PPD Tine Test

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PPD Tine Test uses


INDICATIONS AND USAGE

PPD Tine Test, PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test skin test for persons 5 years of age and older who were previously vaccinated with BCG. (9)

CONTRAINDICATIONS

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

PPD Tine Test should not be administered to:

WARNINGS

Hypersensitivity

Allergic reactions may occur following the use of PPD Tine Test 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 PPD Tine Test. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

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PRECAUTIONS

GENERAL

Diagnostic Limitations

False positive or false negative PPD Tine Test skin test reactions may occur in some individuals.

False positive PPD Tine Test 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 PPD Tine Test test.

Many factors have been reported to cause a decreased ability to respond to the PPD Tine Test test in the presence of tuberculous infection.

INFORMATION FOR PATIENTS

Prior to administration of PPD Tine Test, 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 PPD Tine Test.

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 PPD Tine Test 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, PPD Tine Test testing should be delayed for >1 month after vaccination. (8) (12)

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

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

PPD Tine Test has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.

PREGNANCY

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

NURSING MOTHERS

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

PEDIATRIC USE

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

GERIATRIC USE

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

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ADVERSE REACTIONS

Induration at the PPD Tine Test 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 PPD Tine Test.

General disorders and administration site conditions

Immune system disorders

Respiratory, thoracic and mediastinal disorders

Skin and subcutaneous tissue disorders

Nervous system disorders

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.

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DOSAGE AND ADMINISTRATION

DOSAGE

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

METHOD OF ADMINISTRATION

PPD Tine Test 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:


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 PPD Tine Test. 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

PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test. (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 PPD Tine Test negative.

False Positive Reactions

False positive PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test sensitivity may take up to 8 weeks to develop following exposure to M. tuberculosis, persons who have a negative PPD Tine Test 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 PPD Tine Test reaction. Many factors have been reported to cause a decreased ability to respond to the PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test 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 PPD Tine Test reactions change to positive after one year, should be considered to have newly acquired tuberculosis infection and managed accordingly. (7)

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HOW SUPPLIED

PPD Tine Test, PPD Tine Test 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. PPD Tine Test 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 PPD Tine Test which has been entered and in use for 30 days should be discarded. (22)

Do not use after expiration date.

REFERENCES


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

PPD Tine Test Purified

Protein Derivative

(Mantoux)

PPD Tine Test® 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

PPD Tine Test pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


PPD Tine Test available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


PPD Tine Test destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


PPD Tine Test Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


PPD Tine Test pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming PPD Tine Test?

Depending on the reaction of the PPD Tine Test after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider PPD Tine Test 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 PPD Tine Test 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.

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Review

sdrugs.com conducted a study on PPD Tine Test, 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 PPD Tine Test 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

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