Aplisol Vial is a pack of 10 Test Pack with information on the side effects and uses.
Aplisol is a sterile solution that can be used as an aid in the diagnosis of Tuberculin.The solution is stable with polysorbate (Tween) 80 and has a small amount of phenol as a preservative.
The culture media filtrates of a human strain of Mycobacterium Tuberculosis are isolated by the method of F.B.It is clinically bioequivalent in potency to the standard PPD-S1(5 TU2per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control.
The risk of M. Tuberculosis in the overall population is low.For decades, the United States has seen a decline in Tuberculosis case rates.The case rate increased through 1992 and the mortality rate went up in 1988.The human immunodeficiency virus (HIV) epidemic, the occurrence of Tuberculosis in foreign-born persons from countries that have a high prevalence of it, and the emergence of drug-resistant strains of the disease have been attributed to.The primary strategy for preventing and controlling Tuberculosis in the United States is to minimize the risk of transmission by the early identification and treatment of patients who have active infectious disease.
The detection of infections with mycobacteria can be aided by tuberculin PPD.T cells circulate in the bloodstream for months or years.The sensitization process can take 2 to 10 weeks to develop.Tuberculin sensitivity tends to persist once acquired, although it often fades with time.A delayed-type hypersensitivity response can be caused by the injection of tuberculin into the skin.The reaction becomes evident hours after the injection.Decreased blood flow to the site of the injection is called dermal reactivity.Antigen-specific T lymphocytes release lymphokines, which can be seen at the site.The delayed hypersensitivity reaction is visible 5–6 hours after the tuberculin skin test is administered.The reaction may not be maximal until after 72 hours in geriatric patients or in patients receiving a tuberculin skin test for the first time.
There may be an immediate reaction to tuberculin or the diluent at the injection site.
There is a possibility of a decrease in responsiveness to skin testing in the presence of infections.
Tuberculin skin-test results are less reliable when CD4 counts decline.
The 5TU dose of Tuberculin is used as an aid in the detection of an infectious disease.A quantitative measurement of the response to a specific dose of Tuberculin is used to interpret reactions to the Mantoux test.
3 dose-response studies were conducted to determine if the Tuberculin PPD is equivalent in potency to the standard 5TU PPD-S1.
Tuberculin PPD can be used as an aid in the detection of the disease.The 0.1 mL test dose of Aplisol is equivalent to the 5 TU dose which has been clinically utilized and standardized.People with HIV should get a skin test.
If you have an allergy to Aplisol or any of its components, you should not use it.Because of the severity of reactions that may occur at the test site, aplisol should not be given to people who have previously experienced a severe reaction.
Because of the severity of reactions that may occur at the test site, aplisol should not be given to people who have previously experienced a severe reaction.
Some people will have a delayed reaction to a tuberculin test.There are a number of factors that can cause a decreased ability to respond to the tuberculin test.
A false negative reaction can be caused by any condition that impairs cell immunity.
CD4 counts decline can affect the reliability of tuberculin skin test results.
Don't inject tuberculin subcutaneously.If this happens, no local reaction develops, but a general inflammation around old tuberculous lesions may occur in highly sensitive individuals.
The tuberculin skin test can be used to predict the prevalence of infections with M. tuberculosis and nontuberculous mycobacteria.
A sterile disposable needle and syringe should be used for each patient to prevent the spread of infectious agents from one person to another.The product should not be injected into a blood vessel.
A review of the patient's history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of Aplisol and the presence of any contraindication should be made before the test is administered.
If there is an anaphylactoid or acute hypersensitivity reaction, the product should be immediately available.
Failure to store and handle Aplisol may result in a loss of potency and inaccurate test results.
It is possible to be depressed or suppressed for as long as 6 weeks after immunization with certain live viral vaccines.
Highly sensitive individuals should be told to report adverse events such as vesiculation, ulceration or necrosis if they occur at the test site.Patients should be aware that there may be some pain and pruritus at the injection site.
Patients should be told that they need to return to their doctor or health care provider if they don't have a personal immunization record.
Re reactivity to the test can be depressed or suppressed in patients who are receiving corticosteroids or immunosuppressive agents.The reduced reactivity may be present for as long as 6 weeks after the cessation of therapy.
Some live virus vaccines may temporarily depressed the reactivity to PPD.If a tuberculin test is to be performed, it should be administered either before the live vaccine or given simultaneously, but at a separate site.
There have been no long term studies done on the effects of Aplisol on fertility.
Aplisol has not been used in animal reproduction studies.It is not known if Aplisol can cause fetal harm or affect the reproduction capacity of a pregnant woman.If clearly needed, aplisol should be given to a pregnant woman.The risk of unrecognized Tuberculosis and the contact between a mother with active disease and an infant leaves the infant in grave danger.If the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, the physician will want to consider it.
Tuberculin sensitivity tends to persist once acquired, although it often fades with time.In geriatric patients or patients receiving a tuberculin skin test for the first time, the reaction may not be maximal until after 72 hours.Some people will have a delayed reaction to a tuberculin test.A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as elderly patients with waned sensitivity.Residents and employees of high risk congregate settings who do not meet any of the criteria listed under an induration of >5mm are classified as positive.
The negative tuberculin skin test should not be used to exclude the possibility of active Tuberculosis among person for whom the diagnosis is being considered.
Neonates and infants 6 weeks of age who are infectious with M. Tuberculosis may not have a delayed hypersensitivity reaction to a tuberculin test.When the tuberculin skin test measures 5mm, infants and children who have been exposed to people with active Tuberculosis should be considered positive.Children younger than 4 years of age who are exposed to people at increased risk of acquiring Tuberculosis are considered positive.Children with minimal exposure to Tuberculosis would be considered positive.There are other criteria for positive tuberculin reactions that are applicable to both children and adults.
Highly sensitive individuals can experience strong positive reactions at the test site.Cold packs or steroid preparations can be used for relief of pain and pruritus.
Local hypersensitivity reactions may occur at the injection site.
Systemic allergic reactions have been reported to occur in association with the use of Aplisol.The reactions, including anaphylaxis, generally occurred within 24 hours of exposure.
You can report flawed adverse reactions by contacting Par Pharmaceutical or the FDA.
If either particulate matter or discoloration is seen, aplisol should be discarded.Vials should be thrown out for more than 30 days.
The standard strength used for Mantoux testing is 5 tuberculin units, which is equivalent to the 0.1 mL dose of Aplisol.
The Mantoux test is done by injecting a small amount of Aplisol on the volar aspect of the forearm.The result is read within 48 to 72 hours.Induration is a raised area with clearly defined margins around the injection site.At the injection site, erythema has no diagnostic value.
If a significant part of the dose leaks from the initial injection site, the test should be repeated at another site at least 5 cm away.
Trained health professionals should be able to read Mantoux reactions from 48 to 72 hours after the injection.In duration should not be taken into account in interpreting the test.The length of induration should be measured from the long axis of the forearm to the millimeters.Erythema has no diagnostic value.Although not used in the interpretation of the test, the presence and size of necrosis and edema should be recorded.In the absence of induration, an area of erythema greater than 10mm in diameter may indicate that the injection was made too deep.The index or middle finger can be used to find the margins of the induration.The edges of induration will stop when the tip of the pen is pushed at a 45 angle.
The diameter of induration should be measured from the long axis of the forearm and recorded in millimeters.
Erythema has no diagnostic value.The absence of induration should not be recorded as negative.
The following high-risk settings include prisons and jails, nursing homes and other long-term facilities for the elderly, hospitals, other health care facilities, and homeless shelters.
Patients with organ transplants and other immunosuppressed patients are given the equivalent of 15mg/d of prednisone for 1 mo or more.
Some hematological disorders, such as leukemias and lymphomas, and carcinoma of the head or neck and lung, are high risk for persons with the following clinical conditions.
Children younger than 4 years of age, infants, children, and adolescents are exposed to adults at high-risk.
There is a negative reaction in people with no risk factors for Tuberculosis.It is highly unlikely that there is a lack of hypersensitivity to tuberculous infections.
For as long as 5 to 6 weeks, reactivity to tuberculin may be depressed or suppressed by viral infections, live virus vaccines, or after the cessation of therapy with steroids or immunosuppressive agents.There is a possibility that Malnutrition may have a similar effect.After normal reactivity to non-specific irritants has been demonstrated, a negative test should be accepted as proof that hypersensitivity is absent.A boosting effect on tuberculin reactions may be possible with a primary injection.Children who have been exposed to a person with Tuberculosis should not be free of the disease until at least ten weeks after contact with the tuberculous person has stopped.
A positive tuberculin reaction does not mean active disease.Before a diagnosis of Tuberculosis is made, further diagnostic procedures should be carried out.A small percentage of responders may not have been exposed to M. Tuberculosis.The negative tuberculin skin test should not be used to exclude the possibility of active Tuberculosis among people who are being considered for a diagnosis.
A delayed hypersensitivity response to tuberculin is demonstrated by the skin test when an individual has tubercle bacilli or other mycobacteria.Over time, the delayed hypersensitivity response may diminish.A significant reaction may not be detected if a person receives a tuberculin test at this time.TheStimulus of the test may boost or increase the reaction to a second test, sometimes causing an apparent conversion or development of sensitivity.One week after the stimulating test, this booster effect can be seen on a second test and can last for a year or more.When routine periodic tuberculin testing of adults is done, initially two-stage testing should be considered to minimize the likelihood of interpreting a boosted reaction as a conversion.
A second tuberculin skin test is required for persons who have a negative initial test.The tests should be read and recorded within 48 to 72 hours.Those who have a positive reaction on the second test should be considered to have been previously exposed, and those who had a negative reaction should not be.A positive result on a skin test should be seen as a conversion.7
Tuberculin PPD-Aplisol bioequivalent to 5 US units can be found in the following presentations.
Vials that have been in use for more than 30 days should be discarded.