Tuberculin Ppd Rt23 Aiv

Leaflet attached to the packaging: patient information

Tuberculin PPD RT 23 AJV, 2 T.U./0.1 ml, solution for injection
Tuberculin used in humans, purified protein derivatives

Please read carefully the contents of the leaflet before undergoing the skin test, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse, even if your symptoms are the same
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tuberculin PPD RT 23 AJV and what is it used for
• 2. Important information before undergoing the skin test
• 3. How the skin test is performed
• 4. Possible side effects
• 5. How to store Tuberculin PPD RT 23 AJV
• 6. Contents of the packaging and other information

1. What is Tuberculin PPD RT 23 AJV and what is it used for

Tuberculin PPD RT 23 AJV is a diagnostic agent containing purified protein derivatives obtained from tuberculosis bacteria cultures, used for performing a skin test:

• for the diagnosis of tuberculosis infection
• to qualify for BCG (anti-tuberculosis) vaccination only for people with a negative tuberculin test result or as a test after vaccination.

Tuberculin PPD RT 23 AJV is intended for people of all age groups.

2. Important information before undergoing the skin test

When not to perform the test:

• if the patient is allergic to tuberculin or any of the other components of this medicine (listed in section 6).
• if the patient has had severe reactions at the site of administration of tuberculin products in the past. Severe skin reaction may manifest as blisters and ulcers at the injection site, as well as skin necrosis in the center of a extensive tuberculin reaction. Usually, necrosis resolves after a few days.

Warnings and precautions

Before undergoing the skin test with Tuberculin PPD RT 23 AJV, you should discuss it with your doctor, pharmacist, or nurse.
You should inform your doctor if you:

• have ever had tuberculosis
• have been vaccinated against tuberculosis
• have recently had a non-tuberculous mycobacterial infection
• have been vaccinated against a viral disease (e.g., measles, mumps, rubella) in the last 4-6 weeks.
• have a viral infection (e.g., measles, mumps, mononucleosis, chickenpox, flu)
• have kidney failure
• have diabetes
• have cancer
• are HIV-infected
• have sarcoidosis
• are taking immunosuppressive drugs (e.g., corticosteroids)

After administering tuberculin, severe allergic reactions have been observed - see section 4.
When possible, individuals undergoing the skin test should be observed for allergic reactions for 20 minutes after administration.

Tuberculin PPD RT 23 AJV and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
See "Warnings and precautions"
Tuberculin PPD RT 23 AJV can be safely used with all live inactivated vaccines.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before undergoing the skin test.
The skin test can be performed during pregnancy and breastfeeding.

Driving and using machines

Tuberculin PPD RT 23 AJV has no or negligible influence on the ability to drive and use machines.

Tuberculin PPD RT 23 AJV contains potassium and sodium

The medicine contains less than 1 mmol (39 mg) of potassium and less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "potassium-free and sodium-free".

3. How the skin test is performed

The doctor or nurse will inject Tuberculin PPD RT 23 AJV into the upper layer of skin on the forearm.
The recommended dose is always 0.1 ml for both children and adults.
After injection, a swelling should appear with a diameter of 8-10 mm, lasting for about 10 minutes.
After 48-72 hours, the result of the skin test will be evaluated by the doctor or nurse. An uneven, slightly raised induration surrounded by redness may appear, which should decrease after 72 hours.
If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects
Very rare side effects:may occur in less than 1 in 10,000 people

• severe allergic reactions (anaphylaxis) such as swelling of the mouth, face, and throat, and difficulty breathing. If any of these reactions occur, you should contact your doctor immediately.

Other side effects:
Common side effects:may occur in less than 1 in 10 people

• pain, itching, or irritation at the injection site.

Uncommon side effects:may occur in less than 1 in 100 people

• fever.
• enlargement of lymph nodes.

Rare side effects:may occur in less than 1 in 1,000 people

• superficial skin necrosis (skin necrosis), which usually resolves after a few days.
• blisters.

Frequency not known:cannot be estimated from the available data

• ulceration at the injection site.
• headache.
• urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tuberculin PPD RT 23 AJV

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C – 8°C).
Store in the original packaging to protect from light.
For microbiological reasons, Tuberculin PPD RT 23 AJV should be used immediately after opening.
If it is not used immediately after opening, the user is responsible for the storage time and conditions. Usually, the storage time should not exceed 24 hours at 2°C – 8°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Tuberculin PPD RT 23 AJV does not contain any living material.

6. Contents of the packaging and other information

What Tuberculin PPD RT 23 AJV contains

• The active substance is: Tuberculin PPD RT 23.

1 dose (0.1 ml) of Tuberculin PPD RT 23 AJV 2 T.U. contains:
0.04 micrograms of tuberculin PPD RT 23.

• The other ingredients are: disodium phosphate dihydrate, sodium chloride, potassium dihydrogen phosphate, potassium hydroxyquinoline sulfate, polysorbate 80, water for injections.

What Tuberculin PPD RT 23 AJV looks like and contents of the pack

Tuberculin PPD RT 23 AJV is a solution for injection.
It is a clear, colorless to light yellow solution.
Pack sizes: 1 or 10 vials of 1.5 ml solution (15 doses), in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AJ Vaccines A/S
5, Artillerivej
DK-2300 Copenhagen S
Denmark
phone: +45 7229 7000
email: [email protected]
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
AJ Vaccines A/S
Branch in Poland
ul. Grójecka 22/24 m.53
02-021 Warsaw
phone: +48 22 668 86 73

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Special warnings and precautions for use

Anaphylactic reactions occur very rarely. However, during the Mantoux tuberculin test, means to treat them should always be available. When possible, individuals undergoing the skin test should be observed for allergic reactions for 20 minutes after administration.
You should avoid subcutaneous and intramuscular administration of Tuberculin PPD RT 23 AJV, as this will not produce a swelling and the Mantoux test should be repeated on the other arm or on the same arm, at a distance of at least 4 cm from the site of the first injection.
The medicinal product contains less than 1 mmol (39 mg) of potassium and less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "potassium-free and sodium-free".
Identifiability
To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Interactions with other medicines and other types of interactions

Various factors, such as age, malnutrition, kidney failure, diabetes, immunosuppression caused by medicinal products (e.g., corticosteroids) or diseases, such as cancer, HIV infection, or sarcoidosis, may cause false-negative results of the tuberculin test. Viral infections (such as measles, mumps, mononucleosis, chickenpox, flu, etc.) may decrease reactivity to tuberculin for several months.
A decrease in reactivity may be observed after administration of live virus vaccines, such as measles, mumps, and rubella vaccines. The consequence of decreased reactivity may be a false-negative result. Therefore, if the Mantoux test cannot be performed at the same time as vaccination against measles, mumps, and rubella, the test should be postponed for 4-6 weeks.
Tuberculin PPD RT 23 AJV can be safely used with all live inactivated vaccines.
Many patients co-infected with HIV and Mycobacterium tuberculosis have anergy to tuberculin. In patients with severe tuberculosis (e.g., miliary tuberculosis), reactivity to tuberculin may be weakened.
Previous BCG vaccination or recent infection with non-tuberculous environmental mycobacteria may cause cross-sensitization and a false-positive test result.

Dosage and administration

Dosage
The dose is 0.1 ml of solution.
Tuberculin PPD RT 23 AJV is administered intradermally.
Administration
Below is a detailed description of the use of Tuberculin PPD RT 23 AJV:

• 0.1 ml of solution is injected using a 1 ml syringe with a calibration and a short, beveled needle (25 Ga or 26 Ga).
• The injection must be performed precisely intradermally in the middle third of the forearm, as the reaction may be weaker if administered closer to the elbow or wrist joint.
• The skin should be slightly stretched, and the tip of the needle should be almost parallel to the skin surface, with the bevel facing upwards. The tip of the needle is inserted into the superficial layer of the dermis.
• The needle should be visible through the skin during insertion. The solution should be injected slowly. After injection, a small, pale swelling should appear with a diameter of 8-10 mm, lasting for about 10 minutes.
• If the swelling does not appear, it means that the injection was performed too deeply, and the tuberculin test should be repeated on the other arm or on the same arm, at a distance of at least 4 cm from the site of the first injection (see section 4.4).

National recommendations for performing the Mantoux test may be taken into account.
Evaluation of the reaction
A positive reaction to Tuberculin PPD RT 23 AJV is considered to be a flat, uneven, slightly raised induration with a diameter of at least 6 mm, surrounded by redness. The reaction should be evaluated 48-72 hours after the test. After about 72 hours, the induration should decrease. During the evaluation of the reaction, only the induration (thickening) should be considered. The diameter of the induration (thickening) is measured transversely to the long axis of the forearm using a transparent, flexible, plastic ruler and is expressed in millimeters. The recommendations for the interpretation of the Mantoux test are contained in Table 1.

Table 1: Interpretation of skin test results

Alternative interpretations may be used, depending on national recommendations, individual factors, and epidemiological factors.
Interpretation
A positive reaction indicates an immune response to one or more of the following factors:

• infection with the Mycobacterium tuberculosis complex, including M. tuberculosis, M. bovis, M. africanum,
• M. microti or M. tuberculosis subsp. caprae,
• infection with non-tuberculous mycobacteria,
• BCG vaccination (in individuals vaccinated with BCG, a positive result usually appears after 4-8 weeks).

It is unlikely that reactions greater than 15 mm are caused by previous BCG vaccination or exposure to environmental mycobacteria.
Decreased sensitivity to tuberculin
In most people, sensitivity to tuberculin, indicating infection with Mycobacterium tuberculosis or related mycobacteria, usually persists for life, but in some individuals, it may gradually decrease.
Sensitivity to tuberculin often decreases within a few years in individuals vaccinated with BCG.
Boosting effect
If tuberculin is administered to individuals whose sensitivity to tuberculin has decreased, the reaction to the skin test will be weak or absent. Repeating the tuberculin test a few weeks or months later may produce a more intense response, i.e., a boosting effect.
Repeating the tuberculin test will not produce a positive reaction in individuals who have not previously had cell-mediated immunity to Tuberculin PPD antigens.
Repeat tuberculin test
If a repeat tuberculin test is necessary, e.g., in healthcare workers exposed to tuberculosis, a two-step method is recommended. In individuals who have had a weak or absent reaction to the Mantoux test, a second tuberculin test should be performed within 2-4 weeks of the first test.
Conversion of the skin test in such individuals is defined as a reaction to the second test greater than 10 mm and an increase of at least 6 mm compared to the reaction in the first test.
It should be considered that individuals who have had a conversion of the skin test after the second test have previously been infected with mycobacteria or have been vaccinated with BCG. If the result of the second test is negative, it should be considered that the individual has not been infected.
It should be emphasized that the predictive value of the skin test and the expected risk of tuberculosis should be assessed individually.