilities for the elderly, hospitals and other healthcare facilities, residential facilities for patients with acquired immunodeficiency syndrome (AIDS) and homeless shelters Mycobacteriology laboratory personnel Persons with the following clinical conditions that place them at high risk: silicosis, diabetes mellitus, chronic renal failure, some hematologic disorders (e.g., leukemias and lymphomas), other specific malignancies (e.g., carcinoma of the head or neck and lung), weight loss of ≥10% of ideal body weight, gastrectomy and jejunoileal bypass Children younger than 4 yrs of age or infants, children, and adolescents exposed to adults at high-risk	Persons with no risk factors for TB

A TST conversion is defined as an increase of ≥10 mm of induration within a 2-year period, regardless of age. (10)

The possibility should be considered that the skin test sensitivity may also be due to a previous contact with atypical mycobacteria or previous BCG vaccination. (8) (10)

Negative Reactions

An individual who does not show a positive reaction to 5 TU on the first test, but is suspected of being TB positive, may be retested with 5 TU. Any individual who does not show a positive reaction to an initial injection of 5 TU, or a second test with 5 TU may be considered as Tuberculin Antigen negative.

False Positive Reactions

False positive Tuberculin Antigen reactions can occur in individuals who have been infected with other mycobacteria, including vaccination with BCG. (8) However, a diagnosis of M. tuberculosis infection and the use of preventive therapy should be considered for any BCG-vaccinated person who has a positive TST reaction, especially if the person has been, or is, at increased risk of acquiring TB infection. (14) (15)

False-Negative Reactions

Not all infected persons will have a delayed hypersensitivity reaction to a Tuberculin Antigen test.

In those who are elderly or those who are being tested for the first time, reactions may develop slowly and may not peak until after 72 hours.

Since Tuberculin Antigen sensitivity may take up to 8 weeks to develop following exposure to M. tuberculosis, persons who have a negative Tuberculin Antigen test <8 weeks following possible TB exposure should be retested ≥8-10 weeks following the last known or suspected exposure. (16)

Altered Immune Status

Impaired or attenuated cell mediated immunity (CMI) can potentially cause a false negative Tuberculin Antigen reaction. Many factors have been reported to cause a decreased ability to respond to the Tuberculin Antigen 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. (8) (17) (18) 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 Antigen 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. (18)

BOOSTER EFFECT AND TWO-STEP TESTING

If Tuberculin Antigen 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 Antigen 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 Antigen test (booster) response of ≥10 mm should be considered to have experienced past TB infection. (14) (19)

Persons who do not boost when given repeat tests at one week, but whose Tuberculin Antigen reactions change to positive after one year, should be considered to have newly acquired tuberculosis infection and managed accordingly. (7)

HOW SUPPLIED

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

10-test vial, 1 mL. NDC No. 49281-752-78; package of 1 vial, NDC No. 49281-752-21

50-test vial, 5 mL. 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). (20) Do not freeze. Discard product if exposed to freezing.

Protect from light. Tuberculin Antigen 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. (21)

A vial of Tuberculin Antigen which has been entered and in use for 30 days should be discarded. (22)

Do not use after expiration date.

REFERENCES

• Landi S. Preparation, purification, and stability of Tuberculin Antigen. Appl Microbiol 1963;11:408-412.
• Landi S, et al. Preparation and characterization of a large batch of Tuberculin Antigen purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.
• US Code of Federal Regulations, Title 21, Part 610, Subpart C - Standard preparations and limits of potency.
• Landi S, et al. Adsorption of Tuberculin Antigen PPD to glass and plastic surfaces. Bull. WHO 1966;35:593-602.
• Landi S, et al. Disparity of potency between stabilized and nonstabilized dilute Tuberculin Antigen solutions. Am Rev Respir Dis 1971;104:385-393.
• Landi S, et al. Stability of dilute solutions of Tuberculin Antigen purified protein derivative. Tubercle 1978;59:121-133.
• Menzies D. Interpretation of repeated Tuberculin Antigen tests. Am J Respir Crit Care Med 1999;159:15-21.
• American Thoracic Society: Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376-1395.
• CDC. Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection - United States, 2010. MMWR 2010; 59 (RR-5):1-25.
• CDC. Targeted Tuberculin Antigen testing and treatment of latent tuberculosis infection. MMWR 2000;49(RR-6):23-5.
• Froeschle JE, et al. Immediate hypersensitivity reactions after use of Tuberculin Antigen skin testing. Clin Infect Dis 2002;34:e12-13.
• Brickman HF, et al. The timing of Tuberculin Antigen tests in relation to immunization with live viral vaccines. Pediatrics: 1975;55:392-396.
• 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):1-35.
• CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005;54(RR-17):1-141.
• 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):8-9.
• 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):1-47.
• Mori and Shiozawa. Suppression of Tuberculin Antigen hypersensitivity caused by rubella infection. Am Rev Respir Dis 1985;886-888.
• 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.
• CDC. Prevention and control of tuberculosis in correctional and detention facilities: Recommendations from the CDC. MMWR 2006;55(RR-9):1-44.
• Landi S, et al. Stability of dilute solution of Tuberculin Antigen purified protein derivative at extreme temperatures. J Biol Stand 1981;9:195-199.
• Landi S, et al. Effect of light on Tuberculin Antigen purified protein derivative solutions. Am Rev Respir Dis 1975;111:52-61.
• Landi S, et al. Effect of oxidation on the stability of Tuberculin Antigen 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

April 2016

Printed in Canada

R10-0416 USA

Tuberculin Antigen Purified

Protein Derivative

(Mantoux)

Tuberculin Antigen^® 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

Date opened

Tuberculin Antigen available forms, composition, doses:

• N/A

Indications and Usages:

ATC codes:

• N/A

ICD-10 codes:

• N/A

Tuberculin Antigen destination | category:

• N/A

Drugs with same active ingredients (Pharmaceutical companies):

• Tuberculin Antigen

Frequently asked Questions

Can i drive or operate heavy machine after consuming Tuberculin Antigen?

Depending on the reaction of the Tuberculin Antigen after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tuberculin Antigen not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Tuberculin Antigen addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Tuberculin Antigen, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Tuberculin Antigen consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology