INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TUBERCULIN PPD RT/23 2TU
TUBERCULIN PPD RT/23 5TU

REGISTRATION NUMBER:
2 TU. 28/30.3/0356
5 TU. 28/30.3/0360

PROPRIETARY NAME
(and dosage form):

TUBERCULIN PPD RT/23 2TU
TUBERCULIN PPD RT/23 5TU

DESCRIPTIVE NAME OF MEDICINE:
Tuberculin Purified Protein Derivative (PPD) for intradermal (Mantoux) test.

PHARMACOLOGICAL CLASSIFICATION:
A.30.1 Biological antigen.

SCHEDULING STATUS:
S2.

COMPOSITION:
Sterile solutions in concentrations of either 2 TU or 5 TU PPD, wholly prepared from a master seed lot of Mycobacteriumtuberculosis. The tuberculin dilutions are prepared with phosphate buffered saline containing 0,01% chinosol (potassium hydroxyquinoline sulphate) as preservative and 0,005% Tween 80 (polysorbatum 80) as stabiliser. The antigen fulfills the World Health Organization requirements for PPD.

IDENTIFICATION:
Colourless solution in 1,5 mL or 5 mL clear vials sealed with a rubber stopper and flip-off aluminium overseal.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
The active substances are the proteins of tubercle bacilli which cause induration as a specific skin response of the delayed type at the site of injection in individuals infected with tuberculosis. Induration may be palpable as early as 5 hours after injection, but normally reaches a peak only after 48 to 72 hours. The reaction subsides over the course of several days.

INDICATIONS:
The intradermal (Mantoux) skin test employing PPD RT/23 is used as an aid in the diagnosis of tuberculosis infection. Reactivity to the test may be depressed or suppressed if the individual is suffering from advanced tuberculosis disease, acute viral infection (including immunisation with live viral vaccine during past 14 days), or overwhelming bacterial infection. Patients receiving corticosteroids or other immunosuppressive agents, or who are suffering from malignant conditions, may also react poorly to the tuberculin test.

CONTRA-INDICATIONS:
Known hypersensitivity to the test, such as may occur in individuals who are known tuberculin reactors and who have been repeatedly tested with tuberculin, or in persons who have previously suffered from tuberculosis.

DOSAGE AND DIRECTIONS FOR USE:
Dosage:
For diagnostic purposes, the test is performed at a dosage of 5 TU. Where clinical tuberculosis is suspected, or where testing for an immune response following vaccination is the objective, the test may be performed with 2 TU in order to limit outspoken local reaction. Where used for epidemiological purposes, such as to define the tuberculin test response profile in a cross-section of the population, 2 TU is used.

Method of injection:
The test is made by intradermal injection of exactly 0,1 mL of the tuberculin solution. It is essential that the injection be given in the upper layer of the skin, since a possible positive reaction will be difficult to interpret if the tuberculin is injected too deeply. A suitable injection will result in the formation of a white papule about 10 mm in diameter, which will remain visible for approximately 10 minutes. The most suitable site for the test is the middle third of the flexor side of the lower arm. A disposable 1,0 mL graded tuberculin syringe fitted with a 26 gauge short barrel needle should be used for the injection. Syringes used for tuberculin tests must not be used more than once.

Interpretation of the test:
The test is judged 48 to 72 hours after injection. The transverse diameter of the induration is measured in millimetres, excluding any surrounding erythematous zone. To interpret the test result, the following criteria, based on the diameter of the induration, apply:

Less than 5 mm Negative
5 mm and 9,9 mm Doubtful
10 mm and 14,9 mm Positive
15 mm or more Strongly positive
In children where a BCG vaccination was administered within two years prior to the tuberculin test, or in adults, reactions measuring 15 mm or more (strongly positive) represent infection with tubercle bacilli and warrant further investigation for possibly active tuberculosis. In young children (less than 5 years old) without a recent history of BCG vaccination, or where recent contact with a known case of tuberculosis has been demonstrated, reactions measuring 10 mm or more are indicative of infection with tubercle bacilli, and should be further investigated.

Doubtful reactions are only noted and the patient requested to present for re-investigation 6 months later.

In patients infected with HIV, tuberculin reactions measuring 5 mm or more are taken as positive indication of co-infection with M. tuberculosis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pain and pruritus may occur at the injection site, with vesiculation, ulceration, or necrosis in highly sensitive persons. If given to patients with tuberculosis, a severe reaction may occur. Discomfort at the test site may be relieved by cold packs or topical glucocorticoid ointment or cream. Transient bleeding may occur at the site of injection, but is of no significance.

Adrenaline should be immediately available in the event of an anaphylactic or an acute hypersensitivity reaction occurring.

An immediate, local inflammatory type reaction may occur due to the constituents of the diluent.

Allergic reactions to tuberculin tests have been reported. Less frequently, swelling of the lymph nodes may occur.

Patients should not rub or massage the injection site.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See 'Side-effects and special precautions'. Treatment is symptomatic and palliative.

PRESENTATION:
Vials of 1,5 mL or 5,0 mL containing 2 TU per 0,1 mL packed either singly or in boxes of 10 vials (LABEL PROMINENTLY DISPLAYS '2');

Vials of 1,5 mL containing 5 TU per 0,1 mL packed in boxes of 10 vials (LABEL PROMINENTLY DISPLAYS '5').

STORAGE AND DIRECTIONS:
PPD RT/23 should be stored away from light, and at a temperature between 2°C and 8°C. DO NOT FREEZE.

Once a vial of PPD RT/23 tuberculin has been opened, its contents should be used within 8 hours. Any remaining liquid should be discarded.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Vaccina CC
PO Box 804
Gardenview, 2047, R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 29, 1993

Statens Seruminstitut

Artillerivej 5 . 2300 Copenhagen S . Denmark
12-479-01 00000-0294

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