TUBERCULIN PPD RT 23 AJV

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

TUBERCULIN PPD RT 23

Dostopno od:

DKSH SINGAPORE PTE. LTD.

Koda artikla:

V04CF01

Odmerek:

0.4mcg

Farmacevtska oblika:

INJECTION

Sestava:

TUBERCULIN PPD RT 23 0.4 mcg/ml

Pot uporabe:

SUBCUTANEOUS

Tip zastaranja:

Prescription Only

Izdeluje:

AJ Vaccines A/S

Status dovoljenje:

ACTIVE

Datum dovoljenje:

1998-08-19

Lastnosti izdelka

TUBERCULIN PPD RT 23 AJV
FOR MANTOUX TESTING
SOLUTION FOR INJECTION
1
COMPOSITION
ACTIVE INGREDIENT
One single dose of 2 T.U./0.1 mL contains 0.04 microgram of Tuberculin
PPD RT 23.
EXCIPIENTS
Disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium
chloride, potassium
hydroxyquinoline sulphate, polysorbate 80 and water for injections.
2
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Tuberculin PPD RT 23 AJV 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 RT 23 AJV can be used in all age groups.
This medicinal product is for diagnostic use only.
2.2
DOSAGE AND ADMINISTRATION
DOSAGE AND STRENGTH
The dosage is always 0.1 mL regardless of the strength used.
Tuberculin PPD RT 23 AJV is injected intradermally.
The strength 2 T.U./0.1 mL is recommended.
INJECTION TECHNIQUE
•
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 strictly intradermally on the flexor
surface of the forearm at the junction of
the upper third with the lower two
‐
thirds. 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. The tip of the needle is inserted into the superficial layer
of the dermis.
•
The needle should be visible through the epidermis during insertion.
The 0.1 mL is slowly injected and a
small blanched papule of 8–10 mm in diameter appears. This papule
will disappear after approximately
10 minutes.
•
If no papule appears, the injection has been given too deep, and the
skin test should be repeated on the
other arm or on the same arm, at least 4 cm away from the first
injection site.
Nat