Tuberculin PPD RT23 SSI

Tuberculin PPD RT23 SSI

tuberculin purified protein derivative

Manufacturer:

SSI

Marketer:

Biofarma
Full Prescribing Info
Contents
Purified protein derivative (PPD) of Mycobacterium tuberculosis
Description
Each mL of Tuberculin PPD RT23 2 TU contains Mycobacterium tuberculosis 0.4 mcg, disodium phosphate dihydrate 7.6 mg, potassium dihydrogen phosphate 1.45 mg, sodium chloride 4.8 mg, potassium dihydroxyquinoline sulphate 100 mcg, polysorbate 80 50 mcg, water for injection 1 mL.
Action
Tuberculin PPD RT23 2 TU is a purified protein derivative prepared from a culture of selected strains of the Mycobacterium tuberculosis.
Indications/Uses
For Mantoux tuberculin testing to help diagnose if a person has ever been infected with Mycobacterium tuberculosis.
Dosage/Direction for Use
A dose of 0.1 mL of PPD RT23 is injected intracutaneously in the middle-third of the forearm, since a weak reaction near the wrist of elbow. A 1 mL graduated syringe with a short-beveled 25–26 gauge (0.5 x 10 mm) is recommended for administration of the skin test. As the liquid is injected, a small round wheal or papule of 8-10 mm in diameter should be formed, remaining for about 10 minutes.
Reading: During 48–72 hours after injection, an induration, possibly surrounded by area of redness, can be expected in positive reactors. Measure only the induration (skin reaction) about 3 days after the application. The skin reaction can be palpated as flat, uneven, slightly raised induration which should be measured with a clear, flexible, plastic ruler.
A positive reaction to Tuberculin PPD RT23 is defined as an induration having a diameter of 6 mm or more.
Contraindications
Known hypersensitivity to purified protein derivative (PPD) tuberculin.
Side Effects
A transient burning sensation may be experienced immediately after injection, and pain, irritation or discomfort may rarely occur. In individuals who are extremely sensitive to tuberculin, vesicles, bullae, or ulceration may appear at the injection site, and fever or lymph node swelling has been reported.
Drug Interactions
Vaccination with live attenuated viral vaccine or viral infections such as measles, HIV, or influenza can lower tuberculin reaction for a while. Other diseases, including cancer and sarcoidosis, may decrease sensitivity to tuberculin. Someone who is malnourished and on immunosuppresive treatment may indicate a low reaction to Tuberculin PP RT23 than expected.
Person with active tuberculosis may indicate a reaction of less than 6 mm when the immune system has decreased dramatically due to tuberculosis infection.
One can show a positive Mantoux test results, although not/never been infected with tuberculosis. This can be caused by previous vaccination or prior infection with non-tuberculosis mycobacterium from an environment that does not cause particular disease.
Caution For Usage
Instructions for Use, Handling & Disposal: It is recommended that vials to be discarded 24 hours after the first dose has been removed.
Storage
Preparation of Tuberculin PPD RT23 must be stored at temperatures between +2°C and +8°C protected from light. Expiration date indicated on the label should not be exceeded.
ATC Classification
V04CF01 - tuberculin ; Belongs to the class of diagnostic agents used to test for tuberculosis.
Presentation/Packing
Inj (vial) 2 tuberculin unit (TU) x 1.5 mL x 5's.
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