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JAPAN FREEZE-DRIED TUBERCULIN

REGISTRATION NUMBER:
T645 (Act 101/1965)
T646 (Act 101/1965)

PROPRIETARY NAME
(and dosage form):

JAPAN FREEZE-DRIED TUBERCULIN
PURIFIED PROTEIN DERIVATIVE

DESCRIPTIVE NAME OF MEDICINE:
TUBERCULIN P.P.D.

PHARMACOLOGICAL CLASSIFICATION:
A. 30.3 Biologicals. Other

SCHEDULING STATUS:
S1

COMPOSITION:
Each set consists of 1 vial and 1 ampoule.
Each vial contains 1 µg of Tuberculin P.P.D. equivalent to 50 Tuberculin Units (50 TU).
Each ampoule contains 2 mL diluent.

IDENTIFICATION:
Vial: Contains white, dried, crystalline powder.
Ampoule: Contains clear, colourless diluent.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
Tuberculin P.P.D. is a white dried product obtained from culture filtrate of Mycobacterium tuberculosis. The active substances are the proteins of tubercle bacilli which cause a specific skin response of the delayed type in individuals infected with tuberculosis.

INDICATIONS:
Intradermal Mantoux test. The skin reactions are characterised by a well-defined easily palpable induration. (This product is sufficient to make a solution for 20 Mantoux tests of 2,5 TU or 10 Mantoux tests of 5 TU.)

Interpretation of the test:
The test is judged 3 days after the injection. The largest diameter of induration is measured in millimetres and fractions of millimetres. For interpretation the revised criteria of the American Thoracic Society are employed.
Classification criteria

No reaction or induration of less than 5 mm	Negative
Induration measures between 5 and 9,9 mm	Doubtful
Induration measures 10 mm or more	Positive

CONTRA-INDICATIONS:
Known hypersensitivity to the test.

DOSAGE AND DIRECTIONS FOR USE:

Skin tests with 2,5 TU:	Reconstitute powder with 2 mL of diluent.
Skin tests with 5 TU:	Reconstitute powder with 1 mL of diluent.

Method of reconstitution

1.	Remove the coloured plastic cap at the top of the vial of Tuberculin P.P.D. and wipe the top of the rubber cap with an alcohol cotton swab.
2.	Wipe the neck with an alcohol swab and break off the tip.
3.	Using a sterile syringe of 1 or 2 mL capacity withdraw 1 or 2 mL of diluent from the ampoule. Insert the needle into the vial through the rubber cap and let the diluent enter the vial gently. As the interior of the vial is under reduced pressure, the diluent will flow by itself into the vial when the needle punctures the rubber cap.
4.	Pull the needle out and shake the vial gently a few times without causing bubbles. The powder will dissolve to give a clear, colourless solution.

Method of injection:
The test is made by intradermal injection of 0,1 mL tuberculin dilution. 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 breadth, which will remain for about 10 minutes.
The most suitable site for the test is the middle third of the flexor side of the lower arm. A 1 mL record syringe should be used for the injection. It is most important that the needle should be sharp and fine and attached firmly to the barrel of the syringe. (26 gauge needle, short type.) Syringes used for tuberculin tests must not be used for other injections.

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.
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 supportive.

PRESENTATION:
Box containing 10 vials and 10 ampoules.

STORAGE INSTRUCTIONS:
Store dry powder between 2 and 8°C.
Reconstituted solution is stable for 2 weeks if stored between 2 and 8°C and protected from light, heat and air.
DO NOT FREEZE.
KEEP OUT OF REACH OF CHILDREN.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 March 1985





Manufactured by:
Japan BCG Laboratory
Koishikawa IS Building
2-6 Kohinata 4-chome, Bunkyo-ku, Tokyo 112 Japan

Distributed in R.S.A. by:
Vaccina CC.
P.O. Box 804 Gardenview, 2047, R.S.A
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