2 TU/0.1 ml or 10 TU/0.1 ml Solution for injection
Tuberculin purified protein derivative (PPD) RT 23
What Tuberculin PPD RT 23 AJVaccines is and what it is used for
Tuberculin PPD RT 23 AJVaccines is used as a skin test to diagnose whether you have been infected with bacteria that cause tuberculosis.
What you need to know before you use Tuberculin PPD RT 23 AJVaccines
Do not use Tuberculin PPD RT 23 AJVaccines
• If you are allergic to tuberculin purified protein derivative (PPD) RT 23 or any other ingredient in Tuberculin PPD RT 23 AJVaccines (listed in section 6).
• If you have previously had serious local reactions to tuberculin products, such as blisters or ulceration at the injection site.
Warnings and precautions
Talk to your doctor before using Tuberculin PPD RT 23 AJVaccines:
• If you have had a tuberculin test in the past year.
• If you have been vaccinated in the last 4-6 weeks against tuberculosis or other diseases.
Other drugs and Tuberculin PPD RT 23 AJVaccines
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
False negative test results can occur if you:
- Suffering from diabetes, kidney failure, cancer, HIV infection, or sarcoidosis ( inflammatory disease that can affect many organs, including lungs, lymph nodes, or skin).
- Have reduced immune system due to drug treatment, e.g. if you use corticosteroids.
- Had certain viral diseases, e.g. measles, mumps, glandular fever, chicken pox, and influenza, in recent months.
- Vaccinated with certain live vaccines against viral diseases.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Tuberculin PPD RT 23 AJVaccines.
This skin test can be taken during pregnancy and breastfeeding.
Driving ability and use of machinery
No effects on the ability to drive or use machines have been observed.
Tuberculin PPD RT 23 AJVaccines contains sodium and potassium
This medicine contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose and can be considered potassium- and sodium-free.
How to use Tuberculin PPD RT 23 AJVaccines
The doctor or nurse administers Tuberculin PPD RT 23 AJVaccines into the top layer of skin on your forearm.
The recommended dose is 0.1 ml for both children and adults.
After injection, a blister of 8-10 mm in diameter is formed, which disappears after about 10 minutes. Redness and swelling may also occur at the injection site. After 48-72 hours, your doctor or nurse examines the results of the skin test. If swelling has occurred, it should go down after the examination.
Possible side effects
Like all medicines, Tuberculin PPD RT 23 AJVaccines can cause side effects, although not everybody gets them.
Serious allergic reactions (anaphylactic shock ) such as swelling of the lips, face, and throat, breathing problems, or hives may occur in very rare cases (fewer than 1 in 10,000 people). Contact your doctor immediately if you experience these reactions.
Other side effects:
Common side effects ( affects less than 1 in 10 people):
Pain, itching, and irritation at the injection site.
Uncommon side effects ( affects less than 1 in 100 people):
Fever and swollen lymph nodes.
Rare side effects ( affects less than 1 in 1,000 people):
Superficial tissue death (skin necrosis) usually disappears after a couple of days, and blistering.
Has been reported (occurring in an unknown number of users):
Ulceration at the injection site, headache, and hives ( urticaria ).
How to store Tuberculin PPD RT 23 AJVaccines
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the packaging. The expiration date (Utg.dat) is the last day of the specified month.
- Store in a refrigerator (2ºC-8ºC).
- Store in the original packaging. Light sensitive.
- Tuberculin PPD RT 23 AJVaccines should be used immediately after opening. If Tuberculin PPD RT 23 AJVaccines are not used immediately, in-use storage times and conditions are the responsibility of the user, normally no longer than 24 hours at 2ºC-8ºC.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Tuberculin PPD RT 23 AJVaccines does not contain live material.
Contents of the packaging and other information
Contents declaration
- The active substance is tuberculin purified protein derivative (PPD) RT 23.1 dose (0.1 ml) Tuberculin PPD RT 23 AJVaccines 2 TU contains 0.04 micrograms tuberculin purified protein derivative (PPD) RT 23.1 dose (0.1 ml) of Tuberculin PPD RT 23 AJVaccines 10 TU contains 0.2 micrograms of tuberculin purified protein derivative (PPD) RT 23.
- Other ingredients are disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium chloride, potassium hydroxyquinoline sulfate, polysorbate 80, and water for injections.
Appearance and package sizes of the medicine
Tuberculin PPD RT 23 AJVaccines is a solution for injection ( solution for injection ).
It is a clear, colorless slightly yellowish solution.
Tuberculin PPD RT 23 AJVaccines are sold in two strengths: 2 TU and 10 TU
Pack sizes: vials containing 1.5 ml or 5 ml in pack sizes of 1 or 10.
Not all pack sizes may be marketed.
AJ Vaccines A/S
Artillerivej 5
DK-2300 Copenhagen S
Denmark
Phone: +45 7229 7000
Fax: +45 7229 7999
Email: ajvaccines@ajvaccines.com
Further information about this medicinal product can be obtained from the representative of the holder of the authorization for the product.