TUBERCULIN PPD RT 10 T.U. /0.1 ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TUBERCULIN PPD

Available from:

AJ Vaccines A/S

ATC code:

V04CF01

INN (International Name):

TUBERCULIN PPD

Dosage:

10 T.U. /0.1 ml

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Tuberculosis diagnostics

Authorization status:

Authorised

Authorization date:

2017-01-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tuberculin PPD RT23 "SSI" 10 T.U./0.1 mL, solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tuberculin PPD RT 23.
One single dose of 10 T.U./0.1 mL contains 0.2 micrograms of
Tuberculin PPD RT 23.
EXCIPIENTS
Disodium phosphate dihydrate
0.76 mg
Potassium dihydrogen phosphate
0.145 mg
Sodium chloride
0.48 mg
Potassium hydroxyquinoline sulphate
10 µg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to pale-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tuberculin PPD RT23 "SSI" is used for Mantoux tuberculin skin testing
to diagnose if an individual has ever been
infected with_ Mycobacterium tuberculosis_. Some countries also
recommend Mantoux tuberculin skin testing in
conjunction with BCG vaccination, either to ensure that only
tuberculin-negative individuals are vaccinated or as a
post-vaccination test. Tuberculin PPD RT23 "SSI" is indicated for all
age groups.
This medicinal product is for diagnostic use only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage is always 0.1 mL regardless of the strength used.
Tuberculin PPD RT23 "SSI" is injected intradermally.
The strength 2 T.U./0.1 mL is recommended.
If low tuberculin reactivity is expected 10 T.U./0.1 mL may be used.
METHOD OF ADMINISTRATION
In the following a detailed description of administration of
Tuberculin PPD RT23 "SSI" is given:
0.1 mL is administered with a 1 mL graduated syringe fitted with a
short bevel needle (gauge 25 or 26).
The injection must be given intradermally in the middle third of the
forearm. Administration near the wrist or the
elbow joint may weaken the reaction.
The skin is slightly stretched, and the needle is held almost parallel
with the skin surface with the bevel upwards.
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