Tuberculin PPD RT23 AJV 2 T.U./0.1 mL, solution for injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tuberculin ppd

Tersedia dari:

AJ Vaccines A/S

Kode ATC:

V04CF; V04CF01

INN (Nama Internasional):

Tuberculin ppd

Dosis:

2 T.U. /0.1 ml

Bentuk farmasi:

Solution for injection

Jenis Resep:

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

Area terapi:

Tuberculosis diagnostics; tuberculin

Status otorisasi:

Marketed

Tanggal Otorisasi:

1997-04-23

Selebaran informasi

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TUBERCULIN PPD RT23 AJV 2 T.U./0.1 ML
SOLUTION FOR INJECTION
Tuberculin PPD RT 23
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE SKIN TESTED BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU .

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tuberculin PPD RT23 AJV is and what it is used for
2.
What you need to know before you are skin tested
3.
How you are skin tested
4.
Possible side effects
5.
How to store Tuberculin PPD RT23 AJV
6.
Contents of the pack and other information
1.
WHAT TUBERCULIN PPD RT23 AJV IS AND WHAT IT IS USED FOR
Tuberculin PPD RT23 AJV is used as a skin test to diagnose if you have
ever been infected with a
bacteria causing tuberculosis.
This medicine is for diagnostic use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE SKIN TESTED
YOU SHOULD NOT BE TESTED:

if you are allergic to Tuberculin PPD RT 23 or any of the other
ingredients of Tuberculin PPD
RT23 AJV (listed in section 6).

if you have experienced a severe local reaction to tuberculin
products. A severe local reaction
may include blistering and ulceration at the injection site and skin
necrosis at the centre
widespread tuberculin reaction. The necrosis will generally disappear
after a few days.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before being tested with
Tuberculin PPD RT23 AJV.
Inform your doctor:

if you have had a tuberculin skin test within the last year.

if you have been vaccinated within the last 4–6 weeks against
tuberculosis or any other disease.
OTHER MEDICINES AND TUBERCULIN PPD RT23 AJV
Tell your doctor or pharmaci

Karakteristik produk

Health Products Regulatory Authority
10 January 2022
CRN00CPK8
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tuberculin PPD RT23 AJV 2 T.U./0.1 mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tuberculin PPD RT 23.
One single dose of 2 T.U./0.1 mL contains 0.04 micrograms of
Tuberculin PPD RT 23.
Excipients with known effect
Disodium phosphate dehydrate
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.
Clear, colourless to pale-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tuberculin PPD RT23 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 RT23 AJV 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 0.1 mL.
Tuberculin PPD RT23 AJV is injected intradermally.
Method of administration
In the following a detailed description of administration of
Tuberculin PPD RT23 AJV 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.

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