What does aplisol stand for?
Diagnostic Antigen For Intradermal Injection Only DESCRIPTION Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate
What is the difference between local hypersensitivity and aplisol?
local hypersensitivity reactions (redness, itching, swelling, hives, and rash), and Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis.
How much aplisol is in a Tu?
Aplisol Dosage and Administration. The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux testing.
What is the pathophysiology of aplisol?
Aplisol - Clinical Pharmacology. Once acquired, tuberculin sensitivity tends to persist, although it often wanes with time and advancing age. The injection of tuberculin into the skin stimulates the lymphocytes and activates the series of events leading to a delayed-type hypersensitivity (DTH) response.
What is another name for Aplisol?
The generic name of Aplisol is tuberculin purified protein derivative (PPD), however, a generic version is not available for commercial use in the United States.
How do you administer Aplisol?
Proper use of Aplisol This medicine is injected into the skin on your forearm. Your skin may become red and swollen in the area where the medicine was given. You must return to your doctor's office 2 or 3 days after receiving tuberculin. This is to check at the way your skin has reacted to the medicine.
Who makes Aplisol?
Par Pharmaceuticals, the manufacturer of Aplisol, alerted the CDC that a supply interruption of Aplisol 5mL (50 tests) will begin this month, while the 1mL product (10 tests) is expected to be in shortage by November 2019, and possibly earlier if there is an increase in demand.
What are the side effects from Tubersol?
What Are Side Effects of Tubersol?injection site reactions (redness, ulceration of the skin, skin rash, pain, discomfort, or itching),fever,shortness of breath,generalized rash, and.lightheadedness or fainting.Rarely, an allergic reaction may occur.
What medication is used for TB skin test?
Tuberculin purified protein derivative (PPD) is used in a skin test to help diagnose tuberculosis (TB) infection in persons at increased risk of developing active disease.
How long is TB solution good for?
Date the tuberculin vial when opening and discard it after 30 days. Do not store tuberculin vial with other vials, such as Tdap, that could be mistaken for tuberculin. Fill syringe with tuberculin immediately prior to administering TST; do not pre-fill.
How long can TB solution be out of fridge?
It was found that the PPD solutions of all 3 strengths, 1, 5 and 250 TU per dose, were stable for at least 3 years at 4 degrees C and for 2 years at room temperature (24 degrees C). Even at 37 degrees C the solutions of all 3 strengths were stable for at least 1 year.
Does Tubersol need to be refrigerated?
Tubersol should be stored between 2° and 8°C (35°-48°F). Refrigerate.
What is the TB skin test made of?
The TST is performed by injecting 0.1 ml of tuberculin purified protein derivative (PPD) into the inner surface of the forearm. The injection should be made with a tuberculin syringe, with the needle bevel facing upward.
How do I know if my TB skin test is positive?
The test is "positive" if there is a bump of a certain size where the fluid was injected. This means you probably have TB germs in your body. Most people with a positive TB skin test have latent TB infection. To be sure, your doctor will examine you and give you a chest x-ray.
What drug class is Tubersol?
Tubersol belongs to a class of drugs called Diagnostics, Antimicrobials.
How long before TB test shows positive?
In a person who is newly infected, the skin test usually becomes positive within 4 to 10 weeks after exposure to the person who is ill with TB. (See "Approach to diagnosis of latent tuberculosis infection (tuberculosis screening) in adults".)
Does Tubersol need to be refrigerated?
Tubersol should be stored between 2° and 8°C (35°-48°F). Refrigerate.
How much PPD solution do you use?
The TST is performed by injecting 0.1 ml of tuberculin purified protein derivative (PPD) into the inner surface of the forearm. The injection should be made with a tuberculin syringe, with the needle bevel facing upward.
How long can TB solution be out of fridge?
It was found that the PPD solutions of all 3 strengths, 1, 5 and 250 TU per dose, were stable for at least 3 years at 4 degrees C and for 2 years at room temperature (24 degrees C). Even at 37 degrees C the solutions of all 3 strengths were stable for at least 1 year.
Is Tubersol a vaccine?
Tubersol, Tuberculin Purified Protein Derivative (PPD - Mantoux), is used in a skin test to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. Tubersol is indicated for intradermal injection only. Do not inject intravenously, intramuscularly, or subcutaneously.
What is aplisol diluted?
Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative.
Is Aplisol a pharmacological drug?
Aplisol - Clinical Pharmacology. In the United States, the prevalence of Mycobacterium tuberculosis infection and active disease varies for different segments of the population; however, the risk for M. tuberculosis infection in the overall population is low.
Is aplisol contraindicated?
Aplisol is contraindicated in patients with known hypersensitivity or allergy to Aplisol or any of its components. Aplisol should not be administered to persons who have previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site.
What is the purpose of aplisol?
Aplisol is used in Mantoux tuberculin test (al so called a PPD skin test) to aid diagnosis of tuberculosis (TB) infection in persons at increased risk of developing active disease. This skin test is usually indicated when symptoms, screening, or testing, such as a chest x-ray, show that a person may have TB.
Where to inject aplisol?
A nurse or other trained healthcare provider will give you this medicine in a hospital or clinic. This medicine is injected into the skin on your inner forearm.
What is aplisol used for?
What Is Aplisol? Aplisol ( tuberculin purified protein derivative, diluted [stabilized solution]) is a purified protein fraction used as an aid in the detection of infection with Mycobacterium tuberculosis.
How much Aplisol is equivalent to a TU?
The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux testing.
Can a pregnant woman take aplisol?
Animal reproduction studies have not been conducted with Aplisol. It is also not known whether Aplisol can cause fetal harm when administered to a pregnant woman or can affect the reproduction capacity. Aplisol should be given to a pregnant woman only if clearly needed. However, the risk of unrecognized tuberculosis and the postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Although there have not been any reported adverse effects upon the fetus recognized as being due to tuberculosis skin testing, the prescribing physician will want to consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain high risk populations.
Uses for Aplisol
Tuberculin purified protein derivative (PPD) is used in a skin test to help diagnose tuberculosis (TB) infection in persons at increased risk of developing active disease.
Before using Aplisol
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
Proper use of Aplisol
This section provides information on the proper use of a number of products that contain tuberculin. It may not be specific to Aplisol. Please read with care.
Precautions while using Aplisol
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
Aplisol side effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
What is aplisol diluted?
Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative.
How much Aplisol is equivalent to a TU?
The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux testing.
Can a pregnant woman take aplisol?
Animal reproduction studies have not been conducted with Aplisol. It is also not known whether Aplisol can cause fetal harm when administered to a pregnant woman or can affect the reproduction capacity. Aplisol should be given to a pregnant woman only if clearly needed. However, the risk of unrecognized tuberculosis and the postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Although there have not been any reported adverse effects upon the fetus recognized as being due to tuberculosis skin testing, the prescribing physician will want to consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain high risk populations.
Standard Method (Mantoux Test)
The Mantoux test is performed by intradermally injecting, on the volar aspect of the forearm, with a syringe and needle, exactly 0.1 mL of Aplisol. The result is read 48 to 72 hours later and palpable induration only is considered in interpreting the test.
Interpretation of Tuberculin Reaction
Readings of Mantoux reactions should be made by a trained health professional during the period from 48 to 72 hours after the injection. Induration only should be considered in interpreting the test. The diameter of induration should be measured transversely to the long axis of the forearm and recorded in millimeters.
Booster Effect and Two-Step Testing
Infection of an individual with tubercle bacilli or other mycobacteria or BCG vaccination results in a delayed hypersensitivity response to tuberculin which is demonstrated by the skin test. The delayed hypersensitivity response may gradually wane over a period of years.
Aplisol Description
Aplisol - Clinical Pharmacology
- In the United States, the prevalence of Mycobacterium tuberculosis infection and active disease varies for different segments of the population; however, the risk for M. tuberculosis infection in the overall population is low. Tuberculosis (TB) case rates declined steadily for decades in the United States. However, in 1985 the TB case rate stabilized and subsequently increased throug…
Indications and Usage For Aplisol
- Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin te…
Contraindications
- Aplisol is contraindicated in patients with known hypersensitivity or allergy to Aplisol or any of its components. Aplisol should not be administered to persons who have previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site.
Warnings
- Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see CONTRAINDICATIONS). Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased abilit…
Precautions
- General
The predictive value of the tuberculin skin test depends on the prevalence of infection with M. tuberculosis and the relative prevalence of cross-reactions with nontuberculous mycobacteria.9,12 A separate, sterile, single-use disposable syringe and needle should be used f… - Information to Patients
Patients should be instructed to report adverse events such as vesiculation, ulceration or necrosis which may occur at the test site in highly sensitive individuals. Patients should be informed that pain, pruritus and discomfort may occur at injection site. Patients should be informed of the nee…
Adverse Reactions
- In highly sensitive individuals, strongly positive reactions including vesiculation, ulceration or necrosis may occur at the test site. Cold packs or topical steroid preparations may be employed for symptomatic relief of the associated pain, pruritus and discomfort. Strongly positive test reactions may result in scarring at the test site. Immediate erythematous or other reactions ma…
Aplisol Dosage and Administration
- Aplisol vials should be inspected visually for both particulate matter and discoloration prior to administration and discarded if either is seen. Vials in use for more than 30 days should be discarded. The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux …
How Is Aplisol Supplied
- Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: NDC 42023-104-01 (Bio. 1525) 1 mL (10 tests) – multiple dose vial NDC 42023-104-05 (Bio.1607) 5 mL (50 tests) – multiple dose vial This product is ready for use without further dilution.
References
- Seibert, F.B. The isolation and properties of the purified protein derivative of tuberculin: Am Rev Tuberc 1934; 30:713.
- Seibert, F.B., and Glenn, J.T. Tuberculin purified protein derivative. Preparation and analyses of a large quantity for standard. Am Rev Tuberc 1941; 44:9-25.
- Centers for Disease Control and Prevention (CDC). Essential components of a tuberculosis p…
- Seibert, F.B. The isolation and properties of the purified protein derivative of tuberculin: Am Rev Tuberc 1934; 30:713.
- Seibert, F.B., and Glenn, J.T. Tuberculin purified protein derivative. Preparation and analyses of a large quantity for standard. Am Rev Tuberc 1941; 44:9-25.
- Centers for Disease Control and Prevention (CDC). Essential components of a tuberculosis prevention and control program; and Screening for tuberculosis and tuberculosis infection in high-risk popul...
- Centers for Disease Control and Prevention (CDC). Prevention and control of tuberculosis in correctional facilities: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMW...
